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<|newrecord|> nctId: NCT06359171 id: RBHP 2023 LANHERS briefTitle: Effectiveness of the ARTH-e Application on Adherence to Physical Exercises in Patients Suffering From KOA: RCT acronym: ARTH-e3 overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2025-06-01 date: 2026-01-31 date: 2024-04-11 date: 2024-04-11 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: The aim of this study is to investigate the effectiveness of a smartphone-based e-health application (intervention group) compared with standard care (control group) in terms of changes in adherence in patients with knee osteoarthritis using the EARS questionnaire. In addition, other questionnaires presented in the appendix (KOOS, TSK, EPAP, EQ-5D-3L, pain) will be given to all patients in order to meet the secondary evaluation criteria. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The investigators plan to conduct a multicenter, prospective, comparative, randomised trial. Participants will be randomized to one of two groups: control or experimental. In each group (control or experimental), each participant will be able to use the application for a period of 6 months.
* Control group: physician's advice with examples of self-exercise (knee osteoarthritis booklet) + prescription for 12 physiotherapy sessions + delivery of a GARMIN connected bracelet.
* Intervention group: download the application + adapted physical activity session with an APA/physiotherapist + delivery of the knee osteoarthritis booklet + prescription for 12 physiotherapy sessions + delivery of a GARMIN connected bracelet. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The investigating physician who will carry out the inclusion visit will know the result of the randomization which will be carried out during the consultation. The second evaluator, who will carry out the end-of-study visit, will not know the patient's group. As a result, the assessment will be neutral and the second assessor will evaluate the patient without being influenced by the study group. whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Application ARTH-e measure: Exercise Adherence Rating Scale measure: Pain Visual Analog Scale measure: EPAP questionnaire measure: TSK questionnaire measure: Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire measure: EQ-5D-3L questionnaire measure: Mobility measure: Average number of steps per day measure: Parameters for use of the ARTHE application measure: Functional tests - 30 sec chair lifts measure: Functional tests - Stair Climbing Test measure: Functional tests - 6MWT measure: Functional tests - quadriceps isometric strength test with dynamometer measure: Medico-economic analysis sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Clermont-Ferrand city: Clermont-Ferrand country: France name: Lise Laclautre role: CONTACT phone: 04 73 75 11 95 email: [email protected] name: Charlotte Lanhers, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: CH Emile Roux city: Le Puy-en-Velay country: France name: Gaëlle VIAL role: PRINCIPAL_INVESTIGATOR lat: 45.04366 lon: 3.88523 facility: CHU Montpellier city: Montpellier country: France name: Isabelle TAVARES FIGUEIREDO, Dr role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: CHU Nantes city: Nantes country: France name: Alban FOUASSON CHAILLOUX, Dr role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 hasResults: False
<|newrecord|> nctId: NCT06359158 id: eStethoscope for Med Student briefTitle: Enhancing Respiratory Auscultation Skills Among Medical Students: Digital Stethoscopes in Medical Education overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-31 date: 2024-01-31 date: 2024-04-11 date: 2024-04-11 name: Chung Shan Medical University class: OTHER name: Ministry of Education, Taiwan briefSummary: Objectives: This study aims to assess the effectiveness of a novel digital stethoscope curriculum integrated into respiratory auscultation training for medical students. It seeks to compare the auscultation proficiency gained through this innovative approach with that from traditional teaching methods, to understand the potential of digital stethoscopes in reinvigorating clinical skills training.
Methods: In a single-center, controlled, longitudinal, randomized experimental design, 84 medical students undergoing clinical clerkship rotations at Chung Shan Medical University Hospital were enrolled. Participants were randomly assigned to either the intervention group, receiving training with digital stethoscopes and the Eko auscultation software, or the control group, following a traditional curriculum. Pre- and post-intervention assessments measured auscultation skills, and student feedback on teaching quality was collected. The primary outcome was the improvement in auscultation proficiency, while secondary outcomes included student engagement and feedback on the educational approach.
Expected Results: The investigators hypothesize that the integration of digital stethoscopes into the curriculum will significantly improve the auscultation skills of medical students compared to traditional methods. Enhanced engagement and positive feedback from students are anticipated, underscoring the pedagogical value of incorporating digital health technologies in medical education. conditions: Auscultation conditions: Breathing Sound conditions: Asthma conditions: Pneumonia conditions: Pleural Effusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 84 type: ACTUAL name: Digital stethoscope use measure: Pre-test and Post-test using the Zuvio Interactive Response System (Zuvio, Taipei, Taiwan) measure: Student Feedback sex: ALL minimumAge: 21 Years maximumAge: 30 Years stdAges: ADULT facility: Chung Shan Medical University Hospital city: Taichung state: South zip: 402 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False
<|newrecord|> nctId: NCT06359145 id: EIT and COPD briefTitle: Prediction of COPD Severity Using Electrical Impedance Tomography overallStatus: RECRUITING date: 2023-04-01 date: 2024-06-01 date: 2024-08-01 date: 2024-04-11 date: 2024-04-11 name: Chinese PLA General Hospital class: OTHER briefSummary: The purpose of this study is to predict the CT visual score of emphysema with EIT-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of COPD. conditions: Electric Impedance conditions: Respiratory Function Tests conditions: Pulmonary Disease, Chronic Obstructive studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 150 type: ESTIMATED measure: The predictive power of EIT and PFT for CT visual scoring of emphysema sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PLA status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Zhimei Duan role: CONTACT phone: 13716376758 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06359132 id: TeleConvert-AF briefTitle: mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients. acronym: TeleConvert-AF overallStatus: RECRUITING date: 2022-01-01 date: 2025-01-01 date: 2025-01-01 date: 2024-04-11 date: 2024-04-11 name: Maastricht University Medical Center class: OTHER briefSummary: Despite a clear definition in the European Society of Cardiology (ESC) guidelines, the differentiation between paroxysmal (self-terminating) and persistent (nonself- terminating) atrial fibrillation (AF) remains challenging in clinical practice. Some patients with presumed persistent AF are planned for electrical cardioversion (ECV) but appear to have a paroxysmal pattern or present in sinus rhythm (SR) at the scheduled ECV appointment. This results in unnecessary visits or interventions for patients, and costs and burden for the hospitals and health insurances. Based on the feasibility of the TeleCheck-AF approach, which is an on-demand mobile health (mHealth) infrastructure incorporating app-based heart rate and rhythm monitoring to support remote AF management through teleconsultation, the investigators aim to extend this mHealth approach to the management of presumed persistent AF patients planned for ECV. conditions: Atrial Fibrillation conditions: Arrhythmia conditions: Mobile Health conditions: Electrical Cardioversion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 264 type: ESTIMATED measure: The number of cancelled unnecessary scheduled ECV appointments in patients with presumed persistent AF scheduled for ECV unnecessary scheduled ECV appointments measure: Number of patients that agreed the refined TeleCheck-AF approach is usable and userfriendly as assessed by the System Usability Scale questionnaire extended with additional questions measure: Number of patients that agreed the refined TeleCheck-AF approach is anxious as assessed by the HADS-A scale questionnaire measure: Amount of saved costs for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments measure: Number of patients with paroxysmal AF measure: Time to recurrence of AF measure: Time period of monitoring heart rate and rhythm using the mHealth-based application measure: Amount of burden for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Center status: RECRUITING city: Maastricht state: Limburg country: Netherlands name: Dominik Linz role: CONTACT phone: 043-3877098 email: [email protected] name: Astrid Hermans role: CONTACT phone: 043-3871613 email: [email protected] lat: 50.84833 lon: 5.68889 facility: Viecuri Medical Center status: RECRUITING city: Venlo state: Limburg country: Netherlands name: Wilfred Heesen role: CONTACT phone: (077) 320 56 04 email: [email protected] lat: 51.37 lon: 6.16806 hasResults: False
<|newrecord|> nctId: NCT06359119 id: IMAPing SUBDEP briefTitle: Implementation of Apnoea Test for Patients With Suspected Brain Death overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-31 date: 2024-07-31 date: 2024-04-11 date: 2024-04-11 name: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged class: OTHER_GOV name: Veszprém County Ferenc Csolnoky Hospital briefSummary: This study consists of a survey created for intensive care physicians regarding their current practice of the implementation of apnoea test for patients with suspected brain death. conditions: Brain Death studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: Number of apnoea tests measure: Timeframe between apnoea tests measure: Preoxygenation measure: Baseline arterial carbon dioxide (CO2) level measure: Detection of possible spontaneous breath movements measure: Satisfaction with current practice measure: Continuous positive airway pressure (CPAP) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06359106 id: 2024.3.1 briefTitle: Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia overallStatus: RECRUITING date: 2024-05-10 date: 2025-12-31 date: 2025-12-31 date: 2024-04-11 date: 2024-04-25 name: China Medical University, China class: OTHER briefSummary: This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. conditions: Oxygenation Index studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1098 type: ESTIMATED name: 80% Oxygen name: 40% Oxygen measure: Oxygenation Index measure: pH value in blood gas analysis 48 hours after the operation measure: oxygen inhalation time measure: inspired oxygen concentration measure: oxygen uptake rate measure: 7 days pulmonary complications measure: 30-day Mortality measure: PaCO2 in blood gas analysis 48 hours after the operation measure: Lactic acid in blood gas analysis 48 hours after the operation sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Fourth Affiliated Hospital of China Medical University status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110001 country: China name: Ayong Tian role: CONTACT lat: 41.79222 lon: 123.43278 facility: the First Hospital of China Medical University status: RECRUITING city: Shenyang state: Liaoning zip: 110001 country: China name: Wenfei Tan, M.D.,Ph.D role: CONTACT phone: 024-83283100 email: [email protected] lat: 41.79222 lon: 123.43278 facility: Beijing Friendship Hospital, Capital Medical University status: NOT_YET_RECRUITING city: Beijing country: China name: Yun Wang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Sichuan Provincial People's Hospital status: NOT_YET_RECRUITING city: Chendu country: China name: Qian Shi role: CONTACT facility: Chifeng Municipal Hospital status: NOT_YET_RECRUITING city: Chifeng country: China name: Jiannan Song role: CONTACT lat: 42.26833 lon: 118.96361 facility: First Affiliated Hospital of Chongqing Medical University status: NOT_YET_RECRUITING city: Chongqi country: China name: Ke Wei role: CONTACT lat: 27.00943 lon: 117.18179 facility: Dalian Third People's Hospital status: NOT_YET_RECRUITING city: Dalian country: China name: Shiling Zhao role: CONTACT lat: 38.91222 lon: 121.60222 facility: First Affiliated Hospital, Dalian Medical University status: NOT_YET_RECRUITING city: Dalian country: China name: Yong Luan role: CONTACT lat: 38.91222 lon: 121.60222 facility: First Affiliated Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin country: China name: Kun Wang role: CONTACT lat: 45.75 lon: 126.65 facility: Harbin Medical University Cancer Hospital status: NOT_YET_RECRUITING city: Harbin country: China name: Fei Han role: CONTACT lat: 45.75 lon: 126.65 facility: First Hospital, Jilin University status: NOT_YET_RECRUITING city: Jilin country: China name: Xuesong Song role: CONTACT lat: 43.85083 lon: 126.56028 facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine status: NOT_YET_RECRUITING city: Jinan country: China name: Yongliang Chi role: CONTACT lat: 36.66833 lon: 116.99722 facility: First Medical University and Shandong Provincial Qianfoshan Hospital status: NOT_YET_RECRUITING city: Jinan country: China name: Jianbo Wu role: CONTACT lat: 36.66833 lon: 116.99722 facility: First Affiliated Hospital of Kunming Medical University status: NOT_YET_RECRUITING city: Kunming country: China name: Jianlin Shao role: CONTACT lat: 25.03889 lon: 102.71833 facility: Affiliated Hospital of Qingdao University status: NOT_YET_RECRUITING city: Qingdao country: China name: Wei Feng role: CONTACT lat: 36.06488 lon: 120.38042 facility: Liaoning Cancer Hospital and Institute status: NOT_YET_RECRUITING city: Shenyang country: China name: Zeqing Huang role: CONTACT lat: 41.79222 lon: 123.43278 facility: Shenzhen People's Hospita status: NOT_YET_RECRUITING city: Shenzhen country: China name: Chaoran Wu role: CONTACT lat: 22.54554 lon: 114.0683 facility: First Hospital of Hebei Medical University status: NOT_YET_RECRUITING city: Shijia Zhuang country: China name: Li Wang role: CONTACT lat: 34.17775 lon: 109.84894 facility: Second Hospital of Hebei Medical University status: NOT_YET_RECRUITING city: Shijia Zhuang country: China name: Lining Huang role: CONTACT lat: 34.17775 lon: 109.84894 facility: Tianjin Fifth Central Hospital status: NOT_YET_RECRUITING city: Tianjin country: China name: Shimin Shan role: CONTACT lat: 39.14222 lon: 117.17667 facility: YANBIAN University Hospital（Yanbian Hospital） status: NOT_YET_RECRUITING city: Yanbian country: China name: Yongshan Nan role: CONTACT hasResults: False
<|newrecord|> nctId: NCT06359093 id: 14422023557605 briefTitle: Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients. overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2026-09 date: 2024-04-11 date: 2024-04-22 name: Cairo University class: OTHER briefSummary: The aim of this study is to describe the prevalence of non-carious cervical lesions in middle adulthood patients attending the Cairo University Dental Educational Hospital and to analyze the distribution of lesions by gender and age, tooth functional group, jaw, arch side and tooth surface. Moreover, to explore the associated risk indicators of the lesions as well as the quantity of saliva, as one of the potential etiological factors, will be assessed. conditions: Non-carious Cervical Lesions studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1532 type: ESTIMATED measure: Prevalence of non-carious cervical lesions (NCCLs) in Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital. measure: Associated risk indicators for all participants. 3.Salivary assessment regarding flow rate and pH for subgroup diagnosed with non-carious cervical lesions. sex: ALL minimumAge: 41 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06359080 id: 120200004OL briefTitle: Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study (TPBMASDOL) overallStatus: COMPLETED date: 2022-05-08 date: 2022-12-11 date: 2022-12-11 date: 2024-04-11 date: 2024-04-11 name: JelikaLite LLC class: INDUSTRY briefSummary: The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 10 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open Label Study
This will be an one-arm, open label study. Participants who were in the placebo condition in the previous study, will receive the treatment. Participants who were in the active condition in the previous study will repeat the course of treatment after the intermission of 3-6 months (depending on when they completed the study). primaryPurpose: TREATMENT masking: NONE count: 22 type: ACTUAL name: Cognilum TM: Light Treatment Condition measure: Change in Autism Symptoms sex: ALL minimumAge: 2 Years maximumAge: 7 Years stdAges: CHILD facility: Dr. Steingold Psychology PC city: Brooklyn state: New York zip: 11229 country: United States lat: 40.6501 lon: -73.94958 facility: Dr. Steingold Psychology PC city: New York state: New York zip: 10019 country: United States lat: 40.71427 lon: -74.00597 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2022-05-01 uploadDate: 2024-04-08T10:25 filename: Prot_000.pdf size: 332012 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2022-05-01 uploadDate: 2024-04-08T10:25 filename: SAP_001.pdf size: 134095 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-05-01 uploadDate: 2024-04-08T10:26 filename: ICF_002.pdf size: 172416 hasResults: False
<|newrecord|> nctId: NCT06359067 id: APHP240295 briefTitle: A Real-World Study of Bispecific Antibodies in Multiple Myeloma acronym: BISPEMM overallStatus: COMPLETED date: 2022-07-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-11 date: 2024-04-11 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP). conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 600 type: ACTUAL name: Treated by bispecific antibodies, teclistamab or elranatamab in usual care name: Not treated by bispecific antibodies in usual care measure: Infection rate measure: Global survival measure: Progression-free survivals sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assistance Publique - Hôpitaux de Paris (AP-HP) city: Paris state: IDF zip: 75004 country: France lat: 48.85341 lon: 2.3488 hasResults: False
<|newrecord|> nctId: NCT06359054 id: CelalBayarNRG briefTitle: The Role of 68GA DOTATATE PET/CT In Breast Cancer Imaging overallStatus: COMPLETED date: 2020-11-11 date: 2023-05-15 date: 2023-09-15 date: 2024-04-11 date: 2024-04-11 name: Celal Bayar University class: OTHER briefSummary: Currently, F-18 FDG PET/CT is routinely used for breast cancer staging and treatment response assessment. Most breast cancers express Estrogen Receptor (ER) and Progesterone Receptor (PR) and this subtype shows lower activity on FDG imaging. 68Ga DOTATATE PET/CT is an effective imaging option for somatostatin receptor (SSTR) positive neuroendocrine tumors. There are case reports showing 68Ga DOTATATE uptake in non-Hodgkin lymphoma, meningioma, breast cancer, thyroid adenoma and papillary carcinoma. There are also histochemical studies showing that SSTR is a potential radiopharmaceutical target for ER+/PR+ breast cancer . Its hypothesized that 68Ga DOTATATE PET/CT may be superior to 18F FDG PET/CT primarily in hormone receptor (HR) positive breast cancer. In this study, its aimed to compare the uptake pattern of breast cancer lesions and HR status with 68Ga DOTATATE and 18F FDG uptake in lesions. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 16 type: ACTUAL name: 18F FDG PET/CT name: 68Ga DOTATATE PET/CT measure: Comparative Diagnostic Accuracy of 68Ga DOTATATE and 18F FDG PET/CT sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manisa Celal Bayar University Faculty of Medicine, General Surgery Department city: Manisa zip: 45030 country: Turkey lat: 38.61202 lon: 27.42647 facility: Manisa Celal Bayar University Faculty of Medicine, Nuclear Medicine Department city: Manisa zip: 45030 country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False
<|newrecord|> nctId: NCT06359041 id: CAB-201-004 briefTitle: RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2029-09 date: 2029-09 date: 2024-04-11 date: 2024-04-25 name: Cabaletta Bio class: INDUSTRY briefSummary: RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis conditions: Generalized Myasthenia Gravis (gMG) studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: CABA-201 measure: To evaluate incidence and severity of adverse events (AEs) measure: To evaluate the incidence and severity of adverse events (AEs) measure: To characterize the pharmacodynamics (PD) measure: To characterize the pharmacokinetics (PK) measure: To evaluate disease-related biomarkers measure: To evaluate efficacy by change in Myasthenia Gravis - Activities of Daily Living (MG-ADL) score over time. measure: To evaluate efficacy by change in Quantitative Myasthenia Gravis (QMG) score over time. measure: To evaluate efficacy by change in Myasthenia Gravis Composite (MGC) score over time. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06359028 id: 300103 briefTitle: Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-25 date: 2024-06-20 date: 2024-06-20 date: 2024-04-11 date: 2024-04-25 name: HALEON class: INDUSTRY briefSummary: The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste. conditions: Dentin Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 111 type: ACTUAL name: Stannous fluoride toothpaste name: Crest cavity protection toothpaste measure: Change from Baseline in Schiff Sensitivity Score at Day 56 measure: Change from Baseline in Tactile Threshold at Day 56 measure: Change from Baseline in Schiff sensitivity score at Day 28 measure: Change from Baseline in Tactile Threshold at Day 28 measure: Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 measure: Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 measure: Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 measure: Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 measure: Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56 measure: Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Salus Research city: Fort Wayne state: Indiana zip: 46825 country: United States lat: 41.1306 lon: -85.12886 hasResults: False
<|newrecord|> nctId: NCT06359015 id: 41138 id: 605095 type: OTHER domain: DDD briefTitle: Metformin and Esomeprazole in Preterm Pre-eclampsia overallStatus: ACTIVE_NOT_RECRUITING date: 2021-02-11 date: 2025-06 date: 2025-06 date: 2024-04-11 date: 2024-04-11 name: Christiana Care Health Services class: OTHER briefSummary: The purpose of this study is to better understand diagnosis and treatment of preterm preeclampsia. Currently, there are limited laboratory tests that can be used to diagnosis preeclampsia. Additionally, there are few treatments for this condition. This clinical trial will explore treatment options, Metformin and Esomeprazole, as well as serum markers that could improve the diagnosis and treatment of preterm preeclampsia. conditions: Preeclampsia Severe conditions: Pre-Eclampsia conditions: Preeclampsia conditions: Preeclampsia Second Trimester conditions: Preeclampsia Complicating Childbirth conditions: Preeclampsia Puerperium conditions: Preterm studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups: experimental and control. The control group receives expectant management. The experimental group receives expectant management and medication treatment. primaryPurpose: TREATMENT masking: NONE count: 4 type: ACTUAL name: Metformin name: Esomeprazole measure: Mean plasma difference in sFlt-1 measure: Mean plasma difference in vascular endothelial growth factor (VEGF) measure: Mean plasma difference in placental growth factor (PIGF) measure: Mean plasma difference in soluble endoglin (sEng) measure: sFlt-1:PIGF ratio measure: Prolongation of gestation sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Christianacare Health System city: Newark state: Delaware zip: 19718 country: United States lat: 39.68372 lon: -75.74966 hasResults: False
<|newrecord|> nctId: NCT06359002 id: BYON4413.001 id: 2023-507781-13-00 type: CTIS briefTitle: Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-03 date: 2024-04-11 date: 2024-04-11 name: Byondis B.V. class: INDUSTRY briefSummary: This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS. conditions: Relapsed / Refractory AML conditions: Relapsed / Refractory MDS studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: BYON4413 measure: Incidence of dose-limiting toxicities (dose escalation) measure: Composite Complete Remission Rate (expansion) measure: Incidence and severity of adverse events measure: Number of patients with dose modifications measure: Rate of early death measure: Maximum Plasma Concentration (Cmax) BYON4413 measure: Time to Cmax (Tmax) BYON4413 measure: Area under the curve (AUC) BYON4413 measure: Percentage of patients with confirmed anti-BYON4413 antibodies measure: Composite Complete Remission Rate (dose escalation) measure: Percentage of blasts in bone marrow change from baseline measure: Percentage of blasts in peripheral blood change from baseline measure: Objective response rate measure: Duration of response measure: Relapse-free survival measure: Event-free survival measure: Time to response measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06358989 id: Insulin resistance briefTitle: Association Between Triglycerides Glucose Ratio With HOMA -IR as Indicators of Insulin Resistance in Obese Adults overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-11 date: 2024-04-11 name: Assiut University class: OTHER briefSummary: The aim of the present study was to investigate the correlation between the triglyceride/glucose index (TyG index) and homeostasic model assessment of insulin resistance (HOMA-IR) to predict insulin resistance (IR) in obese adults conditions: Insulin Resistance studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: HOMA IR measure: Association between triglycerides glucose ratio with HOMA -IR as indicators of insulin resistance in obese adults sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06358976 id: Spasticity splint and FMV briefTitle: Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2024-11-30 date: 2024-12-30 date: 2024-04-11 date: 2024-04-15 name: Arab American University (Palestine) class: OTHER briefSummary: Title: The Effect of Vibrating Splint on Hand Function After Stroke
Summary:
This study aims to investigate the effectiveness of a vibrating splint in improving hand function and reducing spasticity among individuals who have experienced a stroke. Stroke is a major global health issue, often resulting in long-term disability and impairments in the upper limbs. Spasticity, a common complication of stroke, causes stiffness and involuntary muscle contractions, leading to difficulties in performing daily activities.
Current treatment options for spasticity include medications and physical therapy techniques. However, these approaches may have limitations in terms of effectiveness and duration of benefits. Therefore, non-pharmacological interventions are being explored to enhance rehabilitation outcomes.
The hypothesis of this study is that the use of a vibrating splint, which applies mechanical vibrations to the hand muscles, will decrease spasticity and improve hand functionality in individuals with chronic stroke. The vibrations from the splint stimulate the sensory receptors in the skin and muscles, leading to muscle relaxation and improved motor control.
The study will be conducted as a pilot randomized controlled trial, involving participants who meet specific eligibility criteria. The participants will be divided into three arms, with each arm receiving a different intervention. Outcome measures, including assessments of spasticity, range of motion, pain levels, and functional abilities, will be collected before and after the intervention period.
The findings from this study will contribute to the understanding of non-pharmacological approaches in managing spasticity and improving hand function after stroke. If the vibrating splint proves to be effective, it could offer a safe and accessible option for stroke survivors to enhance their recovery and regain independence in daily activities.
This research is essential as it addresses the need for more effective interventions for spasticity management and hand rehabilitation after stroke. By providing valuable insights into the potential benefits of the vibrating splint, this study has the potential to improve the quality of life for individuals who have experienced a stroke and empower them to regain control over their hand movements. conditions: Spasticity as Sequela of Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: The interventional study model for this clinical study is a pilot randomized controlled trial. Participants will be randomly assigned to one of three arms: Group A (vibrating splint intervention), Group B (standard splint intervention), or Group C (control group receiving no splint intervention). This model allows for the comparison of different interventions and the evaluation of their effectiveness in improving hand function and reducing spasticity after stroke. Randomization helps ensure that each group is comparable in terms of baseline characteristics, minimizing bias and increasing the validity of the study results. primaryPurpose: OTHER masking: SINGLE maskingDescription: In this clinical trial, due to the nature of the interventions, it may not be possible to mask or blind the participants or therapists to the treatment received. However, efforts will be made to blind the outcome assessors who will be responsible for evaluating the participants' hand function, spasticity, and other outcome measures. Blinding the outcome assessors helps minimize potential bias and ensures the objective assessment of the intervention's effectiveness. By keeping the assessors unaware of the participants' group allocations, the integrity and reliability of the study findings can be enhanced. whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: Vibration plus anti-spastic hand splint name: Anti-spastic hand splint name: Vibration measure: Modified Ashworth Scale (MAS) measure: Fugl-Meyer Assessment of Upper Extremity (FMA-UE) measure: Range of Motion Assessment measure: Numeric pain rating scale (NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arab American University city: Jenin zip: 240 country: Palestinian Territory, occupied name: Hisham Arab Alkabeya, PhD role: CONTACT phone: 0595637776 email: [email protected] lat: 32.45943 lon: 35.30086 hasResults: False
<|newrecord|> nctId: NCT06358963 id: 131 briefTitle: CoQ10 and Omega-3 as Adjuncts to Periodontal Therapy, TAC of Saliva. overallStatus: ENROLLING_BY_INVITATION date: 2024-02-20 date: 2024-04-20 date: 2024-05-10 date: 2024-04-11 date: 2024-04-17 name: Amirhossein Farahmand class: OTHER briefSummary: Comparative evaluation of CoQ10 and Omega-3 as adjuncts to periodontal therapy and total antioxidant capacity of saliva (randomized Double-Blind Clinicalials) conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-blind, Controlled design. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The research was conducted using a double-blind methodology. To ensure impartiality, both the omega-3, Coq10, and control groups were given medications that had identical appearance, packaging, and color. To further eliminate bias, a clinician who had no involvement in the study labeled teh medications as A, B, and C (empty) based on their content, and distributed them among teh patients. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Receive 30 mg of Coq10 name: Non-Medicare Drugs measure: reduction of bleeding on probing measure: total Antioxidant capacity of saliva sex: ALL minimumAge: 28 Years maximumAge: 35 Years stdAges: ADULT facility: Amirhossein Farahmand city: Tehran zip: 1947833113 country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False
<|newrecord|> nctId: NCT06358950 id: ALKS 2860-201 briefTitle: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 acronym: Vibrance-1 overallStatus: RECRUITING date: 2024-03-28 date: 2025-07 date: 2025-07 date: 2024-04-11 date: 2024-04-11 name: Alkermes, Inc. class: INDUSTRY briefSummary: The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone. conditions: Narcolepsy Type 1 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: ALKS 2680 name: Placebo measure: Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6 measure: Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6 measure: Mean weekly cataplexy rate (WCR) as derived by subject cataplexy measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alkermes Investigational Site status: RECRUITING city: Huntersville state: North Carolina zip: 28708 country: United States lat: 35.41069 lon: -80.84285 hasResults: False
<|newrecord|> nctId: NCT06358937 id: #7/2023 briefTitle: Clinical and Microbiological Evaluation of Laser Assisted New Attachment Procedure (LANAP) Using Nd:Yag vs. Diode Laser in the Management Of Stage II Periodontitis overallStatus: RECRUITING date: 2023-11-01 date: 2024-05 date: 2024-05 date: 2024-04-11 date: 2024-04-11 name: Mahmoud Salem class: OTHER briefSummary: The aim of the present study is to compare the efficacy of LANAP to conventional scaling and root planing in the management of stage II periodontitis. conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 27 type: ESTIMATED name: Laser Assisted New Attachment Procedure using ND:YAG laser name: Laser Assisted New Attachment Procedure using diode laser name: Scaling and Root Planing using ultrasonic and curettes measure: Microbiological assessment of Fusobacterium nucleatum measure: Microbiological assessment of Porphyromonas gingivalis measure: Microbiological assessment of Tannerella forsythia measure: Gingival index measure: Plaque index measure: Clinical attachment loss measure: Probing depth sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry, Alexandria University status: RECRUITING city: Alexandria country: Egypt name: Mahmoud Salem, BDS role: CONTACT phone: 111 144 7745 phoneExt: +20 email: [email protected] lat: 31.21564 lon: 29.95527 hasResults: False
<|newrecord|> nctId: NCT06358924 id: FDASU-RecID032004 briefTitle: Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity and Shade Stability overallStatus: COMPLETED date: 2021-11-13 date: 2023-08-25 date: 2023-09-20 date: 2024-04-11 date: 2024-04-23 name: Ain Shams University class: OTHER briefSummary: This study compared the effect of four different desensitizing agents on shade stability and dental hypersensitivity following dental bleaching procedure. The follow-up periods ranged from 24 hours to 1 year. conditions: Tooth Hypersensitivity studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This clinical study was conducted to evaluate the effect of using different desensitizing agents:
1. As recommended by manufacturer
2. Casein phosphopeptide-amorphous calcium phosphate/fluoride (CPP-ACPF) containing desensitizing agent
3. Hydroxyapatite/fluoride/xylitol containing desensitizing agent
4. Poly (amido amine) dendrimer with carboxylic acid terminal functional group containing desensitizing agent.
On patients subjected to bleaching procedure using hydrogen peroxide containing bleaching agent.
The clinical evaluation included:
1. Post-bleaching hypersensitivity.
2. Post-bleaching long-term shade stability. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: This clinical trial was double blinded trial in which both the participant and outcome assessor were blinded to allocation, thus the participant was unaware of which experimental material had been assigned to him/her. Also the outcome assessors were blinded to the treatment that each participant had received. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 48 type: ACTUAL name: Potassium nitrate with fluoride name: Casein phosphopeptide-amorphous calcium phosphate with fluoride name: Hydroxyapatite with fluoride name: PAMAM-carboxylic acid dendrimer measure: Post-bleaching hypersensitivity measure: Shade stability sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Dentistry, Ain Shams University city: Cairo state: El Weilli zip: 4393005 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06358911 id: FDASU-RecID022001 briefTitle: A Clinical Study for the Effect of 4th Generation Poly AmidoAmine Dendrimer on Post-Bleaching Hypersensitivity and Shade Stability overallStatus: COMPLETED date: 2021-11-13 date: 2023-08-05 date: 2023-09-10 date: 2024-04-11 date: 2024-04-23 name: Ain Shams University class: OTHER briefSummary: This study assessed the impact of four desensitizing agents on both color stability and dental sensitivity following a bleaching procedure, spanning from the 24-hour to the 1-year follow-up assessment periods. conditions: Tooth Hypersensitivity studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This clinical study will be conducted to evaluate the effect of using 4th generation Poly amido amine dendrimer (PAMAM-COOH) as a desensitizing agent and compared with three different commercially available desensitizing materials: 3% potassium nitrate and 0.11% fluoride (Ultra EZ), as described by manufacturer, Casein-phosphopeptide-amorphous calcium phosphate with F, (MI paste plusTm), and Hydroxyapatite, Fluoride and Xylitol, Hydroxyapatite and F (ReminPro), on:
1. Long-term Post-bleaching hypersensitivity.
2. Long-term Post-bleaching shade stability. For Patients treated with 40% hydrogen-peroxide bleaching agent. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: This clinical trail was a double blinded trail in which the participant and outcome assessor were blinded to allocation, thus the participant was unaware of which experimental material had been assigned to him/her. Also outcome assessors were blinded to the treatment that each participant had received whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Poly amido amine dendrimer (PAMAM) name: Manufacturer's desensitizing agent, Ultra EZ name: MI paste plus, desensitizing agent name: Hydroxyapatite and F (ReminPro), desensitizing agent measure: Post-bleaching dental hypersensitivity measure: Shade stability sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Dentistry - Ain Shams University city: Cairo state: El Weili zip: 4393005 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06358898 id: 20221207 briefTitle: Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2026-05-31 date: 2026-12-31 date: 2024-04-11 date: 2024-04-12 name: Chinese University of Hong Kong class: OTHER briefSummary: Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population. This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment. conditions: Insomnia conditions: Depression conditions: Adolescent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 343 type: ESTIMATED name: Standard dCBT-I name: Modified Mood enhanced CBT-I (M-dCBT-I) measure: Depressive symptoms measure: Assessor-rated depressive symptomatology measure: Overall severity of depression symptoms measure: Severity of insomnia symptoms measure: Sleep-wake pattern measure: Sleep-related beliefs and cognitions measure: Daytime sleepiness measure: Anxiety and depression symptoms measure: Quality of life by KIDSCREEN-27 measure: Major life events and self-perceived stress measure: Chronotype measure: Pubertal status sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Psychiatry, the Chinese University of Hong Kong city: Sha Tin state: New Territories country: Hong Kong lat: 22.38333 lon: 114.18333 hasResults: False
<|newrecord|> nctId: NCT06358885 id: 22-3123 id: R01AA030480 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA030480 briefTitle: IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention acronym: EBAI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-11 date: 2024-04-11 name: University of North Carolina, Chapel Hill class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) name: National Institutes of Health (NIH) name: Hanoi Medical University name: Johns Hopkins University name: University of Washington name: Washington University School of Medicine briefSummary: This study is a hybrid type 3, cluster randomized implementation trial to examine effective strategies to scale up the Brief Alcohol Intervention (BAI) in ART clinics in Vietnam. One arm will receive only facilitation for BAI implementation. Facilitation is a flexible strategy that helps clinics to address common barriers, such as counselor skills, competing priorities, and resource deficits. In the other arm, in addition to facilitation, clinic staff, irrespective of their own alcohol use, will be offered the BAI themselves as experiential learning (EBAI) to address their own alcohol-related attitudes and behaviors. Clinic staff responsible for delivering the BAI to patients will also be offered 3 consolidation activities to integrate their own experiences with their delivery of the BAI. conditions: HIV-1-infection conditions: Unhealthy Alcohol Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-arm cluster-randomized implementation trial comparing two strategies to scale-up an evidence-based brief alcohol intervention (BAI), in Vietnam, examining the mechanisms of BAI scale-up and the impact of experiential BAI (EBAI) on clinic staff. The two implementation approaches are facilitation only (FAC) and facilitation plus an experiential brief alcohol intervention (EBAI+FAC). primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 930 type: ESTIMATED name: Facilitation (FAC) name: Experiential Brief Alcohol Intervention (EBAI) measure: Fidelity Score measure: Viral Suppression measure: BAI Acceptability Score - Clinic Staff: Acceptability of Intervention Measure (AIM) scale measure: BAI Acceptability score Counselors: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Providers measure: BAI Acceptability PWH: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Consumers measure: Penetration- Proportion of PWH Screened with the AUDIT-C measure: Penetration - Proportion of PWH who screen positive who receive at least one counseling session measure: Costs measure: Sustainability Score: Provider Support of Sustainment Scale (PRESS) measure: AUDIT (total score) - Clinic staff measure: AUDIT (total score) - PWH measure: Fidelity (Extended Window) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hanoi Medical University city: Hanoi country: Vietnam name: Le Minh Giang, MD, PhD role: CONTACT email: [email protected] lat: 21.0245 lon: 105.84117 hasResults: False
<|newrecord|> nctId: NCT06358872 id: 23-39839 briefTitle: Azithromycin for Child Survival in Niger II acronym: AVENIR II overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2028-04-29 date: 2028-04-29 date: 2024-04-11 date: 2024-04-12 name: University of California, San Francisco class: OTHER name: Centre de recherche et interventions en santé publique (CRISP) name: Ministère de la Santé Publique du Niger name: Le Programme National de Santé Oculaire name: Centre de Recherche Médicale et Sanitaire name: Bill and Melinda Gates Foundation briefSummary: Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years. conditions: Mortality conditions: Antimicrobial Resistance studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention will involve biannual oral azithromycin MDA to children 1-59 months old distributed by community health workers. The Centre de Santé Integré (CSI) will be randomized to receive azithromycin MDA or delayed treatment in a stepped wedge design for the first 2 years. The delayed intervention arm will receive usual care for the first 2 years, then will receive the intervention for the next 2 years. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants, community health workers delivering the intervention, and team members supervising the program will not be masked. One biostatistician and one data analyst will remain unmasked to prepare the randomization sequence. Masked personnel include outcome assessors as well as the biostatistician and data analyst conducting the data analyses. whoMasked: OUTCOMES_ASSESSOR count: 3300000 type: ESTIMATED name: Azithromycin for Oral Suspension measure: All-cause mortality measure: All-cause mortality measure: Prevalence of resistance to macrolides - nasopharyngeal swabs measure: Prevalence of resistance to macrolides - nasopharyngeal swabs measure: Load of genetic determinants of resistance to macrolides - rectal swabs measure: Load of genetic determinants of resistance to macrolides - rectal swabs measure: Number of clinic visits - infectious measure: Number of clinic visits - infectious measure: Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs measure: Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs measure: Program Cost Per Dose Delivered sex: ALL minimumAge: 1 Month maximumAge: 59 Months stdAges: CHILD facility: Program National de Santé Oculaire city: Niamey country: Niger lat: 13.51366 lon: 2.1098 hasResults: False
<|newrecord|> nctId: NCT06358859 id: STUDY00004203 id: 1R01MD018208-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MD018208-01 briefTitle: Delta GREENS Food is Medicine Intervention overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-11 date: 2024-04-11 name: Tufts University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) name: Tougaloo College, Mississippi name: Delta Health Center, Mississippi name: Reuben V. Anderson Center for Justice at Tougaloo briefSummary: Though the Mississippi Delta has a rich agricultural history and some of the nation's most fertile soil, residents have experienced the legacy of slavery and economic exploitation through food insecurity and poverty for generations. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and \~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. The Delta Growing a Resilient, Enriching, Equitable, Nourishing food System (GREENS) Food is Medicine (FIM) Project, is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. The project's primary goal is to improve health outcomes by creating a FIM intervention. The Delta GREENS FIM Project aims to become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide. conditions: Cardiometabolic Risk Factors conditions: Diabetes conditions: High Blood Pressure conditions: Obesity conditions: Nutrition Security studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The primary objective is to test whether a multi-level, community-engaged intervention with a food-is-medicine program in the Mississippi Delta can improve metabolic disease in specific minority groups. The basic study design is a cluster randomized controlled trial (RCT), with equal numbers of participants randomized to intervention and control groups. Each participant will be enrolled in the study for 12 months. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group during their 12-month study period. The control group will receive produce boxes later, after their 12-month study participation has ended. Participants will be patients at participating Delta Health Center (DHC) clinics in Mississippi. primaryPurpose: OTHER masking: NONE count: 300 type: ESTIMATED name: Food is Medicine measure: Change in hemoglobin A1c (HbA1c) measure: Change in cardiometabolic risk factor composite score measure: Change in BMI measure: Change in LDL cholesterol measure: Change in non-HDL cholesterol measure: Change in blood pressure measure: Change in nutrition security, assessed via a survey measure: Change in dietary intake of fruits and vegetables, assessed via a survey measure: Change in health care utilization, assessed via review of Electronic Health Records (EHR) measure: Change in food insecurity, assessed via a survey sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts University city: Boston state: Massachusetts zip: 02111 country: United States name: Daniel Schultz, MS, RDN, LD role: CONTACT phone: 262-627-0155 email: [email protected] name: Shanti Sharma, PhD role: CONTACT email: [email protected] lat: 42.35843 lon: -71.05977 hasResults: False
<|newrecord|> nctId: NCT06358846 id: 00004 briefTitle: Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan. overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-07-15 date: 2024-07-31 date: 2024-04-11 date: 2024-04-12 name: SINA Health Education and Welfare Trust class: OTHER name: Aga Khan University briefSummary: There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Secondly, there is a lack of documented research on the foot care knowledge shown by people with T2D residing in the slums of Karachi. In order to assess the knowledge intervention among the individual having T2D through qualified diabetes educators and pictorial educational pamphlet along with the standard care of treatment. Consequently, it may aid in the development of effective methods aimed at mitigating foot-related complications among this specific population. Individuals diagnosed with diabetes are required to engage in proactive and structured self-care activities by providing the foot care knowledge in order to effectively manage their condition and mitigate the risk of potential complications. The incorporation of health-deviation knowledge and activities into routine is crucial. conditions: Diabetic Foot conditions: Educational Intervention conditions: Foot Care conditions: Foot Ulcer, Diabetic conditions: Foot Cellulitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control arm =75 Interventional arm = 75 primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: Self-care behavior to promote foot care through educational guidance among individual with diabetes measure: Improved Foot Care Knowledge measure: Behavior Change measure: Reduction in Foot Complications measure: Empowerment and Self-efficacy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06358833 id: 24-82-03 briefTitle: Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems overallStatus: RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-11 date: 2024-04-18 name: Qassim University class: OTHER briefSummary: Summary:
After a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Irrigation, using either traditional endodontic needles or newer methods like endodontic activation, helps clean the canal. This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation. Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation: the Endo1 device (EA) and the conventional endodontic needles (EN). The study will provide insights into which method is more effective in reducing postoperative pain. conditions: Postoperative Pain conditions: Irreversible Pulpitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients will be masked from the procedure whoMasked: PARTICIPANT count: 34 type: ESTIMATED name: endodontic needle (EN) name: Endodontic activation (EA) measure: Postoperative pain measure: Postoperative pain measure: Postoperative pain measure: Postoperative pain measure: Irrigation time measure: Adverse event measure: Rescue medication sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Muhammad Zubair Ahmad status: RECRUITING city: Ar Rass state: Qassim zip: 58883 country: Saudi Arabia name: Muhammad Zubair Ahmad, BDS, FCPS role: CONTACT phone: 0163011111 phoneExt: 10685 email: [email protected] lat: 25.86944 lon: 43.4973 hasResults: False
<|newrecord|> nctId: NCT06358820 id: PHGaozhou briefTitle: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution overallStatus: RECRUITING date: 2023-12-03 date: 2025-01 date: 2025-07 date: 2024-04-11 date: 2024-04-11 name: The People's Hospital of Gaozhou class: OTHER briefSummary: This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded. conditions: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status of Maintenance Peritoneal Dialysis Patients studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: Amino acid peritoneal dialysis solution measure: blood albumin measure: prealbumin sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gaozhou People's Hospital status: RECRUITING city: Gaozhou state: Guangdong zip: 525200 country: China name: Deng shanshan role: CONTACT phone: 8613927596600 email: [email protected] lat: 21.93924 lon: 110.84607 hasResults: False
<|newrecord|> nctId: NCT06358807 id: M2023438 briefTitle: Microfracture With Platelet Rich Plasma Gel Injection for Ostechondral Lesion of the Talus overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2026-12-31 date: 2024-04-11 date: 2024-04-11 name: Peking University Third Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:
* Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score?
* Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.
Participants will:
* Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel
* Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment
* Take MRI preoperatively and 6, 12 and 24 months after surgery conditions: Osteochondral Lesion of Talus conditions: Microfractures conditions: Platelet Rich Plasma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Arthroscopic microfracture with intraoperative local PRP gel injection name: Isolated microfracture measure: American Orthopedic Foot and Ankle Society Score (AOFAS) measure: Foot and Ankle Outcome Score (FAOS) measure: Ankle Activity Score (AAS) measure: Visual Analogue Scale (VAS) measure: Patient Satisfaction measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) measure: Return-to-Sport Rate measure: Complications sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing country: China name: Guo Qinwei role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06358794 id: IRB00006761-M2022692 briefTitle: Machine Learning Based-Personalized Prediction of Sperm Retrieval Success Rate overallStatus: COMPLETED date: 2022-06-01 date: 2022-12-31 date: 2023-05-31 date: 2024-04-11 date: 2024-04-11 name: Peking University Third Hospital class: OTHER briefSummary: Non-obstructive azoospermia (NOA) stands as the most severe form of male infertility. However, due to the diverse nature of testis focal spermatogenesis in NOA patients, accurately assessing the sperm retrieval rate (SRR) becomes challenging. The current study aims to develop and validate a noninvasive evaluation system based on machine learning, which can effectively estimate the SRR for NOA patients. In single-center investigation, NOA patients who underwent microdissection testicular sperm extraction (micro-TESE) were enrolled: (1) 2,438 patients from January 2016 to December 2022, and (2) 174 patients from January 2023 to May 2023 (as an additional validation cohort). The clinical features of participants were used to train, test and validate the machine learning models. Various evaluation metrics including area under the ROC (AUC), accuracy, etc. were used to evaluate the predictive performance of 8 machine learning models. conditions: Infertility, Male conditions: Azoospermia, Nonobstructive studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2612 type: ACTUAL name: Machine learning-based predictive model measure: SRR of micro-TESE sex: MALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100191 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06358781 id: xuyajun197673-002 briefTitle: A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-05-30 date: 2024-06-30 date: 2024-04-11 date: 2024-04-11 name: Peking University class: OTHER briefSummary: Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations. To address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains. conditions: Chronic Disease Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 48 type: ESTIMATED name: Whole grain wheat flour measure: whole grain plasma and urine biomarkers discovery and identification measure: Validate the performance of the potential WG biomarkers. measure: Dose-response of WG wheat biomarkers. sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Department of Nutrition and Food Hygiene, School of Public Health, Peking University city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06358768 id: ObGynEASC005 briefTitle: Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations acronym: PPH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-31 date: 2024-09-30 date: 2024-04-11 date: 2024-04-16 name: G. d'Annunzio University class: OTHER name: A.O. Ospedale Papa Giovanni XXIII briefSummary: Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management conditions: PPH - Postpartum Hemorrhage studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: teamwork job improvement overall name: teamwork job improvement in actor scenario vs mannequin scenario measure: teamwork measure: skills measure: scenario quality sex: ALL minimumAge: 19 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Claudio Celentano city: Pescara state: PE zip: 65100 country: Italy name: Claudio Celentano, MD role: CONTACT phone: +393285577305 email: [email protected] lat: 42.4584 lon: 14.20283 facility: Ospedale Giovanni XXIII city: Bergamo country: Italy name: Luisa Patanè, MD role: CONTACT phone: 349 3503920‬ phoneExt: +39 email: [email protected] lat: 45.69601 lon: 9.66721 hasResults: False
<|newrecord|> nctId: NCT06358755 id: 10211476 id: P0041308 type: OTHER domain: The Hong Kong Polytechnic University briefTitle: Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-10-31 date: 2024-04-11 date: 2024-04-11 name: The Hong Kong Polytechnic University class: OTHER name: The University of Hong Kong briefSummary: The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. conditions: Myopia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible participants will be randomly allocated into 2 groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigators, including ophthalmologists and optometrists, who are responsible for collection of data related to myopia progression and analysis of data will be blinded to study intervention. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 112 type: ESTIMATED name: Defocus Incorporated Multiple Segments lenses name: single vision spectacle lenses name: Low dose atropine measure: Changes in cycloplegic refraction measure: Changes in axial length sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong city: Hong Kong zip: No postcode country: Hong Kong name: Rachel Ka Man Chun, PhD role: CONTACT phone: +852-27664224 email: [email protected] name: Dennis Yan-yin Tse, PhD role: CONTACT phone: +852-27666096 email: [email protected] name: Christopher Kai-shun Leung, MD and Prof role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False
<|newrecord|> nctId: NCT06358742 id: ORL-GUM-2787 briefTitle: Evaluation of the Effect of Zinc Citrate Trihydrate Toothpaste on the Oral Plaque Microbiome overallStatus: COMPLETED date: 2017-01-10 date: 2017-05-19 date: 2017-05-19 date: 2024-04-11 date: 2024-04-11 name: Unilever R&D class: INDUSTRY name: Intertek briefSummary: This study is of a double-blind, randomised, parallel group study. Subjects will be enrolled onto the study according to the inclusion/exclusion criteria. After recruitment, subjects will be given a fluoride toothpaste without gum care agents to use for the 4-week run-in period prior to the commencement of the test phase of the study. Following the run-in period, baseline supragingival plaque samples will be collected 12 hours after last brushing, from the upper and lower jaws separately. Subjects will then then randomly allocated to one of two products (zinc citrate trihydrate \[ZCT\] toothpaste or control toothpaste) according to the randomization. Subjects will be instructed to use the toothpaste at home, brushing twice a day for 12-weeks. Supragingival plaque samples will be collected again from the upper and lower jaws after 2, 6 and 12 weeks. Plaque samples will then undergo metataxonomic and metatranscriptomic analyses. conditions: Dental Plaque studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE maskingDescription: Toothpaste packaged in white tubes with a study label which only differentiates products with a alphanumeric code. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 142 type: ACTUAL name: ZCT toothpaste name: Control toothpaste measure: Plaque microbiome sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06358729 id: HUM00239775 briefTitle: Pre-Pregnancy Weight Loss and Baby Behavior Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-11 date: 2024-04-11 name: University of Michigan class: OTHER briefSummary: This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple. conditions: Obesity; Familial conditions: Pregnancy Related conditions: Infant Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Order of nipple size use is counter-balanced, caregivers are blind to nipple size and amount of milk in the bottle (i.e., the bottle is covered) to minimize their influence over the infant's consumption. Research assistants will not be blind to nipple size as they will need to set the bottles ups for the mothers. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Typical Nipple name: Challenging Nipple measure: Suck effect measure: Sucking pressure measure: Sucking frequency measure: Milk/Formula intake measure: Milk/Formula consumption rate measure: Number of Feedings Over 24 Hours measure: Total Hours of Sleep per 24 Hours within 24 hours of intervention measure: Total Night Wake-ups within 24 hours of intervention sex: ALL minimumAge: 3 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Amanda Crandall, PhD role: CONTACT name: Amanda Crandall, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
<|newrecord|> nctId: NCT06358716 id: CEIC-3037 briefTitle: Glycaemic Index Determination in Oral Nutrition Supplements acronym: BEGINS overallStatus: RECRUITING date: 2024-04-15 date: 2024-07-15 date: 2024-08-15 date: 2024-04-10 date: 2024-04-10 name: Universitat de Lleida class: OTHER name: Lactalis briefSummary: The glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. Based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. This property is of interest in health and nutrition because it allows estimating the impact the food will have on postprandial glycemia, which may able better food selection in situations where adequate glycemic control is required, such as in individuals diagnosed with Diabetes Mellitus. The objective of this study is to determine the glycemic index of 9 formulations of complete oral nutrition supplements and classify them based on their glycemic response. conditions: Glucose Metabolism Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 15 type: ESTIMATED name: Complete Oral Nutrition Supplement 1 name: Complete Oral Nutrition Supplement 2 name: Complete Oral Nutrition Supplement 3 name: Complete Oral Nutrition Supplement 4 name: Complete Oral Nutrition Supplement 5 name: Complete Oral Nutrition Supplement 6 name: Complete Oral Nutrition Supplement 7 name: Complete Oral Nutrition Supplement 8 name: Complete Oral Nutrition Supplement 9 name: Glucose measure: Glycemic Index sex: ALL minimumAge: 21 Years maximumAge: 60 Years stdAges: ADULT facility: University of Lleida status: RECRUITING city: Lleida zip: 25198 country: Spain name: Jose Serrano, PhD role: CONTACT phone: 973702408 email: [email protected] name: Manuel Portero, PhD role: CONTACT phone: 973702408 email: [email protected] lat: 41.61674 lon: 0.62218 hasResults: False
<|newrecord|> nctId: NCT06358703 id: P400 briefTitle: Impact of Acute iTTP Therapies on Long Term Neurologic and Cognitive Outcomes in iTTP Survivors acronym: NeST overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2028-05 date: 2024-04-10 date: 2024-04-10 name: US Thrombotic Microangiopathy Alliance class: OTHER briefSummary: 1. We expect to find that the silent cerebral infarct (SCI) rate is two fold higher in patients treated without caplacizumab. We also expect to find that the rate of mild and major cognitive impairment in patients treated with caplacizumab within 3 days of starting plasma exchange will be lower than patients treated without caplacizumab.
2. We expect that the differences in cognitive impairment in cases (caplacizumab) versus controls (no caplacizumab) will persist on serial evaluation 1 year later. We also expect that there will be differences in these groups even after adjusting for time since episode and severity of presentation.
3. We expect to find that SCI and cognitive impairment is associated with worse scores on the health related quality of life instrument (SF-36)
4. Based on studies in non-TTP populations, we expect to find that the rate of incident stroke over the period of follow up is at least 2 fold higher in patients that have SCI compared with patients who do not have SCI conditions: Immune Thrombotic Thrombocytopenia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 116 type: ESTIMATED name: Caplacizumab measure: Silent cerebral infarction measure: Cognitive impairment measure: Depression scores on BDI-II measure: SF-36 scores for quality of life measure: Patient reported cognitive performance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USTMA city: Groveport state: Ohio zip: 43125 country: United States name: Clare Martin role: CONTACT phone: 614-999-4900 email: [email protected] lat: 39.8784 lon: -82.88379 hasResults: False
<|newrecord|> nctId: NCT06358690 id: HSC-MS-24-0050 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-10 date: 2024-04-10 name: [Redacted] hasResults: False
<|newrecord|> nctId: NCT06358677 id: HCI171997 briefTitle: Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Metastatic Colorectal Cancer acronym: FACE overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2029-07 date: 2024-04-10 date: 2024-04-17 name: University of Utah class: OTHER briefSummary: The goal of this clinical trial is to learn if using topical tretinoin will help patients with colorectal cancer who are experiencing an acneiform rash as a side effect of their treatment.
Researchers will compare the use of tretinoin on one side of the face to the use of a placebo on the other side of the face to see if there is an impact. conditions: Metastatic Colon Cancer conditions: Metastatic Rectum Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, double-blind, split-face, phase II study of topical tretinoin prophylaxis for anti-EGFR treatment-induced skin toxicity in metastatic colorectal cancer. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Patients will apply topical tretinoin to one half of the face and topical moisturizer (placebo) to the other half of the face daily starting the day that anti-EGFR treatment is initiated. The sides of the face tretinoin and moisturizer are applied to will be randomized. Standardized photographs of the face will be obtained at screening and every two weeks from Week 1 Day 1 until after six weeks of treatment. Photographs will be graded by a dermatologist who will be blinded to treatment sidedness. Facial rash severity will be graded using a modified Investigators Global Assessment (IGA) score. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 25 type: ESTIMATED name: Topical Tretinoin name: Placebo measure: The maximum difference in modified Investigators Global Assessment (IGA) score between the treated and untreated sides of the face at any assessment. measure: Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE version 5.0 and the modified IGA), seriousness, duration, and relationship to study treatment. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huntsman Cancer Institute at University of Utah city: Salt Lake City state: Utah zip: 84112 country: United States lat: 40.76078 lon: -111.89105 hasResults: False
<|newrecord|> nctId: NCT06358664 id: Caffeine Vitrectomy briefTitle: Caffeine and Cataract After Pars Plana Vitrectomy overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-04-10 date: 2024-04-12 name: Vienna Institute for Research in Ocular Surgery class: OTHER briefSummary: Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 74 type: ESTIMATED name: Pars plana vitrectomy measure: Significant cataract formation at year 1 measure: Significant cataract formation at month 6 measure: Distance corrected visual acuity (DCVA) sex: ALL minimumAge: 18 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna status: RECRUITING city: Vienna zip: 1140 country: Austria name: Andreas Schlatter, MD role: CONTACT phone: +4391021 phoneExt: 57564 email: [email protected] name: Christoph Leisser, MMD role: CONTACT phone: +4391021 phoneExt: 57564 email: [email protected] lat: 48.20849 lon: 16.37208 hasResults: False
<|newrecord|> nctId: NCT06358651 id: PH94B-CL042 briefTitle: Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3) acronym: PALISADE-3 overallStatus: RECRUITING date: 2024-03-28 date: 2025-06 date: 2026-06 date: 2024-04-10 date: 2024-04-10 name: VistaGen Therapeutics, Inc. class: INDUSTRY briefSummary: This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study. conditions: Social Anxiety Disorder studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 236 type: ESTIMATED name: Fasedienol Nasal Spray name: Placebo Nasal Spray measure: Subjective Units of Distress Scale (SUDS) measure: Global Impression Scale of Improvement (CGI-I) measure: Patient Global Impression of Change (PGI-C) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vistagen Clinical Site status: RECRUITING city: Oceanside state: California zip: 92056 country: United States lat: 33.19587 lon: -117.37948 facility: Vistagen Clinical Site status: RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States lat: 30.33218 lon: -81.65565 facility: Vistagen Clinical Site status: RECRUITING city: Orlando state: Florida zip: 32801 country: United States lat: 28.53834 lon: -81.37924 facility: Vistagen Clinical Site status: RECRUITING city: New York state: New York zip: 10128 country: United States lat: 40.71427 lon: -74.00597 facility: Vistagen Clinical Site status: RECRUITING city: Memphis state: Tennessee zip: 38119 country: United States lat: 35.14953 lon: -90.04898 hasResults: False
<|newrecord|> nctId: NCT06358638 id: STUDY00000859 briefTitle: Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY acronym: SUN-RAY overallStatus: RECRUITING date: 2024-04 date: 2044-09 date: 2054-09 date: 2024-04-10 date: 2024-04-10 name: Children's National Research Institute class: OTHER name: Alberta Children's Hospital name: The Hospital for Sick Children name: Levine Children's Hospital name: Ann & Robert H Lurie Children's Hospital of Chicago name: Nationwide Children's Hospital name: Children's Hospital at Montefiore name: Doris Duke Charitable Foundation name: Janssen Pharmaceuticals briefSummary: This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety profile in patients with anti-donor red blood cell antibodies, achieving an event-free survival similar to transplanted patients without such antibodies. conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Sickle cell patients, who have matched sibling donors with anti-donor RBC antibodies. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Daratumumab name: Alemtuzumab name: Sirolimus name: Total Body Irradiation measure: To determine the event-free survival of children and adolescents with SCD undergoing nonmyeloablative HCT who received 4 doses of pre-HCT daratumumab for donor-directed red blood cell antibodies. measure: To evaluate changes in antibodies to red blood cell antigens pre and post exposure to daratumumab and HCT. measure: To characterize the safety of adding pre-HCT daratumumab to the conditioning regimen, as defined by adverse events grade 3 or greater. measure: To compare alemtuzumab levels, in mcg/mL, post-HCT among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study. measure: To compare immune reconstitution among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study. measure: To compare donor chimerism (lymphoid vs myeloid) post-HCT among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study. sex: ALL minimumAge: 2 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Children's National Hospital status: RECRUITING city: Washington state: District of Columbia zip: 20010 country: United States name: Maryanne Odinakachukwu role: CONTACT phone: 202-476-2957 email: [email protected] name: Robert Nickel role: PRINCIPAL_INVESTIGATOR name: David Jacobsohn role: SUB_INVESTIGATOR name: Anant Vatsayan role: SUB_INVESTIGATOR name: Blachy Dávila-Saldaña role: SUB_INVESTIGATOR name: Evelio Perez-Albuerne role: SUB_INVESTIGATOR name: Catherine Bollard role: SUB_INVESTIGATOR lat: 38.89511 lon: -77.03637 hasResults: False
<|newrecord|> nctId: NCT06358625 id: 2023-4-1-001 briefTitle: Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer acronym: CRANIUM overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2031-04-30 date: 2031-04-30 date: 2024-04-10 date: 2024-04-10 name: Center Eugene Marquis class: OTHER briefSummary: HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease.
At the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-).