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<|newrecord|> nctId: NCT06386185 id: DRAPE briefTitle: Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography acronym: DRAPE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-07-01 date: 2026-11-01 date: 2024-04-26 date: 2024-04-26 name: Royal United Hospitals Bath NHS Foundation Trust class: OTHER name: Sheffield Teaching Hospitals NHS Foundation Trust name: Royal Free Hospital NHS Foundation Trust name: Golden Jubilee National Hospital name: Papworth Hospital NHS Foundation Trust name: University of Bath briefSummary: The goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (RV) function in echocardiography, and ECG have in detecting pulmonary hypertension.
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The main questions it aims to answer are:
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Can novel markers in ECG and echocardiography suggest the presence of PH? Can existing screening guidelines be improved with the addition of these markers? conditions: Pulmonary Hypertension studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 2500 type: ESTIMATED name: Electrocardiogram name: Transthoracic echocardiogram name: Right heart catheter measure: Distinguish between patients with and without pulmonary hypertension measure: Distinguish between patients with pre-capillary hypertension and post-capillary hypertension measure: Assess the impact of the severity of pulmonary hypertension measure: Assess the impact of additional ECG markers on existing PH probability stratification sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal United Hospital NHS Foundation Trust city: Bath state: Banes zip: BA1 3NG country: United Kingdom lat: 51.3751 lon: -2.36172 facility: Golden Jubilee Hospital city: Glasgow state: Lanarkshire zip: G81 4DY country: United Kingdom lat: 55.86515 lon: -4.25763 facility: Sheffield Teaching Hospitals NHS Foundation Trust city: Sheffield state: South Yorkshire zip: S10 2JF country: United Kingdom lat: 53.38297 lon: -1.4659 facility: Royal Papworth Hospital city: Cambridge zip: CB2 0AY country: United Kingdom lat: 52.2 lon: 0.11667 facility: Royal Free NHS Foundation Trust city: London zip: NW3 2QG country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06386172 id: 2023-03537-01 id: FoUI-986028 type: OTHER_GRANT domain: ALF Medicin, Region Stockholm briefTitle: Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm acronym: ALMA-CKD overallStatus: RECRUITING date: 2023-09-09 date: 2025-04 date: 2026-12 date: 2024-04-26 date: 2024-04-26 name: Karolinska Institutet class: OTHER name: Danderyd Hospital name: Region Stockholm briefSummary: One in 10 adults in Region Stockholm have chronic kidney disease (CKD), which dramatically increases healthcare costs and the risk of medication errors or adverse health outcomes, including cardiovascular disease and death. Identification and early management of these patients is done in primary care settings. However, most adults with CKD in our region are under detected, undiagnosed and undertreated, with low rates of referral to nephrology-specialist care.
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This is a pragmatic cluster randomized controlled trial (RCT) involving 66 primary healthcare centers in Region Stockholm, and testing the effect of an electronic clinical decision support (CDS) triggering system to assist general practitioners through the guideline-recommended processes of CKD care.
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The centers, providing healthcare to approximately 780.000 citizens, will be randomized 50:50 to this CDS trigger (vs basic advice) for 18 months. Study outcomes will consider the improvement in the indicators of CKD care.
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As a pragmatic trial there is no active recruitment or active data collection. The trial is embedded into the ongoing Stockholm CREAtinine Measurements (SCREAM) project, a database collection of healthcare use for the complete population of Stockholm. Using this real-world healthcare data collection, the investigators will be able to measure with precision the impact of our CDS trigger and its potential to improve clinical care. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The primary healthcare network system of the region of Stockholm coordinates 66 public primary healthcare centers. Collectively, these centers offer care to an estimated population of 780.000. Since November 2022, a new platform for CDS (clinical decision support) triggers called ALMA has been implemented in these centers. ALMA is connected to patient records and uses CDS triggers to identify medical problems, issue alerts and propose solutions.
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Using the ALMA platform, this project has the following objectives:
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Objective 1: to develop a CDS trigger connected with the electronic healthcare records specific to the processes of screening, diagnosis, and nephrologist referral of patients with CKD, including individualized CKD management optimization, in primary care.
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Objective 2: to evaluate the effectiveness of this CDS trigger (versus current basic advice) through a 2-arm pragmatic cluster RCT. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 780000 type: ESTIMATED name: Clinical decision support trigger measure: Number of participants screened for creatinine and albuminuria measure: Number of screened participants with retesting for creatinine and albuminuria measure: Number of participants with laboratory-determined CKD receiving a clinical diagnosis measure: Number of participants receiving CKD-modifying agents measure: Number of participants referred to nephrologist care sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Institutet status: RECRUITING city: Stockholm country: Sweden name: Juan J Carrero, Prof role: CONTACT phone: 0046739636948 email: [email protected] lat: 59.33258 lon: 18.0649 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-04-01 uploadDate: 2024-04-23T02:35 filename: SAP_000.pdf size: 292236 hasResults: False
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<|newrecord|> nctId: NCT06386159 id: 2023-1178 briefTitle: Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism overallStatus: RECRUITING date: 2024-03-15 date: 2025-04-30 date: 2025-07-30 date: 2024-04-26 date: 2024-04-26 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application. conditions: Post-extubation Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 69 type: ESTIMATED name: Electrical vagus nerve stimulation measure: functional oral intake scale（FOIS） measure: standardized Swallowing Assessment（SSA） measure: Rate of total oral feeding after the intervention measure: Duration of Enteral Nutrition Tube Indwelling measure: Rate of Re-intubation after Endotracheal Intubation measure: Incidence of aspiration within one week after extubation measure: The incidence of aspiration pneumonia within one week after extubation measure: Inflammation-related indicators: serum C-reactive protein (CRP) measure: Inflammation-related indicators: serum interleukin-6 (IL-6) measure: Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh) measure: Inflammation-related indicators: high mobility group box-1 protein (HMGB1) measure: Days of ICU hospitalization measure: Total days of hospitalization measure: In-hospital survival rate sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Feng Xiuqin status: RECRUITING city: Hangzhou zip: 310000 country: China name: Feng Feng, Xiuqin role: CONTACT phone: 13757119151 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06386146 id: JAB-30355-1001 briefTitle: JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-01 date: 2027-07 date: 2024-04-26 date: 2024-04-26 name: Jacobio Pharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation. conditions: Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: JAB-30355 name: JAB-30355 measure: Dose limiting toxicity (DLT) measure: Number of participants with adverse events measure: Peak Plasma Concentration (Cmax) measure: Time to reach the observed maximum (peak) concentration (Tmax) measure: Terminal half-life (t1/2) measure: Objective response rate (ORR) measure: Duration of response (DOR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06386133 id: MS Boost briefTitle: Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care acronym: MSBoost overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-07-01 date: 2026-04-01 date: 2024-04-26 date: 2024-04-26 name: Ad scientiam class: OTHER name: Assistance Publique - Hôpitaux de Paris briefSummary: The main objective of the MS Boost study is to demonstrate the superiority of MSCopilot Boost over standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (MS).
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The secondary objectives include validating MSCopilot Boost clinical performance in reducing fatigue and its impact as well as evaluating its functional tests performance and its safety of use. The investigation team will also investigate the effects of MSCopilot Boost on patient symptoms, functional parameters and physical activity levels. The investigation team will evaluate patients and healthcare professionals' perceived clinical benefit as well as adherence, satisfaction and user experience related to the mobile application and the web portal. Ultimately, the investigation team will define the medico-economic and organizational impact of the MSCopilot Boost solution.
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Patients' expected benefits are the access to additional clinical tests not routinely performed, covering dimensions not addressed by standard tests like the EDSS for example; a remote monitoring of functional tests similar to those of the modified MSFC with the possibility of adding an evaluation of fatigue through digital questionnaires; improvement of symptoms related to MS fatigue through access to a personalised tele-rehabilitation program.
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Healthcare professionals' expected benefits are to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients' management and to gain time by providing a "big picture" of the patient's condition over time. conditions: Multiple Sclerosis conditions: Fatigue Syndrome, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Boost group: Use of MSCopilot Boost and wear of an actimeter during the whole study participation duration.
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Control group: Standard practice and wear of an actimeter during the whole study participation duration. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 208 type: ESTIMATED name: MS Boost name: Standard of care measure: To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis measure: To evaluate the impact of fatigue in both groups. measure: To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term) measure: To compare the fatigue impact between the two groups. measure: To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home. measure: To assess the number of adverse events of using MSCopilot Boost. measure: To compare the effect of MSCopilot Boost on walking compared to standard practice: -Assessed by the functional standard test performed at the hospital -Assessed at home measure: To compare the proportion of patients whose symptoms improved in both groups on Fatigue impact. measure: To compare the proportion of patients whose symptoms improved in both groups on anxiety and depression. measure: To compare the proportion of patients whose symptoms improved in both groups on Depression. measure: To compare the proportion of patients whose symptoms improved in both groups on Fatigue. measure: To compare the proportion of patients whose symptoms improved in both groups on Walking. measure: To compare the proportion of patients whose symptoms improved in both groups on Dexterity. measure: To compare the proportion of patients whose symptoms improved in both groups on Cognition. measure: To compare the proportion of patients whose symptoms improved in both groups on the Low-contrast Vision. measure: To compare the effect of MSCopilot Boost on quality of life compared to standard practice. measure: To compare the effect of MSCopilot Boost on the mean overall physical activity compared to standard practice. measure: To evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost. measure: To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals. measure: To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals. measure: To assess user compliance with MSCopilot Boost throughout the follow-up period. measure: To evaluate the link between MSCopilot Boost use compliance and fatigue improvement. measure: To assess the relationship between self-reported and objectively measured physical activity. measure: To explore the factors that might influence the effect of MSCopilot Boost on fatigue and its impact. measure: To assess the changes in sleep patterns and areas of life impacted by fatigue, as measured with MSCopilot Boost at home. measure: To assess the evolution of overall physical activity reported by patients. measure: To explore the correlation between overall physical activity and the change in : -Fatigue impact -Fatigue measure: Calculation of cost-effectiveness in reducing fatigue at 1, 3, 6 and 9 months using MSCopilot Boost as an intervention, compared to standard care. measure: To assess the impact of MSCopilot Boost on work-related factors (duration without working, absenteeism from work, return-to-work time, presenteeism) at 3, 6 and 9 months, compared to baseline (Day 0), in both groups. measure: To evaluate behavioral changes in terms of physical activity and energy management. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06386120 id: 2024-z033 briefTitle: Respiratory Function Monitoring of Mechanical Ventilation in Patients With Chest Blunt Injury overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-07 date: 2024-04-26 date: 2024-04-26 name: Peking University People's Hospital class: OTHER briefSummary: The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. The main question it aims to answer is:
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Can lung protective ventilation strategies improve respiratory function in patients with severe chest contusion? We will collect clinical data of participants who already taking lung protective ventilation strategies as part of their regular medical care. conditions: Lung Contusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: PEEP setting strategy measure: ventilation blood flow ratio measure: oxygenation index measure: 28-day mortality measure: Mechanical ventilation-free from day 1 to 28 measure: Length of ICU stay measure: Length of hospital stay measure: The rate of successful weaning sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06386107 id: 23PH188 id: 2023-A02175-40 type: OTHER domain: ANSM briefTitle: Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis acronym: CATforCAT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-08 date: 2024-04-26 date: 2024-04-26 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER name: Diagnostica Stago name: LEO Pharma name: Ligue contre le cancer, France briefSummary: Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment. conditions: Cancer conditions: Pulmonary Embolism conditions: Thrombosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective cohort of consecutive patients initiating full-dose anticoagulant therapy for an episode of CAT, followed up until the 6th month of treatment to assess the risk of clinically relevant adjunctive bleeding events and any other adverse event during anticoagulant therapy (recurrence of CAT, death).
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TGT measurement is fully automated and calibrated with quality control. primaryPurpose: OTHER masking: NONE count: 212 type: ESTIMATED name: Thrombin Generation Assay (TGA) measure: The measurement of the area under the curve ( endogenious thrombin potential) nMxmin measure: the measurement of the lag time unit = seconds measure: the measurement of the peak height unit = nm measure: the measurement of the time to peak unit = seconds measure: Effect of adding TGT results on the performance of bleeding risk prediction scores measure: Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT measure: Occurrence of an event of interest under treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Clermont-Ferrand city: Clermont-Ferrand zip: 63003 country: France name: Jeannot SCHMIDT, MD PHD role: CONTACT name: Jeannot SCHMIDT, MD PHD role: PRINCIPAL_INVESTIGATOR name: Aurélien LEBRETON, MD PHD role: SUB_INVESTIGATOR name: Fares MOUSTAFA, MD PHD role: SUB_INVESTIGATOR name: Nicolas DUBLANCHET, MD role: SUB_INVESTIGATOR name: Dorian TEISSANDIER, MD role: SUB_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: CHU de Grenoble city: Grenoble zip: 38043 country: France name: Gilles PERNOD, MD PHD role: CONTACT phone: 04 76 76 57 17 phoneExt: +33 email: [email protected] name: Gilles PERNOD, MD PHD role: PRINCIPAL_INVESTIGATOR name: Raphaël MARLU, MD PHD role: SUB_INVESTIGATOR lat: 45.16667 lon: 5.71667 facility: HCL city: Lyon country: France name: Yesim DARGAUD, MD PHD role: CONTACT name: Judith CATELLA, MD role: PRINCIPAL_INVESTIGATOR name: Claire GRANGE, MD role: SUB_INVESTIGATOR name: Yesim DARGAUD, MD PHD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Chu St-Etienne city: Saint-Étienne zip: 42055 country: France name: Géraldine POENOU, MD PHD role: CONTACT email: [email protected] name: Laurent BERTOLETTI, MD PHD role: SUB_INVESTIGATOR name: Xavier DELAVENNE, MD PHD role: SUB_INVESTIGATOR name: Coline LEGENDRE, MD role: SUB_INVESTIGATOR name: Pauline NOYEL, MD role: SUB_INVESTIGATOR name: Brigitte TARDY, MD PHD role: SUB_INVESTIGATOR name: Géraldine POENOU, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
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<|newrecord|> nctId: NCT06386094 id: INT/IEC/2023/SPL-902 briefTitle: Cardiac Dysfunction in Patients With Non-alcoholic Fatty Liver Disease overallStatus: RECRUITING date: 2023-07-15 date: 2025-08-15 date: 2025-11-15 date: 2024-04-26 date: 2024-04-26 name: Post Graduate Institute of Medical Education and Research, Chandigarh class: OTHER briefSummary: Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality. conditions: NAFLD conditions: Cardiac Disease conditions: Fatty Liver studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Echocardiographic assessment measure: To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease measure: Presence of myocardial abnormalities in CCM dysfunction measure: Presence of perfusion abnormalities in CCM dysfunction measure: All cause mortality in NAFLD measure: Cardiac event related mortality in NAFLD measure: To determine the severity of cardiac dysfunction in patients with non-alcoholic fatty liver disease sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Madhumita Premkumar status: RECRUITING city: Chandigarh zip: 160012 country: India name: Dr. Madhumita Premkumar, MD role: CONTACT phone: +9101722754777 email: [email protected] lat: 30.73629 lon: 76.7884 hasResults: False
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<|newrecord|> nctId: NCT06386081 id: AC18/00031 briefTitle: Dietary Intervention in Food Allergy acronym: AC18/00031 overallStatus: COMPLETED date: 2021-01-01 date: 2023-01-31 date: 2023-06-30 date: 2024-04-26 date: 2024-04-26 name: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud class: OTHER briefSummary: The goal of this randomized double-blind placebo-controlled clinical study is to determine whether the dietary intervention with pectins leads to food immunomodulation in non-specific lipid transfer proteins (nsLTP) allergic patients. The main question it aims to answer is if the microbiome is a target of intervention against food allergy through the use of prebiotics such as pectins.
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Participants will be enrolled to receive a two-month dietary intervention with either two different pectins (citrus or apple pectin) or placebo. Increase in oral tolerance to the peach nsLTP will be measured through a double-blind placebo-controlled food challenge (DBPCFC). Microbiome, proteomic and metabolomic studies will also be performed in blood and stool samples. conditions: Food Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Treatment will be blinded to the participants and research team. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 51 type: ACTUAL name: Citrus pectin with low DE name: Apple pectin with high DE name: Placebo measure: Clinical efficacy of pectin dietary intervention in nsLTP allergic patients measure: Changes in Pru p 3 (nsLTP of peach) specific IgE production induced by pectin intervention measure: Pru p 3-specific maturational changes of dendritics cells induced by pectin intervention measure: Pru p 3-specific proliferative response of different lymphocytes cell subpopulations after pectin intervention measure: Changes in Pru p 3-specific basophil activation induced by pectin intervention measure: Changes induced in the taxonomic diversity of gut microbiota measure: Changes in feaces metabolome induced by pectin dietary intervention measure: Changes in serum metabolome induced by the pectin dietary intervention measure: Epigenomic changes induced by the pectin dietary intervention measure: Pectin safety profile sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hospital Regional Universitario de Málaga city: Malaga country: Spain lat: 36.72016 lon: -4.42034 hasResults: False
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<|newrecord|> nctId: NCT06386068 id: 2110041 briefTitle: Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Persistent Whiplash Associated Disorders. acronym: VALIANT overallStatus: RECRUITING date: 2024-01-23 date: 2024-06 date: 2024-06 date: 2024-04-26 date: 2024-04-26 name: University of Southern Denmark class: OTHER briefSummary: The goal of this clinical trial is to address the critical need for effective interventions by developing and testing an interdisciplinary values-based cognitive behavioral therapy (V-CBT) program for individuals with persistent whiplash. The main question it aims to answer are:
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* What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with persistent whiplash?
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* What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program?
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Participants will undergo a replicated multiple baselines single-case experimental design (SCED). Twelve participants who meet specific eligibility criteria will be block-randomized to a 1, 2, or 3-week baseline phase, serving as their own controls. The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions, focusing on psychological and physical rehabilitation. Participants will be required to attend these sessions as part of the treatment protocol. Data collection includes daily online self-reports and comprehensive measurements at pre-treatment, post-treatment, and a three-month follow-up. conditions: Whiplash Injuries studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Values-based Cognitive Behavioral Therapy (V-CBT) measure: Value-based living measure: Pain interference measure: Value-based living measure: Pain interference measure: Pain catastrophizing measure: Positive affect measure: Negative affect measure: Stress measure: Fatigue measure: Pain-related acceptance measure: Pain-related self-efficacy measure: Pain severity measure: Neck Disability measure: Depression measure: Anxiety measure: Stress measure: Health-related quality of life measure: Pain-related acceptance measure: Pain-related self-efficacy measure: Sleep quality measure: Pain severity measure: Self-perceived improvement measure: Satisfaction with treatment measure: Pain Disability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Specialized Hospital for Polio and Accident Victims status: RECRUITING city: Rødovre state: Capital Region Of Denmark zip: 2610 country: Denmark name: Anders O Aaby, PhD role: CONTACT email: [email protected] lat: 55.68062 lon: 12.45373 hasResults: False
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<|newrecord|> nctId: NCT06386055 id: STUDY00007545 briefTitle: Air Pollution and Physical Activity: A Randomized Controlled Trial acronym: PARC overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-10-15 date: 2024-12-01 date: 2024-04-26 date: 2024-04-26 name: State University of New York at Buffalo class: OTHER briefSummary: This is a small pilot intervention trial in which we will collect preliminary data to demonstrate the feasibility of an intervention study. conditions: Physical Inactivity conditions: Pollution; Exposure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: Active exercise measure: blood pressure measure: Self-report questionnaire sex: ALL minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: University at Buffalo city: Buffalo state: New York zip: 14214 country: United States lat: 42.88645 lon: -78.87837 hasResults: False
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<|newrecord|> nctId: NCT06386042 id: MEC-2022-0252 briefTitle: Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry acronym: TITRATE-HF overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-05 date: 2029-02-14 date: 2029-04 date: 2024-04-26 date: 2024-04-26 name: Erasmus Medical Center class: OTHER name: Netherlands Heart Institute briefSummary: SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice.
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Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society of Cardiology (ESC) HF 2021 guideline recommendations for patients with heart failure (HF) reduced ejection fraction (HFrEF), and mildly reduced ejection fraction (HFmrEF).
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Study design: The current study is a prospective multi-center national quality of care registry (longitudinal) of regular HF care (as given).
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Study population: The study population consists of patients with heart failure (de novo HF, chronic HF and worsening HF). Study setting is outpatient or inpatient (during admission). Patient sample is set at a minimum of 4000 patients, but can be expanded during the course of the registry project.
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Participating sites: all hospitals with dedicated HF outpatient clinic in the Netherlands can participate.
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Data: aggregated data
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Intervention: none / no
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Main study parameters/endpoints: The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage (%) drug prescription, percentage (%) target dose (order, speed) and reason not to adhere to the guideline (intolerance, side-effects, maximum tolerated dose). The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up.
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Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk in participation, no intervention and no active involvement of patients for specific activities in the study. The project is a registration of care as given (standard care) to the participating subject with heart failure. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4289 type: ESTIMATED name: no intervention, observational study measure: Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF measure: All-cause mortality measure: Hospital admission due to heart failure related event and/or urgent visit with necessity of furosemide iv. measure: Hospital admission due to non heart failure related event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC city: Rotterdam state: Zuid-Holland zip: 3015CE country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False
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<|newrecord|> nctId: NCT06386029 id: STUDY24010191 briefTitle: The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-26 date: 2024-04-26 name: University of Pittsburgh class: OTHER briefSummary: The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are:
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1. Is the Power Down feasible for caregivers to do each night?
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2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep? conditions: Autism conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot, non-blinded intervention trial primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Power Down bedtime manipulation measure: Recruitment rates of participants through the trial measure: Retention rates of participants through the trial measure: Caregiver reported acceptability measure: Treatment adherence measure: Data collection rates- Questionnaires measure: Data collection rates- Daily diaries measure: Data collection rates- Wearing the actigraphy watch measure: Credibility/Expectancy Questionnaire sex: ALL minimumAge: 6 Years maximumAge: 10 Years stdAges: CHILD facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Amy G Hartman, PhD role: CONTACT phone: 614-989-6303 email: [email protected] lat: 40.44062 lon: -79.99589 hasResults: False
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<|newrecord|> nctId: NCT06386016 id: Stethoscope study briefTitle: Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope overallStatus: RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-26 date: 2024-04-26 name: Xiao-dong Zhuang class: OTHER briefSummary: The aim of this study is to develop a deep learning-based application of heart sounds in the diagnosis of valvular heart disease, which can be used to screen patients with valvular heart disease and promote earlier clinical monitoring and intervention. conditions: Valvular Heart Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: artificial intelligence-based stethoscope measure: valvular heart disease sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Sun Yat-Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Xiaodong Zhuang, PhD role: CONTACT phone: +86 13760755035 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06386003 id: 23-230 briefTitle: Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-03 date: 2025-05 date: 2024-04-26 date: 2024-04-26 name: Unity Health Toronto class: OTHER name: Toronto Metropolitan University name: University of Ottawa briefSummary: This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD). conditions: Post Traumatic Stress Disorder conditions: PTSD conditions: Chronic PTSD studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Psilocybin measure: Feasibility and tolerability measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score measure: Posttraumatic stress disorder Checklist-5 (PCL-5) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Generalized Anxiety Disorder Scale, 7-item (GAD-7) measure: Dissociative Experiences Scale II (DES-II) measure: Pittsburgh Sleep Quality Index (PSQI) measure: World Health Organization Well-Being Index, 5-item (WHO-5) measure: Quality of relationships inventory (QRI) measure: Inventory of psychosocial functioning (IPF) measure: Posttraumatic Maladaptive Beliefs Scale (PMBS) measure: Brief Experiential Avoidance Questionnaire (BEAQ) measure: 24-items Multidimensional Psychological Flexibility Inventory (MPFI-24) measure: Working Alliance Inventory- Short Form (WAI-SF) measure: Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) measure: Self-Compassion Scale-Short Form (SCS-SF) measure: Psychological Insight Questionnaire (PIQ) measure: Emotional Breakthrough Inventory (EBI) measure: Altered States of Consciousness Rating Scale (ASC) measure: Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ) measure: Effect on digital physiological passive data collected through the use of a wearable device sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Michael's Hospital, Unity Health Toronto city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06385990 id: 2024ks01 briefTitle: Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy overallStatus: RECRUITING date: 2024-03-29 date: 2025-03-29 date: 2027-03-29 date: 2024-04-26 date: 2024-04-26 name: Hunan Cancer Hospital class: OTHER briefSummary: This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.
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Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles. conditions: Triple Negative Breast Neoplasms studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: UTD1 measure: 2-year disease-free survival (DFS) measure: Overall Survival (OS) measure: Disease Free Survival (DFS) measure: Invasive Disease free survival (iDFS) measure: Distant Disease-free Survival (DDFS) sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Quchang Ouyang status: RECRUITING city: Changsha state: Hunan zip: 410083 country: China name: Quchang Ouyang role: CONTACT phone: 8673189762161 email: [email protected] lat: 28.19874 lon: 112.97087 hasResults: False
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<|newrecord|> nctId: NCT06385977 id: ShaanxiPPH briefTitle: Risk Factors for Chronic Prostatitis Patients in Northwest China overallStatus: RECRUITING date: 2016-01 date: 2024-05 date: 2024-06 date: 2024-04-26 date: 2024-04-26 name: Shaanxi Provincial People's Hospital class: OTHER briefSummary: The goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. The main questions it aims to answer are:
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* Is lifestyle, medication, and sexual habits related to chronic prostatitis / chronic pelvic pain syndrome
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* Is there any medication available to protect men from chronic prostatitis / chronic pelvic pain syndrome.
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Participants will:
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* Independently receive a survey questionnaire on lifestyle, medication, and sexual habits.
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* Symptomatic individuals will undergo additional prostate fluid examination for diagnosis.
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Researchers will compare healthy adult males to see if there are differences on lifestyle, medication and sexual habits between the two groups. conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: lifestyle name: sexual habits name: medication measure: Odds Ratio sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shaanxi Provincial People's Hospital status: RECRUITING city: Xi'an state: Shaanxi zip: 710061 country: China name: Qian Deng, Doctor role: CONTACT phone: 86-029-85251331 phoneExt: 2079 email: [email protected] lat: 34.25833 lon: 108.92861 hasResults: False
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<|newrecord|> nctId: NCT06385964 id: SHR-4597-101 briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-01 date: 2024-04-26 date: 2024-04-26 name: Guangdong Hengrui Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The primary objective of this randomized, double-blind, single/multiple ascending dose, placebo-controlled Phase I clinical trial was to evaluate the safety and tolerability of SHR-4597 in healthy subjects and asthmatic patients. The study consists of two parts: Part 1 involves single ascending inhalation dose in healthy subjects; Part 2 involves multiple ascending inhalation dose in asthmatic patients, further divided into Part 2A: multiple ascending inhalation dose in mild to moderate asthmatic patients, and Part 2B: multiple ascending inhalation dose in moderate to severe asthmatic patients. Subsequent lung pharmacokinetic studies of SHR-4597 inhalation will be conducted based on patients' PKPD data. conditions: Healthy Subjects conditions: Asthmatic Patients studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: SHR-4597 name: Placebo measure: Incidence and severity of inhalant adverse events after 4 days of single inhalation of SHR4597 in healthy subjects measure: Incidence and severity of inhalant adverse events after 16 days of multiple inhalation of SHR4597 in asthmatic patients, sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06385951 id: ONZ-2023-0323 briefTitle: Spatial Navigation for the Early Detection of Alzheimer's Disease. acronym: ALLO-task overallStatus: RECRUITING date: 2024-03-05 date: 2028-03-01 date: 2028-10-01 date: 2024-04-26 date: 2024-04-26 name: University Hospital, Ghent class: OTHER briefSummary: Alzheimer's Disease (AD) is the most common form of dementia and may contribute to 60-70 % of all cases. An early, accurate diagnosis of AD will become increasingly important with disease-modifying therapies. Different types of fluid and neuroimaging biomarkers are available for the early detection of AD. However, implementation of routine use of these biomarkers in clinical settings is held back due to the risk of overdiagnosis, increased cost and invasiveness of the assessment method. Therefore, novel biomarkers are needed beyond the amyloid and tau pathologies for the early diagnosis of AD. Neuropsychological paper and pencil tests can detect AD and discriminate between different clinical stages. Since medial temporal lobe structures, including the hippocampus and entorhinal cortex (EC), are involved in spatial navigation and degenerate in the earliest stages of AD, spatial navigation can be considered as an early cognitive biomarker of the disease. Nonetheless, the measurement of spatial navigation needs further improvement since the current paper and pencil tests lack ecological validity. Therefore, the test environment should be set up in immersive Virtual Reality (iVR). Dr. Andrea Castegnaro (Space and Memory Lab of University College of London) developed the Allocentric Spatial Update Task (ALLO task), which is an iVR task measuring egocentric and allocentric spatial abilities.
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Therefore, the main objective of this study is to evaluate whether allocentric and egocentric spatial navigation, measured by the ALLO iVR task can be considered a cognitive biomarker for the early detection of AD. In addition, the investigators want to report on the neuronal correlates of both spatial navigation strategies.
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Through the Department of Neurology of the University Hospital of Ghent, which has a large cognitive disorders clinic, patients with mild cognitive impairment and mild Alzheimer's dementia will be recruited. Participants will undergo standard clinical assessment, including a neuropsychological examination, Magnetic Resonance Imaging, a 18F-fluorodeoxyglucose PET and a Lumbar Puncture. In addition, participants will also be asked to undergo Tau PET imaging, Amyloid PET imaging and complete the ALLO iVR task. Healthy controls will also be recruited and have to undergo the same investigations, except for the amyloid PET and lumbar puncture. conditions: Mild Cognitive Impairment conditions: Alzheimer Disease conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 160 type: ESTIMATED name: Procedure for patients name: Procedure for healthy controls measure: Spatial navigation abilities measure: Medial Temporal Lobe atrophy measure: Amount and spreading of amyloid in the brain measure: Amount and spreading of tau in the brain measure: Decreases in cerebral glucose metabolism in the brain measure: Cognitive functioning measure: amyloidB1-42 / 40 ratio, total tau and phosphorylated tau sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Gent status: RECRUITING city: Ghent state: East-Flanders zip: 9000 country: Belgium name: Tineke Van Vrekhem role: CONTACT phone: 093326483 email: [email protected] lat: 51.05 lon: 3.71667 hasResults: False
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<|newrecord|> nctId: NCT06385938 id: 23-012048 briefTitle: Ultrasound Imaging and Quantitative Vibro-Acoustic Assessment of Rickets Under the Age of Ten overallStatus: RECRUITING date: 2024-05 date: 2026-04 date: 2026-04 date: 2024-04-26 date: 2024-04-26 name: Mayo Clinic class: OTHER briefSummary: The goal of this study is to find out if the use of ultrasound pictures of bones can spot changes in the growth areas of children with rickets, a condition that affects how bones harden. Researchers want to see if these ultrasound pictures can help tell the difference between children who have rickets and those who don't. conditions: Rickets studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 45 type: ESTIMATED name: Ultrasound with quantitative vibro-acoustic assessment measure: Relationship of quantitative vibro-acoustic ultrasound and rickets severity score measure: Relationship of ultrasound images with radiographic evidence of rickets measure: Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects measure: Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets sex: ALL maximumAge: 10 Years stdAges: CHILD facility: Mayo Clinic Minnesota status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Mary A Johnson role: CONTACT phone: 507-422-6823 email: [email protected] name: Tom D. Thacher, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06385925 id: TSN1611-2023-101 briefTitle: A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation overallStatus: RECRUITING date: 2024-04-30 date: 2026-10-30 date: 2027-04-30 date: 2024-04-26 date: 2024-04-26 name: Tyligand Bioscience (Shanghai) Limited class: INDUSTRY briefSummary: The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part. conditions: Malignant Neoplasm studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: TSN1611 measure: Dose limiting toxicities (DLTs) in phase 1 part measure: Objective response rate (ORR) in phase 2 part measure: Adverse events measure: Area under the plasma concentration-time curve (AUC) measure: Maximum blood concentrations (Cmax) measure: Time to maximum blood concentration (Tmax) measure: Duration of response (DOR) measure: Time to response (TTR) measure: Disease control rate (DCR) measure: Progression free survival (PFS) measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Siqing Fu, MD, PhD role: CONTACT lat: 29.76328 lon: -95.36327 facility: NEXT Oncology status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: David Sommerhalder, MD, PhD role: CONTACT lat: 29.42412 lon: -98.49363 facility: NEXT Virginia status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Alexander Spira, MD, PhD role: CONTACT lat: 38.84622 lon: -77.30637 hasResults: False
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<|newrecord|> nctId: NCT06385912 id: 2024-TJ-SLIDS briefTitle: Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer overallStatus: COMPLETED date: 2006-07-01 date: 2021-02-10 date: 2021-02-10 date: 2024-04-26 date: 2024-04-26 name: Tongji Hospital class: OTHER briefSummary: The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The main question it aims to answer is:
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Does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy?
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The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question. conditions: Ovarian Cancer conditions: Postoperative Complications conditions: Neoadjuvant Therapy conditions: Lymph Node Excision studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1090 type: ACTUAL name: lymphadenectomy measure: Progression free survival (PFS) measure: Overall survival (OS) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06385899 id: : Poorly controlled T2DM-12 briefTitle: Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background overallStatus: COMPLETED date: 2021-08-01 date: 2023-01-01 date: 2023-03-01 date: 2024-04-26 date: 2024-04-26 name: Goztepe Prof Dr Suleyman Yalcın City Hospital class: OTHER briefSummary: In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. It is aimed to determine the characteristics of patients with type 2 diabetes (HbA1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 12 months. conditions: Type 2 Diabetes conditions: Poor Glycemic Control studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 266 type: ACTUAL measure: Changes in HbA1c levels after 12 months treatment measure: percentage of patients who reached the HbA1c target of equal to or below 7% measure: The effect of education on the HbA1c changes measure: The effect of depression on the HbA1c changes measure: The effect of the level of physical activity on the HbA1c changes measure: The effect of weight loss on the HbA1c changes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06385886 id: 1R01HL158807-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL158807-01A1 briefTitle: Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease acronym: RECIPE overallStatus: RECRUITING date: 2023-06-08 date: 2027-10 date: 2027-12 date: 2024-04-26 date: 2024-04-26 name: RTI International class: OTHER briefSummary: The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life? conditions: Sickle Cell Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Linkage Coordinator measure: Identification of unaffiliated patients measure: Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist measure: Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama, Birmingham (UAB) status: RECRUITING city: Birmingham state: Alabama zip: 35233 country: United States name: Julie Kanter, MD role: CONTACT phone: 205-934-0435 email: [email protected] lat: 33.52066 lon: -86.80249 facility: University of California, San Francisco (UCSF) status: RECRUITING city: Oakland state: California zip: 94609 country: United States name: Marsha Treadwell, PhD role: CONTACT phone: 510-428-3356 email: [email protected] lat: 37.80437 lon: -122.2708 facility: Augusta University status: RECRUITING city: Augusta state: Georgia zip: 30901 country: United States name: Robert Gibson, PhD role: CONTACT phone: 706-721-1005 email: [email protected] lat: 33.47097 lon: -81.97484 facility: University of Illinois status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Lewis Hsu, MD, PhD role: CONTACT phone: 312-355-5019 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06385873 id: 2024-SR-233 briefTitle: RC48 Combined With Adebrelimab and Apatinib and S-1 of the Neoadjuvant Therapy of Locally Advanced Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-05-01 date: 2024-04-26 date: 2024-04-26 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: This study is a prospective, open-label, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab, Apatinib and S-1. The purpose is to evaluate the effectiveness and safety of the combined coordinated treatment of multi-mechanism drugs for perioperative treatment of locally advanced gastric cancer with HER2 overexpression. conditions: Gastric Cancer/Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: RC48 name: Adebrelimab name: Apatinib name: S-1 measure: Pathological Complete Response Rate (pCR) measure: Major Pathological Response rate (MPR) measure: R0 Resection rate measure: Disease-Free Survival (DFS） measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06385860 id: GTMGS0423 briefTitle: Prediction Model for Early Biliary Stasis After Bariatric Surgery acronym: PM-EBS-BS overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-09 date: 2025-04 date: 2024-04-26 date: 2024-04-26 name: China-Japan Friendship Hospital class: OTHER briefSummary: Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery conditions: Obesity conditions: Diabetes conditions: Gallstones conditions: Biliary Stasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 200 type: ESTIMATED measure: early biliary stasis measure: prediction model sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06385847 id: GOMIMP briefTitle: To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer overallStatus: RECRUITING date: 2024-05 date: 2025-05 date: 2025-12 date: 2024-04-26 date: 2024-04-26 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective, randomized, open-label, cross-over phase II trial primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Zoladex name: LY01005 measure: Patient preference sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361003 country: China name: Xuegang Wang, doctor role: CONTACT phone: 15960263909 email: [email protected] lat: 24.47979 lon: 118.08187 hasResults: False
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<|newrecord|> nctId: NCT06385834 id: LY2014-041-A briefTitle: The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2028-04-30 date: 2028-07-30 date: 2024-04-26 date: 2024-04-26 name: RenJi Hospital class: OTHER briefSummary: The aim of the study was to intervene in the Aerobic exercise time of patients with STEMI and to explore the optimal exercise time for STEMI patients conditions: ST-segment Elevation Myocardial Infarction (STEMI) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was divided into three groups: morning intervention group (8:00-9:00AM), evening intervention group (16:00-17:00AM) and control group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: In this study, outcome measurement personnel and intervention personnel were separated during the whole process of the experiment, outcome measurement personnel did not know the grouping status, intervention personnel and rehabilitation therapists did not participate in the outcome measurement work. whoMasked: OUTCOMES_ASSESSOR count: 201 type: ESTIMATED name: Morning aerobic exercise name: Evening aerobic exercise measure: left ventricle ejection fraction measure: Oxygen consumption measure: Endothelial Function measure: Skeletal muscle and fat mass measure: Cardiac structure measure: One year major Adverse Cardiovascular Events measure: VE/VCO2-SLOPE measure: Flow-mediated dilation measure: glucose measure: Blood lipid measure: N-terminal pro-BNP sex: ALL minimumAge: 17 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06385821 id: GriQv-ch-III-22 briefTitle: A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus overallStatus: COMPLETED date: 2022-09-21 date: 2023-06-15 date: 2023-10-09 date: 2024-04-26 date: 2024-04-26 name: NPO Petrovax class: INDUSTRY briefSummary: The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination". conditions: Influenza conditions: Influenza A conditions: Influenza, Human conditions: Influenza Type B conditions: Flu conditions: Influenza A H3N2 conditions: Influenza A H1N1 conditions: Influenza Epidemic conditions: Flu, Human conditions: Acute Respiratory Infection conditions: Vaccine Reaction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 824 type: ACTUAL name: Grippol Quadrivalent name: Grippol Plus measure: To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines measure: Geometric mean antibody titers measure: Proportion of those vaccinated with seroconversion and geometric mean titer measure: Multiplicity of the increase in the geometric mean titer measure: Seroprotection measure: Incidence of influenza and acute respiratory infections (ARI) measure: The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications measure: To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus measure: Frequency and nature of SAEs measure: Frequency and nature of medically attended AEs sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD facility: State Autonomous Healthcare Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11" city: Ekaterinburg zip: 620028 country: Russian Federation lat: 56.8519 lon: 60.6122 facility: Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V. Petrovsky" city: Moscow zip: 119435 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Healthcare Institution "Children's City Clinical Hospital No.9 named after G.N. Speransky of Moscow Healthcare Department" city: Moscow zip: 123317 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Health Institution of the Perm Territory "City Children's Clinical Polyclinic No. 5 city: Perm zip: 614066 country: Russian Federation lat: 58.01046 lon: 56.25017 facility: Limited Liability Company "Clinic USI 4D" city: Pyatigorsk zip: 357502 country: Russian Federation lat: 44.04861 lon: 43.05944 facility: Limited Liability Company Medical technology city: Saint Petersburg zip: 192148 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District" city: Saint Petersburg zip: 193312 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Limited Liability Company " Energiia Zdoroviya" city: Saint Petersburg zip: 194156 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Limited Liability Company PiterClinica city: Saint Petersburg zip: 196158 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases under the Federal Medical Biological Agency city: Saint Petersburg zip: 197022 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution City Polyclinic No.106 Children's Polyclinic Department No. 37 city: Saint Petersburg zip: 198328 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: State Budgetary Healthcare Institution of the Samara region "Samara Regional Children's Clinical Hospital named after N.N. Ivanova" city: Samara zip: 443079 country: Russian Federation lat: 53.20007 lon: 50.15 facility: Limited Liability Company Center DNK-issledovaniy city: Saratov zip: 410005 country: Russian Federation lat: 51.54056 lon: 46.00861 facility: Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" of the Ministry of Healthcare of the Russian Federation city: Tyumen zip: 625023 country: Russian Federation lat: 57.15222 lon: 65.52722 hasResults: False
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<|newrecord|> nctId: NCT06385808 id: XJTU1AF-CRF-2023-XK014 briefTitle: Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-26 date: 2024-04-26 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER briefSummary: The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients. conditions: Relapse Leukemia conditions: Refractory Acute Myeloid Leukemia conditions: Conditioning conditions: Hematopoietic Stem Cell Transplantation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells. The one-year recurrence-free survival after transplantation of these patients and the safty of the MTBF regimen will be studied. primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: MTBF regimen measure: Recurrence rate measure: Incidence and Severity of non-hematological adverse events (NCI CTCAE v5.0) measure: Neutrophil recovery time measure: Platelet recovery time measure: OS measure: PFS measure: aGVHD sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06385795 id: NOE-PMM-201 briefTitle: A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-04-30 date: 2024-04-26 date: 2024-04-26 name: Noema Pharma AG class: INDUSTRY briefSummary: The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women. conditions: Menopause Syndrome conditions: Menopause conditions: Hot Flashes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: NOE-115 measure: Withdrawals Due to Adverse Events While on NOE-115 for Any Reason measure: Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs) measure: Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4 measure: Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4 measure: Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4 sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06385782 id: 20dz1207200 briefTitle: Exploring HRV in Antarctic Overwintering Members of Asia overallStatus: COMPLETED date: 2021-03-01 date: 2022-04-01 date: 2023-09-01 date: 2024-04-26 date: 2024-04-26 name: Ya-Wei Xu class: OTHER briefSummary: Extreme changes in the Antarctic environment can cause emotional and autonomic dysfunction. In this study, volunteers from the Antarctica stations in China provided scale scores and heart rate variability (HRV) data, which were used to assess the autonomic nervous system. Enroll twenty-two members from Zhongshan Station and the Great Wall Station who are overwintering. Using the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire-9 (PHQ-9) scale, and the SF-36 quality of life scale to evaluate the individual's general physical and mental health. Analyze HRV and other associated parameters. conditions: Heart Rate Variability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 22 type: ACTUAL name: Antarctic environment measure: changes in HRV sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Tenth People's Hospital city: Shanghai state: Shanghai zip: 200079 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06385769 id: PamukkaleU.ftr-NYıldız-3 briefTitle: Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-01-31 date: 2026-02-28 date: 2024-04-26 date: 2024-04-26 name: Pamukkale University class: OTHER briefSummary: The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.
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The main questions aimed to be answered are:
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What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week). conditions: Urinary Bladder, Overactive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: Transcutaneous tibial nerve stimulation (TTNS) name: Sham Transcutaneous tibial nerve stimulation (TTNS) measure: Decreased frequency of increased voiding measure: Frequency of voiding measure: The Quality of Life measure: Barthel Index for Activities of Daily Living (ADL) measure: The Overactive Bladder Symptom Score (OABSS) measure: Treatment Satisfaction Level measure: Cystometric value sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University city: Denizli country: Turkey lat: 37.77417 lon: 29.0875 hasResults: False
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<|newrecord|> nctId: NCT06385756 id: TJ-IRB202403020 briefTitle: Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-26 date: 2024-04-26 name: Tongji Hospital class: OTHER briefSummary: At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.
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The main questions it aims to answer are:
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* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;
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* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.
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Participants will:
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* Induction of anesthesia with the experimental drug or placebo；
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* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；
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* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded. conditions: Amobarbital Sodium conditions: Hemodynamics Instability studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Amobarbital name: Propofol measure: Mean arterial pressure (MAP) during Induction of anesthesia measure: MAP at different time points measure: Incidence of postoperative nausea and vomiting (ponv) sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06385743 id: yeditepe15 briefTitle: The Effectiveness of Neuromuscular Training-Based Exercise Program overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-17 date: 2024-07-14 date: 2024-12-30 date: 2024-04-26 date: 2024-04-26 name: Yeditepe University class: OTHER briefSummary: This randomised controlled study aimed to investigate the effectiveness of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain.
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The main hypothesis is;
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H0: There is no difference between the "Thrower's Ten" exercise program and the neuromuscular training-based exercise program applied to overhead athletes with shoulder pain, on pain, function, risk factors specific to shoulder injuries, and performance.
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H1: The effects of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain are superior to the effects of "Thrower's Ten" exercise program conditions: Pain, Shoulder conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: Neuromuscular Training-based Exercise Program name: ''Thrower's Ten'' Exercise Program measure: Pain Assessment measure: Disabilities of the Arm, Shoulder and Hand (DASH) measure: Tampa Kinesiophobia Scale measure: Hylyght Injury Prevention and Return to the Sports Screening Program ( measure: Y Balance Test- Upper Quarter measure: Closed Kinetic Chain Extremity Stability Test measure: Single Arm Seated Shot Put Test sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Yeditepe University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06385730 id: SCE2401 briefTitle: Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS) acronym: BLESS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2027-05 date: 2024-04-26 date: 2024-04-26 name: Shanghai Chest Hospital class: OTHER briefSummary: The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). conditions: Esophageal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: neoadjuvant anti-PD-1 name: neoadjuvant anti-PD-1 with LDRT measure: MPR rate measure: pCR rate measure: Adverse events and treatment-related adverse events measure: R0 resection rate measure: Objective Response rate measure: Event-free survival (EFS) measure: Overall survival (OS) measure: Correlation between potential biomarkers and tumor response sex: ALL minimumAge: 76 Years stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai state: Shanghai zip: 200030 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06385717 id: ZhejiangU briefTitle: Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer acronym: ESCORT overallStatus: RECRUITING date: 2024-05-01 date: 2026-01-31 date: 2029-01-31 date: 2024-04-26 date: 2024-04-26 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection. conditions: Esophagus Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: chemo-radiation measure: Incidence of toxic events measure: 3-year overall survival measure: 3-year local-regional recurrence free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Jing Xu, MD role: CONTACT phone: 0086-0571-87783521 email: [email protected] lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University, School of Medicine status: NOT_YET_RECRUITING city: Hangzhou country: China name: Jing Xu role: CONTACT phone: 0086-0571-87783521 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06385704 id: DMRIBFGM0420 briefTitle: Research on Changes in Intestinal Barrier Function and Gut Microbiome in Patients With Type 2 Diabetes After Duodenal Mucosal Resurfacing (DMR) acronym: DMR-IBF-GM overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-26 date: 2024-04-26 name: Wang Siqi class: OTHER name: China-Japan Friendship Hospital briefSummary: The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiomic analysis and High Performance Liquid Chromatography（HPLC）, combined with changes in clinical data. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 100 type: ESTIMATED name: DMR Procedure measure: Microbiome Analysis measure: High Performance Liquid Chromatography sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06385691 id: ET22-145 briefTitle: Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer. acronym: MyDIET overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2026-06-30 date: 2026-08-31 date: 2024-04-26 date: 2024-04-26 name: Centre Leon Berard class: OTHER briefSummary: This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer. conditions: Gastric Cancer conditions: Oesogastric Junction Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective, single-center, single-arm Phase II study. primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: myDIET software tool measure: Proportion of patients starting adjuvant chemotherapy within 2 months measure: Adherence to the tool measure: Number of supportive care and emergency consultations initiated by the caregiver measure: Proportion of patients with malnutrition measure: Evolution of body composition in L3 section (volumes) measure: Evolution of body composition in L3 section (indexes) measure: Evolution of resting energy expenditure measure: Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day measure: Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry measure: Weight changes measure: Brachial circumference changes measure: Triceps skin fold changes measure: Initiation time for post-operative chemotherapy measure: Proportion of patient with incomplete scheme of pre operative chemotherapy measure: Proportion of patient with incomplete scheme of post operative chemotherapy measure: Proportion of patients with severe post operative complication measure: Tolerance to perioperative chemotherapy measure: Changes in food intake measure: Changes in SEFI (Easy Food Intake Score) measure: Measurement of quality of life measure: Average lengh of hospital stay measure: Recurrence free survival (RFS) measure: Overall survival (OS) measure: Adherence to the physical activity program measure: Physical activity levels measure: Assessment of muscular function by the 6-min walk test measure: Assessment of muscular function by muscular strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Léon Berard city: Lyon zip: 69008 country: France name: Pamela Funk-Debleds, MD role: CONTACT phone: 0469856020 phoneExt: +33 email: [email protected] name: Clélia Coutzac, MD role: CONTACT phone: 0469856020 phoneExt: +33 email: [email protected] lat: 45.74848 lon: 4.84669 hasResults: False
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<|newrecord|> nctId: NCT06385678 id: HRS-4642-201 briefTitle: A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-10 date: 2026-08 date: 2024-04-26 date: 2024-04-26 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation. conditions: Advanced KRAS G12D Mutant Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: HRS-4642 name: Adebrelimab name: SHR-A1921 name: Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection measure: Phase IB: Safety endpoints: adverse events (AEs). measure: Phase IB： Maximum tolerated dose (MTD) measure: Phase IB：Recommended phase 2 dose (RP2D) measure: Phase II: Overall response rate (ORR). measure: Efficacy endpoints: Overall response rate (ORR). measure: Efficacy endpoints: Duration of response (DoR). measure: Efficacy endpoints: Disease control rate (DCR). measure: Efficacy endpoints: Progression free survival (PFS). measure: Efficacy endpoints: overall survival (OS). sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai East Hospital city: Shanghai state: Shanghai zip: 200120 country: China name: Caicun Zhou, Doctor role: CONTACT phone: 13301825532 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06385665 id: Xin Peng briefTitle: The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer overallStatus: RECRUITING date: 2024-04-22 date: 2024-04-22 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: Xin Peng class: OTHER briefSummary: The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are:
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1. Patients with advanced breast cancer need family companionship
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2. Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 304 type: ESTIMATED name: Graded companionship measure: Change from Baseline meatal state on GAD-7 at Week 48. measure: Change from Baseline physical state on kps at Week 48. sex: FEMALE minimumAge: 21 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan zip: 430022 country: China name: Peng Xin, postgraduate role: CONTACT lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06385652 id: PekingUFH-MM-NB381 briefTitle: PET Imaging Study of 68Ga-NB381 in Multiple Myeloma overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-12-31 date: 2024-04-26 date: 2024-04-26 name: Peking University First Hospital class: OTHER briefSummary: Multiple myeloma (MM) predominantly affects the elderly, often presenting insidiously and with a rising incidence rate. Current diagnostic methods primarily rely on invasive bone marrow biopsies, which can lead to false-negative results if the biopsy site is improperly chosen. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease.
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Addressing the limitations in specificity and sensitivity of traditional PET imaging agents, this project is dedicated to developing a new type of nanobody PET/CT imaging probe, 68Ga-NB381, which possesses high affinity and targets CD38. This probe, which is an intellectual property of our institution, aims to enhance the accuracy and specificity of early MM diagnosis. In terms of clinical evaluation, the project will implement a comprehensive assessment process including case selection, collection of baseline information, high-precision imaging, expert-level image interpretation, and follow-up studies, comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381. This lays the groundwork for the clinical translation of this radiopharmaceutical in China. Furthermore, the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab, a drug also targeting CD38. This makes the project of significant academic value and clinical importance, thus promoting the development of personalized treatment strategies. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: In this sequential assignment clinical trial, we aim to evaluate and compare the diagnostic performance of two PET imaging agents, 68Ga-NB381 and 18F-FDG, in patients diagnosed with multiple myeloma (MM). The study will enroll MM patients who meet the inclusion criteria and are scheduled for routine diagnostic imaging.
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Each participant will undergo PET imaging with 18F-FDG first, followed by a second PET scan using 68Ga-NB381 (or reversed). To minimize potential interference between the two imaging sessions and ensure patient safety, a minimum interval of one day will be maintained between the two scans, with all imaging completed within one week. This sequential imaging approach allows for direct comparison of the imaging agents in the same patient, thus controlling for inter-patient variability and providing a more accurate assessment of the relative merits of each imaging agent in the same metabolic and pathological condition. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: All PET/CT images are jointly interpreted by at least two imaging and nuclear medicine physicians, each with several years of diagnostic experience and at least at the attending physician level. They compare and record the number of lesions detected and the SUVs (Standard Uptake Values) for both 18F-FDG and 68Ga-NB381 PET/CT scans. After consultation, they provide a unified diagnostic opinion. count: 30 type: ESTIMATED name: 68Ga-NB381 measure: Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Ronghui Yu, Master role: CONTACT phone: +8613466379791 email: [email protected] name: Lei Kang, MD role: PRINCIPAL_INVESTIGATOR name: TIANYAO Wang, PhD role: PRINCIPAL_INVESTIGATOR name: Yongkang Qiu, Master role: SUB_INVESTIGATOR name: Zhenghao Tong, MD role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06385639 id: WK2024005 briefTitle: Efficacy and Safety of Probiotic Products for Digestive Health overallStatus: RECRUITING date: 2024-04-25 date: 2024-05-25 date: 2024-06-25 date: 2024-04-26 date: 2024-04-26 name: Wecare Probiotics Co., Ltd. class: INDUSTRY briefSummary: The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota. conditions: Healthy Adult studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Probiotic measure: Intestinal health sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: [email protected] status: RECRUITING city: Jakarta state: Pusat zip: 10430 country: Indonesia name: Danang A. Yunaidi, MD role: CONTACT phone: 217515932 phoneExt: +62 email: [email protected] lat: -6.21462 lon: 106.84513 hasResults: False
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<|newrecord|> nctId: NCT06385626 id: UREC: 23_15-Raspberry Leaf Tea briefTitle: The Effects of Raspberry Leaf Tea on Blood Glucose Control acronym: RLT overallStatus: RECRUITING date: 2023-12-18 date: 2024-12-23 date: 2024-12-23 date: 2024-04-26 date: 2024-04-26 name: University of Reading class: OTHER briefSummary: The aim of the present clinical trial is to assess how raspberry leaf polyphenols impact on postprandial glucose and insulin levels in healthy individuals consuming sucrose.
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The questions the project will address:
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