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## Prehab for Lung and Esophageal Cancer - NCT ID: NCT06354959 - Study ID: 1030020 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-01-01 - Lead Sponsor: Nova Scotia Health Authority ### Study Description Research indicates that individuals diagnosed with lung or esophageal cancer who enter treatment with higher functional capacities, improved body composition, and better nutrition status tend to experience better outcomes and a higher quality of life. The primary objective of a prehabilitation health coaching program is to enhance the overall health and well-being of patients before they undergo major surgery.This personalized 8-week program encompasses elements such as nutrition, smoking cessation, sleep hygiene, and movement, equipping participants with the knowledge and tools needed to adopt healthier lifestyles. ### Conditions - Neoplasm of Lung - Neoplasms - Exercise - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Prehabilitation ### Outcomes Primary Outcomes - Feasibility- Recruitment - Feasibility- Participant fidelity - Feasibility - Safety - Feasibility - Retention/Attrition - Feasibility - Participant Experience - Feasibility- Attendance Secondary Outcomes - Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E) - Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) - 5x chair stand - Stair climb test - Grip strength - Resting Heart rate - Resting blood pressure ### Location - Facility: Victoria General Hospital, Halifax, Nova Scotia, N/A, Canada @@
## External Validation of Simplified 4C Mortality Score by Deleting CRP - NCT ID: NCT06354946 - Study ID: SCORE 4C - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2022-12-30 - Lead Sponsor: University of Monastir ### Study Description The (Coronavirus Clinical Characterisation Consortoum) 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) based on eight different parameters: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness (Glasgow Coma Scale), urea or blood urea nitrogen (BUN) level, and C reactive protein (CRP). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability. A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use. we aim to validate a modified 4C score. ### Conditions - COVID-19 Pandemic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The primary outcome was all-cause in-hospital mortality rate The primary outcome was all-cause in-hospital mortality rate Secondary Outcomes - Number of patients admitted to the ICU ### Location - Facility: EPS Fattouma Bourguiba University hospital, Monastir, N/A, 5020, Tunisia @@
## Neurological Soft Signs in Neurodegenerative Dementias - NCT ID: NCT06354933 - Study ID: DemeNSS (3785) - Status: COMPLETED - Start Date: 2022-04-01 - Completion Date: 2024-02-01 - Lead Sponsor: University of Milano Bicocca ### Study Description The goal of this observational study is to investigate the prevalence of Neurological Soft Signs (NSS) in various categories of dementia patients compared to matched controls. The main questions it aims to answer are:* Does the prevalence of NSS significantly differ among patients with neurodegenerative dementias compared to controls?* Are NSS associated with neuropsychiatric alterations in dementia patients?* Do NSS correlate with cognitive screening tools?* Do NSS increase over time in patients with neurodegenerative dementias?Participants will undergo assessments including:* Evaluation of NSS using the Heidelberg scale* Neuropsychiatric assessments* Cognitive screening using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB)Researchers will compare dementia groups (Alzheimer's disease, Frontotemporal dementia, Corticobasal syndrome and Lewy body dementia) to controls to determine differences in NSS prevalence. Additionally, associations between NSS and neuropsychiatric symptoms, as well as cognitive performance, will be explored. ### Conditions - Alzheimer Disease - Dementia With Lewy Bodies - Frontotemporal Dementia - Corticobasal Degeneration ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neurological Soft Signs ### Outcomes Primary Outcomes - Difference in NSS Secondary Outcomes - Association between NSS and Neuropsychiatric Inventory (NPI) scores - Correlation between NSS scores and cognitive function assessed by Mini-Mental State Examination (MMSE) - Correlation between NSS scores and cognitive function assessed by Frontal Assessment Battery (FAB) - Longitudinal changes in NSS scores ### Location - Facility: Fondazione IRCCS San Gerardo dei Tintori, Monza, Lombardia, 20900, Italy @@
## M-Well Bonding Bundle to Improve Patient-Physician Relationships - NCT ID: NCT06354920 - Study ID: HUM00247781 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2026-06 - Lead Sponsor: University of Michigan ### Study Description The goal of this clinical trial is to learn more about the interaction between a patient in the hospital and their treating doctor. A good relationship between patients and their doctors can help improve patient care. Doctors will be asked to use strategies to improve their interactions with patients in the hospital. The main questions it aims to answer are:* Will using the intervention strategies improve doctors' empathy towards their patients?* Will using the intervention strategies lead to improved scores in patient views of doctors' empathy?There will be 2 study arms. One group of doctors will be asked to use the intervention strategies. The other group of doctors will provide care as they would normally.Researchers will compare the doctors in the intervention arm to those in the control arm.Doctors are the primary subjects for this study. The doctors in both study arms will be asked to do the following:1. Allow study staff to observe the interaction between them and their patients.2. Complete a brief survey at the end of their 2-week work rotation.Doctors who are in the intervention arm will be asked to use suggested strategies when visiting with patients in the hospital.Patients are secondary subjects for this study. Patients of participating doctors may be asked to do the following:1. Allow study staff to observe the interaction between them and their doctors.2. Complete a brief survey after meeting with their doctor. ### Conditions - Physician-Patient Relations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Bonding Bundle ### Outcomes Primary Outcomes - Jefferson Scale of Empathy (JSE) - Jefferson Scale of Patient's Perceptions of Physician Empathy (JSPPPE) - Communication Assessment Tool - Frequency of use of intervention methods Secondary Outcomes - Perceived duration of interaction - Wake Forest Physician Trust Scale ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP) - NCT ID: NCT06354907 - Study ID: HUM00150780 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-10-03 - Completion Date: 2024-10-02 - Lead Sponsor: University of Michigan ### Study Description Depression and anxiety are major challenges to American children's optimal mental health, with already high rates exacerbated by the Covid-19 pandemic. Yet help is beyond reach for many children who do not have access to care for reasons including a severely depleted cadre of professionally trained service providers, fear of stigma that goes along with a diagnosis, low access to clinics, and lack of insurance. Without help their problems will likely accelerate and become more deleterious to their development as adolescents and young adults. The current study aims to address the lack of care by providing a program in school classrooms that will reduce children's symptoms of depression and anxiety, as well as enhance their emotion regulation and coping skills. The mental health and adjustment of two groups of children are compared and evaluated at twelve week intervals in this clinical trial - those who first participate in the Kids' Empowerment Program (KEP) and a comparison group that participates in the program after the second evaluation. Once proven to be successful, the ultimate goal of the project is to disseminate the program throughout the State of Michigan and beyond, thereby providing children with tools that will empower them to be successful in managing emotional challenges throughout their life. ### Conditions - Child Mental Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - The Kids' Empowerment Program ### Outcomes Primary Outcomes - Revised Children's Anxiety and Depression Scale - Strengths and Difficulties Questionnaire Secondary Outcomes - Cognitive Emotion Regulation Questionnaire ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Percutaneous Pinning Versus Plate and Screws for Surgical Fixation of Proximal Humeral Fractures - NCT ID: NCT06354894 - Study ID: MACOXS - Status: RECRUITING - Start Date: 2020-11-01 - Completion Date: 2024-11-01 - Lead Sponsor: University of Turin, Italy ### Study Description The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws. ### Conditions - Proximal Humeral Fractures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Proximal humeral fracture fixation ### Outcomes Primary Outcomes - Oxford Shoulder Score (OSS) - Quick Disabilities of the arm, shoulder and hand (DASH) score - Subjective Shoulder Value (SSV) - Radiographic outcomes Secondary Outcomes ### Location - Facility: San Luigi Gonzaga Hospital, Orbassano, Turin, 10043, Italy @@
## The Relationship Between Controlling Risk Factors and Cerebral Haemodynamics in Lacunar Stroke - NCT ID: NCT06354881 - Study ID: 0967 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-03 - Lead Sponsor: University of Leicester ### Study Description The goal of this observational study is to look at differences in brain blood flow before and after management of risk factors such as high blood pressure and diabetes in patients with lacunar stroke. Participants will be asked to undergo a simple brain blood flow assessment at their initial appointment, whereby they will be asked to sit and stand twice. The patients will then be asked for a follow-up assessment 4 weeks after, identical to the first. This will allow us to look at any changes in brain blood flow from before management of risk factors and 4 weeks after management of risk factors. ### Conditions - Lacunar Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvres ### Outcomes Primary Outcomes - Cerebral blood velocity measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. - Arterial blood pressure measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. - Heart rate measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. - End-tidal carbon dioxide measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. - Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(CA). - Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed. (VMR). - Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(ARI). Secondary Outcomes ### Location - Facility: University Hospitals of Leicester NHS Trust, Leicester, Leicestershire, LE1 5WW, United Kingdom @@
## A Study to Assess utiLity of BIoEP as an Early Prognostic Indicator for Predicting Anti-Seizure Medication (ASM) Efficacy - NCT ID: NCT06354868 - Study ID: NNBioEP004 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-06 - Lead Sponsor: Neuronostics Ltd ### Study Description This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy ### Conditions - Epilepsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The relationship between BioEP and seizure frequency. Secondary Outcomes - Association between the 12-month change from baseline in BioEP result and the patients reported global impression of change ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## "Which Type of Exercise is More Effective in Chronic Constipation? - NCT ID: NCT06354855 - Study ID: NEU-FTR-FE-04 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-12 - Lead Sponsor: Necmettin Erbakan University ### Study Description In this study, it will be investigated whether a daily 30-minute walk or abdominal breathing exercise is more effective on chronic constipation. ### Conditions - Chronic Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Group is doing breathing exercises while watching videos - Medium pace walking group ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) Secondary Outcomes - Constipation Severity Scale (CSS) ### Location - Facility: Faculty of Nezahat Keleşoğlu Health Sciences Necmettin Erbakan University, Konya, Meram, 42000, Turkey @@
## Measurement of Sweat Sodium Concentration in Patients With Chronic Kidney Disease - NCT ID: NCT06354842 - Study ID: 12345678 - Status: COMPLETED - Start Date: 2018-10-05 - Completion Date: 2020-12-11 - Lead Sponsor: Medical University of Vienna ### Study Description It has been shown that excretion of sodium and water through the skin in the form of sweat represents a regulatory mechanism of electrolyte- and fluid balance. Since patients with chronic kidney disease (CKD) exhibit increased skin sodium content, we investigated the feasibility of sweat testing as a novel experimental tool to a more complete assessment of fluid- and sodium homeostasis.In this cross-sectional feasibility study, we applied pilocarpine iontophoresis to induce sweat testing in 58 patients across various stages of CKD including patients after kidney transplantation as well as a healthy control cohort (n=6) to investigate possible effects of CKD and transplantation status on sweat rate and sodium concentration. Due to non-linear relationships, we modeled our data using polynomial regression.Decline of kidney function showed a significant association with lower sweat rates: adj R²= 0.2278, F(2, 61) = 10.29, p = 0.000141. Sweat sodium concentrations were increased in moderate CKD, however this effect was lost in end stage renal disease: adj R² = 0.3701, F(4, 59) = 10.26, p = 2.261e-06. We observed higher sweat weight in males compared to females.Diagnostic sweat analysis represents an innovative and promising noninvasive option for more thorough investigation of sodium- and fluid homeostasis in CKD patients. Lower sweat rates and higher sweat sodium concentrations represent a unique feature of CKD patients with potential therapeutic implications. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - pilocarpine iontopheresis ### Outcomes Primary Outcomes - Sweat sodium concentration Secondary Outcomes ### Location - Facility: Medical University of Vienna, Vienna, N/A, 1090, Austria @@
## Medical Images Collection Research - NCT ID: NCT06354829 - Study ID: MEDICALBUM - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2049-04 - Lead Sponsor: Mario Negri Institute for Pharmacological Research ### Study Description This is a not-for-profit project for the collection, archiving and reuse of magnetic resonance imaging, computed tomography and ultrasound images, and related demographic and clinical data, for research purposes only. ### Conditions - Kidney Diseases - Brain Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Medical imaging procedures ### Outcomes Primary Outcomes - Creation of a medical images collection Secondary Outcomes ### Location - Facility: Clinical Research Center for Rare Disease Aldo e Cele Daccò, Ranica, BG, 24020, Italy @@
## VENLID: The Application of a 10%-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults - NCT ID: NCT06354816 - Study ID: V 2.0, 07Feb2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-05 - Lead Sponsor: Krankenhaus Barmherzige Schwestern Linz ### Study Description Volunteers are invited to undergo 4 insertions of a peripheral intra-venous 18-gauge catheter (PIVC); 2 insertions at the the start of the study on the plantar side of the hand/vessel at the dorsum manus, 2 insertions after 2-10 hours into the forearm/cubita with and without application of a 10-% lidocaine spray (5 hubs of xylocaine 10%-pump spray; AstraZeneca BV, Zoetermeer, The Netherlands) prior to the insertion of the PIVC. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Xylocaine 10% pump spray - Saline solution isotonic 0.9% NaCl ### Outcomes Primary Outcomes - To demonstrate a reduction of pain caused by PIVC rated by Numerical Rating Scale (NRS), after application of a 10% lidocaine spray- Separately measured for the plantar side of the hand/vessel at the dorsum manus, and for the forearm/cubita Secondary Outcomes - To measure pain caused by PIVC rated by NRS in the dominant vs. non-dominant arm - To measure pain caused by PIVC rated by NRS at the plantar side of the hand/vessel at the dorsum manus vs. at the forearm/cubita - To measure the correlation between pain caused by PIVC rated by NRS and the anticipated pain rated by NRS - To measure the correlation between pain caused by PIVC rated by NRS and the anticipated difficulty by the operator to insert the PIVC - To measure pain rated by NRS depending on success - To describe success rates and compare it - To measure the correlation between PCS and pain caused by PIVC rated by NRS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Pezzi Ball on Balance in Pregnant Women - NCT ID: NCT06354803 - Study ID: KafrelsheikhU 30 - Status: COMPLETED - Start Date: 2023-03-02 - Completion Date: 2024-03-03 - Lead Sponsor: Kafrelsheikh University ### Study Description The effect of kinaesthetic training on performance and postural stability during pregnancy and 2 weeks postpartum ### Conditions - Postural Stability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - proprioceptive training ### Outcomes Primary Outcomes - change of postural stability Secondary Outcomes ### Location - Facility: Faculty of physical therapy kafrelshiekh university, Kafr Ash Shaykh, Kafrelshiekh, 6850001, Egypt @@
## Natural History Study of Children With LAMA2-related Dystrophies - NCT ID: NCT06354790 - Study ID: NatHis LAMA2 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2027-12-31 - Lead Sponsor: Institut de Myologie, France ### Study Description The goal of this natural history study is to characterize the disease course, characteristics in paediatric population of LAMA2-RD (related dystrophies) patients.The aim of the study is to establish a well-described cohort of patients in France with LAMA2-RD for prospective follow-up and recruitment for future clinical trials.Participants will be follow up during a two years period regarding exhaustive aspects of the pathology:* Muscular function* Respiratory function* Cognitive phenotyping* Quality of life* Growth parameters* Biomarkers ### Conditions - Merosin Deficient Congenital Muscular Dystrophy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Motor evaluations - Cognitive assessment - Pulmonary function test - Cardiac evaluation - Quality of life - Spine X Ray - Muscular MRI - Biomarkers collection and analysis ### Outcomes Primary Outcomes - Change in Motor function Measurement (MFM32) score - Change in Motor Milestone Checklist - Change in Revised Upper Limb Module (RULM) score - Change in grip strength measured by dynamometer tool - Change in pinch strength measured by dynamometer tool - Change in arm flexion/extension strength measured by dynamometer tool - Change in 6 Minutes Walking Test - Change in 4 Stairs Climbing Test (4SCT) - Change in 10m Walking Test - Change in Rise from Floor Test - Change in patient's Forced Vital Capacity (FVC) results - Change in patient's Peak Cough Flow (PCF) results - Change in patient's Maximum Expiratory Pressure (MEP) results - Change in patient's Maximal Inspiratory Pressure (MIP) results - Change in patient's Sniff Nasal Inspiratory Pressure (SNIP) results - Change in patient's muscle fat replacement measured by Magnetic Nuclear Resonance - Change in patient's cross-sectional area of the residual muscle measured by MNR Secondary Outcomes - Change in Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV) results - Change in Wechsler Intelligence Scale for Children-V (WISC-V) results - Change in PedsQL questionnaire results - Change in CGI-S questionnaire results - Change in CGI-I questionnaire results - Change in Faces pain rating scale results - Change in Fatigue Severity Scale results - Change in ACTIVLIM questionnaire results - Change in Egen Klassifikation Scale Version 2 (EK2) results - Change in Caregiver burden questionnaire (LMDIS) results ### Location - Facility: Centre de Référence GNMH, Pédiatrie Hôpital Raymond-Poincaré, Garches, N/A, N/A, France @@
## REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry - NCT ID: NCT06354777 - Study ID: EVERCOOL AF - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-12-30 - Lead Sponsor: Heart Rhythm Clinical and Research Solutions, LLC ### Study Description This is a multi-center sub-study examining the effectiveness of active esophageal cooling on subjects undergoing left atrial ablation for symptomatic Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation. ### Conditions - Atrial Fibrillation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ablation Procedure ### Outcomes Primary Outcomes - To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling. - To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling. - To measure long term safety after atrial fibrillation in patients treated with active esophageal cooling. - Patient reported outcomes in patients treated with active esophageal cooling. - Physician reported outcome post procedure with active esophageal cooling. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Propensity to Hospitalize Patients From the ED in European Centers. - NCT ID: NCT06354764 - Study ID: 8780-UC1 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2026-09 - Lead Sponsor: Mario Negri Institute for Pharmacological Research ### Study Description The peer-to-peer comparison means center-to-center comparison, which requires adjusting for possible differences among centers to be fair and convincing. The first step to reach this goal is to develop a predictive model that accurately estimates each patient's probability of being admitted, starting from clinical conditions and boundary variables. Such a model would make it possible to calculate, for each ED, the expected hospitalization rate; that is, the hospitalization rate that would have been observed if the ED had behaved like the average of the EDs that provided the data to build the model itself. Comparing the observed hospitalization rate in the single ED with the expected rate derived from the model provides a rigorous method of comparing the department with the average performance, taking into account the characteristics of the patients treated and the conditions under which the ED operated. In other words, the predictive model represents the benchmark against which each ED is evaluated. ### Conditions - Emergency Medicine ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - Create two separate databases - Multivariable models - Adjusted comparison Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Maternity Care Experiences of Asylum-seeking and Refugee Women in Scotland - NCT ID: NCT06354751 - Study ID: 327236 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-07-01 - Lead Sponsor: University of Aberdeen ### Study Description The International Organisation of Migration reports that over half (52.4%) of international migrants in Europe are women. Evidence suggests that women with immigrant backgrounds often struggle to access healthcare across the world. Among migrant women, asylum-seeking and refugee women face higher risks of poor pregnancy and birth outcomes, including babies with low birth weight, physical and/or mental health problems or death related to pregnancy and/or childbirth. Previous studies have focused on immigrant women's experiences of care during pregnancy and birth and did not differentiate between asylum seekers, refugees, and economic migrants. This can make it difficult to compare studies accurately. This PhD study focuses on asylum-seeking and refugee women, using the definitions provided by the United Nations. Asylum-seeking women refer to women who seek protection in a country other than their own and are waiting for a decision on their status. Asylum seekers become refugees once their application has been processed and accepted.A scoping review was conducted to understand the experiences of asylum-seeking and refugee women accessing maternity care in the UK, with a focus on Scotland. The review found that all studies that focused on the experiences of asylum-seeking and refugee women accessing maternity care were mainly based in England. The review identified the presence of specialist migrant services in maternity settings in Scotland and across the UK, but there was no information on their implementation or impact on women's outcomes. Additionally, there is limited evidence in the UK on the perceptions of healthcare professionals providing care to asylum-seeking and refugee women.This PhD aims to close this gap in research by exploring this area more deeply in Scotland through mixed-methods studies of surveys with asylum-seeking and refugee women and interviews with maternity care leaders, policymakers, maternity healthcare professionals, and asylum-seeking and refugee women. ### Conditions - Refugee - Asylum-seeking Women - Maternity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Exploring and understanding asylum-seeking and refugee women's experiences of maternity care in Scotland. - Evidence of healthcare professionals' experiences of providing maternity care for asylum-seeking and refugee women in Scotland. Secondary Outcomes - Identification of the successful components of specialist migrant maternity services in Scotland. - Identification of gaps between care pathways and practice (implementation gap) and how this affects the quality of maternity care and women's experiences of maternity services - Information for policymakers on approaches needed to improve maternity care for refugee and asylum-seeking women at local and national levels. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Improving Endometrial Cancer Assessment by Combining Genomic Profiling and Surgical Assessment - NCT ID: NCT06354738 - Study ID: S66928 - Status: RECRUITING - Start Date: 2023-01-16 - Completion Date: 2028-11-01 - Lead Sponsor: University Hospital, Gasthuisberg ### Study Description EUGENIE is a prospective multicentre interventional study, focused on improving endometrial cancer (EC) assessment by combining the new technique of genomic profiling with surgical extra uterine disease assessment. The investigators aim to correlate EC stage to each of the molecular subgroups of disease and thereby guide surgical treatment and staging of EC by determining the association between molecular classification and disease stage and evaluating if and how disease stage in each of the molecular subgroups associates with prognosis. ### Conditions - Endometrial Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging ### Outcomes Primary Outcomes - Endometrial cancer stage - Molecular type of endometrial cancer Secondary Outcomes - Overall survival - Time to recurrence ### Location - Facility: UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, N/A, 3000, Belgium @@
## Effect of Weekly Plyometric Training Frequency on Youth Female Basketball Players: A Comparison of Two vs. Four Sessions - NCT ID: NCT06354725 - Study ID: 2vs4 - Status: COMPLETED - Start Date: 2023-11-01 - Completion Date: 2024-02-20 - Lead Sponsor: Bruno Figueira ### Study Description Players were randomly assigned to a two-times-a-week (2PLYO, n = 15) or four-times-a-week (4PLYO, n = 15) PT (Plyometric Training) group. Both groups performed the same weekly total volume of jumps during PT in addition to regular basketball training and competition. The 2PLYO group performed 240 jumps over two sessions (120 jumps per session), and the 4PLYO group performed 240 jumps over four sessions (60 jumps per session). After the eight-week intervention, all players underwent a one-week detraining period with no PT training while basketball training and competitions continued. Testing was performed at baseline (pre-test), after intervention (post-test), and after the detraining period. Players were assessed for lower body power using jump tests (countermovement jump \[CMJ\], drop-jump \[DJ\] from a 20-cm box, and horizontal jump \[HJ\]; change of direction ability using a planned agility test; and speed using a 20-m sprint and a 5-m split. ### Conditions - Physical Performance ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Plyometric ### Outcomes Primary Outcomes - Horizontal jump Secondary Outcomes - CMJ ### Location - Facility: Vytutas Magnus University, Kaunas, N/A, N/A, Lithuania @@
## Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients. - NCT ID: NCT06354712 - Study ID: 2024-45 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2025-03-01 - Lead Sponsor: Mansoura University ### Study Description A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients. ### Conditions - Oral Mucositis (Ulcerative) Due to Radiation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - N-Acetyl-Cysteine with Institutional standard care - Institutional standard care ### Outcomes Primary Outcomes - Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis. Secondary Outcomes - Time to develop oral mucositis with grade ≥ 2. - Duration of oral mucositis with grade ≥ 2. - Pain assessed by Visual Analog Scale (VAS). - Functional oral intake scale - Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4 ### Location - Facility: Clinical Oncology and Nuclear Medicine of Mansoura University Hospital, Mansoura, N/A, N/A, Egypt @@
## A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children - NCT ID: NCT06354699 - Study ID: RGS0000003993 - Status: RECRUITING - Start Date: 2023-06-26 - Completion Date: 2028-07 - Lead Sponsor: Telethon Kids Institute ### Study Description The purpose of this study is to investigate the prevalence, risk factors and consequences of chronic post-surgical pain in children aged 0-16 years through a number of questionnaires completed at various timepoints, from before surgery up to 1 year post surgery. ### Conditions - Chronic Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The prevalence of chronic post-surgical pain after 10- 12 months. Secondary Outcomes - Identifying potential risk factors for chronic post-surgical pain ### Location - Facility: Telethon Kids Institute, Perth, Western Australia, N/A, Australia @@
## Characterizing the Scalp Tolerability of TMS - NCT ID: NCT06354686 - Study ID: STUDY00004245 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2027-05 - Lead Sponsor: Florida State University ### Study Description The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the knee as a surrogate location to safely trial tolerability of novel TMS parameters. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - TMS Tolerability ### Outcomes Primary Outcomes - Tolerability of TMS - Scalp Location - Tolerability of TMS - Stimulation parameters (single pulse, 10 Hz, theta burst). Secondary Outcomes - Tolerability of TMS (Knee Location) ### Location - Facility: Florida State University, Tallahassee, Florida, 32306, United States @@
## Stellate Ganglion Block Combined With Dexmedetomidine or Subanesthetic Ketamine Infusion for Treatment of Neurostorm. - NCT ID: NCT06354673 - Study ID: 278/1-April-2024 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-04 - Completion Date: 2024-10-04 - Lead Sponsor: Zagazig University ### Study Description Neurostorming is a sudden and exaggerated stress response as a result of damage to the brain. With appropriate treatment and time, there is hope for individuals to overcome storming, regain consciousness, and work towards successfully recovering from brain injury. Most treatments for neurostorming involve the use of medications only such as dexmedetomidine, opioids, gabapentin and propofol to address secondary complications like high blood pressure and fever. These medications focus on slowing the body's stress response or relaxing the body. Stellate ganglion block (SGB) is a promising therapy for paroxysmal sympathetic hyperactivity (PSH), overcoming the limitations of systemic medications and may serve to recalibrate aberrant autonomic states. Ketamine is a potent dissociative agent which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Its combination with stellate ganglion block is to oppose its sympathomimetic effect. Dexmedetomidine has analgesic and sedative effect which inhibits the sympathetic nerve activity through its action on the α2 receptor in the spinal cord. Hypothesis: Null hypothesis: There is no difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.Alternative hypothesis: There is a difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Aim of the work is achievement of effective treatment for the neurostorm after traumatic brain injury in critically ill patients with better outcomes and decrease intensive care unit (ICU) stay. ### Conditions - Paroxysmal Sympathetic Hyperactivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stellate ganglion block - Dexmedetomidine - Ketamine ### Outcomes Primary Outcomes - To compare the time of remission of neurostorm symptoms - To assess effect of stellate ganglion block combined with either dexmedetomidine or subanesthetic ketamine infusion on changes in glascow coma scale score. Secondary Outcomes - ▪ To measure the duration of intensive care unit (ICU) stay. ### Location - Facility: Zagazig university, Zagazig, N/A, N/A, Egypt @@
## Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1) - NCT ID: NCT06354660 - Study ID: 18804 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-07 - Lead Sponsor: Eli Lilly and Company ### Study Description The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits. ### Conditions - Diabetes Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Retatrutide - Placebo ### Outcomes Primary Outcomes - Change from Baseline in Hemoglobin A1c (HbA1c) (%) Secondary Outcomes - Percentage of Participants Who Achieve HbA1c < 7.0% - Percentage of Participants Who Achieve HbA1c ≤ 6.5% - Percentage of Participants Who Achieve HbA1c < 5.7% - Change from Baseline in Fasting Serum Glucose - Percent Change from Baseline in Body Weight - Change from Baseline in Body Weight - Percentage of Participants Who Achieve Weight Reduction of ≥ 5% - Percentage of Participants Who Achieve Weight Reduction of ≥ 10% - Percentage of Participants Who Achieve Weight Reduction of ≥ 15% - Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction - Percent Change from Baseline in Triglycerides - Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol - Change from Baseline in Systolic Blood Pressure (SBP) ### Location - Facility: Scottsdale Clinical Trials, Scottsdale, Arizona, 85260, United States @@
## Zirconia-based Primary Anterior Crowns With Retention Grooves Versus Without Retention Grooves - NCT ID: NCT06354647 - Study ID: HM20028419 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-06-01 - Lead Sponsor: Virginia Commonwealth University ### Study Description The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection. ### Conditions - Dental Caries - Tooth Decay ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Zirconia-based primary anterior crowns with retention grooves - Zirconia-based primary anterior crowns without retention grooves ### Outcomes Primary Outcomes - Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes - Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes Secondary Outcomes - Parental satisfaction - Child satisfaction - Oral health impact during early childhood ### Location - Facility: Virginia Commonwealth University, Richmond, Virginia, 23298, United States @@
## Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth - NCT ID: NCT06354634 - Study ID: HM20028439 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-07 - Lead Sponsor: Virginia Commonwealth University ### Study Description The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection. ### Conditions - Dental Caries - Tooth Decay ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Resin polymer (NuSmile Bioflx) crown - Stainless steel crown ### Outcomes Primary Outcomes - The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments - The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments Secondary Outcomes - Parental satisfaction - Child satisfaction ### Location - Facility: Virginia Commonwealth University, Richmond, Virginia, 23298, United States @@
## Impact of Vitamin D Supplementation on Fetomaternal Outcomes in LTBI Pregnant Females - NCT ID: NCT06354621 - Study ID: D/185/FIMS - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2024-03-20 - Lead Sponsor: University of the Punjab ### Study Description The goal of this randomized controlled trial is to see the effect of vitamin D supplementation on fetomaternal outcomes in pregnant females with Latent Tuberculosis infectionThe main question\[s\] it aims to answer are:If Vitamin D supplementation has any impact on maternal outcomes. If Vitamin D supplementation has any impact on fetal outcomes. ### Conditions - Maternal and Child Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Vitamin-D supplementation ### Outcomes Primary Outcomes - Pre-Eclampsia (Maternal Outcome) - Gestational Diabetes Mellitus (Maternal Outcome) - C/Section delivery (Maternal Outcomes) - Low Birth Weight (Foetal Outcome) - Pre-Term delivery (Foetal Outcome) - Apgar Score (Foetal Outcome) Secondary Outcomes - Improvement in maternal vitamin-D levels ### Location - Facility: University of the Punjab, Lahore, Punjab, 54600, Pakistan @@
## The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children - NCT ID: NCT06354608 - Study ID: duygudemirr - Status: RECRUITING - Start Date: 2023-10-25 - Completion Date: 2024-04-30 - Lead Sponsor: University of Yalova ### Study Description The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear. ### Conditions - Procedural Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Audio Book Group - Local Vibration Group ### Outcomes Primary Outcomes - Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES - Comparison of the fear score values of the groups - Comparison of the fear score values of the groups Secondary Outcomes ### Location - Facility: University of Yalova, Yalova, N/A, N/A, Turkey @@
## Feasibility Study of Multidimensional Rehabilitation in the Metaverse - NCT ID: NCT06354595 - Study ID: XiamenU1 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-01 - Lead Sponsor: Qu Shen ### Study Description The investigators evaluated and optimized the Metaverse multi-dimensional rehabilitation platform based on the use of the Metaverse multi-dimensional rehabilitation platform by colorectal cancer survivors and their families, and finally launched the Metaverse multi-dimensional rehabilitation platform. ### Conditions - Colorectal Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Multidimensional Rehabilitation in the Metaverse ### Outcomes Primary Outcomes - Post-Study System Usability Questionnaire (PSSUQ) Third Edition - System Usability Scale (SUS) Secondary Outcomes - Semi-structured interview ### Location - Facility: Yuru Hu, Xiamen, Fujian, 361005, China @@
## Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia - NCT ID: NCT06354582 - Study ID: 2024-085-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-02 - Lead Sponsor: Kunyue Li ### Study Description This study aims to explore the effect of intravenous vitamin C infusion on intrapartum fever after epidural labor analgesia, to reduce the impact of intrapartum fever on maternal and infant, improve maternal and infant outcomes, and provide a reference for clinical preventive medication. ### Conditions - Obstetric Labor Complications - Fever ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Vitamin C Injection - Normal saline ### Outcomes Primary Outcomes - Intrapartum fever or not - The temperature of parturients - The duration of intrapartum fever - Complete blood count indicators Secondary Outcomes - Visual analogue scale(VAS) - Amount of total analgesics - Side effects on mothers - the duration of total labor - Incidence of rupture of membranes - Delivery characteristics 2 - Record the weight of the baby. - Record the gender of the baby. - Apgar score - the incidence of fetal distress - Record the infant ward administration. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children - NCT ID: NCT06354569 - Study ID: 2022.232 - Status: RECRUITING - Start Date: 2024-12-31 - Completion Date: 2024-12-31 - Lead Sponsor: Sichuan Provincial People's Hospital ### Study Description to explore the risk factors of perioperative respiratory adverse events in children, and to establish a risk prediction model of perioperative respiratory adverse events in children ### Conditions - Perioperative Respiratory Adverse Events ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The occurrence of perioperative respiratory adverse events Secondary Outcomes ### Location - Facility: Sichuan provincial Peopel'Hospital, Chengdu, Sichuan, N/A, China @@
## Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects - NCT ID: NCT06354556 - Study ID: HRS-1893-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-05-30 - Lead Sponsor: Shandong Suncadia Medicine Co., Ltd. ### Study Description The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects. ### Conditions - Obstructive Hypertrophic Cardiomyopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HRS-1893 tablet - Verapamil tablet ### Outcomes Primary Outcomes - Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose - Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose - Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose Secondary Outcomes - Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose - Elimination half-life (T1/2) for HRS-1893 after single dose - Apparent oral clearance (CL/F) for HRS-1893 after single dose - Apparent volume of distribution (Vz/F) for HRS-1893 after single dose - Accumulated amount of excretion (Ae) for HRS-1893 after single dose - Urinary excretion fraction（fe）for HRS-1893 after single dose - Renal clearance（CLr）for HRS-1893 after single dose - Number of subjects with adverse events and the severity of adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Arthroplasty Cements Outcomes - A Post-market Follow-up - NCT ID: NCT06354543 - Study ID: CA01-TK-ARTHRO - Status: RECRUITING - Start Date: 2020-12-16 - Completion Date: 2045-12 - Lead Sponsor: Teknimed ### Study Description A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels.Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site. ### Conditions - Arthroplasty ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cemented joint arthroplasty ### Outcomes Primary Outcomes - Survival rate - Superficial and/or deep postoperative infection rate. Secondary Outcomes - Pain Level - Patients' satisfaction - Restoration of function - Evaluation of function and radiological outcomes - Complications rate - Antalgic consumption - Restoration of function - Restoration of function - Adverse events ### Location - Facility: Clinique du Vivarais, Aubenas, Auvergne-rhône-alpes, 07200, France @@
## A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma - NCT ID: NCT06354530 - Study ID: 2023 (315) - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2026-12-31 - Lead Sponsor: Army Medical Center of PLA ### Study Description The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma. ### Conditions - Neoadjuvant Therapy - Esophageal Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - anlotinib - Thoracic radiotherapy ### Outcomes Primary Outcomes - Pathological complete response (pCR), Major pathological response (MPR) - Major pathological response (MPR) Secondary Outcomes - Objective response rate (ORR) - 3-year disease free survival - R0 excision rate - 3-year overall survival ### Location - Facility: Army Medical Center of PLA, Chongqing, None Selected, N/A, China @@
## The Impact of the SENSE Program on NICU - NCT ID: NCT06354517 - Study ID: YIU-M-CI-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-30 - Lead Sponsor: Yuksek Ihtisas University ### Study Description The SENSE program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined. ### Conditions - Pre-Term - Individualized Developmental Care - Sensory Experiences ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - SENSE group ### Outcomes Primary Outcomes - Hammersmıth Neonatal Neurologıcal Examınatıon - Parental Stress Scale: Neonatal Intensive Care Unit - State-trait Anxiety Inventory - Edinburgh Postnatal Depression Scale Secondary Outcomes ### Location - Facility: Yuksek Ihtisas University, Ankara, N/A, N/A, Turkey @@
## Bactericidal Permeability Protein Inhibitor and Interleukin-1beta Levels After Non-surgical Periodontal Treatment - NCT ID: NCT06354504 - Study ID: 20.02.2019/177 - Status: COMPLETED - Start Date: 2019-11-19 - Completion Date: 2020-09-20 - Lead Sponsor: Akdeniz University ### Study Description The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß). ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Non-surgical periodontal treatment ### Outcomes Primary Outcomes - Gingival crevicular fluid Bactericidal/permeability-increasing proteins levels Secondary Outcomes - Gingival crevicular fluid interleukin-1Beta levels ### Location - Facility: Akdeniz Üniversity, Antalya, N/A, 07070, Turkey @@
## An Imaging-based Quantitative Biomarker Assay for NAFLD in Children - NCT ID: NCT06354491 - Study ID: 2023-1494 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: University of Wisconsin, Madison ### Study Description This study will validate recently developed Magnetic Resonance Imaging (MRI) and Ultrasound (US) based methods for liver fat quantification in children with obesity and healthy range of body mass index (BMI). ### Conditions - NAFLD - NASH ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Magnetic Resonance Imaging (MRI) - Ultrasound (US) ### Outcomes Primary Outcomes - MRI - Quantitative US Secondary Outcomes ### Location - Facility: University of Wisconsin, Madison, Madison, Wisconsin, 53705, United States @@
## IV Dexmedetomidine vs Oral Gabapentin and Their Combination for Postoperative Analgesia in Cancer Patients Undergoing Modified Radical Mastectomy - NCT ID: NCT06354478 - Study ID: ms-103-2021 - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2022-07-01 - Lead Sponsor: National Cancer Institute, Egypt ### Study Description Breast cancer is the most common malignant tumour among females with an incidence of about 2.1 million women every year.Nearly about 40-60% of breast surgery patients develop severe acute postoperative pain.⁴ Opioids are the current best standard drugs for postoperative pain relief, however, exposure to large doses of opioids leads to multiple side effects like prolonged sedation, respiratory depression, nausea, and vomiting.We are comparing two different drugs and their combination for perioperative analgesia for MRM.This work is a comparative study that aims to compare the analgesic effects of perioperative IV infusion of dexmedetomidine, preoperative oral gabapentin, and their combination in patients undergoing modified radical mastectomy surgery regarding the time of first rescue analgesia, postoperative morphine consumption, and possible complications. ### Conditions - Breast Cancer - Pain, Postoperative - Pain, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine Hydrochloride 0.5 MG/ML - Gabapentin ### Outcomes Primary Outcomes - The time to first rescue analgesia during the first 24 hour Postoperatively. Secondary Outcomes - Total postoperative morphine consumption till the first 24 hours - The degree of postoperative sedation according to Ramsay scores - VAS scores both at rest and during shoulder movement - Postoperative nausea and vomiting (PONV) as side effects of morphine. ### Location - Facility: National Cancer Institute, Cairo, N/A, N/A, Egypt @@
## Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews - NCT ID: NCT06354465 - Study ID: IRB1967355 - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2024-07-01 - Lead Sponsor: Lifespan ### Study Description This qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. The research aims to understand if XR-B can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. In-depth interviews are conducted with incarcerated individuals and relevant stakeholders. ### Conditions - Opioid Use Disorder - Criminal Justice - Treatment Adherence and Compliance ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Qualitative Transcripts Secondary Outcomes ### Location - Facility: Rhode Island Department of Corrections, Cranston, Rhode Island, 02920, United States @@
## Effect of Statin Therapy on Sepsis-related Mortality in Intensive Care Unit Patients - NCT ID: NCT06354452 - Study ID: HGG2024_01 - Status: COMPLETED - Start Date: 2018-01-01 - Completion Date: 2020-01-31 - Lead Sponsor: Hospital de Granollers ### Study Description The average age of patients with sepsis has increased in recent years in parallel with the incidence of sepsis. Many of these patients are frail and require various medications for the treatment of their chronic diseases. Common treatments, including e.g. sarcopenic drugs (statins, sulphonylureas, methyglinides), antioxidants that prevent sarcopenia (allopurinol) or immunoregulators (corticosteroids) may influence the survival and functional prognosis of these patients. Knowing which drugs influence sepsis survival and to what degree patients who survive sepsis have functional deterioration and increased comorbidity and which modifiable factors limit this may be essential. ### Conditions - Sepsis - Septic Shock ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Person-level linkage of the database looking for relationship with sepsis survival and previous intake of certain drug families and previous dependence on health services. ### Outcomes Primary Outcomes - Death due to sepsis Secondary Outcomes ### Location - Facility: Hospital General de Granollers, Granollers, Barcelona, 08402, Spain @@
## Use of Letrozole for Ectopic Pregnancy - NCT ID: NCT06354439 - Study ID: 77015224.6.1001.5327 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2026-12-31 - Lead Sponsor: Hospital de Clinicas de Porto Alegre ### Study Description A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate ### Conditions - Ectopic Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Letrozole tablets - Methotrexate Sodium ### Outcomes Primary Outcomes - levels of beta fraction of human chorionic gonadotropin (beta-hCG) Secondary Outcomes ### Location - Facility: Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, 90035-903, Brazil @@
## Short-term Mortality Prediction by the SOFA Score in Acute Decompensated Heart Failure - NCT ID: NCT06354426 - Study ID: BVT2022/01 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2023-08-31 - Lead Sponsor: Hanoi Heart Hospital ### Study Description Data on the use of sequential organ failure assessment (SOFA) in patients with cardiovascular disease are increasing. Several studies demonstrated that the SOFA score can identify short-term mortality in patients with acute decompensated heart failure (ADHF). This study was conducted to determine the prognostic value of the admission SOFA score in patients hospitalised for ADHF and to assess its ability in predicting the 30-day readmission rate. ### Conditions - Acute Decompensated Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Mortality Secondary Outcomes - Re-admission rate ### Location - Facility: Hanoi Heart Hospital, Hanoi, Hoan Kiem, 110000, Vietnam @@
## Outcomes of Concomitant Bypass Surgery in Septal Myectomy - NCT ID: NCT06354413 - Study ID: 2023-2261 - Status: COMPLETED - Start Date: 2009-01 - Completion Date: 2023-12 - Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital ### Study Description To investigate clinical characteristics and survival outcomes of patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting during septal myectomy. ### Conditions - Hypertrophic Cardiomyopathy - Coronary Artery Disease - Myocardial Bridging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CABG during myectomy ### Outcomes Primary Outcomes - all-cause mortality Secondary Outcomes - cardiac-related deaths and readmission ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Core Stabilization Training on Chest Expansion, Functional Capacity, Trunk Muscle Endurance in Hearing-Impaired Children - NCT ID: NCT06354400 - Study ID: 2022/001-002 - Status: RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-06-30 - Lead Sponsor: Bezmialem Vakif University ### Study Description Children's motor skills and physical performance increase with age due to the development of neuromuscular and cardiorespiratory systems. Sensory impairment seen in children with hearing loss can cause balance and coordination disorders, as well as decreased muscle strength and respiratory functions.Anatomically, core stabilization is provided by the diaphragm, abdominal, hip, pelvic floor, and gluteal muscles. Training for these muscles is intended to improve strength, endurance, and neuromuscular control. This training can help to improve the control of intra-abdominal pressure, intersegmental control of the spine, and muscular control of trunk movement. It also helps in strengthening the respiratory muscles, especially the main inspiratory muscle, the diaphragm. In this study, the effects of core stabilization training on children with hearing impairments' thoracic mobility, functional ability, and trunk muscle endurance will be examined. ### Conditions - Core Stabilization - Respiration - Functional Capacity - Endurance - Hearing Impaired Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Core stabilization training ### Outcomes Primary Outcomes - Chest expansion Secondary Outcomes - Functional capacity - Trunk muscle endurance ### Location - Facility: Nuh Naci Yazgan University, Kayseri, N/A, N/A, Turkey @@
## Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided With Serum RNase1 and Tumor Expression of PD-L1 - NCT ID: NCT06354387 - Study ID: CMUH110-REC3-246 - Status: RECRUITING - Start Date: 2022-02-16 - Completion Date: 2025-06-01 - Lead Sponsor: China Medical University Hospital ### Study Description Hepatocellular carcinoma (HCC) is the fourth most common cause of cancer-related death and the second most deadly malignancy in Taiwan. Despite decades' intensive studies, surgery and local-regional chemo-embolization, radio-frequency ablation or radiation therapy remain the mainstay of HCC treatments. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Alectinib (Alecensa), Nivolumab (Opdivo) ### Outcomes Primary Outcomes - Objective response rate(ORR) Secondary Outcomes - PFS ### Location - Facility: CMUH, Taichung, N/A, N/A, Taiwan @@
## Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment. - NCT ID: NCT06354374 - Study ID: 24-026 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2024-12 - Lead Sponsor: Ain Shams University ### Study Description Despite the importance of soft tissue dimensions for periodontal, restorative, implant, and orthodontic treatment, the current classifications of tomographic alveolar ridge topography lack the soft tissue component(Tolstunov, 2014). Therefore, the present study will be to evaluate the relationship between soft tissue volume and the dimensions \& tomographic alveolar ridge classes as well as to incorporate the soft tissue volumetric evaluation in the classification system. ### Conditions - Soft Tissue Volume ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - volume survey ### Outcomes Primary Outcomes - the relationship between soft tissue volume & tomographic alveolar ridge classes Secondary Outcomes ### Location - Facility: Ahmed Hamdy, Al Shorouk City, Cairo, 11837, Egypt @@
## Trauma-Informed Goal Management Training for Public Safety Personnel (PSP) With Post-traumatic Stress Disorder (PTSD) - NCT ID: NCT06354361 - Study ID: 17440 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-09 - Lead Sponsor: McMaster University ### Study Description Goal Management Training (GMT) is a program designed to help improve cognitive functioning. For this study, researchers have worked closely with the developers of this program to create a modified version called Trauma-Informed Goal Management Training (TI-GMT), that is more sensitive to the needs of public safety personnel (PSP) diagnosed with Post-Traumatic Stress Disorder (PTSD).The goal of this clinical trial is to find out how effective this modified, Trauma-Informed Goal Management Training program is for public safety personnel diagnosed with Post-Traumatic Stress Disorder, in comparison to the standard Goal Management Training program.The main questions it aims to answer are:1. Does Trauma-Informed Goal Management Training result in better neuropsychological functioning and greater reductions in the severity of PTSD symptoms when compared to standard Goal Management Training?2. Does Trauma-Informed Goal Management Training result in self-reported improvements in cognitive functioning and the overall ability to function (including intent to return to work, and/or intent to stay at work, reductions in disability status, etc.) when compared to standard Goal Management Training?3. Does Trauma-Informed Goal Management Training continue to benefit individuals three months after treatment?Participants will:* complete three separate assessments before starting the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires* participate in a nine-week group treatment program (one day a week for two hours)* complete three separate assessments after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires* complete three separate assessments three months after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires ### Conditions - Post-Traumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Trauma-Informed Goal Management Training (TI-GMT) - Goal Management Training (GMT) ### Outcomes Primary Outcomes - Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('CAPS-5') at post-intervention and follow-up - Change from baseline in scores on the Sustained Attention Response Task ('SART') subtest of the Creyos Battery at post-intervention and follow-up Secondary Outcomes - Demographic Information - Scores on the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('LEC-5') at baseline - Scores on the Childhood Trauma Questionnaire ('CTQ') at baseline - Scores on the Advanced Clinical Solutions ('ACS') Test of Premorbid Functioning ('TOPF') at baseline - Change from baseline in scores on selected neuropsychological assessment measures of Executive functioning, Processing speed and Attention at post-intervention and follow-up - Change from baseline in scores on selected neuropsychological assessment measures of Declarative memory at post-intervention and follow-up - Change from baseline in scores on selected neuropsychological assessment measures of Intellectual functioning at post-intervention and follow-up - Change from baseline in scores on selected neuropsychological assessment measures of Visuospatial and Visuoconstructive Ability and Sensorimotor integration at post-intervention and follow-up - Change from baseline in scores on the Mini International Neuropsychiatric Interview 7.0.2 ('M.I.N.I.') at post-intervention and follow-up - Change from baseline in scores on selected neuropsychological assessment measures of Visual and Visuospatial Working Memory at post-intervention and follow-up - Change from baseline in score on the Depression and Anxiety Stress Scale ('DASS-21') at post-intervention and follow-up - Change from baseline in score on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('PCL-5') at post-intervention and follow-up - Change from baseline in score on the Multiscale Dissociation Inventory ('MDI') at post-intervention and follow-up - Change from baseline in score on the Difficulties in Emotion Regulation Scale ('DERS') at post-intervention and follow-up - Change from baseline in score on the twenty-item Toronto Alexithymia Scale ('TAS-20') at post-intervention and follow-up - Change from baseline in score on the Moral Injury Assessment for Public Safety Personnel ('MIA-PSP') at post-intervention and follow-up - Change from baseline in scores on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) at post-intervention and follow-up - Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention and follow-up - Change from baseline in scores on the Return to work Obstacles and Coping Efficacy - Common Mental Disorders ('ROSES-CMD') at post-intervention and follow-up - Change from baseline in scores on the World Health Organization's Disability Assessment Schedule ('WHODAS 2.0') at post-intervention and follow-up - Change from baseline in scores on the Lam Employment Absence and Productivity Scale ('LEAPS') at post-intervention and follow-up - Change from baseline in scores on the Survey of Perceived Organizational Support ('SPOS') at post-intervention and follow-up ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Practical Ultrasonographic Detection of Sarcopenia in Patients With Long-term Gastrectomy - NCT ID: NCT06354348 - Study ID: GastrectomyUSG - Status: COMPLETED - Start Date: 2023-12-06 - Completion Date: 2024-03-30 - Lead Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital ### Study Description The investigators aimed to evaluate long-term sarcopenia in patients with total and distal gastrectomy by measuring the anterior thigh muscle with USG, which is a more specific and easy method. ### Conditions - Sarcopenia - Gastrectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - USG, Grip strength, Chair stand test (CST) ### Outcomes Primary Outcomes - Sarcopenia (Sonographic thigh adjustment ratio (STAR) was calculated by dividing the anterior thigh muscle thickness (mm) by BMI ) Secondary Outcomes ### Location - Facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, N/A, N/A, Turkey @@
## Impact of a Major Organizational Change on Employee Productivity and Mental Health - NCT ID: NCT06354335 - Study ID: 1-16-02-62-20 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: Aarhus University Hospital ### Study Description The study investigates the short- and long-term impact of a major organizational change on employee health and productivity. Changes in organizations is a common aspect of modern work life in all sectors and public healthcare is no exception. However, emerging evidence suggests that organizational changes may be a potential stressor which can impact on employee well-being and contribute to stress-related health problems. Using a large-scale natural experiment, the overall aim of the study is to investigate the impact of a major organizational change that took place during 2016-19 on employee health and productivity. In addition, we aim to identify groups that may be at increased risk of experiencing negative consequences of the reorganization. These at-risk groups can in turn be candidates for extended preventive measures when planning future major organizational changes. ### Conditions - Work Related Stress - Mental Health Issue - Work-related Illness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Employees exposed to a major hospital reorganisation ### Outcomes Primary Outcomes - Employee health measured by rate of absenteeism, use of health care services and redeemed drug prescriptions Secondary Outcomes - Workplace productivity measured by number of patient contacts and medical procedures ### Location - Facility: Aarhus University Hospital, Aarhus, Central Denmark Region, 8200, Denmark @@
## Unclassified GENotypes of Autoinflammatory Diseases and AA Amyloidosis - NCT ID: NCT06354322 - Study ID: APHP230630 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2034-05 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Patients with autoinflammatory diseases (AID) have recurrent episodes of systemic inflammation accompanied by nonspecific elevation of blood inflammation markers typically absent between attacks. A complication of autoinflammatory diseases is AA amyloidosis, which can lead to renal failure and dialysis. Advances in genetic analysis have led to the identification of new autoinflammatory diseases and thus new pathophysiological pathways.However, genetic analyses are sometimes confronted with results that are difficult to interpret. These are the Variants of Unknown Significance, for which genetic analysis alone does not allow to determine if the genetic mutation is responsible for the symptoms.genetic analysis sometimes has limitations in the diagnosis of AID which can only be overcome by pathophysiological studies of the variants found. ### Conditions - AA Amyloidosis - Autoinflammatory Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Exploration of VUS in AutoInflammatory Diseases Secondary Outcomes - Pathophysiology of Autoinflammatory Diseases - Role of other innate immune cells in AutoInflammatory Diseases - Improve knowledge of AA amyloidosis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study - NCT ID: NCT06354309 - Study ID: vr_study - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2023-10-20 - Lead Sponsor: He Eye Hospital ### Study Description The research project titled "The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study" aimed to evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness, and ocular surface in healthy adult participants. 38 adults (76 eyes) with normal corrected vision and stereo vision were recruited. All subjects used HMVR device for two consecutive training sessions (30 minutes each, 10 minutes intervals). Before training, after the first training and the second training, recorded the results including best corrected visual acuity (BCVA), ocular position, stereo vision, postural stability, non-invasive tear breakup time (NITBUT), tear meniscus height (TMH), red eye analysis, lipid layer classification (TFLL), eye blink frequency, eye surface temperature, simulator sickness questionnaire (SSQ) score, ocular surface disease index (OSDI) dry eye questionnaire score, visual quality questionnaire score and visual fatigue questionnaire score. ### Conditions - Amblyopia - Motion Sickness - Dry Eye ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Virtual reality game ### Outcomes Primary Outcomes - Simulator Sickness Questionnaire Score Secondary Outcomes - Postural stability - Non-invasive tear breakup time - Tear meniscus height - Lipid layer classification - Eye blink frequency - Eye surface temperature - Ocular surface disease index dry eye questionnaire score - Visual quality questionnaire score - Visual fatigue questionnaire score ### Location - Facility: He Eye Hospital, Shenyang, Liaoning, 110034, China @@
## Comparison of the Accuracy of Different Intraocular Lens Power Calculation Formulas in Cataract Patients With Prior Radial Keratotomy - NCT ID: NCT06354296 - Study ID: CAF2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-08-31 - Lead Sponsor: He Eye Hospital ### Study Description The Web-based Barret True K formula with no history formula has been proven to be a good choice for cataract patients after RK in several studies. The American society of cataract and refractive surgeons provides several IOL formulas for cataract patients who have undergone previous corneal refractive surgery. In cases where only IOL-Master data are available, Holladay 1 (Double-K) \[Holladay 1 (D-K)\] can be used for IOL power calculation in cataract patients with a history of RK. The traditional Haigis formula has also been shown to be effective for cataract patients after RK. To compare the accuracy of four intraocular lens (IOL) power calculation formulas in cataract patients after RK. They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula. ### Conditions - Cataract ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Accuracy of the IOL formula Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Progressive Muscle Relaxation Exercises Women With Low Sexual Satisfaction Sexual Satisfaction and Functioning of Women and Their Partners - NCT ID: NCT06354283 - Study ID: Progresif - Status: COMPLETED - Start Date: 2023-04-10 - Completion Date: 2024-02-08 - Lead Sponsor: Halic University ### Study Description This study was conducted to investigate the effect of progressive muscle relaxation exercises on sexual satisfaction and functioning of women and their partners in women with low sexual satisfaction.Method: The single-blind, randomized controlled study was conducted between April 2023 and January 2024. The sample of the study was women with low sexual satisfaction and their partners were randomized into two groups as intervention and control. Each group consisted of 120 couples, n=60. The women in the intervention group were given progressive muscle relaxation techniques three times a week for four weeks. The results of the study focused on the effect on sexual satisfaction and functioning of men and women. ### Conditions - Women With Low Sexual Satisfaction - Partners of Women With Low Sexual Satisfaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Progressive Muscle Relaxation Exercises ### Outcomes Primary Outcomes - Sexual Satisfaction Secondary Outcomes - Sexual Function ### Location - Facility: Fatma Şule Bilgiç, Istanbul, N/A, N/A, Turkey @@
## A Clinical Study to Evaluate the Anti-Sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers - NCT ID: NCT06354270 - Study ID: 300104 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-11 - Completion Date: 2024-06-24 - Lead Sponsor: HALEON ### Study Description The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste. ### Conditions - Dentin Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stannous fluoride toothpaste - Regular fluoride toothpaste (Crest Cavity Protection) ### Outcomes Primary Outcomes - Change from Baseline in Schiff Sensitivity Score at Day 56 Secondary Outcomes - Change from Baseline in Tactile Threshold at Day 56 - Change from Baseline in Schiff Sensitivity Score at Day 28 - Change from Baseline in Tactile Threshold at Day 28 - Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 - Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 - Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 - Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 - Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 - Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 - Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 - Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56 - Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56 ### Location - Facility: Family and Cosmetic Dentistry, All Sums Research Center Ltd., Melbourne, Florida, 32940, United States @@
## A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age - NCT ID: NCT06354257 - Study ID: 220104 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2024-10-30 - Lead Sponsor: GlaxoSmithKline ### Study Description The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used. ### Conditions - Tuberculosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - EE/LNG - GSK3036656 Dose Level 1 - GSK3036656 Dose Level 2 ### Outcomes Primary Outcomes - Area under the plasma drug concentration (AUC)-time curve from time zero to extrapolated to infinity (AUC[0-inf]) of EE after being administered with 14 days of GSK3036656 at DL 2 - Maximum observed concentration (Cmax) of EE after being administered with 14 days of GSK3036656 at DL 2 - AUC(0-inf) of LNG after being administered with 14 days of GSK3036656 at DL 2 - Cmax of LNG after being administered with 14 days of GSK3036656 at DL 2 Secondary Outcomes - AUC over the dosing interval (0-tau) of GSK3036656 after being administered with a single dose of EE/LNG - Cmax of GSK3036656 after being administered with a single dose of EE/LNG - Steady state assessment using trough plasma concentration (Ctau) of GSK3036656 after being administered with a single dose of EE/LNG - Tmax of GSK3036656 after being administered with a single dose of EE/LNG - AUC versus time curve (AUC[0-t]) of EE/LNG after being administered with a single dose of EE/LNG - AUC(0-t) of EE/LNG after being administered with 14 days of treatment with GSK3036656 at DL 2 - Tmax of EE/LNG after being administered with a single dose of EE/LNG - Tmax of EE/LNG after being administered with 14 days of GSK3036656 DL 2 - Apparent terminal half-life (t1/2) of EE and LNG after a single dose of EE/LNG - t1/2 of EE and LNG after a single dose of EE/LNG in combination with 14 days of treatment with GSK3036656 at DL 2 - Number of participants with serious adverse events (SAEs) - Number of participants with Grade 3 or higher severity adverse events (AEs) - Number of participants with drug-related AEs - Number of participants with drug-related AEs following the administration of GSK3036656 - Number of participants withdrawn from the treatment/study due to AEs - Percentage of participants with ECG values of Potential Clinical Importance (PCI) - Percentage of participants with clinical chemistry laboratory values of PCI - Percentage of participants with haematology laboratory values of PCI - Percentage of participants with vital signs parameters of PCI ### Location - Facility: GSK Investigational Site, Madrid, N/A, 28046, Spain @@
## Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions - NCT ID: NCT06354244 - Study ID: 2023-183-KY-02 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences ### Study Description The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions ### Conditions - Urinary Retention - Lower Motor Neurone Lesion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Electroacupuncture of 2 sessions per week - Electroacupuncture of 3 sessions per week - Electroacupuncture of 4 sessions per week ### Outcomes Primary Outcomes - The response rate. Secondary Outcomes - The response rate. - The change in post void residuals (PVR) from baseline. - The change in the proportion of patients reporting severe urinating difficulty from baseline. - The change in the proportion of patients having stool retention from baseline. - The change in the proportion of patients requiring catheterization from baseline. - The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I). - The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis. ### Location - Facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, N/A, N/A, China @@
## DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC - NCT ID: NCT06354231 - Study ID: RC48-C012 - Status: RECRUITING - Start Date: 2023-07-20 - Completion Date: 2026-12-30 - Lead Sponsor: Fudan University ### Study Description Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg/kg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg/kg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment. ### Conditions - Renal Insufficiency - Upper Urinary Tract Urothelial Carcinoma - Solitary Kidney ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - DV - Toripalimab - Laser surgery ### Outcomes Primary Outcomes - Kidney-intact disease-free survival, KI-DFS Secondary Outcomes - Time to progression, TTP - Time to RNU - Disease-specific survival time, DSS - Overall survival - 3m complete remission ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, N/A, N/A, China @@
## Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age - NCT ID: NCT06354218 - Study ID: GXL-005 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2027-12-01 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description This study is a Single Arm, Prospective, Exploratory, Single Center Phase II Clinical Study to evaluate the effectiveness of the combination of Serplulimab and Concurrent Chemoradiotherapy in the treatment of elderly patients with locally advanced esophageal cancer who cannot be treated surgically.Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. ### Conditions - Esophageal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Serplulimab ### Outcomes Primary Outcomes - mPFS Secondary Outcomes - ORR - OS - DOR - Toxic side reactions ### Location - Facility: The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210009, China @@
## Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels - NCT ID: NCT06354205 - Study ID: 24-3.1T/98 - Status: RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-04-01 - Lead Sponsor: Ege University ### Study Description Recently, it has been seen that investigations from saliva samples could be an alternative to those from blood samples. Saliva collection is a simple, non-invasive, cost-effective, and relatively easy method, making it potentially suitable as a new diagnostic tool in pediatric patients. In the current literature, elevated levels of saliva CRP, TNF-α, IL-6, and IFN-γ have been reported in inflammatory conditions. However, while there are animal studies suggesting the use of saliva PCT levels for focal diseases such as gingival inflammation and periodontitis and as a potential tool for non-invasive detection of sepsis, there is no human study regarding its use in systemic infections.The aim of this study is to evaluate the correlation between serum PCT levels and saliva PCT levels in children suspected of SBE and to determine the diagnostic value of saliva PCT. ### Conditions - Bacterial Infections - Children, Only - Procalcitonin - Saliva ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Sliva Procalcitonin ### Outcomes Primary Outcomes - Correlation Secondary Outcomes - Diagnose ### Location - Facility: Ege University School of Medicine, İzmir, N/A, 35100, Turkey @@
## Precision Nudging for Hypertension Management: Observational Study - NCT ID: NCT06354192 - Study ID: 0450 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-11 - Completion Date: 2026-10-11 - Lead Sponsor: Lirio ### Study Description The purpose of the proposed observational study is to explore the relations between data-driven personalization and equitable health outcomes in a digital health intervention (DHI) for hypertension management. In the current intervention, behavioral reinforcement learning is applied to personalize intervention content to maximize the behavioral outcomes of three target behaviors critical for effective hypertension management: clinical encounters, medication adherence, and self-monitoring of blood pressure (SMBP). ### Conditions - Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Precision Nudging for Hypertension Management ### Outcomes Primary Outcomes - Clinical encounter behavioral outcome - Blood pressure reading clinical outcome Secondary Outcomes - Engagement - Medication adherence behavioral outcome - Self-monitoring of blood pressure behavioral outcome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY) - NCT ID: NCT06354179 - Study ID: 87RI23_0031 (EASY) - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-07-01 - Lead Sponsor: University Hospital, Limoges ### Study Description World Health Organization considers non-adherence has a strong negative impact on the health of patients with chronic diseases. In transplantation, adherence to immunosuppressive drug regimens associates with late rejection and graft loss making it a critical determinant of patient outcome. The prevalence of non-adherence in transplant patients, including liver transplant patients, can be as high as 40%. Among others, life-long intake and complexity of immunosuppressive regimen make patients prone to non-adherence. For instance, non-adherence is more prevalent among patients with higher numbers of immunosuppressive drugs. One of the most commonly cited causes of non-adherence is forgetfulness and disruptions in routine, with the evening dose of twice daily regimens being the most likely to be affected6. Besides non-adherence, the constraints generated in everyday life by immunosuppression (including timely and regular drug intake) and the complexity of the immunosuppressive regimens represent a burden for the patients and are probably associated with a health-related quality of life deterioration. Therefore, long-term adherence and quality of life after liver transplantation might be improved by using a well-tolerated and easy-to-handle immunosuppressive regimen.The immunosuppressive regimen after liver transplantation is in most cases based on different combinations of tacrolimus, mycophenolate mofetil and corticosteroids. While corticosteroids are administered once daily, tacrolimus can be administered either twice-daily (BID) as an immediate-release, or once-daily (QD) as an extended-release formulation. Among once-daily tacrolimus formulations, LCP-tacrolimus (ENVARSUS XR®) is approved for the prevention of transplant rejection in adult liver allograft recipients. It has demonstrated similar outcomes compared to immediate-release tacrolimus BID, in both kidney and liver transplantation. Mycophenolate has only been approved for BID administration, preventing from taking all immunosuppressive drugs once daily. Yet, single daily dosing would probably contribute to better adherence and quality of life in patients receiving a life-long treatment.Although the half-life of mycophenolic acid (MPA), the active moiety of mycophenolate mofetil (MMF) is compatible with once-daily administration, no published randomized clinical study has ever evaluated the efficacy and safety of MMF administered QD.The narrow therapeutic index and wide pharmacokinetic variability of tacrolimus and mycophenolate justify individual dose adjustment by means of therapeutic drug monitoring (TDM), in order to minimize the risk of acute rejection and the occurrence of adverse events. For tacrolimus, TDM is generally based on the trough concentration (C0) and sometimes on the area under the concentration-time curve (AUC), while for mycophenolate it should be based on the AUC of MPA. However, the dose adjustment of MMF in liver transplant patients is most of the time performed a posteriori, based on clinical signs of inefficacy of toxicity.Limited sampling strategies with maximum a posteriori Bayesian estimation have been developed by our team for both molecules in adult liver transplant patients to estimate their AUC, which is considered the best marker of exposure for both. Therefore, tacrolimus AUC0-24h can be estimated by Bayesian estimation using samples collected before administration (C0), 8 (C8h) and 12 (C12h) hours after the administration of ENVARSUS XR®, or 1 and 3 hours after the administration of PROGRAF® and ADVAGRAF®. For mycophenolate, the MPA AUC can be estimated using samples collected 20 min, 1 and 3 hours after MMF administration, by Bayesian estimation.Even if limited to 2 or 3 blood samples, tacrolimus TDM for ENVARSUS® requires late sampling (12h post-dose). To overcome the necessity of a longer hospital stay, microsampling devices (MSD) such as the Volumetric absorptive microsampling (VAMS®) device (Mitra®) can be used by the patients to take samples themselves, at home. Moreover, they are less invasive than venipuncture and collect low but accurate volumes of blood for analysis.In this context, we propose a randomized controlled non-inferiority study to demonstrate that in liver transplant recipients, an immunosuppressive strategy based on single daily doses of LCP-tacrolimus (ENVARSUS XR®) and mycophenolate mofetil (CELLCEPT®) started at M6 post-transplantation is not inferior to XR-tacrolimus (ADVAGRAF®) and MMF administered BID, in terms of incidence of treatment failure (see below) at the end of the first year after transplantation, and to obtain adherence, quality of life and safety data. In order to compare solely MMF QD to MMF BID, patients on ENVARSUS XR® and MMF QD will be compared to a third group of patients receiving ENVARSUS XR® and MMF BID. A direct comparison of efficacy and safety, quality of life, adherence and exposure indices will be performed between ENVARSUS XR® and ADVAGRAF®. ### Conditions - Liver Transplantation - Immunosuppression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - XR-tacrolimus QD + MMF BID - LCP-tacrolimus QD + MMF BID - LCP-tacrolimus QD + MMF QD ### Outcomes Primary Outcomes - Treatment failure Secondary Outcomes - Adherence to treatment - measuring of quality of life - Adherence to treatment - measuring of quality of life - Appearance Adverse events - Appearance Adverse events - Comparison tacrolimus daily exposure - Comparison of MPA daily exposure - Comparison of Tacrolimus dose - Comparison of Tacrolimus AUC 0-24h - Comparison of MPA AUC 0-24h ### Location - Facility: Beaujon hospital - APHP, Clichy, N/A, 92110, France @@
## Study Human Digital Support Transitional Care - NCT ID: NCT06354166 - Study ID: 2023-A02745-40 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Divoluci ### Study Description The purpose of the study is to compare the effectiveness of Divomed in organising complex hospital discharges with a conventional organisation. Effectiveness will be assessed by reducing the length of stay of patients in geriatric short-stay care. ### Conditions - Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Unscheduled hospital admissions ### Outcomes Primary Outcomes - length of stay Secondary Outcomes ### Location - Facility: CHRU de Tours - Hôpital Bretonneau, Tours, N/A, 37044, France @@
## Polarity Management Training Program for First Line Nurse Manager - NCT ID: NCT06354153 - Study ID: 0305898 - Status: COMPLETED - Start Date: 2022-12-01 - Completion Date: 2023-04-30 - Lead Sponsor: Matrouh University ### Study Description Polarities are vital issues in healthcare systems. Nursing is a profession riddled with polarities. If first-line nurse managers are well trained to manage polarities in the workplace, this could lead to positive outcomes for nurses, nurse managers and organization performance. ### Conditions - Intervention - Knowledge, Attitudes, Practice ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Polarity Management Training Program ### Outcomes Primary Outcomes - Questionnaire to measure nurse managers' knowledge - Nursing polarity case study situations to assess first-line nurse manager's ability to differentiate between problems to solve and polarities to manage - Questionnaire to measure creativity behavior of first-line nurse managers - questionnaire to measure intrinsic work motivation among first-line nurse managers Secondary Outcomes ### Location - Facility: Faculty of Nursing, Matrouh University, Marsa Matruh, N/A, 002, Egypt @@
## PPIO-008S-1 Combined With Tislelizumab in Patients With Primary Residual Node-negative Esophageal Squamous Cell Carcinoma (ESCC) After Radical Resection With Neoadjuvant Immunotherapy Combined With Chemotherapy, PHASE II STUDY - NCT ID: NCT06354140 - Study ID: WeGuo - Status: RECRUITING - Start Date: 2024-04-07 - Completion Date: 2028-04-30 - Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University ### Study Description To explore the safety and efficacy of Tegafur combined with tislelizumab in patients with esophageal squamous cell carcinoma with residual primary lesion and node-negative after radical resection following neoadjuvant immunotherapy combined with chemotherapy ### Conditions - Postoperative Assistance for Esophageal Squamous Cell Carcinoma With Negative Lymph Nodes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tegafur ### Outcomes Primary Outcomes - 1-year DFS rate Secondary Outcomes - Overall survival - Progression-free survival ### Location - Facility: Army Medical Center of the People's Liberation Army, Chongqing, Chongqing, 400042, China @@
## DWP450 for Treating Moderate to Severe Glabellar Lines - NCT ID: NCT06354127 - Study ID: DW_DWP450009 - Status: COMPLETED - Start Date: 2020-08-12 - Completion Date: 2021-01-25 - Lead Sponsor: Daewoong Pharmaceutical Co. LTD. ### Study Description A multi-center, randomized, double-blind, positive drug-controlled clinical study to evaluate the safety and efficacy of Botulinum Toxin Type A for Injection in the treatment of moderate to severe glabellar lines ### Conditions - Moderate to Severe Glabellar Lines ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DWP450 - Botox® ### Outcomes Primary Outcomes - Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown Secondary Outcomes ### Location - Facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, N/A, China @@
## A Study to Evaluate the Efficacy and Safety in Subjects With Advanced Breast Cancer Treated With SYHX2011 - NCT ID: NCT06354114 - Study ID: SYHX2011-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. ### Study Description The main purpose of this study is to evaluate the efficacy and safety in subjects with advanced breast cancer treated with SYHX2011 ### Conditions - Advanced Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SYHX2011 ### Outcomes Primary Outcomes - Objective Response Rate (ORR) by Investigator Secondary Outcomes - Progression-Free-Survival (PFS) - Time to progression (TTP) - Incidence of adverse events ### Location - Facility: Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, N/A, China @@
## The Purpose of This Registry Study is to Learn More About Metabolic Health: Approximately 15,000 Participants Who Are Overweight or Have Obesity With or Without Metabolic Diseases Are Expected to Participate in This Registry Study. - NCT ID: NCT06354101 - Study ID: CorEvitas-VITALITY - Status: WITHDRAWN - Start Date: 2023-07-01 - Completion Date: 2023-07-01 - Lead Sponsor: CorEvitas ### Study Description The purpose of this registry study is to learn more about metabolic health. The information gathered will be used to support research on the natural history of obesity and weight related diseases, their treatments, and how it affects overall health. Approximately 15,000 participants who are overweight or have obesity with or without metabolic diseases are expected to participate in this registry study. ### Conditions - Metabolic Health ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tirzepatide - Semaglutide ### Outcomes Primary Outcomes - Main Objective of Registry Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Human Models of Selective Insulin Resistance: Alpelisib, Part I - NCT ID: NCT06354088 - Study ID: AAAU9636 - Status: RECRUITING - Start Date: 2024-04-24 - Completion Date: 2026-12 - Lead Sponsor: Columbia University ### Study Description The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels. ### Conditions - Insulin Resistance - Prediabetic State - Overweight and Obesity - Non-Alcoholic Fatty Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Alpelisib 300 mg - Placebo - [1-13C] sodium acetate - [6,6-2H2] D-glucose - Nestlé BOOST Plus ### Outcomes Primary Outcomes - Hepatic de novo lipogenesis (DNL) (absolute value) - Hepatic de novo lipogenesis (DNL) (relative value) - Endogenous glucose production (EGP) (absolute value) - Endogenous glucose production (EGP) (relative value) - Serum insulin level - Plasma glucose level Secondary Outcomes - Triglycerides level - Free fatty acids level - Glucose kinetics: rate of appearance (absolute value) - Glucose kinetics: rate of appearance (relative value) - Glucose kinetics: rate of disappearance (absolute value) - Glucose kinetics: rate of disappearance (relative value) ### Location - Facility: Columbia University Irving Medical Center, New York, New York, 10032, United States @@
## Evaluation of Patient Information in Interventional Radiology - NCT ID: NCT06354075 - Study ID: IRBN302024/CHUSTE - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-03 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description Interventional radiology is developing. Patient information modalities are also evolving, in particular information videos. ### Conditions - Patient Satisfaction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionary ### Outcomes Primary Outcomes - to evaluate satisfaction of patient of explanatory videos in interventional radiology - To evaluate satisfaction of patient of comic book in interventional radiology Secondary Outcomes ### Location - Facility: Chu Saint-Etienne, Saint-Étienne, N/A, 42055, France @@
## Talent Management Intervention Program for First-Line Nurse Managers - NCT ID: NCT06354062 - Study ID: 0305896 - Status: COMPLETED - Start Date: 2022-12-01 - Completion Date: 2023-04-30 - Lead Sponsor: Matrouh University ### Study Description Nurse leaders will be required to manage the rapid change in the healthcare system. Talent management training plays a crucial role in preparing nursing leaders and improving their performance in health care systems. ### Conditions - Intervention - Behavior - Knowledge, Attitudes, Practice ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Talent management intervention program ### Outcomes Primary Outcomes - Questionnaire to measure nurse managers' knowledge - Questionnaire to measure talent management practice among first line nurse managers. - Questionnaire to measure first-line nurse manager job performance Secondary Outcomes ### Location - Facility: Faculty of Nursing, Matrouh University, Mersa Matruh, N/A, 002, Egypt @@
## Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI) - NCT ID: NCT06354049 - Study ID: CASE3Z24 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-03-31 - Lead Sponsor: Case Comprehensive Cancer Center ### Study Description The purpose of this research is to investigate the delivery of Reiki to integrative oncology patients and assess its potential for improving cancer-related symptoms in this population. ### Conditions - Cancer Pain - Oncology Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Reiki ### Outcomes Primary Outcomes - Recruitment rate as measured by the percentage of participants enrolled - Retention rate as measured by the number of participants retained until the final survey point - Attendance rate as measured by number of sessions attended per 6 sessions - Protocol adherence rate as measured by the number of participants treated in manner consistent with the intervention - Acceptability as measured by the patient mean of participant satisfaction survey - Data completeness rate Secondary Outcomes - Patient-reported outcomes as measured by PROMIS-29(Patient-Reported Outcomes Measurement Information System) score - Patient-reported outcomes as measured by ESAS(Edmonton Symptom Assessment System) scale ### Location - Facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, 44106, United States @@
## Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy - NCT ID: NCT06354036 - Study ID: NCC4465 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description Patients who meet the inclusion criteria will undergo laparoscopic proximal gastric cancer radical surgery, and esophagogastric anastomosis will be performed using the ThTV method.Review the surgical video and record the time for making the extracorporeal muscle flap, tunnel passage time, and anastomosis time. The production time of the muscle flap is based on the electric knife incision of the muscle flap as the starting point, and successfully penetrating the muscle flap as the endpoint. The tunnel passes through time, pulling the residual end of the esophagus, and starting to pass through the gastric muscle flap tunnel as the time starting point. The complete placement of the gastric tube into the lower mediastinum is used as the time endpoint. The anastomosis time is calculated from the first needle of suturing the residual stomach and the posterior wall of the esophagus until the end of the plasma flap suturing. Record perioperative indicators such as surgical time, bleeding volume, and postoperative hospital stay. The definition of anastomotic stenosis is that in gastroscopy, those who cannot pass through the anastomotic site with ultra-fine endoscopy are judged as anastomotic stenosis.Postoperative pathology was performed using the 8th edition AJCC staging. Follow up every three months after surgery, including blood tests, liver and kidney function, and tumor markers. According to the situation, choose gastroscopy, upper gastrointestinal imaging, and chest abdominal pelvic enhanced CT. Evaluate postoperative reflux symptoms such as heartburn and sternal pain using the Visick grading system. Gastroscopy Los Angeles grading was used to evaluate postoperative reflux esophagitis. ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - the Transhiatal Tunnel Valvuloplasty technique ### Outcomes Primary Outcomes - The incidence of postoperative reflux esophagitis Secondary Outcomes - the incidence of postoperative anastomotic fistula - the incidence of anastomotic stenosis ### Location - Facility: Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, N/A, 100021, China @@
## Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis - NCT ID: NCT06354023 - Study ID: IAGH for Osteoarthritis - Status: NOT_YET_RECRUITING - Start Date: 2024-05-08 - Completion Date: 2025-05-08 - Lead Sponsor: John Sledge ### Study Description The goal of this clinical trial is to learn if growth hormone injections can be used to treat osteoarthritis (OA) in the knee. Human studies have shown that repeated injections of human growth hormone leads to the production of articular chondrocytes, which are the cells that make up the cartilage in the knee joint. Restoring cartilage in the knee can alleviate pain, improve function, and postpone the need for a joint replacement procedure. The main questions the study aims to answer are:* Do growth hormone injections in the knee joint stimulate cartilage growth?* Do the injections lower pain and stiffness in the participant's treated knee?* Does the participant have more mobility after the injections?The physician will monitor the participant's progress through X-ray images, questionnaires, and physical evaluation of the treated knee.For the trial, participants will:* Receive a growth hormone injection in their knee once per week for six weeks, for a total of 6 injections.* Complete at-home exercises during the treatment period.* Use crutches as needed during the trial.* Have X-rays taken at 8 weeks, 6 months, and 12 months after the first injection.* Go to follow-up visits at 8 weeks, 6 months, and 12 months after the first injection.* Complete treatment surveys before treatment starts and after it is finished. ### Conditions - Osteoarthritis, Knee ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Recombinant human growth hormone ### Outcomes Primary Outcomes - Knee Society Score - Kellgren-Lawrence Grading Scale Secondary Outcomes - Serum IGF-1 Levels ### Location - Facility: BioShift Life Sciences, Santa Monica, California, 90404, United States @@
## Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis - NCT ID: NCT06354010 - Study ID: SENS-NH02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-07 - Lead Sponsor: Sensorion ### Study Description The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene. ### Conditions - Sensorineural Hearing Loss, Bilateral ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Genotyping - Audiological assessments ### Outcomes Primary Outcomes - Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene. - Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene Secondary Outcomes - Genetic characteristics of adult patients with early-onset presbycusis - Audiological characteristics of adult patients with early-onset presbycusis - Mood evaluation in adult patients with early-onset presbycusis carrying mutations in GJB2 gene ### Location - Facility: CHU Gui de Chauliac, Montpellier, N/A, 34295, France @@
## Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients - NCT ID: NCT06353997 - Study ID: 2024000099 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2029-06 - Lead Sponsor: Providence Health & Services ### Study Description This is a Phase II trial to assess feasibility of pembrolizumab + INBRX-106 as a chemotherapy-sparing neoadjuvant therapy. One therapeutic arm is being evaluated to provide an informal comparison of pharmacodynamic and clinical effects of concurrent dosing schedule. ### Conditions - Triple Negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab - INBRX-106 ### Outcomes Primary Outcomes - Pathological response (post-IO) Secondary Outcomes - Pathological response (post-chemotherapy) - IO-path response assessed prior to Cycle 2 - Volumetric response - Event free survival - Overall survival - Toxicity profile ### Location - Facility: Ellison Institute of Technology (EITM), Los Angeles, California, 90064, United States @@
## Effects of In-between Meal Products on Cognitive Function in Older Adults - NCT ID: NCT06353984 - Study ID: Minimeal 1.0 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-12 - Lead Sponsor: Örebro University, Sweden ### Study Description The overall aim of the present 9-week intervention study is to determine how a healthy drinkable in between meal affects cognitive function and brain activity in healthy adults 70 years and older. Secondary, the study also investigates the impact of the intervention on low grade inflammation, immune function, gut health, body composition, physical function, and well-being as secondary or exploratory outcomes. The present study has as the potential to prevent or slow down the onset of cognitive decline as it targets healthy older adults and gives additional insight regarding secondary and exploratory outcomes. ### Conditions - Cognitive Function ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Minimeal product - Reference product ### Outcomes Primary Outcomes - Functional brain activity Secondary Outcomes - Fasting blood glucose/insulin - Blood fats/lipid status - Interleukin-6 - High-sensitivity C-reactive protein - Tumor necrosis factor - Interferon-gamma - Zonulin - Intestinal fatty-acid binding protein - Cognitive function - Magnetic resonance imaging (MRI) - The Perceived Stress Scale - Hospital Anxiety and Depression Scale - SF 36 - Western Ontario and McMaster Osteoarthritis Index - Clinical Outcomes in Routine Evaluation - Gastrointestinal Symptoms Rating Scale - Pittsburgh Sleep Quality Index - International Physical Activity Questionnaire for the Elderly short form - Historical Physical Activity Questionnaire - Food frequency questionnaire - Physical activity - Muscle mass - Fat mass - Body mass index - Waist circumference - Aerobic capacity - Balance - 30-sec repeated chair raise - Maximal leg strength - Maximal handgrip strength ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines - NCT ID: NCT06353971 - Study ID: JSP-CP-010 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-08-04 - Lead Sponsor: Jasper Therapeutics, Inc. ### Study Description This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore two ascending dose levels which will be tested in two sequential cohorts. ### Conditions - Chronic Inducible Urticaria ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Briquilimab ### Outcomes Primary Outcomes - Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines. Secondary Outcomes - Preliminary efficacy of briquilimab ### Location - Facility: Charité - University Clinic Berlin, Berlin, N/A, 12203, Germany @@
## MiSaver® Stem Cell Treatment for Acute Myocardial Infarction - NCT ID: NCT06353958 - Study ID: MiSaver PIIa - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Honya Medical Inc ### Study Description Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.Primary Endpoint:The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.Secondary Outcomes:Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups. ### Conditions - Acute Myocardial Infarction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MiSaver ### Outcomes Primary Outcomes - Safety and adverse events events Secondary Outcomes - Efficacy on ventricular ejection fraction (LVEF) improvement ### Location - Facility: Chung Shan Medical University Hospital, Taichung, N/A, N/A, Taiwan @@
## Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use. - NCT ID: NCT06353945 - Study ID: HB062-24 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2024-05-15 - Lead Sponsor: Herbarium Laboratorio Botanico Ltda ### Study Description The present research project aims to evaluate the perceived effectiveness of the product under investigation under normal conditions of use for 28 days, to defend the claims "High hydration power, relief of discomfort and improvement of vaginal tone." ### Conditions - Vaginal Atrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - vaginal moisturizer ### Outcomes Primary Outcomes - evaluate the perceived effectiveness of the investigational product Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range - NCT ID: NCT06353932 - Study ID: KA-23026 - Status: COMPLETED - Start Date: 2024-01-25 - Completion Date: 2024-02-25 - Lead Sponsor: Hacettepe University ### Study Description The main purpose of our prospective, randomized, controlled, double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat, hoarseness and cough.The secondary aims of our study are to evaluate the effect of intubation duration, smoking, presence of chest disease, presence of blood on the intubation tube after extubation, presence of NG\\OG, and type of surgery on the incidence of sore throat, hoarseness, and cough.The patients were randomly divided into two: a study group with continuous cuff pressure monitoring and a control group without continuous cuff pressure monitoring.The endotracheal cuff pressure of the patients in both groups was measured by a blinded researcher using a cuff manometer after intubation, before extubation, and in long cases, at the 3rd hour after intubation.Patients were evaluated for sore throat, cough, and hoarseness at the 2nd and 24th hours by another researcher blinded to the study groups. ### Conditions - Endotracheal Tube - Cuff Pressure - Sore Throat ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - keeping the endotracheal tube cuff pressure within a certain range ### Outcomes Primary Outcomes - Sore throat - cough - hoarseness Secondary Outcomes ### Location - Facility: Hacettepe University Hospital, Ankara, N/A, 06100, Turkey @@
## Remote Yoga Nidra for Deprescribing BZRAs - NCT ID: NCT06353919 - Study ID: NUNM - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-05-31 - Lead Sponsor: National University of Natural Medicine ### Study Description The overall goal of this application is to assess feasibility and impact of a remotely delivered guided meditation practice called Yoga Nidra, for reducing or stopping use of Benzodiazepine Receptor Agonists (BZRAs) for insomnia and anxiety in a population of older adults recruited from within the Birmingham VA medical system. ### Conditions - Anxiety - Insomnia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Yoga Nidra - Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education ### Outcomes Primary Outcomes - Demand - Recruitment Success - Implementation practicality - Acceptability - Retention - Adherence to Protocol Secondary Outcomes - Use of Benzodiazepine Receptor Agonist medications - Cessation of Benzodiazepine Receptor Agonist medication - Baseline Urine Benzodiazepine Receptor Agonist Concentration - Close-out Urine Benzodiazepine Receptor Agonist Concentration ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer - NCT ID: NCT06353906 - Study ID: N22APC - Status: NOT_YET_RECRUITING - Start Date: 2024-06-14 - Completion Date: 2028-01-14 - Lead Sponsor: The Netherlands Cancer Institute ### Study Description This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis ### Conditions - Urologic Neoplasms - Urogenital Neoplasms - Male Urogenital Diseases - Penile Cancer - Penile Squamous Cell Carcinoma - Locally Advanced Penile Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Carboplatin/Paclitaxel - Pembrolizumab - Partial or total penectomy with inguinal and/or pelvic lymph node dissection ### Outcomes Primary Outcomes - Pathological complete response (pCR) Secondary Outcomes - Drug toxicity - Progression-free survival (PFS) - Overall survival (OS) - Assessment of correlation between clinical endpoints and tumor characteristics - Tumor tissue HPV status in relation to treatment response - Tumor tissue PD-L1 expression in relation to treatment response - Evaluation of changes in patient reported outcome regarding Quality of Life (QoL) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## MRI Evaluation of Integrity Bio-Inductive Implant for Rotator Cuff Tears - NCT ID: NCT06353893 - Study ID: Integrity-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-05-01 - Lead Sponsor: Foundation for Orthopaedic Research and Education ### Study Description The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are:* How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS?* What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant?Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair. ### Conditions - Rotator Cuff Tears ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Anika Integrity Implant System ### Outcomes Primary Outcomes - MRI Assessment of Adverse Events and Structural Integrity Secondary Outcomes - Effectiveness Evaluation with PROMIS outcome tool - Effectiveness Evaluation with PROMIS tool - Effectiveness Evaluation with SANE score - Effectiveness Evaluation with SANE score - Effectiveness Evaluation with ASES rating scale - Effectiveness Evaluation with ASES rating scale ### Location - Facility: Foundation for Orthopaedic Research and Education, Tampa, Florida, 33607, United States @@
## Obesity With Sperm Quality in Men With Fertility Need - NCT ID: NCT06353880 - Study ID: 24K08-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: Yu xiaowei ### Study Description This study aims to investigate the impact of different types of obesity on sperm quality. Participants will be divided into three groups: a normal BMI group, an obese group without pudendal fat wrapping the testicles, and an obese group with pudendal fat wrapping the testicles. Sperm quality parameters will be compared among these groups to assess potential differences associated with different types of obesity. ### Conditions - Sperm Quality - Obesity - Sex Hormones - Visceral Fat ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition. ### Outcomes Primary Outcomes - Investigation of Testicular Fat-Wrapped Testes Incidence and Associated Risk Factors Secondary Outcomes - Comparison of Sperm Quality Across BMI Categories and Testicular Fat-Wrapped Subgroups - Comparison of Sex Hormone Levels Across BMI Categories and Testicular Fat-Wrapped Subgroups ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Group Exercise in Children With Special Needs - NCT ID: NCT06353867 - Study ID: 56365223-050.01.04-2023.13754 - Status: COMPLETED - Start Date: 2022-12-27 - Completion Date: 2023-04-25 - Lead Sponsor: Istanbul Gedik University ### Study Description Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention. ### Conditions - Developmental Disability - Child Autism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Group Exercise ### Outcomes Primary Outcomes - Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF) - Paediatric Balance Scale - Functional Reach Test - Timed Up and Go Test - Stroop Test Secondary Outcomes ### Location - Facility: Marmara University, Istanbul, N/A, N/A, Turkey @@
## Prospective Cohort Study of Immunotherapy Resistance in Metastatic Colorectal Cancer Patients With MSI - NCT ID: NCT06353854 - Study ID: FFCD 2112-CORESIM - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2030-02-12 - Lead Sponsor: Federation Francophone de Cancerologie Digestive ### Study Description Over the last ten years, the discovery of the mechanisms by which tumours escape the control of the immune system, and in particular the T lymphocyte response, has led to the emergence of new therapeutic strategies against cancer, such as the use of "immune checkpoint inhibitors" (ICI). The immune system plays a crucial role in controlling tumour proliferation, and involves several players.Schematically, after recognition of the MHC-peptide complex by the TCR, the T lymphocyte response is modulated by several activating or inhibiting co-stimulatory signals (or "checkpoints"). The balance of these different signals determines whether the T lymphocyte (LT) is activated, resulting in the destruction of the target cell, or whether the T lymphocyte is inhibited (anergy), inducing immune tolerance. By hijacking this system through the expression of inhibitory checkpoints on its surface, the tumour cell is able to evade the effector immune response (1). Monoclonal antibodies (mAbs) directed against inhibitory co-stimulatory molecules such as Programmed-cell death 1 (PD-1) and cytotoxic T lymphocyte antigen 4 (CTLA-4) or their ligand Programmed-cell death ligand 1 (PD-L1) have been developed to restore effective anti-tumour immunity. These ICIs have led to a major improvement in the prognosis of certain cancers, notably melanoma and non-small cell lung cancer.However, the efficacy of ICIs varies from one cancer to another. In addition to the expression of PDL1 by the tumour and/or immune cells, and the mutational load, one of the primary factors predicting response to immunotherapy mentioned in several studies is microsatellite instability (MSI). ### Conditions - Colorectal Cancer Metastatic - Microsatellite Instability-High Colorectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Identification of predictive factors of resistance to pembrolizumab immunotherapy in first-line treatment of unresectable mRCC Secondary Outcomes ### Location - Facility: Ch - Centre Hospitalier de La Côte Basque, Bayonne CEDEX, N/A, 64100, France @@
## Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children - NCT ID: NCT06353841 - Study ID: 2023/435 - Status: RECRUITING - Start Date: 2023-05-03 - Completion Date: 2024-12-31 - Lead Sponsor: Burdur Mehmet Akif Ersoy University ### Study Description The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children. ### Conditions - Functional Constipation - Therapeutic Touch - Infants - Children - Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Therapeutic Touch ### Outcomes Primary Outcomes - Primary Results Follow-up Form - Primary Results Follow-up Form - Primary Results Follow-up Form - Primary Results Follow-up Form - Primary Results Follow-up Form - Primary Results Follow-up Form Secondary Outcomes - Bristol Stool Scale ### Location - Facility: Burdur Bucak State Hospital, Burdur, Bucak, 15030, Turkey @@
## Phase 2a Study to Evaluate IcBD-01 Enema in Active Ulcerative Colitis Patients - NCT ID: NCT06353828 - Study ID: ICBD-UC-01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: CannaMore Biotechs ### Study Description Ulcerative proctitis can lead to considerable morbidity, and the available treatment options are limited. Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa, possesses potent immunomodulatory and anti-inflammatory properties as described in both acute and chronic animal models of inflammation, including IBD models.Based on positive safety and initial efficacy profiles of CBD found in IBD animal and clinical studies, the main aim of this study is to evaluate the safety, tolerability and efficacy of a novel enema formulation of CBD for the treatment of active ulcerative proctitis. ### Conditions - Ulcerative Colitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CBD, synthetic form - Placebo ### Outcomes Primary Outcomes - Change from baseline in Full Mayo Score Secondary Outcomes - Change in Partial Mayo Score - Change in patient reported outcome (PRO-UC) - Change in endoscopic Mayo subscore in distal 15 cm of anus - Change in the length of the inflamed colon ### Location - Facility: Meir Medical Center, Kfar Saba, N/A, N/A, Israel @@
## Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block - NCT ID: NCT06353815 - Study ID: anaesthetic efficacy - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-06 - Lead Sponsor: Cairo University ### Study Description Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars ### Conditions - Restorative Dental Treatment by Buccal Infiltration Anaesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 4% articaine infiltration ### Outcomes Primary Outcomes - Success of local anesthesia Secondary Outcomes - Child behavior during treatment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Relationship Between Chronic Non-Specific Neck Pain And Lumbar Reposition Sense - NCT ID: NCT06353802 - Study ID: P.T.REC/012/004963 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-05 - Lead Sponsor: Cairo University ### Study Description to investigate the correlation between chronic non-specific neck pain and lumbar reposition sense. ### Conditions - Chronic Non-specific Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Chronic non-specific neck pain and lumbar reposition sense ### Outcomes Primary Outcomes - Correlation Between Chronic Non-Specific Neck Pain And Lumbar Reposition Sense Using iPhone inclinometer app Secondary Outcomes ### Location - Facility: Physical Therapy College Cairo University, Giza, N/A, 12613, Egypt @@
## Adolescent Dysmenorrhoea as a Risk Factor for Chronic Pain: Clinical Cohort Study - NCT ID: NCT06353789 - Study ID: RoADPain Clinical Study - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: University of Oxford ### Study Description This study aims to understand whether changes in a variety of body systems which are seen in adult women with period pain are also seen in adolescents in the first few years of having periods. This information will help us to understand 1) how quickly any changes occur, informing clinical practice, and 2) how period pain might lead to other types of chronic pain, potentially allowing development of preventative strategies. ### Conditions - Dysmenorrhea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Quantitative Sensory Testing (QST) - Heart rate (HR) - Change in heart rate - Bladder sensitivity to filling - Volume voided at maximum tolerance - Pain Catastrophising: Pain Catastrophising Scale (PCS) (Sullivan) - Area under the curve (AUC) of single day salivary cortisol profile Secondary Outcomes - Change of pressure pain threshold (PPT) - fMRI scan ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface - NCT ID: NCT06353776 - Study ID: 02052023 - Status: COMPLETED - Start Date: 2023-05-03 - Completion Date: 2023-10-31 - Lead Sponsor: University Tunis El Manar ### Study Description MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. This study aims to bridge this gap by examining the clinical and histopathological effects of MicroPulse TLT on the ocular surface. ### Conditions - Conjunctiva - Cornea ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - conjunctival biopsy after micropulse transscleral laser therapy ### Outcomes Primary Outcomes - conjunctival inflammation or fibrosis - intraocular pression - ocular surface disease index score Secondary Outcomes ### Location - Facility: Mohamed Taher Maamouri Hospital, Nabeul, N/A, 8000, Tunisia @@
## Design, Implementation, and Evaluation of Virtual Reality in the Nursing Curriculum - NCT ID: NCT06353763 - Study ID: CV - Status: COMPLETED - Start Date: 2022-02-24 - Completion Date: 2022-06-30 - Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra ### Study Description The aim of the study is to determine the effectiveness of an immersive virtual reality learning programme for nursing students, based on virtual glasses, in acquiring the competence (knowledge, skills and attitudes) to care for patients with pressure ulcers, and to compare it with the traditional teaching method.The design was an exploratory randomised controlled trial. The variables used to measure effectiveness were competence and its attributes: knowledge assessment by a multiple-choice test (Pressure Ulcer Knowledge Assessment Tool, Pukat 2.0 instrument), skill performance by direct observation of procedural skills (simulated cases with standardised patients) and satisfaction and usability assessment (Usefulness, Satisfaction and Ease of Use Questionnaire). ### Conditions - Pressure Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Immersive virtual reality learning program ### Outcomes Primary Outcomes - Knowledge - Skill performance - Usefulness, Satisfaction, and Ease of Use Secondary Outcomes ### Location - Facility: University of Navarra, Pamplona, Navarra, N/A, Spain @@
## Intracellular Magnesium and Heart Failure - NCT ID: NCT06353750 - Study ID: 331039 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-04-25 - Lead Sponsor: University of Oxford ### Study Description Low magnesium levels are surprisingly common in those with a heart condition known as HFpEF, where the heart pumps well but is too rigid to fill properly with blood. While routine blood tests can check magnesium levels, they don't tell us how much magnesium is actually inside the heart and muscle cells, where it's vital for energy and overall function. Our research aims to get a clearer picture by looking directly at the magnesium inside these cells and understanding its role in the body's energy production and usage. We're also interested in how magnesium levels affect symptoms and the body's handling of sugar. We're using advanced medical imaging techniques, like heart magnetic resonance imaging (MRI) and other heart and muscle function tests, at rest and when the heart is working hard to help answer these questions. We'll compare the magnesium levels inside the cells before and after giving a supplement of magnesium to see if this can make a difference in how the heart and muscles work. ### Conditions - Heart Failure With Preserved Ejection Fraction - Hypomagnesemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Magnesium supplement ### Outcomes Primary Outcomes - Myocardial/ skeletal muscle metabolism and energetics at rest and stress. Secondary Outcomes - Serum versus intracellular magnesium concentration - Cardiac function - Skeletal muscle performance - Symptoms - Insulin sensitivity ### Location - Facility: Oxford Centre for Magnetic Resonance (OCMR), Oxford, N/A, OX3 9DU, United Kingdom @@
## Looking for Asymptomatic Mpox in a Population at High Risk - NCT ID: NCT06353737 - Study ID: CTO 4489 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-03-31 - Lead Sponsor: Unity Health Toronto ### Study Description Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature. ### Conditions - Mpox (Monkeypox) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Asymptomatic prevalence Secondary Outcomes - Symptomatic prevalence - Mpox seropositivity - Characteristics - Characteristics of seropositivity ### Location - Facility: Unity Health Toronto, Toronto, Ontario, M5B 1T8, Canada @@
## Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent - NCT ID: NCT06353724 - Study ID: RP2218 - Status: COMPLETED - Start Date: 2019-10-14 - Completion Date: 2021-01-01 - Lead Sponsor: Tanta University ### Study Description The goal of this clinical trial is to compare between the Effect of Using Conventional and Digital Oral Positional Radiation Stent on Healthy tissues, salivary PH. The main question it aims to answer are: Does the difference in manufacturing method affect on Healthy tissues, salivary PH.Participants will use radiation positioning stent during radiotherapy sessions Two groups will be compared* Group A: OPRS was constructed according to the conventional technique.* Group B: OPRS was constructed digitally using CAD /CAM technology. to evaluate Dosimetric analysis to quantify the radiation dose in OARs, PH of saliva measurement and Mucositis assessment. ### Conditions - Radiotherapy Side Effect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planning - Digital positioning stent ### Outcomes Primary Outcomes - Dosimetric analysis - PH of saliva measurement: - Mucositis assessment: Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Tanta, Gharbia, 31527, Egypt @@
## CA-LINC Black Youth Suicide Detection and Intervention Study - NCT ID: NCT06353711 - Study ID: IRB-23-0746 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-05 - Lead Sponsor: University of North Carolina, Charlotte ### Study Description The Culturally Adapted Linking Individuals Needing Care (CA-LINC) study will recruit a sample of Black youth to participate in a two-arm parallel-comparison single-blinded pilot randomized control trial (RCT). For the pilot RCT, 68 Black youth participants ages 14-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: CA-LINC (n=34) or TAU (n=34).CA-LINC is a 90-day culturally adapted LINC intervention developed with and for Black youth. The CA-LINC intervention integrates engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/linkages, develop/reﬁne safety plans, and create villages of care. The CA-LINC intervention incorporates African-centered principles and empowerment and motivational strategies aimed to support, enhance strengths, promote hope, improve family relationships, and reinforce caring messages. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement and delivery standards.CA-LINC is implemented by Peer Support Specialists and Community Health Workers assigned to mental health "hubs" in Black Faith-Based Organizations (FBOs) that facilitate standardization and access to care for Black youth/families regardless of religious affiliation. Black FBOs effectively mobilize Black communities to promote positive health behaviors. The RCT will explore the "fit" of the culturally adapted intervention (CA-LINC) in Black communities in Charlotte, North Carolina, and inform a scalable RCT for a future study. ### Conditions - Suicide - Suicide Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - CA-LINC Intervention - Treatment as Usual ### Outcomes Primary Outcomes - Change in Suicide Ideation - Change in Suicide Behaviors Secondary Outcomes ### Location - Facility: The University of North Carolina at Charlotte, Charlotte, North Carolina, 28223, United States @@
## Fasting Mimicking Diet With Chemotherapy in Patients With Leukemia - NCT ID: NCT06353698 - Study ID: Nnftri - Status: RECRUITING - Start Date: 2023-07-02 - Completion Date: 2024-05-01 - Lead Sponsor: National Nutrition and Food Technology Institute ### Study Description The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia. ### Conditions - Fasting Mimicking Diet - Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - fasting mimicking diet ### Outcomes Primary Outcomes - Blast cell count - Quality of life Secondary Outcomes ### Location - Facility: Azita Hekmatdoost, Tehran, Middle East, 19835, Iran, Islamic Republic of @@
## De-Escalation Postoperative Radiotherapy for Oral Squamous Cell Carcinoma With pCR/MPR. - NCT ID: NCT06353685 - Study ID: neo-CHART-HNC - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-12-31 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description The prognosis of locally advanced oral squamous cell carcinoma(OSCC ) is poor, and there are still many problems to be solved in the current treatment paradigm. Neoadjuvant chemotherapy combined with immunotherapy can significantly improve the pCR and MPR rates in patients with locally advanced OSCC. For patients who achieve pCR and MPR after neoadjuvant therapy and surgery, it is still hotly debated regarding whether to implement postoperative de-escalation radiotherapy. Neoadjuvant therapy is an ideal predictor of radiosensitivity. In theory, neoadjuvant therapy can eliminate microscopic lesions, thereby reducing the dose and volume of irradiation.Continuous hyperfractionated accelerated radiotherapy (CHART, based on hyperfractionated radiotherapy, increasing daily or weekly treatments and shortening the total treatment duration, but reducing the total dose), is to give a higher dose of radiation to tumor tissue in a shorter period of time, so as to overcome the accelerated reproliferation and inhibit the repair of sublethal damage of tumor cells. It is beneficial to improve the local control rate of tumor, control the acute injury of normal tissue and the yield acceptable late treatment-related complications. The specific protocol was as follows: high-risk CTV area (CTV1), 45Gy in total, fraction dose of 1.5Gy, twice a day, bioequivalent dose (BED) of 51.75Gy; Low-risk CTV area(CTV2), 39Gy in total , fraction dose of 1.3Gy, twice a day, BED of 44.07Gy; A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks. ### Conditions - De-escalated Radiotherapy; Head and Neck Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Continuous, hyperfractionated, accelerated radiotherapy(CHART) ### Outcomes Primary Outcomes - 2-year PFS Secondary Outcomes - 2-year OS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate Safety and Feasibility of Robotic Liver Resection - NCT ID: NCT06353672 - Study ID: RLR-01 - Status: RECRUITING - Start Date: 2020-12-01 - Completion Date: 2026-12-31 - Lead Sponsor: Zhejiang University ### Study Description The robotic surgery system, the most advanced technology in minimally invasive surgery, overcame some shortcomings of laparoscopic surgery and improved the flexibility and precision of liver resection. Several studies have demonstrated that the robotic system was safe and feasible in liver surgery and might be advantageous in complex hepatic vein and hilar dissection, operative bleeding control, and biliary reconstruction. Previous comparative studies found limited evidence for significantly improved outcomes in robotic liver resection (RLR) over laparoscopic liver resection (LLR) or open liver resection (OLR), considering the various degrees of difficulty in liver surgeries.This study aimed to evaluate safety and feasibility of robotic liver resection, by comparing it with LLR or OLR, and gain veritable and relevant data on the benefits of RLR. ### Conditions - Liver Diseases - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Robotic liver resection ### Outcomes Primary Outcomes - Postoperative complications - Postoperative hospital stay - Postoperative unplanned reoperation - Unplanned readmission Secondary Outcomes ### Location - Facility: First Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, Zhejiang, 310003, China @@

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