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## French Cohort of Patients With Rotator Cuff Lesions - NCT ID: NCT06371872 - Study ID: 2024-A00173-44 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2035-12 - Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche ### Study Description The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment. ### Conditions - Rotator Cuff Injuries ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - total transfixing injury to the rotator cuff ### Outcomes Primary Outcomes - Shoulder Pain and Disability Index - European quality of life scale - EQ5D Secondary Outcomes ### Location - Facility: Clinique Maussins-Nollet, Paris, N/A, 75019, France @@
## Human-AI Collaborative Intelligence for Improving Fetal Flow Management - NCT ID: NCT06371859 - Study ID: 3-3031-2915/1 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-12-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description This randomized controlled study evaluates the effectiveness of explainable AI (XAI) in improving clinicians' interpretation of Doppler ultrasound images (UA and MCA) in obstetrics. It involves 92 clinicians, randomized into intervention and control groups. The intervention group receives XAI feedback, aiming to enhance accuracy in ultrasound interpretation and medical decision-making.Objectives:1. To develop an interpretable model for commonly used Doppler flows, specifically the Pulsatility Index (PI) of the umbilical artery (UA) and middle cerebral artery (MCA), with the aim to provide quality feedback on Doppler spectrum images and suggest potential gate placements.2. To test the effects of providing Explainable AI (XAI)-feedback for clinicians compared with no feedback on their accuracy in ultrasound interpretation and management. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - "XAI feedback on MCA/UA Doppler spectral curves and gate placement suggestions" ### Outcomes Primary Outcomes - Responses will be reviewed independently by two fetal medicine sonographers, and in case of disagreement between the two experts, a consensus will be reached. Secondary Outcomes - Accuracy of flow image management among competence groups ### Location - Facility: Rigshospitalet, Copenhagen, Capital Region Of Denmark, 2100, Denmark @@
## Comparative Study of the Surface Electrocardiogram Signals During the Implantation of Conduction System Pacing Devices - NCT ID: NCT06371846 - Study ID: 2023 /10850/I - Status: RECRUITING - Start Date: 2023-03-14 - Completion Date: 2024-07-30 - Lead Sponsor: Parc de Salut Mar ### Study Description Introduction and objectives: Left bundle branch area pacing (LBBAP), is a novel modality of physiologic pacing that requires an adequate assessment of the endocardium as well as the body-surface electrocardiographic signals for a successful pacing-lead implantation. The objective of the study consist of assessing if LBBAP criteria, specifically septal and left bundle branch pacing (LBBP) criteria, can be satisfactory measured using the signals resulting from different cardiac pacing analyzers (PSAs) by comparing them to the 'conventional' signals obtained from multichannel polygraph systems (MPSs) during the implantation procedure.Methods: Comparative observational, prospective, multicenter study between the signals obtained by PSA vs MPS of consecutive patients who underwent a LBBAP strategy as first intention. ### Conditions - Conduction Disorder - Pacemaker DDD ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Selected signals from Pacing System Analyzers ### Outcomes Primary Outcomes - Similarity of signals between multichannel recording system and Pacing System Analyzers Secondary Outcomes - Security ### Location - Facility: Jesus Jiménez López, Barcelona, Cataluña, 08005, Spain @@
## PRIMA EU Retrospective & Prospective - NCT ID: NCT06371833 - Study ID: S-52 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-12 - Lead Sponsor: Limacorporate S.p.a ### Study Description This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications. ### Conditions - Arthroplasty - Replacement - Shoulder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Shoulder Arthroplasy with PRIMA humeral stem ### Outcomes Primary Outcomes - Changes of Costant Murley Score (CS) Secondary Outcomes - Changes in the American Shoudler and Elbow Surgeons (ASES) score - Changes in Range of Motion measures - Radiographic stability of the humeral component - Survival rate (Kaplan-Meier estimate) - Incidence, type and severity of Adverse Events and Adverse Device Effects ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden) - NCT ID: NCT06371820 - Study ID: 2014/1287-31/4 - Status: ACTIVE_NOT_RECRUITING - Start Date: 1965-01-01 - Completion Date: 2043-05-17 - Lead Sponsor: Karolinska Institutet ### Study Description The ESPRESSO study is a collection of data from all computerised gastrointestinal histopathology reports in Sweden. This allows us to study risk factors for gastrointestinal disease, as well as the prognosis of gastrointestinal disease.A review of the study has been published here:https://pubmed.ncbi.nlm.nih.gov/30679926/ ### Conditions - Gastrointestinal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ESPRESSO [The study has no intervention] ### Outcomes Primary Outcomes - Incident Mortality [especially rates] Secondary Outcomes - Incident Cancer - Incident Cardiovascular disease - Incident Neurological disease - Incident Autoimmune diseases ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab - NCT ID: NCT06371807 - Study ID: EU CTR n.º 2023-507008-30-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-12 - Lead Sponsor: Fundacao Champalimaud ### Study Description Phase II, randomized, Active-controlled open label trial for treatment of high risk, HR-/HER2- (triple negative) breast cancer, with two sequences of neoadjuvant chemotherapy on a background of pembrolizumab ### Conditions - Early Breast Cancer - Triple Negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab injection ### Outcomes Primary Outcomes - Detect immunologic activation signal and the immunologically defined most suitable patient population for the synergistic interaction between pembrolizumab and chemotherapy backbone - Rate of pCR - Primary translational endpoint Secondary Outcomes - Changes in the immunogenic phenotype - Incidence of treatment relatred Adverse events ### Location - Facility: Fundaçao Champalimaud, Avenida Brasilia,, Lisbon, N/A, 1400-038, Portugal @@
## EXploring novEl Molecular Determinants of DRAvet Syndrome Phenotype Heterogeneity - NCT ID: NCT06371794 - Study ID: ID 5460 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-07-06 - Completion Date: 2026-05-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Dravet syndrome is characterized as a developmental encephalopathy resulting from mutations of SCN1A, the gene encoding the alpha subunit of the voltage-gated sodium channel Nav1.1. The syndrome typically presents with drug-resistant epilepsy and varying degrees of cognitive disorders. Current treatment efficacy may be hindered by insufficient knowledge of undiscovered molecular determinants of the disease and its heterogeneous nature. Utilizing induced pluripotent stem cells (iPSCs) derived from skin biopsies, accessibility to patients' brain neurons has enabled successful modeling of various genetic neurological diseases. Neurons and brain organoids will be obtained from Dravet syndrome patients exhibiting diverse phenotypic severities, encompassing behavioral and developmental delays, to discern the molecular determinants of phenotypic diversity. Specifically, emphasis will be placed on investigating cellular and molecular mechanisms linking altered neuronal excitability with synaptic dysfunction.The study will focus on exploring the expression of newly identified modifiers potentially associated with neuronal excitability and synaptic function in iPSC-derived human neurons. This aims to establish correlations between the severity of epileptic and cognitive phenotypes and the altered expression of these proteins, whose functions are not fully understood.In the mid to long term, efforts will be directed towards overcoming the limitations of conventional therapeutic approaches for Dravet syndrome. This will involve attempting to reverse the observed morphological and functional alterations in Dravet syndrome neurons using viral vectors to promote overexpression/downregulation of identified modifiers correlated with disease severity. The anticipated outcomes of this project are expected to unveil novel molecular mechanisms underlying the pathophysiology of this severe neurogenetic disease, characterized by varying degrees of cognitive impairment. Moreover, these findings may pave the way for the discovery of innovative therapeutic strategies. ### Conditions - Dravet Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - skin punch biopsy ### Outcomes Primary Outcomes - TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS Secondary Outcomes - TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## Examination of the Relationship Between Weight Gain During Pregnancy and Sfrp-5, Netrin-4 and Resistin Concentrations - NCT ID: NCT06371781 - Study ID: Cumhuriyetobgyn - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2023-07-01 - Lead Sponsor: Cumhuriyet University ### Study Description Researchers thought that the molecules Sfrp-5, Resistin and Netrin-4, which will be examine, they may have a significant effect on weight gain during pregnancy. Based on these foundations, researchers expect changes in the levels of these molecules in women who gain excessive weight during pregnancy. In this study, researchers aimed to examine the moderator relationship between the molecules will be examine and weight gain in women who gained weight above the normal limits determined during pregnancy. For this reason, 44 participant who gained excessive weight during pregnancy and 46 pregnant participant who gained normal weight were included in the study. The levels of Netrin-4, Sfrp-5 and Resistin molecules in the blood serum of the individuals in the study group were measured with a Commercial Elisa kit. ### Conditions - Excessive Weight Gain During Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Serum Netrin-4, Resistin and Sfrp-5 level measurement ### Outcomes Primary Outcomes - Obtaining blood serum for measurement of serum Sfrp-5, Netrin-4 and Resistin Secondary Outcomes - Calculating BMI (kg/m^2) from height (m) and weight (kg) measurement values for diagnosis. ### Location - Facility: Sivas Cumhuriyet University, Sivas, Centre, 58140, Turkey @@
## Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors - NCT ID: NCT06371768 - Study ID: Pro00115400 - Status: NOT_YET_RECRUITING - Start Date: 2025-04-01 - Completion Date: 2029-06-30 - Lead Sponsor: Duke University ### Study Description The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS, which is designed to help adolescent and young adult (AYA) cancer survivors manage symptoms and engage in recommended follow-up care. ### Conditions - Cancer - Breast Cancer - Colorectal Cancer - Sarcoma - Lymphoma - Testicular Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - AYA Educational Information - AYA STEPS ### Outcomes Primary Outcomes - Pain severity and interference as measured by Brief Pain Inventory - Fatigue as measured by PROMIS Fatigue Scale - Emotional distress as measured by PROMIS Depression Short Form - Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference - Emotional distress as measured by PROMIS Anxiety Short Form - Health care engagement as measured by Patient Participation Questionnaire - Patient self-assessment of communication competency with health care providers as measured by Medical Communication Competence Scale (MCCS) patient subscale Secondary Outcomes - Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale - Patient activation as measured by Patient Activation Measure (PAM) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bone Evaluation by Ultrasound Radiofrequency Echographic Multi Spectrometry (REMS) vs Dual X-ray Absorptiometry (DXA) - NCT ID: NCT06371755 - Study ID: ULTRADXA - Status: RECRUITING - Start Date: 2019-11-19 - Completion Date: 2024-12-31 - Lead Sponsor: Paola Pisani ### Study Description Bone Density Evaluation by means of the Ultrasound Technology Named Radiofrequency Echographic Multi Spectrometry (REMS) in Comparison With DXA Technique.Clinical Center involved in the study:IRCCS Orthopedic institute Galeazzi - Sant'Ambrogio The clinical study will evaluate the intra- and inter-operator repeatability of the REMS,(Radiofrequency Echographic Multi Spectrometry) ultrasound diagnostic technology implemented in the EchoStation device (Echolight Spa, Lecce) and the diagnostic accuracy in comparison with DXA (used as standard reference). ### Conditions - Osteoporosis Diagnosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Ultrasound examination with REMS technology ### Outcomes Primary Outcomes - 1. REMS Technology intra - and inter-operator repeatability Evaluation. Secondary Outcomes - 1. Evaluation of the accuracy of the REMS Technology in comparison with the conventional DXA technique. ### Location - Facility: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, Milano, MI, 20157, Italy @@
## Study of the Fluid Intake Effect During Labour - NCT ID: NCT06371742 - Study ID: 539HydrationNutr - Status: COMPLETED - Start Date: 2017-02-01 - Completion Date: 2017-09-14 - Lead Sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL ### Study Description Ingestion during labor is an issue that has attracted the attention of the scientific community in recent decades, with different practices occurring in different countries. However, the scientific evidence of the risk / benefit of fluid intake in labor is still not fully understood. The aim of this study was to contribute with data that allow the evaluation of an eventual relationship between the amount of fluid ingested during labor and the type of delivery, the duration of labor, the occurrence of nausea and vomiting and the value of the Index of Apgar at the 1st and 5th minutes of the newborn's life. An observational study, with a convenience sample of 144 parturient from two hospitals of Portugal were employed. The analysis was based on recording the before mentioned variables and potentially confounding variables. In order to control for potential sources of bias in the study and to guarantee the homogeneity of the sample in the specific statistical treatment of each dependent variable, an observation grid was drawn up for all the participants in the study. Twenty eight of the parturient, the parturient's ambulation, labour analgesia, food intake during labour, the use of oxytocin during labour, the occurrence of postpartum complications, the birth weight of the newborn and the occurrence of birth complications. ### Conditions - Labor Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Liquid ingestion during labour ### Outcomes Primary Outcomes - Type of labour - Duration of labour - Occurrence of nausea and vomiting - Apgar index of the newborn (From 0 to 10) Secondary Outcomes ### Location - Facility: Egas Moniz School of Health and Science, Almada, Monte De Caparica, 2829-699, Portugal @@
## Substrate-based DEEP Mapping Versus Activation Mapping. A Prospective Randomized Multicenter Study. - NCT ID: NCT06371729 - Study ID: DEEP-VT - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-07 - Lead Sponsor: IRCCS Ospedale San Raffaele ### Study Description Substrate-based DEEP mapping and activation mapping are the two main techniques used for ventricular tachycardia (VT) ablation. There is no sufficiently reliable data in the medical scientific literature comparing the extent of applicability, the results of the procedure strategy, and the long-term outcomes between the two mapping strategies. This randomized clinical trial aims to test whether activation mapping is superior to DEEP mapping to reduce ventricular tachycardia recurrence.The primary outcome of the study is to compare the efficacy as a recurrence-free survival rate of ventricular tachycardia, at 6 and 12 months, of substrate-based DEEP mapping versus activation mapping in guiding catheter ablation to prevent VT recurrence. ### Conditions - Ventricular Tachycardia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DEEP mapping - Activation Mapping ### Outcomes Primary Outcomes - Compare the efficacy of substrate-based DEEP mapping versus Activation mapping in guiding catheter ablation to prevent VT recurrences Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions - NCT ID: NCT06371716 - Study ID: EUS-RFA ex-vivo 2016 - Status: TERMINATED - Start Date: 2019-09-12 - Completion Date: 2020-06-12 - Lead Sponsor: IRCCS San Raffaele ### Study Description The study investigates the feasibility and the efficacy to treat pancreatic solid lesions as pancreatic adenocarcinomas (PDAC) and neuroendocrine tumors (NET) with ex-vivo radiofrequency ablation (RFA) under ultrasound (US) control.The study intent is to define the optimal radiofrequency ablation POWER of the system in terms of maximum sizes (diameters) of histological coagulative necrosis obtained at pathological samples. Results will be useful to define the optimal settings to ablate pancreatic solid lesions (PDAC and neuroendocrine tumours). ### Conditions - Pancreatic Cancer - Endoscopic Ultrasound - Radiofrequency Ablation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions - ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions - ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions ### Outcomes Primary Outcomes - diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation Secondary Outcomes ### Location - Facility: IRCCS San Raffaele Hospital, Milan, N/A, N/A, Italy @@
## Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automat-ed Radiopharmaceutical Preparation and Administration System - NCT ID: NCT06371703 - Study ID: PETCT_INTEGO - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2024-10 - Lead Sponsor: IRCCS San Raffaele ### Study Description This project aims to evaluate the impact of the introduction of an automated system for radiopharmaceutical preparation and administration on the radiation safety of the radiographers working in nuclear medicine. This study will help to fill the existing gap in the scientific literature and provide useful guidance for the selection of the safest and most effective automated infusion system. ### Conditions - Radiation Exposure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - automated system in reducing radiation exposure ### Outcomes Primary Outcomes - Change in absorbed dose by radiographers during PET/CT procedures, measured in millisieverts (mSv). Secondary Outcomes ### Location - Facility: Irccs San Raffaele, Milano, N/A, N/A, Italy @@
## The Effects of Using the Web-Based Double Eye Control Program on Medication Error - NCT ID: NCT06371690 - Study ID: 17-11/37 - Status: COMPLETED - Start Date: 2017-11-01 - Completion Date: 2018-09-30 - Lead Sponsor: Izmir Katip Celebi University ### Study Description Methods: The study was carried out as a quasi-experimental study in the Pediatric Surgery Clinics of a university hospital using the "Pre-Test-Post-Test Model in a Single Group". The sample of the study consisted of all high-risk drugs administered by 24 nurses working in these clinics, taking part in medication and agreeing to take part in the study. Data were collected by the researcher using the Medication Observation Form. The Form was created based on the literature, and by making use of the "10 Correct Rules in Medication" and the Medication Skills Steps in the Double Eye Control Program. In the first step, medication error rates were determined through observation method. In the second step; the Web-Based Double-Eye Control Program, which is a standard drug dose calculation and medication program created by the researchers, was started to be implemented. Medication error rates were determined again through post-intervention observation method. Informed voluntary consent, ethics committee and hospital permissions were obtained for the implementation of the study. ### Conditions - Main Heading (Descriptor) Terms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Web-Based Double-Eye Control Program ### Outcomes Primary Outcomes - Error rates Secondary Outcomes ### Location - Facility: Izmir Katip Celebi University, İzmir, Çi̇ğli̇, 35620, Turkey @@
## Polish Nationwide Register of Hospitalized Patients in Cardiac Intensive Care Units - NCT ID: NCT06371677 - Study ID: KB/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2025-03-31 - Lead Sponsor: Medical University of Warsaw ### Study Description Cardiac Intensive Care Units (CICUs) provide care for a diverse patient population. Understanding the clinical characteristics, analysis of treatment modalities, and prognosis of patients hospitalized in the CICU are important to improve cardiovascular care. The purpose of this registry is to determine the demographics, clinical, treatment, and prognosis of patients hospitalized in the Polish CICUs. Data from this multicenter, prospective observational study will provide more robust data to facilitate quantitative characterization of cardiac care in contemporary Polish CICUs and enable the development of infrastructure for clinical trials in CICUs. ### Conditions - Shock - Death - Cardiac Intensive Care Unit - Treatment Complication - Stroke - Multiple Organ Failure - Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - All-cause death Secondary Outcomes - Shock (cardiogenic/hypovolemic/anaphylactic/septic/neurogenic/obstructive) - Treatment-related complications (tamponade, dissection, stroke, embolism, etc.) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Gingival Irritation Due to Bleaching Tray Design in an At-home Bleaching Treatment - NCT ID: NCT06371664 - Study ID: 2023/02 - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2023-04-05 - Lead Sponsor: University of Santiago de Compostela ### Study Description The primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation. Additionally, it aims to investigate whether the design influences the likelihood of dental sensitivity and its impact on the degree of tooth whitening. ### Conditions - Gingival Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Conventional Tray (1 mm) - Extended Tray (3 mm) ### Outcomes Primary Outcomes - Subjective questionnaire of gingival irritation - Objective clinical examination of gingival irritation Secondary Outcomes - Questionnaire of dental sensitivity - Shade evaluation with a dental spectrophotometer ### Location - Facility: School of Medicine and Dentistry, Santiago De Compostela, A Coruña, 15705, Spain @@
## Creatine and GAA for Brain Oxygenation - NCT ID: NCT06371651 - Study ID: 23-1462-3 - Status: COMPLETED - Start Date: 2024-03-01 - Completion Date: 2024-04-12 - Lead Sponsor: University of Novi Sad, Faculty of Sport and Physical Education ### Study Description The main aim of this randomized controlled trial is to evaluate cerebral blood oxygenation after 7-day administration of a creatine-guanidinoacetic acid (GAA) mixture in healthy adults before, during, and after a series of cognitive tests. ### Conditions - Oxygen Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Supplement - Placebo ### Outcomes Primary Outcomes - Brain oxygen saturation Secondary Outcomes - Hemoglobin index ### Location - Facility: Applied Bioenergetics Lab at Faculty of Sport and PE, Novi Sad, Vojvodina, 21000, Serbia @@
## Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD) - NCT ID: NCT06371638 - Study ID: 2024-01 - Status: COMPLETED - Start Date: 2024-01-07 - Completion Date: 2024-03-07 - Lead Sponsor: Udayana University ### Study Description Postoperative cognitive dysfunction (POCD) affects all age groups and can lead to increased morbidity and more extended hospital stays. Dexmedetomidine reduces POCD by inhibiting the increase in proinflammatory cytokines IL-6 and TNF-α, and its anti-inflammatory activity contributes to its protective effect. Previous studies found that dexmedetomidine reduced POCD incidence in non-cardiac and cardiac surgery. Therefore, the goal of this study was to specifically investigate if using TCI dexmedetomidine to maintain anaesthesia in laparotomy surgeries reduces the incidence of POCD compared to inhalation anaesthesia by sevoflurane. ### Conditions - Postoperative Cognitive Dysfunction - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Dexmedetomidine - Sevoflurane ### Outcomes Primary Outcomes - Postoperative cognitive dysfunction (POCD) - Postoperative cognitive dysfunction (POCD) Secondary Outcomes - Intraoperative hemodynamics: mean arterial pressure (MAP) - Intraoperative hemodynamics: heart rate (HR) - Postoperative pain - Postoperative pain - Postoperative pain ### Location - Facility: Prof. Ngoerah General Hospital, Denpasar, Bali, 80114, Indonesia @@
## U/S Guided Transversus Thoracic and Pectoral Nerve Block Versus Pectoral Nerve Block in MRM - NCT ID: NCT06371625 - Study ID: AP2202-30104 - Status: COMPLETED - Start Date: 2022-07-02 - Completion Date: 2023-10-01 - Lead Sponsor: Ahmed Mohamed Soliman ### Study Description Interfascial blocks score over regional anesthetic techniques such as Transversus Thoracic Plane Block and Pectoral Nerves (PECS) Block as they have no risk of sympathetic blockade, intrathecal or epidural spread, which may lead to hemodynamic instability and prolonged hospital stay. The transversus thoracic muscle plane block (TTP) block is a newly developed regional anesthesia technique which provides analgesia to the anterior chest wall. First described by Ueshima et al. in 2015, the TTP block is a single-shot nerve block that deposits local anesthetic in the transversus thoracic muscle plane between the internal intercostal and transversus thoracic muscles. TTP block targets the anterior branches of the intercostal nerves (T2-6).Pectoral plane blocks are recently described . PECS block involves deposition of local anesthetic drug between muscle planes. PECS I block, between Pectoralis Major and Minor at third rib level, and PECS II block, the drug is deposited between Pectoralis minor and Serratus anterior muscle.The pectoral nerves (PECS) block provides analgesia of the lateral mammary region, the intercostobrachial and lateral cutaneous branches of the intercostal nerves (T2-T6), the medial cutaneous nerve of the arm and forearm, and the long thoracic and thoracodorsal nerves. The modified PECS block produces excellent analgesia and can be used to provide balanced anesthesia. ### Conditions - Breast Cancer - Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Transeversus Thoracic Plane Block (TTPB) and Pectoral Nerves (PECS) Block - Pectoral Nerves (PECS) Block ### Outcomes Primary Outcomes - visual analogue scale "VAS score" Secondary Outcomes - total morphine consumption - mean blood pressure - heart rate - first analgesic dose ### Location - Facility: National cancer Insititute Cairo university, Cairo, N/A, 11796, Egypt @@
## Effect of Ball Squeezing and Adhesive Remover Use on Pain and Fear in Children Aged 6-9 Years During the Removal of Peripheral Intravenous Cannula - NCT ID: NCT06371612 - Study ID: MersinUGUGUCU_004 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-11-20 - Lead Sponsor: Mersin University ### Study Description Pediatric nurses have a key role in reducing pain related to interventions during the hospitalisation process. In this context, according to the type of invasive intervention, the nurse determines the appropriate non-pharmacological methods for the effective management of pain, taking into account the child's individuality, developmental stage and clinical presentation. For children during the hospitalisation process, the removal of a peripheral venous line is a painful and stressful experience, as is the insertion of a peripheral venous line. Children experience acute pain during the removal of hypoallergenic adhesives used for fixation of the peripheral venous line. The practice guideline recommends the use of alcohol-free silicone-based aerosol sprays for the removal of medical adhesive/ fixation materials (NICU Brain Sensitive Care Committee, 2015).In this study, it was aimed to examine the effect of ball squeezing (active distraction) as a distraction method and the use of alcohol-free silicone-based aerosol adhesive remover spray on pain and fear in children aged 6-9 years during peripheral intravenous cannula removal. ### Conditions - Procedural Pain - Fear of Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Standard Care - Adhesive Remover Spray - Ball Squeezing + Adhesive Remover Spray ### Outcomes Primary Outcomes* - Pain assesed by Wong-Baker FACES - Fear by Children's Fear Scale Secondary Outcomes - Pain assesed by Wong-Baker FACES - Fear by Children's Fear Scale ### Location - Facility: Mersin University, Mersin, Yenişehir, 33343, Turkey @@
## The Effect of Watching Cartoons and Playing Games as Distraction Method During Peripheral Intravenous Cannula Placement on Pain and Fear in Children Aged 6-9 Years - NCT ID: NCT06371599 - Study ID: MersinUGUGUCU_003 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-11-20 - Lead Sponsor: Mersin University ### Study Description Active and passive distraction methods are frequently used in the nursing management of procedural pain in children. There are no studies comparing the effects of watching cartoon (passive) and playing game (active) as distraction methods on pain and fear associated with peripheral intravenous cannula placement in children aged 6-9 years.This study aimed to compare the effects of playing game (active distraction) and watching cartoon (passive distraction) techniques on pain and fear during peripheral intravenous cannula placement in children aged 6-9 years. ### Conditions - Procedural Pain - Fear of Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Playing game - Watching cartoon ### Outcomes Primary Outcomes* - Pain assesed by Wong-Baker FACES - Fear by Children's Fear Scale Secondary Outcomes - Pain assesed by Wong-Baker FACES - Fear by Children's Fear Scale ### Location - Facility: Mersin University, Mersin, Yenişehir, 33343, Turkey @@
## Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC - NCT ID: NCT06371586 - Study ID: NCC4537 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-03-01 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer. ### Conditions - Gastric Cancer - Diffuse Type Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy ### Outcomes Primary Outcomes - Pathological response rate Secondary Outcomes - EFS - OS - R0 - Safety (adverse events) and surgical complications ### Location - Facility: Cancer hospital，Chinese acadamy of medical sciences, Beijing, N/A, N/A, China @@
## Ultrasound Examination for Spleen Volume Evaluation in Myeloproliferative Neoplasms - NCT ID: NCT06371573 - Study ID: MPN-USspleen - Status: COMPLETED - Start Date: 2017-04-20 - Completion Date: 2024-03-20 - Lead Sponsor: Federico II University ### Study Description Adult patients (\>18 years) with newly diagnosis of Ph negative myeloproliferative neoplasms (MPNs) according to WHO 2016 criteria, will be recruited to this study.This study is the result of the collaboration the Hematology Division of Federico II University Medical School of Naples (Italy), that performed the US investigation and the IRCCS SYNLAB SDN where the patients carried out MR. The study is conducted in accordance with the Declaration of Helsinki. All subjects gave informed consent to receive both US and MR scans of the spleen.All spleen US scans were performed by the same operator (with\>10 years of experience in abdominal US), who used an EPIQ 5 Philips instrument with a 1-5 MHz broadband curvilinear probe. The spleen was scanned in patients who were fasting, in the longitudinal and transverse planes by using an intercostal approach, a subcostal approach, or both.The patient was placed in a supine or right-sided position until complete organ visualization was achieved. Perimeter, longitudinal diameter (LD), and area, defined as the maximum measurements with splenic borders and angles clearly defined, were measured, and SV (in milliliters) was calculated automatically. For each subject, the mean value of 3 measurements repeated on the same imaging session was calculated and recorded for final analysis. Within two weeks from the US, each patient underwent an MRI of the upper abdomen to evaluate the splenic volume. MRI examinations were performed using a 3T Biograph mMR scanner (Siemens Healthcare, Erlangen, Germany) with 4-channel flex phased-array body coil. Routine clinical abdominal MRI acquisition includes coronal T2W Half-Fourier Acquisition Single-shot Turbo spin Echo imaging (HASTE), axial T1 Dual-echo FSE, axial T2 TSE Fat Sat, and an axial diffusion-weighted imaging (DWI). The DWI includes an apparent diffusion coefficient (ADC) map that was automatically generated at the time of acquisition. At last, an isotropic 2mm3 axial Volumetric Interpolated Breath-hold Examination (VIBE) sequence for SV evaluation was acquired. For the latter, attention was paid to optimize the field of view to the spleen, in order to reduce patient's apnea and possible respiratory artifacts. A radiologist with mote than 10 years of experience in abdominal MRI reporting performed measurement of the three orthogonal diameters of the spleen for each patient. Subsequently, SV was calculated using ITK-SNAP software and semi-automatic 3D segmentation approach, firstly based on a signal threshold. ### Conditions - Myeloproliferative Neoplasm - Polycythemia Vera - Essential Thrombocythemia - Primary Myelofibrosis - Prefibrotic/Early Primary Myelofibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ULTRASOUND EXAM AND MRI SCAN ### Outcomes Primary Outcomes - agreement between two different diagnostic methods Secondary Outcomes ### Location - Facility: Federico II University, Naples, N/A, 80131, Italy @@
## Antibiotics, Antibiotic Resistance, and Prescribing Practices Among Periodontists: Cross Sectional KAP Study - NCT ID: NCT06371560 - Study ID: KAP-ABR-Perio - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-10-30 - Lead Sponsor: Cairo University ### Study Description Antibiotic resistance is a global health threats that require attention from all healthcare providers. In Periodontology, antibiotic is prescribed in many clinical situations. The aim of this study is to assess the followings among Periodontists (1) The knowledge, attitude, and practices (KAP) towards antibiotics and antibiotic resistance; (2) The prescribing practices of antibiotics in periodontal therapy; (3) The correlation between personal perception of antibiotics uses and the professional prescription patterns; and (4) The differences in antibiotics prescription in relation to the years of experience and the academic background. ### Conditions - Antibiotic Resistance - Antibiotic Use - Periodontitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - KAP Secondary Outcomes - The prescribing practices of antibiotics in periodontal therapy - The correlation between personal perception of antibiotics uses and the professional prescription patterns - The differences in antibiotics prescription in relation to the years of experience and the academic background. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficiency of Different Gastrocnemius Stretching Exercises - NCT ID: NCT06371547 - Study ID: BEUFTR-3 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-12-15 - Lead Sponsor: Bitlis Eren University ### Study Description The primary aim of this study is to investigate the effects of different types and durations of gastrocnemius stretching on the viscoelastic properties of the gastrocnemius muscle, Achilles tendon, and plantar fascia.In addition, pain threshold of the gastrocnemius muscle and plantar fascia, as well as on hamstring tightness will be measured. ### Conditions - Muscle Tightness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stretching Exercise ### Outcomes Primary Outcomes - Measurement of the Viscoelastic Properties - Ankle-foot Dorsiflexion Index Secondary Outcomes - Measurement of the Mechanosensitivity - Assessment of Hamstring Tightness ### Location - Facility: Bitlis Eren University, Bitlis, Merkez, 13000, Turkey @@
## A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults - NCT ID: NCT06371534 - Study ID: QL2109-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Qilu Pharmaceutical Co., Ltd. ### Study Description The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2109 with DARZALEX FASPRO® in healthy male volunteers.Participants will receive a single injection of QL2109/ DARZALEX FASPRO® Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the two groups. ### Conditions - Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - QL2109 - DARZALEX FASPRO® ### Outcomes Primary Outcomes - AUC0-∞ - Cmax Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310006, China @@
## Ergogenic Effects of Sportlegs - NCT ID: NCT06371521 - Study ID: 4933 - Status: RECRUITING - Start Date: 2024-01-24 - Completion Date: 2024-06-01 - Lead Sponsor: Christopher Bell ### Study Description Sportlegs is a commercially available dietary/sports supplement. It is manufactured by a local, Colorado-based company: Sport Specifics Inc. Although Sportlegs has been on the market for approximately 20-years, very little empirical research has been completed to determine if Sportlegs improves exercise performance. Sport Specifics Inc. has commissioned Colorado State University to investigate the ergogenic effects of Sportlegs. ### Conditions - Performance Enhancing Product Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Sportlegs - Placebo ### Outcomes Primary Outcomes - Maximal Oxygen Uptake - Lactate Threshold - Rating of Perceived Exertion (RPE) - Maximal sustained mean power Secondary Outcomes ### Location - Facility: Colorado State University, Fort Collins, Colorado, 80523, United States @@
## Breast Cancer and Breast Self-examination Education - NCT ID: NCT06371508 - Study ID: 14042024 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-06-15 - Lead Sponsor: Sakarya University ### Study Description According to a news published by the World Health Organization (WHO); More than 2.3 million cases of breast cancer occur each year, making it the most common cancer among adults. In 95% of all countries, breast cancer is the first or second cause of female cancer death. In 2020, 2.3 million women worldwide were diagnosed with breast cancer and 685,000 deaths occurred (WHO, 2023; https://www.who.int/news/item/03-02-2023-who-launches-new-roadmap- on-breast-cancer). In our country, breast cancer ranks first among the most common cancer types in women, and the number of breast cancer cases in women in 2020 was recorded as 74 638 (IARC, 2023). As a result of this situation, WHO (2023) published the Global Breast Cancer Initiative Framework to save 2.5 million lives from breast cancer by 2040. This published framework includes health promotion for early detection, timely diagnosis and comprehensive management of breast cancer.One of the most effective ways to reduce breast cancer mortality and morbidity rate is early diagnosis. It is important to determine early diagnosis and signs and symptoms of cancer before they appear. Early diagnosis of breast cancer is possible with breast self-examination (BSE), clinical breast examination and mammography (Kayar, 2019). Breast self-examination is an important examination method in terms of detecting changes in breast tissue and preventing subsequent complications (Abo Al-Shiekh et al., 2021). It is also an easy-to-apply, cheap and non-invasive method. In our country, it is recommended that women regularly perform breast self-examination every month after the age of 20, women between the ages of 20 and 40 should have a clinical breast examination every two years, and women between the ages of 40 and 69 should have a clinical breast examination every year and have a mammogram every two years (Ministry of Health, 2019). .There are studies showing that fear of breast cancer has a positive and negative impact on early diagnosis behaviors (Champion et al., 2004; Yavan et al., 2010). Champion et al. (2004) stated that women with moderate breast cancer fear had a high rate of early detection behavior, whereas low and high fear levels had a negative effect on behavior. In the study conducted by Yavan et al. (2010) on 188 women, 2% of the women. They found that 3 of them had regular BSE and 78.7% of them had never had a mammography. In addition, 85% of the women included in the study stated that they had a fear of breast cancer due to a family history of breast cancer, being diagnosed with breast cancer, and the presence of risk factors. Study results show that fear of breast cancer affects screening results. Therefore, our aim in the study is; To determine the effect of breast cancer and BSE training given to women on breast cancer fear and BSE skills. ### Conditions - Breast Cancer - Breast Self-Examination ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Education based on breast cancer and breast examination ### Outcomes Primary Outcomes - Champion Breast Cancer Fear Scale Change - Breast Self Examination Checklist Success Score Secondary Outcomes ### Location - Facility: Kocadere Sağlık Evi, Yalova, N/A, N/A, Turkey @@
## Statins Role in Acute Ischemic Stroke - NCT ID: NCT06371495 - Study ID: statins in ischemic stroke - Status: NOT_YET_RECRUITING - Start Date: 2024-08-13 - Completion Date: 2025-08-30 - Lead Sponsor: Assiut University ### Study Description Strokes is amajor cause of death and disabilities in different countried ### Conditions - Stroke, Acute ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - rosuvastatin ### Outcomes Primary Outcomes - Carotid duplex will be done at the onset and after 1 month and 3 months of the onset. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer (Camel-01) - NCT ID: NCT06371482 - Study ID: Camel-01 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2027-12-31 - Lead Sponsor: Hebei Medical University Fourth Hospital ### Study Description This trial aims to assess efficacy and safety of durvalumab combined with chemoradiotherapy for limited stage small cell lung cancer. ### Conditions - SCLC, Limited Stage ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Durvalumab - Chemotherapy drug of EP regimen - radiotherapy ### Outcomes Primary Outcomes - Assessment of objective remission rate (ORR) in limited stage small cell lung cancer treated with durvalumab combined with chemoradiotherapy - Assessment of the incidence of treatment-related adverse events Incidence of Treatment-Emergent Adverse Events. Secondary Outcomes - Assessment of overall survival (OS) in limited stage small cell lung cancer. - Assessment of progression-free survival (PFS) in limited stage small cell lung cancer. - Assessment of disease control rate (DCR) in limited stage small cell lung cancer. ### Location - Facility: Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050011, China @@
## Program of Health Behaviour Against to Cancer (PHeBAC) - NCT ID: NCT06371469 - Study ID: KAEK-769 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-08-20 - Lead Sponsor: Akdeniz University ### Study Description The European Code Against Cancer contains 12 recommendations to reduce the risk of cancer. It is estimated that about half of all cancers could be prevented if all recommendations are followed.The aim of this study was to evaluate the effectiveness of the Program of Health Behaviour Against Cancer (PHeBAC) applied to mothers of children with intellectual disabilities in increasing the participation of mothers and their children with intellectual disabilities in cancer screenings and their health behaviors against cancer. The goal is to improve the preventive health behaviors of children with intellectual disabilities and their mothers against cancer and to increase the rate of participation in cancer screenings. Specific targets are; not smoking and not being exposed to smoking, increasing physical activity, healthy nutrition, limiting alcohol consumption, protection from sunlight, HPV vaccination and increasing participation in breast, cervical and colorectal cancer screenings. ### Conditions - Cancer Prevention - Health Behavior - Disability, Intellectual - Parents - Cancer Screening - Experimental Study Designs - Mothers - Disabilities Mental ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - PHeBAC - Control Group ### Outcomes Primary Outcomes - Health Behaviors and Participation in Cancer Screenings Data Collection Form - Healthy Life Style Behaviors Scale II (Physical Activity and Nutrition Sub-Factors) - Sun Protection Behavior Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Non Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery - NCT ID: NCT06371456 - Study ID: Ain Shams university 111 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-08-01 - Lead Sponsor: Ain Shams University ### Study Description Epidural anesthesia for pain control during normal vaginal delivery is a blind maneuver and so we need a confirmatory sign for being in the correct epidural space.Loss of resistance sign using air may guide us wrongly as it may occur if we entered into the paravertebral muscles or cavities in the interspinal ligaments.So, additional confirmatory sign beside loss of resistance sign by air is strongly needed.We noticed that after occurence of loss of resistance sign by air and insertion of the epidural catheter a dew was formed on the internal sides of the epidural catheter after aspiration to be sure that there are no blood or cerebrospinal fluid in the catheter.This dew formation (Ramy sign) is characteristic for air in the epidural space when transferred from the warm epidural space (temperature about 38-39 celsius degree) to the colder aspect of the catheter outside the patient which nearly has the same operating room temperature (22 celsius degree).This sign may be associated with correct placement and good function of the epidural catheter. ### Conditions - Normal Delivery Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - epidural catheter placement ### Outcomes Primary Outcomes - appearance of the dew sign Secondary Outcomes - epidurogram - visual analogue score - mean blood pressure - mean blood pressure - heart rate - heart rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Suction and Swalloing Exercises for Premature Babies - NCT ID: NCT06371443 - Study ID: ayselkokcudogan - Status: COMPLETED - Start Date: 2021-12-03 - Completion Date: 2022-08-01 - Lead Sponsor: Istanbul Medipol University Hospital ### Study Description Underdeveloped oral structures of preterm infants cause feeding problems. Therefore, the development of sucking reflexes of premature babies should be supported.This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants.The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul. The study sample consisted of 82 premature infants. Of these infants, 41 were assigned to the experimental group and 41 to the control group. Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool. Throughout the study, preterm infants in the experimental group (n=41) were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days. SPSS21 was used to analyze the data. ### Conditions - Premature Infant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sucking and swallowing exercises ### Outcomes Primary Outcomes - The early feeding skills assessment tool (EFS) Secondary Outcomes ### Location - Facility: Medipol University, Istanbul, Beykoz, 34810, Turkey @@
## Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery - NCT ID: NCT06371430 - Study ID: Biointelligent Technology Syst - Status: RECRUITING - Start Date: 2021-04-14 - Completion Date: 2024-06-14 - Lead Sponsor: Biointelligent Technology Systems SL ### Study Description The investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Further, implant surfaces were examined using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies evaluated the efficacy of BBL on dental pulp pluripotent stem cells (DPPSCs) osteogenesis, and inflammatory factor modulation in human macrophages. ### Conditions - Wound Healing Disorder - Wounds and Injuries - Wound Surgical ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Dental Implant insertion and tooth extraction ### Outcomes Primary Outcomes - ISQ measurements - Pain Secondary Outcomes - CBCTs analysis ### Location - Facility: Biointelligent Technology Syst, Barcelona, N/A, 08009, Spain @@
## Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) - NCT ID: NCT06371417 - Study ID: RAY902CT - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2026-06-30 - Lead Sponsor: Chugai Pharmaceutical ### Study Description This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP). ### Conditions - Antiphospholipid Syndrome (APS) - Bullous Pemphigoid (BP) - Behçet's Syndrome (BS) - Dermatomyositis (DM) - Immune-mediated Necrotizing Myopathy (IMNM) - Immune Thrombocytopenia (ITP) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - RAY121 ### Outcomes Primary Outcomes - Adverse events (AEs) Secondary Outcomes - RAY121 concentration - AUCτ - Cmax - Cmin - Active C1s - Total C1s - Complement activity (classical pathway) - Anti-RAY121 antibodies ### Location - Facility: Oregon Health & Science University, Portland, Oregon, 97239, United States @@
## Imaging Traumatic Stress and Alcohol Use Disorder With [18F]Bavarostat - NCT ID: NCT06371404 - Study ID: 2000037129 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2031-06-01 - Lead Sponsor: Yale University ### Study Description The overall objective of this study it to use Positron Emission Tomography (PET) brain imaging and a radiotracer that measures the epigenetic marker Histone Deacetylase 6 (HDAC6) to examine HDAC6 expression in people with Post-Traumatic Stress Disorder (PTSD), Alcohol Use Disorder (AUD), or concurrent PTSD and AUD with control groups. While there are a large number of studies conducted in preclinical stress and addiction models, these findings have not been translated to people living with these disorders. We will examine relationships between HDAC6 and clinical variables of interest. Findings could direct treatment development. ### Conditions - Alcohol Use Disorder - Post Traumatic Stress Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bavarostat ### Outcomes Primary Outcomes - HDAC6 expression in people with Post-Traumatic Stress Disorder - HDAC6 expression in people with Alcohol use Disorder Secondary Outcomes ### Location - Facility: Yale University, New Haven, Connecticut, 06518, United States @@
## Environmental and Occupational Noise Exposure in Relation to Incidence of Type 2 Diabetes - NCT ID: NCT06371391 - Study ID: 2023-02077 - Status: ACTIVE_NOT_RECRUITING - Start Date: 1992-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Karolinska Institutet ### Study Description Large parts of the population are exposed to traffic noise, particularly in urban areas, and high noise levels occur in many workplaces. The aims of this project are to estimate exposure-response relationships for incidence of type 2 diabetes (T2D) related to long-term exposure to road traffic, railway and aircraft noise, as well as occupational noise. Furthermore, mediation by sleep disturbances and overweight/obesity is investigated, as well as interactions with air pollution and clinical biomarkers, to elucidate important etiological pathways. The project is based on pooled analyses of nine Scandinavian cohorts, totally including more than 300 000 individuals. Detailed longitudinal exposure to traffic noise from different sources, air pollutants and greenness, as well as occupational exposures, are estimated with state-of-the-art methods and supplemented with questionnaire and registry data on risk factors as well as clinical measurements. Incidence of T2D is assessed by combining information from medical examinations, high quality registers, questionnaires and biomarker measurements. Population attributable risks are estimated by combining population data on exposure with information on exposure-response relationships. In several aspects the project is unique and addresses questions which have never been studied before. Our results will provide important guidance for prioritization of preventive measures to promote health sustainable urban development and safe workplaces. ### Conditions - Environment Related Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Type 2 diabetes (T2D) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Different Peep Values on Gastric Residual Volume - NCT ID: NCT06371378 - Study ID: gastric residual volume - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-05 - Completion Date: 2024-09-01 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description The aim of this study was to predict the effect of gastric antrum diameter before extubation on intra-abdominal pressure changes and consequently on the risk of pulmonary aspiration in patients undergoing elective spinal surgery under general anaesthesia in the prone position in the Neurosurgery Operating Theatre of the Ministry of Health Ankara City Hospital and to take precautions accordingly. Gastric antrum diameter and intraabdominal pressure measurements may contribute to the improvement of anaesthetic practice by reducing the risk of pulmonary aspiration and additional complications. ### Conditions - Respiratory Aspiration of Gastric Content ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PEEP 0 - PEEP 4 - PEEP 8 ### Outcomes Primary Outcomes - Gastric antrum diameter Secondary Outcomes - Intraabdominal pressure (IAP) measurement - gastric volume measurement ### Location - Facility: Ankara City Hospital, Ankara, Çankaya, N/A, Turkey @@
## Adverse Events for Free Flap Surgery in Head and Neck Cancer - NCT ID: NCT06371365 - Study ID: KMUHIRB-E(II)-20220204 - Status: COMPLETED - Start Date: 2022-10-19 - Completion Date: 2023-09-24 - Lead Sponsor: Kaohsiung Medical University ### Study Description This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022. ### Conditions - Surgical Flaps - Flap Failure Risk Factors - Hematoma Risk Factors - Thrombosis Risk Factors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Free Flap surgery ### Outcomes Primary Outcomes - Number of participants with flap failure Secondary Outcomes - Number of participants with hematoma - Number of participants with thrombosis ### Location - Facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, N/A, N/A, Taiwan @@
## Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression - NCT ID: NCT06371352 - Study ID: JagiellonianU73 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-05 - Lead Sponsor: Jakub Antczak ### Study Description Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression. ### Conditions - Unipolar Depression - Bipolar Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - iTBS - cTBS - Sham ### Outcomes Primary Outcomes - Beck Depression Inventory 2 - Pittsburgh Sleep Quality Index Secondary Outcomes - Brief Psychiatric Rating Scale - Epworth Sleepiness Scale - Fatigue Assessment Scale - Quality of Life in Depression Scale - Sleep propensity non-rapid eye movement 1 sleep stage - Sleep propensity non-rapid eye movement 2 sleep stage ### Location - Facility: Institute of Psychiatry and Neurology, Warsaw, N/A, 02957, Poland @@
## Optimization With a Gamma Camera of the Individualized Patient Dosimetry in Radioiodine Therapy of Thyroid Diseases - NCT ID: NCT06371339 - Study ID: 23 VADS 03 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06 - Lead Sponsor: Institut Claudius Regaud ### Study Description This is a pilot, single-center, prospective, open-label clinical investigation of a medical device (ambulatory gamma camera " MoTI " (Mobile Therapy Imager)) for patients with hyperthyroidism (Graves' disease, toxic nodule and toxic multiheteronodular goiter) for whom 131I treatment is indicated.Its aim is to assess the feasibility of using this ambulatory gamma camera (MoTI) in the clinic in this patient population. The camera will be used to measure the 131I uptake/fixation rates during the thyroid scintigraphy.20 patients will be included in the study. ### Conditions - Hyperthyroidism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Additional acquisitions with the investigational gamma-camera " MoTI ". ### Outcomes Primary Outcomes - The clinical feasibility of using an ambulatory gamma camera. Secondary Outcomes - The level of acceptance of the gamma camera by operators for carrying out examinations - The quality of the images for the expected clinical use - The ability of the gamma camera to generate images compatible with the Picture Archiving and Communication System (PACS) - The quality of the images obtained with the ambulatory gamma camera compared with those obtained during the standard examination (i.e. gamma camera used in the department, Syngula) - The 131I fixation rates will be measured in percent at different times. ### Location - Facility: IUCT-O, Toulouse, N/A, N/A, France @@
## A Study of ZT002 Injection in Participants With Overweight or Obesity - NCT ID: NCT06371326 - Study ID: BJQLZT002004 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-11-21 - Completion Date: 2024-09-30 - Lead Sponsor: Beijing QL Biopharmaceutical Co.,Ltd ### Study Description This study will comprise a randomized, double-blind, placebo-controlled, multiple-ascending-dose, safety, tolerability, and pharmacokinetics study of ZT002 in participants with Overweight or Obesity. ### Conditions - Overweight or Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ZT002 Injection - Placebo ### Outcomes Primary Outcomes - Safety and tolerability of a multiple escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in MAD Cohorts. Number of participants with treatment-emergent adverse events. - Safety and tolerability of a multiple escalation dose of ZT002 through the incidence severity of serious adverse events in MAD Cohorts. Number of participants with serious adverse events. Secondary Outcomes - The Pharmacokinetics (PK) profile of a multiple escalation dose of ZT002 in participants with overweight or obesity. - The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in participants with overweight or obesity. - The anti-drug antibody (ADA) response through testing serum or plasma of the participants post-dosing. ### Location - Facility: First Affiliated Hospital of Bengbu Medical College, Bengbu, N/A, N/A, China @@
## Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism - NCT ID: NCT06371313 - Study ID: GuangdongWCH-LiLi03 - Status: COMPLETED - Start Date: 2023-05-01 - Completion Date: 2024-03-05 - Lead Sponsor: Guangdong Women and Children Hospital ### Study Description This study is a cross-sectional study to explore the endocrine metabolism and inflammatory characteristics of the offspring of mothers with PCOS hyperandrogenism, in order to provide a theoretical basis for finding the cause of PCOS. ### Conditions - PCOS ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Testosterone - Androstenedione - Dehydroepiandrosterone Sulfate - Sex Hormone Hinding Globulin - Free Androgen Index - Fasting Insulin - White Blood Cell Count - Neutrophil Count - High-sensitivity C-reactive Protein - Interleukin-6 Secondary Outcomes ### Location - Facility: Guangdong Women and Children Hosptial, Guanzhou, Guangdong, 511400, China @@
## Photobiomodulation With REd vs BluE Light (REBEL) - NCT ID: NCT06371300 - Study ID: HLS21156 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Aston University ### Study Description The use of photobiomodulation or low-level light therapy (LLLT) in the ophthalmic field stemmed from dermatology which has shown impact on skin blood flow and regeneration. There has been a rise in clinical interest with emerging evidence in the benefits of photobiomodulation in managing chronic inflammatory conditions such as dry eye disease including improvements in ocular discomfort symptoms, tear film stability and tear volume. Despite the observed clinical benefits, limited research has been done to compare photobiomodulation utilising different wavelengths, as most research on dry eye disease has focused on red wavelengths. It has been purported that blue wavelengths may disrupt microbial growth while red wavelengths stimulate energy production and hence increase heat in the affected tissues, although research into these differential impacts at the ocular surface and external eye has been limited. Hence, the aim of this exploratory clinical trial is to compare the impact of using LLLT incorporating red versus blue wavelengths on eyelid haemodynamics and microbiome, as well as conventional ocular surface measures of patients with dry eye disease and blepharitis (inflammation of the eyelids).Participants with dry eye disease, oil gland disruption and blepharitis will receive 3 treatments with these LLLT, each separted by 1 week apart, and followed up to 1 month after the final treatment session. Participants will be randomised to either of 3 groups: Red light only group, Red + Blue light group, or a sham treatment group. ### Conditions - Dry Eye Syndromes - Meibomian Gland Dysfunction - Blepharitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Red LLLT - Blue LLLT - Sham Red LLLT - Sham Blue LLLT ### Outcomes Primary Outcomes - Change from Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 1 Month After Final Treatment Session Secondary Outcomes - Change from Baseline in Visual Acuity to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Blink Rate to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Tear Meniscus Height to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Lipid Layer Pattern Grading to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Limbal Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Bacterial Colony to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Blood Flow to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Saponification Grading to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Demodex Presence to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Meibum Expressibility to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Meibum Quality to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Fluorescein Corneal Staining to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Bulbar Conjunctival Staining to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Meibography Meiboscore to the Final Follow-up 1 Month After Final Treatment Session - Change from Baseline in Total Corneal Nerve Length to the Final Follow-up 1 Month After Final Treatment Session ### Location - Facility: Aston Dry Eye Clinic, Birmingham, West Midlands, B4 7ET, United Kingdom @@
## Effect of Musical Auditory Training on Subjects With Tinnitus Disorder - NCT ID: NCT06371287 - Study ID: 64696022.1.0000.5346 - Status: RECRUITING - Start Date: 2023-02-20 - Completion Date: 2025-02-10 - Lead Sponsor: Universidade Federal de Santa Maria ### Study Description Among the theories of tinnitus generation, there is that of central neuroplastic changes, which reports the association between changes and reorganization that occur in central auditory pathways and impacts on associated areas due to the altered neural signal. Auditory training modifies these altered pathways through auditory exercises, which provoke positive neuroplasticity. Musical auditory training is a proposal to stimulate auditory, cognitive and metalinguistic skills with activities focused on musicality. Therefore, the objective of this study is to verify the effect of musical auditory training (MAT) on the neuroplasticity of the auditory system and the perception of tinnitus disorder in young adults. ### Conditions - Tinnitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Treinamento Auditivo Musical - Placebo ### Outcomes Primary Outcomes - Changes in latency of the long latency auditory evoked potential (LLAEP) Secondary Outcomes ### Location - Facility: Universidade Federal de Santa Maria, Santa Maria, RS, 97.105-970, Brazil @@
## A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC. - NCT ID: NCT06371274 - Study ID: ZYYY-IIT-TNBC-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-04-30 - Lead Sponsor: First Affiliated Hospital of Zhejiang University ### Study Description To evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced, recurrent, or metastatic triple-negative breast cancer who had failed second-line and subsequent therapy. ### Conditions - Triple-negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ATRA - Toripalimab ### Outcomes Primary Outcomes - Objective Response Rate (ORR) Secondary Outcomes - Progression-Free Survival (PFS) - Duration of Response (DOR) - Overall Survival (OS) ### Location - Facility: The first affiliated hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, P.R. China, 310003, China @@
## Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis - NCT ID: NCT06371261 - Study ID: 2023/CHU/07 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2027-03 - Lead Sponsor: Centre Hospitalier Universitaire de la Réunion ### Study Description The pathogenicity of Achromobacter bacteria is not yet well established, but studies show a decline in respiratory function and an increase in mortality associated with chronic colonisation, making it possible to classify the Achromobacter genus as an emerging pathogen in cystic fibrosis. It is possible that certain species or clones are more virulent or resistant, requiring the adaptation of measures to prevent cross-transmission in the centres concerned.However, until now, the identification of Achromobacter species has involved the use of molecular biology techniques that are not routinely applicable in diagnostic laboratories, limiting studies and the collection of epidemiological data. Recently, a database using MALDI-TOF mass spectrometry has been built for rapid and accurate species identification.In view of the local epidemiology and the current lack of data, it would be necessary and interesting to use this tool to study a cohort of cystic fibrosis patients in Réunion island (North and South sites) to see whether one species has a greater clinical impact than another (pathogenicity), and/or is more responsible for chronic colonisation. ### Conditions - Cystic Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biological analyses ### Outcomes Primary Outcomes - Frequency of pulmonary exacerbations according to the species of the Achromobacter genus colonising/infecting cystic fibrosis patients. Secondary Outcomes - Frequency of pulmonary exacerbations as a function of Achromobacter spp. colonisation status. - Emergence or existing presence of clones within the species of the genus Achromobacter circulating among cystic fibrosis patients in Réunion, using genomic analyses. - Presence of virulence factors in these strains using genomic analyses - Search for genes responsible for antibiotic resistance by genomic analysis of these strains - To describe the epidemiology of Achromobacter spp. in cystic fibrosis patients in Réunion ### Location - Facility: CHU la Réunion North, Saint-Denis, N/A, N/A, Réunion @@
## Steady Feet: Preventing Falls in the Community - NCT ID: NCT06371248 - Study ID: 2850 - Status: COMPLETED - Start Date: 2018-11-19 - Completion Date: 2019-12-20 - Lead Sponsor: Changi General Hospital ### Study Description The purpose of this study is to examine the feasibility of Steady Feet, a three-month community-based falls prevention exercise program. ### Conditions - Fall - Feasibility - Older Adults - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Steady Feet - Usual care for fall prevention ### Outcomes Primary Outcomes - Short Physical Performance Battery (SPPB) Secondary Outcomes - CONFbal - Six-minute walk test (6MWT) - Timed up and go (TUG) - Four square step test (FSST) - Feedback and satisfaction survey ### Location - Facility: Changi General Hospital, Singapore, N/A, 529889, Singapore @@
## Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier - NCT ID: NCT06371235 - Study ID: 2024-A00739-38 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-03 - Lead Sponsor: CerbaXpert ### Study Description The main objective of the study is to evaluate the frequency of placental transfer of self-Ab directed against the mother's IFN alpha in the newborn, in all women suffering from a pathology frequently associated with the presence of these autoantibodies and in those seropositive during the pregnancy. ### Conditions - Woman Suffering From a Pathology Frequently Associated With the Presence of These Anti-autoantibodies Type-I Interferons ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Pregiferon ### Outcomes Primary Outcomes - Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm - NCT ID: NCT06371222 - Study ID: BSMMU/2023/6502 - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2024-02-01 - Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh ### Study Description Mitral stenosis, a condition characterized by narrowing of the mitral valve orifice, remains a significant cause of morbidity and mortality worldwide, particularly in regions where rheumatic fever is endemic. Despite advancements in medical and surgical management, patients with mitral stenosis often suffer from symptoms such as dyspnea, fatigue, and reduced exercise tolerance, significantly impacting their quality of life (QoL) \[1\].One of the hallmark features of mitral stenosis is the development of sinus rhythm, which can be associated with elevated heart rates due to decreased diastolic filling time and compensatory mechanisms to maintain cardiac output. Persistent tachycardia in patients with mitral stenosis contributes to increased myocardial oxygen demand, exacerbating symptoms and potentially leading to adverse outcomes \[2\].In recent years, ivabradine, a selective inhibitor of the If current in the sinoatrial node, has emerged as a promising therapeutic option for controlling heart rate in various cardiovascular conditions, including chronic heart failure and ischemic heart disease \[3\]. By specifically targeting the cardiac pacemaker cells, ivabradine reduces heart rate without affecting myocardial contractility or conduction, offering a unique mechanism of heart rate control compared to traditional beta-blockers or calcium channel blockers \[4\].However, the role of ivabradine in patients with mitral stenosis in sinus rhythm remains uncertain, and there is limited evidence regarding its efficacy and impact on QoL in this specific patient population. Therefore, the aim of this randomized controlled trial (RCT) is to investigate the effects of ivabradine on heart rate control and QoL in patients with mitral stenosis in sinus rhythm. ### Conditions - Mitral Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Ivabradine - Beta blocker ### Outcomes Primary Outcomes - effect of ivabradine in MS patients Secondary Outcomes - quality of life of MS patients ### Location - Facility: BSMMU, Dhaka, N/A, 1200, Bangladesh @@
## Kinematics of Ewing Amputees - NCT ID: NCT06371209 - Study ID: 2022P000619 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-05-17 - Completion Date: 2024-07-01 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The agonist-antagonist myoneural interface (AMI) construct, known as the Ewing amputation at the trans-tibial level, has been shown to create a bi-directional neural communication platform as a means of controlling and interpreting proprioceptive feedback from a prosthetic joint. In AMI constructs, agonist-antagonist muscles are mechanically coupled within the residual limb, and volitional contraction of an agonist passively stretches that muscle's antagonist. The natural neural responses from muscle spindles within both muscles are then interpreted by the central nervous system as sensations of joint position and speed, associated with movement of the prosthesis.The aim of this research protocol is to evaluate the electromyographic and kinematic patterns of participants who have undergone unilateral lower extremity Ewing Amputation in order to determine how similar their residual limb data is when compared to their intact limb data. A secondary aim of this research may include comparison of the Ewing participant cohort's biomechanical patterns to a similar cohort of participants who have undergone standard amputation.The investigators hypothesize that the affected limb of patients with the Ewing procedure will demonstrate a pattern of electromyographic activation of their AMI constructs and kinematic data that recapitulates the pattern seen in their intact limb. The investigators secondarily hypothesize that the kinematic assessment of Ewing Amputation patients will demonstrate patterns that are significantly more physiologic than those witnessed in similar assessments of standard amputees. ### Conditions - Lower Extremity Amputation - Trans-Tibial Amputation - Traumatic Lower Extremity Amputation - Agonist-Antagonist Myoneural Interface ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Modified Amputation - Standard Amputation ### Outcomes Primary Outcomes - Duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait - Symmetry of duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait Secondary Outcomes - Symmetry of ankle power generation - Symmetry of peak knee flexion during stance ### Location - Facility: Mass General Brigham, Boston, Massachusetts, 02129, United States @@
## Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule - NCT ID: NCT06371196 - Study ID: BBD-PBC 2024-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2025-12-31 - Lead Sponsor: Mei Han ### Study Description 1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin;2. To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin. ### Conditions - Primary Biliary Cholangitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Babaodan Capsule ### Outcomes Primary Outcomes - Total bilirubin (TBil) reversion rate - Total bilirubin (TBil) efficacy rate Secondary Outcomes - biological response rate - ALT - AST - ALP - TBA - DBil - IBil - 5-D Pruritus Scale Score - Fatigue section of the PBC-40 questionnaire - Immunological indicators - serum IgM - Immunological indicators - serum IgG - Immunological indicators - serum IgA - Immunological indicators - anti-gp210 antibody - Immunological indicators - anti-sp100 antibody - Immunological indicators - autoantibodies AMA/AMA-M2 - Histopathology of the liver - grading of inflammatory activity - Histopathology of the liver - staging of the degree of fibrosis - 12-lead electrocardiogram - Physical examination - Routine blood test - Renal Function Tests-BUN - Renal Function Tests-UA - Renal Function Tests-Scr - Urinalysis - Coagulation tests-PT - Coagulation tests-APTT - Coagulation tests-TT - Coagulation tests-FIB - Urine beta-hCG pregnancy test - adverse event - Body temperature - Heart rate - Number of breaths in 1 min - Blood pressure-Diastolic blood pressure(mmHg) - Blood pressure-Systolic blood pressure(mmHg) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children on June 2024 - NCT ID: NCT06371183 - Study ID: AOMSaidB - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-05-30 - Lead Sponsor: Assiut University ### Study Description A Comparative study of clinical, endoscopic and histopathological features of colitis in children ### Conditions - Role of Ileoscopy in Diagnosis of Colitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Colonoscope ### Outcomes Primary Outcomes - Role of ileoscopy in diagnosis of colitis Secondary Outcomes - To correlate clinical manifestations by colonoscopic picture ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population - NCT ID: NCT06371170 - Study ID: CCPC- 001/22 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2027-01-01 - Lead Sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti ### Study Description The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (\< 16 years old) diagnosed with intracardiac thrombosis. The main question it aims to answer is: Does rivaroxaban treatment resolve the thrombosis during a 3-month treatment?Participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. They will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis. ### Conditions - Intracardiac Thrombus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Rivaroxaban ### Outcomes Primary Outcomes - Thrombus resolution Secondary Outcomes - Bleeding ### Location - Facility: CCPC, Ancona, Marche, 60123, Italy @@
## A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma - NCT ID: NCT06371157 - Study ID: AK104-308 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-02 - Completion Date: 2026-05-23 - Lead Sponsor: Akeso ### Study Description A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AK104 - Lenvatinib - TACE - Placebo for AK104 - Placebo for Lenvatinib ### Outcomes Primary Outcomes - Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Secondary Outcomes - Overall Survival (OS) - PFS per RECIST 1.1 - Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST) - Duration of Response (DOR) per RECIST 1.1 and mRECIST - Disease Control Rate (DCR) per RECIST 1.1 and mRECIST - Time to Response (TTR) per RECIST 1.1 and mRECIST ### Location - Facility: Henan Cancer Hospital, Zhengzhou, Henan, 450004, China @@
## A Randomized Control Trial on Intravenous Paracetamol Versus Intramuscular Tramadol as Intra Partum Labor Analgesia - NCT ID: NCT06371144 - Study ID: NHREC/16/05/22/130 - Status: COMPLETED - Start Date: 2022-06-03 - Completion Date: 2022-09-10 - Lead Sponsor: Darlington-Peter Chibuzor Ugoji ### Study Description ABSTRACT BACKGROUND: Labor pain is one of the most excruciating pain experienced by women. It affects maternal psychology and the course of labor causing apprehension, anxiety, and stress. Therefore there is a need for a safe and effective analgesic with minimal maternal and fetal side effects like intravenous paracetamol which has been shown to have great analgesic effect in labour with minimal maternal and neonatal side effects.OBJECTIVE: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs.METHOD: This would be a hospital based randomized controlled trial comparing intravenous paracetamol to intramuscular tramadol as labour analgesia in pregnant women in active phase of labour in the department of obstetrics and gynecology at Alex-Ekwueme Federal University Teaching Hospital and St. Patrick Mile 4 hospital, Abakaliki. A total of 194 pregnant women in active phase of labour will be included in study after fulfilling the inclusion criteria. These women will be divided into 2 groups of 97 each. Group A will receive a 100ml intravenous infusion containing 1000mg of paracetamol single dose over 15min. Group B: will receive intramuscular tramadol hydrochloride 100mg single dose. Pain intensity of women with both drugs will be noted before administration of drug, one hour, two hours and three hours after administration of drug using the visual analog scale. Perinatal outcome will also be recorded.10 ANALYSIS AND RESULTS: Data will be collated, tabulated and then statistically analyzed using Statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables will be presented as mean and standard deviation (Mean ± 2SD) or median and range as appropriate, while categorical variables will be presented as frequencies and percentages. Chi-square test( or Fisher's exact test where applicable) will be used for comparison between groups for categorical variables while student t test or Mann-Whitney U test will be used for comparison between groups for continuous variables KEYWORDS Labour analgesia, intravenous paracetamol, intramuscular tramadol, visual analog scale, neonate, side effects. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Paracetamol ### Outcomes Primary Outcomes - Mean pain score Secondary Outcomes ### Location - Facility: AEFUTHA, Abakaliki, Ebonyi, 234, Nigeria @@
## Effect of Stellate Ganglion Block on Postoperative Nausea and Vomiting - NCT ID: NCT06371131 - Study ID: PONV of Thyroid Surgery - Status: RECRUITING - Start Date: 2023-04-17 - Completion Date: 2024-08-30 - Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University ### Study Description Postoperative nausea and vomiting is one of the most common postoperative complications second only to postoperative pain. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk patients such as thyroid surgery is even up to 70-80%. PONV not only increased discomfort and prolonged hospital stay; Severe cases can lead to wound dehysis, acid-base imbalance, water and electrolyte metabolism disorders, seriously affect the prognosis of patients. Although various prevention and treatment measures have been adopted in clinical practice, it still cannot be completely eliminated. Therefore, postoperative nausea and vomiting of thyroid is still a concern in clinical anesthesia work, so it is urgent to explore more simple and effective measures to prevent thyroid PONV. SGB is the injection of local anesthetics into loose connective tissue containing stellate ganglion. It has a clear effect on postoperative analgesia of thyroid surgery, and can play a certain role in preventing thyroid PONV by reducing the application of perioperative opioids. Few studies have reported that the incidence of PONV can be significantly reduced after the application of SGB in patients with thyroid surgery, which provides a certain basis for the prevention of thyroid PONV. Therefore, this study aims to explore the effect of right stellate ganglion block on preventing postoperative nausea and vomiting of thyroid, and to explore the possible mechanism of action. ### Conditions - Stellate Ganglion Block - Thyroid Surgery - Postoperative Nausea and Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Right -stellate ganglion block ### Outcomes Primary Outcomes - Incidence of Postoperative nausea and vomiting Secondary Outcomes - Incidence of Postoperative nausea and vomiting during preemptive analgesia - Intensity of nausea and vomiting during preemptive analgesia - Intensity of nausea and vomiting during hospitalization - Hemodynamic parameters after preemptive analgesia - Postoperative pain intensity - Recovery of gastrointestinal function - Sleep quality - Satisfaction score and postoperative analgesia satisfaction score ### Location - Facility: The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400000, China @@
## HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme - NCT ID: NCT06371118 - Study ID: PI 20210032 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-11 - Lead Sponsor: Universidade do Porto ### Study Description This study aims to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling, in comparison to the standard of care strategy, to increase adherence to cervical cancer screening.An experimental and population-based study will be implemented at three primary healthcare centers located in the Western Porto region: Cedofeita, Garcia de Orta, and Prelada. Eligible women will be randomized into a control group or an intervention group. The control group will correspond to the standard of care (invitation to screening in a clinical setting). The intervention group will be randomized into two subgroups: 1) a "directly mailed" group that will receive a self-sampling kit at their home addresses by post; 2) an "opt-in" group that will receive an invitation at home asking if they want to receive a self-sampling kit, with a pre-paid envelope to return the answer to this question. Women who answer "yes" will receive the self-sampling kit at their home addresses by post.Self-sampling samples will be subjected to HPV genotyping. In parallel, high-risk HPV positive women will be called in by their family doctors to undergo screening in a clinical setting so that they can continue their clinical follow-up in the conventional pathway. ### Conditions - Papillomavirus Infections - Early Detection of Cancer - Cervix Cancer - Self-Examination ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Directly mailed self-sampling kit to collect a vaginal sample - Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure - Standard of care - screening in a clinical setting ### Outcomes Primary Outcomes - Adherence to conventional screening in control group - Adherence to HPV self-sampling in intervention 1 (directly mailed) group - Adherence to HPV self-sampling in intervention 2 (opt-in) group - Adherence proportion to HPV self-sampling in intervention 1 (directly mailed) group VS Adherence proportion to conventional screening in control group - Adherence proportion to HPV self-sampling in intervention 2 (opt-in) group VS Adherence proportion to conventional screening in control group Secondary Outcomes - Adherence to first follow-up step in control group - Adherence to first follow-up step in intervention 1 (directly mailed) group - Adherence to first follow-up step in intervention 2 (opt-in) group - Adherence to first follow-up step in control group among women referred for follow-up - Adherence to first follow-up step in intervention 1 (directly mailed) group among women referred for folow-up - Adherence to first follow-up step in intervention 2 (opt-in) group among women referred for folow-up - Adherence to colposcopy in control group - Adherence to colposcopy in intervention 1 (directly mailed) group - Adherence to colposcopy in intervention 2 (opt-in) group - Adherence to colposcopy in control group among women referred for colposcopy - Adherence to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy - Adherence to colposcopy in intervention 2 (opn-in) group among women referred for colposcopy - Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 1 (directly mailed) group - Timelapse (in days) between the invitation to receive a self-sampling kit and the return of the opt-in answer, in intervention 2 (opt-in) group - Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 2 (opt-in) group - Adherence proportion to first follow-up step in intervention 1 (directly mailed) group VS Adherence proportion to first follow-up step in control group - Adherence proportion to first follow-up step in intervention 2 (opt-in) group VS Adherence proportion to first follow-up step in control group - Adherence proportion to first follow-up step in intervention 1 (directly mailed) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up - Adherence proportion to first follow-up step in intervention 2 (opt-in) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up - Adherence proportion to colposcopy in intervention 1 (directly mailed) group VS Adherence proportion to colposcopy in control group - Adherence proportion to colposcopy in intervention 2 (opt-in) group VS Adherence proportion to colposcopy in control group - Adherence proportion to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy - Adherence proportion to colposcopy in intervention 2 (opt-in) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy - Proportion of HR-HPV positivity in control group - Proportion of HR-HPV positivity in intervention 1 (directly mailed) group - Proportion of HR-HPV positivity in intervention 2 (opt-in) group - Proportion of HR-HPV positivity in control group among women who adhered to conventional screening - Proportion of HR-HPV positivity in intervention 1 (directly mailed) group among women who returned the self-sample - Proportion of HR-HPV positivity in intervention 2 (opt-in) group among women who returned the self-sample - Proportion of HR-HPV 16/18 positivity in control group - Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group - Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group - Proportion of HR-HPV 16/18 positivity in control group among women who adhered to conventional screening - Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group among women who returned the self-sample - Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group among women who returned the self-sample - Positive predictive value of self-sampling for the detection of HR-HPV, using clinician-sampling results as gold standard - Sensitivity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard - Specificity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard - Positive likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard - Negative likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard - Accuracy of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard - Sensitivity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard - Specificity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard - Positive likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard - Negative likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard - Accuracy of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard - Sensitivity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard - Specificity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard - Positive likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard - Negative likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard - Accuracy of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Aquatic_Training in Obese Women - NCT ID: NCT06371105 - Study ID: 014_2018 - Status: COMPLETED - Start Date: 2019-01-02 - Completion Date: 2019-03-30 - Lead Sponsor: University of Taipei ### Study Description This study aims to assess the effects of 10-week water-based aerobic training (thrice a week) on anthropometrics, biochemicals, cardiovascular parameters, and explosive strength in young overweight and obese women. The findings indicate that water-based aerobic training could be a useful program to enhance body composition, biochemical, cardiovascular, and explosive strength parameters in young overweight and obese women compared to inactive persons ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 10-week water-based aerobic training ### Outcomes Primary Outcomes - fasting glycemia in millimoles per liter - total cholesterol in millimoles per liter - high-density lipoprotein cholesterol in millimoles per liter - low-density lipoprotein cholesterol in millimoles per liter - triglyceride concentrations in millimoles per liter - systolic blood pressure in millimeters of mercury - diastolic blood pressure in millimeters of mercury - heart rate in beat per minute - fasting glycemia in millimoles per liter - total cholesterol in millimoles per liter - high-density lipoprotein cholesterol in millimoles per liter - low-density lipoprotein cholesterol in millimoles per liter - triglyceride concentrations in millimoles per liter - systolic blood pressure in millimeters of mercury - diastolic blood pressure in millimeters of mercury - heart rate in beat per minute Secondary Outcomes - countermovement jump in centimetres - squat jump in centimeters - chest 3-kg medicine ball throw in meters - countermovement jump in centimetres - squat jump in centimeters - chest 3-kg medicine ball throw in meters ### Location - Facility: Department of Exercise and Health Sciences, University of Taipei, Taipei, N/A, 11153, Taiwan @@
## Efficacy of a Desensitizing Agent During At-home Bleaching - NCT ID: NCT06371092 - Study ID: 2023/01 - Status: COMPLETED - Start Date: 2023-01-31 - Completion Date: 2023-03-01 - Lead Sponsor: University of Santiago de Compostela ### Study Description The main objective of this study is to evaluate if the use of UltraEZ during at-home bleaching treatment is effective in reducing tooth sensitivity, as well as doesn't affect the degree of tooth bleaching. ### Conditions - Sensitivity, Tooth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - UltraEZ - Placebo ### Outcomes Primary Outcomes - Questionnaire of dental sensitivity Secondary Outcomes - Shade evaluation with a dental spectrophotometer ### Location - Facility: School of Medicine and Dentistry, Santiago De Compostela, A Coruña, 15705, Spain @@
## Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs - NCT ID: NCT06371079 - Study ID: NO-OVD-ICL - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06 - Lead Sponsor: Loay Abdulmutalib Almusawi ### Study Description The goal of this observational study is to test whether surgeries for lenses designed to be implanted in the eye to correct refractive error can be done without the need for using viscoelastic substances that are used routinely nowadays to make it easier to introduce them inside the human eye and protect the inside of the eye during the operation.The main question it aims to answer is that is it safe to do the surgery without using them? to answer this question researchers will access recorded data of patients that underwent refractive surgeries in a private clinic since 2017 and compare them as two groups: those who underwent the traditional procedures and those who had it without the use of dispersive viscoelastics in regard to their vision before and after surgery, their ocular pressure and biomicroscopic analysis of the inside of their corneas before and after surgery. ### Conditions - Refractive Errors - Myopia - Myopic Astigmatism - Hypermetropia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - phakic intraocular lens implantation traditional - phakic intraocular lens implantation reduced OVD ### Outcomes Primary Outcomes - unaided visual acuity after the procedure - best corrected visual acuity after the procedure Secondary Outcomes - Intraocular pressure postoperatively - Specular microscopy parameter: endothelial cell density - Specular microscopy parameter: endothelial cells hexagonality - Specular microscopy parameter: coefficient of variation of corneal endothelial cells ### Location - Facility: Al-Ferdows private eye hospital, Baghdad, N/A, N/A, Iraq @@
## The Effect of Video-based Training on the Knowledge Levels of Nursing Students - NCT ID: NCT06371066 - Study ID: EAkyuz-2 - Status: COMPLETED - Start Date: 2021-02-01 - Completion Date: 2021-06-10 - Lead Sponsor: Kırıkkale University ### Study Description Although face-to-face education is widely used as a traditional method, emerging computer technology has allowed new training approaches such as video-based training (VBT) platforms to flourish, especially in the last four decades. Educators adopted VBT as a cost-effective and accessible medium to address some of their training needs. It contains purposely designed visual cues and draws learners' attention during the learning process, and the dynamic details enable learners to better understand the learning contents. The use of new technologies such as e-learning, computer-assisted learning, VBT, and web-based applications for clinical skill education has increased learner satisfaction compared with conventional education methods. Preoperative patient preparation is a crucial element of preoperative nursing care. A surgical nurse is a specialized coordinator of patient care, and the main purposes of this role are to meet the patient's and the family's needs individually and to prepare them for the scheduled procedure and postoperative recovery. Preoperative patient preparation contains multiple components and steps such as preoperative education, including physical, social, psychological, and legal preparation, and preparation for the night and day of surgery. the nature of the process has many components and steps, it is not easy for students to learn this subject, and nursing educators were able to experience this in a clinical practice environment. And the educators started to search for new teaching techniques to teach this subject like the other colleagues. the investigator's aim in this project is to determine the effect of VBT on the knowledge levels of nursing students on preoperative patient preparation when compared to traditional training methods. ### Conditions - Student Nursing - Medical-surgical Nursing - Nursing Care - Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - experimental group - Control group ### Outcomes Primary Outcomes - The Student Information Form - The Knowledge Form for Preoperative Patient Preparation Secondary Outcomes ### Location - Facility: Kirikkale University, Kirikkale, N/A, N/A, Turkey @@
## The Effect of Community Intervention on Different Degrees of Dementia - NCT ID: NCT06371053 - Study ID: community - dementia - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-05 - Lead Sponsor: Babujinaya Cela ### Study Description The goal of this clinical trial is to explore the impact of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals (≥60 year old) with Alzheimer's disease. It primarily aims to address: the effects of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals with Alzheimer's disease in different degrees. All participants are required to undergo a continuous 2-week (14 days) Community Intervention, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each. ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Community Intervention ### Outcomes Primary Outcomes - Mini-Mental State Examination Secondary Outcomes - Barthel Index - Functional near-infrared spectroscopy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis - NCT ID: NCT06371040 - Study ID: V1.0, CART-20230619 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-01 - Lead Sponsor: Ting Chang, MD ### Study Description This study is a single-center, open-label, single-arm, dose-exploration study to evaluate the safety and preliminary effectiveness of CD19-BCMA CAR-T in the treatment of refractory, generalized myasthenia gravis. The study is a dose escalation trial in adult, refractory, systemic MG patients. The Keyboard method will be used to perform dose escalation to explore the maximum tolerated dose (MTD). A total of 12 MG patients who meet the inclusion criteria are expected to be recruited. ### Conditions - Myasthenia Gravis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - CD19-BCMA Targeted CAR-T Dose 1 - CD19-BCMA Targeted CAR-T Dose 2 - CD19-BCMA Targeted CAR-T Dose 2 ### Outcomes Primary Outcomes - Frequency, type, and severity of adverse events Secondary Outcomes - Frequency, type, and severity of abnormal laboratory indicators related to treatment - Changes of blood pressure - Changes of pulse rate - Changes of weight - Changes of Myasthenia Gravis Activities of Daily Living (MG-ADL) scores - Changes of Quantitative Myasthenia Gravis (QMG) scores - Changes of Myasthenia Gravis Composite (MGC) scores - Proportion of subjects who achieved improvement - Time to achieve clinical improvement - Changes of myasthenia gravis-specific autoantibody titers - Changes of immunoglobulins ### Location - Facility: Tangdu Hospital, The Fourth Military Medical University, Xi'an, Shaanxi, 710038, China @@
## Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial - NCT ID: NCT06371027 - Study ID: RECO6U/22-2022 - Status: COMPLETED - Start Date: 2022-11-01 - Completion Date: 2024-04-01 - Lead Sponsor: October 6 University ### Study Description Clinically and radiographically by cone beam CT evaluate the regenerative potentials of silk fibroin (SF) nanofiber membrane, using minimally invasive surgery, for the regenerative treatment of intrabony periodontal defects. ### Conditions - Intrabony Periodontal Defect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Minimally Invasive Surgery Technique (MIST) + Novel Silk Fibroin (SF) nanofiber membrane - Minimally Invasive Surgery Technique (MIST) + collagen membrane - Minimally Invasive Surgery Technique (MIST) ### Outcomes Primary Outcomes - Novel Silk Fibroin Nanofiber Membrane using minimally invasive surgery in Treatment of Periodontal Intrabony Defects Secondary Outcomes ### Location - Facility: faculty of dentistry O6U, Giza, N/A, N/A, Egypt @@
## Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy - NCT ID: NCT06371014 - Study ID: Ondansetron mouth soluble film - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: Shanghai Children's Medical Center ### Study Description Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A (Ondansetron mouth soluble film) or arm-B (Ondansetron tablet). Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone. Children recruited to arm-B received Ondansetron tablet plus dexamethasone. Ondansetron and dexamethasone were given continuously until 48hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy ### Conditions - To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic Chemotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ondansetron oral membrane ### Outcomes Primary Outcomes - Complete Remission Rates in the Acute Phases Secondary Outcomes - Complete Remission Rates in the Delayed Phases ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prevalance Of Helicobacter Pylori Infection In Chonic Kidney Diseased Patient Admitted To Luxor Medical Complex - NCT ID: NCT06371001 - Study ID: Helicobacter Pyloi and CKD - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-07-01 - Lead Sponsor: Assiut University ### Study Description Detect prevalence of Helicobacter pylori infection in chronic kidney diseased patient admitted to Luxor medical complex and possible role of Helicobacter pylori in pathogenesis of chronic kidney diseased patient of unknown etiology ### Conditions - Chronic Kidney Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - disease ### Outcomes Primary Outcomes - Helicobacter pylori infection and Chronic kidney diseased patient Secondary Outcomes - possible role of H pylori in pathogenesis of chronic kidney diseased patient of unkown etiology ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Theta-Burst Stimulation for Bipolar Depression - NCT ID: NCT06370988 - Study ID: 4343 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-05 - Lead Sponsor: Centre for Addiction and Mental Health ### Study Description The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion. ### Conditions - Bipolar Depression - Bipolar Disorder - Treatment- Resistant Bipolar Disorder - Type 2 Bipolar Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - iTBS Stimulation - Sham iTBS Stimulation ### Outcomes Primary Outcomes - Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) Secondary Outcomes - Symptoms of Mania ### Location - Facility: University Health Network, Toronto, Ontario, M5T 2S8, Canada @@
## Effect of Fluid Resuscitation on Lactate in Traumatic Injury Patients - NCT ID: NCT06370975 - Study ID: Fluid resuscitation in trauma - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2025-09 - Lead Sponsor: Assiut University ### Study Description The study aims to investigate the effect of 3% hypertonic saline resuscitation on lactate clearance in comparison to ringer's lactated solution and 0.9% normal saline in traumatic injury patients.Also to provide insights into the optimal fluid resuscitation strategy for traumatic injury patients ### Conditions - Fluid Resuscitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 3% hypertonic Saline - Ringer's lactated solution - 0.9% Normal saline ### Outcomes Primary Outcomes - Rate of lactate clearance following resuscitation with different solutions Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Circadian Rhythm Disorders in Children With Cystic Fibrosis Under CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators - NCT ID: NCT06370962 - Study ID: 69HCL24_0076 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Cystic fibrosis (CF) is a rare disease affecting one out of 4,500 newborns in France (INSERM 2021). Despite major advances in patient care over the past two decades, with significant improvements in life expectancy, cystic fibrosis remains a pathology that considerably impairs quality of life.Several studies have reported the possibility of respiratory and non-respiratory sleep disorders (SD) in patients with CF. Respiratory disorders are reported to affect 30% of children with CF (Barbosa 2020). Among non-respiratory SD, sleep onset and maintenance insomnia are well known in these patients, while chronotype abnormalities (circadian rhythm disorders) are understudied. Chronotype refers to a person's tendency to be more efficient in the morning or evening.The existence of chronotype abnormalities has been suggested in CF patients, but no precise data are available (Louis 2022). The involvement of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) protein dysfunction in the central nervous system (CNS) has been hypothesized as a contributory factor. In vivo, in a mouse model of CF, dysregulation of clock genes such as Clock, Cry2 and Per2 was found in the CNS (Barbato 2019). Among them, certain genes such as Rev-erbα could regulate endobronchial inflammation and contribute to the severity of respiratory pathology. All in all, chronotype abnormalities could be at the origin of sleep debt, impaired cognitive functions or metabolic disturbances.In the era of highly effective modulator therapy (HEMT) for the treatment of CF, the impact of these new therapies on chronotype has been understudied. Assuming that chronotype abnormalities are a direct consequence of CFTR protein dysfunction in the retina and anterior hypothalamus, HEMT should improve sleep quality. However, between 20% and 30% of adult and pediatric patients express an increase in chronotype abnormalities following initiation of treatment.Paradoxically, the perceived gain in respiratory quality of life is counterbalanced by the occurrence of these disorders. Some patients would effectively reverse their treatment in order to limit the phenomenon. A single polysomnographic study evaluated the effect of HEMT Kaftrio-Kalydeco on sleep in adults with CF (Welsner 2022). After 3 months of treatment, patients had a significant reduction in respiratory events, with no change in total sleep time, sleep efficiency or sleep architecture. Chronotype was not mentioned. Currently, no studies on chronotype in children or adults with CF have been carried out. Our hypothesis is that CF patients treated with HEMT would develop an abnormal chronotype of late sleep onset.The aim of this study is to evaluate the chronotype of children with CF treated with HEMT. Chronotype abnormalities could have major consequences for quality of life, the immune system, cognitive functions and metabolism. Systematic detection of these disorders via anamnesis, followed by diagnosis by questionnaire, actimetrics and/or urinary melatonin dosage, would enable their early management, starting with the reversal of Kaftrio-Kalydeco intake between morning and evening. ### Conditions - Cystic Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Result of the Horne and Ostberg questionnaire. Secondary Outcomes ### Location - Facility: Service de pédiatrie, CHRU de Nancy - Hôpitaux de Brabois, Nancy, N/A, 54500, France @@
## The Effectiveness of Bupivacaine and Bupivacaine+Dexmedetomidine Combination in Transversus Abdominis Plane* Block - NCT ID: NCT06370949 - Study ID: 2024-01/17 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-11-30 - Lead Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital ### Study Description Transversus abdominis plane (TAP) block is an anesthesia method that provides somatic analgesia to the anterior and lateral abdominal walls. Thus, TAP block is widely implemented in perioperative management of colorectal cancer patients.Researchers aimed to evaluate the analgesic effectiveness and duration of effect of dexmedetomidine added to bupivacaine in the TAP block applied in colorectal cancer surgeries. ### Conditions - Colorectal Cancer - Colorectal Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bupivacain - bupivacain+dexmedetomidine ### Outcomes Primary Outcomes - Analgesic effectiveness of bupivacain and bupivacain+dexmedetomidine combination in colorectal cancer surgery Secondary Outcomes ### Location - Facility: Turkey Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital, Ankara, Cankaya, 06110, Turkey @@
## The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health - NCT ID: NCT06370936 - Study ID: NL84824.091.23 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Wageningen University ### Study Description Plant-based diets with little to no meat are considered healthy and sustainable by the general public. The increasingly popular plant-based meat analogues (PBMAs) allow consumers to easily decrease meat intake while maintaining their dietary patterns. However, scientific knowledge on the health impact of PBMAs on humans is currently very limited.The primary objective of this clinical trial is to evaluate if and to what extent replacing all meat products in an average Dutch diet with currently commercially available PBMAs affects the systolic blood pressure of middle-aged men and women in a 2x8 week fully dietary controlled crossover intervention study. The secondary objectives are to assess the effect of this replacement of meat products with PBMAs on cardiometabolic health, gut microbiome, intestinal health, well-being, and underlying biological mechanisms.114 men and women with a BMI of 23-40 kg/m2, aged 45-75 years will be included in the study. Participants will follow both an 8-week completely controlled diet in which all meats are of plant-based origin (PBMAs) and an 8-week diet in which all meats are of animal origin in randomized order with a 10-week wash-out period. Before the intervention starts, the participants will be characterized to describe them on anthropometrics, glucose tolerance and insulin sensitivity, genetics, sleep patterns, and stress levels. Before the start and at the end of each 8-week dietary intervention period, several measurements, including systolic blood pressure monitoring and secondary outcome measures will be done. Additionally, systolic and diastolic blood pressure will be monitored throughout the dietary interventions and a small quantity of parameters related to the secondary objectives will be measured. ### Conditions - Blood Pressure - Cardiometabolic Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Standardized diet with commercially available animal meats (comparator products) - Standardized diet with commercially available PBMAs (intervention products) ### Outcomes Primary Outcomes - Systolic blood pressure Secondary Outcomes - Diastolic blood pressure - Home systolic blood pressure - Home diastolic blood pressure - Home heart rate - Fasting blood HbA1c levels - Fasting blood glucose levels - Fasting blood insulin levels - Fasting blood lipid spectrum - Fasting blood metabolite profile - Fasting blood proteomic profile - Fasting blood cell transcriptomic profile - Fasting blood nutritional status - Blood immune markers - Blood immune cell populations - Metabolites in 24-hour urine - Interstitial glucose profile - Physical activity - Fecal microbiome composition - Fasting and postprandial circulating metabolites with a high fat mixed meal (HFMM) challenge - Oral microbiome composition - Microbiome metabolites - Microbiome functionality - Self-reported gastro-intestinal symptoms - Self-reported constipation - Self-reported stool consistency and frequency - Gastro-intestinal transit time - Self reported product-specific attitude towards meat and PBMAs - Self reported meal-specific satiety with meat and PBMAs - Self-reported general attitude toward meat and PBMAs ### Location - Facility: Wageningen University, Division of Human Nutrition, Wageningen, Gelderland, 6708 WE, Netherlands @@
## Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention - NCT ID: NCT06370923 - Study ID: 1R01MH133488-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2028-12 - Lead Sponsor: University of Stellenbosch ### Study Description Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination. Suboptimal engagement with HIV prevention by men increases their risk of HIV acquisition, and is an important driver of new HIV infections in women. HIV self-testing (HIVST) addresses several key facility-based access barriers and HIVST distribution through leveraging male peer networks for HIV prevention is feasible, acceptable and effective in SSA.The objective of this project is to use an implementation science approach to establish the impact of HIVST distribution through male social networks, with phone-based support and improved risk perception, on PrEP (Pre-Exposure Prophylaxis) uptake among men in Eastern Zimbabwe. The project will leverage infrastructure and data associated with 20-year programme of HIV surveillance and behavioural research in a well-characterized population cohort hosted by the Manicaland Centre for Public Health Research, Zimbabwe.The study will utilise a cluster randomised design of 44 clusters (22 Intervention:22 control) comprising on average 81 men in each cluster (total N = 3591) followed for 6 months (giving \>80% power to detect a difference in PrEP initiation among men of 2% versus 8.5%). In intervention clusters the investigators will identify initial distributors who will receive an HIVST kit for personal use and HIVST kits to distribute to local peers. These peers can subsequently become distributors, allowing the intervention to propagate through peer networks. A toll-free helpline will provide pre- and post-test support and an SMS (Short Message Service) -based risk assessment will expedite PrEP initiation at the clinic. The study team will conduct a performance (process) evaluation of the intervention. to assess implementation fidelity, causal mechanisms underlying trial effectiveness including how characteristics of peer networks affect outcomes. Results of the study will be used to quantify the population level impacts and cost-effectiveness of male peer to peer HIVST distribution strategies on the uptake of PrEP in HIV hyper-endemic settings using a fully calibrated individual-based mathematical model. The envisaged long-term impact of this research is the development of a generalizable, multicomponent male peer-based HIVST and PrEP uptake model for settings where HIV incidence is high. ### Conditions - HIV Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Peer Distribution - Community Health Worker Distribution ### Outcomes Primary Outcomes - PrEP initiation Secondary Outcomes - PrEP adherence - ART adherence - Confirmatory tests ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction - NCT ID: NCT06370910 - Study ID: CAAE 58569421.5.0000.5327 - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2024-01-10 - Lead Sponsor: Federal University of Rio Grande do Sul ### Study Description The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. It is known that the postpartum period is when the body is involuting to its pre-pregnancy state. The perineal pain caused by these injuries during childbirth is a determining factor for recovery, and it may affect not only the physical but also the psychological well-being of women. Therefore, it is necessary to employ techniques that can alleviate pain and edema in the immediate postpartum period, directly influencing recovery.Objective: To compare the use of photobiomodulation with cryotherapy in the immediate postpartum period of 2 hours in parturients who suffered 1st and 2nd-degree lacerations and/or episiotomies.Methods: A randomized clinical trial will be conducted to compare two interventions. Data collection will be through a questionnaire and scales for the evaluation of pain and edema, with women who experienced vaginal delivery and those who suffered 1st and 2nd-degree lacerations or episiotomies.Expected results: Reduction of pain, edema, and inflammatory processes with non-pharmacological techniques, leading to greater comfort and better postpartum recovery. ### Conditions - Episiotomy; Complications - Laceration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Low-Level Laser Therapy ### Outcomes Primary Outcomes - To compare two techniques: Low-level laser and cryotherapy Secondary Outcomes - Pain reduction assessed by the Visual Analog Scale (VAS). - Pain reduction assessed by McGill Pain Scale - Evaluate reduction of swelling using the REEDA scale. ### Location - Facility: Hospital de Clínicas de Porto Alegre, Porto Alegre, N/A, RS, Brazil @@
## Prediction & Mechanisms of Recovery Following IEDS - NCT ID: NCT06370897 - Study ID: 337421 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-09 - Lead Sponsor: University of Plymouth ### Study Description Inner Ear Decompression sickness (IEDS) accounts for 20% of all types of decompression sickness (the bends) in divers. The condition commonly affects the peripheral vestibular system (inner ear). IEDS results in acute symptoms of dizzyness (vertigo) and imbalance. Even with the recommended treatment of hyperbaric oxygen therapy some people do not recovery fully. However, even in the presence of a permanent vestibular deficit many people can show a behavioural recovery where symptoms improve over time. Recovery can be aided by vestibular rehabilitation (VR) which is now routine for acute IEDS but was not provided before 2021, and is not widespread across the UK (United Kingdom) or world, meaning people may have a suboptimal recovery.This project will investigate if and how people recover after an acute episode of IEDS and whether people who had IEDS in the past show changes in the central (brain) processing of vestibular function and in symptoms of dizziness, balance and posture.This project has two main parts. Part one is a prospective observational study where people with an acute onset of IEDS are serially monitored while they are receiving hyperbaric treatment and VR over 10-14 days. Part two is a retrospective observational study where who have had IEDS in the past 15 years are re-assessed in a one-off session. The tests in both parts involve clinical tests and specialist eye movement recordings that assess vestibular function. We will also determine the site of any vestibular pathology by using selective stimulation of the vestibular end organ or nerve and assess whether there are any changes in how the structure and function of central vestibular pathways in the brain. In people with chronic IEDS with vestibular symptoms we will offer participants a course of VR over 12 weeks and assess whether this is associated with any improvement in symptoms. ### Conditions - Decompression Sickness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Side of peripheral vestibular damage: Prospective cohort - Site of peripheral vestibular damage: Prospective cohort - Extent of peripheral vestibular damage: Prospective cohort - Side of peripheral vestibular damage: Retrospective cohort - Site of peripheral vestibular damage:Retrospective cohort - Extent of peripheral vestibular damage:Retrospective cohort Secondary Outcomes - VOR gain v HIT: Prospective Study - VOR gain: Prospective Study - VOR Time constant:Prospective Study - Patient reported outcome measure: Prospective Study - Clinical measure of walking: Prospective Study - Clinical measure of balance: Prospective Study - Posturography: Prospective Study - Perception of verticality: Prospective Study - Functional MRI response to an optokinetic stimulus: Prospective Study - Vestibular Evoked myogenic Potentials latency: Prospective Study - Vestibular Evoked myogenic Potentials amplitude: Prospective Study - VOR gain: Retrospective Study - VOR Time constant: Retrospective Study - Patient reported outcome measure: Retrospective Study - Clinical measure of walking: Retrospective Study - Clinical measure of balance: Retrospective Study - Posturography: Retrospective Study - Perception of verticality: Retrospective Study - Functional MRI response to an optokinetic stimulus: Retrospective Study - Vestibular Evoked myogenic Potentials latency: Retrospective Study - Vestibular Evoked myogenic Potentials amplitude: Retrorospective Study ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection - NCT ID: NCT06370884 - Study ID: SURG-2023-29833 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-02-01 - Lead Sponsor: University of Minnesota ### Study Description This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis will be enrolled to have a feeding tube placed at the time of surgery and receive either IMT or a saline solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT or saline, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT/saline, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics). ### Conditions - Recurrent Clostridioides Difficile Infection - Colonic Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - IMT - Saline solution ### Outcomes Primary Outcomes - Evaluate safety of IMT in patients undergoing colon surgery - compare fecal microbiota prior to and after IMT Secondary Outcomes - Evaluate engraftment of donor microbiota - Evaluate changes in circulating markers of inflammation: WBC - Evaluate changes in circulating markers of inflammation: Hemoglobin - Evaluate changes in circulating markers of inflammation: Platelets - Evaluate changes in circulating markers of inflammation: Electrolytes - Evaluate changes in circulating markers of inflammation - Evaluate changes in circulating markers of inflammation: alkaline phosphatase - Evaluate changes in circulating markers: Albumin - Evaluate changes in microbial metabolites: Fecal short-chain fatty-acids - Evaluate changes in microbial metabolites: Fecal IgA - Compare baseline microbiome characteristics with changes over time after IMT ### Location - Facility: University of Minnesota, Minneapolis, Minnesota, 55414, United States @@
## Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma - NCT ID: NCT06370871 - Study ID: 1403-0006 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-04 - Completion Date: 2028-10-13 - Lead Sponsor: Boehringer Ingelheim ### Study Description This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene. This is a study for people whose earlier treatment isn't working anymore, and their doctors suggest a new treatment to stop the sarcoma from getting worse.The purpose of this study is to compare a medicine called brigimadlin in combination with another medicine called ezabenlimab with chemotherapy. Brigimadlin is a so-called MDM2-p53 antagonist that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer.Participants are put into 3 groups by chance:* Ezabenlimab group: Participants receive ezabenlimab as an infusion into a vein every 3 weeks* Brigimadlin + ezabenlimab group: Participants take brigimadlin as tablets and receive ezabenlimab as an infusion into a vein every 3 weeks* Chemotherapy group: Participants get chemotherapy as an infusion into a vein on 2 days every 3 weeks. Chemotherapy is a combination of gemcitabine and docetaxel which is often used in the treatment of sarcoma.There are twice as many participants in the brigimadlin + ezabenlimab group and in the chemotherapy group, compared to those in the ezabenlimab group.Participants can continue treatment in the study as long as they benefit from it and can tolerate it.Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being. This is to find out if their quality of life is changing. ### Conditions - Advanced Soft Tissue Sarcoma - Undifferentiated Pleomorphic Sarcoma (UPS) - Myxofibrosarcoma (MFS) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Brigimadlin - Ezabenlimab - Gemcitabine - Docetaxel ### Outcomes Primary Outcomes - Progression-free survival - Overall survival Secondary Outcomes - Objective response - Duration of objective response - Disease control - Duration of disease control - Occurrence of treatment-emergent adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5 - Occurrence of treatment-emergent AEs leading to study drug discontinuation - Mean change from baseline to Week 12 in the domain fatigue (based on items from the European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) and the EORTC item library) - Mean change from baseline to Week 12 in the domain fatigability (based on items from the EORTC QLQ-C30 and the EORTC item library) - Mean change from baseline to week 12 in the domain physical functioning (based on items from the EORTC QLQ-C30) - Mean change from baseline to week 12 in the domain pain (based on items from the EORTC QLQ-C30) - Mean change from baseline to week 12 in the domain dyspnea (based on items from the EORTC QLQ-C30) - Mean change from baseline to week 12 in the domain global health status / quality of life (based on items from the EORTC QLQ-C30) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure - NCT ID: NCT06370845 - Study ID: 0000-00000; kt24timper - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-10-30 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description The goal of this clinical trial is to investigate the abundance of a natural odour in human cerebrospinal fluid in obese and lean participants after inhalation thereof. Participants will undergo blood sample collection and inhalation of either a natural odour or placebo through an inhaler in addition to a liquor puncture prescribed in standard of care context. ### Conditions - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Inhalation - Natural Odour - Inhalation - Placebo ### Outcomes Primary Outcomes - Detection of a natural odour in human CSF Secondary Outcomes - Abundance of a natural odour in human CSF of obese versus lean participants - Change in abundance of a natural odour in blood before and after olfactory stimulation in relation to abundance in human CSF. - Change in abundance of a natural odour in blood before and after olfactory stimulation in obese as compared to lean participants. ### Location - Facility: University Hospital Basel, Basel, N/A, 4031, Switzerland @@
## Inspiratory Muscle Training in Lung Transplant Candidates - NCT ID: NCT06370832 - Study ID: 22-5171 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-09-30 - Lead Sponsor: University Health Network, Toronto ### Study Description Recovery after lung transplantation (LTx) may be complicated by prolonged mechanical ventilation (MV) and protracted intensive care unit (ICU) stay leading to immobilization and impaired health-related quality of life (HRQoL). In the critical care setting, diaphragm atrophy and weakness have been associated with difficulty weaning from MV, increased risk for readmission to hospital or ICU, and increased mortality. Increasing respiratory muscle strength by inspiratory muscle training (IMT) as part of pre-rehabilitation mitigates respiratory muscle dysfunction peri-operatively and may reduce the risk of post-operative complications. However, IMT is not widely used prior to LTx and the benefits of pre-operative IMT on post-transplant outcomes in LTx candidates have not been studied. Objectives: 1) To evaluate the feasibility of a randomized clinical trial of IMT in LTx candidates in terms of recruitment rate, retention, program adherence, safety and outcome ascertainment. 2)To establish whether IMT improves pre-transplant dyspnea perception, diaphragm structure and function, HRQoL and post-transplant ICU, hospital and 3-month outcomes. 3)To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area, oxidative capacity, inflammatory markers and diaphragm muscle thickness and function. Methods: Prospective study of 50 LTx candidates recruited from the pulmonary rehabilitation program at University Health Network (UHN). Participants will have baseline evaluations of maximal inspiratory pressure (MIP), dyspnea, respiratory muscle endurance, diaphragm thickness and thickening fractions, as well as health-related quality of life questionnaires. After baseline assessments, participants will be randomized to the two study groups: IMT or usual care. IMT will be progressed weekly (max of 70% total MIP) until transplant. Participants will have repeat assessments (from baseline) at 4,8 and 12 weeks and then every 3 months until transplant (final assessment 3 months post-LTx). ### Conditions - Inspiratory Muscle Training ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IMT and exercise training group ### Outcomes Primary Outcomes - Study Recruitment According to Research Team Records - Participant Retention in the Study According to Research Team Records - Self-Reported Adherence to Inspiratory Muscle Training According to Participant IMT Diary - Adverse Events and IMT Training Side Effects Reported by Participants - Inspiratory Muscle Training Satisfaction Questionnaire (IMT Group Only) Secondary Outcomes - Respiratory Muscle Endurance Test - Dyspnea Severity Assessed by Medical Research Council Dyspnea Scale - Qualitative Measures of Dyspnea Assessed by Qualitative Dyspnea Scale - Mood Assessed by Depression, Anxiety, and Stress Scale - Health-Related Quality of Life Assessed by St. George's Respiratory Questionnaire - Respiratory Muscle Strength Assessed by Maximal Inspiratory Pressure - Physical Activity and Exercise Behaviors Assessed by International Physical Activity Questionnaire - Pulmonary Function Testing (Spirometry) - Aerobic Endurance Assessed by the Six-Minute Walk Test - Physical Function Assessed by the Short Physical Performance Battery - Pre-Transplant Hospitalizations - Peri-Transplant Mechanical Ventilation Bridging - Post-Transplant Duration of Mechanical Ventilation (Days) - WIND Weaning Classification - Post-Transplant Hospital Length of Stay (Days) - Post-Transplant Discharge Disposition - Primary Graft Dysfunction - Post-Transplant Mortality - Days Alive and at Home at 90 Days (DAAH90) ### Location - Facility: University Health Network, Toronto, Ontario, M5G 2C4, Canada @@
## A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function - NCT ID: NCT06370819 - Study ID: NN9541-4923 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-19 - Lead Sponsor: Novo Nordisk A/S ### Study Description NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NNC0519-0130 ### Outcomes Primary Outcomes - Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment Secondary Outcomes - Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment - AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure - Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure - Number of adverse events ### Location - Facility: Charité Research Organisation GmbH, Berlin, N/A, 10117, Germany @@
## Lifestyle Intervention for Obstructive Sleep Apnea in Women - NCT ID: NCT06370806 - Study ID: INTERAPNEA-Women - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-01 - Lead Sponsor: Universidad de Granada ### Study Description Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Weight loss and lifestyle intervention ### Outcomes Primary Outcomes - Apnoea-hypopnoea index (AHI) Secondary Outcomes - Oxygen desaturation index (ODI) - Oxygen saturation (SaO2) mean - Oxygen saturation (SaO2) nadir - Sleep efficiency - Light sleep (N1 and N2 stages) - Deep sleep (N3 stage) - Rapid eye movement (REM) sleep - Excessive daytime sleepiness (EDS) - Sleep Quality - Wake After Sleep Onset (WASO) - Fat mass (kg) - Visceral adipose tisue (g) - Body weight (kg) - Neck circumference (cm) - Chest circumference (cm) - Waist circumference (cm) - Mean blood pressure (mm HG) - Plasma glucose (mg/dL) - Change in total cholesterol (mg/dL) from baseline to post-intervention - Change in total triglycerides (mg/dL) from baseline to post-intervention ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ningbo Severe Mental Disorders Cohort - NCT ID: NCT06370793 - Study ID: NBU-2024-011 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2018-07-01 - Completion Date: 2026-12-31 - Lead Sponsor: Ningbo University ### Study Description In recent years, the prevalence of severe mental disorders in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with severe mental disorders and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo Mental Health Information System in Ningbo, a sub-provincial city in the southern wing of the Yangtze River Delta of China, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-diagnosis, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with severe mental disorders.Currently, NEED has accumulated data on more than 50,000 patients with severe mental disorders and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. All diseases follow the World Health Organization International Classification of Diseases 10th Edition (ICD-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (EHR), providing a solid data base for future real-world studies. ### Conditions - Severe Mental Disorder - Schizophrenia - Bipolar Disorder - Schizo-Affective Psychosis - Paranoid Psychoses - Mental Retardation - Epileptic Psychosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patient with severe mental disorder without intervention ### Outcomes Primary Outcomes - Risk of circulatory system diseases - Risk of endocrine system diseases - Risk of pulmonary system and allergy diseases - Risk of gastrointestinal system diseases - Risk of musculoskeletal system diseases - Risk of urogenital system diseases - Risk of hematological system diseases - Risk of cancers - Risk of neurological system diseases - Risk of suicide - Risk of violence Secondary Outcomes ### Location - Facility: Ningbo Mental Health Information System, Ningbo, Zhejiang, 315000, China @@
## Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically - NCT ID: NCT06370780 - Study ID: 5UG3AI176592-02 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2025-04-30 - Lead Sponsor: University of California, Los Angeles ### Study Description Despite the widespread availability of effective antiretroviral therapy (ART) in the United States, there remains significant numbers of people living with HIV (PLWH) who fail to achieve and or maintain viral suppression (VS). Disparities persist with the lowest levels of VS among Black individuals, people who use drugs, youth ages 18-24 and people residing in rural areas. Investigators will examine the syndemics underlying these outcomes including substance use, mental health, and barriers to HIV care including racial discrimination, stigma and rural isolation. ### Conditions - HIV Infections ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - EPI LOVE ### Outcomes Primary Outcomes - Incidence of HIV Viral Suppression - Level of Adherence to HIV medication - Level of Adherence based on HIV appointments Secondary Outcomes ### Location - Facility: University of California, Los Angeles, Los Angeles, California, 90095, United States @@
## Peer Facilitated Waitlist Controlled Transportation Study - NCT ID: NCT06370767 - Study ID: 25634 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Temple University ### Study Description The goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. This project aims to address the following hypotheses:1. Individuals with SMI receiving either of the two peer-mediated travel training transportation interventions will experience an increase in transportation self-efficacy and transportation skills.2. Participants in the intervention arms will increase their transport utilization, participate in significantly more activities in the community, and make significantly more trips in the community.3. Individuals with SMI receiving peer-mediated travel training interventions will retain post-test levels of community participation and self-efficacy 2 months after intervention.Participants will be assigned to an 8-week travel-training intervention either using a bike-share program or public transportation. All participants will complete three data-collection research interviews. ### Conditions - Serious Mental Illness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Bike-Share Travel Training - Public Transportation Travel Training ### Outcomes Primary Outcomes - Temple University Community Participation Measure - LASA Sedentary Behaviors Questionnaire - Transportation Appraisal Scale - Indego Skills Survey - SEPTA Skills Survey - University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified) - National Household Travel Survey - GPS Secondary Outcomes - Internalized Stigma of Mental Illness Inventory (ISMI) (Brief Version) - University of California, Los Angeles, Loneliness Scale - Pearlin Mastery Scale (Coping) - SF- 36 v2 - The PERMA - Profiler Measure - Recovery Assessment Scale (RAS) - Group Identification Scale (GIS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Newly Emerging Immunotherapy for Pancreatic Cancer Treatment - NCT ID: NCT06370754 - Study ID: 2401289-19-2403 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2027-04-30 - Lead Sponsor: Fudan University ### Study Description This is a Phase Ib/II platform clinical study to evaluate the initial efficacy and safety of different novel immunotherapies in patients with advanced pancreatic cancer. ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - JS001 - JS004 - JS007 - JS015 - Irinotecan Liposome Injection - 5-Fluorouracil (5-FU) - Leucovorin (LV) - Nab paclitaxel - Gemcitabine ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicity (DLT) (phase IB) - Objective Response Rate (ORR) (phase II) Secondary Outcomes - Objective Response Rate (ORR) (phase IB) - Disease control rate (DCR) - Duration of Response (DOR) - Progression free survival (PFS) - Overall Survival (OS) - Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment ### Location - Facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University, Shanghai, Shanghai, 200032, China @@
## Effect of Stretching Exercises on Plantar Fascia - NCT ID: NCT06370741 - Study ID: OkanUni. - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-06 - Lead Sponsor: Okan University ### Study Description The plantar fascia (PF) extends over the calcaneal bone with a thin band corresponding to the calcaneal periosteum, continuing as the paratenon of the Achilles tendon.The triceps surae complex, serving as the main extensor and propulsion system of the foot, involves the Achilles tendon, posterior part of the calcaneus, and Plantar Aponeurosis, all integrated with the fibrous skeleton of the triceps surae. Plantar fasciitis, a prevalent musculoskeletal condition affecting individuals of various ages and activity levels (Hye Chang Rhim), is a primary cause of heel pain in adults. Studies have identified the superior efficacy of stretching protocols targeting the Achilles tendon and/or plantar fascia compared to alternative treatments. However, the limitations of traditional approaches become apparent when considering the intricate biomechanics of the foot and ankle. Conventional calf stretches often prove inadequate for addressing its specific lengthening requirements. While contemporary methods like PF-Specific Stretching integrate plantar fascia and calf stretches, their reliance on individual upper extremity strength introduces potential limitations.Therefore, although the exact effect of stretching on the biomechanical properties of the plantar fascia is not known, it will be aimed to determine whether an instrument aid to be designed will have an effect and which method is more effective. In this way, it is planned to guide clinicians in the rehabilitation of possible pathologies specific to the plantar fascia in clinical practice.Myotonometry is a convenient method to assess the stiffness of the plantar fascia because it is cheap, simple and fast. Previous studies have shown that MyotonPRO can reliably assess the stiffness of the plantar fascia. Although the exact effect of stretching on the biomechanical properties of the plantar fascia is not known, it will be determined whether stretching with an instrument to be designed will have an effect and which method is more effective with or without an instrument. ### Conditions - Stretch - Plantar Fascia; Contracture - Fasciitis, Plantar ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Stretching with/without device ### Outcomes Primary Outcomes - Plantar Fascia Mechanical Properties Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants - NCT ID: NCT06370728 - Study ID: 18621 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-03 - Completion Date: 2024-07-15 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Orforglipron - Carbamazepine ### Outcomes Primary Outcomes - Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron - PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron - PK: Maximum Observed Concentration (Cmax) of Orforglipron Secondary Outcomes ### Location - Facility: ICON Early Phase Services, San Antonio, Texas, 78209, United States @@
## A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India - NCT ID: NCT06370715 - Study ID: 18269 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-07 - Lead Sponsor: Eli Lilly and Company ### Study Description The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks). ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Insulin Lispro-aabc - Insulin Glargine ### Outcomes Primary Outcomes - Percentage of Participants with at least 1 Episode of Hypoglycemia Secondary Outcomes - Percentage of Participants with Severe Hypoglycemic Events - Percentage of Participants with Nocturnal Hypoglycemia Events - Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events - Change from Baseline to Week 26 in Body Weight - Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score - Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c) - Percentage of Participants Achieving HbA1c Less Than (<) 7% - Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values - Change from Baseline to Week 26 in Bolus Insulin Dose, Basal Insulin Dose, and Basal: Bolus Ratio - Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values ### Location - Facility: King George Hospital, Visakhapatnam, Vizag, Andhra Pradesh, 530002, India @@
## Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines - NCT ID: NCT06370702 - Study ID: 23-054 - Status: RECRUITING - Start Date: 2023-10-06 - Completion Date: 2027-06-30 - Lead Sponsor: TriHealth Inc. ### Study Description Patients who have a peripherally-inserted central catheter (PICC) placed are at a risk of developing a deep vein thrombosis (DVT). At TriHealth, approximately 2-4 patients per month who have a PICC placed experience a subsequent DVT. One innovative way to possibly mitigate the risk of DVTs is hand grip exercises. The current study will be the first study to evaluate hand grip exercises for the prevention of DVTs in adult patients hospitalized in the United States. ### Conditions - Deep Vein Thrombosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Handgrip Exercises ### Outcomes Primary Outcomes - Deep vein thrombosis Secondary Outcomes ### Location - Facility: Good Samaritan Hospital, Cincinnati, Ohio, 45220, United States @@
## Comparison of Three Pre-oxygenation Strategies - NCT ID: NCT06370689 - Study ID: PRE-OX - Status: NOT_YET_RECRUITING - Start Date: 2024-05-23 - Completion Date: 2025-07-30 - Lead Sponsor: Institute of Mountain Emergency Medicine ### Study Description Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers.Study endpointsPrimary Endpoint:The time taken from the start of preoxygenation until reaching an expiratory oxygen concentration (FeO2) of ≥ 90% or a maximum preoxygenation time of 3 min.Secondary endpoints:* Changes in regional ventilation within the posterior lung regions from baseline to the time when FeO2≥ 90% is achieved, assessed using electrical impedance tomography (EIT)* Difference in Oxygen Reserve Index (ORi) when FeO2≥ 90% is achievedNumber of participants 15 participants per subgroup, i.e. 45 participants in total.Inclusion criteria* Normal-weight adults (body mass index, BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II* Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3* Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day.After informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation SpO2, ORI, regional ventilation). Then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without PEEP) in a randomized order and a 20 min washout between the sessions. Each preoxygenation session is conducted in a supine position and will be proceeded until the measured FeO2 (end expiratory O2 fraction) reaches 90% or up to a maximum time of 3 min. Afterwards 10 min of SpO2, ORI and regional ventilation measurements will follow. ### Conditions - Emergencies - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Preoxygenation ### Outcomes Primary Outcomes - Difference in Oxygen Reserve index (ORi) after 3 minutes of preoxygenation Secondary Outcomes - Difference in expiratory oxygen concentration (FeO2) after 3 minutes of preoxygenation - Time to Oxygen Reserve index (ORi) = 1.0 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location - NCT ID: NCT06370676 - Study ID: ESO-TIP - Status: NOT_YET_RECRUITING - Start Date: 2024-05-23 - Completion Date: 2025-07-30 - Lead Sponsor: Institute of Mountain Emergency Medicine ### Study Description Background An accurate measurement of the core body temperature (CBT) is of pivotal importance in the management of severely hypothermic patients. For instance, triage decisions for or against extracorporeal rewarming of hypothermic patients in cardiac arrest strongly depend on CBT. CBT measurement with an oesophageal probe is currently considered the gold standard in hypothermic patients with a secured airway in the prehospital setting, with the tip of the probe placed into the distal third of the oesophagus (i.e., posteriorly to the heart and distal to the tracheal bifurcation). However, the correct placement of the probe tip cannot be verified in the prehospital setting, and it is unknown how incorrect placement affects temperature readings.Hypothesis and aim The investigators hypothesise that an incorrect placement of the oesophageal temperature probe tip could lead to inaccurate measurements (i.e., temperature readings not reflecting the real CBT). Particularly, a tip location too high in the oesophagus in close proximity to the trachea could lead to falsely low temperature readings, especially when the patient is ventilated with cold air. The aim of the proposed study is to investigate the influence of oesophageal temperature probe tip location on CBT measurement.Methods Experimental, interventional study on 16 healthy volunteers. During the test oesophageal temperature is measured while participants are breathing ambient air first at 20°C (baseline) followed by cold (-20°C) ambient air in supine position for 20 minutes each test in an environmental simulator (terraXcube). Each participant repeats the 20-min test two times with the oesophageal temperature probe tip placed either in the lower third of the oesophagus (i.e., correct position) or too high in the oesophagus, i.e. behind the trachea. ### Conditions - Emergencies - Hypothermia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: DIAGNOSTIC ### Interventions - Oesophageal temperature measurement ### Outcomes Primary Outcomes - Difference in core body temperature between the two tip positions Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma Combining Radiotherapy and HAIC - NCT ID: NCT06370663 - Study ID: SDZLEC2023-109-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Shandong Cancer Hospital and Institute ### Study Description The median survival of intrahepatic cholangiocarcinoma remains less than one year, highlighting the need for new treatments. Hepatic arterial infusion chemotherapy (HAIC), especially with fluoropyrimidine-based regimens, has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity. A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma. However, clinical research on this combination is lacking as first-line therapy for unresectable ICC. Therefore, a single-center, single-arm study aims to assess this treatment approach's safety, efficacy, and molecular predictors. Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment. In conclusion, exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type. ### Conditions - Intrahepatic Cholangiocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radiotherapy - HAIC (GEMOX) - Chemotherapy ### Outcomes Primary Outcomes - Adverse Events Secondary Outcomes - Progression-Free Survival (PFS) ### Location - Facility: Jinbo Yue, Jinan, Shandong, 250000, China @@
## Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study - NCT ID: NCT06370650 - Study ID: soh-med-24-1-9 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-08 - Completion Date: 2024-06-30 - Lead Sponsor: Sohag University ### Study Description For each patient, one side of body will be treated with NB-UVB alone while the other side will be treated with NB-UVB therapy in addition to intradermal injection of PRP every 2 weeks. Patients will be photographed at the first visit, in the middle and at the end of therapy. Each patient will sign a written consent form to be included in the study and to be photographed. ### Conditions - Management of Stable Vitiligo ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - platelet rich plasma, narrow band UVB ### Outcomes Primary Outcomes - Improvement of vitiligo Secondary Outcomes ### Location - Facility: Faculty of Medicine, Sohag University, Sohag, N/A, 82515, Egypt @@
## Efficacy of Cream for Moisture Associated Skin Damage From Fecal Incontinence and/or Diarrhea - NCT ID: NCT06370637 - Study ID: Survey Protocol - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Scotiaderm ### Study Description Scotiaderm Inc. has developed a cream formulation to be used in the treatment of MASD caused diarrhea or fecal incontinence. This study aims to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence. ### Conditions - Incontinence-associated Dermatitis - Moisture Associated Skin Damage (MASD) (E.G., Incontinence-Associated Dermatitis [IAD], Perspiration, Drainage) - Fecal Incontinence Incontinence-associated Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MASD Control Arm ### Outcomes Primary Outcomes - Analysis of Efficacy and Safety for Cream D Primary Outcome Secondary Outcomes - Analysis of Efficacy and Safety for Cream D Secondary Outcome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment. - NCT ID: NCT06370624 - Study ID: 2022/03OCT/360 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-17 - Completion Date: 2025-10-01 - Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain ### Study Description This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores.The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours.A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned. ### Conditions - Encephalopathy, Hypoxic-Ischemic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - MRI-scan ### Outcomes Primary Outcomes - quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE) Secondary Outcomes ### Location - Facility: Cliniques Universitaires Saint Luc, Brussels, N/A, 1200, Belgium @@
## Early Remote Rehabilitation to Improve Health of the Elderly After Cardiac Surgery. (RECARD Trial) - NCT ID: NCT06370611 - Study ID: 2314027 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-09-30 - Lead Sponsor: Ivy susanne Modrau, MD ### Study Description An increasing number of older patients undergo heart surgery. Despite seemingly successful outcomes, these vulnerable patients may face prolonged decreased functional capacity, reduced self-efficacy, and impaired quality of life after discharge. Early engagement in physical activity and education plays a key role in health and well-being after heart surgery The goal of this clinical trial is to evaluate the effectiveness of an app-based exercise program and weekly calls from a physiotherapist in the early stages after open heart surgery.Eligible patients will be randomly assigned to either a control group receiving standard care or an intervention group, which will be introduced to an individually tailored exercise program as an addition to standard care.Follow-up is planned with an out-patient visit six weeks after discharge and a telephone interview six months post-surgery.All participants will undergo assessments at enrollment and during follow-up. Physical performance will be evaluated through physical tests. General well-being, quality of life, self-reported physical activity, and cost-effectiveness of the intervention will be assessed through questionnaires. Muscle health will be examined through blood sampling, CT scans, and muscle biopsies.The primary endpoint is the 30-second Chair Stand Test serving as a measurement of physical function. ### Conditions - Cardiac Rehabilitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Early mobile health intervention supplemented by weekly calls from a physiotherapist ### Outcomes Primary Outcomes - Change (Δ) 30-second chair stand test (30CST) baseline vs. 6-week FU Secondary Outcomes - Change (Δ) in 10-meter Walk Test (10MWT) baseline vs. 6-week FU - Difference in 6-minute Walk Test (6MWT) between groups at 6-week FU - Change (Δ) in WHO-5-score baseline vs. 6-week FU - Change (Δ) in ASS-2-score baseline vs. 6-week FU - Change (Δ) in MDI-2-score baseline vs. 6-week FU - Change (Δ) in Self-reported Physical Activity baseline vs. 6-week FU - Change (Δ) in EuroQol-score baseline vs. 6-week FU - Change in skeletal muscle mass maximum 3 months prior to surgery vs. 6-week FU - Cost-effectiveness analysis - Changes in markers of musculoskeletal health through blood samples baseline vs. 6-week FU - Changes in markers of inflammation through blood samples baseline vs. 6-week FU - Changes in markers of nutrition through blood samples baseline vs. 6-week FU - Changes in markers of liver function through blood samples baseline vs. 6-week FU - Changes in markers of kidney function through blood samples baseline vs. 6-week FU - Changes in markers of hormone levels through blood samples baseline vs. 6-week FU ### Location - Facility: Aarlborg University Hospital, Aalborg, N/A, 9000, Denmark @@
## Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia - NCT ID: NCT06370598 - Study ID: TP-122 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2025-06 - Lead Sponsor: Technophage, SA ### Study Description Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy to the SoC including antibiotic therapy, administered by nebulization. TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . For this study, an effective sample of 15 subjects will be randomly allocated into two arms, in a 3:2 ratio, with 9 subjects receiving TP-122A, in addition to SoC, and 6 subjects receiving the SoC alone. ### Conditions - Pneumonia, Ventilator-Associated ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TP-122A ### Outcomes Primary Outcomes - Evaluate safety and tolerability following nebulization of multiple doses of TP-122A Secondary Outcomes - Proportion of subjects achieving "Clinical Cure" CR - Time to achieve "Clinical Cure" CR - Proportion of subjects achieving "Eradication" or "Presumed Eradication" MR of TP-122A target bacteria - Time to achieve "Eradication" or "Presumed Eradication" MR ### Location - Facility: CH Nantes, Nantes, N/A, N/A, France @@
## Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF - NCT ID: NCT06370585 - Study ID: SOPH229-0823/I - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2024-09-30 - Lead Sponsor: Laboratorios Sophia S.A de C.V. ### Study Description This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects. ### Conditions - Dry Eye Disease - Ocular Surface Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PRO-229 - Lagricel® Ofteno PF ### Outcomes Primary Outcomes - Incidence Unexpected Related Adverse Reactions Secondary Outcomes - Changes in Best Corrected Visual Acuity (BCVA) - Changes in ocular surface staining using SICCA ocular staining score scale - Incidence of chemosis - Incidence of grade 3 or 4 conjunctival hyperemia. - Adherence to treatment (adherence) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments - NCT ID: NCT06370572 - Study ID: CIRB23-1162 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-05 - Lead Sponsor: University of Chicago ### Study Description The purpose of this study is to learn if the Pain in Advanced Dementia (PAINAD) scale can improve emergency pain care in persons living with dementia (PLWD). It is hypothesized that a PAINAD electronic health record (EHR) prompt that appears to emergency department (ED) staff will enable them to accurately assess pain levels and lead to better pain treatment for PLWD. ### Conditions - Dementia - Hip Pain - Emergency Department Patient - Pain in Advanced Dementia Scale ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - PAINAD EHR Prompt ### Outcomes Primary Outcomes - Percentage of eligible patients receiving a PAINAD assessment upon ED arrival Secondary Outcomes - Change in time to administration of first analgesic medication - Change in pain score for patients receiving a repeat PAINAD assessment ### Location - Facility: University of Chicago, Chicago, Illinois, 60637, United States @@