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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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE maskingDescription: Sealed envelopes will be used and opened at the time of inclusion of each participant. Each participant will be randomized to either AI support or no support. The allocation of participants will be performed by (XYZ) who does not have access to the randomization order. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 92 type: ESTIMATED name: "XAI feedback on MCA/UA Doppler spectral curves and gate placement suggestions" measure: Responses will be reviewed independently by two fetal medicine sonographers, and in case of disagreement between the two experts, a consensus will be reached. measure: Accuracy of flow image management among competence groups sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen state: Capital Region Of Denmark zip: 2100 country: Denmark name: Zahra Bashir, MD role: CONTACT name: Zahra Bashir, MD role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Slagelse Hospital status: RECRUITING city: Slagelse state: Region Zealand zip: 4200 country: Denmark name: Zahra Bashir, MD role: CONTACT name: Zahra Bashir, MD role: PRINCIPAL_INVESTIGATOR lat: 55.40276 lon: 11.35459 hasResults: False
<\|newrecord\|> nctId: NCT06371846 id: 2023 /10850/I briefTitle: Comparative Study of the Surface Electrocardiogram Signals During the Implantation of Conduction System Pacing Devices overallStatus: RECRUITING date: 2023-03-14 date: 2024-06-30 date: 2024-07-30 date: 2024-04-17 date: 2024-04-17 name: Parc de Salut Mar class: OTHER briefSummary: 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 conditions: Pacemaker DDD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 78 type: ESTIMATED name: Selected signals from Pacing System Analyzers measure: Similarity of signals between multichannel recording system and Pacing System Analyzers measure: Security sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jesus Jiménez López status: RECRUITING city: Barcelona state: Cataluña zip: 08005 country: Spain name: Jesus Jiménez López role: CONTACT phone: 680714927 email: jejilo78@gmail.com lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06371833 id: S-52 briefTitle: PRIMA EU Retrospective & Prospective overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2026-12 date: 2024-04-17 date: 2024-04-17 name: Limacorporate S.p.a class: INDUSTRY name: Iqvia Pty Ltd briefSummary: 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 conditions: Replacement conditions: Shoulder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 60 type: ESTIMATED name: Shoulder Arthroplasy with PRIMA humeral stem measure: Changes of Costant Murley Score (CS) measure: Changes in the American Shoudler and Elbow Surgeons (ASES) score measure: Changes in Range of Motion measures measure: Radiographic stability of the humeral component measure: Survival rate (Kaplan-Meier estimate) measure: Incidence, type and severity of Adverse Events and Adverse Device Effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371820 id: 2014/1287-31/4 briefTitle: ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden) acronym: ESPRESSO overallStatus: ACTIVE_NOT_RECRUITING date: 1965-01-01 date: 2043-05-17 date: 2043-05-17 date: 2024-04-17 date: 2024-04-17 name: Karolinska Institutet class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 13000000 type: ACTUAL name: ESPRESSO [The study has no intervention] measure: Incident Mortality [especially rates] measure: Incident Cancer measure: Incident Cardiovascular disease measure: Incident Neurological disease measure: Incident Autoimmune diseases measure: Please note that the recorded outcomes above are examples. Other outcomes may also be studied. sex: ALL minimumAge: 0 Years maximumAge: 110 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371807 id: EU CTR n.º 2023-507008-30-00 briefTitle: Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab acronym: KEYPARTNER overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-07 date: 2026-12 date: 2024-04-17 date: 2024-04-17 name: Fundacao Champalimaud class: OTHER briefSummary: 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 conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Pembrolizumab injection measure: Detect immunologic activation signal and the immunologically defined most suitable patient population for the synergistic interaction between pembrolizumab and chemotherapy backbone measure: Rate of pCR measure: Primary translational endpoint measure: Changes in the immunogenic phenotype measure: Incidence of treatment relatred Adverse events sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundaçao Champalimaud, Avenida Brasilia, city: Lisbon zip: 1400-038 country: Portugal name: Ines Sousa, MSc role: CONTACT phone: +351 210480048 email: ines.sousa@fundacaochampalimaud.pt name: Fatima Cardoso, MD role: CONTACT phone: +351 210480048 email: fatimacardoso@fundacaochampalimaud.pt lat: 38.71667 lon: -9.13333 facility: Centro Hospitalar Universitário Lisboa Norte E.P.E city: Lisbon zip: 1649-028 country: Portugal lat: 38.71667 lon: -9.13333 facility: Instituto Português de Oncologia Francisco Gentil, E.P.E city: Oporto zip: 4200-072 country: Portugal name: Joana Maia role: CONTACT phone: 22 508 40 00 phoneExt: 2040 email: joana.h.maia@ipoporto.min-saude.pt name: Miguel Abreu, MD role: CONTACT phone: 22 508 40 00 phoneExt: 2040 email: antonio.m.abreu@ipoporto.min-saude.pt lat: 41.14961 lon: -8.61099 hasResults: False
<\|newrecord\|> nctId: NCT06371794 id: ID 5460 briefTitle: EXploring novEl Molecular Determinants of DRAvet Syndrome Phenotype Heterogeneity acronym: EXEDRA overallStatus: ENROLLING_BY_INVITATION date: 2023-07-06 date: 2025-04-30 date: 2026-05-31 date: 2024-04-17 date: 2024-04-17 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER name: IRCCS San Raffaele briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The ethics committee of the foundation FPG considers the study interventional since patients will undergo skin biopsy procedures ( around 4 mm) primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: skin punch biopsy measure: TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS measure: TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS measure: TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS measure: TO CLASSIFY THE BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS measure: TO CLASSIFY THE BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS measure: TO CLASSIFY THE EPILEPTIC PHENOTYPE SEVERITY OF DS PATIENTS sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06371781 id: Cumhuriyetobgyn id: 1919B012108892 type: OTHER_GRANT domain: TUBITAK briefTitle: Examination of the Relationship Between Weight Gain During Pregnancy and Sfrp-5, Netrin-4 and Resistin Concentrations overallStatus: COMPLETED date: 2022-07-01 date: 2022-07-01 date: 2023-07-01 date: 2024-04-17 date: 2024-04-22 name: Cumhuriyet University class: OTHER name: Scientific and Technological Research Council of Turkey (TUBITAK) briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pregnant women who were given birth at Cumhuriyet University Faculty of Medicine Hospital Gynecology and Obstetrics Clinic between July 1, 2021 and July 1, 2022 and whose pregnancy follow-ups were performed in our hospital will be included in our prospectively designed study. Researchers will divide the study into two main groups. The first group will consist of pregnant women with above-normal weight gain during pregnancy, and the other group will consist of pregnant women with normal weight gain during pregnancy. It is estimated that 46 control and 44 pregnant women with overweight will be reached during this period. In the study, first a form containing demographic data such as age, education, height and weight will be filled out. primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ACTUAL name: Serum Netrin-4, Resistin and Sfrp-5 level measurement measure: Obtaining blood serum for measurement of serum Sfrp-5, Netrin-4 and Resistin measure: Calculating BMI (kg/m^2) from height (m) and weight (kg) measurement values for diagnosis. sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Sivas Cumhuriyet University city: Sivas state: Centre zip: 58140 country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False
<\|newrecord\|> nctId: NCT06371768 id: Pro00115400 briefTitle: Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors acronym: AYA STEPS overallStatus: NOT_YET_RECRUITING date: 2025-04-01 date: 2029-06-30 date: 2029-06-30 date: 2024-04-17 date: 2024-04-17 name: Duke University class: OTHER briefSummary: 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 conditions: Breast Cancer conditions: Colorectal Cancer conditions: Sarcoma conditions: Lymphoma conditions: Testicular Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 260 type: ESTIMATED name: AYA Educational Information name: AYA STEPS measure: Pain severity and interference as measured by Brief Pain Inventory measure: Fatigue as measured by PROMIS Fatigue Scale measure: Emotional distress as measured by PROMIS Depression Short Form measure: Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference measure: Emotional distress as measured by PROMIS Anxiety Short Form measure: Health care engagement as measured by Patient Participation Questionnaire measure: Patient self-assessment of communication competency with health care providers as measured by Medical Communication Competence Scale (MCCS) patient subscale measure: Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale measure: Patient activation as measured by Patient Activation Measure (PAM) measure: Health care utilization: Chart Review measure: Area Deprivation Index (ADI) measure: Health-care utilization: Self-report measure: Health literacy as measured by Medical Term Recognition Test (METER) measure: Participant experiences of discrimination as measured by Everyday Discrimination Scale-Short Form measure: Participant evaluation of study mobile application as measured by User Version of the Mobile Application Rating Scale (uMARs) measure: Satisfaction with Treatment and Interventionist as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) measure: Web-based Portal Use as measured by total time using portal in minutes sex: ALL minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371755 id: ULTRADXA briefTitle: Bone Evaluation by Ultrasound Radiofrequency Echographic Multi Spectrometry (REMS) vs Dual X-ray Absorptiometry (DXA) overallStatus: RECRUITING date: 2019-11-19 date: 2024-12-31 date: 2024-12-31 date: 2024-04-17 date: 2024-04-17 name: Paola Pisani class: INDUSTRY name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 296 type: ESTIMATED name: Ultrasound examination with REMS technology measure: 1. REMS Technology intra - and inter-operator repeatability Evaluation. measure: 1. Evaluation of the accuracy of the REMS Technology in comparison with the conventional DXA technique. sex: FEMALE minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio status: RECRUITING city: Milano state: MI zip: 20157 country: Italy name: Carmelo Messina, Professor role: CONTACT phone: 0039 02 8350 1406 email: carmelomessina.md@gmail.com lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06371742 id: 539HydrationNutr briefTitle: Study of the Fluid Intake Effect During Labour overallStatus: COMPLETED date: 2017-02-01 date: 2017-07-14 date: 2017-09-14 date: 2024-04-17 date: 2024-04-17 name: Egas Moniz - Cooperativa de Ensino Superior, CRL class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 144 type: ACTUAL name: Liquid ingestion during labour measure: Type of labour measure: Duration of labour measure: Occurrence of nausea and vomiting measure: Apgar index of the newborn (From 0 to 10) sex: FEMALE minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Egas Moniz School of Health and Science city: Almada state: Monte De Caparica zip: 2829-699 country: Portugal lat: 38.67902 lon: -9.1569 hasResults: False
<\|newrecord\|> nctId: NCT06371729 id: DEEP-VT briefTitle: Substrate-based DEEP Mapping Versus Activation Mapping. A Prospective Randomized Multicenter Study. overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2027-07 date: 2024-04-17 date: 2024-04-18 name: IRCCS Ospedale San Raffaele class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 222 type: ESTIMATED name: DEEP mapping name: Activation Mapping measure: Compare the efficacy of substrate-based DEEP mapping versus Activation mapping in guiding catheter ablation to prevent VT recurrences sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371716 id: EUS-RFA ex-vivo 2016 briefTitle: Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions overallStatus: TERMINATED date: 2019-09-12 date: 2020-06-12 date: 2020-06-12 date: 2024-04-17 date: 2024-04-17 name: IRCCS San Raffaele class: OTHER briefSummary: 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 conditions: Endoscopic Ultrasound conditions: Radiofrequency Ablation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 15 resected PDAC without neoadjuvant treatment 15 resected PDAC with neoadjuvant treatment 15 resected neuroendocrine tumors
Each group (15 patients each) Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: pathologists (two different pathologist blinded about the power of RFA applied and respect to the other pathologist) will evaluate the effect of ablation (coagulative necrosis at microscopic evaluation) whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ACTUAL name: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions name: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions name: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions measure: diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele Hospital city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06371703 id: PETCT_INTEGO briefTitle: Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automat-ed Radiopharmaceutical Preparation and Administration System overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-10 date: 2024-10 date: 2024-04-17 date: 2024-04-19 name: IRCCS San Raffaele class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: automated system in reducing radiation exposure measure: Change in absorbed dose by radiographers during PET/CT procedures, measured in millisieverts (mSv). sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs San Raffaele city: Milano country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06371690 id: 17-11/37 briefTitle: The Effects of Using the Web-Based Double Eye Control Program on Medication Error overallStatus: COMPLETED date: 2017-11-01 date: 2018-06-30 date: 2018-09-30 date: 2024-04-17 date: 2024-04-17 name: Izmir Katip Celebi University class: OTHER name: Ege University briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 1070 type: ACTUAL name: Web-Based Double-Eye Control Program measure: Error rates sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Izmir Katip Celebi University city: İzmir state: Çi̇ğli̇ zip: 35620 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
<\|newrecord\|> nctId: NCT06371677 id: KB/2024 briefTitle: Polish Nationwide Register of Hospitalized Patients in Cardiac Intensive Care Units acronym: POL-CICU overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2024-12-31 date: 2025-03-31 date: 2024-04-17 date: 2024-04-17 name: Medical University of Warsaw class: OTHER briefSummary: 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 conditions: Death conditions: Cardiac Intensive Care Unit conditions: Treatment Complication conditions: Stroke conditions: Multiple Organ Failure conditions: Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: All-cause death measure: Shock (cardiogenic/hypovolemic/anaphylactic/septic/neurogenic/obstructive) measure: Treatment-related complications (tamponade, dissection, stroke, embolism, etc.) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371664 id: 2023/02 briefTitle: Gingival Irritation Due to Bleaching Tray Design in an At-home Bleaching Treatment overallStatus: COMPLETED date: 2023-03-01 date: 2023-04-05 date: 2023-04-05 date: 2024-04-17 date: 2024-04-17 name: University of Santiago de Compostela class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, triple-blind clinical trial primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 72 type: ACTUAL name: Conventional Tray (1 mm) name: Extended Tray (3 mm) measure: Subjective questionnaire of gingival irritation measure: Objective clinical examination of gingival irritation measure: Questionnaire of dental sensitivity measure: Shade evaluation with a dental spectrophotometer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Medicine and Dentistry city: Santiago De Compostela state: A Coruña zip: 15705 country: Spain lat: 42.88052 lon: -8.54569 hasResults: False
<\|newrecord\|> nctId: NCT06371651 id: 23-1462-3 briefTitle: Creatine and GAA for Brain Oxygenation acronym: CREGAA-OXY overallStatus: COMPLETED date: 2024-03-01 date: 2024-04-10 date: 2024-04-12 date: 2024-04-17 date: 2024-04-17 name: University of Novi Sad, Faculty of Sport and Physical Education class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 19 type: ACTUAL name: Supplement name: Placebo measure: Brain oxygen saturation measure: Hemoglobin index sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Applied Bioenergetics Lab at Faculty of Sport and PE city: Novi Sad state: Vojvodina zip: 21000 country: Serbia lat: 45.25167 lon: 19.83694 hasResults: False
<\|newrecord\|> nctId: NCT06371638 id: 2024-01 briefTitle: Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD) acronym: CODE-POCD overallStatus: COMPLETED date: 2024-01-07 date: 2024-03-01 date: 2024-03-07 date: 2024-04-17 date: 2024-04-19 name: Udayana University class: OTHER briefSummary: 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 conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 112 type: ACTUAL name: Dexmedetomidine name: Sevoflurane measure: Postoperative cognitive dysfunction (POCD) measure: Postoperative cognitive dysfunction (POCD) measure: Intraoperative hemodynamics: mean arterial pressure (MAP) measure: Intraoperative hemodynamics: heart rate (HR) measure: Postoperative pain measure: Postoperative pain measure: Postoperative pain sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prof. Ngoerah General Hospital city: Denpasar state: Bali zip: 80114 country: Indonesia lat: -8.65 lon: 115.21667 hasResults: False
<\|newrecord\|> nctId: NCT06371625 id: AP2202-30104 briefTitle: U/S Guided Transversus Thoracic and Pectoral Nerve Block Versus Pectoral Nerve Block in MRM overallStatus: COMPLETED date: 2022-07-02 date: 2023-08-01 date: 2023-10-01 date: 2024-04-17 date: 2024-04-22 name: Ahmed Mohamed Soliman class: OTHER briefSummary: 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 conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: to determine the analgesic effect of ultrasound guided Transversus Thoracic and Pectoral Nerve Block compared to ultrasound guided Pectoral Nerve Block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Postoperative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 11 per group. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 22 type: ACTUAL name: Transeversus Thoracic Plane Block (TTPB) and Pectoral Nerves (PECS) Block name: Pectoral Nerves (PECS) Block measure: visual analogue scale "VAS score" measure: total morphine consumption measure: mean blood pressure measure: heart rate measure: first analgesic dose sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National cancer Insititute Cairo university city: Cairo zip: 11796 country: Egypt lat: 30.06263 lon: 31.24967 facility: National cancer Insititute city: Cairo zip: 11796 country: Egypt lat: 30.06263 lon: 31.24967 facility: Ahmed Mohamed Soliman city: Giza country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
<\|newrecord\|> nctId: NCT06371612 id: MersinU*GUGUCU_004 briefTitle: 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 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-30 date: 2024-11-20 date: 2024-04-17 date: 2024-04-17 name: Mersin University class: OTHER briefSummary: 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 conditions: Fear of Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The children and their parents will be blinded to the groups. The principal researchers (R1, R2) will be blinded to the research hypotheses. The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. Data entries will be performed using the codes A, B and C. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Standard Care name: Adhesive Remover Spray name: Ball Squeezing + Adhesive Remover Spray measure: Pain assesed by Wong-Baker FACES measure: Fear by Children's Fear Scale measure: Pain assesed by Wong-Baker FACES measure: Fear by Children's Fear Scale sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD facility: Mersin University city: Mersin state: Yenişehir zip: 33343 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False
<\|newrecord\|> nctId: NCT06371599 id: MersinU*GUGUCU_003 briefTitle: 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 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-30 date: 2024-11-20 date: 2024-04-17 date: 2024-04-17 name: Mersin University class: OTHER briefSummary: 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 conditions: Fear of Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The children and their parents will be blinded to the groups. The principal researchers (R1, R2) will be blinded to the research hypotheses. The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. Data entries will be performed using the codes A and B. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Playing game name: Watching cartoon measure: Pain assesed by Wong-Baker FACES measure: Fear by Children's Fear Scale measure: Pain assesed by Wong-Baker FACES measure: Fear by Children's Fear Scale sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD facility: Mersin University city: Mersin state: Yenişehir zip: 33343 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False
<\|newrecord\|> nctId: NCT06371586 id: NCC4537 briefTitle: Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC overallStatus: RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2027-03-01 date: 2024-04-17 date: 2024-04-17 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: 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 conditions: Diffuse Type Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 67 type: ESTIMATED name: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy measure: Pathological response rate measure: EFS measure: OS measure: R0 measure: Safety (adverse events) and surgical complications sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer hospital，Chinese acadamy of medical sciences status: RECRUITING city: Beijing country: China name: Chunxia Du role: CONTACT phone: 87787121 email: retinadcx@vip.163.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06371573 id: MPN-USspleen briefTitle: Ultrasound Examination for Spleen Volume Evaluation in Myeloproliferative Neoplasms overallStatus: COMPLETED date: 2017-04-20 date: 2024-01-20 date: 2024-03-20 date: 2024-04-17 date: 2024-04-17 name: Federico II University class: OTHER briefSummary: 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 conditions: Polycythemia Vera conditions: Essential Thrombocythemia conditions: Primary Myelofibrosis conditions: Prefibrotic/Early Primary Myelofibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 45 type: ACTUAL name: ULTRASOUND EXAM AND MRI SCAN measure: agreement between two different diagnostic methods sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federico II University city: Naples zip: 80131 country: Italy lat: 40.85216 lon: 14.26811 hasResults: False
<\|newrecord\|> nctId: NCT06371560 id: KAP-ABR-Perio briefTitle: Antibiotics, Antibiotic Resistance, and Prescribing Practices Among Periodontists: Cross Sectional KAP Study overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-09-30 date: 2024-10-30 date: 2024-04-17 date: 2024-04-23 name: Cairo University class: OTHER briefSummary: 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 conditions: Antibiotic Use conditions: Periodontitis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Questionnaire measure: KAP measure: The prescribing practices of antibiotics in periodontal therapy measure: The correlation between personal perception of antibiotics uses and the professional prescription patterns measure: The differences in antibiotics prescription in relation to the years of experience and the academic background. sex: ALL minimumAge: 25 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371547 id: BEUFTR-3 briefTitle: Efficiency of Different Gastrocnemius Stretching Exercises overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-10-15 date: 2024-12-15 date: 2024-04-17 date: 2024-04-17 name: Bitlis Eren University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Interventions and assessment will be performed by separate researchers. whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Stretching Exercise measure: Measurement of the Viscoelastic Properties measure: Ankle-foot Dorsiflexion Index measure: Measurement of the Mechanosensitivity measure: Assessment of Hamstring Tightness measure: Dominant Leg Determination measure: Navicular Drop Test measure: Self-reported Effects of Stretching Exercises measure: The Satisfaction Level with the Stretching measure: Compliance with Stretching Exercise Program sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Bitlis Eren University city: Bitlis state: Merkez zip: 13000 country: Turkey lat: 38.40115 lon: 42.10784 hasResults: False
<\|newrecord\|> nctId: NCT06371534 id: QL2109-101 briefTitle: A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-17 date: 2024-04-17 name: Qilu Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 228 type: ESTIMATED name: QL2109 name: DARZALEX FASPRO® measure: AUC0-∞ measure: Cmax sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The First Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310006 country: China name: qingwei zhao, Professor role: CONTACT email: qwzhao@zju.edu.cn name: qingwei zhao, Professor role: PRINCIPAL_INVESTIGATOR name: xingjiang hu, Professor role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: The First Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310006 country: China name: qingwei ZHAO, Professor role: CONTACT email: qwzhao@zju.edu.cn name: xingjiang HU, Professor role: CONTACT email: hxj319@163.com name: qingwei ZHAO, Professor role: PRINCIPAL_INVESTIGATOR name: xingjiang HU, Professor role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06371521 id: 4933 briefTitle: Ergogenic Effects of Sportlegs overallStatus: RECRUITING date: 2024-01-24 date: 2024-06-01 date: 2024-06-01 date: 2024-04-17 date: 2024-04-17 name: Christopher Bell class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, Placebo-Controlled, Double Blind Crossover Intervention primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Investigators and Participants are both blinded to whether the participants will be consuming Sportlegs or Placebo during a given study visit. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: Sportlegs name: Placebo measure: Maximal Oxygen Uptake measure: Lactate Threshold measure: Rating of Perceived Exertion (RPE) measure: Maximal sustained mean power sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Colorado State University status: RECRUITING city: Fort Collins state: Colorado zip: 80523 country: United States name: Christopher Bell, Ph.D. role: CONTACT phone: 970-491-7522 email: christopher.bell@colostate.edu name: Taylor R Ewell, MS role: CONTACT phone: 7197611417 email: taylor.ewell@colostate.edu lat: 40.58526 lon: -105.08442 hasResults: False
<\|newrecord\|> nctId: NCT06371508 id: 14042024 briefTitle: Breast Cancer and Breast Self-examination Education overallStatus: RECRUITING date: 2024-02-01 date: 2024-05-15 date: 2024-06-15 date: 2024-04-17 date: 2024-04-17 name: Sakarya University class: OTHER briefSummary: 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 conditions: Breast Self-Examination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Education based on breast cancer and breast examination measure: Champion Breast Cancer Fear Scale Change measure: Breast Self Examination Checklist Success Score sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Kocadere Sağlık Evi status: RECRUITING city: Yalova country: Turkey name: Muge Saglık, Msc. role: CONTACT phone: +905343817563 email: mge.saglk@gmail.com lat: 40.65501 lon: 29.27693 hasResults: False
<\|newrecord\|> nctId: NCT06371495 id: statins in ischemic stroke briefTitle: Statins Role in Acute Ischemic Stroke acronym: observation overallStatus: NOT_YET_RECRUITING date: 2024-08-13 date: 2025-02-28 date: 2025-08-30 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: Strokes is amajor cause of death and disabilities in different countried conditions: Stroke, Acute studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: rosuvastatin measure: Carotid duplex will be done at the onset and after 1 month and 3 months of the onset. sex: ALL minimumAge: 20 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371482 id: Camel-01 briefTitle: Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer (Camel-01) overallStatus: RECRUITING date: 2023-06-01 date: 2024-12-31 date: 2027-12-31 date: 2024-04-17 date: 2024-04-17 name: Hebei Medical University Fourth Hospital class: OTHER briefSummary: This trial aims to assess efficacy and safety of durvalumab combined with chemoradiotherapy for limited stage small cell lung cancer. conditions: SCLC, Limited Stage studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: Durvalumab name: Chemotherapy drug of EP regimen name: radiotherapy measure: Assessment of objective remission rate (ORR) in limited stage small cell lung cancer treated with durvalumab combined with chemoradiotherapy measure: Assessment of the incidence of treatment-related adverse events Incidence of Treatment-Emergent Adverse Events. measure: Assessment of overall survival (OS) in limited stage small cell lung cancer. measure: Assessment of progression-free survival (PFS) in limited stage small cell lung cancer. measure: Assessment of disease control rate (DCR) in limited stage small cell lung cancer. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fourth Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei zip: 050011 country: China name: Wenbin Shen, PhD role: CONTACT phone: +86 15831183879 email: wbshen1979@sina.com name: Hesong Wang, PhD role: CONTACT phone: +86 18810775196 email: wanghesongmz@163.com lat: 38.04139 lon: 114.47861 hasResults: False
<\|newrecord\|> nctId: NCT06371469 id: KAEK-769 briefTitle: Program of Health Behaviour Against to Cancer (PHeBAC) acronym: PHeBAC overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-07-20 date: 2024-08-20 date: 2024-04-17 date: 2024-04-18 name: Akdeniz University class: OTHER briefSummary: 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 conditions: Health Behavior conditions: Disability, Intellectual conditions: Parents conditions: Cancer Screening conditions: Experimental Study Designs conditions: Mothers conditions: Disabilities Mental studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Mothers participating in the research will not know that they are in the intervention or control group. The data of the research will be collected by an independent investigator. In addition telephone support during the research process will be provided by the independent investigator, too whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: PHeBAC name: Control Group measure: Health Behaviors and Participation in Cancer Screenings Data Collection Form measure: Healthy Life Style Behaviors Scale II (Physical Activity and Nutrition Sub-Factors) measure: Sun Protection Behavior Scale sex: FEMALE minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371456 id: Ain Shams university 111 briefTitle: A Non Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-08-01 date: 2024-04-17 date: 2024-04-17 name: Ain Shams University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: epidural catheter placement measure: appearance of the dew sign measure: epidurogram measure: visual analogue score measure: mean blood pressure measure: mean blood pressure measure: heart rate measure: heart rate sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371443 id: ayselkokcudogan briefTitle: Suction and Swalloing Exercises for Premature Babies overallStatus: COMPLETED date: 2021-12-03 date: 2022-06-01 date: 2022-08-01 date: 2024-04-17 date: 2024-04-17 name: Istanbul Medipol University Hospital class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 41 type: ACTUAL name: Sucking and swallowing exercises measure: The early feeding skills assessment tool (EFS) sex: ALL minimumAge: 34 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: Medipol University city: Istanbul state: Beykoz zip: 34810 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06371430 id: Biointelligent Technology Syst briefTitle: Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery acronym: BBLIS overallStatus: RECRUITING date: 2021-04-14 date: 2024-02-14 date: 2024-06-14 date: 2024-04-17 date: 2024-04-17 name: Biointelligent Technology Systems SL class: INDUSTRY name: Universidad Pública de Navarra name: Dasman Diabetes Institute briefSummary: 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 conditions: Wounds and Injuries conditions: Wound Surgical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 33 type: ESTIMATED name: Dental Implant insertion and tooth extraction measure: ISQ measurements measure: Pain measure: CBCTs analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biointelligent Technology Syst status: RECRUITING city: Barcelona zip: 08009 country: Spain name: Maher Atari, PhD role: CONTACT email: matari@biointelligentsl.com lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06371417 id: RAY902CT briefTitle: Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-06-30 date: 2026-06-30 date: 2024-04-17 date: 2024-04-17 name: Chugai Pharmaceutical class: INDUSTRY briefSummary: 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) conditions: Bullous Pemphigoid (BP) conditions: Behçet's Syndrome (BS) conditions: Dermatomyositis (DM) conditions: Immune-mediated Necrotizing Myopathy (IMNM) conditions: Immune Thrombocytopenia (ITP) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: RAY121 measure: Adverse events (AEs) measure: RAY121 concentration measure: AUCτ measure: Cmax measure: Cmin measure: Active C1s measure: Total C1s measure: Complement activity (classical pathway) measure: Anti-RAY121 antibodies sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon Health & Science University city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Hokkaido University Hospital city: Sapporo state: Hokkaido zip: 060-0808 country: Japan lat: 43.06667 lon: 141.35 facility: Tohoku University Hospital city: Sendai state: Miyagi zip: 980-8574 country: Japan lat: 38.26667 lon: 140.86667 facility: Osaka University Hospital city: Suita state: Osaka zip: 565-0871 country: Japan lat: 34.76143 lon: 135.51567 facility: Hamamatsu University Hospital city: Hamamatsu state: Shizuoka zip: 431-3192 country: Japan lat: 34.7 lon: 137.73333 facility: Toho University Omori Medical Center city: Ota-ku state: Tokyo zip: 143-8540 country: Japan lat: 36.3 lon: 139.36667 hasResults: False
<\|newrecord\|> nctId: NCT06371404 id: 2000037129 briefTitle: Imaging Traumatic Stress and Alcohol Use Disorder With [18F]Bavarostat overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2030-06-01 date: 2031-06-01 date: 2024-04-17 date: 2024-04-17 name: Yale University class: OTHER briefSummary: 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 conditions: Post Traumatic Stress Disorder studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Bavarostat measure: HDAC6 expression in people with Post-Traumatic Stress Disorder measure: HDAC6 expression in people with Alcohol use Disorder sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yale University city: New Haven state: Connecticut zip: 06518 country: United States name: Kelly Cosgrove, PhD role: CONTACT phone: 203-737-6969 email: kelly.cosgrove@yale.edu name: Marc Grasso, Ba role: CONTACT phone: 2037377074 email: marc.grasso@yale.edu name: Kelly Cosgrove, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 hasResults: False
<\|newrecord\|> nctId: NCT06371391 id: 2023-02077 briefTitle: Environmental and Occupational Noise Exposure in Relation to Incidence of Type 2 Diabetes overallStatus: ACTIVE_NOT_RECRUITING date: 1992-01-01 date: 2013-12-31 date: 2026-12-31 date: 2024-04-17 date: 2024-04-19 name: Karolinska Institutet class: OTHER name: The Swedish Research Council briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300000 type: ESTIMATED name: No intervention measure: Type 2 diabetes (T2D) sex: ALL minimumAge: 16 Years maximumAge: 98 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371378 id: gastric residual volume briefTitle: Effect of Different Peep Values on Gastric Residual Volume overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-05 date: 2024-06-01 date: 2024-09-01 date: 2024-04-17 date: 2024-04-19 name: Ankara City Hospital Bilkent class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: PEEP 0 name: PEEP 4 name: PEEP 8 measure: Gastric antrum diameter measure: Intraabdominal pressure (IAP) measurement measure: gastric volume measurement measure: Vital parameters Pulse oximetry (%) measure: Vital parameters systolic and diastolic blood pressure (mmHg) measure: Vital parameters heart rate (beats/minute) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital city: Ankara state: Çankaya country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06371365 id: KMUHIRB-E(II)-20220204 briefTitle: Adverse Events for Free Flap Surgery in Head and Neck Cancer overallStatus: COMPLETED date: 2022-10-19 date: 2023-09-24 date: 2023-09-24 date: 2024-04-17 date: 2024-04-18 name: Kaohsiung Medical University class: OTHER name: Kaohsiung Medical University Chung-Ho Memorial Hospital briefSummary: 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 conditions: Flap Failure Risk Factors conditions: Hematoma Risk Factors conditions: Thrombosis Risk Factors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 540 type: ACTUAL name: Free Flap surgery measure: Number of participants with flap failure measure: Number of participants with hematoma measure: Number of participants with thrombosis sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Chung-Ho Memorial Hospital city: Kaohsiung country: Taiwan lat: 22.61626 lon: 120.31333 hasResults: False
<\|newrecord\|> nctId: NCT06371352 id: JagiellonianU73 briefTitle: Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-05 date: 2024-04-17 date: 2024-04-17 name: Jakub Antczak class: OTHER name: Institute of Psychiatry and Neurology, Warsaw briefSummary: 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 conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, sham-controlled clinical trial in parallel design primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Placebo intervention will be delivered with a sham-coil for magnetic stimulation, which looks identical and elicits similar sounds as the coil used for active stimulation, but induces only negligible magnetic field. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: iTBS name: cTBS name: Sham measure: Beck Depression Inventory 2 measure: Pittsburgh Sleep Quality Index measure: Brief Psychiatric Rating Scale measure: Epworth Sleepiness Scale measure: Fatigue Assessment Scale measure: Quality of Life in Depression Scale measure: Sleep propensity non-rapid eye movement 1 sleep stage measure: Sleep propensity non-rapid eye movement 2 sleep stage sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Psychiatry and Neurology city: Warsaw zip: 02957 country: Poland name: Bogdan Stefanowski role: CONTACT phone: +48 22 45 82 532 email: bstefanowski@ipin.edu.pl name: Jakub Antczak, MD role: CONTACT phone: +48 12 400 25 50 email: jakub.antczak@uj.edu.pl lat: 52.22977 lon: 21.01178 hasResults: False
<\|newrecord\|> nctId: NCT06371339 id: 23 VADS 03 briefTitle: Optimization With a Gamma Camera of the Individualized Patient Dosimetry in Radioiodine Therapy of Thyroid Diseases acronym: THIDOS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-04-17 date: 2024-04-17 name: Institut Claudius Regaud class: OTHER name: Laboratoire IJCLab briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Additional acquisitions with the investigational gamma-camera " MoTI ". measure: The clinical feasibility of using an ambulatory gamma camera. measure: The level of acceptance of the gamma camera by operators for carrying out examinations measure: The quality of the images for the expected clinical use measure: The ability of the gamma camera to generate images compatible with the Picture Archiving and Communication System (PACS) measure: 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) measure: The 131I fixation rates will be measured in percent at different times. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IUCT-O city: Toulouse country: France name: Slimane ZERDOUD role: CONTACT phone: 05 31 15 56 28 email: zerdoud.slimane@iuct-oncopole.fr lat: 43.60426 lon: 1.44367 hasResults: False
<\|newrecord\|> nctId: NCT06371326 id: BJQLZT002004 briefTitle: A Study of ZT002 Injection in Participants With Overweight or Obesity overallStatus: ENROLLING_BY_INVITATION date: 2023-11-21 date: 2024-08-30 date: 2024-09-30 date: 2024-04-17 date: 2024-04-17 name: Beijing QL Biopharmaceutical Co.,Ltd class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: ZT002 Injection name: Placebo measure: 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. measure: 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. measure: The Pharmacokinetics (PK) profile of a multiple escalation dose of ZT002 in participants with overweight or obesity. measure: The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in participants with overweight or obesity. measure: The anti-drug antibody (ADA) response through testing serum or plasma of the participants post-dosing. sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: First Affiliated Hospital of Bengbu Medical College city: Bengbu country: China lat: 32.94083 lon: 117.36083 hasResults: False
<\|newrecord\|> nctId: NCT06371313 id: GuangdongWCH-LiLi03 briefTitle: Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism overallStatus: COMPLETED date: 2023-05-01 date: 2024-03-05 date: 2024-03-05 date: 2024-04-17 date: 2024-04-17 name: Guangdong Women and Children Hospital class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 42 type: ACTUAL measure: Testosterone measure: Androstenedione measure: Dehydroepiandrosterone Sulfate measure: Sex Hormone Hinding Globulin measure: Free Androgen Index measure: Fasting Insulin measure: White Blood Cell Count measure: Neutrophil Count measure: High-sensitivity C-reactive Protein measure: Interleukin-6 sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Guangdong Women and Children Hosptial city: Guanzhou state: Guangdong zip: 511400 country: China hasResults: False
<\|newrecord\|> nctId: NCT06371300 id: HLS21156 briefTitle: Photobiomodulation With REd vs BluE Light (REBEL) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08 date: 2025-12 date: 2024-04-17 date: 2024-04-23 name: Aston University class: OTHER briefSummary: 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 conditions: Meibomian Gland Dysfunction conditions: Blepharitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Each participant is randomised to either of 3 groups: Red light only group, red plus blue light group, or sham treatment group. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Red LLLT name: Blue LLLT name: Sham Red LLLT name: Sham Blue LLLT measure: Change from Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Visual Acuity to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Blink Rate to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Tear Meniscus Height to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Lipid Layer Pattern Grading to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Limbal Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Bacterial Colony to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Blood Flow to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Saponification Grading to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Demodex Presence to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Meibum Expressibility to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Meibum Quality to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Fluorescein Corneal Staining to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Bulbar Conjunctival Staining to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Meibography Meiboscore to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Total Corneal Nerve Length to the Final Follow-up 1 Month After Final Treatment Session sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aston Dry Eye Clinic city: Birmingham state: West Midlands zip: B4 7ET country: United Kingdom name: Jeremy Chung Bo Chiang, PhD role: CONTACT phone: +441212043934 phoneExt: 3934 email: j.chiang@aston.ac.uk lat: 52.48142 lon: -1.89983 hasResults: False
<\|newrecord\|> nctId: NCT06371287 id: 64696022.1.0000.5346 briefTitle: Effect of Musical Auditory Training on Subjects With Tinnitus Disorder overallStatus: RECRUITING date: 2023-02-20 date: 2024-08-10 date: 2025-02-10 date: 2024-04-17 date: 2024-04-24 name: Universidade Federal de Santa Maria class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Treinamento Auditivo Musical name: Placebo measure: Changes in latency of the long latency auditory evoked potential (LLAEP) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Universidade Federal de Santa Maria status: RECRUITING city: Santa Maria state: RS zip: 97.105-970 country: Brazil name: Dayane Domeneghini Didoné role: CONTACT phone: 553220-9362 email: dayane.didone@ufsm.br name: Dayane Domeneghini Didoné D Dayane Domeneghini Didoné role: PRINCIPAL_INVESTIGATOR lat: -29.68417 lon: -53.80694 facility: Universidade Federal de Santa Maria status: RECRUITING city: Santa Maria state: RS zip: 97.105-970 country: Brazil name: Dayane D Didoné, Professora role: CONTACT phone: 553220-9362 email: dayane.didone@ufsm.br name: Christine G Schumacher, Mestranda role: PRINCIPAL_INVESTIGATOR lat: -29.68417 lon: -53.80694 hasResults: False
<\|newrecord\|> nctId: NCT06371274 id: ZYYY-IIT-TNBC-001 briefTitle: A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-04-17 date: 2024-04-17 name: First Affiliated Hospital of Zhejiang University class: OTHER name: Shanghai Longfine Biotechnology Co., Ltd. name: TopAlliance briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: ATRA name: Toripalimab measure: Objective Response Rate (ORR) measure: Progression-Free Survival (PFS) measure: Duration of Response (DOR) measure: Overall Survival (OS) measure: Incidence of Treatment-Emergent Adverse events as assessed by NCI-CTCAE 5.0 measure: Exploratory biomarkers-peripheral blood lymphocyte analysis measure: Exploratory biomarkers-Serum Metabolomics Analysis measure: Exploratory biomarkers-Fecal Microbiota Analysis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first affiliated hospital, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang Province, P.R. China zip: 310003 country: China name: Meihua Lin, MS role: CONTACT name: Jian Liu, MS role: PRINCIPAL_INVESTIGATOR name: Xiaochen Zhang, MD role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06371261 id: 2023/CHU/07 briefTitle: Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis acronym: ACHROMO-MUCO overallStatus: RECRUITING date: 2024-02-29 date: 2027-03 date: 2027-03 date: 2024-04-17 date: 2024-04-26 name: Centre Hospitalier Universitaire de la Réunion class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 35 type: ESTIMATED name: Biological analyses measure: Frequency of pulmonary exacerbations according to the species of the Achromobacter genus colonising/infecting cystic fibrosis patients. measure: Frequency of pulmonary exacerbations as a function of Achromobacter spp. colonisation status. measure: Emergence or existing presence of clones within the species of the genus Achromobacter circulating among cystic fibrosis patients in Réunion, using genomic analyses. measure: Presence of virulence factors in these strains using genomic analyses measure: Search for genes responsible for antibiotic resistance by genomic analysis of these strains measure: To describe the epidemiology of Achromobacter spp. in cystic fibrosis patients in Réunion sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU la Réunion North status: RECRUITING city: Saint-Denis country: Réunion name: VERHILLE Juliette, MD role: CONTACT email: Juliette.verhille@chu-reunion.fr name: Juliette VERHILLE, MD role: PRINCIPAL_INVESTIGATOR lat: -20.88231 lon: 55.4504 facility: CHU la Réunion South status: RECRUITING city: Saint-Pierre country: Réunion name: PERISSON Caroline, MD role: CONTACT email: Caroline.perisson@chu-reunion.fr name: Caroline PERISSON, MD role: PRINCIPAL_INVESTIGATOR lat: -21.3393 lon: 55.47811 hasResults: False
<\|newrecord\|> nctId: NCT06371248 id: 2850 briefTitle: Steady Feet: Preventing Falls in the Community overallStatus: COMPLETED date: 2018-11-19 date: 2019-12-20 date: 2019-12-20 date: 2024-04-17 date: 2024-04-17 name: Changi General Hospital class: OTHER briefSummary: The purpose of this study is to examine the feasibility of Steady Feet, a three-month community-based falls prevention exercise program. conditions: Fall conditions: Feasibility conditions: Older Adults conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 65 type: ACTUAL name: Steady Feet name: Usual care for fall prevention measure: Short Physical Performance Battery (SPPB) measure: CONFbal measure: Six-minute walk test (6MWT) measure: Timed up and go (TUG) measure: Four square step test (FSST) measure: Feedback and satisfaction survey measure: Attendance and completion rates measure: Safety of Steady Feet sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changi General Hospital city: Singapore zip: 529889 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
<\|newrecord\|> nctId: NCT06371235 id: 2024-A00739-38 briefTitle: Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier acronym: Pregiferon overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-09 date: 2027-03 date: 2024-04-17 date: 2024-04-17 name: CerbaXpert class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 250 type: ESTIMATED name: Pregiferon measure: Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371222 id: BSMMU/2023/6502 briefTitle: Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm overallStatus: COMPLETED date: 2023-02-01 date: 2024-01-31 date: 2024-02-01 date: 2024-04-17 date: 2024-04-17 name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 42 type: ACTUAL name: Ivabradine name: Beta blocker measure: effect of ivabradine in MS patients measure: quality of life of MS patients sex: ALL minimumAge: 17 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: BSMMU city: Dhaka zip: 1200 country: Bangladesh lat: 23.7104 lon: 90.40744 hasResults: False
<\|newrecord\|> nctId: NCT06371209 id: 2022P000619 briefTitle: Kinematics of Ewing Amputees overallStatus: ENROLLING_BY_INVITATION date: 2022-05-17 date: 2024-06-29 date: 2024-07-01 date: 2024-04-17 date: 2024-04-17 name: Brigham and Women's Hospital class: OTHER briefSummary: 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 conditions: Trans-Tibial Amputation conditions: Traumatic Lower Extremity Amputation conditions: Agonist-Antagonist Myoneural Interface studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 32 type: ESTIMATED name: Modified Amputation name: Standard Amputation measure: Duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait measure: Symmetry of duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait measure: Symmetry of ankle power generation measure: Symmetry of peak knee flexion during stance measure: Symmetry of step length sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mass General Brigham city: Boston state: Massachusetts zip: 02129 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06371196 id: BBD-PBC 2024-03 briefTitle: Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-07-25 date: 2025-12-31 date: 2024-04-17 date: 2024-04-17 name: Mei Han class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Babaodan Capsule measure: Total bilirubin (TBil) reversion rate measure: Total bilirubin (TBil) efficacy rate measure: biological response rate measure: ALT measure: AST measure: ALP measure: TBA measure: DBil measure: IBil measure: 5-D Pruritus Scale Score measure: Fatigue section of the PBC-40 questionnaire measure: Immunological indicators - serum IgM measure: Immunological indicators - serum IgG measure: Immunological indicators - serum IgA measure: Immunological indicators - anti-gp210 antibody measure: Immunological indicators - anti-sp100 antibody measure: Immunological indicators - autoantibodies AMA/AMA-M2 measure: Histopathology of the liver - grading of inflammatory activity measure: Histopathology of the liver - staging of the degree of fibrosis measure: 12-lead electrocardiogram measure: Physical examination measure: Routine blood test measure: Renal Function Tests-BUN measure: Renal Function Tests-UA measure: Renal Function Tests-Scr measure: Urinalysis measure: Coagulation tests-PT measure: Coagulation tests-APTT measure: Coagulation tests-TT measure: Coagulation tests-FIB measure: Urine beta-hCG pregnancy test measure: adverse event measure: Body temperature measure: Heart rate measure: Number of breaths in 1 min measure: Blood pressure-Diastolic blood pressure(mmHg) measure: Blood pressure-Systolic blood pressure(mmHg) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371183 id: AOMSaidB briefTitle: A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children on June 2024 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-30 date: 2027-05-30 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: A Comparative study of clinical, endoscopic and histopathological features of colitis in children conditions: Role of Ileoscopy in Diagnosis of Colitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients who complaining of lower GI manifestations primaryPurpose: DIAGNOSTIC masking: NONE count: 196 type: ESTIMATED name: Colonoscope measure: Role of ileoscopy in diagnosis of colitis measure: To correlate clinical manifestations by colonoscopic picture sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06371170 id: CCPC- 001/22 briefTitle: Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population overallStatus: RECRUITING date: 2023-01-01 date: 2025-01-01 date: 2027-01-01 date: 2024-04-17 date: 2024-04-19 name: Azienda Ospedaliero, Universitaria Ospedali Riuniti class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Rivaroxaban measure: Thrombus resolution measure: Bleeding sex: ALL minimumAge: 1 Month maximumAge: 16 Years stdAges: CHILD facility: CCPC status: RECRUITING city: Ancona state: Marche zip: 60123 country: Italy name: Francesco Bianco, M.D. role: CONTACT phone: +39 071 596 5316 email: francesco.bianco@ospedaliriuniti.marche.it lat: 43.5942 lon: 13.50337 hasResults: False
<\|newrecord\|> nctId: NCT06371157 id: AK104-308 briefTitle: A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-07-02 date: 2025-10-25 date: 2026-05-23 date: 2024-04-17 date: 2024-04-17 name: Akeso class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 469 type: ESTIMATED name: AK104 name: Lenvatinib name: TACE name: Placebo for AK104 name: Placebo for Lenvatinib measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) measure: Overall Survival (OS) measure: PFS per RECIST 1.1 measure: Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST) measure: Duration of Response (DOR) per RECIST 1.1 and mRECIST measure: Disease Control Rate (DCR) per RECIST 1.1 and mRECIST measure: Time to Response (TTR) per RECIST 1.1 and mRECIST sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital city: Zhengzhou state: Henan zip: 450004 country: China name: Hailiang Li role: CONTACT lat: 34.75778 lon: 113.64861 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410006 country: China name: Shanzhi Gu role: CONTACT lat: 28.19874 lon: 112.97087 facility: Zhongda Hospital Southeast University city: Nanjing state: Jiangsu zip: 210009 country: China name: Gaojun Teng role: CONTACT lat: 32.06167 lon: 118.77778 facility: Shanxi Cancer Hospital city: Taiyuan state: Shanxi zip: 030009 country: China lat: 37.86944 lon: 112.56028 facility: Sichuan Cancer Hospital city: Chengdu state: Sichuan zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Yunnan Cancer Hospital city: Kunming state: Yunnan zip: 650100 country: China lat: 25.03889 lon: 102.71833 facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang zip: 310005 country: China name: Guoliang Shao role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06371144 id: NHREC/16/05/22/130 briefTitle: A Randomized Control Trial on Intravenous Paracetamol Versus Intramuscular Tramadol as Intra Partum Labor Analgesia overallStatus: COMPLETED date: 2022-06-03 date: 2022-09-10 date: 2022-09-10 date: 2024-04-17 date: 2024-04-17 name: Darlington-Peter Chibuzor Ugoji class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 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 primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Double blinded whoMasked: PARTICIPANT count: 194 type: ACTUAL name: Paracetamol measure: Mean pain score sex: FEMALE minimumAge: 15 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT facility: AEFUTHA city: Abakaliki state: Ebonyi zip: 234 country: Nigeria lat: 6.32485 lon: 8.11368 hasResults: False
<\|newrecord\|> nctId: NCT06371131 id: PONV of Thyroid Surgery briefTitle: Effect of Stellate Ganglion Block on Postoperative Nausea and Vomiting overallStatus: RECRUITING date: 2023-04-17 date: 2024-05-30 date: 2024-08-30 date: 2024-04-17 date: 2024-04-26 name: The Second Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: 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 conditions: Thyroid Surgery conditions: Postoperative Nausea and Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental group: right stellate ganglion block 30 minutes before anesthesia induction.Control group: No treatment was given 30minutes before anesthesia induction.Data was recorded at the corresponding time points. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Right -stellate ganglion block measure: Incidence of Postoperative nausea and vomiting measure: Incidence of Postoperative nausea and vomiting during preemptive analgesia measure: Intensity of nausea and vomiting during preemptive analgesia measure: Intensity of nausea and vomiting during hospitalization measure: Hemodynamic parameters after preemptive analgesia measure: Postoperative pain intensity measure: Recovery of gastrointestinal function measure: Sleep quality measure: Satisfaction score and postoperative analgesia satisfaction score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: ling Dan, BD role: CONTACT phone: 86 13983072922 email: 302069@hospital.cqmu.edu.cn lat: 29.56278 lon: 106.55278 hasResults: False
<\|newrecord\|> nctId: NCT06371118 id: PI 20210032 briefTitle: HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme acronym: HERSELF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-11 date: 2024-04-17 date: 2024-04-17 name: Universidade do Porto class: OTHER name: Unidade de Saúde Familiar de Garcia de Orta, Porto name: Unidade de Saúde Familiar da Prelada, Porto name: Unidade de Saúde Familiar de Cedofeita, Porto name: Instituto Portugues de Oncologia, Francisco Gentil, Porto briefSummary: 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.

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