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2. Considering the above pilot study results: What is the overall feasibility of the SMART research protocol in its current form? Are there any changes required for the main trial? This includes: recruitment approach, intervention content and delivery (app, provision of human support), and/or trial assessments (online and in-person). conditions: Health Behavior conditions: Noncommunicable Diseases conditions: Mental Health Issue conditions: Lifestyle Risk Reduction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: LvL UP name: LvL UP + MI name: Comparison measure: Mental well-being measure: Subjective well-being measure: Mental health (depression) measure: Mental health (stress) measure: Health-related quality of life measure: Health behaviours (physical activity) measure: Health behaviours (steps) measure: Health behaviours (diet 1) measure: Health behaviours (diet 2) measure: Health behaviours (sleep) measure: Health behaviours (smoking and alcohol consumption) measure: Anthropometry (body weight) measure: Anthropometry (body height) measure: Anthropometry (waist circumference) measure: Anthropometry (hip circumference) measure: Anthropometry (self-reported height and weight) measure: Resting blood pressure measure: Blood metabolic profile measure: LvL UP app: Response time measure: LvL UP app: Duration of app usage measure: LvL UP app: Actual usage of app components measure: LvL UP app: Coaching topic / sub-topic use measure: LvL UP app: Conversational turns measure: LvL UP app: Breeze (slow-paced breathing tool) usage measure: LvL UP app: Access to smartphone sensors (location - obfuscated) measure: LvL UP app: Access to smartphone sensors (location types) measure: LvL UP app: Access to smartphone sensors (raw gyroscope) measure: LvL UP app: Access to smartphone sensors (raw accelerometer) measure: LvL UP app: Access to smartphone sensors (physical activity) measure: LvL UP app: Access to smartphone sensors (WiFi connection status) measure: LvL UP app: Access to smartphone sensors (WiFi networks in range) measure: LvL UP app: Access to smartphone sensors (bluetooth scan) measure: LvL UP app: Access to smartphone sensors (battery % level and charging status) measure: LvL UP app: Access to smartphone sensors (screen on/off) measure: LvL UP app: Access to smartphone sensors (call and SMS metadata) measure: LvL UP app: Access to smartphone sensors (app usage & app name from notifications and action) measure: LvL UP app: Access to smartphone sensors (step count) measure: LvL UP app: Access to smartphone sensors (brightness) measure: LvL UP app: Access to smartphone sensors (breeze audio) measure: LvL UP app: Access to Apple Healthkit & Google Fit data measure: Process evaluation: Health literacy questionnaire measure: Process evaluation: Stages of change questionnaire measure: Process evaluation: Unintended consequences measure: Process evaluation (intervention group participants only): Net promoter score measure: Process evaluation (intervention group participants only): System usability scale measure: Process evaluation (intervention group participants only): Session alliance inventory measure: Process evaluation (intervention group participants only): Self-report habit index measure: Process evaluation (intervention group participants only): MITI-4 measure: Process evaluation (intervention group participants only): UMars measure: Process evaluation (intervention group participants only): Interview measure: Process evaluation (Research team): Field Notes measure: Exploratory aims: Sociodemographic measure: Exploratory aims: Use of digital health technologies measure: Exploratory aims: Ecologic Momentary Assessment of mood state measure: Exploratory aims: Personality measure: Exploratory aims: Work Engagement measure: Exploratory aims: Self-reported sickness absence sex: ALL minimumAge: 21 Years maximumAge: 59 Years stdAges: ADULT facility: Saw Swee Hock School of Public Health status: RECRUITING city: Singapore zip: 117549 country: Singapore name: Shenglin Zheng, MSc role: CONTACT email: [email protected] lat: 1.28967 lon: 103.85007 facility: Singapore ETH Center status: ACTIVE_NOT_RECRUITING city: Singapore zip: 138602 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06360016 id: Protocol-RAP briefTitle: Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs acronym: Protocol-RAP overallStatus: COMPLETED date: 2023-02-13 date: 2023-05-31 date: 2024-02-01 date: 2024-04-11 date: 2024-04-11 name: Selcuk University class: OTHER name: University of Malaga briefSummary: Protocol of Self Regulation in Early Learners: The Role of Recreational Activity Program (RAP) RAP, which included fun games and lasted 24 sessions, was applied to the students in the study group. Twenty-four sessions include games that help gain rhythm, balance, and patience. The program is planned according to the game theory model, which aims to have fun for children. The program, which aims to develop children's self-regulation skills based on the essential reflections of the model, will include fun games with simple rules. Before the program was implemented, the researchers informed the experimental group about the research and the program, and verbal consent was obtained from the participants. conditions: Self Regulation conditions: Impulsive conditions: Attention Difficulties conditions: Emotion Regulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pre and post-test with the control group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double (Investigator, Outcomes Assessor) whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Recreation Activity Program measure: Self-Regulation Assessment sex: ALL minimumAge: 5 Years maximumAge: 6 Years stdAges: CHILD facility: Selcuk University city: Konya zip: 42400 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06360003 id: SAHoWMU-CR2024-01-109 briefTitle: "Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin overallStatus: RECRUITING date: 2023-04-01 date: 2025-04-01 date: 2025-08-01 date: 2024-04-11 date: 2024-04-11 name: Second Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the identification of the origin of ventricular outflow tract. The secondary aim is to investigate, by using the new method, if it can optimize the procedure of radiofrequency catheter ablation.
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Researches will break the method of this investigation into two steps:
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First step have enrolled 100 patients. This step would be used to compare the results predicted by right ventricular outflow tract posterior septum pacing, with the previously used electrocardiographic criteria and actual target site.
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The second step will enroll another 100 patients. In this step, patients will be divided into two groups, one being the new protocol group and the other being the convention group. Patients will also be followed up, for 1 month and 3 months at outpatient clinic post procedure. Procedure time, success rate, fluoroscopy exposure time and complications, are compared between RVOT posterior septum pacing group and convention group. conditions: Ventricular Outflow Tract Ventricular Arrhythmias conditions: Radio Frequency Catheter Ablation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Right Ventricular Outflow Tract Posterior Septum Pacing name: systemic mapping and ablation measure: Rate of Immediate Ablation Success measure: Rate of Ablation Complication measure: Accuracy of RVOT posterior septal pacing protocol measure: Incidence of Complications Post-operative measure: Incidence of Complication measure: Rate of Recurrence during Follow up measure: Incidence of Complication measure: Rate of Recurrence during Follow up sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou state: Zhejiang zip: 325000 country: China name: Cheng Zheng, PhD role: CONTACT phone: 86-0577-85676609 email: [email protected] lat: 27.99942 lon: 120.66682 hasResults: False
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<|newrecord|> nctId: NCT06359990 id: RushUMCEmezue briefTitle: BrotherlyACT: A Culturally Congruent and Technology-Enhanced Youth Violence and Substance Use Intervention for Black Boys and Men acronym: BrotherlyACT overallStatus: RECRUITING date: 2024-02-15 date: 2026-02-15 date: 2026-02-15 date: 2024-04-11 date: 2024-04-11 name: Rush University Medical Center class: OTHER briefSummary: This study will adapt and test a culturally tailored, multi-component, and trauma-focused digital intervention to reduce the risk and effects of youth violence and substance use and bridge service access gaps for young Black males (YBM) in pediatric emergency and community-based low-resource settings. conditions: Violence in Adolescence conditions: Substance Use conditions: Avoidance of Healthcare studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: BrotherlyACT name: BrotherlyACT Waitlist Control Group (WCG) measure: The Reactive-Proactive Aggression Questionnaire (RPQ) measure: Multidimensional Peer Victimization Scale (MPVS) measure: The Alcohol Use Disorders Identification Test (AUDIT) measure: Drug Use Disorders Identification Test (DUDIT) measure: Change in Attitude toward Substance Use measure: Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) measure: The Kessler Psychological Distress Scale (K-10) measure: The University of Rhode Island Change Assessment Scale (URICA) measure: Intensity-of-Care Measurements measure: Violent Intentions-Teen Conflict Survey sex: MALE minimumAge: 15 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: Rush University Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Chuka N Emezue, PhD, MPH role: CONTACT phone: 312-942-6151 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06359977 id: YB-202442 briefTitle: The Effect of Quantitative EEG Combined With Ultrasound and Sputum Volume on Predicting Weaning Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-05-15 date: 2024-04-11 date: 2024-04-11 name: Qingdao University class: OTHER briefSummary: Neurocritical patients often face the need for removal of endotracheal tubes. However, despite following the extubation criteria for general critical ill patients, neurocritical patients still exhibit a higher rate of weaning failure, significantly higher than that of general critical ill patients. The extubation criteria for general critical patients emphasize the assessment of lung conditions. However, neurological critical patients often have less severe lung damage, but factors such as consciousness level and coughing ability may significantly influence extubation. Quantitative EEG serves as an objective tool to reflect consciousness level status, while bedside ultrasound can assess respiratory muscle function. Additionally, sputum volume may reflect the condition of lung condition. Therefore, we believe that combination of these three indicators can better predict the success of extubation for neurocritical patients. conditions: Weaning Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Quantitative EEG monitoring and beside ultrasound evaluation measure: Quantitative EEG indicators measure: Respiratory muscles thickness in centimeter measure: Respiratory muscles thickening fraction (%) measure: Sputum volume in milliliter sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06359964 id: CRE2023.195 briefTitle: Infective Complications in TP Biopsy Without Antibiotic Prophylaxis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-03-31 date: 2024-04-11 date: 2024-04-11 name: Chinese University of Hong Kong class: OTHER briefSummary: This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1900 type: ESTIMATED name: Transperineal Biopsy without antibiotics prophylaxis name: Transperineal Biopsy with antibiotics prophylaxis measure: The difference in UTI hospitalization rate between the two groups after biopsy measure: The difference in urosepsis rates between the two groups after biopsy measure: Post-biopsy UTI rates between the two groups measure: Assessment of bacteriology and antibiotic resistant profile between the two groups sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06359951 id: 24-0103 briefTitle: Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-02-01 date: 2026-01-31 date: 2024-04-11 date: 2024-04-11 name: Ann & Robert H Lurie Children's Hospital of Chicago class: OTHER name: American Psychological Association Division 53 Society for Clinical Child & Adolescent Psychology briefSummary: This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project YES leads to reductions in depression, anxiety and eating disorder symptoms. conditions: Depression conditions: Eating Disorders conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Project YES measure: Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Generalized Anxiety Disorder -7 (GAD-7) measure: Dietary Restriction Screener - 2 (DRS 2) measure: Adult State Hope Scale measure: Self-Hate Scale measure: Beck Hopelessness -4 measure: Program Feedback Scale sex: ALL minimumAge: 13 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Ann & Robert H Lurie Children's Hospital of Chicago city: Chicago state: Illinois zip: 60611 country: United States name: Anna M Ros, PhD role: CONTACT phone: 312-227-5433 email: [email protected] name: Lisa Kuhns, PhD role: CONTACT phone: 312-227-6119 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06359938 id: Cer22/01 briefTitle: Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF acronym: RSA-PACE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-11 date: 2024-04-11 name: Ceryx Medical Ltd class: INDUSTRY name: Cardiff and Vale University Health Board briefSummary: The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out.
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The main questions the trial aims to answer are:
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* Is the new type of pacemaker safe?
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* Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)?
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Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients. conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Atrial pacing with respiratory sinus arrhythmia (RSA) variability name: Monotonic right atrial overdrive pacing measure: Number of arrhythmia episodes per patient during pacing sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardiff & Vale University Health Board city: Cardiff zip: CF14 4XW country: United Kingdom name: Zaheer Yousef role: CONTACT email: [email protected] name: Avraj Virdi role: CONTACT lat: 51.48 lon: -3.18 hasResults: False
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<|newrecord|> nctId: NCT06359925 id: Suprazygomatic nerve block briefTitle: Suprazygomatic Nerve Block in Tonsillectomy Patients overallStatus: NOT_YET_RECRUITING date: 2024-10-22 date: 2025-09-20 date: 2026-02-20 date: 2024-04-11 date: 2024-04-11 name: Assiut University class: OTHER briefSummary: The use of suprazygomatic maxillary nerve block to reduce postoperative pain and hospital stay is greater than the use of NSAID and opioids. conditions: Tonsillectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine name: Suprazygomatic maxillary nerve block using Bupivacaine measure: time and amount of first postoperative rescue analgesia after two different blocks using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score measure: time and amount of first postoperative rescue analgesia after two different blocks using Paediatric Anaesthesia Emergence Delirium (PAED) scale measure: Parents satisfaction score sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06359912 id: CNYX-EPCs-002-1 briefTitle: Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-07 date: 2024-04-11 date: 2024-04-11 name: Allife Medical Science and Technology Co., Ltd. class: INDUSTRY name: First Affiliated Hospital Xi'an Jiaotong University briefSummary: The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound. conditions: Critical Limb Ischemia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: EPCs name: Clinical standard treatment (CST) measure: adverse events measure: Painless walking and intermittent claudication distance measure: Blood flow of the affected limb measure: Rutherford grade measure: The area of skin ulcer measure: Vascular Quality of Life Questionnaire-6 score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hui Shi status: RECRUITING city: Beijing state: Beijing country: China name: Shaoying Lu, Dr role: CONTACT phone: +862985323473 phoneExt: +862985323473 email: [email protected] name: Fanggang Li role: CONTACT phone: 86-18911352611 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06359899 id: AK0901-2001 briefTitle: A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-10 date: 2024-04-11 date: 2024-04-11 name: Shanghai Ark Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This study is a Phase 3, multicenter, dose-optimized, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity Disorder（ADHD）. conditions: ADHD studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: AK0901 capsule name: Placebo measure: To evaluate the efficacy of AK0901 compared to placebo in children 6 to 12 years old with ADHD. measure: Change from baseline in ADHD-RS-5 total score at Week 4. measure: Changes in ADHD-RS-5 inattention subscale score from baseline to each visit in the Double-Blind Treatment Period measure: Changes in ADHD-RS-5 hyperactivity/impulsivity subscale score from baseline to each visit in the Double-Blind Treatment Period. measure: Change in CGI-S score from baseline to each visit in the Double-Blind Treatment Period measure: CGI-I scores from V3 at each visit in the Double-Blind Treatment Period measure: Change in WREMB-R score from baseline to each visit in the Double-Blind Treatment measure: Proportion of subjects with adverse events (AEs) occurring during the study measure: Proportion of subjects with serious adverse events (SAEs) occurring during the study measure: Changes in respiratory rate during the study measure: Changes in heart rate during the study measure: Changes in body temperature during the study measure: Changes in systolic blood pressure during the study measure: Changes in diastolic blood pressure during the study measure: Change from baseline in QT intervals from resting EKGs measure: Change from baseline in QTcF intervals from resting EKGs measure: Change from baseline in heart rate resting EKGs measure: Change from baseline in QRS intervals from resting EKGs measure: Change from baseline in PR intervals from resting EKGs measure: Change in CSHQ score from baseline to each visit in the Double-Blind Treatment Period sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Beijing anding hospital capital medical university city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking university sixth hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06359886 id: FMASU MD 292/2022 briefTitle: B-lynch Transverse Compression Suture overallStatus: RECRUITING date: 2024-03-20 date: 2025-04 date: 2025-09 date: 2024-04-11 date: 2024-04-11 name: Alexandria University class: OTHER briefSummary: Is B-Lynch transverse compression suture safe and effective in controlling excessive blood loss during conservative management of women with placenta previa? conditions: Blood Loss, Surgical studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A Pilot Study primaryPurpose: PREVENTION masking: NONE count: 25 type: ESTIMATED name: B-Lynch Transverse Compression Suture measure: Intraoperative blood loss measure: Postoperative blood loss measure: Number of received blood components measure: Peripartum haemoglobin level drop sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ain Shams University status: RECRUITING city: Cairo zip: 21526 country: Egypt name: Ahmed S Zeerban, Msc role: CONTACT phone: +201003119968 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06359873 id: LAD-AF briefTitle: Left Atrial Enlargement: A Crucial Indicator for Identifying Atrial Fibrillation in Patients With Hypertension overallStatus: COMPLETED date: 2022-05-01 date: 2022-09-30 date: 2023-05-01 date: 2024-04-11 date: 2024-04-11 name: The Second Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: Based on the data of inpatients with hypertension and a cross-sectional study with a large sample size, this study aims to find the early warning value of the left anteroposterior atrial diameter for the possible occurrence of atrial fibrillation in patients with hypertension, and compare the advantages and disadvantages of the above two methods for the early warning of the risk of atrial fibrillation in patients with hypertension, so as to achieve the purpose of early identification of high-risk groups that may develop atrial fibrillation. conditions: Atrial Fibrillation conditions: Hypertension,Essential conditions: Left Atrial Dilatation studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 58427 type: ACTUAL name: CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD) measure: left atrial diameter (LAD) measure: CHA2DS2-VASc score measure: C2HEST score measure: Atrial fibrillation (AF) measure: Area under the curve (AUC) of LAD and occurrence of AF measure: AUC of CHA2DS2-VASc score and occurrence of AF measure: AUC of C2HEST score and occurrence of AF measure: the LAD cutoff value sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 2ndChongqingMU city: Chongqing state: Chongqing zip: 400010 country: China lat: 29.56278 lon: 106.55278 hasResults: False
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<|newrecord|> nctId: NCT06359860 id: ST-1898-203 briefTitle: A Study of ST-1898 for Unresectable or Metastatic Melanoma overallStatus: RECRUITING date: 2023-11-07 date: 2025-09 date: 2025-09 date: 2024-04-11 date: 2024-04-11 name: Beijing Scitech-Mq Pharmaceuticals Limited class: INDUSTRY briefSummary: ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in subjects with unresectable or metastatic melanoma.
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In phase Ib, the primary objectives are to assess the safety and tolerability, and to determine Recommended Phase 2 dose (RP2D) of ST-1898 tablets in subjects with unresectable or metastatic melanoma. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy.
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In phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in subjects with unresectable or metastatic melanoma. The secondary objective is to evaluate the safety of ST-1898 tablets. conditions: Unresectable or Metastatic Melanoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: ST-1898 tablets measure: Phase Ib Dose Escalation: The Number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs) measure: Phase Ib Dose Escalation: Recommended Phase 2 Dose (RP2D) measure: Phase II Expansion: Objective Response Rate (ORR) measure: Phase Ib Dose Escalation: Trough concentration of ST-1898 measure: Phase Ib Dose Escalation: Peak concentration of ST-1898 measure: Phase Ib Dose Escalation: ORR measure: Phase Ib Dose Escalation: PFS measure: Phase Ib Dose Escalation: DoR measure: Phase Ib Dose Escalation: DCR measure: Phase Ib Dose Escalation: TTP measure: Phase II Dose Expansion: The Number and frequency of treatment-related adverse events and serious adverse events (SAEs) measure: Phase II Dose Expansion: Trough concentration of ST-1898 measure: Phase II Dose Expansion: Peak concentration of ST-1898 measure: Phase II Dose Expansion: PFS measure: Phase II Dose Expansion: DoR measure: Phase II Dose Expansion: DCR measure: Phase II Dose Expansion: TTP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Cancer Hospital & Institute status: RECRUITING city: Beijing zip: 100142 country: China name: Jun GUO, MD role: CONTACT phone: 0086-10-88121122 email: [email protected] name: Chuanliang CUI, MD role: CONTACT phone: 0086-10-88196348 email: [email protected] name: Jun GUO, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06359847 id: ST-1898-202 briefTitle: Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer overallStatus: RECRUITING date: 2023-11-15 date: 2025-12 date: 2025-12 date: 2024-04-11 date: 2024-04-11 name: Beijing Scitech-Mq Pharmaceuticals Limited class: INDUSTRY briefSummary: ST-1898, a multi-targeted tyrosine kinase inhibitor, has demonstrated strong inhibitory activity for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT, etc. The primary purpose of this study is to evaluate the efficacy of ST-1898 tablets in patients with locally advanced or metastatic RAIR-DTC after failure of at least first-line TKI systemic therapy. All subjects will receive ST-1898 180 mg orally once daily until disease progression or intolerable toxicity. conditions: Differentiated Thyroid Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: ST-1898 tablets measure: Objective Response Rate (ORR) measure: The number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs) measure: PFS measure: PFS6m measure: DCR measure: DOR measure: OS measure: Thyroglobulin (Tg) measure: Thyroglobulin Antibody (TgAb) measure: Pharmacokinetic (PK) Parameter: Tmax measure: Pharmacokinetic (PK) Parameter: T1/2 measure: Pharmacokinetic (PK) Parameter: Cmax measure: Pharmacokinetic (PK) Parameter: AUC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Yansong Lin, MD role: CONTACT name: Xin Zhang, MD role: CONTACT name: Yansong Lin, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06359834 id: 4-2023-1693 briefTitle: Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography overallStatus: RECRUITING date: 2024-04-10 date: 2025-04-10 date: 2025-04-30 date: 2024-04-11 date: 2024-04-11 name: Yonsei University class: OTHER briefSummary: Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for endoscopic retrograde cholangiopancreatography. conditions: Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 112 type: ESTIMATED name: Remimazolam besylate name: Propofol measure: Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine status: RECRUITING city: Seoul zip: 120-752 country: Korea, Republic of name: Moon Jae Chung, MD role: CONTACT phone: +82-2-2228-1981 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06359821 id: Z-001 briefTitle: Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry in Metastatic Castration Resistant Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2025-04-15 date: 2026-04-15 date: 2024-04-11 date: 2024-04-12 name: Sichuan University class: OTHER briefSummary: A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting Radiopharmaceutical, in metastatic castration resistant prostate cancer conditions: Metastatic Prostate Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 5 type: ESTIMATED name: ZA-001 measure: The absorbed radiation doses (Gray [Gy] /Megabecquerel [MBq] )for whole body and organ measure: Adverse Event sex: MALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06359808 id: KY20232370 briefTitle: Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-11 date: 2024-04-11 name: Xijing Hospital class: OTHER briefSummary: Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients. conditions: Colitis, Ulcerative conditions: Sleep Quality conditions: Gastrointestinal Microbiome conditions: Autonomic Nervous System Imbalance studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 152 type: ESTIMATED measure: Pittsburgh Sleep Quality Index (PSQI) measure: Disease activity measure: Heart Rate Variability (HRV) measure: Functional Magnetic Resonance Imaging measure: Neurotransmitter Agents measure: Gastrointestinal Microbiome measure: Patient Health Questionnaire (PHQ-9) measure: Generalized Anxiety Disorder (GAD-7) measure: Inflammatory Bowel Diseases Questionnaire (IBDQ) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06359795 id: FAPI-TED briefTitle: Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease overallStatus: RECRUITING date: 2023-12-15 date: 2027-12-31 date: 2027-12-31 date: 2024-04-11 date: 2024-04-11 name: Peking University Third Hospital class: OTHER briefSummary: FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED. conditions: Thyroid Eye Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT measure: Diagnostic accuracy measure: The value to predict therapy response measure: Diagnostic accuracy comparison measure: FAPI expression and SUV metrics sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dept. of Nuclear Medicine, Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Hui Li, Dr. role: CONTACT phone: 86-13121136769 email: [email protected] name: Lingge Suo, Dr. role: CONTACT phone: 86-010-82264935 email: [email protected] name: Hui Li, Dr. role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06359782 id: NL76082.058.20 briefTitle: Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH) acronym: CIAO@SAH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02 date: 2027-02 date: 2024-04-11 date: 2024-04-11 name: Haaglanden Medical Centre class: OTHER name: Leiden University Medical Center name: Takeda briefSummary: Aneurysmal subarachnoid hemorrhage (SAH) can lead to devastating outcomes for patients, like cognitive decline. This is caused by early brain injury (EBI) followed by delayed cerebral ischemia (DCI). Neuroinflammation, triggered by the complement system, has been investigated to be a key mediator in the pathophysiology of EBI and DCI. Inhibition of the complement system is therefore considered to be a potentially important new treatment for SAH.
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This trial aims to study the safety and efficacy of C1-inhibitor Cinryze, an approved inhibitor of the complement system, compared to placebo in patients with SAH. By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response. conditions: Subarachnoid Hemorrhage, Aneurysmal studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, multicenter, randomized, double-blind, placebo-controlled, phase II trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: C1 Esterase Inhibitor Injection [Cinryze] name: Placebo measure: Number of participants with delayed cerebral ischemia (DCI) measure: Number of participants with complications during hospitalization. measure: Number of participants with cerebral infarction on brain CT measure: Number of participants dying measure: Neurological condition measured by Glasgow Coma Scale measure: Complement activity markers measured in serum and CSF measure: Inflammatory markers measured in serum and CSF measure: Number of days in the hospital measure: Number of ICU days measure: Number of ventilator days measure: Clinical outcome measure: Clinical outcome measure: Clinical outcome measure: Clinical outcome measure: Clinical outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06359769 id: GROUPCET briefTitle: Group Cognitive Evolutionary Therapy for Depression acronym: GRCET overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-11 date: 2024-04-11 name: University of Bucharest class: OTHER briefSummary: The goal of this clinical trial is to measure the effects of Group Cognitive Evolutionary Therapy on mental health, especially on depressive symptoms and anxiety.
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Participants will be allocated in one of two conditions: (1) Group Cognitive Evolutionary Therapy (intervention) or (2) Waitlist. The intervention will consist of two 8-hour sessions of Group Cognitive Therapy, in two consecutive days.
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The Group Cognitive Evolutionary Therapy group will be compared to the waitlist group to test the efficacy of the intervention. conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Group Cognitive Evolutionary Therapy measure: Depressive symptomatology measure: Anxiety symptomatology measure: Sleep quality measure: Perceived stress measure: Social provisions measure: Satisfaction with life measure: Self-perceived mate value sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06359756 id: BRAIN-SAVE1 briefTitle: Ischemic Postconditioning in Carotid Surgery acronym: BRAIN-SAVE overallStatus: RECRUITING date: 2023-09-01 date: 2024-05-01 date: 2024-09-01 date: 2024-04-11 date: 2024-04-12 name: Institute for Cardiovascular Diseases "Dedinje" class: OTHER briefSummary: Analyzing changes in cerebral oximetry, transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (IPCT). conditions: Ischemic Postconditioning conditions: Carotid Surgery conditions: Stroke conditions: Carotid Artery Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 250 type: ESTIMATED name: Ischemic postconditioning in carotid surgery name: Eversion Carotid Endarterectomy measure: Number of Participants with perioperative stroke measure: Number of Participants with perioperative death sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Cardiovascular Diseases Dedinje status: RECRUITING city: Belgrade zip: 11000 country: Serbia name: Jovan Petrović, MD role: CONTACT phone: +381113601705 email: [email protected] name: Slobodan Pešić, MD role: SUB_INVESTIGATOR lat: 44.80401 lon: 20.46513 hasResults: False
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<|newrecord|> nctId: NCT06359743 id: 271/7 briefTitle: Ultrasound Guided QLB Versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia After Laparoscopic Hysterectomy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-11 date: 2024-04-11 name: Zagazig University class: OTHER_GOV briefSummary: Pain following laparoscopic hysterectomy may interfere with early ambulation, discharge of patient from hospital and interfere with enhanced recovery with more opioid consumption. Most of methods for postoperative pain depend on the use of high doses of opioids with more side effects such as nausea, vomiting, respiratory center depression, delay bowel motility and hemodynamics instability. To decrease of opioid consumption in postoperative pain management as well as related side effects, previous studies showed that quadratus lumborum block or superior hypogastric plexus block (SHPB) had shown promising success in management of postoperative pain in patients undergoing laparoscopic hysterectomy. The present study will be conducted to compare of ultrasound guided QL block and laparoscopic superior hypogastric plexus block as a part of multimodal analgesia may allow adequate analgesia and decrease the overall use of opioids and allow patient enhanced recovery. conditions: Post Hysterectomy Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 34 type: ESTIMATED name: Quadratus Lamborum versus superior hypogatric measure: Opioid consumption decrease sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of medicine, Zagazig university city: Zagazig state: Sharkia country: Egypt lat: 30.58768 lon: 31.502 hasResults: False
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<|newrecord|> nctId: NCT06359730 id: 253/26-March-2024 briefTitle: Incidence and Risk Factors of Low Anterior Resection Syndrome overallStatus: COMPLETED date: 2017-12-01 date: 2022-12-01 date: 2022-12-01 date: 2024-04-11 date: 2024-04-11 name: Zagazig University class: OTHER_GOV briefSummary: Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.
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With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 120 type: ACTUAL name: LARS score questionnaire measure: age measure: sex measure: medical disease measure: site of tumor measure: neoadjuvant therapy measure: site of anastmosis measure: type of meso-rectal excision measure: adjuvant therapy measure: type of surgery measure: type of anastmosis measure: LARS score sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Zagazig University Hospitals city: Zagazig zip: 44519 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False
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<|newrecord|> nctId: NCT06359717 id: ZU-10490 briefTitle: Prospective Validation of PSMA-RADS acronym: PSMA-RADS overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-04-10 date: 2024-04-20 date: 2024-04-11 date: 2024-04-11 name: Zagazig University class: OTHER_GOV briefSummary: This is a prospective, multicenter study aimed at evaluating the diagnostic accuracy and reliability of the Prostate-Specific Membrane Antigen Reporting and Data System (PSMA-RADS) version 1.0 in detecting prostate cancer using 68Ga-PSMA-11 PET/CT imaging. The study also compared the performance of PSMA-RADS v1.0 with the updated version 2.0.
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Key points:
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* 186 patients with newly diagnosed or recurrent prostate cancer underwent 68Ga-PSMA-11 PET/CT imaging.
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* Three radiologists independently evaluated the scans and assigned PSMA-RADS scores using v1.0, then retrospectively using v2.0.
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* Diagnostic accuracy was assessed against histopathology and follow-up imaging as reference standards.
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* Inter-rater agreement was evaluated using Fleiss\' kappa statistic.
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* The study aimed to validate the diagnostic utility of PSMA-RADS v1.0 and compare it to the updated v2.0. conditions: Cancer Prostate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 208 type: ESTIMATED measure: Diagnostic Accuracy of PSMA-RADS v1.0 and v2.0 measure: Inter-rater Agreement of PSMA-RADS v1.0 and v2.0 sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohammad Abd Alkhalik Basha city: Zagazig state: Select zip: 44631 country: Egypt lat: 30.58768 lon: 31.502 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-21 uploadDate: 2024-04-05T07:38 filename: Prot_SAP_000.pdf size: 692777 hasResults: False
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<|newrecord|> nctId: NCT06359704 id: kevinszc briefTitle: Intervention for Emotions in Caregivers of Dementia overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-01 date: 2025-02-01 date: 2024-04-11 date: 2024-04-12 name: The University of Hong Kong class: OTHER briefSummary: This study aims to evaluate the effectiveness of a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes). conditions: BPSD conditions: Expressed Emotion conditions: Depressive Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: controlled arm with waitlist treatment primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Caregivers Of dementia Processing Emotions (COPE) program measure: Expressed emotions measure: depressive symptoms measure: social dynamics measure: BPSD sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06359691 id: 4UH3HL154302 type: NIH link: https://reporter.nih.gov/quickSearch/4UH3HL154302 id: 4UH3HL154302 type: NIH link: https://reporter.nih.gov/quickSearch/4UH3HL154302 briefTitle: Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-06 date: 2024-04-11 date: 2024-04-12 name: University of California, Los Angeles class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of the study is to promote equitable hypertension (HTN) management across the diverse patient population found in Los Angeles County Department of Health Services (LAC DHS) clinics.
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To achieve this goal, the study team will conduct provider- and patient-focused outreach strategies to understand how to best support adoption of blood pressure management practices already available within LAC DHS.
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LAC DHS clinics will be randomly assigned to one of three study conditions: 1) provider-focused outreach, 2) patient-focused outreach, and 3) usual outreach. The study will occur across 3 years with patient- and provider-focused outreach occurring in Year 1 and 2. In Year 3, study initiated patient- and provider-focused outreach will stop, and clinic use of patient- and provider-focused outreach practices will be observed by the study team.
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Provider-focused outreach includes increasing cultural awareness of factors that hinder and support blood pressure control, increasing access to blood pressure medications, and providing blood pressure management education. Patient-focused outreach includes using culturally sensitive educational materials and reminders to improve patient understanding of blood pressure, education on how to manage the condition, and increasing awareness of available blood pressure management resources. Clinics assigned to the usual outreach condition will operate as per usual in Year 1 but will receive patient- and provider-focused outreach in Year 2. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Three-armed crossover trial design to test effectiveness and sustainment of our implementation strategies across LAC DHS clinics and the communities they serve. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 540 type: ESTIMATED name: Patient-focused strategies name: Provider-focused strategies name: Patient- and provider-focused strategies measure: Overall provider adoption of evidence based practices measure: Provider/Care Team EBP Acceptability, Appropriateness, Feasibility measure: Blood Pressure (BP) Control sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Olive View-UCLA Medical Center city: Sylmar state: California zip: 91342 country: United States name: Soma Wali, MD role: CONTACT phone: 747-210-3205 email: [email protected] lat: 34.30778 lon: -118.44925 hasResults: False
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<|newrecord|> nctId: NCT06359678 id: NL85844.015.23 briefTitle: The Northstar Trial acronym: Northstar overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2025-01-01 date: 2024-04-11 date: 2024-04-11 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: The introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. The introduction of the NorthStar software as an active tracking system holds promise for improving the precision and efficiency of catheter manipulation during these procedures. However, a rigorous evaluation of its accuracy and reliability in a clinical setting is crucial to validate its viability.
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The objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy. conditions: Flutter, Atrial studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: NorthStar measure: Accuracy of Catheter Localization measure: Influences of breathing pattern measure: Influences of procedure duration measure: Influences of complications during ablation measure: Influences of patient characteristics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam country: Netherlands name: Marco Gotte role: CONTACT lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06359665 id: HSR230544 briefTitle: Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-11 date: 2024-04-11 name: Brent DeGeorge class: OTHER briefSummary: The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis. Turmeric is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for thumb-joint arthritis. The main question\[s\] it aims to answer are:
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* Is Turmeric more effective than placebo at relieving pain for thumb-joint arthritis? A placebo is a look-alike substance that contains no active drug.
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* Is Turmeric more effective than placebo at improving patient-reported outcomes for CMC arthritis?
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* Is Turmeric safe for participants with thumb-joint arthritis?
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Participants will:
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* take 4 weeks of daily Turmeric capsules,
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* take 4 weeks of daily placebo capsules
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* answer daily surveys about how they are feeling and functioning. conditions: Arthritis of Carpometacarpal Joint of Left Thumb conditions: Arthritis of Carpometacarpal Joint of Right Thumb studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study design will be a double-blind, randomized controlled trial with crossover. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind Randomized Controlled Trial whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Curcumin name: Placebo measure: Change from Baseline in Pain on the Visual Analog Pain (VAS) Score measure: Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - crossover condition measure: Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score measure: Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition measure: Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score measure: Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - crossover condition measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - crossover condition measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score measure: Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index measure: Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index measure: Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH). measure: Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover condition measure: Change from Baseline in perseverance on the Brief Resilience Index (BRI) measure: Change from Baseline in perseverance on the Brief Resilience Index (BRI) - crossover condition measure: Number of Participants With Treatment-Related Adverse Events measure: Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure measure: Change from Baseline in heart rate measure: Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure measure: Change from Baseline in heart rate measure: Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST) measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: estimated glomerular filtration rate (eGFR) measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR) measure: Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets measure: Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin measure: Change from baseline in serum complete blood count (CBC) parameters: Hematocrit measure: Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV) measure: Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06359652 id: IRB24-0421 briefTitle: Get Fit for Function overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-04 date: 2029-04 date: 2024-04-11 date: 2024-04-11 name: University of Chicago class: OTHER briefSummary: The purpose of this study will be to implement and evaluate a prehab program for pre-frail and frail adults who need to undergo thoracic surgery. The study team hypothesizes using an implementation framework will increase the reach, effectiveness, adoption, and implementation of the prehab program. conditions: Thoracic conditions: Frailty studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 100 type: ESTIMATED name: Prehabilitation Program (Apple Watch Series 6 with exercise flipbook) measure: The change of functional status using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework for implementation evaluation. measure: Number of Participants with Postoperative Complications measure: Number of Participants length of hospital stay post-operative. measure: Number of Participants discharge to not-home post-operative. sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Chicago city: Chicago state: Illinois zip: 60637 country: United States name: Viviana Camacho role: CONTACT phone: 773-795-4391 email: [email protected] name: Leila Yazdanbakhsh role: CONTACT phone: 773-834-5087 email: [email protected] name: Maria Madariaga, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06359639 id: USM/JEPeM/KK/23080645 briefTitle: Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth Among Malaysian Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-04-11 date: 2024-04-11 name: Michelle Choong Poh Kin class: OTHER briefSummary: The goal of this clinical trial is to assess the effectiveness of cognitive restructuring in reducing breakup distress and promoting personal growth among Malaysian young adults. Cognitive restructuring is a therapy skill that focuses on changing unhelpful thoughts. The main question it aims to answer is: Are there differences in their breakup distress and personal growth after receiving cognitive restructuring compared to counselling? Participants will receive five online sessions of either cognitive restructuring or counselling. Data on participants' breakup distress and personal growth will be collected before and after completion of sessions. The hypothesis is that cognitive restructuring will reduce breakup distress and increase personal growth more than counselling. conditions: Breakup Distress conditions: Posttraumatic Growth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Cognitive restructuring name: Supportive counselling measure: Breakup distress measure: Posttraumatic growth sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06359626 id: YHP2205 briefTitle: Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-07-09 date: 2024-07-19 date: 2024-07-24 date: 2024-04-11 date: 2024-04-11 name: Yuhan Corporation class: INDUSTRY briefSummary: A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: two-way crossover primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: YHP2205 name: YHR2401 measure: Area under the plasma drug concentration-time curve [AUCt] measure: Maximum plasma concentration [Cmax] measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] measure: Time of peak concentration [Tmax] measure: Terminal phase of half-life [t1/2] sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06359613 id: 029/IRC/BMR briefTitle: Efficacy Assessment of Gluten Free Cupcakes overallStatus: COMPLETED date: 2019-10-03 date: 2019-12-15 date: 2020-01-03 date: 2024-04-11 date: 2024-04-22 name: University of Veterinary and Animal Sciences, Lahore - Pakistan class: OTHER briefSummary: Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria (n=70, 35 control group +35 intervention group, 3-8years of age). After consumer acceptance against various attributes of aglutenic cupcake, the product will be provided in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2 cupcakes for each day) providing approximately 20% daily value (DV) of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group. Further product will be provided on follow-up visits. The compliance to a gluten free diet GFD and supplemented product will be confirmed by a Food Frequency Questionnaire (FFQ). conditions: Celiac Disease in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The product will be provided to intervention group (n=50) in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2/day) providing approximately 20%DV of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group (n=50) primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 75 type: ACTUAL name: nutrient rich food product name: food product measure: Body Weight measure: Height of the patients measure: Mid upper Arm Circumference (MUAC) measure: Body Mass Index (BMI) measure: Complete Blood Count (CBC) measure: Total Protein measure: Lipid Profile measure: Liver Enzymes measure: Serum Electrolytes measure: Gastrointestinal Symptoms sex: ALL minimumAge: 3 Years maximumAge: 8 Years stdAges: CHILD facility: UVAS city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06359600 id: HS-10501-101 briefTitle: A Study of HS-10501 Tablets in Healthy Subjects overallStatus: RECRUITING date: 2024-03-14 date: 2025-01-31 date: 2025-06-30 date: 2024-04-11 date: 2024-04-11 name: Jiangsu Hansoh Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects. This is the first clinical study of HS-10501 tables. This study has 2 parts. Parts A involve a single dose of HS-10501 tables or placebo and will last about 8 days. Also, this part will also further explore the food effect. Parts B involve multiple doses of HS-10501 tables or placebo and will last about 4 weeks. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 84 type: ESTIMATED name: HS-10501 tablet name: Placebo measure: Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment. measure: Number of participants with clinically significant abnormalities in lab tests measure: Number of participants with clinically significant change from baseline in vital signs measure: Change from baseline in Electrocardiogram (ECG) measure: Pharmacokinetic (PK) profile of HS-10501 - AUC0-t measure: Pharmacokinetic (PK) profile of HS-10501 - AUC0-∞ measure: Pharmacokinetic (PK) profile of HS-10501 - Cmax measure: Pharmacokinetic (PK) profile of HS-10501 - Tmax measure: Pharmacokinetic (PK) profile of HS-10501 - t1/2 measure: Pharmacokinetic (PK) profile of HS-10501 - CL/F measure: Pharmacokinetic (PK) profile of HS-10501- Vz/F measure: Pharmacokinetic (PK) profile of HS-10501-λz measure: Pharmacokinetic (PK) profile of HS-10501- AUC0-τ measure: Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood glucose-time curve after oral glucose tolerance test (OGTT) measure: Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood insulin-time curve after oral glucose tolerance test (OGTT) measure: body weight changes sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The second hospital of Anhui University status: RECRUITING city: Hefei state: Anhui zip: 230601 country: China name: Wei Hu, MD role: CONTACT phone: 13856086475 email: [email protected] lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06359587 id: H22-03005 briefTitle: Re-Purposing the Ordering of Routine Laboratory Tests in Hospitals in British Columbia acronym: RePORT-BC overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2026-10-01 date: 2026-10-01 date: 2024-04-11 date: 2024-04-15 name: University of British Columbia class: OTHER name: Providence Health & Services name: Vancouver Coastal Health name: Fraser Health name: Interior Health name: Northern Hospital, Australia name: Canadian Institutes of Health Research (CIHR) name: Island Health briefSummary: The goal of this stepped-wedge cluster randomized trial is to assess the impact of a laboratory test overuse intervention bundle on laboratory test utilization in 6 health authorities (16 hospitals) in British Columbia. The main question it aims to answer is if the intervention bundle, inclusive of healthcare provider and patient engagement tools, can be effectively implemented for hospitalized medical inpatients in 16 hospitals across BC and reduce laboratory test over-use. Researchers will compare hospital clusters that receive the intervention at different (sequential) time points to see if there are significant changes in the measured outcomes after the intervention. conditions: Hospital Acquired Condition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Intervention Arm (Intervention Bundle Implementation):
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This arm involves the time periods where hospital units are actively receiving the intervention bundle, including healthcare provider (HCP) and patient engagement tools.
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Control Arm (No Intervention Bundle Implementation):
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This arm represents the time periods when the hospital units do not receive the intervention bundle. This time period is the control period. Each hospital will contribute to intervention and control period data. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 700000 type: ESTIMATED name: Laboratory test overuse (LTO) Bundle measure: Change in number of target laboratory tests ordered per patient-day with LTO bundle compared to control period without LTO bundle measure: Change in number of total laboratory tests ordered per patient-day with the LTO bundle measure: Rate of hospital re-admissions and mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06359574 id: IRB-24-0209 briefTitle: Core Competency Model for Corrections acronym: CCM-C overallStatus: ENROLLING_BY_INVITATION date: 2024-04-05 date: 2024-12-31 date: 2025-01-30 date: 2024-04-11 date: 2024-04-16 name: University of North Carolina, Charlotte class: OTHER name: North Carolina Department of Adult Corrections name: North Carolina Department of Health and Human Services briefSummary: The overall goal of this project is to design, implement, and revise the Core Competency Model for Corrections (CCM-C), an evidence-based Self-Directed Violence (SDV) prevention training program for correctional mental health providers in the North Carolina Department of Adult Corrections (DAC). The proposed specific aims are:
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Aim 1: To create the CCM-C training program. Aim 2: To assess preliminary training effectiveness. Aim 3: To gather training program quality improvement feedback from corrections stakeholders. conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Core Competency Model for Corrections (CCM-C) Self-Directed Violence Prevention Training measure: Feasibility measure: Acceptability measure: Appropriateness measure: Usability measure: Perceived self-directed violence prevention skills measure: Willingness to intervene with a suicidal person measure: Beliefs about incarcerated persons engaging in self-directed violence measure: Self-directed violence prevention knowledge measure: Perceived importance of training measure: Compassion fatigue: Job burnout measure: Compassion fatigue: Traumatic stress sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: North Carolina Department of Adult Corrections city: Raleigh state: North Carolina zip: 27699 country: United States lat: 35.7721 lon: -78.63861 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-14 uploadDate: 2024-03-20T14:21 filename: ICF_000.pdf size: 256435 hasResults: False
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<|newrecord|> nctId: NCT06359561 id: 2023-2201 - Cervical lead briefTitle: Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Patients With Cervical Lead Placement overallStatus: ENROLLING_BY_INVITATION date: 2023-10-05 date: 2025-12-31 date: 2025-12-31 date: 2024-04-11 date: 2024-04-11 name: Rijnstate Hospital class: OTHER name: Saluda Medical Pty Ltd briefSummary: This observational, prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with cervical lead placement. conditions: Chronic Pain Syndrome conditions: Multi Focal Pain conditions: Failed Neck Surgery Syndrome conditions: Polyneuropathies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: cervical lead placement measure: Pain intensity in pain region(s) of pain using the 11-box pain numeric rating scale (NRS) measure: Pain distribution using Patient Reported Dermatomal Coverage Map measure: Assessment of holistic outcomes: quality of life in seven domains (physical function, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance) assessed by the PROMIS-29 questionnaire measure: Pain-related medication intake. measure: Programming parameters. measure: Programming parameters. measure: Evaluate stimulation sensation (awareness and quality) measure: Evaluate stimulation coverage in pain region(s) measure: Posture Change Measurements sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rijnstate Hospital city: Arnhem state: Gelderland zip: 6815AD country: Netherlands lat: 51.98 lon: 5.91111 hasResults: False
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<|newrecord|> nctId: NCT06359548 id: XH-24-002 briefTitle: PEELED INTERNAL LIMITING MEMBRANE REPOSITION overallStatus: RECRUITING date: 2024-04-15 date: 2026-06 date: 2026-11 date: 2024-04-11 date: 2024-04-11 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling. conditions: Macular Holes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Peeled ILM Reposition name: ILM Peeling measure: The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively measure: The MH closure rate measure: The range of inner retinal dimpling measure: Postoperative retinal thickness measure: The fixation stability and sensitivity threshold measure: mfERG P1 wave density amplitudes measure: M-score values measure: NEI-VFQ-25 questionnaire scores sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School status: RECRUITING city: Shanghai country: China name: Tian Tian, Dr. role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06359535 id: HSK21542-IIT-02 briefTitle: An Economic Study of HSK21542 Injection for Prevention of Postoperative Nausea and Vomiting overallStatus: RECRUITING date: 2024-02-23 date: 2024-11-06 date: 2024-11-06 date: 2024-04-11 date: 2024-04-11 name: Mengchang Yang class: OTHER briefSummary: This study analyzed the efficacy and safety results of HSK21542 injection for the prevention of postoperative nausea and vomiting in a multicentre, randomized, double-blind, placebo-controlled dose-exploration study, as well as the real-world clinical routine use of troisisone and other (not limited to other setron drugs) for the prevention of postoperative nausea and vomiting and related adverse reaction treatment data. It was transformed into an effect indicator, and the possible costs involved in the study were analyzed, reasonable price parameters of HSK21542 injection were set, and the economic value of HSK21542 was explored. conditions: Nausea and Vomiting, Postoperative studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: HSK21542 name: Placebo measure: Total direct medical costs, direct non-medical costs, indirect costs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital status: RECRUITING city: Chengdu state: Sichuan country: China name: Mengchang Yang, Doctor role: CONTACT phone: +8618140049936 email: [email protected] name: Mengchang Yang role: PRINCIPAL_INVESTIGATOR name: Yu He role: SUB_INVESTIGATOR name: Mengxia Lan role: SUB_INVESTIGATOR name: Ai Wei role: SUB_INVESTIGATOR name: Lina Yang role: SUB_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06359522 id: 22.0334 briefTitle: PDA Occlusion Using NIRS overallStatus: RECRUITING date: 2023-04-18 date: 2025-03-31 date: 2025-09-30 date: 2024-04-11 date: 2024-04-11 name: University of Louisville class: OTHER name: Norton Healthcare briefSummary: Our study will be a prospective observational study of all patients in the Norton Children's Hospital NICU (Neonatal Intensive Care Unit) who undergo a transcatheter PDA occlusion or medical closure of PDA to compare the two populations regarding changes in organ perfusion determined by using NIRS monitoring to follow the regional saturation of oxygen (rSO2) of the cerebral and renal regions. We suspect that medical treatment will have no significant change in rSO2 as described in previous literature. We also suspect that transcatheter occlusion will have minimal effects on rSO2 and be comparable to medical therapy. conditions: Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients who are being treated for PDA closure either via transcatheter occlusion or medical closure as part of routine care are eligible for this study. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: NIRS monitor measure: Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings. measure: Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol. measure: Compare rates of co-morbid conditions between the two groups such as but not limited to necrotizing enterocolitis, feedings intolerance, or failed to extubate within 5 days post treatment. sex: ALL minimumAge: 0 Months maximumAge: 3 Months stdAges: CHILD facility: Norton Children's Hospital status: RECRUITING city: Louisville state: Kentucky zip: 40202 country: United States name: Scott D Duncan, MD role: CONTACT phone: 502-629-5283 email: [email protected] name: Janice E. Sullivan, MD role: CONTACT phone: 502-629-5283 email: [email protected] name: Joshua D Kurtz, MD role: SUB_INVESTIGATOR name: Joshua Lee, MD role: SUB_INVESTIGATOR name: John N Juneau, MD role: SUB_INVESTIGATOR lat: 38.25424 lon: -85.75941 hasResults: False
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<|newrecord|> nctId: NCT06359509 id: SYS6020-001 briefTitle: Study of SYS6020 in BCMA-positive Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-05 date: 2032-05 date: 2024-04-11 date: 2024-04-11 name: Wuhan Union Hospital, China class: OTHER briefSummary: This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for MM. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: BCMA Targeted CAR T-cells measure: Incidence of adverse events (AEs) measure: Dose limiting toxicities (DLTs) measure: Overall response rate (ORR) measure: Percentage of subjects who achieved complete response or strict complete response (CR/sCR) measure: Percentage of subjects who achieved very good partial response (VGPR) and higher response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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