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Participants will attend the Virtual Reality training program. Researchers will compare the use of high-fidelity simulation to see if the non-technical skills were developed. conditions: Educational Problems studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Waitlist-control study primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 180 type: ACTUAL name: Virtual Reality measure: Situation awareness and communication skills measure: Student's self-confidence in learning measure: Participants' sense of presence in this virtual clinical environment sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT facility: Timothy LAI city: Kowloon country: Hong Kong lat: 22.31667 lon: 114.18333 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-01-01 uploadDate: 2024-02-18T20:16 filename: Prot_SAP_000.pdf size: 840053 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-01-01 uploadDate: 2024-02-18T20:16 filename: ICF_001.pdf size: 720367 hasResults: False
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<|newrecord|> nctId: NCT06277544 id: M2024087 briefTitle: Analysis of Prognosis and Risk Factors of LAL Reconstruction Procedure for Patients With AF of the LAL: a Prospective Cohort Study overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-27 date: 2026-06-30 date: 2026-06-30 date: 2024-02-26 date: 2024-02-26 name: Peking University Third Hospital class: OTHER briefSummary: To compare the clinical outcomes of CAI patients with and without lateral ankle avulsion fracture after ligament repair/reconstruction, and to analyze the risk factors associated with the outcome. conditions: Avulsion Fracture of Lateral Ankle Ligament studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: lateral ankle ligament repair or reconstruction measure: Karlsson score measure: Visual Analogue Scale (VAS) measure: American Orthopaedic Foot and Ankle Society (AOFAS) measure: Tegner Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Peking University Third Hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06277531 id: IRB00006761-M2024086 briefTitle: Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE) acronym: ECCBILE overallStatus: RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2027-03-01 date: 2024-02-26 date: 2024-04-03 name: Peking University Third Hospital class: OTHER name: Beijing Tsinghua Changgeng Hospital briefSummary: Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures.
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Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%.
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In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy. conditions: Biliary Stricture conditions: Bile Duct Cancer conditions: Pancreas Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 99 type: ESTIMATED measure: Patient is diagnosed with malignant disease from biliary system sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 1000191 country: China name: Zhuo Cheng, M.D. role: CONTACT phone: +86-18701012781 email: chengzhuo321@pku.edu.cn lat: 39.9075 lon: 116.39723 facility: Beijing Tsinghua Changgung Hospital status: RECRUITING city: Beijing state: Beijing zip: 102218 country: China name: Xiue Yan, M.D. role: CONTACT phone: +86-15811117418 email: pskyq@163.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06277518 id: Liqin Deng briefTitle: System for Postoperative Admission to ICU for Patients With Digestive System Malignancy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-20 date: 2025-12 date: 2026-06-20 date: 2024-02-26 date: 2024-02-26 name: General Hospital of Ningxia Medical University class: OTHER briefSummary: Postoperative admission to ICU for patients with digestive system tumors is one of the most common postoperative complications of all non-cardiac surgeries. The study found that supportive treatment of critically ill patients admitted to ICU after surgery was conducive to reducing mortality, and the most common complications of postoperative ICU admission were infections, especially respiratory infections and surgical site infections. A growing body of evidence supports that ICU stays are expensive, always occupy major hospital resources, and are associated with the worst outcomes. To date, there is insufficient evidence to determine which patients with digestive system tumors benefit the most from being admitted to the ICU after surgery. Therefore, this study intends to adopt retrospective study to determine the risk factors of postoperative ICU transfer for patients with digestive system malignant tumor, and build a risk prediction model for postoperative ICU admission, so as to guide the decision of postoperative ICU transfer for patients with digestive system malignant tumor. conditions: Intensive Care Unit Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 2000 type: ACTUAL name: Surgery for malignant tumors of the digestive system measure: admitted to ICU after surgery sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: General Hospital of Ningxia Medical University city: Yinchuan state: Ningxia zip: 750004 country: China lat: 38.46806 lon: 106.27306 hasResults: False
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<|newrecord|> nctId: NCT06277505 id: 2023(164) briefTitle: Efficacy and Safety Evaluation of Prebiotics Combined With Quadruple Probiotics in Improving Functional Constipation. overallStatus: ENROLLING_BY_INVITATION date: 2024-02-20 date: 2024-04-20 date: 2024-06-20 date: 2024-02-26 date: 2024-02-26 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: The purpose of this study is to analyze the intestinal microecology of patients with functional constipation before and after treatment through intestinal microecological intervention, mainly using the combination of probiotics and prebiotics. We will record the patient's stool diary, including bowel movements, stool quality, bowel time, defecation difficulty, emptying sensation, manual operation and medication. At the same time, we will use the Bristol Fecal Traits Scale (BSFS) and the Constipation Patient Self-Rating Scale (PAC-SYM) and Constipation Patient Quality of Life Scale (PAC-QOL) scores completed weekly. In addition, we will monitor indicators of inflammation (IL-1β, IL-6, TNF-alpha) and intestinal barrier function (LPS), neurotransmitter (serotonin, acetylcholine)) to assess constipation improvement in patients with functional constipation. conditions: Effect of Prebiotics and Probiotics on Functional Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Take prebiotics and probiotics name: lifestyle guidance measure: Change in the number of fully autonomous bowel movements per week at the end of treatment sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The First Affiliated Hospital of Xiamen Univisity city: Xiamen state: Fujian zip: 350000 country: China lat: 24.47979 lon: 118.08187 hasResults: False
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<|newrecord|> nctId: NCT06277492 id: GN-001 briefTitle: A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects overallStatus: RECRUITING date: 2024-02-19 date: 2025-08-09 date: 2025-11-08 date: 2024-02-26 date: 2024-02-26 name: GEN İlaç ve Sağlık Ürünleri A.Ş. class: INDUSTRY name: Sulfateq B.V. briefSummary: The goal of this randomized, double-blind, placebo-controlled, single-center study is to evaluate the safety, tolerability, pharmacokinetics of single and multiple oral doses of SUL-238 in healthy subjects (aged ≥40 years). conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 69 type: ESTIMATED name: Single ascending doses SUL-238 name: Single dose Placebo name: Single dose SUL-238 name: Multiple ascending doses SUL-238 name: Multiple doses Placebo measure: Incidence of Treatment-Emergent Adverse Events as Measured by NCI-CTCAE criteria measure: Incidence of Treatment-Emergent Adverse Events as Measured by Clinical Laboratory Measurements According to Established Clinical Normal Ranges measure: Incidence of Treatment-Emergent Adverse Events as Measured by ECG measure: Incidence of Treatment-Emergent Adverse Events as Measured by physical examination and vital signs measure: Incidence of Treatment-Emergent Adverse Events as Measured by central nervous system (CNS) and autonomic nervous system (ANS) examination. measure: PK parameter: Maximum drug concentration in plasma (Cmax) of SUL-238 after a single ascending dose (Part 1 and Part 2). measure: PK parameter: Maximum drug concentration in plasma (Cmax) of SUL-238 after multiple ascending doses (Part 3). measure: PK parameter: Area under the concentration-time curve in plasma (AUC) of SUL-238 after single ascending dose (Part 1 and Part 2). measure: PK parameter: Area under the concentration-time curve in plasma (AUC) of SUL-238 after multiple ascending doses (Part 3). measure: Renal clearance and percentage of drug excreted in urine after single and multiple ascending doses of SUL-238. measure: Percentage of drug excreted in feces after multiple ascending doses of SUL-238. measure: The cerebrospinal fluid (CSF) levels of SUL-238 sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University IKUM Center status: RECRUITING city: Kayseri zip: 38030 country: Turkey name: Zafer Sezer, MD role: CONTACT phone: +903522076666 phoneExt: 24405 email: drzafersezer@gmail.com lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06277479 id: Rigshospitalet. Hematology briefTitle: Late Effects and HRQoL in Survivors of Allo-HSCT - a Cross Sectional Study overallStatus: ENROLLING_BY_INVITATION date: 2024-03 date: 2024-09 date: 2024-09 date: 2024-02-26 date: 2024-02-29 name: Rigshospitalet, Denmark class: OTHER name: Danish Cancer Society briefSummary: The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life. conditions: Hematological Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1600 type: ESTIMATED measure: EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100) measure: Health literacy Questionnaire (HLQ) measure: Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mette Schaufuss Engedal city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06277466 id: XYFY2023-KL478-01 briefTitle: Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls overallStatus: RECRUITING date: 2024-01-01 date: 2028-01-31 date: 2028-01-31 date: 2024-02-26 date: 2024-02-28 name: The Affiliated Hospital of Xuzhou Medical University class: OTHER briefSummary: In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.
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Participants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes. conditions: Type 2 Diabetes Mellitus conditions: Gene Polymorphisms conditions: Genetic Mutations conditions: Susceptibility, Genetic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs name: Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs measure: Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients measure: Detection of T2DM susceptibility gene expression in controls measure: Correlation between T2DM susceptibility gene expression and clinicopathological features measure: Baseline BMI of newly diagnosed with T2DM patients with different genotypes measure: Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes measure: Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes measure: Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes measure: Baseline TC of newly diagnosed with T2DM patients with different genotypes measure: Baseline TG of newly diagnosed with T2DM patients with different genotypes measure: Baseline HDL-C of newly diagnosed with T2DM patients with different genotypes measure: Baseline LDL-C of newly diagnosed with T2DM patients with different genotypes measure: Baseline BMI of controls with different genotypes measure: Baseline WHR of controls with different genotypes measure: Baseline FPG of controls with different genotypes measure: Baseline HbA1c of controls with different genotypes measure: Baseline TC of controls with different genotypes measure: Baseline TG of controls with different genotypes measure: Baseline HDL-C of controls with different genotypes measure: Baseline LDL-C of controls with different genotypes sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China, Jiangsu, Department of Endocrinology status: RECRUITING city: Xuzhou zip: 221006 country: China name: Hongwei Ling, MD role: CONTACT phone: 18052268607 email: linghongwei@medmail.com.cn name: Renguo Chen, MD role: PRINCIPAL_INVESTIGATOR name: Yuhan Huang, MD role: SUB_INVESTIGATOR lat: 34.18045 lon: 117.15707 hasResults: False
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<|newrecord|> nctId: NCT06277453 id: 2024KY010 briefTitle: Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2023-08-25 date: 2024-09-30 date: 2024-02-26 date: 2024-02-26 name: Fujian Medical University class: OTHER briefSummary: To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy. conditions: Locally Advanced Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 219 type: ACTUAL name: surgery measure: 3-year overall survival sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Gastric Surgery， Fujian Medical University Union Hospital city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 hasResults: False
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<|newrecord|> nctId: NCT06277440 id: NSTC 112-2314-B-341-001 briefTitle: Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-09-30 date: 2024-02-26 date: 2024-02-26 name: Taipei Medical University class: OTHER briefSummary: To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. A magnetoencephalographic examination will be arranged to explore how brain network activation works.
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Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated. conditions: Attention Deficit Hyperactivity Disorders conditions: Developmental Delays studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Twenty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated by an investigator blinded to the group's allocation before and after 12 weeks of treatment. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome measurements will be performed by a researcher who is blind to the groups' allocation. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: cognitive training name: active control measure: Changes of executive function measure: changes of symptoms of attention deficit hyperactivity disorder measure: changes of attention measure: Changes of sensory integration measure: changes of intelligence measure: changes of functional performance measure: Changes of family impact measure: Changes of quality of life measure: Changes in performance activity in kindergarten measure: changes of brain network connectivity sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: Shin Kong Wu Ho-Su Memorial Hospital city: Taipei zip: 111-01 country: Taiwan name: Ru-Lan Hsieh, MD role: CONTACT phone: 886-2-28332211 phoneExt: 2538 email: rulanhsieh@gmail.com name: Ru-Lan Hsieh, MD role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06277427 id: [2023]S208 briefTitle: Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells overallStatus: RECRUITING date: 2024-02-05 date: 2026-02-01 date: 2027-01-31 date: 2024-02-26 date: 2024-02-26 name: Lingli Dong class: OTHER name: Shenzhen Pregene Biopharma Co., Ltd. briefSummary: Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis. conditions: Lupus Nephritis conditions: ANCA Associated Vasculitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: PRG-1801 （CAR-T against BCMA） measure: AE Incidence of PRG-1801 Single Infusion measure: Types and incidence of dose-limiting toxicity(DLT) after PRG-1801 cells infusion in subjects with refractory ANCA-associated vasculitis and refractory LN. measure: Therapeutic effects-For refractory ANCA-associated vasculitis(The proportion of subjects who maintained remission after cell infusion) measure: Therapeutic effects-For refractory ANCA-associated vasculitis(Changes in VDI (Vasculitis Damage Index) scores from baseline after cell infusion) measure: Therapeutic effects-For refractory ANCA-associated vasculitis (Changes in glomerular filtration rate compared to baseline after cell infusion in subjects with renal involvement.) measure: Therapeutic effects-For refractory LN (Changes in SLEDAI-2000 score from baseline after cell infusion) measure: Therapeutic effects-For refractory LN (Changes in FACIT fatigue score from baseline after cell infusion ) measure: Therapeutic effects-For refractory LN (Changes in PGA score (0-10) from baseline after cell infusion) measure: Therapeutic effects-For refractory LN (Changes in eGFR(mL/min/1.73 m2) relative to baseline after cell infusion) measure: Therapeutic effects-For refractory LN (Changes in UPCR (g/24h）relative to baseline after cell infusion） measure: Therapeutic effects-For refractory LN (The proportion of subjects who achieved overall response rate after cell infusion.） measure: Therapeutic effects-For refractory LN（The proportion of subjects who achieved complete renal response after cell infusion.） measure: PK feature evaluation (PK parameters related to CAR copy number） measure: Serum sBCMA level measure: Serum ANCA titer level (AAV) measure: Serum dsDNA level (LN) measure: Serum ANA titer level (LN) measure: Serum complement C3 levels measure: Serum complement C4 levels measure: Serum immunoglobulin quantification measure: Levels of CRP levels measure: Levels of ferritin levels measure: Levels of cytokine levels measure: Changes of peripheral blood lymphocyte subsets measure: Expression levels of BCMA on peripheral blood B cell subsets surface measure: The level of anti drug antibody (ADA) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Lingli Dong, MD role: CONTACT phone: 86-27-83665519 email: tjhdongll@163.com name: Cong Ye, MD role: CONTACT phone: 86-27-83665518 email: Yecong@163.com lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06277414 id: 2024ll0204001 briefTitle: a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication overallStatus: RECRUITING date: 2018-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: The First Affiliated Hospital of University of South China class: OTHER briefSummary: To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP conditions: Endoscopic Retrograde Cholangiopancreatography studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: collection of laboratory test results, imaging results and symptoms measure: Number of Participants with Pancreatitis measure: Number of Acute PEC(post-ERCP-cholecystitis ) measure: Number of Participants with Cholangitis measure: Number of Participants with Perforation measure: Number of Participants with bile duct stents sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of University of South China status: RECRUITING city: Hengyang state: Hunan country: China name: Chen Guodong, PhD role: CONTACT phone: 15211450345 email: Chenguodong@usc.edu.cn lat: 26.88946 lon: 112.61888 hasResults: False
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<|newrecord|> nctId: NCT06277401 id: RCT_hypermobile_knee briefTitle: Exercise in Patients With Hypermobile Joints and Knee Pain acronym: HIPEr-Knee overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-06-01 date: 2026-06-01 date: 2024-02-26 date: 2024-02-26 name: University of Southern Denmark class: OTHER name: Independent Research Fund Denmark name: Odense Patient Data Explorative Network briefSummary: Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain. conditions: Hypermobility, Joint conditions: Hypermobility Syndrome conditions: Knee Discomfort studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The patients will be kept blind to treatment allocation by being provided with minimal information about the content of the two exercise interventions and the study hypotheses; the patients will be informed that the study compares two different exercise protocols that both include safe exercises to reduce knee pain and increase knee function.
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An independent biostatistician blinded to group allocation will perform the primary RCT analysis. To reduce the risk of interpretation bias, blinded results from the analyses (group A compared with group B) will be presented to all authors, who will agree on two alternative written interpretations before the data manager unblinds the randomisation code. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Neuromuscular training for the knee name: High-load strength training for the knee measure: Visual Analogue Scale Nominated Activity measure: Knee injury and Osteoarthritis Outcome Score (KOOS) measure: Adverse events measure: Dynamic knee strength measure: Knee reposition sense measure: Single-Leg-Hop for Distance measure: Knee pain past week measure: Tampa scale of Kinesiophobia (TSK) 11 item measure: EQ-5D-5L measure: EQ VAS measure: Global perceived effect (GPE) measure: PASS measure: TF measure: Clinical important difference measure: Knee instability questions measure: Tendon stiffness measure: Quadriceps rate of torque development (RTD) measure: Patella instability measure: Quadriceps maximal voluntary isometric contraction sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Physiotherapy Clinics Region of Southern Denmark city: Odense state: Fyn zip: 5000 country: Denmark name: Behnam Liaghat, PhD role: CONTACT phone: +4526826801 email: bliaghat@health.sdu.dk lat: 55.39594 lon: 10.38831 facility: University of Southern Denmark city: Odense state: Fyn zip: 5230 country: Denmark name: Behnam Liaghat, PhD role: CONTACT phone: +4526826801 email: bliaghat@health.sdu.dk lat: 55.39594 lon: 10.38831 hasResults: False
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<|newrecord|> nctId: NCT06277388 id: GASTO-10108 briefTitle: Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment. overallStatus: RECRUITING date: 2021-06-05 date: 2024-06-05 date: 2024-07-01 date: 2024-02-26 date: 2024-02-28 name: Sun Yat-sen University class: OTHER briefSummary: This study aimed to investigate the role of impedance cardiography (ICG) in evaluating hemodynamic changes during the 6-minute walk test (6MWT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who underwent combined concurrent chemoradiotherapy (CCRT) and immunotherapy. Additionally, It sought to analyze the predictive significance of cardiac parameters to both treatment toxicity and survival prognosis. conditions: Non-small Cell Lung Cancer conditions: Cardiac Toxicity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 237 type: ESTIMATED name: Impedance cardiography measure: Stroke volume（SV） sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hui Liu status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Hui Liu, MD role: CONTACT phone: +86-020-87343031 email: liuhuisysucc@126.com lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06277375 id: 813/793 briefTitle: The Effect of Slow Stroke Back Massage on Pain and Fatigue in Women With Fibromyalgia overallStatus: ENROLLING_BY_INVITATION date: 2023-09-14 date: 2024-02-15 date: 2024-03-15 date: 2024-02-26 date: 2024-02-26 name: TC Erciyes University class: OTHER briefSummary: Fibromyalgia syndrome (FM) is defined as a non-inflammatory chronic pain syndrome with widespread pain in the musculoskeletal system, tender points (PINs) on physical examination and no specific laboratory findings. T Sampling was calculated using Power power (G Power 3.1.9.4) analysis. The effect size of the study was calculated based on the mean pain scores and standard deviations of the control and experimental groups taken from the study conducted by Field, et al. (2002). Accordingly, when 25 patients were included in each group, it was determined that the power was 85% at 5% Type I error level. The application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes. data will be collected with patient information form, fatigue severity scale and vas. conditions: Massage Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Massage measure: VAS measure: Fatigue sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dilek Efe Arslan city: Kayseri state: Melikgazi zip: 38280 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06277362 id: CLTI012023 briefTitle: Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia acronym: PiPER overallStatus: RECRUITING date: 2020-01-31 date: 2025-12 date: 2027-06 date: 2024-02-26 date: 2024-02-26 name: EndoCore Lab s.r.l. class: OTHER briefSummary: The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI. conditions: Peripheral Arterial Disease conditions: Critical Limb-Threatening Ischemia conditions: Diabetic Foot studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Safety Composite measure: Procedural Success measure: Primary Patency measure: Secondary Patency measure: A-V fistula flow rate measure: Minor amputation rates measure: Major amputation rates measure: Re-Treatment rate measure: Wound Size measure: TpcO2 measure: WIFi class measure: Freedom from all cause death measure: Freedom from procedure-related death measure: Rutherford class sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Pederzoli status: RECRUITING city: Peschiera Del Garda state: Veneto zip: 37019 country: Italy name: Bruno Migliara, MD role: CONTACT email: bruno.migliara@gmail.com lat: 45.43912 lon: 10.68614 facility: Ospedale San Martino status: NOT_YET_RECRUITING city: Belluno zip: 32100 country: Italy name: Luca Ferretto, MD role: CONTACT name: Luca Ferretto, MD role: PRINCIPAL_INVESTIGATOR lat: 46.14262 lon: 12.2156 facility: Ospedale Bufalini status: NOT_YET_RECRUITING city: Cesena zip: 47521 country: Italy name: Gabriele Testi, MD role: CONTACT name: Gabriele Testi, MD role: PRINCIPAL_INVESTIGATOR lat: 44.1391 lon: 12.24315 facility: Ospedale di Conegliano - USLL2 status: NOT_YET_RECRUITING city: Conegliano zip: 31015 country: Italy name: Massimo Corato, MD role: CONTACT name: Massimo Corato, MD role: PRINCIPAL_INVESTIGATOR lat: 45.88805 lon: 12.30201 facility: Ospedale Cardarelli status: NOT_YET_RECRUITING city: Napoli zip: 80131 country: Italy name: Gianluca Cangiano, MD role: CONTACT name: Gianluca Cangiano, MD role: PRINCIPAL_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Arcispedale Santa Maria Nuova status: NOT_YET_RECRUITING city: Reggio Emilia zip: 42122 country: Italy name: Antonio Fontana, MD role: CONTACT name: Antonio Fontana, MD role: PRINCIPAL_INVESTIGATOR lat: 44.69825 lon: 10.63125 facility: Ospedale Santa Chiara status: NOT_YET_RECRUITING city: Trento zip: 38123 country: Italy name: Stefano Bonvini, MD role: CONTACT name: Stenano Bonvini, MD role: PRINCIPAL_INVESTIGATOR lat: 46.06787 lon: 11.12108 hasResults: False
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<|newrecord|> nctId: NCT06277349 id: MAUV1005 briefTitle: Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery overallStatus: COMPLETED date: 2009-03-04 date: 2011-01-04 date: 2011-01-04 date: 2024-02-26 date: 2024-03-13 name: Moorfields Eye Hospital NHS Foundation Trust class: OTHER briefSummary: The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery. conditions: Cornea conditions: Astigmatism conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled trial with intra-patient comparison (bilateral study), patients are either receiving implant of a multifocal toric IOL or implant of a standard multifocal IOL combined with limbal relaxing incisions. primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 30 type: ACTUAL name: Toric multifocal IOL name: Non-toric multifocal IOL measure: Composite scoring of unaided distance and near vision (monocularly) measure: Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2009-02-06 uploadDate: 2024-02-23T13:05 filename: Prot_000.pdf size: 169392 hasResults: False
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<|newrecord|> nctId: NCT06277336 id: 2023-01716; kt23ChristCrain3 briefTitle: Effects of Intravenous [Pyr1]Apelin-13 on Healthy Volunteers With Artificially Induced SIAD acronym: ESCAPE overallStatus: RECRUITING date: 2024-03-01 date: 2024-12 date: 2025-12 date: 2024-02-26 date: 2024-04-12 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: Hyponatremia is a common electrolyte imbalance which often results from hormonal disregulation. The study aims to investigate whether the apelin hormone, which plays a role in regulating salt and water balance in the body, can be used to treat hyponatremia.
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The study will involve healthy volunteers who will be given a medication that causes their bodies to retain water, thus inducing a temporary hyponatremia state. The researchers will measure the volunteers' blood and urine electrolyte levels to see how these are influenced by apelin administration. As comparison, the same measurements will be done in volunteers dosed with placebo instead of apelin.
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The researchers believe that apelin may be able to help to correct hyponatremia by increasing urine output. If the study focused in the healthy volunteers population is successful, the investigators will assess the effect of apelin administration in patients with chronic hyponatremia.
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The study's hypothesis is that intravenous apelin will increase urinary excretion and sodium levels in healthy participants with artificially induced hyponatremia. conditions: SIAD - Syndrome of Inappropriate Antidiuresis conditions: Hyponatremia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 20 type: ESTIMATED name: Placebo name: Apelin Low Dose name: Apelin High Dose name: Selected Apelin Dose measure: Total urinary excretion (ml) measure: Hourly and total urinary excretion (ml) measure: Change in electrolyte free water clearance (ml/min) measure: Change in free water clearance (ml/min) measure: Change in plasma osmolality (mOsm/kg) measure: Change in plasma sodium (mmol/l) measure: Change in body weight (kg) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel status: RECRUITING city: Basel zip: 4031 country: Switzerland name: Mirjam Christ-Crain, Prof. Dr. role: CONTACT phone: +41 61 328 70 80 email: Mirjam.Christ-Crain@usb.ch name: Mirjam Christ-Crain, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Sophie Monnerat, Dr. Med. role: SUB_INVESTIGATOR name: Julie Refardt, PD. Dr. Med. role: SUB_INVESTIGATOR name: Neeraj Dhaun, Dr. role: SUB_INVESTIGATOR name: Fiona A. Chapman, PhD role: SUB_INVESTIGATOR name: Anthony P. Davenport, Prof. role: SUB_INVESTIGATOR name: Janet Maguire, PhD role: SUB_INVESTIGATOR lat: 47.55839 lon: 7.57327 hasResults: False
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<|newrecord|> nctId: NCT06277323 id: Cardio briefTitle: UCLA Health Patient Cardiology Care Gaps overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-30 date: 2025-07-30 date: 2025-07-30 date: 2024-02-26 date: 2024-02-26 name: University of California, Los Angeles class: OTHER name: UCLA Health Department of Medicine briefSummary: This is a prospective randomized clinical trial evaluating how two behaviorally-informed interventions (i.e., monthly report card and storyboard interventions) impact physician behavior, with the goal of closing care gaps in preventive care and disease management.
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In particular, the monthly report card intervention seeks to elevate physicians' intentions to close their patients' care gaps, while the storyboard intervention seeks to prompt action by making patients' care gaps salient. The trial investigates the separate and joint impacts of the proposed behaviorally-informed interventions on encouraging physicians to close their patients' care gaps. conditions: Health Maintenance conditions: Cardiology studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel randomized trial at the physician level. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 46 type: ACTUAL name: Monthly report card intervention name: Storyboard intervention measure: Care gap closure (patients seen) measure: Care gap closure (all patients in panel) measure: Number of care gaps closed (patients seen) measure: Number of care gaps closed (all patients in panel) measure: HCC/RAF care gap closure (all patients in panel) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA Health Department of Medicine, Quality Office city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06277310 id: 3WP in SNH briefTitle: Implementation of the 3 Wishes Project in Safety-Net Hospitals overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-19 date: 2028-04 date: 2028-08 date: 2024-02-26 date: 2024-04-02 name: University of California, Los Angeles class: OTHER name: Olive View-UCLA Education & Research Institute name: LAC+USC Medical Center briefSummary: Dignified and compassionate end-of-life (EOL) care is a cornerstone of high-quality, patient-centered care, but in safety-net hospitals EOL care is often overlooked, considered too late, or not at all. By eliciting and implementing final wishes for dying patients, the 3 Wishes Project (3WP) has demonstrated, in tertiary academic centers, that acts of compassion can improve the EOL experience and help families cope with loss. The investigators propose to implement the 3WP in safety-net hospitals where there are less resources and more diverse, disadvantaged patient populations, and hypothesize that there will be similar positive effects on the EOL experience for patients, families, and clinicians. conditions: End of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a before and after stepped wedge study design primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 900 type: ESTIMATED name: 3 Wishes Project measure: Families' assessment of the quality of end-of-life, particularly in emotional and spiritual support. measure: Family anxiety and depression measure: Nurse Burnout measure: Family PTSD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LA General Hospital city: Los Angeles state: California zip: 90033 country: United States lat: 34.05223 lon: -118.24368 facility: Ronald Reagan UCLA Medical Center city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 facility: Olive View Medical Center city: Sylmar state: California zip: 91342 country: United States lat: 34.30778 lon: -118.44925 facility: Harbor-UCLA city: Torrance state: California zip: 90502 country: United States lat: 33.83585 lon: -118.34063 hasResults: False
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<|newrecord|> nctId: NCT06277297 id: NP/2022/4583 briefTitle: Prognotic Role of CMR in Takotsubo Syndrome acronym: EVOLUTION overallStatus: RECRUITING date: 2022-11-09 date: 2026-11 date: 2032-11 date: 2024-02-26 date: 2024-02-28 name: University of Cagliari class: OTHER briefSummary: The primary objective of this observational registry is to develop a comprehensive clinical and imaging score (incorporating echocardiography and cardiac magnetic resonance data) that enhances risk stratification for patients with Takotsubo syndrome.
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The secondary objectives of this registry are as follows:
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Investigate the diagnostic value of cardiac magnetic resonance parameters in predicting in-hospital and long-term outcomes in patients with Takotsubo syndrome.
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Compare the proposed risk stratification score for patients with Takotsubo syndrome with previously existing scores.
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Investigate the contribution of machine learning models in predicting in-hospital and long-term outcomes compared to standard clinical scores.
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The design and rationale of this registry are available at 10.1097/RTI.0000000000000709 conditions: Takotsubo Cardiomyopathy conditions: Machine Learning conditions: Magnetic Resonance Imaging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 350 type: ESTIMATED measure: All-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Cagliari status: RECRUITING city: Cagliari zip: 09100 country: Italy name: Riccardo Cau role: CONTACT phone: +393393493317 email: riccardo.cau@unica.it name: Luca Saba role: PRINCIPAL_INVESTIGATOR name: Riccardo Cau role: PRINCIPAL_INVESTIGATOR lat: 39.23054 lon: 9.11917 hasResults: False
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<|newrecord|> nctId: NCT06277284 id: MG-K10-I-002 briefTitle: Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-23 date: 2024-01-26 date: 2024-04 date: 2024-02-26 date: 2024-02-26 name: Shanghai Mabgeek Biotech.Co.Ltd class: OTHER_GOV name: The Second Hospital of Anhui Medical University briefSummary: Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults conditions: Pharmacokinetics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: MG-K10 humanized monoclonal antibody injection (prefilled syringe) name: MG-K10 humanized monoclonal antibody injection（Penicillin bottle） measure: Pharmacokinetic: the maximum concentration (Cmax) measure: Pharmacokinetic: area under the curve of o~t measure: Pharmacokinetic: area under the curve of o~∞ measure: Safety evaluation index sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The Second Affiliated Hospital of Anhui Medical University city: Hefei state: Anhui zip: 230061 country: China lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06277271 id: 1901611-9 briefTitle: E-cigarettes as a Harm Reduction Strategy overallStatus: RECRUITING date: 2023-06-20 date: 2024-02-20 date: 2024-03-20 date: 2024-02-26 date: 2024-02-26 name: Prisma Health-Upstate class: OTHER name: Clemson University briefSummary: E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). This study aims to evaluate the feasibility and acceptability of implementing a cigarette harm reduction intervention involving e-cigarettes in office-based buprenorphine clinics. conditions: Smoking studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: E-cigarette measure: Percentage of people who are eligible measure: Percentage of consented participants measure: Percentage of participants who report using the e-cigarette at least once a day measure: Percentage of participants with at least one puff of study e-cigarette measure: Percentage of daily diary completed measure: Cigarette dependence measured via the Fagerstrom test for nicotine dependence measure: Cigarette demand measured via the cigarette purchase task measure: Combustible cigarette smoking measure: Switching to e-cigarettes measure: Smoking reduction sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prisma Health status: RECRUITING city: Greenville state: South Carolina zip: 29609 country: United States name: Alain Litwin, MD role: CONTACT phone: 864-455-5648 email: alain.litwin@prismahealth.org lat: 34.85262 lon: -82.39401 hasResults: False
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<|newrecord|> nctId: NCT06277258 id: BSMMU/2022/9656 briefTitle: Patient Empowerment in the Management of Gestational Diabetes Mellitus overallStatus: RECRUITING date: 2023-01-31 date: 2024-10 date: 2024-12 date: 2024-02-26 date: 2024-02-26 name: Public Health Foundation of Bangladesh class: OTHER briefSummary: This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. It will be conducted in four centres in Dhaka city of Bangladesh. The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control. Target of Glycemic Status: For Pregnant Mother, Fasting, 95 mg/dL (5.3 mmol/L), Two-hour postprandial,120 mg/dL (6.7 mmol/L), For Neonate glycemic status at or above 2.5 mmol/l. Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI, Decrease pre-eclampsia, Decrease Antepartum Hemorrhage and Polyhydramnios. Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery, Decrease chance of obstructed labour. Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage, Decrease chance of puerperal sepsis. Fetal Outcome- Less chance of Intra uterine death and prematurity. Neonatal Outcome- Less chance of Birth injury, Birth asphyxia, Perinatal death, Good Apgar score (≥ 7) in 1st and 5th minute, Less need for NICU care and Less chance of macrosomia (≥ 4 kg) at term. Fewer proportion of patients will require insulin to manage GDM. The secondary outcomes will be patient satisfaction and the patient will be a future resource person. conditions: Diabetes Mellitus in Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: At the end of the study, the outcome will be assessed by blinded. whoMasked: OUTCOMES_ASSESSOR count: 388 type: ESTIMATED name: Patient Empowerment model measure: Number of Participants with adverse maternal pregnancy outcome measure: Number of Participants with adverse foetal outcome measure: Number of Participants with adequate glycaemic control measure: Maternal satisfaction sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Azimpur Maternity hospital ( MCHTI) status: RECRUITING city: Dhaka zip: 1205 country: Bangladesh name: Rukhsana Parvin, MSc role: CONTACT phone: +8801303701545 email: rukhsana.nipa44@gmail.com lat: 23.7104 lon: 90.40744 facility: Shaheed Suhrawardy Medical College (ShSMC) status: RECRUITING city: Dhaka zip: 1207 country: Bangladesh name: Farhana Akter, MSc role: CONTACT phone: +8801819138421 email: isha.farhana19@gmail.com name: Fatema Ashraf, MBBS, FCPS, MS,MPH role: PRINCIPAL_INVESTIGATOR lat: 23.7104 lon: 90.40744 facility: Bangabandhu Sheikh Mujib Medical University (BSMMU) status: RECRUITING city: Dhaka zip: 1217 country: Bangladesh name: Naznin Akter, MSc role: CONTACT phone: +8801739867303 email: zshela286@gmail.com name: Tabassum Parvin, MBBS, FCPS role: PRINCIPAL_INVESTIGATOR lat: 23.7104 lon: 90.40744 hasResults: False
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<|newrecord|> nctId: NCT06277245 id: LK001303 briefTitle: A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis. overallStatus: RECRUITING date: 2024-02-06 date: 2025-09-30 date: 2025-11-30 date: 2024-02-26 date: 2024-03-20 name: Lynk Pharmaceuticals Co., Ltd class: INDUSTRY briefSummary: This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable).
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The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 354 type: ESTIMATED name: LNK01001 name: Placebo measure: Eczema Area and Severity Index (EASI-75) at Week 16 measure: Investigator's Global Assessment (IGA) score of 0/1 at Week 16 measure: Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16 measure: Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at all visits other than Week 16. measure: Change from Baseline in Eczema Area and Severity Index at all visits. measure: Eczema Area and Severity Index (EASI 75) at all visits other than Week 16 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dermatological Hospital of Southern Medical University status: RECRUITING city: Guangzhou country: China name: Bing Yang, Doctor role: CONTACT phone: 020-87257353 email: yangbin101@hotmail.com lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06277232 id: HMV-2023-00504 id: 2022-05364-02 type: OTHER domain: The Swedish Ethical Review Authority briefTitle: Nutrition Care in Patients Living With Chronic Pain overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-30 date: 2026-10-31 date: 2024-02-26 date: 2024-03-22 name: Linkoeping University class: OTHER_GOV name: Ostergotland County Council, Sweden name: Fibromyalgia foundation briefSummary: The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain.
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The study is planned to include 20 patients with complex chronic pain and non-optimal BMI (underweight or overweight/obesity) to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes. conditions: Nutrition Poor conditions: Overweight and Obesity conditions: Mobile Phone Use conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Repeated measures, single-subject withdrawal design. All subjects who enroll in the study will receive the intervention and there is no randomization. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Nutrition care name: Dialogue and education (part of Interdisciplinary Pain Rehabilitation Program) name: activity training (part of Interdisciplinary Pain Rehabilitation Program) name: meetings (part of Interdisciplinary Pain Rehabilitation Program) name: Cognitive behavioral therapy (part of Interdisciplinary Pain Rehabilitation Program) name: Relaxation techniques (part of Interdisciplinary Pain Rehabilitation Program) name: Physical exercise (part of Interdisciplinary Pain Rehabilitation Program) measure: Pain intensity (numeric rating scale) measure: Pain interference (one aspect in Multidimensional Pain inventory) measure: Dietary habits (a lifestyle questionnaire) measure: Perceived Usability (System Usability Scale) measure: Perceived benefit (numeric rating scale) measure: Adherences/ compliances of nutritional care (numeric rating scale) measure: Difficulty sleeping (Insomnia Severity Index) measure: Emotional distress (The Hospital Anxiety and Depression Scale, HAD) measure: Impact of chronic pain (Multidimensional Pain inventory) measure: Health- related quality of life 1 (EQ-5D) measure: Health- related quality of life 2 (RAND-36) measure: Pain coping (Chronic Pain Acceptance Questionnaire, CPAQ) measure: Fear of movement (Tampa scale for Kinesiophobia) measure: Physical activity and sedentary behavior (self-estimated time, questionnaire) measure: Body fatness (physiological parameter) measure: Body weight (physiological parameter) measure: Biomarkers explored from blood samples (physiological parameters such as proteins, lipids, metabolites and micro-RNA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06277219 id: LAT010-01 briefTitle: A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1) acronym: LIGHTSPEED-1 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2027-03 date: 2024-02-26 date: 2024-02-26 name: Latticon Antibody Therapeutics, Inc class: INDUSTRY briefSummary: This is an open-label, multicenter, Phase 1/2, first-in-human (FIH), dose-escalation and cohort-expansion study of LAT010 to evaluate the safety, tolerability, immunogenicity, PK, PD, and antitumor activity in patients with advanced solid tumors. The study consists of 2 parts: Phase 1 dose-escalation and Phase 2 cohort expansion. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: LAT010 name: LAT010 + ICI measure: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (Phase 1) measure: Incidence of changes in clinical laboratory values (Phase 1) measure: Incidence of dose-limiting toxicities (DLTs) (Phase 1) measure: Objective response rate (ORR) per RECIST 1.1 (Phase 2) measure: Maximum plasma concentration (Cmax) of LAT010 measure: Area under the plasma concentration-time curve (AUC) of LAT010 measure: Terminal phase half-life (t1/2) of LAT010 measure: Time to maximum concentration of LAT010 measure: Trough concentration of LAT010 measure: Volume of distribution of LAT010 measure: Clearance of LAT010 measure: ADA occurrence and titer in serum measure: Objective response rate (ORR) per RECIST 1.1 (Phase 1 ) measure: Duration of response (DOR) measure: Disease control rate (DCR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Incidence of AEs and SAEs measure: Epigenetic assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and natural killer (NK) cells. measure: Optional flow cytometry assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and NK cells. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huntsman Cancer Institute city: Salt Lake City state: Utah zip: 84112 country: United States name: Jeana McKenney role: CONTACT phone: 801-213-8414 email: jeana.mckenney@hci.utah.edu name: Benjamin L Maughan, MD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False
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<|newrecord|> nctId: NCT06277206 id: FAPIPDAC02 briefTitle: A Study Using 18F-FAPI PET to Evaluate Treatment Response in Pancreatic Adenocarcinoma overallStatus: COMPLETED date: 2021-08-04 date: 2023-11-19 date: 2024-02-10 date: 2024-02-26 date: 2024-02-26 name: Zhejiang University class: OTHER briefSummary: To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC conditions: 18F-FAPI conditions: Pancreas Adenocarcinoma conditions: Systemic Treatment conditions: Pathologic Response studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 59 type: ACTUAL name: 18F-FAPI PET/CT measure: Change of Maximum standardized uptake value measure: Change of Mean standardized uptake value measure: Maximum standardized uptake value measure: Mean standardized uptake value measure: Metabolic Tumor Volume measure: Total Lesion FAP expression measure: Change of Metabolic Tumor Volume measure: Change of Total Lesion FAP expression sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Medical College of Zhejiang University city: Hangzhou state: Zhejiang zip: 310003 country: China lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06277193 id: KonyaBeyhekimTRH briefTitle: Investigation of the Relationship Between Sarcopenia and Balance, Fear of Falling and Fall Risk in Older Female Patients overallStatus: COMPLETED date: 2020-11-03 date: 2022-12-01 date: 2023-09-28 date: 2024-02-26 date: 2024-02-26 name: Konya Beyhekim Training and Research Hospital class: OTHER_GOV briefSummary: This study (study type: cross-sectional) aims to investigate the relationship of sarcopenia level with balance, fear of falling and risk of falling in the elderly female population. In the first stage, 166 participants were divided into two groups: sarcopenia and non-sarcopenia. Afterwards, they were categorized according to sarcopenia level (probable sarcopenia group, sarcopenia group, severe sarcopenia group, group without sarcopenia) and comparisons were made between these subgroups. Then, they were evaluated with various scales and tests (in terms of balance, fear of falling and risk of falling). conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 166 type: ACTUAL name: valuation of balance status, fear of falling and risk of falling in patients non-sarcopenia. name: Evaluation of balance status, fear of falling and risk of falling in patients with probable sarcopenia. name: Evaluation of balance status, fear of falling and risk of falling in patients with sarcopenia. name: Evaluation of balance status, fear of falling and risk of falling in patients with severe sarcopenia. measure: Sociodemographic data measure: Berg Balance Scale(BBS) measure: Falls Efficacy Scale (FES) measure: Balance and Gait Assessment Scale measure: Biochemical data measure: Co-morbidities measure: Number of drugs measure: Basic activities of daily living (Katz) measure: Instrumental activities of living (Lawton-Brody; IADL) measure: Mini-nutritional evaluation (MNA-Short form) measure: Mini-mental state assessment (MMSE) measure: Yesavage Geriatric Depression Scale Short Form (GDS-SF) measure: FRAIL fragility index measure: Short physical performance battery (SPPB) measure: Timed up and go test (TUG) measure: The Tampa Scale for Kinesiophobia (TSK) sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic city: Selçuklu state: Konya country: Turkey lat: 37.8842 lon: 32.49222 hasResults: False
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<|newrecord|> nctId: NCT06277180 id: TCR-FAPI for MTC Surgery briefTitle: 68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC overallStatus: RECRUITING date: 2023-10-01 date: 2025-12-31 date: 2027-12-31 date: 2024-02-26 date: 2024-02-26 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER name: Peking University name: Peking University Cancer Hospital & Institute briefSummary: This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level. conditions: Medullary Thyroid Cancer conditions: Prositron Emission Tomography conditions: Fibroblast Activation Protein Inhibitor conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Surgery name: Surgery measure: 1-month post-surgery calcitonin level measure: 2-year event free survival measure: Ratio of patient that change surgical plan measure: Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Beijing zip: 100021 country: China name: Shaoyan Liu, M.D. role: CONTACT phone: 0086-010-87787190 email: shaoyanliu.bj@263.net lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06277167 id: KXZY-GB05-101 briefTitle: A Phase I Study of Human Interferon Alfa 1b Inhalation Solution in Healthy Participants overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-07 date: 2024-05-21 date: 2024-05-21 date: 2024-02-26 date: 2024-02-26 name: Kexing Biopharm Co., Ltd. class: INDUSTRY name: Guoxin Pharmaceutical Technology (Beijing) Co., Ltd. name: The Third Hospital of Changsha name: Beijing SSYP Data Technology Development Co.,Ltd. name: United-Power Pharma Tech（Shanghai）Co., Ltd. briefSummary: A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 35 type: ACTUAL name: Human interferon alfa 1b inhalation solution name: Human interferon alfa 1b inhalation solution placebo name: Human interferon alfa 1b inhalation solution name: Human interferon alfa 1b inhalation solution placebo measure: TEAEs measure: (ADRs) measure: (SAE) measure: TEAEs that lead to subject discontinuation from the study measure: Cmax After a Single Dose of GB05 Drug Product measure: Tmax After a Single Dose of GB05 Drug Product measure: AUC0-t and AUC0-inf After a Single Dose of GB05 Drug Product measure: t1/2 After a Single Dose of GB05 Drug Product measure: Ke After a Single Dose of GB05 Drug Product measure: Vd After a Single Dose of GB05 Drug Product measure: MRT After a Single Dose of GB05 Drug Product measure: CL After a Single Dose of GB05 Drug Product measure: Cmax,ss After Multiple Doses of GB05 Drug Product measure: Cmin,ss After Multiple Doses of GB05 Drug Product measure: Css_av After Multiple Doses of GB05 Drug Product measure: DF After Multiple Doses of GB05 Drug Product measure: (Cmax,ss-Cmin,ss)/Cmin,ss After Multiple Doses of GB05 Drug Product measure: ADA measure: NAb sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The Third Hospital of Changsha city: Changsha country: China lat: 28.19874 lon: 112.97087 hasResults: False
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<|newrecord|> nctId: NCT06277154 id: MASCT-I-2004 briefTitle: MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-02 date: 2027-02 date: 2024-02-26 date: 2024-02-26 name: HRYZ Biotech Co. class: INDUSTRY briefSummary: This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma. conditions: Leiomyosarcoma conditions: Liposarcoma conditions: Synovial Sarcoma conditions: Angiosarcoma conditions: Undifferentiated Pleomorphic Sarcoma conditions: Epithelioid Sarcoma conditions: Malignant Peripheral Nerve Sheath Tumors conditions: Fibrosarcoma conditions: Pleomorphic Rhabdomyosarcoma conditions: Endometrial Stromal Sarcoma conditions: Desmoplastic Small Round Cell Tumor studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 148 type: ESTIMATED name: MASCT-I name: Doxorubicin name: Ifosfamide measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of response (DoR) measure: Adverse events and serious adverse events measure: Adverse events and serious adverse events related to MASCT-I measure: Rate and severity of clinically-significant abnormalities in laboratory testings measure: Immune response to tumor-associated antigens sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou country: China name: Xing Zhang role: CONTACT email: zhangxing@sysucc.org.cn name: Xing Zhang role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06277141 id: M230742 briefTitle: The Vitality Mammography Messaging Study acronym: VMS overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-27 date: 2024-03-31 date: 2024-03-31 date: 2024-02-26 date: 2024-03-22 name: Wits Health Consortium (Pty) Ltd class: OTHER name: Discovery Vitality briefSummary: The investigators will be conducting a randomized controlled trial amongst members of a Wellness Program to test receipt of mammogram using the Whatsapp social media platform and testing various messages. conditions: Breast Cancer Female studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: SCREENING masking: NONE count: 6665 type: ESTIMATED name: Standard message name: Radiology booking site link. name: Radiology practice telephone numbers name: Radiology site link and telephone numbers measure: Comparison of mammography screening rates using WhatsApp sex: FEMALE minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Witwatersrand city: Johannesburg state: Gauteng country: South Africa lat: -26.20227 lon: 28.04363 hasResults: False
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<|newrecord|> nctId: NCT06277128 id: WS016-Ⅱ-01 briefTitle: A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia. overallStatus: RECRUITING date: 2023-09-11 date: 2024-04-18 date: 2024-08-04 date: 2024-02-26 date: 2024-02-26 name: Waterstone Pharmaceutical (Wuhan) Co., LTD. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase. conditions: Hyperkalemia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: WS016 3g name: WS016 6g name: WS016 12g name: Matching Placebo measure: Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase measure: Exponential rate of change in S-K levels during the maintenance treatment phase measure: Mean change in S-K levels during the acute treatment phase measure: Proportion of participants recover from hyperkalemia measure: Time to normalization in S-K levels measure: Proportion of patients remaining normokalemic measure: Mean change in S-K levels during the maintenance treatment phase sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Li Zuo role: CONTACT phone: 86+ 13910028495 email: zuoli@bjmu.edu.cn lat: 39.9075 lon: 116.39723 facility: Peking University Shougang Hospital status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Zhenzhong Zhu role: CONTACT phone: 86+ 13811830871 email: doczzz@sina.com lat: 39.9075 lon: 116.39723 facility: Zhongshan Hospital, Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361000 country: China name: Tianjun Guan role: CONTACT phone: 86+ 13950199068 email: guantianjun@aliyun.com lat: 24.47979 lon: 118.08187 facility: The Affiliated Hospital of Hebei University status: RECRUITING city: Baoding state: Hebei zip: 071000 country: China name: Yan Gao role: CONTACT phone: 86+ 13613125826 email: gaoyan227@sina.com lat: 38.85111 lon: 115.49028 facility: Hebei Traditional Chinese Medicine Hospital status: RECRUITING city: Shijiazhuang state: Hebei zip: 050000 country: China name: Jinchuan Tan role: CONTACT phone: 86+ 13831187910 email: 1955981973@qq.com lat: 38.04139 lon: 114.47861 facility: The Second Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei zip: 050000 country: China name: Shaomei Li role: CONTACT phone: 86+ 15803210955 email: lishaomeitougao@126.com lat: 38.04139 lon: 114.47861 facility: The First Hospital of Qiqihar status: RECRUITING city: Qiqihar state: Heilongjiang zip: 161000 country: China name: Yanjun Zhao role: CONTACT phone: 86+ 13945277125 email: 18603622020@126.com lat: 47.34088 lon: 123.96045 facility: The First People's Hospital of Nanyang City status: RECRUITING city: Nanyang state: Henan zip: 473000 country: China name: Mingai Song role: CONTACT phone: 86+ 18937765862 email: ai13837706962@163.com lat: 32.99472 lon: 112.53278 facility: Puyang Oilfield General Hospital status: RECRUITING city: Puyang state: Henan zip: 457000 country: China name: Xianjun Xue role: CONTACT phone: 86+ 13839288161 email: 13839288161@163.com lat: 29.45679 lon: 119.88872 facility: Shiyan Taihe Hospital status: RECRUITING city: Shiyan state: Hubei zip: 442000 country: China name: Qinghong Zhang role: CONTACT phone: 86+ 13971930628 email: zhangqinghong9809@126.com lat: 32.6475 lon: 110.77806 facility: Wuhan No.4 Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Chuanwen Xu role: CONTACT phone: 86+ 18607171819 email: chuanwenxu@sina.com lat: 30.58333 lon: 114.26667 facility: Zhuzhou Central Hospital status: RECRUITING city: Zhuzhou state: Hunan zip: 412000 country: China name: Qingfeng Peng role: CONTACT phone: 86+ 13973319588 email: 460593067@qq.com lat: 27.83333 lon: 113.15 facility: Affiliated Hospital of Inner Mongolia Medical University status: RECRUITING city: Hohhot state: Inner Mongolia zip: 010000 country: China name: Jianrong Zhao role: CONTACT phone: 86+ 13848129952 email: zjr13848129952@163.com lat: 40.81056 lon: 111.65222 facility: Sir Run Run Hospital, Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Wenwen Li role: CONTACT phone: 86+ 13951644706 email: 546466035@qq.com lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Junwei Yang role: CONTACT phone: 86+ 18951767513 email: jwyang@njmu.edu.cn lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Nantong University status: RECRUITING city: Nantong state: Jiangsu zip: 226000 country: China name: Xinzhong Huang role: CONTACT phone: 86+ 13912288751 email: huangxz421@126.com lat: 32.03028 lon: 120.87472 facility: Shenyang Central Hospital, affiliated to Shenyang Medical College status: RECRUITING city: Shenyang state: Liaoning zip: 110000 country: China name: Zhenhua Ji role: CONTACT phone: 86+ 18002477058 email: jzh642@sina.com lat: 41.79222 lon: 123.43278 facility: General Hospital of Ningxia Medical University status: RECRUITING city: Yinchuan state: Ningxia zip: 750000 country: China name: Na Tian role: CONTACT phone: 86+ 13995216063 email: 13995216063@163.com lat: 38.46806 lon: 106.27306 facility: The First People's Hospital of Tancheng County status: RECRUITING city: Linyi state: Shandong zip: 276100 country: China name: Changyou Sun role: CONTACT phone: 86+ 15168960721 email: scy6119125@126.com lat: 35.06306 lon: 118.34278 facility: Qilu Hospital of Shandong University (Qingdao) status: RECRUITING city: Qingdao state: Shandong zip: 266000 country: China name: Lanjie He role: CONTACT phone: 86+ 18561812668 email: nxhelanjie@126.com lat: 36.06488 lon: 120.38042 facility: Minhang District Central Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Xudong Xu role: CONTACT phone: 86+ 18918169003 email: xxdmzx@sina.com lat: 31.22222 lon: 121.45806 facility: Shanghai First People's Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Qiuling Fan role: CONTACT phone: 86+ 13904012680 email: cmufql@163.com lat: 31.22222 lon: 121.45806 facility: Shanghai No.5 Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Jianying Niu role: CONTACT phone: 86+ 18918168518 email: njyphd2008@163.com lat: 31.22222 lon: 121.45806 facility: Shanghai Tongji Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Chen Yu role: CONTACT phone: 86+ 13311996821 email: yuchen@tongji.edu.cn lat: 31.22222 lon: 121.45806 facility: The Second Affiliated Hospital of Tianjin Medical University status: RECRUITING city: Tianjin state: Tianjin zip: 300000 country: China name: Rong Li role: CONTACT phone: 86+ 18698061623 email: beilloa@sohu.com lat: 39.14222 lon: 117.17667 facility: Tianjin People's Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300000 country: China name: Gang Long role: CONTACT phone: 86+ 13602121007 email: longgang@hotmail.com lat: 39.14222 lon: 117.17667 hasResults: False
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<|newrecord|> nctId: NCT06277115 id: BASEC Nr. 2020-02002 briefTitle: Acute and Long-term Effects of CPAP in OSA overallStatus: RECRUITING date: 2021-02-01 date: 2024-07 date: 2024-12 date: 2024-02-26 date: 2024-02-28 name: University of Zurich class: OTHER briefSummary: Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. The trial has been designed as a validation of the CPAP-withdrawal model. Baseline in-laboratory sleep studies will be performed prior to CPAP initiation, after 6-8 weeks on CPAP (treatment effect) and following 2 weeks of CPAP therapy withdrawal (withdrawal effect, effect of OSA recurrence). conditions: Obstructive Sleep Apnea of Adult studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Two-phase intervention: several weeks of CPAP therapy followed by two weeks CPAP therapy withdrawal primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Continuous positive airway pressure (CPAP) measure: Nocturnal systolic blood pressure measure: Epworth Sleepines Scale Score (ESS) measure: 48h, 24h, diurnal and nocturnal systolic and diastolic blood pressure measure: Office systolic and diastolic blood pressure measure: 48h, 24h, diurnal, nocturnal and office heart rate measure: Heart rate variability in the time and frequency domain (CV, RMSSD, pRR50, LF, HF, LF/HF) measure: Blood pressure variability (BPV, systolic and diastolic) measure: Baroreflex sensitivity (BRS) measure: Arterial stiffness measure: Measures of nocturnal hypoventilation (median and maximal transcutaneous partial pressure of CO2 = tcpCO2) measure: Measures of nocturnal hypoxaemia (mean nocturnal oxygen saturation = ¢SpO2) measure: Measures of nocturnal hypoxaemia (time spent with SpO2 below 90% = t<90) measure: Measures of nocturnal hypoxaemia (hypoxic burden) measure: Measures of OSA severity (apnoea-hypopnoea-index) measure: Measures of OSA severity (oxygen-desaturation index) measure: Sleepiness (Stanford Sleepiness Scale (SSS)) measure: Fatigue (fatigue severity scale (FSS)) measure: Disease-specific quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ)) measure: Superoxide dismutase measure: Urinary catecholamines measure: Pulse rise index (>6 beats per minute) measure: Nocturnal oxymetry measures (¢SpO2, t<90, ODI-3%, ODI-4%) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich status: RECRUITING city: Zurich zip: 8091 country: Switzerland name: Esther I Schwarz, MD role: CONTACT phone: 0041442553828 email: estherirene.schwarz@usz.ch name: Joël J Herzig role: CONTACT email: joel.herzig@usz.ch lat: 47.36667 lon: 8.54999 hasResults: False
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<|newrecord|> nctId: NCT06277102 id: Music pain FHF briefTitle: Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture overallStatus: RECRUITING date: 2024-01-26 date: 2024-06-01 date: 2024-06-01 date: 2024-02-26 date: 2024-02-26 name: Hospital Authority, Hong Kong class: OTHER_GOV briefSummary: Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. No study has been conducted focusing on pain control among cases with fragility hip fractures in an acute ward setting with non-schedule non-elective orthopaedic operation.
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In Queen Elizabeth Hospital a standardized analgesic protocol is used for all fragility hip fracture cases unless contraindicated, a suboptimal post-operative pain control is not uncommonly seen. Stepping up analgesics is usually a concern in the elderly with a higher rate of side effects, a safe and simple non-pharmacological intervention for pain control is therefore needed.
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The aim of this study is to study the effectiveness of incorporating music on pain intensity and mobility with the standard postoperative rehabilitation care of fragility hip fracture in Queen Elizabeth Hospital. conditions: Hip Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: music listening measure: Pain intensity measured by 11-point pain intensity numerical rating scale after music listening in postoperative Day 1 - 2 among subjects with fragility hip fracture measure: Modified functional ambulatory classification (MFAC) in postoperative Day 3 among subjects with fragility hip fracture measure: New mobility score (NMS) in postoperative Day 3 among subjects with fragility hip fracture sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Ward G9, Queen Elizabeth Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Kwan Yiu Jeffrey Lau role: CONTACT phone: 62017014 email: lky194a@ha.org.hk name: Kwan Yiu Jeffrey Lau role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06277089 id: Correction of EOS by casts briefTitle: Curve Correction of Early Onset Scoliosis by Mehta Serial Casts overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-09-01 date: 2024-02-26 date: 2024-02-26 name: Assiut University class: OTHER briefSummary: Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis conditions: Scoliosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Casts measure: Difference of the scoliotic cobb angle at last cast sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06277076 id: FMD1234 briefTitle: Accuracy of Computer- Guided Implant Surgery in Partially Edentulous Patients. overallStatus: COMPLETED date: 2023-01-28 date: 2023-05-02 date: 2023-08-15 date: 2024-02-26 date: 2024-02-26 name: Saint-Joseph University class: OTHER briefSummary: The dental implant placed freehand with a digital planing is vastly increasing. The accuracy between the planned and the placed implants still not well determined. Between a single implant and a full mouth rehabilitation, the precision is very wide. A precision scale must be settled according to each indication in order to offer the clinician a safety and a predictability for his procedures. conditions: Dental Implant conditions: Computer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 13 type: ACTUAL name: Computer Implant guided Surgery measure: Assess Accuracy of Implant Placement in Vertical Displacement (VD). measure: Assess Accuracy of Implant Placement in Horizontal Displacement (HD) measure: Assess Accuracy of Implant Placement in Error Depth (ED) measure: Assess Accuracy of Implant Placement in Error Angle (EA) measure: Evaluate Precision of the Printed Guide measure: Study Complications and Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Joseph University of Beirut/Dental school city: Beirut zip: 1107 2180 country: Lebanon lat: 33.88894 lon: 35.49442 hasResults: False
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<|newrecord|> nctId: NCT06277063 id: NFEC-2024-057 briefTitle: nVNS for the Prevention and Treatment of Primary Headache overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2026-08-31 date: 2026-12-30 date: 2024-02-26 date: 2024-03-13 name: Nanfang Hospital, Southern Medical University class: OTHER name: BrainClos Co., LTD. name: Zhuhai Fudan Innovation Institute briefSummary: This study is a single-center, randomized, double-blind controlled study. Patients will be randomly assigned to two groups by envelope drawing. The subjects will be divided into two groups: the acute intervention group and the preventive intervention group. In each group, the subjects will be randomly divided into the experimental group and the control group by means of envelope extraction.
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Children and adolescents (7-20 years old) with migraine who met the inclusion criteria will be enrolled as subjects in the experimental group, and the changes in headache scores before and after the intervention will be compared. The intervention method is as follows: ictal intervention, in which subjects will be evaluated for headache improvement after a short intervention during an acute exacerbation. By wearing a vagus stimulator, the stimulating electrode will be located in the concha region rich in vagus nerve fiber endings, and the appropriate stimulation intensity will be adjusted for stimulation. Therefore, this study will verify the effect of nVNS on the acute attack and preventive treatment of primary headache in children and adolescents. Based on the electrocardiogram and electromyography indicators during the intervention process of nVNS, an objective evaluation system for the improvement of headache by nVNS is established, and the role of stimulation parameters on the effect is further explored to realize the optimization of parameters. conditions: Primary Headache conditions: Migraine in Adolescence conditions: Migraine in Children conditions: Cluster Headache conditions: Tension Headache studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 288 type: ESTIMATED name: Transcutaneous auricular vagus nerve stimulation name: Sham transcutaneous auricular vagus nerve stimulation measure: Visual analogue scales(VAS)-actue period measure: Visual analogue scales(VAS)-prevention period measure: Heart rate variability(HRV) measure: Electromyography(EMG) sex: ALL minimumAge: 7 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong country: China name: Ji Ya-Bin, post-doc role: CONTACT phone: +8615913186246 email: yabinji@126.com lat: 23.11667 lon: 113.25 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol date: 2024-02-03 uploadDate: 2024-03-06T22:03 filename: Prot_SAP_ICF_002.pdf size: 158671 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form: Informed Consent Form date: 2024-02-03 uploadDate: 2024-03-06T22:01 filename: ICF_003.pdf size: 139248 hasResults: False
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<|newrecord|> nctId: NCT06277050 id: NPC-ICMB briefTitle: Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-03-07 date: 2029-02-20 date: 2030-02-20 date: 2024-02-26 date: 2024-03-07 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure.
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The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy). conditions: Nasopharyngeal Carcinoma conditions: High-Risk Cancer conditions: Maintenance Therapy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 264 type: ESTIMATED name: Maintenance Therapy with Toripalimab and Capecitabine name: Maintenance Therapy with Capecitabine measure: Progression-free Survival measure: Distant Metastasis-Free Survival measure: Overall Survival measure: Loco-Regional Recurrence-Free Survival sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06277037 id: AB-729-204 briefTitle: Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729) overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2029-08-30 date: 2029-10-30 date: 2024-02-26 date: 2024-04-01 name: Arbutus Biopharma Corporation class: INDUSTRY briefSummary: This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study \[EOS\] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation). conditions: Long Term Follow-up studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 35 type: ESTIMATED name: Non-interventional measure: To evaluate the durability of effect of imdusiran on HBV parameters measure: To evaluate the durability of effect of imdusiran on HBV parameters measure: To evaluate the durability of effect of imdusiran on HBV parameters sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Alfred Hospital city: Melbourne state: Victoria zip: 3004 country: Australia name: Stuart Roberts role: CONTACT role: CONTACT email: S.Roberts@alfred.org.au lat: -37.814 lon: 144.96332 facility: Fiona Stanley Hospital city: Murdoch zip: 6150 country: Australia name: Sam Galhenage role: CONTACT lat: -32.06987 lon: 115.83757 facility: Queen Mary Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Prince of Wales Hospital city: Shatin country: Hong Kong name: Grace Wong role: CONTACT lat: 22.38333 lon: 114.18333 facility: Changhua Christian Hospital city: Changhua city zip: 600566 country: Taiwan lat: 24.07327 lon: 120.56276 facility: Chia-Yi Christian Hospital city: Chiayi City zip: 60002 country: Taiwan name: Chi-Yi Chen role: CONTACT lat: 23.47917 lon: 120.44889 facility: Kaohsiung Medical University Chung-Ho Memorial Hospital city: Kaohsiung zip: 80756 country: Taiwan name: Wan-Long Chuang role: CONTACT lat: 22.61626 lon: 120.31333 facility: E-Da Hospital city: Kaohsiung zip: 82445 country: Taiwan name: Gin-Ho Lo role: CONTACT lat: 22.61626 lon: 120.31333 facility: Taichung Veterans General Hospital city: Taichung zip: 40705 country: Taiwan name: Sheng-Shun Yang role: CONTACT lat: 24.1469 lon: 120.6839 facility: Chang Gung Medical Foundation Linkou city: Taoyuan zip: 33305 country: Taiwan name: Chao-Wei Hsu role: CONTACT lat: 24.95233 lon: 121.20193 facility: University Hospital of Wales, Cardiff city: Cardiff zip: CF144XW country: United Kingdom name: Jonathan Underwood role: CONTACT lat: 51.48 lon: -3.18 facility: Royal London Hospital city: London zip: E11FR country: United Kingdom lat: 51.50853 lon: -0.12574 facility: King's College Hospital city: London zip: SE59RS country: United Kingdom name: Kosh Agarwal role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06277024 id: FUGES-32 briefTitle: A Study on the Safety and Efficacy of the Combination of Candenizumab, Lenvatinib, and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients overallStatus: RECRUITING date: 2023-01-01 date: 2024-12-31 date: 2027-12-31 date: 2024-02-26 date: 2024-02-26 name: Fujian Medical University class: OTHER briefSummary: Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients conditions: Overall Response Rate studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Combination of Cardonizumab with Lenvatinib and SOX regimen measure: ORR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Gastric Surgery， Fujian Medical University Union Hospital status: RECRUITING city: Fuzhou state: Fujian country: China name: Changming Huang, MD role: CONTACT phone: +8613805069676 email: hcmlr2002@163.com lat: 26.06139 lon: 119.30611 hasResults: False
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<|newrecord|> nctId: NCT06277011 id: Meta10-19-004 briefTitle: Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research overallStatus: RECRUITING date: 2023-02-10 date: 2025-02-01 date: 2025-05-15 date: 2024-02-26 date: 2024-02-26 name: Anhui Provincial Hospital class: OTHER_GOV name: Leman Biotech Co., Ltd briefSummary: A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory CD19-positive B cell Hematological Malignancies conditions: Acute Lymphoblastic Leukemia conditions: Non-hodgkin Lymphoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Metabolically Armed CD19 CAR-T cells measure: MTD measure: Objective response rate (ORR) measure: Concentration of CAR-T cells measure: Pharmacodynamics of CAR-T cells sex: ALL minimumAge: 3 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital status: RECRUITING city: Hefei state: Anhui zip: 518000 country: China name: Xingbing Wang, PhD role: CONTACT phone: +8613856007984 email: wangxingbing@ustc.edu.cn lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06276998 id: LK001304 briefTitle: A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis overallStatus: RECRUITING date: 2023-12-12 date: 2025-08-04 date: 2026-11-20 date: 2024-02-26 date: 2024-03-22 name: Lynk Pharmaceuticals Co., Ltd class: INDUSTRY briefSummary: Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to biologic DMARDs(bDMARDs).
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The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of LNK01001 12 mg twice daily (BID) versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.
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The study objective of Period 2 (Week 24 to Week 76) is to evaluate the long-term safety, tolerability, and efficacy of LNK01001 12 mg BID in participants with RA who completed Period 1. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 430 type: ESTIMATED name: LNK01001 name: Placebo measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 measure: Change from Baseline in Disease Activity Score 28 (DAS28) (CRP) at week 24 measure: Percentage of Participants with an American College of Rheumatology 50% (ACR50) Response at week 24 measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at all visits. measure: Percentage of Participants with an American College of Rheumatology 70% (ACR70) Response at all visits. measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at all visits. measure: Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at all visits measure: Percentage of Participants with an American College of Rheumatology 20% (ACR20) Response at all visits (except week 24). measure: Change from Baseline in the Severity of Morning Stiffness at all visits. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing country: China name: Xiaofeng Zeng role: CONTACT phone: 0086-010-69158793 email: xiaofeng.zeng@cstar.org.cn lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06276985 id: 977/91 briefTitle: Impact of Injectable Platelet Rich Fibrin Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements During Clear Aligner Therapy overallStatus: ENROLLING_BY_INVITATION date: 2024-02-25 date: 2024-06-25 date: 2024-07-25 date: 2024-02-26 date: 2024-02-26 name: Al-Azhar University class: OTHER briefSummary: The aim of this prospective clinical project will be to compare the effect of platelet rich fibrin versus low- intensity pulsed ultrasound on therate of different orthodontic tooth movements during clear aligner therapy. conditions: Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 82 type: ESTIMATED name: low intensity pulsed ultrasound and iPRF measure: Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter sex: ALL minimumAge: 15 Years maximumAge: 22 Years stdAges: CHILD stdAges: ADULT facility: AlAzhar university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06276972 id: P.T.REC/012/005000 briefTitle: Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical in Scoliosis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-12 date: 2024-03-01 date: 2024-03-15 date: 2024-02-26 date: 2024-02-26 name: Delta University for Science and Technology class: OTHER name: Benha University briefSummary: To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents conditions: Scoliosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 89 type: ACTUAL name: no intervention measure: Cobb's angle measure: Coronal balance measure: length of the the tibia and femur measure: tibiofemoral angle measure: knee joint line convergence angle measure: lower limb mechanical axis; and mechanical axis deviation sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Delta university for science and technology city: Gamasa state: Dakahleya zip: 7731168 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False
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<|newrecord|> nctId: NCT06276959 id: WCHSIRB-D-2022-430 briefTitle: The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth overallStatus: RECRUITING date: 2023-01-01 date: 2025-03-01 date: 2025-03-01 date: 2024-02-26 date: 2024-04-12 name: West China College of Stomatology class: OTHER briefSummary: As a new emerging technology for the diagnosis of dental caries, near-infrared imaging requires further research and validation to determine its effectiveness. This study aims to compare near-infrared imaging with cone-beam computed tomography (CBCT) to validate the efficiency of near-infrared imaging in diagnosing proximal caries using large-scale clinical data through retrospective cross-sectional studies. conditions: Dental Caries studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 120 type: ESTIMATED name: intraoral scanning name: clinical oral examination name: cone-beam computed tomography measure: positive percent agreement measure: negative percent agreement measure: overall percent agreement measure: Proximal caries positive site diagnosed by CBCT measure: Proximal caries positive site diagnosed by near-infrared imaging (NIRI) measure: Proximal caries positive site diagnosed by unaided visual examination (UVE) sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital of Stomatology, Sichuan University status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: Zhihe Zhao, Doctor role: CONTACT phone: +86 139 8188 1666 email: zhzhao@scu.edu.cn lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06276946 id: LCCC2244 briefTitle: Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2028-07 date: 2029-01 date: 2024-02-26 date: 2024-03-22 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.
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This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering. conditions: Oropharynx Cancer conditions: Head and Neck Cancer conditions: Xerostomia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 98 type: ESTIMATED name: standard radiotherapy name: experimental radiotherapy measure: The difference in patient-reported xerostomia 6 months measure: Saliva mass measure: Parotid duct dose constraint measure: The difference in patient-reported xerostomia 12 months measure: Xerostomia by NCI-CTCAE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 hasResults: False
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<|newrecord|> nctId: NCT06276933 id: MA-NSCLC-II-039 briefTitle: A Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2025-11-22 date: 2026-11-22 date: 2024-02-26 date: 2024-02-26 name: Tongji University class: OTHER name: Shanghai Pulmonary Hospital, Shanghai, China briefSummary: To explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients conditions: Lung Cancer conditions: Camrelizumab studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Camrelizumab + chemotherapy+Thalidomide name: Camrelizumab + chemotherapy+placebo measure: Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP) measure: Median time to RCCEP measure: Median time to RCCEP of level 3 or above measure: Incidence rate of ≥G3 grade RCCEP measure: Overall Response Rate (ORR) measure: Progression-Free Survival (PFS) measure: Overall Survival(OS) measure: Treatment-related Adverse Events (TRAE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276920 id: 2024/5554(1) briefTitle: Evaluation of Joint Position Sense in Healthy Individuals overallStatus: RECRUITING date: 2024-02-07 date: 2024-02-29 date: 2024-02-29 date: 2024-02-26 date: 2024-02-26 name: Inonu University class: OTHER briefSummary: It was aimed to measure the elbow joint position sense in healthy individuals in the case of a closed kinetic chain and to compare it with the measurement made in the case of an open kinetic chain. conditions: Proprioception studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 4 type: ESTIMATED measure: Joint position sense measurement with universal goniometer in close kinetic chain measure: Joint position sense measurement with universal goniometer in open kinetic chain sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Inonu University status: RECRUITING city: Malatya zip: 12000 country: Turkey name: DILAN DEMİRTAŞ KARAOBA role: CONTACT phone: 0554112779 email: dilandemirtas92@gmail.com lat: 38.35018 lon: 38.31667 hasResults: False
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<|newrecord|> nctId: NCT06276907 id: ILBS-ACLF-16 briefTitle: An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-12-31 date: 2027-12-31 date: 2024-02-26 date: 2024-02-26 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: Rationale: Current understanding of the pathophysiology of ACLF suggests that unresolved injury, poor infection control, and liver regeneration result in persistent systemic inflammation and cytokine storm, which subsequently lead to systemic inflammatory response syndrome (SIRS) resulting in multiple organ failures, septic shock and deaths in ACLF. Nearly 74% of ACLF patients initially diagnosed without SIRS, sepsis, or organ failure developed SIRS by day 7 which increases the onset of secondary organ failure and sepsis with high short-term mortality. The emerging use of plasma exchange has shown some potential benefits in terms of dampening systemic inflammation and improvement of outcomes in some ACLF patients. However, there is currently no randomized controlled trial exploring the potential role in ameliorating secondary organ dysfunctions in patients with ACLF is not known. Hence in the current objective, we want to study the role of plasma exchange in the management of sec. organ failure in ACLF patients in a randomized controlled trial and identify the biomarker to access the treatment response to therapy. conditions: Acute on Chronic Liver Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 190 type: ESTIMATED name: Plasma Exchange name: Standard Medical Treatment measure: The AARC grading is done by AARC score the values of which vary from 5-15 , pts are divided into 3 grades i.e AARC score 5-7- grade 1, 8-10- grade 2, and AARC 11-15 as grade 3. Improvement in 1 grade is associated with 40% improvement in 28-day survival measure: Transplant-free survival at 28-days measure: The impact of TPE on the progression or resolution of secondary organ failures at day 7, 14 and 28 measure: the development of infection at day 7 and 14 in patients who had no infection measure: Duration of ICU and hospital stay measure: The proportion of patients developing adverse events will be compared between the two groups sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Liver & Biliary Sciences city: New Delhi state: Delhi zip: 110070 country: India name: Dr Rakhi Maiwall, DM role: CONTACT phone: 01146300000 email: rakhi_2011@yahoo.co.in lat: 28.63576 lon: 77.22445 hasResults: False
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<|newrecord|> nctId: NCT06276894 id: IRB #2064530-1 briefTitle: Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention acronym: fNIRS overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-01 date: 2025-02-01 date: 2024-02-26 date: 2024-02-26 name: Craig Hospital class: OTHER briefSummary: The purpose of this study is to evaluate the safety and feasibility of using a portable neuroimaging device called functional near-infrared spectroscopy (fNIRS) to successfully analyze fNIRS data in individuals with chronic TBI during treadmill training augmented with VR. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Motek C-Mill™ treadmill name: training session with and without VR wearing the fNIRS cap measure: Incidence of Treatment-Related Adverse Events (e.g., Safety and Tolerability) measure: Acceptability of the intervention measure: fNIRS Data Quality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Craig Hospital city: Englewood state: Colorado zip: 80113 country: United States lat: 39.64777 lon: -104.98776 hasResults: False
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<|newrecord|> nctId: NCT06276881 id: DSC1001 id: 1R43DA054845-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R43DA054845-01 briefTitle: Visual Stimulation for Pain Relief overallStatus: COMPLETED date: 2022-06-03 date: 2022-12-28 date: 2023-05-01 date: 2024-02-26 date: 2024-04-03 date: 2024-04-03 name: Dandelion Science class: INDUSTRY name: National Institutes of Health (NIH) name: National Institute on Drug Abuse (NIDA) briefSummary: The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 75 type: ACTUAL name: Visual Stimulation measure: Visual Analog Scale (VAS) Score measure: Event-related Potential (ERP) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Dandelion Science city: Hoboken state: New Jersey zip: 07030 country: United States lat: 40.74399 lon: -74.03236 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-12-21 uploadDate: 2024-03-08T12:20 filename: Prot_SAP_000.pdf size: 689133 hasResults: True
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<|newrecord|> nctId: NCT06276868 id: HELEN-017 briefTitle: Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-07-01 date: 2029-06-01 date: 2024-02-26 date: 2024-02-26 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy. conditions: Breast Cancer conditions: HER2-positive Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single arm clinical study primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Dalcilib+letrozole+HP treatment group measure: pathologic complete response measure: Adverse event occurrence measure: objective response rate measure: Residual cancer burden measure: Event free survival measure: Disease free survival measure: Distant disease/recurrence free survival sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan cacer hospital city: Henan state: Henan zip: 450008 country: China hasResults: False
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