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Research hypothesis:
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Capacitive and resistive energy transfer therapy is comparable to dry needling therapy for the treatment of myofascial trigger points.
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It is estimated that the presence of trigger points is the main cause of pain in 30-85% of patients visiting primary health care facilities and pain management clinics. The presence of trigger points may significantly affect the patient's functional status and daily functioning. Recently, diagnostic criteria and methods of treating trigger points have evolved significantly. However, the usefulness of different imaging methods in the diagnosis of trigger points has not yet been established. Despite numerous studies, the long-term effectiveness of the dry needling method is still unknown. Furthermore, there is no available research on the short- and long-term effectiveness of capacitive and resistive energy transfer therapy in the treatment of trigger points.
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Therefore, the objectives of the work were:
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Determination and comparison of the short- and long-term effects of capacitive and resistive energy transfer therapy and the dry needling technique of myofascial trigger points located in the upper trapezius muscle (UT) on the strength, neck range of motion and pain intensity within this muscle.
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The study is planned to include a group of 26 men aged 25 to 45 who suffer from pain caused by the presence of myofascial trigger points in the upper trapezius muscle. The subjects will be divided into two groups of equal number of people. The first group will undergo therapy using the dry needling technique, while the second group will undergo capacitive and resistive energy transfer therapy.
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In order to determine the immediate effects of capacitive and resistive energy transfer therapy and dry needling techniques, measurements of muscle strength, the intensity of pain in the upper trapezius muscle and neck range of motion will be performed before and after each therapeutic session (2 session in 2 weeks are planed). In turn, to determine the long-term effects of capacitive and resistive energy transfer therapy and dry needling, the next above-mentioned measurements will be performed four weeks after the end of first therapy. conditions: Myofascial Pain Syndrome of Neck conditions: Myofascial Trigger Point Syndrome conditions: Myofascial Trigger Point Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 22 type: ACTUAL name: TECAR name: Dry needling measure: Pain - Pressure pain threshold (PPT) measure: Pain - numerical rating scale (NRS) measure: Muscle strength measure: Cervical spine range of motion (ROM) sex: MALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Medical fit city: Ruda Śląska state: Śląsk zip: 41-717 country: Poland lat: 50.2584 lon: 18.85632 hasResults: False
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<|newrecord|> nctId: NCT06273501 id: D-NR 2022-02876-01 briefTitle: MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer acronym: POSVUC overallStatus: ENROLLING_BY_INVITATION date: 2022-03-24 date: 2024-12-01 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Sahlgrenska University Hospital, Sweden class: OTHER briefSummary: The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis. conditions: Vulvar Cancer conditions: Lymph Node Metastasis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: Magtrace measure: Sentinel lymph node identification sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Obstetrics and gynecology city: Gothenburg zip: 41345 country: Sweden lat: 57.70716 lon: 11.96679 hasResults: False
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<|newrecord|> nctId: NCT06273488 id: EXZL20240002 briefTitle: The Role of Auricular Point Diagnosis and Treatment in ERAS During TKA overallStatus: RECRUITING date: 2024-03-23 date: 2024-11-01 date: 2024-12-01 date: 2024-02-22 date: 2024-04-08 name: Peking Union Medical College class: OTHER briefSummary: To further improve the surgical outcomes of patients undergoing total knee arthroplasty (TKA). This study aims to use ear acupoint therapy to address the following clinical issues: 1 The degree of postoperative inflammation and edema in the patient; 2. Patient pain; 3. Patient functional recovery. 4. Surgical scar repair for patients; 5. Patient perioperative anxiety and postoperative satisfaction. Exploring the safety and effectiveness of ear acupoint therapy in the postoperative application of TKA, leveraging the advantages of suitable traditional Chinese medicine techniques in simplicity, convenience, effectiveness, and cost-effectiveness, and further improving the ERAS Chinese and Western medicine collaborative plan for TKA. conditions: Auriculotherapy conditions: Arthroplasty, Replacement, Knee conditions: Enhanced Recovery After Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 86 type: ESTIMATED name: Auriculotherapy measure: Range of motion(ROM) measure: Visual Analogue Pain Scale (VAS) measure: Self-Assessment Survey for Anxiety(SAS) measure: Acupoint electrical measurement value(AE) measure: Vancouver Scar Assessment Scale(VSS) measure: Dosage of painkillers measure: Hospital stay measure: HSS knee joint scoring measure: Thigh circumference(knee joint circumference) measure: Kine siphobia (TSK) score measure: C-reactive protein (CRP) measure: Erythrocyte Sedimentation Rate(ESR) measure: Postoperative satisfaction measure: Expenses during hospitalization measure: Demand rate and satisfaction rate of auricular point diagnosis and treatment measure: Adverse events related to auricular acupuncture diagnosis and treatment measure: Affected limb drainage volume measure: Preoperative Anxiety Scale (PAS-7) score measure: Total number of pain pump uses (presses) sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: qindong Mi role: CONTACT phone: 8615871784551 email: mqd2022ky@163.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06273475 id: OUH RoboRehab briefTitle: Robot-Assisted Training Versus Standard Training in Ischemic Stroke overallStatus: RECRUITING date: 2024-05-01 date: 2025-03-01 date: 2027-02-01 date: 2024-02-22 date: 2024-04-18 name: Odense University Hospital class: OTHER name: University of Southern Denmark name: Rigshospitalet, Denmark name: Herlev and Gentofte Hospital name: Stanford University name: Sygehus Lillebaelt name: Danish Association of the Physically Disabled briefSummary: The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation.
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The main hypothesis of the study is:
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Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training. conditions: Stroke conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentre randomised (1:1) parallel-group intervention study with assessor-blinding. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Data will be analysed by the PhD student blinded towards group allocation. The test leader responsible for RCT outcome assessment will be blinded towards group allocation. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Robot-assisted Training name: Standard Training measure: Fugl-Meyer Lower Extremity Assessment of Motor Function measure: Modified Rankin Scale Score (between-group change) measure: Functional Ambulation Category (between-group change) measure: Berg Balance Scale (between-group change) measure: Barthel-100 Index (between-group change) measure: Global Rating of Change (between-group change) measure: International Physical Activity Questionnaire - Short Form (between-group change) measure: Fatigue Severity Scale 7 (between-group change) measure: EQ-5D-5L Quality of Life (between-group change) measure: Hand-grip strength (between-group change) measure: Gait speed (between-group change) measure: Contractile Muscle Power (between-group change) measure: Modified Sit-to-Stand Test (between-group change) measure: Blood Biomarkers (between-group change) measure: Modified Ashworth Scale (between-group change). measure: Oxford Cognitive Screen (between-group change) measure: Montreal Cognitive Assessment (between-group change) measure: Major Depression Inventory (between-group change) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet and Herlev Gentofte Hospital status: NOT_YET_RECRUITING city: Copenhagen country: Denmark name: Jon Skovgaard Jensen, Ph.d.-student role: CONTACT email: jskovgaard@health.sdu.dk name: Christina Rostrup Kruuse, Professor, MD, PhD, DMSc role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Odense University Hospital status: RECRUITING city: Odense country: Denmark name: Jon Skovgaard Jensen, Ph.d.-student role: CONTACT email: jskovgaard@health.sdu.dk name: Anders Holsgaard-Larsen, Professor role: PRINCIPAL_INVESTIGATOR lat: 55.39594 lon: 10.38831 hasResults: False
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<|newrecord|> nctId: NCT06273462 id: NMCSD.2024.0006 briefTitle: Palmitoylethanolamide for Chronic Inflammatory Pain Conditions overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-05-30 date: 2024-02-22 date: 2024-02-22 name: Navy Medical Center San Diego class: FED briefSummary: The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.
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Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks. conditions: Chronic Pain studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective Randomize Double Blind Placebo Controlled study comparing the supplement palmitoylethanolamide (PEA) to a visually identical placebo primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double Blinded, patients will receive visually identical capsules from research pharmacist with study label indicating PEA vs Placebo whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Palmitoylethanolamide 600mg twice a day name: placebo measure: Pain Level measure: Pain interference and function measure: Pain Catastrophizing Scale (PCS) measure: Patient Reported Outcome Measurement Information System (PROMIS) (Pain interference, Social satisfaction; Physical function) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Naval Medical Center San Diego city: San Diego state: California zip: 92118 country: United States name: Naval Medical Center Institutional Review Board role: CONTACT phone: 619-532-9927 email: kristina.m.umali.civ@health.mil name: Brian McLean COL, USA MC, MD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 hasResults: False
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<|newrecord|> nctId: NCT06273449 id: 385/2023 briefTitle: A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures overallStatus: RECRUITING date: 2022-12-29 date: 2024-08-30 date: 2024-08-30 date: 2024-02-22 date: 2024-02-22 name: National Dental Centre, Singapore class: OTHER name: National Medical Research Council (NMRC), Singapore briefSummary: Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production. conditions: Partial-edentulism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: 1. Conventional: The Standard of Care (SOC) workflow, which will act as a baseline compared to the other 2 groups.
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2. Partial digital workflow: Adopts the same teeth profile capture method, where a physical impression of teeth profile is taken from the subject. However, instead of using physical wax pattern on the stone model for design, the stone model is scanned and, on the scan, the design is performed digitally. For fabrication of RPD, instead of using lost wax casting, the digital design is used for additive manufacturing.
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3. SmartRPD digital workflow Adopts a different teeth profile capture method by using the intraoral scanner to digitally scan and save the subject's teeth profile. From the intraoral scan, a digital model of the subject's teeth profile is created but on the digital model instead, the design of RPD is digitally performed. The digital design is used for additive manufacturing. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 141 type: ESTIMATED name: Group 3 - 3D Printed Removable Partial Denture name: Group 2 - 3D Printed Removable Partial Denture measure: Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows measure: Comparison of Patient Satisfaction with RPD Prostheses Fabricated Using Three Workflows measure: Comparison of Fabrication Cost and Time Across Three Workflows sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Dental Centre Singapore status: RECRUITING city: Singapore zip: 168938 country: Singapore name: Hazel Goh Si Ying role: CONTACT phone: 63248754 email: goh.si.ying@ndcs.com.sg name: Zi Ying Phang role: PRINCIPAL_INVESTIGATOR name: Khim Hean Teoh role: SUB_INVESTIGATOR name: Janice Tan Zhi Hui role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06273436 id: Pro00130902 briefTitle: Healing, Equity, Advocacy and Respect for Mamas acronym: HEAR4Mamas overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2028-11-30 date: 2028-11-30 date: 2024-02-22 date: 2024-04-22 name: Medical University of South Carolina class: OTHER name: Patient-Centered Outcomes Research Institute briefSummary: The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities. conditions: Postpartum Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 2894 type: ESTIMATED name: H.E.A.R. for Mamas measure: Emergency Department (ED) visits within six weeks postpartum measure: Patient Reported Outcomes (PROs) measure: Social Determinants of Health (SDoH), Patient Activation, Shared Decision Making measure: Patient Activation measure: Shared Decision Making sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06273423 id: OULA for Postpartum Depression briefTitle: Feasibility Evaluation of a Dance Fitness Program overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2025-05 date: 2025-06 date: 2024-02-22 date: 2024-02-22 name: Montana State University class: OTHER briefSummary: The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD). conditions: Postpartum Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: OULA, Mind-body Physical Activity measure: Feasibility and acceptability measure: Changes in postpartum depression measure: Changes in postpartum anxiety sex: FEMALE minimumAge: 20 Years maximumAge: 39 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06273410 id: 0453-6/2022 briefTitle: Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive overallStatus: COMPLETED date: 2022-10-13 date: 2023-11-28 date: 2023-11-28 date: 2024-02-22 date: 2024-02-22 name: Hams Hamed Abdelrahman class: OTHER briefSummary: Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Its application in restorative dentistry may be significant, promoting remineralization of carious lesions \& reduction of polymerization shrinkage. The study will aim to compare the clinical performance of Cention N (with and without adhesive) and composite resin (Filtek Bulk Fill) in class I restorations using FDI criteria. Thirty-six class I cavities will be selected and equally allocated into 3 groups: Group I (n=12): (Cention N with adhesive), Group II (n=12): (Cention N without adhesive) \& Group III (n=12): composite resin (Filtek Bulk Fill) in class I cavities. Patients will be followed up at 1 week 3, 6, and 12 months and evaluated using the FDI criteria. Postoperative sensitivity, staining, and recurrent caries will be evaluated in this clinical trial. conditions: Dental Restoration Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ACTUAL name: Cention N name: Cention N + Adhesive name: Bulk Fill Composite measure: Change in pain sensitivity measure: Change in occurrence of recurrent caries measure: Change in occurrence of marginal stains sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Alexandria Faculty of Dentistry city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06273397 id: ACME-AHF briefTitle: Acetazolamide or Metolazone in Acute Heart Failure acronym: ACME-AHF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-03-01 date: 2027-05-01 date: 2024-02-22 date: 2024-03-18 name: Clinica Alemana de Santiago class: OTHER briefSummary: Impact of Acute Heart Failure:
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According to the World Health Organization (WHO), approximately 26 million people suffer from Heart Failure (HF), with a mortality rate of up to 50% within five years of diagnosis. Acute Heart Failure (AHF) exacerbations, leading to hospitalization, are common and represent the primary cause of hospital admissions in those over 65. Effective decongestion during hospitalization is crucial, as failure to achieve it doubles the risk of rehospitalization and mortality, incurring significant healthcare costs.
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Use of Diuretics in Acute Heart Failure:
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Diuretics, particularly loop diuretics like furosemide, are a cornerstone in managing AHF by inducing natriuresis and achieving decongestion. Clinical experience supports their use, though limited clinical trials exist. Pharmacological concepts guide their administration, emphasizing intravenous delivery in high doses and adjusting subsequent doses based on decongestive efficacy. Additionally, sequential tubular blockade with other diuretics like metolazone and acetazolamide is explored to enhance decongestion.
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Use of Metolazone and Acetazolamide:
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Sequential tubular blockade, using metolazone and acetazolamide in conjunction with furosemide, aims to achieve rapid and effective decongestion. While metolazone targets the distal tubule, inhibiting sodium-chloride channels, acetazolamide affects proximal tubular function. Studies like ADVOR (acetazolamide) and CLOROTIC (thiazide-like diuretic) demonstrate the potential benefits of combining these diuretics for quicker decongestion but with potential risks (in the case of Hydrochlorothiazide).
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Outcomes Measured by Major Studies:
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Recent studies assessing decongestion in AHF reveal a lack of uniformity in outcome selection. The primary focus should be on reducing rehospitalizations and post-discharge mortality by achieving effective decongestion. The ADVOR study, using a simple congestion score based on clinical and imaging criteria, underscores the importance of reaching a congestion score of 0 or 1 promptly.
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Congestion Monitoring:
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Monitoring diuretic treatment solely based on clinical aspects may not capture subclinical congestion, necessitating biochemical and imaging parameters. The ACME-AHF trial proposes a diagnostic score integrating clinical and imaging aspects to evaluate congestion status. Secondary outcomes include cumulative diuresis, weight loss, diuretic efficiency, and natriuresis, with a focus on natriuresis as a reliable physiological parameter for decongestion.
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Aim of the study:
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The ACME-AHF trial is designed to compare the efficacy and safety of two diuretic combination strategies: acetazolamide with furosemide and metolazone with furosemide. The primary objective is to relieve congestion, assessed using a congestion score, within the first three days of treatment during an hospitalization for acute heart failure. conditions: Heart Failure Acute conditions: Decompensated Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an Open, Multicenter, Prospective, and Randomized study with three treatment arms. The outcomes to be assessed in the initial phase will be at 4 days post-randomization, followed by evaluation at 90 days after hospital discharge. primaryPurpose: TREATMENT masking: NONE count: 1050 type: ESTIMATED name: Acetazolamide 250 MG name: Metolazone 2.5 MG name: Furosemide Injection measure: Treatment success measure: Mortality measure: Worsening Heart Failure measure: Cumulative 24-hour Natriuresis measure: Cumulative weight loss measure: Subclinical congestion measure: Change in Hematocrit value measure: Change in NT-proBNP concentration measure: Change in CA125 value measure: Any adverse event measure: Changes in pH value measure: Change in plasma electrolyte values sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06273384 id: Si 062/2023 briefTitle: Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding acronym: CIM overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Mahidol University class: OTHER briefSummary: The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are:
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* To evaluate the efficacy of CIM method for H. pylori detection compared to rapid urease test(RUT), histopathology, polymerase chain reaction (PCR), and urea breath test (UBT) in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer, and their sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio.
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* To evaluate the advantages of CIM method for H. pylori detection comparing to RUT, histopathology, PCR, and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index (NRI).
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* To study the associated factors in false negative value of H. pylori detection methods with CIM, RUT, histopathology, PCR, and UBT. conditions: Helicobacter Pylori Infection conditions: Peptic Ulcer Hemorrhage studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 135 type: ESTIMATED measure: The efficacy of CIM method for H. pylori detection measure: The advantages of CIM method for H. pylori detection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine Siriraj Hospital, Mahidol University city: Bangkok Noi state: Bangkok zip: 10700 country: Thailand lat: 13.76266 lon: 100.47798 hasResults: False
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<|newrecord|> nctId: NCT06273371 id: DELISA2023 briefTitle: Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain acronym: DELISA overallStatus: COMPLETED date: 2023-12-12 date: 2023-12-21 date: 2023-12-21 date: 2024-02-22 date: 2024-02-22 name: Lactalis class: INDUSTRY briefSummary: Damira 2000© is a 100% extensive casein hydrolysate (eHCF). It is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (CMPA), to be well tolerated and to help improve symptoms.Damira 2000 is indicated for allergy/intolerance to cow's milk proteins, atopic dermatitis secondary to CMPA, intestinal malabsorption processes and prevention of allergy/intolerance to cow's milk proteins.The study aimed at evaluating the tolerance of Damira 2000 in a cohort of children with CMPA. conditions: Cow's Milk Protein Allergy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 61 type: ACTUAL name: Damira 2000 Infant formula measure: Tolerance measure: Weight measure: Height measure: Weight for height and BMI measure: Head circumference sex: ALL minimumAge: 0 Months maximumAge: 12 Months stdAges: CHILD facility: Hospital Quirónsalud de Córdoba city: Córdoba state: Andalucia country: Spain lat: 37.89155 lon: -4.77275 facility: H. Virgen del Rocío city: Sevilla state: Andalucia country: Spain lat: 37.38283 lon: -5.97317 facility: H. Virgen Macarena city: Sevilla state: Andalucia country: Spain lat: 37.38283 lon: -5.97317 facility: Instituto Hispalense de pediatría city: Sevilla state: Andalucia country: Spain lat: 37.38283 lon: -5.97317 facility: Hospital Materno infantil de Ourense city: Orense state: Galicia country: Spain lat: 42.33669 lon: -7.86407 facility: H. Clínico de Santiago city: Santiago De Compostela state: Galicia country: Spain lat: 42.88052 lon: -8.54569 facility: Clínica privada Dr. Romera city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Fundación Jiménez Día city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06273358 id: Study Sleep Quality briefTitle: Preoperative Sleep Quality and Postoperative Delirium overallStatus: COMPLETED date: 2023-08-01 date: 2023-12-18 date: 2024-01-27 date: 2024-02-22 date: 2024-02-22 name: Konya City Hospital class: OTHER briefSummary: Background: Delirium is a neurocognitive illness that has lately been connected to sleep difficulties. It is a stressful condition. is still not fully understood. A poor sleep burden and its progress were investigated in this study to determine their correlations with the risk of delirium following surgical procedures.
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Methods: Between August 1st and December 5th, 2023, 124 patients undergoing non-cardiac general anesthesia (mean age 63.68 ± 8.81 years \[SD\]; range 46-82 years) reported on their sleep characteristics. PSQI, 1- sleep duration, 2- sleep disturbance, 3- sleep latency, 4- daytime dysfunction resulting from sleepiness, 5- sleep efficiency, 6- overall sleep quality, and 7- usage of sleep medications were among these sleep characteristics. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score ranges from 0 to 21 and is calculated by adding the component scores. Higher scores indicate poorer sleep quality. A three-day median follow-up time was used to analyze hospitalization records to gather data on new-onset delirium (n = 26). Approximately 124 people on average, with a mean. conditions: PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUM studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ACTUAL measure: Sleep quality and delirium index measure: Preop. and postop. sleep quality index measure: Sleep quality and QR 15 score sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasin Tire city: Konya state: Meram zip: 42140 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06273345 id: IOV-PR-1-2022-OLIGOS briefTitle: OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate acronym: OLIGOS overallStatus: RECRUITING date: 2023-01-23 date: 2025-01 date: 2025-01 date: 2024-02-22 date: 2024-02-22 name: Istituto Oncologico Veneto IRCCS class: OTHER briefSummary: The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria.
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The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel/androgen receptor signal inhibitors (ARTA)).
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The above criteria define 'high metastatic volume' disease with the following parameters
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* ≥ 4 bone metastases, including at least one outside the spine and pelvis
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* Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics. conditions: Oligometastatic Prostate Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Overall survival (OS) measure: Cancer-specific survival measure: CRPCa development measure: Radiological progression-free survival measure: Quality of life assessment measure: Quality of life assessment measure: Complications sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale di Bressanone status: NOT_YET_RECRUITING city: Bressanone state: Bolzano country: Italy name: Michael Aigner, MD role: CONTACT email: michael.aigner@sabes.it name: Michael Aigner, MD role: PRINCIPAL_INVESTIGATOR lat: 46.71503 lon: 11.65598 facility: Casa di Cura Abano Terme status: RECRUITING city: Abano Terme state: Padova country: Italy name: Daniele Romagnoli, MD role: CONTACT email: dromagnolo@casacura.it name: Daniele Romagnoli, MD role: PRINCIPAL_INVESTIGATOR lat: 45.35753 lon: 11.78725 facility: Ospedale di Dolo status: RECRUITING city: Dolo state: Venezia country: Italy name: Gianna Pace, MD role: CONTACT email: gianna.pace@aulss3.veneto.it name: Gianna Pace, MD role: PRINCIPAL_INVESTIGATOR lat: 45.42528 lon: 12.08429 facility: Ospedale di Bassano Del Grappa status: RECRUITING city: Bassano Del Grappa state: Vicenza country: Italy name: Antonio Celia, MD role: CONTACT email: antonio.celia@aulss7.veneto.it name: Antonio Celia, MD role: PRINCIPAL_INVESTIGATOR lat: 45.76656 lon: 11.72739 facility: Ospedale dell'Angelo - Mestre status: RECRUITING city: Mestre country: Italy name: Francesco Gerardo Mandato, MD role: CONTACT email: francesco.mandato@aulss3.veneto.it name: Francesco Gerardo Mandato, MD role: PRINCIPAL_INVESTIGATOR lat: 45.49167 lon: 12.24538 facility: Istituto Oncologico Veneto IRCCS status: RECRUITING city: Padova zip: 35128 country: Italy name: Angelo Porreca, MD role: CONTACT phone: 0423 421321 phoneExt: +39 email: angelo.porreca@iov.veneto.it name: Gian Luca De Salvo, MD role: CONTACT phone: 049 8215710 phoneExt: +39 email: gianluca.desalvo@iov.veneto.it name: Angelo Porreca, MD role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 facility: Azienda Ospedale Università Padova status: NOT_YET_RECRUITING city: Padova country: Italy name: Fabio Zattoni, MD role: CONTACT email: fabio.zattoni@unipd.it name: Fabio Zattoni, MD role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 facility: Ospedale MAter Salutis - Legnago status: NOT_YET_RECRUITING city: Padova country: Italy name: Pierpaolo Curti, MD role: CONTACT phone: 0442 622387 phoneExt: +39 email: pierpaolo.curti@aulss9.veneto.it name: Pierpaolo Curti, MD role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 facility: Ospedali Riuniti Padova Sud status: RECRUITING city: Padova country: Italy name: Nicola Zanovello, MD role: CONTACT email: nicola.zanovello@aulss6.veneto.it name: Nicola Zanovello, MD role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) status: NOT_YET_RECRUITING city: Trieste country: Italy name: Carlo Trombetta, MD role: CONTACT email: trombcar@units.it name: Carlo Trombetta, MD role: PRINCIPAL_INVESTIGATOR lat: 45.64953 lon: 13.77679 facility: Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC) status: NOT_YET_RECRUITING city: Udine country: Italy name: Gianluca Giannarini, MD role: CONTACT email: gianluca.giannarini@asufc.sanita.fvg.it name: Gianluca Giannarini, MD role: PRINCIPAL_INVESTIGATOR lat: 46.0693 lon: 13.23715 facility: Azienda Ospedaliera Universitaria Integrata - Verona status: RECRUITING city: Verona country: Italy name: Alessandro Antonelli, MD role: CONTACT phone: 0458127702/03 phoneExt: +39 email: alessandro.antonelli@aovr.veneto.it name: Alessandro Antonelli, MD role: PRINCIPAL_INVESTIGATOR lat: 45.4299 lon: 10.98444 hasResults: False
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<|newrecord|> nctId: NCT06273332 id: AI surgery protocol briefTitle: Assessment of the Artifical Intelligence Assisted Registration Versus Conventional Point Based Registration on Cone Beam-computed Tomography (CBCT) With Heavy Metal Artifacts overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-20 date: 2024-01-20 date: 2024-02-25 date: 2024-02-22 date: 2024-02-22 name: Ain Shams University class: OTHER briefSummary: Our study investigates the accuracy and duration needed for 3D model registration using artifical intelligence (AI) assistance compared to conventional point-based registration. Manual segmentation of all cone beam computed tomography (CBCT) scans will be performed before the registration procedure. conditions: Registration Accuracy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: AI-assisted registration name: Point-based registration measure: Registration accuracy measure: Duration for registration sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Private maxillofacial digital lab city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06273319 id: 010656 briefTitle: The Effect of Oxygen Application With Double Nasal Cannula on Respiratory Complications overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-05-01 date: 2024-06-01 date: 2024-02-22 date: 2024-02-22 name: Inonu University class: OTHER briefSummary: To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy. conditions: Gastric Disease conditions: Gastric Distress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: 2 whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: OXYGEN THERAPY measure: Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95% sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu universitesi city: Malatya zip: 44050 country: Turkey lat: 38.35018 lon: 38.31667 hasResults: False
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<|newrecord|> nctId: NCT06273306 id: HULP.PI-4519 id: PI22/00777 type: OTHER_GRANT domain: Fondo de investigaciones sanitarias.Instituto de Salud Carlos III briefTitle: Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC) acronym: IMIDOC overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-12-31 date: 2026-12-31 date: 2024-02-22 date: 2024-02-22 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER briefSummary: The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.
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This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App. conditions: Telemedicine conditions: Telehealth conditions: eHealth conditions: Rheumatic Diseases conditions: Arthritis, Rheumatoid conditions: Spondylarthritis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 360 type: ESTIMATED name: IMIDOC measure: To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included measure: To identify features associated with adherence to follow-up through the MAM. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06273293 id: EPIC35-PROMETEUS briefTitle: Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL) overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-01-20 date: 2026-01-20 date: 2024-02-22 date: 2024-03-13 name: Fundación EPIC class: OTHER briefSummary: the use of pressure wires is the standar of care to evaluate angiographically intermediate coronary lesions, however, limitations in the management of these type of lesions continue to be a challenge for the interventional cardiologist. The use of FFR has some limitations such as the use of adenosine due to its cost, adverse effects (e.g. transient atrioventricular block, angina, headache, etc.), time consuming and some relative contraindications for its use. In this sense, in recent years new rest indices (iFR, RFR, dPR) and hyperemic indices without adenosine (cFFR-NTG, Pd/Pa-NTG or cFFR) have been developed, demonstrating an improvement in terms of outcomes with its use, so they can also be used as a tool to guide us to plan our strategy. These new indices, particularly the cFFR-NTG, are simpler, at least as safe and have an excellent correlation with the FFR with adenosine in the assessment of intermediate coronary lesions.
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In recent years, functional assessment after intervention has also been increasingly implemented, which, like intracoronary imaging, can make us change our attitude and correlate with the prognosis. The lower implementation of this practice, especially in multivessel patients, may result from having to lose the position of the wire to check equalization, difficulty in crossing the wire, wear/breakage of the material after diagnosis (2-3 vessels), use more time and contrast, etc. These problems could be reduced, at least partially, with the use of the workhorse coronary guidewire pressure microcatheter to measure post-PCI functional assessment. Although the usefulness of post-PCI FFR has been demonstrated, there is no clearly established cut-off value (0.84-0.96) and it seems that in reality the values are a continuum of risk so that the higher the value, the better the prognosis . Furthermore, other simpler indices such as rest or hyperemic indices without adenosine have not been correlated with FFR in post-PCI.
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The purpose of this study is to evaluate the correlation between cFFR-NTG and other indices taking FFR as a reference in multivessel patients after undergoing intervention. Establish cut-off points and correlate it with adverse cardiovascular events (MACE) in a 1-year clinical follow-up. conditions: Coronary Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Fractional Flow Reserve measure: Agreement between cFFR+NTG and FFR measure: SAFETY: MACE measure: Agreement between Pd/Pa or dPR and FFR measure: Cut-off point for cFFR+NTG post-ICP measure: Evaluate the change in strategy that the measurement of FFR values ≤0.90 post-PCI measure: Cardiac death measure: Cardiovascular death measure: Acute myocardial infarction of the lesion treated/functionally evaluated measure: Acute myocardial infarction from any lesion measure: Need for revascularization of the lesion treated/functionally evaluated measure: Need for revascularization of any lesion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06273280 id: Z-2023025 briefTitle: Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction. acronym: ReQUAD-HF overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-14 date: 2025-12 date: 2026-03 date: 2024-02-22 date: 2024-02-28 name: Ziekenhuis Oost-Limburg class: OTHER name: King Baudouin Foundation briefSummary: The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score.
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Participants will be randomized towards control (standard of care, SOC) or intervention group.
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Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT. conditions: Heart Failure conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the study design, the study is open-label. In order to reduce bias, a study nurse (blinded for allocation arm) will see or call the patient to register the heart failure medication and dose of loop diuretics at three months and optionally 12months (open-label, endpoint-blinded). whoMasked: OUTCOMES_ASSESSOR count: 345 type: ESTIMATED name: SOC name: Protocolized up-titration measure: Weighed composite score of maximal guideline-directed medical therapy measure: All-cause mortality and heart failure hospitalizations measure: Change in NTproBNP measure: Change in renal function measure: All-cause mortality measure: Number of patients with heart failure hospitalizations measure: Change in prescription rate per GDMT class measure: Incidence of predefined safety endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuis Oost-Limburg AV city: Genk state: Limburg zip: 3600 country: Belgium lat: 50.965 lon: 5.50082 hasResults: False
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<|newrecord|> nctId: NCT06273267 id: APHP231232 briefTitle: Initiating Pediatric Palliative Care in ACT Group 4 acronym: StartSPP overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-08 date: 2024-08 date: 2024-02-22 date: 2024-02-22 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.
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This classification includes four groups. ACT 4 category is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).
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Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.
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The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention. conditions: Encephalopathy conditions: Cerebral Palsy conditions: Cerebral Malformation conditions: Traumatic Head Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Collection of data from the patient's medical file measure: Description of first pediatric palliative care intervention measure: Description of the patient situation measure: Timing of pediatric palliative care intervention sex: ALL maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Hôpital Necker-Enfants Malades city: Paris zip: 75015 country: France name: Ashley RIDLEY, M.D. role: CONTACT phone: 1 42 19 27 28 phoneExt: +33 email: ashley.ridley@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06273254 id: SCVL-TFZ-1009 briefTitle: A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-09 date: 2024-02-22 date: 2024-02-22 name: Viatris Inc. class: INDUSTRY briefSummary: Primary objective is to is to evaluate the bioequivalence of two formulations conditions: Bioequivalence Study studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 48 type: ESTIMATED name: Sacubitril and Valsartan Tablets 49mg/51mg name: Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg) measure: Cmax measure: AUC measure: tmax measure: t1/2 measure: λz measure: AUC0-t/AUC0-∞ measure: residual area sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Medica Innova Co Ltd city: Bangkok zip: 10310 country: Thailand name: Ariya Khunvichai, Ph.D role: CONTACT phone: 666 2428 7178 email: ariya@medicainnova.com name: Suvimol Niyomnaitham, Assist. Prof., M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 hasResults: False
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<|newrecord|> nctId: NCT06273241 id: IPHA-2024-009 briefTitle: Impact of Food Intake on Berberine Kinetics acronym: BERKI-3 overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-09-30 date: 2024-09-30 date: 2024-02-22 date: 2024-02-22 name: University Medicine Greifswald class: OTHER briefSummary: The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to our expectations, the previously observed sex difference could not be confirmed.
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In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, they ate a meal. Shortly after meal intake, the plasma concentration curve peaked again BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, we will also measure insulin and glucose after the meal at noon.
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As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One By measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively.
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24 heathy volunteers with an equal ratio of man and women will be enrolled. conditions: Pharmacokinetic Study in Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is an unblinded, randomized, prospective study comparing berberine intake in fasted condition and after a high or low caloric meal in a cross-over design. primaryPurpose: TREATMENT masking: NONE maskingDescription: This study will be an open label study. Participants will be selected from an existing database of our Institute. count: 24 type: ESTIMATED name: food intake measure: Berberine plasma concentration fasted vs fed measure: Berberine plasma concentrations light vs heavy meal measure: Blood glucose concentrations measure: Blood insulin concentrations sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University Medicine Greifswald, Institute of Pharmacology city: Greifswald state: Mecklenburg-Vorpommern zip: 17487 country: Germany name: Stefan Engeli, Prof. role: CONTACT phone: +49 3834865633 email: stefan.engeli@med.uni-greifswald.de name: Christin Jeschke role: CONTACT phone: +491746471584 email: Christin.Jeschke@med.uni-greifswald.de name: Stefan Engeli, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.09311 lon: 13.38786 hasResults: False
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<|newrecord|> nctId: NCT06273228 id: STUDY00000788 briefTitle: Parenting Young Children in Pediatrics overallStatus: RECRUITING date: 2023-09-27 date: 2024-10-01 date: 2024-10-01 date: 2024-02-22 date: 2024-02-22 name: University of Oregon class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: Research suggests that one in eight children in the U.S. currently lives with a parent with a substance use disorder. Parents who misuse substances are at increased risk of using harsh and other negative parenting practices with their young children, who are more likely to face challenges with emotional and behavioral regulation and subsequently misuse substances themselves. There is thus an urgent need for evidence-based interventions to promote positive parenting skills in parents who misuse substances. Interventions must be convenient, non-stigmatizing, and accessible to parents with problematic substance use, who frequently face barriers to engaging with healthcare systems. Pediatric primary care is an ideal setting to offer a brief intervention for maladaptive parenting behaviors associated with parental substance use, as the vast majority of children under 5 access pediatric primary care at least annually and parents generally report high levels of trust in their child's pediatrician.
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