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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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] name: Gian Luca De Salvo, MD role: CONTACT phone: 049 8215710 phoneExt: +39 email: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] name: Christin Jeschke role: CONTACT phone: +491746471584 email: [email protected] 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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The Family Check-Up (FCU) Online app, which was created specifically to promote positive parenting skills in parents with past or current substance misuse, is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief, convenient, and delivered in a self-directed format that parents favor. The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online, a brief, app-based parenting intervention, for parents reporting lifetime problematic substance use in a pediatric primary care setting.
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In this study, investigators will partner with pediatric primary care providers to recruit parent participants, then evaluate feasibility and acceptability by systematically assessing parents' engagement with the FCU Online app. Engagement data from the app includes time spent in app overall and in each module, activities completed, and which modules were accessed. Investigators will also administer a consumer satisfaction survey, which will ask parents to report on their perceptions of the app (e.g., helpfulness, useability, and effects on parenting). To assess engagement in telehealth coaching sessions, investigators will use the following variables: number of telehealth sessions completed, length of session, content of sessions, and coaches' ratings of participant engagement in the session and barriers to using the app. Coaches will also rate participant engagement on a 3-point scale from "low" to "high." Lastly, investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online, focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting.
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A second aim of this study is to assess pediatric healthcare providers' perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation. Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers, investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings. conditions: Parenting conditions: Parent-Child Relations conditions: Substance Use Disorders conditions: Stress conditions: Depression conditions: Anxiety conditions: Parenting Self-efficacy conditions: Pediatrics studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Parents will be recruited in pediatric primary care settings and will be assessed at baseline and at a 3-month follow-up. Parents will receive the intervention between baseline and follow-up. Nine parents will be randomly selected for an additional follow-up interview. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 36 type: ESTIMATED name: Family Check-Up Online measure: change from baseline in parenting skills measure: change from baseline in parenting efficacy measure: change from baseline in parent executive functioning measure: change from baseline in child social-emotional behavior measure: change from baseline in family conflict measure: change from baseline in parental substance use measure: change from baseline in parental depression measure: change from baseline in parental anxiety measure: change from baseline in parental stress measure: change from baseline in parental impact of negative life events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prevention Science Institute, University of Oregon status: RECRUITING city: Eugene state: Oregon zip: 97403 country: United States name: Katherine Hails, PhD role: CONTACT phone: 610-457-8627 email: [email protected] name: Elizabeth Stormshak, PhD role: CONTACT phone: 541-912-3792 email: [email protected] name: Katherine Hails, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.05207 lon: -123.08675 hasResults: False
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<|newrecord|> nctId: NCT06273215 id: DCTC-IIR202217 briefTitle: Evaluation of the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Diabetic Patients overallStatus: RECRUITING date: 2023-03-05 date: 2025-12-31 date: 2025-12-31 date: 2024-02-22 date: 2024-02-22 name: Peking University Third Hospital class: OTHER briefSummary: 1.To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Diabetic patients (including the non-obese T2DM, obese T2DM, elderly T2DM, and T1DM). conditions: Diabetes studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 48 type: ESTIMATED name: The combinations of 10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin were administered to diabetic patients on an empty stomach. measure: Pharmacokinetics of study drug measure: Concentration of endogenous markers of CYP3A and OATP measure: Genotype of OATP and BCRP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Yafen Li role: CONTACT phone: 18222566785 email: [email protected] name: Dongyang Liu role: PRINCIPAL_INVESTIGATOR name: Tianpei Hong role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06273202 id: 6257 briefTitle: Ultrasound Monitoring of Muscle Thickness in Premature Patients acronym: NeoMassage overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-07 date: 2025-01 date: 2024-02-22 date: 2024-02-22 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment.
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The main questions it aims to answer are:
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* To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle. Specifically, changes in muscle thickness and trophism of the quadriceps femoris.
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* Potential effects on spontaneous motility and stature-ponderal growth of infants. In addition, the discomfort and behavioral status of the infant before and after massage will be investigated infant.
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Patients included in the study will be randomized according to a random sequence with a 1:1 ratio into theexperimental group (GS) or the control group (GC). Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative, to which patients in the control group will be subjected exclusively control.
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Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV).
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Ultrasound will be performed at the time of randomization (T0) and then 1 time per week until the 35th week by two operators (SN and VA); at the same time, the circumference of the thigh subjected to ultrasound examination. A 12Hz linear ultrasound probe will be used, applied perpendicular to the skin. The infant will be placed supine, with the thigh extended, in a neutral position; excessive compression will be avoided by applying a generous amount of gel. At the midpoint of the thigh, the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia. The average of at least 2 measurements will be then calculated. The Heckmatt scale will be used to assess the echogenicity of muscle and bone. In addition, at time T0 and at week 35 the following data will be collected: weeks gestational age, weight at birth and at the end of treatment, rectal temperature, blood gas parameters if present. conditions: Prematurity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Infant Massage measure: Quadriceps femuri thickness measure: Quadriceps femuri trophism measure: To valuate the discomfort/behavioral status of the infant. measure: To valuate the potential effects on spontaneous motility. measure: To evaluate differences in ponderal growth. sex: ALL minimumAge: 28 Weeks maximumAge: 35 Weeks stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06273189 id: 2017/558 briefTitle: Ultrasonic Bone Scalpel in BSSO overallStatus: COMPLETED date: 2018-12-15 date: 2020-12-15 date: 2021-12-15 date: 2024-02-22 date: 2024-02-22 name: TC Erciyes University class: OTHER briefSummary: The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO. conditions: Maxillofacial Abnormalities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double blind primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Conventional name: Bone Scalpel measure: Cutting Time measure: neurosensory disturbance measure: The length of the procedure measure: The splitting time measure: The pattern of the split measure: postoperative edema sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Selin Çelebi city: Kayseri state: Melikgazi zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06273176 id: MEC-2020-0812 briefTitle: The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma acronym: RECMAP overallStatus: RECRUITING date: 2023-01-01 date: 2027-01-01 date: 2028-01-01 date: 2024-02-22 date: 2024-02-22 name: Erasmus Medical Center class: OTHER name: Haaglanden Medical Centre name: Universitaire Ziekenhuizen KU Leuven name: University Hospital Heidelberg name: Technical University of Munich name: Insel Gruppe AG, University Hospital Bern name: Massachusetts General Hospital name: University of California, San Francisco briefSummary: Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.
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This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.
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The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM). conditions: Glioblastoma, IDH-wildtype conditions: Glioblastoma conditions: Glioblastoma Multiforme of Brain conditions: Astrocytoma, Malignant conditions: Brain Neoplasms conditions: Brain Neoplasms, Adult, Malignant conditions: Brain Neoplasms, Adult conditions: Recurrent Adult Brain Tumor conditions: Recurrent Glioblastoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Awake mapping under local anesthesia name: Asleep mapping under general anesthesia name: Resection under general anesthesia without mapping measure: Residual volume measure: Neurological morbidity at 6 weeks measure: Overall survival measure: Progression-free survival measure: Onco-functional outcome (OFO) measure: Serious Adverse Events measure: Neurological morbidity at 3 months measure: Neurological morbidity at 6 months measure: Overall functioning at 6 weeks measure: Overall functioning at 3 months measure: Overall functioning at 6 months measure: Quality of life at 6 weeks (EORTC QLQ C30) measure: Quality of life at 3 months (EORTC QLQ C30) measure: Quality of life at 6 months (EORTC QLQ C30) measure: Quality of life at 6 weeks (EORTC QLQ BN20) measure: Quality of life at 3 months (EORTC QLQ BN20) measure: Quality of life at 6 months (EORTC QLQ BN20) measure: Quality of life at 6 weeks (EQ-5D) measure: Quality of life at 3 months (EQ-5D) measure: Quality of life at 6 months (EQ-5D) sex: ALL maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Mitchel Berger, MD PhD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Brian Nahed, MD PhD role: CONTACT lat: 42.35843 lon: -71.05977 facility: University Hospital Leuven status: RECRUITING city: Leuven country: Belgium name: Steven De Vleeschouwer, MD PhD role: CONTACT lat: 50.87959 lon: 4.70093 facility: Universitätsklinikum Heidelberg status: RECRUITING city: Heidelberg country: Germany name: Christine Jungk, MD PhD role: CONTACT name: Sandro Krieg, MD PhD role: CONTACT lat: 49.40768 lon: 8.69079 facility: Technical University Munich status: NOT_YET_RECRUITING city: Munich country: Germany name: Arthur Wagner, MD role: CONTACT lat: 48.13743 lon: 11.57549 facility: Erasmus Medical Center status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands name: Jasper Gerritsen, MD PhD role: CONTACT lat: 51.9225 lon: 4.47917 facility: Haaglanden Medical Center status: RECRUITING city: The Hague country: Netherlands name: Marike Broekman, MD PhD role: CONTACT lat: 52.07667 lon: 4.29861 facility: Inselspital Universitätsspital Bern status: NOT_YET_RECRUITING city: Bern country: Switzerland name: Philippe Schucht, MD PhD role: CONTACT lat: 46.94809 lon: 7.44744 hasResults: False
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<|newrecord|> nctId: NCT06273163 id: STU-2023-1168 briefTitle: Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation overallStatus: RECRUITING date: 2024-03-05 date: 2024-12-31 date: 2024-12-31 date: 2024-02-22 date: 2024-03-08 name: University of Texas Southwestern Medical Center class: OTHER name: UT Southwestern Nutrition Obesity Research Center briefSummary: Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (\~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized repeated measures between-subjects design primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Complete masking is not feasible given the nature of the interventions - the program coordinator and participants will know if the participant receives home delivered medically tailored meals, a smart device application subscription, or usual care. The care provider will not be told the participants group assignment, but the participant may reveal it themselves in discussions with the provider. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Medically tailored meals name: Noom® name: Usual care measure: Intervention Adherence measure: Intervention Satisfaction measure: Percent weight loss maintained measure: Diet quality measure: Incremental cost effective ratio (ICER) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UT Southwestern Medical Center status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Carolyn Haskins, MS role: CONTACT email: [email protected] name: Jessica Turcios, BS role: CONTACT email: [email protected] name: Kelseanna Hollis-Hansen, PhD, MPH role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False
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<|newrecord|> nctId: NCT06273150 id: 142048 briefTitle: Dentatorubral-pallidoluysian Atrophy Natural History and Biomarkers Study acronym: DRPLA NHBS overallStatus: RECRUITING date: 2022-05-01 date: 2026-04 date: 2026-04 date: 2024-02-22 date: 2024-02-22 name: University College, London class: OTHER name: University of North Carolina, Chapel Hill name: NYU Grossman School of Medicine briefSummary: DRPLA Natural History and Biomarkers Study (DRPLA NHBS) is a prospective observational study that will lay the foundation for clinical trials in DRPLA. The aims of this project are:
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* To characterize the natural history of DRPLA in both juvenile- and adult-onset patients and study different modalities of biomarkers in this condition.
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* To identify genetic factors and biomarkers that could predict disease progression.
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* To provide a platform to support the design and conduct of clinical trials.
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This study has three arms:
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1. Adult Participants: this arm of the study will require participants to be 16 years old or over to participate.
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2. Pediatric Participants: this arm of the study will require participants to be under 16 years old to participate.
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3. Remote Participants: patients that cannot or do not wish to travel to one of the study sites can participate in this arm of the study, irrespective of their age.
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Participants will have an annual visit for three years (baseline visit and two follow-up visits, three visits in total). Subjects who complete the whole protocol will be assessed on two consecutive days to reduce patient burden.
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This project will allow for a better understanding of DRPLA and its course, and therefore allow for future clinical trials on this condition to be more precisely and effectively conducted. conditions: Dentatorubral-Pallidoluysian Atrophy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Positive genetic test for pathological expansion in ATN1 measure: Scale for the assessment and rating of ataxia (SARA) measure: Brain atrophy measure: Neurofilament plasma concentration (NfL) measure: Inventory of non-ataxia signs (INAS) measure: Upper limb function test AIM-S measure: Redenlab DRPLA specific speech battery measure: Clinical Assessment of Dysphagia in Neurodegeneration (CADN) measure: Tau plasma concentration measure: Glial fibrillary acidic protein (GFAP) concentration measure: Ubiquitin carboxyterminal hydrolase L1 (UCH-L1) concentration sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Grossman School of Medicine status: RECRUITING city: New York state: New York zip: 10017 country: United States name: Claire Miller role: CONTACT phone: 212-263-4838 email: [email protected] lat: 40.71427 lon: -74.00597 facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599-7025 country: United States name: Yael Shiloh-Malawsky role: CONTACT phone: 919-966-2528 email: [email protected] lat: 35.9132 lon: -79.05584 facility: University College London status: RECRUITING city: London zip: WC1N 3BG country: United Kingdom name: Paola Giunti role: CONTACT phone: +44 7899974923 email: [email protected] lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06273137 id: 2963 briefTitle: Positive Affect Treatment for Adolescents With Early Life Adversity acronym: PAT4ELA overallStatus: RECRUITING date: 2024-02-03 date: 2026-02-16 date: 2026-10-16 date: 2024-02-22 date: 2024-02-28 name: University of California, Irvine class: OTHER briefSummary: Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For this pilot, the investigators will recruit 22 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. At study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be randomized 1:1 to either receive PAT upon enrollment or after a waitlist period. primaryPurpose: PREVENTION masking: NONE count: 22 type: ESTIMATED name: Positive affect treatment measure: Positive affect measure: depressive symptoms - total measure: depressive symptoms - anhedonia subscale measure: Systemic inflammation - C-reactive protein (CRP) measure: Inflammatory gene expression sex: ALL minimumAge: 12 Years maximumAge: 16 Years stdAges: CHILD facility: University of California Irvine status: RECRUITING city: Irvine state: California zip: 92617 country: United States name: Kate R Kuhlman role: CONTACT phone: 949-824-5574 email: [email protected] lat: 33.66946 lon: -117.82311 hasResults: False
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<|newrecord|> nctId: NCT06273124 id: 150-1261-00 briefTitle: Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes overallStatus: RECRUITING date: 2024-03-07 date: 2025-01-15 date: 2025-01-15 date: 2024-02-22 date: 2024-04-25 name: Tandem Diabetes Care, Inc. class: INDUSTRY name: Jaeb Center for Health Research briefSummary: The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).
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Participants will be asked to:
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1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
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2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour conditions: Type1diabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods. primaryPurpose: TREATMENT masking: NONE count: 260 type: ESTIMATED name: SteadiSet Extended Wear Infusion Set measure: Primary Outcome Measure measure: Primary Outcome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hoag Memorial Hospital Presbyterian status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States name: Brittany Dennis role: CONTACT phone: 949-764-6896 email: [email protected] name: David Ahn, MD role: PRINCIPAL_INVESTIGATOR lat: 33.61891 lon: -117.92895 facility: Stanford University status: NOT_YET_RECRUITING city: Stanford state: California zip: 94305 country: United States name: Rayhan Lal role: CONTACT phone: 925-727-1317 email: [email protected] name: Rayhan Lal, MD role: PRINCIPAL_INVESTIGATOR lat: 37.42411 lon: -122.16608 facility: Barbara Davis Center status: NOT_YET_RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Samantha Lange role: CONTACT phone: 303-724-7514 email: [email protected] name: Erin Cobry, MD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Endocrine Research Solutions status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States name: Jessica Tapia role: CONTACT phone: 678-878-4750 email: [email protected] name: John C Reed, MD role: PRINCIPAL_INVESTIGATOR lat: 34.02316 lon: -84.36159 facility: Rocky Mountain Clinical Research status: NOT_YET_RECRUITING city: Idaho Falls state: Idaho zip: 83404 country: United States name: Wyatt Larson role: CONTACT phone: 208-525-3736 email: [email protected] name: David Liljenquist, MD role: PRINCIPAL_INVESTIGATOR lat: 43.46658 lon: -112.03414 facility: Northwestern University status: NOT_YET_RECRUITING city: Evanston state: Illinois zip: 60208 country: United States name: Grazia Aleppo role: CONTACT phone: 312-926-5431 email: [email protected] name: Grazia Aleppo, MD role: PRINCIPAL_INVESTIGATOR lat: 42.04114 lon: -87.69006 facility: Massachusetts General Hospital status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Amy Sabean role: CONTACT phone: 617-726-1729 email: [email protected] name: Melissa Putman, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Henry Ford Health System status: NOT_YET_RECRUITING city: Detroit state: Michigan zip: 48202 country: United States name: Davida Kruger role: CONTACT phone: 313-916-3906 email: [email protected] name: Davida Kruger, NP role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 facility: International Diabetes Center - HealthPartners Institute status: NOT_YET_RECRUITING city: Minneapolis state: Minnesota zip: 55416 country: United States name: Kathryn Leet, RD,LD, CDCES role: CONTACT phone: 952-993-9793 email: [email protected] name: Richard Bergenstal, MD role: PRINCIPAL_INVESTIGATOR lat: 44.97997 lon: -93.26384 facility: Mayo Clinic status: NOT_YET_RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Corey Kurek role: CONTACT phone: 507-255-0316 email: [email protected] name: Yogish Kudva, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 facility: Icahn School of Medicine at Mt. Sinai status: NOT_YET_RECRUITING city: New York state: New York zip: 10029 country: United States name: Denisa Tamarez role: CONTACT phone: 212-241-9089 email: [email protected] name: Camilla Levister, MS, ANCP-C role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: SUNY Upstate Medical University status: RECRUITING city: Syracuse state: New York zip: 13210 country: United States name: Suzan Bzdick, RN, CDCES role: CONTACT phone: 315-464-9006 email: [email protected] name: Ruth Weinstock, MD role: PRINCIPAL_INVESTIGATOR lat: 43.04812 lon: -76.14742 facility: Texas Diabetes and Endocrinology status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78731 country: United States name: Emmanuel Lopez role: CONTACT phone: 512-334-3505 email: [email protected] name: Jean Chen, MD role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 facility: Rainier Clinical Research Center status: NOT_YET_RECRUITING city: Renton state: Washington zip: 98057 country: United States name: Tina Mitchell role: CONTACT phone: 425-251-1720 email: [email protected] name: Frances Broyles, MD role: PRINCIPAL_INVESTIGATOR lat: 47.48288 lon: -122.21707 facility: University of Washington status: NOT_YET_RECRUITING city: Seattle state: Washington zip: 98109 country: United States name: Dori Khakpour role: CONTACT phone: 206-945-4965 email: [email protected] name: Irl Hirsch, MD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06273111 id: 73840 briefTitle: Topical Simvastatin for Treating Infantile Hemangioma acronym: TSTIH overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-07-31 date: 2025-12-31 date: 2024-02-22 date: 2024-02-22 name: Joyce Teng class: OTHER name: Stanford University briefSummary: This is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial IH.
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The primary objective:
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To evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial IH over 24 weeks.
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The secondary objective:
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1.1 To evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. Evaluation is performed at each clinic visit via investigator global assessment (IGA) based on standardized 3D digital photography and hemangioma activity score (HAS).
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1.2 To evaluate the impact of 5% simvastatin ointment on quality of life using the IH-QoL questionnaire. conditions: Hemangioma Skin studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: 5% simvastatin ointment measure: Number of Participants with Treatment-Related Adverse Events measure: Percentage of participants achieved a 50% HAS reduction at week 12 compared to baseline measure: Percentage of participants achieved a 75% HAS reduction from baseline by the end of the study (week 24) compared to baseline. measure: Percentage of targeted hemangiomas with complete or nearly complete resolution (IGA 0 or 1), defined as a minimal degree of telangiectasia, skin thickening, and no definitive palpable cutaneous texture changes. measure: Percentage of targeted hemangiomas that are stabilized (no noticeable change to baseline) or continue to progress. measure: Percentage of participants with a significant improvement in quality-of-life, defined as > 50% reduction in the IH-QoL questionnaire score from baseline to week 24. sex: ALL minimumAge: 3 Months maximumAge: 5 Years stdAges: CHILD facility: Stanford University city: Palo Alto state: California zip: 94304 country: United States name: Ramrada Lekwuttikarn, MD role: CONTACT phone: 650-313-8207 email: [email protected] name: Thomas Buschbacher role: CONTACT phone: 352-278-7603 email: [email protected] lat: 37.44188 lon: -122.14302 hasResults: False
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<|newrecord|> nctId: NCT06273098 id: 73162 briefTitle: School-Based Bladder Health Intervention overallStatus: WITHDRAWN date: 2028-01-01 date: 2033-12-31 date: 2033-12-31 date: 2024-02-22 date: 2024-04-24 name: Stanford University class: OTHER briefSummary: The aim of this study is to promote healthy bladder behaviors among school children. We hypothesize that a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies can promote healthy bladder behaviors among school children. conditions: Urinary Dysfunction conditions: Lower Urinary Tract Symptoms conditions: Urinary Tract Infections conditions: Urinary Tract Infections in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 0 type: ACTUAL name: Bladder Health Education measure: Bathroom use measure: Symptom score measure: Urine volume sex: ALL minimumAge: 5 Years maximumAge: 10 Years stdAges: CHILD facility: Stanford Hospital and Clinics city: Palo Alto state: California zip: 94304 country: United States lat: 37.44188 lon: -122.14302 hasResults: False
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<|newrecord|> nctId: NCT06273085 id: MOD00016877 briefTitle: Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction overallStatus: RECRUITING date: 2024-02-01 date: 2025-02 date: 2025-02 date: 2024-02-22 date: 2024-02-26 name: Medstar Health Baltimore class: OTHER briefSummary: The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital. conditions: Heart Failure conditions: Patient Acceptance of Health Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 500 type: ESTIMATED name: Patient education measure: Change in GDMT score measure: Heart Failure hospitalization measure: cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant measure: Number of GDMT classes of medications in use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medstar Union Memorial Hospital status: RECRUITING city: Baltimore state: Maryland zip: 21218 country: United States name: Ahmad Amin, MD role: CONTACT phone: 401-533-0696 email: [email protected] lat: 39.29038 lon: -76.61219 facility: Medstar Harbor Hospital status: RECRUITING city: Baltimore state: Maryland zip: 21225 country: United States name: Sumanth Bandaru, MBBS role: CONTACT phone: 646-240-5289 email: [email protected] lat: 39.29038 lon: -76.61219 facility: Medstar Franklin Medical Center status: RECRUITING city: Baltimore state: Maryland zip: 21237 country: United States name: Anup Agarwal, MD role: CONTACT phone: 505-620-7815 email: [email protected] lat: 39.29038 lon: -76.61219 facility: Medstar Good Samaritan Hospital status: RECRUITING city: Baltimore state: Maryland zip: 21239 country: United States name: Sumanth Bandaru, MBBS role: CONTACT phone: 646-240-5289 email: [email protected] lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06273072 id: IRB00409080 id: R34HL166438-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/R34HL166438-01A1 briefTitle: Metformin IN Asthma for Overweight and Obese Individuals (MINA) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-09-30 date: 2028-12-31 date: 2024-02-22 date: 2024-03-15 name: Johns Hopkins University class: OTHER name: Baylor College of Medicine name: National Heart, Lung, and Blood Institute (NHLBI) name: Temple University briefSummary: This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy. conditions: Asthma conditions: Asthma Chronic conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Metformin hydrochloride extended-release tablets name: Visually identical placebo Metformin hydrochloride extended-release tablets measure: Number of completed telemedicine visits measure: Adherence to study drug measure: Retention rate measure: Asthma control as assessed by the Asthma Control Test (ACT) score measure: Change in Asthma exacerbations rate measure: Pre-bronchodilator lung function measure: Fractional exhaled nitric oxide (FeNO) measure: Airways hyperresponsiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06273059 id: 22-07-0717 briefTitle: Genomic Study of Young-Onset Diabetes Mellitus overallStatus: RECRUITING date: 2022-09-12 date: 2024-12-12 date: 2024-12-12 date: 2024-02-22 date: 2024-02-22 name: Indonesia University class: OTHER briefSummary: Diabetes Mellitus (DM) has been a major contributor to health burden in Indonesia and currently its burden still continues to rise. This is a result of increasing DM prevalence in the country as well as high rates of chronic complications from DM. Findings in Indonesia show that there is a high proportion of young people with diabetes, and also a high risk of therapeutic failure and complications from DM occurring in the younger population.
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Young-onset DM has a wide clinical spectrum, including autoimmune DM, polygenic DM, and monogenic DM such as Mature Onset Diabetes of the Young (MODY). Identification and proper diagnosis of young-onset DM spectrum is crucial to treatment outcomes, as certain spectrums, such as some subtypes of MODY, may benefit from cost-efficient alternatives with better outcomes.
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However, proper diagnosis of young-onset DM in Indonesia is still a great challenge, as currently some examinations, including genetic testing, has not yet been feasibly done in the country. With current advances in genomics, genetic testing may prove to be fundamental in providing optimal and personalized treatment and care for DM patients.
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This study is a pilot project aimed to initiate genomic research in young-onset DM patients in Indonesia. In the short term, this study aims to identify genetic variants that may be able to increase diagnostic accuracy of the young-onset DM spectrum. In the long term, this study aims to identify new genetic variants of young-onset DM. The study also aims to identify genetic variants associated with risks of chronic complications. conditions: Genomic conditions: Diabetes Mellitus conditions: MODY studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED measure: The overall objective of this study is to identify and describe genetic variation of young-onset DM in Indonesia. measure: To describe the proportion of MODY in young-onset DM measure: To describe genetic variation of MODY in Indonesia. measure: To describe genetic variation in young-onset DM with diabetic complications in various systems: sex: ALL minimumAge: 8 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Cipto Mangunkusumo Hospital status: RECRUITING city: Jakarta Pusat state: DKI Jakarta zip: 10430 country: Indonesia role: CONTACT phone: 1 500 135 lat: -6.1818 lon: 106.8223 hasResults: False
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<|newrecord|> nctId: NCT06273046 id: PR(AG)614/2023 briefTitle: Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback overallStatus: RECRUITING date: 2024-04-19 date: 2025-04-28 date: 2025-12-31 date: 2024-02-22 date: 2024-04-25 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs.
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Hypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders.
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Aim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques.
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Selection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment.
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Intervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome.
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Biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times.
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Placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home. conditions: Fecal Incontinence conditions: Outlet Dysfunction Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 96 type: ESTIMATED name: Biofeedback name: Placebo measure: Fecal incontinence study: Number of anal leaks measure: Dyssinergic defecation study: Number of bowel movements measure: Incontinence study: Wexner scale measure: Incontinence study: Quality of life measure: Incontinence study: anxiety and depression measure: Incontinence study: Anal sphincter function measure: Dyssinergic defecation study: sensation of outlet obstructed evacuation measure: Dyssinergic defecation study: Wexner scale measure: Dyssinergic defecation study: Quality of life measure: Dyssinergic defecation study: anxiety and depression measure: Dyssinergic defecation study: defecatory maneuvers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Vall d'Hebron status: RECRUITING city: Barcelona country: Spain name: Jordi Serra, MD role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06273033 id: CONCORDE briefTitle: Implementation of Contemporary Coronary CT Angiography in Clinical Practice acronym: CONCORDE overallStatus: RECRUITING date: 2023-10-10 date: 2024-10 date: 2025-01 date: 2024-02-22 date: 2024-03-01 name: Humanitas Hospital, Italy class: OTHER briefSummary: Coronary CT angiography (CCTA) has been recognized as the first-line diagnostic test for most patients with suspected coronary syndrome, often acting as a gatekeeper for invasive coronary angiography. It is therefore pivotal to understand instances of discrepancies that are encountered in clinical practice. Moreover, most of the literature on this topic relies on obsolete machines or definitions of coronary artery stenosis that cannot be defined as severe.
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The investigators aim 1) to report the real word data on the performance of last-generation CCTA in identifying obstructive coronary artery disease (also considering different thresholds of stenosis, i.e., moderate or severe) and 2) to identify predictors of discrepancies. conditions: Coronary Artery Disease of Significant Bypass Graft conditions: Coronary Syndrome conditions: Coronary Arteriosclerosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a patient with suspected CAD. measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a patient with suspected CAD. measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a vessel of a patient with suspected CAD measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a vessel of a patient with suspected CAD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: Milano zip: 20089 country: Italy name: Carlo Andrea Pivato, MD role: CONTACT phone: +39 02 8224 7235 email: [email protected] lat: 45.38193 lon: 9.1559 hasResults: False
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