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Prepare a test set of patch testing tapes, each containing a small amount of a different household cleaner, hand disinfectant, their ingredients, and control with proper dilution. The safety dose of the tested products and agents will be defined beforehand.
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Before exposure, selected areas of forearm skin will be cleaned and moistened. Electrical impedance will be measured by electrical impedance spectroscopy (EIS) to assess skin barrier integrity.
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2. Patch Application:
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Apply the prepared patches on the skin of the forearm. Patches will be removed after 5 minutes of exposure.
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During the exposure period, subjects will be instructed not to touch, wash, or wet the exposed area to avoid interfering with the action of the testing reagents. 3. Patch Removal and Post-Exposure Monitoring:
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The patch will be gently removed from the skin. Exposed areas of skin will be evaluated by EIS at specific times up to 24 hours after the treatment. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: Cleaning product exposure measure: Skin barrier evaluation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Swiss Institute of Allergy and Asthma Research city: Davos state: Graubuenden zip: 7265 country: Switzerland name: Yasutaka Mitamura, MD PhD role: CONTACT phone: +41 (0) 81 410 08 48 email: [email protected] name: Cezmi A Akdis, MD professor role: CONTACT phone: +41 (0) 81 410 08 48 email: [email protected] name: Manru Li role: SUB_INVESTIGATOR name: Marie-Charlotte Brueggen, MD PhD professor role: SUB_INVESTIGATOR lat: 46.80429 lon: 9.83723 hasResults: False
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<|newrecord|> nctId: NCT06269302 id: 2 briefTitle: Comparison of the Effect of Warfarin and Direct Oral Anticoagulants overallStatus: COMPLETED date: 2022-01-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-21 date: 2024-02-21 name: Samsun Education and Research Hospital class: OTHER briefSummary: In this study, it was aimed to compare the frequency of new oral anticoagulants and warfarin usage, and to reveal the rates of recurrent upper gastrointestinal bleeding among patients who applied to our hospital with upper gastrointestinal bleeding conditions: Anticoagulants and Bleeding Disorders conditions: Gastrointestinal Hemorrhage studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 346 type: ACTUAL measure: Change in the incidence of recurrent bleeding sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsun Education and Research Hospital city: Samsun state: İlkadım country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False
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<|newrecord|> nctId: NCT06269289 id: SBU-KOMSERN-001 briefTitle: Effects of Web-Based Education on Patient Empowerment and Asthma Control in Asthma Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2024-06-30 date: 2024-09-30 date: 2024-02-21 date: 2024-02-21 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Asthma is defined as a chronic inflammatory disorder of the airways associated with an extreme increase in airway hyperresponsiveness leading to recurrent wheezing, shortness of breath, chest tightness, and coughing attacks. The World Health Organization states that approximately 339 million individuals worldwide have asthma and more than 400 thousand deaths occur due to asthma every year.
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With effective and sustainable asthma management, it is possible to reduce disease-related complaints, admissions to emergency units and hospitalizations, limit the physiological and psychological effects of the disease, prevent dependence on healthcare professionals and caregivers, increase the quality of life and reduce the mortality of the disease. Patient education, which is within the educational role of professional nurses, is very important in asthma management. The research was planned in a single-center, randomized control group pretest-posttest design. The sample will consist of individuals who applied to the Allergy and Immunology clinic of Sureyyapasa Chest Diseases and Surgery Training and Research Hospital between May 2024 and January 2024, who have been diagnosed with asthma for at least one year and who accept the study \[25 intervention group - 25 control group\]. Groups will be determined using the random numbers table from the simple random sampling method. A web-based asthma education module will be created in line with the literature, and participants in the intervention group will be given synchronous training in 5 modules. After meeting the individuals in the intervention and control groups and obtaining verbal and written consent, they will be asked to fill out the Patient Information Form, Patient Empowerment Scale and Asthma Control Test prepared via Google Forms. A 30-minute training session will be given to the intervention group every week and there will be short evaluations after each training. When the 5th Module is completed, the intervention group will be asked to fill out the Patient Empowerment Scale and Asthma Control Test Scale. No intervention will be applied to the control group. 5. At the end of the module, the Patient Empowerment Scale and Asthma Control Test will be completed by individuals in the control group. It is thought that web-based asthma education that individuals will receive will positively affect their empowerment levels and increase their disease control. conditions: Asthma conditions: Patient Empowerment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research was designed as a randomized controlled experimental study with a pretest-posttest design. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: web based education name: Standard education brochure measure: patient empowerment scale (PES) measure: Asthma Control Test (ACT) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital city: Istanbul zip: 34854 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06269276 id: CAVCU briefTitle: Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study overallStatus: COMPLETED date: 2020-09-20 date: 2021-01-15 date: 2021-01-15 date: 2024-02-21 date: 2024-02-21 name: Namik Kemal University class: OTHER briefSummary: This study was conducted to evaluate the Turkish validity and reliability of the Caregiver Contribution to Self-Care in Ostomy Patient Index, to evaluate the relatives of patients with stoma who contribute to their self-care in Turkish society, and to contribute to the nursing literature of the measurement tool.
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This methodological type of research was carried out between September 2020 and January 2021 in a state and a university hospital in Tekirdağ. The research sample consisted of 223 individuals who contributed to the self-care of individuals with colostomy, ileostomy and urostomy who applied for outpatient control. In the analysis of the data, descriptive statistics, language and content validity, confirmatory factor analysis, item analysis, internal consistency and test-retest methods were used.
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At the end of the study, it was determined that the scale was suitable for Turkish society and was valid and reliable in Turkish. conditions: Stoma Colostomy conditions: Stoma Ileostomy conditions: Caregiver conditions: Self Care studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 223 type: ACTUAL name: Caregiver Contribution to Self-Care in Ostomy Patient Index measure: Caregiver Contribution to Self-Care in Ostomy Patient Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tekirdag Namık Kemal University city: Tekirdag state: Suleymanpasa zip: 59000 country: Turkey lat: 40.9781 lon: 27.51101 hasResults: False
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<|newrecord|> nctId: NCT06269263 id: 339/23-ek briefTitle: Pilot Study to Determine Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF) acronym: Pilot-CRHF overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2025-02 date: 2025-02 date: 2024-02-21 date: 2024-02-21 name: University of Leipzig class: OTHER briefSummary: The proposed study will determine the willingness of patients for participation. Furthermore, the assessment of tests to identify eligible patients and the type of exercise intervention that goes along with a high patient compliance is crucial. Also, more information about possible factors preventing patients from participating is required. Therefore, if the patient is willing to participate, we will assess patients' medical history, medication and QoL as well as parameters of routine diagnostics (i.e. echocardiography, laboratory testing, MRI). Following, while the in-patient stay due to cardiac decompensation, we will conduct several assessment-tests to determine the physical status, the exercise capacity and the cognitive function. Moreover, physiotherapists will instruct the patients in the exercise program. After discharge from the hospital, physiotherapist will visit the patient at home to instruct them again in the exercises. Then, the patients will conduct the program on their own for a period of 12 weeks. During the exercise period, a doctoral student will visit the patients at home every 3 weeks to check whether they are doing the exercises correctly and to determine whether there are any problems with the program. After the exercise period of 12 weeks, the baseline characteristics will be assessed again at the University Hospital Leipzig. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot study of home-based cardiac rehabilitation primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Home-based cardiac rehabilitation measure: Percentage of patients completing the program measure: Quality of life measure: Exercise capacity sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Leipzig city: Leipzig state: Saxony zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 hasResults: False
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<|newrecord|> nctId: NCT06269250 id: ANDI-MFA2023_10 briefTitle: Acceptance and Perceived Benefits of Digitalization by Medical Assistants acronym: ANDI-MFA overallStatus: RECRUITING date: 2023-11-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Jacobs University Bremen gGmbH class: OTHER name: Mirjam Jansen; medmedia Academy briefSummary: The aim of this project is to improve the integration of digital processes, including e-prescriptions, within medical and dental practices for healthcare professionals. Through a better understanding of the obstacles healthcare workers encounter during the adoption of digital processes and their feedback post-implementation, this study will add to the current state of science, contributing to digital process optimization in healthcare. conditions: Health Care Providers conditions: Patient Safety conditions: eHealth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Policy Change measure: Adoption and acceptance of information technology (IT) measure: Requests by patients regarding IT measure: Perceived Benefits of IT measure: Knowledge and Digital health literacy measure: Preferred learning format sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Germany status: RECRUITING city: Bremen zip: 28759 country: Germany name: Sonia Lippke, Prof. Dr. role: CONTACT phone: +49 421 200 4730 email: [email protected] name: Keller Franziska, PhD role: CONTACT phone: +49 421 200 4730 email: [email protected] lat: 53.07516 lon: 8.80777 hasResults: False
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<|newrecord|> nctId: NCT06269237 id: 2023LTA briefTitle: Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-06-01 date: 2024-07-01 date: 2024-02-21 date: 2024-02-21 name: He Eye Hospital class: OTHER briefSummary: To quantify and compare tear levels of Intense pulsed light (IPL) and traditional dry eye clinical tests in dry eye patients before and after Intense pulsed light (IPL) treatment. conditions: Dry Eye studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: M22 name: sham M22 measure: LTA measure: Non-invasive tear break-up time (NITBUT) measure: Fluorescein and lissamine conjunctival and cornea staining (CFS) measure: Meibomian quality measure: Tear Film Lipid Layer Score(TFLL) measure: Tear meniscus height (TMH) measure: Conjunctival hyperemia (RS score) measure: Ocular Surface Disease Index (OSDI) sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06269224 id: HU-FTR-KS-01 briefTitle: Examining Factors Influencing Thoracolumbar Mobility in Runners overallStatus: COMPLETED date: 2022-09-01 date: 2023-01-01 date: 2024-01-01 date: 2024-02-21 date: 2024-02-22 name: Hacettepe University class: OTHER briefSummary: The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running. conditions: Runners conditions: Mobility conditions: Fascia conditions: Range of Motion studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 90 type: ACTUAL name: Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners. measure: Myoton Assessment sex: ALL minimumAge: 30 Years maximumAge: 45 Years stdAges: ADULT facility: Hacettepe University city: Ankara state: Altındağ zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06269211 id: RTS-019 briefTitle: Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer With EGFR Mutation and PD-L1 Positive Expression acronym: TOPLINE overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2027-01-31 date: 2030-01-31 date: 2024-02-21 date: 2024-02-21 name: Ruijin Hospital class: OTHER name: Guangdong Provincial People's Hospital briefSummary: The study is a prospective, open label, multicenter, single arm Phase II clinical trial, aiming to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients. This study will provide valuable information for further clinical trials of neoadjuvant Toripalimab and other immune checkpoint inhibitors in NSCLC patients with EGFR mutations and PD-L1 positive expression. conditions: Carcinoma, Non-Small-Cell Lung studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study has only one arm, neoadjuvant Toripalimab treatment arm. Primary endpoint is MPR. We apply the optimal design of Simon's two-stage model to calculate the sample size and set both sides α= 0.05 and power=0.8, resulting in a total sample size of 29. Among them, 10 patients will be enrolled in the first stage. If the number of MPR cases in the first stage is less than or equal to 1, the study will be terminated in the early stage; On the contrary, participants in the second stage will continue to be enrolled. If the total number of MPR cases is greater than or equal to 5 after the completion of the second stage, the study is considered positive. primaryPurpose: TREATMENT masking: NONE count: 29 type: ESTIMATED name: Toripalimab measure: Major Pathological Response (MPR) measure: Pathological Complete Response (pCR) measure: Objective Response Rate (ORR) measure: 2-year Event Free Survival (EFS) measure: 2-year Overall Survival (OS) measure: Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events) measure: Feasibility (Number of Participants Who Finished Neoadjuvant therapy and Receive Surgery Within 3-6 Weeks After Neoadjuvant Therapies) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial People's Hospital city: Guangzhou state: Guangdong zip: 510180 country: China lat: 23.11667 lon: 113.25 facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine city: Shanghai state: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06269198 id: WARD - SX - RCT II briefTitle: Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System acronym: WARD-SX-RCT-II overallStatus: RECRUITING date: 2023-10-31 date: 2025-04-01 date: 2027-04-01 date: 2024-02-21 date: 2024-03-25 name: Rigshospitalet, Denmark class: OTHER name: Bispebjerg Hospital name: Hvidovre University Hospital briefSummary: The primary objective of this study is to determine the effect on complication severity of using a clinical monitoring system with automatic vital sign alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery.
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Other objectives include documentation of the severity of complications within seven days of surgery, frequency of serious adverse events, mortality, length of stay and delay of planned chemotherapy. conditions: Postoperative Complications conditions: Cancer, Treatment-Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomisation stratified by study site primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Participants will not be given information on group allocation. Care-providers will not be blinded, due to having to carry out the intervention.
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Investigator will not be blinded to carrie out roles such as safety surveillance, error-solving and quality assurance.
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Outcome assessor will be blinded to study allocation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 504 type: ESTIMATED name: WARD-CSS measure: Overall complication severity - 30 days measure: Overall complication severity - 7 days measure: Frequency of Serious adverse events measure: Days alive and out of hospital measure: Days alive and out of hospital measure: Time to initiation of post-operative adjuvant chemotherapy measure: Completion of post-operative adjuvant chemotherapy measure: Frequency of severe clinical complications measure: ICU admission measure: Surgical reintervention of any kind measure: Post-discharge readmission measure: Health-economic cost-effectiveness. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University hospital - Rigshospitalet status: RECRUITING city: Copenhagen state: Other (Non US) zip: 1665 country: Denmark name: Jesper Mølgaard, PhD role: CONTACT phone: +4535453545 email: [email protected] name: Eske K Aasvang, DMSc role: CONTACT phone: +4535450802 email: [email protected] lat: 55.67594 lon: 12.56553 facility: Bispebjerg Hospital status: RECRUITING city: Copenhagen state: Other (Non US) zip: 2400 country: Denmark name: Christian S Meyhoff, PhD role: CONTACT phone: +4524910542 email: [email protected] name: Christian S Meyhoff, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Hvidovre Hospital status: NOT_YET_RECRUITING city: Hvidovre state: Other (Non US) zip: 2650 country: Denmark name: Katja B L Glud, RN role: CONTACT phone: +4538625713 email: [email protected] name: Søren Kjær, MD role: PRINCIPAL_INVESTIGATOR lat: 55.65719 lon: 12.47364 hasResults: False
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<|newrecord|> nctId: NCT06269185 id: 2024_IFXvsADAinUC briefTitle: Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis overallStatus: RECRUITING date: 2024-03-06 date: 2025-03-01 date: 2025-03-01 date: 2024-02-21 date: 2024-03-15 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations.
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The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment. conditions: Ulcerative Colitis conditions: Inflammatory Bowel Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 270 type: ESTIMATED name: Infliximab name: Adalimumab measure: Percentage of patients achieving steroid-free clinical remission measure: Percentage of patients achieving clinical response measure: Percentage of patients achieving clinical remission measure: Percentage of patients achieving biochemical remission measure: Percentage of patients achieving clinical remission measure: Percentage of patients achieving biochemical remission measure: Percentage of patients achieving endoscopic response measure: Percentage of patients achieving endoscopic remission measure: Remission rates in the subpopulations of UC-patients with severe, moderate and mild disease respectively sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Västra Götalandsregionen status: RECRUITING city: Göteborg country: Sweden name: Börje Jonefjäll role: CONTACT phone: +46703753933 email: [email protected] lat: 57.70716 lon: 11.96679 hasResults: False
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<|newrecord|> nctId: NCT06269172 id: 162076 id: 322453 type: OTHER domain: HRA briefTitle: Perceptions Across Ethnicities to Develop an Adapted Intervention for Breathlessness acronym: Paint overallStatus: RECRUITING date: 2024-02-12 date: 2025-11-30 date: 2025-11-30 date: 2024-02-21 date: 2024-02-21 name: University Hospitals, Leicester class: OTHER briefSummary: An individual's experience of their breathlessness is influenced by multiple factors including their medical condition, psychology, sociological and situational circumstances which will include ethnicity. There is currently a lack of evidence exploring the impact of ethnicity in the experience and presentation of breathlessness.
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The non-medical management of breathlessness in respiratory diseases includes pulmonary rehabilitation (PR). PR is a highly evidenced exercise-based intervention to help manage breathlessness, improving health-related quality of life and improving survival. Recent audits in England and Wales showed 89% of patients attending PR were recorded as having a White British ethnicity which is in contrast to national ethnicity demographics. This may be because the cultural acceptability of PR components are not fully considered. Therefore, this study will explore how individuals with cardiorespiratory disease from different ethnicities from the Leicestershire population experience and manage their breathlessness through art workshops, focus groups and interviews. Informed by these results, the study team will work with individuals from under-represented ethnicities and key stakeholders to co-design adaptations of PR that may improve the management of breathlessness in underrepresented ethnicities that do not attend conventional PR programmes.
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The study is funded by the Wellcome Trust as part of the Leicestershire Health Inequalities Improvement Programme at the University of Leiceste conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: intereviews measure: Art Workshops, Focus Groups and Semi-Structured Interviews measure: : Experience Based Co-design The co-development of an intervention for breathlessness for under-represented ethnicities. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glenfield Hospital status: RECRUITING city: Leicester state: Leicestershire zip: LE39QP country: United Kingdom name: Holly Ms Drover role: CONTACT email: [email protected] lat: 52.6386 lon: -1.13169 hasResults: False
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<|newrecord|> nctId: NCT06269159 id: ONZ-2023-0185 briefTitle: The Power of 24-hour: Co-designing Intervention Components overallStatus: RECRUITING date: 2023-09-05 date: 2025-03-31 date: 2025-03-31 date: 2024-02-21 date: 2024-02-21 name: University Hospital, Ghent class: OTHER briefSummary: Most of the existing lifestyle interventions in adults with overweight or obesity focus on one movement behavior in isolation (i.e. moderate to vigorous physical activity (MVPA)). However, recent research suggests to incorporate all movement behaviors performed in one day to explore the possible synergistic health effects of targeting more than one behavior. Moreover, more optimal 24-hour movement behavior compositions are related with better cardiometabolic health. Literature shows that adults with obesity have less optimal 24-hour compositions (8-9). Therefore it would be of interest to discover the needs related to an optimal 24-hour movement behavior intervention for a group of adults with overweight and obesity using co-design to develop an intervention.
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This study will conduct a concept mapping protocol to explore the needs to of people with overweight and obesity to change their sedentary behavior into more physical activity as well to include the opinion of health care providers (HCP are physiotherapists) on the needs of their patients. conditions: Overweight and Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 210 type: ESTIMATED name: Concept mapping: brainstorm name: Concept mapping: clustering and rating measure: Themes measure: Score of effectiveness measure: Score of feasibility measure: Score of modifiability sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ghent university Hospital status: RECRUITING city: Ghent zip: 9000 country: Belgium name: Bruno Lapauw role: CONTACT email: [email protected] lat: 51.05 lon: 3.71667 hasResults: False
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<|newrecord|> nctId: NCT06269146 id: 806035 id: 1R61MH129380-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R61MH129380-01 briefTitle: Pramipexole to Enhance Social Connections overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-03 date: 2025-03 date: 2024-02-21 date: 2024-02-21 name: University of California, San Diego class: OTHER name: National Institute of Mental Health (NIMH) name: New York State Psychiatric Institute briefSummary: This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention. conditions: Anxiety Disorders conditions: Anxiety conditions: Depression conditions: Social Disconnection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The pharmacy will blind drug and placebo through identical encapsulation. Placebo will match the study drug in mode of administration, color, size, and taste. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Pramipexole Pill name: Placebo Pill measure: Neural activation during social reward anticipation measure: Neural activation during opportunities to disclose to others measure: Motivation to engage in shared experiences with others measure: Positive affect in response to the social affiliation task measure: Social approach goals during the social affiliation task measure: Social approach behavior during the social affiliation task measure: Future approach motivation measure: Blood plasma pramipexole concentrations measure: Negative affect in response to the social affiliation task measure: Neural activation during social punishment anticipation measure: Social avoidance goals during the social affiliation task measure: Anxious behavior during the social affiliation task sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of California, San Diego city: San Diego state: California zip: 92093 country: United States name: Margaret K Satchwell, BS role: CONTACT phone: 858-822-4357 email: [email protected] lat: 32.71533 lon: -117.15726 facility: New York State Psychiatric Institute city: New York state: New York zip: 10032 country: United States name: Liza Handler, BS role: CONTACT phone: 917-652-6355 email: [email protected] lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06269133 id: R2810-ONC-22115 briefTitle: Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-21 date: 2027-03-31 date: 2027-06-23 date: 2024-02-21 date: 2024-03-13 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This multi-year cohort study will assess the real-world safety and effectiveness of 1L treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC patient subgroups defined by age, sex, race, and ethnicity. Patients will be retrospectively identified from at least two US electronic health record (EHR)-based databases. conditions: Advanced Non-small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1000 type: ESTIMATED name: REGN2810 name: Platinum-doublet chemotherapy measure: Real-world response rate (rwRR) measure: Any treatment-emergent immune-mediated adverse event (imAE) measure: Any treatment-emergent imAE resulting in hospitalization measure: Any treatment-emergent imAE resulting in death measure: Specific treatment-emergent imAEs measure: Real-world duration of response (rwDOR) measure: Real-world progression-free survival (rwPFS) measure: Real-world overall survival (rwOS) measure: Treatment-emergent immune-mediated adverse events (imAEs) measure: Infusion-related reaction (IRR) measure: IRR resulting in hospitalization measure: IRR resulting in death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Regeneron Research Facility city: Tarrytown state: New York zip: 10591 country: United States lat: 41.07621 lon: -73.85875 hasResults: False
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<|newrecord|> nctId: NCT06269120 id: NN9924-7787 id: U1111-1290-8109 type: OTHER domain: World Health Organization (WHO) briefTitle: SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-09-30 date: 2024-09-30 date: 2024-02-21 date: 2024-02-21 name: Novo Nordisk A/S class: INDUSTRY briefSummary: Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of normal doctor's appointment. conditions: Type 2 Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 470 type: ESTIMATED name: Oral Semaglutide measure: Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5% measure: Change in HbA1c measure: Change in fasting plasm glucose (FPG) measure: Absolute change in body weight (BW) measure: Relative change in BW measure: HbA1c less than (<) 7.0% measure: HbA1c <6.5% measure: Body weight reduction ≥5% measure: HbA1c reduction ≥1%-point and BW reduction ≥5% measure: HbA1c reduction ≥1%-point and BW reduction ≥3% measure: Change in waist circumference measure: Change in blood pressure (BP) (systolic and diastolic) measure: Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG]) measure: Change in high sensitive C-reactive protein (hsCRP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06269107 id: NN1535-4988 id: U1111-1283-8648 type: OTHER domain: World Health Organization (WHO) id: 2022-502484-38-00 type: OTHER domain: European Medicines Agency (EMA) briefTitle: A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4) acronym: COMBINE 4 overallStatus: RECRUITING date: 2024-02-15 date: 2025-06-05 date: 2025-07-10 date: 2024-02-21 date: 2024-04-18 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks). conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 474 type: ESTIMATED name: IcoSema name: Insulin glargine measure: Change in glycated haemoglobin (HbA1c) measure: Change in body weight measure: Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]) measure: Time spent less than (<) 3.0 mmol/L (54 mg/dL) measure: Time spent greater than (>) 10.0 mmol/L (180 mg/dL) measure: Weekly basal insulin dose measure: Change in fasting plasma glucose (FPG) measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3) measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) measure: Number of severe hypoglycaemic episodes (level 3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scripps Whittier Diabetes Inst status: RECRUITING city: La Jolla state: California zip: 92037 country: United States lat: 32.84727 lon: -117.2742 facility: First Valley Med Grp Lancaster status: RECRUITING city: Lancaster state: California zip: 93534 country: United States lat: 34.69804 lon: -118.13674 facility: Clinical Trials Research_Sacramento status: RECRUITING city: Lincoln state: California zip: 95648 country: United States lat: 38.89156 lon: -121.29301 facility: Desert Oasis Hlthcr Med Group status: RECRUITING city: Palm Springs state: California zip: 92262 country: United States lat: 33.8303 lon: -116.54529 facility: Northeast Research Institute status: RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States lat: 30.0933 lon: -81.71898 facility: Clinical Research of Central Florida_Winter Haven status: RECRUITING city: Winter Haven state: Florida zip: 33880 country: United States lat: 28.02224 lon: -81.73286 facility: Atlanta Diabetes Associates status: RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States lat: 33.749 lon: -84.38798 facility: Endo Res Solutions Inc status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States lat: 34.02316 lon: -84.36159 facility: Elite Clinical Trials status: RECRUITING city: Blackfoot state: Idaho zip: 83221 country: United States lat: 43.19047 lon: -112.34498 facility: Cedar-Crosse Research Center status: RECRUITING city: Chicago state: Illinois zip: 60607 country: United States lat: 41.85003 lon: -87.65005 facility: NorthShore Univ Hlth Sys status: RECRUITING city: Skokie state: Illinois zip: 60077 country: United States lat: 42.03336 lon: -87.73339 facility: Cotton-O'Neil Diab & Endo Ctr status: RECRUITING city: Topeka state: Kansas zip: 66606 country: United States lat: 39.04833 lon: -95.67804 facility: Methodist Phys. Clinic status: RECRUITING city: Omaha state: Nebraska zip: 68114 country: United States lat: 41.25626 lon: -95.94043 facility: Albuquerque Clin Trials, Inc. status: RECRUITING city: Albuquerque state: New Mexico zip: 87102 country: United States lat: 35.08449 lon: -106.65114 facility: Albany Medical College - Endo status: RECRUITING city: Albany state: New York zip: 12206 country: United States lat: 42.65258 lon: -73.75623 facility: Southgate Medical Group, LLP status: RECRUITING city: West Seneca state: New York zip: 14224 country: United States lat: 42.85006 lon: -78.79975 facility: Physician's East Endocrinology status: RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Diab & Endo Assoc of Stark Co status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States lat: 40.79895 lon: -81.37845 facility: Advanced Medical Research status: RECRUITING city: Maumee state: Ohio zip: 43537 country: United States lat: 41.56283 lon: -83.65382 facility: New Venture Medical Research status: RECRUITING city: Wadsworth state: Ohio zip: 44281-9236 country: United States lat: 41.02561 lon: -81.72985 facility: Holston Medical Group status: RECRUITING city: Kingsport state: Tennessee zip: 37660 country: United States lat: 36.54843 lon: -82.56182 facility: Amarillo Med Spec LLP status: RECRUITING city: Amarillo state: Texas zip: 79106 country: United States lat: 35.222 lon: -101.8313 facility: Velocity Clinical Research- Cedar Park status: RECRUITING city: Cedar Park state: Texas zip: 78613 country: United States lat: 30.5052 lon: -97.82029 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: North Texas Endocrine Center status: RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: Diabetes and Thyroid Ctr of FW status: RECRUITING city: Fort Worth state: Texas zip: 76132 country: United States lat: 32.72541 lon: -97.32085 facility: Fmc Science, Llc status: RECRUITING city: Lampasas state: Texas zip: 76550 country: United States lat: 31.06378 lon: -98.1817 facility: Consano Clinical Research, LLC status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: Wade Family Medicine status: RECRUITING city: Bountiful state: Utah zip: 84010 country: United States lat: 40.88939 lon: -111.88077 facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing zip: 100044 country: China lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 facility: Chongqing University Three Gorges Hospital status: RECRUITING city: Chongqing state: Chongqing zip: 404000 country: China lat: 29.56278 lon: 106.55278 facility: Huizhou Central People's Hospital status: RECRUITING city: Huizhou state: Guangdong zip: 516001 country: China lat: 23.11147 lon: 114.41523 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu zip: 212001 country: China lat: 32.21086 lon: 119.45508 facility: Jinan Central Hospital status: RECRUITING city: Jinan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 facility: Jinan Central Hospital status: NOT_YET_RECRUITING city: Jinan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 facility: Shanghai Pudong New Area People's Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 201200 country: China lat: 31.22222 lon: 121.45806 facility: Harrison International Peace Hospital status: WITHDRAWN city: Hengshui zip: 053000 country: China lat: 37.73222 lon: 115.70111 facility: Evangelismos Hospital status: RECRUITING city: Athens zip: GR-10676 country: Greece lat: 37.97945 lon: 23.71622 facility: 'G. Gennimatas' General Hospital of Athens status: RECRUITING city: Athens zip: GR-115 27 country: Greece lat: 37.97945 lon: 23.71622 facility: "Laiko" General Hospital of Athens status: RECRUITING city: Athens zip: GR-11527 country: Greece lat: 37.97945 lon: 23.71622 facility: General Hospital of Kalamata status: RECRUITING city: Kalamata zip: 24100 country: Greece lat: 37.03913 lon: 22.11265 facility: Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease status: RECRUITING city: Larissa zip: GR-41110 country: Greece lat: 39.63689 lon: 22.41761 facility: "Thermi" Private Hosital status: RECRUITING city: Thessaloniki zip: GR-57001 country: Greece lat: 40.64361 lon: 22.93086 facility: Ramaiah Memorial Hospital status: RECRUITING city: Bangalore state: Karnataka zip: 560054 country: India lat: 12.97194 lon: 77.59369 facility: Ramaiah Memorial Hospital status: NOT_YET_RECRUITING city: Bangalore state: Karnataka zip: 560054 country: India lat: 12.97194 lon: 77.59369 facility: Mysore Medical College and Research Institute status: NOT_YET_RECRUITING city: Mysore state: Karnataka zip: 570001 country: India lat: 12.29791 lon: 76.63925 facility: BYL Nair Hospital and T N Medical College Department of endo status: RECRUITING city: Mumbai state: Maharashtra zip: 400008 country: India lat: 19.07283 lon: 72.88261 facility: BYL Nair Hospital and T N Medical College Department of endo status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400008 country: India lat: 19.07283 lon: 72.88261 facility: Seth GS Medical College & KEM Hospital status: RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: Seth GS Medical College & KEM Hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: BSES MG hospital status: RECRUITING city: Mumbai state: Maharashtra zip: 400058 country: India lat: 19.07283 lon: 72.88261 facility: BSES MG hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400058 country: India lat: 19.07283 lon: 72.88261 facility: Chellaram Diabetes Institute status: RECRUITING city: Pune state: Maharashtra zip: 411021 country: India lat: 18.51957 lon: 73.85535 facility: SMS Medical College & Hospital status: NOT_YET_RECRUITING city: Jaipur state: Rajasthan zip: 302004 country: India lat: 26.91962 lon: 75.78781 facility: Diabetes, Thyroid and Endocrine Centre status: RECRUITING city: Jaipur state: Rajasthan zip: 302006 country: India lat: 26.91962 lon: 75.78781 facility: Madras Diabetes Research Foundation status: RECRUITING city: Chennai state: Tamil Nadu zip: 600086 country: India lat: 13.08784 lon: 80.27847 facility: Madras Diabetes Research Foundation status: NOT_YET_RECRUITING city: Chennai state: Tamil Nadu zip: 600086 country: India lat: 13.08784 lon: 80.27847 facility: Udyaan Health Care status: RECRUITING city: Lucknow state: Uttar Pradesh zip: 226002 country: India lat: 26.83928 lon: 80.92313 facility: Post Graduate Institute of Medical Education & Research status: NOT_YET_RECRUITING city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 facility: IPGME&R and SSKM Hospital status: NOT_YET_RECRUITING city: Kolkata zip: 700020 country: India lat: 22.56263 lon: 88.36304 facility: Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia status: RECRUITING city: L'Aquila state: Abbruzzo zip: 67100 country: Italy lat: 42.35055 lon: 13.39954 facility: Casa Sollievo della Sofferenza reparto endocrinologia status: RECRUITING city: San Giovanni Rotondo state: FG zip: 71013 country: Italy lat: 41.70643 lon: 15.7277 facility: I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani status: NOT_YET_RECRUITING city: Ancona zip: 60127 country: Italy lat: 43.5942 lon: 13.50337 facility: Casa della Salute di Ceccano (FR) status: RECRUITING city: Ceccano (Frosinone) zip: 03023 country: Italy facility: ASL 4 Chiavarese status: NOT_YET_RECRUITING city: Chiavari (genova) zip: 16034 country: Italy facility: ASST Grande Ospedale Metropolitano Niguarda status: RECRUITING city: Milano zip: 20162 country: Italy lat: 45.46427 lon: 9.18951 facility: Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser status: RECRUITING city: Perugia zip: 06129 country: Italy lat: 43.1122 lon: 12.38878 facility: A.O.U. Policlinico Umberto I status: RECRUITING city: Rome zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 facility: Heiwadai Hospital status: RECRUITING city: Miyazaki-shi state: Miyazaki zip: 880-0034 country: Japan lat: 31.91667 lon: 131.41667 facility: Tokuyama clinic status: RECRUITING city: Chiba zip: 261-0004 country: Japan lat: 35.6 lon: 140.11667 facility: Oodouri Diabetes, Internal medicine Clinic status: RECRUITING city: Hokkaido zip: 060-0001 country: Japan lat: 43.41104 lon: 142.88878 facility: Oyama East Clinic status: RECRUITING city: Tochigi zip: 323-0022 country: Japan lat: 36.38333 lon: 139.73333 facility: Tokyo-Eki Center-building Clinic status: RECRUITING city: Tokyo zip: 103-0027 country: Japan lat: 35.6895 lon: 139.69171 facility: Fukuwa Clinic status: RECRUITING city: Tokyo zip: 104-0031 country: Japan lat: 35.6895 lon: 139.69171 facility: Juntendo University Hospital status: RECRUITING city: Tokyo zip: 113-8431 country: Japan lat: 35.6895 lon: 139.69171 facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska status: RECRUITING city: Bialystok state: Podlaskie zip: 15-435 country: Poland lat: 53.13333 lon: 23.16433 facility: SNZOZ Lege Artis status: RECRUITING city: Bialystok zip: 15-404 country: Poland lat: 53.13333 lon: 23.16433 facility: Uniwersyteckie Centrum Kliniczne Regionalne Centrum Diabetologii status: RECRUITING city: Gdansk zip: 80-214 country: Poland lat: 54.35205 lon: 18.64637 facility: Grazyna Pulka Specjalistyczny Osrodek "All-Med" status: RECRUITING city: Krakow zip: 30-033 country: Poland lat: 50.06143 lon: 19.93658 facility: Gabinet Lekarski Malgorzata Saryusz-Wolska status: RECRUITING city: Lodz zip: 90-132 country: Poland lat: 51.75 lon: 19.46667 facility: Centrum Terapii Wspolczesnej status: RECRUITING city: Lodz zip: 90-338 country: Poland lat: 51.75 lon: 19.46667 facility: Ko-Med Nova Sp.zo.o. Lublin II status: RECRUITING city: Lublin zip: 20-362 country: Poland lat: 51.25 lon: 22.56667 facility: Ko-Med Nova Sp.zo.o. STASZOW status: RECRUITING city: Staszow zip: 28-200 country: Poland lat: 50.56307 lon: 21.16593 facility: NBR Polska Tomasz Klodawski status: RECRUITING city: Warszawa zip: 00-710 country: Poland lat: 52.22977 lon: 21.01178 facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA status: RECRUITING city: Warszawa zip: 02-507 country: Poland lat: 52.22977 lon: 21.01178 facility: Clinhouse Centrum Medyczne status: RECRUITING city: Zabrze zip: 41-807 country: Poland lat: 50.32492 lon: 18.78576 facility: Advanced Clinical Research LLC status: RECRUITING city: Bayamon zip: 00959 country: Puerto Rico lat: 18.39856 lon: -66.15572 facility: Dr R Dulabh status: RECRUITING city: Johannesburg state: Gauteng zip: 1812 country: South Africa lat: -26.20227 lon: 28.04363 facility: Dr R Dulabh status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 1812 country: South Africa lat: -26.20227 lon: 28.04363 facility: Newtown Clinical Research status: RECRUITING city: Johannesburg state: Gauteng zip: 2001 country: South Africa lat: -26.20227 lon: 28.04363 facility: Roodepoort Medicross Clinical Research Centre status: RECRUITING city: Roodepoort state: Gauteng zip: 1724 country: South Africa lat: -26.1625 lon: 27.8725 facility: Clinical Research Institute of South Africa status: RECRUITING city: KwaDukuza state: KwaZulu Natal zip: 4449 country: South Africa lat: -29.32816 lon: 31.28954 facility: Dr Pillay's Rooms status: RECRUITING city: Durban state: KwaZulu-Natal zip: 4450 country: South Africa lat: -29.8579 lon: 31.0292 facility: Dr Pillay's Rooms status: NOT_YET_RECRUITING city: Durban state: KwaZulu-Natal zip: 4450 country: South Africa lat: -29.8579 lon: 31.0292 facility: Langeberg Clinical Trials status: RECRUITING city: Cape Town state: Western Cape zip: 7572 country: South Africa lat: -33.92584 lon: 18.42322 facility: Akdeniz University Tip Fakultesi Hastanesi status: RECRUITING city: Antalya zip: 07058 country: Turkey lat: 36.90812 lon: 30.69556 facility: Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi status: RECRUITING city: Istanbul zip: 34371 country: Turkey lat: 41.01384 lon: 28.94966 facility: Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji status: RECRUITING city: Istanbul zip: 34390 country: Turkey lat: 41.01384 lon: 28.94966 facility: T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi status: RECRUITING city: Istanbul zip: 34899 country: Turkey lat: 41.01384 lon: 28.94966 facility: Tekirdag Namık Kemal UTF status: RECRUITING city: Tekirdag zip: 59030 country: Turkey lat: 40.9781 lon: 27.51101 hasResults: False
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<|newrecord|> nctId: NCT06269094 id: MB-2312 briefTitle: A Study to Understand How Continuous Glucose Monitors Impact Eating Behavior overallStatus: RECRUITING date: 2024-02-14 date: 2024-05 date: 2024-05 date: 2024-02-21 date: 2024-03-13 name: Midwest Center for Metabolic and Cardiovascular Research class: OTHER briefSummary: The purpose of this study is to evaluate if and how continuous glucose monitors (CGMs) impact food consumption, choice, and purchasing in individuals attempting to lose weight using their own weight management approach. conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: CGM measure: Qualitative insights on consumer behavior sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Biofortis, Inc. status: RECRUITING city: Addison state: Illinois zip: 60101 country: United States name: Grace Mooney, MS role: CONTACT phone: 630-617-2000 email: [email protected] name: Gina Castiglione, RD role: CONTACT phone: 6306172000 email: [email protected] name: Aditi M Shah, MD role: PRINCIPAL_INVESTIGATOR lat: 41.9317 lon: -87.98896 hasResults: False
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<|newrecord|> nctId: NCT06269081 id: R01NR020770 type: NIH link: https://reporter.nih.gov/quickSearch/R01NR020770 id: R01NR020770 type: NIH link: https://reporter.nih.gov/quickSearch/R01NR020770 briefTitle: Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV overallStatus: RECRUITING date: 2024-04-08 date: 2027-01-31 date: 2027-01-31 date: 2024-02-21 date: 2024-04-03 name: Medical College of Wisconsin class: OTHER name: National Institute of Nursing Research (NINR) briefSummary: Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV. conditions: HIV studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 352 type: ESTIMATED name: Supportive-Expressive Peer Social Support Group Intervention name: Individual Strengths-Based Case Management Intervention measure: Viral Suppression measure: Antiretroviral Treatment Medication Adherence measure: Health-Related Quality of Life measure: Depressive Symptoms measure: Social Support measure: Loneliness measure: Internalized HIV Stigma measure: General Self-Efficacy measure: HIV Treatment Adherence Self-Efficacy measure: Accessing Needed Social and Medical Services measure: Structural Barriers sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for AIDS Intervention Research, Medical College of Wisconsin status: RECRUITING city: Milwaukee state: Wisconsin zip: 53202 country: United States name: Jennifer Walsh role: CONTACT phone: 414-955-7710 email: [email protected] lat: 43.0389 lon: -87.90647 hasResults: False
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<|newrecord|> nctId: NCT06269068 id: 12.01.2024.10 briefTitle: Investigation of the Relationship Between Central Sensitization and Neuropathic Pain in Lumbar Disc Herniation overallStatus: RECRUITING date: 2024-01-16 date: 2024-04-10 date: 2024-06-01 date: 2024-02-21 date: 2024-02-21 name: Marmara University class: OTHER briefSummary: Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with in many musculoskeletal diseases with chronic pain has been demonstrated in several studies. CS is also one of the main mechanisms proposed in the generation of neuropathic pain, and the relationship between pain sensitization and neuropathic complaints has been shown in different diseases.In this study, it was aimed to investigate the effect of central sensitization on the distribution pattern and neuropathic character of pain in patients with lumbar disc herniation who applied to the physical medicine and rehabilitation outpatient clinic. conditions: Central Sensitisation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 180 type: ESTIMATED name: Central sensitization inventory name: Short form-36 name: Oswestry Low Back Pain Disability Questionnaire name: Douleur Neuropathique 4 name: Visual analogue scale measure: Central Sensitization Inventory (CSI) measure: DN4 measure: VAS pain measure: SF-36 measure: ODI sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University School of Medicine status: RECRUITING city: Istanbul state: Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik zip: 34899 country: Turkey name: Feyza Nur Yücel role: CONTACT phone: 5385577059 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06269055 id: 73151 briefTitle: Long-term Result of DTPA (Diethylenetriamine Pentaacetate) Chelation for Gadolinium Deposition Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-09 date: 2025-12-31 date: 2024-02-21 date: 2024-04-18 name: Stanford University class: OTHER briefSummary: This study is aimed at describing the degree of benefit, if any, and the adverse effects, if any, from receiving 5 or more treatment sessions of Gadolinium Deposition Disease using two-day chelation treatment with the chelating agents Calcium Diethylenetriamine pentaacetate (Ca-DTPA) and Zinc Diethylenetriamine pentaacetate (Zn-DTPA). conditions: Gadolinium Deposition Disease conditions: Ca-DTPA studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: Interview measure: Rating of Gadolinium Deposition Disease Symptoms at start of GDD and currently measure: PROMIS Item Bank v2.0 - Cognitive Function- Short Form 8a measure: Sheehan Disability Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University Medical Center city: Stanford state: California zip: 94305 country: United States name: Lorrin Koran, M.D. role: CONTACT phone: 650-799-1647 email: [email protected] lat: 37.42411 lon: -122.16608 hasResults: False
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<|newrecord|> nctId: NCT06269042 id: 0010 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength and Heart Rate Variability overallStatus: NOT_YET_RECRUITING date: 2024-03-02 date: 2024-03-07 date: 2024-03-15 date: 2024-02-21 date: 2024-02-21 name: Sierra Varona SL class: OTHER name: Universidad Europea de Madrid briefSummary: Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.
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According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in older adults could influence cardiorespiratory function.
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In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.
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Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: Inspiratory muscle training measure: Respiratory muscle strength measure: Diaphragmatic thickness and thickening fraction measure: Diaphragm movement curve measure: Heart rate variability sex: ALL minimumAge: 60 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06269029 id: P.T.Rec/012/004297 briefTitle: Chest Mobility Exercises Versus Proprioceptive Neuromuscular Facilitation in Patients With COPD overallStatus: RECRUITING date: 2024-02-17 date: 2024-05-30 date: 2024-06-30 date: 2024-02-21 date: 2024-04-18 name: Cairo University class: OTHER briefSummary: Chest mobility exercise versus proprioceptive neuromuscular facilitation in patients with chronic obstructive pulmonary disease conditions: Chronic Obstructive Pulmonary Disease Moderate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Chest mobility exercises name: proprioceptive neuromuscular facilitation measure: Pulmonary function test sex: MALE minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT facility: Cairo university- faculty of physical therapy status: RECRUITING city: Cairo state: Dokki zip: 12556 country: Egypt name: Zahraa Serry, PHD role: CONTACT phone: 012854566880 phoneExt: 02 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06269016 id: P.T.REC/012/003888 briefTitle: Effect of Hip Strengthening Exercises and Pelvic Floor Exercises on Stress Urinary Incontinence in Postnatal Women overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-20 date: 2023-08-25 date: 2024-04-20 date: 2024-02-21 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: this study will investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. Clinical practice guidelines recommend PFMT as the first-line treatment for female SUI . Also, it has been speculated that the hip muscles are involved in the continence mechanism and that their deficiency could destabilize the normal function of the system. The addition of hip muscle exercises, regardless of PFM contractions, aimed to improve muscular condition for the motor or synergic strategies in PFM contraction. Secondary effects of these techniques, such as the influence of passive lumbar rotational mobilization in improving hip flexor strength, have been of high interest in physiotherapy in general conditions: Stress Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ACTUAL name: expremental pre and post test measure: hip muscles strengthening exercise. sex: FEMALE minimumAge: 30 Years maximumAge: 35 Years stdAges: ADULT facility: Mai Mohamed Sherif Mohamed Hassan city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06269003 id: STUDY00001223 id: 1K99CA281094-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1K99CA281094-01A1 briefTitle: Responses to Message Source and Presentation Using Psychophysiology overallStatus: ENROLLING_BY_INVITATION date: 2024-02-08 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: University of Massachusetts, Worcester class: OTHER name: National Cancer Institute (NCI) briefSummary: The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape. conditions: Vaping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 112 type: ESTIMATED name: Expert name: Peer name: 1 Sided name: 2 Sided measure: Visual attention measure: Orienting response measure: Arousal measure: Attitudes measure: Behavioral intentions sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT facility: UMass Chan Medical School Shaw Building city: Worcester state: Massachusetts zip: 01605 country: United States lat: 42.26259 lon: -71.80229 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-17 uploadDate: 2024-01-31T10:39 filename: SAP_000.pdf size: 176628 hasResults: False
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<|newrecord|> nctId: NCT06268990 id: FE 1159/6-1 briefTitle: FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT acronym: DACH overallStatus: RECRUITING date: 2023-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Wiebke Kristin Fenske class: OTHER name: Medical University of Graz briefSummary: This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects. conditions: Morbid Obesity conditions: Metabolic Syndrome conditions: Diabetes conditions: PreDiabetes conditions: Insulin Resistance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Fecal microbiota transplantation measure: Insulin sensitivity measure: Insulin sensitivity measure: Glucose homeostasis measure: Body weight measure: Blood pressure measure: Fasting lipid profile measure: Fasting blood liver enzyme levels measure: Dietary intake levels measure: Metabolic inflammation measure: Gut hormones measure: Hunger and Satiety Scores measure: Fecal microbiota composition measure: Health-related quality of life measure: Tolerability of repeated FMT sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Department of Internal Medicine, Medical University Graz status: RECRUITING city: Graz zip: 8010 country: Austria name: Julia K Mader, Assoc. Prof. role: CONTACT phone: +43 316 38582383 email: [email protected] name: Julia K Mader, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR name: Patrizia Kump, PD Dr role: SUB_INVESTIGATOR lat: 47.06667 lon: 15.45 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-05-14 uploadDate: 2024-01-29T10:24 filename: Prot_SAP_000.pdf size: 651727 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-09-15 uploadDate: 2024-02-16T08:19 filename: ICF_001.pdf size: 276426 hasResults: False
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<|newrecord|> nctId: NCT06268977 id: SGLt2i in diabetic type 2 briefTitle: Using of SGLt2 Inhibitors in Patients With Type 2 DM overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-30 date: 2024-02-21 date: 2024-02-21 name: Assiut University class: OTHER briefSummary: To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes.
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- To detect the side-effects of SGLT2i conditions: Type 2 Diabetes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: SGLT2 inhibitor measure: Effect of adding SGLTi on BP measure: Effect of adding SGLTi on BMI sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06268964 id: 2023-5 briefTitle: Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics acronym: FAPD_RCT overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-21 date: 2024-02-21 name: Universidad de Colima class: OTHER briefSummary: The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.
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Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children. conditions: Functional Abdominal Pain Syndrome conditions: Functional Gastrointestinal Disorders conditions: Irritable Bowel Syndrome Variant of Childhood studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 82 type: ESTIMATED name: Trimebutine name: Lactobacillus rhamnosus name: Placebo measure: Average Score on Visual Analog Scale for Abdominal Pain measure: Improvement in Quality of Life with PedsQL 3.0 measure: Improvement in Quality of Life with PedsQL 3.0 measure: Average Score on Visual Analog Scale for Abdominal Pain measure: Number of Participants with Treatment-Related Adverse Events sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: School of Medicine, University of Colima status: RECRUITING city: Colima zip: 28040 country: Mexico name: Pablo H Sandoval-Villaseñor, MD role: CONTACT phone: +523123007655 email: [email protected] name: Fabián Rojas-Larios, PhD role: CONTACT email: [email protected] name: Carmen A Sánchez-Ramírez, PhD role: SUB_INVESTIGATOR name: Pablo H Sandoval-Villaseñor, MD role: PRINCIPAL_INVESTIGATOR name: Fabián Rojas-Larios, PhD role: SUB_INVESTIGATOR lat: 19.24997 lon: -103.72714 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-01-09 uploadDate: 2024-02-16T21:12 filename: Prot_SAP_ICF_000.pdf size: 6823982 hasResults: False
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<|newrecord|> nctId: NCT06268951 id: 23-005485 briefTitle: Recovery and Symptom Relief Following Percutaneous Ablation of Abdominal Wall Endometriosis overallStatus: ENROLLING_BY_INVITATION date: 2024-04 date: 2027-02 date: 2027-12 date: 2024-02-21 date: 2024-04-15 name: Mayo Clinic class: OTHER briefSummary: To determine the characteristics of recovery and symptom relief following ablation of abdominal wall endometriosis. conditions: Endometriosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Symptom severity due to abdominal wall endometriosis following ablation. sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06268938 id: mastoid obliteration briefTitle: Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-04 date: 2028-11-01 date: 2028-12-01 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery conditions: Cholesteatoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 4 type: ACTUAL name: Canal wall down tympanomastoidectomy measure: Size of mastoid cavity in mm sex: ALL minimumAge: 5 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Assiut university hospital city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 facility: Rehab Abd Elal Mohammed city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06268925 id: UAHS briefTitle: The Feasibility And Efficacy Of A Telerehabilitation Program For People With Knee Osteoarthiritis In Sri Lanka overallStatus: ENROLLING_BY_INVITATION date: 2024-02-22 date: 2024-04-22 date: 2024-05-03 date: 2024-02-20 date: 2024-02-20 name: University of Peradeniya class: OTHER briefSummary: it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 14 people with knee osteoarthritis will be recruited and conducted group classes through zoom primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: Exercises measure: Efficacy of telerehabilitation program measure: Feasibility and acceptability measure: lower extremity muscle strength and dynamic balance measure: pain, measure: pain stiffness and physical activity sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: M.S.F.Sarjana city: Puttalam state: North Western zip: 61300 country: Sri Lanka lat: 8.0362 lon: 79.8283 hasResults: False
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<|newrecord|> nctId: NCT06268912 id: END-ECL-2022-01 id: END-ECL-2022-01 type: OTHER domain: UIC briefTitle: Cryoanalgesia for Irreversible Pulpitis acronym: CryPain overallStatus: COMPLETED date: 2022-09-07 date: 2023-09-07 date: 2024-01-07 date: 2024-02-20 date: 2024-02-20 name: Universitat Internacional de Catalunya class: OTHER briefSummary: The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis. conditions: Pulpitis - Irreversible studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Cold Mepivacaine name: Mepivacaine at room temperature measure: Assessment of Pain and Anxiety sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gonzalo Gomez city: Barcelona zip: 08 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06268899 id: E-77082166-302.08.01-285977 briefTitle: First Mobilization Protocol for Total Knee Arthroplasty Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-08 date: 2024-03-30 date: 2024-03-30 date: 2024-02-20 date: 2024-02-20 name: Gazi University class: OTHER name: Baskent University briefSummary: This single blinded randomized controlled study evaluates the effect of developed First Mobilization Protocol applied to knee arthroplasty patients on state anxiety, kinesiophobia, initial mobilization related symptoms. conditions: Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study protocol describes the design of a single-center, single-blind, statistician-blind randomized controlled trial to be conducted in the Orthopedics and Traumatology Clinic of a provincial university hospital in Turkey. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participant: the researcher learned the study and control groups after the pre-test data. The study group was trained with the mobilization protocol. The control group received training on the current mobilization procedure of the clinic. Participants did not know which group they were in.
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Outcomes Assessor. Study and control groups data were coded into the SPSS programme as group one and group two. Analysis of data was done by an independent statistician. The statistician has no information about which group the patients belong to. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 78 type: ACTUAL name: First mobilization protocol measure: Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI) measure: Kinesiophobia evaluated using the Tampa Kinesiophobia Scale measure: Anxiety evaluated using the State Anxiety Inventory (State Anxiety Inventory, SAI) measure: Symptoms evaluated using the Numerical Rating Scale for Symptoms Related to First Mobilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University Health Research and Application Center city: Ankara zip: 06560 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06268886 id: CN008-0003 id: 2023-504840-32-00 type: REGISTRY domain: EU Trial Number id: U1111-1290-3539 type: REGISTRY domain: WHO briefTitle: Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease acronym: TargetTau-1 overallStatus: RECRUITING date: 2024-03-20 date: 2027-08-31 date: 2027-11-16 date: 2024-02-20 date: 2024-04-29 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease. conditions: Alzheimer Disease, Early Onset studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 475 type: ESTIMATED name: BMS-986446 name: Placebo measure: Mean change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score measure: Mean change from baseline in brain tau deposition as measured by tau positron emission tomography (PET) measure: Mean change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score measure: Mean change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score measure: Mean change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score measure: Mean change from baseline in Mini Mental State Examination (MMSE) score sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD First Research - Chandler status: NOT_YET_RECRUITING city: Chandler state: Arizona zip: 85226-3732 country: United States name: Hemant Pandey, Site 0068 role: CONTACT phone: 480-508-1038 lat: 33.30616 lon: -111.84125 facility: Gilbert Neurology status: NOT_YET_RECRUITING city: Gilbert state: Arizona zip: 85297-0441 country: United States name: Jonathan Hodgson, Site 0102 role: CONTACT phone: 602-761-9631 lat: 33.35283 lon: -111.78903 facility: Xenoscience Inc. - 21st Century Neurology status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85004 country: United States name: Stephen Flitman, Site 0019 role: CONTACT phone: 602-265-6500 lat: 33.44838 lon: -112.07404 facility: Imaging Endpoints LLC status: NOT_YET_RECRUITING city: Scottsdale state: Arizona zip: 85258-4595 country: United States name: Nida Laurin, Site 0026 role: CONTACT lat: 33.50921 lon: -111.89903 facility: Office of Allan M. Block, MD status: NOT_YET_RECRUITING city: Scottsdale state: Arizona zip: 85258-5133 country: United States name: Allan Block, Site 0018 role: CONTACT phone: 480-471-6132 lat: 33.50921 lon: -111.89903 facility: Tucson Neuroscience Research, LLC status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85710-6160 country: United States name: Robert Mutterperl, Site 0128 role: CONTACT phone: 520-230-1373 lat: 32.22174 lon: -110.92648 facility: Center for Neurosciences - Tucson status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85718-6522 country: United States name: Michael Badruddoja, Site 0077 role: CONTACT phone: 520-320-2147 lat: 32.22174 lon: -110.92648 facility: The Banner Alzheimer's Institute - Tucson status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85718-6632 country: United States name: Allan Anderson, Site 0038 role: CONTACT phone: 520-694-4124 lat: 32.22174 lon: -110.92648 facility: Local Institution - 0164 status: NOT_YET_RECRUITING city: Encino state: California zip: 91316-1511 country: United States name: Site 0164 role: CONTACT lat: 34.15917 lon: -118.50119 facility: Local Institution - 0139 status: NOT_YET_RECRUITING city: Fullerton state: California zip: 92835-1040 country: United States name: Site 0139 role: CONTACT lat: 33.87029 lon: -117.92534 facility: Local Institution - 0152 status: NOT_YET_RECRUITING city: La Jolla state: California zip: 92037 country: United States name: Site 0152 role: CONTACT lat: 32.84727 lon: -117.2742 facility: Local Institution - 0183 status: NOT_YET_RECRUITING city: Lakewood state: California zip: 90805-4590 country: United States name: Site 0183 role: CONTACT lat: 33.85363 lon: -118.13396 facility: Local Institution - 0073 status: ACTIVE_NOT_RECRUITING city: Lomita state: California zip: 90717-2101 country: United States lat: 33.79224 lon: -118.31507 facility: Local Institution - 0142 status: NOT_YET_RECRUITING city: Los Alamitos state: California zip: 90720-3589 country: United States name: Site 0142 role: CONTACT lat: 33.80307 lon: -118.07256 facility: Neurovations status: NOT_YET_RECRUITING city: Napa state: California zip: 94558-2415 country: United States name: Eric Grigsby, Site 0037 role: CONTACT phone: 707-252-9666 lat: 38.29714 lon: -122.28553 facility: UCSF Medical Center- Mission Bay status: NOT_YET_RECRUITING city: San Francisco state: California zip: 94143-2350 country: United States name: Peter Ljubenkov, Site 0052 role: CONTACT phone: 415-502-7562 lat: 37.77493 lon: -122.41942 facility: Local Institution - 0137 status: NOT_YET_RECRUITING city: Santa Ana state: California zip: 92705-8675 country: United States name: Site 0137 role: CONTACT lat: 33.74557 lon: -117.86783 facility: Local Institution - 0135 status: NOT_YET_RECRUITING city: Seal Beach state: California zip: 90740-6653 country: United States name: Site 0135 role: CONTACT lat: 33.74141 lon: -118.10479 facility: California Neuroscience Research Medical Group, Inc (CNR) status: NOT_YET_RECRUITING city: Sherman Oaks state: California zip: 91403-2131 country: United States name: Thomas Shiovitz, Site 0046 role: CONTACT phone: 818-986-9716 lat: 34.15112 lon: -118.44925 facility: Rocky Mountain Movement Disorder Center status: NOT_YET_RECRUITING city: Englewood state: Colorado zip: 80113-2776 country: United States name: Rajeev Kumar, Site 0092 role: CONTACT phone: 303-357-5455 lat: 39.64777 lon: -104.98776 facility: Associated Neurologists, P.C. - Danbury Office status: NOT_YET_RECRUITING city: Danbury state: Connecticut zip: 06810-4088 country: United States name: Behzad Habibi Khameneh, Site 0106 role: CONTACT phone: 203-748-2551 lat: 41.39482 lon: -73.45401 facility: Local Institution - 0148 status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510 country: United States name: Site 0148 role: CONTACT lat: 41.30815 lon: -72.92816 facility: Hasbani Neurology status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06511-5249 country: United States name: Mayer Hasbani, Site 0056 role: CONTACT phone: 212-241-8329 lat: 41.30815 lon: -72.92816 facility: Local Institution - 0153 status: NOT_YET_RECRUITING city: Stamford state: Connecticut zip: 06905-1206 country: United States name: Site 0153 role: CONTACT lat: 41.05343 lon: -73.53873 facility: Neurology of Central Florida status: NOT_YET_RECRUITING city: Altamonte Springs state: Florida zip: 32714-2436 country: United States name: Alicia Cabrera, Site 0022 role: CONTACT phone: 407-790-4990 lat: 28.66111 lon: -81.36562 facility: JEM Research Institute status: NOT_YET_RECRUITING city: Atlantis state: Florida zip: 33462-6631 country: United States name: Linda Pao, Site 0048 role: CONTACT phone: 561-968-2933 lat: 26.5909 lon: -80.10088 facility: Local Institution - 0020 status: NOT_YET_RECRUITING city: Clermont state: Florida zip: 34711-5933 country: United States name: Site 0020 role: CONTACT lat: 28.54944 lon: -81.77285 facility: Arrow Clinical Trials status: RECRUITING city: Daytona Beach state: Florida zip: 32117-5532 country: United States name: David Billmeier, Site 0009 role: CONTACT phone: 386-304-7070 lat: 29.21081 lon: -81.02283 facility: Local Institution - 0059 status: NOT_YET_RECRUITING city: Greenacres City state: Florida zip: 33467 country: United States name: Site 0059 role: CONTACT lat: 26.62368 lon: -80.12532 facility: Local Institution - 0187 status: NOT_YET_RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States name: Site 0187 role: CONTACT lat: 30.33218 lon: -81.65565 facility: Charter Research - Lady Lake status: RECRUITING city: Lady Lake state: Florida zip: 32159 country: United States name: Jeffrey Norton, Site 0151 role: CONTACT phone: 352-775-1000 lat: 28.91749 lon: -81.92286 facility: Local Institution - 0146 status: NOT_YET_RECRUITING city: Lakeland state: Florida zip: 33805-2208 country: United States name: Site 0146 role: CONTACT lat: 28.03947 lon: -81.9498 facility: Local Institution - 0143 status: NOT_YET_RECRUITING city: Maitland state: Florida zip: 32751 country: United States name: Site 0143 role: CONTACT lat: 28.62778 lon: -81.36312 facility: Merritt Island Medical Research status: RECRUITING city: Merritt Island state: Florida zip: 32952-3616 country: United States name: Gregory Kirk, Site 0027 role: CONTACT phone: 386-785-8009 lat: 28.53917 lon: -80.672 facility: Premier Clinical Research Institute - Miami status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33122-1335 country: United States name: Emelina Arocha, Site 0058 role: CONTACT phone: 786-587-9425 lat: 25.77427 lon: -80.19366 facility: Optimus U, Inc. status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33125-4013 country: United States name: Yaneicy Gonzalez Rojas, Site 0013 role: CONTACT lat: 25.77427 lon: -80.19366 facility: Project 4 Research status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33125-4719 country: United States name: Ibrahim Menendez Perez, Site 0034 role: CONTACT phone: 786-536-5755 lat: 25.77427 lon: -80.19366 facility: Vitae Research Center status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33135-2957 country: United States name: Mercedes Ponce De Leon, Site 0014 role: CONTACT phone: 786-288-2598 lat: 25.77427 lon: -80.19366 facility: Advance Medical Research Center status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33135-2968 country: United States name: Ana Acosta, Site 0005 role: CONTACT phone: 786-360-4423 lat: 25.77427 lon: -80.19366 facility: Miami Jewish Health Systems status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33137-2706 country: United States name: Marc Agronin, Site 0008 role: CONTACT phone: 305-514-8710 lat: 25.77427 lon: -80.19366 facility: Local Institution - 0176 status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33155-6540 country: United States name: Site 0176 role: CONTACT lat: 25.77427 lon: -80.19366 facility: Hope Research Network, LLC status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33166-2710 country: United States name: Jorge Jorge, Site 0071 role: CONTACT phone: 305-244-8113 lat: 25.77427 lon: -80.19366 facility: Local Institution - 0156 status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33175-3598 country: United States name: Site 0156 role: CONTACT lat: 25.77427 lon: -80.19366 facility: IMIC Research status: RECRUITING city: Miami state: Florida zip: 33176-7947 country: United States name: Ramon Leon, Site 0039 role: CONTACT phone: 786-600-7005 lat: 25.77427 lon: -80.19366 facility: Suncoast Clinical Research status: NOT_YET_RECRUITING city: New Port Richey state: Florida zip: 34652-4020 country: United States name: Cathy Barnes, Site 0017 role: CONTACT phone: 727-849-4131 lat: 28.24418 lon: -82.71927 facility: Local Institution - 0144 status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34471 country: United States name: Site 0144 role: CONTACT lat: 29.1872 lon: -82.14009 facility: Headlands Research - Orlando status: RECRUITING city: Orlando state: Florida zip: 32819-8031 country: United States name: Theodore Lee, Site 0035 role: CONTACT phone: 407-705-3471 lat: 28.53834 lon: -81.37924 facility: Local Institution - 0141 status: NOT_YET_RECRUITING city: Palm Beach Gardens state: Florida zip: 33410-4303 country: United States name: Site 0141 role: CONTACT lat: 26.82339 lon: -80.13865 facility: Alzheimer's Research and Treatment Center Stuart status: NOT_YET_RECRUITING city: Stuart state: Florida zip: 34997-5765 country: United States name: Adam Falchook, Site 0012 role: CONTACT lat: 27.19755 lon: -80.25283 facility: Local Institution - 0136 status: NOT_YET_RECRUITING city: Stuart state: Florida zip: 34997-6405 country: United States name: Site 0136 role: CONTACT lat: 27.19755 lon: -80.25283 facility: Baycare Clinical Research, LLC status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33607-6616 country: United States name: Arnaldo Orellana, Site 0080 role: CONTACT phone: 813-368-5738 lat: 27.94752 lon: -82.45843 facility: First Choice Neurology - Tampa Neurology Associates status: RECRUITING city: Tampa state: Florida zip: 33609-4090 country: United States name: Susan Steen, Site 0087 role: CONTACT phone: 813-353-9613 lat: 27.94752 lon: -82.45843 facility: Johnnie B. Byrd, Sr. Alzheimer's Foundation, Inc status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33613-4808 country: United States name: Amanda Smith, Site 0042 role: CONTACT phone: 813-974-4355 lat: 27.94752 lon: -82.45843 facility: Alzheimer's Research and Treatment Center - Wellington Location status: NOT_YET_RECRUITING city: Wellington state: Florida zip: 33414-9320 country: United States name: David Watson, Site 0011 role: CONTACT phone: 561-209-2400 lat: 26.65868 lon: -80.24144 facility: Local Institution - 0149 status: NOT_YET_RECRUITING city: West Palm Beach state: Florida zip: 33409-6611 country: United States name: Site 0149 role: CONTACT lat: 26.71534 lon: -80.05337 facility: Waypoint Research LLC status: RECRUITING city: Windermere state: Florida zip: 34786-8919 country: United States name: Craig Curtis, Site 0029 role: CONTACT phone: 352-500-5252 lat: 28.49556 lon: -81.5348 facility: Conquest Research LLC status: RECRUITING city: Winter Park state: Florida zip: 32789-1848 country: United States name: Rekha Gandhi, Site 0101 role: CONTACT phone: 321-285-2369 lat: 28.6 lon: -81.33924 facility: Charter Research - Winter Park status: RECRUITING city: Winter Park state: Florida zip: 32792 country: United States name: Edgardo Rivera, Site 0154 role: CONTACT phone: 407-863-1326 lat: 28.6 lon: -81.33924 facility: Columbus Memory Center status: NOT_YET_RECRUITING city: Columbus state: Georgia zip: 31909-1692 country: United States name: Jonathan Liss, Site 0105 role: CONTACT phone: 706-327-4000 lat: 32.46098 lon: -84.98771 facility: Great Lakes Clinical Trials status: RECRUITING city: Chicago state: Illinois zip: 60640-2831 country: United States name: Jeffrey Ross, Site 0021 role: CONTACT phone: 847-252-7300 lat: 41.85003 lon: -87.65005 facility: Local Institution - 0161 status: NOT_YET_RECRUITING city: Elk Grove Village state: Illinois zip: 60007-3362 country: United States name: Site 0161 role: CONTACT lat: 42.00392 lon: -87.97035 facility: Great Lakes Clinical Trials d/b/a Flourish Research Gurnee status: RECRUITING city: Gurnee state: Illinois zip: 60031 country: United States name: Yevgeniy Bukhman, Site 0003 role: CONTACT phone: 773-275-3500 lat: 42.3703 lon: -87.90202 facility: Local Institution - 0145 status: NOT_YET_RECRUITING city: Park Ridge state: Illinois zip: 60068 country: United States name: Site 0145 role: CONTACT lat: 42.01114 lon: -87.84062 facility: Southern Illinois University School of Medicine - SIU Neurology Clinic status: NOT_YET_RECRUITING city: Springfield state: Illinois zip: 62702-4968 country: United States name: Jennifer Arnold, Site 0081 role: CONTACT phone: 217-545-7200 lat: 39.80172 lon: -89.64371 facility: Boston Clinical Trials status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02131-2515 country: United States name: Deborah Green-LaRoche, Site 0025 role: CONTACT phone: 617-636-7606 lat: 42.35843 lon: -71.05977 facility: Boston Neuropsychiatry status: NOT_YET_RECRUITING city: Braintree state: Massachusetts zip: 02184-1939 country: United States name: Malini Nair, Site 0015 role: CONTACT phone: 617-302-6388 lat: 42.22232 lon: -70.99949 facility: ActivMed Practices & Research, Inc. - Methuen status: NOT_YET_RECRUITING city: Methuen state: Massachusetts zip: 01844-5864 country: United States name: Michael McCartney, Site 0118 role: CONTACT phone: 19789789696897 lat: 42.7262 lon: -71.19089 facility: Boston Center for Memory status: NOT_YET_RECRUITING city: Newton state: Massachusetts zip: 02459-3328 country: United States name: Paul Solomon, Site 0040 role: CONTACT phone: 617-699-6927 lat: 42.33704 lon: -71.20922 facility: Office of Donald S. Marks, M.D., P.C. status: NOT_YET_RECRUITING city: Plymouth state: Massachusetts zip: 02360-7223 country: United States name: Donald Marks, Site 0120 role: CONTACT phone: 508-269-0403 lat: 41.95844 lon: -70.66726 facility: Adams Clinical Trials, LLC status: NOT_YET_RECRUITING city: Watertown state: Massachusetts zip: 02472-4153 country: United States name: Stephanie Rutrick, Site 0045 role: CONTACT phone: 617-697-1843 lat: 42.37093 lon: -71.18283 facility: Local Institution - 0150 status: NOT_YET_RECRUITING city: Ozark state: Missouri zip: 65721 country: United States name: Site 0150 role: CONTACT lat: 37.02089 lon: -93.20602 facility: Local Institution - 0169 status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63104-1027 country: United States name: Site 0169 role: CONTACT lat: 38.62727 lon: -90.19789 facility: ActivMed Practices & Research, Inc. - Portsmouth status: NOT_YET_RECRUITING city: Portsmouth state: New Hampshire zip: 03801-6822 country: United States name: Marc Shay, Site 0119 role: CONTACT phone: 603-319-8863 lat: 43.07176 lon: -70.76255 facility: Princeton Medical Institute status: NOT_YET_RECRUITING city: Princeton state: New Jersey zip: 08540-2859 country: United States name: Sanjay Varma, Site 0031 role: CONTACT phone: 609-921-3555 lat: 40.34872 lon: -74.65905 facility: Advanced Memory Research Institute of NJ status: NOT_YET_RECRUITING city: Toms River state: New Jersey zip: 08755-5043 country: United States name: Sanjiv Sharma, Site 0062 role: CONTACT phone: 732-341-9500 lat: 39.95373 lon: -74.19792 facility: Neurology Specialists of Monmouth County, PA status: NOT_YET_RECRUITING city: West Long Branch state: New Jersey zip: 07764-1021 country: United States name: Noah Gilson, Site 0130 role: CONTACT phone: 732-935-1850 lat: 40.29039 lon: -74.01764 facility: Neurological Associates of Albany, P.C. status: NOT_YET_RECRUITING city: Albany state: New York zip: 12208-3464 country: United States name: Richard Holub, Site 0060 role: CONTACT phone: 518-426-0575 lat: 42.65258 lon: -73.75623 facility: Local Institution - 0157 status: NOT_YET_RECRUITING city: Amherst state: New York zip: 14226-1727 country: United States name: Site 0157 role: CONTACT lat: 42.97839 lon: -78.79976 facility: The Feinstein Institute for Medical Research status: NOT_YET_RECRUITING city: Manhasset state: New York zip: 11030-3816 country: United States name: Marc Gordon, Site 0061 role: CONTACT phone: 516-562-3492 lat: 40.79788 lon: -73.69957 facility: Neurological Associates of Long Island status: NOT_YET_RECRUITING city: New Hyde Park state: New York zip: 11042-1028 country: United States name: David Podwall, Site 0107 role: CONTACT phone: 516-466-4700 lat: 40.7351 lon: -73.68791 facility: Icahn School of Medicine at Mount Sinai (ISMMS) - Alzheimer's Disease Research Center status: NOT_YET_RECRUITING city: New York state: New York zip: 10029-6504 country: United States name: Laili Soleimani, Site 0104 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Columbia University Medical Center - The Neurological Institute of New York status: NOT_YET_RECRUITING city: New York state: New York zip: 10032-3726 country: United States name: Lawrence Honig, Site 0133 role: CONTACT phone: 212-305-0851 lat: 40.71427 lon: -74.00597 facility: Local Institution - 0095 status: NOT_YET_RECRUITING city: New York state: New York zip: 11220 country: United States name: Site 0095 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Alzheimer's Memory Center status: NOT_YET_RECRUITING city: Matthews state: North Carolina zip: 28105-8336 country: United States name: Mohammad Bolouri, Site 0043 role: CONTACT phone: 7043644000225 lat: 35.11681 lon: -80.72368 facility: Local Institution - 0155 status: NOT_YET_RECRUITING city: Beachwood state: Ohio zip: 44122 country: United States name: Site 0155 role: CONTACT lat: 41.4645 lon: -81.50873 facility: Abington Neurological Associates (ANA) status: NOT_YET_RECRUITING city: Abington state: Pennsylvania zip: 19001-3816 country: United States name: David Weisman, Site 0057 role: CONTACT phone: 215-886-7000 lat: 40.12067 lon: -75.11795 facility: Hospital of the University of Pennsylvania status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Sanjeev Vaishnavi, Site 0032 role: CONTACT phone: 215-662-7810 lat: 39.95233 lon: -75.16379 facility: Keystone Clinical Studies, LLC status: RECRUITING city: Plymouth Meeting state: Pennsylvania zip: 19462-7401 country: United States name: Cherian Verghese, Site 0023 role: CONTACT lat: 40.10233 lon: -75.27435 facility: Rhode Island Mood & Memory Research Institute status: NOT_YET_RECRUITING city: East Providence state: Rhode Island zip: 02914-1318 country: United States name: John Stoukides, Site 0024 role: CONTACT phone: 401-435-8950 lat: 41.81371 lon: -71.37005 facility: Rhode Island Hospital - Alzheimer's Disease and Memory Disorders Center status: NOT_YET_RECRUITING city: Providence state: Rhode Island zip: 02903-4923 country: United States name: Chuang-Kuo Wu, Site 0098 role: CONTACT phone: 401-444-5742 lat: 41.82399 lon: -71.41283 facility: Local Institution - 0163 status: NOT_YET_RECRUITING city: Providence state: Rhode Island zip: 02906-4800 country: United States name: Site 0163 role: CONTACT lat: 41.82399 lon: -71.41283 facility: Neurology Clinic, P.C. - Germantown Park Location status: NOT_YET_RECRUITING city: Cordova state: Tennessee zip: 38018-4254 country: United States name: Kendrick Henderson, Site 0132 role: CONTACT phone: 901-866-9252 lat: 35.15565 lon: -89.7762 facility: Local Institution - 0140 status: NOT_YET_RECRUITING city: Franklin state: Tennessee zip: 37067-5922 country: United States name: Site 0140 role: CONTACT lat: 35.92506 lon: -86.86889 facility: Senior Adults Specialty Research status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78757-8046 country: United States name: Jaron Winston, Site 0069 role: CONTACT phone: 512-476-3556 lat: 30.26715 lon: -97.74306 facility: Gadolin Research status: NOT_YET_RECRUITING city: Beaumont state: Texas zip: 77702 country: United States name: Kandasami Senthilkumar, Site 0033 role: CONTACT phone: 409-331-6040 lat: 30.08605 lon: -94.10185 facility: Kerwin Research Center and Memory Care status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75231-4316 country: United States name: Diana Kerwin, Site 0051 role: CONTACT phone: 972-433-9100 lat: 32.78306 lon: -96.80667 facility: Neurology Consultants of Dallas status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75243-1288 country: United States name: Duc Tran, Site 0134 role: CONTACT phone: 214-750-0322 lat: 32.78306 lon: -96.80667 facility: Baylor College of Medicine status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Melissa Yu, Site 0041 role: CONTACT phone: 713-798-6107 lat: 29.76328 lon: -95.36327 facility: Memorial Neurological Association - Main Office status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77074-1812 country: United States name: Nelson Berrios, Site 0016 role: CONTACT lat: 29.76328 lon: -95.36327 facility: Central Texas Neurology Consultants (CTNC) status: NOT_YET_RECRUITING city: Round Rock state: Texas zip: 78681-3578 country: United States name: Elizabeth Peckham, Site 0129 role: CONTACT phone: 512-218-1222 lat: 30.50826 lon: -97.6789 facility: Be Well MD status: NOT_YET_RECRUITING city: Round Rock state: Texas zip: 78681-3596 country: United States name: Mark Carlson, Site 0028 role: CONTACT lat: 30.50826 lon: -97.6789 facility: Local Institution - 0168 status: NOT_YET_RECRUITING city: Richmond state: Virginia zip: 23294 country: United States name: Site 0168 role: CONTACT lat: 37.55376 lon: -77.46026 facility: Local Institution - 0065 status: NOT_YET_RECRUITING city: Madison state: Wisconsin zip: 53792 country: United States name: Site 0065 role: CONTACT lat: 43.07305 lon: -89.40123 facility: Local Institution - 0002 status: NOT_YET_RECRUITING city: Darlinghurst state: New South Wales zip: 2010 country: Australia name: Site 0002 role: CONTACT lat: -33.87939 lon: 151.21925 facility: Local Institution - 0111 status: NOT_YET_RECRUITING city: East Gosford state: New South Wales zip: 2250 country: Australia name: Site 0111 role: CONTACT lat: -33.43874 lon: 151.35338 facility: Local Institution - 0170 status: NOT_YET_RECRUITING city: Macquarie Park state: New South Wales zip: 2113 country: Australia name: Site 0170 role: CONTACT lat: -33.7751 lon: 151.11272 facility: Local Institution - 0116 status: NOT_YET_RECRUITING city: Southport state: Queensland zip: 4215 country: Australia name: Site 0116 role: CONTACT lat: -27.96724 lon: 153.39796 facility: Local Institution - 0115 status: NOT_YET_RECRUITING city: Carlton North state: Victoria zip: 3053 country: Australia name: Site 0115 role: CONTACT lat: -37.78333 lon: 144.96667 facility: Local Institution - 0093 status: NOT_YET_RECRUITING city: Heidelberg state: Victoria zip: 3084 country: Australia name: Site 0093 role: CONTACT lat: -37.75 lon: 145.06667 facility: Local Institution - 0001 status: NOT_YET_RECRUITING city: Malvern state: Victoria zip: 3144 country: Australia name: Site 0001 role: CONTACT lat: -32.02849 lon: 151.32225 facility: Local Institution - 0125 status: NOT_YET_RECRUITING city: Melbourne state: Victoria zip: 03181 country: Australia name: Site 0125 role: CONTACT lat: -37.814 lon: 144.96332 facility: Local Institution - 0147 status: NOT_YET_RECRUITING city: Parkville state: Victoria zip: 3050 country: Australia name: Site 0147 role: CONTACT lat: -37.78333 lon: 144.95 facility: Local Institution - 0094 status: NOT_YET_RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Site 0094 role: CONTACT lat: -31.98184 lon: 115.8073 facility: Local Institution - 0122 status: NOT_YET_RECRUITING city: Anderlecht state: Brussels zip: 1070 country: Belgium name: Site 0122 role: CONTACT lat: 50.83619 lon: 4.31454 facility: Local Institution - 0175 status: NOT_YET_RECRUITING city: Antwerpen state: Brussel zip: 2018 country: Belgium name: Site 0175 role: CONTACT lat: 51.21989 lon: 4.40346 facility: Local Institution - 0074 status: NOT_YET_RECRUITING city: Brussel state: BRU zip: 1020 country: Belgium name: Site 0074 role: CONTACT lat: 50.85045 lon: 4.34878 facility: Local Institution - 0082 status: NOT_YET_RECRUITING city: Kortrijk state: VWV zip: 8500 country: Belgium name: Site 0082 role: CONTACT lat: 50.82803 lon: 3.26487 facility: Local Institution - 0078 status: NOT_YET_RECRUITING city: Liege state: WLG zip: 4000 country: Belgium name: Site 0078 role: CONTACT lat: 50.63373 lon: 5.56749 facility: Local Institution - 0097 status: NOT_YET_RECRUITING city: Brussels zip: 1200 country: Belgium name: Site 0097 role: CONTACT lat: 50.85045 lon: 4.34878 facility: Local Institution - 0076 status: NOT_YET_RECRUITING city: Leuven zip: 3000 country: Belgium name: Site 0076 role: CONTACT lat: 50.87959 lon: 4.70093 facility: Local Institution - 0064 status: NOT_YET_RECRUITING city: Kelowna state: British Columbia zip: V1Y 4N7 country: Canada name: Site 0064 role: CONTACT lat: 49.88307 lon: -119.48568 facility: Local Institution - 0049 status: NOT_YET_RECRUITING city: West Vancouver state: British Columbia zip: V7T 2Z3 country: Canada name: Site 0049 role: CONTACT lat: 49.36672 lon: -123.16652 facility: Local Institution - 0112 status: NOT_YET_RECRUITING city: Ottawa state: Ontario zip: K1Z 8R7 country: Canada name: Site 0112 role: CONTACT lat: 45.41117 lon: -75.69812 facility: Local Institution - 0162 status: NOT_YET_RECRUITING city: Peterborough state: Ontario zip: K9H 2P4 country: Canada name: Site 0162 role: CONTACT lat: 44.30012 lon: -78.31623 facility: Local Institution - 0047 status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M3B 2S7 country: Canada name: Site 0047 role: CONTACT lat: 43.70011 lon: -79.4163 facility: Local Institution - 0044 status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Site 0044 role: CONTACT lat: 43.70011 lon: -79.4163 facility: Local Institution - 0109 status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M6A 2E1 country: Canada name: Site 0109 role: CONTACT lat: 43.70011 lon: -79.4163 facility: Local Institution - 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<|newrecord|> nctId: NCT06268873 id: D6972C00003 briefTitle: A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. overallStatus: RECRUITING date: 2024-03-29 date: 2027-12-10 date: 2027-12-10 date: 2024-02-20 date: 2024-04-25 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone.
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Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued. conditions: Chronic Kidney Disease and Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Placebo controlled whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2500 type: ESTIMATED name: Baxdrostat/dapagliflozin name: Dapagliflozin in combination with placebo measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time. measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio). measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP. measure: To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease). measure: To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate). sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: Research Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85016 country: United States lat: 33.44838 lon: -112.07404 facility: Research Site status: NOT_YET_RECRUITING city: Surprise state: Arizona zip: 85374 country: United States lat: 33.63059 lon: -112.33322 facility: Research Site status: NOT_YET_RECRUITING city: Searcy state: Arkansas zip: 72143 country: United States lat: 35.25064 lon: -91.73625 facility: Research Site status: NOT_YET_RECRUITING city: Beverly Hills state: California zip: 90211 country: United States lat: 34.07362 lon: -118.40036 facility: Research Site status: NOT_YET_RECRUITING city: Canyon Country state: California zip: 91351 country: United States lat: 34.42333 lon: -118.47203 facility: Research Site status: RECRUITING city: Fullerton state: California zip: 92835 country: United States lat: 33.87029 lon: -117.92534 facility: Research Site status: NOT_YET_RECRUITING city: Huntington Park state: California zip: 90255 country: United States lat: 33.98168 lon: -118.22507 facility: Research Site status: RECRUITING city: Lincoln state: California zip: 95648 country: United States lat: 38.89156 lon: -121.29301 facility: Research Site status: NOT_YET_RECRUITING city: 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48202 country: United States lat: 42.33143 lon: -83.04575 facility: Research Site status: NOT_YET_RECRUITING city: Pontiac state: Michigan zip: 48341 country: United States lat: 42.63892 lon: -83.29105 facility: Research Site status: NOT_YET_RECRUITING city: Saint Joseph state: Michigan zip: 49085 country: United States lat: 42.10976 lon: -86.48002 facility: Research Site status: NOT_YET_RECRUITING city: Columbia state: Missouri zip: 65201 country: United States lat: 38.95171 lon: -92.33407 facility: Research Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64111 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64128 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64151 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63136 country: United States lat: 38.62727 lon: -90.19789 facility: Research Site status: NOT_YET_RECRUITING city: Saint Peters state: Missouri zip: 63376 country: United States lat: 38.80033 lon: -90.62651 facility: Research Site status: NOT_YET_RECRUITING city: Eatontown state: New Jersey zip: 07724 country: United States lat: 40.29622 lon: -74.05097 facility: Research Site status: NOT_YET_RECRUITING city: Binghamton state: New York zip: 13905 country: United States lat: 42.09869 lon: -75.91797 facility: Research Site status: NOT_YET_RECRUITING city: Buffalo state: New York zip: 14203 country: United States lat: 42.88645 lon: -78.87837 facility: Research Site status: NOT_YET_RECRUITING city: Middletown state: New York zip: 10940 country: United States lat: 41.44593 lon: -74.42293 facility: Research Site status: NOT_YET_RECRUITING city: New Hyde Park state: New York zip: 11042 country: United States lat: 40.7351 lon: -73.68791 facility: Research Site 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35.78264 lon: -80.8873 facility: Research Site status: NOT_YET_RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Research Site status: NOT_YET_RECRUITING city: Wilmington state: North Carolina zip: 28412 country: United States lat: 34.22573 lon: -77.94471 facility: Research Site status: NOT_YET_RECRUITING city: Columbus state: Ohio zip: 43213 country: United States lat: 39.96118 lon: -82.99879 facility: Research Site status: NOT_YET_RECRUITING city: Columbus state: Ohio zip: 43215 country: United States lat: 39.96118 lon: -82.99879 facility: Research Site status: NOT_YET_RECRUITING city: Maumee state: Ohio zip: 43537 country: United States lat: 41.56283 lon: -83.65382 facility: Research Site status: NOT_YET_RECRUITING city: Roseburg state: Oregon zip: 97471 country: United States lat: 43.2165 lon: -123.34174 facility: Research Site status: NOT_YET_RECRUITING city: Chester state: Pennsylvania zip: 19013 country: United States lat: 39.84967 lon: -75.35707 facility: Research Site status: NOT_YET_RECRUITING city: Langhorne state: Pennsylvania zip: 19047 country: United States lat: 40.17455 lon: -74.92267 facility: Research Site status: RECRUITING city: Uniontown state: Pennsylvania zip: 15401 country: United States lat: 39.90008 lon: -79.71643 facility: Research Site status: NOT_YET_RECRUITING city: East Providence state: Rhode Island zip: 02914 country: United States lat: 41.81371 lon: -71.37005 facility: Research Site status: NOT_YET_RECRUITING city: East Providence state: Rhode Island zip: 02915 country: United States lat: 41.81371 lon: -71.37005 facility: Research Site status: NOT_YET_RECRUITING city: Providence state: Rhode Island zip: 02904 country: United States lat: 41.82399 lon: -71.41283 facility: Research Site status: NOT_YET_RECRUITING city: Columbia state: South Carolina zip: 29203 country: United States lat: 34.00071 lon: -81.03481 facility: Research Site status: NOT_YET_RECRUITING 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133.78333 facility: Research Site status: NOT_YET_RECRUITING city: Matsuyama-city zip: 790-0024 country: Japan lat: 33.83916 lon: 132.76574 facility: Research Site status: NOT_YET_RECRUITING city: Naka zip: 311-0113 country: Japan lat: 36.05 lon: 140.16667 facility: Research Site status: NOT_YET_RECRUITING city: Nishinomiya-Shi zip: 662-0918 country: Japan lat: 34.71562 lon: 135.33199 facility: Research Site status: NOT_YET_RECRUITING city: Obihiro-shi zip: 080-0848 country: Japan lat: 42.91722 lon: 143.20444 facility: Research Site status: NOT_YET_RECRUITING city: Oita-shi zip: 870-0033 country: Japan lat: 33.23333 lon: 131.6 facility: Research Site status: NOT_YET_RECRUITING city: Osaka-shi zip: 553-0003 country: Japan lat: 34.69374 lon: 135.50218 facility: Research Site status: NOT_YET_RECRUITING city: Osaka zip: 553-0003 country: Japan lat: 34.69374 lon: 135.50218 facility: Research Site status: NOT_YET_RECRUITING city: Sapporo zip: 064-8570 country: Japan lat: 43.06667 lon: 141.35 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NOT_YET_RECRUITING city: Dammam zip: 31444 country: Saudi Arabia lat: 26.43442 lon: 50.10326 facility: Research Site status: NOT_YET_RECRUITING city: Riyadh zip: 11426 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: Research Site status: NOT_YET_RECRUITING city: Riyadh zip: 11462 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: Research Site status: NOT_YET_RECRUITING city: Riyadh zip: 11525 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: Research Site status: NOT_YET_RECRUITING city: Riyadh zip: 12713 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: Research Site status: NOT_YET_RECRUITING city: Belgrade zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 facility: Research Site status: NOT_YET_RECRUITING city: Belgrade zip: 11120 country: Serbia lat: 44.80401 lon: 20.46513 facility: Research Site status: NOT_YET_RECRUITING city: Kragujevac zip: 34000 country: Serbia lat: 44.01667 lon: 20.91667 facility: Research Site status: NOT_YET_RECRUITING city: Nis zip: 18000 country: Serbia lat: 43.32472 lon: 21.90333 facility: Research Site status: NOT_YET_RECRUITING city: Novi Sad zip: 21000 country: Serbia lat: 45.25167 lon: 19.83694 facility: Research Site status: NOT_YET_RECRUITING city: Banska Bystrica zip: 974 01 country: Slovakia lat: 48.73946 lon: 19.15349 facility: Research Site status: NOT_YET_RECRUITING city: Dolný Kubín zip: 02601 country: Slovakia lat: 49.20983 lon: 19.30341 facility: Research Site status: NOT_YET_RECRUITING city: Kosice zip: 04001 country: Slovakia lat: 48.71395 lon: 21.25808 facility: Research Site status: NOT_YET_RECRUITING city: Lucenec zip: 984 01 country: Slovakia lat: 48.33249 lon: 19.66708 facility: Research Site status: NOT_YET_RECRUITING city: Myjava zip: 90701 country: Slovakia lat: 48.75876 lon: 17.56866 facility: Research Site status: NOT_YET_RECRUITING city: Nitra zip: 949 01 country: Slovakia lat: 48.30763 lon: 18.08453 facility: Research Site status: NOT_YET_RECRUITING city: Nitra zip: 949 11 country: Slovakia lat: 48.30763 lon: 18.08453 facility: Research Site status: NOT_YET_RECRUITING city: Presov zip: 080 01 country: Slovakia lat: 48.99839 lon: 21.23393 facility: Research Site status: NOT_YET_RECRUITING city: Puchov zip: 020 01 country: Slovakia lat: 49.12494 lon: 18.32597 facility: Research Site status: NOT_YET_RECRUITING city: Rožňava zip: 048 01 country: Slovakia lat: 48.66009 lon: 20.53758 facility: Research Site status: NOT_YET_RECRUITING city: Trnava zip: 91708 country: Slovakia lat: 48.37741 lon: 17.58723 facility: Research Site status: NOT_YET_RECRUITING city: Zilina zip: 010 01 country: Slovakia lat: 49.22315 lon: 18.73941 facility: Research Site status: NOT_YET_RECRUITING city: Benoni zip: 1501 country: South Africa lat: -26.18848 lon: 28.32078 facility: Research Site status: NOT_YET_RECRUITING city: Bloemfontein zip: 9301 country: South Africa lat: -29.12107 lon: 26.214 facility: Research Site status: NOT_YET_RECRUITING city: Cape Town zip: 7570 country: South Africa lat: -33.92584 lon: 18.42322 facility: Research Site status: NOT_YET_RECRUITING city: Cape Town zip: 7925 country: South Africa lat: -33.92584 lon: 18.42322 facility: Research Site status: NOT_YET_RECRUITING city: Durban zip: 4001 country: South Africa lat: -29.8579 lon: 31.0292 facility: Research Site status: NOT_YET_RECRUITING city: Lenasia zip: 1827 country: South Africa lat: -26.32052 lon: 27.83564 facility: Research Site status: NOT_YET_RECRUITING city: Midrand zip: 1685 country: South Africa lat: -25.98953 lon: 28.12843 facility: Research Site status: NOT_YET_RECRUITING city: Newton zip: 2113 country: South Africa facility: Research Site status: NOT_YET_RECRUITING city: Parow zip: 7505 country: South Africa lat: -33.89723 lon: 18.59992 facility: Research Site status: NOT_YET_RECRUITING city: Stanger zip: 4450 country: South Africa lat: -29.32816 lon: 31.28954 facility: Research Site status: NOT_YET_RECRUITING city: Almeria zip: 4009 country: Spain lat: 36.83814 lon: -2.45974 facility: Research Site status: NOT_YET_RECRUITING city: Badalona zip: 08916 country: Spain lat: 41.45004 lon: 2.24741 facility: Research Site status: NOT_YET_RECRUITING city: L'Hospitalet de Llobregat zip: 08907 country: Spain lat: 41.35967 lon: 2.10028 facility: Research Site status: NOT_YET_RECRUITING city: La Coruna zip: 15006 country: Spain lat: 43.37135 lon: -8.396 facility: Research Site status: NOT_YET_RECRUITING city: Lugo zip: 27004 country: Spain lat: 43.00992 lon: -7.55602 facility: Research Site status: NOT_YET_RECRUITING city: Madrid zip: 28040 country: Spain lat: 40.4165 lon: -3.70256 facility: Research Site status: NOT_YET_RECRUITING city: Malaga zip: 29010 country: Spain lat: 36.72016 lon: -4.42034 facility: Research Site status: NOT_YET_RECRUITING city: Málaga zip: 29010 country: Spain lat: 36.72016 lon: -4.42034 facility: Research Site status: NOT_YET_RECRUITING city: Palma deMallorca zip: 07010 country: Spain lat: 39.56939 lon: 2.65024 facility: Research Site status: NOT_YET_RECRUITING city: Pamplona zip: 31008 country: Spain lat: 42.81687 lon: -1.64323 facility: Research Site status: NOT_YET_RECRUITING city: Sevilla zip: 41950 country: Spain lat: 37.38283 lon: -5.97317 facility: Research Site status: NOT_YET_RECRUITING city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 facility: Research Site status: NOT_YET_RECRUITING city: Danderyd zip: 182 57 country: Sweden lat: 59.3987 lon: 18.02942 facility: Research Site status: NOT_YET_RECRUITING city: Gavle zip: 80188 country: Sweden lat: 60.67452 lon: 17.14174 facility: Research Site status: NOT_YET_RECRUITING city: Göteborg zip: 413 46 country: Sweden lat: 57.70716 lon: 11.96679 facility: Research Site status: NOT_YET_RECRUITING city: Linkoping zip: 58185 country: Sweden lat: 58.41086 lon: 15.62157 facility: Research Site status: NOT_YET_RECRUITING city: Rättvik zip: 79530 country: Sweden lat: 60.88632 lon: 15.11787 facility: Research Site status: NOT_YET_RECRUITING city: Stockholm zip: 141 86 country: Sweden lat: 59.33258 lon: 18.0649 facility: Research Site status: NOT_YET_RECRUITING city: Uppsala zip: 751 85 country: Sweden lat: 59.85882 lon: 17.63889 facility: Research Site status: NOT_YET_RECRUITING city: Varberg zip: 43281 country: Sweden lat: 57.10557 lon: 12.25078 facility: Research Site status: NOT_YET_RECRUITING city: Kaohsiung City zip: 80756 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site status: NOT_YET_RECRUITING city: Kaohsiung zip: 81362 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site status: NOT_YET_RECRUITING city: Taichung zip: 402 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site status: NOT_YET_RECRUITING city: Taichung zip: 40447 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site status: NOT_YET_RECRUITING city: Taipei City zip: 110 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: NOT_YET_RECRUITING city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: NOT_YET_RECRUITING city: Taipei zip: 112 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: NOT_YET_RECRUITING city: Yung Kang City zip: 71044 country: Taiwan facility: Research Site status: NOT_YET_RECRUITING city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site status: NOT_YET_RECRUITING city: Bangkok zip: 10700 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site status: NOT_YET_RECRUITING city: Chiang Mai zip: 50200 country: Thailand lat: 18.79038 lon: 98.98468 facility: Research Site status: NOT_YET_RECRUITING city: Hat Yai zip: 90110 country: Thailand lat: 7.00836 lon: 100.47668 facility: Research Site status: NOT_YET_RECRUITING city: Muang zip: 34000 country: Thailand facility: Research Site status: NOT_YET_RECRUITING city: Muang zip: 40002 country: Thailand facility: Research Site status: NOT_YET_RECRUITING city: Phutthamonthon zip: 73170 country: Thailand facility: Research Site status: NOT_YET_RECRUITING city: Ratchathewi zip: 10400 country: Thailand lat: 13.759 lon: 100.53358 facility: Research Site status: NOT_YET_RECRUITING city: Adana zip: 01060 country: Turkey lat: 37.00167 lon: 35.32889 facility: Research Site status: NOT_YET_RECRUITING city: Adapazarı zip: 54100 country: Turkey lat: 40.78056 lon: 30.40333 facility: Research Site status: NOT_YET_RECRUITING city: Afyonkarahisar zip: 03030 country: Turkey lat: 38.75667 lon: 30.54333 facility: Research Site status: NOT_YET_RECRUITING city: Ankara zip: 06230 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site status: NOT_YET_RECRUITING city: Antalya zip: 07059 country: Turkey lat: 36.90812 lon: 30.69556 facility: Research Site status: NOT_YET_RECRUITING city: Bursa zip: 16059 country: Turkey lat: 40.19559 lon: 29.06013 facility: Research Site status: NOT_YET_RECRUITING city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 facility: Research Site status: NOT_YET_RECRUITING city: Kahramanmaras zip: 46100 country: Turkey lat: 37.5847 lon: 36.92641 facility: Research Site status: NOT_YET_RECRUITING city: Kayseri zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 facility: Research Site status: NOT_YET_RECRUITING city: Kocaeli zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 facility: Research Site status: NOT_YET_RECRUITING city: Chernivtsі zip: 58002 country: Ukraine facility: Research Site status: NOT_YET_RECRUITING city: Ivano-Frankivsk zip: 76000 country: Ukraine lat: 48.9215 lon: 24.70972 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 02081 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 02125 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 03037 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 03057 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 04050 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Ternopil zip: 46000 country: Ukraine lat: 49.55589 lon: 25.60556 facility: Research Site status: NOT_YET_RECRUITING city: Ternopil zip: 46001 country: Ukraine lat: 49.55589 lon: 25.60556 facility: Research Site status: NOT_YET_RECRUITING city: Uzhhorod zip: 88018 country: Ukraine lat: 48.61667 lon: 22.3 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsia zip: 21009 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsia zip: 21018 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsia zip: 21029 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsya zip: 21001 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Bristol zip: BS105NB country: United Kingdom lat: 51.45523 lon: -2.59665 facility: Research Site status: NOT_YET_RECRUITING city: Cambridge zip: CB2 0XY country: United Kingdom lat: 52.2 lon: 0.11667 facility: Research Site status: NOT_YET_RECRUITING city: Harrow zip: HA3 7LT country: United Kingdom lat: 51.57142 lon: -0.33371 facility: Research Site status: NOT_YET_RECRUITING city: Leicester zip: LE1 5WW country: United Kingdom lat: 52.6386 lon: -1.13169 facility: Research Site status: NOT_YET_RECRUITING city: Liverpool zip: L9 7AL country: United Kingdom lat: 53.41058 lon: -2.97794 facility: Research Site status: NOT_YET_RECRUITING city: London zip: EC1A 2BE country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SE5 9RJ country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Newcastle-Under-Lyme zip: ST4 6QG country: United Kingdom lat: 53.0 lon: -2.23333 facility: Research Site status: NOT_YET_RECRUITING city: Nottingham zip: NG5 1PB country: United Kingdom lat: 52.9536 lon: -1.15047 facility: Research Site status: NOT_YET_RECRUITING city: Wolverhampton zip: WV10 0QP country: United Kingdom lat: 52.58547 lon: -2.12296 facility: Research Site status: NOT_YET_RECRUITING city: Bien Hoa zip: 810000 country: Vietnam lat: 10.94469 lon: 106.82432 facility: Research Site status: NOT_YET_RECRUITING city: Da Nang zip: 550000 country: Vietnam lat: 16.06778 lon: 108.22083 facility: Research Site status: WITHDRAWN city: Ha Noi zip: 100000 country: Vietnam lat: 20.47366 lon: 106.02292 facility: Research Site status: NOT_YET_RECRUITING city: Ho Chi Minh zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site status: NOT_YET_RECRUITING city: Hochiminh city zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 hasResults: False
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<|newrecord|> nctId: NCT06268860 id: 20220015 briefTitle: A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants overallStatus: RECRUITING date: 2024-02-15 date: 2024-08-29 date: 2024-08-29 date: 2024-02-20 date: 2024-04-12 name: Amgen class: INDUSTRY briefSummary: The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 230 type: ESTIMATED name: Rocatinlimab vial injection name: Rocatinlimab prefilled syringe measure: Maximum Observed Serum Concentration (Cmax) of Rocatinlimab measure: Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab measure: AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) measure: Number of Participants Experiencing Serious Adverse Events (SAE) measure: Number of Participants Positive to Anti-rocatinlimab Antibody sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fortrea Clinical Research Unit - Daytona Beach status: RECRUITING city: Daytona Beach state: Florida zip: 32117-5116 country: United States lat: 29.21081 lon: -81.02283 facility: Fortrea Clinical Research Unit - Dallas status: RECRUITING city: Dallas state: Texas zip: 75247-4968 country: United States lat: 32.78306 lon: -96.80667 facility: Fortrea Clinical Research Unit Limited - Leeds status: RECRUITING city: Leeds state: LDS zip: LS2 9LH country: United Kingdom lat: 53.79648 lon: -1.54785 hasResults: False
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<|newrecord|> nctId: NCT06268847 id: DERMATIDYSS briefTitle: Efficacy of Marine By-product Hydrolysate on the Reduction of Atopic Dermatitis Symptoms overallStatus: RECRUITING date: 2024-01-09 date: 2024-06-18 date: 2024-06-18 date: 2024-02-20 date: 2024-02-20 name: Abyss Ingredients class: INDUSTRY name: Eurofins briefSummary: This interventional, double-blind, randomized, placebo-controlled study aims to evaluate the effect of a marine by-product hydrolysate supplementation on the reduction of atopic dermatitis symptoms. conditions: Atopic Dermatitis conditions: Eczema studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Placebo name: ACT01 name: ACT02 measure: SCORAD (SCORing Atopic Dermatitis) measure: EASI (Eczema Area and Severity Index) measure: Investigator Global Assessment scale measure: Corneometer measure: Tewameter measure: Quality of Life Index - Perceived Stress measure: Participant's Satisfaction sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Eurofins status: RECRUITING city: Barcelona zip: 08013 country: Spain name: Jessica Zumaquero role: CONTACT phone: +34 932 85 14 46 phoneExt: 1110 email: [email protected] lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06268834 id: ZonulinPPI briefTitle: Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome overallStatus: COMPLETED date: 2023-10-04 date: 2023-12-31 date: 2023-12-31 date: 2024-02-20 date: 2024-02-20 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: Our study aims to investigate the effect of bacterial overgrowth induced by long-term PPI use on zonulin levels. conditions: Proton Pump Inhibitor Adverse Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: PREVENTION masking: NONE count: 75 type: ACTUAL name: Blood for zonulin level was drawn from the group. measure: Zonulin levels in long-term proton pump inhibitor users sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06268821 id: ADC-UK-PMS-23059 briefTitle: Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-01 date: 2025-01 date: 2024-02-20 date: 2024-02-20 name: Abbott Diabetes Care class: INDUSTRY briefSummary: The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen. conditions: Type 2 Diabetes Treated With Insulin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 82 type: ESTIMATED name: FreeStyle Libre 2 Flash Glucose Monitoring System measure: HbA1c measure: Time in range (TIR) measure: Time above range (TAR) measure: Time below range (TBR) measure: Frequency of hypoglycaemia events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pihlajalinna Jämsä, Välikatu 1, city: Jämsä zip: 42100 country: Finland name: Henri Honka, MD, PhD role: CONTACT lat: 61.8642 lon: 25.19002 facility: Pihlajalinna Koskiklinikka, Hatanpäänvaltatie 1, city: Tampere zip: 33100 country: Finland name: Elina Pimiä, MD role: CONTACT lat: 61.49911 lon: 23.78712 hasResults: False
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<|newrecord|> nctId: NCT06268808 id: ADC-UK-PMS-23058 briefTitle: Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2024-12 date: 2024-02-20 date: 2024-02-20 name: Abbott Diabetes Care class: INDUSTRY briefSummary: The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen. conditions: Type 2 Diabetes Treated With Insulin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 82 type: ESTIMATED name: FreeStyle Libre 2 Flash Glucose Monitoring System measure: HbA1c measure: Time in range (TIR) measure: Time above range (TAR) measure: Time below range (TBR) measure: Frequency of hypoglycaemia events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari city: Bari country: Italy name: Francesco Giorgino role: CONTACT lat: 41.11148 lon: 16.8554 facility: Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O. Endocrinologia city: Catania country: Italy name: Lucia Frittitta role: CONTACT lat: 37.49223 lon: 15.07041 facility: Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O.C. Medicina Interna city: Catania country: Italy name: Salvatore Piro role: CONTACT lat: 37.49223 lon: 15.07041 facility: Azienda Ospedaliera - Università di Padova city: Padova country: Italy name: Gian Paolo Fadini role: CONTACT lat: 45.40797 lon: 11.88586 facility: Azienda Ospedaliero-Universitaria di Parma city: Parma country: Italy name: Riccardo Bonadonna role: CONTACT lat: 44.79935 lon: 10.32618 facility: La Sapienza Università di Roma, AOU Policlinico Umberto I city: Rome country: Italy name: Raffaella Buzzetti role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06268795 id: BASE briefTitle: A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study) overallStatus: RECRUITING date: 2024-03-20 date: 2028-09-01 date: 2028-09-01 date: 2024-02-20 date: 2024-04-24 name: Wrightington, Wigan and Leigh NHS Foundation Trust class: OTHER briefSummary: The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI. conditions: Periprosthetic Joint Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 244 type: ESTIMATED measure: Comparison of diagnostic accuracy measure: Culture analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust status: RECRUITING city: Wigan state: Lancashire zip: WN6 9EP country: United Kingdom name: Zaid Z Hamoodi role: CONTACT email: [email protected] lat: 53.54295 lon: -2.63705 hasResults: False
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<|newrecord|> nctId: NCT06268782 id: 1204202118 briefTitle: The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women overallStatus: COMPLETED date: 2021-09-21 date: 2023-01-24 date: 2023-09-19 date: 2024-02-20 date: 2024-02-22 name: University of Turku class: OTHER name: Finnish Cultural Foundation briefSummary: The aim of this quasi-experimental study was to assess the effectiveness of a 6-week online exercise program on self-assessed quality of life (QoL), physical activity (PA), and dysfunctions of pelvic floor muscles of postpartum women immediately and 6 months after the online intervention. The data were collected with e-questionnaires. The data collection started in September 2021 and ended in September 2023. conditions: Quality of Life conditions: Physical Activity conditions: Urinary Incontinence conditions: Pelvic Organ Prolapse studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 308 type: ACTUAL name: Rehabilitate your core measure: Quality of Life measure: Physical activity measure: Urinary incontinence measure: Pelvic organ prolapse sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nursing Science, Faculty of Medicine, University of Turku city: Turku zip: 20014 country: Finland lat: 60.45148 lon: 22.26869 hasResults: False
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<|newrecord|> nctId: NCT06268769 id: TaC:Drop id: 2023-503531-18-00 type: OTHER domain: EUCT Number briefTitle: Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs acronym: TaC:Drop overallStatus: RECRUITING date: 2024-03-09 date: 2026-12 date: 2029-09 date: 2024-02-20 date: 2024-04-08 name: Edward Geissler class: OTHER name: Chiesi Pharmaceuticals GmbH briefSummary: The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit. conditions: Immunosuppression studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A dynamic allocation technique assigns participants in a 1:1 ratio to one of two treatment arms: Envarsus tablets (test IMP) or Advagraf capsules (comparator IMP). Randomisation is stratified by two factors: a) trial site, in order to minimise systematic treatment bias at the level of the trial centre and reduce the influence of inter-centre variability, and b) participation in the optional pharmacokinetic sub-study, in order to ensure an equal representation of Envarsus- and Advagraf-treated patients in the sub-study. primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Tacrolimus Pill name: Tacrolimus capsule measure: Dose-normalised blood trough level of tacrolimus (concentration/dose ratio) measure: Time to reach the first trough level in target range measure: Proportion of patients with trough levels lower, within, or higher than the target range measure: Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels measure: Mean daily dose of tacrolimus and inter-patient variability (range) of tacrolimus daily dose measure: Tacrolimus concentration/dose (C/D) ratio measure: Intra-patient variability of C/D ratio and daily dose measure: Treatment failure rate measure: Time to treatment failure after transplantation measure: Incidence rate, severity and time to clinically-confirmed biopsy-proven acute rejection measure: Incidence rate of graft failure measure: Mortality rate measure: Graft function measured by eGFR (estimated glomerular filtration rate) measure: Incidence rate of for-cause biopsies measure: Incidence rate of acute rejection episodes requiring treatment measure: Incidence rate of steroid-resistant episodes of biopsy-proven acute rejection measure: Incidence rate of delayed graft function measure: Incidence rate of primary non-function of the renal allograft measure: Incidence of hepatotoxicity measure: Incidence of CMV and BKV infection (including organ manifestation, if relevant) measure: Incidence, type, severity and seriousness of adverse reactions (ARs) measure: Blood pressure measure: Incidence of de novo tremor measure: Incidence of gastrointestinal disorders requiring diagnostic investigation measure: Incidence of new onset diabetes mellitus after transplantation (NODAT) measure: Recurrence of primary kidney disease measure: Incidence of de novo DSA measure: Patient-reported health-related quality-of-life measured using the Kidney Transplant Questionnaire-34 (KTQ-34) measure: Doses and duration of glucocorticosteroid treatment measure: Dose of mycophenolate measure: Incidence and time to study treatment discontinuation measure: Incidence, time to and reason for patient withdrawal from study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care status: NOT_YET_RECRUITING city: Berlin zip: 10117 country: Germany name: Klemens Budde, Prof. Dr. role: CONTACT lat: 52.52437 lon: 13.41053 facility: University Hospital Dresden, Division of Nephrology status: RECRUITING city: Dresden zip: 01307 country: Germany name: Christian Hugo, Prof. Dr. role: CONTACT lat: 51.05089 lon: 13.73832 facility: University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology) status: NOT_YET_RECRUITING city: Hamburg zip: 20251 country: Germany name: Malte A. Kluger, PD Dr. role: CONTACT lat: 53.57532 lon: 10.01534 facility: University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology) status: NOT_YET_RECRUITING city: Mainz zip: 55131 country: Germany name: Julia Weinmann-Menke, Prof. Dr. role: CONTACT lat: 49.98419 lon: 8.2791 facility: University Hospital Regensburg, Department of Nephrology status: RECRUITING city: Regensburg zip: 93053 country: Germany name: Edward K. Geissler, PhD role: CONTACT phone: +49 941 944 phoneExt: 6961 email: [email protected] name: Bernhard Banas, MD, PhD role: CONTACT phone: +49 941 944 phoneExt: 7301 email: [email protected] lat: 49.01513 lon: 12.10161 hasResults: False
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<|newrecord|> nctId: NCT06268756 id: 2023_RIPH_020_RESANXIEST briefTitle: Fear of Other's Judgment, Self-esteem and Use of Social Networks Among Students acronym: RESANXIEST overallStatus: RECRUITING date: 2024-02-07 date: 2024-04-07 date: 2024-06-07 date: 2024-02-20 date: 2024-02-20 name: Université de Reims Champagne-Ardenne class: OTHER briefSummary: Fear of being judged negatively by others can lead to avoidance of social situations or even social isolation. If the intensity of this fear is excessive and results in significant impairment of functioning or significant suffering, the subject may suffer from social anxiety.
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The considerable growth of social networks in a decade has led to the emergence of new behaviors among young people. Individuals spend on average 2 hours and 27 minutes per day with differences in usage: time spent, social network used, function sought. The use of these networks may be reasonable and moderate but may also be excessive and abusive (Amnon, 2014). Some authors even talk about addiction or dependence on social networks (Perales and Billieux, 2020) even if the existence of this disorder is not consensus.
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People who fear being judged negatively by others may be more at risk of misuse of social networks. Indeed, the use of social networks would compensate for their existing problems (Kardefelt-Winther, 2014) and would thus be a new emotional management strategy. It would also reduce dreaded social situations such as face-to-face exchanges (Weidman and Rodebaugh, 2012; Yen and Ko, 2012). Self-esteem is defined as a subjective judgment of oneself in relation to one's values and vision of the real and ideal self (Rosenberg. 1979). The greater the gap between the vision of the real self and the ideal self, the lower the self-esteem. conditions: Self-esteem studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: Data collection measure: Rosenberg Self-esteem Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ufr Medecine Urca status: RECRUITING city: Reims zip: 51100 country: France name: Coralie Barbe role: CONTACT phone: 326913665 phoneExt: +33 email: [email protected] lat: 49.25 lon: 4.03333 facility: Université de Reims Champagne Ardenne status: RECRUITING city: Reims zip: 51100 country: France name: CURRS CURRS role: CONTACT phone: 0326918822 email: [email protected] lat: 49.25 lon: 4.03333 hasResults: False
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<|newrecord|> nctId: NCT06268743 id: 2023-114 briefTitle: Effects of a Combined Exercise Intervention on the Gut Microbiome of People With Type 2 Diabetes acronym: GUTFIT overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-08 date: 2026-08 date: 2024-02-20 date: 2024-03-01 name: University of New Brunswick class: OTHER name: Laval University briefSummary: The goal of this experimental trial is to learn about the changes in bacterial diversity in individuals with type 2 diabetes who perform endurance and strength training at different intensities.
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Participants with type 2 diabetes will be randomly assigned to 16 weeks of either moderate-intensity endurance and strength training or high-intensity endurance and strength training.
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Researchers will compare the moderate-intensity and high-intensity exercise groups for differences in glycemia and bacterial diversity. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel group, single blinded, randomized trial primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: High intensity name: Moderate intensity measure: Glycemic control through glycated hemoglobin measure: Gut microbiome diversity through 16S ribosomal RNA genes sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06268730 id: 23-2437 briefTitle: Effects of SinuSonic on Psychological and Physical Well-Being overallStatus: RECRUITING date: 2024-03-28 date: 2024-07 date: 2024-07 date: 2024-02-20 date: 2024-03-29 name: University of North Carolina, Chapel Hill class: OTHER name: Healthy Humming, LLC briefSummary: The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion.
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The study aims are:
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* Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion;
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* Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion;
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* Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion.
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Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage. conditions: Nasal Congestion and Inflammations conditions: Sinus Congestion Chronic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will follow the same procedures. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: SinuSonic measure: Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale measure: Change in the Depression Subscale of the Hospital Anxiety and Depression Scale measure: Change in the Body Perception Questionnaire measure: Change in the Total Nasal Symptom Score measure: Change in the Patient Global Impression of Change measure: Adverse Traumatic Experiences Survey at Baseline measure: Short Form Health Survey (SF-20) at Baseline sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599-7160 country: United States name: Keri J Heilman, PhD role: CONTACT email: [email protected] name: Keri J Heilman, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
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<|newrecord|> nctId: NCT06268717 id: 23-0316 briefTitle: GI Alpha-Gal Study overallStatus: RECRUITING date: 2023-10-17 date: 2024-10-17 date: 2025-10-17 date: 2024-02-20 date: 2024-02-20 name: University of North Carolina, Chapel Hill class: OTHER name: Revivicor, Inc briefSummary: This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms. conditions: Alpha-Gal Syndrome conditions: Irritable Bowel Syndrome conditions: Diarrhea conditions: Abdominal Pain conditions: Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind crossover. Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges. One food challenge will contain pork meat containing alpha-gal sugar; one challenge will contain pork meat without alpha-gal sugar. primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: The principal investigator and clinical research coordinators will be blinded to the challenges during the course of the study. The metabolic kitchen and a delegated research staff member will be unblinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Ground pork containing alpha-gal name: Pork meat not containing alpha-gal measure: Allergic reaction (food challenge positive) measure: No allergic reaction (food challenge negative) measure: Lactulose excretion measure: C13 mannitol excretion measure: Basophil activation threshold response at timepoint 0 measure: Basophil activation threshold response at 2 hours measure: Basophil activation threshold response at 4 hours measure: Basophil activation threshold response at 6 hours measure: Serum tryptase at timepoint 0 measure: Serum tryptase at 2 hours measure: Serum tryptase at 4 hours measure: Serum tryptase at 6 hours measure: Mast cell count on stomach biopsies (per high powered field (hpf)) measure: Mast cell count on small bowel biopsies (per high powered field (hpf)) measure: Eosinophil cell count on stomach biopsies (per high powered field (hpf)) measure: Eosinophil cell count on small bowel biopsies (per high powered field (hpf)) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Sarah McGill, MD role: CONTACT phone: 919-966-7047 email: [email protected] name: Sarah McGill, MD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
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<|newrecord|> nctId: NCT06268704 id: UNM HRRC #23-503 briefTitle: Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection overallStatus: RECRUITING date: 2024-03-27 date: 2025-01-01 date: 2025-05-01 date: 2024-02-20 date: 2024-03-29 name: University of New Mexico class: OTHER briefSummary: This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain. conditions: Sacroiliac Joint Dysfunction conditions: Sacro-Iliac Spondylosis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 230 type: ESTIMATED name: Dexamethasone name: Methylprednisolone name: 2% Lidocaine HCl Injection measure: Pain using Numeric Pain Rating Score sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of New Mexico Hospital status: RECRUITING city: Albuquerque state: New Mexico zip: 87131 country: United States name: Mark W Shilling, BS role: CONTACT phone: 505-925-7599 email: [email protected] lat: 35.08449 lon: -106.65114 hasResults: False
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<|newrecord|> nctId: NCT06268691 id: ProjectCOLOMBIA-ZMG.U-Freiburg briefTitle: Sustainable Reduction of Dengue in Colombia: Vector Breeding Site Intervention With an Insecticidal Coating overallStatus: COMPLETED date: 2019-02-04 date: 2019-09-02 date: 2023-07-31 date: 2024-02-20 date: 2024-02-20 name: Rocio Cardenas Sanchez class: OTHER name: Göteborg University name: Instituto Nacional de Salud, Colombia name: Instituto Departamental de Salud de Norte de Santander name: Universidad Francisco de Paula de Santander briefSummary: Effective control of Aedes aegypti mosquitoes in breeding sites with high reproductive rates could have a major impact on reducing arbovirosis in endemic communities. The application of a safe, effective, low cost and sustained insecticide coating (IC) could be an affordable response to dengue for local health services. Therefore, a cluster randomised trial for the application of a new vector control tool (insecticidal coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. The IC is an aqueous solution containing polymeric microcapsules of insecticides and insect growth regulators (pyriproxyfen-PPF (0.063%) and alphacypermertrin-ACM (0.07%) in suspension, without interaction between them, development by INESFLY®, Spain.
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The main questions it aims to answer are:
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Whether the control of the main breeding sites of Aedes mosquitoes, through the application of insecticide coating, in clusters of dwellings, could reduce dengue transmission in a sustainable way, compared to untreated clusters, in Cúcuta, Colombia.
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Whether the control of the main breeding sites of Aedes mosquitoes through the application of insecticide coating, in clusters of dwellings, could reduce the Aedes Indices in a sustainable way, compared to untreated clusters. The initial preparation phases: i) socialization ii) A safety evaluation to determine the health risks of IC in domestic water containers; iii) The determination of the effects and efficacy of IC on Aedes aegypti.
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The Baseline study to characterise the study clusters from entomological, epidemiological and socio-economic approaches was carried out in 2019-2020. The IC application phase in the intervention arm was carried out between Nov-2021 and Jan-2022, with the respective monitoring of the safety of IC use. This was followed by entomological monitoring. Finally, the 9-month post-intervention evaluation. Epidemiological data were obtained from the National Public Health Surveillance System - SIVIGILA.
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The study was conducted in 20 clusters of 2000 dwellings each, where 10 clusters were randomly assigned to the control arm and 10 clusters to the intervention arm.
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In order to determine the effect of IC application in household tanks, the dengue incidence and entomological indices are compared in the study clusters. The data are analysed under the difference in difference approach. Additionally, the acceptance of IC in the intervened communities and local health services is determined. conditions: Dengue conditions: Vector Borne Diseases conditions: Arbovirus Infections conditions: Zika conditions: Chikungunya Fever studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A cluster randomised trial for the application of a new vector control tool (insecticide coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. Each cluster comprising approximately 2,000 dwellings. primaryPurpose: PREVENTION masking: NONE count: 35000 type: ACTUAL name: Insecticide Coating INESFLY measure: Change of dengue incidence for 12 months measure: Change of vector densities estimated through larval and pupal indices. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Departamental de Salud de Norte de Santander city: Cúcuta state: Norte De Santander zip: 540001 country: Colombia lat: 7.89391 lon: -72.50782 facility: Centre for Medicine and Society city: Freiburg state: Baden-Württemberg zip: 79098 country: Germany lat: 47.9959 lon: 7.85222 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2019-03-11 uploadDate: 2024-02-12T15:19 filename: Prot_000.pdf size: 2263350 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2019-03-11 uploadDate: 2024-02-12T15:19 filename: SAP_001.pdf size: 768947 hasResults: False
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<|newrecord|> nctId: NCT06268678 id: 4539513 briefTitle: The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis overallStatus: RECRUITING date: 2023-12-08 date: 2025-01-30 date: 2025-01-30 date: 2024-02-20 date: 2024-02-20 name: University of Exeter class: OTHER name: Pvolve briefSummary: The combination of dietary protein ingestion and resistance exercise are essential to increase muscle protein synthesis. The vast majority of studies assessing protein intake following resistance exercise in young adults has been conducted exclusively in men or in studies where both men and women are assessed. The increase in muscle mass is thought to be impacted by sex hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis following exercise is not known. conditions: Menstrual Cycle Phase conditions: Muscle Protein Synthesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomised cross-over design. primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Phase of the menstrual cycle measure: Muscle protein synthesis measure: Plasma amino acid kinetics measure: Serum insulin concentrations measure: Sex hormone concentrations measure: Energy expenditure sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX1 2LT country: United Kingdom name: Marianna Apicella role: CONTACT lat: 50.7236 lon: -3.52751 hasResults: False
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<|newrecord|> nctId: NCT06268665 id: UCDCC307 briefTitle: Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2027-02 date: 2027-06 date: 2024-02-20 date: 2024-02-20 name: Eve Rodler class: OTHER briefSummary: This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.
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Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2). conditions: Breast Cancer conditions: Breast Cancer Stage I conditions: Breast Cancer Stage II conditions: Breast Cancer Stage III conditions: Breast Cancer Stage IV conditions: Invasive Breast Cancer conditions: Ovarian Cancer conditions: Ovarian Cancer Stage 1 conditions: Ovarian Cancer Stage II conditions: Ovarian Cancer Stage III conditions: Ovarian Cancer Stage IV conditions: Ovarian Cancer Stage IA conditions: Ovarian Cancer Stage IB conditions: Ovarian Cancer Stage IC conditions: Ovarian Cancer Stage 2 conditions: Ovarian Cancer Stage 3 conditions: Ovarian Cancer Stage IIIb conditions: Ovarian Cancer Stage IIIC conditions: Breast Cancer Stage IIIA conditions: Breast Cancer Invasive conditions: Breast Cancer, Stage IA conditions: Breast Cancer, Stage IB conditions: Breast Cancer Stage IIA conditions: Breast Cancer Stage IIB conditions: Breast Cancer Stage IIIB conditions: Breast Cancer Stage IIIc conditions: Cancer, Breast conditions: Tumors, Breast conditions: Mammary Cancer conditions: Mammary Carcinoma conditions: Breast Carcinoma conditions: Breast Neoplasm conditions: Malignant Breast Neoplasm conditions: Malignant Tumor of Breast conditions: Cancer of Ovary conditions: Ovary Cancer conditions: Ovary Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 86 type: ESTIMATED name: Tart Cherry Juice measure: Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. measure: Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. measure: Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy. measure: Tolerability of daily intake of high-dose and low-dose tart cherry juice. measure: Safety profile of daily intake of high-dose and low-dose tart cherry juice. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California Davis Comprehensive Cancer Center city: Sacramento state: California zip: 95827 country: United States name: Eve Rodler, MD role: CONTACT phone: 916-734-5409 email: [email protected] name: Eve Rodler, MD role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 hasResults: False
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<|newrecord|> nctId: NCT06268652 id: B2023-686-01 briefTitle: Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer overallStatus: RECRUITING date: 2024-01-15 date: 2026-02-15 date: 2028-01-15 date: 2024-02-20 date: 2024-02-20 name: Sun Yat-sen University class: OTHER briefSummary: This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment (OGPT)versus treatment of physician's choice (TPC) in previously treated refractory breast cancer. conditions: Breast Cancer conditions: Refractory Breast Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 302 type: ESTIMATED name: Organoid-guided personalized treatment name: Gemcitabine name: Capecitabine name: Vinorelbine name: Eribulin measure: Progression-free survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Disease Control Rate (DCR) measure: Incidence of Treatment-related Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yanxia Shi status: RECRUITING city: Guangzhou state: None Selected zip: 510060 country: China name: Yanxia Shi role: CONTACT phone: 020-87343368 email: [email protected] lat: 23.11667 lon: 113.25 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-12 uploadDate: 2024-01-23T03:33 filename: Prot_000.pdf size: 469389 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-12 uploadDate: 2024-01-23T02:42 filename: ICF_001.pdf size: 330483 hasResults: False
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<|newrecord|> nctId: NCT06268639 id: ECM#2024-216 id: RGP1/347/44 type: OTHER_GRANT domain: King Khalid University briefTitle: Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique acronym: BIDOS overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-04-30 date: 2024-06-30 date: 2024-02-20 date: 2024-03-15 name: King Khalid University class: OTHER briefSummary: The study investigates the impact of osseodensification drills on bone density changes surrounding dental implants. Osseodensification, a novel technique, is hypothesized to enhance primary stability of implants by densifying bone rather than removing it during osteotomy. Participants undergo pre-operative and post-operative DentaScan CT analyses to measure bone density in Hounsfield units at apical, mesial, and distal positions around the implant sites. This intervention-based research aims to quantify the benefits of osseodensification in improving bone quality and implant success. Data from 32 sites, analyzed via the Radiant DICOM software, undergo statistical examination using SPSS to ascertain significant differences in bone density pre- and post-surgery. The outcome could redefine surgical approaches in implantology, emphasizing osseodensification's role in achieving superior bone-implant integration. conditions: Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study employs a single-group, interventional model to examine the impact of osseodensification on bone density at dental implant sites. It involves a sequential process starting from pre-operative bone density assessment using DentaScan CT, followed by surgical intervention using osseodensification drills, and concluding with a post-operative bone density evaluation to compare changes. This approach aims to determine if osseodensification can significantly enhance bone density and stability around implant sites, thereby potentially improving the success rates of dental implants. The methodology includes detailed pre-operative and post-operative assessments, with statistical analysis conducted to evaluate the effectiveness of the intervention. primaryPurpose: TREATMENT masking: NONE maskingDescription: The study employs an open-label design, where no masking is applied. This means that the participants, care providers, investigators, and outcomes assessors are all aware of the intervention being administered. Given the nature of the intervention-osseodensification technique used in dental implant surgery-it is not feasible to blind the study participants or the clinical staff involved in the procedure and assessment to the intervention being studied. The open-label approach allows for direct observation of the intervention's effects on bone density without the complexity of blinding, which is often the case in surgical and procedural interventions where the treatment administered is evident. count: 32 type: ESTIMATED name: Osseodensification measure: Increase in Bone Density at Implant Sites Using Osseodensification Technique sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06268626 id: H22-02426 id: F22-01302 type: OTHER_GRANT domain: Canadian Institutes of Health Research (CIHR) id: F21-03695 type: OTHER_GRANT domain: Canadian Institutes of Health Research (CIHR) briefTitle: Detection of Endometrial Cancer Through Risk Modelling acronym: DETECTR overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-01 date: 2027-01 date: 2024-02-20 date: 2024-02-20 name: University of British Columbia class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The goal of this study is to combine information on risk factors from health questionnaires with minimally invasive biological tests (vaginal DNA and microbiome swabs, pH, hormones) to predict the risk of endometrial cancer (EC), better understand progression of the disease, and identify opportunities for intervention.
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This study will recruit patients who are already scheduled to undergo diagnostic evaluation for abnormal uterine bleeding via endometrial biopsy. In Part A, consented participants will be asked to fill out an online risk factor questionnaire. Samples will be collected by the gynecologist at the biopsy appointment. After biopsy results are obtained, all samples from participants diagnosed with EC or precursors, plus a random subset with benign results, will be selected to be sequenced and analyzed.
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In Part B, that subset of selected non-malignant participants, based on biopsy, will be invited to take part in lifestyle tracking using a Fitbit, questionnaires, and to provide another round of at-home vaginal samples to identify any persistent genetic mutations or microbiome alterations 6-8 months later. conditions: Endometrial Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Association Between Risk Factor Data and Endometrial Cancer and It's Precursors. measure: Change in Risk Prediction of Endometrial Cancer When Mutation and Microbiome Data Is Combined With Traditional Risk Factors, Compared to Traditional Risk Factors Alone. measure: Persistence of Mutations and Microbiome Alterations in Participants With Endometrial Hyperplasia. sex: FEMALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VGH Research Pavilion city: Vancouver state: British Columbia zip: V5Z 1M9 country: Canada name: Aline Talhouk, PhD role: CONTACT phone: +1 (604) 875-4111 phoneExt: 21365 email: [email protected] name: Elise Abi Khalil, PhD role: CONTACT phone: +1 (604) 875-4111 phoneExt: 21369 email: [email protected] name: Aline Talhouk, PhD role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 hasResults: False
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<|newrecord|> nctId: NCT06268613 id: SB27-1005 briefTitle: A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy overallStatus: RECRUITING date: 2024-01-16 date: 2025-05 date: 2025-12 date: 2024-02-20 date: 2024-04-19 name: Samsung Bioepis Co., Ltd. class: INDUSTRY briefSummary: The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:
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• What the body does to the study drug, which is called "pharmacokinetic"
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Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.
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Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda. conditions: Non-small Cell Lung Cancer Stage II conditions: Non-small Cell Lung Cancer Stage IIIA studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 135 type: ESTIMATED name: SB27 name: EU sourced Keytruda name: US sourced Keytruda measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1 measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6 measure: Disease-free Survival measure: Overall Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SB Investigative Site status: RECRUITING city: Busan country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: SB Investigative Site status: RECRUITING city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: SB Investigative Site status: RECRUITING city: Hwasun country: Korea, Republic of lat: 35.06125 lon: 126.98746 facility: SB Investigative Site status: RECRUITING city: Jinju country: Korea, Republic of lat: 35.19278 lon: 128.08472 facility: SB Investigative Site status: RECRUITING city: Seongnam country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: SB Investigative Site status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: SB Investigative Site status: RECRUITING city: Suwon country: Korea, Republic of lat: 37.29111 lon: 127.00889 facility: SB Investigative Site status: RECRUITING city: Szczecin country: Poland lat: 53.42894 lon: 14.55302 facility: SB Investigative Site status: RECRUITING city: Leganés state: Madrid country: Spain lat: 40.32718 lon: -3.7635 facility: SB Investigative Site status: RECRUITING city: A Coruña state: Santiago De Compostela country: Spain lat: 43.37135 lon: -8.396 facility: SB Investigative Site status: RECRUITING city: Jaén country: Spain lat: 37.76922 lon: -3.79028 facility: SB Investigative Site status: RECRUITING city: Málaga country: Spain lat: 36.72016 lon: -4.42034 hasResults: False
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<|newrecord|> nctId: NCT06268600 id: NPC-Thyroid function briefTitle: The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2019-01-01 date: 2024-11-30 date: 2025-11-30 date: 2024-02-20 date: 2024-04-11 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area. conditions: Nasopharyngeal Carcinoma conditions: Nasopharyngeal Cancer conditions: Hypothyroidism studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 320 type: ESTIMATED name: Modified neck target volume delineation measure: Regional Recurrence-free Survival measure: Radiation-induced hypothyroidism measure: Overall Survival measure: Progression-free Survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital status: RECRUITING city: Nanchang state: None Selected zip: 330029 country: China name: Tianzhu Lu role: CONTACT phone: 8615270186250 email: [email protected] role: CONTACT phoneExt: Li email: [email protected] name: Jingao Li, PhD role: PRINCIPAL_INVESTIGATOR name: Xiaochang Gong, PhD role: SUB_INVESTIGATOR lat: 28.68396 lon: 115.85306 hasResults: False
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<|newrecord|> nctId: NCT06268587 id: 2023/80 briefTitle: A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery overallStatus: COMPLETED date: 2019-09-01 date: 2022-02-28 date: 2022-02-28 date: 2024-02-20 date: 2024-02-20 name: Centre Hospitalier Universitaire de Liege class: OTHER briefSummary: The goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. The main question it aims to answer is:
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