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## Effect of Neuromuscular Stimulation and Mindfulness Breathing in Patients With Stroke - NCT ID: NCT06302946 - Study ID: P.T.REC/012/005024 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-12-30 - Lead Sponsor: Cairo University ### Study Description It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation , mindfulness breathing and traditional physiotherapy while the control group will stick to traditional physiotherapy only. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - neuromuscular stimulation ,mindfulness breathing and traditional physiotherapy program - traditional physiotherapy program ### Outcomes Primary Outcomes - level of physical function Secondary Outcomes - ventilatory function - level of stress ### Location - Facility: Faculty of Physical Therapy, Cairo, Dokki, 11432, Egypt @@
## Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms - NCT ID: NCT06302933 - Study ID: ANRS 12414 PediacamNEG - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-08-30 - Lead Sponsor: ANRS, Emerging Infectious Diseases ### Study Description The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in CameroonThe hypothesis of better control of HIV infection through interactions between immunological, viral, and genetic factors was made to build the following objectives:* Immunological aspect: lack of humoral response or immune activation* Virological aspect: Reduced HIV reservoir size* Determine the HLA phenotype in the different groups of children included and the KIR genotypes. ### Conditions - HIV Infections ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Blood sampling ### Outcomes Primary Outcomes - Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma - Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma - Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma - Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma - Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma - Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma - Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma Secondary Outcomes - - Humoral response to vaccines against tetanus, pertussis, and viral hepatitis B - - Functional and phenotypic characterization of B and T lymphocytes - - Size of the HIV reservoir - - Residual viremia in perinatally HIV-infected adolescent - - Level of HIV plasma p24 - - HLA phenotype and the KIR genotypes ### Location - Facility: Centre Pasteur Cameroun, Yaounde, N/A, 1274, Cameroon @@
## Effect of Kinesiotaping on Pain,Edema and Kinesiophobia in Patients With Complex Regional Pain Syndrome - NCT ID: NCT06302920 - Study ID: 0001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2024-12-20 - Lead Sponsor: Alanya Alaaddin Keykubat University ### Study Description Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. The applied kinesio tape will remain on the patient for 5 days and will be taped again after 2 days without tape. In this way, taping will be done 3 times in total, once a week for 3 weeks. During this period, patients will continue their routine physical therapy program and measurements will be taken by the same researcher in the 1st week of treatment and 3 weeks later. ### Conditions - Complex Regional Pain Syndrome Type I ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Kinesiotape ### Outcomes Primary Outcomes - Resting pain - Edema - Kinesiophobia Secondary Outcomes ### Location - Facility: Alanya Alaaddin Keykubat University, Antalya, N/A, N/A, Turkey @@
## The Effect of Adding Sodium Bicarbonate 8.4% to Local Anesthesia on Pain During Upper Canine Infiltration - NCT ID: NCT06302907 - Study ID: M/45- 14.1.2023 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-01-14 - Completion Date: 2024-06-30 - Lead Sponsor: Al-Wataniya University ### Study Description The aim of the present study was to evaluate the pain during local anesthetic buccal infiltration for the maxillary canines after adding Sodium Bicarbonate 8.4% during local anesthesia. ### Conditions - Local Anesthetic Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Buffered Local anaesthesia - Unbuffered Local anaesthesia ### Outcomes Primary Outcomes - Pain on injection Secondary Outcomes ### Location - Facility: Al Wataniya Private University, Hama, Hama Government, 00000, Syrian Arab Republic @@
## The Effect of the Nursing Intervention Program on Adolescent Problematic Internet Users - NCT ID: NCT06302894 - Study ID: BAIBU-SBF-EC-01 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: Abant Izzet Baysal University ### Study Description In this study; The effect of the nursing intervention program (education enriched with web 2.0 tools based on the Health Belief Model) on problematic internet use, loneliness and family harmony in adolescents who use the internet with problems will be determined. ### Conditions - Internet Addiction Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Self-sufficiency ### Outcomes Primary Outcomes - Internet Addiction Scale Secondary Outcomes ### Location - Facility: Bolu Abant İzzet Baysal University Faculty of Health Sciences, Bolu, N/A, 14300, Turkey @@
## Differentiating Tumor-stroma Ratio in Pancreatic Ductal Adenocarcinoma - NCT ID: NCT06302881 - Study ID: liaohongfan - Status: ACTIVE_NOT_RECRUITING - Start Date: 2013-01 - Completion Date: 2024-03 - Lead Sponsor: First Affiliated Hospital of Chongqing Medical University ### Study Description This study introduces a novel transfer learning-based contrastive language-image pretraining adapter (CLIP-adapter) model for predicting the tumor-stroma ratio (TSR) in pancreatic ductal adenocarcinoma (PDAC) using preoperative dual-phase CT images. The primary aim is to develop an efficient and accessible tool for risk stratification and personalized treatment planning. ### Conditions - Pancreatic Ductal Adenocarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The diagnostic AUC value of pancreatic ductal adenocarcinoma with deep learning algorithm. Secondary Outcomes - The diagnostic accuracy of pancreatic ductal adenocarcinoma with deep learning algorithm. - The diagnostic sensitivity of pancreatic ductal adenocarcinoma with deep learning algorithm. - The diagnostic specificity of pancreatic ductal adenocarcinoma with deep learning algorithm. - The diagnostic positive predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm. - The diagnostic negative predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias - NCT ID: NCT06302868 - Study ID: 006215 - Status: RECRUITING - Start Date: 2023-10-03 - Completion Date: 2024-08-01 - Lead Sponsor: University of South Florida ### Study Description The purpose of this study is to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. The secondary purpose is to preliminarily examine the efficacy of using Doxy.me VR vs. TMH in reducing phobia severity. ### Conditions - Arachnophobia - Cynophobia - Ophidiophobia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Telemedicine Exposure Therapy Using Photos and Videos - Telemedicine-Based Virtual Reality Exposure Therapy ### Outcomes Primary Outcomes - Phobia symptom severity Secondary Outcomes ### Location - Facility: University of South Florida, Tampa, Florida, 33613, United States @@
## Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care - NCT ID: NCT06302855 - Study ID: 2024-00124 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-09-01 - Lead Sponsor: Karim Gariani ### Study Description Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test).Secondary objectives include assessing the prevalence of periodontal disease (PD) in this diabetic sample population and evaluating the presence of specific biomarkers related to it.The final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. The aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment. ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - dental expertise ### Outcomes Primary Outcomes - adherence of diabetic patients to periodontal Secondary Outcomes - calculate the prevalence of periodontitis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pilot Open Label Study With Commercial Supplementation in Healthy Subjects - NCT ID: NCT06302842 - Study ID: 20J201 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-07-01 - Completion Date: 2024-04-30 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description A bidirectional relationship among nutrition, infection and immunity exists: changes in one component affect the others. Various micronutrients are essential for immunocompetence, particularly vitamins A, C, D, E, B2, B6, and B12, folic acid, iron, selenium, and zinc. Micronutrient deficiencies are a recognized global public health issue, and poor nutritional status predisposes to certain infections. Immune function may be improved by restoring deficient micronutrients to recommended levels, thereby increasing resistance to infection and supporting faster recovery when infected. Diet alone may be insufficient and tailored micronutrient supplementation based on specific age-related needs is necessary.Aim of the study is to investigate whether nutrient supplementation may affect different functional parameters of the innate and adaptive immunity. ### Conditions - Supportive Care ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Bioritmon Immuno Defend ### Outcomes Primary Outcomes - Change in neutrophil chemotaxis - Change in neutrophil phagocytosis - Change in neutrophil oxidative burst - Change in mononuclear CD4pos69pos - Change in mononuclear CD56pos69pos granzymepos - Change in plasma cytokine levels Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano IRCCS, Milan, N/A, 20145, Italy @@
## Comparison of IMES Versus DN on ATrPs of AC - NCT ID: NCT06302829 - Study ID: RiphahIU Shafia Anjum - Status: RECRUITING - Start Date: 2024-01-21 - Completion Date: 2024-07-30 - Lead Sponsor: Riphah International University ### Study Description The aim of our study to compare DN and IMES for pressure pain threshold, ROM and the shoulder function in active trigger points with adhesive capsulitis. This study will add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative of therapy. Moreover, it would add to the society as there are very limited researches done in Pakistan using needling for trigger points in adhesive capsulitis. ### Conditions - Shoulder Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dry needling - intramusuar electrical stimulation ### Outcomes Primary Outcomes - Algometer (pressure pain threshold) Secondary Outcomes - ROM Shoulder (Flexion) - ROM Shoulder (Abduction) - ROM Shoulder (External rotation) - ROM Shoulder (Internal Rotation) - ASES Questionnaire; (American shoulder and elbow surgeons scale) ### Location - Facility: Railway general hopsital, Rawalpindi, Punjab, 46000, Pakistan @@
## Effects of Tupler and Scoop Exercises in Diastasis Recti - NCT ID: NCT06302816 - Study ID: REC/RCR&AHS/23/0580 - Status: RECRUITING - Start Date: 2023-02-23 - Completion Date: 2024-09-01 - Lead Sponsor: Riphah International University ### Study Description To compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis. ### Conditions - Diastasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TUPLER exercises - SCOOP EXERCISES ### Outcomes Primary Outcomes - Digital nylon calipers for inter recti distance (IRD) - NPRS for low back pain - Manual muscle testing for intra-abdominal strength - Short form Pelvic Floor Distress Inventory for Urogynaecological symptoms Secondary Outcomes ### Location - Facility: Innovative Health Concepts, Lahore, N/A, 05499, Pakistan @@
## Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial) - NCT ID: NCT06302803 - Study ID: NFEC-2024-033 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-07-01 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent fasting plus time-restricted eating - Calorie restriction ### Outcomes Primary Outcomes - Change in body weight over 12 months Secondary Outcomes - Change in body mass index （BMI） - Change in waist circumference - Change in body fat composition meassured by DEXA - Change in liver fat - Change in systolic blood pressure - Change in diastolic blood pressure - Change in concentration of serum triglyceride - Change in concentration of serum total cholesterol - Change in concentration of serum LDL-c - Change in concentration of HbA1c - Change in insulin sensitivity - Change in β cell function - Change in arterial stiffness measured by pulse wave velocity - Change in depression score measured by the Patient Health Questionnaire-9 - Change in quality of sleep score measured by the Pittsburgh sleep quality index - Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire ### Location - Facility: Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, 510515, China @@
## Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy - NCT ID: NCT06302790 - Study ID: AcuteMolliiSuitEffects - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-05-01 - Lead Sponsor: Kırıkkale University ### Study Description The aim of our study is to examine the acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy. ### Conditions - Mollii Suit - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Molli Suit Apply ### Outcomes Primary Outcomes - Gross Motor Function Classification System (GMFCS) - Modified Tardiue Scale (MTS) - Modifiye Modified Ashworth Scale (MAS) - NMC Tests with Seansamove Sensbalance Secondary Outcomes ### Location - Facility: Gazi University, Ankara, N/A, N/A, Turkey @@
## MAIN-IMAGE Registry - NCT ID: NCT06302777 - Study ID: 2023-1184 - Status: RECRUITING - Start Date: 2023-09-26 - Completion Date: 2031-09-26 - Lead Sponsor: Goethe University ### Study Description All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic progression. ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Major adverse cardiovascular Events (MACE) Secondary Outcomes ### Location - Facility: Frankfurt University Hospital, Frankfurt, Hesse, 60590, Germany @@
## Emergency Medical Staff Workload Analysis - NCT ID: NCT06302764 - Study ID: WZiKS.4.1.2023.2 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-06-30 - Lead Sponsor: Jagiellonian University ### Study Description The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows:1. Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms.2. Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams.3. Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols.4. Assessment of the potential for implementing the results in solutions utilizing virtual reality technology.5. Formation of an interdisciplinary international research team. ### Conditions - Stress - Work Related Stress - PTSD - Mental Stress - Medical Emergencies ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Qualitative & Quantitative Research ### Outcomes Primary Outcomes - Focused Interview - Posttraumatic Stress Disorder Checklist (PCL-5) - Patient Health Questionnaire (PHQ-9) - Depersonalization Mechanism Scale (DMS) Secondary Outcomes ### Location - Facility: Institute of Applied Psychology, Jagiellonian University in Krakow, Poland, Krakow, Małopolska, 30-348, Poland @@
## A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer - NCT ID: NCT06302751 - Study ID: 3647 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2026-08-31 - Lead Sponsor: Istituto Clinico Humanitas ### Study Description The unplanned readmission rate after colorectal cancer surgery is still high, despite the implementation of enhanced recovery programs. The use of a mobile-based application for perioperative remote monitoring may improve the postoperative outcomes and reduce the unplanned postoperative readmissions. ### Conditions - Colorectal Cancer - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Care 4 Today ® (Johnson and Johnson) mobile app ### Outcomes Primary Outcomes - Unplanned hospital readmissions Secondary Outcomes - Severity of postoperative complications - Length of hospital stay - Time from symptoms onset to diagnosis - Healthcare costs ### Location - Facility: IRCCS Humanitas Research Hospital, Rozzano, MI, 20089, Italy @@
## Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern - NCT ID: NCT06302738 - Study ID: 09C221 - Status: RECRUITING - Start Date: 2023-05-04 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description High blood pressure is the most common modifiable risk factor for cardiovascular diseases (CV). The large interindividual variability in clinical expression of the disease and response to treatment, however, makes the management of the hypertensive patient complex.Therefore, identifying phenotypes of hypertensive patients associated with a specific CV outcome or who tend to respond/not respond to treatment is of paramount importance for improving CV prevention.It has been shown that the phenotype of hypertensive patient with poor control of nighttime blood pressure values, especially when associated with a "non-dipper" profile, was associated with an increased risk of developing CV and cerebrovascular complications.The non-dipper profile and nocturnal hypertension are caused by several factors including excessive salt intake and dysautonomia. However, they are also inevitably influenced by sleep duration and the presence of sleep disorders: obstructive sleep apnea (OSA), but also insomnia and periodic movements of the lower limbs,such as those frequently seen in restless legs syndrome, are among the the main determinants related to altered nighttime pressure pattern. However, such disturbances are not systematically assessed during the performance of monitoring 24h pressor and their impact in the outcome of the hypertensive patient is unknown.The primary objective of this study is to phenotype non-dipper patients with or without nocturnal hypertension to determine the prevalence of sleep disorders such as sleep apnea syndrome, insomnia, and restless legs syndrome (RLS) (OSA diagnosed considering AHI\>5 events/hour, insomnia and RLS according to ICSD 3 criteria) and correlate the presence of various sleep disorders with cardiac organ damage, vascular, and renal damage mediated by hypertension. ### Conditions - Hypertension - Sleep Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - polysomnography ### Outcomes Primary Outcomes - Prevalence of sleep disorders Secondary Outcomes ### Location - Facility: UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari,, Bari, Italy, Bari, 70120, Italy @@
## Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases - NCT ID: NCT06302725 - Study ID: APHP231514 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-03 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection (yes/no) after VSS proposal Secondary objectives: - To describe the HPV typology and the rate of co-infection (with several high-risk HPV (HR-HPV)) in this population - To describe the factors associated with the presence of HPV infection - To determine the rate of HPV clearance after one year, during the second screening at 12 months- To determine the percentage of pre-cancerous cervical lesions and cervical cancer in the event of subsequent cervical smear - To determine the factors associated with persistence (or non-clearance ) of HPV infection - To determine the factors associated with the presence of pre-cancerous and cancerous cervical lesions - To determine the characteristics, tolerance and acceptability of VSS - To determine the rate of cervical cancer screening carried out following French Health Authorities guidelines -To determine the HPV vaccination coverage Secondary endpoints: 1/ HPV typology and presence of co-infection (Yes/No, type) or HPV multi-infection (more than 2 HPV, Yes/No) identified on samples at inclusion and at 1 year. 2/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: presence of HPV infection during follow-up. 3/ Characteristics, acceptability, obstacles and tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). 4/ Up-to-date cervical cancer screening rate in accordance with HAS recommendations at 12 months post-procedure. 5/ Proportion of cervical cytological abnormalities and cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 6/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressants; variable to be explained: presence of cervical precancerous lesions and cervical cancer, authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 7/ HPV vaccination coverage rate (measured on initial self-questionnaire) 8/ Prevalence of HR-HPV(s) at second screening at one year, in the case of initial positivity (Persistence of HPV infection (Yes/No). 9/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: persistence of cervical HPV infection at one year (in the case of initial positivity). ### Conditions - HPV Infection - Systemic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Vaginal self sampling detecting HPV ### Outcomes Primary Outcomes - prevalence of HPV infection (yes/no) after VSS proposal Secondary Outcomes - the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population - The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population ### Location - Facility: Service de Médecine Interne - Hôpital Bichat Claude Bernard, Paris, N/A, 75018, France @@
## Traditional Islamically Integrated Psychotherapy for Muslims With OCD in Pakistan - NCT ID: NCT06302712 - Study ID: TIIP - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-11-30 - Lead Sponsor: International Islamic University Malaysia ### Study Description The current study aims to determine the effectiveness of the first culturally adapted Traditional Islamically Integrated Psychotherapy (TIIP) for Muslims with OCD in Pakistan along with the module effectiveness in reducing OCD symptoms with comorbidities like anxiety, depression, stress, thought control, thought-action fusion, and enhancing the spiritual quality of life of participants. ### Conditions - Obsessive-Compulsive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Traditional Islamically Integrated Psychotherapy ### Outcomes Primary Outcomes - Yale Brown Obsessive Compulsive Scale Secondary Outcomes - Depression, Stress, Anxiety - Thought Action Fusion - Thought Control - Spiritual Quality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Detecting Minimal Residual Diseases (MRD) and Monitoring Clonal Evolution Using Ultrasensitive Chromosomal Aberrations Detection (UCAD) in Multiple Myeloma - NCT ID: NCT06302699 - Study ID: UCAD-MM-001 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2026-03-01 - Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China ### Study Description The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method. ### Conditions - Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Detection of copy number variation Secondary Outcomes - Serial monitoring of treatment response ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions - NCT ID: NCT06302686 - Study ID: INRCA_004_2023 - Status: RECRUITING - Start Date: 2023-10-09 - Completion Date: 2024-06-24 - Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani ### Study Description The objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates social robots. ### Conditions - Mild Cognitive Impairment - Older Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - engAGE system - Group practicing with only the support of a booklet ### Outcomes Primary Outcomes - Change in perceived stability of cognitive status by the older adults Secondary Outcomes - Change in cognitive impairment in older adults - Change in depression in older adults - Change in frailty status in older adults - Change in mental well being in older adults - Change in quality of life in older adults - Change in acceptability of the engAGE system in older adults - Change in quality of life in informal caregivers - Change in mental well being in informal caregivers - Change in caregiver burden ### Location - Facility: IRCCS INRCA Hospital, Ancona, N/A, 60127, Italy @@
## The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients - NCT ID: NCT06302673 - Study ID: 23081229 - Status: RECRUITING - Start Date: 2023-10-09 - Completion Date: 2024-10 - Lead Sponsor: Indonesia University ### Study Description This study to determine the effectiveness of a combination of pre-surgical laserpuncture with standard anti-emetic therapy for PONV symptoms in adult patients after strabismus surgery under general anesthesia compared to a combination of pre-surgical placebo laserpuncture with standard anti-emetic therapy. Research design using a double blinded randomized controlled trial (RCT) where research subjects and data takers who will be disguised. The research will be carried out in the Operation and Inpatient Room, Kirana Building, RSUPN Dr. Cipto Mangunkusumo (RSCM) with research subjects as adult patients undergoing strabismus surgery under general anesthesia. Assessment of nausea and vomiting using AVS ( Analog Visual Scale) consists of scoring using a score from 1-5 which indicates the severity of nausea and vomiting. ### Conditions - Nausea and Vomiting, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Laserpuncture and anti emetic standar therapy - Sham Laserpuncture and anti emetic standar therapy ### Outcomes Primary Outcomes - Analog Visual Scale for nausea vomitting Secondary Outcomes ### Location - Facility: RSUPN Dr. Cipto Mangunkusumo, Jakarta Pusat, Jakarta, N/A, Indonesia @@
## Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors - NCT ID: NCT06302660 - Study ID: 22/LO/0169 - Status: RECRUITING - Start Date: 2022-03-09 - Completion Date: 2025-06-01 - Lead Sponsor: Imperial College London ### Study Description The goal of this observational study is to learn about long term symptoms in oesophageal cancer survivors. The main question it aims to answer is are:* Study the changes in gut bacteria by examining saliva, stool and blood.* Investigate the products of bacteria in breath to develop a non-invasive breath test to detect the changes in gut bacteria.* Develop new strategies to treat this change and trial new treatments to improve quality- of-life in oesophageal cancer survivors.Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath, saliva, blood, urine, stool and complete validated healthy-related quality-of-life questionnaires.Researchers will compare symptomatic and asymptomatic participants to detect the changes stated above. ### Conditions - Oesophageal Cancer - Quality of Life - Bacterial Overgrowth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Breath test - Saliva sample - Blood sample - Urine sample - Stool sample - Health-related Quality of life questionnaires ### Outcomes Primary Outcomes - Identify microbiome dysbiosis in saliva associated with long-term functional symptoms. - Identify microbiome dysbiosis in stool associated with long-term functional symptoms. Secondary Outcomes - Identify underlying metabolic pathways associated with microbiome derived metabolites. - Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis. - Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors. ### Location - Facility: Barking, Havering and Redbridge University Hospitals NHS Trust, London, N/A, N/A, United Kingdom @@
## Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment - NCT ID: NCT06302647 - Study ID: PI-6022 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-06-30 - Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz ### Study Description Study objective:To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. In addition, we will also evaluate the degree of awareness existing in society about clinical trials.Study subjects: General population, patient, physicians, pharmaceutical-biotechnological industry.Keywords: healthy volunteer, patient, pharma industry, patient associaiton, questionnaire, clinical trial, platform, recruitment, engagement. ### Conditions - Assessing Interest in a Platform for Early Phase Clinical Trial Recruitment ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaires ### Outcomes Primary Outcomes - percentage of each of the three groups that would find the platform useful Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cardio-Oncology Rehabilitation Care Process - NCT ID: NCT06302634 - Study ID: ReCO - Status: RECRUITING - Start Date: 2022-06-22 - Completion Date: 2027-06-22 - Lead Sponsor: Hospital Clinico Universitario de Santiago ### Study Description The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2). ### Conditions - Cardio-Oncology - Rehabilitation - Cardiovascular Diseases - Exercise ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Exercise-based cardio-oncology rehabilitation ### Outcomes Primary Outcomes - Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography - Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP) - Decrease in functional capacity assessed by estimated VO2peak - Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors. - Changes in fasting blood glucose - Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels - Change in haemoglobin - Significant cardiovascular and non-cardiovascular adverse effects during treatment. Secondary Outcomes - Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire. - Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test. - Change in lower limb strength measured by squat dynamometry (kg). - Change in biceps strength by dynamometry (kg). - Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella - Changes in peak expiratory flow - Change in upper limb strength measured by dynamometry (kg). - Change in anthropometric parameters: weight in kg. - Change in anthropometric parameters: Body mass index (BMI) in kg/m^2 - Change in anthropometric parameters: abdominal circumference in cm. - Change in resting heart rate measured by pulse oximetry (beats per min). - Change in resting blood pressure (mmHg) measured by a blood pressure monitor. - Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ). - Change in cardiovascular treatment by its presence or absence. ### Location - Facility: Hospital Clínico Universitario de Santiago, Santiago de Compostela, A Coruña, 15706, Spain @@
## Pemigatinib + Afatinib in Advanced Refractory Solid Tumors - NCT ID: NCT06302621 - Study ID: 21-725 - Status: RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-12-01 - Lead Sponsor: Massachusetts General Hospital ### Study Description This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors.The study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects.This research study involves the study drugs Afatinib and Pemigatinib. ### Conditions - Advanced Solid Tumor - Unresectable Solid Tumor - Metastatic Solid Tumor - Cholangiocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Afatinib - Pemigatinib ### Outcomes Primary Outcomes - Maximum tolerated dose (MTD) - Objective response rate (ORR) Secondary Outcomes - Disease Control Rate - Duration of Response - Overall Survival - Progression-free Survival - Best Overall Response - Time to response - Treatment Related Adverse Events - Maximum Plasma Concentration [Cmax]) and C trough of pemigatinib and afatinib - Molecular correlates of response ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02115, United States @@
## Safety and Efficacy Study of NGGT001 in Bietti Crystalline Corneoretinal Dystrophy - NCT ID: NCT06302608 - Study ID: NGGT-BCD-P-2203 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-08 - Completion Date: 2028-05-29 - Lead Sponsor: Xiamen Ophthalmology Center Affiliated to Xiamen University ### Study Description Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD) ### Conditions - Bietti's Crystalline Dystrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - NGGT001 ### Outcomes Primary Outcomes - BCVA - Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Secondary Outcomes ### Location - Facility: Xiuju Chen, Xiamen, Fujian, 361000, China @@
## MRI Guided Prostate Biopsy - NCT ID: NCT06302595 - Study ID: 2022P001093 - Status: RECRUITING - Start Date: 2023-08-24 - Completion Date: 2024-08-31 - Lead Sponsor: Brigham and Women's Hospital ### Study Description This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template. ### Conditions - Suspected Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - MRI-guided prostate biopsy using the needle holder frame. ### Outcomes Primary Outcomes - Accuracy of needle placement Secondary Outcomes ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury - NCT ID: NCT06302582 - Study ID: stress injury - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-11-25 - Lead Sponsor: Liaocheng People's Hospital ### Study Description This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury. ### Conditions - Pressure Injuries - Stage 3 - Pressure Injuries - Stage 4 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs) - Control group ### Outcomes Primary Outcomes - Change From Baseline in Pressure Ulcer Scale for Healing (PUSH) - Change from baseline in Determination of growth factor content Secondary Outcomes - Wound healing time - Positive rate of bacterial culture ### Location - Facility: Central laboratory, Liaocheng, Shandong, 252000, China @@
## Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma - NCT ID: NCT06302569 - Study ID: Bellini INT 2024-511587-93-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-05 - Lead Sponsor: Giuseppe Procopio ### Study Description This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin.Approximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice.Patients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin.The study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes. ### Conditions - Bellini Carcinoma - Collecting Duct Carcinoma - Renal Medullary Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab + Enfortumab Vedotin ### Outcomes Primary Outcomes - ORR in patients treated with Pembrolizumab plus Enfortumab Vedotin Secondary Outcomes - Progression-free survival (PFS) in patients treated with Pembrolizumab plus Enfortumab Vedotin - Overall-survival (OS) in patients treated with Pembrolizumab plus Enfortumab Vedotin - Number of Participants treated with Pembrolizumab + Enfortumab Vedotin who experience AEs/SAEs ### Location - Facility: Fondazione Irccs Istituto Dei Tumori Di Milano, Milan, N/A, 20133, Italy @@
## The Role of Immune Checkpoints in Lung Transplant (ILTRA) - NCT ID: NCT06302556 - Study ID: 2022XJ9W4F - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-02 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description The goal of this observational study is to learn about rejection in lung transplantation.The main question it aims to answer is:• what is the role of immune checkpoints in lung transplantation? Participants will describe pathways of rejection in lung transplantation analyzing the immune checkpoints on explanted lungs as well as trans-bronchial biopsies. ### Conditions - Lung Transplant Rejection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Immune checkpoints analysis - Gene expression analysis ### Outcomes Primary Outcomes - Lung-tissue immune-checkpoint profile and bronchoalveolar immune-cells mRNA signature in acute rejection after lung transplantation. - Lung-tissue immune-checkpoint profile in chronic rejection after lung transplantation. Secondary Outcomes ### Location - Facility: Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy @@
## Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells - NCT ID: NCT06302543 - Study ID: POI bone marrow - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10-24 - Lead Sponsor: abdulmajeed hammadi ### Study Description investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone.Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program. ### Conditions - Premature Ovarian Insufficiency ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - autologous bone marrow cells injection ### Outcomes Primary Outcomes - change in gonadotropin levels Secondary Outcomes ### Location - Facility: Ministry of Health, Baghdad, N/A, 964, Iraq @@
## "Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex" - NCT ID: NCT06302530 - Study ID: UCV/2022-2023/155 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir ### Study Description This research project compares the effectiveness of different surgical techniques for lengthening the gastrocnemius-soleus system in patients with equinus deformity. The study will compare 2 techniques: gastrocnemius tendon recession (Strayer) and plantaris resection. Increased ankle range of motion, complications, operative time, recovery time, pain scales and function will be measured. The results will help determine which technique is most effective and safe for correcting equinus deformity. ### Conditions - Gastrocnemius Equinus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stayer - Plantar transection ### Outcomes Primary Outcomes - Ankle range of motion Secondary Outcomes - Visual Analog Scale. - American Orthopedic Foot and Ankle Score - Complications ### Location - Facility: Podologia Avançada, Granollers, Barcelona, 08401, Spain @@
## Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From General Anesthesia - NCT ID: NCT06302517 - Study ID: K2020097 - Status: COMPLETED - Start Date: 2020-09-01 - Completion Date: 2022-08-29 - Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine ### Study Description ①Effects of BIS Index (BIS) monitoring on delirium incidence in Post-anesthesia care unit (PACU) in patients undergoing general anesthesia②Effects of BIS BIS Index (BIS) monitoring on the quality of nursing care in the Post-anesthesia care unit (PACU) ### Conditions - Delirium, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - BIS-guided ### Outcomes Primary Outcomes - Ricker sedation-agitation scale - The nursing activity score (NAS) - vital signs （Mean arterial pressure, heart rate, pulse oxygen saturation ） - Comparison of complications during the PACU period - The comprehensive satisfaction score Secondary Outcomes ### Location - Facility: The Fourth Affiliated Hospital, School of Medicine, Zhejiang University, Jinhua, Zhejiang, 322000, China @@
## Nature-based Mindfulness Intervention Program for Family Carers - NCT ID: NCT06302504 - Study ID: Nature - Status: RECRUITING - Start Date: 2023-04-15 - Completion Date: 2024-03-31 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total. ### Conditions - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Nature-based mindfulness program ### Outcomes Primary Outcomes - depression - anxiety - stress - family functioning - family conflict - well-being Secondary Outcomes ### Location - Facility: The Hong Kong Polytechnic University, Hong Kong, N/A, 852, Hong Kong @@
## A Study of Safety and Efficiency of AND017 in Patients With Transfusion Dependent and Non-transfusion Dependent β-thalassemia - NCT ID: NCT06302491 - Study ID: AND017-BTH-205 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-07 - Lead Sponsor: Kind Pharmaceuticals LLC ### Study Description This is a phase II, randomized, double-blinded, placebo-controlled study to treat patients with transfusion-dependent and non-transfusion dependent β -thalassemia with AND017 and optimal supportive care, including blood transfusion and iron removal, based on the clinician's judgment and practice. ### Conditions - β -Thalassemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AND017 capsules - AND017 Placebo ### Outcomes Primary Outcomes - Evaluate the safety and tolerability of different oral doses of AND017 in the treatment of β-thalassemia subjects Secondary Outcomes - Change in mean Hb levels relative to baseline at weeks 8-12 and week 20-24 post-treatment compared to baseline (mean Hb values during the 4 weeks prior to the first dose). - The level of Hb and the change from baseline at each visit throughout the treatment period. - Proportion of patients with mean Hb elevation ≥1.0 g/dL from baseline to weeks 8-12 after dosing. - Levels of and changes from baseline in red blood cell count throughout the treatment period - Levels of and changes from baseline in reticulocyte count throughout the treatment period - Levels of and changes from baseline in mean corpuscular volume (MCV) throughout the treatment period - Levels of and changes from baseline in mean corpuscular hemoglobin (MCH) throughout the treatment period - Levels of and changes from baseline in mean corpuscular hemoglobin concentration (MCHC) throughout the treatment period - Throughout the treatment period, changes in the levels and relative baseline of transferrin will be assessed. - Throughout the treatment period, changes in the levels and relative baseline of transferrin saturation (TSAT) will be assessed. - Throughout the treatment period, changes in the levels and relative baseline of ferritin will be assessed. - Throughout the treatment period, changes in the levels and relative baseline of serum iron level will be assessed. - Throughout the treatment period, changes in the levels and relative baseline of total iron binding capacity (TIBC) will be assessed. - Change in transfusion load (units transfused) at 12-24 weeks post-dose compared to baseline (12 weeks to W0 before first dose). - Change in number of transfusions at 12-24 weeks post-dose compared to baseline (12 weeks to W0 before first dose). - Proportion of subjects with ≥33% reduction in transfusion load (transfusion units) relative to baseline (12 weeks prior to first dose to W0) from baseline to any consecutive 12-week period after dosing. - Duration (days) of maintenance below this transfusion dose after a 33% reduction in transfusion load from baseline has been achieved. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders - NCT ID: NCT06302478 - Study ID: KhonKaenU001 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-10-31 - Lead Sponsor: Khon Kaen University ### Study Description The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are:* Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care?* Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care?* Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different?Participants in the intervention group will receive the 5E program, including* Education: health education regarding venous thromboembolism prevention* Elevation: leg elevation of 10-20 degrees* Exercise: ankle exercises* Enough fluid: adequate fluid uptake* Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission ### Conditions - Venous Thromboembolism - Spinal Cord Diseases - Spinal Cord Injuries - Nurse's Role ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - 5E program ### Outcomes Primary Outcomes - The rate of venous thromboembolism Secondary Outcomes - Signs and symptoms of deep venous thrombosis and pulmonary embolism - Thigh and calf circumference ### Location - Facility: Chaiyaphum Hospital, Chaiyaphum, N/A, 36000, Thailand @@
## Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells - NCT ID: NCT06302465 - Study ID: PKUPH-sarcoma 18 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Peking University People's Hospital ### Study Description Malignant tumor of bone is rare with poor prognosis. Surgery is the main treatment for non- metastatic bone tumor. Although neoadjuvant chemotherapy for non-metastatic bone tumor cannot improve survival rate based on adjuvant chemotherapy, it can reduce and clarify tumor boundary. Control of local recurrence rate is the core objective of oncotherapy. Surgery way and boundary have a significant effect on prognosis of non- metastatic bone tumor. Narlumosbartmab, a RANKL inhibitor, can make tumor boundary clear and reduce surgical difficulty by inhibiting osteoclast. This is a prospective, randomized, controlled, two-arm, open, single-center clinical trial to compare the efficacy and safety of narlumosbartmab combined with neoadjuvant chemotherapy and neoadjuvant chemotherapy alone in bone-derived malignancies with bone lytic lesions and multinucleated giant cells. Investigators mainly observe the local recurrence rate to evaluate the survival benefit for patients with poor prognosis. ### Conditions - Malignant Bone Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide - doxorubicin、cisplatin、methotrexate、ifosfamide ### Outcomes Primary Outcomes - local recurrence rate Secondary Outcomes - tumor necrosis rate - R0 removal rate - Event-free survival - Overall survival ### Location - Facility: Peking University People's Hospital, Beijing, Beijing, 100044, China @@
## Adult Trauma Centers RE-AIM at Gun Safety (ACTFAST) Prevention - NCT ID: NCT06302452 - Study ID: IRB00433605 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-02 - Lead Sponsor: Johns Hopkins University ### Study Description The goal of this interventional study is to evaluate the implementation and effectiveness of a comprehensive a universal firearm injury prevention program, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), in level 1 trauma centers. The main aims of the study are:1. (Primary Aim 1) Increase the adoption, implementation, and maintenance of a universal firearm injury prevention intervention at three participating trauma centers in the mid-Atlantic states;2. (Primary Aim 2) Assess firearm injury prevention knowledge, attitudes, and safe storage practices among trauma patients treated within participating trauma centers. ### Conditions - Firearm Injury - Safety Issues ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Adopting Comprehensive Training for FireArm Safety in Trauma Centers ### Outcomes Primary Outcomes - Proportion of admitted injured patients receiving each element of the ACTFAST Program - Percentage of admitted injured patients receiving elements of the ACTFAST Program - Patient firearm safety attitudes and behaviors as assessed by survey Secondary Outcomes - Clinician firearm safety knowledge and confidence as assessed by survey ### Location - Facility: Johns Hopkins Bayview Medical Center, Baltimore, Maryland, 21224, United States @@
## PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency - NCT ID: NCT06302439 - Study ID: INZ701-007 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2034-05 - Lead Sponsor: Inozyme Pharma ### Study Description The purpose of this prospective registry is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase1(ENPP1) Deficiency and the infantile-onset form of adenosine triphosphate (ATP) binding cassette transporter protein subfamily C member 6 (ABCC6) Deficiency longitudinally. The registry will prospectively gather information about the genetic, biochemical, physiological, anatomic, radiographic, and functional manifestations (including patient reported outcomes \[PROs\]) of each disease during routine, standard-of-care visits, with the aim of developing a comprehensive understanding of the burden of illness and progressive nature of the disease. ### Conditions - Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 Deficiency - ATP-Binding Cassette Subfamily C Member 6 Deficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No Intervention for this observational study ### Outcomes Primary Outcomes - Characterization of the natural history of ENPP1 Deficiency and the infantile-onset form of ABCC6 Deficiency longitudinally - Assessment of Patient Functional changes through a validated Patient Reported Outcomes (PROs) tool - Assessment of Health-Related Quality-of-Life (HRQoL) changes through validated Patient Reported Outcomes (PROs) tools - Measurement of inorganic phosphate (PPi) levels in patients' venous blood Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Trial of INI-4001 in Patients With Advanced Solid Tumours - NCT ID: NCT06302426 - Study ID: INI-4001-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-29 - Completion Date: 2026-04-30 - Lead Sponsor: Inimmune Corporation ### Study Description Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - INI-4001 - Nivolumab - Pembrolizumab - Cemiplimab - Avelumab - Atezolizumab - Durvalumab ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicities (DLTs) during Cycle 1 to determine the maximum tolerated dose of INI-4001 Monotherapy Secondary Outcomes - Incidence, type, and severity of treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment after multiple ascending doses - Incidence and nature of dose-limiting toxicities (DLTs) and regimen-limiting toxicities (RLTs) leading to discontinuation of study treatment after multiple ascending doses - Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses - Number of Participants with a Change from baseline in body weight after multiple ascending doses - Number of Participants with a Change from baseline in clinical laboratory parameters (haematology) after multiple ascending doses - Number of Participants with a Change from baseline in clinical laboratory parameters (serum chemistry) after multiple ascending doses - Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis) after multiple ascending doses - Change from baseline in measurements of HR in beats per minute after multiple ascending doses - Change from baseline in measurements of PR interval via 12-lead electrocardiogram after multiple ascending doses - Change from baseline in measurements of QT interval via 12-lead electrocardiogram after multiple ascending doses - Change from baseline in measurements of RR interval in breaths per minute via 12-lead electrocardiogram after multiple ascending doses - Change from baseline in measurements of QRS duration via 12-lead electrocardiogram after multiple ascending doses - Change from baseline in measurements of QTcF via 12-lead electrocardiogram after multiple ascending doses - Change from baseline in Eastern Cooperative Oncology Group (ECOG) score after multiple ascending doses - Single dose PK Parameters - maximum observed concentration (Cmax) - Multiple dose PK Parameters - maximum observed concentration (Cmax) - Single dose PK Parameters - Time to Cmax (Tmax) - Multiple dose PK Parameters - Time to Cmax (Tmax) - Single dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) - Single dose PK Parameters - Total amount excreted in urine (Ae) - Single dose PK Parameters - Fraction excreted in the urine (Fe) - Single dose PK Parameters - Renal clearance (CLr) - Multiple dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) - Single dose PK Parameters - Area under the concentration-time curve (AUC0-t) - Multiple dose PK Parameters - Area under the concentration-time curve (AUC0-t) - Single dose PK Parameters - Half-life (t1/2) - Multiple dose PK Parameters - Half-life (t1/2) - Single dose PK Parameters - Clearance (Cl) - Multiple dose PK Parameters - Clearance (Cl) - Single dose PK Parameters - Volume of distribution (Vz) - Multiple dose PK Parameters - Volume of distribution (Vz) ### Location - Facility: The Border Cancer Hospital, Albury, New South Wales, 2640, Australia @@
## Enhancing Prospective Thinking in Early Recovery - NCT ID: NCT06302413 - Study ID: 1805574553; Aims 9-10 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2027-07-31 - Lead Sponsor: Indiana University ### Study Description The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question\[s\] this trial aims to answer are:Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above. ### Conditions - Alcohol Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Virtual Reality - Virtual Reality ### Outcomes Primary Outcomes - Reduced Use of Drug Using Days - Increased Length of Abstinence - Increased (overall) Abstinence - Future Self-identification with Future Self Continuity Questionnaire - Future Time Perspective with the Delayed Discounting Behavioral Task and Future Self Continuity Questionnaire - Delayed Reward Preference with the Delayed Discounting Behavioral Task Secondary Outcomes ### Location - Facility: Indiana University School of Medicine - Goodman Hal, Indianapolis, Indiana, 46202, United States @@
## Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma - NCT ID: NCT06302400 - Study ID: RS-IC04 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2027-02 - Lead Sponsor: Imperial College London ### Study Description The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . The main questions it aims to answer are:* What is the safety and toxicity profile of the 166-Holmium microspheres?* Is the device effective in treating HCC?Participants will undergo a range of screening procedures to confirm they are eligible and to record their baseline results, including:* A Computed Tomography (CT) scan* A Magnetic Resonance Imaging (MRI) scan* Blood tests* Quality of life questionnairesBefore receiving treatment with QuiremSpheres® the participant will receive a 'scout' dose of the microspheres, to check whether there is distribution of the radioactivity to other non-target areas of the body. This is measured using Single-Photon Emission Computed Tomography-CT imaging. If the distribution to non-target areas is deemed to not be too high, the participant will go on to receive the individualised therapeutic dose of QuiremSpheres®. Follow-up visits will occur 3 and 6 weeks post-treatment dose, and then at 3 and 6 months. ### Conditions - Carcinoma, Hepatocellular ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 166Holmium microspheres (QuiremSpheres®) ### Outcomes Primary Outcomes - The incidence of adverse and serious adverse events in patients receiving individualized treatment with 166Ho- microspheres, using National Cancer Institute CTCAE v5.0. Secondary Outcomes - The rate of efficacy as defined as overall response rate (ORR) in patients receiving individualized treatment with 166Ho- microspheres, using modified RECIST (mRECIST) response evaluation criteria. ### Location - Facility: Imperial College Healthcare NHS Trust, London, N/A, W12 0HS, United Kingdom @@
## Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability - NCT ID: NCT06302387 - Study ID: BEC-LSMU(R)-27 - Status: COMPLETED - Start Date: 2018-01-01 - Completion Date: 2023-02-01 - Lead Sponsor: Harvard Medical School (HMS and HSDM) ### Study Description This study looks at two ways to make gums thicker and bones stable around dental implants for people with thin gums. It compares two methods in 40 people: one method uses a special graft, and the other uses a technique called tenting. The goal is to see which method might work better for making the gums and bones around implants healthier. The check-ups are planned when the implant is put in and again after one year. The study focuses on how these methods are done without talking about what the results are. ### Conditions - Soft Tissue Augmentation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acellular Dermal Matrix - Soft Tissue Expansion using Tenting Technique ### Outcomes Primary Outcomes - Crestal Bone Levels Secondary Outcomes - Vertical soft tissue thickness - PPD - BOP - PI ### Location - Facility: VIC Clinic, Vilnius, N/A, 01362, Lithuania @@
## Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults - NCT ID: NCT06302374 - Study ID: GR2001-001 - Status: COMPLETED - Start Date: 2023-03-04 - Completion Date: 2024-02-19 - Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. ### Study Description The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and Immunogenicity characteristics of GR2001 and compare the anti-tetanus neutralizing antibody titers of GR2001 with human tetanus immunoglobulin (HTIG)in healthy adult subjects. ### Conditions - Tetanus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GR2001 - Placebo - HTIG - Tetanus Toxoid ### Outcomes Primary Outcomes - Incidence of AEs(Phase I) - Tetanus-antibody titer(Phase II) Secondary Outcomes - Tetanus-antibody titer(Phase I/II) - Incidence of ADA(Phase I/II) - Incidence of AEs(Phase II) - Peak plasma concentration(Cmax) - Area under the plasma concentration versus time curve (AUC) - Time of maximum plasma concentration (Tmax) - Terminal half-life (T1/2) - Apparent total body clearance (CL/F) - Apparent volume of distribution (Vd/F) - The elimination rate constant (Kel) - Mean Residence Time (MRT) ### Location - Facility: Huashan Hospital affiliated of Fudan University, Shanghai, Shanghai, 200040, China @@
## Lymphovenous Anastomosis for Breast Cancer Lymphedema - NCT ID: NCT06302361 - Study ID: 23/54225 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-06-30 - Lead Sponsor: Odense University Hospital ### Study Description This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research. ### Conditions - Lymphedema - Lymphedema Arm - Breast Cancer Lymphedema - Lymphedema, Secondary - Lymphedema; Surgical - Lymphedema of Upper Limb - Lymphedema, Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Lymphovenous anastomosis (LVA) ### Outcomes Primary Outcomes - Arm volume (Water Displacement) - Arm volume (Arm Circumferences) Secondary Outcomes - Health-related quality of life (LYMPH-Q) - General quality of life (SF-36) - Arm and shoulder function (DASH) - L-Dex - LVA patency - Skin Fibrosis - Surgery duration - Body composition ### Location - Facility: Department of Plastic Surgery, Odense University Hospital, Odense, Region Of Southern Denmark, 5000, Denmark @@
## A Study of Sepiapterin in Participants With Phenylketonuria (PKU) - NCT ID: NCT06302348 - Study ID: PTC923-PKU-401 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2031-02-28 - Lead Sponsor: PTC Therapeutics ### Study Description The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood. ### Conditions - Phenylketonuria ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sepiapterin ### Outcomes Primary Outcomes - Mean Change From Baseline in Full-scale Intelligence Quotient (FSIQ) Weschler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV) Score - Mean Change From Baseline in FSIQ Weschler Intelligence Scale for Children - Fifth Edition (WISC-V) Score Secondary Outcomes - Change From Baseline in Phenylketonuria-Quality of Life (PKU-QOL) Questionnaire Score - Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Score - Mean Change From Baseline in FSIQ (WPPSI-IV) Score - Mean Change From Baseline in FSIQ (WISC-V) Score - Change From Baseline in Mean Blood Phe Levels ### Location - Facility: Indiana University, Indianapolis, Indiana, 46202, United States @@
## Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection - NCT ID: NCT06302335 - Study ID: 2022-0442 - Status: RECRUITING - Start Date: 2023-01-02 - Completion Date: 2027-12-31 - Lead Sponsor: Hospital de Clinicas de Porto Alegre ### Study Description Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil. ### Conditions - Surgical Site Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Povidone-iodine - Saline solution ### Outcomes Primary Outcomes - Surgical site infection Secondary Outcomes - Intracavitary surgical infection ### Location - Facility: Hospital de Clinicas de Porto Alegre, Porto Alegre, RS, 90.035-903, Brazil @@
## Long-term Follow up of Mucosal Tissue Height Influence on Peri-implant Bone Levels. - NCT ID: NCT06302322 - Study ID: 158200-07-512-149 - Status: COMPLETED - Start Date: 2021-01-07 - Completion Date: 2022-10-01 - Lead Sponsor: Harvard Medical School (HMS and HSDM) ### Study Description Our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. We include 59 people and divide them into three groups based on their gum tissue thickness. Some have naturally thin gums, some have thin gums that were made thicker with a special procedure, and some already had thick gums. We try to find out if having thicker gums, whether naturally or through enhancement, can help keep the bone around dental implants healthy in the long run. ### Conditions - Edentulous Alveolar Ridge ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Thin Tissues - Thick Tissues - Surgically augmented thin tissues ### Outcomes Primary Outcomes - Crestal Bone Levels Secondary Outcomes - PPD - BOP - PI ### Location - Facility: VIC Clinic, Vilnius, N/A, 01362, Lithuania @@
## Tackling Anxiety-related Freezing of Gait in People With Parkinson's Disease - NCT ID: NCT06302309 - Study ID: NL85217.091.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-09 - Lead Sponsor: Radboud University Medical Center ### Study Description The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease. ### Conditions - Freezing of Gait ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Psychological intervention ### Outcomes Primary Outcomes - % time frozen during a personalized gait trajectory Secondary Outcomes - subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale - Heart Rate Variability - The Parkinson Anxiety Scale (PAS) - Gait-Specific Attention Profile - he Updated Perceived Control over Falling Scale (UP-COF) - New Freezing of Gait Questionnaire - The Parkinson's Disease Questionnaire - The Rosenberg self-esteem score - Perceived Stress Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement - NCT ID: NCT06302296 - Study ID: Hama University/ - Status: RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-07-15 - Lead Sponsor: Hama University ### Study Description One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. The previous studies evaluating platelet-rich fibrin (PRF) and orthodontic tooth movement (OTM) are limited, which makes the results difficult to generalize. ### Conditions - Tooth Mobility - Injectable Platelet-rich Fibrin ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - injectable form of PRF - Placebo injection ### Outcomes Primary Outcomes - Leveling and alignment maxillary incisors Secondary Outcomes ### Location - Facility: Fadi Jnaid, Hama, N/A, N/A, Syrian Arab Republic @@
## Collateral Effects of Pandemics - Care for Informal Caregivers - NCT ID: NCT06302283 - Study ID: 114/23-EP - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: University of Bonn ### Study Description The study is a workpackage in the German research consortium COLLPAN. The study will map collateral effects in terms of psychosocial and spiritual burden of informal caregivers during after the pandemic and identification/mapping of risk factors.It will also map available therapeutic and preventive interventions and relief of this burden for the present situation and for future pandemics. ### Conditions - Bereavement ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Survey ### Outcomes Primary Outcomes - Bereavement burden - Anxiety - Depression - Caregiving burden Secondary Outcomes ### Location - Facility: University Hospital Bonn, Bonn, N/A, 53127, Germany @@
## CFTR Modulators in Pregnancy and Postpartum - NCT ID: NCT06302270 - Study ID: K2024-0507 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2039-01-31 - Lead Sponsor: Region Stockholm ### Study Description Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk. ### Conditions - Cystic Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Health effects in the newborn infant Secondary Outcomes ### Location - Facility: Stockholm CF center, Stockholm, N/A, N/A, Sweden @@
## Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine in Labor Epidural Analgesia. - NCT ID: NCT06302257 - Study ID: 0532-23-HMO - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Hadassah Medical Organization ### Study Description Abstract: Background: The current "gold standard" epidural analgesia involves some undesirable side effects such as motor and sympathetic blockade. Here, the investigators suggest a new approach for inducing prolonged differential pain blockade during labor by selectively targeting local anesthetic chloroprocaine to the pain-related peripheral (nociceptive) fibers. The investigators approach involves nociceptor-selective anesthesia by selective targeting of ionized local anesthetics into nociceptive fibers via activation of nociceptor-specific TRPV1 channels. The authors demonstrated that activation of these channels by specific TRPV1-agonists (capsaicin or the local anesthetic lidocaine), allows entry of a polarized, membrane-impermeable lidocaine derivative (QX-314) specifically into nociceptive neurons, inhibiting their activity and pain blockade, without causing other neural effects. Capsaicin and QX-314 are not suitable for clinical use, as capsaicin causes severe injection pain and QX-314 is neurotoxic. Here, the investigators use lidocaine as the TRPV1 agonist, and use the high pKa chloroprocaine as the ionized local anesthetic instead of the toxic QX-314. Both drugs are in routine clinical use, but have not been described in co-administration before. The investigators preclinical results show that co-administration of chloroprocaine with TRPV1 agonists, leads to prolonged nociceptor-specific analgesia. KKK Hypothesis: The investigators hypothesize that co-administration of epidural lidocaine (to activate TRPV1 channels) and chloroprocaine (as a polarized local anesthetic which can gain preferential access to nociceptors via opened TRPV1 pores) will elicit selective nociceptive-anesthesia. Methodology: This study assess epidural local analgesia in nulliparous labor. There are 2 stages: Stage 1: Prior to direct comparison of lidocaine (Group L), chloroprocaine (Group C), and a lidocaine-chloroprocaine combination (Group L-C), the investigators first determine equipotential doses of epidural chloroprocaine and lidocaine using double-blinded up-down sequential analysis using the well-established minimum local anesthetic concentration (MLAC or ED50) design. ED50 is estimated using Dixon-Massey analysis and Wilcoxon and Litchfield probit regression. Stage 2: The main phase of the study involves a randomized double-blinded comparison between Groups L, C and L-C where all drug concentrations are based on the ED50/MLAC from the Stage 1. The primary endpoint is a composite measure of selective nociceptive analgesia (VAS pain score / modified Bromage motor score). Secondary outcomes are: 1. pain (VAS 0-100), 2. modified Bromage motor score, 3. thermal imaging of feet and hands, 4. sensory assessment to cold sensation using ice, 5. anesthesia requirement from the PCEA pump, 6. maternal blood pressure. 7. ambulation, and pushing ability in labor. Primary endpoint is assessed using repeated measures ANOVA (first 30-min) and mixed models ANOVA until first analgesic request. Implications: Positive findings will be the first evidence in humans of nociceptor-specific local anesthesia; will provide a more effective neuraxial analgesia protocol for labor, and will lead to future studies of systemic nociceptor-specific local anesthesia. ### Conditions - Labor Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Chlorprocaine - Lidocaine - Lidocaine-chlorprocaine combination ### Outcomes Primary Outcomes - VAS pain score / modified Bromage motor block score Secondary Outcomes - Segmental sympathectomy - Sensory assessment to cold sensation - Anesthesia requirement. - Pushing ability in labor. - Maternal Blood pressure ### Location - Facility: Hadassah Hebrew University Medical Center, POB 12000, Jerusalem, N/A, 91120, Israel @@
## Multimodal Neuromonitoring in Acute Brain Injury - NCT ID: NCT06302244 - Study ID: R-21075263 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2017-03-27 - Completion Date: 2024-11-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description Acute brain injury due to aneurysmal subarachnoid haemorrhage (SAH) or traumatic brain injury (TBI) is a condition with a high mortality, and surviving patients often have permanent disabilities. Multimodal neuromonitoring of intracranial pressure, brain tissue oxygen tension (PbtO2), and brain energy metabolism (measured with microdialysis (MD)) may help individualise the treatment of this patient group to protect the brain and potentially improve outcomes. However, there is still a significant lack of knowledge regarding the advantages and disadvantages of this type of monitoring.The present study consists of four substudies with the overall aim of examining which factors are most influential for regulating commonly measured intracerebral parameters such as oxygenation, glucose, and lactate. Additionally, the influence of these of parameters on functional outcome and mortality will be explored.The individual studies are detailed below: ### Conditions - Acute Brain Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Correlation between systemic glucose and microdialysis glucose - Median goodness of fit (Pearsons R2) of the relationship between PaO2 (kPa) and PbtO2 (mmHg). - Correlation between systemic lactate and microdialysis lactate when corrected for PbtO2 and cerebral perfusion pressure. - The predictive value of glutamate measured by intracerebral microdialysis for episodes of neuroworsening - The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcome Secondary Outcomes - Length of hospital stay - Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg). - Functional outcome at six months - Mortality at six months - Length of stay in the ICU ### Location - Facility: Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity - NCT ID: NCT06302231 - Study ID: 16690919.5.0000.5347 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Federal University of Rio Grande do Sul ### Study Description Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated.Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity.The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity. ### Conditions - Time Restricted Eating - Obesity - Intermittent Fasting - Overweight and Obesity - Time Restricted Feeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dietary and Exercise Approaches - Dietary and Exercise Approaches - Dietary Approach ### Outcomes Primary Outcomes - Insulin sensitivity (indices) Secondary Outcomes - Insulin resistance (indices) - Fasting insulin levels (µIU/mL) - Fasting glucose levels (mg/dL) - Glucose tolerance - Fasting lipid profile levels - β cell function (indices) - Fat Mass (kg) - Fat Percentage (%) - Fat Free Mass (kg) - Body Weight (kg) - Body Weight (kg) - Bone Mineral Content (kg) - Body Mass Index (kg/m^2) - Fasting ketones (β-hydroxybutyrate) levels (mmol/L) - Resting metabolic rate (Kcal/day) - Substrate Oxidation (respiratory exchange ratio) - Absolute Peak oxygen consumption - Relative Peak oxygen consumption - Fasting Leptin Levels - Fasting Adiponectin Levels - Inflammatory Markers Levels - LDL-cholesterol levels - Non-HDL-cholesterol levels ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## ESPB vs iPACK+ACB in Total Knee Arthroplasty - NCT ID: NCT06302218 - Study ID: 5/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-10-30 - Lead Sponsor: Poznan University of Medical Sciences ### Study Description Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty ### Conditions - Knee Arthritis - Knee Arthropathy - Knee Osteoarthritis - Knee Pain Chronic - Knee Disease - Knee Rheumatism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ropivacaine 0.2% Injectable Solution - Ropivacaine 0.2% Injectable Solution - control group ### Outcomes Primary Outcomes - Opioid consumption Secondary Outcomes - Time to first rescue opiate analgesia - Numerical Rating Scale [range 0:10] - Numerical Rating Scale [range 0:10] - Numerical Rating Scale [range 0:10] - Numerical Rating Scale [range 0:10] - Numerical Rating Scale [range 0:10] - Numerical Rating Scale [range 0:10] - Numerical Rating Scale [range 0:10] - Numerical Rating Scale [range 0:10] - Neutrophil-to-lymphocyte ratio - Neutrophil-to-lymphocyte ratio - Platelet-to-lymphocyte ratio - Platelet-to-lymphocyte ratio - Quadriceps muscle strength assessed using medical research council scale [range 0:5] ### Location - Facility: Poznan University of Medical Sciences, Poznan, Poznań, 61-701, Poland @@
## A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity - NCT ID: NCT06302205 - Study ID: S66232 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2026-12 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Research demonstrated that transplant recipients benefit from physical activity, but there is a gap in knowledge regarding the required intensity. In the PHOENIX-Liver study, researchers aim to investigate the adequate intensity of rehabilitation programs after liver transplantation. Patients will be randomized into one of the three PHOENIX-Liver training groups (low, moderate, moderate to high). The six months rehabilitation program is conducted from the patient's home but supervised by a PHOENIX-investigator.At baseline, after three months of rehabilitation and after six months of rehabilitation, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. Questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness.To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at UZ Leuven is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase. ### Conditions - Liver Transplantation - Physical Fitness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physical activity - Sham intervention ### Outcomes Primary Outcomes - Cardiorespiratory fitness Secondary Outcomes - Functional exercise capacitiy - Hand grip strength - Knee-extensor strength - Endothelial function - Arterial stiffness - Graft function - Occurence of adverse events - Motor fitness - Blood pressure - Blood profile ### Location - Facility: UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study) - NCT ID: NCT06302192 - Study ID: 4302 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-30 - Lead Sponsor: Policlinico Hospital ### Study Description This is a multicenter international observational prospective cohort study. The main questions it aims to answer are:* PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset* SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation ### Conditions - Acute Kidney Injury - ARDS, Human ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ARDS+AKI ### Outcomes Primary Outcomes - cumulative incidence Secondary Outcomes - AKI14 - AKIstage - cross talk lung-kidney - CRRT - incidence of failed exam - CKD progression ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Risk Factors of Venous Thromboembolism After Colorectal Cancer Surgery - NCT ID: NCT06302179 - Study ID: 140-14/24 - Status: COMPLETED - Start Date: 2015-01 - Completion Date: 2023-05 - Lead Sponsor: Pirogov Russian National Research Medical University ### Study Description Aim of our study is to find frequency and identify risk factors for venous thromboembolism development in patients who underwent surgery for colorectal cancer. There were 137 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2016 to December 2017. Compression duplex ultrasound of lower legs veins was performed in 2-14 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism. ### Conditions - Colorectal Cancer - Venous Thromboembolism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Venous Thromboembolism Secondary Outcomes ### Location - Facility: Pirogov Russian National Research Medical University, Moscow, N/A, 117997, Russian Federation @@
## Effects of HICT and Intermittent Fasting on PCOS - NCT ID: NCT06302166 - Study ID: HafsaJaved - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-07-01 - Lead Sponsor: Riphah International University ### Study Description The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns. ### Conditions - Polycystic Ovary Syndrome - PCO ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High Intensity Circuit training (HICT) - Intermittent Fasting (IF) - Combination of HICT and IF ### Outcomes Primary Outcomes - PCOS Morphology Secondary Outcomes - Anthropometrics - Clinical Hyperandrogenism - Body Image concerns ### Location - Facility: AlMuratza Hospital, Rawalpindi, Punjab, 44000, Pakistan @@
## Progressive Loading Exercises and Conditioning Exercises on Calf Strain - NCT ID: NCT06302153 - Study ID: amnashahid - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2024-02-10 - Lead Sponsor: Riphah International University ### Study Description Calf pain is a common complaint among runners of all ages but is most frequent in masters athletes. The most common calf injury is a tear of the medial gastrocnemius muscle (Tennis Leg) but other structures including the lateral gastrocnemius, plantaris and soleus also may be the cause of muscular pain.There are multiple techniques for the management that involves loading the strained calf musculature through rest, taping techniques, and appropriate soft tissue massage techniques, modalities such as dry needling or western acupuncture can be popular amongst runners and may also be useful. Progressive loading is a principle of resistance training exercise program design that typically relies on increasing load to increase neuromuscular demand to facilitate further adaptations whereas Athletic performance is based on a number of skills that can be developed through a sports conditioning program. This particular program focuses on improving both muscular strength and power using a technique called post-activation potentiation (PAP), also commonly referred to as complex training. ### Conditions - Range of Motion, Pain, Sports Injuries, Stretching, Triceps Surae ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Progressive Loading Exercises ### Outcomes Primary Outcomes - pain , range of motion, functions Secondary Outcomes ### Location - Facility: Jawad club, Alfatah sports complex, Faisalābad, Punjab, 38000, Pakistan @@
## A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers - NCT ID: NCT06302140 - Study ID: VT3996-102 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2025-10 - Lead Sponsor: Viracta Therapeutics, Inc. ### Study Description This study will determine how nanatinostat is absorbed, modified, and removed from the body (Part A), the amount of nanatinostat that becomes available to the body (Part B), and will evaluate the safety and tolerability of nanatinostat (Part C) in patients with advanced cancers. ### Conditions - Advanced Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - [14C]-Nanatinostat - Nanatinostat (free base) tablets in combination with Valganciclovir - Nanatinostat mesylate tablets in combination with Valganciclovir - Single-agent Nanatinostat (free base) tablets ### Outcomes Primary Outcomes - The amount of radioactivity in excreta [Part A] - Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part B] - Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part B] - Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part B] - Pharmacokinetic Parameter: Fraction of the administered dose in comparison with a standard (Frel) [Part B] - Incidence of adverse events and serious adverse events [Part C] Secondary Outcomes - Incidence of adverse events and serious adverse events [Parts A and B] - Incidence of clinically significant changes in selected safety assessments [Parts A and B] - Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part A] - Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part A] - Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part A] - Pharmacokinetic Parameter: elimination half-life (t1/2) [Part A] - Pharmacokinetic Parameter: apparent total clearance (CL/F) [Part A] - Pharmacokinetic Parameter: apparent volume of distribution during terminal phase (Vz/F) [Part A] - Pharmacokinetic Parameter: elimination rate constant from the central compartment (Kel) [Part A] - The ratio of total radioactivity in blood relative to plasma [Part A] - [14C]-metabolic profile and identification of metabolites in plasma [Part A] - Major radioactive peak/metabolites in urine and fecal radiochromatograms as a percentage of the radioactive dose [Part A] - Pharmacokinetic Parameter: elimination half-life (t1/2) [Part B] - Pharmacokinetic Parameter: metabolite-to-parent ratio [Part B] - Objective Response Rate (ORR) [Part C] - Time to Response (TTR) [Part C] - Duration of Response (DOR) [Part C] - Disease Control Rate (DCR) [Part C] ### Location - Facility: START Madrid - CIOCC - Hospital Universitario HM Sanchinarro, Madrid, N/A, 28050, Spain @@
## County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial - NCT ID: NCT06302127 - Study ID: CCHDS - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-05-20 - Lead Sponsor: Peking University ### Study Description The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management. ### Conditions - Hypertension - Diabetes Mellitus Type 2 - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Team-based care - Risk-stratified care pathway - Strengthened health education - Financial incentives for integration of care - Supporting health information system ### Outcomes Primary Outcomes - CVD 10-year risk Secondary Outcomes - CVD incidence rate - systolic blood pressure - total cholesterol ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Upper Extremity Asymmetries in Overhead Athletes - NCT ID: NCT06302114 - Study ID: Tubitak - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-03-30 - Lead Sponsor: Pamukkale University ### Study Description Although overhead sports have different characteristics, the movements in the shoulder and upper extremity are similar. These sports may involve a combination of symmetrical, asymmetrical, bilateral and unilateral movements. In sports involving asymmetric movements, biomechanical changes are observed in that area due to the use of the dominant extremity. One of the reliable methods to reveal the stress effects caused by biomechanical stresses is to determine limb asymmetries. Considering the literature, limb asymmetries may be related to injury and performance. ### Conditions - Extremity Asymmetries - Injury;Sports - Performance ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Assessment of overhead athletes ### Outcomes Primary Outcomes - Medicine ball forward throw - Y balanced test - Range of motion of internal and external rotation - Strength of Internal and External Rotator Muscles Secondary Outcomes ### Location - Facility: Pamukkale University, Pamukkale, Denizli, 20000, Turkey @@
## Telerehabilitation Exercise in Older Adults - NCT ID: NCT06302101 - Study ID: Exercise in older adults - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2024-04-30 - Lead Sponsor: Pamukkale University ### Study Description The aim of this study was to investigate the effectiveness of chair-based exercises and cognitive exercises through synchronous telerehabilitation in older adults.Older adults will be divided into two groups (intervention group n=16; control group n=16) . ### Conditions - Pain - Elderly - Balance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - chair-based exercises - cognitive exercises ### Outcomes Primary Outcomes - Berg Balance Scale - Timed Up and Go Test During Dual Tasking - Geriatric Pain Measure - Older people's quality of life-brief (OPQOL-brief) Secondary Outcomes - Hodkinson Mental Test - Dominant Side One Leg Stand Test - Timed Up and Go Test - chair sit and stand test - Geriatric Depression Scale - Successful Aging Scale ### Location - Facility: Elif Gur Kabul, Usak, Center, 64200, Turkey @@
## The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals - NCT ID: NCT06302088 - Study ID: STUDY00026205 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2027-12 - Lead Sponsor: Oregon Health and Science University ### Study Description The safety integration stakeholders (saints) program to integrate worker and patient safety in Oregon rural hospitals. The rationale is that the saints program will positively impact outcomes by identifying and training peer leaders on strategies to optimize environmental, administrative, and educational components to become a saint and regularly collaborate with safety stakeholders/administrative leaders at each site through continuous improvement cycles (e.g. plan-do-study-act). ### Conditions - Accidental Falls - Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - SAINTS program ### Outcomes Primary Outcomes - Safety participation Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol - NCT ID: NCT06302075 - Study ID: UKA-L2086 - Status: RECRUITING - Start Date: 2021-11-16 - Completion Date: 2025-12-01 - Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio ### Study Description The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B). ### Conditions - Gonarthrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - One Day Rehabilitation - Fast Rehabilitation ### Outcomes Primary Outcomes - Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome) Secondary Outcomes ### Location - Facility: Istituto Clinico San Siro, Milan, Italia, N/A, Italy @@
## Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors - NCT ID: NCT06302062 - Study ID: FIT003-001 - Status: RECRUITING - Start Date: 2023-06-06 - Completion Date: 2026-06-30 - Lead Sponsor: Guangzhou FineImmune Biotechnology Co., LTD. ### Study Description A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection.To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others. ### Conditions - Advanced Solid Tumor - Tumor Associated Lymph Node T Cell - Immunotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tumor Associated Lymph node T cell - cyclophosphamide - IL-2 - Serplulimab Injection ### Outcomes Primary Outcomes - DLT - MDT - Number of participants with treatment-related adverse events as assessed by CTCAE V4.03 Secondary Outcomes - ORR - PFS - life quality score ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Gaungdong, 510700, China @@
## Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis - NCT ID: NCT06302049 - Study ID: 12345 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Sadat City University ### Study Description The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters. ### Conditions - Fatty Liver Disease - Steatohepatitis, Nonalcoholic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Esomeprazole - Placebo ### Outcomes Primary Outcomes - Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS) Secondary Outcomes - Liver function improvement - Reduction of oxidative stress ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Emotional Freedom Techniques (EFT) on Stress, Anxiety and Depression in University Students Experiencing Earthquakes - NCT ID: NCT06302036 - Study ID: 7777777 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-04-28 - Lead Sponsor: Emine Yıldırım ### Study Description After two earthquakes in Kahramanmaraş Pazarcık in our country, the continuation of long-term aftershocks caused repetition of psychological problems and difficulties in recovery. Social and spiritual support plays a key role in the post-traumatic recovery period. It is necessary to use psychological support methods that can be applied in a short time and whose effect can be observed in a short time in the spiritual healing and healing of traumas. The emotional freedom technique (EFT) is One of the short-term psychotherapeutic techniques and ıt can also be applied online. EFT, which can be easily applied by individuals or professionals after receiving the necessary training; Cognitive therapy, acceptance and commitment therapy combine elements of acupuncture point stimulation, relying on manual stimulation of acupuncture points rather than using acupuncture needles. When we look at the literature, many scientific studies have been found in which the effectiveness of EFT on anxiety, stress and depression has been evaluated, but there has been no randomized controlled study evaluating the effectiveness of EFT online on individuals who have experienced earthquakes. With this project, it is aimed to determine the effect of online Emotional Freedom Techniques (EFT) on stress, anxiety and depression in university students who experienced earthquakes.This study, which will be carried out as a randomized controlled experimental study, will be carried out between 16.12.2023 and 20.12.2023 by online with university students who score 17 or higher on the Beck Depression Scale. Total of 60 students with depressive symptoms will be recruited to the intervention and control groups, EFT sessions will be applied to the intervention group, and the control group will only be followed. At the beginning of the application, pre-tests (Information Form, Beck Depression Inventory, State Trait Anxiety Inventory, Perceived Stress Inventory) and at the end of the last session, post-tests will be applied for both groups.With this study, a randomized controlled study will be brought to the literature on the effectiveness of a therapeutic method such as EFT, which is a method that can be used after an earthquake, which is easy to apply, has no cost, and can be accessed online in hard-to-reach areas. Our project will both contribute to the literature and provide short and long-term benefits in practice, in terms of raising awareness of students about important mental problems such as anxiety and depression, which are likely to be experienced after the earthquake, and enabling them to continue their education in a healthy way. It is aimed to present the work planned within the project as a paper in at least one national / international congress. It is aimed to publish in journals within the scope of SCI, SCI-Expanded related to the research area. The results and outputs of the research will be shared in various media (Kırklareli University and Osmaniye Korkut Ata University website and social media accounts).By determining the stress, anxiety and depression status of university students who have experienced an earthquake, it will be possible to reduce their stress, anxiety and depression with EFT application. The fact that the application used is a short-term, effective and easy psychotherapy method will prevent the disruption of the normal education processes of the students. It will make an economic contribution by reducing the need for psychological drugs that may be needed to reduce the effects of the earthquake. ### Conditions - Emotional Problem - University Students Who Experienced an Earthquake ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EFT ### Outcomes Primary Outcomes - depression Secondary Outcomes - stress, anxiety ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor - NCT ID: NCT06302023 - Study ID: HE661462 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-05-31 - Lead Sponsor: Khon Kaen University ### Study Description The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm laborThe main questions it aims to answer are:* Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor?* How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups* Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day* Group 2 (control) Participant will not need to take a DHA ### Conditions - Pregnant Women Diagnosed With Threatened Preterm Labor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Docosahexaenoic acid (DHA) 1000 mg ### Outcomes Primary Outcomes - Number of Participants with preterm birth Secondary Outcomes - Rate of low birth weight neonate - Rate of Neonatal Intensive care unit admission ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy - NCT ID: NCT06302010 - Study ID: KafkasU3636 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-31 - Lead Sponsor: Hümeyra TÜLEK DENİZ ### Study Description This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST. ### Conditions - Anxiety - Fetal Conditions - Pregnancy Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Stress Ball Intervention ### Outcomes Primary Outcomes - Anxiety Secondary Outcomes - Fetal well-being - Fetal well-being - Fetal well-being - Fetal well-being - Fetal well-being ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Herbal Compound for Psoriasis - NCT ID: NCT06301997 - Study ID: IRCT20210218050404N5 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-01 - Completion Date: 2024-12-30 - Lead Sponsor: Fasa University of Medical Sciences ### Study Description The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is:• Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks.Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by psoriasis after treatment with ZAX.1400.P03 for 3 weeks. ### Conditions - Psoriasis - Inflammation - Skin Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ZAX.1400.P03 - Placebo ### Outcomes Primary Outcomes - Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 Secondary Outcomes - Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in erythema score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in Swelling score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in pruritus score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in flake score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 - Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 ### Location - Facility: Fasa university of medical sciences, Fasa, Fars, 7461686688, Iran, Islamic Republic of @@
## Safety and Efficacy Evaluation of Insight GS Growing System - NCT ID: NCT06301984 - Study ID: ANDROMEDA_01_2023_V1 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-08 - Lead Sponsor: EVEREST PESQUISA E DESENVOLVIMENTO LTDA ### Study Description Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth.The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE).Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study.Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events. ### Conditions - Early Onset Scoliosis (EOS) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Insight GS ### Outcomes Primary Outcomes - Cobb Angle Secondary Outcomes - Adverse event - Trunk height - Pain - Satisfaction ### Location - Facility: Hospital Ortopédico AACD, São Paulo, SP, 04027-000, Brazil @@
## A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants - NCT ID: NCT06301971 - Study ID: CVL-231-HV-1011 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-04 - Lead Sponsor: Cerevel Therapeutics, LLC ### Study Description The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity in plasma and whole blood following a single oral dose of \[14C\]-emraclidine in healthy adult male participants. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Emraclidine ### Outcomes Primary Outcomes - Area Under the Concentration Time Curve (AUC) from Zero to Infinity (AUCinf) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood - AUC from Time 0 to last Quantifiable Concentration (AUClast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood - Maximum Plasma Concentration (Cmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood - Time to Last Measurable Concentration (Tlast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood - Time to Maximum Observed Concentration (Tmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood - Apparent Terminal Elimination Half-life (t½) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood - Terminal Rate Constant (λz) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood - Total Plasma Clearance After Oral Administration (CL/F) of Emraclidine - Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Emraclidine - Ratio of Plasma AUCinf for Emraclidine to Plasma AUCinf for Total Radioactivity - Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Total Radioactivity - Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Emraclidine - Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma AUCinf for Total Radioactivity - Amount Excreted in Urine (Aeu) of Total Radioactivity - Cumulative Aeu of Total Radioactivity - Percentage Excreted in Urine (feu) of Total Radioactivity - Cumulative feu of Total Radioactivity - Amount Excreted in Feces (Aef) of Total Radioactivity - Cumulative Aef of Total Radioactivity - Percentage Excreted in Feces (fef) of Total Radioactivity - Cumulative fef of Total Radioactivity - Percentage Dose (%Dose) of Total Radioactivity Excreted in Urine Plus Feces Combined - Cumulative Percentage Dose of Total Radioactivity Excreted in Urine Plus Feces Combined Secondary Outcomes - Metabolite Profile of Emraclidine in Plasma, Urine and Feces - Structural Identification of Emraclidine Metabolites Found in Plasma, Urine and Feces - Number of Participants with Treatment Emergent Adverse Events (TEAEs) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values - Number of Participants with Clinically Significant Changes in Vital Signs - Number of Participants with Clinically Significant Changes in Laboratory Assessments - Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results - Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score ### Location - Facility: Austin, Texas, Austin, Texas, 78744, United States @@
## Dextrose Prolotherapy on Articular Cartilage - NCT ID: NCT06301958 - Study ID: 202102567A3 - Status: RECRUITING - Start Date: 2023-01-21 - Completion Date: 2024-08-31 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. In the past, it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the "self-healing mechanism." However, some studies have pointed out that this treatment can cause cell apoptosis. In my clinical work, I often perform dextrose prolotherapy. I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients. We believe that the concentration of 25% hypertonic glucose solution should show a stepwise decrease in the joint cavity. Our preliminary cell experiment results using 2-fold serial dilutions of 25% glucose solution showed that 25%, 12% and 6% glucose solution will trigger the apoptosis of chondrocytes, vascular endothelial cells and immune cells, and will also inhibit the expression of the pro-inflammatory factor IL-6. Glucose solution below 3% will not have the effect of inducing apoptosis on cells. We believe that the therapeutic effect of 25% hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically. Therefore, in this study, we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis. The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution. The joint pain level assessment of different types of patients (OA and RA) before dextrose prolotherapy (preliminary period), 1 month after treatment (midterm period) and 3 months after treatment (late period) will be collected, and joint effusion will be measured. Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid.We hope that through this study, we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells. This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions. ### Conditions - Arthritis Knee ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Dextrose prolotherapy ### Outcomes Primary Outcomes - Visual Analogue Scale (VAS) Secondary Outcomes - Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Interleukin 6 (IL-6) ### Location - Facility: Chang Gung Memorial Hospital, Chiayi, Chiayi City, 嘉義市, 600, Taiwan @@
## Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors - NCT ID: NCT06301945 - Study ID: Maastro Clinic - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2027-08-01 - Lead Sponsor: Erasmus Medical Center ### Study Description Thymic epithelial tumors are rare neoplasms in the anterior mediastinum. The cornerstone of the treatment is surgical resection. Administration of postoperative radiotherapy is usually indicated in patients with more extensive local disease, incomplete resection and/or more aggressive subtypes, defined by the WHO histopathological classification.In this classification thymoma types A, AB, B1, B2, B3, and thymic carcinoma are distinguished. Studies have shown large discordances between pathologists in subtyping these tumors. Moreover, the WHO classification alone does not accurately predict the risk of recurrence, as within subtypes patients have divergent prognoses.The investigators will develop AI models using digital pathology and relevant clinical variables to improve the accuracy of histopathological classification of thymic epithelial tumors, and to better predict the risk of recurrence.In this multicentric and international project three existing databases will be used from Rotterdam, Maastricht and Lyon. For all models one database will be used to build AI models, and the other two for external validation.The ultimate goal of this project is to develop AI models that support the pathologist in correctly subtyping thymic epithelial tumors, in order to prevent patients from under- or overtreatment with adjuvant radiotherapy. ### Conditions - Thymic Epithelial Tumor - Thymic Carcinoma - Thymoma - Thymoma and Thymic Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Artificial Intelligence Diagnostics - Recurrence Prediction Tool ### Outcomes Primary Outcomes - WP1 - Databases/Data Pre-processing Secondary Outcomes - WP2 - Deep Learning-Model for TET Classification and Recurrence Prediction ### Location - Facility: Erasmus MC, Rotterdam, South Holland, 3015 GD, Netherlands @@
## The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy - NCT ID: NCT06301932 - Study ID: ANE-2562-06771 - Status: COMPLETED - Start Date: 2006-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Chiang Mai University ### Study Description This observational study is to compare the effectiveness and outcomes of epidural analgesia in patients undergoing open hepatectomy: A propensity score matching analysis.The main question is: What is the superior method of pain control in open hepatectomy: epidural analgesia or intravenous PCA? ### Conditions - Epidural Analgesia - Patient Controlled Analgesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Open liver resection ### Outcomes Primary Outcomes - Post-operative opioid consumption Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization - NCT ID: NCT06301919 - Study ID: IRBN042024/CHUSTE - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-01 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties.Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization.The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting. ### Conditions - Haemostasis Embolisation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Clinical data - Imaging data - Biological data ### Outcomes Primary Outcomes - Evaluation of technical success Secondary Outcomes - Assessment of clinical success - Assessment of clinical success - Assessment of clinical success - Assessment of clinical success - Assessment of clinical success ### Location - Facility: CHU de Saint-Etienne, Saint-Priest-en-Jarez, N/A, 42270, France @@
## Red Yeast Rice for Primary Prevention of Hypercholesterolemia - NCT ID: NCT06301906 - Study ID: 202301060A3 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2025-12-31 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35\~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota. ### Conditions - Hypercholesterolemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - LipoCol Forte Capsule 600mg bid ### Outcomes Primary Outcomes - Low Density Lipoprotein-Cholesterol (LDL-C) Secondary Outcomes - 10-Year ASCVD Risk ### Location - Facility: Taoyuan branch of Chang Gung Memorial Hospital, Taoyuan, N/A, 333, Taiwan @@
## Uganda Sickle Surveillance Study (US-3) - NCT ID: NCT06301893 - Study ID: US-3_Uganda (IRB#2013-4576) - Status: RECRUITING - Start Date: 2013-09-07 - Completion Date: 2032-12-31 - Lead Sponsor: Children's Hospital Medical Center, Cincinnati ### Study Description It is estimated that over 250,000 babies are born with sickle cell disease (SCD) annually in sub-Saharan Africa, and only 10% - 50% of them survive beyond five years of age. Data describing the magnitude of the sickle cell problem are lacking in most African countries. The available data on prevalence were mainly from older studies and small numbers of hospitalized patients. In Uganda, approximately 25,000 children are born with SCD but 70-80% die before their 5th birthday. Lehmann and Raper found 'sicklaemia' prevalence of 0.8% and 45% in the Sebei and Bambaa ethnic groups, respectively. A recent study found a SCT and SCD prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of Uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. The objective of this study is to determine the prevalence and map out the burden of SCT and SCD in Uganda. ### Conditions - Sickle Cell Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of HbSS and HbA Secondary Outcomes - Incidence of HbSS and HbA ### Location - Facility: Makerere University, Kampala, N/A, N/A, Uganda @@
## Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow - NCT ID: NCT06301880 - Study ID: 3200 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-01-31 - Lead Sponsor: Damascus University ### Study Description Forty-six consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled. After the left IMA was harvested, free flow was measured under controlled hemodynamic conditions before any intervention (flow 1) and at a mean of 12.5 minutes after the topical application of one of three agents (milrinone, nitroglycerin or normal saline) on the IMA (flow 2). ### Conditions - Internal Mammary Artery Syndrome - Vasodilation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The topical application of a vasodilator on the LIMA graft ### Outcomes Primary Outcomes - LIMA free flow Secondary Outcomes ### Location - Facility: Damascus University Cardiac Surgery Hospital, Damascus, N/A, N/A, Syrian Arab Republic @@
## Preventing Failed Extubations - NCT ID: NCT06301867 - Study ID: Pro00113877 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-31 - Lead Sponsor: Duke University ### Study Description More than 300,00 people in the United States experience acute respiratory failure and require mechanical ventilation every year. Of those that recover and are extubated, the most common reason for reintubation is recurrent respiratory failure. Our study proposes a novel methodology for identifying those patients most at risk for recurrent respiratory failure. ### Conditions - Mechanical Ventilation Complication - Weaning Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Plateau Pressure ### Outcomes Primary Outcomes - Percentage of patients who had a plateau pressure measured prior to extubation as a measure of feasibility Secondary Outcomes - Percentage of patients who were reintubated prior to hospital discharge ### Location - Facility: Duke University Medical Center, Durham, North Carolina, 27710, United States @@
## Long-term Safety of TPN171H Tablet in Erectile Dysfunction. - NCT ID: NCT06301854 - Study ID: TPN171H-E302 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2025-04-30 - Lead Sponsor: Vigonvita Life Sciences ### Study Description This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction. ### Conditions - Erectile Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TPN171H ### Outcomes Primary Outcomes - Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation. Secondary Outcomes - Change From Baseline in the International Index of Erectile Function - Erectile Function. - Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responses. - Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses. - Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the 3rd and 6th month of medication. - Change From Baseline to the 3rd months and 6th months Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction. - Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd and 6th month. - Change From Baseline in the International Index of Erectile Function - Erectile Function. - Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responses. - Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses. - Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the the 3rd，6th，9th，12th month of medication. - Change From Baseline to the 3rd，6th，9th，12th month Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction. - Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd，6th，9th，12th month . ### Location - Facility: The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230000, China @@
## An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care - NCT ID: NCT06301841 - Study ID: 2023-A00903-42 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-07-15 - Lead Sponsor: University Hospital, Caen ### Study Description Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia. ### Conditions - To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - experimental ### Outcomes Primary Outcomes - Duration of antibiotic therapy Secondary Outcomes ### Location - Facility: Medical Intensive Care Unit, CHU Caen, Caen, N/A, 14000, France @@
## Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors - NCT ID: NCT06301828 - Study ID: KY202401 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2026-02-21 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment. ### Conditions - Gastrointestinal Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Envafolimab Injection - Endostar ### Outcomes Primary Outcomes - DCR - ORR Secondary Outcomes - PFS - Incidence of Treatment-Emergent Adverse Events ### Location - Facility: Nanjing First Hospital, Nanjing, Jiangsu, 210006, China @@
## Feasibility of Measuring Vertical Perception in Acute Stroke - NCT ID: NCT06301815 - Study ID: Shaw_Stroke_REC24/YH/0010_2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: University of Winchester ### Study Description The goal of this observational study is to establish if it is feasible to identify vertical perception deficits in people with acute stroke. The primary purpose to the study is:• To establish the feasibility of completing the Catherine Bergego Scale, Scale for Contraversive Pushing (SCP) and bucket test in a clinical environment with acute stroke patients to assist with identification of vertical perception loss.Participants will be asked to complete the assessments with a therapist 48 hours after admission. If they are not completed for any reason attempts will be made to complete them at one, two and four weeks after admission. Some participants will have them completed again on discharge. The Catherine Bergego Scale and SCP are observational and will involve a therapist watching the participant undertake daily activities. The bucket test involves a therapist placing a bucket in front of the face of the participant and asking them to identify when a line on the bottom of the bucket is vertical. Acceptabiliy and feasibility will be further investigated using a survey of participants who complete the assessments and through focus groups with the rehabilitation professionals admininstering the assessments.If it is feasible and acceptable to complete these assessments then further research can use them as an acceptable measure of vertical alignment in the clinical setting. ### Conditions - Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Scale for Contraversive Pushing - Catherine Bergego Scale - Bucket Test ### Outcomes Primary Outcomes - Bucket Test to measure subjective visual vertical (SVV). - Catherine Bergego Scale to measure neglect. - Scale for Contraversive Pushing to measure lateropulsion Secondary Outcomes ### Location - Facility: Royal Hampshire County Hospital, Winchester, N/A, SO22 5DG, United Kingdom @@
## Outcomes of Proactive Management of Children With Myelomeningocele - NCT ID: NCT06301802 - Study ID: myelomeningocele management - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2026-03-15 - Lead Sponsor: Assiut University ### Study Description Spina bifida birth prevalence in Africa is 0.13%. Myelomeningocele (MMC) represents the most frequent and most severe cause of NB in children. Treatment of neuropathic bladder secondary to spina bifida is an ongoing challenge. Damage of the renal parenchyma in children with NB is preventable given adequate evaluation, follow-up and proactive management. Proactive management was defined as use of clean intermittent catheterization (CIC), and/or anticholinergics at presentation, or based on initial high-risk urodynamic findings by 1 year of age. The proactive approach to treat SB (CIC and pharmacotherapy) has contributed to decreasing chronic kidney disease (CKD). Myelomeningocele is considered a complex congenital disease. Hence, a multidisciplinary team is the best choice for management of spina bifida, involving neurosurgeons, orthopedic surgeons, urologists, physical medicine and rehabilitation specialists and pediatricians. Currently, children with spina bifida in Egypt must visit multiple different locations to access the complex care they need. Here, we review our experience with patients with spina bifida who will be followed with this team with an emphasis on patients' upper urinary tract protection and decreasing urinary incontinence. ### Conditions - Urologic Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CIC - Anticholinergic ### Outcomes Primary Outcomes - upper tract affection Secondary Outcomes ### Location - Facility: Assiut university hospital, Assiut, N/A, 11571, Egypt @@
## Role of Magnesium Sulphate as an Adjuvant to Bupivacaine in U.S Guided Quadratus Lumborum Block in Lower Abdominal Cancer Surgeries - NCT ID: NCT06301789 - Study ID: Quadratus lumborum block - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-03 - Lead Sponsor: Assiut University ### Study Description The aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries. ### Conditions - QLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries ### Outcomes Primary Outcomes - Postoperative analgesia Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Prospective, Experimental, Multicenter, Open-label, Randomized, Controlled Trial of 3-month Dual Antiplatelet Therapy Followed by Ticagrelor Versus 6-month Dual Antiplatelet Therapy Followed by Ticagrelor After Implanting Bridge - NCT ID: NCT06301776 - Study ID: Bridge-2023-02-0A - Status: RECRUITING - Start Date: 2023-12-05 - Completion Date: 2026-06-30 - Lead Sponsor: The Fourth Affiliated Hospital of China Medical University ### Study Description To compare the incidence of the composite endpoints of non-fatal ischaemic stroke, transient ischaemia (TIA) and all-cause mortality at 12-month follow-up after implantation of Bridge for the treatment of symptomatic vertebral artery stenosis in subjects who had been taking different durations of dual-antiplatelet therapy (3 vs 6 months) and ticagrelor monotherapy. ### Conditions - Brain Disease - Vertebral Artery Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ticagrelor ### Outcomes Primary Outcomes - Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months. Secondary Outcomes - Incidence of the composite endpoint of major bleeding and hemorrhagic stroke at 12-months. - Incidence of target vessel-related stroke and neurological death at 1month - Incidence of stroke and neurological death at 12 month. - Incidence of all-cause mortality at 12 month. - Incidence of in-stent-stenosis at 12 month (subgroup of imaging follow-up). ### Location - Facility: the Fourth Affiliated Hospital of China Medical University, Shenyang, Liaoning, 110032, China @@
## Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma - NCT ID: NCT06301763 - Study ID: nosencekCancer-old - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2022-12-31 - Lead Sponsor: Muhammad ### Study Description This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent Oral-esophageal Tube Feeding - nasogastric tube feeding ### Outcomes Primary Outcomes - Hemoglobin Level - Serum albumin Level - Total serum protein Level - Serum prealbumin Level - Body Mass Index Level Secondary Outcomes - Depression - Swallowing-Quality of Life questionnaire - Functional Oral Intake Scale - Penetration-Aspiration Scale ### Location - Facility: Ubonratchathani Hospital, Ubon Ratchathani, N/A, N/A, Thailand @@
## Oral Enteral Nutrition Feeding in Alzheimer's Patients - NCT ID: NCT06301750 - Study ID: Tube-Alzheimer - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Muhammad ### Study Description This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared. ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional Care - Intermittent Oral-esophageal Tube Feeding - Nasogastric tube ### Outcomes Primary Outcomes - Level of Hemoglobin - Level of Serum albumin - Level of Total serum protein - Level of Serum prealbumin Secondary Outcomes - Body Mass Index - Pulmonary Infections - Mini Nutritional Assessment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Lidocaine Injection: A Nove Block Therapy for Stroke-related Dysphagia - NCT ID: NCT06301737 - Study ID: SGB-YanD - Status: COMPLETED - Start Date: 2022-06-21 - Completion Date: 2023-05-17 - Lead Sponsor: Muhammad ### Study Description This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Comprehensive rehabilitation - Injection - Lidocaine Hydrochloride ### Outcomes Primary Outcomes - Video fluoroscopic swallowing study Secondary Outcomes - Rosenbek penetration-aspiration scale - Functional Oral Intake Scale ### Location - Facility: Zhen No.1 Hos., Taiwan, N/A, N/A, China @@
## Effectiveness of Stellate Ganglion Block in Individuals With Parkinson's Disease - NCT ID: NCT06301724 - Study ID: SGB-PKS - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Muhammad ### Study Description The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Injection - Lidocaine hydrochloride ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Modified Barthel Index - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigation of Potential Mechanisms in Stellate Ganglion Block in Individuals With Cerebral Small Vessel Disease - NCT ID: NCT06301711 - Study ID: SGB-CVSD - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Ahmadu Bello University Teaching Hospital ### Study Description This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index. ### Conditions - Cerebral Small Vessel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation therapy - Stellate ganglion block - Lidocaine Hydrochloride ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Modified Barthel Index - Mini-Mental State Examination - Swallowing duration - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effectiveness of Stellate Ganglion Block in Managing Dysphagia in Patients With Medullary Infarction - NCT ID: NCT06301698 - Study ID: SGB-BP - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Ahmadu Bello University Teaching Hospital ### Study Description This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function. ### Conditions - Bulbar Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Comprehensive rehabilitation - Injection - Lidocaine Hydrochloride ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Functional Oral Intake Scale - Murray secretion severity scale - Yale pharyngeal residue severity rating scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum Disorder - NCT ID: NCT06301685 - Study ID: SGB-AST - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Muhammad ### Study Description The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated. ### Conditions - Autistic Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Routine therapy - Injection - Lidocaine Hydrochloride ### Outcomes Primary Outcomes - Childhood Autism Rating Scale Secondary Outcomes - Children's Communication Checklist - Social Interaction Assessment Scale - Children's Depression Inventory - Childhood Anxiety Sensitivity Index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Oral Enteral Nutrition in Nasopharyngeal Carcinoma Survivors With Swallowing Disorders - NCT ID: NCT06301672 - Study ID: NecknoseCancer-Xin - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-08 - Lead Sponsor: Muhammad ### Study Description This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Nasogastric Tube Feeding - Intermittent Oral-esophageal Tube Feeding - comprehensive rehabilitation therapy ### Outcomes Primary Outcomes - concentration of Hemoglobin - concentration of Serum albumin - concentration of Serum prealbumin - Body Mass Index Secondary Outcomes - Depression - Functional Oral Intake Scale - Penetration-Aspiration Scale - Feeding amount ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Adapted Mirror Therapy on Individuals With Hemiparesis of the Upper Limb Following a Stroke - NCT ID: NCT06301659 - Study ID: Jingxiang-Jiu - Status: COMPLETED - Start Date: 2022-08-01 - Completion Date: 2023-08-31 - Lead Sponsor: Ahmadu Bello University Teaching Hospital ### Study Description Patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy. On day 1 and day 30, patients' Upper Limb function were compared. ### Conditions - Hemiparesis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - routine rehabilitation therapy - Modified mirror therapy ### Outcomes Primary Outcomes - Fugl-Meyer Assessment-Upper Extremity Secondary Outcomes - coordinated contraction rate-Surface electromyography - Visual Analog Scale - Anxiety - Depression ### Location - Facility: Center Rehabilitation Hospital, Yangon, N/A, N/A, Myanmar @@

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