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<\|newrecord\|> nctId: NCT06335238 id: IEO 0729 briefTitle: Radiotherapy Treatments for Neoplasms in the Abdominal-pelvic Region overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: Evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of abdominal-pelvic region radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the tabdominal-pelvic region. conditions: Abdominal Cancer conditions: Pelvic Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 7700 type: ESTIMATED measure: Overall survival measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06335225 id: 2023-NHLHCRF-YXHZ-ZRMS-06 briefTitle: Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics overallStatus: RECRUITING date: 2024-03-13 date: 2025-07-31 date: 2025-07-31 date: 2024-03-28 date: 2024-03-28 name: China-Japan Friendship Hospital class: OTHER briefSummary: With the aging of population and the change of lifestyle, the prevalence of prediabetes is increasing year by year. Nutritional factors are one of the important environmental factors in the occurrence and development of abnormal glucose metabolism. The medical nutritional treatment of diabetes is recommended as the cornerstone of diabetes treatment by various guidelines. With the development of nutrigenomics, it has been found that genes related to the absorption, metabolism, distribution and excretion of various nutrients are related to diabetes. This study intends to conduct precision nutrition intervention for prediabetic patients based on nutritional genes, and evaluate the effectiveness and safety of these nutritional interventions. conditions: Prediabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Precise nutritional intervention name: Conventional nutritional intervention measure: HbA1c measure: Concentration of fasting plasma glucose measure: Concentration of 2-hour plasma glucose measure: Concentration of fasting insulin measure: Concentration of fasting C peptide measure: Concentration of TC, TG, LDL-C, and HDL-C measure: Concentration of ALT, AST, TBIL measure: Concentration of creatinine measure: BMI measure: Waist hip ratio sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan Friendship Hospital status: RECRUITING city: Beijing country: China name: Xiao Ma, MD role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06335212 id: IRBNET ID 1448963 briefTitle: Peripheral Defocus Profile of Multifocal Minus Contact Lenses overallStatus: COMPLETED date: 2019-06-01 date: 2019-08-01 date: 2019-08-05 date: 2024-03-28 date: 2024-03-28 name: State University of New York College of Optometry class: OTHER briefSummary: Purpose: Numerous studies have proven that emmetropization in young animals including humans is regulated by visual input. It has long been hypothesized that peripheral myopic defocus may act as a stop signal to reduce myopia progression and axial elongation. As such, multifocal soft contact lenses (MFCLs) have been utilized for myopia control in school-aged children, with variable efficacies. One potential explanation is that the actual peripheral myopic defocus an eye experiences during MFCL wear may not be identical to the Add power and not sufficient to reduce myopia progression. Our study investigated and compared the peripheral power profiles of myopic eyes when they were uncorrected and wore single vision contact lenses (SVCLs) and MFCLs of different Add powers.
Methods: Subjects with -1.00 D to -10.00 D of myopia (SE, determined with manifest refraction) were custom fit with both single vision (SV) and MFCLs (+2.00 and +4.00 D Add; provided by Specialeyes) in both eyes. These Specialeyes MFCLs had an aspheric design with a standard total optical zone of 8.0mm. Cycloplegic central autorefraction was conducted with both Grand Seiko WAM-5500 open-field auto-refractor (Grand Seiko Co Ltd) and OPD OPD-Scan III Wavefront Aberrometer (Marco) on the subjects in the following conditions: (1) no CLs, (2) SVCLs, (3) MFCLs (+2.00D Add), and (4) MFCLs (+4.00D Add). Relative peripheral power profiles were measured using the OPD under the same 4 conditions after cycloplegia. Data in the right eye was used for analysis. conditions: Myopia conditions: Refractive Errors conditions: Contact Lens studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 19 type: ACTUAL name: Single vision and multifocal contact lenses measure: refractive power sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: State University of New York, College of Optometry city: New York state: New York zip: 10036 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06335199 id: H24109 id: 5P2CHD086844-09 type: NIH link: https://reporter.nih.gov/quickSearch/5P2CHD086844-09 briefTitle: tVNS Responsiveness Testing With Pupil Size overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-31 date: 2025-04-30 date: 2024-03-28 date: 2024-04-01 name: Georgia Institute of Technology class: OTHER name: Emory University name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The goal of this study is to learn about the acute pupil response to transcutaneous vagus nerve stimulation (tVNS) in stroke survivors and healthy adults. The main question it aims to answer is whether pupil size response is greater with bilateral tVNS compared to unilateral tVNS. Participants will receive tVNS and sham at the outer ear unilaterally and bilaterally in resting condition. The pupil size of the participants will be recorded during tVNS. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Unilateral tVNS stimulation name: Bilateral tVNS stimulation name: Unilateral Sham stimulation name: Bilateral Sham stimulation measure: Pupil size change sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Human Neuromuscular Physiology Lab city: Atlanta state: Georgia zip: 30318 country: United States name: Minoru Shinohara, Ph.D. role: CONTACT phone: 404-894-1030 email: shinohara@gatech.edu lat: 33.749 lon: -84.38798 hasResults: False
<\|newrecord\|> nctId: NCT06335186 id: Soh-Med-24-03-04MS briefTitle: Predictive and Prognostic Significance of Age,Blood Tests,Comorbidities(ABC) Score,Cologne Watch(C-watch)Score and Rockall Score for Risk of Variceal Re-bleeding Among Cirrhotic Patients overallStatus: RECRUITING date: 2024-02-10 date: 2025-03 date: 2025-03 date: 2024-03-28 date: 2024-03-28 name: Sohag University class: OTHER briefSummary: Introduction
Portal hypertension is a common complication of liver cirrhosis and is often underestimated in clinical diagnosis. The incidence of portal hypertension is approximately 20% to 98% in patients with cirrhosis (Wu et al., 2022). It is the major driver in the transition from the compensated to the 'decompensated' stage of cirrhosis, defined by the presence of clinical complications, including ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, and hepatic encephalopathy (Berzigotti., 2017).
Acute variceal bleeding is one of the most lifethreatening complications of liver cirrhosis. Twenty two percent to sixty one percent of cirrhotic patients receiving primary prophylaxis will develop first variceal bleeding during the first two years of follow up. Furthermore, variceal bleeding is associated with high risk of rebleeding and mortality (Tantai et al., 2019).
Patients with cirrhosis, although much progress has been made in diagnosis and treatment using vasoactive drugs, preventive antibiotics, early endoscopy and interventional radiology, the 6-week mortality rate remains high, ranging from 10 to 20%, mainly due to failure to control bleeding in the first days. Therefore, the prognostic method of patients with acute variceal bleeding is to determine the risk of rebleeding and resistance to standard treatment (accounting for 20-30%) and mortality rate in order to be able to adopt more aggressive treatment measures. The prognosis is very important but also difficult, not only because of the bleeding status but also depending on the severity of the underlying cirrhosis (Huy et al., 2023).
Many risk factors are known to influence the outcome in Upper Gastrointestinal Bleeding (UGIB) setting: Age, comorbidities, presence of shock, endoscopic diagnosis, haemoglobin values at the time of bleeding, stigmata of recent haemorhage and need for blood transfusion have all been described as significant risk factors for rebleeding and death (Monteiro S et al., 2016).
Many risk assessment score systems, including pre-endoscopy and post-endoscopy evaluations, have been developed to predict outcomes such as the need for hospital-based intervention, endoscopic therapy, and admission to an intensive care unit (ICU), rebleeding, and mortality. Some studies showed that these scoring systems distinguish low-risk patients who can potentially be managed as outpatients, allowing more efficient use of resources. Other studies suggested that these score systems distinguish higher-risk patients who might require emergency endoscopy or management in an intensive care unit (Li et al., 2022).
In 1993, the Rockall Scoring system was introduced to predict the mortality after UGIB and was validated for its use to identify the patients at high risk for re-bleed and mortality. Complete Rockall scoring system is based on an initial clinical score at the time of admission which consist of age (score 0-2), presence of shock (0-2), co-morbidities (score 0-3) and post endoscopic diagnosis (score 0-2) with stigmata of recent hemorrhages (score 0-2). Both clinical and post endoscopic scores added together gives a complete Rockall score with maximum score being 11 (Dewan et al., 2018).
In 2020, Laursen S.B. and colleagues conducted a multicenter international study and developed a new prognostic scoring system for UGIB called the ABC score. This scoring system is based on three criteria: age, blood test results, and comorbidities. The score ranges from 0 to 18 points, categorizing the risk into low (≤3 points), moderate (4-7 points), and high (≥8 points) levels. The 30-day mortality rates for high-risk UGIB patients in these three risk groups were 1%, 7%, and 25%, respectively ( Ky et al., 2023)
The new Cologne Watch (C-Watch) score was designed as a pre-endoscopic score for acute variceal and non-variceal UGIB and incorporates laboratory values only (c-reactive protein, white blood cell count, alanine-aminotransferase, thrombocytes, creatinine, and hemoglobin) with a minimum point value of 0 and a maximum point value of 8. Within the validation set, it predicted a composite endpoint consisting of recurrent bleeding, need for intervention (interventional radiology, surgery), or death within 30 days with an area under the receiver-operating characteristics curve (AUROC) of 0. About 38.7% of patients were within the high-risk group, i.e., ≥2 points, reached the composite endpoint, whereas no patient classified as low risk (≤1 point) (Allo et al., 2022). conditions: Upper Gastrointestinal Variceal Bleeding in Cirrhotic Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: upper endoscopy measure: ABC score. measure: Rockall score sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
<\|newrecord\|> nctId: NCT06335173 id: ACU193-201 id: 2023-509807-34-00 type: REGISTRY domain: EU CT Number briefTitle: A Study to Evaluate Efficacy and Safety of Intravenous ACU193 in Participants With Early Alzheimer's Disease (ALTITUDE-AD) acronym: ALTITUDE-AD overallStatus: RECRUITING date: 2024-02-29 date: 2031-01 date: 2031-01 date: 2024-03-28 date: 2024-03-29 name: Acumen Pharmaceuticals class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the efficacy of ACU193 infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2040 type: ESTIMATED name: ACU193 name: Placebo measure: Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score measure: Change from Baseline in ADCS-iADL Score measure: Change from Baseline in ADAS-Cog13 Score measure: Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) measure: Change from Baseline in Mini-Mental State Examination (MMSE) measure: Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) measure: Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score measure: Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) measure: Change from Baseline in Resource Utilization in Dementia (RUD) measure: Change from Baseline in Zarit Burden Interview (ZBI) measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by iADRS measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADCS-iADL measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADAS-Cog13 measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by CDR-SB measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by MMSE measure: Percentage of Participants with No Clinical Progression at One Year measure: Number of Participants with Treatment-Related Adverse Events (TEAEs) measure: Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) measure: Number of Participants who Discontinue or Withdraw due to TEAE measure: Number of Participants with Anti-Drug Antibodies (ADA) and Neutralizing Antibodies measure: Number of Participants with Amyloid-Related Imaging Abnormality with Edema/Effusions (ARIA-E) and ARIA with Hemorrhage/Hemosiderin Deposition (ARIA-H) as Measured by Magnetic Resonance Imaging (MRI) measure: Number of Participants with Suicidal Ideation and Behavior as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) measure: Serum Concentration of ACU193 measure: Concentration of ACU193 in Cerebrospinal Fluid (CSF) measure: CSF Concentrations of ACU193 in a Subset of Participants measure: Correlation Between ACU193 Exposure with Clinical Efficacy Measures measure: Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids measure: Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) of Whole Brain Volume, Ventricular Volume, and Volume of Selected Regions of Interest measure: Target Engagement Assessed by Measurement of ACU193- Amyloid-β oligomer (AβO) Complex in CSF measure: Change from Baseline in CSF Concentrations of Amyloid, Tau and Other Neurodegenerative Biomarkers measure: Change from Baseline in CSF Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers in a Subset of Participants measure: Change from Baseline in Blood Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers measure: Correlation Between Change in Biomarker that Reflect Disease Progression and Clinical Changes sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Banner Alzheimer's Institute- Clinical Trials Department status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85006 country: United States lat: 33.44838 lon: -112.07404 facility: IMA Clinical Research - Phoenix status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85012 country: United States lat: 33.44838 lon: -112.07404 facility: The Neurology Center of Southern California - Carlsbad status: NOT_YET_RECRUITING city: Carlsbad state: California zip: 92011-4219 country: United States lat: 33.15809 lon: -117.35059 facility: Neurology Center of North Orange County status: NOT_YET_RECRUITING city: Fullerton state: California zip: 92835 country: United States lat: 33.87029 lon: -117.92534 facility: Irvine Medical Research status: NOT_YET_RECRUITING city: Irvine state: California zip: 92614 country: United States lat: 33.66946 lon: -117.82311 facility: Healthy Brain Research status: NOT_YET_RECRUITING city: Long Beach state: California zip: 90804 country: United States lat: 33.76696 lon: -118.18923 facility: Sharp Mesa Vista Hospital status: NOT_YET_RECRUITING city: San Diego state: California zip: 92123 country: United States lat: 32.71533 lon: -117.15726 facility: Syrentis Clinical Research status: NOT_YET_RECRUITING city: Santa Ana state: California zip: 92705 country: United States lat: 33.74557 lon: -117.86783 facility: CenExel - California Neuroscience Research Medical Group, Inc (CNR) status: NOT_YET_RECRUITING city: Sherman Oaks state: California zip: 91403-2131 country: United States lat: 34.15112 lon: -118.44925 facility: Alpine Clinical Research Center status: NOT_YET_RECRUITING city: Boulder state: Colorado zip: 80301-1880 country: United States lat: 40.01499 lon: -105.27055 facility: The Mile High Research Center status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80218 country: United States lat: 39.73915 lon: -104.9847 facility: Yale School of Medicine - Alzheimer's Disease Research Unit (ADRU) status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510-3330 country: United States lat: 41.30815 lon: -72.92816 facility: Research Center for Clinical Studies, LLC status: NOT_YET_RECRUITING city: Norwalk state: Connecticut zip: 06851-4903 country: United States lat: 41.1176 lon: -73.4079 facility: Re:Cognition Health - Fairfax status: NOT_YET_RECRUITING city: Washington state: District of Columbia zip: 22031 country: United States lat: 38.89511 lon: -77.03637 facility: JEM Research Institute status: RECRUITING city: Atlantis state: Florida zip: 33462 country: United States name: Clinical Research Coordinator role: CONTACT phone: 561-968-2933 email: research@jemri.net lat: 26.5909 lon: -80.10088 facility: Bradenton Research Center status: NOT_YET_RECRUITING city: Bradenton state: Florida zip: 34205 country: United States lat: 27.49893 lon: -82.57482 facility: Gil Fernandez-Yera, MD, PA status: NOT_YET_RECRUITING city: Coral Gables state: Florida zip: 33135 country: United States lat: 25.72149 lon: -80.26838 facility: Brain Matters Research status: NOT_YET_RECRUITING city: Delray Beach state: Florida zip: 33445 country: United States lat: 26.46146 lon: -80.07282 facility: Coral Clinical Research status: NOT_YET_RECRUITING city: Homestead state: Florida zip: 33032 country: United States lat: 25.46872 lon: -80.47756 facility: K2 Medical Research - Villages status: RECRUITING city: Lady Lake state: Florida zip: 32159 country: United States name: Kylie Webster role: CONTACT phone: 352-565-7524 email: kylie.webster@k2med.com lat: 28.91749 lon: -81.92286 facility: Verus Clinical Research status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33125 country: United States lat: 25.77427 lon: -80.19366 facility: Finlay Medical Research status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33126 country: United States lat: 25.77427 lon: -80.19366 facility: Collier Neurologic Specialists (CNS), L.L.C. status: NOT_YET_RECRUITING city: Naples state: Florida zip: 34105-8522 country: United States lat: 26.14234 lon: -81.79596 facility: Ocala Health - Family Care Specialists - Ocala I status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34470 country: United States lat: 29.1872 lon: -82.14009 facility: Progressive Medical Research status: NOT_YET_RECRUITING city: Port Orange state: Florida zip: 32127 country: United States lat: 29.13832 lon: -80.99561 facility: Alzheimer's Research and Treatment Center - Stuart status: NOT_YET_RECRUITING city: Stuart state: Florida zip: 34997 country: United States lat: 27.19755 lon: -80.25283 facility: K2 Medical Research - Tampa status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 facility: Charter Research - Lady Lake status: RECRUITING city: The Villages state: Florida zip: 32162 country: United States name: Brittany Ortiz role: CONTACT phone: 352-775-1000 email: brittany.ortiz@charterresearch.com lat: 28.93408 lon: -81.95994 facility: Alzheimers Research and Treatment Center - Wellington status: NOT_YET_RECRUITING city: Wellington state: Florida zip: 33414 country: United States lat: 26.65868 lon: -80.24144 facility: Conquest Research status: RECRUITING city: Winter Park state: Florida zip: 32789 country: United States name: Elizabeth Schneider role: CONTACT phone: 689-488-9113 email: elizabeth.schneider@ConquestResearch.com lat: 28.6 lon: -81.33924 facility: Charter Research - Winter Park status: NOT_YET_RECRUITING city: Winter Park state: Florida zip: 32792 country: United States lat: 28.6 lon: -81.33924 facility: Columbus Memory Center status: NOT_YET_RECRUITING city: Columbus state: Georgia zip: 31909 country: United States lat: 32.46098 lon: -84.98771 facility: Accel Research- Neurostudies status: NOT_YET_RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: CenExel - iResearch Atlanta status: NOT_YET_RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: CenExel - iResearch Savannah status: NOT_YET_RECRUITING city: Savannah state: Georgia zip: 31405 country: United States lat: 32.08354 lon: -81.09983 facility: Office of Jeffrey S. Ross, MD status: NOT_YET_RECRUITING city: Northbrook state: Illinois zip: 60640 country: United States lat: 42.12753 lon: -87.82895 facility: KU Wichita Center for Clinical Research status: NOT_YET_RECRUITING city: Wichita state: Kansas zip: 67214 country: United States lat: 37.69224 lon: -97.33754 facility: ActivMed Practices and Research status: NOT_YET_RECRUITING city: Methuen state: Massachusetts zip: 03801 country: United States lat: 42.7262 lon: -71.19089 facility: Boston Center for Memory status: NOT_YET_RECRUITING city: Newton state: Massachusetts zip: 02459 country: United States lat: 42.33704 lon: -71.20922 facility: Donald S. Marks, MD. P.C. status: NOT_YET_RECRUITING city: Plymouth state: Massachusetts zip: 02360 country: United States lat: 41.95844 lon: -70.66726 facility: Hattiesburg Clinic - Memory Center status: NOT_YET_RECRUITING city: Hattiesburg state: Mississippi zip: 39401-7246 country: United States lat: 31.32712 lon: -89.29034 facility: Las Vegas Medical Research Center status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89113-2215 country: United States lat: 36.17497 lon: -115.13722 facility: Princeton Psychiatric Center status: NOT_YET_RECRUITING city: Princeton state: New Jersey zip: 08540-2859 country: United States lat: 40.34872 lon: -74.65905 facility: The Cognitive and Research Center of New Jersey status: NOT_YET_RECRUITING city: Springfield state: New Jersey zip: 07081 country: United States lat: 40.70491 lon: -74.31723 facility: CenExel - Advanced Memory Research Institute of NJ status: RECRUITING city: Toms River state: New Jersey zip: 08755 country: United States name: Anna Anna Brocco role: CONTACT phone: 732-341-9500 phoneExt: 3510 email: amri.recruitment@cenexel.com lat: 39.95373 lon: -74.19792 facility: IMA Clinical Research - Albuquerque status: NOT_YET_RECRUITING city: Albuquerque state: New Mexico zip: 87109 country: United States lat: 35.08449 lon: -106.65114 facility: Neurological Associates of Albany status: NOT_YET_RECRUITING city: Albany state: New York zip: 12208 country: United States lat: 42.65258 lon: -73.75623 facility: Neurological Institute of New York status: NOT_YET_RECRUITING city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 facility: SUNY Upstate Medical University - Upstate University Hospital (SUNY Health Science Center) status: NOT_YET_RECRUITING city: Syracuse state: New York zip: 13210-2342 country: United States lat: 43.04812 lon: -76.14742 facility: AMC Research status: NOT_YET_RECRUITING city: Matthews state: North Carolina zip: 28105 country: United States lat: 35.11681 lon: -80.72368 facility: Cleveland Clinic - Lou Ruvo Center for Brain Health (CCLRCBH) status: NOT_YET_RECRUITING city: Lakewood state: Ohio zip: 44107 country: United States lat: 41.48199 lon: -81.79819 facility: Summit Research Network status: NOT_YET_RECRUITING city: Portland state: Oregon zip: 97210 country: United States lat: 45.52345 lon: -122.67621 facility: Abington Neurological Associates status: NOT_YET_RECRUITING city: Abington state: Pennsylvania zip: 19001 country: United States lat: 40.12067 lon: -75.11795 facility: Keystone Clinical Research status: RECRUITING city: Norristown state: Pennsylvania zip: 19462 country: United States name: Cherian Verghese role: CONTACT phone: 610-277-8073 email: CVerghese@flourishresearch.com lat: 40.1215 lon: -75.3399 facility: Rhode Island Mood and Memory status: NOT_YET_RECRUITING city: East Providence state: Rhode Island zip: 02914 country: United States lat: 41.81371 lon: -71.37005 facility: Neurology Clinic. P.C status: NOT_YET_RECRUITING city: Cordova state: Tennessee zip: 38018 country: United States lat: 35.15565 lon: -89.7762 facility: The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group) status: NOT_YET_RECRUITING city: Knoxville state: Tennessee zip: 37920-1511 country: United States lat: 35.96064 lon: -83.92074 facility: Senior Adult Specialty Research status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78757 country: United States lat: 30.26715 lon: -97.74306 facility: Gadolin Research, LLC status: NOT_YET_RECRUITING city: Beaumont state: Texas zip: 77702 country: United States lat: 30.08605 lon: -94.10185 facility: Kerwin Medical Center status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: Okanagan Clinical Trials status: NOT_YET_RECRUITING city: Kelowna state: British Columbia country: Canada lat: 49.88307 lon: -119.48568 facility: Office of Alexandre Henri-Bhargava, MD status: NOT_YET_RECRUITING city: Victoria state: British Columbia country: Canada lat: 48.43294 lon: -123.3693 facility: Parkwood Institute status: NOT_YET_RECRUITING city: London state: Ontario country: Canada lat: 42.98339 lon: -81.23304 facility: Hippocampe d/b/a Ottawa Memory Clinic status: NOT_YET_RECRUITING city: Ottawa state: Ontario country: Canada lat: 45.41117 lon: -75.69812 facility: The Kawartha Regional Memory Clinic (KRMC) status: NOT_YET_RECRUITING city: Peterborough state: Ontario country: Canada lat: 44.30012 lon: -78.31623 facility: Baycrest - The Rotman Research Institute (RRI) status: NOT_YET_RECRUITING city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 facility: Toronto Memory Program (TMP) (Neurology Research Inc.) status: NOT_YET_RECRUITING city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 facility: University Health Network (UHN) - Toronto Western Hospital (TWH) - Krembil Neuroscience Centre (KNC) - Memory Clinic status: NOT_YET_RECRUITING city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 facility: MoCA Research and Innovations status: NOT_YET_RECRUITING city: Greenfield Park state: Quebec country: Canada lat: 45.48649 lon: -73.46223 facility: Amiens university hospital status: NOT_YET_RECRUITING city: Amiens country: France lat: 49.9 lon: 2.3 facility: Chu Pellegrin status: NOT_YET_RECRUITING city: Bordeaux country: France lat: 44.84044 lon: -0.5805 facility: Hopital Neurologique Pierre Wertheimer status: NOT_YET_RECRUITING city: Bron country: France lat: 45.73333 lon: 4.91667 facility: Hôpital de la Timone status: NOT_YET_RECRUITING city: Marseille Cedex 05 country: France lat: 43.29551 lon: 5.38958 facility: Chu Montpellier status: NOT_YET_RECRUITING city: Montpellier country: France lat: 43.61092 lon: 3.87723 facility: Hopital Lariboisiere status: NOT_YET_RECRUITING city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Institut de la Mémoire et de la Maladie d'Alzheimer -IM2A status: NOT_YET_RECRUITING city: Paris country: France lat: 48.85341 lon: 2.3488 facility: CHU de Rennes, CMRR status: NOT_YET_RECRUITING city: Rennes country: France lat: 48.11198 lon: -1.67429 facility: CHU de NANTES-Hôpital Nord Laennec status: NOT_YET_RECRUITING city: Saint-Herblain country: France lat: 47.21765 lon: -1.64841 facility: Hôpitaux Universitaires de Strasbourg status: NOT_YET_RECRUITING city: Strasbourg country: France lat: 48.58392 lon: 7.74553 facility: Centre de Recherche du Gérontopôle - CHU de Toulouse Hôpital la Grave status: NOT_YET_RECRUITING city: Toulouse country: France lat: 43.60426 lon: 1.44367 facility: Charité - Universitaetsmedizin Berlin status: NOT_YET_RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 facility: Pharmakologisches Studienzentrum Chemnitz GmbH status: NOT_YET_RECRUITING city: Chemnitz country: Germany lat: 50.8357 lon: 12.92922 facility: University Hospital of Cologne status: NOT_YET_RECRUITING city: Cologne country: Germany lat: 50.93333 lon: 6.95 facility: Saarland University Hospital status: NOT_YET_RECRUITING city: Homburg country: Germany lat: 49.32637 lon: 7.33867 facility: Zentralinstitut für seelische Gesundheit status: NOT_YET_RECRUITING city: Mannheim country: Germany lat: 49.4891 lon: 8.46694 facility: Technical University of Munich, School of Medicine and Health, Klinikum rechts der Isar status: NOT_YET_RECRUITING city: Munich country: Germany lat: 48.13743 lon: 11.57549 facility: Rostock University Medical Center status: NOT_YET_RECRUITING city: Rostock country: Germany lat: 54.0887 lon: 12.14049 facility: Praxisgemeinschaft Dr. Springub/Schwarz status: NOT_YET_RECRUITING city: Westerstede country: Germany lat: 53.25682 lon: 7.92737 facility: Fondazione Istituto G. Giglio di Cefalù status: NOT_YET_RECRUITING city: Cefalù country: Italy lat: 38.03856 lon: 14.02285 facility: Policlinico San Martino status: NOT_YET_RECRUITING city: Genova country: Italy lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milano country: Italy lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS San Gerardo dei Tintori status: NOT_YET_RECRUITING city: Monza country: Italy lat: 45.58005 lon: 9.27246 facility: Neurology Clinic status: NOT_YET_RECRUITING city: Perugia country: Italy lat: 43.1122 lon: 12.38878 facility: IRCCS Neuromed status: NOT_YET_RECRUITING city: Pozzilli country: Italy lat: 41.51142 lon: 14.06252 facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Sapienza Università di Roma - AOU Policlinico Umberto I status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: SSD Alzheimer's disease and related dementias status: NOT_YET_RECRUITING city: Torino country: Italy lat: 45.07049 lon: 7.68682 facility: A.O. Piafondazione Card. G. Panico status: NOT_YET_RECRUITING city: Tricase country: Italy lat: 39.93018 lon: 18.35421 facility: Centrum Medyczne Neuromed status: NOT_YET_RECRUITING city: Bydgoszcz country: Poland lat: 53.1235 lon: 18.00762 facility: Krakowska Akademia Neurologii Sp. z o.o. status: NOT_YET_RECRUITING city: Krakow country: Poland lat: 50.06143 lon: 19.93658 facility: NZOZ Syntonia status: NOT_YET_RECRUITING city: Pruszcz Gdanski country: Poland lat: 54.26217 lon: 18.63625 facility: RCMed status: NOT_YET_RECRUITING city: Sochaczew country: Poland lat: 52.22944 lon: 20.23838 facility: Centrum Medyczne Senior status: NOT_YET_RECRUITING city: Sopot country: Poland lat: 54.4418 lon: 18.56003 facility: Centrum Medyczne NeuroProtect status: NOT_YET_RECRUITING city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: Hospital Universitari General de catalunya status: NOT_YET_RECRUITING city: Sant Cugat Del Vallès state: Barcelona country: Spain lat: 41.47063 lon: 2.08611 facility: Fundacion CITA alzheimer status: NOT_YET_RECRUITING city: San Sebastián state: Gipuzkoa country: Spain lat: 43.31283 lon: -1.97499 facility: Fundacion Neuropolis - Hospital Viamed Montecanal status: NOT_YET_RECRUITING city: Cuarte de Huerva state: Zaragoza country: Spain lat: 41.59466 lon: -0.93268 facility: Fundacio ACE status: NOT_YET_RECRUITING city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Reina Sofia status: NOT_YET_RECRUITING city: Cordoba country: Spain lat: 37.89155 lon: -4.77275 facility: Cae Oroitu status: NOT_YET_RECRUITING city: Getxo country: Spain lat: 43.35689 lon: -3.01146 facility: Hospital Ruber status: NOT_YET_RECRUITING city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Policlínica Gipuzkoa status: NOT_YET_RECRUITING city: San Sebastian country: Spain lat: 43.31283 lon: -1.97499 facility: Hospital Victoria Eugenia status: NOT_YET_RECRUITING city: Sevilla country: Spain lat: 37.38283 lon: -5.97317 facility: Hospital Universitari i Politècnic La Fe status: NOT_YET_RECRUITING city: Valencia country: Spain lat: 39.46975 lon: -0.37739 facility: Re:Cognition Health - Plymouth status: NOT_YET_RECRUITING city: Plymouth state: Devon country: United Kingdom lat: 50.37153 lon: -4.14305 facility: Panthera Biopartners - Enfield status: NOT_YET_RECRUITING city: Enfield Town state: Greater London country: United Kingdom lat: 51.65147 lon: -0.08497 facility: Re:Cognition Health - London status: NOT_YET_RECRUITING city: London state: Greater London country: United Kingdom lat: 51.50853 lon: -0.12574 facility: St. Pancras Clinical Research Ltd. status: NOT_YET_RECRUITING city: London state: Greater London country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Panthera Bio-Partners - Rochdale status: NOT_YET_RECRUITING city: Rochdale state: Greater Manchester country: United Kingdom lat: 53.61766 lon: -2.1552 facility: Re:Cognition Health - Winchester status: NOT_YET_RECRUITING city: Winchester state: Hampshire country: United Kingdom lat: 51.06513 lon: -1.3187 facility: Neuroclin Glasgow status: NOT_YET_RECRUITING city: Motherwell state: Lanarkshire country: United Kingdom lat: 55.78924 lon: -3.99187 facility: Panthera Bio-Partners - Preston status: NOT_YET_RECRUITING city: Preston state: Lancashire country: United Kingdom lat: 53.76282 lon: -2.70452 facility: Re:Cognition Health - Guildford status: NOT_YET_RECRUITING city: Guildford state: Surrey country: United Kingdom lat: 51.23536 lon: -0.57427 facility: Re:Cognition Health - Birmingham status: NOT_YET_RECRUITING city: Birmingham state: West Midlands country: United Kingdom lat: 52.48142 lon: -1.89983 facility: Panthera Biopartners - Sheffield status: NOT_YET_RECRUITING city: Sheffield state: Yorkshire country: United Kingdom lat: 53.38297 lon: -1.4659 facility: Re:Cognition Health - Bristol status: NOT_YET_RECRUITING city: Bristol country: United Kingdom lat: 51.45523 lon: -2.59665 hasResults: False
<\|newrecord\|> nctId: NCT06335160 id: Mebendazole Ulcerative Colitis briefTitle: Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-05 date: 2024-03-28 date: 2024-03-28 name: Tanta University class: OTHER briefSummary: To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Mebendazole measure: change in disease activity measure: change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity measure: Change in Hemoglobin Concentration measure: Change in Erythrocyte sedimentation rate (ESR) measure: Change in Serum albumin measure: Change in Serum Interleukin -6 (IL-6) measure: Change in Serum Nitric oxide (NO) measure: Change in Serum Intra cellular adhesion molecule 1 (ICAM-1) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335147 id: HLX10IIT114 briefTitle: PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-31 date: 2026-01-31 date: 2024-03-28 date: 2024-03-28 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: Evaluate the efficacy and safety of PD1 monoclonal antibody combined with mFOLFOX6 neoadjuvant therapy for advanced resectable metastatic colon cancer with enriched pro-inflammatory pan macrophage subpopulations conditions: Metastatic Colon Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 23 type: ESTIMATED name: Serplulimab, mFOLFOX6 measure: pathologic complete response（pCR） measure: Objective response rate (ORR) measure: 2-year overall survival rate measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335134 id: SCW0502-1016 briefTitle: A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin overallStatus: RECRUITING date: 2023-07-14 date: 2024-01-08 date: 2024-03-31 date: 2024-03-28 date: 2024-03-28 name: Hangzhou Sciwind Biosciences Co., Ltd. class: INDUSTRY briefSummary: This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: XW003 injection name: Metformin name: Warfarin name: Rosuvastatin name: Digoxin measure: Pharmacokinetics of metformin: AUC0-inf measure: Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf measure: Pharmacokinetics of rosuvastatin: AUC0-inf measure: Pharmacokinetics of digoxin: AUC0-inf sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: West China Second University Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Qin Yu role: CONTACT phone: 02885503960 lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06335121 id: 21120602 id: 1R01MH134264 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH134264 briefTitle: Implementation of PrEP Care Among Women in Family Planning Clinics overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-12 date: 2027-06 date: 2024-03-28 date: 2024-03-28 name: Rush University Medical Center class: OTHER name: National Institute of Mental Health (NIMH) name: University of Illinois at Chicago name: Planned Parenthood of Illinois briefSummary: This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers. conditions: PrEP Uptake conditions: HIV conditions: Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 250 type: ESTIMATED name: POWER Up strategies - measure: PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP. measure: Receipt of PrEP refills among Black women accessing FP services at 6 months. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335108 id: SenoEx_TLA_Maligne briefTitle: Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 ) overallStatus: RECRUITING date: 2022-12-05 date: 2024-12-01 date: 2024-12-01 date: 2024-03-28 date: 2024-03-28 name: University Hospital Tuebingen class: OTHER briefSummary: The present study aims to investigate the impact of Tumescent Local Anesthesia (TLA) on pain perception following surgeries typical for breast cancer. Previous research has already confirmed the feasibility of conducting operations in TLA for benign breast conditions. In contrast to general anesthesia, Tumescent Local Anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. Additionally, if needed, sedatives or further anesthesia can be administered through the vein. Building upon the successful applications of TLA in benign breast surgeries, this follow-up study at the Department of Women's Health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. Simultaneously, our goal is to gather scientific data regarding the application of this technique. This research contributes to the continuous advancement of medical practices in the field of breast surgery. conditions: Breast Carcinoma conditions: Breast Carcinoma in Situ studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: General Anaesthesia name: Local tumescent anaesthesia measure: Postoperative Pain measure: HRQoL/ Quality of life measure: Postoperative pain medication requirements measure: Complications measure: Length of hospital stay measure: Duration of surgery measure: Drainage delivery rate measure: Follow-up surgery for R1 situation measure: Preoperative fear of surgery and anaesthesia measure: Costs measure: Satisfaction of the surgeon with the course of the operation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Women's Hospital status: RECRUITING city: Tübingen zip: 72076 country: Germany name: Bettina Böer, Dr. role: CONTACT phone: +49 7071 29 82211 email: Bettina.Boeer@med.uni-tuebingen.de lat: 48.52266 lon: 9.05222 hasResults: False
<\|newrecord\|> nctId: NCT06335095 id: a319 briefTitle: Gait Analysis and Degenerative Spine overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2026-09 date: 2024-03-28 date: 2024-03-28 name: Universidade Nova de Lisboa class: OTHER briefSummary: The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:
* What are the biomechanical variables affected by the disease
* How they evolve with disease progression and treatment conditions: Spinal Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Kinematic sensors measure: Change from baseline in gait parameter - speed (m/s) - at 3 months measure: Change from baseline in gait parameter - speed (m/s) - at 6 months measure: Change from baseline in gait parameter - speed (m/s) - at 12 months measure: Change from baseline in gait parameter - step length (m) - at 3 months measure: Change from baseline in gait parameter - step length (m) - at 6 months measure: Change from baseline in gait parameter - step length (m) - at 12 months measure: Change from baseline in gait parameter - step width (m) - at 3 months measure: Change from baseline in gait parameter - step width (m) - at 6 months measure: Change from baseline in gait parameter - step width (m) - at 12 months measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335082 id: DISRUPT-AF briefTitle: A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF acronym: DISRUPT-AF overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-11-30 date: 2027-01-30 date: 2024-03-28 date: 2024-04-11 name: Heart Rhythm Clinical and Research Solutions, LLC class: OTHER name: Boston Scientific Corporation briefSummary: The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF). conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 900 type: ESTIMATED name: Pulsed Field Ablation measure: Long term effectiveness measure: Long-term safety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arrhythmia Institute at Grandview city: Birmingham state: Alabama zip: 35243 country: United States name: Anil Rajendra, MD role: CONTACT phone: 205-971-7578 email: arajendra@alcardio.com name: Susan Thorington role: CONTACT phone: 205-971-7578 email: susan.thorington@grandviewhealth.com name: Anil Rajendra, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: Community Memorial Health Systems city: Ventura state: California zip: 93003 country: United States name: Jonathan Dukes, MD role: CONTACT phone: 805-653-0101 email: jonathan_dukes@mac.com name: Jennifer Freeland role: CONTACT phone: 805-948-8278 email: jfreeland@cmhshealth.org name: Jonathan Dukes, MD role: PRINCIPAL_INVESTIGATOR lat: 34.27834 lon: -119.29317 facility: Endeavor Health (Northshore) city: Glenview state: Illinois zip: 60026 country: United States name: Mark Metzl, MD role: CONTACT phone: 847-570-2640 email: mmetzl@northshore.org name: Marisa Durante role: CONTACT phone: 847-687-8527 email: mdurante@northshore.org name: Mark Metzl, MD role: PRINCIPAL_INVESTIGATOR lat: 42.06975 lon: -87.78784 facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Jorge Romero, MD role: CONTACT phone: 617-732-5241 email: jeromero@bwh.harvard.edu name: Fernando Moreno role: CONTACT phone: 617-732-5241 email: fmoreno2@bwh.harvard.edu name: Jorge Romero, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Cardiovascular Associates of Delaware Valley city: Haddon Heights state: New Jersey zip: 08035 country: United States name: George Mark, MD role: CONTACT phone: 856-546-3003 email: gmark4@yahoo.com name: Erin Siderio role: CONTACT phone: 856-582-2000 phoneExt: 5207 email: esiderio@hearthousenj.com name: George Mark, MD role: PRINCIPAL_INVESTIGATOR lat: 39.87734 lon: -75.06462 facility: Texas Cardiac Arrhythmia Research Foundation (St. Davids) city: Austin state: Texas zip: 78705 country: United States name: Andrea Natale, MD role: CONTACT phone: 512-522-9410 email: tcarfan@gmail.com name: Deb Cardinal, RN role: CONTACT phone: 512-431-4868 email: dscardinal@austinheartbeat.com name: Andrea Natale, MD role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 hasResults: False
<\|newrecord\|> nctId: NCT06335069 id: 2023-508066-15-00 briefTitle: 18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-03 date: 2024-03-28 date: 2024-03-28 name: Maastricht University Medical Center class: OTHER briefSummary: The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients. conditions: Breast Cancer conditions: Breast Neoplasms conditions: Breast Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-group, single-center pilot study primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ESTIMATED name: 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI measure: To investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a radioactive PET tracer in patients with ER+ breast cancer. measure: To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Center+ city: Maastricht zip: 5800 country: Netherlands name: Thiemo JA van Nijnatten, MD, PhD role: CONTACT email: thiemo.nijnatten@mumc.nl lat: 50.84833 lon: 5.68889 hasResults: False
<\|newrecord\|> nctId: NCT06335056 id: IRBAM-21-0702 id: 1R15HD108765-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R15HD108765-01A1 briefTitle: Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools acronym: ProudMe overallStatus: ENROLLING_BY_INVITATION date: 2024-02-19 date: 2025-12 date: 2026-04 date: 2024-03-28 date: 2024-03-28 name: Louisiana State University and A&M College class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: Pennington Biomedical Research Center name: Texas A&M University name: University of Nevada, Las Vegas briefSummary: This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost. conditions: Treatment (ProudMe) conditions: Waitlist Control studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this 12-week long intervention project, 480 adolescent participants are randomized, at the school level, to 2 arms - ProudMe or waitlist control conditions. primaryPurpose: PREVENTION masking: NONE count: 480 type: ESTIMATED name: ProudMe name: Waitlist Control measure: Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers measure: Screen time measure: Food environment measure: Body mass index z score measure: Waist circumference measure: Activity self-efficacy measure: Self-monitoring measure: Social support measure: School Wellness Policy measure: Cafeteria Nutrition sex: ALL minimumAge: 10 Years maximumAge: 15 Years stdAges: CHILD facility: LSU Pedagogical Kinesiology Lab city: Baton Rouge state: Louisiana zip: 70803 country: United States lat: 30.45075 lon: -91.15455 hasResults: False
<\|newrecord\|> nctId: NCT06335043 id: 119245 briefTitle: Personalized Pharmacotherapy Using Pharmacogenetics in Veterans acronym: PGx overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-04-01 date: 2024-03-28 date: 2024-03-28 name: Lawson Health Research Institute class: OTHER briefSummary: This study is an observational clinical trial aimed at to evaluate the use of pharmacogenetic testing (PGx) for mental health treatment in members and Veterans of the CAF and RCMP patient population as well as the attitudes of both St. Joseph's OSI Clinic Psychiatrists and patients towards PGx. Both OSI Clinic Psychiatrists participants and patient participants will be administered a brief demographic survey in addition to a survey examining their views on, and current knowledge of PGx. Patient participants will have an opportunity to opt-in to or opt-out of receiving PGx. For patient participants who opt-in to PGx (PGx-guided treatment group), a report summarizing the PGx results will be sent to each patient participants' respective OSI Clinic Psychiatrist, alongside a questionnaire that captures the OSI Clinic Psychiatrist participant's treatment planning and changes to treatment planning. Where applicable, past treatment data from patient participants acquired at the St. Joseph's OSI Clinic will be used to identify the number of prior medication changes. Patient participants who opt-out of PGx but continue to receive pharmacologic care at the St. Joseph's OSI Clinic will act as a standard care comparator treatment group. Patient participant's outcomes including PTSD, depression and anxiety severity, and medication-related side effects, will be assessed until the patient participant is discharged from the OSI Clinic or after 24 weeks, whichever comes first. All patient participants, regardless of their study treatment group, will have their symptomatology collected via standard care data collection protocol (Client Reported Outcomes Monitoring Information System (CROMIS) and electronic medical records (EMR)); a self-report assessing the presence of side effects will be completed via Lawson REDCap. OSI Clinic Psychiatrist participants and patient participants will be asked to complete a virtual exit interview at the end of their participation. conditions: Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 155 type: ESTIMATED name: Pharmacogenetics Testing measure: PHQ-9 - Patient Health Questionnaire 9 measure: GAD-7 - General Anxiety Disorder-7 measure: PCL-5 - Posttraumatic Stress Disorder Checklist - 5 measure: OQ-45 - Outcome Questionnaire 45 measure: Pharmacological Side Effect Measure measure: Electronic Medical Record Extraction Measure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335030 id: 2.1_AUT-SP2_001_Tancredi briefTitle: Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism overallStatus: RECRUITING date: 2021-03-29 date: 2024-01-30 date: 2024-11-30 date: 2024-03-28 date: 2024-03-28 name: IRCCS Fondazione Stella Maris class: OTHER name: Ospedale Borgo Trento - Verona name: Università degli Studi di Trento briefSummary: Brief Summary: Eating problems and in particular food selectivity is a condition that worsens a long-life disorder such as Autism Spectrum Disorder (ASD) , both on an individual level, both on family and social ones .
Children (2-6 years) diagnosed with ASD according to Diagnostic and Statistical Manual of Mental Disorders 5 Edition (DSM5) criteria were enrolled in an observational, cross-sectional and multicentric study conducted by three different Italian clinical centers. Regarding this sample, principal aims of the study are to describe characteristics of food selectivity, to evaluate its correlation with ASD symptoms, with cognitive and adaptive functioning of ASD preschoolers, to describe its impact on parental stress. conditions: Autism Spectrum Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Child Oral and Motor Proficiency Scale (ChOMPS) measure: Brief Autism Mealtime Behavior Inventory (BAMBI) measure: Sensory Profile 2 (SP2) measure: Child Behavior Checklist (CBCL) measure: Parenting Stress Index (PSI) measure: Observation of child meal-time measure: Food Diary measure: Gastrointestinal severity symptom index (GSSI) measure: Mac Arthur measure: Autism Quotient (AQ) measure: Autism Diagnostic Observation Schedule-2 (ADOS-2) measure: Vineland-II scales (VABS II) sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD facility: IRCCS Stella Maris status: RECRUITING city: Pisa state: PI zip: 56128 country: Italy name: Raffaella Tancredi role: CONTACT phone: +39050886292 email: raffaella.tancredi@fsm.unipi.it name: Roberta Nencioli role: CONTACT phone: +39050886347 email: roberta.nencioli@fsm.unipi.it lat: 43.70853 lon: 10.4036 facility: Università degli Studi di Trento-Laboratorio di Osservazione, Diagnosi e Formazione status: TERMINATED city: Rovereto zip: 38068 country: Italy lat: 45.8904 lon: 11.04053 facility: Azienda Ospedaliera Borgo Trento status: TERMINATED city: Verona zip: 37126 country: Italy lat: 45.4299 lon: 10.98444 hasResults: False
<\|newrecord\|> nctId: NCT06335017 id: 294-2024-HFH briefTitle: Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous overallStatus: RECRUITING date: 2024-04-10 date: 2024-12 date: 2024-12 date: 2024-03-28 date: 2024-04-12 name: Holy Family Hospital, Nazareth, Israel class: OTHER briefSummary: The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in multiparous women.
The main question it aims to answer are:
Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline.
In the control group, the catheter will be inserted into cervical canal without ingestion of castor oil. conditions: Induction of Labor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 216 type: ESTIMATED name: Induction of labor measure: time to delivery measure: balloon expulsion time measure: Bishop score at catheter expulsion measure: Number of women that will have non-vertex presentation after removal of the catheter measure: Duration of active phase measure: Duration of second stage measure: Mode of delivery measure: Indications for cesarean or vacuum deliveries measure: Number of patients that will have intrapartum fever ≥ 38 °C measure: Number of patients that will require use of intrapartum use of antibiotic treatment measure: Number of Participants with that will develop clinical signs of chorioamnionitis. measure: Number of Participants with that will develop 3rd and 4th degrees perineal lacerations. measure: Number of Participants with develop postpartum hemorrhage. measure: Number of Participants with need blood transfusion. measure: Number of women that will have side effects related to castor oil use measure: Oxytocin dosage measure: Number of participants with Umbilical Cord prolapse. measure: Number of neonates that will have Apgar score (range 0 to 10) <7. measure: number of women with cord artery pH <7.1 measure: Neonatal birthweight measure: Number of neonates with Neonatal fever ≥ 38 °C measure: The number of neonates that will develop neonatal sepsis. measure: The number of neonates that will require antibiotic treatment. measure: number of neonates with any neonatal complications measure: The number of neonates that will Admit to neonatal intensive care unit (NICU) measure: Length of stay in NICU. measure: Number of neonatal death measure: Maternal hemoglobin level after delivery. measure: Number of participants that will require postpartum hysterectomy. measure: Number of participants that will require postpartum laparotomy. measure: Number of women that will develop postpartum complications measure: The length of stay from birth to discharge home. measure: Maternal satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Holy Family hospital, Nazareth status: RECRUITING city: Nazareth country: Israel name: Wiaam Khatib, MD role: CONTACT phone: 0549192433 email: wiaam.khatib.95@gmail.com name: Raed Salim, MD role: CONTACT email: r.salim@hfhosp.org name: Wiaam Khatib, MD role: PRINCIPAL_INVESTIGATOR lat: 32.69925 lon: 35.30483 hasResults: False
<\|newrecord\|> nctId: NCT06335004 id: 926 briefTitle: Evaluation of Brain Waste Clearance Pathways Using Magnetic Resonance Imaging in Pediatric Patients With White Matter Diseases overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-01 date: 2024-12-31 date: 2025-02-28 date: 2024-03-28 date: 2024-03-28 name: IRCCS Eugenio Medea class: OTHER briefSummary: The dilation of perivascular spaces can be the result of various etiopathogenetic processes. White matter atrophy can cause enlargement of these perivascular spaces (PVS) but also obstruction of fluid drainage systems (interstitial fluid, ISF) and metabolites, as evidenced by some recent studies. Focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction. Dilation of PVS can be associated with changes in white matter and microhemorrhages. We want to study these etiopathogenetic phenomena by implementing specific MRI methods. conditions: Glymphatic System conditions: White Matter Disease conditions: Pediatric Disorder conditions: Perivascular Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Magnetic resonance imaging measure: Extent of white matter lesions measure: Number of perivascular spaces measure: Volume of parasagittal dural space sex: ALL minimumAge: 9 Months maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Institute IRCCS Eugenio Medea city: Bosisio Parini state: Lecco zip: 23842 country: Italy lat: 45.80075 lon: 9.29 hasResults: False
<\|newrecord\|> nctId: NCT06334991 id: QUILT-106 briefTitle: Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-30 date: 2027-03-30 date: 2024-03-28 date: 2024-03-28 name: ImmunityBio, Inc. class: INDUSTRY briefSummary: Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL). conditions: Non-Hodgkin Lymphoma Refractory/ Relapsed studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study is open label, for Refractory/ Relapsed Non-Hodgkin Lymphoma. Up to 10 subjects will receive at least 1 dose of study drug. The initial 3 subjects will receive study drug in a staggered fashion, with a 7 day interval between each subject to evaluate any toxicities. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: CD19 t-haNK measure: Overall safety evaluation in combining CD19 t haNK as a single agent with rituximab measure: Incidence of treatment-emergent AEs (TEAEs) and serious AEs (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 5.0.Clinically important changes in safety laboratory tests and vital signs. measure: Best tumor response in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334978 id: 1-2024 briefTitle: The Effectiveness of Osteopathic Treatment in Cervical Whiplash. overallStatus: COMPLETED date: 2021-01-13 date: 2022-07-10 date: 2022-08-10 date: 2024-03-28 date: 2024-03-28 name: Hospital San Juan de Dios del Aljarafe de Sevilla class: OTHER name: Hospital Universitario Virgen Macarena name: University of Seville briefSummary: Introduction. Whiplash is common after road traffic accidents and affects millions of people worldwide; 50% develop chronic symptoms and 15% have their ability to work compromised. The aim of this study was to evaluate an osteopathic intervention in whiplash and determine whether pain, mobility and quality of life improve with respect to conventional treatment.
Methodology. A randomised, controlled clinical trial between 13/01/2021_10/08/2022 conducted at Hospital San Juan de Dios del Aljarafe. The control group followed the hospital's protocol, and the experimental group also received an osteopathic intervention. Statistical analysis: Statistical Package for the Social Sciences (SPSS-vs27.0); intra-subject comparison: Student's t-test for dependent samples, Wilcoxon's test; inter-group comparisons: Student's t-test for independent samples, Mann-Whitney U, chi-squared. conditions: Whiplash Injury of Cervical Spine conditions: Osteopathia conditions: Quality of Life conditions: Chronic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Randomised controlled clinical trial primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: The study was blinded: patients were unaware of the group to which they had been assigned. Patient evaluations at the start and end were performed by a physiotherapist different to the one performing the intervention, who was also unaware of the patient assignment. The same person performed all therapies for both the control and intervention groups and was unaware of the pre-intervention measurements. The statistician who analysed the data was also unaware of the group to which each patient belonged. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ACTUAL name: Osteopathic intervention measure: Cervical Pain measure: Quality of life in Whiplash Disability measure: Functionality-Neck Disability Index measure: Number of sites measure: Number of analgesics measure: Measuring mobility using inclinometry measure: Measurement of pressure pain using algometry sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: María Victoria RUIZ ROMERO city: Bollullos de la Mitación state: Sevilla zip: 41110 country: Spain lat: 37.34014 lon: -6.13719 hasResults: False
<\|newrecord\|> nctId: NCT06334965 id: APHP230279 briefTitle: Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort acronym: OPERANDI-HCC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-11 date: 2029-09 date: 2024-03-28 date: 2024-03-28 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI.
Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic and follow-up PET-MRI, in patients with HCC treated with TARE. conditions: Hepatocellular Carcinoma conditions: Radioembolization studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 180 type: ESTIMATED name: Simultaneous 18F-Choline PET-MRI measure: Clinical response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beaujon hospital city: Clichy country: France name: Mohamed BOUATTOUR role: CONTACT lat: 48.90018 lon: 2.30952 facility: CHU Nantes city: Nantes country: France name: Yann TOUCHEFEU role: CONTACT lat: 47.21725 lon: -1.55336 hasResults: False
<\|newrecord\|> nctId: NCT06334952 id: RCAPHM23_0074 id: ID-RCB type: OTHER domain: 2023-A02482-43 briefTitle: Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic acronym: GALVANI GS-3 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-31 date: 2027-04-30 date: 2024-03-28 date: 2024-03-28 name: Assistance Publique Hopitaux De Marseille class: OTHER name: CRMBM-CEMEREM name: Institut National de la Santé Et de la Recherche Médicale, France - LTSI name: Neuroelectrics Corporation briefSummary: The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. The main questions it aims to answer are:
* Changes in quality of life
* Percent of newly reported side effects after the stimulation period
* Scores in epilepsy severity. Participants will be randomized in a cross-over, and will receive 10 days of tDCS or Sham. Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off (with 40 minutes of cathodal stimulation total). conditions: Epilepsy conditions: Drug Resistant Epilepsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: transcranial direct current stimulation measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction) measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction) measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction) measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction) measure: Evaluate the number of seizure-free patients measure: Evaluate the number of seizure-free patients measure: Evaluate the number of seizure-free patients measure: Evaluate the number of seizure-free patients measure: Quality of life after stimulation sessions with the baseline period measure: Quality of life after stimulation sessions with the baseline period measure: Quality of life after stimulation sessions with the baseline period measure: Quality of life after stimulation sessions with the baseline period measure: Evaluation of the change in seizure severity measure: Evaluation of the change in seizure severity measure: Evaluation of the change in seizure severity measure: Evaluation of the change in seizure severity measure: Changes in psychiatric comorbidities measure: Changes in psychiatric comorbidities measure: Changes in psychiatric comorbidities measure: Changes in psychiatric comorbidities measure: Safety assessment and possible side effects measure: Safety assessment and possible side effects measure: Safety assessment and possible side effects measure: Safety assessment and possible side effects measure: Compare brain functional connectivity before and after tDCS treatment measure: Evaluation of the impact of tDCS on interictal epileptic spikes (IESs) measure: Evaluation of the impact of tDCS on interictal epileptic spikes measure: Evaluation of the impact of tDCS on interictal epileptic spikes measure: Evaluation of the impact of tDCS on interictal epileptic spikes measure: Evaluation of the impact of tDCS on interictal epileptic spikes sex: ALL minimumAge: 9 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques city: Bordeaux zip: 33000 country: France name: Jerome Aupy role: CONTACT email: Jerome.aupy@chu-bordeaux.fr lat: 44.84044 lon: -0.5805 facility: Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon city: Bron zip: 69677 country: France name: Sylvain Rheims role: CONTACT email: Sylvain.rheims@chu-lyon.fr lat: 45.73333 lon: 4.91667 facility: Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille city: Lille zip: 59037 country: France name: Philippe Derambure role: CONTACT email: Philippe.Derambure@chru-lille.fr lat: 50.63297 lon: 3.05858 facility: Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone city: Marseille zip: 13005 country: France name: Fabrice Bartolomei role: CONTACT email: Fabrice.bartolomei@ap-hm.fr lat: 43.29551 lon: 5.38958 facility: Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne city: Paris zip: 75014 country: France name: Martine Gavaret role: CONTACT email: m.gavaret@ghu-paris.fr lat: 48.85341 lon: 2.3488 facility: Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou city: Rennes zip: 35033 country: France name: Anca Nica role: CONTACT email: Anca.nica@chu-rennes.fr lat: 48.11198 lon: -1.67429 facility: Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet city: Toulouse zip: 31059 country: France name: Luc Valton role: CONTACT email: valton.l@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False
<\|newrecord\|> nctId: NCT06334939 id: KSH.2023-32 briefTitle: Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries overallStatus: RECRUITING date: 2024-01-01 date: 2024-05-01 date: 2024-05-30 date: 2024-03-28 date: 2024-03-28 name: Ahmet Yuksek class: OTHER_GOV briefSummary: Emergence agitation; generally refers to a situation that may occur after a surgical intervention or anesthesia. This situation describes the irritability and agitation of the patient during the recovery process and the period of recovery from anesthesia. Recovery agitation may occur when the patient begins to recover and is usually a short-term condition. It resolves spontaneously. However, in some cases, this agitation may be more pronounced and disturbing. This may affect the patient\&#39;s condition and relaxation. Rapid recovery from anesthesia in the clinic is also a risk factor for agitation.
When the literature is examined, there are not enough studies on Bis suppression ratio and its relationship with recovery agitation is not yet known enough. For this purpose, our study aimed to question this relationship. conditions: Emergence Agitation conditions: Anesthesia Recovery conditions: Bispectral Index Monitor studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Bispectal index Monitoring measure: Relationship between BIS SR value and Emergence Agitation measure: Relationship between average and lowest BIS values and Emergence agitation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli City Hospital status: RECRUITING city: Kocaeli state: Izmıt zip: 41100 country: Turkey name: Mehmet Yilmaz, Associate Proffessor role: CONTACT phone: 505-217-4432 email: drmyilmaz33@gmail.com name: Ahmet Yuksek, Md role: PRINCIPAL_INVESTIGATOR lat: 39.62497 lon: 27.51145 hasResults: False
<\|newrecord\|> nctId: NCT06334926 id: EK 18-002-VK briefTitle: BMI and Lymph Node Count in Colorectal Cancer overallStatus: COMPLETED date: 2017-12-01 date: 2020-03-31 date: 2020-03-31 date: 2024-03-28 date: 2024-03-28 name: Klinikum Floridsdorf class: OTHER name: Medical University of Vienna name: Klinik Favoriten name: Salzkammergut Klinikum Vöcklabruck briefSummary: Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Also, the number of resected lymph nodes (LN) during surgery is very important for correct staging. The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.
Methods: Patients treated for CRC between 1998 and 2011 at the Klinik Favoriten in Vienna, Austria were analyzed in this retrospective single-center cohort analysis concerning OS. conditions: The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long Term studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1192 type: ACTUAL name: no intervention, retrospective data analysis measure: overall survival sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinik Floridsdorf city: Wien zip: 1210 country: Austria lat: 48.20849 lon: 16.37208 hasResults: False
<\|newrecord\|> nctId: NCT06334913 id: IRAS 332286 briefTitle: A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-04-01 date: 2029-04-01 date: 2024-03-28 date: 2024-03-28 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER briefSummary: The investigators will assess the use of a smart phone app to monitor patient reported outcomes and record biometric data in patients with myeloproliferative neoplasms. conditions: Myeloproliferative Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Patient reported outcomes - Myeloproliferative Neoplasm-10 Total Symptom Score measure: Healthcare adherence measure: Biometric data analysis - activity index measure: Biometric data analysis - sleep score measure: Biometric data analysis - heart rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334900 id: 69HCL24_0297 briefTitle: Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia acronym: Ata-GAD overallStatus: RECRUITING date: 2023-10-01 date: 2024-01-01 date: 2024-06-30 date: 2024-03-28 date: 2024-03-28 name: Hospices Civils de Lyon class: OTHER briefSummary: Glutamic acid decarboxylase (GAD) is an enzyme whose function in the body is to decarboxylate glutamate to GABA. GAD65 antibodies (GAD65Ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (SPS/PERM), cerebellar ataxia (CA), limbic encephalitis (LE) and temporal lobe epilepsy. These syndromes all seem to result from a reduced transmission of GABA. These neurological conditions are rare and can cause symptoms like confusion, memory loss, muscle stiffness, muscle spasms, behavioural disorders, and pharmacoresistant epilepsy. When finding high levels of GAD65-Ab in the serum, a cerebrospinal fluid (CSF) sample should be taken to look for oligoclonal IgG bands and intrathecal GAD-Ab production to prove an auto-immune cause for the various neurological symptoms. conditions: GAD-receptor Antibodies-associated Encephalitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: GAD patients measure: GAD Patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est status: RECRUITING city: Bron zip: 69677 country: France name: Jérôme Honnorat, professor role: CONTACT phone: +33 4 72 35 78 06 email: jerome.honnorat@chu-lyon.fr lat: 45.73333 lon: 4.91667 hasResults: False
<\|newrecord\|> nctId: NCT06334887 id: PID2021-124409OB-I00_O3 briefTitle: esTOCma, an App Used by Teachers: an RCT overallStatus: RECRUITING date: 2024-02-26 date: 2024-05-31 date: 2024-05-31 date: 2024-03-28 date: 2024-04-01 name: University of Valencia class: OTHER name: Ministry of Science and Innovation briefSummary: The aim of the present study is to assess the efficacy of a mobile application called esTOCma in promoting mental health literacy, reducing stigmatizing attitudes related to the Obsessive-Compulsive Disorder (OCD) and improving teachers' confidence in dealing with students that might have OCD. A parallel, randomized controlled trial with two conditions (experimental and control group) will be carried out in a sample of teachers that work in primary and secondary education. Pre-post changes will be assessed. Experimental group will use the app until they finish it (within a set period of 10 days), whereas control group will do nothing for 10 days. Primarily, it is expected that after the use of the app, participants will show an improvement in OCD-related literacy, stigmatizing attitudes, desired social distance and their comfort, confidence and perceived ability in teaching and handling students with OCD. Secondarily, the investigators hypothesize that experimental group might show a reduction in obsessive-compulsive symptoms. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A parallel randomized controlled trial (RCT) with two arms: experimental group (use of esTOCma) and control group (untreated) will be carried out.
As participants enroll in the study, those that meet the inclusion criteria will be randomized into experimental or control group and into contamination or aggressive vignette (see Outcome Measures). Everyone will complete the baseline measures (T1). Then, those assigned to experimental group will use the app esTOCma until they finish it (they will be given a 10-days deadline), whereas control group will do nothing for 10 days. After that, all the participants will complete again the assessment instruments (T2). primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Use of esTOCma measure: Change in general OCD literacy measure: Change in OCD literacy associated with a vignette measure: Change in stigmatizing attitudes related to OCD associated with a vignette measure: Change in comfort in addressing OCD measure: Change in desired social distance measure: Change in obsessive-compulsive symptoms sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Valencia/ Universitat de València status: RECRUITING city: Valencia zip: 46010 country: Spain name: Gemma Garcia-Soriano, PhD role: CONTACT lat: 39.46975 lon: -0.37739 hasResults: False
<\|newrecord\|> nctId: NCT06334874 id: REC-FPFUE-32/2023 briefTitle: Study of the Efficacy and Safety of Antioxidants Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients. overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-08-01 date: 2024-03-28 date: 2024-04-12 name: Future University in Egypt class: OTHER briefSummary: Community acquired pneumonia (CAP) is one of the most common and morbid conditions encountered in clinical practice, which causes serious morbidity worldwide. In CAP, oxidative stress is linked to inflammation, demonstrated by increased production of interleukin (IL)-6 and tumor necrosis factor (TNF)-α, which attract inflammatory cells and increase oxidant production by these cells. Attenuation of oxidative stress via antioxidants would be expected to result in reduced pulmonary damage. Antioxidants have been found to be effective in alleviating lung injury and protecting against damage of other organs. conditions: Community-acquired Pneumonia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Astaxanthin Oral Capsule name: Placebo measure: change in IL-6 after treatment in the ASX group compared with those in the control group. measure: change in IL-10 after treatment in the ASX group compared with those in the control group. measure: change in tumor necrosis alpha after treatment in the ASX group compared with those in the control group. measure: difference in CURB 65 scores after treatment in the ASX group compared with the control group. measure: o Adverse drug reactions related to ASX as increase bowel movement, stomach pain and increase PT and APTT will be assessed. measure: Length of hospital and ICU stay. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elmatarya Teaching Hospital status: RECRUITING city: Cairo zip: 4650201 country: Egypt name: fatma makram role: CONTACT phone: 01015000329 email: fatma.aboelhassan@fue.edu.eg name: eman elmokadam role: CONTACT email: Eman.abdellatif@fue.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06334861 id: 5001 briefTitle: Multidisciplinary Hospital-Territory Vaccine Center: a Model for Achieving the Herpes Zoster Vaccine Coverage acronym: CeVOT-Her-Zo overallStatus: RECRUITING date: 2022-06-23 date: 2024-05-15 date: 2024-06-30 date: 2024-03-28 date: 2024-03-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The National Vaccination Program, updated by the Ministry of Health in 2021, provides a new vaccination opportunity for frail patients against Herpes zoster virus (HZ). The new treatment option, on the other hand, is designed by combining VZV-specific antigen (gE) with an adjuvant system (AS01B) to induce antigen-specific cellular and humoral immune responses in individuals with preexisting immunity to VZV. Efficacy, assessed in people given two doses 2 months apart, is around 97% in those aged 50 years and 91% in those over 70 years. In the studies conducted, HZ-related hospitalizations were significantly reduced. The vaccine schedule calls for the administration of two doses 2 months apart. The current HZ Vaccination Program implemented at the regional level recommends its active and free offer in people from 18 years of age with congenital and/or acquired immunodepression, through a collaborative relationship involving, on the one hand, multispecialist and multiprofessional medical staff and, on the other hand, citizens called to play a role that is no longer passive but the subject of empowerment by consciously making their own health choices. The collaboration with ASL Roma1, in this sense, acquires value as guarantor of the supply of the adjuvanted recombinant anti-HZ vaccine and of the appropriate reporting of vaccination coverage, which to date is still far from the targets set by the PNPV'17-'19 in adults at risk for disease.
The purpose of this study Single-center prospective longitudinal observational cohort study is to verify patients' compliance with the proposed vaccination, the effectiveness of counseling carried out by a multidisciplinary team in the hospital setting. conditions: Herpes Zoster studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 48 type: ESTIMATED name: Herpes Zoster adjuvanted recombinant vaccine measure: Compliance to vaccination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli - UCSC status: RECRUITING city: Roma state: RM zip: 00168 country: Italy name: Patrizia Laurenti, MD PHD role: CONTACT email: patrizia.laurenti@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06334848 id: TOT versus mini sling briefTitle: Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-09 date: 2024-03-28 date: 2024-03-28 name: Ain Shams University class: OTHER briefSummary: To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence. conditions: Stress Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: transobturator tape measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function sex: FEMALE maximumAge: 60 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334835 id: 1/23 OSS SDN briefTitle: Long Non-coding RNAs and Their Role on Epigenome as Diagnostic Markers in Childhood Acute Lymphoblastic Leukemia of T Cells. overallStatus: RECRUITING date: 2023-04-30 date: 2023-12-31 date: 2026-05-31 date: 2024-03-28 date: 2024-04-03 name: IRCCS SYNLAB SDN class: OTHER name: Fondazione Santobono Pausilipon briefSummary: Long non-coding RNAs (lncRNAs) are a class of biomarkers of crescent interest in the hematologic and oncologic field.
They do not encode proteins and can alter gene expression by acting on different steps of regulation, including DNA methylation and chromatin structure. Recent data identified recurrent somatic alterations in genes involved in DNA methylation and post-translational histone modifications in T-ALL, suggesting that epigenetic homeostasis is critically required in restraining tumor development in the T-cell lineage. Further, recent studies showed that the expression levels of specific lncRNAs correlate with the prognosis of patients with Acute Lymphoblastic Leukemia of T-cells (T-ALL). The objectives of this research project are to identify T-ALL-specific lncRNAs to be used as new diagnostic and prognostic biomarkers of disease and to explore their role on chromatin reorganization and transcriptional regulation that may lead to the onset and progression of T-ALL. conditions: Acute Lymphoblastic Leukemia, Pediatric studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: lncRNA signature analyses measure: Evaluation of the expression of selected lncRNAs in pediatric T-ALL patients and cellular models of T-ALL sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Irccs Synlab Sdn status: RECRUITING city: Naples zip: 80143 country: Italy name: Giovanni Smaldone, PhD role: CONTACT phone: 3398768331 email: giovanni.smaldone@synlab.it lat: 40.85216 lon: 14.26811 hasResults: False
<\|newrecord\|> nctId: NCT06334822 id: HFT-2024-01 briefTitle: Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK. acronym: HF-TRACK overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-04-30 date: 2024-03-28 date: 2024-03-28 name: Heartfelt Technologies class: INDUSTRY briefSummary: The objective of our research is to evaluate the effectiveness of an innovative medical device designed to measure foot and lower leg sizes in detecting early indications of deteriorating heart failure. This health condition frequently causes leg swelling and breathing difficulties due to fluid accumulation. Early detection of these symptoms is vital for effective management, potentially preventing the need for hospitalization.
Fluid retention in the lower legs and lungs, manifesting as swollen ankles and shortness of breath, is a common sign of progressing heart failure. Often, a slight increase in body weight is the first warning of fluid accumulation, occurring before noticeable swelling or breathing issues arise. Early identification of these fluid accumulation signs is critical for timely intervention, which can avert the necessity for hospital admittance. Patients are usually encouraged to monitor their weight, check for swelling in the ankles, observe their breathing, and consult with their healthcare provider or heart failure specialist at the first sign of these symptoms. In many cases, patients can report these symptoms in time for their healthcare team to adjust their treatment accordingly. Diuretics, or water pills, are often prescribed to help eliminate excess fluid, effectively preventing hospital admissions when used promptly.
The Heartfelt device may provide a useful solution for individuals who find it challenging to consistently monitor these indicators and their weight. It is designed to detect early warning signs seamlessly without imposing additional tasks on the patient's daily routine. The device, intended to complement rather than replace self-monitoring practices, is user-friendly and operates by scanning the feet for any size changes, positioned conveniently by the bedroom floor. This capability allows healthcare professionals to make informed decisions swiftly about patient care, potentially adjusting treatments to avoid further health complications. The device captures images of the feet only, ensuring privacy.
This study aims to ascertain the device's practical effectiveness in real-world scenarios, aiming to collect precise data to confirm its potential benefits for patients facing heart failure challenges. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This 6-month study involves up to 210 patients using the Heartfelt device at home. It is a crossover trial with a 21-day break between two 69-day periods to prevent overlap effects. Patients will either receive standard care or standard care plus Heartfelt alerts. The Heartfelt group is further divided into three 23-day sub-studies to test different alert systems.
Another 60 patients will have monthly measurements taken at the pharmacy without being part of the main randomisation. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Only outcomes assessors will be blinded. whoMasked: OUTCOMES_ASSESSOR count: 270 type: ESTIMATED name: Heartfelt Device installed name: Standard care name: Questionnaires name: Heartfelt Device in pharmacy name: Heartfelt device alerting system measure: All-Cause Mortality Rate. measure: Heart Failure Hospitalisation Incidence. measure: Device-Related Complication Rate. measure: Comparison of Data Availability (number of days with data in a month): Heartfelt Device vs. Existing Remote Monitoring Devices measure: Hospital Admission Duration measure: Cause of Hospitalization measure: Date of Changes in HF Medication Post-Discharge measure: Changes in dosage of HF Medication Post-Discharge measure: Cause of Death measure: Date of Death measure: Loss of Independence measure: Hospitalisation Admission Route measure: Scheduling of Care Events measure: Setting of Care Events measure: Timestamp of Health Alerts Generated by the Heartfelt Device measure: Frequency of Health Alerts Generated by the Heartfelt Device measure: Foot volume measure: Peripheral oedema grading measure: Weight sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr R Raut & Partnership (General Practice) city: Hull state: East Riding Of Yorkshire zip: HU7 5DD country: United Kingdom name: Rajeev Raut, MD role: CONTACT phone: +441482 835880 email: HF-TRACK@hftech.org name: Rajeev Raut, MD role: PRINCIPAL_INVESTIGATOR lat: 53.7446 lon: -0.33525 hasResults: False
<\|newrecord\|> nctId: NCT06334809 id: 028FPO22 briefTitle: INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations acronym: INSIDE overallStatus: RECRUITING date: 2023-03-09 date: 2026-12-31 date: 2027-12-31 date: 2024-03-28 date: 2024-03-28 name: Fondazione del Piemonte per l'Oncologia class: OTHER briefSummary: 400 patients will be enrolled and divided into 3 cohorts: Cohort A: patients with high risk localized prostate cancer (PC) defined as \>cT3 or PSA \> 20 ng/mL or presence of ECE or SVI at mpMRI;
Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC);
Cohort C: patients with metastatic castration resistant prostate cancer (mCRPC) progressing on a standard treatment. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Number, type and frequency of DDR and MMR germline/somatic alterations measure: Changes in PSA levels in the 3 cohorts measure: Number of patient-derived preclinical models sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo status: RECRUITING city: Candiolo state: Turin zip: 10060 country: Italy name: Pasquale Rescigno, MD role: CONTACT email: pasquale.rescigno@ircc.it name: Ilaria Buondonno, PhD role: CONTACT phone: +390119933393 email: ilaria.buondonno@ircc.it lat: 44.95858 lon: 7.59812 facility: AOU San Luigi Gonzaga status: RECRUITING city: Orbassano state: Turin zip: 10060 country: Italy name: Francesco Porpiglia, MD role: CONTACT lat: 45.00547 lon: 7.53813 hasResults: False
<\|newrecord\|> nctId: NCT06334796 id: 10476 briefTitle: Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology acronym: AIDEN overallStatus: COMPLETED date: 2023-10-01 date: 2024-01-01 date: 2024-01-01 date: 2024-03-28 date: 2024-03-28 name: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia class: OTHER name: Entelai briefSummary: This study examines the use of an AI-powered virtual assistant for quickly identifying and handling neurological emergencies, particularly in places with limited medical resources. The research aimed to check if this AI tool is safe and accurate enough to move on to more advanced testing stages. In a first-of-its-kind trial, the virtual assistant was tested with patients having urgent neurological issues. Neurologists first reviewed the AI's recommendations using clinical records and then assessed its performance directly with patients. The findings were as follows: neurologists agreed with the AI's decisions nearly all the time, and the AI outperformed earlier versions of Chat GPT in every tested aspect. Patients and doctors found the AI to be highly effective, rating it as excellent or very good in most cases. This suggests the AI could significantly enhance how quickly and accurately neurological emergencies are dealt with, although further trials are needed before it can be widely used. conditions: Stroke conditions: Guillain-Barre Syndrome conditions: Facial Palsy conditions: Migraine conditions: Status Epilepticus conditions: Vertigo Benign Positional conditions: Delirium conditions: Trigeminal Neuralgia conditions: Meningitis conditions: Subarachnoid Hemorrhage studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The model of this Phase 1 interventional study involves evaluating the diagnostic accuracy and utility of an AI-powered virtual assistant in the triage of emergency neurological conditions. Patients and healthcare professionals interacted with the assistant, providing real-world clinical scenarios to assess its effectiveness. The study's design aimed to demonstrate the assistant's potential to enhance emergency neurological care by comparing its performance with established diagnostic tools and patient outcomes. primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ACTUAL name: Virtual Assistant measure: Diagnostic performance measure: Appropriate medical conduct or recommendation measure: Assessment of Usability and Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fleni city: Buenos Aires zip: 1428 country: Argentina lat: -34.61315 lon: -58.37723 hasResults: False
<\|newrecord\|> nctId: NCT06334783 id: HV-IIT briefTitle: TIL for Patients With Advanced Solid Tumor overallStatus: RECRUITING date: 2023-05-30 date: 2025-12-31 date: 2026-12-31 date: 2024-03-28 date: 2024-03-28 name: Hervor Therapeutics class: INDUSTRY name: Jinling Hospital, China name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences name: Women's Hospital School Of Medicine Zhejiang University briefSummary: Background:
Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to patients.
TIL therapy has shown strong efficacy for the treatment of solid tumors and has achieved high objective response rates in multiple cancers, such as melanoma, NSCLC, and cervical cancer.
Objective:
To evaluate the safety and efficacy of TIL for the patients with advanced solid tumor.
Eligibility:
Adults aging 18-75 with advanced solid tumor.
Design:
1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
2. Freshly resected patient tumors were dissected by the surgeon.
3. TIL cells were isolated from the patient's tumor tissue, then cultured in vitro, activated and expanded.
4. At last TIL cells will be re-infused into the patients. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Autologous tumor-infiltrating lymphocyte cells measure: Safety of TIL measure: Overall Response Rate (ORR) measure: Duration of Response (DOR) measure: Disease Control Rate (DCR) measure: Progression free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center status: RECRUITING city: Shenzhen state: Guangdong country: China name: Xiugui Sheng, PhD role: CONTACT email: hanxiuchen@yeah.net lat: 22.54554 lon: 114.0683 facility: Nanjing Jinling Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Tangfeng Lv, PhD role: CONTACT phone: +86 25 8086 0114 email: bairoushui@163.com lat: 32.06167 lon: 118.77778 facility: Wowen's hospital, School of medicine, Zhejiang University status: NOT_YET_RECRUITING city: Hangzhou state: Zhejiang country: China name: Hui Wang, PhD role: CONTACT email: 5198008@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06334770 id: FDASuRecD032136 briefTitle: Influence of Roxolid Implant Material on the Implant Stability Implant Stability acronym: BLX overallStatus: COMPLETED date: 2021-06-15 date: 2022-01-22 date: 2023-12-12 date: 2024-03-28 date: 2024-03-28 name: Ain Shams University class: OTHER briefSummary: Fourteen completely edentulous patients were selected to participate in this study. From the outpatient clinic of Prosthodontic Department, Faculty of Dentistry, Ain Shams University.
After fabrication of complete denture for all patients, patients were randomly divided to:
Group A: Seven patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® implant were inserted opposed by mandibular complete denture.
Group B: Seven patients were rehabilitated with implant retained maxillary overdenture where four conventional acid etched implants were inserted opposed by mandibular complete denture.
After implant placement using surgical guide, smart peg and ostell device were used to measure the primary stability of the implant then cover screw was placed and after six weeks, secondary stability was measured for both groups.
After four months, the second stage started in which exposure of the implant fixtures took place and pick up was carried out.
Patients were recalled frequently for post-insertion inspection and adjustment. conditions: Completely Edentulous Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 18 type: ACTUAL name: Roxolid implants name: Titanium implants measure: measuring primary at time of surgery measure: secondary implant stability after 6 weeks sex: ALL minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry of Dentistry Ainshams Univeristy city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06334757 id: HLX10IIT22 briefTitle: Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure overallStatus: RECRUITING date: 2023-05-08 date: 2024-08-31 date: 2025-06-30 date: 2024-03-28 date: 2024-03-28 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients. conditions: Non-Squamous Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Serplulimab name: Bevacizumab Biosimilar HLX04 name: Pemetrexed name: Carboplatin measure: ORR(Overall Response Rate) measure: PFS(Progression Free Survival) measure: OS(Overall Survival) measure: AE(Adverse Event) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital status: RECRUITING city: Zhengzhou state: Henan zip: 450003 country: China name: zhen he role: CONTACT phone: 13523530961 lat: 34.75778 lon: 113.64861 hasResults: False
<\|newrecord\|> nctId: NCT06334744 id: COVAR briefTitle: Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active. overallStatus: COMPLETED date: 2021-11-17 date: 2023-01-08 date: 2023-06-08 date: 2024-03-28 date: 2024-03-29 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER briefSummary: To evaluate the serum neutralizing antibody titre in cancer patients undergoing active treatment against variants (VOC) before and after the third dose of BNT162b2 COVID-19 vaccine. conditions: Oncologic Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ACTUAL measure: Determination of the change in neutralizing antibodies against SARS-CoV-2 (CLIA method) towards VOCs before the third dose of COVID-19 vaccine and 21 days after the same. measure: Evaluation of the kinetics of neutralizing antibodies and anti-SARS-CoV-2 IgG titer (CLIA method) up to 52 weeks after the third dose of COVID-19 vaccine measure: Evaluation of the incidence of virologically confirmed cases of VOC after administration of the third dose of vaccine. measure: Evaluation of the incidence of local and systemic adverse reactions (ARs), directly or indirectly linked to the vaccine, in an observation period up to 4 weeks later the third dose of vaccine. measure: Evaluation of the incidence of "New onset" immune-related adverse events (IRAEs), such as immune-related pruritus, rashes, hypophysitis, hepatitis, pneumonia, diarrhoea, colitis in patients undergoing immunotherapy. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs San Matteo Pavia city: Pavia state: PV zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06334731 id: 045.PHA.2021.D briefTitle: Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic overallStatus: RECRUITING date: 2021-07-06 date: 2024-12 date: 2024-12 date: 2024-03-28 date: 2024-03-28 name: Methodist Health System class: OTHER briefSummary: Assess the incidence and rates of resistant pathogens prior to and during the COVID-19 pandemic. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED measure: Incidence of third generation cephalosporin-resistant bacteria (3GCRB) measure: Incidence of ESBLPE measure: Incidence of CRB measure: Incidence of other pathogens measure: Incidence of nosocomial infections measure: Incidence of clinical outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Dallas Medical Center status: RECRUITING city: Dallas state: Texas zip: 75203 country: United States name: Matthew Crotty, PharmD role: CONTACT phone: 214-941-2400 email: matthewcrotty@mhd.com name: Matthew Crotty, PharmD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False
<\|newrecord\|> nctId: NCT06334718 id: 318417 id: NIHR204382 type: OTHER_GRANT domain: National Institute for Health and Care Research briefTitle: Drone Delivered Defibrillators (The 3D Project). overallStatus: RECRUITING date: 2024-03-29 date: 2024-08-22 date: 2024-10-31 date: 2024-03-28 date: 2024-04-09 name: University of Warwick class: OTHER name: Welsh Ambulance Service NHS Trust briefSummary: The goal of this observational study is to explore the optimisation and integration of a drone-delivered Automated External Defibrillator (AED) system into the pre-hospital response to out-of-hospital cardiac arrest. The study is being conducted by the University of Warwick and Welsh Ambulance Service National Health Service Trust (both in the UK)
There are two separate packages of work. In work package 1 the investigators will interview people who have been involved in emergency (999) calls for cardiac arrest, asking them about their experiences with the call-handler and how they feel they might have responded if they had received an AED that had been delivered by a flying drone.
In work package 2 the investigators will conduct simulated cardiac arrests. The participants in the study will make an emergency (999) call to a trained call-handler and, once the cardiac arrest is identified during the call, a drone will be activated from a distant location and fly up to 2km to the test site and deliver an AED. The investigators will record how long it takes to retrieve and attach the AED, and ask the participants for their views about the interaction with the call-handler, AED and drone. conditions: Cardiac Arrest, Out-Of-Hospital studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 44 type: ESTIMATED name: Interviews and simulation measure: Time away from patient's side (SIMULATION) measure: Barriers and facilitators to drone-delivered AED use (INTERVIEW) measure: Interventions to overcome barriers to drone delivered AED use (INTERVIEW) measure: Hands off CPR time (SIMULATION) measure: Total time from start of 999 call to AED application and first shock (SIMULATION) measure: Total drone flight time (SIMULATION) measure: Time from drone arrival to safe to approach (SIMULATION) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Warwick status: RECRUITING city: Coventry country: United Kingdom name: Christopher M Smith, MBChB, PhD role: CONTACT phone: (+44)2476151083 lat: 52.40656 lon: -1.51217 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-27 uploadDate: 2024-03-11T10:47 filename: Prot_000.pdf size: 1072430 hasResults: False
<\|newrecord\|> nctId: NCT06334705 id: C22-11 id: 2022-A02312- 41 type: REGISTRY domain: IDRCB briefTitle: EGEA4 THE 30 YEAR FOLLOW UP OF THE EGEA STUDY overallStatus: RECRUITING date: 2024-02-15 date: 2027-02-15 date: 2028-02-15 date: 2024-03-28 date: 2024-03-28 name: Institut National de la Santé Et de la Recherche Médicale, France class: OTHER_GOV name: APHP name: CHU LYON name: APHM name: University Hospital, Grenoble name: University Hospital, Montpellier briefSummary: Cardiovascular (CV) diseases affect 523 million people worldwide, and are the leading cause of death, accounting for over 18 million deaths (around 30% of all deaths) every year. CV diseases account for around 45% of all deaths in Europe, or around 140,000 deaths a year in France. Asthma is one of the main non-communicable diseases, with a significant societal and individual burden, particularly in subjects suffering from severe asthma. The prevalence of asthma worldwide has risen rapidly over the past five decades, and now affects 272 million people worldwide, representing a prevalence of around 3.6%.
Asthma is often associated with multimorbidity. Allergic rhinitis, chronic sinusitis, sleep apnea syndrome, gastro-oesophageal reflux disease, obesity and hormonal disorders are among the most common conditions associated with asthma. More recently, other chronic conditions linked to asthma have been suggested, including CV diseases.
Although data from the literature in recent years suggest that asthma is associated with an increased risk of major CV events, the underlying mechanisms remain poorly understood. In particular, it is not known whether asthma and CV disease share common etiological processes, such as anthropometric parameters, lifestyle, social, environmental and/or genetic factors, or whether CV disease is a direct consequence of certain features of asthma, such as systemic inflammation or asthma treatments.
Our study is based on the hypothesis that the risk of CV events is increased in patients with asthma, which is supported by a growing body of scientific data.However, it remains to be determined to what extent this increased risk is a consequence of asthma or is linked to shared risk factors between asthma and CV health.
We hypothesize that asthma, and more specifically adult and moderate-to-severe asthma, are associated with early markers of CV risk. Furthermore, by providing a better understanding of the mechanisms involved in this association, we hypothesize that EGEA_30years may help to disentangle and prioritize actionable levers of life-threatening cardiovascular comorbidities in asthma. conditions: Healthy Volunteer EGEA4 Cohort studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 1000 type: ESTIMATED name: blood test, food collection, hair collection, calcium scan, etc. measure: Framingham score variability between asthmatics and non-asthmatics measure: Aortic pulse wave velocity measure: validated predictive biomarkers of CV disease (NTproBNP, Troponin(I) hs), measure: Soluble ST2 measure: coronary calcium score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Universitaire Grenoble Alpes status: RECRUITING city: Grenoble zip: 38043 country: France name: Bruno DEGANO, PhD role: CONTACT email: BDEGANO@chu-grenoble.fr lat: 45.16667 lon: 5.71667 facility: Hopital de la Croix Rousse status: RECRUITING city: Lyon zip: 69317 country: France name: Gilles Mr DEVOUASSOUX, MD role: CONTACT email: gilles.devouassoux@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: APHM status: RECRUITING city: Marseille zip: 13000 country: France name: Pascal CHANEZ, PhD role: CONTACT email: pascal.chanez@univ-amu.fr lat: 43.29551 lon: 5.38958 facility: Hôpital Arnaud De Villeneuve status: RECRUITING city: Montpellier zip: 34295 country: France name: Pascal Mr DEMOLY, PHD role: CONTACT email: pascal.demoly@inserm.fr lat: 43.61092 lon: 3.87723 facility: APHP - Hôpital Bichat Claude Bernard status: RECRUITING city: Paris zip: 75018 country: France name: Camille TAILLE, PHD role: CONTACT email: camille.taille@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06334692 id: BLINDER briefTitle: Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome acronym: BLINDER overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2028-05 date: 2024-03-28 date: 2024-04-11 name: Mario Negri Institute for Pharmacological Research class: OTHER briefSummary: This retrospective study is aimed at evaluating the levels of circulating anti-nephrin autoantibodies in patients with INS, including those with MCD/FSGS and in patients who have experienced relapse of FSGS post-transplant, compared to those of a control group of patients with nephrotic syndrome due to primary membranous nephropathy (MN). conditions: Nephrotic Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa). measure: Levels of circulating anti-nephrin autoantibodies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center for Rare Disease Aldo e Cele Daccò city: Ranica state: BG zip: 24020 country: Italy name: Federica Casiraghi, PhD role: CONTACT phone: +3903545351 email: federica.casiraghi@marionegri.it lat: 45.72328 lon: 9.71335 hasResults: False
<\|newrecord\|> nctId: NCT06334679 id: zeynepersoz briefTitle: The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage overallStatus: RECRUITING date: 2024-01-15 date: 2024-11-15 date: 2024-12-15 date: 2024-03-28 date: 2024-03-28 name: Marmara University class: OTHER briefSummary: Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. It has been reported that the incidence of itching is high in burn patients during the maturation stage of wound healing. The literature suggests that in managing the symptom of itching, skin hydration support along with cold application methods can also be used. The integrity of the skin, the duration, frequency, characteristics, areas of itching, and identifying conditions that increase or decrease itching are important for managing itching. This study is planned to be conducted with a randomized controlled design to examine the effect of applying cold gel packs to burn areas of burn patients during the maturation stage on itching. This researcher's hypothesis is that burn patients who applied cold gel packs to burn areas during the maturation phase had lower itching severity (frequency, duration, intensity) than those who did not. conditions: Burns conditions: Pruritus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is a prospective interventional type two-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as clinical routine (liquid petroleum jelly) and cold gel pack, and Group-2 (Control) was designed as clinical routine (liquid petroleum jelly). primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: When cold application studies in the literature are examined, cold gel packs are placed in a sheath and contacted with the skin of the patients. Therefore, due to the nature of the application method to be used, patients and the researcher will not be considered blind. The evaluator will be considered blind in the analysis of the study. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Cold Gel Packet Application measure: Itching severity measure: Itching grade sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kartal Dr.Lütfi Kırdar City Hospital status: RECRUITING city: Istanbul country: Turkey name: Zeynep Ersoz role: CONTACT phone: 05553496718 email: zeynepersoz08@gmail.com name: Gaye Filinte role: CONTACT phone: 5339576333 email: gayetaylan@yahoo.com lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06334666 id: SI 172/2024 briefTitle: The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-06-01 date: 2024-03-28 date: 2024-03-28 name: Mahidol University class: OTHER briefSummary: The study conducted a health survey among Thai adults in 2022 and found a significant increase in obesity and nonalcoholic fatty liver disease (NAFLD), leading to metabolic-associated steatotic liver disease (MASLD). The prevalence of NAFLD was 19.7%, with higher rates in individuals with metabolic syndrome and diabetes. MASLD is associated with insulin resistance and genetic polymorphisms, particularly the patatin like phospholipase domain containing 3-rs738409 variant. Additionally, physical activity was inversely related to liver disease risk, with higher step counts associated with reduced incidence of NAFLD and liver-related mortality. The study aims to investigate the impact of dietary advice and pedometer use on physical activity levels and health outcomes in MASLD patients over 24 weeks. conditions: Daily Step Count conditions: MASLD conditions: BMI conditions: Metabolic Syndrome conditions: NAFLD conditions: Insulin Resistance conditions: Genetic Polymorphism conditions: Cardiovascular Disease (CVD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 86 type: ESTIMATED name: Encourage using pedometer measure: To compare the changes in hepatic fat accumulation assessed by MRI-PDFF between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior. measure: To compare changes in metabolic parameters between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments. measure: To study the impact of genes on changes in hepatic fat accumulation between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334653 id: H-23069670 briefTitle: Exercise-regulated Organ Crosstalk, Influence of IL-6 acronym: EVEX overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2024-11-01 date: 2024-11-01 date: 2024-03-28 date: 2024-04-09 name: Helga Ellingsgaard class: OTHER briefSummary: Overall the study investigates organ crosstalk during exercise. More specifically, the study investigates the role of IL-6 in regulating glucose, fatty acid, and amino acid kinetics at whole body level and in skeletal muscle, liver, and brain. Furthermore, the study investigates the uptake and release of extracellular vesicles in skeletal muscle, liver, and brain in reponse to exercise. conditions: Healthy Volunteers Only conditions: Energy Metabolism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: exercise measure: Whole body substrate kinetics. measure: Tissue specific utilization and production of substrates. measure: IL-6 regulation of protein synthesis and degradation. measure: Number of EVs from muscle, liver, and brain. measure: Size of EVs from muscle, liver, and brain. measure: EVs from muscle, liver, and brain. measure: Influence of exercise on EV number. measure: Influence of exercise on EV size measure: Influence of exercise on EV content. measure: Tissue specific proteomic content of EVs. measure: Lactate. measure: Pyruvate. measure: Keto acids. measure: Ketone bodies. measure: Influence of IL-6 on fatty acid oxidation rates. measure: Influence of IL-6 on insulin. measure: Influence of IL-6 on glucagon. measure: Influence of IL-6 on epinephrine. measure: Influence of IL-6 on norepinephrine. measure: IL-6 levels. measure: Influence of IL-6 on substrate usage. measure: Influence of IL-6 on perceived exertion. sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Rigshospitalet city: Copenhagen state: Capital Region zip: 2100 country: Denmark name: Helga Ellingsgaard, PhD role: CONTACT phone: +4535457544 email: helga.ellingsgaard@regionh.dk name: Peter S Plomgaard, MD PhD role: CONTACT phone: +4535457544 email: Peter.Plomgaard@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

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