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## Resonance Breathing Training for Long Covid-related Myocardial Injury - NCT ID: NCT06379672 - Study ID: 2023[No.193] - Status: NOT_YET_RECRUITING - Start Date: 2024-05-25 - Completion Date: 2024-09-05 - Lead Sponsor: Chengdu Sport University ### Study Description An investigation of the efficacy of resonance breathing training in the rehabilitation of patients with Long covid-related myocardial injury ### Conditions - Long COVID - Myocardial Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Resonance breathing ### Outcomes Primary Outcomes - New YorkHeart Association (NYHA) - left ventricle global longitudinal strain, LVGLS Secondary Outcomes - hypertension - Average heart rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Intrauterine Growth Hormone Administration as an add-on Therapy to Conventional Hormone Therapy Compared to Placebo in Patients With Thin Endometrium Undergoing Frozen Thawed Embryo Transfer - NCT ID: NCT06379659 - Study ID: IR.MUI.MED.REC.1402.449 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2024-11 - Lead Sponsor: Isfahan University of Medical Sciences ### Study Description The purpose of this clinical trial is to see if intrauterine growth hormone infusions can help subjects reach a suitable endometrial thickness in patients who are resistant to routine hormonal therapy for embryo transfer in the In Vitro Fertilization (IVF) cycle.The primary aim of this study is to assess the effectiveness of injecting Growth hormone directly into the uterus to enhance endometrial thickness. Additionally, we aim to compare the likelihood of pregnancy between patients receiving the Growth hormone infusion and those receiving a placebo. ### Conditions - Thin Endometrium - Infertility Female - Infertility ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Growh hormone - Placebo ### Outcomes Primary Outcomes - Endometrial thickness Secondary Outcomes - Clinical Pregnancy Rate - Response to treatment - Implantation rate - IVF cancellation rate - Early pregnancy complications ### Location - Facility: Isfahan Shahid Beheshti hospital, Hazrat e Maryam Fertility Center, Isfahan, N/A, 8174673461, Iran, Islamic Republic of @@
## An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease - NCT ID: NCT06379646 - Study ID: YTS109-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2026-04-21 - Lead Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. ### Study Description An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease ### Conditions - Systemic Lupus Erythematosus - Systemic Sclerosis - Inflammatory Myopathy - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - Antiphospholipid Syndrome - Sjogren's Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - YTS109 ### Outcomes Primary Outcomes - Safety outcomes - Efficacy outcomes for SLE - Efficacy outcomes for Sjogren's Syndrome - Efficacy outcomes for Systemic Sclerosis - Efficacy outcomes for Inflammatory Myopathy - Efficacy outcomes for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - Efficacy outcomes for Antiphospholipid Syndrome Secondary Outcomes - Peak Plasma Concentration (Cmax) of YTS109 - Time to Peak (Tmax) of YTS109 - Area under the plasma concentration versus time curve (AUC) of YTS109 - PD parameters ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Virtual Reality Exposure for Socially Anxious Adolescents - NCT ID: NCT06379633 - Study ID: s67010 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2026-06 - Lead Sponsor: KU Leuven ### Study Description Overall in this project, the primary goal is to evaluate the efficacy of virtual reality exposure (VRE) for adolescents with elevated social anxiety using a three-arm randomized controlled trial: (1) virtual reality exposure (VRE); (2) in vivo exposure (IVE); and (3) waitlist (WL) - the control condition.It is predicted that both VRE and IVE will be more successful in decreasing social anxiety symptoms than the WL condition at post-assessment and that VRE will be as effective as in vivo in reducing social anxiety symptoms. Furthermore, it is expected that there will be no difference between the two active conditions in the long term (at 3- months \& 6-months follow up). Similar results are expected in the secondary outcome measures, intended to capture the participants' general well-being.Moreover, the study has the following (secondary) objectives:* To elucidate potential working mechanisms of VRE and IVE* To identify predictors of adolescents' response to VRE and IVE* To assess to what extent adolescents accept VRE and IVE and how they experience it ### Conditions - Social Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - In vivo exposure - (Virtual reality) exposure ### Outcomes Primary Outcomes - Brief version of the Social Phobia and Anxiety Inventory (SPAI-18) - Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Avoidance subscale - Behavioral assessment task (BAT) - Peak anxiety Secondary Outcomes - Brief Resilience Scale (BRS) - Multidimensional Adolescent Functioning Scale (MAFS) - Peer and General functioning subscales - Revised Children's Anxiety and Depression Scale (RCADS) - Self-Efficacy Questionnaire for Children (SEQ-C) - Social efficacy subscale - Social Phobia Weekly Summary Scale (SPWSS) - Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Fear subscale - Adolescent Social Cognitions Questionnaire (ASCQ) - Behavioral assessment task (BAT) - Anticipatory anxiety - Behavioral assessment task (BAT) - Physiological assessment - Behavioral assessment task (BAT) - Physiological assessment - Behavioral assessment task (BAT) - Physiological assessment - Behavioral assessment task (BAT) - Task duration - Behavioral assessment task (BAT) - Confederate rating ### Location - Facility: Psychological Institute (PSI) of KU Leuven, Leuven, N/A, 3000 Leuven, Belgium @@
## Pilot Open Label Use of the Hi-OXSR for the Treatment of Post COVID-19 Cognitive Dysfunction - NCT ID: NCT06379620 - Study ID: 22-5544 - Status: COMPLETED - Start Date: 2022-11-29 - Completion Date: 2024-03-04 - Lead Sponsor: University Health Network, Toronto ### Study Description During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is on the rise and no effective treatment exists yet to improve cognitive function. Recent research has shown that people with even mild COVID had a greater decline in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation.Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction. ### Conditions - Post COVID-19 Condition ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Hi-OxSR Sequential Rebreathing mask (oxygen concentrator) ### Outcomes Primary Outcomes - Safety of use of Hi-OX sequential rebreathing device Secondary Outcomes ### Location - Facility: University Health Network, Toronto, Ontario, M5G 2C4, Canada @@
## High Flow Nasal Cannula Rates in Pediatric Asthma - NCT ID: NCT06379607 - Study ID: HFNC2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2025-09-30 - Lead Sponsor: University of Rochester ### Study Description This is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations. ### Conditions - Pediatric Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - "High Flow" High Flow Nasal Cannula - "Low Flow" High Flow Nasal Cannula ### Outcomes Primary Outcomes - Percent of participants enrolled Secondary Outcomes - Mean Change in Pediatric Asthma Severity Score (PASS) - Mean Change in Respiratory Rate - Mean Total Duration of Continuous Albuterol - Percentage of Children with Escalation of Respiratory Support - Mean Total Duration of Respiratory Support - Percentage of Participants placed on Adjunct Asthma Therapies - Percentage of Participants who needed Sedation - Percentage of Participants on Antibiotics - Mean PICU Length of Stay (LOS) - Mean Hospital Length of Stay (LOS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## UK Based Remote Brain Health Clinic (BHC) for Patients With Mild Cognitive Impairment (MCI) - NCT ID: NCT06379594 - Study ID: 294633 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-06-20 - Completion Date: 2028-06 - Lead Sponsor: South London and Maudsley NHS Foundation Trust ### Study Description This project aims to understand the feasibility, acceptability and real-world evidence of a novel UK-based remote brain health clinic for patients with mild cognitive impairment (MCI). A timely and accurate diagnosis of dementia is a priority in the UK and MCI is indicative of future risk of cognitive decline. An accurate etiological diagnosis of MCI (MCI-subtyping - distinguishing those who are likely to go on to develop dementia and those who are not) is vital for treatment planning. Whilst the assessment of molecular biological markers (biomarkers) for etiological diagnosis of MCI and Alzheimer's disease (AD) is increasingly recommended and employed internationally, the uptake is low in UK memory clinics. The Brain Health Clinic (BHC) has been specifically designed as a state-of-the-art diagnostic centre for those with MCI. Procedures will include a range of clinical and biomarker assessments, with molecular biomarkers based on lumbar puncture and cerebrospinal fluid (CSF) analysis. Additionally, the clinic will employ remote neuropsychiatric assessments using digital and telephonic methods. This allows for regular contact, whilst adhering to changes in clinical practice and national guidance due to the COVID-19 pandemic. Our overarching objectives are to first establish the acceptability and feasibility of the remote Brain Health Clinic and its novel clinical and biomarker assessment programme. Then secondly establish the impact of care under the Brain Health Clinic on i) care management decisions (e.g. follow-up and treatment planning); ii) time to etiological diagnosis of MCI (MCI-subtyping); and iii) time to diagnosis of dementia and severity of dementia at the time of diagnosis. ### Conditions - Mild Cognitive Impairment - Mild Cognitive Impairment Due to Alzheimer's Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI. - To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI. Secondary Outcomes - To establish the acceptability and feasibility of the following procedures/ biomarker assessment in a Brain Health Clinic - 2. To establish the acceptability and feasibility of administering the following cognitive assessments remotely in a brain health clinic - To establish the validity of novel MRI analysis software tools - 5. To investigate the acceptability and feasibility of remote tablet-based cognitive training - To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme - To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme - To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme - To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme ### Location - Facility: King's College London, London, Denmark Hill, SE5 8AF, United Kingdom @@
## Skin Cancer Diagnostics Using Photoacoustic Imaging - NCT ID: NCT06379581 - Study ID: 2022-04900-02 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-10-01 - Lead Sponsor: Region Skane ### Study Description In this clinical study, photoacoustic imaging will be used on patients with suspected skin cancer (primarily melanoma, basal cell carcinoma, and squamous cell carcinoma) to determine the tumor borders both superficially and at a depth. ### Conditions - Skin Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Tumor thickness - Tumor size Secondary Outcomes ### Location - Facility: Department of Ophthamology, Lund, Skåne University Hospital, Lund, N/A, 22185, Sweden @@
## Risk of Aspergillus Infection in Patients With Chronic Lung Disease - NCT ID: NCT06379568 - Study ID: SichuanPPHLC01 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2024-01-31 - Lead Sponsor: Lin Chen ### Study Description Large doses of systemic corticosteroids ，severe lung tissue damage and longer COPD diagnosis may increase the risk of IPA in patients with chronic structural lung disease. By comparing the risk factors of aspergillus colonization group and aspergillus infection group, the main risk factors of aspergillus pneumonia were determined. ### Conditions - Fungal Infection Lungs ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Descriptive statistical index - Independent risk factor for aspergillus pneumonia - The area under ROC curve of risk factors for aspergillus pneumonia Secondary Outcomes - Threshold analysis of aspergillus pneumonia ### Location - Facility: Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610072, China @@
## Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study - NCT ID: NCT06379555 - Study ID: 2023-A02756-39 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-01 - Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche ### Study Description Wrist articular fractures are more difficult to treat and rehabilitation takes longer. Furthermore, these joint fractures are frequently accompanied by ligament lesions of the carpal bones.For these reasons, it is strongly recommended to check the interior of the wrist joint. This check can be done with wrist arthroscopy. Therefore, fracture reduction can be improved, "step of stairs" can be eliminated under arthroscopic control and ligament rupture of carpal bones can be treated.WALANT anesthesia (Wide Awake Local Anesthesia No Tourniquet) designates a new local anesthesia technique. This technique which allows to maintain the arm or fingers mobility offers several significant advantages:* Greater precision of the surgical procedure.* A reduction in discomfort, risks and related adverse effects to anesthesia.* Faster recovery.WALANT technique is very comfortable for patient and fits perfectly with principles of Enhanced Recovery in Surgery.In this context, this study is based on the hypothesis that it is possible to combine arthroscopy and the WALANT anesthesia technique for reducing wrist fractures ### Conditions - Wrist Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Walanpoigne ### Outcomes Primary Outcomes - Failure percentage Secondary Outcomes - Pain assessment - Patient experience - Wrist mobility - Functional characteristics of the wrist - Functional characteristics of the wrist - Complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections - NCT ID: NCT06379542 - Study ID: XC8-03-05-2023 - Status: RECRUITING - Start Date: 2023-12-04 - Completion Date: 2025-12-31 - Lead Sponsor: Valenta Pharm JSC ### Study Description The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo. ### Conditions - Acute Respiratory Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - XC8 - Placebo ### Outcomes Primary Outcomes - Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1 Secondary Outcomes - Number of cough attacks by day 5, day 8, day 11 and day 15 - Time (days) from visit 1 until clinical cough cure is achieved - Proportion of patients with presence of ≤ 1 score for the "daytime cough" and "nighttime cough" sections Daytime and nighttime cough scales by days 5, 8, 11, and 15 after visit 1 - Change (score) in cough severity by digital rating scale by days 5, 8, 11 and 15 compared to visit 1 - Percentage of patients needed acetylcysteine - Proportion of patients with complete resolution of all symptoms of acute respiratory infection by days 4, 7, 10 and 14 - Percentage of patients with each category of Global Physician-Researcher Assessment of Therapy Effectiveness at visits 2, 3, 4, and 5 - Number of adverse events (AEs) - Adverse reactions - Serious adverse events (SAEs) - Percentage of patients with AEs - Percentage of patients who interrupted treatment ### Location - Facility: City Pediatric Outpatient Clinic number 5, Perm, N/A, 614066, Russian Federation @@
## The COPD CARE Study: Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events - NCT ID: NCT06379529 - Study ID: USCOPD2022B - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12 - Lead Sponsor: NuvoAir Medical PC ### Study Description A 12 month interventional study of up to 1,050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events, reduces healthcare utilization, and lowers the total cost of care compared to a control cohort that receives standard care only. ### Conditions - COPD Exacerbation - COPD - Cardio/Pulm: Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - NuvoAir clinical service ### Outcomes Primary Outcomes - Moderate & Severe Exacerbations Secondary Outcomes - Severe COPD Exacerbations - Major Adverse Cardiac Event - 30-Day COPD Related Readmissions - All-Cause Hospitalizations - All-Cause Readmissions - Days Hospitalized due to COPD - Cost of Care Related to COPD - Medication Adherence - Quality of Life (QOL) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Process Validation in Dermatology: Assessing Wound Creation Methods and Treatment Efficacy - NCT ID: NCT06379516 - Study ID: NB240004-NB-V - Status: COMPLETED - Start Date: 2024-01-17 - Completion Date: 2024-02-16 - Lead Sponsor: NovoBliss Research Pvt Ltd ### Study Description The primary objective of this study is to validate controlled methods of wound, including 1%w/v SLS, 3%w/v SLS, and 24-24 times tape stripping, on the forearms of subjects.The study aims to standardize the procedures for creating wounds and systematically evaluate the effects of these methods on various skin parameters. ### Conditions - Validation of the Process of Wound Creation and Evaluation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Moisturising Cream (5%) - Moisturising Cream (10%) - Coconut Oil ### Outcomes Primary Outcomes - Trans Epidermal Water Loss (TEWL) - Skin hydration - Skin surface topography Secondary Outcomes - Dermatological Assessment ### Location - Facility: NovoBliss Research Pvt Ltd, Gandhinagar, Gujarat, 382421, India @@
## Effect of Heart Yoga Applıed To Patıents Undergoıng Cardıovascular Surgery on Sleep, Depressıon And Qualıty of Lıfe - NCT ID: NCT06379503 - Study ID: 2021/37-04 - Status: COMPLETED - Start Date: 2021-12-15 - Completion Date: 2023-06-18 - Lead Sponsor: Dokuz Eylul University ### Study Description This type of study is a randomized controlled trial. The aim is to contribute to the literature by comparing the effects of heart yoga on the depression level, sleep and quality of life of patients who do and do not do heart yoga.The main elements it aims to answer are:* Heart yoga applied to patients who have undergone heart surgery improves their sleep quality compared to those who have not.* Heart yoga applied to patients who have undergone heart surgery reduces the level of depression compared to those who have not.* Heart yoga applied to patients who have undergone heart surgery increases the quality of life compared to those who have not.Patients who accept the study will practice heart yoga simultaneously with heart yoga videos via an online link every other day for 12 weeks after heart surgery.Researchers will compare intervention and control groups to see if there are any effects on sleep quality, depression level, and quality of life. ### Conditions - Cardiac Disease - Yoga - Nursing Caries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - HEART YOGA - routine nursing care ### Outcomes Primary Outcomes - sleep quality - depression - life quality Secondary Outcomes ### Location - Facility: Dokuz Eylül Üniversitesi Hastanesi, İ̇zmi̇r, Balçova, 35330, Turkey @@
## Ultrasound-guided Infraclavicular Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures - NCT ID: NCT06379490 - Study ID: CTA no: 2024-510572-20-00 - Status: RECRUITING - Start Date: 2024-04-23 - Completion Date: 2025-09-01 - Lead Sponsor: Nordsjaellands Hospital ### Study Description To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations but at the same volume. In addition to motor and sensory blockade during repositioning, feasibility will also be assessed by other patient-related and block-related factors, as well as by factors related to the repositioning and plastering procedure. ### Conditions - Distal Radius Fractures - Lidocaine - Ropivacaine - Fracture Dislocation - Closed Reduction of Fracture and Application of Plaster Cast - Colles' Fracture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ropivacaine 0.2% Injectable Solution - Lidocaine epinephrine - Ropivacaine 0.5% Injectable Solution ### Outcomes Primary Outcomes - Block success Secondary Outcomes ### Location - Facility: Copenhagen University Hospital - North Zealand, Hillerød, N/A, 3400, Denmark @@
## Correction of Refractive Error Surprises After Cataract Surgery in Adults - NCT ID: NCT06379477 - Study ID: refractive error surprises - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-30 - Lead Sponsor: Assiut University ### Study Description A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. It can cause anisometropia or dominance switch and is a source of patient dissatisfaction due to unmet expectations.The best way to manage refractive surprise is to prevent it. The 2017 NICE guidelines on the management of cataracts provide advice on prevention of refractive surprise through accurate biometry, A-constant optimisation, intraocular lens (IOL) formula selection and avoiding wrong lens implant errors.Benchmark standards for NHS cataract surgery dictate that 85% of eyes should be within 1 dioptre (D) and 55% within 0.5D of target spherical equivalent refraction following surgery. ### Conditions - Refractive Errors ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Refractive surgeries ### Outcomes Primary Outcomes - Diagnosis and treatment of the resulting refractive error surprises Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Screening of New Markers of Gut Microbiota in Stroke and Depression: a Cross-sectional Study - NCT ID: NCT06379464 - Study ID: CALM2303 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-12-30 - Lead Sponsor: Zhujiang Hospital ### Study Description Objectives of Study： Through the cross-sectional study of stroke and depression, key biomarkers are targeted by screening disease-associated intestinal bacteria, metabolites and immune factors through multi-omics techniques. ### Conditions - Acute Ischaemic Stroke - Depression ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The severity of neurological damage in stroke patients - The functional recovery outcomes after stroke - The severity of symptoms in patients with depression Secondary Outcomes ### Location - Facility: Zhujiang Hospital of Southern Medical University, Guanzhou, Guangdong, 510145, China @@
## An Clinical Study of NKG2D-CAR-NK Cells for the Treatment of Refractory Recurrent Multiple Myeloma - NCT ID: NCT06379451 - Study ID: [2023]YLJSA088 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-18 - Completion Date: 2025-12-31 - Lead Sponsor: Changzhou No.2 People's Hospital ### Study Description Multiple myeloma (MM) is a malignant disease characterized by the abnormal proliferation of clonal plasma cells. However, multiple myeloma remains an incurable disease and requires the exploration of more effective treatment methods to improve the efficacy of relapsed refractory multiple myeloma and prolong survival time.Currently, clinical application of CAR-T is mostly based on autologous T cell preparation, while relapsed/refractory AML patients have undergone multiple chemotherapy treatments, resulting in impaired self-T cell function, which affects the efficacy and prognosis of CAR-T therapy. Therefore, it is necessary to find new alternative treatments. NK cells are important immune cells in the body and are an important component of innate immunity. Compared with CAR-T cell therapy, CAR-NK cells have unique advantages in adoptive cell therapy. NKG2D receptor is an activating receptor expressed on NK cells, which can recognize NKG2D ligands (NKG2DL) expressed on tumor cells, activating NK cell killing activity through NKG2D-NKG2DL interaction. Therefore, the investigators plan to treat relapsed multiple myeloma by infusing NKG2D-CAR-NK cells to evaluate its efficacy and safety. ### Conditions - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NKG2D Chimeric Antigen Receptor NK Cell Injection ### Outcomes Primary Outcomes - Incidence of Dose Limiting Toxicity (DLTs) - Treatment Emergent Adverse Events (TEAEs) Secondary Outcomes - Objective Response Rate of subjects ### Location - Facility: Changzhou Second People's Hospital, Changzhou, Jiangsu, 213000, China @@
## Treatment of Aphtous Ulcers With Photodynamic Therapy - NCT ID: NCT06379438 - Study ID: 06/16022018 - Status: COMPLETED - Start Date: 2018-03-05 - Completion Date: 2019-03-08 - Lead Sponsor: Yuzuncu Yıl University ### Study Description The search for methods that can shorten the treatment process of aphthous ulcers, the etiology of which is not fully understood, continues. The aim of this study was to determine whether photodynamic therapy (PDT) is a clinically effective alternative in the treatment of oral aphthous ulcers. ### Conditions - Oral Ulcer - Aphthous Recurrent Ulcers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Photodynamic therapy (indocyanine green+laser) ### Outcomes Primary Outcomes - Ulcer wound healing with diameter measurement - Level of recovery Secondary Outcomes - Pain evaluation with Visual Analogue Scale ### Location - Facility: Yuzuncu Yil University, Van, Merkez, 65080, Turkey @@
## Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries - NCT ID: NCT06379425 - Study ID: 23-0050 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: Northwell Health ### Study Description This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures. ### Conditions - Pain, Postoperative - Postoperative Pain, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Acetaminophen - Celecoxib - Gabapentin ### Outcomes Primary Outcomes - Time to initiation of active trial of void Secondary Outcomes ### Location - Facility: Northwell Health South Shore Surgery Center, Bay Shore, New York, 11706, United States @@
## A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Colorectal Cancer - NCT ID: NCT06379412 - Study ID: Zhujianghmy - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2024-12 - Lead Sponsor: Zhujiang Hospital ### Study Description The goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (CRC). The main question it aims to answer is: Are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? Participants will provide biological specimens (blood, feces, colon tissue obtained during surgery) ### Conditions - Colorectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - observational study, no intervention ### Outcomes Primary Outcomes - HPLC-MS/MS was used to detect peptidoglycan fragment content in biological specimens of 200 participants Secondary Outcomes ### Location - Facility: Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, 510000, China @@
## Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type mCRC - NCT ID: NCT06379399 - Study ID: IRB-2023-1072 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Wangxia LV ### Study Description This study is a single-center, prospective, single-arm exploratory study aimed at evaluating the efficacy and safety of trifluridine/tipiracil in combination with cetuximab in the treatment of third-line and above RAS/BRAF wild-type metastatic colorectal cancer. ### Conditions - Colorectal Cancer Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cetuximab - Trifluridine/Tipiracil ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Overall survival (OS) - Overall Response Rate (ORR) - Disease Control Rate( DCR) - Quality of life: EORTC QLQ-C30 - Adverse Events(safety) ### Location - Facility: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China @@
## Long-term Prognosis and Valve Durability of TAVR - NCT ID: NCT06379386 - Study ID: TRACE TAVR Registry - Status: RECRUITING - Start Date: 2016-01 - Completion Date: 2030-12 - Lead Sponsor: Xijing Hospital ### Study Description This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner. ### Conditions - Aortic Valve Stenosis and Insufficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transcatheter aortic valve replacement ### Outcomes Primary Outcomes - All-casuse mortality - Valve-related long-term clinical efficacy Secondary Outcomes - Combined early safety and clinical efficacy outcomes - Rate of technical success - Rate of device success - Combined clinical efficacy outcomes - Valve-related long-term clinical efficacy ### Location - Facility: Xijing Hospital, Xi'an, Shannxi, 710032, China @@
## Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention - NCT ID: NCT06379373 - Study ID: 2023-KLS-190-02 - Status: RECRUITING - Start Date: 2023-02-01 - Completion Date: 2025-12-31 - Lead Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University ### Study Description Tourette syndrome is a refractory type of tic disorder. Previous clinical studies have confirmed that Tuina has a good effect on TS, but the mechanism of action is still uncertain. Studies have found that the pathogenesis of TS may be related to immune factors, and patients will accompanied by the overflow of inflammatory factors such as interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) during the onset of the disease. Other studies have found that the serum levels of IgG1, IgG2, IgG3, IgG4, IgGM, IgGA, IgGE, complement C3 and complement C4 are closely related to the pathogenesis of TS, and the abnormal humoral immune response mediated by food intolerance has an important impact on the pathogenesis of mental illness in children. The immune system plays a very complex role in TS. Based on this, we hypothesized that there may be differences in serum humoral immune effector levels between children with TS and healthy children, whether these differences are related to the consumption of certain allergenic foods or not, and so does Tuina spinal balancing can improve the clinical symptoms of children with TS by changing the levels of inflammatory and immune factors in peripheral serum. This study studied the peripheral mechanism of humoral immune effector mediated by Tourette syndrome and the intervention effect of Tuina through comprehensive scale analysis and advanced laboratory technology, which will provide a scientific theoretical basis and a safe and effective method for the treatment of multiple tics, and will have broad application prospects. ### Conditions - Tourette Syndrome in Children - Food Intolerance - Inflammatory Response ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Spine manipulation; westren medicine ### Outcomes Primary Outcomes - Change from Baseline in scores on Yale global Tic severity scale(YGTSS) at Week4 and Week8 - Change from Baseline in scores on TCM Syndrome Points at Week4 and Week8 Secondary Outcomes - Change from Baseline in difference in the spacing of the lantoine side ### Location - Facility: First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310006, China @@
## Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients - NCT ID: NCT06379360 - Study ID: SZAMLLRM01 - Status: RECRUITING - Start Date: 2020-11-01 - Completion Date: 2028-12-31 - Lead Sponsor: The First Affiliated Hospital of Soochow University ### Study Description HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Hypomethylating agent, Azacitidine or Decitabine ### Outcomes Primary Outcomes - Relapse free survival (RFS) Secondary Outcomes - Overall survival (OS) - Cumulative incidence of relapse (CIR) ### Location - Facility: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China @@
## HOspitalized Patients and Clinical flUid Status, Assessment Using Point Of Care UltraSound - NCT ID: NCT06379347 - Study ID: FZ 23/41 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2025-03 - Lead Sponsor: Flevoziekenhuis ### Study Description Point of care ultrasound (POCUS) of the inferior vena cava (IVC) is a tool for assessing volume status through ultrasonography. Using a point of care ultrasound device, the physician can perform an ultrasound of the vena cava at the bedside. Previous research has demonstrated a correlation between right atrial pressure and the vena cava's diameter. Nonetheless, the majority of research has been conducted in critically ill populations to predict fluid responsiveness in patients with more complex hemodynamics. There is limited data available on the value of IVC ultrasound in the sub-acute setting on the regular ward for clinical decision-making regarding whether a patient is hypovolemic or hypervolemic. This study's objective is to assess the diagnostic utility of point-of-care ultrasonography of the IVC, by using a standardized methodology, performed by qualified ward physicians in a conventional nursing ward. ### Conditions - Volume Status ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - POCUS perfomed on clinica indication ### Outcomes Primary Outcomes - Volume status Secondary Outcomes ### Location - Facility: Flevoziekenhuis, Almere, N/A, N/A, Netherlands @@
## Discovering Urinary Protein Biomarkers for Hepatocellular Carcinoma in Chronic Hepatitis B Population - NCT ID: NCT06379334 - Study ID: I-22PJ911 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2020-12-06 - Completion Date: 2026-12-06 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description Chronic hepatitis B (CHB) can lead to hepatocellular carcinoma (HCC), imposing a significant health and economic burden globally. Early detection of hepatitis B virus-related HCC (HBV-HCC) in CHB with potential biomarkers has become a pressing and difficult challenge. Recent advancements in urinary proteomics offer a promising approach for HBV-HCC biomarker identification, utilizing Liquid chromatography with tandem mass spectrometry for urine proteome analysis. Differential analysis using limma in R software will uncover upregulated proteins in HBV-HCC. ### Conditions - Hepatocellular Carcinoma - Hepatitis B ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Urine test ### Outcomes Primary Outcomes - upregulated proteins - downregulated proteins Secondary Outcomes ### Location - Facility: Peking Union Medical College Hospital, Beijing, N/A, N/A, China @@
## A Retrospective/Prospective, Post-market Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System - NCT ID: NCT06379321 - Study ID: 24-362 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2034-05-01 - Lead Sponsor: The Cleveland Clinic ### Study Description This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).Clinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years. ### Conditions - Knee Arthropathy - Recurrence - Knee Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Triathlon Hinge Knee (THK) System ### Outcomes Primary Outcomes - Survivorship Secondary Outcomes ### Location - Facility: Cleveland Clinic Florida, Weston, Florida, 33331, United States @@
## Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study - NCT ID: NCT06379308 - Study ID: IRBN552024/CHUSTE. - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates). ### Conditions - Anterior Cruciate Ligament Rupture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - questionaries - datas of medical record ### Outcomes Primary Outcomes - Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) - Results of Functional score questionary Tegner Activity Scale (TAS) - Results of Functional score questionary Simple Knee Value (SKV) - Results of Functional score questionary International Knee Documentation Commitee (IKDC) Secondary Outcomes - Surgical complications ### Location - Facility: CHU Saint-Etienne, Saint-Étienne, N/A, N/A, France @@
## Coronary Artery Calcification Assessed on PET/CT - NCT ID: NCT06379295 - Study ID: CHUO-2024-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-21 - Completion Date: 2025-05-21 - Lead Sponsor: Centre Hospitalier Régional d'Orléans ### Study Description Calcification artery calcium (CAC) scoring is a valuable tool for determining the risk of major adverse cardiac events.It was found that CAC can be quantitatively assessed, by manual scoring or using deep-learning, on low-dose non ECG-gated, contrast-enhanced or non-enhanced CT scans performed in association of PET acquisition, with a good agreement with standard scans.The purpose of this study is to determine the impact of a systematic coronary artery calcification evaluation in patients undergoing 18F-FDG PET/CT imaging to improve primary prevention of cardiovascular diseases.A visual CAC assessment will be made for each patient, dividing them into four groups: none, mild, moderate or heavy CAC. When possible, a CAC score will be computed.Each patient will complete a questionnaire to collect risk factors, history of cardiovascular diseases and medications. ### Conditions - Coronary Artery Disease - Coronary Artery Calcification ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - Prevalence of moderate CAC in participants without history of cardiac disease Secondary Outcomes - Prevalence of coronary heart disease among participants - Correlation of CAC with the medical indication for PET imaging - Prevalence of CAC in young participants (< 45 years old) - Prevalence of moderate CAC in participants not taking low-cholesterol drug - Prevalence of no CAC in participants taking statins ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia - NCT ID: NCT06379282 - Study ID: FHMS 21-22 263 EGA - Status: RECRUITING - Start Date: 2022-10-14 - Completion Date: 2026-08-01 - Lead Sponsor: University of Surrey ### Study Description This randomised control clinical trial aims to investigate the effects of exercise training and diet on physical and functional fitness and immunological and metabolic changes in adults with chronic lymphocytic leukaemia. Investigators will randomise participants to either 12 weeks of supervised/semi-supervised exercise only, exercise + nutritional guidance, or no exercise. ### Conditions - Chronic Lymphocytic Leukemia - Frailty - Muscle Function - Immune Function - Lipid Cell; Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - HIT - EXE+ Nutritional Guidance ### Outcomes Primary Outcomes - Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12 - Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12 Secondary Outcomes - Frailty - Muscle Strength and Endurance - Muscle Health - Change in Quality of Life using the EORCT-QLQ-C30 - Change in muscle oxygen metabolism during a single bout of exercise - Change in B-CLL Cell Function - Change in systemic and cellular bioenergetics ### Location - Facility: University of Surrey, Guildford, N/A, GU2 7WG, United Kingdom @@
## Effectiveness Verification of a Smartphone-based System for Assessment and Health Care on Myofascial Pain Syndrome - NCT ID: NCT06379269 - Study ID: CMUH112-REC3-160 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: China Medical University Hospital ### Study Description Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the identified muscle.With the high penetration rate of smartphones, it would be convenient to utilize smartphones as the assistive technology in the assessment and intervention of MPS. The smartphone-based MPS assessment and care system could eliminate the restrictions of the epidemic, and provide an independent usage, precisely identifying muscle with TrPs and personalized care plan application. Therefore, the purpose of this study is to 1. develop a smartphone-based assessment and health care system for patients with myofascial pain syndrome. And to 2. verify the feasibility and validity of the system assessment function. And to 3. testify the effectiveness of the system health care functions for patient intervention. ### Conditions - Myofascial Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - App healthcare - Control ### Outcomes Primary Outcomes - current pain visual analogue scale Secondary Outcomes - functional questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy - NCT ID: NCT06379256 - Study ID: 202400364B0 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2032-03-17 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description Radiation therapy (RT) is a highly effective modality for managing localized solid tumors and has become a fundamental component of treating unresectable hepatocellular carcinoma (HCC). Our previous preclinical investigation (Hsieh et al., Science Immunology 2022) revealed that RT can initiate immunogenic cell death and facilitate the cross-presentation of tumor antigens by antigen-presenting cells, thereby augmenting systemic anti-tumor T cell responses in murine tumor models. However, this immune response subsequent to irradiation has not been comprehensively evaluated in clinical trials involving HCC patients. Given that RT represents a standard therapeutic approach for unresectable HCC, our ongoing phase II non-randomized trial aims to prospectively assess immunological responses and dose-volumetric parameters, while identifying predictors of clinical outcomes in patients undergoing definitive RT for HCC. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Photon or proton radiotherapy ### Outcomes Primary Outcomes - Progression free survival (PFS) Secondary Outcomes - Local control (LC) - Time to progression (TTP) - Overall Response Rate (ORR) - Overall survival (OS) - Incidence and severity of adverse events ### Location - Facility: Chang Gung Memorial Hospital at Linkou, Taoyuan City, N/A, 333, Taiwan @@
## Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures - NCT ID: NCT06379243 - Study ID: KY-2023-008-02 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2027-12-31 - Lead Sponsor: The Seventh Affiliated Hospital of Sun Yat-sen University ### Study Description In this project, IDEAL-IQ technology and PDFF and R2\* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2\) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year). ### Conditions - Osteoporosis Fracture - Osteoporosis Vertebral - Compression Fracture - Perform PVP / PKP Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - PVP/PKP ### Outcomes Primary Outcomes* - Non-operative vertebral re-fracture within 1 year after PVP / PKP Secondary Outcomes - Visual Analog Score (VAS) at 1 year after PVP/ PKP - Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP ### Location - Facility: The Seventh Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, N/A, China @@
## A Retrospective Study on Epidemiological Characteristics of Chinese NF1 Patients in Real World (PROMISE) - NCT ID: NCT06379230 - Study ID: SH9H-2023-T378-1 - Status: RECRUITING - Start Date: 2019-01-01 - Completion Date: 2025-02-28 - Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University ### Study Description Background/Rationale: Neurofibromatosis type 1 (NF1) affects about 1 in every 3000 people worldwide. Globally, 30\~50% NF1 patients will develop plexiform neurofibromas (PNs), which grow rapidly in early childhood and can cause disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder and bowel dysfunction. This systemic disease imposes a heavy psychosomatic and financial burden on patients and their caregivers. In NF1 patients, the lifetime risk of MPNST developed from PN is 8% to 13%. The mean age for NF1-associated death was approximately 20 years lower than that for the general population. Limited epidemiological and clinical data of Chinese NF1 patients is available to date. And the treatment pattern of Chinese NF1-PN patients is also unknown.Objectives and Hypotheses: It is a descriptive study without formal hypothesis. The primary objective of this study is determining the percentage of NF1 patients who develop PN. The secondary objectives of this study include describing the clinical characteristics, tumor progression and treatment pattern of NF1-PN. The exploratory objective is exploring the epidemiological characteristics of other NF1 manifestations.Methods:Study design: The study is a retrospective multi-center chart review study. Data Source(s): All the data will be collected by CRF from inpatient and outpatient electronic medical records in every study site from January 1, 2019 to December 31, 2022.Study Population: Patients who attended the study sites between January 1, 2019 - December 31, 2022 and were diagnosed with NF1 were included in this study. Statistical Analysis: This study is purely descriptive without any formal hypotheses.Missing data for baseline characteristics will be assessed and addressed as a categorical variable with a level for missingness. All reported measures will be summarized in the study tables. Point estimates and their 95% CIs will be presented in the final analyses. ### Conditions - Neurofibromatosis 1 - Plexiform Neurofibroma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - This study is purely descriptive study. ### Outcomes Primary Outcomes - Determine the percentage of NF1 patients developed PN at the baseline. Secondary Outcomes - Clinical characteristics of NF1-PN: - Tumor progression of NF1-PN - Treatment pattern of NF1-PN: ### Location - Facility: Xuanwu Hospital, Capital Medical University, Beijing, Beijing, N/A, China @@
## NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. - NCT ID: NCT06379217 - Study ID: CAAA617H12101 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-18 - Completion Date: 2027-06-04 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gonadotropin Releasing Hormone Receptor (GRPR)) between the start and after the completion of radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC). ### Conditions - Metastatic Neuroendocrine Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - [68Ga]Ga-PSMA-11 - [68Ga]GA-DOTA-TATE - [68Ga]Ga-NeoB - [177Lu]Lu-PSMA-617 - [177Lu]Lu-DOTA-TATE - [177Lu]Lu-NeoB - L-Lysine HCl-L-Arginine HCl, 2.5 %, - Gonadotropin-releasing hormone (GnRH) analogues - GnRH antagonists - Antiemetics & antinauseants - Metoclopramide ### Outcomes Primary Outcomes - Number/extent of lesions with at least a moderate uptake of any of the Radioligand Imaging (RLI) - Percentage changes in qualitative PET parameters. Secondary Outcomes - Overall Response Rate (ORR) - Disease Control Rate (DCR) - Duration of response (DOR) - Radiographic Progression-free Survival (rPFS) - Proportion of participants with a decline in PSA level - Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Radioligand Therapy (RLT) - Dose modifications for [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB - Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Radioligand Imaging (RLI) - Blood radioactivity concentration of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB) - Blood mass concentration of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB) - Observed maximum blood concentrations (Cmax) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB - Time of maximum blood concentration (Tmax) occurence of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB - Area under the blood concentration time curve (AUC) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB - Total systemic clerance (CL) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB - Volume of distribution during the terminal phase (Vz) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB - Terminal half-life (T^1/2) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB - Absorbed radiation doses of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB - Time Activity Curves (TACs) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test - NCT ID: NCT06379204 - Study ID: No.2022026 - Status: COMPLETED - Start Date: 2022-11-04 - Completion Date: 2023-09-19 - Lead Sponsor: Taiyuan Central Hospital of Shanxi Medical University ### Study Description Analyze the clinical intervention effects and differences of progressive precision exercise prescriptions formulated by two methods for determining exercise intensity on metabolic syndrome (MS). Compare the effects of the two on the cardiovascular endurance of the MS population and verify the effectiveness of individualized methods in reducing absolute exercise intensity for MS patients. ### Conditions - Metabolic Syndrome X ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - the maximum physiological value standardized group - the ventilatory threshold individualized group ### Outcomes Primary Outcomes - Peak oxygen uptake Secondary Outcomes ### Location - Facility: Taiyuan Cardiac Rehabilitation Center, Taiyuan, Shanxi, 030009, China @@
## The Efficacy of WeChat-based Multidisciplinary Full-course Nutritional Management Program - NCT ID: NCT06379191 - Study ID: ZS-3411 - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2023-10-30 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description As the most malignant type of cancer in the female reproductive system, ovarian cancer (OC) has become the second leading cause of death among Chinese women. Chemotherapy is the main treatment for OC patients, and its numerous adverse effects can easily lead to malnutrition. It is difficult to centrally manage OC patients in the intervals between chemotherapy. The utility of WeChat, an effective and more cost-efficient mobile tool, in chronic disease management has been highlighted. ### Conditions - Ovarian Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Nutrition intervention model based on WeChat applets ### Outcomes Primary Outcomes - patient-generated subjective global assessment (PG-SGA) Secondary Outcomes - nutrition-related blood indices, such as total protein (g/L), albumin (g/L), prealbumin (g/L), and hemoglobin (g/L) - inflammation-related blood indices, such as leukocytes (10^9/L), lymphocytes (10^9/L), neutrophils (10^9/L), and platelets (10^9/L) - nutrition-inflammation composite indices, such as prognostic nutritional index (PNI) and systemic immunoinflammatory index (SII) ### Location - Facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, N/A, China @@
## Effect of Oral Colostrum Applications Every 2 Hours and 4 Hours In Order to Achieve Trophic Feeding in Preterm Infants - NCT ID: NCT06379178 - Study ID: 6462e56fe8177 - Status: COMPLETED - Start Date: 2023-02-19 - Completion Date: 2023-08-31 - Lead Sponsor: Gadjah Mada University ### Study Description The goal of this clinical trial is aims to evaluate the effects of applying colostrum orally every 4 and 2 hours in order to achieve trophic feeding in preterm infants. The main question it aims to answer is the optimal frequency of colostrum application that can be applied Participants will be divided by randomization using permutation blocks after meeting the inclusion and exclusion criteria and deemed eligible. These blocks were then randomized using computer software such as Microsoft Excel, determining the sequence for allocation to the control and intervention groups based on the randomization order from the permutation code, every 2 hours and every 4 hours. Researchers will investigate the effects of oropharyngeal colostrum application frequency, every 4 hours and every 2 hours, in order to achieve trophic feeding in preterm infants \<34 weeks gestational age. ### Conditions - Trophic Feeding - Very Low Birth Weight Baby - Preterm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oral colostrum application 2 hours - Oral colostrum application 4 hours ### Outcomes Primary Outcomes - Days to Achieve Trophic Feeding Secondary Outcomes ### Location - Facility: Neonatal Intensive Care Unit RSUP Dr. Sardjito, Sleman, Daerah Istimewa Yogyakarta, 55281, Indonesia @@
## Efficacy and Safety Study of Meloxicam Nanocrystal Injection for the Treatment of Moderate to Severe Pain - NCT ID: NCT06379165 - Study ID: SYH9015-002 - Status: COMPLETED - Start Date: 2023-05-17 - Completion Date: 2023-07-13 - Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. ### Study Description The purpose of this study is to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Meloxicam Nanocrystal Injection - Placebo ### Outcomes Primary Outcomes - PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose) Secondary Outcomes - TOTPAR (time-weighted sum of pain relief scores): TOTPAR12, TOTPAR18, TOTPAR24, TOTPAR48. - SPID2、SPID6、SPID12、SPID18、SPID18-24、SPID24-48、SPID42-48、SPID48 - Time to the first dose of the remedial analgesia - Number of times of remedial analgesia administered 0-24h and 24-48h after the first dose - Proportion of subjects requiring remedial analgesia - The total amount of remedial analgesia used 24 h and 48 h after the first dose - The subject's analgesic treatment satisfaction score (0-4 point categorical scale score) - The investigator's satisfaction score (0-4 point categorical scale score) for the subject's analgesic treatment ### Location - Facility: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, N/A, N/A, China @@
## Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction - NCT ID: NCT06379152 - Study ID: 2024-04-16 - Status: RECRUITING - Start Date: 2020-09-20 - Completion Date: 2024-07-01 - Lead Sponsor: Chongqing Medical University ### Study Description Factors influencing the prognosis of patients with heart failure with preserved ejection fraction (HFpEF) have been extensively studied. Previous studies have found that elevated serum total bilirubin levels are associated with cardiac death, heart failure readmission, and all-cause mortality in patients with chronic heart failure. However, the relationship between direct bilirubin and prognosis in patients with HFpEF is unclear. ### Conditions - Heart Failure With Preserved Ejection Fraction - Prognathism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The level of direct bilirubin - a composite of heart failure rehospitalization or all-cause mortality Secondary Outcomes - heart failure rehospitalization - all-cause mortality ### Location - Facility: The First Affiliated Hospital of Chongqing Medical University, Chongqing, N/A, N/A, China @@
## Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients - NCT ID: NCT06379139 - Study ID: MALDINEY J'InvEst-I 2022 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03 - Lead Sponsor: Centre Hospitalier Universitaire Dijon ### Study Description Biofilm is a microstructure organised into aggregates of microbiological species within a polymeric matrix. As early as the 2000s, the Centers for Disease Control and Prevention (CDC) recognised the possible role of the biofilm lining endotracheal endotracheal tubes in the development of ventilator-associated pneumonia (VAP) , the most common infection in intensive care, with a high morbidity and mortality rate and a significant increase in hospital costs.Targeting biofilm therefore now appears to be a new area of interest for limiting the risk of VAP, and this rationale has led to the development of an intraluminal for abrading biofilm deposited on the inside of the intubation probe. Evaluation of this type of strategy nevertheless justifies the introduction of more precise methods for characterisation of the biofilm.To this end, the investigator carried out an initial clinical study describing the biofilm on intubation probes, BIOPAVIR 1, showing the existence of several biofilm structures, each associated with a specific microbiological signature. Several limitations including a lack of power due to an insufficient number of patients and the use of number of patients, and the use of a confocal microscopy technique with poor axial without the possibility of acquiring metabolic images of the biofilm.Based on the previous description of biofilm by optical coherence tomography (OCT), and a recent experience with an optimised form of high-resolution OCT, called full-field OCT, the investigator hypothesise that full-field OCT will allow more accurate characterisation of biofilm, due to its high spatial resolution and its potential ability to capture metabolic activity in the biofilm BIOPAVIR 2 proposes to use the performance of full-field OCT to better characterise the biofilm lining endotracheal tubes in patients undergoing mechanical ventilation in intensive care units. This project represents a first step towards understanding the link between the development of biofilm on intubation and the occurrence of VAP ### Conditions - Healthcare Associated Infection - Critically Ill - Endotracheal Tube ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube ### Outcomes Primary Outcomes - Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type - type of microbiological associated with each shape Secondary Outcomes ### Location - Facility: CH William Morey, Chalon-sur-Saône, N/A, N/A, France @@
## The Diagnostic and Prognostic Value of TAT, PIC, tPAI·C and TM in Sepsis-induced Coagulopathy - NCT ID: NCT06379126 - Study ID: Yuting Li05 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-04-20 - Lead Sponsor: The First Hospital of Jilin University ### Study Description In order to evaluate the diagnostic and prognostic value of thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） in sepsis-induced coagulopathy(SIC), hospitalized patients with sepsis were prospectively included. Plasma TAT, PIC, tPAI·C,TM levels within 24 h after sepsis diagnosis were detected by MCL60 chemiluminescence analyzer. According to the SIC score (≥4), they were divided into SIC group and non-SIC group, and ROC curve analysis was performed according to the biomarker test results. ### Conditions - Sepsis-induced Coagulopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Test thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） ### Outcomes Primary Outcomes - Thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） level Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients - NCT ID: NCT06379113 - Study ID: 53211030-2 - Status: RECRUITING - Start Date: 2022-07-13 - Completion Date: 2025-03-30 - Lead Sponsor: Xiaojun Chen ### Study Description To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients. ### Conditions - Endometrial Neoplasms - Atypical Endometrial Hyperplasia - Progesterone Resistance - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - GnRH antagonist - Letrozole 2.5mg ### Outcomes Primary Outcomes - Complete response rates within 28 weeks of treatment Secondary Outcomes - Adverse events - Time to achieve complete response - Relapse rates - Rates of fertility outcomes - Compliance ### Location - Facility: Obstetrics and Gynecology Hospital, Fudan University, Shanghai, N/A, N/A, China @@
## Cerebellar iTBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease - NCT ID: NCT06379100 - Study ID: KY20232388 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-09-25 - Lead Sponsor: Xijing Hospital ### Study Description Study the therapeutic effect and potential neural mechanisms of cerebellar iTBS mode transcranial magnetic stimulation on Alzheimer's disease patients through MRI and EEG. ### Conditions - Transcranial Magnetic Stimulation - Alzheimer Disease - Magnetic Resonance Imaging - Electroencephalogram ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transcranial magnetic stimulation ### Outcomes Primary Outcomes - The changes in CDR（Clinical Dementia Rating） Secondary Outcomes - The changes in MMSE(Mini Mental State Examination) - NPI (Neuropsychiatric Inventory) - ADL( Lawton-Brody Activities of Daily Living) - DST (Digital Span Test; Forward and Backward) - ADAS-cog（Alzheimer's disease assessment scale) - DMS(Delayed matching-to-sample task) - MEP（Motor evoked potential） - MRI measures - EEG（electroencephalogram） ### Location - Facility: Xijing Hospital of Air Force Military Medical University, Xi'an, Shaanxi, 710032, China @@
## Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC - NCT ID: NCT06379087 - Study ID: NEO-PIONEER - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Ji Yongling ### Study Description This study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. The efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer are observed. Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer. ### Conditions - Non-Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Anlotinib Hydrochloride Capsule - Tislelizumab Injection - Hypofractionated Radiotherapy ### Outcomes Primary Outcomes - 1-year EFS Rate Secondary Outcomes - pCR Rate - MPR Rate - Adverse Events (AEs) according to CTCAE (V5.0) (Safety Evaluation) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health - NCT ID: NCT06379074 - Study ID: 2022PMFMSE - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2025-10-06 - Lead Sponsor: University of Rome G. Marconi ### Study Description Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes. ### Conditions - Postpartum Depression - Insomnia - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Improving sleep health and resilience during pregnancy - Information on pregnancy-related issues ### Outcomes Primary Outcomes - Stress reactivity - Sleep efficiency - Depressive symptoms - Insomnia symptoms - Anxiety symptoms - Valence of affective states - Arousal of affective states - Emotion regulation Secondary Outcomes - Mothers' parenting stress - Partners' insomnia symptoms - Children sleep difficulties ### Location - Facility: Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy, Bologna, N/A, 40126, Italy @@
## Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts - NCT ID: NCT06379061 - Study ID: MM-01-24 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-03-31 - Lead Sponsor: Beckman Coulter, Inc. ### Study Description The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (\>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance. ### Conditions - Infection, Bacterial - Infection Viral ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Blood Specimen Collection Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain - NCT ID: NCT06379048 - Study ID: 2021.12.282 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2022-09-20 - Lead Sponsor: Başakşehir Çam & Sakura City Hospital ### Study Description Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair. ### Conditions - Labor; Prolonged, Second Stage - Episiotomy Wound ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Matress Suturing - Primary Suturing - Continuous Subcutaneous Suturing ### Outcomes Primary Outcomes - Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score - Pain by Visual Analog Scale (VAS) Secondary Outcomes ### Location - Facility: Cam and Sakura City Hospital, Istanbul, Basaksehir, 34494, Turkey @@
## Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients - NCT ID: NCT06379035 - Study ID: Protozoa in CRC patients - Status: NOT_YET_RECRUITING - Start Date: 2024-11-01 - Completion Date: 2025-12-31 - Lead Sponsor: Assiut University ### Study Description 1. Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.2. Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression. ### Conditions - Blastocystis Infection - Cryptosporidium Infection - Colorectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ELISA / PCR ### Outcomes Primary Outcomes - Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University. Secondary Outcomes - Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Proteomic Analysis of Newly Restored Single Implants - NCT ID: NCT06379022 - Study ID: AUTh-29/21-11-2018 - Status: COMPLETED - Start Date: 2018-12-03 - Completion Date: 2019-11-29 - Lead Sponsor: Aristotle University Of Thessaloniki ### Study Description In 10 systemically healthy non-smokers, free of periodontitis, one newly restored implant (baseline-T0) and one corresponding tooth were followed over 12 months (T1). All implants were screw-retained, and platform-switched. Oral hygiene was closely monitored during the study. Probing pocket depth (PPD), attachment levels (CAL), bleeding and plaque indices and crevicular fluid were collected from an implant-site (PICF) and a tooth-site (GCF). Total proteomic profiles in PICF and GCF were investigated using label-free quantitative proteomics. ### Conditions - Peri-Implantitis - Peri-implant Mucositis - Periodontal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Plaque control ### Outcomes Primary Outcomes - Probing pocket depth - Protein expression Secondary Outcomes - Recession - Bleeding upon probing - Inflammation index ### Location - Facility: Dental School, Aristotle University, Thessaloniki, N/A, 54124, Greece @@
## Effect of Home-based Training Program for Kidney Transplant Recipients (HOMETRAIN-KTR) - NCT ID: NCT06379009 - Study ID: 473076 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2028-01-01 - Lead Sponsor: Oslo University Hospital ### Study Description Does home-based training work in kidney transplant recipients with reduced physical function?The goal of this clinical trial is to learn if home-based training works to better physical function in adult kidney transplant recipients. It will also learn about participants preoperative physical function. The main question it aim to answer is* Does home-based training improves physical function in kidney transplant recipients.* All the participants are assessed to have reduced physical function before the transplantationParticipants will:* follow either a home-based training program or todays standard of physical activity after kidney transplantation* the program starts 4 weeks after the transplantation and lasts for 12 weeks. A physiotherapist will help the participants in the beginning.* the program consists of both cardio-training, strength-straining and optional activity* the training group will be followed up every week by phone. Their activity will be documented via patients logs and heart rate monitor.* the effect of the training will be evaluated one year after the transplantation ### Conditions - Kidney Transplant; Complications - Frailty - Physical Disability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Training ### Outcomes Primary Outcomes - 6-minute walking distance test - Clinical Frailty Scale Secondary Outcomes - Hand-grip strength - 30 seconds Sit-to-stand test - Bone density test - Bioelectrical impedance phase angle to measure muscle mass and strength. ### Location - Facility: Oslo University Hospital, Oslo, N/A, 0372, Norway @@
## Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring - NCT ID: NCT06378996 - Study ID: S68535 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2024-10 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate.Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days).This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry. ### Conditions - Mitral Valve Prolapse - Ventricular Arrythmia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 14-day rhythm monitoring ### Outcomes Primary Outcomes - Time to arrhythmic mitral valve prolapse detection - Number of days with high PVC-burden ≥5% - Number of days with complex ventricular arrhythmia (nsVT, VT, or VF) - Day-to-day variation in percentage PVC burden Secondary Outcomes - Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI - Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI - Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography - Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography ### Location - Facility: UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Clinical Trial of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne - NCT ID: NCT06378983 - Study ID: SYSKY-2023-1149-02 - Status: RECRUITING - Start Date: 2022-09-01 - Completion Date: 2024-06-30 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description This study plans to select 100 AV patients and randomly divide them into two groups in a 1:1 ratio: the experimental group will be treated with MRF combined with oral isotretinoic acid for 8 consecutive weeks, with a total of 3 MRF treatments at weeks 1, 4, and 8. The control group received oral administration of isotretinoic acid alone for 8 weeks. The main observation indicators are the percentage of effective skin injury clearance achieved by subjects at week 20, as well as the change in ECCA acne scar score compared to baseline at week 20. I hope this study can clarify that the combination therapy of the two can achieve the effects of improving efficacy, shortening treatment course, reducing recurrence, not increasing adverse reactions, and reducing the risk of scar formation. ### Conditions - Moderate to Severe Acne Vulgaris ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Oral isotretinoin - Oral isotretinoin combined with microneedle radiofrequency therapy ### Outcomes Primary Outcomes - Changes in ECCA acne scar score from baseline at week 20 - The percentage of effective skin lesion clearance rate in the 20th week Secondary Outcomes ### Location - Facility: Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University., Guangzhou, N/A, 510030, China @@
## Audio Books Effects on Anxiety and Vital Sings - NCT ID: NCT06378970 - Study ID: 22-1T/49 - Status: COMPLETED - Start Date: 2022-04-15 - Completion Date: 2022-07-15 - Lead Sponsor: Ege University ### Study Description Objectives: This study aimed to investigate the effect of audio book use on anxiety and vital signs in patients receiving non-invasive mechanical ventilation (NIMV) support.Research Methodology/Design: It is an experimental-randomised controlled study. Settings: The study was carried out with patients hospitalised in the Chest Diseases Intensive Care Unit of a university hospital and NIMV support. The participants consisted of 60 people, 30 in the intervention group and 30 in the control group. Before starting the application in the intervention group, the book preferences of the patients were determined and the selected audio book was played to the patients with headphones via tablet/smartphone. No additional application was made to the control group.Main Outcome Measures: Anxiety levels and vital signs in the intervention group were evaluated before, 15 minutes, 30 minutes and 30 minutes after the end of the intervention. In the control group, only routine care continued and anxiety levels, and vital signs were assessed simultaneously with the intervention group. ### Conditions - Non-invasive Mechanical Ventilation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Audio Book Application ### Outcomes Primary Outcomes - Facial Anxiety Scale - Patient Follow-up Form - Audio Book Application Preference Form - Patient Information Form Secondary Outcomes ### Location - Facility: Ege University, Bornova, İzmir, 35100, Turkey @@
## Behavioral Pharmacology of Orally Administered THC and D-limonene - NCT ID: NCT06378957 - Study ID: IRB00436545 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2027-12-31 - Lead Sponsor: Johns Hopkins University ### Study Description The current clinical trial will investigate the effects of orally administered d-limonene (limonene), delta-9-tetrahydrocannabinol (THC) and the combination in healthy adult volunteers. ### Conditions - Subjective Drug Effects - THC - D-limonene ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - D-Limonene - Delta-9-THC - Placebo ### Outcomes Primary Outcomes - Subjective Drug Effect as assessed by Visual Analog Scale Secondary Outcomes - Subjective Drug Liking as assessed by Visual Analog Scale - Subjective anxiety as assessed by Visual Analog Scale - Subjective hunger as assessed by Visual Analog Scale - Subjective paranoia as assessed by Visual Analog Scale ### Location - Facility: Johns Hopkins Behavioral Pharmacology Research Unit, Baltimore, Maryland, 21224, United States @@
## Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer - NCT ID: NCT06378944 - Study ID: 61/23 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2029-01-01 - Lead Sponsor: Omphis Foundation ### Study Description The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Application of green indocyanine colorant - Technetium99 ### Outcomes Primary Outcomes - Number of Sentinel lymph node detected. Scale of numbers Secondary Outcomes - Number of possitive lymph nodes - surgery time in minutes ### Location - Facility: Sandra Lopez Gordo, Cerdanyola Del Valles, Barcelona, 08290, Spain @@
## Quality of Life Change in Patients Undergoing Parathyroidectomy With End-stage Renal Failure - NCT ID: NCT06378931 - Study ID: 2024HX161 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-12-30 - Lead Sponsor: Chunling Jiang ### Study Description The purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure. ### Conditions - Secondary Hyperparathyroidism - End Stage Renal Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Quality of life progression after parathyroidectomy ### Outcomes Primary Outcomes - Measure quality of life scores change with respect to time Secondary Outcomes - Measure anxiety and depression score change with respect to time - Measure bone pain scores change with respect to time - Length of hospital stay ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus - NCT ID: NCT06378918 - Study ID: 2023-A02791-44 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2027-04-15 - Lead Sponsor: University Hospital, Angers ### Study Description Pilonidal disease is a common disease characterized by the presence of abscess in the intergluteal groove. During periods of abscess, current recommendations are to make a simple incision with daily wicking of the abscess. Direct excision at this time is not recommended because there is a risk of incomplete excision. The principle of directed healing after incision of the abscess results in an average dressing period of 21 days. A definitive resection is recommended after 4 to 6 weeks, when healing has been achieved, in order to limit the risk of infectious recurrence.An alternative has recently been proposed, consisting of a puncture of the abscess, aimed at emptying it under antibiotic coverage. The major advantage of this treatment is that patients no longer need general anesthesia to flatten the abscess. Although this technique is promising, it is currently not the subject of any published or ongoing randomized controlled study registered on Clinicaltrials.gov.The research hypothesis is that the two techniques have the same results in terms of recurrence before definitive surgical treatment but that drainage puncture would imply a faster healing time, a lower cost of treatment, a quality of superior support, reduced support time and reduced work stoppage. ### Conditions - Pilonidal Cyst ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - puncture - incision of the abscess ### Outcomes Primary Outcomes - healing time Secondary Outcomes - Effectiveness of the 2 procedures - Cost-utility analysis - Duration of nursing care - Duration of work stoppage - Returning to work - Quality of life - Healing after definitive resection ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cukurova Score Validation Study - NCT ID: NCT06378905 - Study ID: 141/57 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-03 - Lead Sponsor: Cukurova University ### Study Description Despite significant advancements in imaging technologies, surgical techniques, chemotherapeutic regimens, and treatment strategies in recent years, ovarian cancer continues to remain the most deadly gynecological malignancy. Approximately 90% of ovarian cancers originate from the coelomic epithelium or modified mesothelial cells and are classified as epithelial ovarian cancers. The majority of patients with epithelial ovarian cancer (70-80%) present in advanced stages. The primary treatment for advanced-stage (stage 3-4) disease consists of primary cytoreductive surgery followed by adjuvant chemotherapy. Cytoreductive surgery aims to remove all visible tumor implants regardless of the extent of the disease and achieve no visible residual tumor (complete cytoreduction, R0) at the end of the surgery. In cases where R0 cannot be achieved (due to poor general condition and/or extensive tumor that cannot be completely excised surgically), the option of neoadjuvant chemotherapy followed by interval cytoreductive surgery is considered. Primary cytoreductive surgery is still the preferred option and is considered a quality indicator for centers performing advanced-stage ovarian cancer surgeries. Despite advancements in surgery, the decision for interval surgery following primary surgery or neoadjuvant chemotherapy is often based on the surgeon's experience, imaging results, and clinic preferences. Various methods and scores have been published and applied to predict which patients are suitable for primary surgery.The Cukurova score developed in our clinic conceptualizes prioritizing surgical procedures using radiological imaging and diagnostic exploratory laparoscopy to achieve complete cytoreduction in harmony with the patient's clinical and performance status, rather than focusing solely on tumor burden. The score showed high success rates for complete cytoreduction and also was useful in terms of predicting the morbidity and mortality. However, the Cukurova score study was conducted in single center. Validation of scores in centers with different capacities is expected to facilitate their widespread use and acceptance. Therefore, in this study, the investigators plan to conduct a validation study of the score in a total of 20 centers in Turkey, including our center. This study aims to evaluate the validity of the Cukurova score in predicting outcomes of primary cytoreduction in advanced ovarian cancer patients and thus determining the decision for primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval cytoreductive surgery. ### Conditions - Epithelial Ovarian Cancer - Primary Cytoreduction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of complete cytoreduction Secondary Outcomes - Rate of postoperative 90-days mortality ### Location - Facility: Cukurova University, Adana, N/A, 01330, Turkey @@
## A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib - NCT ID: NCT06378892 - Study ID: CRO-2023-78 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2028-05 - Lead Sponsor: Centro di Riferimento Oncologico - Aviano ### Study Description This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib. Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent. ### Conditions - Non Small Cell Lung Cancer Metastatic - ALK Gene Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Lorlatinib ### Outcomes Primary Outcomes - Compare Progression Free Survival between patients treated with Pemetrexed (PT)/pem-based chemotherapy plus Lorlatinib after Lorlatinib versus retrospective data of 3,2 months for patients treated with PT/pem-based chemotherapy after Lorlatinib. Secondary Outcomes - Intracranial Progression Free Survival (PFS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib. - Overall survival (OS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib progression - Describe the safety of PT/pem-based chemotherapy plus Lorlatinib combination ### Location - Facility: Centro di Riferimento Oncologico (CRO) IRCCS, Aviano, N/A, 33081, Italy @@
## Intermittent Boluses Versus Infusion of Propofol During Gastroscopy - NCT ID: NCT06378879 - Study ID: 1073/1/3/26 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2025-07-30 - Lead Sponsor: Al-Balqa Applied University ### Study Description It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events. ### Conditions - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Propofol 100 MG in 10 ML Injection ### Outcomes Primary Outcomes - Sedation induction time (minutes) - Total dose of propofol (mg) - Recovery time (minutes) Secondary Outcomes - Involuntary movement - Quality of sedation - Adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial - NCT ID: NCT06378866 - Study ID: MC230502 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-04-30 - Lead Sponsor: Mayo Clinic ### Study Description This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT. ### Conditions - Recurrent Castration-Sensitive Prostate Carcinoma - Stage IVB Prostate Cancer AJCC v8 - Recurrent Prostate Cancer - Castration-resistant Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Abiraterone - Apalutamide - Biospecimen Collection - Bone Scan - Computed Tomography - Darolutamide - Degarelix - Enzalutamide - Goserelin - Histrelin - Leuprolide - Magnetic Resonance Imaging - Patient Observation - Positron Emission Tomography - Prednisone - Questionnaire Administration - Relugolix - Stereotactic Body Radiation Therapy - Triptorelin ### Outcomes Primary Outcomes - Modified radiographic progression-free survival (mrPFS) Secondary Outcomes - Overall survival (OS) - Biologic progression-free survival (bPFS) - Time to local progression (TLP) - Time to distant progression (TDP) - Adverse event (AE) rate ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Risk Factors of Postoperative Complications and Survival Rate in Pancreatic Ductal Adenocarcinoma Patients - NCT ID: NCT06378853 - Study ID: 2023DZKY-049-01 - Status: COMPLETED - Start Date: 2019-01-01 - Completion Date: 2024-02-28 - Lead Sponsor: Jinling Hospital, China ### Study Description By evaluating the nutritional status of patients with pancreatic ductal adenocarcinoma (PDAC) admitted to Jinling Hospital, collecting relevant clinical data. we aim to conduct correlation analysis with patient clinical information, such as survival time, hospitalization time, nutritional status, hematological indicators, etc., in order to reveal the prognostic factors for overall survival and postoperative complications of PDAC patients. ### Conditions - Pancreatic Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - complications - overall survival - risk factors Secondary Outcomes ### Location - Facility: Jinling Hospital, Nanjing, N/A, N/A, China @@
## the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer - NCT ID: NCT06378840 - Study ID: KY2021-268-B - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2024-12-30 - Lead Sponsor: RenJi Hospital ### Study Description To explore the predictive value of immune cells by single-cell sequencing on the outcome of locally advanced cervical cancer treated by concurrent chemoradiotherapy Followed by PD-1 inhibitor ### Conditions - Locally Advanced Cervical Carcinoma - Concurrent Chemoradiotherapy - Immunotherapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nab-paclitaxel/Platinum, Sintilimab ### Outcomes Primary Outcomes - the change of immune cells in the blood after chemoradiotherapy and immunotherapy - the predictive value of the changed immune cell subtype in the blood on the side effect of immunotherapy - the predictive value of the changed immune cell subtype in the blood on the effect of chemoradiotherapy and immunotherapy Secondary Outcomes - the change of immune cells in the tissue after chemoradiotherapy - the predictive value of the changed immune cell subtype in the tissue on the effect of chemoradiotherapy and immunotherapy - the predictive value of the changed immune cell subtype in the tumor microenvironment on the side effect of immunotherapy ### Location - Facility: RenJi hospital, Shanghai, N/A, 200127, China @@
## Intraoperative Dexmedetomidine and Coronary Artery Bypass Graft Surgery - NCT ID: NCT06378827 - Study ID: 418-1/2 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2024-10 - Lead Sponsor: University of Novi Sad ### Study Description This is a prospective randomized clinical trial designed to determine the effect of intraoperative dexmedetomidine administration on renal function after coronary artery bypass graft surgery. ### Conditions - Acute Kidney Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Dexmedetomidine ### Outcomes Primary Outcomes - Indicator of renal function - An early biomarker of kidney injury - The change of inflammatory markers Secondary Outcomes - Length of postoperative mechanical ventilation - Length of stay in the intensive care unit ### Location - Facility: University of Novi Sad, Faculty of Medicine, Novi Sad, N/A, 21000, Serbia @@
## Outcome of Selective & Nonselective Caries Removal in Permanent Teeth - NCT ID: NCT06378814 - Study ID: IRAS N335444 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2030-04-30 - Lead Sponsor: King's College London ### Study Description Patients presenting with deep decay within permanent teeth presents a common clinical challenge to dentists. The aim of this trial is to compare the success rate of the non-selective caries removal (NSCR) and selective caries removal (SCR) in managing deep caries, as both methods are commonly used in clinical practice.This study will be a randomized controlled trial, with participants divided into two groups: NSCR group and SCR group. Participants of deep caries lesions (reaching more than two-thirds of dentin on periapical radiographs) Both groups will undergo either NSCR or SCR, followed by Partial Pulpotomy (PP) in cases with pulp exposure. Success rates will be assessed at follow-up visits scheduled 1, 3, and 5 years radiographs will be used to assess for pulp health(vitality).The success rate of the two categories will be assessed using a scale that includes factors such as tooth vitality, caries recurrence, and clinical signs of pulpitis. The scale will be applied at follow-up visits. The trial will be conducted in post-graduate dental clinics at Guy's hospital.Deep caries in permanent teeth is a common clinical problem that can lead to pulp exposure and subsequent restorative challenges. The aim of this study is to provide evidence-based guidance for clinicians in managing deep caries lesions, as both NSCR and SCR are commonly used in clinical practice. The results of this study will help clinicians to make informed decisions when choosing the appropriate treatment approach for their patients.In conclusion, this trial aims to compare the success rate of NSCR and SCR in managing deep caries lesions in permanent teeth, as both methods are commonly used in clinical practice. The results of this study will provide valuable insights into the effectiveness of these two treatment approaches and will help clinicians to make informed decisions when choosing the appropriate treatment approaches. ### Conditions - Deep Caries - Carious Exposure of Pulp ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Selective Caries Removal (No Pulp Exposure) - Non-Selective Caries Removal (No Pulp exposure) - Partial Pulpotomy (Pulp Exposed) ### Outcomes Primary Outcomes - To compare the success rate of maintaining pulp vitality assessed by pulp sensibility test between Selective Caries Removal or Non- Selective Caries Removal techniques after one year of the intervention. Secondary Outcomes - Periapical Health Assessment Using Periapical Index Score in Deep Caries Lesion Treatment - Quality of Life Assessment ( Using OHIP-14 questionnaire) in Deep Caries Lesion Treatment: A Comparative Study of Selective Caries Removal and Partial Pulpotomy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Radicle Relaxation 24: A Study of Health and Wellness Products on Stress and Related Health Outcomes - NCT ID: NCT06378801 - Study ID: RADX-P-2408 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-08 - Lead Sponsor: Radicle Science ### Study Description A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes ### Conditions - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Placebo Control Form 1 - Relaxation Active Study Product 1.1 ### Outcomes Primary Outcomes - Change in stress Secondary Outcomes - Change in feelings of anxiety - Change in cognitive function - Change in mood (emotional distress-depression) - Minimal clinically important difference (MCID) in stress - Minimal clinically important difference (MCID) in feelings of anxiety - Minimal clinically important difference (MCID) in cognitive function - Minimal clinically important difference (MCID) in mood (emotional distress-depression) ### Location - Facility: Radicle Science, Inc, Del Mar, California, 92014, United States @@
## Muscle Architecture and Muscle Strength in Fibromyalgia - NCT ID: NCT06378788 - Study ID: 2023/211 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-06-30 - Lead Sponsor: Bezmialem Vakif University ### Study Description The goal of this observational study is to determine whether there is decrease in muscle mass and muscle strength in Fibromyalgia Syndrome (FMS) patients in comparison to controls. And to determine whether these parameters are correlated with clinical ones. Briefly the main questions investigators aims to answer are:* Is there a significant difference in muscle morphology between FMS and controls?* Is there a significant difference in muscle strength between FMS and controls?* Is there a relationship between muscle thickness and pennation angle of the Quadriceps, gastrocnemius medialis, gastrocnemius lateralis and Tibialis anterior muscles and disease activity, pain and functionality?* Is there a correlation between muscle strength in FMS and disease activity, pain and functionality? ### Conditions - Fibromyalgia - Sarcopenia - Muscle Weakness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Demographic information form - widespread pain index (WPI) - symptom severity scale (SSS) - Fibromyalgia Impact Questionnaire (FIQ) - Tender Point examination - Muscle Architecture visualized with ultrasound - Sarcopenia assessed by measuring isometric strengths of different parts of the body - Timed Up & Go (TUG) ### Outcomes Primary Outcomes - Quadriceps Femoris Vastus Lateralis Muscle Thickness - Quadriceps Femoris Vastus Lateralis Fascicle Length - Quadriceps Femoris Vastus Medialis Muscle Thickness - Quadriceps Femoris Vastus Medialis Fascicle Length - Quadriceps Femoris Rectus Femoris Muscle Thickness - Quadriceps Femoris Rectus Femoris Fascicle Length - Tibialis Anterior Muscle Thickness - Tibialis Anterior Muscle Fascicle Length - Gastrocnemius Muscle Vastus Medialis Muscle Thickness - Gastrocnemius Muscle Vastus Medialis Fascicle Length - Gastrocnemius Muscle Vastus Lateralis Muscle Thickness - Gastrocnemius Muscle Vastus Lateralis Fascicle Length - Cervical Muscle strength - Truncal Muscle strength - Shoulder Muscle strength - Hip Muscle strength - Knee Muscle strength - Ankle Muscle strength - Timed Up & Go (TUG) Secondary Outcomes ### Location - Facility: Bezmialem Vakif University, Istanbul, Fatih, 34093, Turkey @@
## Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery - NCT ID: NCT06378775 - Study ID: H23-03334 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-12-01 - Lead Sponsor: Cardiology Research UBC ### Study Description The study objective is to compare standard CABG to a hybrid revascularization strategy (RA-MIDCAB + PCI) in patients who have multi-vessel CAD and an indication for surgery, but who have a slightly higher risk of post-operative complications. ### Conditions - Coronary Artery Disease - Multivessel Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Coronary Artery Bypass Graft - Robotically-assisted minimally-invasive direct coronary artery bypass - Percutaneous Coronary Intervention ### Outcomes Primary Outcomes - Post-operative Length of Stay Secondary Outcomes - Conversion to sternotomy / CABG ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Interference of Endurance Training on Strength Development and Neuromuscular Adaptations - NCT ID: NCT06378762 - Study ID: 6/2021 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-04-01 - Completion Date: 2025-07-30 - Lead Sponsor: University of Lisbon ### Study Description This study aims to find out if performing combined strength and endurance exercise in the same program (called concurrent training-CT) leads to similar long-term improvements in neuromuscular function as doing each type of exercise separately. The main questions it seeks to answer are:Does performing CT result in similar improvements in strength and power as doing just strength training? Does performing CT result in similar improvements in cardiorespiratory fitness as doing just endurance training? Are neuromuscular adaptations similar between CT and just strength training? Researchers will compare the results between three groups: the CT group, the endurance training group (E), and the strength training group (S) to answer these questions. ### Conditions - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Endurance Exercise - Strength Exercise - Concurrent Exercise ### Outcomes Primary Outcomes - Maximal Isometric Strength - Maximal Dynamic Strength - Surface EMG - H-reflex excitability - V-wave - Lower Body Muscle Power - Muscle architecture of the quadriceps femoris Secondary Outcomes ### Location - Facility: Faculdade de Motricidade Humana - Universidade de Lisboa, Lisboa, Cruz Quebrada - Dafundo, 1499-002, Portugal @@
## Previvors Recharge: A Resilience Program for Cancer Previvors - NCT ID: NCT06378749 - Study ID: 1R43CA275673 - Status: RECRUITING - Start Date: 2024-04-11 - Completion Date: 2024-07-31 - Lead Sponsor: Pro-Change Behavior Systems ### Study Description It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes (HCS), a cancer risk that is associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Individuals with an HCS who have never been diagnosed with cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an increased risk of developing multiple primary cancers during their lifetime, often with onset at an early age. Previvors face multiple forms of adversity, including a multitude of annual cancer screenings and the uncertainty of not only their own health but the health of affected family members. This study will examine the acceptability and preliminary effects of PreCharge, a resilience-boosting solution specifically designed for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will be recruited for a 30-day pilot test. Participants will complete a baseline assessment, and then be provided with 30 days of access to the PreCharge program. At the end of the 30 days, they will be prompted to complete a follow-up assessment. Outcomes include 1) acceptability of the program, as evidenced by obtaining 75% endorsement that users would recommend the program to a fellow Previvor; (2) engagement as evidenced by continued receipt of text messages and one or more interactions with the online tools by at least 70% of participants; and (3) benefit from the program, evidenced by statistically significant pre-post improvement on the Connor Davidson Resilience Scale. ### Conditions - Hereditary Cancer - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - PreCharge ### Outcomes Primary Outcomes - Connor Davidson Resilience Scale (CDRISC) Secondary Outcomes - Cantril/Gallup Life Evaluation Index - Acceptance and Action Questionnaire (AAQII) ### Location - Facility: Pro-Change Behavior Systems, Narragansett, Rhode Island, 02882, United States @@
## Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus - NCT ID: NCT06378736 - Study ID: 21-1027 - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2026-03-23 - Lead Sponsor: Northwell Health ### Study Description Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. This lupus-related cognitive dysfunction (termed SLE-CD) is recognized as the most prevalent of the nineteen neuropsychiatric SLE syndromes, as it affects up to 80% of patients and can significantly decrease their quality of life. The goal is to have tools that can be used for diagnosis and for monitoring responses after targeted interventions and therapies. This study will focus on electroencephalographic (EEG) signals, which will be detected noninvasively from scalp placed surface electrodes while the subjects are in a state of wakeful rest. Our hypothesis is that a subset of brain oscillations known as theta and gamma, and their co-modulation or coupling will be disrupted in SLE patients. This research protocol will subject patients with systemic lupus erythematosus (SLE) to scalp electroencephalography (EEG), with the goal of determining whether specific EEG patterns ('theta-gamma coupling') appear abnormal during wakeful-rest periods of 20 minutes. The investigators are interested in using scalp EEG because it is a standard, safe and robust technique for monitoring the electrophysiological activity of neurons in the cerebral cortex. ### Conditions - Systemic Lupus Erythematosus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest. ### Outcomes Primary Outcomes - A measure of the amount and relationship of theta and gamma waves in the EEG recording. The ability to perform the block building task and the ability to choose among unfolded three-dimensional objects. Secondary Outcomes ### Location - Facility: Northwell Health-Feinstein Insitute, Manhasset, New York, 11030, United States @@
## The Relationship Between Upper Extremity Functionality, Trunk Control and Balance in Children With Cerebral Palsy - NCT ID: NCT06378723 - Study ID: 2024/01/24 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-04-16 - Lead Sponsor: Eastern Mediterranean University ### Study Description The aim of this study is to examine the relationship between trunk control, upper extremity functionality and balance in children with cerebral palsy and to compare this relationship with healthy sedentary children.This study is carried out through Eastern Mediterranean University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit. ### Conditions - Cerebral Palsy - Diplegic Cerebral Palsy - Balance; Distorted ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Balance Tests ### Outcomes Primary Outcomes - trunk control - upper extremity functionality - balance - Weight and Height Secondary Outcomes ### Location - Facility: Eastern Mediterranean University, Famagusta, N/A, 99628, Cyprus @@
## Haemodynamic and Respiratory Effects of a Low Positive End Expiratory Pressure Associated With a Fluid Challenge in Knee-chest Position - NCT ID: NCT06378710 - Study ID: 22-0219 - Status: RECRUITING - Start Date: 2023-01-20 - Completion Date: 2025-01-30 - Lead Sponsor: University Hospital, Caen ### Study Description The genu pectoral position is a surgical position used for spine surgery. This surgical position will lead to physiological hemodynamic and respiratory changes during the procedure.The knee-pectoral position notably induces an increase in CRF and improves pulmonary ventilation/perfusion ratios. On the other hand, it has been shown that it is accompanied by a reduction in cardiac output of approximately 15% Protective perioperative ventilation including a tidal volume between 6 and 8 ml/kg of theoretical ideal weight, PEEP and alveolar recruitment maneuvers is applied in the operating room to reduce postoperative pulmonary complications. The application of high PEEP and the performance of recruitment maneuvers induce arterial hypotension through changes in intra- and transpulmonary pressures. However, investigators hypothesize that the deleterious hemodynamic effects of PEEP seem to counterbalance its beneficial respiratory effects in this particular position.The combination of the effects of the knee-pectoral position and protective ventilation could be potentiated and be the cause of the sometimes severe arterial hypotension observed in clinical practice. Since this position improves pulmonary ventilation perfusion ratios, the investigators hypothesized that a lower PEEP and the elimination of intraoperative recruitment maneuvers could be beneficial from a hemodynamic point of view without being deleterious in terms of perioperative pulmonary complications. An exploratory study was carried out at the CAEN University Hospital in 2021 under the name PEEP POSTURE (CLERS Agreement No. 2198 of February 17, 2021) on 90 patients aiming to collect hemodynamic and respiratory parameters in 3 surgical positions: supine decubitus, ventral decubitus , pectoral genu. No difference was found in the evolution of respiratory compliance. On the other hand, a significant drop in SBP, DBP and MAP in the pectoral position was shown compared to the supine group as well as greater vascular filling.The investigators therefore hypothesize that a reduction in PEEP and optimization of vascular filling could help reduce the adverse effects on blood pressure linked to the surgical position. ### Conditions - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Optimized PEEP ### Outcomes Primary Outcomes - Number of occurrences of a MAP Secondary Outcomes ### Location - Facility: CAEN University Hospital, Caen, N/A, N/A, France @@
## A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis - NCT ID: NCT06378697 - Study ID: AK111-303 - Status: RECRUITING - Start Date: 2023-11-10 - Completion Date: 2026-04-30 - Lead Sponsor: Akeso ### Study Description This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis. ### Conditions - Ankylosing Spondylitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AK111 - Placebo+AK111 ### Outcomes Primary Outcomes - the response rate of ASAS20 Secondary Outcomes - The response rate of ASAS40 - The response rate of ASAS20 - The response rate of ASAS40 - The response rate of ASAS5/6 - Change from baseline on the ASDAS-CRP - Change from baseline on the SF-36 PCS - Change from baseline on the ASQoL scores - Treatment-emergent adverse events - Serious adverse events - Clinically significant examination results ### Location - Facility: 1006-The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, N/A, China @@
## To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers - NCT ID: NCT06378684 - Study ID: JW22105 - Status: COMPLETED - Start Date: 2023-09-10 - Completion Date: 2024-01-13 - Lead Sponsor: JW Pharmaceutical ### Study Description The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3) - Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3) - Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3) - Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3) - Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3) - Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3) ### Outcomes Primary Outcomes - Cmax,ss - AUCτ,ss Secondary Outcomes ### Location - Facility: Clinical Trial Center, Severance Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough - NCT ID: NCT06378671 - Study ID: ColdCough - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: Guangzhou Medical University ### Study Description Chronic cough is one of the most common complaints in respiratory specialty clinics, imposing significant economic burden on patients and severely affecting their quality of life. Currently, the pathogenesis of chronic refractory cough remains incompletely understood, and treatment remains a major challenge in clinical practice. Cryotherapy treatment via bronchoscopy has shown efficacy in certain airway diseases, but there is currently no research reporting its effects on chronic refractory cough.The goal of this clinical trial is to learn if Cryotherapy treatment works to treat individuals with chronic cough. It will also learn about The safety and effectiveness of the cryotherapy treatment system produced by Ningbo SensCure Biotechnology Co., Ltd.. The main questions it aims to answer are:* Does cryotherapy treatment lower the frequency and severity of cough and enhance quality of life?* Will there be safety or operational performance issues when using this cryotherapy treatment system? Researchers will compare cryotherapy treatment with no treatment to determine if cryotherapy treatment is effective for treating chronic cough.Participants will:* Take routine bronchoscopy examination, lavage, and mucosal biopsy ,with/without cryotherapy treatment locally (around the left and right main bronchi, upper trachea, and carina)* undergo a screening period of approximately 28 days. Follow-up visits and necessary examinations will be scheduled for the 3rd day after treatment initiation and at weeks 1, 2, 4, 8, and 12 thereafter.* Monitor vital signs and clinical manifestations. ### Conditions - Chronic Cough ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - General treatment - Cryotherapy Treatment ### Outcomes Primary Outcomes - Device/Surgery-Related Serious Adverse Events - Device/Surgery Adverse Event Rate - Serious Adverse Event Rate - Device Defect Rate - Cough Visual Analogue Scale (VAS) - Cough frequency within 2 hours - Modified Cough Evaluation Tool (CET) - Leicester Cough Questionnaire (LCQ) - Tracheal Vibratory Cough Stimulation Test - Capsaicin Cough Stimulation Test - Performance evaluation of Cryotherapy Ablation Equipment - Performance evaluation of Cryotherapy Ablation Catheter Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510163, China @@
## A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants - NCT ID: NCT06378658 - Study ID: 22253 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2024-05-20 - Lead Sponsor: Bayer ### Study Description Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations.Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.The absorption of BAY2927088 into the blood is dependent on the amount of acid present in the stomach. Esomeprazole is a medicine which is used in the treatment of heartburn and excessive acid in the stomach. Both food and esomeprazole may change the amount of acid present in the stomach.The main purpose of this study is to find out how food and esomeprazole may affect the absorption of BAY2927088 into the blood of healthy participants. For this, researchers will measure the levels of BAY2927088 in participants' blood when it is given with or without food as well as with or without esomeprazole. Researchers will then calculate the following:* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' bloodThe study will have 4 treatment periods:- Periods 1 to 3 (Day 1 to Day 9): All participants will take BAY2927088 with a low-fat meal, with a high-fat meal, and on an empty stomach, but in a different order, over the 3 study periods. Each period will last for 3 days and BAY2927088 will be given on the first day of each period.On Day 9, participants will take esomeprazole on an empty stomach.- Period 4 (Day 10 to Day 14): On Days 10 and 11, participants will take esomeprazole on an empty stomach. On Day 12, participants will take esomeprazole on an empty stomach. After 1 and a half hours, participants will take low-fat meal and BAY2927088.On Day 13, participants will take esomeprazole on an empty stomach.Participants will be in this study for about 8 weeks with 3 visits to the study clinic.Participants will visit the study clinic:* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study* once on the day before the treatment starts and will stay in the clinic until Day 14 of the treatment* once, 7 to 10 days after last dose of BAY2927088, for a health check-upDuring the study, the doctors and their study team will:* do physical examinations* collect blood samples from the participants to measure the levels of BAY2927088* check participants' health by performing tests, such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective of whether they think it is related or not to the study treatment. ### Conditions - Advanced Non-small Cell Lung Cancer - EGFR Mutation - HER2 Mutation - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - BAY2927088 - Esomeprazole - Food ### Outcomes Primary Outcomes - Cmax for BAY2927088 in plasma - AUC for BAY2927088 in plasma Secondary Outcomes - Number of participants with treatment-emergent adverse events (TEAEs) ### Location - Facility: PAREXEL International, Baltimore, Baltimore, Maryland, 21225, United States @@
## Effect of Propofol vs. Sevoflurane on Erections During Narcosis In Transurethral Surgery - NCT ID: NCT06378645 - Study ID: 2023-01682 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-12-01 - Lead Sponsor: Etienne Xavier Keller ### Study Description Penile erection is an unwanted event in transurethral (through the urethra) surgeries, which may be associated with adverse outcomes such as impaired access, prolonged operation time, the need to abort the operation, or the necessity for ancillary measures to achieve penile flaccidity, such as the injection of certain medications directly into the penis.To reduce greenhouse gas emissions, the primary use of propofol instead of gaseous agents is being recommended for general anesthesia. Whether propofol may be associated with an increased or decreased rate of unwanted intraoperative penile erection compared to other anesthetic agents is not known. More generally, there are no high-quality studies available to evaluate the impact of the type of general anesthesia on the risk of unwanted penile erections during surgery.This study aims to determine whether general anesthesia with propofol is more likely to cause intraoperative erections compared to sevoflurane during transurethral operations. ### Conditions - Erection; Incomplete ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - General Anesthesia: Propofol - General Anesthesia: Sevoflurane ### Outcomes Primary Outcomes - Intraoperative Penile Erection Secondary Outcomes - Prolongation of the surgery - Change in operative strategy - Adaptions of instruments or approaches - Altered operative outcome - Necessity for a drug application to decrease penile tumescence - Complications arisen ### Location - Facility: University Hospital Zurich, Zürich, N/A, 8091, Switzerland @@
## AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM - NCT ID: NCT06378632 - Study ID: CLN0011 DETECT-HF - Status: RECRUITING - Start Date: 2022-02-11 - Completion Date: 2024-12-01 - Lead Sponsor: Cordio Medical ### Study Description Study Design:This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system. ### Conditions - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hearo App ### Outcomes Primary Outcomes - Heart Failure Events (HFEs) Secondary Outcomes ### Location - Facility: Eastern Shore Research Institute, Fairhope, Alabama, 36532, United States @@
## Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach - NCT ID: NCT06378619 - Study ID: CSAPG-50 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06 - Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf ### Study Description In clinical practice, it is sometimes difficult to establish whether a patient's tremor is due to Parkinson's disease or essential tremor. The distinction is crucial as the health implications differ significantly between the two conditions. Therefore, the present study aims to develop a diagnostic method based on machine learning techniques to help differentiate whether a patient's tremor is due to one condition or the other. To achieve this, 110 patients with tremor, correctly diagnosed with either Parkinson's disease or essential tremor, will participate. They will undergo two diagnostic tests (tapping test and Archimedean spiral) to capture data that can be processed using machine learning techniques. ### Conditions - Tremor - Essential Tremor - Parkinson Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tapping Test - Archimedes Spiral ### Outcomes Primary Outcomes - Sensitivity - Specificity Secondary Outcomes - Reliability ### Location - Facility: Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf, Barcelona, Cataluña, 08810, Spain @@
## Effect of Technology on Cognitive Function in Elderly - NCT ID: NCT06378606 - Study ID: P.T.REC/012/004907 - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2024-06-01 - Lead Sponsor: Nourhan Hesham Ali ### Study Description Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive. ### Conditions - Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - cognitive therapy ### Outcomes Primary Outcomes - Cognitive functions assessment Secondary Outcomes - Quality of life survey ### Location - Facility: Nour Ali, Cairo, Giza, 12511, Egypt @@
## A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations - NCT ID: NCT06378593 - Study ID: 3HP-2827-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-06 - Lead Sponsor: 3H (Suzhou) Pharmaceuticals Co., Ltd. ### Study Description The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. ### Conditions - Solid Tumors With FGFR2 Alterations, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - 3HP-2827 ### Outcomes Primary Outcomes - Dose Escalation Stage- incidence of adverse events (AEs) - Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) - Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs - Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results - Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters - Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827 - Expansion stage -Objective response rate（ORR） Secondary Outcomes - Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy. - Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy. - Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy. - Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy. - Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy. - Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy. - Duration of Response (DOR) as assessed by RECIST v1.1 - Disease control rate (DCR) as assessed by RECIST v1.1 - Progression-free survival (PFS) as assessed by RECIST v1.1 - Overall survival (OS) - Dose escalation stage - Objective Response Rate (ORR) - Expansion Stage- incidence of adverse events (AEs) - Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs - Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results - Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters - Expansion Stage -Changes in patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer Core QoL Questionnaire (EORTC QLQ-C30) in patients with advanced solid tumors ### Location - Facility: Beijing Cancer Hospital, Beijing, Beijing, 100142, China @@
## The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma - NCT ID: NCT06378580 - Study ID: LGF22H160084 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2024-04-01 - Lead Sponsor: Luo Cong ### Study Description Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive tumor with a poor prognosis, despite the emergence of chemotherapies, unmet medical needs and limited treatment options still exist for patients with metastatic PDAC (mPDAC). Surufatinib is a small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor (VEGFR) 1, 2, 3, fibroblast growth factor receptor 1 (FGFR1), and colony stimulating factor 1 receptor (CSF-1R), and ex vivo experiments have demonstrated its effect on PC models.A retrospective analysis of patients with PDAC who underwent surufatinib at Zhejiang Cancer Hospital (Hangzhou,China) from July 2022 to July 2023.The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing surufatinib in the investigators' hospital. ### Conditions - Pancreatic Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surufatinib combine immune checkpoint inhibitor - AG/FOLFIRINOX ### Outcomes Primary Outcomes - Median progression-free survival Secondary Outcomes ### Location - Facility: Zhejiang Province Cancer Hospital, Hangzhou, Zhejiang, 310000, China @@
## A Study to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood - NCT ID: NCT06378567 - Study ID: HCD J8923 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-05 - Lead Sponsor: The Water Street Collective ### Study Description A home placement, randomized, double blind, placebo-controlled, study to determine the effect of dietary liquid shot beverage products on self-reported measures of sleep, stress and mood on generally healthy participants with current self-reported mild/moderate sleep difficulties (but not clinical insomnia) and mild/moderate stress. ### Conditions - Sleep - Mood - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Dietary supplement liquid shot beverage products ### Outcomes Primary Outcomes - Sleep Disturbance Secondary Outcomes - Sleep Impairment - Insomnia Severity - Restorative Sleep - Contentedness/Anxiety - Profile of Mood States (POMS) - Daily Sleep diary ### Location - Facility: Sago Atlanta - The Palisades Complex, Atlanta, Georgia, 30328, United States @@
## Cereset Research for Performance Improvement in a Hospital Nursing Unit - NCT ID: NCT06378554 - Study ID: IRB00111227 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation. ### Conditions - Health Personnel - Stress - Anxiety - Job Performance - Insomnia - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cereset Research ### Outcomes Primary Outcomes - Percent of ortho trauma unit staff who complete Cereset intervention Secondary Outcomes ### Location - Facility: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States @@
## Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE) - NCT ID: NCT06378541 - Study ID: SDR 21-267 - Status: NOT_YET_RECRUITING - Start Date: 2024-11-01 - Completion Date: 2028-10-31 - Lead Sponsor: VA Office of Research and Development ### Study Description This study will test whether a new intervention, Virtual Hope Box Enhanced Facilitation (VHB-EF), reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization. Additionally, this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings. ### Conditions - Suicide Prevention - Suicide Attempt - Suicidal Ideation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Virtual Hope Box Enhanced Facilitation - Enhanced Usual Care ### Outcomes Primary Outcomes - Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] and medical chart review) Secondary Outcomes - Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]) ### Location - Facility: VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, 48105-2303, United States @@
## Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP) - NCT ID: NCT06378528 - Study ID: 2023-1706 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-08 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The objectives of this study are to investigate the feasibility, tolerability, and efficacy of repeated ketamine-assisted psychotherapy sessions in adolescents with severe posttraumatic stress disorder. The study will enroll adolescents with a current diagnosis of posttraumatic stress disorder (PTSD) to complete three intravenous ketamine administrations immediately prior to a psychotherapy session over the span of six weeks. All participants will complete an initial set of preparatory sessions, and each dosing session will be followed by three integration sessions. Finally, participants will complete 7 nights of at-home sleep recordings. The investigators hypothesize that this protocol will be well-tolerated by adolescents and that patients will experience decreases in PTSD symptom severity at follow-up. ### Conditions - Posttraumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ketamine - SmartSleep EEG recording headband ### Outcomes Primary Outcomes - Summary of Adverse Events Attributable to Ketamine Administration Secondary Outcomes - Number of Participants Adhering to the Study Protocol - Number of Visits Completed Throughout the Study Duration ### Location - Facility: University of Wisconsin, Madison, Wisconsin, 53705, United States @@
## Physical Activity, Sleep and Brain Health Based on the Glymphatic System - NCT ID: NCT06378515 - Study ID: Glymphactive - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: University of Valencia ### Study Description This study is aiming to analyze the impact of physical activity on neurohydrodynamics and glymphatic activity on young adults. This study is designed as a multicenter descriptive observational study with information collection at two different times: before performing a short exercise routine and during its performance using a wearable wireless device Glymphometer. ### Conditions - Brain Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Physical activity, postural changes and cognitive tasks ### Outcomes Primary Outcomes - Brain health Secondary Outcomes - Physical activity (habitual) - Sleep duration - Sleep Quality - Chronotype - Self-reported health status - Other variables ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Different Antibiotic Protocols on Peri-implant Tissue Health - NCT ID: NCT06378502 - Study ID: antibiotic-resistence - Status: NOT_YET_RECRUITING - Start Date: 2024-05-03 - Completion Date: 2026-06-30 - Lead Sponsor: Universita degli Studi di Genova ### Study Description The aim of the present project (non-inferiority trial) is to evaluate the effect of different antibiotic strategies (long-span vs. short-span) for implant surgery on peri-implant tissue health, oral microbiome (included resistome) and salivary MiRNomics in healthy patients. ### Conditions - Antibiotic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Amoxicillin Short - Amoxicillin Long ### Outcomes Primary Outcomes - Mean peri-implant bone loss Secondary Outcomes - Incidence of biological and technical complications at the implant site - implant survival rate - Antibiotic sensitivity - Peri-implant myco-, microbiome and resistome - Salivary miRNomics - Adverse reactions - Development of a 3D bone model - Plaque index (PI) - Bleeding on probing (BOP) - Peri-implant pocket probing depth (PPD) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study - NCT ID: NCT06378489 - Study ID: 2022-0346-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-05-31 - Lead Sponsor: University of the Philippines ### Study Description Endometrial hyperplasia without atypia is a condition in which the endometrium (the lining of the uterus) becomes abnormally thick. Although endometrial hyperplasia without atypia is not cancer, it can lead to endometrial cancer in 1-3% of women. This disease is treated by giving progestins. The optimal route, dosage and duration of progestin treatment for endometrial hyperplasia has not yet been determined until now. However, several publications have suggested the use of levonorgestrel releasing IUD as first-line treatment for endometrial hyperplasia without atypia. The other common medications used are the oral progestins medroxyprogesterone (MPA) and norethisterone acetate (NETA).The etonogestrel implant (Implant NXT) has been approved for contraceptive use by the US FDA in 2006. The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia. Off-label use of the implant for adrnomyosis, endometriosis and chronic pelvic pain has already been described in various studies. However, its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet. The researchers propose to use the etonogestrel implant (Implant NXT) as novel treatment for endometrial hyperplasia without atypia. The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant. ### Conditions - Endometrial Hyperplasia Without Atypia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Etonogestrel implant ### Outcomes Primary Outcomes - Rate of (resolution) regression to normal endometrium - Endometrial thickness (by ultrasound) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment - NCT ID: NCT06378476 - Study ID: 855188 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-09 - Lead Sponsor: University of Pennsylvania ### Study Description Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are half as likely to receive a transplant and are often excluded from home dialysis. Structural racism creates complex barriers to optimal CKD care, providing an explanation for these findings. The Penn Medicine IMPaCT Community Health Worker (CHW) program is a rigorously tested approach to employ people from local communities to dismantle structural racism within health care systems and improve outcomes for marginalized patients. This trial will innovate by training CHWs to focus specifically on CKD care for minoritized people. The investigators will also train primary care clinicians caring for CKD patients on how to provide trauma-informed care (TIC). The first aim is to determine the feasibility, acceptability, and reach of a clinic-level TIC training to address the needs and concerns of Black and other minoritized patients. The second aim will be to conduct a three arm trial comparing individuals in usual care to individuals randomized to either our tailored CHW intervention in conjunction with clinic-level TIC training or to clinic-level TIC intervention only. The investigators will examine whether patients in the intervention arms have greater improvements in quality of life (primary). The investigators will also explore the impact of the interventions on patient activation, hospitalizations, and ESKD treatment preferences. ### Conditions - Chronic Kidney Diseases - Racism, Systemic - Trauma, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - IMPaCT Community Health Worker Program - Trauma-Informed Care Training ### Outcomes Primary Outcomes - Kidney Disease Quality of Life Instrument (KDQOL) Secondary Outcomes - Patient Activation Measure - All-Cause Hospitalizations - Patient preferences for end-stage renal disease treatment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI) - NCT ID: NCT06378463 - Study ID: PSY-2324-S-0362 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-04 - Lead Sponsor: University of Groningen ### Study Description Seven per cent of patients suffering from severe mental illness (SMI) need long-term intensive treatment and support in a clinical setting or sheltered living. These service users often experience problems on multiple domains, such as persistent complaints as a result of medication resistance, physical health problems and self-care, psychosocial and cognitive dysfunctioning. Cognitive remediation (CR) training is a type of training aimed at improving thinking abilities (cognitive functioning) and daily functioning. However, we don't yet know if CR training can also help people with SMI who need supported housing due to their severe cognitive and daily living problems. In this project, we are investigating whether we can improve daily functioning in this group by using a form of CR training that focuses on learning new cognitive skills and how to use these new skills in everyday life. Additionally, we are exploring whether combining CR training with mild brain stimulation (transcranial Direct Current Stimulation) can enhance the effects of CR training. ### Conditions - Severe Mental Illness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive remediation + active tDCS - Cognitive remediation + sham tDCS ### Outcomes Primary Outcomes - Independent Living Skills Survey self- and observer-rated questionnaire (ILSS) - Goal Attainment Scale (GAS) Secondary Outcomes - Controlled Oral World Association Task (COWAT) - Trail Making Test (TMT) - Digit span (forward & backward) - Wechsler Memory Scale - Visual Reproduction I and II - Stroop Color and Word Task (SCWT) - 15 Word Test (15-WT) - Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task - Cognitive Failure Questionnaire (CFQ) - Self-Evaluation of Negative Symptoms (SNS) - DEX self/informant - General Self-Efficacy Scale (GSES) - Nurses' Observation Scale of Cognitive Abilities (NOSCA) ### Location - Facility: Cosis, Assen, Drenthe, 9400 AE, Netherlands @@
## Dose-Response Effects of Mindfulness Meditation - NCT ID: NCT06378450 - Study ID: 2022-23892-31512-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-11-30 - Lead Sponsor: University of Melbourne ### Study Description The goal of this randomized controlled trial is to test for evidence of dose-response effects in a sample of healthy adults with little to no prior experience with meditation.The main question it aims to answer is whether larger doses of mindfulness meditation yield greater positive changes in wellbeing than smaller doses.Our hypotheses are that (1) larger doses of mindfulness training will yield significantly larger effects, and (2) different doses will be significantly associated with variation in participant engagement, with lower engagement associated with higher doses.Researchers will compare each of three dose conditions, 10-min, 20-min, 30-min, against a minimal dose condition of 3-4 min.Participants will take a 28-day mindfulness meditation course, with guided audio instructions provided daily throughout the intervention period (excluding one rest day per week). They will also be asked to respond to surveys before, during, and after the intervention. ### Conditions - Well-Being, Psychological - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Mindfulness meditation guided practice ### Outcomes Primary Outcomes - Psychological wellbeing Secondary Outcomes - Psychological Distress - Anxiety - Depression - Nonattachment - Trait Mindfulness - Decentering - Equanimity - Repetitive Negative Thoughts - Emotional Regulation - Attentional Control - Emotional Reactivity - Social Anxiety - Sleep Quality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of GLB-001 in Patients With Myeloid Malignancies - NCT ID: NCT06378437 - Study ID: GLB-001-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2027-12-31 - Lead Sponsor: Hangzhou GluBio Pharmaceutical Co., Ltd. ### Study Description Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV/ET, or study participants with MF/LR-MDS/HR-MDS/AML, respectively. Dose expansion (Phase 1c) will be followed to determine the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Approximately 108 study participants may be enrolled in the study. ### Conditions - Polycythemia Vera - Essential Thrombocythemia - Myelofibrosis - Myelodysplastic Syndromes - Acute Myeloid Leukemia - Myeloid Malignancy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - GLB-001 ### Outcomes Primary Outcomes - Dose-limiting Toxicity (DLT) - Maximum Tolerated Dose (MTD) - Recommended Expansion Doses (RED) - Incidence, Relatedness, Seriousness and Severity of Adverse Events (AEs) - Recommended Phase 2 Dose (RP2D) - Response Assessment in Study Participants With PV - Response Assessment in Study Participants With ET - Response Assessment in Study Participants With MF - Response Assessment in Study Participants With LR-MDS - Response Assessment in Study Participants With HR-MDS - Response Assessment in Study Participants With AML Secondary Outcomes - GLB-001 and GLB-C183-A-2 (diastereoisomer of GLB-001) Pharmacokinetics after Single Administration - AUC0-last - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-24 - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-inf - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Cmax - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Tmax - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - T1/2 - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Vz/F - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - CL/F - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - λz - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Tmax,ss - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cav,ss - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmax,ss - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmin,ss - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - AUC0-tau - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-AUC0-last - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - λz - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Vz/F - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - CLss/F - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - T1/2 - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [AUC] - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [Cmax] - GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-DF ### Location - Facility: Henan Cancer Hospital, Zhengzhou, Henan, 450003, China @@
## The Effectiveness of Local Dry Cold, Hot and Vibration Applications in Peripheral Intravenous Catheterization - NCT ID: NCT06378424 - Study ID: 2023-6/6 - Status: COMPLETED - Start Date: 2023-03-22 - Completion Date: 2023-08-23 - Lead Sponsor: Uludag University ### Study Description Aim: The aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults.Methods: The study included 120 adults who were randomly selected between March and August 2023. One application group (n=30) received local hot application, one group (n=30) received local cold application, and one (n=30) received local vibration using the Buzzy® device. The applications, to the site of the peripheral intravenous catheterization, lasted one minute. The control group (n=30) the received standard peripheral intravenous catheterization application. The groups' venous dilation was assessed on the vein assessment scale and the level of pain felt during catheterization was assessed using a visual analog scale. ### Conditions - Pain Management - Emergency Unit - Diarrhea - Nausea - Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cold Application - Heat Application - Vibration Application ### Outcomes Primary Outcomes - pain intensity in mm - venous dilation in score - procedure duration in sec Secondary Outcomes - weight - height ### Location - Facility: Bursa Uludag University Hospital, Bursa, Nilüfer, N/A, Turkey @@
## Development and Application of a Musical Game for Motor Rehabilitation - NCT ID: NCT06378411 - Study ID: P109 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2024-10 - Lead Sponsor: Universidade da Madeira ### Study Description The aim of this study is to develop, adapt a musical game for residents of RAM, and evaluated the usability and correlation between this game with the improvement of motor coordination in short time. ### Conditions - Health People - Survivors of Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Music Game Intervention ### Outcomes Primary Outcomes - Motor Coordination - Usability Secondary Outcomes ### Location - Facility: Universidade da Madeira, Funchal, N/A, N/A, Portugal @@
## A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy - NCT ID: NCT06378398 - Study ID: UMCC 2023.037 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-08 - Lead Sponsor: University of Michigan Rogel Cancer Center ### Study Description This trial will obtain biomarker data on the possible preventive effects of omeprazole and low-dose aspirin in colorectal tissue. Persons who have had 5 or more adenomas, 5 or more serrated polyps, or an incompletely removed adenoma or serrated polyp in the colon or rectum are potentially eligible. Before participating in the study, study staff will explain the study and review the consent form. If you are interested and provide consent, study staff will then confirm your eligibility. Once enrolled, participants will take two 20 mg omeprazole tablets and two 81 mg aspirin tablets each day before the first meal each day for 25-45 days.The study does involve biopsies of the colorectal tissue before and after taking the study medications. The biopsies are samples of tissue, about the size of a grain of rice, that will be taken from the colon or rectum before and after taking the study medications. This is done during a usual, clinical colonoscopy exam and during one more limited exam, called flexible sigmoidoscopy, that is done for the research study. The flexible sigmoidoscopy requires less preparation. Which procedure comes first depends on what fits best with each participant's clinical scenario. Biopsies of both normal mucosa and polyps (if possible) are collected. ### Conditions - Colorectal Neoplasia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Omeprazole - Aspirin ### Outcomes Primary Outcomes - Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum Secondary Outcomes - Evaluation of gene expression changes ### Location - Facility: The University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, 48109, United States @@
## Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition - NCT ID: NCT06378385 - Study ID: DevelopmentCEOAS - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-20 - Lead Sponsor: University of Nove de Julho ### Study Description Premature, non-physiological tooth wear in childhood has numerous repercussions for oral health. This is a growing problem with multifactorial causes and associated with the current lifestyle. The aim of the present study was the development and determination of content validity of the Childhood Early Oral Aging Syndrome (CEOAS) index for the primary dentition as a diagnostic and epidemiological survey tool considering the current changes found in this population. ### Conditions - Aging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Childhood Early Oral Aging Syndrome index ### Outcomes Primary Outcomes - Development of CEOAS index Secondary Outcomes - Validation of CEOAS index ### Location - Facility: Universidade Metropolitana de Santos - UNIMES, Santos, São Paulo, 11045-002, Brazil @@