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## Dismantling the U.S. Social Norm of the "Kids' Food" Archetype (REACH Project) - NCT ID: NCT06266533 - Study ID: Pro2023002473 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2024-07-01 - Lead Sponsor: Rutgers, The State University of New Jersey ### Study Description This project is the first stage of a health promotion campaign to shift social norms about marketing and feeding children ultra-processed foods. Embedded within a longitudinal ethnographic study using photo-elicitation techniques, mothers of preschool-age children will be randomly assigned to arts-based or traditional education about ultra-processed food. ### Conditions - Food Selection - Environmental Exposure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Conventional Ultra-processed Food Nutrition Education - Arts-based Ultra-processed Food Nutrition Education ### Outcomes Primary Outcomes - Ultra-Processed Food Knowledge - Environmental assessment of ultra-processed food Secondary Outcomes ### Location - Facility: Leaguers Inc. Head Start, Newark, New Jersey, 07102, United States @@
## MNK Therapy in Releasing the Superficial Fascia for Patients With AAS: an Assessor-blinded, Randomised Controlled Trial - NCT ID: NCT06266520 - Study ID: DongyangH - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-06-01 - Lead Sponsor: Sen-wei Lu ### Study Description The goal of this type of randomized controlled trial, employing a blinded evaluator methodology, to verify the clinical efficacy and safety of MNK therapy. This aims to provide a reference for clinical practitioners and AAS patients in their decision-making process.Participants will randomly allocated into two groups using a random number table method, with forty patients in each group. The experimental group (Group 1) underwent MNK therapy to release the superficial fascia, while the control group (Group 2) received conventional acupuncture treatment. ### Conditions - Acute Ankle Sprain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MNK therapy to release the superficial fascia - acupuncture ### Outcomes Primary Outcomes - Visual Analogue Scale (VAS) - Kofoed Ankle Score Secondary Outcomes ### Location - Facility: The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China, Dongyang, Zhejiang, 322100, China @@
## Examining the Effect of Occupational Therapy-Based Parent Coaching on Feeding Problems in Children With a Preterm Birth - NCT ID: NCT06266507 - Study ID: 169 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-03-15 - Lead Sponsor: Ankara Medipol University ### Study Description Feeding problems are common in children with a history of premature birth, and these problems continue into early childhood. Feeding problems are affected by many biopsychosocial factors, and the context in which feeding takes place and the attitudes and behaviors of parents can also be effective in the emergence or continuation of these problems. The aim of our study is to evaluate the effects of occupational therapy-based parent coaching intervention on mothers and their children, who are considered to be primarily responsible for the feeding of children in our country. 46 mothers with premature children will be included in our study and participants will be randomly assigned to intervention/control groups. Mothers will fill out a sociodemographic information form, Behavioral Pediatric Feeding Assessment Scale, Sensory Profile Questionnaire - Oral Sensory Processing Subtest, Family Feeding Strategies Scale and Parental Self-Efficacy Scale via Google forms. Mothers in the research group will be given online occupational therapy-based parent coaching training for 10 weeks. Second evaluations will be carried out after the training; Final evaluations will be applied after 1 month of follow-up. ### Conditions - Feeding Behavior - Mother-Child Relations - Feeding and Eating Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Ergotherapy Based Parent Coaching - Informative Brochure Distribution ### Outcomes Primary Outcomes - Behavioral Pediatric Feeding Assessment Scale - Sensory Profile Questionnaire - Oral Sensory Processing Test Secondary Outcomes - Feeding Strategies Quesstionnaire - Parental Self-Efficacy Scale ### Location - Facility: Ankara Medipol University, Ankara, Ankara/ Altındağ, 06110, Turkey @@
## Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis - NCT ID: NCT06266494 - Study ID: 23-1349 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-08 - Lead Sponsor: University of Colorado, Denver ### Study Description This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems. ### Conditions - Frostbite ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Long-Acting silver dressings - Aloe Vera - Dalbavancin ### Outcomes Primary Outcomes - The number of positive microbial wound cultures on admission - The number of positive microbial wound cultures on hospital day 4 - The number of positive microbial wound cultures on hospital day 8 - The number of positive microbial wound cultures on hospital day 12 - The number of positive microbial wound cultures on hospital day 16 - The number of positive microbial wound cultures on hospital day 20 - The number of positive microbial wound cultures on hospital day 24 - The number of positive microbial wound cultures on hospital day 28 - The number of positive microbial wound cultures on hospital day 32 - The number of positive microbial wound cultures on hospital day 36 - The number of positive microbial wound cultures on hospital day 40 - The number of positive microbial wound cultures on hospital day 44 - The number of positive microbial wound cultures on hospital day 48 - The number of positive microbial wound cultures on hospital day 52 - The number of positive microbial wound cultures on hospital day 56 - The number of positive microbial wound cultures on hospital day 60 - Number of gram positive cultures at admission - Number of gram positive cultures on hospital day 4 - Number of gram positive cultures on hospital day 8 - Number of gram positive cultures on hospital day 12 - Number of gram positive cultures on hospital day 16 - Number of gram positive cultures on hospital day 20 - Number of gram positive cultures on hospital day 24 - Number of gram positive cultures on hospital day 28 - Number of gram positive cultures on hospital day 32 - Number of gram positive cultures on hospital day 36 - Number of gram positive cultures on hospital day 40 - Number of gram positive cultures on hospital day 44 - Number of gram positive cultures on hospital day 48 - Number of gram positive cultures on hospital day 52 - Number of gram positive cultures on hospital day 56 - Number of gram positive cultures on hospital day 60 - Change in serum concentration of dalbavancin in plasma (mcg/ml) over time - Dalbavancin concentrations in subcutaneous tissue - Change in presence of Augmented Renal Clearance Secondary Outcomes ### Location - Facility: University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, 80045, United States @@
## Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce POST in Shoulder Arthroscopic Surgeries: A Comparative Study - NCT ID: NCT06266481 - Study ID: pua04202312313157 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-30 - Lead Sponsor: Pharos University in Alexandria ### Study Description postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted. ### Conditions - Postoperative Sore Throat ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Topical dexamethasone - 10% lidocaine was sprayed over the tube for the second group ### Outcomes Primary Outcomes - Topical dexamethasone versus topical lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study Secondary Outcomes ### Location - Facility: Pharos University, Alexandria, N/A, 21348, Egypt @@
## Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children - NCT ID: NCT06266468 - Study ID: STUDY00149178 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-21 - Completion Date: 2025-12-31 - Lead Sponsor: University of Kansas Medical Center ### Study Description The overall objective of this application is to pilot test an mHealth nutrition intervention within pediatric clinics serving Latino families and evaluate its potential for implementation. The investigators hypothesize the intervention will improve child diet quality and will be feasible for use within the clinic setting. To test this hypothesis, the investigators will pursue 3 specific aims and 1 exploratory aim:1. Aim 1: Pilot Nutricity with 40 Latino families (English or Spanish speaking) vs. 40 waitlist control in primary care clinics and estimate differences in child diet quality at 3 month's post Nutricity exposure. Preliminary data will inform power calculations for a future larger Nutricity intervention.2. Aim 2: Evaluate other individual (dyad) level factors including reach, engagement, and changes in secondary effectiveness outcomes (e.g. nutrition literacy, BMI, skin carotenoid, psychosocial constructs) at 3 months post exposure.3. Aim 3: Evaluate organizational-level factors (adoption, implementation, and organizational-level maintenance) in Latino-serving pediatric clinics that may support or inhibit future uptake of Nutricity. The investigators will seek to understand the context of interventions and scalability to other clinics using mixed methods.4. Exploratory Aim 1: Explore the relationship among nutrition literacy, psychosocial constructs and diet quality outcomes; and explore how engagement and satisfaction influence outcomes. ### Conditions - Diet Quality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Nutricity ### Outcomes Primary Outcomes - Change in Diet quality (Healthy Eating Index) (child) Secondary Outcomes - Nutrition Literacy (parent) - Body Mass Index (child) - Skin Carotenoid - Feeding Behaviors of Parent and Children - Mediation of Children's Media Use - Parent Self-Efficacy - Parent Nutrition Attitudes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment - NCT ID: NCT06266455 - Study ID: Pro00000615 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2034-01 - Lead Sponsor: Children's National Research Institute ### Study Description Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment.Recent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques.Through this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. Brain qMRI will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age. ### Conditions - Very Preterm Maturity of Infant - Very Low Birth Weight Infant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Standardized Fortification - Adjustable Fortification - Adjustable Fortification ### Outcomes Primary Outcomes - Weight Gain Velocity - Length Growth Velocity - Head Circumference Growth Velocity - Total and Regional Brain Volumes - Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) - Mullen Scales of Early Learning (MSEL) - Mullen Scales of Early Learning (MSEL) - Wechsler Preschool and Primary Scale of Intelligence (4th edition) (WPPSI-IV) - Differential Abilities Scale (2nd edition)-(DAS-II) Secondary Outcomes ### Location - Facility: Children's National Hospital, Washington, District of Columbia, 20010, United States @@
## M. Avium WGS During Mav-PD Treatment - NCT ID: NCT06266442 - Study ID: Mav-WGS - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2026-09 - Lead Sponsor: University Health Network, Toronto ### Study Description This is a prospective observational study using whole genome sequencing (WGS) to investigate whether new strains (other than the initially identified strain(s)) of M. avium are responsible for persistently culture positive sputum during treatment (refractory disease), or the reversion to culture positive sputum after prior conversion to negative. The study will further investigate for differences between participants living in the Toronto/York region versus participants living elsewhere.The primary goal of this prospective observational study is to understand why some patients with M. avium lung disease have persistent or recurrent M. avium in their sputum despite treatment. The aim is to understand whether it is usually due to treatment failure or new infection. ### Conditions - Mycobacterium Avium - Mycobacterium Infections, Nontuberculous - Mycobacterium Infections - Nontuberculous Mycobacterial Lung Disease - Respiratory Tract Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Whole genome sequencing testing ### Outcomes Primary Outcomes - Proportion of patients with persistent culture-positive sputum despite antimicrobial therapy Secondary Outcomes - Whether patients with Mav-PD have evidence of polyclonal infection as demonstrated by the presence of >1 strain of M. avium in the pre-treatment sputum or a sputum sample during treatment - Whether there is a source of infection from the home water environment ### Location - Facility: University Health Network, Toronto, Ontario, M5G, Canada @@
## Metabolomic Profiling of Racial Disparity - NCT ID: NCT06266429 - Study ID: STUDY00001304 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12-31 - Lead Sponsor: Olubukola Nafiu ### Study Description Tonsillectomy ± adenoidectomy (T\&A) is one of the most common surgical operations with over 500,000 pediatric T\&As performed annually in the United States. Unfortunately, despite advances in anesthetic and surgical techniques, moderate-severe post-tonsillectomy pain (PTP) remains a significant problem affecting up to 62% of children. PTP is thought to arise from pharyngeal mucosal inflammation, which produces local nerve irritation and pharyngeal muscle spasm. Patient factors and surgical techniques also play major roles. Race is an important phenotypic risk factor for moderately severe early PTP. The underlying molecular basis of this differential pain experience is presently unknown. This gap in knowledge means that therapies are poorly targeted and often unsuccessful. Indeed, treatment options for PTP have not advanced substantively for many years. Metabolomics provides novel opportunities to investigate common and unique "metabolic signature" of PTP through the analysis of low molecular weight compounds produced in response to tissue injury. Therefore, the central themes of this proposal are that (1) PTP is a complex process that may be determined by molecular level factors such as preoperative systemic inflammation and metabolic profile, and (2) these molecular level factors may explain the excess burden of PTP among minority children. Here the investigators seek to utilize a combined clinical, biological and untargeted metabolomics approach to identify candidate small and large serum molecules that may influence the frequency and severity of PTP in children across racial groups. This approach to exploring the molecular basis of PTP is novel and knowledge from the study should substantially enhance understanding of the mechanisms underlying pediatric PTP - and narrow the racial disparities in post-operative pain. ### Conditions - Adenoid Hypertrophy - Tonsillar Hypertrophy - Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood collection ### Outcomes Primary Outcomes - Mean fold-change of metabolomics markers by race using untargeted reverse-phase liquid-chromatographic mass spectrometry - Highest pain score - Last pain score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## IMARA for Black Male Caregivers and Girls Empowerment (IMAGE) - NCT ID: NCT06266416 - Study ID: 115207 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2028-05-31 - Lead Sponsor: University of Illinois at Chicago ### Study Description The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence. ### Conditions - Sexually Transmitted Infections (Not HIV or Hepatitis) - HIV Infections - Sexual Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - IMARA for Black Male Caregivers and Girls Empowerment - Time-matched control program ### Outcomes Primary Outcomes - STI Incidence in Participants Secondary Outcomes - Rate of STI History among Participants - Number of Participants Using Condoms - Number of Sexual Partners of Participants ### Location - Facility: University of Illinois Chicago, Chicago, Illinois, 60612, United States @@
## Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications - NCT ID: NCT06266403 - Study ID: STUDY00024154 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-03 - Lead Sponsor: Penn State University ### Study Description The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and age-matched speakers.The question is, What are the effects of communicative interaction on verbal communication in people with ALS?Participants will read words and sentences while they are in a solo setting and interactive setting. ### Conditions - Amyotrophic Lateral Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Structured Communicative Interaction - Clear Speech - Unstructured communicative interaction - Clear Speech Structured Communicative Interaction ### Outcomes Primary Outcomes - Formant frequencies of speech sounds - Intelligibility of recorded speech - Syntactic properties - Pragmatic Properties - Duration of speech sounds Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Engaging sgACC With TMS for Depression - NCT ID: NCT06266390 - Study ID: 855007 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2026-04 - Lead Sponsor: University of Pennsylvania ### Study Description The purpose of this study is to investigate the responses of the brain region known as the subgenual anterior cingulate cortex (sgACC) during transcranial magnetic stimulation (TMS) in individuals with depression. Specifically, investigators aim to determine whether the sgACC is engaged when TMS is delivered to specific targets and if the engagement of sgACC changes throughout a full TMS treatment intervention. To achieve this goal, the investigators will employ a combination of TMS and Magnetic Resonance Imaging (MRI) procedures.Study participation will include completing various questionnaires, clinical assessments, receiving a full transcranial magnetic stimulation (TMS) treatment intervention (every weekday for 4-6 weeks), and undergoing MRI scans, both with and without concurrent TMS. ### Conditions - Depression - Major Depressive Disorder - Persistent Depressive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Transcranial Magnetic Stimulation (TMS) ### Outcomes Primary Outcomes - sgACC Blood Oxygen Level Dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs TMS Off) Secondary Outcomes - Change in sgACC evoked response Pre/Post TMS treatment with positive and negative sgACC correlated targets ### Location - Facility: University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States @@
## AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder - NCT ID: NCT06266377 - Study ID: 11122023 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2025-11-30 - Lead Sponsor: University of Pavia ### Study Description The main goal of this multi-center interventional study is to improve the meal experience of children and adolescents with autism spectrum disorder trough the development of menus for collective catering targeted to their nutritional and sensory needs and the drafting of nutritional indications that can be a reference for collective catering nationwide. After an initial assessment of participants' consumption of meals in the collective service, menus adapted to their nutritional and sensory needs will be administered, and consumption between the initial and adapted menus will be compared. A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder - Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder ### Outcomes Primary Outcomes - Food acceptance of canteen menus by individuals enrolled in the study Secondary Outcomes - Reduction in food selectivity as a result of the targeted nutrition education course ### Location - Facility: Milano Ristorazione S.p.A., Milano, N/A, 20139, Italy @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06266364 - Study ID: IRB-24-22 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## EVALUATION OF CATS TONOMETER PRISM IN LASIK SUBJECTS - NCT ID: NCT06266351 - Study ID: LASIKIOP - Status: NOT_YET_RECRUITING - Start Date: 2024-02-12 - Completion Date: 2024-08-01 - Lead Sponsor: Intuor Technologies, Inc. ### Study Description The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes. ### Conditions - Glaucoma - Ocular Hypertension - Normal Tension Glaucoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - This is observational IOP measurement ### Outcomes Primary Outcomes - IOP measurement difference between CATS and GAT in LASIK patients Secondary Outcomes ### Location - Facility: Arizona Eye Consultants, Tucson, Arizona, 85710, United States @@
## Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix) - NCT ID: NCT06266338 - Study ID: STU-2023-1118 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2026-10-31 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description The main purpose of this study is to gather information about an investigational drug combination, Lenvatinib in combination with pembrolizumab, that may help to treat cervical cancers. In this study, we are looking to see whether the combination of lenvatinib and pembrolizumab has any effect on slowing tumor growth in cervical cancer tumors. ### Conditions - Cervix Cancer - Cervical Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab - Lenvatinib ### Outcomes Primary Outcomes - Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1 Secondary Outcomes - Progression Free Survival (PFS) assessed by Response Evaluation Criteria in Solid Tumors v1.1 ### Location - Facility: UT Southwestern Medical Center, Dallas, Texas, 75390, United States @@
## Development and Validation of a Dementia Life Expectancy Tool - NCT ID: NCT06266325 - Study ID: 6138 - Status: COMPLETED - Start Date: 2010-04-01 - Completion Date: 2022-12-31 - Lead Sponsor: University of Toronto ### Study Description Individuals with dementia and their caregivers are faced with challenging decisions throughout the course of the disease. These decisions may be about medical care (e.g., continuation of routine cancer screening, pursuit of cardiopulmonary resuscitation, initiation of palliative care services), institutionalization (i.e., transition to a long-term care facility), or financial planning. These inherently difficult decisions are made more difficult by prognostic uncertainty. Indeed, life expectancy is challenging to predict in dementia. Consequently, prognosis is infrequently discussed by healthcare providers with individuals with dementia and their families, which compromises their ability to plan for the future. A lack of prognostic awareness makes it difficult for patients, their caregivers, and their healthcare providers to make medical decisions that strike the appropriate balance between prolonging life and promoting the quality of it. A clinical prediction tool has the promise to provide personalized and accurate estimations of life expectancy in individuals with dementia. Therefore, similar to the existing clinical prediction tools on our Project Big Life platform (www.projectbiglife.ca), we seek to create and to test a statistical model to predict survival, and to implement the model as a user-friendly, web-based calculator. The calculator will use self-reported sociodemographic, clinical, cognitive, functional, and nutritional information that is entered by patients, their caregivers, and/or their healthcare providers to output an estimated life expectancy. This estimate could inform the shared decision-making process, thereby empowering decisions that are compatible with a patient's clinical reality and concordant with their life goals. ### Conditions - Dementia - Death ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - There is no intervention. Exposures are predictor variables of mortality. ### Outcomes Primary Outcomes - Mortality Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer - NCT ID: NCT06266312 - Study ID: Maastricht UMC+ - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Maastricht University Medical Center ### Study Description The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy. ### Conditions - Breast Cancer - Breast Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - A multimodal prehabilitation programme ### Outcomes Primary Outcomes - Recruitment rate (%) - Characteristics of included participants - Attendance rate for MIET sessions (%) - Adherence rate, exercise relative dose intensity (ExRDI) MIET (%) - Reasons for not having executed a training session as intended - Attendance rate HIIT + strength sessions (%) - Adherence rate, ExRDI HIIT training (%) - Adherence rate, ErXDI strength training (%) - Attendance rate for dietary consultations (%) - Percentage of use of the digital food diary 'Mijn Eetmeter'(%) - Percentage of days on which nutritional requirements were achieved (%) - Reasons for not achieving the nutritional requirements as intended - Drop-out rate (%) - Time point of drop-out - Reasons for drop-out - Serious adverse events (SAE) - Study related adverse events - Acceptance - Experiences with the multimodal lifestyle intervention - Acceptance - Suitability of the multimodal lifestyle intervention and study procedures - Acceptance - Barriers and enablers regarding participation in the study Secondary Outcomes - Fatigue - Cardiorespiratory fitness - Muscle strength - Nutritional status - Weight (kg) - Height (cm) - Body Mass Index (BMI) - Energy and protein intake (absolute kcal and gr and gr/kg body weight per day) - Energy requirements (kcal) - Protein requirements - Circumference of upper arm and waist (cm) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of KK2269 in Adult Participants With Solid Tumors - NCT ID: NCT06266299 - Study ID: 2269-001 - Status: RECRUITING - Start Date: 2024-01-25 - Completion Date: 2027-12 - Lead Sponsor: Kyowa Kirin, Inc. ### Study Description This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies.In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible. ### Conditions - Advanced Solid Tumor - Metastatic Solid Tumor - Gastric Adenocarcinoma - Gastroesophageal Junction Adenocarcinoma - Esophageal Adenocarcinoma - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - KK2269 - Docetaxel ### Outcomes Primary Outcomes - Number of Subjects Experiencing Dose-limiting Toxicity - Number of Adverse Events Secondary Outcomes ### Location - Facility: National Cancer Center Hospital East, Kashiwa City, Chiba, 277-8577, Japan @@
## EXOPULSE Mollii Suit & Cerebral Palsy - NCT ID: NCT06266286 - Study ID: 2022-A00233-40 - Status: RECRUITING - Start Date: 2023-09-13 - Completion Date: 2025-10-30 - Lead Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences ### Study Description Spasticity is a frequent and debilitating symptom in patients with cerebral palsy. It can alter the patients' balance, mobility, as well as their quality of life (QoL). The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous electric nerve stimulation using EXOPULSE Mollii suit, might be of help in this context. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - EXOPULSE MOLLII SUIT (active) - EXOPULSE MOLLII SUIT (sham) ### Outcomes Primary Outcomes - Improvement in balance using the PBS (Pédiatric Balance Scale) before and after active and sham stimulation Secondary Outcomes - Evaluation of the cumulative effects of EXOPULSE Mollii suit on balance using the PBS - Evaluation of the effects of EXOPULSE Mollii suit on spasticity using the Modified Ashworth Scale (MAS) - Evaluation of the effects of EXOPULSE Mollii suit on mobility using the Timed Up and Go test (TUG) - Quality of life will be measured using the EuroQol 5 dimensions quality of life questionnaire for youth (EQ-5D-Y) - Pain will be assessed using the Pain Scale Chart (PSC) - Evaluation of overall improvement using the Clinical Global Impression (CGI) ### Location - Facility: Centre Hospitalier Intercommunal D'Aix Pertuis, Aix-en-Provence, N/A, N/A, France @@
## Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale - NCT ID: NCT06266273 - Study ID: SBA 23/442 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-08-30 - Lead Sponsor: Hacettepe University ### Study Description "Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale" is crucial in determining the specific functional status of the shoulder joint, especially for overhead athletes experiencing shoulder pain, to identify which sporting activities restrict them the most and to fill the gap in the literature. Additionally, visually indicating activities through photographs will provide visual feedback, making it easier to assess functional status. Our study aims to develop a specific functional survey for the shoulder joint in overhead athletes, examine the validity and reliability of this scale, and contribute to the literature. ### Conditions - Questionnaire - Athletes - Shoulder Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - No intervention ### Outcomes Primary Outcomes - Investigating the Development, Validity, and Reliability of The Sports Activity Avoidance Photo Scale Secondary Outcomes ### Location - Facility: Elif Turgut, Ankara, N/A, 06300, Turkey @@
## Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP) - NCT ID: NCT06266260 - Study ID: 5486 - Status: RECRUITING - Start Date: 2023-09-11 - Completion Date: 2026-04-01 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description A minimally invasive procedure to directly assess portal pressure gradient under endoscopic ultrasound guidance (EUS-PPG) has become available and initial data have proved the technique to be safe. Aims of our proposal are: (i) to assess performance of EUS-PPG as compared to HVPG in evaluating hemodynamic response to non selective betablockers (NSBBs) in a large cohort of patients with CSPH;(ii) identification of markers of hemodynamic response(iii) identification of factors potentially affecting the accuracy of PPG measurement. ### Conditions - Portal Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - EUS PPG measurement ### Outcomes Primary Outcomes - Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs) - Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs) Secondary Outcomes - Markers of hemodynamic response - Markers of hemodynamic response - Markers of hemodynamic response ### Location - Facility: Policlinico Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## How Sirtuin Levels Change During Behçet Disease - NCT ID: NCT06266247 - Study ID: 06-2023/16 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-10-30 - Lead Sponsor: Karamanoğlu Mehmetbey University ### Study Description Our primary aim in our study is to evaluate the relationship between the activity, which will be evaluated by clinical and standard phase reactants, and the IL-6 and TNF-α levels, which will be measured in serum, in Behçet\'s patients. Our secondary aim was to evaluate Sirtuin-1 in Behcet\'s patients and compare it with the normal population. Our third aim is to find out whether there is a relationship between these values and organ involvement. ### Conditions - Behçet Disease - Inflammation - Vasculitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Take blood samples ### Outcomes Primary Outcomes - Our primary aim is to evaluate the relationship between the activity to be evaluated with clinical and standard acute phase reactants and the IL-6 and TNF-α levels to be measured in serum in Behçet's patients. Secondary Outcomes ### Location - Facility: Karamanoğlu Mehmetbey University, Karaman, N/A, N/A, Turkey @@
## Characterization by Automated System on Infantile Spasmes - NCT ID: NCT06266234 - Study ID: APHP230600 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Infantile spasms are defined by the occurrence of epileptic episodes characterized by the appearance of very specific motor seizures, made up of rapid, repeated contractions in flexion or extension known as spasms. This syndrome is of high concern as it will lead to mental retardation if it is not early identified and treated. Most often, spasms are characterized by sudden contractions of the body in flexion. More rarely, spasms occur in extension: the neck and legs suddenly tense, and the arms move upwards or sideways. Spasms may be accompanied by eye revulsion. They are brief, lasting 0.5 to 2 seconds each. At the start of the attack, they may be isolated, but then may occur in series lasting up to several tens of minutes.Because of its nature and duration, infantile spasm is often difficult to identify and is often confused with benign motor manifestations in children, such as hiccups or muscular jerks. This difficulty often leads to delays in diagnosis. Indeed, patients are often seen at the stage when cognitive regression has set in.The gold standard for diagnosing infantile spasms is to capture them on video-EEG to conﬁrm the ictal correlate of the seizure. Although multiple variations are known, the ictal correlation is often a diffuse slow wave of high amplitude with subsequent electrodecrement. Yet continuous video electroencephalogram is an expensive and time-consuming resource often unavailable in developing countries and in many parts of the developed world. Furthermore, in an appropriate clinical scenario, continuous video-EEG may be unnecessary. For example, a home video examination with typical spasms combined with a deﬁnitively epileptic ambulatory EEG may certainly be adequate for the diagnosis of infantile spasmsAs part of Mr. Diop's thesis, the study team have developed a system for analyzing videos acquired in 2 dimensions from a simple smartphone or webcam and highlighting the existence of spasms in a child. The principle is to use computer vision and computer learning model to identify the spasms from these videos. The first prototype of this system achieved a positive predictive value of 77%, which is very good considering the small sample used (\< 100) but quite insufficient to obtain a diagnostic prediction for medical use, for which we hope for sensitivity and specificity of around 95%.The aim is to achieve a sensitivity and specificity of over 95% so that we can offer this detection system to healthcare professionals and parents of children who do not have rapid access to diagnosis. The aim is to develop a system enabling broad screening at the population level so that identified children can be more rapidly directed towards the healthcare system and appropriate treatment for their disease.To achieve this goal, we need access to a standardized reference database that currently exists in the various pediatric electrophysiology laboratories of the Assistance Publique - Hôpitaux de Paris and the Île-de-France region. we propose using the films stored in these laboratories to teach the computer to recognize spasms that have already been formally identified by electrophysiologists and by ictal concordance. ### Conditions - Infantile Spasm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Automated computer detection of the spasms > 95% Secondary Outcomes - Automated computer detection of the non spasms > 95% ### Location - Facility: Department of paediatric neurological care and intensive care unity (PICU), Raymond Poincaré hospital - APHP, Garches, N/A, 92380, France @@
## Severe Erythema Multiforme - CORTICO - NCT ID: NCT06266221 - Study ID: APHP200073 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-11-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Erythema multiforme (EM) is an acute and often recurrent mucocutaneous disease. EM is considered a hypersensitivity immune-mediated reaction. The two main known triggering factors are Herpes simplex virus (HSV) and Mycoplasma pneumoniae (MP) infections. Typical target skin lesions characterize EM, especially oral MMs. EM is in fact mainly linked to the oral MM involvement, including intense mucosal pain, impaired food intake, weight loss, hospitalization and potential risk of fibrotic sequelae (oral, ocular, genital, oesophageal, respiratory tract) and recurrences.The objectives of treatment for severe EM in the acute phase are to reduce the duration of lesions, prevent complications and mucosal sequelae. However, despite the lack of evidence and consensus some medical teams often use a short regimen of SCS hoping to obtain a quicker improvement of the condition. However, the use of SCS at the acute phase is not codified and remains debated according to the existent literature. Current studies are mostly retrospective and based on small cohorts or case reports. A randomized, controlled trial would be therefore essential to properly evaluate the benefit of SCS in this pathology and provide strong support to clinicians in their decision making in severe EM during the acute phase.This research will be a Phase III randomized, multicentric, double-blind, controlled trial with two parallel groups. The efficacy of prednisone, oral at 1 mg/kg/day for 3 days, tapered to 0.75 mg/kg/day for 3 days, 0.50 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days is compared to that of placebo, oral for 12 days or IV methylprednisolone if oral route is impossible because of the self-reported inability for the patient to swallow due to the impacts of the oral lesions, with dosage equivalence at 0.8 mg/kg/day for 3 days, tapered to 0.6 mg/kg/day for 3 days, 0.4 mg/kg/day for 3 days, 0.2 mg/kg/day for 3 days, then stopped, compared to that of placebo.A stratification according to the food intake classification (0,1,2 vs 3) will be performed.An interim analysis is planned after the inclusion of 50 patients. Results of the interim analysis will be presented to the DSMB. During the interim analysis, inclusions may continue. ### Conditions - Erythema Multiforme ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Prednisone 20 Mg - Oral Placebo - Methylprednisolone 120 Mg - IV Placebo ### Outcomes Primary Outcomes - Time to success - Evaluation of Pain - Food intake - Rescue therapy intake Secondary Outcomes - Time to clear or almost clear healing of all sites - Time to fever resolution - Length of hospital stay - Number of days of consumption of level III analgesics - Evaluation of pain - Chopped or solid food intake resumption - Rate of patients in the two groups with need for a rescue therapy - Rate of sequelae - Rate of adverse events during the treatment and follow-up - Evaluation of the quality of life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte - NCT ID: NCT06266208 - Study ID: UCV/2021-2022/201 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-07-15 - Lead Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir ### Study Description This study will evaluate the usefulness of ultrasonography in detecting dorsal osteophytes associated with claw nails compared to radiographs. The hypothesis will be that the larger the size of the osteophyte, the greater the nail curvature.Nail curvature and osteophyte height will be measured in patients with clamp nails. Nail-phalange distance will also be measured with radiography and ultrasonography.The investigators to find a positive correlation between nail curvature and osteophyte height. Furthermore, a strong agreement is expected between both imaging techniques to measure nail-phalange distance.Ultrasonography could constitute a safe and effective alternative to radiology for detecting dorsal osteophytes in claw nails, especially in mild cases, follow-ups or young patients. ### Conditions - Exostosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Exostectomy - Cut fingernail ### Outcomes Primary Outcomes - Nail-phalange distance Secondary Outcomes - Nail Curvature Index - Thickness of the nail plate - Dorsal Osteophyte Height ### Location - Facility: Enieto podologos, Logroño, La Rioja, 26003, Spain @@
## Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared - NCT ID: NCT06266195 - Study ID: 5452 - Status: RECRUITING - Start Date: 2023-03-15 - Completion Date: 2025-02-28 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma. ### Conditions - Vesicle ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - sierological test ### Outcomes Primary Outcomes - primary endpoint Secondary Outcomes ### Location - Facility: FPGemelliIRCCS, Roma, Lazio, 00168, Italy @@
## The Effect of an Online ACT Intervention on Meaning-Making Process in Cancer Patients Following Hematopoietic Cell Transplantation - NCT ID: NCT06266182 - Study ID: 2020/39/B/HS6/01927 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-04 - Lead Sponsor: University of Social Sciences and Humanities, Warsaw ### Study Description This trial aimed to test internet-based Acceptance and Commitment Therapy (ACT) intervention to induce a meaning-making process in cancer patients following hematopoietic cell transplantation (HCT). ACT includes identifying personal values and engaging in activities consistent with these values, developing acceptance, as well as focusing on the present moment or performing activities with greater awareness. In total, 192 patients following the first (autologous or allogeneic) HCT will be randomly assigned in equal numbers to either the ACT intervention or an education session. Participants in both conditions will take part in 14-day training (about 5-10 minutes a day). The outcomes will be measured at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. Moreover, 6-9 additional participants will be randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at each post-intervention measure. The researchers hypothesized that ACT intervention would foster a meaning-making process and thus reduce distress induced by the discrepancy between global and situational meaning as compared to education. ### Conditions - Hematopoietic Cell Transplantation Recipient - Acceptance and Commitment Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Acceptance and Commitment Therapy - Education ### Outcomes Primary Outcomes - Distress (Global Meaning Violation Scale; GMVS) Secondary Outcomes - Illness perception (Brief-Illness Perception Questionnaire; B-IPQ) - Global meaning (Meaning in Life Questionnaire; MLQ) - Psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-9; CompACT-9) - Coping self-efficacy (Coping Self-Efficacy Scale; CSE - selected items) - Deliberate meaning-making (Core Beliefs Inventory; CBI) - Automatic meaning-making (Event-Related Rumination Inventory; ERRI - intrusive ruminations subscale) - Post-traumatic growth (the "current standing" Post-Traumatic Growth Inventory-Short Form; C-PTGI-SF ) - Meanings made (Meaning of Loss Codebook; MLC) - Anxiety and depressive symptoms (Patient Health Questionnaire-4; PHQ-4) - Loneliness (The Revised UCLA Loneliness Scale; R-UCLA - selected items) - Loneliness (the Community Life Survey) - Health-related quality of life (Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer; EORTC QLQ-C3) - Daily subjective health (Daily Subjective Health Scale) - Daily affect (Daily Positive and Negative Affect Scale) - Daily meaning-making (Event-Related Rumination Inventory-daily form; ERRI-daily form) - Daily meanings made (Meaning of Loss Codebook-daily form; MCL-daily form) - Daily psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-daily form; CompACT-daily form) ### Location - Facility: Maria Skłodowska-Curie National Research Institute of Oncology Gliwice Branch, Department of Bone Marrow Transplantation and Oncohematology, Gliwice, N/A, 44-102, Poland @@
## Application of Spectral Methods to Assess Gametes, Embryos, and Human Reproductive Capabilities - NCT ID: NCT06266169 - Study ID: fpc-2023-ivf-01 - Status: RECRUITING - Start Date: 2023-09-20 - Completion Date: 2025-12-31 - Lead Sponsor: Family Planning Center of Women's Welfare Clinic #44 of Pushkin District ### Study Description Relevance of the research topic: At present, in the world, a kind of "plateau" in the efficiency of assisted reproductive technologies has been achieved, which ensures a birth rate of 30% per embryo transfer. At the same time, a relatively high (15-20%) and stable rate of miscarriages is preserved. Until now, no effective methods for assessing the potential of gametes and embryos, as well as human reproductive capabilities, have been offered. In these conditions, to increase the rate of births after IVF, clinicians have to increase the number of transferred embryos at a time, however, this leads to a sharp increase in complications of IVF, such as multiple pregnancy. In addition, until today, the clinical effectiveness of assessing the potential of endometrium using gene expression determination methods has not been shown. Therefore, to ensure the effectiveness and safety of infertility treatment, it is necessary to develop methods for predicting the potential of gametes and embryos, as well as human reproductive capabilities. For this purpose, the investigators assume to use Raman spectroscopy of the environment obtained from the objects of research, as well as fluorescent spectroscopy of endometrium. The objects of the research are gametes (spermatozoa) and embryos, used culture medium, endometrium. The subject of the study is the set of factors, that exists in the objects of research and their ability to determine the outcomes of infertility treatment. ### Conditions - Infertility ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - making artificial intelligence based decisions of gamete, embryo and endometrial potential ### Outcomes Primary Outcomes - Embryonic model performance - Gamete model performance - Endometrial model performance - Embryonic model clinical efficiency - Endometrial model clinical efficiency Secondary Outcomes ### Location - Facility: Family planning center, Saint Petersburg, Pushkin, 196608, Russian Federation @@
## Evaluation of The Effect of Consecutive Dental Visits on Dental Anxiety of Paediatric Patients - NCT ID: NCT06266156 - Study ID: BMU-HTUNC-01 - Status: COMPLETED - Start Date: 2023-08-05 - Completion Date: 2023-12-27 - Lead Sponsor: Burdur Mehmet Akif Ersoy University ### Study Description The goal of this observational study is to learn about in effect of consecutive dental visits on dental anxiety of paediatric patients.The main question\[s\]it aims to answer are:* Did the anxiety level of pediatric patients decrease in consecutive treatment sessions?* Were there changes in the physiological parameters related to stress level of pediatric patients in consecutive treatment sessions?Participants will fill out the questionnaire about dental anxiety in each dental treatment sessions before and after dental treatment.Researchers will compare paeditric patients have two caries on mandibular molars to see if changes dental anxiety levels and physiological parameters such as heart rates and oxygen saturations during dental treatments in consecutive dental treatment sessions. ### Conditions - Dental Anxiety ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Score of anxiety questionnaire - Heart rate - Oxygen saturation ### Outcomes Primary Outcomes - Determination of sample size. - Inviting participants to the study. - Determination of dental anxiety score of participants before dental treatment in first dental session - Heart rate measuring in first dental session. - Oxygen saturation measuring in first dental session. - Determination of dental anxiety score of participants after dental treatment in first dental session - Determination of dental anxiety score of participants before dental treatment in second dental session - Heart rate measuring in second dental session. - Oxygen saturation measuring in second dental session. - Determination of dental anxiety score of participants after dental treatment in second dental session Secondary Outcomes ### Location - Facility: Burdur Mehmet Akif Ersoy University Faculty of Dentistry, Burdur, Centrum, 15100, Turkey @@
## A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer - NCT ID: NCT06266143 - Study ID: Y101D03 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-08 - Completion Date: 2024-12-31 - Lead Sponsor: Wuhan YZY Biopharma Co., Ltd. ### Study Description The Phase Ib/II study is an open-label, single-arm, multicenter trial designed to assess the efficacy and safety of Y101D in combination with Gemcitabine and Albumin Paclitaxel as first-line systemic treatment for advanced pancreatic cancer patients. The Phase Ib portion of the study aims to evaluate the safety of escalating doses of Y101D in combination with the standard regimen of Gemcitabine and Albumin Paclitaxel and determine the recommended phase 2 dose (RP2D). The Phase II portion of the study aims to evaluate the effectiveness of this combination treatment in a small population of patients. ### Conditions - Advanced Pancreatic Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Y101D ### Outcomes Primary Outcomes - Dose Limiting Toxicities (DLTs) - RP2D - Objective Response Rate (ORR) Secondary Outcomes - Peak Serum Concentration (Cmax) - Trough Serum Concentration (Ctrough) - Area under the serum concentration versus time curve (AUC) during one treatment cycle (21 days) - The TGF-β concentration in serum - The CA19-9 concentration in serum - The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab) - Disease control rate (DCR) - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) ### Location - Facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China @@
## Digital Bonding vs. Direct Bonding Study - NCT ID: NCT06266130 - Study ID: EM-11-050087 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-08 - Lead Sponsor: 3M ### Study Description This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets. ### Conditions - Orthodontic Brackets ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Treatment Group Digital Bonding Tray - Control Group Direct Bonding ### Outcomes Primary Outcomes - Prep-and-bonding time Secondary Outcomes - Number of adjustment visits to complete treatment - Overall chair time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pain, Anxiety, and Comfort Levels in Coronary Angiography - NCT ID: NCT06266117 - Study ID: SBF-HMS-GES-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-07-30 - Lead Sponsor: Abant Izzet Baysal University ### Study Description The study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit. ### Conditions - Pain - Anxiety - Nursing Caries ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pain level - Anxiety - Comfort Secondary Outcomes ### Location - Facility: Abant Izzet Baysal University Faculty of Health Science, Bolu, Merkez, 14100, Turkey @@
## Image Enhanced Endoscopy IBD - NCT ID: NCT06266104 - Study ID: Protocol V1.4_04012024 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2026-03-01 - Lead Sponsor: Royal Perth Hospital ### Study Description Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future. ### Conditions - Inflammatory Bowel Diseases - Dysplasia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Image Enhanced Endoscopy Filters ### Outcomes Primary Outcomes - Dysplasia Detection Rate Secondary Outcomes - Withdrawal times - Characterisation of lesions ### Location - Facility: Royal Perth Hosptial, Perth, Western Australia, 6000, Australia @@
## Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody - NCT ID: NCT06266091 - Study ID: M70102 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-11-24 - Completion Date: 2024-12-31 - Lead Sponsor: Wuhan YZY Biopharma Co., Ltd. ### Study Description A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 in treating Patients with Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer combined with Systemic Therapy. ### Conditions - Malignant Ascites ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - M701 - paracentesis ### Outcomes Primary Outcomes - Puncture-free survival, PuFS Secondary Outcomes - objective response rate (ORR) of malignant ascites - Progression-free Survival, PFS - Overall survival, OS - Quality of Life, QoL - Safety profiles - Positive rate of ADA and Nab in serum - The EpCAM expression in ascites - Trough serum concentration (Ctrough) - Peak serum concentration (Cmax) ### Location - Facility: The First Medical Center of Chinese PLA General Hospital, Beijing, Beijing, 100141, China @@
## A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment - NCT ID: NCT06266078 - Study ID: School of Nursing - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-15 - Lead Sponsor: University of Campinas, Brazil ### Study Description Background: Many factors influence Personal Protective Equipment (PPE) compliance for use in health care, specifically the PPE usability and related human factors. It is known that issues related to the usability of new technologies, including professional behavioral and attitudinal patterns, the technologies adoption within the workflow and teamwork strengths can be investigated by using Simulation-Based Research (SBR) before its implemented. This study aims to develop and validate a simulation protocol for the assessment of human factors and usability of innovative PPEs used in critical care units. The ultimate goals is to define a standard method for PPEs assessment and comparison worldwide. Method: methodological study with a quantitative approach to be carried out in two phases: a) development and validation by experts of a simulation protocol; b) piloting of the simulation protocol. For the protocol validation phase, 14 experts with experience in the themes of infection prevention and control or clinical simulation will be included. The experts will be invited via email and will assess the simulation protocol content using the criteria of pertinence, clarity and relevance. To ensure that the simulation protocol is feasible and reliable, a piloting phase will take place at the simulation center in São Paulo and 36 health professionals with work experience in critical care units will be included. The health professionals will perform specific tasks assigned to them, wearing pre-defined PPEs in each simulation round. Errors and difficulties during PPE assembly, donning and doffing; performance of individual and team activities, as well as communication problems and self-contamination risk, will be observed during the tasks. At the end of the simulation round, the participants will take part in a debriefing, where they will answer questionnaires about comfort, perception of safety, thermal sensations, usability and perceived workload related to the PPE used. Content validity index (CVI) and intraclass correlation coefficient (ICC) will be calculated. This study protocol was approved by the Research Ethics Committee of the School of Nursing, University of São Paulo. The informed consent form will be applied both to the experts and to the health care workers. ### Conditions - Personal Protective Equipment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Innovative PPE - Traditional PPE ### Outcomes Primary Outcomes - Content Validity of the items included in the "Innovative PPE assessment tool" and in the "Simulation scenario script" - Errors during PPE assembly/preparation, donning and doffing - Communication impairments while using PPE - Self-contamination risk in the professional while using and doffing the PPE - Influence of PPE on individual performance - Influence of PPE on team performance and behavioral changes - Changes in mobility and comfort while using PPE - Thermal sensations - Perception regarding safety and satisfaction of the PPE user - Perceived workload - Usability Secondary Outcomes - Complementary Content Analysis - qualitative data ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia - NCT ID: NCT06266065 - Study ID: 8.1-23/260-2;02/013AG - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2026-06 - Lead Sponsor: Clinical Hospital Centre Zagreb ### Study Description The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter \< 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia. ### Conditions - Coronary Artery Disease - Angina Pectoris ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Coronary Sinus Reducer ### Outcomes Primary Outcomes - Impact of Coronary Sinus Reducer on Coronary Microcirculation Secondary Outcomes - Myocardial Ischemia assessment - Angina assessment - Functional capacity assessment ### Location - Facility: University Hospital Centre Zagreb, Zagreb, N/A, 10000, Croatia @@
## Evaluation of the Effects of Four Different Flap Designs on Tissue Healing in Lower Third Molar Surgery - NCT ID: NCT06266052 - Study ID: 2019/04 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-20 - Completion Date: 2024-04-20 - Lead Sponsor: Recep Tayyip Erdogan University ### Study Description The aim of this study is to prospectively evaluate the effectiveness of 4 different flap types used during mandibular impacted wisdom teeth surgery on postoperative quality of life, soft tissue and hard tissue healing at the end of the 3rd month. ### Conditions - Soft Tissue Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Triangular Flap - Berwick Flap - Saurez Flap - Heitz Flap ### Outcomes Primary Outcomes - Eudema Amount - Pain Level - Trismus Level - Halitosis Amount - bone healing condition Secondary Outcomes ### Location - Facility: RTEU Faculty of Dentistry, Rize, N/A, N/A, Turkey @@
## Introduction of Long Acting Buprenorphine in France - NCT ID: NCT06266039 - Study ID: 2022-0328-01 - Status: RECRUITING - Start Date: 2023-03-31 - Completion Date: 2024-09-30 - Lead Sponsor: University of Bordeaux ### Study Description The current available pharmacological treatment formulations (i.e., daily formulations of buprenorphine or methadone) for OUD in France may have several inconveniences, such as: compliance, burden of daily intake, and risk of misuse; that may hinder their effectiveness. Long acting formulations of buprenorphine (LAB) such as Buvidal have been developed to favor retention and compliance and minimize the risk of diversion. Previous studies are promising on the advantage of LAB to treat opioid addiction, however more evidence is needed in the French healthcare context. However, in addition to randomized clinical trials, the French National Healthcare Agency (HAS "Haute Autorité de Santé") recommends conducting "real-life" studies (i.e., in naturalistic conditions) during the development of a medication and the use of "Patient Reported Outcome Measures" (PROMs) to analyze patient quality of life and/or other measures relevant to patients (e.g., severity, efficiency), without interpretation of the answers by a health professional. In this regard, our study proposes to use the Addiction Severity Index (ASI) self-report questions and several scales on treatment satisfaction and quality of life to collect the patient's opinion of perceived changes following the use of Buvidal.Main objectives:The objectives of this prospective open observational study, in naturalistic conditions, are to examine in individuals with an opioid use disorder, over a period of 6 months after LAB treatment initiation: the change in substance addiction severity and the changes in health-related quality of life, craving, opioids and other substance and non-substance uses and misuses, alcohol, tobacco and non-substance addiction severity, satisfaction with LAB treatment, severity of others domains related to addiction severity (i.e., medical, social, psychological) and psychiatric comorbiditiesMain hypotheses:1. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of the CS of "Drug use" (i.e., substance addiction severity) at 6 months compared to baseline.2. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of opioids and other substance and non-substance uses and misuses, other substances and non-substances addiction severity, craving, severity of others domains related to addiction (i.e., medical status, employment and support, family/social status, psychological status), an improvement of quality of life and a good satisfaction with treatment at follow-ups compared to baseline. ### Conditions - Addiction Opiate ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The change in the composite score of the "Drug use" section from the Addiction Severity Index (ASI) at 6 months after treatment initiation Secondary Outcomes - The change in addiction severity at 6 months after treatment initiation - The change in quality of life with EuroQoL-5 Dimensions-5 Levels (EQ-5DL-5L) at 6 months after treatment initiation - The change in quality of life with the 12-Item Short Form Survey (SF-12) at 6 months after treatment initiation - The change in quality of life with nottingham health profile part 1 and part 2 (NHP1 and NHP2) at 6 months after treatment initiation - The change in quality of life with assisted quality of life assessment chart (TEAQV) at 6 months after treatment initiation - The change in other use at 6 months after treatment initiation - The change in craving at 6 months after treatment initiation - The change in other domains of addiction severity at 6 months after treatment initiation - The change in Treatment Satisfaction Questionnaire for Medication (TSQM) at 6 months after treatment initiation - Cues - craving - use links and others factors variations measure with EMA after treatment initiation ### Location - Facility: University of Bordeaux, Bordeaux, Gironde, 33000, France @@
## ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography. - NCT ID: NCT06266026 - Study ID: ThermoBreast - Status: RECRUITING - Start Date: 2023-12-11 - Completion Date: 2029-12 - Lead Sponsor: ThermoMind Ltd. ### Study Description Breast cancer is one of the most worrisome health concerns facing women. Early detection and active patient monitoring are crucial to survival. The chances of a cure are high when detected and treated in the early stages. Standard breast cancer diagnostic methods such as mammography, ultrasound, and MRI have limitations such as ionizing radiation, high false-positive rates, and/or high expenses.Medical Thermography might overcome these limitations: It is a non-invasive , adjunctive physiologic imaging technology that uses a high-resolution infrared camera and computer processing to produce an image (thermogram) of a patient's skin surface temperatures. It is a non-contact screening method, which does not involve radiation exposure or invasive procedures, and is safe for both the patient and the trained personnel performing the screening. While mammography and ultrasound depend primarily on structural and anatomical variation of the tumor from the surrounding breast tissue, thermography detects pathophysiological changes within the breast such as metabolic and vascular changes caused by cancer. The heat transfer in the body is conducted by the circulatory system; hence, pathologies identified by thermography are generally associated with changes in blood perfusion.To date, there has been no completed or ongoing large-scale, prospective, multicenter, international study that evaluates the diagnostic performance of thermal video streams coupled with advanced Artificial Intelligence algorithms for early-stage breast cancer screening and diagnosis. The proposed study will be crucial for the development of a new imaging modality that aims to be both cost-effective and to carry a minimal level of risk, facilitating screening of women of all age groups and breast densities, enabling early detection of abnormalities caused by malignant processes and improving patient monitoring. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - ThermoBreast - AI-based evaluation of dynamic breast thermography imaging ### Outcomes Primary Outcomes - Sensitivity (true-positive rate) - Specificity (true-negative rate) Secondary Outcomes - Cancer detection rate - Detection rate of ductal carcinoma in situ (DCIS) - Detection rate of tumor category pT1 - Recall rate - Sensitivity - Specificity - Positive-predictive value - Negative-predictive value - Diagnostic performance in the three trial cohorts - Proportion of breast quadrant localization - Proportion of correct histopathologic subtype identification - Proportion of correct tumorbiologic subtype identification - Proportion of correct axillary lymph node involvement identification - Effect of hormonal status on diagnostic performance - Effect of breast density on diagnostic performance - Effect of ethnicity on diagnostic performance - Timing of ThermoBreast - Screening time - Cost-effectiveness - Lived Experience ### Location - Facility: Heidelberg University Hospital, Heidelberg, N/A, N/A, Germany @@
## Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength, Muscle Oxygen Saturation, and Functional Capacity - NCT ID: NCT06266013 - Study ID: 009 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-14 - Completion Date: 2024-03-10 - Lead Sponsor: Sierra Varona SL ### Study Description Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between diaphragmatic fatigue and muscular strength in upper and lower limbs, in both healthy and pathological subjects, as well as the association between such fatigue and other variables, including maximal inspiratory pressure, functionality and muscle tissue oxygen levels.According to our hypothesis, the execution of a protocol inducing diaphragmatic fatigue in older adults could influence muscular strength, cardiorespiratory function, exercise capacity, and muscle tissue oxygenation.In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.Measurements of variables, such as maximal inspiratory pressure, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and functional capacity, will be conducted. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - inspiratory muscle training ### Outcomes Primary Outcomes - Muscle oxygen saturation (SmO2) - Functional mobility - Respiratory muscle strength - Diaphragmatic thickness and thickening fraction - Functional capacity - Diaphragm movement curve Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of 2 Extracts of Saw Palmetto Versus Placebo on BPH Symptoms - NCT ID: NCT06266000 - Study ID: PROPAL - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: RDC Clinical Pty Ltd ### Study Description A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on the symptoms of benign prostate hyperplasia (BPH) in 120 generally healthy participants, 45 - 80 years. ### Conditions - Benign Prostatic Hyperplasia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Saw palmetto extract 320mg per day - Commercial Saw palmetto extract 320mg per day - Palm Oil capsule ### Outcomes Primary Outcomes - International Prostate Symptom Score (IPSS) - Daily Urinary Frequency Diary Secondary Outcomes - Brief Sexual Function Inventory (BSFI) - International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) - Electrolytes (E/LFT) blood test - Liver Function (E/LFT) blood test - Inflammatory marker - JM27 - Blood pressure - Pulse rate - Adverse event frequency - Adverse event severity - Discontinuation due to adverse events ### Location - Facility: RDC Clinical Pty Ltd, Brisbane, Queensland, 4006, Australia @@
## Maternal and Fetal Characteristics Influencing Image Quality in Prenatal Ultrasonography - NCT ID: NCT06265987 - Study ID: ECHOQUALITY2 - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2024-01-31 - Lead Sponsor: Poitiers University Hospital ### Study Description The objective of this observational study is to identify maternal and fetal characteristics that impact image quality in prenatal ultrasonography. The investigators have assembled a retrospective cohort of 198 patients, each contributing three ultrasound images taken between 18 and 18 weeks and 6 days of gestation. For each image, the investigators assess the quality of two distinct elements as well as the overall image through both subjective and objective evaluations.The primary questions the study seeks to address are:What maternal and fetal characteristics influence image quality in prenatal ultrasonography? ### Conditions - Ultrasonography - Obstetrics - Fetus - Pregnant Women ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Maternal and fetal characteristics can influence quality image in ultrasonography Secondary Outcomes ### Location - Facility: University Hospital La MILETRIE, Poitiers, N/A, 86000, France @@
## Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio - NCT ID: NCT06265974 - Study ID: ECHOQUALITY - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2024-01-31 - Lead Sponsor: Poitiers University Hospital ### Study Description The goal of this observational study is to determine whether the subjective assessment of the quality of obstetrical ultrasonography pictures can be similar to that of an objective tool.The main question it aims to answer is:Is the subjective assessment of the quality of obstetrical ultrasonography pictures by a young practitioner and an experienced one can be similar to that of an objective tool, such as the contrast-to-noise ratio (CNR)? The contrast-to-noise ratio is commonly used in radiology to evaluate image quality by assessing the ability to distinguish differences between two elements.The investigators selected a retrospective cohort of 198 patients, including three pictures per fetus screened between 18 and 18 weeks and 6 days. For each picture, the investigators assessed the quality of two different elements and the entire image, and then calculated the CNR using software. The investigators will compare the three assessment between them ### Conditions - Ultrasonography - Obstetrics ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The comparability between a subjective and objective assessment of the contrast to noise ratio of an obstetric ultrasound image Secondary Outcomes ### Location - Facility: University Hospital La MILETRIE, Poitiers, N/A, 86000, France @@
## Efficiency of the Bibliotherapy Method in Developing Cultural Intelligence and Competencies of Nurses - NCT ID: NCT06265961 - Study ID: 02.01.2024_39 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-01 - Completion Date: 2024-05-31 - Lead Sponsor: Eskisehir Osmangazi University ### Study Description The study aims to evaluate the effectiveness of the developmental bibliotherapy method in developing the cultural intelligence and competence of nurses.The study will be carried out in an embedded intervention research model using a combination design (Quantitative + Qualitative) in the intervention design, which is one of the advanced mixed methods designs. In the embedded mixed research model where the quantitative approach is dominant, randomized controlled experimental research and qualitative research will be conducted simultaneously.1.1. Research questions for the qualitative phase 1.1.1. Research questions for the exploratory phase Q1. How successful are nurses in distinguishing the cultural differences of the individuals they care for? Q2. What are nurses\' views on cross-cultural nursing care? Q4. How do nurses approach the culturally-based behaviors of the individuals they care for? Q5. What are the cultural experiences that nurses have with the individuals they care for?1.1.2. Research questions for the integrative phase Q1. What are the contributions of the books read to the cultural intelligence and competence of nurses? Q2. What are the contributions of the stories read to the cultural intelligence and competence of nurses? Q3. What are the contributions of the watched movie to the cultural intelligence and competence of nurses?1.1.3. Research questions for the explanatory phase Q1. What effect did bibliotherapy practice have on nurses\' cultural intelligence? Q2. What impact did bibliotherapy practice have on nurses\' cultural competence?1.2. Research hypotheses of the quantitative phase1. H1. Bibliotherapy intervention will increase the cultural intelligence levels of the nurses in the study group.2. H1. The cultural intelligence levels of the nurses in the study group will be higher than the nurses in the control group.3. H1. Bibliotherapy intervention will increase the cultural competence of the nurses in the study group.4. H1. The cultural competence of the nurses in the study group will be higher than the nurses in the control group. ### Conditions - Cultural Competency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Education - Bibliotherapy ### Outcomes Primary Outcomes - Cultural intelligence - Cultural competence Secondary Outcomes ### Location - Facility: Eskisehir Osmangazi University, Eskisehir, Odunpazarı, 26040, Turkey @@
## Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia - NCT ID: NCT06265948 - Study ID: comparsion drugs in cancer - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-05 - Lead Sponsor: Assiut University ### Study Description ( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries ) ### Conditions - Abdominal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - post operative pain Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Diaphragmatic Breathing Exercise on Fatigue and Quality of Life in Pregnant Women With Gestational Diabetes - NCT ID: NCT06265935 - Study ID: Ataturk Unıversıty - Neslihan - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-10-15 - Lead Sponsor: Ataturk University ### Study Description Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. GDM, which is in the high-risk pregnancy category, causes fatigue during pregnancy due to both hormonal changes and pregnancy complications (1). Fatigue is a general complaint that occurs in almost all physical and mental diseases. Fatigue also negatively affects an individual's well-being, daily performance, activities of daily living (ADLs) and relationships. Fatigue is one of the symptoms that, if not controlled, negatively affects the individual's daily living activities and quality of life (2). While breathing itself is a way of relaxation, it is also a part of all relaxation exercises and is an exercise that can be used in daily life. Breathing correctly and deeply is the first step in learning to relax. (3). It is important to identify fatigue, minimize it, plan daily living activities and improve quality of life in patients with GDM. This study will be conducted as a randomized controlled study to determine the fatigue and quality of life of diaphragmatic breathing exercises, one of the non-pharmacological methods, on pregnant women with gestational diabetes. ### Conditions - Gestational Diabetes Mellitus in Pregnancy - Pregnancy in Diabetic - Fatigue - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Experimental Group ### Outcomes Primary Outcomes - SF-36 Quality of Life Scale: Secondary Outcomes - Visual Similarity Scale for Fatigue ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cerebellar rTMS in Patients With Multiple Sclerosis - NCT ID: NCT06265922 - Study ID: P.T.REC/012/003937 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-18 - Completion Date: 2024-06-02 - Lead Sponsor: Cairo University ### Study Description To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis. ### Conditions - Patients With Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High frequency repetitive transcranial magnetic stimulation - Sham repetitive transcranial magnetic stimulation ### Outcomes Primary Outcomes - Biodex balance system Secondary Outcomes - Berg balance scale - Nine-Hole Peg Test (9-HPT) - Four square step test (FSST) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prospective Real World Study on Therapy Prediction Algorithm Training - NCT ID: NCT06265909 - Study ID: PRW001 - Status: COMPLETED - Start Date: 2015-03-01 - Completion Date: 2022-12-31 - Lead Sponsor: Mobio Interactive PTE LTD ### Study Description This study examines the impact of using an algorithm to select therapy content for patients engaged with the mobile mental health platform AmDTx (Mobio Interactive). The algorithm is to be trained with three separate sources of data. Two sources of data come from self-reports by the patients themselves, provided before and after engaging with therapy content. The third source of data comes from an objective measurement of psychological stress, made possible through artificial analysis of computer vision data captured from the mobile device camera as the patient completes a 30 second selfie video before and after engaging with therapy content. ### Conditions - Stress - Emotional Wellbeing ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AmDTx ### Outcomes Primary Outcomes - Objective Stress Level (OSL) - Self-Reported Stress (SRS) - Self-Reported Mood (SRM) Secondary Outcomes ### Location - Facility: Mobio Interactive Pte Ltd, Singapore, N/A, 389637, Singapore @@
## Effect of Kinesiotaping on Activation of Abdominal Muscles in Female Patients With Stress Urinary Incontinence - NCT ID: NCT06265896 - Study ID: P.T.REC/012/004948 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-01 - Lead Sponsor: Cairo University ### Study Description This study will be conducted to evaluate the effect of kinesiotaping on activation of abdominopelvic cavity for management of stress urinary incontinence females' patients. ### Conditions - Stress Urinary Incontinence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Kinesio taping - Pelvic floor exercise training ### Outcomes Primary Outcomes - Pelvic floor impact questionnaire- short form 7 (PFIQ-7) - King's Health Questionnaire (KHQ) Secondary Outcomes - Assessment of pelvic floor muscle strength ### Location - Facility: Cairo University, Giza, N/A, N/A, Egypt @@
## Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT - NCT ID: NCT06265883 - Study ID: MIIR-16-Retro - Status: COMPLETED - Start Date: 2019-07-01 - Completion Date: 2022-12-31 - Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University ### Study Description This multicenter retrospective study evaluated consecutive patients with large HCC and PVTT who received lenvatinib plus DEB-TACE with/without FOLFOX-HAIC between July 2019 and June 2021. Tumor response, time to progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups. ### Conditions - Hepatocellular Carcinoma Non-resectable ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Len+DEB-TACE+HAIC - Len+DEB-TACE ### Outcomes Primary Outcomes - Time to progression (TTP) Secondary Outcomes - objective response rate (ORR) - Disease control rate (DCR) - overall survival - treatment-related adverse events (TRAEs) ### Location - Facility: The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510260, China @@
## Specific Versus Empirical Anthelminthic Treatment in Eosinophilia - NCT ID: NCT06265870 - Study ID: Parasite in Eosinophilia - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-12-31 - Lead Sponsor: Prince of Songkla University ### Study Description There are a few guidelines recommend about management of eosinophilia worldwide, most of guielines recommend a thorough history-taking and physical examination. Subsequently, investigations are requested based on suspected causes. In cases where parasite infection is suspected, particularly in developing countries, stool microscopy and serology are recommended. However, limitations such as low sensitivity of stool microscopy, the inconvenience of collecting multiple stool samples, and the high cost and unavailability of serology may arise. Consequently, some physicians opt for empiric anthelminthic regimens in managing eosinophilic patients, even without stool tests or if stool test results are normal. If subsequent complete blood count (CBC) results show a recovery of absolute eosinophil count, it is assumed that eosinophilia was caused by a parasite infection. While some studies demonstrate the efficacy and simplicity of this approach, there is a risk of overestimating parasite infection in eosinophilic patients, potential adverse drug reactions from unnecessary anthelminthic treatment, and the possibility of drug resistance due to inappropriate dosing. To address this gap, no study has yet compared the efficacy between specific anthelminthic treatment based on test results and empirical anthelminthic treatment in eosinophilic patients. Therefore, the investigators are conducting this study. ### Conditions - Eosinophilia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Albendazole - Ivermectin or albendazole ### Outcomes Primary Outcomes - Eosinophilia recovery Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients - NCT ID: NCT06265857 - Study ID: IOE-naoxiaoxueguan - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-06 - Lead Sponsor: Zeng Changhao ### Study Description Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach. ### Conditions - Cerebral Small Vessel Diseases - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent Oro-esophageal Tube Feeding - Nasogastric Tube Feeding - comprehensive rehabilitation therapy ### Outcomes Primary Outcomes - Video Fluoroscopic Swallowing Study Secondary Outcomes - Functional Oral Intake Scale - Body mass index - Serum albumin - Hemoglobin - Pneumonia - Activities of daily living - World Health Organization Quality of Life Assessment Instrument Brief Version ### Location - Facility: Thai Rehabilitation Community Center, Ban Phon Ko, N/A, N/A, Thailand @@
## Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma - NCT ID: NCT06265844 - Study ID: IOE-Biyanai - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-09-30 - Lead Sponsor: Zeng Changhao ### Study Description This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent Oral-esophageal Tube Feeding - Nasogastric Tube Feeding - comprehensive rehabilitation therapy ### Outcomes Primary Outcomes - Hemoglobin - Serum albumin - Body Mass Index - Serum prealbumin Secondary Outcomes - Depression - Functional Oral Intake Scale - Penetration-Aspiration Scale - Swallowing-Quality of Life questionnaire - Feeding amount ### Location - Facility: Saint Martin Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## The Effect of Face Hand Fan Application on Dyspnea - NCT ID: NCT06265831 - Study ID: BU-FHS-NC-03 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-01 - Completion Date: 2024-03 - Lead Sponsor: Bartın Unıversity ### Study Description Diagnosing and managing dyspnea in patients with COPD is very important. Although pharmacological and non-pharmacological methods are used in the management of dyspnea, it is recommended that pharmacological methods be supported by non-pharmacological methods. Hand fan application, which is one of the non-pharmacological methods used in dyspnea management, provides an increase in self-efficacy in patients in addition to the stimulation of cold air flow to the trigeminal nerve branches, mucosa and skin. Although there are studies reporting that applying cold air to the face with a hand fan is effective in reducing the severity of dyspnea in different patient groups, the number of studies examining the effectiveness of applying cold air to the face with a hand fan in patients with COPD is quite limited. This project was planned to determine the effect of applying cold air to the face with a fan on the severity of dyspnea and quality of life in COPD patients. ### Conditions - COPD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Hand-fan application to the face ### Outcomes Primary Outcomes - Modified Borg Scale Secondary Outcomes - Saint George Respiratory Questionnaire ### Location - Facility: Necmiye ÇÖMLEKÇİ, Bartın, N/A, 74100, Turkey @@
## The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder - NCT ID: NCT06265818 - Study ID: 2024-KY-0126 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05 - Lead Sponsor: Zeng Changhao ### Study Description The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups. ### Conditions - Respiratory Rhythm Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Rehabilitation training - Active Breathing Exercises ### Outcomes Primary Outcomes - The Penetration-Aspiration Scale Secondary Outcomes - The Functional Oral Intake Scale - Yale Pharyngeal Residue Severity Rating Scale - Fiberoptic Endoscopic Dysphagia Severity Scale - Murray Secretion Scale - Swallowing Quality of Life ### Location - Facility: Center Rehabilitation Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients - NCT ID: NCT06265805 - Study ID: 2024-KY-0125-015 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-12-30 - Lead Sponsor: Zeng Changhao ### Study Description The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups. ### Conditions - Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - comprehensive rehabilitation therapy - Intermittent Oro-esophageal Tube Feeding - Nasogastric Tube Feeding ### Outcomes Primary Outcomes - Generalized Anxiety Disorder 7 Secondary Outcomes - Patient Health Questionnaire-9 - Self-made questionnaire ### Location - Facility: Hsinchu Rehabilitation Hospital, Xinzhu, N/A, N/A, Taiwan @@
## Efficacy of Stellate Ganglion Block in Obstructive Sleep Apnea - NCT ID: NCT06265792 - Study ID: 2024-KY-0125 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-15 - Lead Sponsor: Zeng Changhao ### Study Description The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - routine rehabilitation treatment - Stellate ganglion block ### Outcomes Primary Outcomes - Epworth Sleepiness Scale Secondary Outcomes - Apnea-Hypopnea Index ### Location - Facility: Center Rehabilitation Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia - NCT ID: NCT06265779 - Study ID: 2024-KY-0122 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-12-15 - Lead Sponsor: Zeng Changhao ### Study Description The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect. ### Conditions - Cerebral Infarction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Comprehensive rehabilitation therapy - Intermittent Oro-esophageal Tube Feeding - Transcranial direct current stimulation ### Outcomes Primary Outcomes - Penetration Aspiration Scale Secondary Outcomes - Functional Oral Intake Scale - Swallowing Quality of Life Questionnaire - Patient Health Questionnaire-9 - Body weight - Nutritional status-total protein - Nutritional status-albumin ### Location - Facility: Center Rehabilitation Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Brain STimulation for Arm Recovery After Stroke 2 - NCT ID: NCT06265766 - Study ID: NL85511.041.24 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-12-31 - Lead Sponsor: Jord Vink ### Study Description Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days.Objective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center.Study design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial.Study population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a Motricity Index between 9 and 99, in whom cTBS treatment can be started within 3 weeks after stroke onset.Intervention: 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb.Main study parameters/endpoints: The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days after stroke. Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test, Nine Hole Peg Test, Stroke Impact Scale, EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - cTBS ### Outcomes Primary Outcomes - Upper extremity section of the Fugl-Meyer Assessment Secondary Outcomes - Upper extremity section of the Fugl-Meyer Assessment - Action Research Arm Test - modified Rankin Scale - Hand section of Stroke Impact Scale - Participation section of Stroke Impact Scale - EuroQol-5D - Nine Hole Peg Test - Ipsilesional corticospinal excitability - iMTA medical consumption and productivity cost questionnaire ### Location - Facility: Reade, Amsterdam, N/A, N/A, Netherlands @@
## Gastrocinemius Function Massage on Lower Extemity Spasticity - NCT ID: NCT06265753 - Study ID: Gastrocimemius spasticity - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-23 - Completion Date: 2024-09-01 - Lead Sponsor: Pamukkale University ### Study Description This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients. ### Conditions - Stroke - Stroke Ischemic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Gastrocinemius Function Massage - Sham application ### Outcomes Primary Outcomes - Spasticity - Gait parameters and fall risk Secondary Outcomes ### Location - Facility: University Address, Denizli, Muş Alparslan University, 20100, Turkey @@
## Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota - NCT ID: NCT06265740 - Study ID: RBHP 2023 GALLOT (PREMABIOTE) - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-11 - Lead Sponsor: University Hospital, Clermont-Ferrand ### Study Description Objectives: to assess the relevance of the "RiboTaxa" algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population.Study description: Longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth). ### Conditions - Premature Birth - Vaginal Flora ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - vaginal swab ### Outcomes Primary Outcomes - Early diagnosis of preterm birth using vaginal microbiota analysis Secondary Outcomes ### Location - Facility: CHU de Clermont-Ferrand, Clermont-Ferrand, N/A, N/A, France @@
## A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors - NCT ID: NCT06265727 - Study ID: CRB-701-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-01-27 - Lead Sponsor: Corbus Pharmaceuticals Inc. ### Study Description The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4.The main questions it aims to answer are:What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701?Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors. ### Conditions - Solid Tumor, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - CRB-701 ### Outcomes Primary Outcomes - Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701 - Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR) - Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR) Secondary Outcomes - Parts A, B, % C: To characterize the safety profile of CRB-701 - Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax) - Maximum observed plasma concentration of free MMAE (Cmax) - Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax) - Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax) - Time to reach Cmax of free MMAE (Tmax) - Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax) - Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax) - Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC) - Total Area Under the plasma concentration-time curve of free MMAE (AUC) - Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC) ### Location - Facility: Moores Cancer Centre at UC San Diego Health, San Diego, California, 92037, United States @@
## The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia - NCT ID: NCT06265714 - Study ID: LB.02.01/VII/005/KEP005/2022 - Status: COMPLETED - Start Date: 2021-07-23 - Completion Date: 2023-09-23 - Lead Sponsor: Indonesia University ### Study Description Patients in the Intensive Cardiovascular Care Unit (ICCU) often present with cardiovascular disease (CVD) issues accompanied by various non-cardiovascular conditions. However, a widely applicable scoring system to predict patient outcomes in the ICCU is lacking. Therefore, developing and validating scores for predicting ICCU patient outcomes are warranted. The aims of the IndONEsia ICCU (One ICCU) registry include developing an epidemiological registry of ICCU patients and establishing a multicentre research network to analyse patient outcomes.This nationwide multicenter cohort will capture data from patients receiving cardiovascular critical care treatment in 10 Indonesian hospitals with ICCU facilities. Recorded data will encompass demographic characteristics, physical examination findings at hospital and ICCU admission, diagnoses at ICCU admission, therapy, intervention, complications on days 3 and 5 of in-ICCU care, in-hospital outcomes, and 30-day outcomes. The One ICCU is a large, prospective registry describing the care process and advancing clinical knowledge in ICCU patients. It will serve as an investigational platform for predicting the mortality of ICCU patients. ### Conditions - Cardiovascular Diseases - Acute Coronary Syndrome - Heart Failure - Heart Disease, Coronary - Infections - Sepsis - Stroke - Shock - Chronic Kidney Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Alive - Death - Readmitted to ICCU - Rehospitalization Secondary Outcomes ### Location - Facility: Prof. dr. I.G.N.G. Ngoerah General Hospital, Denpasar, Bali, N/A, Indonesia @@
## Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms? - NCT ID: NCT06265701 - Study ID: IRB0148200 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-03-12 - Lead Sponsor: Cornell University ### Study Description The goal of this clinical trial is to explore the efficacy of a reflective journaling intervention-"Me Through Time"- in decreasing levels of derailment, and its impact on downstream depressive symptoms. ### Conditions - Depression - Depressive Symptoms - Derailment - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Derailment-Focused Reflective Journaling - Everyday Tasks Reflective Journaling ### Outcomes Primary Outcomes - Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment) - Change from Pre-Assessment in Levels of Derailment on the Derailment Scale at Session 5 Secondary Outcomes - Change from Pre-Assessment in Anxiety Symptoms on the Generalized Anxiety Disorder - 7 (GAD-7) at Week 2 (Session 6/Post-Assessment) - Change from Pre-Assessment in Levels of Positive and Negative Affect on the Positive and Negative Affect Schedule (PANAS) at Week 2 (Session 6/Post-Assessment) - Change from Pre-Assessment in Levels of Perceived Stress on the Perceived Stress Scale (PSS) at Week 2 (Session 6/Post-Assessment) - Change from Pre-Assessment in Levels of Optimism Versus Pessimism on the Life Orientation Test - Revised (LOT - Revised) at Week 2 (Session 6/Post-Assessment ### Location - Facility: Cornell University, Ithaca, New York, 14850, United States @@
## First In Human Study of CX-2051 in Advanced Solid Tumors - NCT ID: NCT06265688 - Study ID: CTMX-2051-101 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2029-03-31 - Lead Sponsor: CytomX Therapeutics ### Study Description The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 in adult participants with advanced solid tumors. ### Conditions - Solid Tumor, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CX-2051 ### Outcomes Primary Outcomes - Safety and tolerability of CX-2051 - Determine the recommended Phase 2 dose (RP2D) Secondary Outcomes - Objective response rate (ORR) - Duration of response (DOR) - Progression-free survival (PFS) - Disease control rate (DCR) - Duration of disease control (DODC) - Overall survival (OS) ### Location - Facility: Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States @@
## Comparison of the Efficacy of Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve - NCT ID: NCT06265675 - Study ID: E1-4066/2023 - Status: RECRUITING - Start Date: 2024-01-24 - Completion Date: 2025-06-24 - Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital ### Study Description There are different neurolysis methods. Aim of this study is to compare two different methods, phenol block and corticosteroid local anesthetic block. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Phenol - Celestone - Lidocain ### Outcomes Primary Outcomes - Numeric Rating Scale (NRS) Secondary Outcomes - Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Patient Global Impression of Change (PGIC) - Sixt Minute Walk Test (6MWT) - The Timed-Up and Go test - Frequency of analgesic usage ### Location - Facility: Gaziler, Ankara, Çankaya, N/A, Turkey @@
## A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand - NCT ID: NCT06265662 - Study ID: 66701100301 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-09 - Lead Sponsor: Chulalongkorn University ### Study Description The goal of this quasi-experimental study is to test the effectiveness of a digital health program designed to prevent non-communicable diseases (NCDs) in employees within a workplace setting in Thailand. The main questions it aims to answer are:* Can a digital health program help participants lose weight?* Does the digital health program improve other health outcomes such as Body Mass Index (BMI), blood lipid levels (triglycerides and LDL), blood sugar levels (HbA1c or fasting plasma glucose), and blood pressure? Is the digital health program feasible and acceptable in the Thai workplace setting, as measured by participation rates, usage, and participant satisfaction?Participants will:* Attend four group health education sessions, each lasting one hour, scheduled over a six-month period.* Have unlimited access to individual chat consultations with a healthcare team, including doctors, dietitians, fitness coaches, and psychologists, available from 9:00 AM to 5:00 PM on workdays, excluding public holidays. ### Conditions - Chronic Disease - Noncommunicable Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand ### Outcomes Primary Outcomes - Weight Secondary Outcomes - BMI - Total cholesterol - Triglycerides - HDL - LDL - HbA1c - Fasting plasma glucose - blood pressure - Feasibility (number of consented participants to all eligible participants ratio) - Acceptability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of NOM for ACLD Between Medical and Surgical Ward - NCT ID: NCT06265649 - Study ID: NOM-ALCD - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-03 - Lead Sponsor: Ospedali Riuniti Trieste ### Study Description In Europe, patients with acute left colon diverticulitis (ALCD) are usually admitted to surgical wards even when only medical treatment is required. The study compares ALCD non-operative management (NOM) between surgical and non-surgical environments regarding clinical outcomes, hospitalization length(LOS), and follow-up. ### Conditions - Diverticulitis - Colon Disease - Acute Diverticulitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - NOM ### Outcomes Primary Outcomes - Hospitalization length Secondary Outcomes - Follow-up and recurrences ### Location - Facility: Manuela Mastronardi, Trieste, TS, 34149, Italy @@
## Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders - NCT ID: NCT06265636 - Study ID: 2006202325523 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-17 - Completion Date: 2026-05-15 - Lead Sponsor: OrigenKinesis fisioterapia ### Study Description Temporomandibular disorders (TMD) encompass dysfunction and pain of the masticatory muscles and temporomandibular joint (TMJ). Pain in the TMJ, restricted jaw movement, and joint sounds are common conditions in this disorder. This can impact patients' ability to perform daily activities such as eating, speaking, laughing, or yawning, significantly affecting their quality of life.The TMJ and masticatory muscles are innervated by the auriculotemporal branch and the mandibular nerve (V3), a branch of the trigeminal nerve. An estimated 60% to 70% of the population shows signs of TMD, of which up to 12% report intense symptoms requiring treatment.Percutaneous electrical nerve stimulation (PENS) could be a clinically relevant therapy in TMD patients applied through minimally invasive physiotherapy. To our knowledge, there are no trials evaluating the non-surgical clinical efficacy of PENS on the mandibular nerve.The project's objective is to assess the effectiveness of PENS on the mandibular nerve in this type of condition. ### Conditions - Temporomandibular Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Percutaneous nerve stimulation - Manual therapy - exercise ### Outcomes Primary Outcomes - pain intensity - Pressure pain thresholds (PPT) - Pain-free mandibular opening range of motion Secondary Outcomes - Self-reported quality of life (SF-12) - Electromyographic activation rate of the masseter muscle. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study). - NCT ID: NCT06265623 - Study ID: UKE-IKPT 2024/01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-09-30 - Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf ### Study Description This study aims to analyze if patients with chronic obstructive lung disease who experience a decline of blood oxygen saturation during physical exercise have a disease course different from that of COPD patients who do not experience a decline in blood oxygen saturation during exercise. Patients will be followed for a total of 3 years. ### Conditions - Chronic Obstructive Pulmonary Disease (COPD) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No active intervention, but observational follow-up ### Outcomes Primary Outcomes - Difference in FEV1(% of LLN) between baseline and end-of-follow-up Secondary Outcomes - Difference in all-cause mortality during follow-up between groups - Difference in COPD-related mortality during follow-up between groups - Difference in frequency of hospital admissions for exacerbation of COPD during follow-up between groups - Difference in frequency of hospital admissions for causes other than exacerbation of COPD during follow-up between groups - Sensitivity of plasma biomarkers (spec. ADMA and SDMA) to predict the prevalence of exertional desaturation in COPD patients - Sensitivity and specificity of plasma biomarkers (spec. ADMA and SDMA) measured at baseline to prospectively predict the slope of lung function decline in COPD patients - Sensitivity and specificity of plasma biomarkers at baseline to prospectively predict the mortality rate in COPD patients - Difference in incidence and extent of exercise hypoxemia between carriers and non-carriers of single nucleotide polymorphisms (SNPs) in genes of the L-arginine - dimethylarginine pathway - Difference in positive and negative predictive value of bicycle ergometry, 6-minute walk test, and 15-sec breath-hold test to discriminate between COPD patients with exertional desaturation versus those without exertional desaturation ### Location - Facility: University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology, Hamburg, N/A, 20246, Germany @@
## A Comparison Of The Effect Of Target-Controlled Infusion Anesthesia And Inhalation Anesthesia - NCT ID: NCT06265610 - Study ID: 2022/186 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2023-10-01 - Lead Sponsor: TC Erciyes University ### Study Description A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study. ### Conditions - Pediatric Patients - Cardiology ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - TIVA/TCI ### Outcomes Primary Outcomes - intraoperative period - postoperative period - hemodynamic parameters Secondary Outcomes - Modified Aldrete Recovery Score ### Location - Facility: Sibel Seçkin Pehlivan, Kayseri, Talas, 38039, Turkey @@
## The Effect of Healthy Nutrition and Yoga Program on Obese Children - NCT ID: NCT06265597 - Study ID: EU-SBE-DŞ-01 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-09-14 - Completion Date: 2024-12-02 - Lead Sponsor: TC Erciyes University ### Study Description This study was planned to examine the effects of a healthy nutrition and yoga program given to obese children on nutritional behavior, physical activity and anthropometric measurements. ### Conditions - Obesity, Childhood ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Healthy Nutrition and Yoga Program ### Outcomes Primary Outcomes - Anthropometric Measurements and Child Follow-up Form - Family Nutrition and Physical Activity Scale - Adolescent Identification Form Secondary Outcomes ### Location - Facility: Karaman Provincial Directorate of National Education, Karaman, N/A, 70200, Turkey @@
## Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant - NCT ID: NCT06265584 - Study ID: IRB-300011730 (UAB2370) - Status: NOT_YET_RECRUITING - Start Date: 2024-06-28 - Completion Date: 2028-05 - Lead Sponsor: University of Alabama at Birmingham ### Study Description In an effort to reduce graft versus host disease (GVHD) and enhance graft versus leukemia (GVL) effect post allogenic hematopoietic stem cell transplantation (AHSCT), recent research has focused on host immune cell depletion. Frame shifting anti-thymocyte globulin (ATG) backwards to earlier days before days 0 can result in deeper host and less graft T-cell depletion, leading to better immune reconstitution. Preliminary data where 80% of the ATG dose is given on days -6,-5,-4 and 20% given on day -1, showed effective prevention of severe acute GVHD, chronic GVHD and favorable early immune reconstitution. We hypothesize that our 2 step ATG dosing platform when combined with standard tacrolimus and mini methotrexate can prevent grade III-IV acute GVHD and chronic GVHD, resulting in improvement of GVHD/relapse free survival at one year post transplant. ### Conditions - Acute Leukemia - Myelodysplastic Syndrome - Myeloproliferative Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ATG dosing platform when combined with standard tacrolimus and mini methotrexate ### Outcomes Primary Outcomes - Rate of GRFS (graft versus host disease GVHD, relapse free survival) at one year post transplant. Secondary Outcomes ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## Postoperative Pain in Shoulder Surgery - NCT ID: NCT06265571 - Study ID: EskisehirUO - Status: COMPLETED - Start Date: 2020-11-15 - Completion Date: 2021-07-15 - Lead Sponsor: Eskisehir Osmangazi University ### Study Description After the approval of the ethics committee, the files of the patients who underwent arthroscopic shoulder surgery between 01.01.2019 and 01.03.2020 were evaluated retrospectively.Data were recorded including age, gender, duration of anesthesia, duration of surgery, postoperative analgesia consumption, complications such as respiratory distress due to hemidiaphragmatic paralysis and complications such as hematoma and nerve damage due to block intervention. ### Conditions - Pain, Postoperative ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - perineural injection ### Outcomes Primary Outcomes - rescue analgesia - difference between the analgesic methods Secondary Outcomes ### Location - Facility: Ferda YAMAN, Eskişehir, Odunpazarı, 26040, Turkey @@
## Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery - NCT ID: NCT06265558 - Study ID: PROICM 2023-08 TPN - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-02 - Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle ### Study Description There is little scientific data concerning the use of negative pressure therapy after immediate breast reconstruction.That strategy of treatment-reconstruction has expanded increasingly since the last years.The current literature reports only 3 studies on the use of preventive negative pressure therapy in oncologic breast surgery.Moreover, all three are retrospective, case-control studies with serious limitations.The largest published series reports a reduction in the overall complication rate from 15.9% to 8.5%, and a significant reduction in several criteria: infection, scar dehiscence and necrosis. However, the study presents significant biases, with non-comparable populations in terms of comorbidities, surgical procedure performed, inclusion periods (and therefore experience in performing oncological surgery).There was also a high probability of under-assessment or postponement of post-operative complications, which is typical of published retrospective surgical studies.The published results therefore strongly encourage further investigation of negative pressure therapy in oncological breast surgery. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Negative pressure therapy (NPT) - Dressing ### Outcomes Primary Outcomes - Rate of patients with post-operative scarring trouble Secondary Outcomes - Rate of patients with a surgical site infection - Surgical revision rate - Rate of patients with at least one rehospitalization - Surgical complication rate by Clavien-Dindo classification - Time to initiation of adjuvant therapy - Quality of life evaluated by questionnaire QLQ-C30 (Version 3) - Quality of life evaluated by questionnaire QLQ-BReast cancer (BR23) - Patient satisfaction about cosmetic result evaluated using the BR23 questionnaire - Medical cost of post-surgery care ### Location - Facility: Centre Hospitalier de Nîmes, Nîmes, Gard, 30900, France @@
## Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia - NCT ID: NCT06265545 - Study ID: RR-AML-2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-06-30 - Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China ### Study Description To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens. ### Conditions - AML - Refractory - Relapsed ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Ivosidenib,Venetoclax,gilteritinib,Selinexor ### Outcomes Primary Outcomes - Complex response (CRc) rate (including CR and CRi) Secondary Outcomes - mortality associated with salvage treatment (30 days, 60 days) - MRD-negative complete response rate - Overall survival - Event-free survival - Relapse-free survival ### Location - Facility: Blood Hospital, Tianjin, N/A, 300020, China @@
## Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect - NCT ID: NCT06265532 - Study ID: Pro00060157 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2025-05-31 - Lead Sponsor: Hal Chapman ### Study Description The primary purpose of this substudy is to determine if collagen-targeted PET using the type 1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can inform as to drug effect of EGCG and assist in dose selection. ### Conditions - Idiopathic Pulmonary Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - EGCG 300 mg - Placebo for EGCG 300 mg - EGCG 600 mg - Placebo for EGCG 600 mg ### Outcomes Primary Outcomes - Change in collagen probe uptake over the entire lungs Secondary Outcomes ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## Association of Urine BDNF and NGF With Lower Urinary System Parameters - NCT ID: NCT06265519 - Study ID: MAR.UAD.008 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-07-01 - Lead Sponsor: Marmara University ### Study Description Histologically, BPH is a benign proliferative process involving both epithelial and stromal elements and is characterised by progressive enlargement of the prostate. Symptom complex including increased frequency of urination, sudden feeling of urge to urinate, nocturia, difficulty in urinating, feeling of incomplete emptying of the bladder, decreased flow rate and intermittent urination are called lower urinary tract symptoms (LUTS). The most important cause of LUTS in men is BPH. Many structural and physiological changes occur in the lower urinary system with bladder outlet obstruction. Detrusor hypertrophy and bladder hyperactivity may occur due to bladder outlet obstruction. Although the density of afferent and efferent nerves in the bladder decreases after urethral obstruction, enlargement of their trunks indicates that changes occur in these nerves. In addition, changes also occur in the neural pathways of the central nervous system following lower urinary tract obstruction. Nerve growth factor (NGF) and brain derived neurotropin factor (BDNF) are trophic proteins that act as retrograde messengers between peripheral effector tissue and the nerves that innervate it. In peripheral tissues, the source of NGF and BDNF is presumed to be the target tissues innervated by nerves. Smooth muscle cells, fibroblasts, astrocytes and other cells synthesise NGF and BDNF in culture medium. Many potential stimuli that increase NGF in the lower urinary system have been identified. These are denervation, inflammation and mechanical tension. This information has led to the idea that autonomic innervation changes in the bladder may be related with changing NGF levels. Altered afferent and adrenergic innervation in the obstructed bladder increases the possibility that NGF plays an important role in this neural growth because this type of nerves are highly sensitive to this neurotrophin.In this study, we investigated NGF ve BDNF levels in urine samples obtained before surgery (Transurethral Prostate Resection, Prostate Enucleation with Holmium Laser and Prostate Enucleation with Thulium Fibre Laser) and after removal of obstruction in patients with bladder outlet obstruction secondary to benign prostatic enlargement using ELISA method, We aimed to determine the role of NGF and BDNF in bladder outlet obstruction and bladder changes secondary to obstruction by comparing with control patients without obstruction. ### Conditions - Benign Prostatic Hyperplasia With Outflow Obstruction - Lower Urinary Tract Obstructive Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Holmium laser enucleation of the prostate ### Outcomes Primary Outcomes - Uroflowmetry Secondary Outcomes - International prostate symptom score ### Location - Facility: Marmara University Hospital, Istanbul, N/A, N/A, Turkey @@
## Virtual Incentive Treatment for Alcohol - NCT ID: NCT06265506 - Study ID: 20320 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-19 - Completion Date: 2028-04-04 - Lead Sponsor: Washington State University ### Study Description The overall objective of this program of research is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention. This study will test a telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth \>= 200 ng/mL), and alcohol-related harms (e.g., smoking, drug use). This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. Investigators will conduct an economic analysis to place the cost of this model in the context of downstream CM-associated cost-offsets and improvements in personal and public health. ### Conditions - Alcohol Use Disorder - Alcohol Drinking - Alcohol Abuse - Alcohol Dependence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Contingency Management - Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT) ### Outcomes Primary Outcomes - Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3) - Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite - Aim 2) Alcohol-Related Harms: Patient Health Questionnaire-9 (PHQ-9) - Aim 2) Alcohol-Related Harms: Generalized Anxiety Disorder-7 (GAD-7) - Aim 2) Alcohol-Related Harms: Short Form Health Survey-12 (SF-12) - Aim 2) Alcohol-Related Harms & Aim 4) Cost Analysis: Non-study Medical and Other Services (NMOS) form - Aim 2) Alcohol Related Harms: Fagerstrom - Aim 2) Alcohol Related Harms: Urine Drug Tests - Aim 2) Alcohol Related Harms: Perceived Stress Scale (PSS-10) - Aim 3) Predictors: Demographics - Aim 3) Predictors: Addictions Neuroclinical Assessment (ANA) Questionnaire - Aim 3) Predictors: TestMyBrain - Aim 3) Predictors: Positive Negative Affect Schedule (PANAS) - Aim 3) Predictors: Situational Confidence Questionnaire-8 (SCQ-8) - Aim 3) Predictors: Alcohol Craving VAS - Aim 4) Cost Analysis: Drug Abuse Treatment Cost Analysis Program (DATCAP) - Aim 4) Cost Analysis: PROPr Secondary Outcomes - Aim 1) Alcohol Abstinence: Regular excessive drinking ### Location - Facility: Washington State University, Spokane, Washington, 99201, United States @@
## Postoperative Infectious Complications Calculator for Elderly Patients - NCT ID: NCT06265493 - Study ID: PLAGH-AOC-L02 - Status: COMPLETED - Start Date: 2021-06-01 - Completion Date: 2023-09-30 - Lead Sponsor: Weidong Mi ### Study Description The investigators established a first-ever convenient scoring system for clinicians to assess the risk of Postoperative infectious complications (PICs) for elderly patients. Our scoring system can aid in the early detection of potential risks for postoperative infections. Higher-score patients were more likely to experience postoperative infections. ### Conditions - Postoperative Infection - Geriatrics - Prediction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Postoperative Infectious Complications Calculator for Elderly Patients Secondary Outcomes ### Location - Facility: Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital, Beijing, Beijing, 100853, China @@
## FallFitness Fallprevention Program for Older Adults - NCT ID: NCT06265480 - Study ID: 2023-04577-01 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Dalarna University ### Study Description The overall aim with this project is to collaborate with four organisations for retired persons located in a small region of middle Sweden. The project aims to test and evaluate a newly developed group-based fall prevention exercise program regarding the effects and experiences of both leading and participating in the intervention. The design of the study is a randomised controlled trial including a total of 100 participants (60+), 50 participants in the intervention and 50 participants in the control group. ### Conditions - Fall Injury - Fall - Self Efficacy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - FallFitness intervention group ### Outcomes Primary Outcomes - Physical function by Short Physical Performance Battery Secondary Outcomes - Self-efficacy (balance confidence) - Fear of Falling - EuroQoL-5 Dimension Questionnaire (EQ-5D) - Fallfrequency - Falling techniques - Handgrip strength ### Location - Facility: Marina Arkkukangas, Eskilstuna, Sormland, N/A, Sweden @@
## Evaluation of Two Different Techniques for Sinus Elevation, Open Versus Closed . - NCT ID: NCT06265467 - Study ID: 28909108800228 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-07-01 - Lead Sponsor: Misr International University ### Study Description A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. One technique is the open lateral window technique and the second is the closed crestal technique. ### Conditions - Alveolar Ridge Augmentation - Sinus Floor Augmentation - Maxillary Sinus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Closed Sinus Elevation - Open Sinus Elevation ### Outcomes Primary Outcomes - Implant Stability Secondary Outcomes - Radiographic bone gain ### Location - Facility: Suez Canal University, Ismailia, N/A, 41522, Egypt @@
## Low Dose Atropine Eye Drops in Myopic Egyptian Children - NCT ID: NCT06265454 - Study ID: LDAED IN MC - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-03-30 - Lead Sponsor: Ain Shams University ### Study Description Previous Studies reported that low concentration atropine eye drops may be effective in increasing the choroidal blood flow and thickness and this slows myopia progression.purpose of the study is to compare changes in axial length, anterior chamber depth, choroidal thickness, central corneal thickness and anterior scleral thickness among myopic children receiving atropine 0.05% or 0.01% and placebo. ### Conditions - Myopia Progression - Axial Length, Eye - Sclera Thickness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - low dose atropine eye drops - Placebo ### Outcomes Primary Outcomes - change in the average Choroidal Thickness over follow up period. Secondary Outcomes ### Location - Facility: Ain shams university, Cairo, Abbasia, 11517, Egypt @@
## Comparison of Pain Relief Post Knee Arthroscopy Using IPACK + Adductor Canal Block vs. Adductor Canal Block Alone - NCT ID: NCT06265441 - Study ID: MS42/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10-01 - Lead Sponsor: Ain Shams University ### Study Description In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries focusing on VAS score assessment at 8 hours postoperative. ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected - Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25% ### Outcomes Primary Outcomes - Assessment of pain using the visual analogue scale (VAS) upon first ambulation after 8 hours from the completion of the surgical procedure and skin closure. Secondary Outcomes - Total analgesics consumption - The time till first analgesic requirement - The range of movement (ROM) - The number of steps ### Location - Facility: Ain Shams University, Cairo, Abbassia, 00202, Egypt @@
## A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer - NCT ID: NCT06265428 - Study ID: DB-1303-O-3001 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2026-02 - Lead Sponsor: DualityBio Inc. ### Study Description This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane. ### Conditions - HER2-positive Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DB-1303/BNT323 - T-DM1 ### Outcomes Primary Outcomes - Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Secondary Outcomes - Overall Survival (OS) - Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1 - Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1 - Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1 - PK parameters: maximum observed concentration (Cmax) - PK parameters: time to maximum concentration (Tmax) - Adverse events (AEs) - Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30 - Patient reported outcomes (PROs): EORTC QLQ-BR45 - Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) - European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) - Anti-drug antibodies (ADA) ### Location - Facility: The Fifth Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, Beijing, 100039, China @@
## Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine - NCT ID: NCT06265415 - Study ID: Soh-Med-24-01-07MS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2025-03-30 - Lead Sponsor: Sohag University ### Study Description Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.control of blood pressure is of crucial importance to avoid maternal and fetal complications.Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE ### Conditions - Severe Preeclampsia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Labetalol - Nitroglycerine - Nifedipine ### Outcomes Primary Outcomes - duration of control blood pressure Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Retrolaminar Block Versus Tab Block in Abdomioasty - NCT ID: NCT06265402 - Study ID: 36264 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2025-12-15 - Lead Sponsor: Tanta University ### Study Description The aim of the study is to compare the analgesic efficacy of Us guided retrolaminar block versus transversus abdominis plane block in patient under going abdominal plastic surgery ### Conditions - Block ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Tab block versus retrolaminar block in abdominal plastic surgery ### Outcomes Primary Outcomes - Total dose of morphine consumption in the first postoperative 24hours Secondary Outcomes ### Location - Facility: TantaU U, Tanta, N/A, N/A, Egypt @@
## Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug - NCT ID: NCT06265389 - Study ID: Pentoxifylline in pneumonia - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10-30 - Lead Sponsor: Tanta University ### Study Description Pentoxifylline is a xanthine-derived, commercially produced drug approved for the management of intermittent claudication in patients suffering from a chronic occlusive arterial disease of the limbs. Pentoxifylline has been documented to display anti-inflammatory and immunomodulatory effects, as well as some antithrombotic and antiviral effects. This drug has also been shown to reduce lung fibrosis in patients with COVID-19, as well as to prevent thromboembolic events. This work aims to assess the benefit of oral Pentoxifyllin supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with community-acquired pneumonia ### Conditions - Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pentoxifylline Oral Tablet ### Outcomes Primary Outcomes - Respiratory distress - Temperature - Oxygen saturation - CRP - LDH - D-dimer - Interleukin 6 Secondary Outcomes - Hospital stays - Pneumonia complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Do Patient Educational Videos Improve Pain and Recovery After Laparoscopic Hysterectomy? - NCT ID: NCT06265376 - Study ID: IRB22-046 - Status: RECRUITING - Start Date: 2023-03-13 - Completion Date: 2024-07-01 - Lead Sponsor: Benaroya Research Institute ### Study Description The use of multi-model patient education has been used in a variety of medical specialties to educate patients on expectations for various medical procedures and improve patients' understanding of their own health care. However, it is unknown what type of audio and/or visual materials work best in a given clinical setting. By surveying overall pain/post-operative recovery satisfaction we can measure how well our video intervention educates and reinforces post-operative management at home when compared to the current method of education that patients receive at the pre-operative visit prior to laparoscopic hysterectomy at this institution. ### Conditions - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Educational Video ### Outcomes Primary Outcomes - Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy Secondary Outcomes - Pain score at the time of survey completion (0=no pain 10=worst pain - Average pain score for the first 7 days as perceived by the patients (likert scale) - Number of post-op phone calls received - Number of post-op emergency room visits - Number of readmissions - Number of patients with steri-strips still in place - Number opioids taken since surgery - Overall satisfaction with pre-operative education regarding surgery (5 point Likert scale) - ding surgery (5 point likert scale) Overall satisfaction with educations regarding what to expect post-operatively (5 point Likert scale) ### Location - Facility: Virginia Mason Medical Center, Seattle, Washington, 98101, United States @@
## Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey. - NCT ID: NCT06265363 - Study ID: Turkey BigROP Study - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-11-01 - Lead Sponsor: Baskent University Ankara Hospital ### Study Description The study includes preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in 94 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of \>1500 g or ≥ 33 weeks' gestation who are screened for retinopathy of prematurity are included. The incidence of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP development will also be evaluated. ### Conditions - Retinopathy of Prematurity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of ROP Secondary Outcomes - The role of being SGA in infants in the development of ROP - The role of sepsis in infants in the development of ROP - The role of mechanical ventilation in infants in the development of ROP - The role of chorioamnionitis in infants in the development of ROP - Laser photocoagulation treatment - Anti-VEGF treatment - Vitreoretinal surgery ### Location - Facility: Baskent University, Ankara, N/A, N/A, Turkey @@
## Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases - NCT ID: NCT06265350 - Study ID: Liver Project 5 - Status: RECRUITING - Start Date: 2024-02-02 - Completion Date: 2027-01-30 - Lead Sponsor: Sun Yat-sen University ### Study Description This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases. ### Conditions - Hepatocellular Carcinoma - Liver Cancer Stage IV - Pulmonary Metastases - Cadonilimab - Bevacizumab - Cryoablation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cadonilimab - Bevacizumab - Cryoablation ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Progression free survival (PFS) - Overall survival (OS) ### Location - Facility: Sun Yat-sen University Cancer Center, Guanzhou, Guangdong, 510000, China @@
## Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response? - NCT ID: NCT06265337 - Study ID: LAMETA-OGTT - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-01 - Lead Sponsor: University of Aarhus ### Study Description To investigate whether co-administration of lactate with a glucose load affects postprandial glucose levels/handling, gastrointestinal hormones, gastric emptying, and appetite sensations in individuals with pre-diabetes when compared to placebo.Hypothesis:Oral lactate administration improves/lowers glucose excursions following an oral glucose tolerance test (OGTT) by stimulating insulin secretion and delaying glucose absorption. ### Conditions - PreDiabetes - Metabolic Syndrome - Insulin Resistance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Lactate - Placebo ### Outcomes Primary Outcomes - Difference in integrated glucose concentrations between CTR and LAC following an OGTT Secondary Outcomes - Difference in glucose absorption - Difference in insulin sensitivity - Difference in insulin secretion - Difference in free fatty acids concentration - Difference in ventricular emptying rate - Difference in subjective appetite sensation - Difference in integrated GLP-1 concentrations ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Drug-coated Balloon Treatment in Coronary Lesions - NCT ID: NCT06265324 - Study ID: Soh-Med-23-12-04MD - Status: NOT_YET_RECRUITING - Start Date: 2024-02-10 - Completion Date: 2025-02-10 - Lead Sponsor: Sohag University ### Study Description This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions ### Conditions - Drug-coated Balloon ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Angioplasty ### Outcomes Primary Outcomes - Major adverse cardiac events at 6 months Secondary Outcomes ### Location - Facility: Sohag faculty of medicine, Sohag, N/A, N/A, Egypt @@
## IDUS in CBD Stone Recurrence High Risk Patients - NCT ID: NCT06265311 - Study ID: 20221307-2 - Status: RECRUITING - Start Date: 2021-11-02 - Completion Date: 2024-06 - Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine ### Study Description This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP.Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis. ### Conditions - Choledocholithiasis - Cholangiopancreatography, Endoscopic Retrograde - Ultrasonography ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - IDUS examination ### Outcomes Primary Outcomes - recurrence of bile duct stone or cholangitis - need for a nasobiliary tube - need for stents Secondary Outcomes - operation time - radiation time - hospitalization cost - Questionnaire of Symptoms and conditions after ERCP - White blood cell count - Red blood cell count - Platelet count - total bilirubin, direct bilirubin - Liver function test (ALT, AST) - albumin - total protein - Gamma-glutamyl transferase (GGT) test - An alkaline phosphatase (ALP) test - whether have a resection of gallbladder checklist ### Location - Facility: Shang General Hospital, Shanghai, N/A, 200080, China @@
## Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium - NCT ID: NCT06265298 - Study ID: RECHMPL23_0099 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-02 - Lead Sponsor: University Hospital, Montpellier ### Study Description Objectives The transparent surface of the eye, called the cornea, plays a crucial role in transmitting light to the retina and in protecting the eye. On its external surface, the cornea is composed of a constantly renewing multistratified epithelium. This mechanism is fueled by stem cells located in the limbus (the transition zone between the cornea and the sclera). Limbal Stem Cell Deficiency (LSCD) is characterized by a decrease or cessation of epithelial renewal and neovascularization of the cornea. Consequently, the cornea loses its integrity and transparency. This visually impairing condition is currently in a therapeutic impasse as only autologous limbal or allogeneic corneal grafts are viable options, but they pose significant risks to patients.Studies have shown that the oral cavity contains stem cells that can be isolated, cultured, and transdifferentiated into limbal stem cells (LSCs). However, to date, these studies are limited, and no protocol has been validated. In this study, the advantage of the accessibility of the oral cavity is used to develop a protocol for differentiating cells from the oral mucosa into limbal stem cells (LSCs) for use in a future clinical trial with patients.Methodology This prospective monocentric study will be conducted on patients from the ophthalmology department of the Montpellier University Hospital who have an indication for conjunctival reconstruction. After obtaining consent from the patients, cells from the oral wall will be sent to the tissue bank of the Montpellier University Hospital, where they will be cultured. Finally, the transdifferentiation steps will be analyzed by the "Eye" research team at the Institute of Neuroscience in Montpellier, which is collaborating on the project. The investigators have established objective factors to assess the success of the developed protocol based on the literature : (i) \> 3% of stem cells in primary cultures, (ii) \<10% aborted colonies, (iii) Expression of LSC markers (Pax6, Krt14, p63). ### Conditions - Limbal Stem Cell Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Conjunctival reconstruction ### Outcomes Primary Outcomes - Successful Transdifferentiation - Successful Transdifferentiation - Successful Transdifferentiation - Successful Transdifferentiation - Successful Transdifferentiation Secondary Outcomes ### Location - Facility: CHU Gui de Chauliac - Service d'Ophtamologie, Montpellier, Occitanie, 34295, France @@
## Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program - NCT ID: NCT06265285 - Study ID: MC230716 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2026-12-31 - Lead Sponsor: Mayo Clinic ### Study Description This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and/or effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients. ### Conditions - Advanced Esophageal Squamous Cell Carcinoma - Advanced Renal Cell Carcinoma - Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8 - Clinical Stage IIB Cutaneous Melanoma AJCC v8 - Clinical Stage IIC Cutaneous Melanoma AJCC v8 - Clinical Stage III Cutaneous Melanoma AJCC v8 - Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 - Clinical Stage IV Cutaneous Melanoma AJCC v8 - Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8 - Esophageal Carcinoma - Gastroesophageal Junction Adenocarcinoma - Hepatocellular Carcinoma - Locally Advanced Urothelial Carcinoma - Lung Non-Small Cell Carcinoma - Malignant Solid Neoplasm - Metastatic Colorectal Carcinoma - Metastatic Cutaneous Melanoma - Metastatic Esophageal Squamous Cell Carcinoma - Metastatic Head and Neck Squamous Cell Carcinoma - Metastatic Urothelial Carcinoma - Recurrent Esophageal Squamous Cell Carcinoma - Recurrent Head and Neck Squamous Cell Carcinoma - Renal Cell Carcinoma - Stage III Renal Cell Cancer AJCC v8 - Stage IV Colorectal Cancer AJCC v8 - Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 - Stage IV Renal Cell Cancer AJCC v8 - Unresectable Cutaneous Melanoma - Unresectable Esophageal Squamous Cell Carcinoma - Urothelial Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Home Health Encounter - Nivolumab - Patient Monitoring - Questionnaire Administration ### Outcomes Primary Outcomes - Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks Secondary Outcomes - Patient preferred treatment location - Patient level of comfort with receiving injections at home - Patient-reported symptoms - PRO-CTCAE - Patient-reported function - EORTC QLQ-F17 - Patient-reported side effect impact - GP5 - Incidence of Adverse Events (AEs) - Emergency room visits and hospitalizations - Overall survival (OS) ### Location - Facility: Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States @@
## Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis - NCT ID: NCT06265272 - Study ID: 2022P002594 - Status: RECRUITING - Start Date: 2023-12-10 - Completion Date: 2026-12-19 - Lead Sponsor: Massachusetts General Hospital ### Study Description A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols.The specific hypotheses include:* Ga-PSMA PET/MRI may allow robust and reproducible noninvasive in vivo quantitation of hepatic macro and microhemodynamics in cirrhotic patients* Dedicated simultaneously acquired DWI sequences might quantitate liver fibrosis and improve hemodynamic quantitation.* Ga-PSMA PET/MRI may allow noninvasive and reproducible quantitation of portal venous hypertension and predict its evolution, as well as response to treatments* Ga-PSMA PET/MRI may improve noninvasive and reproducible qualitative and quantitative assessment of liver function, structure, nodules and predict evolution of cirrhosis ### Conditions - Liver Cirrhosis - Hepatic Cell Carcinoma - Portal Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Injection of a gadolinium contrast agen - Radiotracer Injection - Imaging ### Outcomes Primary Outcomes - Assessment of LI-RADS with Ga-PSMA-PET/MRI Secondary Outcomes - Quantification of Macro- and Microperfusion in Cirrhotic Liver with Ga-PSMA-PET/MRI - Quantification of liver fibrosis with Ga-PSMA-PET/MRI vs. MRI and stand-alone PET - PET/MR protocol in liver cirrhosis ### Location - Facility: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, Massachusetts, 02129, United States @@
## Efficacy of the Use of Vasopressin as a Primary Vasoconstrictor in Critically Ill Patients - NCT ID: NCT06265259 - Study ID: 31-05-2023/25481 - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2026-01-31 - Lead Sponsor: University of Thessaly ### Study Description Current guidelines recommend the inititaion of noradrenaline and if shock is refractory, then vasopressin should be administered. Data indicate that the earlier use of vasopressin may improve survival. Two large randomized controlled trial failed to prove a survival benefit from the early use of vasopressin. The present study will investigate the effect of an early initiation protocol of vasopressin (as the first vasoconstrictor drug) on the degree of multiorgan failure improvement and also on the course of sepsis (if in septic patients) versus early initiation of noradrenaline as first vasoconstrictor drug in hemodynamically unstable patients. ### Conditions - Circulatory Shock ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Initiation of vasopressine as a first vasoconstrictive drug - Initiation of noradrenaline as a first vasoconstrictive drug ### Outcomes Primary Outcomes - Multiorgan failure improvement assessment Secondary Outcomes - Sepsis course - Sepsis course - Sepsis course - Duration of administration of vasoconstrictors - laboratory tests - laboratory tests - laboratory tests - laboratory tests - laboratory tests - laboratory tests - laboratory tests - laboratory tests - laboratory tests - laboratory tests - laboratory tests - Cardiac enzymes - Cardiac enzymes - renal function - renal function - renal function - Mechanical ventilation duration - length of ICU stay - 28 day mortality - ICU mortality - Adverse events ### Location - Facility: General University Hospital of Larissa, Intensive Care Unit, Larissa, Thessaly, 41110, Greece @@
## Impact of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults - NCT ID: NCT06265246 - Study ID: 104993 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-05-15 - Lead Sponsor: University of Saskatchewan ### Study Description Milk and dairy products contain significant amounts of nutrients that contribute to optimal health - nutrients like calcium, vitamin D, and high-quality protein. Fermented milk products or fermented dairy products are dairy foods that have been fermented with certain bacteria. Yogurt is a fermented dairy product containing millions of beneficial bacteria. In this study, the invesgitagtors will look at the effect of milk (a non-fermented dairy product) and yogurt (a fermented dairy product) supplementation on bone health and the amount of fat and muscle mass in Canadian young adults over a 24-month period. While dairy products contain significant amounts of nutrients, the scientific community does not know the impact of long-term supplementation of fermented (i.e., yogurt) or non-fermented (i.e., milk) dairy food on bone health and the amount of fat and muscle mass in young adults. To fill this knowledge gap, the investigators will recruit participants with low calcium intake and assign them to three different groups: 1) milk (intervention) group; 2) yogurt (intervention) group; and 3) control group. The investigators will ask the participants in the milk group to drink 1.5 servings (375 mL) of milk per day for 24 months. Participants in the yogurt group will consume 2 servings (350 g) of yogurt per day for 24 months. Those in the control group will continue their usual diets. Using a randomized controlled trial design, the investigators will measure bone health parameters, hormonal indices related to bone metabolism, body composition (e.g., muscle mass, fat mass), and the number and composition of bacteria living in the gastrointestinal (GI) tract. The hypothesis is that supplementation with yogurt will have more positive effects on bone health indices, particularly femoral neck BMD as the primary outcome, than milk in Canadian adults aged 19-30 years. The secondary hypothesis is that supplementation with yogurt, as a fermented milk product, will have a more beneficial effect than milk on body composition measures. The data will provide valuable information for developing targeted health initiatives and marketing strategies regarding the benefits of fermented and non-fermented dairy product consumption. ### Conditions - Osteoporosis - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Habitual Diet + Milk - Habitual Diet + Yogurt ### Outcomes Primary Outcomes - Femoral neck bone mineral density Secondary Outcomes - Bone mineral density (total hip, lumbar spine, whole body) - Bone mineral content (total hip, femoral neck, lumbar spine, whole body) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@