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Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24. conditions: Bell's Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 336 type: ACTUAL name: Laser acupuncture name: Steroids measure: House Brackmann Grading System (HB) measure: Sunnybrook Facial Grading Scale (SB Grading) measure: Facial Disability Index (FDI) measure: Facial Clinimetric Evaluation Scale (FaCE Scale) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing TongRen Hospital, Capital Medical University city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06280781 id: 22CX7971 id: NIHR152027 type: OTHER_GRANT domain: National Institute of Health Research - Health Technology Assessment briefTitle: Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance) acronym: IP9-ATLAS overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2029-06 date: 2032-06 date: 2024-02-28 date: 2024-02-28 name: Imperial College Healthcare NHS Trust class: OTHER name: East London NHS Foundation Trust name: King's College name: University College, London name: University of York name: University College London Hospitals briefSummary: The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy.
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Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)?
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Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories \[ no visible lesion, diffuse changes, discrete visible lesion\]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Current (NICE defined active surveillance):
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PSA 3 monthly in year 1 and then 6 monthly with rectal exam annually. MRI will be carried out at 12 months (if not had one at diagnosis). A biopsy will be required if indicated due to changes in rectal exam or PSA.
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Planned (Regular MRI based active surveillance):
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Patients with a visible lesion or medium risk cancer will have PSA 6 monthly and MRI annually. All other patients will undergo PSA 6 monthly and MRI in years 1, 3 and 5. In all patients, a targeted biopsy will be carried out if the MRI PRECISE score is \>/=4. primaryPurpose: OTHER masking: NONE count: 1263 type: ESTIMATED name: MRI Scans measure: Biopsy measure: Staging measure: Cost-effectiveness measure: Biopsy Measurement measure: MRI & biopsy-related adverse events measure: Treatment measure: Compliance measure: EPIC Questionnaires measure: HADS Questionnaires measure: EQ-5D-5L Questionnaires sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-07 uploadDate: 2024-01-24T08:54 filename: Prot_SAP_000.pdf size: 1231033 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-07 uploadDate: 2024-01-24T09:01 filename: ICF_001.pdf size: 286927 hasResults: False
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<|newrecord|> nctId: NCT06280768 id: SHR-2004-102 briefTitle: Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Beijing Suncadia Pharmaceuticals Co., Ltd class: INDUSTRY briefSummary: This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: SHR-2004 injection measure: Incidence and severity of adverse events (including bleeding events) measure: Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax) measure: Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC) measure: Pharmacokinetics of Dupilumab: Elimination half life (t1/2) measure: PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity measure: PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT) measure: Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004 sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06280755 id: ICO-S-002 briefTitle: Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study. acronym: RECLAIM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-04 date: 2027-04 date: 2024-02-28 date: 2024-02-28 name: icometrix class: INDUSTRY name: Charite University, Berlin, Germany name: Ruhr University of Bochum name: Technische Universität Dresden name: University Hospital, Lille name: Casa di Cura IGEA name: General University Hospital, Prague name: Hoffmann-La Roche name: Bristol-Myers Squibb name: Imcyse SA name: AB Science name: Nocturne UG name: Aalto University briefSummary: The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression. conditions: Multiple Sclerosis conditions: NMO Spectrum Disorder conditions: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease conditions: Radiologically Isolated Syndrome conditions: Clinically Isolated Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 7000 type: ESTIMATED measure: The number of patients from each institution who have contributed data to the database. measure: The number of patients from each institution whose data was mapped to the common data model of the harmonised database. measure: The number of patients from the control arms of clinical trials who have contributed data to the database. measure: The data completeness of each variable in the harmonised database. measure: The representativeness of the harmonised dataset for the MS patient population as evaluated by age range, gender balance, the distribution of country of residence, the distribution of race/ethnicity and the distribution of educational level measure: The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable. measure: The temporal uniformity of each institution's data over time as assessed by the number of changes to variables over time (addition of new variables or variables no longer being captured, alterations to how variables are captured). measure: The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable. measure: The presence of contextual information on standard data gathering and analysis processes of each institution measure: The presence of a unique and pseudonymised patient ID for all data of each patient, allowing to link such data of each patient. measure: The temporal uniformity of MRI data over time as assessed by the comparability of MRI scans and the average time between subsequent MRI assessments for each patient. measure: The percentage of MRI data sets which are compliant with the MAGNIMS-CMSC-NAIMS acquisition guidelines. measure: The percentage of MRI data sets for which the automated quality control process of icobrain ms did not indicate any quality issues upon analysis. measure: The percentage of patients with a complete disease modifying treatment history available, from the date of diagnosis to the current day. measure: The percentage of patients with a complete disease history available, from the date of diagnosis to the current day. measure: The validity and temporal uniformity for disability assessment as clinically determined by EDSS, Functional systems score, T25FWT, 9HPT and SDMT. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06280742 id: APHP221366 briefTitle: Study of Neuroinflammation in Multiple Sclerosis by PET-MRI Imaging Using the Radiotracer ([18F]-DPA-714) : a Multicentre Cohort Study (INFLANET) acronym: INFLANET overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-03-01 date: 2026-03-01 date: 2024-02-28 date: 2024-04-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The Service Hospitalier Frédéric-Joliot (SHFJ) and Paris Brain Institute (ICM) groups have identified \[18F\]-DPA-714 as a promising second-generation TSPO tracer, a macromolecule overexpressed in neuroinflammatory conditions, for PET imaging. They have also developed a non-invasive quantification methodology, enabling the generation of individual neuroinflammation maps in MS patients. Recent findings from \[18F\]-DPA-714 PET imaging in MS patients revealed that most of the white matter lesions contained a smoldering component, even when considered inactive on MRI, and that their neuroinflammatory profiles were associated with longitudinal disability worsening. The Inflanet project aims to leverage a unique consortium comprising French radiochemists, radiopharmacists, nuclear medicine/neuroimaging experts, and MS neurologists to establish the first national network dedicated to \[18F\]-DPA-714 PET imaging in MS, so far limited to monocentric studies.
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The objectives of the INFLANET project are (1) to conduct the first multicenter study assessing neuroinflammation in patients with active MS using \[18F\]DPA-714 PET tracer, and (2) to establish a methodology suitable for the quantification of multicenter PET data obtained with \[18F\]DPA-714. The INFLANET initiative aims to disseminate TSPO PET within the French MS research community, thereby opening the unique perspective of future large-scale, multicenter studies. These endeavors are expected to enhance our capacity to predict diseases, stratify patients, and assess new therapeutic interventions. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 41 type: ESTIMATED name: PET-MRI with [18F]-DPA-714 measure: To quantify the smoldering component of white matter lesions in people with MS, as compared with [18F]-DPA-714 binding in the white matter of HC who underwent a PET a acquisition with the same camera camera than patients in each center. measure: To quantify for each patient the regional neuroinflammatory load, measured as [18F]-DPA-714 DVR, in specific regions of interest: total brain, normal appearing white matter, cortex, thalami, deep grey matter. measure: The MRI signatures of each lesional subtypes, and correlation between MRI metrics and [18F]-DPA-714 DVR in each region of interest. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Département de Neurologie,Pierre Wertheimer Neurological Hospital city: Lyon zip: 69500 country: France name: Françoise DURAND-DUBIEF, MD role: CONTACT phone: 04 72 35 75 22 phoneExt: +33 email: francoise.durand-dubief@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: CERMEP city: Lyon zip: 69677 country: France name: Françoise DURAND-DUBIEF, MD role: CONTACT phone: 04 72 35 75 22 phoneExt: +33 email: francoise.durand-dubief@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: CIC Neurosciences, GH Pitié-Salpêtrière city: Paris zip: 75013 country: France name: Bruno Stankoff, MD role: CONTACT phone: 0171970659 phoneExt: +33 email: bruno.stankoff@aphp.fr lat: 48.85341 lon: 2.3488 facility: Centre Eugène Marquis city: Rennes zip: 35000 country: France name: Xavier Palard, MD role: CONTACT phone: 02 99 25 30 83 phoneExt: +33 email: x.palard@rennes.unicancer.fr lat: 48.11198 lon: -1.67429 facility: Service de Neurologie, CHU Pontchaillou city: Rennes zip: 35000 country: France name: Anne Kerbrat, MD role: CONTACT phone: 02 99 28 42 94 phoneExt: +33 email: anne.kerbrat@chu-rennes.fr lat: 48.11198 lon: -1.67429 hasResults: False
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<|newrecord|> nctId: NCT06280729 id: AI-TRYDIA briefTitle: AI-Predicted Disease Trajectories in Diabetes: A Retrospective Study acronym: AI-TRYDIA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2026-03-01 date: 2024-02-28 date: 2024-02-28 name: IRCCS San Raffaele class: OTHER briefSummary: The study explores the utilization of artificial intelligence (AI) to predict disease progression trajectories in patients with diabetes. By analyzing historical data from a retrospective cohort, we aim to identify patterns and predictors of disease evolution. The approach seeks to enhance personalized treatment strategies and improve outcomes by foreseeing potential complications and disease milestones. The findings could pave the way for more targeted and effective management of diabetes through AI-driven insights. conditions: Diabetes Mellitus, Type 1 conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 10000 type: ESTIMATED name: AI-Analyis measure: Primary Endpoint measure: Primary Endpoint measure: Primary Endpoint measure: Exploratory Objectives sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Diabetes Research Institute-IRCCS Ospedale San Raffaele city: Milan state: Lombardy zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06280716 id: 18817 id: J2T-MC-KGBW type: OTHER domain: Eli Lilly and Company briefTitle: A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-12-17 date: 2026-11-04 date: 2024-02-28 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab with/without Topical Corticosteroid Treatment in Participants with Moderate-to-Severe Atopic Dermatitis. The study will last approximately 62 weeks. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, parallel group, placebo controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 430 type: ESTIMATED name: Placebo name: Lebrikizumab name: Topical Corticosteroid measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) at Week 16 for Mono Cohort measure: Percentage of Participants Achieving EASI-75 at Week 16 for Combo Cohort measure: Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Combo Cohort measure: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16 for Combo Cohort measure: Percentage of Participants With a Itch Numerical Rating Scale (NRS) Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Combo Cohort measure: Percentage Change From Baseline in EASI Score at Week 16 for Combo Cohort measure: Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Mono Cohort measure: Percentage of Participants Achieving EASI-90 at Week 16 for Mono Cohort measure: Percentage of Participants With a Itch NRS Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Mono Cohort measure: Percentage Change From Baseline in EASI Score at Week 16 for Mono Cohort sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Wannan Medical College Yijishan Hospital city: Wuhu state: Anhui zip: 241001 country: China name: Chao Ci role: PRINCIPAL_INVESTIGATOR lat: 31.33728 lon: 118.37351 facility: China-Japan Friendship Hospital city: Beijing state: Beijing zip: 100029 country: China name: Yong Cui role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100034 country: China name: Jianzhong Zhang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Children's hospital, Capital Medical University city: Beijing state: Beijing zip: 100045 country: China name: Zigang Xu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital city: Beijing state: Beijing zip: 100050 country: China name: Linfeng Li role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100091 country: China name: Wenhui Wang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Tongren Hospital affiliated to Capital Medical University city: Beijing state: Beijing zip: 100730 country: China name: Aihua Wei role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Tsinghua Changgung Hospital city: Beijing state: Beijing zip: 102202 country: China name: Yi Zhao role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: The Children's Hospital of Chongqing Medical University city: Chongqing state: Chongqing zip: 400065 country: China name: Hua Wang role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 facility: Zhongshan Hospital Fudan University (Xiamen Branch) city: Xiamen state: Fujian zip: 361015 country: China name: Yi Wei role: PRINCIPAL_INVESTIGATOR lat: 24.47979 lon: 118.08187 facility: Guangdong Province Dermatology Hospital city: Guangzhou state: Guangdong zip: 510018 country: China name: Yunsheng Liang role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital, Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510180 country: China name: Jiande han role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Shenzhen Children's Hospital city: Shenzhen state: Guangdong zip: 518026 country: China name: Ping Li role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 facility: Peking University Shenzhen Hospital city: Shenzhen state: Guangdong zip: 518036 country: China name: Xia Dou role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 facility: The University of Hong Kong-Shenzhen Hospital city: Shenzhen state: Guangdong zip: 518053 country: China name: zhenying zhang role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 facility: Hainan General Hospital city: Haikou state: Hainan zip: 570311 country: China name: Ke Han role: PRINCIPAL_INVESTIGATOR lat: 20.04583 lon: 110.34167 facility: The First Hospital of Wuhan city: Wuhan state: Hubei zip: 430022 country: China name: Liuqing Chen role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Wuhan Union Hospital city: Wuhan state: Hubei zip: 430022 country: China name: Nengxing Lin role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Renmin Hospital of Wuhan University city: Wuhan state: Hubei zip: 430060 country: China name: Tiechi Lei role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Hunan Children's Hospital city: Changsha state: Hunan zip: 410007 country: China name: Zhu Wei role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 410008 country: China name: Su Juan role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: The Second Xiangya Hospital of Central South University city: Changsha state: Hunan zip: 410011 country: China name: Hai Long role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: Wuxi No.2 People's Hospital city: Wuxi state: Jiangsu zip: 214000 country: China name: Xunyi Dai role: PRINCIPAL_INVESTIGATOR lat: 31.56887 lon: 120.28857 facility: Affiliated Hospital of Jiangsu University city: Zhenjiang state: Jiangsu zip: 212000 country: China name: Yumei Li role: PRINCIPAL_INVESTIGATOR lat: 32.21086 lon: 119.45508 facility: The Second Hospital of Jilin University city: Changchun state: Jilin zip: 130000 country: China name: Fuqiu Li role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: The First Hospital of Jilin University city: Changchun state: Jilin zip: 130021 country: China name: Shanshan Li role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'An state: Shaanxi zip: 710004 country: China name: Songmei Geng role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 facility: Huashan Hospital Affiliated Fudan University city: Shanghai state: Shanghai zip: 200040 country: China name: Chaoying Gu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Shanghai Tenth People's Hospital city: Shanghai state: Shanghai zip: 200072 country: China name: Jun Gu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Children's Hospital of Shanxi city: Taiyuan state: Shanxi zip: 030013 country: China name: Xinglian Zhang role: PRINCIPAL_INVESTIGATOR lat: 37.86944 lon: 112.56028 facility: West China Hospital, Sichuan University city: Cheng Du state: Sichuan zip: 610041 country: China name: Xian Jiang role: PRINCIPAL_INVESTIGATOR facility: Kunming Children's hospital city: Kunming state: Yunnan zip: 650034 country: China name: Hong Shu role: PRINCIPAL_INVESTIGATOR lat: 25.03889 lon: 102.71833 facility: The First Affiliated Hospital, Zhejiang University city: Hangzhou state: Zhejiang zip: 310003 country: China name: Jianjun Qiao role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: Hangzhou Third People's Hospital city: Hangzhou state: Zhejiang zip: 310009 country: China name: Aie Xu role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: Sir Run Run Shaw Hospital city: Hangzhou state: Zhejiang zip: 310016 country: China name: Hao Cheng role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: Zhejiang University School of Medicine - The Fourth Affiliated Hospital city: Yiwu state: Zhejiang zip: 322000 country: China name: Lunfei Liu role: PRINCIPAL_INVESTIGATOR lat: 29.31506 lon: 120.07676 facility: The First Affiliated Hospital Of Fujian Medical University city: Fuzhou zip: 350005 country: China name: Chao JI role: PRINCIPAL_INVESTIGATOR lat: 26.06139 lon: 119.30611 facility: Shanghai Skin Disease Hospital city: Shanghai zip: 200071 country: China name: Yuling Shi role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: The First Hospital of Hebei Medical University city: Shijiazhuang zip: 050031 country: China name: Guoqiang Zhang role: PRINCIPAL_INVESTIGATOR lat: 38.04139 lon: 114.47861 facility: The Catholic University of Korea, Incheon St. Mary's Hospital city: Bupyeong-gu state: Incheon-gwangyeoksi [Incheon] zip: 21431 country: Korea, Republic of name: Sang-Hyun Cho role: PRINCIPAL_INVESTIGATOR facility: Korea University Ansan Hospital city: Ansan-si state: Kyǒnggi-do zip: 15355 country: Korea, Republic of name: Sang Wook Son role: PRINCIPAL_INVESTIGATOR lat: 37.32361 lon: 126.82194 facility: National Medical Center city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 01812 country: Korea, Republic of name: JiYoung Ahn role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Asan Medical Center city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 05505 country: Korea, Republic of name: Chong Hyun Won role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06280703 id: 18792 id: J4P-MC-IYAB type: OTHER domain: Eli Lilly and Company id: U1111-1301-8386 type: OTHER domain: Universal Trial Number id: 2023-510365-10-00 type: OTHER domain: EU Trial Number briefTitle: A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-02-17 date: 2025-02-17 date: 2024-02-28 date: 2024-03-06 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec.
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The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected.
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The study will be conducted in three parts (A, B, and C). Healthy participants in part A will receive one single dose of LY3938577 or a placebo, whereas participants in Parts B and C with T1DM will receive single doses of either LY3938577 or Insulin Deglude given via intravenous (IV) infusion.
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The study will last up to approximately 5.5, 10 and 13 weeks for parts A, B, and C, respectively, including screening period. conditions: Healthy conditions: Type 1 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Parallel (Part A) and Crossover design (Part B and Part C) primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Double-Blind (Part A) and Open-Label (Part B and Part C) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: LY3938577 name: Placebo name: Insulin Degludec name: Insulin Lispro measure: Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration. measure: Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration. measure: Part A: Number of Participants With Clinically Significant Changes in Vital Signs measure: Part B: Number of Participants With Clinically Significant Changes in Vital Signs measure: Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters measure: Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters measure: Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 measure: Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 measure: Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577 measure: Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577 measure: Part C: PK: Concentration of LY3938577 measure: Part B: Pharmacodynamic (PD): Area under the glucose infusion rate curve (GIR AUC) of LY3938577 measure: Part C: PD: Glucose infusion rate (GIR) of LY3938577 sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Profil Institut für Stoffwechselforschung city: Neuss state: Nordrhein-Westfalen zip: 41460 country: Germany role: CONTACT phone: +49 (0) 2131 4018 450 name: Oliver Klein role: PRINCIPAL_INVESTIGATOR lat: 51.19807 lon: 6.68504 hasResults: False
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<|newrecord|> nctId: NCT06280690 id: NL83765.058.23 briefTitle: SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia acronym: SGM-T1 overallStatus: RECRUITING date: 2024-01-31 date: 2025-04-30 date: 2025-07-30 date: 2024-02-28 date: 2024-02-29 name: Leiden University Medical Center class: OTHER briefSummary: This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101. conditions: Colorectal Cancer conditions: Image conditions: Low Grade Dysplasia of Colon studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a single center prospective, non-randomized phase 2 proof of concept study, on the performance of SGM-101 to discriminate T1RC/HGD from LGD in patients that will be scheduled for endoscopic local en-bloc resection in the Leiden University Medical Centre (LUMC). primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: SGM-101 measure: The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic). measure: - Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective) measure: - In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope. measure: - The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo measure: -The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo measure: - The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3) measure: - The agreement of resection margins status (R0 vs R1) assessed by fluorescence and histopathology. A resection margin is classified positive when there is a fluorescent hotspot visible in the wound bed or on the specimen. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leiden University Medical Center status: RECRUITING city: Leiden zip: 2333ZA country: Netherlands name: Mats Warmerdam, Msc role: CONTACT phone: +31715298420 email: m.i.warmerdam@lumc.nl lat: 52.15833 lon: 4.49306 hasResults: False
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<|newrecord|> nctId: NCT06280677 id: 2023.Aurora-Donor briefTitle: Aurora Test for ART Donor Patients (AURORA-Donor) overallStatus: RECRUITING date: 2024-02-16 date: 2025-04 date: 2025-09 date: 2024-02-28 date: 2024-02-28 name: Fertiga, Belgium class: INDUSTRY name: Fertilab name: Ferring Pharmaceuticals briefSummary: This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger. conditions: Infertility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED name: AURORA-Donor measure: Basic clinical donor patient and stimulation characteristics: P4 measure: Basic clinical donor patient and stimulation characteristics: E2 measure: Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose measure: Clinical evaluation: number of Follicles measure: Clinical evaluation: number of cumulus-oocyte complex measure: Clinical evaluation: Meiosis II oocytes measure: Clinical evaluation: Abnormal fertilization measure: Clinical evaluation: Normal Fertilization measure: Clinical evaluation: Day 3 embryo evaluation measure: Clinical evaluation: Day 5/6 embryo evaluation measure: Clinical evaluation: Day5/6 good quality blastocyst rate measure: Clinical evaluation: Embryo utilization measure: Expression profile: blastocyst formation measure: Biochemical pregnancy measure: Clinical pregnancy with positive fetal heartbeat measure: Expression profile: pregnancy prediction measure: Normalized messenger ribonucleic acid (mRNA) expression measure: Ongoing pregnancy rate measure: Live birth measure: Cumulative pregnancy measure: Cumulative live birth measure: Miscarriage rate sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Fertilab status: RECRUITING city: Barcelona zip: 08017 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06280664 id: IRB20-1151 briefTitle: Efficacy Of Hiatal Closure For GERD overallStatus: RECRUITING date: 2020-10-02 date: 2024-10 date: 2024-10 date: 2024-02-28 date: 2024-02-28 name: University of Chicago class: OTHER briefSummary: The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD. conditions: Gastro Esophageal Reflux studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Concentration of pH testing sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The University of Chicago status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Carlisa Dixon role: CONTACT phone: 773-834-4337 email: cdixon520@bsd.uchicago.edu name: Leila Yazdanbakhsh role: CONTACT phone: 773-834-5087 email: leila.yazdanbakhsh@bsd.uchicago.edu lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06280651 id: RGP 2/348/44 id: RGP 2/348/44 type: OTHER_GRANT domain: kING kHALID UNIVERSITY briefTitle: Dietary Impacts on Oral Health in Autistic Children: A Cross-Sectional Analysis acronym: OHIDPAP-CS overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-04-30 date: 2024-05-15 date: 2024-02-28 date: 2024-03-15 name: King Khalid University class: OTHER briefSummary: The study aims to explore how dietary habits affect oral health in children with autism. By examining a cross-section of the autistic paediatric population, the research seeks to identify patterns or specific dietary preferences that may contribute to or mitigate oral health issues. This observational study does not intervene in participants' diets but observes existing habits and their oral health outcomes, aiming to provide insights that could guide better dietary recommendations and oral health practices for children with autism. conditions: Dental Caries in Children conditions: Autistic Disorder conditions: Dietary Habits studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: dietary preferences and their implications for oral health in children with Autism Spectrum Disorder measure: Assess the association between oral hygiene and periodontal disease severity to identify potential implications of dietary preferences for oral health status sex: ALL minimumAge: 2 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06280638 id: 2023-2095 briefTitle: CT-derived Virtual Stenting Optimize Coronary Revascularization (CT-COMPASS) acronym: CT-COMPASS overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2025-12 date: 2024-02-28 date: 2024-02-28 name: China National Center for Cardiovascular Diseases class: OTHER_GOV briefSummary: A considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina at 1 year or adverse events at 2 years. Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable "after the fact" given selected stents, site of deployment and procedural technique.
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Computed tomography (CT) coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure.
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However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of "Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90). conditions: Percutaneous Coronary Intervention conditions: Coronary Physiology conditions: Computed Tomography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 280 type: ESTIMATED name: Virtual stent-guided incremental optimization strategy (VIOS) name: Standard angiographic strategy measure: The proportion of patients with a final post-PCI FFR result ≥0.90 measure: The proportion of patients with final post-PCI FFR ≤0.80 measure: The rate of target vessel failure (TVF) and its component features at 6 months. measure: The rate of target vessel failure (TVF) and its component features at 1 year. measure: Change from baseline in self-reported Health-related quality of life evaluation at 6 months. measure: Change from baseline in self-reported Health-related quality of life evaluation at 1 year. measure: Change from baseline in self-reported Angina status evaluation at 6 months. measure: Change from baseline in self-reported Angina status evaluation at 1 year. measure: Procedure Duration measure: Fluoroscopy Dose measure: Contrast Material Dose sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College city: Beijing state: Beijing zip: 100037 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06280625 id: 24388 briefTitle: The Effect of the Inclusion of Soybean Flour on Glycemic Responses overallStatus: RECRUITING date: 2024-03-01 date: 2025-02-28 date: 2025-03-25 date: 2024-02-28 date: 2024-02-28 name: University of Illinois at Urbana-Champaign class: OTHER name: Kenneth Dallmier Consulting, LLC briefSummary: Foods that release glucose rapidly, leading to spikes in blood sugar and insulin (known as high glycemic index foods), generate lower satiety responses than foods with low glycemic index. High glycemic index foods are also linked to an increased risk of developing diabetes. The partial replacement of carbohydrates in rich staple foods with soy flour has the potential to reduce glycemic response and improve satiety.
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In many regions of Latin America, as well as in the Middle East and North Africa (MENA) regions, bread is the staple source of calories, but it is a relatively poor source of balanced nutrition. Bread enriched with soy flour could provide higher dietary protein while moderating blood glucose (and insulin) spikes, which can help reduce insulin resistance and metabolic diseases. The results of this study could provide government and private human nutritionists with the evidence they need to formulate soy flour into bread, corn tortillas, and arepas for schools and homes. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: People will be evaluated with a food product prepared with different % of replacement of wheat flour for soy flour. Each person will be their own control. In other words, in randomized order, they will all be assessed with the food product prepared with the regular wheat flour (either bread, tortillas or arepas) and on two other visits with different percentages of soy flour. primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants will be given the food product without information on whether it is prepared 100% with wheat flour or with different soy flour %. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Replacement of wheat flour by soyflour measure: Plasma glucose measure: Plasma insulin measure: Hunger-Satiety sex: ALL minimumAge: 21 Years maximumAge: 45 Years stdAges: ADULT facility: University of Illinois at Urbana Champaign status: RECRUITING city: Champaign state: Illinois zip: 61820 country: United States name: Marta Y Pepino, MSc, RD role: CONTACT phone: 217-300-2374 email: ypepino@illinois.edu name: Stephanie Okoye, Pharm D role: CONTACT phone: 2173004709 email: siokoye2@illinois.edu lat: 40.11642 lon: -88.24338 hasResults: False
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<|newrecord|> nctId: NCT06280612 id: RCS10042023 briefTitle: The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients overallStatus: COMPLETED date: 2023-06-01 date: 2023-07-15 date: 2023-09-01 date: 2024-02-28 date: 2024-03-01 name: Karadeniz Technical University class: OTHER briefSummary: It is known that animals are good for humans physiologically and psychologically. Therefore, in this study, the effects of live cat and robotic cat therapies on the symptoms and happiness levels of oncology patients after chemotherapy were examined. conditions: Therapy-Associated Cancer conditions: Cancer Patient conditions: Happiness conditions: Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The sample number of the research was calculated in the G\*Power 3.1.9.6 program. While α=0.05 was the error amount, 0.628 was the effect size, and 0.90 (90%) was the targeted test power, it was calculated as 36 patients for three groups (living cat group, robotic cat group, control group). Since there was no previous study on the subject, a study examining happiness levels in a different sample group was used as a reference. Considering situations such as wanting to leave the study or death during the research, each group was increased by 25%, and a total of 45 patients, 15 patients for each group, were included in the study. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Since the possibility of patients being affected by each other was minimal, the study was continued with only one of the live cat groups, the simulation cat group, and the control group. For example, only the live cat group and those who received chemotherapy treatment were studied before Monday afternoon. whoMasked: PARTICIPANT count: 45 type: ACTUAL name: Pet therapy measure: Edmonton Symptom Diagnostic Scale measure: Oxford Happiness Scale Short Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gümüşhane University city: Gümüşhane zip: 29600 country: Turkey lat: 40.46001 lon: 39.47176 hasResults: False
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<|newrecord|> nctId: NCT06280599 id: SON KMU briefTitle: Transitional Care Model for Patients With Stroke overallStatus: RECRUITING date: 2023-09-01 date: 2024-04-01 date: 2024-04-29 date: 2024-02-28 date: 2024-04-03 name: Kaohsiung Medical University class: OTHER briefSummary: Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients were divided into two groups: intervention (n=40) and contrast (n=40). Both groups received post-stroke usual care. The intervention group received an 8-week transitional care model for stroke patients, which included comprehensive discharge planning and home follow-up primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Transitional care model measure: Self-efficacy measure: Activities of daily living measure: Instrumental activities of daily living measure: Depression symptoms measure: Quality of life in stroke patients sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RSUD Prof. Dr. W Z Johannes Kupang status: RECRUITING city: Kupang zip: 308 country: Indonesia name: Sakti Oktaria Batubara role: CONTACT email: oktariabatubara@gmail.com role: CONTACT phoneExt: Saragih email: itadaryanti05@gmail.com name: Ita Daryanti Saragih, Doctoral role: SUB_INVESTIGATOR lat: -10.17083 lon: 123.60694 hasResults: False
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<|newrecord|> nctId: NCT06280586 id: 44/21 briefTitle: Effectiveness of Intervention in Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Community Elderly acronym: ESPAI-F overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-15 date: 2023-10-30 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Consorci Sanitari del Maresme class: OTHER briefSummary: Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Frail people have more difficulty in carrying out the usual activities of daily life and a greater risk of needing help to be able to do them.
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The aim of this study is to evaluate the safety and effectiveness of an intervention based on the control of chronic diseases, a good use of medicines, diet, physical exercise and good social support, in the prevention . of frailty in old people who are at risk of frailty.
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These criteria for participating in the study are why we invite you to participate. Your participation is voluntary. Your decision to participate or not in the study will not affect the medical care you may need. Before making a decision, read this information sheet carefully and ask the person who informs you the questions you want.
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In the study there will be two groups, one will receive the study intervention and the other will not receive any special treatment (we call it the control group). The assignment of each individual to one group or the other will take place once you have decided to participate. This assignment will be made at random so that neither you nor your doctor can know "a priori" which group you will be in. conditions: Muscle Strengh conditions: Frailty conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 232 type: ACTUAL name: Multidisciplinary intervention measure: Muscle Mass measure: Muscle strength and/or Muscle function measure: Sarcopenia measure: Frailty measure: Functional Capacity 1 measure: Functional Capacity 2 measure: Functional Capacity 3 measure: Functional Capacity 4 measure: Functional Capacity 5 measure: Functional Capacity 6 sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Consorci Sanitari del Maresme city: Mataró state: Barcelona zip: 08304 country: Spain lat: 41.54211 lon: 2.4445 facility: Mateu Serra-Prat city: Mataró state: Barcelona zip: 08304 country: Spain lat: 41.54211 lon: 2.4445 hasResults: False
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<|newrecord|> nctId: NCT06280573 id: MS1 briefTitle: COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS) acronym: COBRAMS overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-01 date: 2025-12-01 date: 2025-12-01 date: 2024-02-28 date: 2024-03-19 name: Comenius University class: OTHER briefSummary: The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis.
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Researchers will compare the effect to control groups of MS patients without intervention. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Wim Hoff method measure: concentration of pro-inflammatory cytokines measure: concentration of markers of oxidative stress measure: concentration of NfL measure: concentration of GFAP measure: concentration of ecDNA measure: Expanded Disability Status Scale measure: Timed 25-Foot Walk measure: Nine-Hole Peg Test measure: Symbol Digit Modalities Test measure: Fatigue Scale for Motor and Cognitive Functions measure: General Anxiety Disorder-7 measure: Patient Health Questionnaire-9 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Derer's University Hospital city: Bratislava zip: 83305 country: Slovakia lat: 48.14816 lon: 17.10674 hasResults: False
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<|newrecord|> nctId: NCT06280560 id: 2109-FIVI-087-FD id: PI23/00860 type: OTHER_GRANT domain: Instituto de Salud Carlos III, co-funded by European Union briefTitle: Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation acronym: HormoSenoRec overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-06-30 date: 2024-02-28 date: 2024-02-28 name: Fundación IVI class: OTHER name: Instituto Valenciano de Infertilidad, IVI VALENCIA briefSummary: Both controlled ovarian stimulation (COS) and frozen embryo transfer has become an integral part of in vitro fertilization (IVF) treatment. Fresh embryo transfer is usually performed by providing Luteal Phase Support (LPS) with progesterone after COS. Frozen embryo transfer (FET) is usually performed in artificial cycles with hormone replacement treatment (HRT), in which exogenous progesterone is administered, although it can also be performed in a Natural Cycle (without hormone supplementation) (NC). There is evidence that the supraphysiologic levels of estradiol and progesterone during COS+LPS and HRT could lead to morphologic and biochemical endometrial modifications, altering endometrial receptivity and lowering implantation and pregnancy rates.
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We hypothesize that the supraphysiologic hormone levels required for both COS+LPS, and HRT may be inducing alterations in endometrial composition and function, specifically the chronic accumulation of senescent cells; either due to an excessive hormonal induction, a lack of clearance due to a deficit of uNKs, or a combination of both, ultimately affecting both endometrial receptivity and decidualization, worsening IVF outcomes.
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The in vitro clearance of endometrial senescent cells by selective induction of apoptosis has been found to enhance the decidualization capacity of the rest of Endometrial Stromal Cells (EnSC), which could represent in a future adjuvant strategy to reduce the potentially deleterious effects of supraphysiologic hormone levels and improve reproductive outcomes in IVF patients.
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The results derived from this project would have a direct impact on clinical practice. First, the results would allow us to evaluate, based on experimental data, potential endometrial side effects of stimulation protocols commonly used in IVF treatments. In addition, in the case of finding a pathological accumulation of senescent cells affecting endometrial receptivity, we will be able to in vitro evaluate the effectiveness of adjuvant senolytic (drugs designed to specifically remove senescent cells) compounds to in vitro improve the expression of endometrial receptivity markers, as a first step to demonstrate the effectiveness of their use in improving the reproductive outcomes of IVF patients. conditions: Endometrial Receptivity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Controlled Ovarian Stimulation + Luteal Phase Support name: Hormonal Replacement Therapy programmed artificial cycle name: Natural Cycle (NC) name: Endometrial receptivity reference group measure: Endometrial receptivity measure: Senescent Cell Pathological Accumulation sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: IVI-RMA Valencia Clinic status: RECRUITING city: Valencia zip: 46015 country: Spain name: Laura Caracena, PhD role: CONTACT phone: 651791000 email: Laura.Caracena@ivirma.com lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06280547 id: CUP 13-2 id: Cairo university type: OTHER domain: Cairo University briefTitle: The Effect of Oral Health Education on Knowledge, Attitude, Practice and Dental Caries Among Egyptian School Children acronym: KAP overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2024-03-02 date: 2024-04-02 date: 2024-02-28 date: 2024-02-28 name: Cairo University class: OTHER briefSummary: Aim of the study Assessing the effect of an oral health education program on knowledge, attitude, practice, and dental caries among a group of school children in a governmental school in Fayoum, Egypt. conditions: Dental Caries in Children conditions: Knowledge, Attitudes, Practice studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 115 type: ESTIMATED name: Oral health education measure: Oral health related attitude measure: Change in oral health related Knowledge, attitude and practice measure: Caries experience sex: ALL minimumAge: 6 Years maximumAge: 15 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06280534 id: XT1061-2022-01 briefTitle: Safety, Tolerability Phase Ia Study of XT1061 in Single and Multiple Doses in Healthy Subjects acronym: XT1061 overallStatus: RECRUITING date: 2023-07-18 date: 2024-02-29 date: 2024-03-31 date: 2024-02-28 date: 2024-02-28 name: Xi'an Xintong Pharmaceutical Research Co.,Ltd. class: OTHER briefSummary: A Randomized, Double-Blind, Single-Center Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects. conditions: Chronic Hepatitis b studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: Test drug XT1061 capsules and placebo,Single dose group name: Test drug XT1061 capsules and placebo，Multiple dosing group name: Test drug XT1061 capsules and placebo，Food Impact Group measure: Treatment-related adverse events measure: Cmax measure: Tmax measure: t1/2 measure: AUC measure: CL/F measure: Vz/F measure: CLr/F measure: Ae0-72 h measure: Fe0-72 h measure: bioavailability sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Hospital of Jilin University status: RECRUITING city: Jilin state: Changchun country: China name: Ding Yanhua, master role: CONTACT phone: 18743062721 email: 1023307193@qq.com lat: 43.85083 lon: 126.56028 hasResults: False
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<|newrecord|> nctId: NCT06280521 id: 38RC23.0331 briefTitle: Validation of the Girls Questionnaire for Autism Spectrum Condition in French Langage acronym: fGQ-ASC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-05 date: 2024-02-28 date: 2024-02-28 name: University Hospital, Grenoble class: OTHER briefSummary: Autism spectrum disorders (ASD) are currently diagnosed at a rate of approximately 3 males per 1 female, while evidence suggests the rate may be 1.8 males per 1.2 females. It has been shown that affected women receive an autism diagnosis on average 5 years later than men. This delay is associated with deleterious consequences on the educational, psychological and physical health levels in these women. Currently, there are a number of obstacles that delay or prevent women with ASD from accessing diagnosis and specialized support. These include, in particular, gendered assumptions about how ASD manifests depending on the gender of the person concerned, a tendency for clinicians to attribute female autistic traits to causes other than ASD, measures of standardized ASD assessments that may not be sensitive enough to identify ASD females, and finally a demonstrated greater tendency among ASD females to camouflage or mask autistic traits in order to blend in in social situations. It is in this context that the Girl Questionnaire for Autism Spectrum Conditions (GQ-ASC) was developped and validated to address these fundamental gaps in the early identification and measurement of female ASD symptoms.
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The GQ-ASC is presented as a self-questionnaire with 29 items which assess clinical characteristics specific to the adult female presentation of ASD in the dimensions (five) of imagination and play, camouflage, sensoriality, social situations and interests. To date, several studies have relevantly used the GQ-ASC in populations of adult ASD women, but none in French.
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The main objective of this online study is therefore to measure the predictive validity of the French version of the Girl Questionnaire for Autism Spectrum Conditions (fGQ-ASC) for the diagnosis of ASD in adult women over 18 years of age and speaking French kindergarten. Subjects included in this online study will complete the protocol using any computer, tablet, or cell phone. We will include 400 participants (100 females-ASD, 100 females-nonASD, 100 males-ASD, 100 males-nonASD). This study will validate for the first time a screening tool for the diagnosis of ASD in women of French mother tongue over 18 years of age (the Girls Questionnaire for Autism Spectrum Condition French version - fGQ-ASC). This tool will have particularly significant benefits since it will help reduce the diagnostic delay among adult women with ASD in France and accelerate their access to specialized support. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 400 type: ESTIMATED name: fGQ-ASC measure: VP fGQ-ASC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06280508 id: SYSKY-2024-082-01 briefTitle: Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2027-03-31 date: 2028-03-31 date: 2024-02-28 date: 2024-04-23 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer. conditions: Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Adebrelimab, Apatinib, Gemcitabine, cisplatin measure: 1-year EFS rate measure: R0 Resection rate measure: EFS measure: RFS measure: OS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University status: RECRUITING city: Guangzhou state: China/Guangdong country: China name: Yajin Chen role: CONTACT phone: 13719006202 email: cyj0509@126.com name: Changzhen Shang role: CONTACT phone: 13711279678 email: shangchangzhen@139.com lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06280495 id: INTENSIFY-CRC briefTitle: Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-31 date: 2028-12-31 date: 2024-02-28 date: 2024-03-04 name: Sun Yat-sen University class: OTHER briefSummary: The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone. conditions: Colorectal Cancer conditions: Liver Metastases studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized, multicenter clinical trial. Stratified randomization based on liver metastasis characteristics, including timing, number, and size, will be conducted in eligible patients. primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: Oxaliplatin name: Fluorouracil name: Serplulimab name: Bevacizumab measure: 3-year Progression-Free Survival Rate measure: Median Overall Survival measure: Major Pathological Response (MPR) measure: Pathologic complete response (pCR) measure: Pathological Partial Response measure: Disease Free Survival measure: Treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Yu-hong Li, MD, Ph D role: CONTACT email: liyh@sysucc.org.cn name: Yu-hong Li, MD, Ph D role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06280482 id: HSC-MS-23-0332 briefTitle: Nicotinamide Riboside (NR) to Treat Moyamoya-like Cerebrovascular Disease in Smooth Muscle Dysfunction Syndrome (SMDS) overallStatus: RECRUITING date: 2024-03-06 date: 2025-07-25 date: 2025-07-25 date: 2024-02-28 date: 2024-04-05 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: The purpose of this study is to determine whether SMDS patients treated with NR at the proposed dose exhibit decreased glucose uptake in the aorta, to determine if NR treatment results in measurable changes of blood NAD+ and NR levels, to determine if aortic measurements are stable after treatment with NR and to evaluate the safety and tolerability of NR in SMDS patients. conditions: Smooth Muscle Dysfunction Syndrome (SMDS) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Nicotinamide riboside (NR) measure: Change in Fluoro-18-Deoxyglucose (18F-FDG ) uptake in aortic wall as measured by positron emission tomography (PET)/computerized tomography (CT) imaging measure: Change in Levels of Nicotinamide adenine dinucleotide (NAD+) in whole blood as measured by high-performance liquid chromatography (HPLC) measure: Change in Levels of NR in whole blood as measured by high-performance liquid chromatography (HPLC) measure: Change in aortic measurements as assessed by echocardiography measure: Safety as assessed by number of participants that show drug toxicity as shown in bloodwork measure: Safety as assessed by number of participants that show drug toxicity as shown in bloodwork measure: Tolerability as assessed by the number of patients who complete study sex: ALL minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: The University of Texas Health Science Center at Houston status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: David Murdock, MD role: CONTACT phone: 713-500-6735 email: David.R.Murdock@uth.tmc.edu name: Dianna Milewicz, MD, PhD role: CONTACT phone: (713) 500-6725 email: Dianna.M.Milewicz@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06280469 id: KY20232298-C-1 briefTitle: Single-operator Versus Double-operator in Single-Balloon Enteroscopy acronym: SBE overallStatus: RECRUITING date: 2024-01-01 date: 2025-12 date: 2025-12 date: 2024-02-28 date: 2024-02-28 name: Shuhui Liang class: OTHER briefSummary: Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy. conditions: Single-balloon Enteroscopy conditions: Operation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Single-Balloon Enteroscopy measure: Maximum insertion depth measure: Total enteroscopy rate measure: Positive findings measure: Advent events measure: procedural time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital of Digestive Diseases status: RECRUITING city: Xi'an country: China name: Shuhui Liang role: CONTACT phone: +862084771536 email: liangsh@fmmu.edu.cn lat: 34.25833 lon: 108.92861 hasResults: False
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<|newrecord|> nctId: NCT06280456 id: 2023-09-017A briefTitle: Tranexamic Acid Injection With Different Drainage Clamping Time After Anterior Cruciate Ligament Reconstruction overallStatus: COMPLETED date: 2022-09-05 date: 2023-01-05 date: 2023-02-05 date: 2024-02-28 date: 2024-02-28 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: Post-anterior cruciate ligament reconstruction (ACLR) hemarthrosis may result in increased pain thus delaying postoperative rehabilitation, which may eventually lead to arthrofibrosis and a functional deficit. Many antifibrinolytic agents, including tranexamic acid (TXA), have been used in orthopedic surgeries to reduce postoperative bleeding. Moreover, TXA was proved effective to reduced the events of hemarthrosis and increased the post-operative functional outcomes of the patients in several studies. The purpose of this study is to evaluate the efficacy of intra-articular injection of TXA with different drainage clamping time in patients receiving arthroscopic ACLRs. Patients were randomized into four groups. An intra-articular suction drain was placed recorded 24 h postoperatively. Group 1 patients(TXA 4hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 4 hours. Group 2 patients(TXA 8hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 8 hours. Clinical evaluations using an IKDC functional score and a Visual Analogue Scale (VAS) pain score were performed during admission, at postoperative day 3 and week 4. conditions: Anterior Cruciate Ligament Reconstruction conditions: Tranexamic Acid conditions: Hemarthrosis, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 150 type: ACTUAL name: Tranexamic Acid Powder measure: The volume of drainage measure: Visual analog scale (VAS) measure: International Knee Documentation Committee (IKDC) functional score sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital city: Taipei country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06280443 id: CE22407B briefTitle: Sarcopenia in Chronic Lung Diseases overallStatus: RECRUITING date: 2022-11-25 date: 2024-10-13 date: 2032-09-30 date: 2024-02-28 date: 2024-04-04 name: Taichung Veterans General Hospital class: OTHER briefSummary: Inclusion criteria A)Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment.
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B) Patients who agree to provide the ID card number to the research team for usage as a link to the National Health Insurance research database and Health bank to explore the continuity of care and the use of medical resources conditions: Sarcopenia conditions: COPD conditions: Asthma conditions: ILD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: sarcopenia rate sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Veterans General Hospital status: RECRUITING city: Taichung zip: 40705 country: Taiwan name: Pin-Kuei Fu, MD, PhD role: CONTACT phone: 886-4-23592525 phoneExt: 3213 email: yetquen@gmail.com lat: 24.1469 lon: 120.6839 hasResults: False
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<|newrecord|> nctId: NCT06280430 id: Vascular affection in behcet briefTitle: Vascular Affection in Behcet Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: To measure the level of serum elafin in patients with behcet disease and to assess the correlation between serum elafin and vascular affection and their relation with disease activity conditions: Behcet Disease and Vascular Involvement studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 90 type: ESTIMATED measure: To measure the level of serum elafin in behcet patients and compare it with control group sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06280417 id: Unreamed IMN In IIIa tibia briefTitle: Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-08-01 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: To study the incidence of non union of Unreamed intramedullary nailing in type IIIa Open diaphyseal fractures of the tibia as a primary outcome and the incidence of complications and clinical and functional outcome as a secondary outcome . conditions: Tibia Fracture studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Unreamed intramedullary tibial nail measure: Incidence of non union measure: Incidince of fracture related infection measure: The rate of reoperation for delayed union or non-union , infection and fasciotomy measure: functional evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06280404 id: Body first in lap chole briefTitle: Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-08-08 date: 2024-02-28 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: The aim of this study is to evaluate the body first approach on the rate of conversion to open technique \& VBI in patients with obscure calot's triangle. conditions: Cholecystitis, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Lap cholecystectomy measure: Safe laparoscopic cholecystectomy. measure: Evaluation of the body first approach technique sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06280391 id: ACT18018 id: U1111-1295-3237 type: REGISTRY domain: ICTRP id: 2023-508663-70 type: REGISTRY domain: CTIS briefTitle: A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis overallStatus: RECRUITING date: 2024-02-20 date: 2026-03-24 date: 2026-08-11 date: 2024-02-28 date: 2024-04-12 name: Sanofi class: INDUSTRY name: Regeneron Pharmaceuticals briefSummary: ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive).
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Study details include:
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* The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks.
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* The treatment duration will be up to 24-52 weeks.
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* The follow-up duration will be 20 weeks.
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* Site/phone visits are at a monthly interval. conditions: Bronchiectasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Itepekimab (SAR440340) name: Placebo measure: Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period measure: Time to first moderate or severe PE over the treatment period measure: Percentage of participants who are PE free over the treatment period measure: Annualized rate of severe PEs over the treatment period measure: Percentage of participants who are severe PE free over the treatment period measure: Time to first severe PE over the treatment period measure: Change From Baseline in FEV1 at Week 8 and Week 24 measure: Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use measure: Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24 measure: Change from baseline in SGRQ total score at Week 24 measure: Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24 measure: Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period measure: Serum concentrations of itepekimab from baseline to end of study measure: Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Allianz Research Institute Site Number : 8400013 status: RECRUITING city: Westminster state: California zip: 92683 country: United States lat: 33.75918 lon: -118.00673 facility: Southeastern Research Center Site Number : 8400008 status: RECRUITING city: Winston-Salem state: North Carolina zip: 27103 country: United States lat: 36.09986 lon: -80.24422 facility: Investigational Site Number : 8260008 status: RECRUITING city: Norwich state: Norfolk zip: NR4 7UY country: United Kingdom lat: 52.62783 lon: 1.29834 facility: Investigational Site Number : 8260003 status: RECRUITING city: Tyne And Wear state: North Tyneside zip: NE29 8NH country: United Kingdom facility: Investigational Site Number : 8260001 status: RECRUITING city: Newcastle upon Tyne zip: NE7 7DN country: United Kingdom lat: 54.97328 lon: -1.61396 facility: Investigational Site Number : 8260005 status: RECRUITING city: Reading zip: RG1 5AN country: United Kingdom lat: 51.45625 lon: -0.97113 hasResults: False
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<|newrecord|> nctId: NCT06280378 id: CP-KL003-003/01 briefTitle: A Phase I/II Clinical Study of the KL003 Cell Injection in β-Thalassemia Major Participants overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-05 date: 2027-05 date: 2024-02-28 date: 2024-02-28 name: Kanglin Biotechnology (Hangzhou) Co., Ltd. class: INDUSTRY briefSummary: This is a non-randomized, open label, single-dose study in up to 41 participants with β-thalassemia major. The goal of this clinical trial is to evaluate the safety and efficacy of KL003 cell injection in subjects with β-thalassemia major. conditions: Transfusion-dependent Beta-Thalassemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 41 type: ESTIMATED name: KL003 Cell Injection Drug Product measure: KL003 engraftment measure: Engraftment time of neutrophil and platelet measure: Overall Survival measure: The number, frequency and severity of adverse events (AE) within 1 year after infusion of KL003 drug products measure: Clonal dominance or secondary tumors caused by lentiviral vector insertional-mutation measure: Numbers of Participants With Vector-Derived Replication-Competent Lentivirus (RCL) measure: The proportion of participants achieved Transfusion Independence (TI)for at least 6 months measure: The proportion of participants achieved TI 12 measure: The start time of Transfusion Independence (TI) after KL003 infusion measure: Total Hb and the vector-derived HbA^T87Q sex: ALL minimumAge: 3 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai country: China name: Wei Tang, PhD role: CONTACT phone: +86 13472889588 name: Saijuan Chen, PhD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Institute of Hematology & Blood Diseases Hospital city: Tianjin state: Tianjin country: China name: Zhen Gao, Master role: CONTACT phone: +86 15522360862 email: Gaozhen@ihcams.ac.cn name: Jun Shi, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False
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<|newrecord|> nctId: NCT06280365 id: 012 briefTitle: MWM Technique in Patients With Knee OA overallStatus: COMPLETED date: 2024-02-19 date: 2024-03-15 date: 2024-03-15 date: 2024-02-28 date: 2024-04-03 name: Okan University class: OTHER briefSummary: The aim of this study is to investigate the effect of the MWM technique on pain, normal joint movement, proprioception and quality of life in patients with knee osteoarthritis (OA). conditions: Mobilization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Mulligan Mobilization with Movement Technique measure: Visual Analog Scale (VAS) measure: Short form-36 (SF-36) measure: Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) measure: Evaluation of proprioception measure: The range of motion sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emine Atıcı city: Tuzla state: İstanbul country: Turkey hasResults: False
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<|newrecord|> nctId: NCT06280352 id: AUVA_Knieathlon_2024 briefTitle: Robotic Assisted vs Custom Made Total Knee Arthroplasty acronym: Knieathlon overallStatus: RECRUITING date: 2024-03-01 date: 2024-12 date: 2026-12 date: 2024-02-28 date: 2024-03-12 name: Austrian Workers Compensation Board Styria class: OTHER briefSummary: The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:
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* Which implant/philosophy yields better clinical outcomes?
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* Which implant/philosophy yields better satisfaction?
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* Which system is more OR efficient? Participants will be followed for 2 years postoperatively. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Custom made Total Knee Arthroplasty name: Functionally aligned robotically assisted total knee arthroplasty measure: Clinical Outcome using the Forgotten Joint Score measure: Clinical outcomes using the Kujala anterior knee pain Score measure: Patient satisfaction measure: Visual analog pain (VAS) scale measure: Surgical and total theatre time measure: Opioid use measure: Number of physiotherapy sessions measure: Range of motion measurements (in degrees) measure: Radiographic data including radiolucent lines measure: Revision rate sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AUVA UKH Steiermark Standort Graz status: RECRUITING city: Graz state: Styria zip: 8020 country: Austria name: Antonio Klasan, MD, PHD, EMBA role: CONTACT lat: 47.06667 lon: 15.45 facility: AUVA UKH Steiermark Standort Kalwang status: RECRUITING city: Kalwang state: Styria zip: 8775 country: Austria name: Antonio Klasan, MD, PhD, EMBA role: CONTACT lat: 47.42172 lon: 14.75221 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-27 uploadDate: 2024-02-05T09:59 filename: Prot_SAP_000.pdf size: 156436 hasResults: False
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<|newrecord|> nctId: NCT06280339 id: IRB23-0190 briefTitle: Food Cravings Strategies During Dietary Weight Loss overallStatus: RECRUITING date: 2024-01-29 date: 2024-06-01 date: 2024-08-01 date: 2024-02-28 date: 2024-02-28 name: University of Illinois at Urbana-Champaign class: OTHER briefSummary: The purpose is to optimize the EMPOWER program by integrating strategies to reduce food cravings, a critical yet often overlooked factor for long-term success in weight management.
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The objective of this study is to determine the efficacy of craving coping strategies on weight loss outcomes by conducting a randomized controlled trial. Participants will be randomized to receive one of the two strategies to manage food cravings. conditions: Obesity conditions: Food Cravings conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be enrolled in dietary weight loss program. Before the first meeting they will be randomized to one of the two study groups that focus on teaching participants different strategies to cope with food cravings (Inclusion vs. Avoidance).. To ensure balanced representation and meaningful study results, the randomization process will consider specific characteristics, including BMI category, sex, and age. This stratified randomization method helps us compare the effects of the intervention between different groups of participants. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Test two food cravings strategies during dietary weight loss name: Dietary weight loss program +Food cravings strategies measure: Body weight measure: Food Craving Strategies Compliance measure: Food Cravings measure: Food Cravings measure: Dietary intake sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bevier HAll UIUC status: RECRUITING city: Urbana state: Illinois zip: 61801 country: United States name: Nouf Alfouzan role: CONTACT phone: 217-898-5480 email: noufa2@illinois.edu lat: 40.11059 lon: -88.20727 facility: Bevier HAll UIUC status: RECRUITING city: Urbana state: Illinois zip: 61801 country: United States name: Nouf Alfouzan role: CONTACT phone: 217-898-5480 email: noufa2@illinois.edu name: Manabu Nakamura role: PRINCIPAL_INVESTIGATOR lat: 40.11059 lon: -88.20727 hasResults: False
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<|newrecord|> nctId: NCT06280326 id: Orogastric Tube Removal briefTitle: Effect of Different Materials Used in Orogastric Tube Removal on Skin Condition in Premature Babies overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-05 date: 2024-06-05 date: 2024-08-05 date: 2024-02-28 date: 2024-02-28 name: Ondokuz Mayıs University class: OTHER briefSummary: While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage. conditions: Neonatal Skin Conditions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled experimental trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 86 type: ACTUAL name: Sunflower oil name: Slicone based spray measure: Neonatal Skin Condition Score sex: ALL minimumAge: 32 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: Hatice Uzşen city: Samsun state: Atakum zip: 55100 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False
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<|newrecord|> nctId: NCT06280313 id: uHCC-STI-TJ01 briefTitle: Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension overallStatus: RECRUITING date: 2024-03-15 date: 2027-03-15 date: 2028-03-15 date: 2024-02-28 date: 2024-04-10 name: Zhiyong Huang class: OTHER name: Wuhan Union Hospital, China name: Wuhan University name: Renmin Hospital of Wuhan University name: Taihe Hospital name: Hubei Cancer Hospital name: Xiangyang Central Hospital name: Wuhan Central Hospital name: Yichang Third Renmin Hospital briefSummary: Currently, the combination of targeted therapy and immunotherapy is the first-line treatment for advanced hepatocellular carcinoma (HCC). However, a subset of HCC patients with severe splenomegaly, splenic hyperfunction, and esophagogastric varices due to liver cirrhosis and portal hypertension may be unable to undergo or sustain the combination therapy, ultimately missing the optimal treatment window. Prior studies have indicated that splenectomy can significantly improve liver function and hepatic reserve in cirrhotic patients. It also addresses splenic hyperfunction and reduces the risk of bleeding from esophagogastric varices by combining splenectomy with devascularization around the cardia. Additionally, splenectomy contributes to the improvement of liver fibrosis and restoration of immune function in cirrhotic patients. This study aims to elucidate the impact of splenectomy on the efficacy of combination targeted and immunotherapy in unresectable HCC patients with cirrhotic portal hypertension, particularly those with poor liver function, significant splenic hyperfunction, and severe esophagogastric varices. The research also seeks to explore whether changes in the tumor immune microenvironment before and after splenectomy can influence the effectiveness of immunotherapy. Ultimately, the goal is to provide therapeutic opportunities for this specific patient population. conditions: Unresectable Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Splenectomy+Targeted therapy+ Immunotherapy measure: Objective Response Rate (ORR) measure: Overall Survival (OS) measure: Progression Free Survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Zhiyong Huang role: CONTACT phone: 86-13995507729 email: Zyhuang126@126.com name: Erlei Zhang role: CONTACT email: baiyu19861104@163.com lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06280300 id: UVMMC2203 briefTitle: Multi-disciplinary Care for Brain Metastases overallStatus: RECRUITING date: 2023-11-16 date: 2024-11-01 date: 2025-11-01 date: 2024-02-28 date: 2024-02-28 name: University of Vermont Medical Center class: OTHER briefSummary: This is a health services intervention study aimed at understanding the impact of intensive multi-disciplinary care compared with standard care on patient-reported symptom outcomes and prognostic awareness in patients with brain metastases. conditions: Brain Metastases, Adult studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: cohort study primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 40 type: ESTIMATED name: health services intervention measure: Patient reported outcomes measure: Feasibility measure: Patient understanding of prognosis measure: survival measure: Exploratory survival outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vermont Medical Center status: RECRUITING city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 hasResults: False
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<|newrecord|> nctId: NCT06280287 id: FAPI-PLAQUE briefTitle: PET Imaging of Fibroblast Activation in Atherosclerosis overallStatus: RECRUITING date: 2021-08-01 date: 2024-12-31 date: 2025-12-31 date: 2024-02-28 date: 2024-02-28 name: Peking Union Medical College Hospital class: OTHER briefSummary: Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. This study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome. conditions: Atherosclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: FAPI PET measure: SUVmax of atherosclerotic plaque in carotid or coronary arteries measure: TBR of atherosclerotic plaque in carotid or coronary arteries sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Li Huo role: CONTACT phone: 86-13910801986 email: huoli@pumch.cn lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06280274 id: STUDY00025798 briefTitle: Metformin Use in Patients Undergoing Total Joint Replacement Surgery overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2025-05-30 date: 2025-05-30 date: 2024-02-28 date: 2024-03-01 name: Oregon Health and Science University class: OTHER briefSummary: The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.
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