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protocolSection identificationModule nctId: NCT06383572, orgStudyIdInfo id: 2024-0196, secondaryIdInfos id: NCI-2024-03505, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To find a recommended dose of PRAME-TCR-NK cells that can be given to patients with AML or MDS., conditionsModule conditions: Lymphodepleting Chemotherapy, conditions: Myeloid Malignancies, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Cyclophosphamide, interventions name: Fludarabine phosphate, interventions name: Decitabine, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Jeremy Ramdial, MD, role: CONTACT, phone: 713-745-0146, email: jlramdial@mdanderson.org, contacts name: Jeremy Ramdial, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False

protocolSection identificationModule nctId: NCT06383559, orgStudyIdInfo id: TJMUCH-GI-GC07, briefTitle: Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with Sintilimab (\>=60kg, 200 mg; \<60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Lenvatinib and Sintilimab, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: OS, secondaryOutcomes measure: PFS, otherOutcomes measure: AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University Cancer Institute and Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, country: China, contacts name: Ting Deng, MD, role: CONTACT, phone: 022-23340123, phoneExt: 1053, email: xymcdengting@126.com, contacts name: Yi Ba, MD, role: CONTACT, phone: 022-23340123, phoneExt: 1053, email: bayi@tjmuch.com, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False

protocolSection identificationModule nctId: NCT06383546, orgStudyIdInfo id: XHEC-C-2024-053-1, briefTitle: Artificial Intelligence-enabled ECG Detection of Congenital Heart Disease in Children: a Novel Diagnostic Tool, acronym: AI-ECG-CHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: Congenital heart disease (CHD) is the most common congenital disease in children. The early detection, diagnosis and treatment of CHD in children is of great significance to improve the prognosis and reduce the mortality of children, but the current screening methods have limitations. Electrocardiogram (ECG), as an economical and rapid means of heart disease detection, has a very important value in the auxiliary diagnosis of CHD.Big data and deep learning technologies in artificial intelligence (AI) have shown great potential in the medical field. The advent of the big data era provides rich data resources for the in-depth study of CHD ECG signals in children. The development of deep learning technology, especially the breakthrough in the field of image recognition, provides a strong technical support for the intelligent analysis of electrocardiogram. The particularity of children electrocardiogram requires the development of a special algorithm model. At present, the research on the application of deep learning models to identify children's electrocardiograms is limited, and the training and verification from large data sets are lacking. Based on the Chinese Congenital Heart Disease Collaborative Research Network, this project aims to integrate data and deep learning technology to develop a set of intelligent electrocardiogram assisted diagnosis system (CHD-ECG AI system) suitable for children with CHD, so as to improve the early detection rate of CHD and improve the efficiency of congenital heart disease screening., conditionsModule conditions: Artificial Intelligence, conditions: Electrocardiogram, conditions: Deep Learning, conditions: Congenital Heart Disease in Children, conditions: Diagnosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Large-scale ECG database for children, primaryOutcomes measure: Artificial intelligence-assisted electrocardiogram model for CHD in Children, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Sun Jing, MD, role: CONTACT, phone: 15618497517, email: sunjing02@xinhuamed.com.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06383533, orgStudyIdInfo id: IRB-2023-385, briefTitle: Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, descriptionModule briefSummary: It is a single arm, open-label, phase II cinical trial to evaluate the efficacy and safety of Disitamab Vedotin Plus Cadonilimab in second-line treatment of patients with Advanced or Metastatic Bile Duct Adenocarcinoma, conditionsModule conditions: Bile Duct Adenocarcinoma Non-Resectable, conditions: HER2 Gene Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Disitamab Vedotin Plus Cadonilimab, outcomesModule primaryOutcomes measure: Objective response rate(ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Incidence of Treatment-Emergent 3/4 Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310022, country: China, contacts name: Jieer Ying, Doctor, role: CONTACT, phone: 13858195803, email: hzyingjieer@163.com, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06383520, orgStudyIdInfo id: XLan-0415, briefTitle: Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-30, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: This is a diagnostic study. Patients were recruited from patients with clinically suspected or confirmed hepatocellular carcinoma and healthy volunteers were recruited for PET/or PET/CT imaging targeting a GPC3-specific probe (in the case of 68Ga-NOTA-aGPC3-scFv), to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET CT imaging in patients with contraindications. General Information, clinical data, blood routine, liver and renal function, and other imaging data were collected. The final diagnosis was based on the histopathology of biopsy or surgical specimens., conditionsModule conditions: Malignant Neoplasm of Liver, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-aGPC3-scFv/Fab, outcomesModule primaryOutcomes measure: Visual and standardized uptake values assessment of lesions and biodistribution, secondaryOutcomes measure: Radioactivity in the blood and urine samples, secondaryOutcomes measure: Concentration of tumor markers (e.g., APF) in participants' blood, secondaryOutcomes measure: Pathological sections of tumour tissue, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China, Hubei Province, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Xiaoli Lan, PhD, role: CONTACT, phone: +86-027-83692633, email: lxl730724@hotmail.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False

protocolSection identificationModule nctId: NCT06383507, orgStudyIdInfo id: CHT101, briefTitle: A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2027-04-21, completionDateStruct date: 2029-04-21, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, descriptionModule briefSummary: This is a single-center, single-arm ，open-label ，dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns., conditionsModule conditions: Metastatic Tumor, conditions: Advanced Solid Tumor, conditions: Renal Cell Carcinoma, conditions: Ovarian Cancer, conditions: Cervix Cancer, conditions: Head and Neck Squamous Cell Carcinoma, conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: CHT101, outcomesModule primaryOutcomes measure: Incidence of Adverse events after CD70 UCAR-T cells infusion (Safety and Tolerability), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Objective response rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383494, orgStudyIdInfo id: IRB-2024-356（IIT）, briefTitle: GMA-TulipTM, i-gelTM and the LMA-SupremeTM (LMA-S) Devices in Airway Management, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, descriptionModule briefSummary: Patients were randomly assigned to three extraglottic airway (EGA) devices groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded., conditionsModule conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 276, type: ESTIMATED, armsInterventionsModule interventions name: LMA supreme group, interventions name: I-gel group, interventions name: GMA-Tulip, outcomesModule primaryOutcomes measure: Glottic exposure grading, secondaryOutcomes measure: Peak inspiratory pressures, secondaryOutcomes measure: Pharyngalgia, secondaryOutcomes measure: Bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310022, country: China, contacts name: Jiangling Wang, Ph. D, role: CONTACT, phone: +86 571 88122106, email: wangjl@zjcc.org.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06383481, orgStudyIdInfo id: TDK-2024-13362, briefTitle: The Effect of Mobile-Based Education on Postoperative Recovery and Quality of Life in Thyroidectomy Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-04-22, completionDateStruct date: 2025-08-22, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: Thyroid diseases constitute one of the most common health problems around the world and in our country. In its treatment; Drug therapy, radioactive iodine therapy and surgical treatment can be applied alone or together. Advances in the diagnosis of thyroid diseases have led to an increase in the number of thyroidectomies. When there are no complications after thyroidectomy, patients are discharged from the hospital on the day of surgery or are hospitalized for only a few days. In this context, since technical care is given priority, discharge training remains incomplete.Patients who have had thyroidectomy are discharged within 1-2 days after surgery if no problems occur. For this reason, patient education provided by health professionals and especially nurses may be insufficient. Post-discharge patient education in surgical services can sometimes be ignored, and it is noteworthy that this situation is not given importance due to the busy nature of surgical services. Although short hospital stays after surgery are beneficial in many ways, it increases the need for patient education.In this study, a mobile application that covers the entire perioperative process and includes education will be developed for patients undergoing thyroidectomy. This developed mobile application aims to manage post-operative problems such as neck pain and discomfort and voice changes experienced by patients, and to improve post-operative recovery, voice quality and, accordingly, quality of life. In this context, it is believed that even in cases where patients cannot access health care professionals, their educational needs will be met, problem management will be provided with applications for the problems they experience, and accordingly, their post-operative recovery, voice and quality of life will increase, starting from the hospital before the surgery until the end of the recovery period, including the home care process after discharge.When the literature on the subject is examined, studies involving education in patients with thyroidectomy are limited. However, no studies have been found on mobile health applications that include training to reduce neck pain and discomfort experienced by thyroidectomy patients, ensure postoperative recovery, and improve voice quality and quality of life., conditionsModule conditions: Thyroid Diseases, conditions: Healthy Lifestyle, conditions: Thyroid, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: Mobile based education, outcomesModule primaryOutcomes measure: Postoperative Recovery Index (ASII), primaryOutcomes measure: SF-36 Quality of Life Scale, secondaryOutcomes measure: Visual Comparison Pain Scale(GKAÖ), secondaryOutcomes measure: Turkish- Computer System Usability Questionnaire Short Version (TCSUQ- SV), secondaryOutcomes measure: Neck Pain and Discomfort Scale (BARÖ), secondaryOutcomes measure: Voice Handicap Index (Voice Handicap Index 10)(VHI10), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383468, orgStudyIdInfo id: AK120-301, briefTitle: A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2026-01-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Akeso, class: INDUSTRY, descriptionModule briefSummary: This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis., conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: AK120, outcomesModule primaryOutcomes measure: Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75, secondaryOutcomes measure: Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Luhe Hospital Affiliated to Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tongren Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing Three Gorges Medical College Affiliated People's Hospital, status: RECRUITING, city: Chongqing, state: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Chongqing Traditional Chinese Medicine Hospital, status: RECRUITING, city: Chongqing, state: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: The First Affiliated Hospital of Fujian Medical University, status: RECRUITING, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: The Second Affiliated Hospital of Xiamen Medical College, status: RECRUITING, city: Xiamen, state: Fujian, country: China, geoPoint lat: 24.47979, lon: 118.08187, locations facility: Guangdong Provincial People's Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Southern Medical University Southern Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Zhujiang Hospital of Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Yuebei People's hospital, Guangdong, China, status: RECRUITING, city: Shaoguan, state: Guangdong, country: China, geoPoint lat: 24.8, lon: 113.58333, locations facility: Shunde Hospital of Southern Medical University, status: RECRUITING, city: Shunde, state: Guangdong, country: China, geoPoint lat: 22.84067, lon: 113.2503, locations facility: Guangdong Medical University Affiliated Hospital, status: RECRUITING, city: Zhanjiang, state: Guangdong, country: China, geoPoint lat: 21.28145, lon: 110.34271, locations facility: The Affiliated Hospital of Guizhou Medical University, status: RECRUITING, city: Guiyang, state: Guizhou, country: China, geoPoint lat: 26.58333, lon: 106.71667, locations facility: Hainan General Hospital, status: RECRUITING, city: Haikou, state: Hainan, country: China, geoPoint lat: 20.04583, lon: 110.34167, locations facility: Hainan Provincial Fifth People's Hospital, status: RECRUITING, city: Haikou, state: Hainan, country: China, geoPoint lat: 20.04583, lon: 110.34167, locations facility: The First Affiliated Hospital of Hainan Medical College, status: RECRUITING, city: Haikou, state: Hainan, country: China, geoPoint lat: 20.04583, lon: 110.34167, locations facility: Chengde Medical College Affiliated Hospital, status: RECRUITING, city: Chengde, state: Hebei, country: China, geoPoint lat: 40.9519, lon: 117.95883, locations facility: The Second Affiliated Hospital of Xingtai Medical College, status: RECRUITING, city: Xingtai, state: Hebei, country: China, geoPoint lat: 37.06306, lon: 114.49417, locations facility: Harbin Medical University Affiliated Second Hospital, status: RECRUITING, city: Harbin, state: Heilongjiang, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: Heilongjiang Provincial Hospital, status: RECRUITING, city: Harbin, state: Heilongjiang, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: The Second Affiliated Hospital of Henan University of Science and Technology, status: RECRUITING, city: Luoyang, state: Henan, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: Renmin Hospital of Wuhan University Hubei General Hospital, status: RECRUITING, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Tongji Hospital, status: RECRUITING, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Changde First People's Hospital, status: RECRUITING, city: Changde, state: Hunan, country: China, geoPoint lat: 29.04638, lon: 111.6783, locations facility: Xiangya Hospital of Central South University, status: RECRUITING, city: Changsha, state: Hunan, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The First Affiliated Hospital of South China University, status: RECRUITING, city: Hengyang, state: Hunan, country: China, geoPoint lat: 26.88946, lon: 112.61888, locations facility: Inner Mongolia Medical University Affiliated Hospital, status: RECRUITING, city: Hohhot, state: Inner Mongolia, country: China, geoPoint lat: 40.81056, lon: 111.65222, locations facility: The First Affiliated Hospital of Bengbu Medical College, status: RECRUITING, city: Bengbu, state: Jiangsu, country: China, geoPoint lat: 32.94083, lon: 117.36083, locations facility: Changzhou First People's Hospital, status: RECRUITING, city: Changzhou, state: Jiangsu, country: China, geoPoint lat: 31.77359, lon: 119.95401, locations facility: Yancheng First People's Hospital, status: RECRUITING, city: Yancheng, state: Jiangsu, country: China, geoPoint lat: 33.3575, lon: 120.1573, locations facility: Jiangsu University Affiliated Hospital, status: RECRUITING, city: Zhenjiang, state: Jiangsu, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: The First Affiliated Hospital of Gannan Medical College, status: RECRUITING, city: Ganzhou, state: Jiangxi, country: China, locations facility: The First Bethune Hospital of Jilin University, status: RECRUITING, city: Changchun, state: Jilin, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Panjin Liaoyou Gemstone Flower Hospital, status: RECRUITING, city: Panjin, state: Liaoning, country: China, geoPoint lat: 41.121, lon: 122.0739, locations facility: Shenyang Integrated Traditional Chinese and Western Medicine Hospital, status: RECRUITING, city: Shenyang, state: Liaoning, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Zhongyi Northeast International Hospital, status: RECRUITING, city: Shenyang, state: Liaoning, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: General Hospital of Ningxia Medical University, status: RECRUITING, city: Yinchuan, state: Ningxia, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Shandong Provincial Dermatology Hospital, status: RECRUITING, city: Jinan, state: Shandong, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shandong University Qilu Hospital, status: RECRUITING, city: Jinan, state: Shandong, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Qingdao Municipal Hospital, status: RECRUITING, city: Qingdao, state: Shandong, country: China, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Shanghai Dermatology Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Baoji Central Hospital, status: RECRUITING, city: Baoji, state: Shanxi, country: China, locations facility: Sichuan Provincial People's Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Xinjiang Uygur Autonomous Region People's Hospital, status: RECRUITING, city: Urumqi, state: Xinjiang, country: China, geoPoint lat: 43.80096, lon: 87.60046, locations facility: The First Affiliated Hospital of Kunming Medical University, status: RECRUITING, city: Kunming, state: Yunnan, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Hangzhou First People's Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Hangzhou Third People's Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Jiaxing First People's Hospital, status: RECRUITING, city: Jiaxing, state: Zhejiang, country: China, geoPoint lat: 30.7522, lon: 120.75, locations facility: Ningbo First Hospital, status: RECRUITING, city: Ningbo, state: Zhejiang, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Ningbo Huamei Hospital, University of Chinese Academy of Sciences, status: RECRUITING, city: Ningbo, state: Zhejiang, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Wenzhou Medical University First Affiliated Hospital, status: RECRUITING, city: Wenzhou, state: Zhejiang, country: China, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False

protocolSection identificationModule nctId: NCT06383455, orgStudyIdInfo id: Observational, briefTitle: Effects of Smoking on Clinical and Microbiological Response in Individuals With Periodontitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-09-15, primaryCompletionDateStruct date: 2019-02-01, completionDateStruct date: 2019-03-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Trakya University, class: OTHER, descriptionModule briefSummary: This study aimed to compare the distribution of subgingival periodontal pathogens following non-surgical periodontal therapy in smoking and non-smoking people with periodontitis. The main question it aims to answer is:- Does smoking affect the results of non-surgical periodontal treatment on subgingival flora in participants with periodontal disease?Researchers performed non-surgical periodontal therapy on 48 participants with stage III/IV periodontitis and recorded clinical measurements. They obtained subgingival plaque samples from periodontal pockets at the onset and after four weeks of treatment, determining the level of periodontopathogens using a polymerase chain reaction-based method., conditionsModule conditions: Periodontitis, conditions: Smoking Habit, conditions: Subgingival Plaque, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Non-surgical periodontal therapy, outcomesModule primaryOutcomes measure: Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis, secondaryOutcomes measure: Change in clinical attachment level (CAL), secondaryOutcomes measure: Change in probing depth (PD), secondaryOutcomes measure: Change in gingival index (GI) scores, secondaryOutcomes measure: Change in plaque index (PI) scores, secondaryOutcomes measure: Change in Bleeding on Probing (BOP), eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Trakya University, city: Edirne, zip: 22030, country: Turkey, geoPoint lat: 41.67719, lon: 26.55597, hasResults: False

protocolSection identificationModule nctId: NCT06383442, orgStudyIdInfo id: N202103041, briefTitle: HIIT on Overweight Middle-aged Adults, acronym: HIIT, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-25, primaryCompletionDateStruct date: 2023-07-31, completionDateStruct date: 2023-11-22, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Taipei Medical University, class: OTHER, descriptionModule briefSummary: 36 middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. All groups carried out the training stage for 8 weeks (three sessions per week) and the detraining stage for 4 weeks in order to investigate the effects induced by different HIIT interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss., conditionsModule conditions: Overweight or Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants were evenly distributed according to a counterbalanced design and divided into three different groups by the body fat percentage of subjects: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise /2 min Rest), 3. Control group. Target intensities of each interval bout, exercise and rest (Ex./R.), were 85-90% VO2peak/65-70% VO2peak zones, respectively., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: L-HIIT, interventions name: M-HIIT, outcomesModule primaryOutcomes measure: Aerobic Capacity Test, primaryOutcomes measure: Aerobic Capacity Test, primaryOutcomes measure: Anti-fatigue performance, primaryOutcomes measure: skinfold thickness, primaryOutcomes measure: Body composition_body fat, secondaryOutcomes measure: Glucose, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: low-density lipoprotein (LDL), secondaryOutcomes measure: high-density lipoprotein (HDL), secondaryOutcomes measure: creatine kinase (CK) level, secondaryOutcomes measure: C-reactive protein (CRP), secondaryOutcomes measure: tumor necrosis factor (TNF)-R1, secondaryOutcomes measure: TNF-R2, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei Medical University, city: Taipei, zip: 110, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False

protocolSection identificationModule nctId: NCT06383429, orgStudyIdInfo id: P.T-WH-10/2023-521, briefTitle: Relation Between Forward Head Posture and Incidence of Headache in Obese Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-03-14, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ahram Canadian University, class: OTHER, descriptionModule briefSummary: Cross sectional study to detect relation between forward head posture and headache. We will take information from the patient about:* Detailed history of patient* Forward head posture by using mobile application* Headache disability index, conditionsModule conditions: Obese, conditions: Headache, conditions: Neck Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: forward head posture by using mobile application. And patients will fill out headache disability index., outcomesModule primaryOutcomes measure: forward head posture, primaryOutcomes measure: BMI, primaryOutcomes measure: headache disability index, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ababa physical therapy center, city: Banī Suwayf, state: Beni- Suaf, zip: 2711860, country: Egypt, geoPoint lat: 29.07441, lon: 31.09785, hasResults: False

protocolSection identificationModule nctId: NCT06383416, orgStudyIdInfo id: P.T-INT-10/2023-522, briefTitle: Incidence of Headache and Its Effect on Quality of Life in Geriatric Patients With Chronic Neck Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-21, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ahram Canadian University, class: OTHER, descriptionModule briefSummary: cross sectional study to detect the incidence of headache and its effect on quality of life in geriatric patients with chronic neck pain. Patients will fill out quality of life questionnaire and headache disability index. We will take information from the patients about:* The frequency of headache occurrence.* Visual analogue scale of chronic neck pain. Main measures: chronic neck pain will be assessed by visual analogue scale. Patients will fill out quality of life questionnaire and headache disability index., conditionsModule conditions: Geriatric Patients With Neck Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Neck pain by VAS, outcomesModule primaryOutcomes measure: Visual analogue scale, primaryOutcomes measure: headache disability index, primaryOutcomes measure: SF-36 quality of life questionare, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ababa physical therapy center, city: Banī Suwayf, zip: 2711860, country: Egypt, geoPoint lat: 29.07441, lon: 31.09785, hasResults: False

protocolSection identificationModule nctId: NCT06383403, orgStudyIdInfo id: CLIN-60190-463, secondaryIdInfos id: 2024-510695-20-00, type: CTIS, briefTitle: A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid., acronym: ELSPIRE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-06-22, completionDateStruct date: 2026-12-21, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ipsen, class: INDUSTRY, descriptionModule briefSummary: The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms.Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment).The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months)., conditionsModule conditions: Primary Biliary Cholangitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Elafibranor, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of participants with normalisation of Alkaline Phosphate (ALP) Levels, secondaryOutcomes measure: Percentage of participants with normalisation of ALP Levels, secondaryOutcomes measure: Change from baseline in ALP levels, secondaryOutcomes measure: Percentage of participants with normalisation of ALP Levels and ≥15% decrease from Baseline, secondaryOutcomes measure: Percentage of participants with ≥40% decrease from Baseline in ALP Levels, secondaryOutcomes measure: Percentage of participants with ALP <0.5 × Upper Limit of Normal (ULN), secondaryOutcomes measure: Changes from baseline in Total Bilirubin (TB) Levels, secondaryOutcomes measure: Percentage of participants with TB <0.7 × ULN, secondaryOutcomes measure: Percentage of participants with normalisation of ALP and TB <0.7 × ULN, secondaryOutcomes measure: Percentage of participants with normalisation of TB and ALP Levels, secondaryOutcomes measure: Percentage of participants with complete biochemical response, secondaryOutcomes measure: Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score, secondaryOutcomes measure: Percentage of participants with moderate to severe pruritus at baseline (i.e. score ≥4) with a clinically meaningful response in PBC Worst Itch NRS, secondaryOutcomes measure: Change from baseline in 5-D itch score, secondaryOutcomes measure: Change from baseline in Patient Global Impression of Severity (PGI-S) scores, secondaryOutcomes measure: Patient Global Impression of Change (PGI-C) scores, secondaryOutcomes measure: Change from baseline in PBC-40 Quality of Life (QoL) scores, secondaryOutcomes measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a scores, secondaryOutcomes measure: Percentage of participants experiencing Treatment- Emergent Adverse Events (TEAEs), treatment- related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)., secondaryOutcomes measure: Percentage of participants developing clinically significant changes in physical examination, secondaryOutcomes measure: Percentage of participants developing clinically significant changes in vital signs, secondaryOutcomes measure: Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) Readings, secondaryOutcomes measure: Percentage of participants developing clinically significant changes in laboratory parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383390, orgStudyIdInfo id: 18584, secondaryIdInfos id: J1I-MC-GZBO, type: OTHER, domain: Eli Lilly and Company, secondaryIdInfos id: 2023-508630-34-00, type: OTHER, domain: EU CTR Number, briefTitle: The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-02, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Retatrutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time to First Occurrence of Composite Endpoints, primaryOutcomes measure: Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death, secondaryOutcomes measure: Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3), secondaryOutcomes measure: Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF, secondaryOutcomes measure: Time to Occurrence of All-Cause Death, secondaryOutcomes measure: Time to First Occurrence of composite endpoint of ≥ 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death, secondaryOutcomes measure: Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Research Associates, city: Birmingham, state: Alabama, zip: 35205, country: United States, contacts name: David D. DeAtkine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Alliance for Multispecialty Research, LLC, city: Daphne, state: Alabama, zip: 36526, country: United States, contacts name: Michael T. Ledet, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.60353, lon: -87.9036, locations facility: Nephrology Consultants, city: Huntsville, state: Alabama, zip: 35805, country: United States, contacts name: Michael Quadrini, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.7304, lon: -86.58594, locations facility: Alliance for Multispecialty Research, LLC, city: Mobile, state: Alabama, zip: 36608, country: United States, contacts name: Harry E Studdard, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.69436, lon: -88.04305, locations facility: Alaska Heart and Vascular Institute, city: Anchorage, state: Alaska, zip: 99508, country: United States, contacts name: Suneet Nitin Purohit, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 61.21806, lon: -149.90028, locations facility: Helios Clinical Research - SAZ-PDV-026, city: Paradise Valley, state: Arizona, zip: 85253, country: United States, contacts name: Gerald Asin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.53115, lon: -111.94265, locations facility: Phoenix Clinical LLC, city: Phoenix, state: Arizona, zip: 85014, country: United States, contacts name: Brock Adam Merritt, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Arizona Cardiovascular Research Center, city: Phoenix, state: Arizona, zip: 85016, country: United States, contacts name: Vijendra Swarup, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Synexus Clinical Research US, Inc./Orange Grove Family Practice, city: Tucson, state: Arizona, zip: 85741, country: United States, contacts name: Kevin Lee Pounds, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Cardiology and Medicine Clinic, city: Little Rock, state: Arkansas, zip: 72204, country: United States, contacts name: Joe Louis Hargrove, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Kidney & Hypertension Center - Apple Valley, city: Apple Valley, state: California, zip: 92307, country: United States, contacts name: Edgard Vera, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.50083, lon: -117.18588, locations facility: AHF Westside, city: Beverly Hills, state: California, zip: 90211, country: United States, contacts name: Carl E Millner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.07362, lon: -118.40036, locations facility: Hope Clinical Research, Inc., city: Canoga Park, state: California, zip: 91303, country: United States, contacts name: Hessam Aazami, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.20112, lon: -118.59814, locations facility: Valley Clinical Trials, Inc., city: Covina, state: California, zip: 91723, country: United States, contacts name: Fahed G Bitar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.09001, lon: -117.89034, locations facility: Neighborhood Healthcare Institute of Health, city: Escondido, state: California, zip: 92025, country: United States, contacts name: James H Schultz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.11921, lon: -117.08642, locations facility: HB Clinical Trials - Fountain Valley, city: Fountain Valley, state: California, zip: 92708, country: United States, contacts name: Vinod Malhotra, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.70918, lon: -117.95367, locations facility: Scripps Whittier Diabetes Institute, city: La Jolla, state: California, zip: 92037, country: United States, contacts name: Athena Philis-Tsimikas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: North America Research Institute, city: Lynwood, state: California, zip: 90262, country: United States, contacts name: Sita Yanamadala, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.93029, lon: -118.21146, locations facility: Valley Clinical Trials, Inc., city: Northridge, state: California, zip: 91325, country: United States, contacts name: Christopher Chow, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.22834, lon: -118.53675, locations facility: California Liver Research Institute, city: Pasadena, state: California, zip: 91105, country: United States, contacts name: Edward Mena, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.14778, lon: -118.14452, locations facility: Western University of Health Sciences, city: Pomona, state: California, zip: 91766, country: United States, contacts name: Airani Sathananthan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05529, lon: -117.75228, locations facility: California Kidney Specialists, city: San Dimas, state: California, zip: 91773, country: United States, contacts name: Aamir Jamal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.10668, lon: -117.80673, locations facility: Southern California Dermatology, Inc., city: Santa Ana, state: California, zip: 92701, country: United States, contacts name: Wayne Ho, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.74557, lon: -117.86783, locations facility: Encompass Clinical Research, city: Spring Valley, state: California, zip: 91978, country: United States, contacts name: Hanid Audish, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.74477, lon: -116.99892, locations facility: Valiance Clinical Research, city: Tarzana, state: California, zip: 91356, country: United States, contacts name: Kalpesh Patel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.17334, lon: -118.55397, locations facility: National Institute of Clinical Research (NICR) - High Desert, city: Victorville, state: California, zip: 92393, country: United States, contacts name: Jay Shankar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.53611, lon: -117.29116, locations facility: Synexus Clinical Research US - Vista, city: Vista, state: California, zip: 92083, country: United States, contacts name: Isabel J. Pereira, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.20004, lon: -117.24254, locations facility: Excel Medical Clinical Trials, city: Boca Raton, state: Florida, zip: 33434, country: United States, contacts name: Rasha Youssef, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.3669, lon: -80.13033, locations facility: Fleming Island Center for Clinical Research, city: Fleming Island, state: Florida, zip: 32003, country: United States, contacts name: Jennifer M Sidey, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.0933, lon: -81.71898, locations facility: Florida Kidney Physicians - Fort Lauderdale, city: Fort Lauderdale, state: Florida, zip: 33316, country: United States, contacts name: Zachary Yablon, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.12231, lon: -80.14338, locations facility: Inpatient Research Clinic, city: Miami Lakes, state: Florida, zip: 33014, country: United States, contacts name: Alexis Gutierrez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.90871, lon: -80.30866, locations facility: New Age Medical Research Corporation, city: Miami, state: Florida, zip: 33186, country: United States, contacts name: Janet K. Gersten, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Elixia Central Florida, city: Orlando, state: Florida, zip: 32806, country: United States, contacts name: Arvind Madan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Omega Research Orlando, city: Orlando, state: Florida, zip: 32808, country: United States, contacts name: Kwabena Ayesu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Florida Kidney Physicians - Port Charlotte, city: Port Charlotte, state: Florida, zip: 33952, country: United States, contacts name: Kianoosh Kaveh, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.97617, lon: -82.09064, locations facility: Florida Kidney Physicians - Tampa, city: Riverview, state: Florida, zip: 33578, country: United States, contacts name: Amit Johnsingh, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.86614, lon: -82.32648, locations facility: Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research, city: Tampa, state: Florida, zip: 33609, country: United States, contacts name: Scott E Miller, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, locations facility: American Clinical Trials - Acworth, city: Acworth, state: Georgia, zip: 30101, country: United States, contacts name: CHINEDU PATRICK NWEKE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.06635, lon: -84.67837, locations facility: Atlanta Diabetes Associates, city: Atlanta, state: Georgia, zip: 30318, country: United States, contacts name: Bruce Bode, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, locations facility: Fides Clinical Research, city: Atlanta, state: Georgia, zip: 30342, country: United States, contacts name: Elizabeth Nguyen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, locations facility: Southeastern Clinical Research Institute, city: Augusta, state: Georgia, zip: 30904, country: United States, contacts name: Matthew J Diamond, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.47097, lon: -81.97484, locations facility: American Clinical Trials - Douglasville, city: Douglasville, state: Georgia, zip: 30134, country: United States, contacts name: Ayorinde Soipe, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.7515, lon: -84.74771, locations facility: Center for Advanced Research & Education, city: Gainesville, state: Georgia, zip: 30501, country: United States, contacts name: Angela Dawn Ritter, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.29788, lon: -83.82407, locations facility: East Coast Institute for Research, LLC, city: Macon, state: Georgia, zip: 31210, country: United States, contacts name: Thomas Cunningham Jones, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84069, lon: -83.6324, locations facility: North Georgia Clinical Research, city: Woodstock, state: Georgia, zip: 30189, country: United States, contacts name: Bram Wieskopf, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.10149, lon: -84.51938, locations facility: Clinical Investigation Specialists, city: Gurnee, state: Illinois, zip: 60031, country: United States, contacts name: Luis Gonzalez-Orozco, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.3703, lon: -87.90202, locations facility: Accellacare - DuPage, city: Lombard, state: Illinois, zip: 60148, country: United States, contacts name: Yoko Momoyama, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.88003, lon: -88.00784, locations facility: Alliance for Multispecialty Research, LLC, city: Park Ridge, state: Illinois, zip: 60068, country: United States, contacts name: Saifullah Nasir, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.01114, lon: -87.84062, locations facility: Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative, city: Springfield, state: Illinois, zip: 62711, country: United States, contacts name: Diana Widicus, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.80172, lon: -89.64371, locations facility: Reid Physician Associates, city: Richmond, state: Indiana, zip: 47374, country: United States, contacts name: John Edward McGinty, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.82894, lon: -84.89024, locations facility: Iowa Diabetes and Endocrinology Research Center, city: West Des Moines, state: Iowa, zip: 50265, country: United States, contacts name: Anuj Bhargava, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.57721, lon: -93.71133, locations facility: The University of Kansas - Clinical Research Center, city: Fairway, state: Kansas, zip: 66205, country: United States, contacts name: Kristine Grdinovac, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.02223, lon: -94.6319, locations facility: Alliance for Multispecialty Research, LLC, city: Newton, state: Kansas, zip: 67114, country: United States, contacts name: Richard Glover, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.04668, lon: -97.34504, locations facility: Cotton O'Neil Clinical Research Center - Central Office, city: Topeka, state: Kansas, zip: 66606, country: United States, contacts name: Katherine Willingham, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.04833, lon: -95.67804, locations facility: Cotton O'Neil Clinical Research Center, city: Topeka, state: Kansas, zip: 66606, country: United States, contacts name: susan brian, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.04833, lon: -95.67804, locations facility: Qualmedica Research, city: Bowling Green, state: Kentucky, zip: 42101, country: United States, contacts name: J Christopher Christopher Sartore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.99032, lon: -86.4436, locations facility: L-MARC Research Center, city: Louisville, state: Kentucky, zip: 40213, country: United States, contacts name: Harold E. Bays, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Cambridge Medical Trials, city: Alexandria, state: Louisiana, zip: 71301, country: United States, contacts name: Naseem Jaffrani, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.31129, lon: -92.44514, locations facility: IMA Clinical Research Monroe - Armand, city: Monroe, state: Louisiana, zip: 71201, country: United States, contacts name: Clinton Guillory, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.50931, lon: -92.1193, locations facility: Alliance for Multispecialty Research, LLC, city: New Orleans, state: Louisiana, zip: 70119, country: United States, contacts name: Robert J Noveck, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Maryland Cardiovascular Specialists, city: Baltimore, state: Maryland, zip: 21229, country: United States, contacts name: Jeffrey F. Cole, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Joslin Diabetes Center, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Osama Hamdy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: NECCR PrimaCare Research, city: Fall River, state: Massachusetts, zip: 02721, country: United States, contacts name: Ehab Sorial, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.70149, lon: -71.15505, locations facility: Alliance for Multispecialty Research, LLC., city: Dearborn, state: Michigan, zip: 48126, country: United States, contacts name: Elias H Kassab, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.32226, lon: -83.17631, locations facility: Revival Research Institute - Dearborn, city: Dearborn, state: Michigan, zip: 48126, country: United States, contacts name: Qaiser Shafiq, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.32226, lon: -83.17631, locations facility: Elixia MKC, LLC, city: Pontiac, state: Michigan, zip: 48341, country: United States, contacts name: Fahd Al-Saghir, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.63892, lon: -83.29105, locations facility: St. Clair Nephrology, city: Shelby, state: Michigan, zip: 48315, country: United States, contacts name: Joel Michels Topf, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.67087, lon: -83.03298, locations facility: Arcturus Healthcare, PLC, Troy Internal Medicine Research Division, city: Troy, state: Michigan, zip: 48098, country: United States, contacts name: Neil J. Fraser, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.60559, lon: -83.14993, locations facility: Alliance for Multispecialty Research, LLC, city: Kansas City, state: Missouri, zip: 64114, country: United States, contacts name: Martha Sue Fanning, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Mercy Research - Smith Glynn Callaway, city: Springfield, state: Missouri, zip: 65807, country: United States, contacts name: Gregory Ledger, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.21533, lon: -93.29824, locations facility: Mercury Street Medical Group, PLLC, city: Butte, state: Montana, zip: 59701, country: United States, contacts name: John Pullman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.00382, lon: -112.53474, locations facility: Boeson Research MSO, city: Missoula, state: Montana, zip: 59804, country: United States, contacts name: Aubrey May Remmers, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.87215, lon: -113.994, locations facility: DaVita Clinical Research - Las Vegas, city: Las Vegas, state: Nevada, zip: 89107, country: United States, contacts name: MARK VISHNEPOLSKY, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Long Island Cardiovascular Consultants, city: Lake Success, state: New York, zip: 11042, country: United States, contacts name: Kenneth Cohen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.77066, lon: -73.71763, locations facility: Northwell Health Physician Peconic, city: Riverhead, state: New York, zip: 11901, country: United States, contacts name: Sean M Donahoe, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.91704, lon: -72.66204, locations facility: Medication Management, city: Greensboro, state: North Carolina, zip: 27405, country: United States, contacts name: Jagadeesh (Jay) R. Ganji, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.07264, lon: -79.79198, locations facility: IMA Clinical Research - Lenoir, city: Lenoir, state: North Carolina, zip: 28645, country: United States, contacts name: Johnny Dy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.91402, lon: -81.53898, locations facility: West Clinical Research, city: Morehead City, state: North Carolina, zip: 28557, country: United States, contacts name: Patrick Morgante, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.72294, lon: -76.72604, locations facility: Accellacare - Raleigh, city: Raleigh, state: North Carolina, zip: 27609, country: United States, contacts name: John Rubino, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.7721, lon: -78.63861, locations facility: Accellacare - Wilmington - 1917 Tradd Court, city: Wilmington, state: North Carolina, zip: 28401, country: United States, contacts name: John Charles Parker, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Guthrie Medical Group, P.C., city: Sayre, state: Pennsylvania, zip: 18840, country: United States, contacts name: Sahzene Yavuz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.97896, lon: -76.5155, locations facility: Clinical Renal Associates - Panoramic Science, city: Upland, state: Pennsylvania, zip: 19013, country: United States, contacts name: Chike Nathan Okechukwu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.85261, lon: -75.38269, locations facility: Accellacare Trident Cardiology, city: Charleston, state: South Carolina, zip: 29456, country: United States, contacts name: William D Yarbrough, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Walker Family Care, city: Little River, state: South Carolina, zip: 29566, country: United States, contacts name: Stephen Dale Grubb, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.87323, lon: -78.61418, locations facility: South Carolina Clinical Research LLC, city: Orangeburg, state: South Carolina, zip: 29118, country: United States, contacts name: Moustafa Ashraf Hamed Moustafa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.49182, lon: -80.85565, locations facility: Circle Clinical Research, city: Sioux Falls, state: South Dakota, zip: 57104, country: United States, contacts name: Elizabeth Jensen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.54997, lon: -96.70033, locations facility: Alliance for Multispecialty Research, LLC, city: Knoxville, state: Tennessee, zip: 37920, country: United States, contacts name: William B. Smith, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.96064, lon: -83.92074, locations facility: Care Access - Memphis, city: Memphis, state: Tennessee, zip: 38128, country: United States, contacts name: Joseph Seth Weinstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.14953, lon: -90.04898, locations facility: IMA Clinical Research Austin, city: Austin, state: Texas, zip: 78745, country: United States, contacts name: Nomita Kim, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Headlands Research - Brownsville, city: Brownsville, state: Texas, zip: 78526, country: United States, contacts name: Christopher Romero, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.90175, lon: -97.49748, locations facility: South Texas Clinical Research, city: Corpus Christi, state: Texas, zip: 78404, country: United States, contacts name: Travis Taylor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.80058, lon: -97.39638, locations facility: Baylor Soltero CV Research Center, city: Dallas, state: Texas, zip: 75226, country: United States, contacts name: Cara East, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Renal Disease Research Institute, city: Dallas, state: Texas, zip: 75246, country: United States, contacts name: Bernard Fischbach, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: South Texas Research Institute, city: Edinburg, state: Texas, zip: 78539, country: United States, contacts name: Rashmee Patil, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.30174, lon: -98.16334, locations facility: El Paso Medical Research Institute, city: El Paso, state: Texas, zip: 79902-4646, country: United States, contacts name: Javier Vasallo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.75872, lon: -106.48693, locations facility: Diabetes and Thyroid Center of Ft. Worth, city: Fort Worth, state: Texas, zip: 76132, country: United States, contacts name: Anjanette Tan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.72541, lon: -97.32085, locations facility: Valley Institute of Research - Fort Worth, city: Fort Worth, state: Texas, zip: 76164, country: United States, contacts name: alex guevara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.72541, lon: -97.32085, locations facility: Aqua Research Institute, city: Houston, state: Texas, zip: 77058, country: United States, contacts name: Justin David Merszei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Northwest Houston Cardiology - Cypress, city: Houston, state: Texas, zip: 77070, country: United States, contacts name: Aditya Samal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Clinical Trial Network, city: Houston, state: Texas, zip: 77074, country: United States, contacts name: Ritesh Mathur, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Endocrine Ips, Pllc, city: Houston, state: Texas, zip: 77079, country: United States, contacts name: Prashant G Koshy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Amir A Hassan, MD, PA, city: Houston, state: Texas, zip: 77089, country: United States, contacts name: Amir Ali Hassan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Accurate Clinical Research, Inc, city: Humble, state: Texas, zip: 77346, country: United States, contacts name: Brian Yuan Chou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.99883, lon: -95.26216, locations facility: Texas Institute for Kidney and Endocrine Disorders, city: Lufkin, state: Texas, zip: 75904, country: United States, contacts name: Lance A Sloan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.33824, lon: -94.7291, locations facility: Wellness Clinical Research, city: McKinney, state: Texas, zip: 75069, country: United States, contacts name: Zahid Zafar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.19762, lon: -96.61527, locations facility: PRX Research, city: Mesquite, state: Texas, zip: 75149, country: United States, contacts name: Samer Nachawati, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.7668, lon: -96.59916, locations facility: National Institute of Clinical Research (NICR) - San Antonio - South Laredo Street, city: San Antonio, state: Texas, zip: 78204, country: United States, contacts name: Robert G. Szewc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Clinical Advancement Center, city: San Antonio, state: Texas, zip: 78212, country: United States, contacts name: Pablo E Pergola, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Diagnostics Research Group, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Lisa J Blair, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Endeavor Clinical Trials, city: San Antonio, state: Texas, zip: 78240, country: United States, contacts name: Nitendra Agarwal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: DaVita Clinical Research - North Houston, city: Shenandoah, state: Texas, zip: 77384, country: United States, contacts name: Adam Immanuel Frome, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.18022, lon: -95.45577, locations facility: Revival Research Institute, LLC, city: Sherman, state: Texas, zip: 75092, country: United States, contacts name: Syed Saghir, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.63566, lon: -96.60888, locations facility: Medrasa Clinical Research, city: Wylie, state: Texas, zip: 75098, country: United States, contacts name: Tanvir Ahmad, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.01512, lon: -96.53888, locations facility: Alpine Research Organization, city: Clinton, state: Utah, zip: 84015, country: United States, contacts name: Justin Mansfield, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.13967, lon: -112.0505, locations facility: Alliance for Multispecialty Research, LLC, city: Layton, state: Utah, zip: 84041, country: United States, contacts name: Craig K. Julien, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.06022, lon: -111.97105, locations facility: Synexus Clinical Research US, Inc., city: Salt Lake City, state: Utah, zip: 84106, country: United States, contacts name: Michael Adams, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Utah Kidney Research Institute, city: Salt Lake City, state: Utah, zip: 84115, country: United States, contacts name: Sanjiv Anand, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Alliance for Multispecialty Research, LLC, city: Norfolk, state: Virginia, zip: 23502, country: United States, contacts name: Mary C. L. Bailey, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.84681, lon: -76.28522, locations facility: Eastside Research Associates, city: Redmond, state: Washington, zip: 98052, country: United States, contacts name: Kevin Michael Hanson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.67399, lon: -122.12151, locations facility: Universal Research Group, city: Tacoma, state: Washington, zip: 98405, country: United States, contacts name: Sabrina Ann Benjamin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.25288, lon: -122.44429, locations facility: IMA Clinical Research, city: Morgantown, state: West Virginia, zip: 26505, country: United States, contacts name: WARD J PAINE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.62953, lon: -79.9559, locations facility: St. Vincent Hospital d/b/a Prevea Health, city: Green Bay, state: Wisconsin, zip: 54303, country: United States, contacts name: Aliaksandr Trusau, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.51916, lon: -88.01983, locations facility: Clinical Investigation Specialists, city: Kenosha, state: Wisconsin, zip: 53144, country: United States, contacts name: Bharathi Pulla, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.58474, lon: -87.82119, locations facility: IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas, city: Ciudad de Buenos Aires, state: Buenos Aires, zip: C1012AAR, country: Argentina, contacts name: Santiago Oscar Bruzone, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Médico Lebensohn, city: Junín, state: Buenos Aires, zip: 6000, country: Argentina, contacts name: Maria José Pelagagge, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.58382, lon: -60.94332, locations facility: Hospital Italiano de La Plata, city: La Plata, state: Buenos Aires, zip: 1900, country: Argentina, contacts name: Matías Re, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.92145, lon: -57.95453, locations facility: Clínica Privada Independencia, city: Munro, state: Buenos Aires, zip: 1605, country: Argentina, contacts name: Maan Sarem, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.53021, lon: -58.52421, locations facility: Instituto De Investigaciones Clinicas Quilmes, city: Quilmes, state: Buenos Aires, zip: 1878, country: Argentina, contacts name: Adrian Hrabar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.72904, lon: -58.26374, locations facility: Stat Research S.A., city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1023AAB, country: Argentina, contacts name: Lucas Lisandro Gutnisky, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Investigaciones Medicas Imoba Srl, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1056ABH, country: Argentina, contacts name: Silvia Ines Orio, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Médico Viamonte, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1120AAC, country: Argentina, contacts name: Diego Aizenberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Mautalen Salud e Investigación, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1128AAF, country: Argentina, contacts name: José Osvaldo Fretes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: CEMEDIAB, city: C.a.b.a., state: Ciudad Autónoma De Buenos Aires, zip: C1205AAO, country: Argentina, contacts name: Alejandro Mario Chertkoff, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Consultorio de Investigación Clínica EMO SRL, city: Ciudad Autonoma de Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: 1405, country: Argentina, contacts name: Pablo Rene Costanzo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Instituto Médico Río Cuarto, city: Río Cuarto, state: Córdoba, zip: X5800AEV, country: Argentina, contacts name: Rodrigo Carnero, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.13067, lon: -64.34992, locations facility: Centro de Salud e Investigaciones Médicas, city: Santa Rosa, state: La Pampa, zip: 6300, country: Argentina, contacts name: Marcos Alejandro Mayer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -36.61667, lon: -64.28333, locations facility: Polo de Salud Vistalba, city: Luján de Cuyo, state: Mendoza, zip: 5509, country: Argentina, contacts name: Cristian Hernan Lecussan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.03547, lon: -68.87782, locations facility: Instituto de Especialidades de la Salud Rosario, city: Rosario, state: Santa Fe, zip: 2000, country: Argentina, contacts name: Ana Elisa Chiesa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, locations facility: Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica, city: Rosario, state: Santa Fe, zip: 2000, country: Argentina, contacts name: Horacio Angel Sessa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, locations facility: Hospital Provincial del Centenario, city: Rosario, state: Santa Fe, zip: S2002KDS, country: Argentina, contacts name: Martin Najenson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, locations facility: Sanatorio San Martin, city: Venado Tuerto, state: Santa Fe, zip: 2600, country: Argentina, contacts name: Oscar Gomez Vilamajo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.74556, lon: -61.96885, locations facility: Centro de Investigaciones Médicas Tucuman, city: SAN M. DE Tucuman, state: Tucumán, zip: T4000AXL, country: Argentina, contacts name: Leonardo Pablo Serra, role: PRINCIPAL_INVESTIGATOR, locations facility: CONEXA Investigacion Clinica S.A., city: Buenos Aires, zip: 1012, country: Argentina, contacts name: María Florencia Scioscia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Buenos Aires Macula S.A, city: Buenos Aires, zip: 1061, country: Argentina, contacts name: Adrian Proietti, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Instituto Médico Especializado (IME), city: Buenos Aires, zip: 1405, country: Argentina, contacts name: Patricia Mabel Castaño, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Cardiología Palermo, city: Buenos Aires, zip: 1425, country: Argentina, contacts name: Paula Perez Terns, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Sanatorio Privado Duarte Quirós, city: Córdoba, zip: 5002, country: Argentina, contacts name: Hugo Raul Colombo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Centro de Diagnóstico y Rehabilitación (CEDIR), city: Santa Fe, zip: 3000, country: Argentina, contacts name: Antonio Enrique Saleme, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.63333, lon: -60.7, locations facility: Clínica de Nefrología, Urología y Enfermedades Cardiovasculares, city: Santa Fe, zip: 3000, country: Argentina, contacts name: MARIA GUILLERMINA BEVILACQUA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.63333, lon: -60.7, locations facility: Centro de Investigaciones Clinicas del Litoral, city: Santa Fe, zip: S3000FWO, country: Argentina, contacts name: Miguel Hominal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.63333, lon: -60.7, locations facility: Sanatorio Norte, city: Santiago del Estero, zip: 4200, country: Argentina, contacts name: Franklin Hector Abalos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.79511, lon: -64.26149, locations facility: Optimus Clinical Research, city: Botany, state: New South Wales, zip: 2019, country: Australia, contacts name: Paul Bird, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.94599, lon: 151.19591, locations facility: Northern Beaches Clinical Research, city: Brookvale, state: New South Wales, zip: 2100, country: Australia, contacts name: Richard de Solom, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.76108, lon: 151.27446, locations facility: The AIM Centre / Hunter Diabetes Centre, city: Merewether, state: New South Wales, zip: 2291, country: Australia, contacts name: Claire Morbey, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94801, lon: 151.74325, locations facility: Nightingale Research, city: Adelaide, state: South Australia, zip: 5000, country: Australia, contacts name: Andrew Hamilton, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.92866, lon: 138.59863, locations facility: Emeritus Research, city: Camberwell, state: Victoria, zip: 3124, country: Australia, contacts name: Stuart Game, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.84205, lon: 145.0694, locations facility: Zentrum für klinische Studien Dr Hanusch Gmbh, city: Vienna, state: Wien, zip: 1060, country: Austria, contacts name: Ursula Hanusch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Centro de Pesquisas Clínicas Dr. Marco Mota, city: Maceio, state: Alagoas, zip: 57051-160, country: Brazil, contacts name: Marco Antonio Mota Gomes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -9.66583, lon: -35.73528, locations facility: CPHOSP Manaus Medicina, Ensino e Pesquisa, city: Manaus, state: Amazonas, zip: 69057-088, country: Brazil, contacts name: Gustavo Akerman Augusto, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -3.10194, lon: -60.025, locations facility: L2IP - Instituto de Pesquisas Clínicas - FC072920211954380192, city: Brasília, state: Distrito Federal, zip: 70200730, country: Brazil, contacts name: Eduardo Freire Vasconcellos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -15.77972, lon: -47.92972, locations facility: Consultoria em Controle de Infecção Hospitalar, city: Belo Horizonte, state: Minas Gerais, zip: 30150-320, country: Brazil, contacts name: Flávia Coimbra Maia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -19.92083, lon: -43.93778, locations facility: Eurolatino Pesquisas Medicas, city: Uberlandia, state: Minas Gerais, zip: 38400-500, country: Brazil, contacts name: Flavia Arantes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -18.91861, lon: -48.27722, locations facility: PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR, city: Curitiba, state: Paraná, zip: 80230-130, country: Brazil, contacts name: Jose Fortes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -25.42778, lon: -49.27306, locations facility: Centro de Endocrinologia Geloneze, city: Campinas, state: São Paulo, zip: 13073-350, country: Brazil, contacts name: Bruno Geloneze, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -22.90556, lon: -47.06083, locations facility: IBPClin - Instituto Brasil de Pesquisa Clínica, city: Rio de Janeiro, zip: 20241-180, country: Brazil, contacts name: JOSELITA BODART, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Ruschel Medicina e Pesquisa Clínica, city: Rio De Janeiro, zip: 22270-060, country: Brazil, contacts name: Luiza Siffert, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Hospital Pro-Cardiaco, city: Rio de Janeiro, zip: 22280-003, country: Brazil, contacts name: Diane Avila, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -22.90278, lon: -43.2075, locations facility: CPQuali Pesquisa Clínica, city: São Paulo, zip: 01228-000, country: Brazil, contacts name: Gustavo Akerman Augusto, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Núcleo de Pesquisa Clínica da Rede São Camilo, city: São Paulo, zip: 04014-002, country: Brazil, contacts name: Luana Casari da Silva Lima, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, locations facility: SMH Cardiology Clinical Trials, city: Surrey, state: British Columbia, zip: V3V 0C6, country: Canada, contacts name: Kapil Bhagirath, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.10635, lon: -122.82509, locations facility: Winnipeg Clinic, city: Winnipeg, state: Manitoba, zip: R3C 0N2, country: Canada, contacts name: Vincent Woo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.8844, lon: -97.14704, locations facility: G A Research Associates, city: Moncton, state: New Brunswick, zip: E1G 1A7, country: Canada, contacts name: Jocelyn Cormier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.09454, lon: -64.7965, locations facility: Care Access - Cape Breton, city: Sydney, state: Nova Scotia, zip: B1M 0A1, country: Canada, contacts name: Tony Valente, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.13511, lon: -60.1831, locations facility: Western Centre for Public Health and Family Medicine, city: London, state: Ontario, zip: N6G 2M1, country: Canada, contacts name: Stewart Harris, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.98339, lon: -81.23304, locations facility: North York Diagnostic and Cardiac Centre, city: North York, state: Ontario, zip: M6B 3H7, country: Canada, contacts name: Subodh Verma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.76681, lon: -79.4163, locations facility: Lakeridge Health, city: Oshawa, state: Ontario, zip: L1G 2B9, country: Canada, contacts name: Andrew Steele, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.90012, lon: -78.84957, locations facility: Unité de Recherche Clinique du CISSS des Laurentides, city: St-Jerome, state: Quebec, zip: J7Z 2V4, country: Canada, contacts name: Yves Pesant, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.78036, lon: -74.00365, locations facility: UNIVMED, city: Brno, state: Brno-město, zip: 602 00, country: Czechia, contacts name: Ota Hlinomaz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.19522, lon: 16.60796, locations facility: Fakultni Nemocnice u sv. Anny v Brne, city: Brno, state: Jihomoravský Kraj, zip: 602 00, country: Czechia, contacts name: Robert Prosecky, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.19522, lon: 16.60796, locations facility: Kardio Chlumec, city: Chlumec nad Cidlinou, state: Královéhradecký Kraj, zip: 503 51, country: Czechia, contacts name: Martin Wiendl, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.1544, lon: 15.46026, locations facility: MaderMED, city: Ostrava, state: Moravskoslezský Kraj, zip: 710 00, country: Czechia, contacts name: David Maderic, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.83465, lon: 18.28204, locations facility: Kardiologicka ambulance, city: Litovel, state: Olomoucký Kraj, zip: 784 01, country: Czechia, contacts name: Petra Maskova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.70121, lon: 17.07615, locations facility: Agentura Science Pro, city: Olomouc, state: Olomoucký Kraj, zip: 779 00, country: Czechia, contacts name: Tomas Brychta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.59552, lon: 17.25175, locations facility: Private Practice - Dr. Miroslav Koliba, city: Ostrava, state: Ostrava Město, zip: 702 00, country: Czechia, contacts name: Miroslav Koliba, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.83465, lon: 18.28204, locations facility: Diakom, s.r.o. - Přeštice, city: Přeštice, state: Plzeň-jih, zip: 334 01, country: Czechia, contacts name: Renata Arias, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.57298, lon: 13.3335, locations facility: MUDr. Jana Parkanyiova, city: Prague, state: Praha 1, zip: 110 00, country: Czechia, contacts name: Jana Kostarova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Synexus Czech, city: Prague, state: Praha 2, zip: 120 00, country: Czechia, contacts name: Iva Skarpova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: MEDICON, city: Prague, state: Praha 4, zip: 140 00, country: Czechia, contacts name: Drahomira Gulakova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Fakultni Thomayerova nemocnice, city: Prague, state: Praha 4, zip: 14059, country: Czechia, contacts name: Jiri Skopek, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Nefrologie, city: Prague, state: Praha 4, zip: 149 00, country: Czechia, contacts name: Lucie Hornova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: DiaVize s.r.o., city: Praha, state: Praha 4, zip: 140 00, country: Czechia, contacts name: Marta Klementova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Centrum Kardiovaskularni Mediciny, city: Prague, state: Praha 6, zip: 169 00, country: Czechia, contacts name: Jean-Claude Lubanda, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: ResTrial s.r.o., city: Praha, state: Praha 8, zip: 18100, country: Czechia, contacts name: Emilia Malicherova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: MUDr. Barbora Diepoltova, city: Praha 9 - Klanovice, state: Praha 9, zip: 190 14, country: Czechia, contacts name: Barbora Diepoltova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: FLEDIP - Na dlouhem lanu, city: Prague, state: Praha, Hlavní Mešto, zip: 160 00, country: Czechia, contacts name: Milan Flekac, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Diabetologie a endokrinologie, J.Venerová, city: Praha 6, state: Praha, Hlavní Mešto, zip: 169 00, country: Czechia, contacts name: Johana Venerova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Kardiologicka ambulance, city: Brandýs nad Labem-Stará Boleslav, state: Praha-východ, zip: 250 01, country: Czechia, contacts name: Jiri Krupicka, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.18709, lon: 14.66326, locations facility: Kardioma, city: Kolin, state: Středočeský Kraj, zip: 280 02, country: Czechia, contacts name: Vit Maratka, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.02806, lon: 15.1998, locations facility: Clinical Trials Service s.r.o., city: Uherské Hradiště, state: Zlínský Kraj, zip: 686 01, country: Czechia, contacts name: Vladimir Cech, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.06975, lon: 17.45969, locations facility: EDUMED - Náchod, city: Náchod, zip: 547 01, country: Czechia, contacts name: Alica Vesela, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.4167, lon: 16.16289, locations facility: Diabetologicke centrum s.r.o., city: Olomouc, zip: 779 00, country: Czechia, contacts name: KATARINA NOVAKOVA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.59552, lon: 17.25175, locations facility: Kardiologicka ambulance MUDr. Ferkl s.r.o., city: Trutnov, zip: 541 01, country: Czechia, contacts name: Richard Ferkl, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.56101, lon: 15.9127, locations facility: Cardio Research, s.r.o, city: Zlín, zip: 760 01, country: Czechia, contacts name: Tomas Fiala, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.22645, lon: 17.67065, locations facility: Sanos Clinic - Nordjylland, city: Gandrup, state: Nordjylland, zip: 9362, country: Denmark, contacts name: Helene Rovsing, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.74249, lon: 9.82298, locations facility: Polyclinique Vauban, city: Valenciennes, state: Nord, zip: 59300, country: France, contacts name: Sebastien Caudmont, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.35, lon: 3.53333, locations facility: CRS Clinical Research Services Mannheim, city: Mannheim, state: Baden-Württemberg, zip: 68167, country: Germany, contacts name: Thomas Forst, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.4891, lon: 8.46694, locations facility: Nephrologisches Zentrum Villingen-Schwenningen, city: Villingen-Schwenningen, state: Baden-Württemberg, zip: 78052, country: Germany, contacts name: Bernd Hohenstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.06226, lon: 8.49358, locations facility: Praxis Sauter & Sauter & Vorbach, city: Wangen im Allgäu, state: Baden-Württemberg, zip: 88239, country: Germany, contacts name: Joachim Sauter, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.6895, lon: 9.83247, locations facility: ZKS Suedbrandenburg, city: Elsterwerda, state: Brandenburg, zip: 04910, country: Germany, contacts name: Andreas n.a. Hagenow, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.46043, lon: 13.52001, locations facility: Kerckhoff-Klinik, city: Bad Nauheim, state: Hessen, zip: 61231, country: Germany, contacts name: Roland Klingenberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.36463, lon: 8.73859, locations facility: Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen - Heidering, city: Hannover, state: Niedersachsen, zip: 30625, country: Germany, contacts name: Georg Schlieper, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37052, lon: 9.73322, locations facility: Kardiologische Praxis Papenburg, city: Papenburg, state: Niedersachsen, zip: 26871, country: Germany, contacts name: Andreas Wilke, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.07738, lon: 7.40444, locations facility: Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen, city: Bad Oeynhausen, state: Nordrhein-Westfalen, zip: 32545, country: Germany, contacts name: Michael Hauber, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.20699, lon: 8.80365, locations facility: InnoDiab Forschung Gmbh, city: Essen, state: Nordrhein-Westfalen, zip: 45136, country: Germany, contacts name: Helga Zeller-Stefan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Unterfrintroper Hausarztzentrum Klinische Forschung, city: Essen, state: Nordrhein-Westfalen, zip: 45359, country: Germany, contacts name: Georg Plaßmann, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Institut für Diabetesforschung GmbH Münster, city: Münster, state: Nordrhein-Westfalen, zip: 48145, country: Germany, contacts name: Ludger Rose, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.96236, lon: 7.62571, locations facility: Zentrum für klinische Studien, city: Saint Ingbert, state: Saarland, zip: 66386, country: Germany, contacts name: Alexander Segner, role: PRINCIPAL_INVESTIGATOR, locations facility: Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien, city: Dresden, state: Sachsen, zip: 01277, country: Germany, contacts name: Christoph Axthelm, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05089, lon: 13.73832, locations facility: AmBeNet GmbH, city: Leipzig, state: Sachsen, zip: 04107, country: Germany, contacts name: Hans-Detlev Stahl, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Universität zu Lübeck - Institut für Endokrinologie und Diabetes, city: Lübeck, state: Schleswig-Holstein, zip: 23562, country: Germany, contacts name: Svenja Meyhöfer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.86893, lon: 10.68729, locations facility: RED-Institut GmbH, city: Oldenburg, state: Schleswig-Holstein, zip: 23758, country: Germany, contacts name: Thomas Schaum, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.14118, lon: 8.21467, locations facility: emovis GmbH, city: Berlin, zip: 10629, country: Germany, contacts name: Kerstin Sturm, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Kardiologisch-Angiologische Praxis - Herzzentrum Bremen, city: Bremen, zip: 28277, country: Germany, contacts name: Ertan Dogu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.07516, lon: 8.80777, locations facility: Diabetes Zentrum Wilhelmsburg, city: Hamburg, zip: 21109, country: Germany, contacts name: Peter Witzel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Diabetes Zentrum Wandsbek, city: Hamburg, zip: 22041, country: Germany, contacts name: Thorsten Koch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Allergo-Derm Bakos Kft, city: Szolnok, state: Jász-Nagykun-Szolnok, zip: 5000, country: Hungary, contacts name: Noemi Bakos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.18333, lon: 20.2, locations facility: CRU Early Phase Unit, city: Kistarcsa, state: Pest, zip: 2143, country: Hungary, contacts name: Robert J. Kirschner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.54757, lon: 19.26247, locations facility: Óbudai Egészségügyi Centrum, city: Budapest, zip: 1036, country: Hungary, contacts name: Alexandra Marian, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.49801, lon: 19.03991, locations facility: PVN Kutató Kft, city: Budapest, zip: 1102, country: Hungary, contacts name: Judit Nádas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Privát Doktor Egészségügyi Zrt, city: Budapest, zip: 1132, country: Hungary, contacts name: Andras R Vertes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Újpesti Egészségügyi Nonprofit Kft, city: Budapest, zip: H-1046, country: Hungary, contacts name: Eva Judit Takacs, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.49801, lon: 19.03991, locations facility: G.B. Pant Institute of Postgraduate Medical Education & Research, city: New Delhi, state: Delhi, zip: 110002, country: India, contacts name: Vimal Mehta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.63576, lon: 77.22445, locations facility: Shri Bachubhai Dahyabhai Mehta Mahavir Heart Institute, city: Surat, state: Gujarat, zip: 395002, country: India, contacts name: Atul Damodar Abhyankar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.19594, lon: 72.83023, locations facility: Life Care Hospital and Research Centre, city: Bangalore, state: Karnataka, zip: 560092, country: India, contacts name: Prasad M Bhat, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Manipal Hospitals, city: Mysore, state: Karnataka, zip: 570015, country: India, contacts name: Chakrabhavi Keshavamurthy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 12.29791, lon: 76.63925, locations facility: Government Medical College - Kozhikode, city: Kozhikode, state: Kerala, zip: 673008, country: India, contacts name: Neeraj Manikath, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 11.24802, lon: 75.7804, locations facility: Shrikrishna Hrudayalaya And Critical Care Center, city: Nagpur, state: Maharashtra, zip: 440012, country: India, contacts name: Mahesh Chandumal Fulwani, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.14631, lon: 79.08491, locations facility: All India Institute of Medical Sciences (AIIMS) - Nagpur, city: Nagpur, state: Maharashtra, zip: 441108, country: India, contacts name: Amol Bhawane, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.14631, lon: 79.08491, locations facility: All India Institute of Medical Sciences, city: Bhubaneswar, state: Odisha, zip: 751019, country: India, contacts name: Saroj Kumar Sahoo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.27241, lon: 85.83385, locations facility: S C B Medical College and Hospital, city: Cuttack, state: Odisha, zip: 753001, country: India, contacts name: Dipak Ranjan Das, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.46497, lon: 85.87927, locations facility: Medway Hospitals - Kodambakkam, city: Chennai, state: Tamil Nadu, zip: 600024, country: India, contacts name: Jai Shankar Krishnamoorthy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 13.08784, lon: 80.27847, locations facility: Motilal Nehru Medical College Hospital, city: Allahabad, state: Uttar Pradesh, zip: 211002, country: India, contacts name: Santosh kumar maurya, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.44478, lon: 81.84322, locations facility: K care Hospital, city: Kanpur, state: Uttar Pradesh, zip: 208001, country: India, contacts name: Amit Kumar Gupta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.46523, lon: 80.34975, locations facility: LPS Institute of Cardiology, city: Kanpur, state: Uttar Pradesh, zip: 208002, country: India, contacts name: Awadhesh Kumar Sharma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.46523, lon: 80.34975, locations facility: Dr. Ram Manohar Lohia Institute of Medical Sciences, city: Lucknow, state: Uttar Pradesh, zip: 226010, country: India, contacts name: Naveen Jamwal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.83928, lon: 80.92313, locations facility: Shri Mahant Indiresh Hospital, city: Dehradun, state: Uttarakhand, zip: 248001, country: India, contacts name: Vivek Ruhela, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.32295, lon: 78.03168, locations facility: Diabetes Medical Center, city: Tel Aviv, state: HaMerkaz, zip: 6937947, country: Israel, contacts name: Maya Ish Shalom, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08088, lon: 34.78057, locations facility: Centro de Investigacion en Artritis y Osteoporosis SC, city: Mexicali, state: Baja California, zip: 21200, country: Mexico, contacts name: Francisco Fidencio Cons Molina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.62781, lon: -115.45446, locations facility: Centro de Investigacion Cardiovascular y Metabólica, city: Tijuana, state: Baja California, zip: 22500, country: Mexico, contacts name: Pedro Fajardo Campos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.5027, lon: -117.00371, locations facility: Cryptex Investigación Clínica S.A. de C.V., city: Cuauhtémoc, Ciudad De México, state: Distrito Federal, zip: 06100, country: Mexico, contacts name: Juan Alfredo Tamayo y Orozco, role: PRINCIPAL_INVESTIGATOR, locations facility: RM Pharma Specialists, city: Mexico City, state: Distrito Federal, zip: 03100, country: Mexico, contacts name: Mariana Zolandi Crespo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Clínicos Asociados BOCM, city: Mexico City, state: Distrito Federal, zip: 03300, country: Mexico, contacts name: Israel Olvera-Alvarez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Hospital de Jésus, I.A.P., city: Mexico City, state: Distrito Federal, zip: 06090, country: Mexico, contacts name: Efrain Villeda Espinosa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Clinica Omega, city: Mexico City, state: Distrito Federal, zip: 06700, country: Mexico, contacts name: Jose Hector Sanchez Mijangos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, city: Mexico City, state: Distrito Federal, zip: 11650, country: Mexico, contacts name: Melchor Alpizar Salazar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: ProcliniQ Investigación Clínica SA de CV, city: Mexico City, state: Distrito Federal, zip: 14050, country: Mexico, contacts name: Mauricio Lopez Meneses, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Clinstile, S.A. de C.V., city: Mexico, state: Distrito Federal, zip: 06700, country: Mexico, contacts name: Vicente Eduardo Ruiz Ruiz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Medimanage Research, city: Tlalpan, state: Distrito Federal, zip: 14050, country: Mexico, contacts name: Olynka Vega-Vega, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.29513, lon: -99.16206, locations facility: Instituto Cardiovascular de León S.C., city: León, state: Guanajuato, zip: 37520, country: Mexico, contacts name: Luis Adolfo Venegas Carrillo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.12908, lon: -101.67374, locations facility: Centro de Atencion al Diabetico Actopan, city: Actopan, state: Hidalgo, zip: 42500, country: Mexico, contacts name: Marco Antonio Morales de Teresa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.26961, lon: -98.94377, locations facility: Centro de Investigacion Medica Integral, city: Guadalajara, state: Jalisco, zip: 44160, country: Mexico, contacts name: Carlos Alejandro Stobschinski de Alba, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Centro de Investigación Clínica y Medicina Traslacional (CIMeT), city: Guadalajara, state: Jalisco, zip: 44340, country: Mexico, contacts name: Ramon Medina-Gonzalez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario, city: Guadalajara, state: Jalisco, zip: 44670, country: Mexico, contacts name: Maria Del Rosario Arechavaleta Granell, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Unidad de Investigación Clínica y Atención Médica HEPA, city: Guadalajara, state: Jalisco, zip: 44670, country: Mexico, contacts name: Marisol Herrera Marmolejo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Virgen Cardiovascular Research SC, city: Guadalajara, state: Jalisco, zip: 44670, country: Mexico, contacts name: Luis Ramon Virgen Carrillo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: CINVEC Medica, city: Guadalajara, state: Jalisco, zip: 44690, country: Mexico, contacts name: Ricardo Orozco Castellanos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Clinica de Enfermedades Crónicas y de Procedimientos Especiales, city: Morelia, state: Michoacán, zip: 58249, country: Mexico, contacts name: Helios Vega, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.70078, lon: -101.18443, locations facility: Instituto de Diabetes, Obesidad y Nutricion, city: Cuernavaca, state: Morelos, zip: 62250, country: Mexico, contacts name: Leobardo Sauque Reyna, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.9261, lon: -99.23075, locations facility: PanAmerican Clinical Research - Cuernavaca, city: Cuernavaca, state: Morelos, zip: 62290, country: Mexico, contacts name: Yovani Robles-Abarca, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.9261, lon: -99.23075, locations facility: Investigación Nefrológica, city: Cuernavaca, state: Morelos, zip: 62448, country: Mexico, contacts name: MARIA MAGDALENA LAFRAGUA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.9261, lon: -99.23075, locations facility: Servicios de Oncología Medica Integral - Monterrey - José Benitez, city: Monterrey, state: Nuevo León, zip: 64040, country: Mexico, contacts name: Jesus Zacarias Villarreal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Cardiolink Clin Trials, city: Monterrey, state: Nuevo León, zip: 64060, country: Mexico, contacts name: Elías García, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: IMED Internal Medicine Clin Trials, city: Monterrey, state: Nuevo León, zip: 64060, country: Mexico, contacts name: Jose Angel Garza Ruiz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Unidad biomedica avanzada monterrey, city: Monterrey, state: Nuevo León, zip: 64460, country: Mexico, contacts name: Raymundo Garcia Reza, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Clínica García Flores SC, city: Monterrey, state: Nuevo León, zip: 64610, country: Mexico, contacts name: Pedro Alberto Garcia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Centro de investigación y control metabólico, city: Monterrey, state: Nuevo León, zip: 66465, country: Mexico, contacts name: Ramiro Guadalupe Banda Elizondo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Centro de Investigacion Clinica de Oaxaca, city: Oaxaca de Juarez, state: Oaxaca, zip: 68020, country: Mexico, contacts name: Jesus Antonio Perez Ríos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 17.06542, lon: -96.72365, locations facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C., city: Culiacan, state: Sinaloa, zip: 80230, country: Mexico, contacts name: Manuel Odin de los Rios Ibarra, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.79032, lon: -107.38782, locations facility: Consultorio de Medicina Especilizada del Sector Privado, city: Xalapa, state: Veracruz, zip: 91193, country: Mexico, contacts name: Enrique Lopez Rosas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.53124, lon: -96.91589, locations facility: Medical Care and Research SA de CV, city: Merida, state: Yucatán, zip: 97070, country: Mexico, contacts name: Carlos Eduardo Medina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.97537, lon: -89.61696, locations facility: EME RED Hospitalaria, city: Mérida, state: Yucatán, zip: 97000, country: Mexico, contacts name: Hugo Antonio Laviada Molina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.97537, lon: -89.61696, locations facility: Fundación Cardiovascular de Aguascalientes A.C., city: Aguascalientes, zip: 20230, country: Mexico, contacts name: Edmundo Alfredo Bayram Llamas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.88234, lon: -102.28259, locations facility: Enclifar Ensayos Clínicos Farmacológicos Sc, city: Chihuahua, zip: 31110, country: Mexico, contacts name: Luis Alejandro Nevarez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.63528, lon: -106.08889, locations facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C., city: Durango, zip: 34000, country: Mexico, contacts name: Hector Eduardo Delgado Gomez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.02032, lon: -104.65756, locations facility: Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia, city: Durango, zip: 34000, country: Mexico, contacts name: Juan Carlos Núñez Fragoso, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.02032, lon: -104.65756, locations facility: Boca Clinical Trials Mexico SC, city: Puebla, zip: 72160, country: Mexico, contacts name: Carlos Gonzalez Parra, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.03793, lon: -98.20346, locations facility: Centro de Estudios Clínicos de Querétaro (CECLIQ), city: Querétaro, zip: 76000, country: Mexico, contacts name: Marco Antonio Alcocer Gamba, role: PRINCIPAL_INVESTIGATOR, locations facility: PanAmerican Clinical Research - Querétaro - Avenida Antea, city: Querétaro, zip: 76100, country: Mexico, contacts name: Juan Villagordoa Mesa, role: PRINCIPAL_INVESTIGATOR, locations facility: Centro de Atención e Investigación Cardiovascular del Potosí, city: San Luis Potosí, zip: 78200, country: Mexico, contacts name: José Luis Arenas León, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.14982, lon: -100.97916, locations facility: Instituto Veracruzano en Investigación Clínica S.C., city: Veracruz, zip: 91851, country: Mexico, contacts name: Rosa Isela Luna Ceballos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.18095, lon: -96.1429, locations facility: FAICIC S. de R.L. de C.V., city: Veracruz, zip: 91900, country: Mexico, contacts name: Sandro Fabricio Avila, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.18095, lon: -96.1429, locations facility: Arké SMO S.A de C.V, city: Veracruz, zip: 91910, country: Mexico, contacts name: Luis Horacio Aguilar Espinoza, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.18095, lon: -96.1429, locations facility: Emotional Brain FlevoResearch, city: Almere, state: Flevoland, zip: 1311 RL, country: Netherlands, contacts name: Mazin Alhakim, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37535, lon: 5.25295, locations facility: Medisch Centrum Thomsonplein, city: The Hague, state: Zuid-Holland, zip: 2565 KV, country: Netherlands, contacts name: Boudewijn Alexander Hoek, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Huisartsenpraktijk Broekman, city: Zwijndrecht, state: Zuid-Holland, zip: 3333 GZ, country: Netherlands, contacts name: Matthijs Broekman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.8175, lon: 4.63333, locations facility: Huisartsenpraktijk Disha, city: Den Haag, zip: 2572 GM, country: Netherlands, contacts name: Ravee Rambharose, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Dokters van Nederhoven, city: Zwijndrecht, zip: 3334 SB, country: Netherlands, contacts name: Ralph Verkleij, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.8175, lon: 4.63333, locations facility: NZOZ Centurm Medyczne SERAFIN-MED, city: Zarow, state: Dolnośląskie, zip: 58-130, country: Poland, contacts name: Ryszard Serafin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.94116, lon: 16.49466, locations facility: NZOZ Centrum Medyczne KERmed, city: Bydgoszcz, state: Kujawsko-pomorskie, zip: 85-231, country: Poland, contacts name: Tomasz Lugowski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.1235, lon: 18.00762, locations facility: INTERCOR, city: Bydgoszcz, state: Kujawsko-pomorskie, zip: 85-605, country: Poland, contacts name: Grzegorz Grzesk, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.1235, lon: 18.00762, locations facility: CenterMed Lublin NZOZ, city: Lublin, state: Lubelskie, zip: 20-044, country: Poland, contacts name: Grzegorz Drelich, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.25, lon: 22.56667, locations facility: Ekamed, city: Lublin, state: Lubelskie, zip: 20-718, country: Poland, contacts name: Ewa Maria Szyprowska, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.25, lon: 22.56667, locations facility: Balsam Medica, city: Warsaw, state: Mazowieckie, zip: 01-249, country: Poland, contacts name: Marcin Grabowski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Polsko-Amerykańskie Kliniki Serca PAKS Małopolskie Centrum Sercowo-Naczyniowe, city: Chrzanow, state: Małopolskie, zip: 32-500, country: Poland, contacts name: Aleksander Zurakowski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.13546, lon: 19.40203, locations facility: NZOZ Diab-Endo-Met, city: Krakow, state: Małopolskie, zip: 31-261, country: Poland, contacts name: Joanna Mirocka, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Centrum Szybkiej Diagnostyki Kardiologicznej "Kardiomed" M. Żabówka E. Żabówka, city: Tarnow, state: Małopolskie, zip: 33-100, country: Poland, contacts name: Maciej Stanislaw Zabowka, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.01381, lon: 20.98698, locations facility: EndoPractica, city: Opole, state: Opolskie, zip: 45-301, country: Poland, contacts name: Agata Bronisz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.67211, lon: 17.92533, locations facility: KLIMED Marek Klimkiewicz, city: Bialystok, state: Podlaskie, zip: 15-704, country: Poland, contacts name: Irena Glowinska, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.13333, lon: 23.16433, locations facility: Centrum Kliniczno-Badawcze, city: Elblag, state: Warmińsko-mazurskie, zip: 82-300, country: Poland, contacts name: Bozena Gornikiewicz-Brzezicka, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.1522, lon: 19.40884, locations facility: Poliklinika Kardiologiczna Serce, city: Leszno, state: Wielkopolskie, zip: 64-100, country: Poland, contacts name: Witold Piotrowski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.84034, lon: 16.57494, locations facility: Centrum Zdrowia Metabolicznego Pawel Bogdanski, city: Poznań, state: Wielkopolskie, zip: 60-589, country: Poland, contacts name: Pawel Bogdanski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.40692, lon: 16.92993, locations facility: Pro Salus Centrum Medyczne, city: Lodz, state: Łódzkie, zip: 91-473, country: Poland, contacts name: Marcin Ojrzanowski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.75, lon: 19.46667, locations facility: Polsko-Amerykańskie Kliniki Serca II Oddział Kardiologiczny, city: Bielsko-Biala, state: Śląskie, zip: 43-300, country: Poland, contacts name: Krzysztof Milewski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.82245, lon: 19.04686, locations facility: Diab Serwis Popenda Spółka Jawna, city: Chorzow, state: Śląskie, zip: 41-500, country: Poland, contacts name: Grazyna Popenda, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.30582, lon: 18.9742, locations facility: Polsko-Amerykańskie Kliniki Serca, city: Tychy, state: Śląskie, zip: 43-100, country: Poland, contacts name: Adam Janas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.13717, lon: 18.96641, locations facility: Advanced Clinical Research, LLC, city: Bayamón, zip: 00959, country: Puerto Rico, contacts name: Angel Luis Comulada-Rivera, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.39856, lon: -66.15572, locations facility: IN-DIA, city: Lucenec, state: Banskobystrický Kraj, zip: 984 01, country: Slovakia, contacts name: Livia Tomasova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.33249, lon: 19.66708, locations facility: MUDr. Judita Gondova, city: Poltar, state: Banskobystrický Kraj, zip: 987 01, country: Slovakia, contacts name: Judita Gondova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.43094, lon: 19.79408, locations facility: ENRIN, s.r.o., city: Rimavská Sobota, state: Banskobystrický Kraj, zip: 979 01, country: Slovakia, contacts name: Jana Horvath Bercikova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.38284, lon: 20.02239, locations facility: Sin Azucar, city: Malacky, state: Bratislavský Kraj, zip: 901 01, country: Slovakia, contacts name: Barbora Zobokova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.43604, lon: 17.02188, locations facility: NOVUM+, city: Kosice, state: Košický Kraj, zip: 040 01, country: Slovakia, contacts name: Viera Donicova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.71395, lon: 21.25808, locations facility: Tatratrial s.r.o., city: Rožňava, state: Košický Kraj, zip: 04801, country: Slovakia, contacts name: Beata Lachova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.66009, lon: 20.53758, locations facility: Areteus s.r.o., city: Trebisov, state: Košický Kraj, zip: 075 01, country: Slovakia, contacts name: Dasa Skripova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.62858, lon: 21.71954, locations facility: Fakultná nemocnica Nitra, city: Nitra, state: Nitriansky Kraj, zip: 950 01, country: Slovakia, contacts name: Peter Minarik, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.30763, lon: 18.08453, locations facility: Funkystuff, city: Nove Zamky, state: Nitriansky Kraj, zip: 940 02, country: Slovakia, contacts name: Miriam Teplanova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.98544, lon: 18.16195, locations facility: MEDIKALS, city: Piešťany, state: Trnavský Kraj, zip: 921 01, country: Slovakia, contacts name: Slavka Kalinova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.59479, lon: 17.82591, locations facility: ENDIAMED s.r.o, city: Dolny Kubin, state: Žilinský Kraj, zip: 026 01, country: Slovakia, contacts name: Jan Truban, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.20983, lon: 19.30341, locations facility: JM-Interna s.r.o, city: Dolny Kubin, state: Žilinský Kraj, zip: 02601, country: Slovakia, contacts name: Jan Micik, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.20983, lon: 19.30341, locations facility: NEDÚ - Národný endokrinologický a diabetologický ústav n.o., city: Lubochna, state: Žilinský Kraj, zip: 034 91, country: Slovakia, contacts name: Emil Martinka, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.12011, lon: 19.16891, locations facility: AMBORA s.r.o. Interna ambulancia, city: Martin, state: Žilinský Kraj, zip: 036 01, country: Slovakia, contacts name: Boris Raska, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.06651, lon: 18.92399, locations facility: MediPrax, s.r.o., city: Trstena, state: Žilinský Kraj, zip: 028 01, country: Slovakia, contacts name: Ivana Škerdová, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.36101, lon: 19.61249, locations facility: B-Medical, s.r.o., city: Tvrdošín, state: Žilinský Kraj, zip: 027 44, country: Slovakia, contacts name: Maria Balekova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.337, lon: 19.556, locations facility: IRIDIA, city: Vrutky, state: Žilinský Kraj, zip: 038 61, country: Slovakia, contacts name: Radovan Plasil, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.11328, lon: 18.91714, locations facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE), city: Sevilla, zip: 41003, country: Spain, contacts name: Alberto Aliaga Verdugo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Eskisehir Osmangazi University, city: Eskisehir, state: Eskişehir, zip: 26480, country: Turkey, contacts name: Yuksel Cavusoglu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.77667, lon: 30.52056, locations facility: Istanbul Universitesi Cerrahpasa, city: Istanbul- Fatih, state: İstanbul, zip: 34098, country: Turkey, contacts name: Nurhan Seyahi, role: PRINCIPAL_INVESTIGATOR, locations facility: Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases, city: Meram, state: Konya, zip: 42080, country: Turkey, contacts name: Kultigin Turkmen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.82985, lon: 32.46777, locations facility: Adana Sehir Egitim ve Arastirma Hastanesi, city: Adana, zip: 01370, country: Turkey, contacts name: Ibrahim Halil Kurt, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.00167, lon: 35.32889, locations facility: Ankara Bilkent Şehir Hastanesi, city: Ankara, zip: 06800, country: Turkey, contacts name: Burcu Demirkan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, locations facility: T.C. Saglik Bakanligi - Hitit Universitesi Corum Egitim ve Arastirma Hastanesi, city: Corum, zip: 19040, country: Turkey, contacts name: Lütfü Bekar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.54889, lon: 34.95333, locations facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi, city: Gaziantep, zip: 27310, country: Turkey, contacts name: Fatih Mehmet Erdur, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.05944, lon: 37.3825, locations facility: Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi, city: Istanbul, zip: 34668, country: Turkey, contacts name: Baris Gungor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştirma Hastanesi, city: Istanbul, zip: 34865, country: Turkey, contacts name: Gokhan Alici, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri, city: Kayseri, country: Turkey, contacts name: Ismail Kocyigit, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.73222, lon: 35.48528, locations facility: Ophthalmology, city: Kocaeli, zip: 41380, country: Turkey, contacts name: Necmi Eren, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.62497, lon: 27.51145, locations facility: T.C. Saglik Bakanligi - Dumlupinar Universitesi Kutahya Evliya Celebi Egitim ve Arastirma Hastanesi, city: Kütahya, zip: 43100, country: Turkey, contacts name: Taner Sen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.42417, lon: 29.98333, locations facility: Homecroft Surgery, city: Redruth, state: Cornwall, zip: TR16 4ET, country: United Kingdom, contacts name: Mark Simon Danielsen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.23315, lon: -5.22434, locations facility: Rame Medical Ltd, city: Torpoint, state: Cornwall, zip: PL11 2TB, country: United Kingdom, contacts name: Lawrence Barnes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.37505, lon: -4.19566, locations facility: FutureMeds - Birmingham, city: Birmingham, zip: B21 9RY, country: United Kingdom, contacts name: Tehmina Ahmed, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.48142, lon: -1.89983, hasResults: False

protocolSection identificationModule nctId: NCT06383377, orgStudyIdInfo id: Pre-market parallel study, briefTitle: Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2030-03-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Wishbone SA, class: INDUSTRY, collaborators name: EVAMED, collaborators name: Pharmalex, collaborators name: Advimago, descriptionModule briefSummary: This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket., conditionsModule conditions: Bone Regeneration, conditions: Safety Issues, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The parallel group will be treated with the product Bio-Oss® in a 1:1 randomization. Bio- Oss® is a natural bone mineral of bovine origin. Bio-Oss® is available as granules of spongious bone. Sterilization of Bio-Oss® is carried out by irradiation. Bio-Oss® has a macro- and microporous structure similar to human spongious bone. Bio-Oss® supports the in-growth of new bone at the implantation site by serving as a stable scaffold for osteoblasts; over time it is subject to the physiological remodeling process. Bio-Oss® is slowly resorbable, depending on the physiological environment of the individual patient, or integrated into the host bone. The highly purified osteoconductive mineral structure is produced from natural bone in a multistage purification process, adhering to the strictest safety regulations., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients will not be informed of their randomization assignment until the 1 year post implant placement follow-up visit. At this timepoint, the primary endpoint will have been achieved (at the implant placement visit) as well as the majority of the secondary endpoints. After the bone grafting surgery, all patients will receive an identic implant cart that does not break the blinding of the study. 1 year after implant placement, the patients will receive their definitive implant cart., whoMasked: PARTICIPANT, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Tooth extraction and bone graft procedure, outcomesModule primaryOutcomes measure: Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure., secondaryOutcomes measure: Assessment of the bone density at implant placement., secondaryOutcomes measure: Evaluation of the implant primary stability., secondaryOutcomes measure: Assessment of the implant osteointegration after implant placement, secondaryOutcomes measure: Implant survival rate and success evaluated at 3-, 6- and 12-months and 3- and 5- To evaluate implant survival and success 3-, 6- and 12- months and 3- and 5-years after implant placement, secondaryOutcomes measure: Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness, secondaryOutcomes measure: Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire., secondaryOutcomes measure: Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement., secondaryOutcomes measure: Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique de la Source DentalMe, status: RECRUITING, city: Louvain-la-Neuve, state: Brabant Wallon, zip: 1348, country: Belgium, contacts name: Sami El Masri, role: CONTACT, email: dentiste.elmasri@gmail.com, contacts name: Laurane Pansaers, role: SUB_INVESTIGATOR, geoPoint lat: 50.66829, lon: 4.61443, locations facility: Cabinet Debaty-Techy, status: RECRUITING, city: Aubel, state: Liège, zip: 4880, country: Belgium, contacts name: Bertrand Debaty, role: CONTACT, email: bertranddebaty@gmail.com, geoPoint lat: 50.70189, lon: 5.85812, locations facility: Clinique du Faubourg DentalMe, status: RECRUITING, city: Chaudfontaine, state: Liège, zip: 4053, country: Belgium, contacts name: Souheil Salem, role: CONTACT, email: souhsal@yahoo.fr, geoPoint lat: 50.5828, lon: 5.6341, locations facility: Centre Hospitalier Université de Liège, status: RECRUITING, city: Liège, zip: 4000, country: Belgium, contacts name: Bruno De Carvalho, role: CONTACT, email: mailto:bruno.decarvalho@chuliege.be, contacts name: Lemmy Liegeois, role: SUB_INVESTIGATOR, contacts name: Gilles Szotek, role: SUB_INVESTIGATOR, geoPoint lat: 50.63373, lon: 5.56749, locations facility: Centre Oxalys, status: RECRUITING, city: Namur, zip: 5020, country: Belgium, contacts name: Adrien Bolette, role: CONTACT, email: bolette.adrien@gmail.com, geoPoint lat: 50.4669, lon: 4.86746, hasResults: False

protocolSection identificationModule nctId: NCT06383364, orgStudyIdInfo id: SHS-Pharm - 1 - 2024, briefTitle: The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment, acronym: MEDCOOR, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Southern Denmark, class: OTHER, descriptionModule briefSummary: To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan to reduce the risk of post-hospital inappropriate medication usage., conditionsModule conditions: Medication Administered in Error, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Medication Coordinator, outcomesModule primaryOutcomes measure: Reduction of potentially inappropriate medication according to Potentially Inappropriate Medication List, secondaryOutcomes measure: Evaluation of patients experiences quality of life with the EQ-5D and EQ-VAS., secondaryOutcomes measure: Evaluation of patients experienced quality of life with visual analogue scale (VAS)., secondaryOutcomes measure: Evaluation of patients experienced treatment burden with the questionnaire Multimorbidity treatment burden questionnaire (MTBQ)., secondaryOutcomes measure: Evaluation of patients experienced medication burden with visual analogue scale (VAS)., secondaryOutcomes measure: Patient readmission 30 days after hospital discharge, secondaryOutcomes measure: Patient contact to the ward 30 days after hospital discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sygehus Sønderjylland, city: Aabenraa, state: Southern Denmark, zip: 6200, country: Denmark, geoPoint lat: 55.04434, lon: 9.41741, hasResults: False

protocolSection identificationModule nctId: NCT06383351, orgStudyIdInfo id: BQ001, briefTitle: Patients' Illness Perception of Peri-implant Diseases. A Cross-sectional Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Siena, class: OTHER, descriptionModule briefSummary: Despite extensive research on periodontitis, little attention has been given to the symptoms and perception of peri-implant diseases and their impact on oral health-related quality of life. The study aims to assess patient perception of these diseases and their impact on quality of life through a cross-sectional observational study. Patients will be recruited from the Unit of Periodontics at "Le Scotte" University Hospital and will undergo diagnosis followed by questionnaire assessments. No follow-up visits are planned, and validated questionnaires will be administered to evaluate perception and impact on quality of life. Study procedures will include recording biometric peri-implant parameters and administering questionnaires such as the Brief Illness Perception Questionnaire (BIPQ) and Oral Health Impact Profile-14 (OHIP-14)., conditionsModule conditions: Peri-implant Mucositis, conditions: Perception, conditions: Survey, conditions: Questionnaires, conditions: Peri-Implantitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Assessment of patient's perception of their peri-implant disease through the Brief Illness Perception Questionnaire (Brief IPQ), primaryOutcomes measure: Assessment of peri-implant disease's impact on the oral health-related quality of life through the Oral Health Impact Profile 14., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AOUS, status: RECRUITING, city: Siena, zip: 53100, country: Italy, contacts name: Nicola Discepoli, role: CONTACT, phone: 3395256148, email: nicola.discepoli2@unisi.it, geoPoint lat: 43.31822, lon: 11.33064, hasResults: False

protocolSection identificationModule nctId: NCT06383338, orgStudyIdInfo id: PEGASUS, briefTitle: A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma., acronym: PEGASUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Murdoch Childrens Research Institute, class: OTHER, descriptionModule briefSummary: PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population. The study will be conducted in patients (6-25 years of age) with Hodgkin lymphoma or non-Hodgkin lymphoma as exemplar cohort, but with the understanding that cancer-directed and supportive care medicines of the CYP3A4, CYP2C19, and CYP2D6 metabolic pathways are commonly utilised for the treatment of many paediatric, adolescent, young adult, and adult cancers.The study involves administration of the probe medication at timepoints which align with pre-determined hospital visits for the treatment of lymphoma and subsequent blood draws to measure the metabolism of the probe medications.The acceptability and feasibility of this study will inform future studies in phenoconversion within the paediatric cancer population to direct more personalised precision medicine., conditionsModule conditions: Hodgkin Lymphoma, conditions: Non Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Omeprazole, interventions name: Dextromethorphan, outcomesModule primaryOutcomes measure: Proportion of patients who consent to study and complete baseline and at least two longitudinal timepoints with successful measurement of probe drug MR (Metabolic ratio), secondaryOutcomes measure: Percentage of participants completing all required longitudinal blood sampling, secondaryOutcomes measure: Proportion of participants with successful detection of probe drug overall and at each sampling timepoint, secondaryOutcomes measure: Proportion of participants where phenotype can be classified according to MR overall at each sampling timepoint, secondaryOutcomes measure: The level of acceptability of participation in pharmacogenomic & phenoconversion testing using the PEGASUS specific survey tool (based on the Theoretical Framework of Acceptability [TFA]), secondaryOutcomes measure: Percentage of participants experiencing an adverse event (AE) during probe drug administration, secondaryOutcomes measure: Incidence of genotype and phenotype mismatch, overall and across longitudinal timepoints, secondaryOutcomes measure: Proportion of participants with disease staging and biomarkers of extent of disease, secondaryOutcomes measure: Proportion of participants with a systemic inflammatory state, secondaryOutcomes measure: Proportion of participants taking medications involving the CYP P450 pathway, secondaryOutcomes measure: Participant demographic information, secondaryOutcomes measure: Proportion of participants with other environmental factors, secondaryOutcomes measure: Longitudinal inflammatory profile of participants with Hodgkin or non-Hodgkin Lymphoma as measured by a panel including serum levels of procalcitonin, c-reactive protein and cytokine analysis., eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Peter MacCallum Cancer Centre, city: Melbourne, state: Victoria, zip: 3000, country: Australia, contacts name: Marliese Alexander, Doctor of Philosophy, role: CONTACT, geoPoint lat: -37.814, lon: 144.96332, hasResults: False

protocolSection identificationModule nctId: NCT06383325, orgStudyIdInfo id: Livertoxcicity in AL, briefTitle: Livertoxcicity in Acute Leukemia Patients During Chemotherapy Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Detection of hepatotoxcicity in acute leukemia and study the outcome of acute leukemia patients that suffer from hepatic toxiciyt, conditionsModule conditions: Liver Toxicity, Chemically-Induced, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Chemotherapy, outcomesModule primaryOutcomes measure: Detection of hepatotoxcicity in acute leukemia during chemotherapy treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383312, orgStudyIdInfo id: E-10840098-772.02-4248, briefTitle: Magnetic Reflexologic Insoles for Primary Dysmenorrhea, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Istanbul Medipol University Hospital, class: OTHER, descriptionModule briefSummary: In the study, easy-to-access and easy-to-use reflexologic magnetic insoles were used in women with primary dysmenorrhea who did not want to receive medical treatment; In addition to reducing symptoms such as pain, nausea, dizziness, fainting, vomiting, weakness, constipation/acute gastroenteritis, it is aimed to increase individuals' participation in daily life activities and increase their quality of life by increasing their emotional state., conditionsModule conditions: Primary Dysmenorrhea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two groups; treatment group and sham group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Reflexologic Magnetic Insole Group, interventions name: Orthopedic Insole Group, outcomesModule primaryOutcomes measure: McGill Pain Questionnaire-Short Form:, primaryOutcomes measure: Menstruation Attitude Questionnaire, primaryOutcomes measure: Menstruation Symptom Questionnaire, primaryOutcomes measure: Visual Analogue Scale (VAS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Medipol University, city: Istanbul, zip: 34815, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06383299, orgStudyIdInfo id: AnkaraYbuMNC, briefTitle: The Validity and Reliability Study of Turkish Version of Calgary Sleep Apnea Quality of Life Index, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2021-07-01, completionDateStruct date: 2021-08-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate its validity and reliability of the questionarre whose original English name was "Calgary Sleep Apnea Quality of Life Index" which we plan to translate into Turkish as Sleep Apnea Quality of Life Index., conditionsModule conditions: Obstruvtive Sleep Apnea Syndrome (OSAS), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Calgary Sleep Apnea Quality of Life İndex (C-SAQLI), primaryOutcomes measure: Short Form 36, primaryOutcomes measure: Epworth Sleepiness Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Yildirim Beyazıt University, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06383286, orgStudyIdInfo id: AnkaraYBUfby, briefTitle: The Relationship Between Physical Activity Levels and Anxiety, Depression, Stress of Disabled Athletes, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-12-01, primaryCompletionDateStruct date: 2021-03-01, completionDateStruct date: 2022-03-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: It is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in Tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time, conditionsModule conditions: Paralympic Athletes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 56, type: ACTUAL, outcomesModule primaryOutcomes measure: State-Trait Anxiety Inventory (STAI), primaryOutcomes measure: The Center for Epidemiological Studies Depression Scale (CES-D), primaryOutcomes measure: Fatigue Severity Scale, primaryOutcomes measure: International Physical Activity Questionnaire short form, primaryOutcomes measure: Perceived Stress Scale (PSS-14), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Yıldırım Beyazıt Univercity, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06383273, orgStudyIdInfo id: MELT-3-001, briefTitle: A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Melt Pharmaceuticals, class: INDUSTRY, collaborators name: MedTrials Incorporated, collaborators name: Evolution Research Group, collaborators name: Catalent, collaborators name: Pharmalex, descriptionModule briefSummary: The goal of this clinical trial is to learn if MELT-300 works on procedural sedation in adult participants undergoing cataract extraction with lens replacement (CELR). It will also learn about the safety of MELT-300. Researchers will compare MELT-300 to a placebo (a look-alike substance that contains no drug) to see if MELT-300 works on procedural sedation in adult participants undergoing CELR. Researchers will also include a comparator SL midazolam to confirm the benefit of inclusion of ketamine in the combined drug product.The main questions it aims to answer are:1. Does MELT-300 is effective in comparison to placebo on procedural sedation for cataract surgery?2. To determine the effectiveness of MELT-300 compared with midazolam on procedural sedation (to determine the contribution of ketamine component and inform the risk of ketamine in MELT-300)3. To determine the time to achieve preoperative target sedation level with MELT-3004. What medical problems do participants have when taking MELT-300 vs placeboEligible participants will admitted to the study unit on Day 1. Participants will be randomized prior to surgery 4:1:1 to1. MELT-300 (i.e. 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine)2. Midazolam (i.e. 1 matching midazolam sublingual tablet which contains 3 mg midazolam)3. Placebo (i.e. 1 matching placebo sublingual tablet)Participants will receive study medication 30 (± 5) minutes, without food or water, before planned surgery start (defined as instillation of topical ocular anesthetic gel \[i.e.. 3 drops of chloroprocaine hydrochloride ophthalmic gel)\].The effectiveness of MELT-300 will be performed after study medication is administered before surgery, in the course of surgery, and postoperative on Day 1 (end of surgery defined as just prior to drape removal). The safety of MELT-300 will be performed at baseline, in the course of surgery, postoperatively on Day 1, and on Day 3 ± 1 day post dose of study medication., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center Study, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-masked, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 486, type: ESTIMATED, armsInterventionsModule interventions name: MELT-300 sublingual tablet, interventions name: Midalozam sublingual tablet, interventions name: Placebo sublingual tablet, outcomesModule primaryOutcomes measure: Percentage of Participants Achieving Successful Procedural Sedation, secondaryOutcomes measure: Percentage of Participants Requiring Rescue Sedation Medication, secondaryOutcomes measure: Percentage of Participants Achieving Preoperative Procedural Sedation Without Need For Rescue Sedation Medication, secondaryOutcomes measure: Percentage of Participants Requiring Rescue Sedation Medication Preoperatively, secondaryOutcomes measure: Percentage of Participants Requiring Rescue Sedation Medication Intraoperatively, secondaryOutcomes measure: Assessment of Sedation Scores in Participants Without Requiring Rescue Sedation Medication, secondaryOutcomes measure: Percentage of Participants Able to Complete the Surgery, secondaryOutcomes measure: Percentage of Participants Able to Complete the Surgery Without Intervention (Other Than Rescue Sedation Medication), secondaryOutcomes measure: Duration to Achieve Preoperative Target Sedation (RSS level 2 or 3), secondaryOutcomes measure: Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Percentage of Participants Reporting Adverse Events Special Interest (AESIs), secondaryOutcomes measure: Mean Change from Baseline in Blood Pressure (mmHg), secondaryOutcomes measure: Mean Change from Baseline in Heart Rate [beats per minute (bpm)], secondaryOutcomes measure: Mean Change from Baseline in Respiratory Rate (breath per minute), secondaryOutcomes measure: Mean Change from Baseline in Body Temperature (degrees Fahrenheit), secondaryOutcomes measure: Mean Change from Baseline in Pulse Oximetry (%), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383260, orgStudyIdInfo id: 009-0001-7719-1189, briefTitle: Assessing the Prevalence of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Undiagnosed Young Adults:A Cross Sectional Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Jinnah Sindh Medical University, class: OTHER, descriptionModule briefSummary: To asses the prevalence of Attention deficit hyperactivity disrorder in undiagnosed young adults., conditionsModule conditions: Finding the Prevalence of ADHD in Undiagnosed Young Adults, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: Behavioral diagnostic, outcomesModule primaryOutcomes measure: Assess the prevalence of undiagnosed ADHD in Young adults, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule locations facility: JSMU, city: Karachi, state: Sindh, zip: 75330, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-09-01, uploadDate: 2024-04-21T04:06, filename: Prot_SAP_000.pdf, size: 834129, hasResults: False

protocolSection identificationModule nctId: NCT06383247, orgStudyIdInfo id: AMU-PD-multicenter, briefTitle: The Efficacy of Repetitive Transcranial Magnetic Stimulation With Precision Neuronavigation in Parkinson's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Anhui Medical University, class: OTHER, descriptionModule briefSummary: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country., conditionsModule conditions: Parkinson Disease, conditions: Transcranial Magenetic Stimualtion, conditions: Supplementary Motor Area, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: transcranial magnetic stimulation, outcomesModule primaryOutcomes measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores, secondaryOutcomes measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅰ scores, secondaryOutcomes measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores, secondaryOutcomes measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cognitive Neuropsychology Lab Anhui Medical University, city: Hefei, state: Anhui, zip: 230032, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False

protocolSection identificationModule nctId: NCT06383234, orgStudyIdInfo id: PAR 89/21, briefTitle: REduced Pain After Bariatric Surgery - Sleeve Gastrectomy, acronym: REPABS-SG, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-10, primaryCompletionDateStruct date: 2023-09-21, completionDateStruct date: 2023-09-28, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Campus Bio-Medico, class: OTHER, descriptionModule briefSummary: This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo)., conditionsModule conditions: Pain, conditions: Postoperative Pain, conditions: Acute Pain, conditions: Analgesia, conditions: Bariatric Surgery Candidate, conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 110, type: ACTUAL, armsInterventionsModule interventions name: LG-TAP block with local anesthetic, interventions name: LG-TAP block with saline solution, interventions name: Port site infiltration, outcomesModule primaryOutcomes measure: Pain Score, secondaryOutcomes measure: Morphine Consumption, secondaryOutcomes measure: Toradol Consumption, secondaryOutcomes measure: Nausea and/or vomiting, secondaryOutcomes measure: Lenght of Hospital Stay, secondaryOutcomes measure: Time to walking, secondaryOutcomes measure: Time to first flatus, secondaryOutcomes measure: Surgical Complication, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario Campus Bio-medico, city: Rome, zip: 00128, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06383221, orgStudyIdInfo id: 83244570, briefTitle: Study of the Intervention Effect of Stepped-care Models on Depression Symptoms During Pregnancy., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2025-10-20, completionDateStruct date: 2026-03-10, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Fangbiao Tao, class: OTHER, descriptionModule briefSummary: In this study, pregnant women were screened and managed for depression in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. Pregnant women who screened positive for depression during pregnancy were dynamically enrolled in the study and stratified into randomized groups based on gestation period (early/mid/late) and randomly assigned to the intervention and control groups on a 1:1 basis. Pregnant women in the intervention group attended a three-week "mental fitness boot camp" and were assessed at 3 weeks, and if they still screened positive for depression, they were offered 4 times one-on-one counseling sessions by the obstetrician. The control group received routine care., conditionsModule conditions: Perinatal Depression, conditions: Stepped Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care, outcomesModule primaryOutcomes measure: Edinburgh Postnatal Depression Scale, secondaryOutcomes measure: Generalized Anxiety Disorder, secondaryOutcomes measure: World Health Organization Five-item Well-Being Index, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06383208, orgStudyIdInfo id: 2024-ZF-13, briefTitle: Cardiovascular-Renal Adverse Prognosis Assessment System for Coronary Heart Disease With Chronic Kidney Disease Based on Metabolomics, acronym: CRUISE-MET, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: China-Japan Friendship Hospital, class: OTHER, descriptionModule briefSummary: Coronary heart disease (CHD) combined with chronic kidney disease (CKD) affects a substantial portion of the population and carries a significant disease burden, often leading to poor outcomes. Despite efforts to strictly control traditional risk factors, the efficacy in improving outcomes for patients with both CHD and CKD has been limited. Recent advancements in lipid metabolism research have identified new lipid metabolites associated with the occurrence and prognosis of CHD and CKD. Our preliminary trial has shown that levels of certain lipid metabolites, such as Cer(18:1/16:0), HexCer(18:1/16:0), and PI(18:0/18:1), are notably elevated in patients with CHD and reduced kidney function compared to those with relatively normal kidney function. This suggests that dysregulation of these non-traditional lipid metabolites may contribute to residual risk for adverse outcomes in these patients.Furthermore, the emerging concept of "cardiovascular-kidney-metabolic syndrome" and the availability of new treatment options highlight the urgent need for a risk stratification tool tailored to modern management strategies and treatment goals to guide preventive measures effectively. To address this, we propose to conduct a prospective cohort study focusing on CHD combined with CKD. This study aims to comprehensively understand the clinical characteristics, diagnosis, treatment status, and cardiovascular-kidney prognosis in these patients. Through advanced metabolomics analysis, we seek to identify lipid metabolism profiles and non-traditional lipid metabolites associated with the progression of coronary artery disease in CHD-CKD patients. Leveraging clinical databases and metabolomics data, we will develop a robust risk prediction model for adverse cardiovascular-kidney outcomes, providing valuable guidance for clinical diagnosis, treatment decisions, and ultimately improving patient prognosis., conditionsModule conditions: Chronic Kidney Diseases, conditions: Coronary Heart Disease, conditions: Lipid Metabolism Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 470, type: ESTIMATED, armsInterventionsModule interventions name: lipid metabolomics, outcomesModule primaryOutcomes measure: Incidence of cardiovascular adverse events, primaryOutcomes measure: Incidence of Renal composite endpoint event, secondaryOutcomes measure: Incidence of All-cause mortality, secondaryOutcomes measure: Incidence of Repeat revascularization, secondaryOutcomes measure: Incidence of bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China-Japan Friendship Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Chen Qiang, MD, role: CONTACT, phone: +86 13882712184, email: dawangchen@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06383195, orgStudyIdInfo id: SBA 24/189, briefTitle: The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2026-03-20, completionDateStruct date: 2026-03-20, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: This study assesses the test-retest reliability, construct validity, and minimal detectable change of the Ankylosing Spondylitis Performance Index (ASPI) in assessing the physical function of patients with Enthesitis-related arthritis (ERA)., conditionsModule conditions: Enthesitis Related Arthritis, conditions: Enthesitis Related Arthritis, Juvenile, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: Ankylosing Spondylitis Performance Index (ASPI), secondaryOutcomes measure: Childhood Health Assessment Questionnaire (CHAQ), secondaryOutcomes measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), secondaryOutcomes measure: Bath Ankylosing Spondylitis Functional Index (BASFI), secondaryOutcomes measure: Bath Ankylosing Spondylitis Metrology Index (BASMI), secondaryOutcomes measure: Modified Paediatric Mini Mental Scale (MPMMS), eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Sinan Buran, RA, role: CONTACT, email: pt.sinanburan@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06383182, orgStudyIdInfo id: Y (2024) 054, briefTitle: Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-07, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: General Hospital of Shenyang Military Region, class: OTHER, descriptionModule briefSummary: Acute ischaemic stroke (AIS) results in high rates of neurological morbidity and mortality, especially in patients with large vessel occlusion (LVO). Endovascular therapy (EVT) has been approved as the most effective treatment for patients with LVO, but about half patients undergoing EVT did not achieve good outcome. The mechanisms of poor prognosis are complex. How to accurately identify serological biomarkers related to patients' clinical prognosis is an important research topic nowadays., conditionsModule conditions: Ischemic Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: endovascular treatment, outcomesModule primaryOutcomes measure: Dynamic changes in serum biomarkers after endovascular treatment, secondaryOutcomes measure: favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2, secondaryOutcomes measure: excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1, secondaryOutcomes measure: distribution of modified Rankin Scale (mRS) score, secondaryOutcomes measure: early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS), secondaryOutcomes measure: changes in National Institute of Health stroke scale (NIHSS), secondaryOutcomes measure: symptomatic intracranial hemorrhage (sICH), secondaryOutcomes measure: occurence of new stroke or other vascular events, otherOutcomes measure: the association between cerebral circulation time (CCT) and clinical outcomes, otherOutcomes measure: the association between serum biomarkers and clinical outcomes, otherOutcomes measure: the association between serum biomarkers and status of vessel recanalization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General Hospital of Northern Theater Command, city: ShenYang, zip: 110840, country: China, geoPoint lat: 41.79222, lon: 123.43278, hasResults: False

protocolSection identificationModule nctId: NCT06383169, orgStudyIdInfo id: wanglizhong, briefTitle: Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-05-01, primaryCompletionDateStruct date: 2022-05-01, completionDateStruct date: 2022-05-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: First Hospital of Zhangjiakou City, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effect of external lumbar cistern drainage in preventing postoperative hydrocephalus in patients who have undergone meningioma surgery and its impact on patient satisfaction., conditionsModule conditions: Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 86, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Comparison of general clinical data, primaryOutcomes measure: Comparison of the response rate, primaryOutcomes measure: Comparison of GCS scores and intracranial pressure, primaryOutcomes measure: Comparison of KPS scores and satisfaction, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Hospital of Zhangjiakou City, city: Zhangjiakou, country: China, geoPoint lat: 40.81, lon: 114.87944, hasResults: False

protocolSection identificationModule nctId: NCT06383156, orgStudyIdInfo id: MD157/2023, briefTitle: The Use of Lung US, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT : A Comparative Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2024-09-18, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare between The Use of Lung ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT in elective thoracic surgeries., conditionsModule conditions: Endotracheal Tube Wrongly Placed During Anesthetic Procedure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Double lumen endotracheal tube, outcomesModule primaryOutcomes measure: the specificity in confirming the position of the LDLT and matching the observation of flexible bronchoscope, secondaryOutcomes measure: sensitivity and accuracy in confirming the position of the LDLT., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383143, orgStudyIdInfo id: AC-020-IT, briefTitle: Promoting Diagnosis and Management of AL in Italy (ProDigALIty), acronym: ProDigALIty, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: IRCCS Policlinico S. Matteo, class: OTHER, descriptionModule briefSummary: We plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to:1. Implement a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis among at-risk patients, including patients with monoclonal gammopathy of undetermined significance, MGUS, and altered free light chain ratio (aFLCR), and patients with smoldering multiple myeloma (SMM)2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical/clinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy;3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis, conditionsModule conditions: AL Amyloidosis, conditions: Smoldering Multiple Myeloma, conditions: Monoclonal Gammopathy of Undetermined Significance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 760, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Assess proportion of patients with newly diagnosed AL identified through the biomarker-based screening of at-risk patient, primaryOutcomes measure: Assess the proportion of patients with deep haematological response after frontline therapy (best response evaluation) in the new enhanced, contemporary, real-world series of AL patients enrolled during the study., primaryOutcomes measure: 3. Identify associations of clonal light chain features with different clinical features at baseline., secondaryOutcomes measure: Description of the baseline characteristics and 6-months outcome, as well as the time to AL development for patients with AL identified through the biomarker-based screening, secondaryOutcomes measure: Description of the baseline characteristics of MGUS/SMM patients with abnormal FLCR, secondaryOutcomes measure: Identification of clinical and biological correlates of hematological response, secondaryOutcomes measure: To verify whether implementing a dedicated pipeline for referral of AL patients to the National Referral Center will increase the proportion of patients from spoke centers, secondaryOutcomes measure: Identification of associations of clonal light chain features with event-free survival, secondaryOutcomes measure: Validation of existing algorithms for predicting AL amyloidosis status, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliera Policlinico Consorziale, status: RECRUITING, city: Bari, country: Italy, contacts name: PELLEGRINO MUSTO, MD, role: CONTACT, phone: 080 5593471, email: ematologiacontrapianto@policlinico.ba.it, contacts name: PELLEGRINO MUSTO, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Angela Minervini, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco, status: RECRUITING, city: Catania, country: Italy, contacts name: Francesco Di Raimondo, MD, role: CONTACT, phone: 095/378.1956, email: segremat@unict.it, contacts name: Francesco Di Raimondo, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Concetta Maria Sebastiana Conticello, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 37.49223, lon: 15.07041, locations facility: Fondazione Irccs Policlinico San Matteo, status: RECRUITING, city: Pavia, country: Italy, contacts name: GIOVANNI PALLADINI, MD, PhD, role: CONTACT, phone: +390382502994, email: segreteria.amiloidosi@smatteo.pv.it, contacts name: GIOVANNI PALLADINI, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Luca Arcaini, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mario Ulisse Nuvolone, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.19205, lon: 9.15917, locations facility: EMATOLOGIA - Città della Scienza e Salute - Torino, status: RECRUITING, city: Torino, country: Italy, contacts name: FRANCESCA MARIA GAY, MD, PhD, role: CONTACT, phone: 011.633.5550 - 5935, email: ematologia@cittadellasalute.to.it, contacts name: FRANCESCA MARIA GAY, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Stefania Oliva, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False

protocolSection identificationModule nctId: NCT06383130, orgStudyIdInfo id: 24SM8792, briefTitle: London Asthma Diagnostics Study, acronym: LADS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: Asthma UK, collaborators name: General Practitioners Research Institute, descriptionModule briefSummary: The goal of this trial is to learn if the addition of oscillometry with reversibility testing increases diagnostic accuracy in adult asthma diagnosis, when added to current standard of care tests: spirometry with reversibility testing and Fractional Exhaled Nitric Oxide (FeNO). The main question it aims to answer is:- Does oscillometry with reversibility testing increase diagnostic accuracy in detection of asthma in adults when added to spirometry with reversibility and FeNO?Researchers will evaluate the diagnostic accuracy of this approach with the reference standard, which is a clinically adjudicated diagnosis of asthma by two respiratory clinicians based on history and investigation results.Participants will* Undergo oscillometry testing alongside their routine asthma investigations within their scheduled clinic visit* Optionally participate in our sub-studies on new breath and nasal swab tests for asthma* Optionally participate in our qualitative substudy on patients views and attitudes to asthma testing and oscillometry, conditionsModule conditions: Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Oscillometry with reversibility testing, interventions name: Breath volatile testing, interventions name: Nasal eosinophil peroxidase, interventions name: Handheld capnometry, outcomesModule primaryOutcomes measure: To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO, secondaryOutcomes measure: To conduct an analysis comparing the diagnostic accuracy of (i) oscillometry ± reversibility with spirometry ± reversibility, (ii) spirometry±reversibility with FeNO and (iii) oscillometry ±reversibility and FeNO, secondaryOutcomes measure: To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO), secondaryOutcomes measure: To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests, otherOutcomes measure: To evaluate the diagnostic accuracy of the targeted reactive aldehyde species (RASP) panel in breath for asthma diagnosis, otherOutcomes measure: To evaluate the diagnostic accuracy of nasal biomarker eosinophil peroxidase (EPX), otherOutcomes measure: To evaluate the diagnostic accuracy of tidal breath CO2 waveforms using the N-Tidal handheld capnometry device, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Imperial College Healthcare NHS Trust, city: London, zip: W2 1PG, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial College Healthcare NHS Trust, city: London, zip: W21NY, country: United Kingdom, contacts name: Eleanor Quek, MBBS, role: CONTACT, phone: 07411429994, email: e.quek@imperial.ac.uk, contacts name: Salman Siddiqui, PhD, role: CONTACT, email: s.siddiqui@imperial.ac.uk, contacts name: Salman Siddiqui, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Nottingham University Hospitals NHS Trust, city: Nottingham, zip: NG7 2UH, country: United Kingdom, contacts name: Matthew Martin, PhD, role: CONTACT, email: matthew.martin4@nottingham.ac.uk, contacts name: Matthew Martin, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False

protocolSection identificationModule nctId: NCT06383117, orgStudyIdInfo id: UL1TR002378, type: NIH, link: https://reporter.nih.gov/quickSearch/UL1TR002378, secondaryIdInfos id: KL2TR002381, type: NIH, link: https://reporter.nih.gov/quickSearch/KL2TR002381, briefTitle: Understanding Effects of Calcium on the Gut-Bone Axis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2024-02-23, completionDateStruct date: 2024-02-23, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Georgia, class: OTHER, collaborators name: National Center for Advancing Translational Sciences (NCATS), descriptionModule briefSummary: The study team is inviting 13 healthy people to complete a study to explore how calcium affects hormones and bones after eating. Participants will be asked to complete two study visits within eight weeks. Before each visit, participants will be asked to not eat or drink (except water) for 9 hours. At each visit, participants will eat the same meal provided by the research team. Along with their meal, they will take a pill - in one session, this will be a calcium supplement, and in the other, a placebo (a pill with no calcium), but they won't know which one they are taking at which session. A phlebotomist will draw blood before the meal and pill, then again several times after eating. Blood draws will take place over three hours. During that time, participants will complete questionnaires about health, diet, and physical activity.Blood will be analyzed to check on various health indicators, like bone health markers and certain hormones, to see how they change after the meal. The difference in these health indicators between the calcium and placebo sessions will help the study team understand the impact of calcium on health after eating. This could help increase knowledge of the impact of calcium on hormones and bone health., conditionsModule conditions: Healthy, conditions: Adult, conditions: Calcium, conditions: Bone Resorption, conditions: Endocrine; Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized placebo crossover trial, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Investigator, participants, team distributing pills blinded to treatment arm, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: Calcium carbonate, interventions name: Placebo Control, outcomesModule primaryOutcomes measure: Difference in GIP (gastric inhibitory peptide) area under the curve between calcium and placebo, primaryOutcomes measure: Difference in GLP-1 (glucagon-like peptide 1) area under the curve between calcium and placebo, secondaryOutcomes measure: Difference in CTX (carboxy-terminal collagen crosslinks) area under the curve between calcium and placebo, secondaryOutcomes measure: Difference in P1NP (N-terminal propeptide) area under the curve between calcium and placebo, otherOutcomes measure: Difference in insulin area under the curve between calcium and placebo, otherOutcomes measure: Difference in glucose area under the curve between calcium and placebo, otherOutcomes measure: Difference in PTH (parathyroid hormone) area under the curve between calcium and placebo, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Georgia Clinical and Translational Research Unit, city: Athens, state: Georgia, zip: 30606, country: United States, geoPoint lat: 33.96095, lon: -83.37794, hasResults: False

protocolSection identificationModule nctId: NCT06383104, orgStudyIdInfo id: MyoLupus, briefTitle: Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in Patients With Systemic Lupus Erythematosus., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-05-28, completionDateStruct date: 2024-06-26, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universidad Católica San Antonio de Murcia, class: OTHER, descriptionModule briefSummary: Introduction. Systemic lupus erythematosus is an autoimmune disease. The musculoskeletal system is affected in 90% of patients. The most common manifestations are myalgias, arthralgias and arthritis.Objective. To analyse the efficacy of an intervention using myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus.Methods. Randomised clinical study with 20 patients with systemic lupus erythematosus, randomised to an experimental and control group. The intervention will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques.Expected results. Improvement of knee and ankle pain intensity, functional capacity, basic mobility skills, strength, balance, agility and fatigue., conditionsModule conditions: System; Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Intervention, outcomesModule primaryOutcomes measure: Change from baseline joint pain after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline functional capacity after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline functionality after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline joint pain after treatment and at 4 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Universidad Católica San Antonio, Murcia, status: RECRUITING, city: Murcia, zip: 30107, country: Spain, contacts name: RUBEN CUESTA-BARRIUSO, PhD, role: CONTACT, phone: +34 968278545, email: rcuesta@ucam.edu, geoPoint lat: 37.98704, lon: -1.13004, hasResults: False

protocolSection identificationModule nctId: NCT06383091, orgStudyIdInfo id: IRB00380938, briefTitle: Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy, acronym: Man Total Thy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, descriptionModule briefSummary: In this clinical trial, the investigators are seeking to learn if a course of voice therapy, including neck massage, stretches and pain science education in addition to voice exercise and scar massage will effectively treatment patient complaints of swallowing or voice changes after total thyroidectomy as compared to voice exercise and scar massage alone.The main questions it aims to answer are:Will neck massage, stretches and pain science education reduce patient complaints of swallowing changes after total thyroidectomy?Will neck massage, stretches and pain science education reduce patient complaints of voice changes after total thyroidectomy?Will neck massage, stretches and pain science education reduce patient complaints of scar tethering and quality changes after total thyroidectomy?Will neck massage, stretches and pain science education improve quality of life after total thyroidectomy?Participants will:Participate in 4 visits with the participant's endocrine/laryngology surgeon. One prior and 3 after surgery for endoscopic evaluation and tests.Participate in 5 Speech-Language Pathology Sessions for intervention exercises and tests. One prior and 4 after surgery.Complete a journal of the participant's Home Exercise Practice, conditionsModule conditions: Total Thyroidectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is meant to be a parallel study. However, The Speech Language Pathologists will not be blinded as the Speech Pathologists are providing each regimen. If a participant in either group requires more intensive sessions or a differing regimen given the severity of complaints, the participants will receive it as per the recommendation of the Speech-Language Pathologist so as not to unblind the PI. An intent to treat analysis will be performed to accurately describe the data in the case of crossover and/or dropout., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Anterior Neck Manual Therapy, interventions name: Pain Neuroscience Education, interventions name: Neck Stretches, interventions name: Scar massage, interventions name: Voice Exercises, interventions name: Placebo Anterior Neck Manual Therapy, interventions name: Placebo Pain Neuroscience Education, interventions name: Placebo Neck Stretches, outcomesModule primaryOutcomes measure: Acoustic measures of voice clarity, primaryOutcomes measure: Acoustic measures of speaking voice pitch, primaryOutcomes measure: Acoustic measures of speaking voice quality subjectively, primaryOutcomes measure: Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10, primaryOutcomes measure: Laryngeal sensation, primaryOutcomes measure: Scar Tethering Distance, primaryOutcomes measure: Scar Quality as assessed by The Patient and Observer Scar Assessment Scale, primaryOutcomes measure: Voice Quality of Life as measures by the Voice Related Quality of Life - 10, secondaryOutcomes measure: Adverse Effects in the Experimental Group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Hospital, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Claire Ligon, Masters of Education, role: CONTACT, phone: 434-390-6387, email: cligon4@jhmi.edu, contacts name: Kristine Pietsch, Masters of Arts, role: CONTACT, phone: 518-461-3610, email: kteets1@jhmi.edu, contacts name: Claire Ligon, Masters of Education, role: SUB_INVESTIGATOR, contacts name: Kristine Pietsch, Masters of Arts, role: SUB_INVESTIGATOR, contacts name: Michelle Wilson, Masters of Science, role: SUB_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Suburban Hospital, city: Bethesda, state: Maryland, zip: 20817, country: United States, contacts name: Claire Ligon, Masters of Education, role: CONTACT, phone: 434-390-6387, email: cligon4@jhmi.edu, contacts name: Vaninder Dhillon, Medical Doctor, role: CONTACT, phone: 925-360-5939, email: vdhillo2@jhmi.edu, contacts name: Vaninder Dhillon, Medical Doctor, role: PRINCIPAL_INVESTIGATOR, contacts name: Claire Ligon, Masters of Education, role: SUB_INVESTIGATOR, contacts name: Michelle Wilson, Masters of Science, role: SUB_INVESTIGATOR, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False

protocolSection identificationModule nctId: NCT06383078, orgStudyIdInfo id: MA-PC-II-012, briefTitle: HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer., conditionsModule conditions: Efficacy and Safety, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: HR070803, interventions name: Oxaliplatin, interventions name: Tegafur, interventions name: Folinic acid, interventions name: 5-Fluorouracil, outcomesModule primaryOutcomes measure: 1-year Disease-free survival rate, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Disease-free survival（DFS）, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06383065, orgStudyIdInfo id: YDU/2020/76-1007, briefTitle: Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-02-01, primaryCompletionDateStruct date: 2021-04-30, completionDateStruct date: 2022-01-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Near East University, Turkey, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the early effects of Inspiratory Muscle Training (IMT) applied before and after bariatric surgery on respiratory function, respiratory muscle strength and functional capacity in individuals with type 2 diabetes.The study will be conducted with 40 individuals with type 2 diabetes aged between 25-65. Individuals will be randomly assigned to the IMT (trained at 30% of maximum inspiratory pressure with an IMT threshold device) and control group. As measurement parameters, a 6-minute walk test for functional capacity, a spirometry test for respiratory function, and a portable device (Cosmed Pony FX Desktop Spirometer, USA) will be used for respiratory muscle strength. Hand grip strength will be measured with a Baseline dynamometer. All measurements will be repeated on the first day before surgery and on the fourth day before discharge after surgery., conditionsModule conditions: Type 2 Diabetes, conditions: Bariatric Surgery Candidate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: IMT Group, outcomesModule primaryOutcomes measure: Respiratory Muscle Strength, primaryOutcomes measure: Respiratory Function, primaryOutcomes measure: Functional Capacity: The 6-minute walk test, primaryOutcomes measure: Hand Grip Strength, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Near East University, city: Nicosia, country: Cyprus, geoPoint lat: 35.17531, lon: 33.3642, hasResults: False

protocolSection identificationModule nctId: NCT06383052, orgStudyIdInfo id: NYM032Z01, briefTitle: A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Norroy Bioscience Co., LTD, class: INDUSTRY, descriptionModule briefSummary: 177Lu-NYM032 injection is a radioligand therapeutic agent that targets prostate specific membrane antigen (PSMA)-expressing prostate tumors. NYM032 is a small molecular with strong affinity for PSMA., conditionsModule conditions: Metastatic Castration-resistant Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: 177Lu-NYM032 injection, outcomesModule primaryOutcomes measure: Number of Patients With Dose Limiting Toxicity (DLT), primaryOutcomes measure: Maximum Tolerated Dose (MTD), eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affliated Hospital of Jiangnan University, status: RECRUITING, city: Wuxi, zip: 214000, country: China, contacts name: Chunjing Yu, role: CONTACT, phone: 15312238622, email: ycj_wxd1978@163.com, geoPoint lat: 31.56887, lon: 120.28857, hasResults: False

protocolSection identificationModule nctId: NCT06383039, orgStudyIdInfo id: ZSoy, briefTitle: Transcranial Direct Current Stimulation and Balance, acronym: tDCS, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-16, primaryCompletionDateStruct date: 2022-09-06, completionDateStruct date: 2023-05-13, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Zeynep Soy, class: OTHER, descriptionModule briefSummary: Postural control is an adaptive sensorimotor process involving continuous integration of sensory information from three channels. These; visual, somatosensory (proprioceptive) and vestibular senses. The study will be carried out at Istanbul Medipol University. 30 healthy individuals between the ages of 18-25 will be included. To each individual Anodal-supplementary motor area tDCS, Anodal-cerebellar tDCS, Sham tDCS applications will be cross-applied. tDCS application will take 20 minutes and each individual will receive 3 sessions in total. There will be a 72-hour rest period between sessions. Individuals assessed with Demographic Information Form for demographic information, Wii-Fit and Balance Error Scoring System for Static Balance Evaluation, Star Balance Test and Timed Get Up and Go Test for Dynamic Balance Assessment. The aim of this study is to investigate the effect of transcranial direct current stimulation applied on the supplementary motor area and cerebellum on static and dynamic balance in healthy individuals., conditionsModule conditions: Balance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: All participants received 3 different interventions at different times., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants were not informed which type of current was applied., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Transcranial Direct Current Stimulation, outcomesModule primaryOutcomes measure: Demographic Information Form, primaryOutcomes measure: Wii-Fit, primaryOutcomes measure: balance error scoring system, primaryOutcomes measure: star excursion balance test, primaryOutcomes measure: Time Up & Go Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Medipol University, city: Istanbul, state: Beykoz, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06383026, orgStudyIdInfo id: PRO00047199, briefTitle: Transgender and Gender-Diverse Breast Cancer Screening Pilot, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Medical College of Wisconsin, class: OTHER, descriptionModule briefSummary: This investigation is a prospective breast cancer screening study open to all transgender and gender-diverse persons (regardless of sex assigned at birth). Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with gender-affirming therapy and family cancer history and 2) investigate TGD persons perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Breast Cancer Screening, interventions name: Survey/Interview, interventions name: Focus Group, outcomesModule primaryOutcomes measure: Callback and Biopsy Rates after Breast Cancer Screening, primaryOutcomes measure: Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Transgender and Gender Diverse Persons, primaryOutcomes measure: Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening, eligibilityModule sex: ALL, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical College of Wisconsin, status: RECRUITING, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, contacts name: Chandler S Cortina, MD, MS, role: CONTACT, email: ccortina@mcw..edu, geoPoint lat: 43.0389, lon: -87.90647, hasResults: False

protocolSection identificationModule nctId: NCT06383013, orgStudyIdInfo id: BB-101-BBCBB1A, briefTitle: Phase II Study of BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Blue Blood Biotech Corp., class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer., conditionsModule conditions: Diabetic Foot Ulcer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: BB-101, outcomesModule primaryOutcomes measure: Efficacy Evaluation, secondaryOutcomes measure: Safety Evaluation, secondaryOutcomes measure: Secondary Efficacy Evaluation, otherOutcomes measure: Exploratory Objectives, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare, status: RECRUITING, city: Taipei, country: Taiwan, contacts name: Shug-Cheng Chang, MD, role: CONTACT, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False

protocolSection identificationModule nctId: NCT06383000, orgStudyIdInfo id: BLZ2024MOH, briefTitle: Assessment of Effectiveness of Continuous Non-invasive Haemodynamic Monitor by Compared to Invasive Blood Pressure and Pulse Oximeter Monitoring on Patients Undergoing General Anesthesia Surgeries for More Than 60 Minutes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: BLZ Technology (Wuhan) Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: The goal of this observational study is to assess whether the continuous non-invasive haemodynamic monitor MOH200 (measuring blood pressure as well as pulse rate) is effective or not in people undergoing general anesthetic surgeries for more than 60 minutes with planned invasive blood pressure and pulse oximeter monitoring.Researchers will compare blood pressure data derived from MOH200 to the invasive blood pressure (IBP) data to see if the MOH200 is effective to measure the blood pressure of a surgical person. Also, researchers will compare pulse rate data drived from MOH200 to that from the pulse oximeter to see if the MOH200 is effective to measure the pulse rate of a surgical person.Participants will be asked to be applied with MOH200 monitoring while IBP monitoring and pulse oximeter are applied. And after 30 minutes of the surgery, researchers will monitor the adverse effects occurred on the skin of participants to assess the safety of MOH200., conditionsModule conditions: General Anesthesia, conditions: Blood Pressure, conditions: Pulse Rate, conditions: Arterial Line, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 55, type: ESTIMATED, outcomesModule primaryOutcomes measure: Continuous Non -invasive Blood Pressure Measurement from MOH200, primaryOutcomes measure: Invasive Blood Pressure Measurement from Arterial Line, primaryOutcomes measure: Pulse Rate Measurement from MOH200, primaryOutcomes measure: Pulse Rate Measurement from Pulse Oximeter, secondaryOutcomes measure: The Occurrence of Pressure Pores, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06382987, orgStudyIdInfo id: IM011-1124, briefTitle: A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect), acronym: RePhlect, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast., conditionsModule conditions: Plaque Psoriasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Deucravacitinib, interventions name: Apremilast, outcomesModule primaryOutcomes measure: Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib., primaryOutcomes measure: Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up, primaryOutcomes measure: Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up, primaryOutcomes measure: Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up, primaryOutcomes measure: Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation), secondaryOutcomes measure: Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast, secondaryOutcomes measure: Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up, secondaryOutcomes measure: Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up, secondaryOutcomes measure: Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up, secondaryOutcomes measure: Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up, secondaryOutcomes measure: Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up, secondaryOutcomes measure: Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mebix. Inc., status: RECRUITING, city: Minato-ku, state: Tokyo, zip: 1070052, country: Japan, contacts name: Minoru Tonogai, Site 0001, role: CONTACT, geoPoint lat: 34.2152, lon: 135.1501, locations facility: Fukuoka University Hospital, status: RECRUITING, city: Fukuoka, country: Japan, geoPoint lat: 33.6, lon: 130.41667, hasResults: False

protocolSection identificationModule nctId: NCT06382974, orgStudyIdInfo id: 3-3-14, briefTitle: Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This case series study aims to evaluate the local effects of Atorvastatin (which belongs to the family of lipid-lowering drugs, known as statins) combined with β-TCP (which is a synthetic osteoconductive bone graft), on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw cyst enucleation using CBCT-based volumetric analysis to calculate the shrinkage rate of these defects., conditionsModule conditions: Infection, conditions: Bone Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A case series study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Cyst enucleation and bone grafting, outcomesModule primaryOutcomes measure: Shrinkage Rate, secondaryOutcomes measure: Inflammation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University, city: Cairo, country: Egypt, contacts role: CONTACT, phone: 23634965, email: surgery@dentistry.cu.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06382961, orgStudyIdInfo id: SZUS_231101, briefTitle: Postoperative Dexmedetomidine in Prevention of Postoperative Delirium, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-11, primaryCompletionDateStruct date: 2024-03-06, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd., class: INDUSTRY, collaborators name: Shenzhen People's Hospital, collaborators name: Dongyuan People's Hospital, collaborators name: Kunming Children's Hospital, descriptionModule briefSummary: The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?2. Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.Participants will undergo routine postoperative care:1. Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine2. Postoperative visit twice a day for at least seven days, conditionsModule conditions: Delirium in Old Age, conditions: Anesthesia; Adverse Effect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 287, type: ACTUAL, armsInterventionsModule interventions name: Dexmedetomidine injection, interventions name: Sufentanil injection, outcomesModule primaryOutcomes measure: Incidence of postoperative delirium, secondaryOutcomes measure: Incidence of postoperative nausea and vomiting, secondaryOutcomes measure: incidence of postoperative complications, secondaryOutcomes measure: Pain intensities, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kunming Children's Hospital, city: Kunming, state: Yunnan, zip: 650100, country: China, geoPoint lat: 25.03889, lon: 102.71833, hasResults: False

protocolSection identificationModule nctId: NCT06382948, orgStudyIdInfo id: MedOPP545, secondaryIdInfos id: 2024-512926-27-00, type: CTIS, briefTitle: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i., acronym: ADELA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: MedSIR, class: OTHER, collaborators name: Stemline Therapeutics, Inc., descriptionModule briefSummary: This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations., conditionsModule conditions: Advanced Breast Cancer, conditions: ER-positive Breast Cancer, conditions: HER2-negative Breast Cancer, conditions: ESR1 Gene Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind, parallel group (two arms: elacestrant plus everolimus, and elacestrant plus placebo)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: A blinded, independent IRC will perform a review of radiographic images and clinical information collected on study to determine the protocol-defined endpoints of disease response and progression. Further information on the independent review process will be provided in the BIRC Charter., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Everolimus, interventions name: Elacestrant, interventions name: Placebo, interventions name: Auxiliary Medicinal Product - Dexamethasone, interventions name: Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues, outcomesModule primaryOutcomes measure: To demonstrate superiority of elacestrant+everolimus vs. elacestrant+placebo in prolonging PFS based on a BIRC in patients with ER[+]/HER2[-], ESR1-mutated, ABC that have previously received ET+CDK4/6i (all patients)., secondaryOutcomes measure: To compare overall survival (OS) between treatment groups, in all patients., secondaryOutcomes measure: To compare investigator-assessed PFS based on local assessment between treatment groups, in all patients., secondaryOutcomes measure: To compare objective response rate (ORR) between treatment groups, in all patients., secondaryOutcomes measure: To compare clinical benefit rate (CBR) between treatment groups, in all patients., secondaryOutcomes measure: To compare overall time to response (TTR) between treatment groups, in all patients., secondaryOutcomes measure: To compare duration of response (DoR) between treatment groups, in all patients., secondaryOutcomes measure: To compare best percentage of change in tumor burden between treatment groups, in all patients., secondaryOutcomes measure: To describe the changes in health-related quality-of-life (HRQoL) from baseline using the EuroQoL 5 Dimension 5 Level (EQ-5D-5L) scale., secondaryOutcomes measure: To describe the changes in HRQoL from baseline using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)., secondaryOutcomes measure: To describe the changes in HRQoL from baseline using the EORTC Quality of Life Questionnaire Breast Cancer module (EORTC QLQ-BR45)., secondaryOutcomes measure: To assess adverse events (AEs) between treatment groups in all patients., secondaryOutcomes measure: To assess adverse events leading to study treatment withdrawal., secondaryOutcomes measure: To assess adverse events leading to dose modification., secondaryOutcomes measure: To assess the number of participants with abnormal hematology and/or chemistry values that are related to treatment., secondaryOutcomes measure: To assess the number of participants with changes on vital signs and/or AEs that are related to treatment., secondaryOutcomes measure: To assess the number of participants with changes on cardiac function measured by ECG QT Interval Corrected by Fridericia formula (QTcF) that are related to treatment effect ., secondaryOutcomes measure: To assess the number of participants with changes on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) that are related to treatment., otherOutcomes measure: Exploratory endpoint: protein expression studies using blood samples to investigate the potential association with clinical outcomes., otherOutcomes measure: Exploratory endpoint: analysis of allele mutation frequencies in circulating tumor DNA (ctDNA) in blood samples to investigate the potential association with clinical outcomes., otherOutcomes measure: Exploratory endpoint: Genetic studies using blood samples to investigate the potential association with clinical outcomes., otherOutcomes measure: Exploratory endpoint: Analysis of medical imaging (radiomics) to identify potential biomarkers associated with clinical outcomes., otherOutcomes measure: Exploratory endpoint: Pharmacokinetic (PK) parameter of maximum (Peak) Observed Serum Concentration (Cmax)., otherOutcomes measure: Exploratory endpoint: Pharmacokinetic (PK) parameter of Plasma Through Concentration (Ctrough)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06382935, orgStudyIdInfo id: 34-24, briefTitle: Impact of Non-surgical Periodontal Treatment of miRNome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-09-22, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Catania, class: OTHER, descriptionModule briefSummary: A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on miRNome in gingival crevicular fluid, conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Sealed envelopes, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Probin Pocket Depth reduction, outcomesModule primaryOutcomes measure: Probing Pocket Depth, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AOU Policlinico G. Rodolico, status: RECRUITING, city: Catania, zip: 95124, country: Italy, contacts name: Gaetano Isola, DDS, role: CONTACT, phone: 0953785652, email: gaetano.isola@unict.it, geoPoint lat: 37.49223, lon: 15.07041, hasResults: False

protocolSection identificationModule nctId: NCT06382922, orgStudyIdInfo id: PAPAML022019, briefTitle: Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-29, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Rome Tor Vergata, class: OTHER, descriptionModule briefSummary: In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a "real life" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. All cases of proven/probable IA, observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015, were retrospectively collected in a multicenter study involving 38 Italian hematologic centers. The investigators observed 56 (2.2%) cases of IA \[43 probable (1.7%) and 13 proven (0.5%)\]. The overall mortality rate and the mortality rate attributable to IA (AMR) on day 120 were 16% and 9%, respectively. In multivariate analysis, parameters that influenced the outcome were age ≥60 years and treatment with high doses of cytarabine (HDAC).The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase. The results from this study show that in a large real-world setting the mold active PAP, with itraconazole or posaconazole, decreases the rate of IA after consolidation course.In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low. However, the mortality is not negligible, mainly in older patients. Further, a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP., conditionsModule conditions: Invasive Aspergillosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: the incidence of proven, probable and possible IA in patients enrolled in the study in both groups of patients, secondaryOutcomes measure: overall mortality rate, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tor Vergata University, status: RECRUITING, city: Roma, state: RM, zip: 00133, country: Italy, contacts name: Maria Ilaria Del Principe, role: CONTACT, phone: 3394080659, email: del.principe@med.uniroma2.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06382909, orgStudyIdInfo id: 202302, briefTitle: Effect of Probiotic Compound K11T e K11TMax in ASD, acronym: ASD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-07-07, completionDateStruct date: 2025-04-07, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Deivis de Oliveira guimaraes, class: NETWORK, collaborators name: SENAI CIMATEC, descriptionModule briefSummary: The research is characterized as a randomized, double-blind clinical trial (phase III) in which administered the probiotic K11-T (with and without added amino acids, fatty acids and vitamins) to children between 3 and 11 years old with Autism Spectrum Disorder - ASD, being subsequently assessed outcomes related to inflammatory markers and neuropsychiatric and sociopedagogical criteria. To this end, the study will create three groups, one of which will be a control group, which will receive a placebo, the other will receive the probiotic without micronutrients and another will receive the probiotic with added nutrients., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blind, randomized, with placebo control, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 505, type: ACTUAL, armsInterventionsModule interventions name: Inflammatory level, interventions name: Cognitive assessment, interventions name: Pedagogical assessment, outcomesModule primaryOutcomes measure: Inflammation biomarker 1, primaryOutcomes measure: Inflammation biomarker 2, primaryOutcomes measure: Inflammation biomarker 3, primaryOutcomes measure: Inflammation biomarker 4, primaryOutcomes measure: Inflammation biomarker 5, primaryOutcomes measure: Neuropsychological Assessment, secondaryOutcomes measure: Psychiatric Assessment, secondaryOutcomes measure: Psychopedagogical Assessment, otherOutcomes measure: Comparative of outcomes between arm that took K11-T and arm that took K11-Tmax., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: Gon1 P&D, city: Vitoria, state: ES, zip: 29050335, country: Brazil, geoPoint lat: -20.31944, lon: -40.33778, locations facility: Gon1 gestora de Projetos, city: Vitória, state: ES, zip: 29050335, country: Brazil, geoPoint lat: -20.31944, lon: -40.33778, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-22, uploadDate: 2024-04-18T21:12, filename: Prot_000.pdf, size: 369916, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-22, uploadDate: 2024-04-16T10:55, filename: ICF_001.pdf, size: 192688, hasResults: False

protocolSection identificationModule nctId: NCT06382896, orgStudyIdInfo id: FirstAHXiamenU-YB-2, briefTitle: Effect of Oliceridine on Rebound Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xiamen University, class: OTHER, descriptionModule briefSummary: The purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. A total of 320 patients undergoing arthroscopic knee arthroscopy under general anesthesia combined with femoral nerve block were selected to record the time and duration of postoperative pain outbreak, pain degree, age, gender, operation type, previous surgical history and other related risk factors., conditionsModule conditions: Rebound Pain, conditions: Arthroscopic Knee Surgery, conditions: Oliceridine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Time of onset of postoperative rebound pain, primaryOutcomes measure: The duration of the rebound pain, primaryOutcomes measure: The degree of the rebound pain, primaryOutcomes measure: age, primaryOutcomes measure: sex, primaryOutcomes measure: Surgical procedure, primaryOutcomes measure: Previous surgical history, secondaryOutcomes measure: Movement recovery time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Xiamen University, status: RECRUITING, city: Xiamen, state: Fujian, zip: 361000, country: China, contacts name: Bin Yang, doctor, role: CONTACT, phone: 13859986036, email: yangbin4332@outlook.com, geoPoint lat: 24.47979, lon: 118.08187, hasResults: False

protocolSection identificationModule nctId: NCT06382883, orgStudyIdInfo id: FINELO2024, briefTitle: Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment, acronym: ELO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-07-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Filha ry, class: OTHER, collaborators name: University of Jyvaskyla, collaborators name: Organisation for Respiratory Health in Finland, collaborators name: Central Finland Hospital District, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive sleep apnea (OSA), physical activity (PA) levels and sedentary behavior (SB), as well as health and wellbeing in overweight participants with moderate to severe OSA treated with CPAP. Emphasis of the individually tailored SEMC-intervention (protocol of the Sports Medicine Outpatient Clinic of The Wellbeing Services County of Central Finland) is on increasing the amount of total physical activity.The main questions the trial aims to answer are:* Can individually tailored lifestyle intervention, in combination with CPAP therapy, alleviate the severity or symptoms of OSA in overweight participants with moderate to severe OSA?* Does the addition of an individually tailored lifestyle intervention to CPAP therapy improve the quality of life, increase physical functioning, change body composition, and increase physical activity levels or decrease sedentary behavior of participants diagnosed with moderate to severe OSA?* Can enhanced behavioral support (EBS), when integrated with lifestyle intervention and CPAP therapy, lead to more substantial and enduring changes in participants' levels of physical activity or sedentary behavior?Participants will be randomized to either SEMC-intervention group, combination of SEMC-intervention and EBS, or to a control group.In this study, it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA severity and symptoms, improve their quality of life, body composition and physical functioning, as well as increase physical activity levels and decrease their sedentary behavior compared to the control group. In addition, it is hypothesized that participants receiving SEMC-intervention and EBS in combination with CPAP therapy will increase their physical activity levels, and decrease their sedentary behavior to a greater extent, and these changes will be more sustained compared to merely SEMC-intervention or control group., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Individually tailored lifestyle and physical activity intervention, interventions name: Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS), outcomesModule primaryOutcomes measure: Change in apnea-hypopnea-index (AHI), secondaryOutcomes measure: Change on sleep apnea symptoms, secondaryOutcomes measure: Change in the mean daily total light physical activity time, secondaryOutcomes measure: Change in the mean daily total moderate to vigorous (MVPA) physical activity time, secondaryOutcomes measure: Change in the mean daily total sedentary time, secondaryOutcomes measure: Change in 6-minute walk distance (6MWD) in meters, secondaryOutcomes measure: Change in hand grip strength in kilograms, secondaryOutcomes measure: Change in waist circumference in centimeters, secondaryOutcomes measure: Change in body weight in kilograms, secondaryOutcomes measure: Change in visceral fat area (VFA) in square centimeters, secondaryOutcomes measure: Change in muscle mass in kilograms, secondaryOutcomes measure: Change in Quality of Life RAND 36-Item Health Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Finland Hospital District, status: RECRUITING, city: Jyväskylä, zip: 40620, country: Finland, contacts name: Merja Perhonen, role: CONTACT, email: merja.perhonen@hyvaks.fi, contacts name: Antti Saarinen, role: CONTACT, email: antti.saarinen@filha.fi, geoPoint lat: 62.24147, lon: 25.72088, hasResults: False

protocolSection identificationModule nctId: NCT06382870, orgStudyIdInfo id: 107.2023fbu, briefTitle: Simulation-Based Training for Child Neglect and Abuse, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-29, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-29, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Fenerbahce University, class: OTHER, descriptionModule briefSummary: Child abuse and neglect is a broad structure that includes physical abuse, sexual abuse, emotional abuse and neglect. Child neglect and abuse is one of the primary areas of responsibility of health professionals, which negatively affects child health and threatens public health in the long term. All healthcare professionals are legally obligated to report known or suspected cases of child abuse and neglect. Health professionals, in particular, play an important role in stopping child abuse by assessing children, identifying risk factors, and reporting suspected child maltreatment to authorities. Early diagnosis of a neglected and abused child is important in reducing the recurrence of maltreatment.Regarding the evaluation of child neglect and abuse, healthcare professionals should approach a child who presents with suspicious injuries, thinking that he or she may be abused. The key here is to be aware of the problem. Health professionals should carefully examine children and fulfill their responsibilities by identifying possible clues to abuse and neglect. It is recommended that clues to recognize neglect and abuse be taught within the scope of in-service training for healthcare professionals working in hospitals., conditionsModule conditions: Simulation-based Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: education, outcomesModule primaryOutcomes measure: The awareness level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06382857, orgStudyIdInfo id: 823779-MDF Niger, briefTitle: Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Epicentre, class: OTHER, collaborators name: Epicentre, Niger, collaborators name: National Nutrition Direction, Niger, collaborators name: Ministry of Public Health and Social Affairs, Niger, collaborators name: Regional Direction of Public Health, Maradi, descriptionModule briefSummary: This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission., conditionsModule conditions: Malnutrition, Child, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 7356, type: ESTIMATED, armsInterventionsModule interventions name: MDF, interventions name: RUTF, interventions name: RUSF, outcomesModule primaryOutcomes measure: Programmatic recovery by 12 weeks from admission, primaryOutcomes measure: Sustained recovery at 24 weeks from admission, secondaryOutcomes measure: Default, secondaryOutcomes measure: Non-response, secondaryOutcomes measure: Time to recovery, secondaryOutcomes measure: For MAM children: Deterioration to SAM, secondaryOutcomes measure: Change in weight gain, secondaryOutcomes measure: Change in weight-for-length Z (WLZ), secondaryOutcomes measure: Change in length-for-age Z (LAZ), secondaryOutcomes measure: Change in weight-for-age Z (WAZ), secondaryOutcomes measure: Change in MUAC, secondaryOutcomes measure: Serious adverse events, secondaryOutcomes measure: Hospitalization, secondaryOutcomes measure: Death, secondaryOutcomes measure: Motor, cognitive, language, social-emotional, and mental health skills, secondaryOutcomes measure: Cost effectiveness, secondaryOutcomes measure: Dietary intake, secondaryOutcomes measure: Adherence, secondaryOutcomes measure: Microbiome profile at enrollment, week 4, program discharge, and study discharge, secondaryOutcomes measure: Plasma proteome profile at enrollment, week 4, program discharge, and study discharge, secondaryOutcomes measure: Environmental enteric dysfunction at enrollment, program discharge, and study discharge, secondaryOutcomes measure: Change of fat mass and fat-free mass at program discharge and study discharge, secondaryOutcomes measure: Micronutrient status at enrollment, program discharge and study discharge, secondaryOutcomes measure: Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only), eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 23 Months, stdAges: CHILD, contactsLocationsModule locations facility: Epicentre Niger, status: RECRUITING, city: Maradi, country: Niger, contacts name: Ousmane Guindo, MD, role: CONTACT, email: ousmane.guindo@epicentre.msf.org, contacts name: Ibrahim Ngoumboute, MD, role: CONTACT, email: ibrahim.ngoumboute@epicentre.msf.org, geoPoint lat: 13.5, lon: 7.10174, hasResults: False

protocolSection identificationModule nctId: NCT06382844, orgStudyIdInfo id: PI23/00486, secondaryIdInfos id: PI2023 08 1416, type: REGISTRY, domain: Ethics Committee for Drug Research of the Salamanca Health Area, briefTitle: Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Biomédica de Salamanca, class: OTHER, collaborators name: Carlos III Health Institute, descriptionModule briefSummary: Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)/Sézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF/SS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination/procedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and/or NGS, performed on cell populations previously sorted by flow cytometry)., conditionsModule conditions: Cutaneous T-Cell Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS)., outcomesModule primaryOutcomes measure: Optimizing Marker Combination for Specific Identification and Quantification of Sézary Cells using Spectral Flow Cytometry, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto de Investigación Biomédica de Salamanca (IBSAL), status: RECRUITING, city: Salamanca, zip: 37007, country: Spain, contacts name: Ricardo López Pérez, PhD, role: CONTACT, phone: +34 923 29 12 00, phoneExt: 55144, email: uicec.gestion@ibsal.es, contacts name: Esperanza López Franco, PhD, role: CONTACT, phone: +34 923 29 12 00, phoneExt: 55779, email: uicec.coordinacion@ibsal.es, geoPoint lat: 40.96882, lon: -5.66388, hasResults: False

protocolSection identificationModule nctId: NCT06382831, orgStudyIdInfo id: IndonesiaU240201, briefTitle: Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery, conditionsModule conditions: Anesthesia and Analgesia, conditions: Anesthesia, Endotracheal, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine, interventions name: Fentanyl, outcomesModule primaryOutcomes measure: Postoperative nausea and vomiting (PONV), primaryOutcomes measure: Pain score, primaryOutcomes measure: Time to laryngeal mask exertion, primaryOutcomes measure: Adverse effect, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06382818, orgStudyIdInfo id: PROICM 2023-10 PRO, briefTitle: Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability, acronym: PROBA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2027-04-26, completionDateStruct date: 2036-04-26, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Institut du Cancer de Montpellier - Val d'Aurelle, class: OTHER, descriptionModule briefSummary: Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: * COHORT A = Low risk of recurrence / Low risk of breast toxicity* COHORT B = Low risk of recurrence / High risk of breast toxicity* COHORT C = High risk of recurrence / Low risk of breast toxicity* COHORT D = High risk of recurrence / High risk of breast toxicity, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 854, type: ESTIMATED, armsInterventionsModule interventions name: COHORT A, interventions name: COHORT B, interventions name: COHORT C, interventions name: COHORT D, outcomesModule primaryOutcomes measure: Rate of patients without any grade 2 or more fibrosis, nor radio-induced sarcoma, secondaryOutcomes measure: Acute toxicity, secondaryOutcomes measure: Late toxicity, secondaryOutcomes measure: Local recurrence rate (LRR), secondaryOutcomes measure: Relapse-free survival (RFS) rate, secondaryOutcomes measure: Overall survival (OS) rate, secondaryOutcomes measure: Radiation-induced Breast Sarcoma prevalence, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut Du Cancer de Montpellier, city: Montpellier, country: France, contacts name: MOUSSION AURORE, role: CONTACT, phone: 0467613102, email: aurore.moussion@icm.unicancer.fr, contacts name: AZRIA DAVID, role: PRINCIPAL_INVESTIGATOR, contacts name: MEGE ALICE, role: PRINCIPAL_INVESTIGATOR, contacts name: BRETON-CALLU CHRISTEL, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False

protocolSection identificationModule nctId: NCT06382805, orgStudyIdInfo id: HasanKU_FTR_AA_02, briefTitle: Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy in Lateral Epicondylitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Hasan Kalyoncu University, class: OTHER, descriptionModule briefSummary: Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. The purpose of this study is to compare the effectiveness of kinesio tape and high intensity laser in the treatment of lateral epicondylitis., conditionsModule conditions: Tennis Elbow, conditions: Physical Therapy, conditions: Kinesiotaping, conditions: Laser, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are three groups in the study. The groups consist of the control group, kinesio tape group and high intensity laser group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Physiotherapy program, interventions name: Kinesio Tape, interventions name: High Intensity Laser therapy, outcomesModule primaryOutcomes measure: Pain Measurement, primaryOutcomes measure: Hand grip strength, primaryOutcomes measure: Patient-Rated Tennis Elbow Evaluation, secondaryOutcomes measure: Pain Sensitivity Measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hasan Kalyoncu University, city: Gaziantep, zip: 27000, country: Turkey, geoPoint lat: 37.05944, lon: 37.3825, hasResults: False

protocolSection identificationModule nctId: NCT06382792, orgStudyIdInfo id: 2024PI059, briefTitle: Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature)., conditionsModule conditions: Shoulder Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: proximal humeral resection for tumor and allograft prosthetic composite reconstruction, outcomesModule primaryOutcomes measure: Osteolysis (bone stock in cm3), secondaryOutcomes measure: Constant score, secondaryOutcomes measure: Complications, secondaryOutcomes measure: Revision, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Hopital, city: Nancy, zip: 54000, country: France, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False

protocolSection identificationModule nctId: NCT06382779, orgStudyIdInfo id: 2024PI057, briefTitle: Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: Proximal humerus is a common site for primary bone tumors and metastatic disease. Reconstruction with reverse shoulder arthroplasty (RSA) after resection is a surgical challenge and presented high risk of complication. The options for reconstruction after proximal humerus tumor resection are limited, and depend on the soft tissue conditions and bone loss. The most commonly used techniques include long cemented stem alone (in case of limited resection), allograft prosthetic composite (APC), massive prosthesis. In some cases two step procedure are performed : first step is resection and RSA with cement sleeve, and second step is APC or massive prosthesis., conditionsModule conditions: Shoulder Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: reverse shoulder arthroplasty, outcomesModule primaryOutcomes measure: Constant score, secondaryOutcomes measure: complication, secondaryOutcomes measure: mortality, secondaryOutcomes measure: revision, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU - Centre chirurgical emile galle, city: Nancy, zip: 54000, country: France, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False

protocolSection identificationModule nctId: NCT06382766, orgStudyIdInfo id: SMU in malnutrition, briefTitle: Skeletal Muscle Ultrasonography in Detection of Malnutrition, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: * To detect the role of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children.* To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional assessment tools ., conditionsModule conditions: Skeletal Muscle Ultrasonography, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Skeletal Muscle Ultrasonography, outcomesModule primaryOutcomes measure: accuracy of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children comared with other traditional nutritional assessment tools ., eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06382753, orgStudyIdInfo id: 20-24-PAR, briefTitle: Impact of Periodontal Supportive Therapy in Patients With Gingivitis and Periodontitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Catania, class: OTHER, descriptionModule briefSummary: The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development., conditionsModule conditions: Gingivitis, conditions: Periodontitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Gingival inflammation, outcomesModule primaryOutcomes measure: Bleeding on Probing, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AOU Policlinico G. Rodolico, status: RECRUITING, city: Catania, zip: 95124, country: Italy, contacts name: Gaetano Isola, DDS, role: CONTACT, phone: 0953785652, email: gaetano.isola@unict.it, geoPoint lat: 37.49223, lon: 15.07041, hasResults: False

protocolSection identificationModule nctId: NCT06382740, orgStudyIdInfo id: AOP2097, briefTitle: Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years, acronym: Over70-LT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera di Padova, class: OTHER, descriptionModule briefSummary: Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years., conditionsModule conditions: End Stage Liver DIsease, conditions: Liver Transplantation, conditions: Old Age, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Liver transplantation, outcomesModule primaryOutcomes measure: 1 year patient survival, secondaryOutcomes measure: 1 year graft survival, secondaryOutcomes measure: 3 months mortality and morbidity, eligibilityModule sex: ALL, minimumAge: 71 Years, maximumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova, status: RECRUITING, city: Padova, zip: 35128, country: Italy, contacts name: Umberto Cillo, MD, role: CONTACT, email: cillo@unipd.it, geoPoint lat: 45.40797, lon: 11.88586, hasResults: False

protocolSection identificationModule nctId: NCT06382727, orgStudyIdInfo id: ER008, briefTitle: CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care, acronym: CONTINUE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Emma Ridley, class: OTHER, descriptionModule briefSummary: Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally.The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation).The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN.This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation., conditionsModule conditions: Critical Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: CONTINUE is a multi-centre, open-label, prospective parallel, pilot randomised controlled trial being conducted in Australia., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: EN will be continued up to extubation (EN will not be withheld prior to extubation), outcomesModule primaryOutcomes measure: Fasting time (hours), secondaryOutcomes measure: Reintubation rate, secondaryOutcomes measure: Days alive and free of mechanical ventilation, secondaryOutcomes measure: Commencement of antibiotics, secondaryOutcomes measure: Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2), secondaryOutcomes measure: ICU length of stay, secondaryOutcomes measure: In-hospital mortality, secondaryOutcomes measure: Nutrition delivery, secondaryOutcomes measure: Recruitment rate, secondaryOutcomes measure: Protocol compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gold Coast University Hospital, city: Southport, state: Queensland, zip: 4215, country: Australia, contacts name: James Mccullogh, Dr, role: CONTACT, geoPoint lat: -27.96724, lon: 153.39796, locations facility: St Vincent's Hospital Melbourne, city: Fitzroy, state: Victoria, zip: 3065, country: Australia, contacts name: Alastair Brown, Dr, role: CONTACT, geoPoint lat: -37.79839, lon: 144.97833, locations facility: The Alfred Hospital, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Emma Ridley, A/Prof, role: CONTACT, contacts name: Sean Keem, Dr, role: CONTACT, geoPoint lat: -37.814, lon: 144.96332, hasResults: False

protocolSection identificationModule nctId: NCT06382714, orgStudyIdInfo id: 2023-12/13, briefTitle: Virtual Museum Visit on Dialysis Symptoms and Anxiety in Hemodialysis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Cumhuriyet University, class: OTHER, descriptionModule briefSummary: The main purpose of dialysis used in the treatment of end-stage renal failure is; By relieving the patient from uremic symptoms, controlling excess fluid, electrolyte and acid base disorders, improving the well-being of the patients and also improving the quality of life of the patients. In addition to its contribution to the continuation of life, dialysis can significantly affect the biological and physiological balance and normal life order of patients. Some of these effects may be negative on patients. During this process, patients may frequently experience symptoms such as changes in fluid-electrolyte balance, increased fatigue, and weakness, as well as psychopathological conditions such as anxiety. In this context, it is extremely important to handle patients from a holistic perspective and keep their homeostatic balance under control during the hemodialysis process. In addition to pharmacological treatments, many integrative methods are used in the management of symptoms for reasons such as being low in cost, having fewer side effects than pharmacological treatments, and strengthening the immune system. Museum visit, one of these integrative treatment methods, has become an area of art therapy where help is received for various reasons such as coping with the symptoms of chronic diseases, reducing the side effects of medications, preventing mental depression, strengthening healthy behaviors, and avoiding tension and loss of control. In this context, the research was planned as a randomized controlled study investigating the effect of virtual museum tour on dialysis symptom index and anxiety in hemodialysis patients..T.R. The "https://sanalmuze.gov.tr" site belonging to the Ministry of Culture and Tourism will be shown to the patients five times and the virtual museum visit will be made by showing the patient's preferred museum five times among the 53 museums prepared by the General Directorate of Information Technologies of the Ministry of Culture and Tourism, and the Initiative Group, Control It will be compared with its group. Research data; It will be collected using the Patient Information Form, Dialysis Symptom Index and Beck Anxiety Scale (BAI). At the end of the study, the data will be evaluated in the SPSS program. The museum visit applied to the Intervention Group will also be applied to the control group after the study is completed, taking into account the ethical dimension., conditionsModule conditions: DIALYSIS SYMPTOMS AND ANXIETY, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: For the intervention group, a museum visit with virtual reality glasses will be applied., outcomesModule primaryOutcomes measure: Dialysis Symptom Index (DSI), primaryOutcomes measure: Beck Anxiety Scale (BAI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mukadder, city: Mollaoğlu, state: Sivas, zip: 58140, country: Turkey, contacts name: Mukadder Mollaoğlu, Prof Dr., role: CONTACT, phone: 90 5055723985, email: mukaddermollaoglu2@gmail.com, contacts name: Songül Mollaoğlu, Assoc Prof, role: CONTACT, phone: 90 532 480 08 32, email: songulmollaoglu@gmail.com, geoPoint lat: 39.70028, lon: 30.28306, hasResults: False

protocolSection identificationModule nctId: NCT06382701, orgStudyIdInfo id: Kayseri, briefTitle: Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-09-06, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety., conditionsModule conditions: Hemodialysis Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study was designed as a randomized controlled and double-blind study to evaluate the effect of clove oil applied to arterio-venous fistula on pain and anxiety caused by cannulation and to determine the effect of the application on satisfaction., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Pre-cannulation spray application to the intervention and placebo groups will be provided by an interviewer trained by the researchers. Cannulations will be performed by nurses in the institution where the study is conducted. Data will be collected by the responsible nurses in the institutions.Patients participating in the study, researchers, and the nurse in charge will not know who is in the intervention and placebo groups.The research will be completed in twelve sessions over four weeks., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: aromatherapy, interventions name: placebo, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: State and Trait Anxiety Inventory (STAI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University, city: Melikgazi, state: Kayseri, zip: 38260, country: Turkey, hasResults: False

protocolSection identificationModule nctId: NCT06382688, orgStudyIdInfo id: 23-08-0010, briefTitle: IV Administration of ChromaDex's Niagen® as Compared to NAD+, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-03-08, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Franklin Health Research, class: OTHER, descriptionModule briefSummary: This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV., conditionsModule conditions: Healthy Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 53, type: ACTUAL, armsInterventionsModule interventions name: NAD+ (nicotinamide adenine dinucleotide) IV, interventions name: Niagen® (nicotinamide riboside) IV, interventions name: Niagen® (nicotinamide riboside) oral, interventions name: Placebo, outcomesModule primaryOutcomes measure: Blood Pressure, primaryOutcomes measure: Heart rate, primaryOutcomes measure: Total NAD measured through dried blood spot testing, primaryOutcomes measure: Glucose, primaryOutcomes measure: Insulin Levels, primaryOutcomes measure: total NAD measured through blood and plasma, primaryOutcomes measure: Tolerable Infusion Rate, secondaryOutcomes measure: Complete Blood Count, secondaryOutcomes measure: Comprehensive Metabolic Panel, secondaryOutcomes measure: Sleep Scale, secondaryOutcomes measure: Energy Scale, otherOutcomes measure: Subjective Experience, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nutraceuticals Research Institute, city: Franklin, state: Tennessee, zip: 37067, country: United States, geoPoint lat: 35.92506, lon: -86.86889, hasResults: False

protocolSection identificationModule nctId: NCT06382675, orgStudyIdInfo id: TA-PF-01-DE, secondaryIdInfos id: CIV-23-11-044643, type: OTHER, domain: Unique identification number EUDAMED, briefTitle: Clinical Performance of the New Plasma Filter PX2 in TPE Treatments, acronym: plasmaFlux, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Fresenius Medical Care Deutschland GmbH, class: INDUSTRY, collaborators name: KLIFO GmbH, descriptionModule briefSummary: The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process.The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment., conditionsModule conditions: Autoimmune Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Interventional, single arm, multi-centric, open-label, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2, outcomesModule primaryOutcomes measure: Analysis of TPE treatments with the Plama Filter PX2, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinikum Aschaffenburg-Alzenau, city: Aschaffenburg, state: Bavaria, zip: 63739, country: Germany, contacts name: Stefan Büttner, Dr. med., role: CONTACT, email: Stefan.buettner@klinikum-ab-alz.de, geoPoint lat: 49.97704, lon: 9.15214, locations facility: Städtisches Klinikum Braunschweig, city: Braunschweig, state: Niedersachsen, zip: 38126, country: Germany, contacts name: Gabriele Eden, Dr. med., role: CONTACT, email: g.eden@skbs.de, geoPoint lat: 52.26594, lon: 10.52673, hasResults: False

protocolSection identificationModule nctId: NCT06382662, orgStudyIdInfo id: PMDAC-01, briefTitle: Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Other Skeletal Muscle Relaxants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Primus Pharmaceuticals, class: INDUSTRY, collaborators name: Sun Valley Arthritis Center, descriptionModule briefSummary: Every participant will receive active study drug and (tone) 1 comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be (four) 4 visits., conditionsModule conditions: Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) versus metaxalone 800 mg in healthy subjects., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: metaxalone m640, interventions name: Tizanidine, outcomesModule primaryOutcomes measure: Change from baseline, Standard Deviation of Lateral Position, primaryOutcomes measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes, secondaryOutcomes measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale, secondaryOutcomes measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test), secondaryOutcomes measure: The number of product related adverse events experienced by participants from Visit 1 through Visit 4, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Valley Arthritis Center, status: RECRUITING, city: Peoria, state: Arizona, zip: 85381, country: United States, contacts name: Study Investigator, role: CONTACT, phone: 623-566-3550, email: jtuber@svacltd.com, contacts name: Study Coordinator, role: CONTACT, phone: 623-566-3550, geoPoint lat: 33.5806, lon: -112.23738, hasResults: False

protocolSection identificationModule nctId: NCT06382649, orgStudyIdInfo id: 202403051, briefTitle: Rivastigmine for Antimuscarinic Delirium, acronym: RIVA-AM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: American Academy of Clinical Toxicology, descriptionModule briefSummary: Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine, the standard antidote for AMD, currently has very limited availability in the United States due to an interruption of production.Recent case reports and small observational studies suggest that rivastigmine might be useful in the treatment of AMD, but there is not direct prospective evidence comparing rivastigmine to physostigmine or supportive care. In order to investigate the effectiveness of rivastigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine for antimuscarinic delirium will experience more rapid resolution of agitation and delirium than those treated with placebo., conditionsModule conditions: Anticholinergic Toxicity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Rivastigmine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time to control of agitation and delirium, secondaryOutcomes measure: Duration of agitation and delirium, secondaryOutcomes measure: Total amount of sedatives administered, secondaryOutcomes measure: Use of sedative infusions, secondaryOutcomes measure: Use of physical restraints, secondaryOutcomes measure: Disposition, secondaryOutcomes measure: Time to medical clearance, secondaryOutcomes measure: Oversedation, secondaryOutcomes measure: Intubation, secondaryOutcomes measure: Seizure, secondaryOutcomes measure: Gastrointestinal upset, secondaryOutcomes measure: Bradycardia, eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Kevin Baumgartner, role: CONTACT, phone: 314-273-1109, email: baumgartner.k@wustl.edu, geoPoint lat: 38.62727, lon: -90.19789, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-10, uploadDate: 2024-04-19T15:42, filename: ICF_000.pdf, size: 1060713, hasResults: False

protocolSection identificationModule nctId: NCT06382636, orgStudyIdInfo id: 23-101, briefTitle: Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes, acronym: OPUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, descriptionModule briefSummary: The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening \& Diagnostic Testing (PS\&D) in an informed and evidence-based fashion by developing an innovative digital tool to support patients' decision-making and contributing fundamental knowledge to advance science in a way that promotes patients' access to new prenatal applications of genomic science and technology. Our central hypothesis is that, by focusing on patient engagement as a key driver to improve patient outcomes, the use of an evidence-based artificial-intelligence (AI) powered patient engagement tool will increase patients' ability to seek information and structure a decision-making process that, in turn, increases informed decisions about PS\&D and decreases decisional conflict associated with those decisions.Using data from NEST (Ensuring Patients Informed Access to NIPT \[non-invasive prenatal testing\]), the investigators designed the next iteration of NEST, a point-of care shared decision-making tool powered by artificial intelligence (AI) to provide a personalized and dynamic decision support tool: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS). OPUS is an AI-enabled healthcare chatbot (a computer program capable of processing and simulating human conversation) that provides patients with personalized information and decision-making support at different stages of the PS\&D pathway. It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient, using a conversational and adaptable interaction. It also contains nested tiers of information, ranging from introductory to detailed information about patient engagement, health literacy, the different PS\&D options, and resources to learn about insurance coverage for PS\&D. OPUS was designed to be accessed by patients with different technological resources and preferences, using a cell phone, a mobile device, or a computer., conditionsModule conditions: Prenatal Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Standard Care, interventions name: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot, outcomesModule primaryOutcomes measure: Patient activation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Neighborhood Family Practice, city: Cleveland, state: Ohio, zip: 44102, country: United States, contacts name: Heidi Gullett, MD, role: CONTACT, phone: 216-368-0776, email: hlg31@case.edu, geoPoint lat: 41.4995, lon: -81.69541, locations facility: MetroHealth Medical Center, city: Cleveland, state: Ohio, zip: 44109, country: United States, contacts name: Angela Ranzini, MD, role: CONTACT, phone: 216-778-3513, email: aranzini@metrohealth.org, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Cleveland Clinic, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Ruth Farrell, MD, MA, role: CONTACT, phone: 216-445-7085, email: farrelr@ccf.org, contacts name: Christina Collart, MEd, role: CONTACT, phone: 216-470-9796, email: collarc@ccf.org, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False

protocolSection identificationModule nctId: NCT06382623, orgStudyIdInfo id: 43, briefTitle: Efficacies of Different Managements in Patients With Trigger Finger, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, class: OTHER, descriptionModule briefSummary: The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger., conditionsModule conditions: Trigger Finger, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: The percutaneous A1 pulley release, interventions name: The peritendinous Betamethasone group, outcomesModule primaryOutcomes measure: Stage of the disease, secondaryOutcomes measure: Pain intensity, secondaryOutcomes measure: severity of triggering, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06382610, orgStudyIdInfo id: 2024-002, briefTitle: Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Redlands, class: OTHER, descriptionModule briefSummary: Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body., conditionsModule conditions: Sleep, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Repeated measures crossover trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Melatonin, outcomesModule primaryOutcomes measure: Salivary melatonin level, secondaryOutcomes measure: Side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 22 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Redlands, city: Redlands, state: California, zip: 92373, country: United States, geoPoint lat: 34.05557, lon: -117.18254, hasResults: False

protocolSection identificationModule nctId: NCT06382597, orgStudyIdInfo id: AWFiS/2024_2_P-GM, briefTitle: Four Weeks of Nordic Hamstring Exercises Impact the Strength and Balance of the Hamstring Muscle Group, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-10, completionDateStruct date: 2024-07-10, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Gdansk University of Physical Education and Sport, class: OTHER, descriptionModule briefSummary: The aim of the study is to assess the impact of 4 weeks of eccentric Nordic Hamstring Exercise training on changes in the hamstring muscle group, as well as to analyze parameters such as maximum muscle strength of the knee flexors, RFD (rate of force development) and static balance, dynamics for the dominant leg., conditionsModule conditions: Hamstring Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 2, type: ESTIMATED, armsInterventionsModule interventions name: Nordic hamstring exercise, outcomesModule primaryOutcomes measure: Biodex Balance System, secondaryOutcomes measure: Biodex System, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 26 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06382584, orgStudyIdInfo id: IRB_23.09.01, briefTitle: Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur, acronym: ANTI_XA, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: In 2023, oral anticoagulant treatments (anti Xa: apixaban, rivaroxaban, etc.) are tending to replace anti vitamin K treatments in many medical indications. Their prescription is increasing rapidly in the elderly.In this context, the Nimes University Hospital receives a large number of elderly patients who have suffered a fracture of the end of the femur requiring surgery and who are taking anti Xa drugs.To avoid massive intra- and post-operative haemorrhage, surgical management is postponed because of the need to suspend the treatment, allowing a return to near-normal biological haemostasis within a few days. No consensus has been reached on the withdrawal period required to authorise surgery, as the elimination kinetics of the drug are altered in this context (elderly patients, dehydration, hypovolaemia, impaired renal function). A plasma assay (threshold of \<30 to 60 ng/mL) has been proposed without any real justification. This waiting period exposes the elderly to excess mortality. Reversing these treatments by adding coagulation factors would be an attractive alternative, as it would allow surgery to be performed earlier, but this would expose patients to an increased thrombotic risk.Before considering a prospective randomised study (early vs delayed surgery on AOD), we wish to retrospectively analyse data on patients admitted to the Nimes University Hospital on anti Xa and operated on for fracture of the upper end of the femur between 1 January 2022 and 1 June 2023, conditionsModule conditions: Direct Oral Anticoagulants (DOACs), conditions: Femoral Fractures, conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 610, type: ACTUAL, armsInterventionsModule interventions name: Femoral fracture surgery, outcomesModule primaryOutcomes measure: Hospital Mortality, secondaryOutcomes measure: Duration of the surgery, secondaryOutcomes measure: Transfusion, secondaryOutcomes measure: Postoperative comorbidities, secondaryOutcomes measure: Hospital stay, secondaryOutcomes measure: Anti Xa assay, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de NIMES, city: Nimes, zip: 30029, country: France, geoPoint lat: 43.83333, lon: 4.35, hasResults: False

protocolSection identificationModule nctId: NCT06382571, orgStudyIdInfo id: 026/66, briefTitle: Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-01-01, primaryCompletionDateStruct date: 2020-12-31, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).Methods: The retrospective cohort study was designed to collect data on Thai heart failure with reduced ejection fraction patients at Out-patient Clinic, Trat Hospital and Phrapokklao Hospital from January 2016 to December 2020. Thirteen factors were analyzed to determine their association with the sub-target group., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 396, type: ACTUAL, armsInterventionsModule interventions name: Renin-Angiotensin System Inhibitor, outcomesModule primaryOutcomes measure: factors associated with sub - target dose of ACEIs,ARBs,ARNI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06382558, orgStudyIdInfo id: s68470, secondaryIdInfos id: C2M/23/060, type: OTHER_GRANT, domain: KU Leuven, briefTitle: Validity and Reliability of Sensorimotor Processing Paradigm, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: KU Leuven, class: OTHER, descriptionModule briefSummary: Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal assessment for sensory processing, one of the most important sensory functions, does not exists. However, our research team has developed a novel assessment paradigm using the KINARM End-Point robot to assess the level of sensory processing of the upper limb. Within a previous study, the investigators examined the validity within 20 chronic stroke patients and 80 age-matched healthy controls by comparing the novel robotic assessment with a set of existing clinical and robotic assessments for the upper limb. The investigators hypothesize that the stroke patients will show a poorer performance on this novel assessment compared to the healthy controls, that the novel assessment will show better correlation coefficients with other sensory tests compared to motor tests, that the novel assessment can differentiate between different motor subgroups of chronic stroke patients, and that the novel assessment shows good test-retest reliability., conditionsModule conditions: Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Kinarm: Passive and active discrimination task, secondaryOutcomes measure: Kinarm: Arm position matching task, secondaryOutcomes measure: Kinarm: Visually guided reaching task, secondaryOutcomes measure: Erasmus modified Nottingham sensory assessment, secondaryOutcomes measure: Tactile discrimination test, secondaryOutcomes measure: Tactile functional object recognition, secondaryOutcomes measure: Stereognosis section of the original Nottingham sensory assessment, secondaryOutcomes measure: Wrist position sense test, secondaryOutcomes measure: Perceptual threshold of touch, secondaryOutcomes measure: Fugl-Meyer upper extremity assessment, secondaryOutcomes measure: Action research arm test, secondaryOutcomes measure: Barthel index, secondaryOutcomes measure: Montreal cognitive assessment, secondaryOutcomes measure: Star cancellation test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: KU Leuven, status: RECRUITING, city: Leuven, zip: 3001, country: Belgium, contacts name: Geert Verheyden, Prof. Dr., role: CONTACT, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False

protocolSection identificationModule nctId: NCT06382545, orgStudyIdInfo id: Approval number 36.3.22, briefTitle: Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2022-07-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Ahram Canadian University, class: OTHER, descriptionModule briefSummary: Comparing the intensity of post-operative pain following endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) rotary files., conditionsModule conditions: Endodontic Treatment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Fanta (Pepsi gold) (FPG), interventions name: M3-pro+ Gold (assorted) (MPG), outcomesModule primaryOutcomes measure: comparing the intensity of post-instrumentation pain, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Oral and Dental medicine, Ahram Canadian University, city: Giza, zip: 12573, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False

protocolSection identificationModule nctId: NCT06382532, orgStudyIdInfo id: AFMMUChina_NSRT, briefTitle: Diagnosis of Depressive Disorder Malinger Using the Niacin Skin Response Test (NSRT), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Air Force Military Medical University, China, class: OTHER, descriptionModule briefSummary: This study will explore the specific response characteristics of the niacin skin response test in the population with depressive disorder malinger. The investigators expect that depressive disorder malinger can be discriminated by the niacin skin reaction test., conditionsModule conditions: Depressive Disorder, conditions: Malingering, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 410, type: ESTIMATED, armsInterventionsModule interventions name: Niacin skin reaction test, outcomesModule primaryOutcomes measure: Niacin reaction test, secondaryOutcomes measure: Model specificity and sensitivity, secondaryOutcomes measure: The F Scale in Minnesota Multiphasic Personality Inventory, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Air Force Medical Center, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Jin Wang, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06382519, orgStudyIdInfo id: Thal in VEOIBD, briefTitle: Thalidomide Therapy for VEOIBD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Fudan University, class: OTHER, descriptionModule briefSummary: This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease, conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Thalidomide, outcomesModule primaryOutcomes measure: endoscopic response rate, secondaryOutcomes measure: clinical response rate, secondaryOutcomes measure: biomarker remission rate, secondaryOutcomes measure: growth development, secondaryOutcomes measure: clinical remission rate with steroid-free, secondaryOutcomes measure: adverse event, secondaryOutcomes measure: treatment persistence, eligibilityModule sex: ALL, minimumAge: 28 Days, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06382506, orgStudyIdInfo id: 2024/138, briefTitle: The Effect of Hazelnut Flour on Blood Glucose, acronym: Hazelnut, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2024-04-21, completionDateStruct date: 2024-04-21, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: One of the factors affecting human health is nutrition. The effects of foods on blood glucose are still under investigation. The Glycemic Index (GI), which is associated with many diseases today, is a value that measures the rate at which carbohydrate-containing foods raise blood glucose. It is thought that the loaves of bread produced will be a product with low GI value and can be consumed by celiacs and diabetics. It is aimed to investigate the effect of adding different amounts of hazelnut flour to bread recipes using gluten-free corn flour on blood glucose., conditionsModule conditions: Obesity, conditions: Celiac Disease, conditions: Blood Glucose, conditions: Flour Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: Consumption of Cornbread with Hazelnut Bread, outcomesModule primaryOutcomes measure: One loaf of bread was consumed each week and the study will continue for a month. Blood glucose measurements were performed with a glucometer at 0 (fasting), 15, 30, 45, 60, 90, and 120 minutes after each bread consumption., secondaryOutcomes measure: This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Avrasya University, city: Trabzon, zip: 61000, country: Turkey, geoPoint lat: 41.005, lon: 39.72694, hasResults: False

protocolSection identificationModule nctId: NCT06382493, orgStudyIdInfo id: B-2011-648-005, briefTitle: Tegoprazan-containing Sequential for H. Pylori, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-02-01, primaryCompletionDateStruct date: 2024-12-12, completionDateStruct date: 2024-12-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Seoul National University Bundang Hospital, class: OTHER, descriptionModule briefSummary: As H. pylori eradication, we prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy, conditionsModule conditions: Helicobacter Pylori Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Tegoprazan-containing sequential H. pylori eradication therapy, outcomesModule primaryOutcomes measure: Eradication rate, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Bundang Hospital, status: RECRUITING, city: Seongnam-si, state: Gyeonggi-do, zip: 463-707, country: Korea, Republic of, contacts name: Nayoung Kim, M.D.,Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.43861, lon: 127.13778, hasResults: False

protocolSection identificationModule nctId: NCT06382480, orgStudyIdInfo id: 90/2023, briefTitle: PROTeIn-rich Meals to Control Glucose, acronym: PROTIME, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: German Institute of Human Nutrition, class: OTHER, collaborators name: Charite University, Berlin, Germany, collaborators name: Helmholtz Center Munich, collaborators name: Hasso Plattner Institute, Potsdam, Germany, descriptionModule briefSummary: The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status., conditionsModule conditions: Overweight, conditions: Obesity, conditions: Prediabetes, conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake divided by a 4-week wash-out phase., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Diet with specific macronutrient composition., outcomesModule primaryOutcomes measure: Mean 24-hour glucose, secondaryOutcomes measure: Measurement of height, secondaryOutcomes measure: Measurement of body weight, secondaryOutcomes measure: Waist and hip circumference / waist to hip ratio, secondaryOutcomes measure: Systolic and diastolic blood pressure, secondaryOutcomes measure: Body fat and lean mass, secondaryOutcomes measure: Energy expenditure and substrate oxidation rates, secondaryOutcomes measure: Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT)), secondaryOutcomes measure: Renal values (creatinine, urea, uric acid), secondaryOutcomes measure: Intra- und inter-day glycemic variability, secondaryOutcomes measure: Glucose levels in meal tolerance test (MTT), secondaryOutcomes measure: Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin), secondaryOutcomes measure: Inflammatory markers and T cell populations analyses, secondaryOutcomes measure: Satiety and hunger scores, secondaryOutcomes measure: Sleep/wake timing and sleep quality, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Adipose tissue transcriptome, secondaryOutcomes measure: Gene expression in peripheral blood mononuclear cells (PBMC), secondaryOutcomes measure: Gut microbiota and microbiome-derived metabolites, secondaryOutcomes measure: Determination of decision behavior, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Olga Ramich, status: RECRUITING, city: Potsdam, state: Potsdam-Rehbrücke, zip: 14558, country: Germany, contacts name: Olga Ramich, PD Dr., role: CONTACT, phone: +4933200882749, email: olga.ramich@dife.de, contacts name: Marina D'Urso, role: CONTACT, phone: +4933200882690, email: marina.durso@dife.de, geoPoint lat: 52.39886, lon: 13.06566, hasResults: False

protocolSection identificationModule nctId: NCT06382467, orgStudyIdInfo id: 2401-136-016, briefTitle: Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Chung-Ang University Gwangmyeong Hospital, class: OTHER, descriptionModule briefSummary: This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements., conditionsModule conditions: Neurologic Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Remimazolam besylate + propofol MCT, interventions name: Propofol MCT, outcomesModule primaryOutcomes measure: Incidence of intraoperative hypotension, secondaryOutcomes measure: Amount and number of inotropic agents, secondaryOutcomes measure: Incidence of participants' intraoperative involuntary movement, secondaryOutcomes measure: scores of neurophysiologic monitoring quality, secondaryOutcomes measure: onset time of study drugs, secondaryOutcomes measure: The administration number of rescue anti-emetic agents, secondaryOutcomes measure: Time-weighted average of intraoperative hypotension, secondaryOutcomes measure: recovery time of study drugs (remimazolam+propofol or propofol), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06382454, orgStudyIdInfo id: E2-23-5921, briefTitle: Upper Extremity Robot-Assisted Therapy in Stroke Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, collaborators name: Interact Medical Technologies Inc., descriptionModule briefSummary: Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Robot-assisted therapy is an approach to post-stroke rehabilitation that uses robotic devices to provide motor or task-oriented training to patients. When the literature is examined, there are studies showing that robot-assisted therapies are similar or superior to conventional methods. In order to provide the most effective rehabilitation approach in upper extremity robots, it is suggested that it may be more accurate to consider the robotic device as a training platform consisting of various therapeutic techniques and principles, not as a tool alone. A robotic system will be used to overcome the disadvantages of the existing robotic systems in the literature such as not providing support to the patient at the time of need, not providing fluidity in shoulder movements by not taking into account the scapulohumeral rhythm in upper extremity movements, long installation times, and ignoring task-oriented training. The system to be used is a self-aligning exoskeleton system for robot-assisted upper extremity rehabilitation. The system provides safe and versatile rehabilitation at increasing intensity and also allows for objective assessments. The aim of this clinical study was to evaluate the efficacy of robot-assisted upper limb rehabilitation in stroke patients., conditionsModule conditions: Stroke, conditions: Upper Extremity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Assist-On Arm Robot Group, interventions name: Control Group, outcomesModule primaryOutcomes measure: Modified Ashworth Scale, primaryOutcomes measure: Fugl-Meyer Assessment Upper Extremity, primaryOutcomes measure: Action Research Arm Test, primaryOutcomes measure: Box and Block Test, primaryOutcomes measure: Nine Hole Peg Test, secondaryOutcomes measure: ACTIVLIM, secondaryOutcomes measure: ABILHAND Assessment, secondaryOutcomes measure: Stroke Impact Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation, city: Ankara, state: Altındağ, Ankara, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06382441, orgStudyIdInfo id: KC/KE-23-0122/ER-4, briefTitle: A Tele-exercise Program for Breast Cancer Survivors, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Hong Kong Baptist University, class: OTHER, descriptionModule briefSummary: The research protocol outlines a pilot study for a home-based and group-based tele-exercise program designed for breast cancer survivors. The study is a randomized controlled trial (RCT) led by Dr. Yang Gao from Hong Kong Baptist University, with multiple other investigators from Kwong Wah Hospital and the university itself.Breast cancer is identified as the most prevalent cancer among women globally and in Hong Kong. The document states that adjuvant therapies post-surgery, such as radiation and chemotherapy, can have both short-term and long-term side effects, which may affect the survivors' physical and mental health.The study is based on evidence that physical activity levels often decrease after a breast cancer diagnosis and that exercise can mitigate the side effects of treatment, improving health and quality of life. The pilot aims to test the acceptability and feasibility of a 12-week tele-exercise program that combines psychological theories and behaviour change techniques, transitioning from supervised to unsupervised exercise to build sustainable exercise habits.The study will enrol 24 patients, randomly assigning them to an intervention group or an active control group. The intervention group will receive 12 online training sessions plus 4 psychological counselling sessions, whereas the control group will receive educational essays on exercise and health.The training sessions for the intervention group will include various exercises with increasing intensity and duration over the 4 weeks, monitored by a pulse oximeter to ensure exercises are done at the appropriate heart rate. The sessions will be led by qualified coaches, with Dr. Gao overseeing quality control., conditionsModule conditions: Behavior, Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: tele-exercise, outcomesModule primaryOutcomes measure: Acceptability (quantitative), primaryOutcomes measure: Acceptability (qualitative), primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Attendance rate, primaryOutcomes measure: Compliance rate, secondaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: muscle strength, secondaryOutcomes measure: balance, secondaryOutcomes measure: % body fat, secondaryOutcomes measure: skeletal muscle mass, secondaryOutcomes measure: height, secondaryOutcomes measure: Shoulder joint range of motion (ROM) of affected side, secondaryOutcomes measure: Limb circumference and lymphedema, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Physical activity level (min/week), eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xiong Zhennan, city: Kowloon Tong, state: Kowloon, country: Hong Kong, geoPoint lat: 22.33312, lon: 114.17969, locations facility: Yan SUN, city: Kowloon Tong, state: Kowloon, country: Hong Kong, geoPoint lat: 22.33312, lon: 114.17969, hasResults: False

protocolSection identificationModule nctId: NCT06382428, orgStudyIdInfo id: T-DAYICAN-002, briefTitle: The Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method in the Postpartum Period, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-30, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Izmir Tinaztepe University, class: OTHER, collaborators name: Biruni University, collaborators name: Yeditepe University, collaborators name: Fenerbahce University, descriptionModule briefSummary: Pelvic floor muscle training (PFMT) is routinely recommended to treat and prevent pelvic floor symptoms in the postpartum period. However, due to the high cost, remoteness of the location, and responsibilities of the baby, women cannot participate in PFMT whenever and wherever they want. Telerehabilitation (TR) may be an effective method to facilitate women's access to PFMT. Therefore, our study aims to compare the short and medium-term effects of PFMT applied with the TR method on pelvic floor symptoms, symptom-related quality of life and pelvic floor muscle function with supervised PFMT. This randomized controlled study was conducted at Yeditepe University Hospital Bağdat Street Polyclinic Pelvic Floor Center and online synchronous platform on women aged 18-35 and between the 6th and 8th weeks postpartum. Participants were randomly assigned to the synchronized PFMT performed with the telerehabilitation method (TR-PFMT) group and the supervised PFMT (S-PFMT) group. The same PFMT program was carried out in both groups for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program was carried out via a synchronous online platform (Skype™ program) in the TR-PFMT group, and as a face-to-face session in the S-PFMT group. Participants' pelvic floor symptoms were evaluated with the Pelvic Floor Distress Inventory-20 (PFDI-20), symptom-related quality of life was evaluated with the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and pelvic floor muscle function was evaluated with superficial electromyography. Evaluations were made 3 times in total: before the exercise program, after the exercise program and at the 8th week after the exercise program (6th month postpartum)., conditionsModule conditions: Pelvic Floor Disorders, conditions: Postpartum Disorder, conditions: Quality of Life, conditions: Mothers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 58, type: ACTUAL, armsInterventionsModule interventions name: Pelvic floor muscle training, outcomesModule primaryOutcomes measure: Pelvic Floor Distress Inventory-20 to measure the total pelvic floor symptoms, primaryOutcomes measure: Pelvic Floor Distress Inventory-20 to measure the pelvic organ prolapse symptoms, primaryOutcomes measure: Pelvic Floor Distress Inventory-20 to measure the colorectal-anal symptoms, primaryOutcomes measure: Pelvic Floor Distress Inventory-20 to measure the urinary symptoms, primaryOutcomes measure: Pelvic Floor Impact Questionnaire-7 to measure the total pelvic floor symptoms related quality of life, primaryOutcomes measure: Pelvic Floor Impact Questionnaire-7 to measure the pelvic organ prolapse symptoms related quality of life, primaryOutcomes measure: Pelvic Floor Impact Questionnaire-7 to measure the colorectal-anal symptoms related quality of life, primaryOutcomes measure: Pelvic Floor Impact Questionnaire-7 to measure the urinary symptoms related quality of life, primaryOutcomes measure: Surface electromyography (EMG) to measure the pre-basal activity of the pelvic floor muscles, primaryOutcomes measure: Surface electromyography (EMG) to measure the phasic activity of the pelvic floor muscles, primaryOutcomes measure: Surface electromyography (EMG) to measure the tonic activity of the pelvic floor muscles, primaryOutcomes measure: Surface electromyography (EMG) to measure the endurance activity of the pelvic floor muscles, primaryOutcomes measure: Surface electromyography (EMG) to measure the post-baseline rest activity of the pelvic floor muscles, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yeditepe University, city: Istanbul, zip: 34010, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06382415, orgStudyIdInfo id: VINCat_PDO_2, briefTitle: Organ/Space Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery, acronym: VINCat_PDO_2, statusModule overallStatus: COMPLETED, startDateStruct date: 2011-01-01, primaryCompletionDateStruct date: 2016-12-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Hospital de Granollers, class: OTHER, descriptionModule briefSummary: In rectal cancer surgery, the organ/space surgical site infection (O/S-SSI) has an impact on patient's prognosis. Its influence in the oncologic outcomes remains controversial. The main objective is to assess the possible effect of O/S-SSI on long-term overall survival and cancer recurrence., conditionsModule conditions: Rectal Cancer, conditions: Organ-Space Surgical Site Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3826, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Rate of overall cancer recurrence, primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Rate of Organ-space surgical site infection, secondaryOutcomes measure: Rate of surgical complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital General de Granollers, city: Granollers, state: Barcelona, zip: 08402, country: Spain, geoPoint lat: 41.60797, lon: 2.28773, hasResults: False

protocolSection identificationModule nctId: NCT06382402, orgStudyIdInfo id: 23.0924, briefTitle: A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Louisville, class: OTHER, descriptionModule briefSummary: This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI., conditionsModule conditions: Myocardial Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: CCTA scan, outcomesModule primaryOutcomes measure: MACE, primaryOutcomes measure: Cardiovascular (CV) mortality, primaryOutcomes measure: Nonfatal MI, stroke, primaryOutcomes measure: Hospitalization for unstable angina, primaryOutcomes measure: Hospitalization for heart failure, primaryOutcomes measure: Unplanned revascularization, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: In-hospital and 90-day costs, secondaryOutcomes measure: Patient quality of life at 90 days, secondaryOutcomes measure: Diagnostic certainty scores, secondaryOutcomes measure: Individual components of the primary endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Louisville School of Medicine, Division of Cardiovascular Diseases, city: Louisville, state: Kentucky, zip: 40202, country: United States, contacts name: Dinesh Kalra, MD, role: CONTACT, phone: 502-588-7010, email: diniesh.kalra@louisville.edu, contacts name: Rongras Damrongwatanasuk, MD, role: CONTACT, phone: 502-588-7010, email: rongras.damrongwatanasuk@louisville.edu, geoPoint lat: 38.25424, lon: -85.75941, hasResults: False

protocolSection identificationModule nctId: NCT06382389, orgStudyIdInfo id: DR220204, secondaryIdInfos id: 2023-504691-18-00, type: CTIS, briefTitle: Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial-, acronym: PROTO-EHPAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Hospital, Tours, class: OTHER, descriptionModule briefSummary: Depression in neurocognitive disorders (Alzheimers' disease and related disoders) is a highly prevalent condition, especially in nursing homes. While it is associated with significant distress, the current conventional antidepressants have shown only modest efficacy and exposed to potentially severe side effects.Recent evidence suggests that nitrous oxide (N2O) in its most commonly used packaging of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) has rapid antidepressant properties and a good safety profile. However, no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes.The principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks, with a dosage escalation procedure., conditionsModule conditions: Depression, conditions: Neurocognitive Disorders, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel assignement, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: EMONO, interventions name: Medical air, outcomesModule primaryOutcomes measure: Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline)., secondaryOutcomes measure: CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8, secondaryOutcomes measure: CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8, secondaryOutcomes measure: The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8, secondaryOutcomes measure: Collection of adverse events at all study visits, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06382376, orgStudyIdInfo id: 2024-60, briefTitle: The Effect of Analgesia Methods Applied in Gynecological Cancer Surgeries on Postoperative Analgesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, class: OTHER_GOV, descriptionModule briefSummary: The aim of this study is to compare the effectiveness of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia in gynecological cancer surgeries.The key question(s) it aims to answer are:\[Is intrathecal morphine more effective in postoperative analgesia?\] Patients who underwent gynecological cancer surgery were examined retrospectively. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia on pain scores and postoperative opioid use., conditionsModule conditions: Gynecological Cancer Surgery, conditions: Regional Anesthesia Morbidity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 71, type: ACTUAL, armsInterventionsModule interventions name: Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied group, outcomesModule primaryOutcomes measure: postoperative numerical rating scale, secondaryOutcomes measure: postoperative opioid use, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Başakşehir Çam and Sakura City Hospital, city: Istanbul, state: Basaksehir, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06382363, orgStudyIdInfo id: UW21-363, briefTitle: Improving T2DM Detection Using Spot cHbA1c Test - a Cluster RCT, acronym: DM-REACH, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-11, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Hospital Authority, Hong Kong, collaborators name: Food and Health Bureau, Hong Kong, descriptionModule briefSummary: Objectives: To evaluate the effectiveness of active opportunistic screening using point-of-care capillary Hemoglobin-A1c (POC-cHbA1c) testing, compared to venous HbA1c (vHbA1c) testing, in improving detection of type 2 diabetes mellitus (T2DM) among at-risk primary care patients.Design: Pragmatic cluster randomized controlled trial.Setting: 8 public primary care clinics in Hong Kong.Participants: A minimum of 776 patients (97 per clinic) who have ≥1 risk factor for T2DM, but no known diagnosis of DM or DM screening in the past 12 months.Intervention: Participants at intervention clinics (n=4) will be offered free POC-cHbA1c testing on-site, immediately informed of test results and DM risk, and scheduled for confirmatory oral glucose tolerance test (OGTT) if screened positive (i.e. HbA1c≥5.6%). Participants at control clinics will be offered free vHbA1c testing scheduled on a separate day, informed of test results and DM risk via phone, and scheduled for confirmatory OGTT if screened positive.Main outcome measures: Primary outcomes are uptake rate of POC-cHbA1c versus vHba1c testing, and difference in proportion of T2DM detected between intervention and control groups.Secondary outcomes include number-needed-to-screen to detect one more T2DM case.Data analysis: Participants' characteristics and test uptake rates will be summarized by descriptive statistics. Difference in the proportion of T2DM detected between groups will be compared using Chi-squared test. Number-needed-to screen to identify one additional patient with DM will be calculated.Expected results: A greater proportion of T2DM patients will be detected by POC-cHbA1c than vHbA1c due to a higher screening test uptake rate among the studied population., conditionsModule conditions: Diabetes Mellitus, conditions: Pre-diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 776, type: ESTIMATED, armsInterventionsModule interventions name: POC-cHbA1c testing, outcomesModule primaryOutcomes measure: Proportional difference in detection of T2DM, primaryOutcomes measure: Uptake rate, secondaryOutcomes measure: Proportion of high-risk HbA1c concentration, secondaryOutcomes measure: Difference in uptake rate of OGTT, secondaryOutcomes measure: Number-needed-to-screen to detect one more T2DM case, secondaryOutcomes measure: Proportion of patients who refuse to join the study, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aberdeen Jockey Club General Out-Patient Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Kwun Tong Community Health Centre, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Lek Yuen General Out-Patient Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Li Po Chun General Out-Patient Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Ma On Shan Family Medicine Centre, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Sai Ying Pun Jockey Club General Out-patient Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Tseung Kwan O (Po Ning Road) General Out-patient Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Yau Ma Tei Jockey Club Specialist Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False

protocolSection identificationModule nctId: NCT06382350, orgStudyIdInfo id: KHL-002-2024, briefTitle: Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems, acronym: SAFEDRIVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Hospital, Motol, class: OTHER, descriptionModule briefSummary: The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy, conditionsModule conditions: Type 1 Diabetes Mellitus, conditions: Type 1 Diabetes Mellitus With Hypoglycemia, conditions: Drive, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: MiniMed 780 G, outcomesModule primaryOutcomes measure: The frequency of hypoglycemia (<3.9 mmol/l) during the driving periods, secondaryOutcomes measure: Period of time spent in a range between 3.9 and 4.5 mmol/l (a risky period) during driving., otherOutcomes measure: Specific CGM analysis in relation to recorded the daily activities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06382337, orgStudyIdInfo id: A03010240S, briefTitle: Immediate Dental Implants in The Upper Anterior Region, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-21, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: The aim of the study will be to evaluate maxillary anterior teeth replacement with immediate dental implant utilizing vestibular socket therapy versus ice cream cone technique both clinically and radiographically., conditionsModule conditions: Teeth Loss, conditions: Alveolar Bone Resorption, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Group A : ice cream cone technique, interventions name: Group B : the vestibular socket therapy, outcomesModule primaryOutcomes measure: Bone changes, secondaryOutcomes measure: soft tissue changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry Mansoura University, city: Mansoura, zip: 7650001, country: Egypt, contacts role: CONTACT, phone: 050 2248512, email: dentfac@mans.edu.eg, contacts name: Mohamed Fa Shoeib, demonstrator, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False

protocolSection identificationModule nctId: NCT06382324, orgStudyIdInfo id: 202301280B0, briefTitle: The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: Anterior cruciate ligament (ACL) reconstruction surgery is a common procedure performed by orthopedic surgeons. Postoperatively, patients often experience pain, muscle tension, and concerns about their ability to return to sports. These factors influence the recovery and return to sports capabilities of ACL patients. According to research, only 64% of patients are able to recover to their pre-injury level after surgery, and the success rate for returning to competitive sports is only 56%. Psychological factors during the recovery process may explain this disparity. ACL injury is associated with anxiety, pain reaction, and emotional disorders, with fear of re-injury being the most common obstacle to returning to sports, accounting for 19%. A study by Lentz et al. (2015) also found no significant differences in pain assessments between individuals who were afraid of re-injury and those who were able to return to sports at six months and one year after surgery. This suggests that fear of pain may limit activity and increase the risk of unsuccessful return to sports.Mindfulness intervention is a psychological approach that involves non-judgmental awareness and focus on moment to moment. Mindfulness practice is known to reduce stress in athletes, promote recovery, enhance athletic performance, and improve sleep quality. Good sleep quality contributes to emotional stability and physical recovery. Even short daytime naps can be beneficial for athletes. A review of 37 studies of moderate quality found that daytime napping can improve physical and cognitive performance, psychological state, and nighttime sleep.Therefore, investigators hypothesize that integrating mindfulness practice into daytime napping may lead to improved spirit upon waking, reduce sleep inertia, and over time, potentially increase the rate of return to sports after ACL reconstruction., conditionsModule conditions: Anterior Cruciate Ligament (Acl) Reconstruction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention method:* Mindfulness napping group: listening to a record of mindfulness meditation practice for 40 minutes.* Control group: listening to light music for 40 minutes., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The outcome assessor of polysomnography did not know the data belongs which group, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: mindfulness practice of body scan, interventions name: listening to light music, outcomesModule primaryOutcomes measure: Electroencephalogram (EEG), primaryOutcomes measure: Electrooculography (EOG), primaryOutcomes measure: Electromyography (EMG), primaryOutcomes measure: ECG (Electrocardiography), primaryOutcomes measure: Nasal/Oral airflow, primaryOutcomes measure: Thermistor, primaryOutcomes measure: Chest and abdominal belt, primaryOutcomes measure: Oximetry, primaryOutcomes measure: Snoring, secondaryOutcomes measure: Karolinska Sleepiness Scale (KSS), secondaryOutcomes measure: Five Facet Mindfulness Questionnaire (FFMQ), secondaryOutcomes measure: State-Trait Anxiety Inventory (STAIS), secondaryOutcomes measure: Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) (Short Version), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ChangGungMH, status: RECRUITING, city: Keelung, zip: 204004, country: Taiwan, contacts name: Jian-Hong Chen, role: CONTACT, phone: 096-130-7506, email: psydr.jc@gmail.com, contacts name: Chang Gung Memorial Hospital, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.12825, lon: 121.7419, hasResults: False

protocolSection identificationModule nctId: NCT06382311, orgStudyIdInfo id: 221824, briefTitle: A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2024-08-21, completionDateStruct date: 2025-05-21, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered healthy adults 18 to 85 years of age., conditionsModule conditions: Influenza, Human, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Data will be collected in an observer-blind manner in Phase 1 and Phase 2., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1080, type: ESTIMATED, armsInterventionsModule interventions name: Flu Pandemic mRNA_Dose level 1, interventions name: Flu Pandemic mRNA_Dose level 2, interventions name: Flu Pandemic mRNA_ Dose level 3., interventions name: Flu Pandemic mRNA_ Dose level 4, interventions name: Flu Pandemic mRNA_Dose level 5, interventions name: Flu Pandemic mRNA_Dose level 6, interventions name: Flu Pandemic mRNA_Dose level 7, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with medically attended adverse events (MAAEs) [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with serious adverse events (SAEs) [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with adverse events of special interest (AESIs) [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Phase 1: Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8, primaryOutcomes measure: Phase 1: Percentage of participants with increased in FDA toxicity grading in hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 29, primaryOutcomes measure: Phase 1: Percentage of participants with increased in haematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8, primaryOutcomes measure: Phase 1: Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 29, primaryOutcomes measure: Percentage of participants with anti- hemagglutinin inhibition (HI) titers >= 1:40 at Day 43 [Phase 1 and Phase 2 Part A], primaryOutcomes measure: Percentage of participants with solicited administration site events [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with solicited systemic events [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with unsolicited AEs [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with MAAEs [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with SAEs [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with AESIs [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 [Phase 2 Part B], primaryOutcomes measure: Percentage of participants with anti-HI titers >= 1:40 at Day 22 [Phase 2 Part B], secondaryOutcomes measure: Geometric mean titers (GMTs) of HA antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Geometric mean increase (GMI) of HA antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Percentage of participants with HA antibody Seroconversion rate (SCR) [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Percentage of participants with anti-HI antibody titers >= 1:40 [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: Percentage of seropositive participants for the HA antibody titers [Phase 1 and Phase 2 Part A], secondaryOutcomes measure: GMT of Anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: GMI of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: GMI of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: GMI of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B], secondaryOutcomes measure: Percentage of participants with anti-HI antibody >= 1:40 [Phase 2 Part B], secondaryOutcomes measure: Percentage of participants with seropositivity of anti-HI antibody titers [Phase 2 Part B], eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Anniston, state: Alabama, zip: 36207, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Almena L Free, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.65983, lon: -85.83163, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Little Rock, state: Arkansas, zip: 72204, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Derek Lewis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.74648, lon: -92.28959, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Fort Collins, state: Colorado, zip: 80525, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Michael Thakor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.58526, lon: -105.08442, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Fort Myers, state: Florida, zip: 33912, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Pedro P Ylisastigui, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.62168, lon: -81.84059, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: West Palm Beach, state: Florida, zip: 33409, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mira Baron, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.71534, lon: -80.05337, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Chamblee, state: Georgia, zip: 30341, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Adebowale Akintayo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.89205, lon: -84.29881, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: El Dorado, state: Kansas, zip: 67042, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Michael Rausch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.81724, lon: -96.86225, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Lenexa, state: Kansas, zip: 66219, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Carlos A Fierro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.95362, lon: -94.73357, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Lexington, state: Kentucky, zip: 40509, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mark S Adams, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Kansas City, state: Missouri, zip: 64114, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Martha Sue Fanning, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.09973, lon: -94.57857, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Omaha, state: Nebraska, zip: 68144, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Tamara Doehner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.25626, lon: -95.94043, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Las Vegas, state: Nevada, zip: 89102, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Raj Singh, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.17497, lon: -115.13722, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Rochester, state: New York, zip: 14609, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Matthew G Davis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Greensboro, state: North Carolina, zip: 27408, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Alexander Vance Murray, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.07264, lon: -79.79198, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Winston-Salem, state: North Carolina, zip: 27103, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Robert Dean Rosen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.09986, lon: -80.24422, locations facility: GSK Investigational Site, status: NOT_YET_RECRUITING, city: Edmond, state: Oklahoma, zip: 73013, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Kyle Rickner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.65283, lon: -97.4781, locations facility: GSK Investigational Site, status: RECRUITING, city: Yukon, state: Oklahoma, zip: 73099, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Robert J. 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protocolSection identificationModule nctId: NCT06382298, orgStudyIdInfo id: PROJECT00009332, briefTitle: Cottonseed Oil Versus Matched PUFA Effects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Georgia, class: OTHER, collaborators name: United States Department of Agriculture (USDA), descriptionModule briefSummary: Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk.The specific aims are:* Examine the impact of CSO vs. PUFA on fasting and postprandial lipids.* Examine the impact of CSO on other markers of chronic disease risk.Participants will be asked to:* Consume provided meal replacement shakes daily for 28-days.* Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials,* Attend two longer (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast.Researchers will compare CSO vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets., conditionsModule conditions: Dyslipidemia, conditions: Overweight and Obesity, conditions: Nutrition, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three groups of 28-day parallel feeding trials with two groups receiving 20% of energy needs from CSO, or matched PUFA diet, and one group serving as control receiving 20% of energy needs as a mixture of oils that match the fatty acid profile of the average American intake., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Participants are blinded to oil intervention group. Investigator blinded to participant's oil intervention group., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: COTTONSEED OIL, interventions name: MATCHED PUFA DIET, interventions name: CONTROL, outcomesModule primaryOutcomes measure: Change in fasting serum lipoprotein and cholesterol concentrations, primaryOutcomes measure: Change in fasting serum lipoprotein particle numbers, primaryOutcomes measure: Change in fasting and postprandial plasma triglyceride concentrations, primaryOutcomes measure: Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations, primaryOutcomes measure: Change in fasting and postprandial plasma glucose concentrations, primaryOutcomes measure: Change in fasting and postprandial plasma insulin concentrations, primaryOutcomes measure: Change in fasting and postprandial plasma appetite control hormones concentrations, primaryOutcomes measure: Change in fasting and postprandial subjective feelings related to appetite, primaryOutcomes measure: Change in fasting and postprandial plasma Malondialdehyde (MDA), primaryOutcomes measure: Change in fasting and postprandial plasma total antioxidant capacity, primaryOutcomes measure: Change in fasting inflammatory cytokine concentrations, primaryOutcomes measure: Change in fasting plasma markers of coagulation potential, primaryOutcomes measure: Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins, primaryOutcomes measure: Change in fasting insulin resistance metrics, primaryOutcomes measure: Desaturation index, secondaryOutcomes measure: Change in fasting serum hepatic enzymes, secondaryOutcomes measure: Change in fasting serum hepatic proteins, secondaryOutcomes measure: Change in fasting serum bilirubin, secondaryOutcomes measure: Change in additional fasting plasma inflammatory cytokine concentrations, secondaryOutcomes measure: Change in additional fasting plasma markers of coagulation potential, secondaryOutcomes measure: Change in acute dietary intake, otherOutcomes measure: Change in blood pressure, otherOutcomes measure: Change in body weight, otherOutcomes measure: Change in body composition, otherOutcomes measure: Change in diet composition, otherOutcomes measure: Change in fasting tocopherol concentrations, otherOutcomes measure: Change in anthropometric circumferences, otherOutcomes measure: Change in resting metabolic rate, otherOutcomes measure: Change in Perceived Stress, otherOutcomes measure: Change in anxiety, otherOutcomes measure: Change in self reported physical activity levels, otherOutcomes measure: Change in Body Mass Index (BMI), eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Georgia, city: Athens, state: Georgia, zip: 30602, country: United States, geoPoint lat: 33.96095, lon: -83.37794, hasResults: False

protocolSection identificationModule nctId: NCT06382285, orgStudyIdInfo id: 0206-22-ASF, briefTitle: The Effect of a Prolonged Peripheral Nerve Block on the Level of Pain After a Knee Replacement, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-30, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Assaf-Harofeh Medical Center, class: OTHER_GOV, descriptionModule briefSummary: The aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery, conditionsModule conditions: Knee Replacement Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study will include 50 patients who underwent a knee replacement surgery, who will be randomized to 2 groups. 6 hours after surgery the two groups will be connected to a prolonged block pump. One group will receive the peripheral block ropivacaine 0.2% according to the protocol of 8-10 cc per hour up to 24 hours after surgery. The second group will receive saline according to the same protocol, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Continues peripheral block, outcomesModule primaryOutcomes measure: Pain level, primaryOutcomes measure: Analgesic use, secondaryOutcomes measure: Physiotherapy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False