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## Effect of Bacillus Subtilis ATCC 122264 Supplementation on Gas Symptoms and Quality of Life in Participants With Functional Bloating - NCT ID: NCT06308146 - Study ID: S21-1249496 - Status: COMPLETED - Start Date: 2022-04-21 - Completion Date: 2022-10-11 - Lead Sponsor: Kerry Group P.L.C ### Study Description A randomized, double blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy of Bacillus subtillis in providing relief and improving quality of life in participants suffering from functional abdominal bloating/distension when administered for a period of 8 weeks. ### Conditions - Functional Bloating ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bacillus subtilis ATCC 122264 - Placebo ### Outcomes Primary Outcomes - Effect on intestinal gas symptoms and quality of life Secondary Outcomes - Effect on intestinal gas symptoms and quality of life ### Location - Facility: Apex Trials, Guelph, Ontario, N1G 0B4, Canada @@
## Biological Variables Affecting CD34+ Peripheral Cells Collection Efficiency - NCT ID: NCT06308133 - Study ID: CD34+CE_2023 - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2023-12-31 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description All procedures performed during the study will comply with current clinical practice, international and national guidelines. Main object of the study is the PBSC apheresis procedure performed by using the continuous mononuclear cells collection (cMNC) system with Spectra Optia (Terumo BCT), specifically the biological and clinical factors affecting the procedure efficiency. ### Conditions - Optimize PBSC Harvest Through Automated Buffy Coat ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - apheresis procedure ### Outcomes Primary Outcomes - measured by statistical correlation - Correlation of clinical Secondary Outcomes ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, Milan, Milano, 20122, Italy @@
## A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB - NCT ID: NCT06308120 - Study ID: ISI-IONCN-002 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-09-30 - Lead Sponsor: Intuitive Surgical ### Study Description Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules. ### Conditions - Pulmonary Nodule, Solitary - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Ion Endoluminal System - superDimension Navigation System and Accessories ### Outcomes Primary Outcomes - Diagnostic Yield Secondary Outcomes - Sensitivity for malignancy of biopsy obtained samples - Incidence of pneumothorax that requires chest tube placement and/or re-hospitalization or extended hospitalization - Incidence of intraoperative severe airway bleeding ### Location - Facility: Shanghai Chest Hospital, Shanghai, Shanghai, N/A, China @@
## Safety and Feasibility of Hyperkalemic Cardioplegia With Diazoxide in Cardiac Surgery (CPG-DZX) Trial - NCT ID: NCT06308107 - Study ID: IRB00433127 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-04-30 - Lead Sponsor: Johns Hopkins University ### Study Description This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. Thirty patients will receive treatment. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery. ### Conditions - Myocardial Stunning ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - IV Diazoxide ### Outcomes Primary Outcomes - Safety as assessed by mean change in blood pressure - Safety as assessed by change in blood glucose levels - Safety as assessed by incidence of adverse events Secondary Outcomes - Efficacy as assessed by change in ejection fraction - Efficacy as assessed by use of mechanical circulatory support - Efficacy as assessed by change in Vasoactive Inotropic Score (VIS) - Efficacy as assessed by time to separate from Cardiopulmonary Bypass (CPB) ### Location - Facility: Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States @@
## 320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation. - NCT ID: NCT06308094 - Study ID: IRB00429859 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-04-01 - Lead Sponsor: Johns Hopkins University ### Study Description This study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation (AF), specifically after catheter ablation. It aims to use Cardiac CT, an accessible tool, to measure left ventricular extracellular volume (ECV) as an indicator of fibrosis. The study will assess if higher ECV levels correlate with increased risks of AF recurrence, hospitalization, and poor cardiac function recovery. Positive findings could make ECV a key factor in deciding AF treatment strategies. ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - CT ### Outcomes Primary Outcomes - Recurrence of Atrial Fibrillation - Occurrence of ER visits, hospitalizations for cardiovascular causes Secondary Outcomes - Change in Ejection Fraction - Quality of Life as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Social Media Anti-Vaping Messages to Reduce ENDS Use Among Sexual and Gender Minority Teens - NCT ID: NCT06308081 - Study ID: UPCC 13023 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2025-12-31 - Lead Sponsor: Abramson Cancer Center at Penn Medicine ### Study Description The investigators long-term goal is to reduce tobacco use and tobacco-related health disparities among SGM populations. The objective of Project SMART (Social Media Anti-Vaping Messages to Reduce ENDS Use Among Sexual and Gender Minority Teens) is to evaluate the effectiveness of an sexual gender minority (SGM) -tailored social media intervention to prevent vaping initiation among SGM youth ages 13-20 years. The investigators central hypothesis is that SGM-tailored anti-vaping social media messages will be more effective than existing non-tailored messages to prevent vaping initiation among SGM youth. The scientific premise for this work is based on principles of cultural tailoring in health communication for vulnerable populations, the Health Equity Promotion Model, and the Message Impact Framework. The investigators are developing and evaluating a social media intervention because SGM youth have a high rate of social media use and are more likely to go online for health information than non-SGM youth. Social media, moreover, are increasingly used for health promotion to address health disparities and well-being of SGM populations. The investigators will conduct rapid-cycle feedback with stakeholders including SGM organization leaders to provide input on the message design, testing, and intervention implementation to ensure feasibility and acceptability of the intervention. ### Conditions - Vaping - Adolescent Behavior - Communication Research ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Tailored ### Outcomes Primary Outcomes - Susceptibility to vaping Secondary Outcomes - Vaping initiation ### Location - Facility: University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States @@
## Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers - NCT ID: NCT06308068 - Study ID: BE24-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-30 - Completion Date: 2024-08-18 - Lead Sponsor: International Bio service ### Study Description To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions ### Conditions - Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Diacerein 50 mg Capsule ### Outcomes Primary Outcomes - Bioequivalence based on Cmax period - Bioequivalence based on AUC parameters Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Abiomed Impella RT-DAQ - Observational Study - NCT ID: NCT06308055 - Study ID: 2022-R01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Abiomed Inc. ### Study Description Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition ### Conditions - Cardiogenic Shock ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Data Acquisition ### Outcomes Primary Outcomes - Collection of hemodynamic parameters (Cardiac Output in l/min) - Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg) - Collection of hemodynamic parameters (Mixed Venous Saturation in %) - Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 ) Secondary Outcomes - Rate of Patient Survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Remote Evaluation in Patients With Multiple Sclerosis - NCT ID: NCT06308042 - Study ID: 2024/5558 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-06-29 - Lead Sponsor: Inonu University ### Study Description This study aimed to demonstrate the remote reliability of the 30-second sit-to-stand test in patients with multiple sclerosis. ### Conditions - Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 30 second sit and stand test ### Outcomes Primary Outcomes - 30 second sit and stand test Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment - NCT ID: NCT06308029 - Study ID: Edge003203 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2028-03-20 - Lead Sponsor: Universiteit Antwerpen ### Study Description The scientific goals of the project are:1. The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to: * usual care (i.e. superiority of the eHealth self-management support program) and * a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program) on pain-related disability (measured with the Pain Disability Index).2. The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including: * Other dimensions of pain * Health-related quality of life * Physical functioning, including physical activity levels * Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence * Participation in society, including return to work * Healthcare-related costs for the patient and society3. The tertiary scientific objectives of this study are * to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets. * To examine the implementation process, mechanisms of impact and contextual factors. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - eHealth self-management support program - Face-to-face rehabilitation program ### Outcomes Primary Outcomes - Pain-related disability Secondary Outcomes - Pain related disability - Pain severity - Severity of neuropathic Pain - Medication use - Pain location - Knowledge of neurophysiology of pain - Physical Activity pattern - Physical functioning - Fatigue - Sleep disturbance - Pain Beliefs - Pain-related worrying - Vigilance to bodily sensations - Depression - Anxiety - Determinants for physical activity - Participation - Well-being - Social Support - Return to work rate - Medical costs of medical consumption - Indirect costs related to disease outside health care - Health-related quality of life - Patient Global Impression of Change ### Location - Facility: Universiteit Antwerpen, Antwerpen, N/A, N/A, Belgium @@
## Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification. - NCT ID: NCT06308016 - Study ID: 25/IRE/23 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-12-01 - Lead Sponsor: Regina Elena Cancer Institute ### Study Description Multicenter retrospective study of a cohort of patients affected by laryngeal carcinoma and subjected to total laryngectomy surgery at the centers participating in the reference period and responding to inclusion criteria. ### Conditions - Laryngeal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Identification of risk factors Secondary Outcomes - Stratify patients ### Location - Facility: "Regina Elena" National Cancer Institute, Rome, N/A, 00144, Italy @@
## Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty - NCT ID: NCT06308003 - Study ID: PTA CONF - Status: RECRUITING - Start Date: 2023-02-13 - Completion Date: 2025-09 - Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio ### Study Description The study is, in accordance with current legislation, definable as monocentric Prospective Observational.The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.adult patients who will undergo surgery of hip arthroplasty.Patients will undergo:Preoperative T0: clinical visit/medical history, completion of the VAS questionnaire, Blood sampling to assess hemoglobin values Operative T1: hip arthroplasty surgery using one of the surgical approaches routinely used within our Institute T2 - Postoperative at 1 day from T1: VAS questionnaire, evaluation of any Adverse events T3 - Postoperative at 3 days from T1: blood loss based on the values of hemoglobin (Hb), assessment of any adverse events, and VAS questionnaire T4- Post operative at 45 days +/- 10 days from T1: evaluation of any events adverse, follow-up visit. ### Conditions - Hip Arthropathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Anterior hip arthroplasty ### Outcomes Primary Outcomes - The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day. Secondary Outcomes ### Location - Facility: Istituto Clinico San Siro, Milan, N/A, N/A, Italy @@
## Understanding, Diagnosis and Monitoring of Thyroid Hormone Action Defects - NCT ID: NCT06307990 - Study ID: 05M202 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-04-30 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The goal of this observational study is to learn about the neurological and cardiological phenotype of patients with resistance to thyroid hormone (RTH) syndromes beta and alpha (RTHß and RTHa) due to dominant negative variants in the genes encoding the thyroid hormone receptors alpha (THRA) and beta (THRB).The main question\[s\] it aims to answer are:* Define frequency and improve early diagnosis for RTH syndromes* Developing tools to accelerate diagnosis of RTH syndromes* Development and validation of monitoring toolsParticipants, recruited at neonatal screening or from cohorts of patients with unexplained specific neuro-cognitive or cardiovascular phenotypes will be submitted to biochemical and genetic investigations. In addition pluripotent stem cells will be generated from peripheral blood cells of RTHs patients and studied in vitro to understand the molecular mechanisms underlying neurological and cardiovascular consequences. In vitro and clinical data, will be correlated to identify biomarkers for monitoring treatment. ### Conditions - Resistance, Thyroid Hormone ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - NGS sequencing - serological tests ### Outcomes Primary Outcomes - to define the frequency and improve early diagnosis for RTH syndromes. - to demonstrate that zebrafish zygotes are useful for screening of the pathogenicity of new TR mutations - Direct differentiation of THRA mutant patients-derived human induced pluripotent stem cells (hiPSCs) to neural progenitors (hiPSc-CNeu) and cardiomyocyte (hiPSC-CMs) - To identify TH-target genes involved in determining stemness, proliferation potential and differentiation of hiPSC Secondary Outcomes - to define the prevalence of RTH syndromes in specific cohorts of patients with unexplained phenotypes - Generation of a comprehensive RTH database ### Location - Facility: Istituto Auxologico Italiano IRCCS, Milan, N/A, 20145, Italy @@
## Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples - NCT ID: NCT06307977 - Study ID: R01DA059272 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2029-02 - Lead Sponsor: Hunter College of City University of New York ### Study Description This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC). ### Conditions - Substance Use - HIV Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Couples Health Project ### Outcomes Primary Outcomes - Drug use Frequency - Urine assay for drug use - CAS with casual partners Secondary Outcomes - Bacterial sexually transmitted infections - Binge Drinking - PrEP Uptake ### Location - Facility: Wayne State University, Detroit, Michigan, 48201, United States @@
## Intra-Hepatic Microbiota in Alcoholic Hepatitis - NCT ID: NCT06307964 - Study ID: 69HCL23_1137 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-07 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Alcoholic hepatitis (AH) is a serious complication of alcoholic liver disease (ALD). The histological presentation of AH is characterized by neutrophilic lobular inflammation, macrovesicular steatosis, hepatocyte ballooning and necrosis and the presence of Mallory bodies. In cases of severe HA, defined by a modified Maddrey score of 32 or above, mortality at 1 month is estimated at between 10 and 50%. The only treatment to reduce early mortality is corticosteroid therapy. However, only 60% of patients respond to corticosteroids, and no benefit has been demonstrated on late mortality. Identifying new therapeutic targets is therefore a major challenge in this disease.Numerous pre-clinical studies and human data suggest the involvement of the intestinal microbiota in the pathogenesis of AH. Translocation of viable bacteria and microbial products from the digestive tract to the liver contributes to local and systemic inflammation, hepatocyte death and fibrogenesis. However, the intrahepatic microbial environment has never been characterized in HA.The study hypothesis is that the intrahepatic microbiota is modulated by bacterial translocation and is associated with clinical outcomes.The aim of this study is to determine the composition of the intrahepatic (obtained from transjugular liver biopsy), blood and fecal microbiota in patients with suspected severe AH from a monocentric prospective cohort in the Hepatology Department at Croix-Rousse Hospital (Lyon). Fifty consecutive patients with clinical suspicion of AH and indication for transjugular liver biopsy will be included. About thirty-five patients are expected in the confirmed AH group, and 15 in the group "alcoholic liver disease with no AH", based on data from the literature. The composition of the various microbiota will be determined by sequencing the 16S rRNA gene, and the results will be correlated with clinical data (corticosteroid sensitivity, overall survival, transplant-free survival, MELD score in particular) and histological data.This exploratory study will enable to analyze the intra-hepatic microbiota, and to study its link with intra-hepatic inflammation and the clinical course of patients with AH. The data generated by HepMAH will thus help identify potential new therapeutic targets linked to the gut microbiota, and provide a scientific basis for the development of therapeutic interventions targeting the microbiota in HA. ### Conditions - Cirrhosis - Alcoholic Liver Disease - Alcoholic Hepatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biological sampling ### Outcomes Primary Outcomes - Microbiota composition Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exploration of Infant and Young Child Feeding Practices and Their Determinants - NCT ID: NCT06307951 - Study ID: JCDC/BHR/24/012 - Status: RECRUITING - Start Date: 2023-04-25 - Completion Date: 2025-11-30 - Lead Sponsor: Hirabai Cowasji Jehangir Medical Research Institute ### Study Description The goal of this observational study is to assess infant and young child-feeding practices among women living in urban areas and slums in Pune and rural areas around Pune, India, and to investigate the reasons for the adopted infant and young child-feeding practices in Slum-dwelling women aged 18 to 49 years who have an infant/s less than 24 months of age.The main question it aims to answer are:* Are infant and young child-feeding practices among women living in urban areas and slums appropriate?* What the reasons for the adopted infant and young child-feeding practices in Slum-dwelling women Participants will be measured for their height and weight, interviewed for Socio-demographic characteristics, birth history of the infant, infant feeding indicators and will be involved in focused group discussions and in-depth interviews to gain understanding into their adopted appropriate and inappropriate feeding practices. ### Conditions - Infant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Infant and young child-feeding practices among women living in urban areas and slums in Pune and rural areas around Pune, India will have been assessed Secondary Outcomes - Reasons for the adopted infant and young child-feeding practices will have been investigated ### Location - Facility: Hirabai Cowasji Jehangir Medical Research Institute, Pune, Maharashtra, 411001, India @@
## Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer - NCT ID: NCT06307938 - Study ID: 619020 - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2027-12 - Lead Sponsor: Helse Nord-Trøndelag HF ### Study Description CoLiQ is an observational study designed to evaluate the clinical usefulness of circulating tumor DNA (ctDNA) markers found in blood, as a liquid biopsy for diagnosis, prognosis and follow-up of colorectal cancer. The main questions it aims to answer are: 1) Can a panel of ctDNA markers identify CRC patients among the other patients summoned for colonoscopy? and 2) Does the type, number and level of ctDNA markers vary with the subtype and clinical course of CRC? Participants will be asked to answer a questionnaire and give a blood sample at inclusion. In addition, patients with CRC will be asked to give an extra test tube at their routine treatment and follow-up blood sampling. ### Conditions - Colorectal Cancer - Colorectal Adenoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - liquid biopsy ### Outcomes Primary Outcomes - Colorectal cancer - Colorectal adenoma - Inflammatory bowel disease Secondary Outcomes - Recurrence - Death - Treatment response ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors - NCT ID: NCT06307925 - Study ID: HC010-001 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2025-12-31 - Lead Sponsor: HC Biopharma Inc. ### Study Description This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HC010 ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicity - Adverse events - serious adverse events - Maximum Tolerated Dose - Recommended Dose for Phase II Clinical Studies Secondary Outcomes - pharmacokinetics:Cmax - Objective response rate - duration of response - progression-free survival - overall survival - Disease control rate - pharmacokinetics:AUC0-last - pharmacokinetics:tmax - pharmacokinetics:Vd ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, N/A, China @@
## Physiotherapists' Placebo or Nocebo Communication Regarding VR - NCT ID: NCT06307912 - Study ID: 202301 - Status: COMPLETED - Start Date: 2023-11-01 - Completion Date: 2023-12-01 - Lead Sponsor: HAN University of Applied Sciences ### Study Description Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered nonpharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in healthy participants.Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in healthy participants.Study design: Web-based randomized controlled trial.Study population: 126 participantsIntervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ). ### Conditions - Communication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Video placebo communication - Video nocebo communication ### Outcomes Primary Outcomes - Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ) - Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ) Secondary Outcomes - Change in openness to VR measured using a single question ### Location - Facility: HAN University of Applied Sciences, Nijmegen, Overijssel, 6525EN, Netherlands @@
## Immediate Effects of Different Stretching Methods for Pectoralis Minor Muscle - NCT ID: NCT06307899 - Study ID: E-77082166-302.08.01-639069 - Status: RECRUITING - Start Date: 2023-09-11 - Completion Date: 2024-09-04 - Lead Sponsor: Gazi University ### Study Description The aim of our study is to compare the effects of different stretching methods for the pectoralis minor (PM) muscle on scapula position, PM muscle length and scapular muscle activation in individuals with shoulder protraction. Unilateral corner stretching, manual stretching and proprioceptive neuromuscular facilitation (PNF) stretching methods will be applied randomly, 2 days apart, to volunteer individuals who agree to participate in our study. Three different stretching methods (unilateral corner stretching, manual stretching and PNF stretching) will be applied to individuals randomly, 48 hours apart, and PM length, PM index, scapula upward rotation and EMG values will be recorded by a blind evaluator before and after the stretching application. ### Conditions - Rounded Shoulder Posture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Unilateral Corner Stretch - Manual Stretching - PNF Stretching ### Outcomes Primary Outcomes - Pectoralis Minor Length - Pectoralis Minor Length - Pectoralis Minor Index - Pectoralis Minor Index - Scapula Upward Rotation Measurement - Scapula Upward Rotation Measurement - EMG Analysis - EMG Analysis Secondary Outcomes ### Location - Facility: Gazi University, Ankara, Çankaya, 06490, Turkey @@
## Comparison of Five-year Survival and Disease-free Survival in Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator - NCT ID: NCT06307886 - Study ID: GaziosmanpasaTREHSs - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2028-09-01 - Lead Sponsor: Gaziosmanpasa Research and Education Hospital ### Study Description Comparison of five-year survival and disease-free survival in patients diagnosed with endometrium cancer who underwent total laparoscopic hysterectomy with and without a uterine manipulator ### Conditions - Endometrial Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulator - lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulator ### Outcomes Primary Outcomes - five year survival in patients diagnosed with endometrial cancer - disease-free survival in patients diagnosed with endometrial cancer Secondary Outcomes ### Location - Facility: Gaziosmanpasa Training and research hospital, Istanbul, N/A, N/A, Turkey @@
## Comparison of the Effects of Sacrospinous Fixation and V-notes Lateral Suspension Operations - NCT ID: NCT06307873 - Study ID: GaziosmanpasaTREH. - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-09-01 - Lead Sponsor: Gaziosmanpasa Research and Education Hospital ### Study Description Comparison of the effects of sacrospinous fixation and v-notes lateral suspension operations on anatomical recovery, effectiveness and quality of life in a training and research hospital gynecology and obstetrics clinic. ### Conditions - Genital Prolapse, Unspecified ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - pre and post operative POP-Q results - pre and post operative PİSQ-12 results ### Outcomes Primary Outcomes - Pre and post operative assessment of POP-Q measurements - Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual Secondary Outcomes ### Location - Facility: Gaziosmanpasa Training and Research Hospital, Istanbul, N/A, N/A, Turkey @@
## Comparison of Different Ablation Surgeries on Left Atrial Reverse Remodeling in Patients With Atrial Fibrillation - NCT ID: NCT06307860 - Study ID: 15270977512@163.com - Status: RECRUITING - Start Date: 2022-06-01 - Completion Date: 2025-03-01 - Lead Sponsor: Yun Wan ### Study Description The goal of this Ambispective cohort Study is to compare in patients with paroxysmal atrial fibrillation undergo pulse field ablation and radiofrequency ablation, respectively. The main question it aims to answer are:Comparison of the therapeutic effects of pulse field ablation and traditional thermal ablation on patients with paroxysmal atrial fibrillation and postoperative left atrial reverse remodeling.Participants will Perform pulse field ablation or radiofrequency ablation according to different groups, and cooperate to complete outpatient follow-up 6 months after surgery. ### Conditions - Atrial Fibrillation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - pulsed field ablation - radiofrequency ablation ### Outcomes Primary Outcomes - Recurrence rate of atrial arrhythmias - Left atrial end diastolic diameter Secondary Outcomes - p wave dispersion - Pulmonary vein stenosis rate ### Location - Facility: Ganzhou People's Hospital, Ganzhou, Jiangxi, 341000, China @@
## Pivotal Study to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis - NCT ID: NCT06307847 - Study ID: SP-HA-003 - Status: COMPLETED - Start Date: 2021-04-14 - Completion Date: 2022-10-25 - Lead Sponsor: Shin Poong Pharmaceutical Co. Ltd. ### Study Description This is a randomized, double-blind, multicenter, non-inferiority, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M001) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis. ### Conditions - Osteoarthritis Thumb ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SP5M001 inj - Synovian inj ### Outcomes Primary Outcomes - Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2) Secondary Outcomes - Changes in the following at each visit : Weight Bearing pain(WBP) (Weeks 2, 6, 24, and 36) from baseline (Visit 2) - Changes in the following at each visit : Rest pain (RP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) - Changes in the following at each visit : Night pain (NP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) - Changes in the following at each visit : Motion pain (MP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) - Changes in the following at each visit : Patient Global Assessment(PGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) - Changes in the following at each visit : Investigator Global Assessment (IGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) - Changes in the following at each visit : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total score and individual score evaluation (Pain, function, stiffness) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) - Physical assessments at each post-administration visit: Swelling (Weeks 2, 6, 12, 24, and 36) - Physical assessments at each post-administration visit: joint-line tenderness on pressure (Weeks 2, 6, 12, 24, and 36) - Physical assessments at each post-administration visit: range of motion (Weeks 2, 6, 12, 24, and 36) - Proportion of participants who took rescue medication at each post-administration visit and dose of rescue medication (Weeks 2, 6, 12, 24, and 36) - Post-administration response rate A. Proportion at which WBP decreases by at least 20 mm or improves by at least 40% from baseline at the time of evaluation (B section-Description) ### Location - Facility: Yeungnam University Medical Center, Daegu, N/A, N/A, Korea, Republic of @@
## Restoring Grasp Ability in Stroke Survivors Through MI-Based Training - NCT ID: NCT06307834 - Study ID: 26760 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: North Carolina State University ### Study Description Stroke is a leading cause of disability. Most stroke survivors face challenge in using their arm and hand to carry out daily task, such as grasping or holding objects. This issue makes it tough for nearly 65% of stroke survivors to return to work and take care of themselves. The cause of their disability is changes in their brain's activity patterns of the motor cortex area. Traditional therapy does not directly alter these brain changes, which makes it less effective. As a way to help stroke survivors, people are looking into ways to train the brain directly. A method they found is motor imagery, which involves mental practicing of a task. Studies suggest that this type of training can potentially alter the brain's patterns, which can be seen through EEG. An EEG shows a fixed pattern during movement, called SMR (sensory motor rhythm). Studies have found that people can learn to control this SMR through mental practice of a task. The SMR changes in a similar way during both movement and motor imagery. Therefore, mental practice of hand tasks can lead to improvement in actual hand movements. It has already been shown that stroke survivors can open their hands more easily after receiving SMR training. Along with that, they also have trouble to hold and release objects. SMR training may be able to address these issues by changing brain patterns. But it is not clear yet if SMR training can improve all three stages of grasping (open, close, release), and to what extent it can enhance overall hand function.This study plans to include 20 adults who have experienced a stroke and have ongoing problems with moving their hands. Half of these participants will take part in a training in which they will learn to control their SMR for three distinct hand tasks (open, close, and release). The first session will be followed by eight training sessions. To guide users toward specific changes in EEG activity, we will provide visual feedback in training. As soon as an appropriate EEG change is made, a hand exoskeleton will help them open and close their hand. The other group of 10 patients will have traditional therapy. They will do 9 sessions of hand exercises. During and after the training, we will test both groups to see how well their hand function improved. The result will help us determine which training method is better for stroke survivors. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neurofeedback - based therapy - Standard hand exercise therapy ### Outcomes Primary Outcomes - Change of Box & Block test (BBT) - Change of Action Research Arm Test (ARAT) - Change of Wolf Motor Function Test (WMFT) Secondary Outcomes ### Location - Facility: Hand Rehabilitation Lab, Raleigh, North Carolina, 27695, United States @@
## the Role of Probiotic in Protein Metabolism - NCT ID: NCT06307821 - Study ID: WK2024002 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-07-30 - Lead Sponsor: Wecare Probiotics Co., Ltd. ### Study Description This study investigates the functional effects of probiotics on athletes by administering Weizmannella coagulans BC99 for six weeks. It aims to assess the probiotic's influence on skeletal muscle content, athletic performance, and protein digestion and metabolism. This is achieved by monitoring changes in digestive enzymes, amino acids, body composition, and hormone levels. The research seeks to offer a theoretical foundation for optimizing athletes' training and nutrition strategies and suggests the potential of probiotics in enhancing nutrient absorption and utilization, particularly in individuals with compromised digestive capabilities. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probiotic ### Outcomes Primary Outcomes - Digestibility and absorption of dietary protein Secondary Outcomes ### Location - Facility: Henan University of Science and Technology, Luoyang, Henan, 471000, China @@
## Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination - NCT ID: NCT06307808 - Study ID: Vitamin - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-10-01 - Lead Sponsor: University Hospital, Grenoble ### Study Description Solid Organ Transplantation (SOT) is made possible by the use of a lifelong immunosuppressive treatment. This treatment limits the response of the immune system, enabling long-term survival of the transplanted organ, but also leading to weaker anti-infectious responses.In this study, we will compare the response to a booster Hepatitis B vaccination (HBV) in SOT patients, either after kidney or liver transplantation. We will also compare the immune response depending on the immunosuppressive treatment.In order to provide a detailed picture of the immune response, we will investigate the usual serological response (anti-HBs antibodies), but also the cellular memory (both T and B) using ELISpot assays and flow-cytometry, over a 6 months period following booster vaccination. ### Conditions - HBV - Kidney Transplantation - Liver Transplantation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tacrolimus - Belatacept ### Outcomes Primary Outcomes - Titer of anti-HBs ELISA antibody Secondary Outcomes - Number of anti-HBs memory B cells ### Location - Facility: Grenoble University Hospital, Grenoble, Aura, 38043, France @@
## A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors - NCT ID: NCT06307795 - Study ID: ANS014004-I-US-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-10 - Lead Sponsor: Avistone Biotechnology Co., Ltd. ### Study Description This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors. ### Conditions - Locally Advanced or Metastatic Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ANS014004 ### Outcomes Primary Outcomes - Incidence of Adverse Events (AEs) - Incidence of Serious Adverse Events (SAEs) - Incidence of dose-limiting toxicities (DLT) as defined in the protocol - Incidence of baseline laboratory finding, ECG and vital signs changes - Proportion of patients with radiological response (ORR) Secondary Outcomes - Objective Response Rate (ORR) - Duration of Response (DoR) - Disease Control Rate (DCR) - Progression free Survival (PFS) - Overall Survival (OS) - Pharmacokinetics of ANS014004: Plasma PK concentrations - Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC) - Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max) - Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max) - Pharmacokinetics of ANS014004: Clearance - Pharmacokinetics of ANS014004: Half-life ### Location - Facility: Sarah Cannon Research Institute, Denver, Colorado, 80218, United States @@
## The Effect of Oral Whey Consumption on Insulin Resistance, Cortisol, Crp, Albumin Level and Healing Quality Before Total Hip Arthroplasty - NCT ID: NCT06307782 - Study ID: 12833 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-06-25 - Completion Date: 2024-12-30 - Lead Sponsor: TC Erciyes University ### Study Description Purpose: It was planned to determine the effect of oral whey given before total hip arthroplasty (THA) on postoperative insulin resistance, cortisol, CRP((C reactive protein), albumin level and healing quality.Design: It was planned as Randomized Controlled. Method: Research: The study is planned to include individuals aged 50-70, who are planned for THA in the orthopedics and traumatology clinic of a public hospital, who have undergone spinal anesthesia, who have BMI \<40 and ASA (American Society of Anesthesiologists)1,2,3. Individuals with endocrine or renal disorders or allergies to whey will be excluded from the study. It was planned to include at least 60 patients in the study (30 in the intervention group, 30 in the control group). It is planned to use the Patient Introduction Information Form, Physiological Measurements Chart (vital findings (blood pressure, pulse, respiratory SpO2 (pulse oximetry) value), blood glucose, cortisol, CRP and albumin value and insulin resistance) and postoperative recovery quality scale in data collection. The intervention group will be given 600 ml of oral whey 6 hours before the surgery, and the control group will be allowed to drink 600 ml of drinking water 6 hours before the surgery. 3ml of blood will be taken for blood glucose, CRP, cortisol, albumin and insulin resistance values 24 hours before the surgery, just before entering the surgery and 24 hours after the surgery. The first part of the healing quality scale is planned to be evaluated immediately before the surgery, and the second part 24 hours after the surgery.Conclusion: When the literature was scanned, it was seen that the number of studies examining the effect of oral whey on metabolic and endocrine values in orthopedic patients was very limited and academic studies were needed. In this context, examining the effect of whey intake given before THA on the patient's blood glucose, CRP, albumin, cortisol, insulin resistance and healing quality is an original research that will contribute to the field. ### Conditions - Crp - Insulin Resistance - Cortisol; Hypersecretion - Albus; Lichen - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - whey protein intake before surgery - Water before surgery ### Outcomes Primary Outcomes - Rate of C Reactive Protein - Rate of insulin resistance - Rate of albumen - Rate of cortisol - Healing Quality Secondary Outcomes ### Location - Facility: HÜMEYRA, Nevşehir, Nevşehi̇r, 50000, Turkey @@
## Ten-meter Walking Test With Obstacle in Geriatric Individuals. - NCT ID: NCT06307769 - Study ID: 2024.02.42 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-05-25 - Lead Sponsor: Ataturk University ### Study Description Balance and fall problems are one of the most common geriatric syndromes in the elderly. Falls are one of the leading factors causing mortality in the elderly. One-third of individuals aged sixty-five and over fall once or more every year. When the causes of death in elderly individuals are examined; Accidents come in fifth place, and 2/3 of these accidents occur due to falls. The frequency of falls increases with age in 22% of individuals between the ages of 65-69. This rate is stated as 31% between the ages of seventy-five and seventy-nine, and 40% between the ages of 80-84.Geriatric individuals may be at risk of falling in different situations, often inside and outside the home. Falls generally occur more frequently in indoor areas such as bathrooms, kitchens and bedrooms. In these areas, falls caused by potentially dangerous factors such as slippery floors, carpet edges, and high thresholds are more common. A frequent fall occurs when jumping over an obstacle. Factors such as poor balance, vision problems or reduced muscle strength when overcoming obstacles can increase the risk of falling in this situation. The ability of geriatric individuals to overcome obstacles during daily activities is an important factor determining quality of life. Climbing stairs or crossing high thresholds is an important part of daily living activities and poses a risk of falling. Therefore, determining the stair height threshold and assessing obstacle crossing skills should be considered effective measures. When the literature is examined, clinicians generally prefer simpler functional tests because assessments involving disabilities take a long time to be administered, involve some equipment, and also require training to perform the assessment. In the literature, there is currently a version of the functional tests that is applied only by adding obstacles to the timed get up and go test. Thanks to this test, the ability of geriatric individuals to overcome obstacles can be evaluated and people can be trained with this test. For this reason, we wanted to determine the suitability of the 10-meter walking test, which is frequently used in geriatric individuals, when applied with the addition of an obstacle. ### Conditions - Geriatric - Balance ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Ten Meter Walk Test Secondary Outcomes - Berg Balance Scale - Functional Reach Test - Timed up and go test ### Location - Facility: Ataturk University, Erzurum, N/A, N/A, Turkey @@
## The Effect of Music on Maternal Stress and Milk Amount - NCT ID: NCT06307756 - Study ID: SayıNo:521 - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2024-06-15 - Lead Sponsor: Adiyaman University ### Study Description Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. Mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. It is stated that mothers of babies in the neonatal intensive care unit experience stress and anxiety due to reasons such as being separated from their babies, the baby's illness, the baby's sensitive body structure, the baby's appearance and behavior, and the baby's dependence on devices. This stress experienced by mothers of premature babies can prevent mothers from providing enough milk to feed their babies. Mothers whose babies are in the neonatal intensive care unit cannot have adequate contact with their babies and cannot breastfeed; It causes insomnia, stress and anxiety, and the hormonal axis is disrupted, negatively affecting the amount of breast milk. In order to support the healing process of preterm babies, it is important to increase the amount of milk produced by mothers and increase the rate at which babies can receive breast milk. Music improves endothelial function by dilating the vessels; It has been reported that it reduces mental stress by increasing the release of nitrite oxide and endorphins and causes many physiological reactions such as a decrease in blood pressure and pulse. This study will examine the effect of music played to mothers with premature babies on maternal anxiety and the amount of breast milk. ### Conditions - Amount of Breast Milk - Maternal Anxiety Level ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Music group ### Outcomes Primary Outcomes - amount of breast milk measured at the same time every day Secondary Outcomes - State Anxiety Inventory ### Location - Facility: Sağlık Bilimleri Üniversitesi Gazi Yaşargil Eğitim ve Araştırma Hastanesi, Diyarbakır, N/A, N/A, Turkey @@
## Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke - NCT ID: NCT06307743 - Study ID: RAPID-SAVE - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-09-15 - Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital ### Study Description The objective of this clinical trial is to determine whether rapid local ischemic postconditioning (RL-IPostC) is effective in preventing brain edema and safe in acute ischemic stroke (AIS) patients treated with mechanical thrombectomy. In this trial, researchers will block antegrade cerebral blood flow temporarily by the way of balloon inflation/deflation in AIS patients immediately after revascularization. It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration. Researchers will evaluate the protective role and safety of different duration of balloon inflation/deflation. The optimal postconditioning intervention dose will be determined for further confirmative investigation. ### Conditions - Acute Ischemic Stroke - Mechanical Thrombectomy - Ischemic Postconditioning - Brain Edema ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - rapid local ischemic postconditioning ### Outcomes Primary Outcomes - Number of Participants without clinically meaningful cerebral swelling, significant increase in infarct volume from baseline and intervention-related serious adverse events. Secondary Outcomes - Rate of participants without clinically meaningful cerebral swelling - Rate of participants with significant increase in infarct volume from baseline or intervention-related serious adverse events. - Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours - Change of net water uptake (∆NWU24) at 24 hours - Change of net water uptake (∆NWU72) at 72 hours - Midline shift at 24 hours - Midline shift at 72 hours - Change of NIHSS at 24 hours - Early therapeutic response to treatment - Good outcome at 90 days - Excellent outcome at 90 days ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Application of the Recommendations of the SPLIF (French Society of Infectious Pathology) in a Geriatric Population on the Duration of Treatment for Bacterial Pneumonia - NCT ID: NCT06307730 - Study ID: CHSD_0033_GERIATRIE - Status: COMPLETED - Start Date: 2023-01-02 - Completion Date: 2023-04-30 - Lead Sponsor: Centre Hospitalier de Saint-Denis ### Study Description Pneumopathy is the leading cause of death from infectious disease in the elderly. Prior to 2021, the recommended duration of antibiotic therapy for pneumonia, in adults, was 7 days.Two theses have shown that these recommendations were poorly applied in geriatric services. Indeed, the duration of treatment exceeded 7 days, and less than 30% of antibiotic antibiotic treatments were re-evaluated at 72 hours.In 2021, the SPLIF ( published new recommendations reducing this duration to 5 days in the event of clinical improvement observed on the 3rd day of treatment. These new recommendations are based on studies, in which the average age of participants was 65 years. However, the average age of patients in geriatric short-stay departments is 84.7 years.In addition, the geriatric population is characterized by immunosenescence, pulmonary vulnerability and undernutrition, raising questions about the validity of these recommendations in the geriatric population.The investigators offer a monocentric, retrospective, observational study of the geriatric hospital Casanova to assess the application of SPLIF recommendations in the geriatric population. ### Conditions - Pneumonia, Bacterial - Pneumopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Sex - Age - Weight - Phone Number - Origins - Autonomy in daily life's score before hospitalisation - Charlson's morbidity score Secondary Outcomes ### Location - Facility: Centre Hopitalier de Saint-Denis, Saint-Denis, Seine Saint Denis, 93200, France @@
## Effects of Volatile Anaesthetics on Incidence of Postoperative Depression and Anxiety in Elderly Patients - NCT ID: NCT06307717 - Study ID: PLAGH-DA-002 - Status: COMPLETED - Start Date: 2020-04-01 - Completion Date: 2022-04-30 - Lead Sponsor: Chinese PLA General Hospital ### Study Description This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the impact of volatile anaesthetics on the incidence of postoperative depression and anxiety among elderly patients. ### Conditions - Cohort Studies ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - volatile anaesthetic (sevoflurane, isoflurane, desflurane) ### Outcomes Primary Outcomes - Depression Secondary Outcomes - Anxiety ### Location - Facility: Chinese PLA General Hospital, Beijing, Beijing, N/A, China @@
## Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients - NCT ID: NCT06307704 - Study ID: LUSPEEPORRPC - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-09 - Lead Sponsor: Nazmy Edward Seif ### Study Description There is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (RARPC).Preventing lung atelectasis without inducing overdistention of the lung is challenging. Many studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. However, the use of these methods is limited by inaccuracy and the need for sophisticated devices.Bedside Lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. Ultrasound-guided PEEP titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability.The aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise PEEP optimization in patients undergoing RARPC on oxygenation, intraoperative and early postoperative pulmonary complications. ### Conditions - Prostate Cancer - Urinary Bladder Cancer - Surgery - Positive End Expiratory Pressure - Lung Ultrasound ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Lung Ultrasound - guided Stepwise PEEP - Standard Ventilation Protocol ### Outcomes Primary Outcomes - Post-operative lung consolidation Secondary Outcomes ### Location - Facility: Cairo University Hospitals, Cairo, N/A, N/A, Egypt @@
## Clinical and Radiographic Evaluation of Immediate Implant Placement Using Osseodensification Versus Traditional Drilling Protocol - NCT ID: NCT06307691 - Study ID: 11423 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2026-12-20 - Lead Sponsor: Cairo University ### Study Description For the purpose of the study, patients will be divided into two groups, i.e., Group A and Group B. In Group (A), 14 immediate implants will be placed using traditional drilling technique, while in Group (B), 14 immediate implants will be placed using OD drilling technique Osseodensification is a system for implant osteotomy preparation, it compresses the cancellous bone around the revolving drills. It largely improves low bone volume by physically increasing the interlocking between the bone and the implant surface. The Densah burs enhances bone density while generating the least amount of heat.Traditional oversized drilling is the regular manufacturer recommended technique of drilling. It functions by cutting the bone during osteotomy preparation by sharp fluted drills. The undersizing of the preparation allows the implant to partially compact the bone during insertion.The objective of the current study is to compare between osseodensification drilling protocol versus traditional undersized drilling protocol in immediate implant placement in anterior maxillary region in terms of implant stability. ### Conditions - Implant Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional drilling - Osseodensification drilling ### Outcomes Primary Outcomes - Implant stability quotient (ISQ) Secondary Outcomes - Crestal bone level ### Location - Facility: Faculty of Dentistry Cairo University, Cairo, N/A, N/A, Egypt @@
## Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators - NCT ID: NCT06307678 - Study ID: AtaturkU-DHF-MS-01 - Status: COMPLETED - Start Date: 2023-07-07 - Completion Date: 2023-12-10 - Lead Sponsor: Ataturk University ### Study Description Calcium hydroxide is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited.The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on the release of RANKL/OPG, TNF-α, PGE-2 and TGF-β1 in root canal treated teeth with periapical lesions. ### Conditions - Periapical; Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Calcium Hydroxide - Calcium Silicate ### Outcomes Primary Outcomes - preoperative and postoperative levels of RANKL/OPG ratio - preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio - preoperative and postoperative levels of TNF alpha ratio - preoperative and postoperative levels of TGF beta ratio Secondary Outcomes - dependent variables (sex, age, teeth number, smoking habit) ### Location - Facility: Ataturk University, Erzurum, N/A, 25240, Turkey @@
## Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma - NCT ID: NCT06307665 - Study ID: D6934C00001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-08 - Completion Date: 2027-10-13 - Lead Sponsor: AstraZeneca ### Study Description The purpose of this study is to compare the budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI) administered as needed on severe asthma exacerbations in adolescent participants aged 12 to \< 18 years with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year. ### Conditions - Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BDA MDI - AS MDI ### Outcomes Primary Outcomes - Annualized rate of severe asthma exacerbations (AAER) Secondary Outcomes - Time to first (TTF) severe asthma exacerbation - Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma - Number of participants with adverse events (AEs) and severe adverse events (SAEs) - Maximum Observed Concentration (Cmax) - Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) - Area under plasma concentration-time curve from time 0 to infinity (AUCinf) - Time to reach maximum concentration following drug administration (Tmax) - Time to reach maximum concentration following drug administration (Tlast) - Terminal elimination half-life (t½λz) - Terminal elimination rate constant (λz) - Apparent total body clearance (CL/F) - Apparent volume of distribution based on the terminal phase (Vz/F) ### Location - Facility: Research Site, White Marsh, Maryland, 21162, United States @@
## Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function - NCT ID: NCT06307652 - Study ID: D6402C00012 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-12 - Completion Date: 2027-06-11 - Lead Sponsor: AstraZeneca ### Study Description This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events. ### Conditions - Heart Failure and Impaired Kidney Function ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg - balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg - dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin ### Outcomes Primary Outcomes - Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation Secondary Outcomes - Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation - Total occurrences (first and recurrent) of HF hospitalisations - Time to CV death - The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation - Time to death from any cause ### Location - Facility: Research Site, Alexander City, Alabama, 35010, United States @@
## Seminal Levels of PGK2 and ACRV1 as Predictors of Micro-TESE Results in NOA - NCT ID: NCT06307639 - Study ID: MYMSwifee - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Assiut University ### Study Description * Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).* Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples. ### Conditions - Male Infertility Due to Azoospermia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE). ### Outcomes Primary Outcomes - Know more about the functional role of PGK2 and ACRV1 in the process of spermatogenesis. - Detect if PGK2 and/or AVRV1 level can used as predictor for spermatogenesis in infertile men with non-obstructive azoospermia undergoing Testicular Sperm Extraction. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease. - NCT ID: NCT06307626 - Study ID: ARGX-113-2309 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2027-10 - Lead Sponsor: argenx ### Study Description This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.After an up to 28-day screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively. Study drug will be administered subcutaneously during the 24-week double-blinded treatment period (DBTP). At the end of the DBTP (week 24), proptosis responders will enter a follow-up observational period (52 weeks) to assess the safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy. Proptosis nonresponders and participants who have proptosis relapse during the 52-week follow-up observational period will receive open-label treatment with efgartigimod PH20 SC for up to 24 weeks. ### Conditions - Thyroid Eye Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Efgartigimod PH20 SC - Placebo PH20 SC ### Outcomes Primary Outcomes - Percentage of participants who were proptosis responders Secondary Outcomes - Change in proptosis measurement in the study eye from baseline - Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline - Percentage of participants with a resolution of diplopia (responders) ### Location - Facility: Advanced Research, Boynton Beach, Florida, 33437, United States @@
## A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease - NCT ID: NCT06307613 - Study ID: ARGX-113-2301 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2027-10 - Lead Sponsor: argenx ### Study Description This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.After an up to 28-day screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively. Study drug will be administered subcutaneously during the 24-week double-blinded treatment period (DBTP). At the end of the DBTP (week 24), proptosis responders will enter a follow-up observational period (52 weeks) to assess the safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy. Proptosis nonresponders and participants who have proptosis relapse during the 52-week follow-up observational period will receive open-label treatment with efgartigimod PH20 SC for up to 24 weeks. ### Conditions - Thyroid Eye Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Efgartigimod PH20 SC - Placebo PH20 SC ### Outcomes Primary Outcomes - Percentage of participants who were proptosis responders Secondary Outcomes - Change in proptosis measurement in the study eye from baseline - Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline - Percentage of participants with a resolution of diplopia (responders) ### Location - Facility: Advanced Clinical Research, Coral Springs, Florida, 33067, United States @@
## The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia - NCT ID: NCT06307600 - Study ID: BHCT-RD06-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-04-01 - Lead Sponsor: Anhui Provincial Hospital ### Study Description This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia. ### Conditions - B Lymphoblastic Leukemia/Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - RD06-03 cell injection ### Outcomes Primary Outcomes - Dose-limiting toxicity Secondary Outcomes ### Location - Facility: Anhui Provincial Hospital, Hefei, Anhui, 230036, China @@
## Vastus Intermedius Dry Needling for Knee Stiffness Resulted From Surgically Managed Femoral Fractures With Open Reduction & Internal Fixation. - NCT ID: NCT06307587 - Study ID: 2023/2355 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-03-12 - Lead Sponsor: Al-Razi Hospital ### Study Description Orthopedic traumatic injuries are considered a major health epidemic, challenged by high morbidity, mortality, and socioeconomic burden. The management of traumatic orthopedic injuries is challenging and complex, with high resources utilization. Particularly, the prevalence of femoral fractures in Kuwait is 8.8%, being one of the most prevalent injuries. Open reduction and internal fixation (ORIF) is a common surgical procedure for the management of femoral fractures demonstrating successful outcome for allowing minimally invasive percutaneous plate osteosynthesis, early union of 93% to 100%, and low infection rate of only 0% to 2%. Yet, one of the major complications post ORIF is knee stiffness and reduced function, which brings many inconveniences to patients' daily lives, lead to disability, and could seriously threaten the functional activities of patients. The incidence of knee stiffness requiring surgical intervention is 14.5%. Particularly, the potential loss of knee flexion is 30 to 40 degrees, 13% of the patients failed to reach 90 degrees of knee flexion, and only 48% of patients reached \>120 degrees of flexion. Ultimately, knee stiffness in flexion forms a major issue in distal femoral fractures. Various reasons could explain such complication including intrinsic adhesions, fibrosis and shortening of the vastus intermedius muscle.There are various surgical procedures which could be used to manage knee stiffness. However, there is no consensus regarding the ideal approach and strategy with many postoperative complications including deep sepsis, quadricep tendon rupture, skin dehiscence and infection, delayed wound healing, patella fracture, lateral femoral condyle fracture and extension lag. In contrast, dry needling (DN) is a minimal invasive intervention for the management of musculoskeletal dysfunction, and it could be used to reduce the adhesion and fibrosis between the vastus intermedius and the femoral bone. However, there is limited research investigating the effect of DN on the vastus intermedius muscle after ORIF of the femoral fractures. The effectiveness of DN was explored for the management of various musculoskeletal conditions, and a systematic review addressing DN in the lower quarter concluded that DN is an effective procedure (Morihisa et a,., 2016). In ACL reconstruction, DN for the vastus medialis improved ROM at short-term and improved function at both short and long term. DN has been proposed as a useful addition to the rehabilitation of ACL reconstructed in reducing pain intensity, increasing knee flexion range, and modifying the mechanical properties of the quadriceps muscle during the late-stage of rehabilitation. DN has also altered the passive mechanical properties of the quadriceps muscle where decrement and resistance of the vastus medialis were significantly reduced. It is hypothesized that releasing the adhesions and fibrosis of the vastus intermedius could play an important role in managing knee stiffness post ORIF of the distal femur fractures. Therefore, the aim of this project is to identify the incidence rate and risk factors of knee stiffness resulted from surgically managed femoral fractures with open reduction and internal fixation in Kuwait, and to investigate the effect of DN on the vastus intermedius muscle in improving knee joint range of motion and function after ORIF of the distal femur using single blind randomized controlled trial (RCT). ### Conditions - Femur Fracture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - dry needling ### Outcomes Primary Outcomes - knee flexion range of motion Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## bpMedManage: Digital Technology to Support Adherence to Hypertension Medications - NCT ID: NCT06307574 - Study ID: STUDY00002804 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2025-12 - Lead Sponsor: University of Arizona ### Study Description The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomized controlled trial. A total of 100 older adults will be recruited. There will be two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on an education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes on primary and secondary measures will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention. ### Conditions - Aging - Mild Cognitive Impairment - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - bpMedManage ### Outcomes Primary Outcomes - Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap) - Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne) Secondary Outcomes - Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings - Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale - System Usability measured by the System Usability Scale ### Location - Facility: University of Arizona, Tucson, Arizona, 85721, United States @@
## The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia - NCT ID: NCT06307561 - Study ID: GGurzoglu - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2024-01-01 - Lead Sponsor: Acıbadem Atunizade Hospital ### Study Description Dystonia is the most common movement disorder in the pediatric population after spasticity. It can affect normal motor development and cause significant motor retardation. The presence of dystonia may affect motor function, pain, and ease of care in CP. Additionally, it can cause serious difficulties in daily living activities and social participation and long-term joint deformity. The increase in the severity of dystonia in CP children with secondary dystonia may affect the quality of life, activity and participation of the children, as well as the caregiver. The importance of caregivers is an undeniable fact, especially in these patient groups. This study aims to investigate the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia. ### Conditions - Secondary Dystonia - Cerebral Palsy, Mixed ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The Barry-Albright Dystonia Scale (BADS) - The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) - The Care and Comfort Hypertonicity Questionnaire (CCHQ) Secondary Outcomes ### Location - Facility: Acıbadem Altunizade Hospital, Istanbul, Altunizade, 34662, Turkey @@
## Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer - NCT ID: NCT06307548 - Study ID: I-3670923 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-06-01 - Lead Sponsor: Roswell Park Cancer Institute ### Study Description This phase I/II trial studies the side effects and how well fluorescence image guided surgery followed by intraoperative photodynamic therapy for improving local tumor control in patients with colorectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back after a period of improvement (recurrent). Fluorescence image guided surgery uses a drug named aminolevulinic acid hydrochloride. Aminolevulinic acid hydrochloride is a photosensitizing agent, meaning that is activated by light and, is converted to another drug in cancer cells more than in normal cells. The converted drug emits fluorescence red light when activated with low power blue light. It is used to assist the surgeon to see cancer cells and small cancerous tissue that may have been missed during routine surgery. In addition to emitting fluorescence light, the converted drug in the cancer cells and tissue can be activated with red laser light to kill cancer cells. This procedure is called photodynamic therapy (PDT). Performing fluorescence image guided surgery followed by intraoperative photodynamic therapy after the surgical removal of the colorectal tumor before the surgical site will be closed may be effective and improve outcomes in patients with locally advanced or recurrent colorectal cancer. ### Conditions - Locally Advanced Colorectal Carcinoma - Recurrent Colorectal Carcinoma - Stage III Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Aminolevulinic Acid - Biospecimen Collection - Computed Tomography - Fluorescence-Guided Surgery - Magnetic Resonance Imaging - Photodynamic Therapy - Surgical Procedure ### Outcomes Primary Outcomes - Accuracy of the fluorescence imaging (Phase I) - Incidence of adverse events (Phase I) - Evidence of disease (Phase II) - Changes in carcinoembryonic antigen (CEA) and circulating tumor deoxyribonucleic acid (ctDNA) (Phase II) Secondary Outcomes - Changes in CEA and ctDNA (Phase I) - Rate of recurrence (Phase I) - Rate of local recurrence (Phase II) - Disease free survival (Phase II) - Correlation between disease free survival and changes in levels of CEA (Phase II) - Correlation between disease free survival and changes in levels of ctDNA (Phase II) ### Location - Facility: Roswell Park Cancer Institute, Buffalo, New York, 14263, United States @@
## A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer - NCT ID: NCT06307535 - Study ID: 23-376 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2029-03-01 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description Participants will complete 1 set of questionnaires about 2 weeks before beginning their Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. Participants will then be assigned to receive either MCP-C or SP-C for 7 sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of MCP-C or SP-C. It will take between 35 and 50 minutes to complete each set of questionnaires.After participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires, their participation in this study will end. If participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires.Participants may remain in the study and continue to receive all 7 sessions of MCP-C or SP-C even if their loved one passes away. ### Conditions - Caregiver Burden - Caregiver Burnout - Caregiver Stress Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Meaning-Centered Psychotherapy for Caregivers - Supportive Psychotherapy for Caregivers ### Outcomes Primary Outcomes - Number of participants with improved primary outcomes Secondary Outcomes ### Location - Facility: University of Miami (Data Collection AND Data Analysis), Miami, Florida, 33136, United States @@
## MRG-001 in Patients With Alcoholic Hepatitis - NCT ID: NCT06307522 - Study ID: MRG24ALC - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-12-01 - Lead Sponsor: MedRegen LLC ### Study Description The goal of this study is to test MRG-001 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of MRG-001 in patients with severe alcoholic hepatitis (AH). ### Conditions - Alcoholic Hepatitis - Acute Alcoholic Hepatitis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - MRG-001 ### Outcomes Primary Outcomes - Assessment of Treatment-Emergent Adverse Events Secondary Outcomes - Pharmacokinetic Response - Pharmacodynamic Response ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Adiposity and Immunometabolism in Sepsis - NCT ID: NCT06307509 - Study ID: GN23AN097 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-07-31 - Lead Sponsor: NHS Greater Glasgow and Clyde ### Study Description Obesity has been shown to increase adverse outcomes in some critically ill patients e.g. those with COVID-19. For patients with sepsis this association is less clear cut but there is evidence that body fat distribution, resulting from impaired subcutaneous adipose tissue function, is associated with adverse clinical outcomes in critical care. The investigators aim to study subcutaneous adipose tissue function in lean and obese sepsis patients in critical care and compare that to healthy controls.First, the study will investigate differences in adipose tissue function (inflammation and mitochondrial function) related to obesity. Second, the investigators will examine whether lean critically ill patients with sepsis have enhanced adipose tissue inflammation and mitochondrial dysfunction compared to lean controls and whether this is further exacerbated by obesity.Patients will be either undergoing emergency abdominal surgery, or will have been admitted to a critical care unit with a diagnosis of sepsis.The investigators will collect blood and adipose tissue biopsies from the patients, and these will be analysed for markers of inflammation and of mitochondrial function.The aim is to better understand the relationship between obesity, inflammation, mitochondrial dysfunction and sepsis. The investigators hope that this may improve the understanding of the pathophysiology of sepsis and allow more targeted interventions for patients based on differences in their baseline metabolic state. ### Conditions - Obesity - Sepsis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diagnosis of sepsis ### Outcomes Primary Outcomes - Difference in adipocyte cytokine secretion between patients with sepsis, and patients without sepsis, and between SAT and VAT samples Secondary Outcomes - Differences in adipocyte size - Differences in mitochondrial morphology - Differences in adipocyte pro-inflammatory gene expression - Differences in adipocyte mitochondrial number - Differences in adipocyte mitochondrial viability - Differences in SVF cytokine secretion - Differences in capacity of pre-adipocytes to differentiate into mature adipocytes ### Location - Facility: Department of Critical Care Medicine, Queen Elizabeth University Hospital, Glasgow, N/A, G51 4TF, United Kingdom @@
## VIDeOS for Smoking Cessation - NCT ID: NCT06307496 - Study ID: Pro00133913 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-07 - Lead Sponsor: Medical University of South Carolina ### Study Description The purpose of the current study is to pilot the efficacy, feasibility, and acceptability of an evidence-based smoking cessation intervention adapted for cancer patients and delivered via video. Investigators aim to assess if this intervention is considered acceptable by participants, feasible to implement, and effective at increasing knowledge about smoking cessation before conducting a fully powered clinical trial. ### Conditions - Cancer - Smoking Cessation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Smoking cessation intervention - Informational intervention ### Outcomes Primary Outcomes - Acceptability - Feasibility - Retention Rates Secondary Outcomes - Changes in knowledge about quitting smoking - Changes in smoking behaviors ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dose-effect Relationship of Tai Chi on Health Promotion in Different Age Groups - NCT ID: NCT06307483 - Study ID: 20240108 - Status: COMPLETED - Start Date: 2023-08-25 - Completion Date: 2023-11-25 - Lead Sponsor: Beijing Sport University ### Study Description The purpose of this study is to investigate the physical and mental health status of middle-aged and elderly people of different ages and practicing Tai chi for different periods of time, so as to provide a strong theoretical basis and practical guidance for delaying age-related aging and preventing and treating the occurrence and development of chronic diseases. ### Conditions - Sleep Disorder - Cardiovascular Diseases - Hypertension - Cognitive Impairment - Metabolic Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Taichi group - Exercise group ### Outcomes Primary Outcomes - Pittsburgh Sleep Quality Index - Heart rate variability (HRV) - Flow-mediated dilation (FMD) - Cardiac Output (CO) - Intima-Media Thickness (IMT) - The Berg Balance Scale（BBS） - The 30-s Chair Stand Test - Lower limb muscle strength test Secondary Outcomes - Body Fat Percentage - Finger-Ring Test - Hand Grip Strength - Upper and Lower Body Flexibility - The SARC-F scale - Shape Trail Test (STT) - 1-back Task more-odd shifting Task Stroop Task - Timed Up and Go - Close-eyed stepping in place - Single-leg stance with eyes closed - Ankle-Brachial Index (ABI) - Short-Physical Performance Battery (SPPB) - Hospital Anxiety and Depression Scale (HADS) - Blood pressure variability (BPV) - HUR Labs Balance Software Suite - E/A ratio - Star Excursion Balance Test apparatus（SEBT） - Montreal Cognitive Assessment(MoCA) - Brachial-ankle pulse wave velocity (BaPWV) ### Location - Facility: Beijing Sport University, Beijing, N/A, N/A, China @@
## Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors - NCT ID: NCT06307470 - Study ID: 276879 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-05-30 - Lead Sponsor: University of Arkansas ### Study Description The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:1. What is the feasibility of this intervention in an online, private setting?2. What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 8 - 10 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time. ### Conditions - Women's Health: Neoplasm of Breast - Menopause, Premature - Body Image - Sexual Dysfunction - Cancer, Breast ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience) ### Outcomes Primary Outcomes - Vulvovaginal Symptoms Questionnaire (VSQ) - Body Image Scale - Female Sexual Functioning Index Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark. - NCT ID: NCT06307457 - Study ID: A5481188 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-06 - Completion Date: 2024-08-31 - Lead Sponsor: Pfizer ### Study Description The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer. The study will consider participants who:* have advanced or metastatic breast cancer that is spread to other parts of the body.* have HR+/HER2- (hormone receptor positive\* / human epidermal growth factor receptor 2 negative\\) breast cancer types. * Hormone receptor positive (HR+): are cells that have a group of proteins that bind to a specific hormone. For example, some breast cancer cells have receptors for the hormones estrogen or progesterone.These cells are hormone receptor positive, and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Knowing if the cancer is hormone receptor positive may help plan treatment.* Human epidermal growth factor receptor 2 negative (HER2-): cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Checking to see if a cancer is HER2 negative may help plan treatment. * have started treatment in the period between January 2017 and December 2021.The study will describe the treatment effect for different patient groups in terms of age and comorbidities. Comorbidity is the condition of having two or more diseases at the same time. The data is collected by the Danish Breast Cancer Group in the period between 2017 to 2023. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Palbociclib in combination with AI ### Outcomes Primary Outcomes - Progression-free Survival (PFS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment - Overall Survival (OS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment Secondary Outcomes - Age distribution in the full data set of mBC patients receiving palbociclib + AI as first-line treatment - PFS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment - PFS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment - PFS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment - OS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment - OS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment - OS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into Charlson Comorbidity Index (CCI) point score of 0 - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1 - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2 - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 3 or higher (3+) - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 0 - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1 - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2 - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 3 or higher (3+) - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease - PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease - OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system ### Location - Facility: Copenhagen University Hospital, Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain. - NCT ID: NCT06307444 - Study ID: stellate block and ESP block - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-11-01 - Lead Sponsor: Tanta University ### Study Description Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions. ### Conditions - Acute Herpes Zoster Pain Managment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Ultrasound-Guided Stellate Ganglion Block - T2 T3 (High Thorathic) ESP Block ### Outcomes Primary Outcomes - reduction of a numeric rating scale (NRS) pain score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004) - NCT ID: NCT06307431 - Study ID: V940-004 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2032-06-08 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS. ### Conditions - Renal Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - V940 - Pembrolizumab - Placebo ### Outcomes Primary Outcomes - Disease-Free Survival (DFS) Secondary Outcomes - Overall Survival (OS) - Distant Metastasis-free survival (DMFS) - Percentage of Participants Who Experience an Adverse Event (AE) - Percentage of Participants Who Discontinue Study Treatment Due to an AE ### Location - Facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 0102), New Haven, Connecticut, 06510, United States @@
## Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport - NCT ID: NCT06307418 - Study ID: Carer eSupport RCT - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2025-10-31 - Lead Sponsor: Uppsala University ### Study Description The aim of this randomized controlled trial is to investigate the effects of internet-based support (Carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer. The main question\[s\] it aims to answer are:* What are the effects of internet-based support on informal caregivers preparedness for caregiving?* What are the effects of internet-based support on informal caregivers burden and wellbeing?Informal caregivers who are randomized to Carer eSupport will have access to Carer eSupport for 18 weeks and they will be asked to complete questionnaires (outcome measures) at:* baseline (before randomization)* 18 weeks (post-intervention) and at* 3 months after the intervention is completed (long term follow-up).Informal caregivers in the intervention group will be compared to informal caregivers who receive standard care support regarding preparedness for caregiving, caregiver burden and wellbeing. ### Conditions - Head and Neck Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Carer eSupport ### Outcomes Primary Outcomes - The self-reported questionnaire Preparedness for caregiving scale Secondary Outcomes - The self-reported questionnaire Caregiver Burden Scale - The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21) - The self-reported health-related quality of life questionnaire RAND-36 ### Location - Facility: Örebro University Hospital, Örebro, Blekinge Län, 70185, Sweden @@
## The Value of mNGS in Diagnosis of Pulmonary Infection - NCT ID: NCT06307405 - Study ID: WJP2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-09-30 - Lead Sponsor: Yunfeng Hou ### Study Description Retrospective analysis of clinical data from 50 hospital-admitted patients with suspected pulmonary infection (as judged by clinical manifestations and imaging findings) was performed on study participants who had collected two different samples of alveolar lavage fluid (BALF) and sputum and underwent metagenomic next generation sequencing (mNGS) and routine pathogen detection, respectively. The positive rate of pathogen detection and the consistency of pathogen detection results of the two detection methods were compared to evaluate the clinical manifestation and role of mNGS in pathogen diagnosis. ### Conditions - Pulmonary Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - next generation sequencing ### Outcomes Primary Outcomes - Etiological detection rates of two detection techniques Secondary Outcomes - Consistency of detection results of two detection techniques ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial) - NCT ID: NCT06307392 - Study ID: RC22_0393 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2027-03-31 - Lead Sponsor: Nantes University Hospital ### Study Description Emergency intubation is routinely performed in the prehospital setting. Airway management in the prehospital setting has substantial challenges, such as hostile environment or lack of technical support in case of first attempt intubation failure, and inherent risk of complications, such as hypoxemia, aspiration or oesophageal intubation. This risk is higher when several attempts are needed to succeed endotracheal intubation. Thus, a successful first attempt intubation is highly desirable to avoid adverse intubation-related events. Noteworthy, prehospital emergency intubation is associated with a lower rate of first attempt intubation success when compared to emergency intubation in the emergency department (ED). Research is needed to overcome the specific challenges of airway management in the prehospital setting, and to improve the safety and efficiency of prehospital emergency intubation. Literature reports that the use of assistive devices such as bougie may increase the rate of first-attempt intubation success in the ED. To date, no randomized trial has ever studied this device in the prehospital setting. Thus, the aim of the BETA trial is to compare first attempt intubation success facilitated by the bougie versus the endotracheal tube alone in the prehospital setting. ### Conditions - Acute Respiratory Failure Requiring Intubation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - First intubation attempt with endotracheal tube plus bougie - First intubation attempt with endotracheal tube alone ### Outcomes Primary Outcomes - Number of first pass success during prehospital emergency intubation Secondary Outcomes - Occurrence of hypoxia - Occurrence of bradycardia - Occurrence of cardiac arrest - Occurrence of death - Occurrence of pulmonary aspirations - Occurrence of severe cardiovascular collapse - Time between blade introduction to the confirmation of a correct tube placement - Change in SpO2 (pulsed oxygen saturation) from the time of induction to lowest SpO2 up to 2 minutes after confirmation of correct tube placement - Occurrence of change in SpO2 of more than 3% from the time of induction to 2 minutes after confirmation of correct tube placement - Cormack-Lehane grade of glottic view at first intubation attempt - Number of laryngoscopies attempts to achieve correct endotracheal tube placement - Number of patients for whom the placement of an endotracheal tube was not possible in the pre-hospital setting - Difficulty perceived by the operator on first intubation attempt - Occurrence of injuries - Occurrence of complications - Change of SpO2/FiO2 ratio (pulsed oxygen saturation / fraction of inspired oxygen) between the time of confirmation of correct tube placement and the minimum ratio ### Location - Facility: Nantes University Hospital, Nantes, Loire Atlantique, 44093, France @@
## Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures - NCT ID: NCT06307379 - Study ID: EC 23022 - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2025-12-30 - Lead Sponsor: Vitaz ### Study Description 'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare.Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce. ### Conditions - Bronchial Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - Procedure-related dyspnea scale (VAS) - Procedure-related pain scale (VAS) - Procedure related cough scale (VAS) - General patient satisfaction Secondary Outcomes - Procedure-related complications: - Sedation-related complications - Diagnostic yield ### Location - Facility: VITAZ, Sint-Niklaas, N/A, N/A, Belgium @@
## Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research - NCT ID: NCT06307366 - Study ID: ErasmusMC10365 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Erasmus Medical Center ### Study Description Despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. Neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. Furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. To date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. Therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research. ### Conditions - Mental Illness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention will be used ### Outcomes Primary Outcomes - Themes around the topics (related to perceptions and experiences) explored. Secondary Outcomes ### Location - Facility: Erasmus Medical Center, Rotterdam, Zuid-Holland, 3000CB, Netherlands @@
## Trends of Contraception Methods in Urban Medical Center in el_Balyana - NCT ID: NCT06307353 - Study ID: Soh_Med_23_12_05MS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Sohag University ### Study Description family planning is avital primary Health care intervention that saves lives of mothers and infants empowers women and support their choices regarding their health public life and additional education .In addition family planning is considered as a short term intervention to limit population growth and manage overpopulation problems.Globally the contraception prevalance rate an indicator for family planning programs continue to face challenges in developing countries. ### Conditions - Contraception ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - trends of contraception methods ### Outcomes Primary Outcomes - number of married women in child bearing period attending the El_Balyana Medical Center using contraception methods . Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations - NCT ID: NCT06307340 - Study ID: 22-01058 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: NYU Langone Health ### Study Description During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors. ### Conditions - Polysubstance Abuse - Posttraumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT) - Treatment as Usual ### Outcomes Primary Outcomes - Proportion of Eligible Participants - Proportion of Eligible Participants who Enroll - Number of Intervention Sessions Completed - Clinician-Rated Feasibility of Intervention Measure (FIM) Score - Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score - Number of Days of Co-Use of Cocaine and Illicit Opioids - Number of Substances Used based on ASI Self-Report - Number of Substances Used based on Urine Drug Screen - Number of Substances Used based on Chart Abstraction of Toxicology Results - PTSD Checklist for DSM-5 (PCL-5) Score - Negative Mood Regulation Scale Score - Inventory of Interpersonal Problems Score Secondary Outcomes ### Location - Facility: Florida State University, Tallahassee, Florida, 32306, United States @@
## Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis - NCT ID: NCT06307327 - Study ID: NFEC-2024-098 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples. ### Conditions - Head and Neck Cancer - Radiation-Induced Mucositis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluation consistency Secondary Outcomes ### Location - Facility: Southern medical university, Guangzhou, Guangdong, 510515, China @@
## Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis - NCT ID: NCT06307314 - Study ID: NFEC-2024-093 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-12-31 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients. ### Conditions - Nasopharyngeal Carcinoma - Head and Neck Cancer - Radiotherapy-induced Oral Mucositis - Biomarker ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Different grades radiotherapy-induced oral mucositis Secondary Outcomes - Start and duration of radiotherapy-induced oral mucositis - Side effects of radiotherapy - Tumor response ### Location - Facility: Nanfang hospital, Southern medical university, Guangzhou, Guangdong, 510515, China @@
## Study in ALS With Abatacept & IL-2 - NCT ID: NCT06307301 - Study ID: PRO00031998 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-10-28 - Completion Date: 2024-10-17 - Lead Sponsor: The Methodist Hospital Research Institute ### Study Description In Amyotrophic Lateral Sclerosis (ALS), the reduction of regulatory T-lymphocyte (Treg) numbers and suppressive function correlates with rapid disease progression. The investigator completed a phase 1 study of infusions of expanded autologous Tregs in combination with subcutaneous IL-2 injections in ALS patients, which showed enhancement of Treg numbers and suppressive function in vivo. The enhanced Treg suppressive function correlated strongly with slowing and stabilization of disease progression. Drugs that enhance endogenous Treg numbers and suppressive function may also stabilize disease in ALS. This phase 1 study aims to determine whether the combination therapy of subcutaneous IL-2 and abatacept (Orencia®) is safe and well-tolerated in 6 patients with ALS, and whether the therapy enhances Treg numbers and suppressive function in vivo. ### Conditions - Amyotrophic Lateral Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Abatacept Injection [Orencia] and Proleukin (aldesleukin) ### Outcomes Primary Outcomes - To evaluate adverse events and laboratory abnormalities to assess the safety and tolerability of abatacept followed by Interleukin 2 (IL-2) administration in ALS patients Secondary Outcomes - Change in Regulatory T cells (Tregs) numbers in the blood from baseline - Change in Regulatory T cells (Tregs) suppressive function in the blood from baseline - Changes in the level of cytokines secreted by PBMCs from baseline ### Location - Facility: Houston Methodist Research Institute, Houston, Texas, 77030, United States @@
## Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea - NCT ID: NCT06307288 - Study ID: 20240301-2 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-10-16 - Completion Date: 2024-06-01 - Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University ### Study Description Rosacea is a chronic inflammatory skin disease with a complex pathogenesis involving multiple factors. Currently, the treatment of rosacea remains highly challenging. Mast cells, as key participants in the pathogenesis of rosacea, have been shown to alleviate rosacea symptoms with some topical, oral, and injectable mast cell stabilizers in recent years. Tranilast stabilizes mast cells and basophils by acting on their cell membranes and preventing their degranulation. Tranilast has been used in the treatment of various skin disease, such as hypertrophic scars and atopic dermatitis. Minocycline is a first-line treatment for rosacea, and low-dose minocycline treatment (50mg/day) is believed to have anti-inflammatory effects without antibacterial effects, thus minimizing the dysbiosis and bacterial resistance caused by antibiotic use. Therefore, this study aims to investigate the effectiveness and safety of combining mast cell stabilizer tranilast with low-dose minocycline treatment for rosacea, providing new treatment options and insights for rosacea patients. ### Conditions - Rosacea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - minocycline - tranilast ### Outcomes Primary Outcomes - lesion counts - Clinician's Erythema Assessment score - Global Flushing Severity Scale score - Global Acne Grading System score Secondary Outcomes - patient satisfaction evaluation - melanin index - erythema index - transepidermal water loss - Dermatology Life Quality Index score ### Location - Facility: The Second Affiliated Hospital of Xi'an Jiaotong Universi, Xi'an, Shaanxi, 710000, China @@
## Intermittent Fasting on Body Fat and Quality of Life - NCT ID: NCT06307275 - Study ID: 5170221 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-12-31 - Lead Sponsor: Loma Linda University ### Study Description The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Fasting - non fasting ### Outcomes Primary Outcomes - Body fat percentage - Visceral fat Secondary Outcomes ### Location - Facility: Loma Linda University, Loma Linda, California, 92350, United States @@
## European Registry of Transcatheter Repair for Tricuspid Regurgitation - NCT ID: NCT06307262 - Study ID: EuroTR Registry - Status: RECRUITING - Start Date: 2023-10-23 - Completion Date: 2030-12-31 - Lead Sponsor: LMU Klinikum ### Study Description To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement. ### Conditions - Tricuspid Regurgitation - Valvular Heart Disease - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - T-TEER ### Outcomes Primary Outcomes - All-cause mortality Secondary Outcomes - Technical success - Procedural Safety - Heart Failure Biomarker - Dyspnea on exertion - Functional capacity - Right ventricular size - Right ventricular function - Tricuspid regurgitation reduction - Tricuspid valve stenosis - Pulmonary hypertension - Right heart congestion - Hospitalization for heart failure ### Location - Facility: LMU Klinikum, Munich, Bavaria, 81377, Germany @@
## Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA - NCT ID: NCT06307249 - Study ID: LU_HH_Cancer_Precision Therapy - Status: RECRUITING - Start Date: 2023-02-15 - Completion Date: 2027-12 - Lead Sponsor: Lebanese University ### Study Description Solid tumors pose significant challenges in current therapeutic approaches. Targeted therapy has emerged as a promising avenue, aiming to enhance treatment efficacy while minimizing adverse effects. This clinical trial focuses on an innovative combination of two targeted inhibitors, Palbociclib and Bevacizumab, for their potential synergistic effects in addressing these challenging malignancies. Moreover, this study incorporates a molecular approach by considering Long Non-Coding RNAs (LncRNAs) as biomarkers. Initiating with a focus on colorectal cancer, the study aims to expand its scope to other solid tumors, including lung, breast, ovarian and other cancers. Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, disrupts the cell cycle progression, particularly in cancer cells with specific molecular characteristics. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, targets angiogenesis-a critical process for tumor growth and metastasis. The rationale behind combining these agents lies in their complementary mechanisms of action, potentially leading to enhanced antitumor effects. LncRNAs have shown promise in predicting treatment response and prognosis in various cancers, providing an additional layer of precision to the treatment strategy. By elucidating the molecular basis through LncRNA analysis, the trial aims to tailor the treatment to the specific molecular profile of each patient, ultimately striving for better outcomes and improved survival rates. This novel combination therapy, coupled with a personalized biomarker-driven approach, represents a cutting-edge strategy in the pursuit of more effective and individualized treatment for solid tumors. ### Conditions - Cancer - Solid Tumor - Colorectal Cancer - Breast Cancer - Ovarian Cancer - Lung Cancer - Targeted Therapy - Chemotherapy - Immunotherapy - Precision Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SNP - Palbociclib 125mg - Bevacizumab ### Outcomes Primary Outcomes - Assessment of Cancer Progression - Identification of Potential Biomarkers - Evaluation of Treatment Response to Palbociclib and Bevacizumab Combination Therapy Secondary Outcomes - Survival Rates - Adverse Events - Assessment of Immune Checkpoint Expression (e.g., PD-1 and CTLA-4) - Measurement of Angiogenic Factors (e.g., VEGF) - Measurement of Tumor Proliferation Markers (e.g., Ki67, P16) ### Location - Facility: Haykel Hospital, Tripoli, North Lebanon, 961, Lebanon @@
## Dysmenorrhea of Emotional Freedom Techniques (EFT) and Its Effect on Perceived Stress Level - NCT ID: NCT06307236 - Study ID: E-41997688-050.99-105442 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-12-15 - Completion Date: 2024-04-15 - Lead Sponsor: Kutahya Health Sciences University ### Study Description The aim of the study is to determine the effect of EFT application on the level of dysmenorrhea and stress perception in women with dysmenorrhea. For this purpose, EFT will be applied to women with dysmenorrhea with high stress perception assigned to the experimental and control groups, and their stress perceptions and dysmenorrhea levels will be re-evaluated after the application. Perceived Stress Scale (PSS) and Visual Analog Scale (VAS) will be used in the research. ### Conditions - Dysmenorrhea Primary - Stress - Emotional Freedom ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Emotional Freedom Techniques ### Outcomes Primary Outcomes - EFT application - Control Secondary Outcomes ### Location - Facility: Kütahya Health Science University, Kütahya, N/A, 43000, Turkey @@
## Efficacy and Safety of 30% Supramolecular Salicylic Acid Combined With Supramolecular Active Zinc in the Treatment of Malassezia Folliculitis - NCT ID: NCT06307223 - Study ID: 20240301 - Status: COMPLETED - Start Date: 2022-06-07 - Completion Date: 2023-09-20 - Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University ### Study Description Malassezia folliculitis is a common dermatological disorder. While antifungal agents generally demonstrate efficacy in application, the prevalence of recurrence and drug resistance remains a common occurrence. Supramolecular salicylic acid represents a novel class of superficial chemical peel agents, exhibiting keratolytic, anti-inflammatory, and bacteriostatic properties. Zinc pyrithione has broad spectrum antibacterial, antifungal, and anti-inflammatory effects. In the present study, investigators evaluated the clinical efficacy of topical application of supramolecular salicylic acid in combination with zinc pyrithione for the treatment and prevention of Malassezia folliculitis recurrence. All data are recorded and compared after the end of the experiment. The enrolled patients received daily application of topical supramolecular active zinc anti-dandruff lotion, in conjunction with weekly application of 30% supramolecular salicylic acid, for a duration of 8 weeks. Lesion counts, Malassezia detection, clinical symptom scores, patient satisfaction, and side effects were recorded at each visit till the week 12. ### Conditions - Malassezia Folliculitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 30% supramolecular salicylic acid - supramolecular active zinc ### Outcomes Primary Outcomes - lesion counts - The reduction rate of lesion counts - Clinical efficacy Secondary Outcomes - Clinical symptoms scores ### Location - Facility: The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710000, China @@
## Is Inpatient Rehabilitation Effective for Very Old Patients? - NCT ID: NCT06307210 - Study ID: coreset_2020_2022 - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2023-01-01 - Lead Sponsor: Klinik Valens ### Study Description The goal of this retrospective longitudinal observational study is to compare the effects of physical and mental performance as well as quality of life in patients with neurological and musculoskeletal disorders.The main question it aims to answer is: Do very old patients benefit in a similar way from inpatient rehabilitation like younger patients? Data from about 2000 patients will be retrospectively analyzed. Functional Independence Measurement (FIM), Timed Up and Go Test (TUG), EuroQol 5 Dimensions (EQ-5D) and Patient Reported Outcomes Measurement Information System (PROMIS) were recorded on admission and discharge.Researchers will compare the age group 75 to 84 and 85 to 99 to see if physical and mental performance as well as quality of life will improve. ### Conditions - Activity, Motor - Elderly Patients - Musculoskeletal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - inpatient rehabilitation ### Outcomes Primary Outcomes - FIM - TUG - EQ-5D (Quality of life) - PROMIS Secondary Outcomes ### Location - Facility: Klinik Valens, Valens, Saint Gallen, CH-7317, Switzerland @@
## HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia - NCT ID: NCT06307197 - Study ID: INRCA_008_2023 - Status: RECRUITING - Start Date: 2023-10-02 - Completion Date: 2024-04-15 - Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani ### Study Description HAAL project aims to test several technological devices in order to improve the quality of life of older people with dementia and their informal and formal caregiver. ### Conditions - Dementia - Devices - Artificial Intelligence - Older People - Caregiver Burden ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - HAAL platform ### Outcomes Primary Outcomes - Care load of caregivers Secondary Outcomes ### Location - Facility: IRCCS INRCA Hospital, Ancona, N/A, N/A, Italy @@
## Assessing the Convenience of Natural Proliferative Phase Frozen Embryo Transfer - NCT ID: NCT06307184 - Study ID: 2301-LIS-007-AN - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2025-07 - Lead Sponsor: Instituto Valenciano de Infertilidade de Lisboa ### Study Description This study will assess the convenience of the natural proliferative phase frozen embryo transfer (NPP-FET) in terms of number of number of appointments needed before cycle scheduling. ### Conditions - Frozen Embryo Transfer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Natural proliferative phase frozen embryo transfer ### Outcomes Primary Outcomes - Number of appointments needed before cycle scheduling Secondary Outcomes - Cycle duration until embryo transfer (days) - Proportion of patients with low progesterone values on the day of embryo transfer - Human corionic gonadotropin (hCG) positive rate - Miscarriage rate - Ongoing pregnancy rate - Live birth rate ### Location - Facility: Instituto Valenciano de Infertilidade, Lisboa, N/A, N/A, Portugal @@
## Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers - NCT ID: NCT06307171 - Study ID: 2023-11 - Status: RECRUITING - Start Date: 2023-05-22 - Completion Date: 2026-11 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples.General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria. ### Conditions - Leishmaniasis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - In-house Western blot, specific for Leishmania ### Outcomes Primary Outcomes - Biomarkers from Leishmania spp Secondary Outcomes - ARPs in different Leishmania infantum and L. donovani strains - Cross reaction ### Location - Facility: IRCCS Sacro Cuore Don Calabria hospital, Negrar, Verona, 37024, Italy @@
## Influence of Intraoperative Blood Salvage and Autotransfusion on Tumor Recurrence After Deceased Donor Liver Transplantation - NCT ID: NCT06307158 - Study ID: CT2024-ZJU-OBS1 - Status: COMPLETED - Start Date: 2015-01-01 - Completion Date: 2021-12-31 - Lead Sponsor: Zhejiang University ### Study Description The practice of intraoperative blood salvage and autotransfusion (IBSA) during deceased donor liver transplantation (DDLT) for hepatocellular carcinoma (HCC) can potentially reduce the need for allogeneic blood transfusion. However, implementing IBSA remains debatable due to concerns about its possible detrimental effects on oncologic recurrence. Hence, a nationwide multi-center study was conducted to investigate further the association between IBSA and post-transplant HCC recurrence, including a stratified subgroup analysis. ### Conditions - Liver Transplant; Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Postoperative recurrence of liver cancer Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Korea Hip Replacement Surgery Registry - NCT ID: NCT06307145 - Study ID: K-NHIS-HIP - Status: COMPLETED - Start Date: 2003-01-01 - Completion Date: 2020-12-31 - Lead Sponsor: Samsung Medical Center ### Study Description This cohort study obtained data from the Korean National Health Insurance Service (K-NHIS) database. For the hip replacement registry, we included all adult patients older than 19 who received total or hemiarthroplasty surgery between January 1, 2003, and December 31, 2019. Using this registry, we compared efficacy and safety by type of head or liner. ### Conditions - Hip Replacement Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Cancer Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules - NCT ID: NCT06307132 - Study ID: SAHoWMU-CR2024-03-106 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-31 - Completion Date: 2024-08-31 - Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University ### Study Description This project will be based on the bioequivalence test of Aximus capsules, measuring the body composition indicators of healthy subjects before and after medication, and collecting urine samples from subjects at different time periods after medication, measuring urine drug concentration, calculating urine excretion, analyzing the individualized differences in metabolism and excretion of Aximus capsules under different health states of human components, and providing guidance for clinical precision medication. ### Conditions - Bioequivalence Trial ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Aximus capsules（test） - Aximus capsules（reference） ### Outcomes Primary Outcomes - Excretion volume Secondary Outcomes ### Location - Facility: The Second Affiliated Hospital of WMU Phase l Clinical Trial Unit /Center Of Bioequivalence Study, Wenzhou, N/A, N/A, China @@
## Model of Human Occupation-Based Intervention on Premenstrual Syndrome Symptoms - NCT ID: NCT06307119 - Study ID: 2020-01 - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2024-03-02 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description This study was conducted to examine the effect of two different occupational therapy interventions on premenstrual syndrome symptoms in university students. This study was designed according to the CONSORT statement, which provides a standard method for randomised controlled trial (RCT) design. The study was approved by the Local Ethics Committee. Written informed consent was obtained from all participants before the study. ### Conditions - Premenstrual Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Occupational Therapy and Relaxation Group - Relaxation Group ### Outcomes Primary Outcomes - Occupational Self-Assessment Secondary Outcomes - The Model of Human Occupation Screening Tool (MOHOST) ### Location - Facility: University of Health Sciences Turkey, Ankara, N/A, N/A, Turkey @@
## Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study - NCT ID: NCT06307106 - Study ID: #40\14-Jan-2024 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-14 - Completion Date: 2024-07-14 - Lead Sponsor: Zagazig University ### Study Description Since post hemorrhoidectomy pain is a severe and common post operative symptom so there is a need to find a suitable method for reducing this pain, up to our knowledge, this the first study in ZUH to compare between ketrolac, light Marcaine, corticosteroids and diclofenac sodium injection at surgical site for relieve of post operative pain. This is a randomizes comparative prospective clinical trial. ### Conditions - Acute Post Operative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - ketorolac and light marcaine - light marcaine - Corticosteroids injection - Diclofenac Sodium Gel ### Outcomes Primary Outcomes - age - sex - number of hemorrhoids - degree of hemorroids - post operative pain - ambulation - return to work - patient satisfaction Secondary Outcomes ### Location - Facility: Zagazig University Hospitals, Zagazig, N/A, 44519, Egypt @@
## Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms - NCT ID: NCT06307093 - Study ID: CL01860198 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-01 - Completion Date: 2025-07 - Lead Sponsor: R-Pharm ### Study Description The goal of this double-blind, randomized study is to establish the equivalence of pharmacokinetic properties, as well as the comparability of safety, immunogenicity and pharmacodynamics of the drug RPH-075 (international nonproprietary name (INN) is pembrolizumab) in comparison with the drug Keytruda® (INN is pembrolizumab) after a single intravenous injection to patients with malignant neoplasms as a first or second line therapy in a monotherapy regimen.The main main tasks are:* To evaluate and compare the pharmacokinetic properties of RPH-075 and Keytruda® after a single intravenous administration of pembrolizumab to patients with malignant neoplasms;* To evaluate the safety profile of the drug RPH-075 in comparison with the drug Keytruda® when used in patients with malignant neoplasms when used as a 1st or 2nd line therapy in a monotherapy regimen.This study will also include a comparative assessment of immunogenicity, pharmacodynamic parameters and a pilot evaluation of RPH-075 efficacy. ### Conditions - Skin Melanoma - Squamous Non-small-cell Lung Cancer - Head and Neck Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RPH-075 - Keytruda® ### Outcomes Primary Outcomes - Area under the curve "concentration-time" (AUC(0-504)) of pembrolizumab - Incidence of Adverse Reactions (ARs) Secondary Outcomes - Maximum Plasma Concentration (Cmax) of pembrolizumab - Maximum serum concentration of pembrolizumab at steady state (Сmax ss) - Minimal serum concentration of pembrolizumab at steady state (Сmin ss) - Area under the curve "concentration-time" of pembrolizumab at steady state (AUCtau ss) - Incidence of Treatment-Emergent Adverse Events (AEs) - Incidence of Immune-mediated adverse reactions (imARs) - Incidence of Treatment-Emergent AEs with grade 3 or more - Incidence of Treatment-Emergent ARs with grade 3 or more - Incidence of imARs with grade 3 or more - Incidence of serious adverse events (SAEs) - Incidence of serious adverse reactions (SARs) - The proportion of patients (%) who required therapy discontinuation due to AR development - The proportion of patients (%) who developed binding antibodies and neutralizing antibodies to pembrolizumab ### Location - Facility: State Budgetary Healthcare Institution of the city of Moscow "Moscow City Oncological Hospital No. 62 of the Department of Health of the City of Moscow", Istra, Moscow Region, 143423, Russian Federation @@
## Clinical Study of Multi-mode Thermal Ablation for the Treatment of Pancreatic Cancer With Liver Metastasis - NCT ID: NCT06307080 - Study ID: IIT2023-064 - Status: RECRUITING - Start Date: 2023-10-08 - Completion Date: 2024-12-31 - Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine ### Study Description 1. Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.2. Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy.3. Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies. ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Multi-mode thermal ablation device - Intravenous anti-PD-1 and chemotherapy ### Outcomes Primary Outcomes - Safety and efficacy assessment Secondary Outcomes - Survival benefit ### Location - Facility: Shanghai General Hospital, Shanghai, Shanghai, 200040, China @@
## Improving Care for Uncomplicated URinary Tract Infection-associated Symptoms in Primary Healthcare Settings in INDOnesia - NCT ID: NCT06307067 - Study ID: URINDO - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2025-06-01 - Lead Sponsor: Erasmus Medical Center ### Study Description In the present study, we aim to analyze the impact of the introduction of a urinary dipstick test for patients presenting with uncomplicated UTI-associated symptoms on antibiotic prescription in primary health care in Indonesia. In addition, the knowledge of HCW regarding antibiotics and prudent use of antibiotics in the community setting will be investigated.Specific aims of the study:1. To analyze the quality of antibiotic prescriptions for uncomplicated UTI in the primary health care settings in Indonesia, before introduction of urinary dipstick testing compared to after introduction of urinary dipstick testing.2. To analyze the knowledge level of healthcare workers on uncomplicated UTI and prudent antibiotic use in primary health care settings in Indonesia. ### Conditions - Urinary Tract Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Urine dipstick ### Outcomes Primary Outcomes - appropriateness of prescriptions for uncomplicated UTI-associated symptoms in the primary health care settings in Indonesia Secondary Outcomes ### Location - Facility: Erasmus Medical Center, Rotterdam, Zuid-Holland, 3015 GD, Netherlands @@
## CLL-1 CAR-NK Cells for Relapsed/Refractory AML - NCT ID: NCT06307054 - Study ID: SHSY-CAR-NK-AML01 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-03-15 - Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine ### Study Description This study is a single-arm, open-label, dose-escalation clinical trial aimed at exploring the safety, tolerability, and pharmacokinetic characteristics of the CLL-1 CAR NK cells, as well as providing preliminary observations on its efficacy in subjects with relapsed/refractory acute myeloid leukemia. ### Conditions - Relapsed Adult AML - Refractory AML ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - anti-CLL-1 CAR NK cells ### Outcomes Primary Outcomes - AE - DLT Secondary Outcomes - Peak Plasma Concentration (Cmax) - PD - Complete response - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Number of participants with treatment-related AEs as assessed by CTCAE v5.0 ### Location - Facility: Shanghai General Hospital, Shanghai, Shanghai, 200080, China @@
## Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses on Clinical Gingival Parameters - NCT ID: NCT06307041 - Study ID: OSATAGUN - Status: COMPLETED - Start Date: 2023-04-03 - Completion Date: 2023-08-11 - Lead Sponsor: Özlem SARAÇ ATAGÜN ### Study Description This study aimed to evaluate the effects of 0.2% HA-impregnated dental flosses on the clinical periodontal parameters of patients with gingivitis. ### Conditions - Gingivitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dental floss+Gengigel - Dental Floss ### Outcomes Primary Outcomes - Clinical Periodontal Parameter-Gingival Index (GI) - Clinical Periodontal Parameter-Papillary Bleeding Index (PBI) - Clinical Periodontal Parameter-Plaque Index(PI) Secondary Outcomes ### Location - Facility: Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi, Ankara, N/A, 06010, Turkey @@
## Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P) - NCT ID: NCT06307028 - Study ID: Pro2023002116 - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2024-08-31 - Lead Sponsor: Rutgers, The State University of New Jersey ### Study Description In this project, the investigators will provide a new HIV prevention training and empowerment sessions to Black women in Washington D.C. who are at high risk for getting HIV. This training is tailored to the experience of Black women and seeks to reduce the high HIV transmission rates in the Black community. ### Conditions - Health Behavior, Risky - Health Knowledge, Attitudes, Practice - Health-Related Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - SISTA-P Intervention ### Outcomes Primary Outcomes - Feasibility of the Intervention Scale - Acceptability of the Intervention Scale - Appropriateness of the Intervention Scale Secondary Outcomes - Recruitment - Intervention Fidelity- participant characteristics - Intervention Fidelity - Acceptability of the intervention delivery - Participant Enrollment - Participant Retention - Feasibility of delivering 6 sessions in 6 weeks - Visual confirmation of self-reported PrEP uptake - Post-Intervention Follow-up ### Location - Facility: The Women's Collective, Washington, District of Columbia, 20002, United States @@
## De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE) - NCT ID: NCT06307015 - Study ID: 2023/ETH02441 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2031-12 - Lead Sponsor: Royal North Shore Hospital ### Study Description The goal of this prospective clinical trial is to determine if HPV-associated oropharyngeal squamous cell carcinoma that is non-hypoxic on FMISO PET can be successfully treated with a lower dose of radiation therapy.The main questions it aims to answer are:1. What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection?2. What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT?3. What are the acute and late toxicities in patients selected for radiation dose de-escalation?4. What are the quality of life scores in patients selected for radiation dose de-escalation?5. What are the local, regional and distant failure rates of patients selected for radiation dose de-escalation?Patients with cT1-2N1-2b (AJCC 7th edition) oropharyngeal tumours will undergo surgical resection of the primary tumour. Following this, they will be allocated to standard radiation therapy (70Gy with concurrent cisplatin chemotherapy) or de-escalation radiation therapy (30Gy with concurrent cisplatin chemotherapy) based on the results of FMISO PET. Patients with non-hypoxic tumours at baseline OR after two weeks of radiation therapy will be allocated to the de-escalated group. 3-4 months after completion of radiation therapy, all patients in the de-escalated group will undergo mandatory neck dissection to assess pathologic response.Researchers will assess the pathologic response rate after surgery in the de-escalation group. They will also compare the outcomes (oncological outcomes and quality of life) between the group receiving the standard treatment (70Gy) and the group receiving de-escalated radiation therapy (30Gy). ### Conditions - HPV Positive Oropharyngeal Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - De-escalation - Standard of care ### Outcomes Primary Outcomes - Pathologic complete response Secondary Outcomes - Correlation between MRI and FMISO PET assessment of hypoxia - Quality of Life of patients undergoing de-escalation radiation therapy - Quality of Life of patients undergoing de-escalation radiation therapy - Local control - Regional control - Distant metastases - Acute toxicities - Late toxicities ### Location - Facility: Northern Sydney Cancer Centre, Royal North Shore Hospital, Saint Leonards, New South Wales, 2065, Australia @@
## Evaluating What's My Method? in Barbados - NCT ID: NCT06307002 - Study ID: CAS_EB_2024 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-07-30 - Lead Sponsor: Quinnipiac University ### Study Description The purpose of this study is to measure the impact of the What's My Method game on participants' sense of agency, education, and empowerment around contraceptive decision-making. Patients receiving standard of care contraceptive counseling will be compared to those who play the game in addition to counseling. ### Conditions - Contraception Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Playing a contraception education videogame ### Outcomes Primary Outcomes - Contraceptive Self-Efficacy (CSE) score Secondary Outcomes - Method Adoption - Qualitative feedback on game intervention ### Location - Facility: Barbados Family Planning Association, Bridgetown, Saint Michaels, BB11085, Barbados @@
## Observational Clinical Study of Letermovir for Preventing CMV Infection After Allo-HSCT - NCT ID: NCT06306989 - Study ID: Zhengzhou University - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-12-01 - Lead Sponsor: Cao Weijie ### Study Description The goal of this observational study is to get a series of clinical data related to the prevention of CMV infection after allo-HSCT with letemovir. The main question it aims to answer are:* Efficacy and safety of letemovir for the prevention of CMV infection after allo-HSCT.* Optimal initiation of letemovir to prevent CMV infection. Participants will be categorized into high-risk and intermediate-risk groups based on risk factors for CMV infection.Initiate letemovir prophylaxis on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients.(240 mg, qd in patients with concomitant cyclosporine; 480 mg, qd in patients with concomitant tacrolimus) to +100 days. For patients with comorbid GVHD who require intensive immunosuppression, consider extending the regimen to +200 days.Treatments they will be given and use bullets. ### Conditions - Letemovir for the Prevention of CMV Infection After Allo-HSCT ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Letermovir ### Outcomes Primary Outcomes - Prevalence of CMV viremia and CMV disease within 100 days after allogeneic hematopoietic stem cell transplantation. Secondary Outcomes - +30-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +30-day relapse rate; +30-day aGVHD incidence. - +100-day overall survival, non-relapse mortality; + 100-day relapse rate; + 100-day aGVHD incidence. - +180-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +180-day relapse rate; +180-day aGVHD incidence. ### Location - Facility: Cao, Weijie, Zhengzhou, Henan, 450000, China @@
## Shear-Wave Elastography - NCT ID: NCT06306976 - Study ID: 2066031 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03 - Completion Date: 2025-08 - Lead Sponsor: Prisma Health-Upstate ### Study Description Prospective cohort study of patients with midline ventral incisional hernia with a range of hernia morphology who plan to undergo open retromuscular VHR.Study groups: Study groups are selected across a range of morphology and based on factors known or suspected to affect the ability to achieve fascial closure.Control groups: The study plans to enlist 5 volunteers with no incisional hernia or prior laparotomy to establish internal baseline SWE values and interrater reliability. The study will also plan to recruit 5 patients undergoing primary laparotomy in order to correlate SWE findings with closure tension. ### Conditions - Ventral Incisional Hernia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Elective Midline Laparotomy - Imaging: Ultrasound - Tensiometry ### Outcomes Primary Outcomes - Determine Elasticity of Abdominal Wall Muscles (Specific Aim 1) - Correlate Elastography measurements with MFR (Specific Aim 2) - Correlate SWE Assessment to Tensiometer (Specific Aim 3) Secondary Outcomes ### Location - Facility: Prisma Health, Greenville, South Carolina, 29615, United States @@
## Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias - NCT ID: NCT06306963 - Study ID: 23-004669 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2026-09-01 - Lead Sponsor: Mayo Clinic ### Study Description The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning. ### Conditions - Gastric Antral Vascular Ectasia - Cirrhosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gastric Emptying ### Outcomes Primary Outcomes - Abridged Bowel Disease Questionnaire - Nepean Dyspepsia Index - Leuven Postprandial Distress Scale Secondary Outcomes - Gastric Emptying Half Time (T 1/2) of Solids - Gastric Emptying Half Time (T 1/2) of liquids ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## Prioritization of Cerebral Deoxygenation in Severe Traumatic Brain Injury and Mortality Benefit. - NCT ID: NCT06306950 - Study ID: PMK-00098 - Status: COMPLETED - Start Date: 2021-04-01 - Completion Date: 2024-02-28 - Lead Sponsor: Phramongkutklao College of Medicine and Hospital ### Study Description Severe traumatic brain injury with a decrease in cerebral oximetry is associated with multiple impaired systemic microcirculations, more morbidities, and a higher mortality rate. When using the brain as an index organ, interventions to improve brain oxygen delivery may have systemic benefits for these patients. ### Conditions - Cerebral Hypoxia - Severe Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Near infrared spectroscopy neuromonitor to prevent cerebral desaturation ### Outcomes Primary Outcomes - modified Rankin scale (mRS) followed up at 1 year Secondary Outcomes ### Location - Facility: Phramongkutklao College of Medicine and Hospital, Bangkok, N/A, 10400, Thailand @@
## Serum Levels of Vitamin D and IL8 in Patients With Periodontitis - NCT ID: NCT06306937 - Study ID: A24020822 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2023-09-30 - Lead Sponsor: Mansoura University ### Study Description We evaluated vitamin D and IL8 levels in the serum of patients with periodontitis as well as the healthy controls to correlate their levels with the degree of periodontitis. ### Conditions - Periodontal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Evalution of serum levels of vitamin D and IL8 ### Outcomes Primary Outcomes - Serum Levels of 25(OH)vitamin D - Serum Levels of IL8 Secondary Outcomes - Plaque Index (Pl) - Clinical Attachment Loss (CAL) - Probing Pocket Depth (PPD) ### Location - Facility: Mansoura University, Faculty of Dentistry, Mansoura, Dakahlia, 35516, Egypt @@
## UNC Metastatic Cancer Radiation Therapy Registry - NCT ID: NCT06306924 - Study ID: LCCC2303 - Status: RECRUITING - Start Date: 2024-04-21 - Completion Date: 2033-05 - Lead Sponsor: UNC Lineberger Comprehensive Cancer Center ### Study Description The purpose of this registry is to collect clinical data from participants attending UNC Hospitals who present with metastatic cancer and are evaluated to receive radiation therapy as part of their standard of care treatment. The goal of this study is to provide a foundation for studies designed to identify projects across the translational continuum related to metastatic cancer and radiation therapy treatment. The relevant clinical data will be linked to patient-reported outcomes (PROs) thus allowing for a unique and robust dataset. Ultimately, this registry will provide current and future studies with the ability to analyze the correlation of radiation therapy regimens with metastatic cancer outcomes. ### Conditions - Cancer - Metastatic Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Radiation therapy ### Outcomes Primary Outcomes - Clinical Data Secondary Outcomes - Patient reported outcomes (PRO) ### Location - Facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, 27599, United States @@
## Bioavailability of Aronia Melanocarpa - NCT ID: NCT06306911 - Study ID: BB-BAM - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-07 - Lead Sponsor: Maastricht University Medical Center ### Study Description The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). The bioavailability and kinetics of AME will be assessed via frequent blood sampling, urine collection, and faecal sampling, in which AME and metabolite profiles will be quantified. ### Conditions - Bioavailability - Kinetics ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Aronia Melanocarpa extract ### Outcomes Primary Outcomes - Aronia metabolites in blood - Aronia metabolites in urine Secondary Outcomes - Aronia metabolites in feces - length - baseline characteristics - weight - baseline characteristics - blood pressure (systolic and diastolic) - baseline characteristics ### Location - Facility: Maastricht University, Maastricht, N/A, N/A, Netherlands @@
## Intra-Arrest-Ventilation in Human Cadavers - NCT ID: NCT06306898 - Study ID: IAV-2024-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-12-31 - Lead Sponsor: Gerrit Jansen ### Study Description The study investigates the influence of non-synchronized bag-device-ventilation and intermittent positive pressure ventilation (IPPV), as recommended in the current resuscitation guidelines of the European Resuscitation Concil (tidal Volume (Vt) = 5-6 mL/kg body weight, respiratory rate = 10 min-1) and Chest Compression Synchronized Ventilation (pInsp = 40 mbar; respiratory rate = chest compression rate) with regard to achieving a sufficient tidal volume and the tightness of various supraglottic airway devices (laryngeal mask, i-Gel-laryngeal mask, laryngeal tube) and endotracheal intubation. ### Conditions - Cardiac Arrest ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Endotracheal Intubation - Laryngeal tube - Laryngeal mask - I-Gel-Laryngeal Mask ### Outcomes Primary Outcomes - Expiratory Volume with different Airway Devices in IPPV - Ventilation Pressure with different Airway devices in CCSV Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Early Sleep After Action Observation and Motor Imagery After Metacarpal Fracture Surgery - NCT ID: NCT06306885 - Study ID: CLF23/03 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-05-01 - Lead Sponsor: Istituto Clinico Humanitas ### Study Description The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures.Fifty-one patients with hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform an AOMI-training before sleeping or in the morning respectively, while Control group will be asked to observe landscape video-clips. Participants will be assessed for manual dexterity, hand range of motion, hand disability and quality of life at baseline before and after the training and at 1 month after the training end. ### Conditions - Hand Injuries - Action Observation - Motor Imagery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Action observation plus motor imagery followed by sleep - Action observation plus motor imagery - Control ### Outcomes Primary Outcomes - Changes in Purdue Pegboard Test Secondary Outcomes - Changes in kinematic indexes during Nine Hole Peg Test - Changes in Visual Analogue Scale - Changes in Quick-DASH - Changes in EQ5D - Changes in Total Active Motion - Hand-grip strength ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules - NCT ID: NCT06306872 - Study ID: ABSK-011-102 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-12-31 - Lead Sponsor: Abbisko Therapeutics Co, Ltd ### Study Description The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Sequence A ABSK-011 - Sequence B ABSK-011 ### Outcomes Primary Outcomes - Cmax - AUC - tmax Secondary Outcomes - AEs - SAEs SAEs - t1/2 - Vz/F - CL/F CL/F ### Location - Facility: Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, 214062, China @@
## Development of Health Monitoring System on Patient's Well Being in Dialysis Context - NCT ID: NCT06306859 - Study ID: SIKIDI 2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-12-31 - Lead Sponsor: Universitas Muhammadiyah Yogyakarta ### Study Description One of the goals in the Sustainable Development Goals (SDGs) is the availability of a healthy and prosperous life for all ages. This goal mentions health priorities i.e. non-communicable diseases. Chronic kidney failure (CRF) is one of the non-communicable diseases that is the main cause of death and disability both in the world and in Indonesia. The prevalence of CRF in Indonesia is 0.5% with 83.2% of patients being of productive age and the highest number of CRF patients in North Kalimantan, Southeast Sulawesi, DKI Jakarta and Yogyakarta. Monitoring and evaluation of patients with CRF is currently mostly carried out conventionally not using health technology that is integrated with hospital information systems. This study aims to design and provide a health information system for patients with CRF, hereinafter referred to as SIKIDI, which integrates mobile-health applications used independently by patients with existing information systems in hospitals. ### Conditions - Quality of Life - Self Efficacy - Chronic Kidney Diseases - M-health ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Using m-health for monitoring and education provision - Standard care ### Outcomes Primary Outcomes - Quality of Life that will be measured using KDQOL before and after intervention Secondary Outcomes - Self-efficacy that will be measured using CKD SE before and after ### Location - Facility: RS PKU Muhammadiyah Bantul, Bantul, Yogy, 55183, Indonesia @@

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