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<|newrecord|> nctId: NCT06377527 id: 2023-0945 id: NCI-2024-03342 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA) overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2035-12-28 date: 2037-12-28 date: 2024-04-22 date: 2024-04-22 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To develop a database of medical information about patients with MLA in an effort to increase our understanding of the characteristics of MLA, which is the rarest form of endometrial carcinoma. conditions: Mesonephric-like Adenocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 2000 type: ESTIMATED measure: Tumor Registry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Jeffrey How, MD role: CONTACT name: Jeffrey How, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06377514 id: PCOL109PHNG briefTitle: Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-10-31 date: 2025-10-31 date: 2024-04-22 date: 2024-04-22 name: Johnson & Johnson Surgical Vision, Inc. class: INDUSTRY briefSummary: Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial. conditions: Cataracts studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Test IOL Model DEN00V name: Control IOL Model DCB00 measure: Monocular photopic DCIVA (first eyes) at 66 cm measure: Monocular Depth of Focus measure: Monocular Photopic BCDVA at 4m measure: Monocular Photopic DCVA at 100 cm measure: Monocular photopic DCNVA at 40 cm (first eyes) sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06377501 id: 804687 briefTitle: Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL) overallStatus: RECRUITING date: 2023-03-07 date: 2024-07-01 date: 2024-07 date: 2024-04-22 date: 2024-04-22 name: University of California, San Diego class: OTHER briefSummary: This study will evaluate the feasibility of an 8-week vegan whole-food, plant-based dietary intervention in subjects with low risk CLL who are undergoing observation. Over the course of 8 weeks, participants will attend weekly group cooking classes via Zoom lead by a RD. Participants will also attend weekly individual meetings with a health coaches to assist with adherence to the dietary intervention. conditions: Chronic Lymphocytic Leukemia Stage A(0) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Whole-food, plant-based diet measure: Adherence to the Dietary Intervention measure: Satisfaction with the Dietary Intervention measure: Cooking Class Adherence measure: Recruitment measure: Retention measure: White blood cell count measure: Absolute lymphocyte count measure: Anthropometric Measures (height, weight, body mass index) measure: Anthropometric Measures (waist circumference) measure: Biomarkers of cardiometabolic health (complete metabolic panel) measure: Biomarkers of cardiometabolic health (hemoglobin A1c) measure: Biomarkers of cardiometabolic health (cholesterol and triglycerides) measure: Concentration of vitamin B12 measure: Concentration of vitamin B9 measure: Concentration of iron measure: Concentration of ferritin measure: Blood pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UC San Diego status: RECRUITING city: San Diego state: California zip: 92093 country: United States name: Ariel Portera, DO role: CONTACT phone: 858-249-6896 email: aportera@health.ucsd.edu lat: 32.71533 lon: -117.15726 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-02-23 uploadDate: 2024-04-17T18:09 filename: ICF_000.pdf size: 514422 hasResults: False
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<|newrecord|> nctId: NCT06377488 id: CR-6542 briefTitle: Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-06-24 date: 2024-06-24 date: 2024-04-22 date: 2024-04-22 name: Johnson & Johnson Vision Care, Inc. class: INDUSTRY briefSummary: This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity. conditions: Visual Acuity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 155 type: ESTIMATED name: JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at distance 4m measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at intermediate distance 64cm measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at near distance 40cm measure: Subjective Vision CLUE Scores measure: Rotational Stability measure: Absolute Rotation Error measure: Incidence of Unacceptable Lens Fit measure: Slit Lamp Findings measure: Subjective Handling Scores measure: Subjective Comfort Scores measure: Subjective Vision Scores measure: Lens Fit Success sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. James Weber & Associates, PA - City Square Blvd city: Jacksonville state: Florida zip: 32218 country: United States lat: 30.33218 lon: -81.65565 facility: Stam & Associates Eye Care city: Jacksonville state: Florida zip: 32256 country: United States lat: 30.33218 lon: -81.65565 facility: Omega Vision Center city: Longwood state: Florida zip: 32779 country: United States lat: 28.70305 lon: -81.3384 facility: Maitland Vision Center - North Orlando Ave city: Maitland state: Florida zip: 32751 country: United States lat: 28.62778 lon: -81.36312 facility: Mid-State Eye city: Clinton state: Illinois zip: 61727 country: United States lat: 40.15365 lon: -88.96453 facility: Kannarr Eye Care city: Pittsburg state: Kansas zip: 66762 country: United States lat: 37.41088 lon: -94.70496 facility: Birmingham Vision Care city: Bloomfield Hills state: Michigan zip: 48301 country: United States lat: 42.58364 lon: -83.24549 facility: Center for Ophthalmic and Vision Research/Eye Associates of New York city: Manhattan state: New York zip: 10022 country: United States lat: 40.78343 lon: -73.96625 facility: Sacco Eye Group city: Vestal state: New York zip: 13850 country: United States lat: 42.08507 lon: -76.05381 facility: ProCare Vision Centers city: Granville state: Ohio zip: 43023 country: United States lat: 40.06812 lon: -82.5196 facility: Luxe Vision and Optical city: Powell state: Ohio zip: 43065 country: United States lat: 40.15784 lon: -83.07519 facility: Dr. David W. Ferris & Associates city: Warwick state: Rhode Island zip: 02888 country: United States lat: 41.7001 lon: -71.41617 facility: Optometry Group, LLC city: Memphis state: Tennessee zip: 38111 country: United States lat: 35.14953 lon: -90.04898 facility: Tyler Eye Associates city: Tyler state: Texas zip: 75703 country: United States lat: 32.35126 lon: -95.30106 facility: New River Vision Care city: Oak Hill state: West Virginia zip: 25901 country: United States lat: 37.97233 lon: -81.14871 hasResults: False
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<|newrecord|> nctId: NCT06377475 id: 2024-00148 id: 2024-00148 type: REGISTRY domain: EKNZ briefTitle: Fabrication and Insertion of Michigan Splints by Dental Students overallStatus: ENROLLING_BY_INVITATION date: 2024-03-08 date: 2024-05 date: 2025-12 date: 2024-04-22 date: 2024-04-22 name: Juliana Marotti Großhausen class: OTHER briefSummary: The aim of this study is to investigate the potential effects of different jaw relation determination (KRB) techniques on the fabrication of Michigan splints, in particular by comparing conventional methods with a wax plate and the use of an anterior jig. All materials and methods for the fabrication of the Michigan splint are already part of the curriculum of the Clinic for Dental Prosthodontics for first-year Master-students. Therefore, we intend to conduct a retrospective study (for the 2023 cohort) and a prospective analysis of the data (for the 2024 and 2025 cohorts). Questionnaires, models and intraoral scans will be used to evaluate the efficacy and precision of the different KRB methods as well as the fabrication process of the Michigan splint. conditions: Impression Technic, Dental conditions: Jaw Relationship conditions: Bruxism studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 73 type: ESTIMATED name: Jaw relation name: Questionnaire measure: Wax vs JIG Registration measure: Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZB city: Basel zip: 4058 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False
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<|newrecord|> nctId: NCT06377462 id: VEXAS-Registry briefTitle: Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection overallStatus: RECRUITING date: 2024-03-13 date: 2029-12-31 date: 2030-12-31 date: 2024-04-22 date: 2024-04-22 name: Technische Universität Dresden class: OTHER name: Bristol-Myers Squibb name: University Hospital Munich briefSummary: The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers conditions: VEXAS Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Collection of epidemiological data on VEXAS measure: Collection and monitoring of initial disease manifestations measure: Documentation of the treatment approaches and therapy sequences measure: Analysis of clinical-relevant clinical endpoints measure: Describe disease cluster measure: Laboratory diagnostics measure: Correlation clinical endpoints with treatment approaches measure: Quality of life data (QoL), fatigue questionnaire (Facit-F) measure: Accompanying translational research measure: Collection of Biospecimens sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Carl Gustav Carus status: RECRUITING city: Dresden zip: 01307 country: Germany name: Katja Sockel, Dr. med. role: CONTACT lat: 51.05089 lon: 13.73832 hasResults: False
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<|newrecord|> nctId: NCT06377449 id: UIL-CSP-18052023 briefTitle: Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2026-01-01 date: 2024-04-22 date: 2024-04-22 name: Saint Petersburg State University, Russia class: OTHER briefSummary: The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\[s\] it aims to answer are:
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* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.
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* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.
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Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients. conditions: Ischemic Heart Disease conditions: Aortic Stenosis, Severe conditions: Aortic Insufficiency conditions: Mitral Stenosis conditions: Mitral Insufficiency conditions: Mitral Stenosis With Insufficiency conditions: Tricuspid Insufficiency conditions: Ascending Aortic Aneurysm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, single-center study with 2 groups of patients (investigating and control arms) primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 186 type: ESTIMATED name: Ultrasound examination of the lungs measure: The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination measure: Postoperative pulmonary complications measure: Cumulative dosage of diuretics measure: Number of nights at home after hospital discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Petersburg State University Clinic city: Saint Petersburg zip: 190020 country: Russian Federation name: Sergei M Efremov, MD, PhD role: CONTACT phone: +79137946090 email: sergefremov@mail.ru lat: 59.93863 lon: 30.31413 hasResults: False
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<|newrecord|> nctId: NCT06377436 id: PRAISE briefTitle: Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme acronym: PRAISE overallStatus: RECRUITING date: 2023-03-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-22 date: 2024-04-22 name: University of Milan class: OTHER briefSummary: The goal of this clinical trial is to implement a personalized training program to prevent functional decline in frail subjects but not yet disable. The purpose of the project is to test the training in a subject at particularly high risk of entering the disabled condition. A total of 80 frail subjects, divide the participants into two groups "Divida Senso Group" (experimental group) and "Standard of care Group" (Control group) will be recruited.
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The expected outcome is to slow down a functional decline not only in isolation in the domains trained by the program. conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Experimental training measure: Changes in the Functional decline measure: Intrinsic Capacity (IC) measure: Intreaction between IC and cardiac autonomic control (CAC) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Gabriella CERRI status: RECRUITING city: Milano zip: 20100 country: Italy name: Gabriella GC CERRI, Full Professor role: CONTACT phone: +393402527675 email: gabriella.cerri@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06377423 id: A54678775 briefTitle: Comparison Between Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases overallStatus: COMPLETED date: 2021-08-01 date: 2024-01-01 date: 2024-01-10 date: 2024-04-22 date: 2024-04-22 name: Prince Sattam Bin Abdulaziz University class: OTHER briefSummary: Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. The formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years. conditions: Dental Leakage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 28 type: ACTUAL name: Direct technique name: Indirect technique measure: Percentage % of patients with marginal staining sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Ali Elkaffas city: Al Kharj country: Saudi Arabia lat: 24.15541 lon: 47.33457 hasResults: False
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<|newrecord|> nctId: NCT06377410 id: FF-2023-433 briefTitle: Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients acronym: SyProNAC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-30 date: 2026-11-30 date: 2024-04-22 date: 2024-04-22 name: National University of Malaysia class: OTHER briefSummary: As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial.
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Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation.
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Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency . conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Syrup Prospan name: N-Acetylcysteine measure: To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact. measure: to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life. measure: to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry measure: to determine change of Forced Vital Capacity in litres/minute using spirometry measure: to determine adverse effects of Syrup Prospan (in %) measure: to determine adverse effects of N-Acetylcysteine (in %) measure: To assess satisfaction of treatment using the 5 point Likert Scale (1- Not Satisfied, 5 - Most Satisfied) sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National University of Malaysia city: Cheras state: Kuala Lumpur zip: 56000 country: Malaysia name: Mohamed Faisal Abdul Hamid, MBBS (IIUM) role: CONTACT phone: 0391455555 email: faisal.hamid@ppukm.ukm.edu.my lat: 3.05 lon: 101.76667 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-02-01 uploadDate: 2024-04-08T19:34 filename: Prot_SAP_ICF_000.pdf size: 1474657 hasResults: False
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<|newrecord|> nctId: NCT06377397 id: IIRPIG-2023-0000070 briefTitle: Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates acronym: SAUNA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2028-04-14 date: 2024-04-22 date: 2024-04-22 name: Indian Council of Medical Research class: OTHER_GOV name: Lady Hardinge Medical College name: King George's Medical University name: Indira Gandhi Institute of Child Health name: Institute of Obstetrics and Gynecology name: Government Medical College, Chandigarh name: Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak name: Government Medical College, Aurangabad name: King Edward Memorial Hospital, Mumbai briefSummary: Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis.
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The goal of this research study is to find out:
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1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life.
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2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life.
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3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes"). conditions: Sepsis conditions: PROM, Preterm (Pregnancy) conditions: Early-Onset Neonatal Sepsis conditions: Preterm Premature Rupture of Membrane conditions: Preterm Birth studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Neonates will be randomized to 1 of the following groups:
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1. Group 1: Intervention group (Selective antibiotic group)
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2. Group 2: Comparison group (Universal antibiotic group) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Project staff, nurses and resident doctors looking after the neonate will not be blinded. The assessment of the primary outcome will be performed by a blinded adjudicator, who is not involved in the recruitment and monitoring of subjects. A part of the case report form (CRF) containing relevant details of all episodes of sickness in the 1st week of life will be detached from the main form and will be sent to the blinded adjudicator. This part will be linked to the main form only by a unique identification number. No patient identifiers or allocation group will be mentioned on the part sent to the blinded adjudicator. whoMasked: OUTCOMES_ASSESSOR count: 1500 type: ESTIMATED name: Antibiotics measure: Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomization measure: Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization measure: All-cause Mortality within 1st 7 days after randomization measure: Blood culture-positive sepsis of any severity within 1st 7 days after randomization measure: Episode of severe sepsis within 1st 7 days after randomization measure: Composite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomization measure: Individual components of composite outcome within 1st 72 hours after randomization measure: Composite of mortality/blood culture positive sepsis/severe sepsis during hospital stay measure: Individual components of composite outcome during hospital stay measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay measure: Composite of mortality/blood culture positive sepsis/severe sepsis during 1st 30 days after randomization measure: Individual components of composite outcome during 1st 30 days measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria measure: Sepsis-related mortality within 1st 72 hours after randomization measure: Sepsis-related mortality within 7 day after randomization measure: Sepsis-related mortality during hospital stay after randomization measure: Sepsis-related mortality during 1st 30 days after randomization measure: Clinical sepsis within 1st 72 hours after randomization measure: Clinical sepsis within 7 days after randomization measure: Clinical sepsis during hospital stay measure: Clinical sepsis within 1st 30 days after randomization measure: Episode of Probable EONS within 72 hours after randomization measure: Episode of Probable EONS within 7 days after randomization measure: Episode of asymptomatic proven EONS within 72 hours after randomization measure: Need for sepsis workup during 1st 72 hours after randomization measure: Need for sepsis workup during 1st 7 days after randomization measure: Need for sepsis workup during 1st 30 days after randomization measure: Need for sepsis workup during hospital stay measure: Cumulative duration of antibiotic therapy during 1st 7 days after randomization measure: Cumulative duration of antibiotic therapy during 1st 72 hrs after randomization measure: Cumulative duration of antibiotic therapy during hospital stay measure: Duration of hospitalization measure: Episodes of healthcare associated infection during hospital stay. measure: Adverse effects until day 30 after randomization measure: Serious adverse effects until day 30 after randomization sex: ALL minimumAge: 0 Hours maximumAge: 4 Hours stdAges: CHILD facility: Post Graduate Institute of Medical Education and Research (PGIMER) city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-02 uploadDate: 2024-04-02T01:02 filename: Prot_SAP_000.pdf size: 213987 hasResults: False
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<|newrecord|> nctId: NCT06377384 id: DHP-33-FLIGHT briefTitle: FLIGHT Study for Childhood Chronic Illness overallStatus: RECRUITING date: 2022-04-20 date: 2025-09 date: 2025-09 date: 2024-04-22 date: 2024-04-23 name: Documenting Hope Project class: OTHER briefSummary: The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care for children with chronic illness. A mixed methods outcomes evaluation will be performed. The primary goal of this study is to evaluate the most feasible and promising strategies to inform a more streamlined and scalable intervention in the future. Up to 14 participants may be enrolled, but fewer are expected to achieve the primary goal of the study. conditions: Chronic Illnesses, Multiple studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: FLIGHT Intervention measure: Total Load Index (TLI) measure: Child Health Inventory for Resilience and Prevention (CHIRP) measure: Children's Sleep Habits Questionnaire (CSHQ) measure: Vineland Adaptive Behavior Scale measure: Sensory Profile 2 measure: Quick Environmental Exposure and Sensitivity Inventory (QEESI) measure: Hayward Environmental Illness Severity Scale measure: Parenting Stress Index, 4th edition (PSI-4) measure: Beck Anxiety Inventory (BAI) sex: ALL minimumAge: 2 Years maximumAge: 15 Years stdAges: CHILD facility: Epidemic Answers status: RECRUITING city: Windsor state: Connecticut zip: 06095 country: United States name: Study Coordinator role: CONTACT phone: 833-935-5543 email: info@epidemicanswers.org lat: 41.8526 lon: -72.6437 hasResults: False
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<|newrecord|> nctId: NCT06377371 id: 23-03025815 briefTitle: Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-22 date: 2024-04-22 name: Weill Medical College of Cornell University class: OTHER name: Curium US LLC briefSummary: The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device. conditions: Meningioma studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Brain Imaging with [Cu64]DOTATATE name: Radio-guided Surgery With Neoprobe Utilization measure: Preoperative [Cu64]DOTATATE PET SUV measure: 1st Post-operative [Cu64]DOTATATE PET SUV measure: 2nd Post-operative [Cu64]DOTATATE PET SUV measure: MRI Size Measurements measure: GTR vs STR Assessment measure: MRI Progression Assessment measure: Target Lesion Neoprobe Count measure: Subtotal Neoprobe Count measure: Reference Background Neoprobe Count measure: SSTR2 expression measure: WHO grade measure: Ki67 Proliferation Index measure: ER/PR expression sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New York-Presbyterian/Weill Cornell Medical Center city: New York state: New York zip: 10021 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06377358 id: CEEAH CA31 briefTitle: Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy. overallStatus: COMPLETED date: 2022-05-09 date: 2022-07-25 date: 2023-06-22 date: 2024-04-22 date: 2024-04-22 name: CAPENERGY MEDICAL, SL class: INDUSTRY name: University of Malaga name: Alfonso X El Sabio University briefSummary: The Scope of this study is to assess the visceral and subcutaneous fat loss in patients having Tecar (Radiofrequency) Therapy and its effects on other anthropometric variables, adipokines and inflammation.
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20 obese patients will be treated with Tecar Therapy (Radiofrequency). Each patient will have 4 active, automatic plates placed on the abdomen (200 cm2 per plate), two on the right side of the midline and two on the left side. Energy will be applied for 50 minutes, controlling the temperature. Subsequently, 15 minutes of Capacitive and Resistive manual electrodes will be applied to the abdomen, simultaneously, 20 minutes of Lymphatic Drainage placing one active plate in the foot and the other in the lumbo-dorsal area. Patients will be informed that they will only feel comfortable warmth. Five sessions will be applied from Monday to Friday resting Saturday and Sunday, for 2 weeks. Total 10 sessions.
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Subcutaneous and visceral fat will be measured by MRI. Anthropometric variables (Body Mass Index, Waist to Hip ratio and skinfold) will be also measured.
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Metabolic and inflammatory effects of the RF treatment will be evaluated measuring adipokines (Leptin, adiponectin and resistin) as well as citokines (IL-6, TNF-a and C reactive Protein).
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Results will be analyzed using the SPSS statistics package. A Kolmogorov-Smirnov test will be applied, if the data behaves normally, parametric tests will be applied. If not, non-parametric tests will be performed. The differences between proportions will be analyzed using Fischer's exact test. The differences between the medians will be assessed using the Student's t-test for paired samples and independent samples. conditions: Obesity, Visceral conditions: Obesity; Endocrine studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Tecar Theraty was applied to 20 obese patients in order to assess the effect on the body fat loss, serum adipocytokines and imflammation. It was an interventional study in one group of patients. No controls. No masking. primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Tecar Therapy measure: Visceral fat loss (cm3) measure: Visceral fat loss (g) measure: Subcutaneous fat loss (cm3) measure: Subcutaneous fat loss (g) measure: Tumor Necrosis Factor alfa measure: Interleukin 6 levels measure: C reactive Protein levels measure: Leptin levels measure: Adiponectin levels measure: Resistin levels measure: Total cholesterol changes measure: Total triglycerides changes measure: LDL Cholesterol changes measure: HDL Cholesterol changes measure: Glucose measure: Body Mass Index loss measure: Waist to Hip Index loss measure: Skinfold Thickness (cm) sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inneo Terapia Despi city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-02-01 uploadDate: 2024-03-21T05:39 filename: Prot_SAP_000.pdf size: 597014 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-02-01 uploadDate: 2024-04-11T07:17 filename: ICF_001.pdf size: 543945 hasResults: False
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<|newrecord|> nctId: NCT06377345 id: 202312-00011 briefTitle: Remote Patient Monitoring Solution for Chronic Respiratory Disease Management overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-12-31 date: 2025-03-30 date: 2024-04-22 date: 2024-04-22 name: SingHealth Polyclinics class: OTHER briefSummary: Aim: To evaluate the use of AeviceMD Monitoring System (AeviceMD) asthma in reducing acute exacerbation.
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Methodology: Using a randomized controlled trial design, this project aims evaluate the effectiveness of AeviceMD in improving patients' outcomes in terms of reducing exacerbation, healthcare utilization, improving quality of life, self-efficacy, and cost effectiveness. Paediatric patients above age 7 and adults will be recruited. The data follow-up period is 3 months. It will also evaluate the usability of the device from both patients' and clinicians' perspective. 180 patients (124 adults, 56 pediatrics) and 120 clinicians will be recruited.
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Importance of study: This study will evaluate if the AeviceMD can help improve disease management and reduce recurrence of asthma exacerbation.
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Potential benefits and risk: AeviceMD allows for remote monitoring and tracking of patients' lung sounds, which could be used by patients to monitor their lung condition and prevent an episode of exacerbation or worsening exacerbations culminating in an admission which who further utilize already limited healthcare resources. An exacerbation is an episode of severe shortness of breath, cough, and chest tightening which warrants a visit to a healthcare institution. Through self-monitoring, patients can be empowered to self-manage their asthma, with aid of the asthma action plan which is given to all patients with asthma. AeviceMD can also help provide clinicians with patients' objective lung data. In the primary care setting, care is also fragmented as patients are often followed-up by a different doctor or healthcare providers. Clinicians have no objective data to track patients, and is dependent on patients' self-report and possible recall bias. There is no expected risk with the use of the device. conditions: Asthma conditions: Asthma Attack conditions: Asthma in Children conditions: Asthma Acute conditions: Asthma Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-group randomized controlled trial (RCT) design will be used. The control group will receive the usual care, and the intervention group will receive the Aevice device on top of usual care. Outcomes will be measured at baseline, week 4, and week 12. This is to evaluate the long-term impacts of the Aevice device. Clinicians who have interacted with participants using Aevice will also be invited to participate in an interview and clinician perception survey. A convenience sampling will be used for the recruitment of clinicians. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcomes assessor will not be aware of the participants' group whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: AeviceMD device name: Standard care measure: Rescue therapy measure: Dose of oral Prednisolone use measure: Visit to hospital emergency department measure: Hospitalisation measure: Euro Quality of Life 5 dimensions (EQ5D) measure: Asthma quality of life questionnaire (AQLQ) measure: Pediatric asthma quality of life questionnaire (PAQLQ) measure: Self-efficacy measure: Usability measure: Heart rate measure: Respiratory rate measure: Wheeze detection trend measure: Medication log measure: Duration of device usage measure: Payment sex: ALL minimumAge: 7 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06377332 id: X23-0330 briefTitle: Biomarkers of Dementia in Chronic Sleep and Breathing Disorders acronym: ORACLE overallStatus: RECRUITING date: 2023-12-01 date: 2025-07-01 date: 2025-07-01 date: 2024-04-22 date: 2024-04-22 name: Woolcock Institute of Medical Research class: OTHER briefSummary: Chronic obstructive pulmonary disease (COPD), obstructive sleep apnoea (OSA) and overlap syndrome are associated with obstructions in breathing and disturbed sleep.
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Chronic breathing disruptions and poor sleep may lead to cognitive impairment and brain changes linked with early neurodegenerative processes. As such, identifying early markers of cognitive impairment and dementia risk in individuals with chronic respiratory and sleep breathing disorders is crucial for understanding how these diseases may contribute to accelerated brain ageing. This study will comprehensively measure sleep, lung function, cognitive performance and blood-based markers of dementia risk and inflammation. The investigators will use innovative technologies to identify biomarkers of cognitive impairment and dementia risk in people with chronic sleep and breathing disorders. The investigators will also investigate the relationships between disrupted sleep and abnormal breathing and the brain. This research may also inform future early interventions to improve cognition and brain health in chronic sleep and respiratory disease. conditions: COPD conditions: Overlap Syndrome conditions: OSA studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 104 type: ESTIMATED name: High density electroencephalogram (HdEEG) name: Functional near infrared spectroscopy (fNIRS) name: Magnetic resonance imaging (MRI) name: Blood collection name: Neuropsychological battery name: Questionnaires name: Pulmonary Function Test (PFT) name: Cognitive Assessment name: Polysomnogram (PSG) measure: Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk. measure: Blood levels of amyloid beta (Aβ40/Aβ42 ratio). measure: Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep. measure: Brain tissue oxygenation during cognitive tasks and sleep. measure: Hypoxemia as measured by pulse oximetry. measure: Sleep Fragmentation measure: Assessment of premorbid functioning and preinjury through the Test of Premorbid Functioning (TOPF). measure: Assessment of verbal learning and memory through the Rey Auditory Verbal Learning Test (RAVLT). measure: Assessment of mild forms of cognitive dysfunction through Delis Kaplan Executive Functioning System (D-CEFS) neuropsychological assessment. measure: Assessment of speed of processing and executive functioning through the Trail Making Test (TMT). measure: Assessment of verbal fluency through the Controlled Oral Word Association Test (COWAT). measure: Assessment of attention, perceptual speed, motor speed and visual scanning through the Symbol Digits Modalities Test (SDMT). measure: Blood levels of fibrinogen. measure: Blood levels of clusterin. measure: Blood levels of 8-isoprostane measure: Blood levels of C-reactive protein (CRP) measure: Blood levels of erythrocyte sedimentation rate (ESR). measure: Blood levels of plasma tau. measure: Blood levels of neurofilament light chain (NFL). measure: Blood levels of Glial fibrillary acidic protein (GFAP). measure: Blood levels of Apolipoprotein E gene (APOE-4). measure: Blood levels of interleukin-8 (IL-8). measure: Blood levels of interleukin-6 (IL-6). measure: Blood levels of tumor necrosis factor alpha (TNFα). measure: Blood levels of amyloid beta (Aβ40/Aβ42 ratio). measure: Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk. measure: Brain structure: cortical thickness and volumetric brain maps measure: Brain structure: diffusion-weighted imaging measure: Brain function: resting-state BOLD fMRI measure: Brain pathology: T1-weighted, T2-weighted, diffusion-weighted imaging, and FLAIR measure: Assessment of sensorimotor function and comprehension through the Motor Screening Task (MOT) of CANTAB. measure: Assessment of processing and psychomotor speed through the Reaction Time (RTI) test of CANTAB. measure: Assessment of working memory and strategy through the Spatial Working Memory (SWM) test of CANTAB. measure: Assessment of visual episodic memory through the Paired Associate Learning (PAL) test of CANTAB. measure: Sleep Spindles During Non-Rapid Eye Movement (NREM) Sleep measure: Traditional sleep staging. measure: Absolute Electroencephalography (EEG) Power During Rapid Eye Movement (REM) Sleep. measure: Obstructive sleep apnoea (OSA) severity metrics measure: Lung function as measured by clinical pulmonary function tests (PFT) sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Woolcock Institute of Medical Research status: RECRUITING city: Sydney state: New South Wales zip: 2113 country: Australia name: Angela D'Rozario, PhD role: CONTACT phone: 02 9850 3246 email: angela.drozario@mq.edu.au name: Laura Harris, MScMed role: CONTACT phone: 02 9805 3194 email: laura.harris@woolcock.org.au lat: -33.86785 lon: 151.20732 hasResults: False
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<|newrecord|> nctId: NCT06377319 id: 101080905 briefTitle: Decision Support System for Diagnosis and Progression of Heart Failure acronym: STRATIFYHF overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-31 date: 2027-07-31 date: 2024-04-22 date: 2024-04-23 name: Coventry University class: OTHER name: Newcastle University name: University of Cambridge name: University of Novi Sad name: University of Florence name: University of Regensburg name: Utrecht University name: Servicio Madrileño de Salud, Madrid, Spain briefSummary: Heart failure (HF) is a complex clinical syndrome associated with impaired heart function, poor quality of life for patients and high healthcare costs. Accurate risk stratification and early diagnosis in HF are challenging as signs and symptoms are non-specific. Here the investigators propose to address this global challenge by developing novel analytic methods for HF (STRATIFYHF). A prospective clinical study will collect patient-specific data related to medical history, a physical examination for signs and symptoms, blood tests including natriuretic peptides, an electrocardiogram (ECG), an echocardiogram (ultrasound of the heart), cardiovascular magnetic resonance imaging (MRI), demographic, socio-economic and lifestyle data along with novel technologies (cardiac output response to stress (CORS) test and voice recognition biomarkers) from individuals at-risk of developing HF and those with a confirmed diagnosis of HF. STRATIFYHF will use these data to support clinical validation of an artificial intelligence (AI)-driven decision support system (DSS) and mobile application for risk prediction, diagnosis, and progression of HF to enhance patients' quality of life and lead to more cost-effective health care. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1600 type: ESTIMATED name: Cardiac Output Response to Stress (CORS) test measure: Diagnostic accuracy of the DSS measure: Demographic and clinical predictors of risk, diagnosis, and progression of heart failure. sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06377306 id: MC study briefTitle: Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes overallStatus: RECRUITING date: 2023-11-05 date: 2026-01-30 date: 2027-01-30 date: 2024-04-22 date: 2024-04-22 name: Wingate Institute class: OTHER name: Weizmann Institute of Science name: Kaplan Medical Center name: Ministry of Innovation, Science and Technology of Israel briefSummary: Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential "noise" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking.
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The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes.
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200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC.
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Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment. conditions: Menstrual Cycle conditions: Athletes conditions: Physical Activity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Effect of training loads and sport performance level on health and sport performance measure: Stool Microbiome measure: Serum metabolomics measure: VO2max measure: Countermovement jump measure: Flexibility measure: Grip Strength measure: Lower leg Strength measure: Blood tests measure: Knee valgus measure: Anthropometric (Height) measure: Psychological questionnaire (Positive-Affect Negative-Affect scale - PANAS) measure: Anthropometric (Weight) measure: Percentage body fat (%) measure: Psychological questionnaire (The Sport Emotion Questionnaire (SEQ) sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Wingate Institute status: RECRUITING city: Netanya country: Israel name: Yotam Shribman, B.Sc role: CONTACT phone: +972-54-5723401 email: research@wingate.org.il lat: 32.33291 lon: 34.85992 hasResults: False
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<|newrecord|> nctId: NCT06377293 id: FEMH-IRB-TSAI2024 briefTitle: Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2025-12 date: 2029-06 date: 2024-04-22 date: 2024-04-23 name: Far Eastern Memorial Hospital class: OTHER briefSummary: In patients with kidney failure, disturbances in bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial metabolites are frequent. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, inflammation, protein-energy wasting and dysbiosis. The investigators hypothesize that therapeutic diet intervention reverses these uremic complications and thereby reduces cardiovascular risk in patients with kidney failure. In this study, the investigators crafted 4-week dialysis-specific therapeutic diet to illustrate the clinical implications of therapeutic diet for dialysis patients. conditions: End-Stage Kidney Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A randomized, active-controlled trial with cross-over design primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Laboratory technicians who assess the study outcomes will be masked whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Dialysis-specific therapeutic diet measure: Concentrations of intact fibroblast growth factor 23 (pg/mL) measure: Concentrations of C-terminal fibroblast growth factor 23 (RU/mL) measure: Concentrations of phosphate (mg/dL) measure: Concentrations of calcium (mg/dL) measure: Concentrations of intact parathyroid hormone (pg/mL) measure: Concentrations of bone-specific alkaline phosphatase (μg/L) measure: Concentrations of procollagen-type 1 N-terminal-propeptide (P1NP) (ng/mL) measure: Concentrations of tartrate resistance acid phosphatase-5b (TRACP-5b) (mIU/ml) measure: Concentrations of alkaline phosphatase (ALP) (IU/L) measure: Concentrations of free indoxyl sulfate (mg/L) measure: Concentrations of free p-cresol sulfate (mg/L) measure: Concentrations of pre-albumin (g/dL) measure: Concentrations of albumin (g/dL) measure: Concentrations of C-reactive protein (mg/dL) measure: Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells measure: Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells measure: Absolute number (per μl blood) of monocytes measure: Concentrations of fetuin-A (μg/ml) measure: Concentrations of trimethylamine-N-oxide (TMAO) (μM) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06377280 id: NAV-0011 briefTitle: En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device. overallStatus: RECRUITING date: 2024-01-18 date: 2024-10 date: 2024-12 date: 2024-04-22 date: 2024-04-22 name: Wellspect HealthCare class: INDUSTRY briefSummary: This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks.
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Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact. conditions: Bowel Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Navina Mini measure: Patient satisfaction measure: Assessment of clinical benefit measure: Ease of handling measure: Safety Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skåne University Hospital status: RECRUITING city: Malmö country: Sweden name: Louis Banka Johnson, MD role: CONTACT phone: +4640336557 email: louis_banka.johnson@med.lu.se name: Sara Strandberg role: CONTACT phone: +4640336377 email: sara.strandberg@skane.se lat: 55.60587 lon: 13.00073 hasResults: False
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<|newrecord|> nctId: NCT06377267 id: ESR-20-21103 briefTitle: Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial) acronym: STROBE overallStatus: RECRUITING date: 2024-02-06 date: 2024-04 date: 2025-09 date: 2024-04-22 date: 2024-04-22 name: Vall d'Hebron Institute of Oncology class: OTHER briefSummary: Background:
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The study aims to address the challenge of accurately identifying patients with ovarian cancer who would benefit from poly-ADP ribose inhibitors (PARPi) as first-line maintenance therapy. While BRCA1/2-mutated epithelial ovarian cancer (EOC) patients have shown significant benefits from PARPi treatment, the efficacy in homologous recombination deficient (HRD) patients remains inconclusive. Current assays used to estimate HR status do not effectively differentiate between patients who benefit most from PARPi and those who do not, making it inefficient to treat all patients. There is a need for a more accurate HR status testing method to optimize PARPi benefit. This study aims to assess the performance of the VHIO-CARD-300 test in determining HR status compared to SOPHiA DDM™ Dx HRD Solution.
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Summary:
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The study is a prospective, non-randomized trial designed to evaluate the concordance of the VHIO-CARD-300 test in establishing HR status compared to SOPHiA DDM™ Dx HRD Solution. Additionally, it aims to assess the association between HRD status determined by the VHIO-CARD-300 test and treatment efficacy. Patients with advanced FIGO stage III-IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer will be invited to participate. Those eligible will undergo testing with both VHIO-CARD-300 and SOPHiA DDM™ Dx HRD Solution. Patients classified as HRD positive will receive olaparib in combination with bevacizumab, while others will receive bevacizumab alone. Treatment will be administered according to approved doses, with follow-up evaluations conducted until RECIST progression. conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Bevacizumab name: Olaparib measure: Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution measure: Performance Assessment of VHIO-CARD-300 Test for HR Status Identification measure: Association Between VHIO-CARD-300 Test Groups and Efficacy Outcomes(i.e., HRD positive and HRD negative) and efficacy outcomes. measure: Analysis of Progression-Free Survival (PFS) and Overall Survival (OS) in Discrepant HRD Cases measure: Safety and Tolerability of Olaparib Plus Bevacizumab measure: To evaluate the failure rate for the VHIOCARD-300 test and SOPHiA DD Dx HRD Solution. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vall d'Hebron Institute of Oncology status: RECRUITING city: Barcelona country: Spain name: Ana Oaknin role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06377254 id: BB/X015173/1 briefTitle: Multi-organ Responses to CHronic Physical Activity and INactivity acronym: CHAIN overallStatus: RECRUITING date: 2024-03-12 date: 2027-12-17 date: 2028-10-31 date: 2024-04-22 date: 2024-04-22 name: University of Nottingham class: OTHER name: Biotechnology and Biological Sciences Research Council briefSummary: Life expectancy has been increasing for the last 150 years, but the maintenance of health has not kept pace with increased lifespan, and on average, UK adults spend the last decade of life in poor-health, with major consequences for society and the individual.
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Persistent physical inactivity is thought to be a key contributing factor to the risk of poor health and functional decline occurring in middle-aged and older adults. It is therefore concerning that most middle-aged adults spend \>8hrs/day being sedentary, with average step count of 3000-4000 steps/day.
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To be able to holistically assess the effectiveness of future strategies to address age-related decline in health, and devise public health messages to help individuals reach older age in better health, it is essential that the complex physiological effects that activity and inactivity have across biological systems are characterised.
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The goal of this intervention study is to compare the impact of physical activity and inactivity on body functioning. Twenty moderately active participants will decrease their physical activity for six months to match the average amount carried out by middle-aged people in the UK. They will then undertake 3-months of reconditioning training to restore their fitness. In addition, twenty sedentary participants will increase their physical activity to UK recommended levels for six months.
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Before and at points during the intervention period, participants will be asked to make some measurements at home and attend the University of Nottingham to have multiple assessments made. These include;
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* fitness, muscle strength and function tests,
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* completion of questionnaires and computer-based brain puzzles
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* having muscle and fat tissue biopsies and blood samples taken.
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* The study also involves having MRI scans.
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This 5-year study will commence in January 2024, with participant recruitment starting in March 2024 and finishing in May 2027. conditions: Sedentary Behavior conditions: Metabolic Syndrome conditions: Age-related Cognitive Decline conditions: Age-Related Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Non-randomised, parallel design lifestyle intervention primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Those undertaking analysis of biological samples and MRI data will be masked as to the group the participant is allocated to. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Decreased Physical Activity name: Increased Physical activity measure: Change in Cardiorespiratory fitness (VO2 max) measure: Change in Isometric leg strength measure: Change in time to leg fatigue measure: Change in incremental area under the curve (iAUC) for blood glucose concentration measure: Change in iAUC for serum insulin concentration measure: Change in fasting glucose oxidation rate measure: Change in 'fed' glucose oxidation rate measure: Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score measure: Change in Short Form Health Survey (SF36) Questionnaire aggregated and normalised 'mental' score measure: Change in World Health Organisation Quality of Life (WHOQoL) score measure: Change in Pittsburgh Sleep Quality Index (PSQI) measure: Change in Stroop test; % Accuracy measure: Change in Stroop test; reaction time measure: Change in four-choice reaction time test; % Accuracy measure: Change in four-choice reaction time test; reaction time measure: Change in card sort test; % Accuracy measure: Change in card sort test; reaction time measure: Change in Logical reasoning test; % accuracy measure: Change in Logical reasoning test; reaction time measure: Change in serial subtractions test; number of responses in 2 minutes measure: Change in Corsi blocks test; score measure: Change in Muscle protein synthesis rate measure: Change in Muscle protein breakdown rate measure: Change in whole body fat volumes measure: Change in liver fat volumes measure: Change in thigh muscle fat volumes measure: Change in whole body muscle volumes measure: Change in muscle phosphocreatine synthesis rate measure: Change in cerebral volume measure: Change in cortical thickness measure: Change in plasma metabolome measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration sex: ALL minimumAge: 55 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: David Greenfield Human Physiology Unit status: RECRUITING city: Nottingham state: Notts zip: NG72UH country: United Kingdom name: Sara Brown role: CONTACT phone: +44(0)115 8230434 email: sara.brown@nottingham.ac.uk name: Joanne Mallinson, PhD role: CONTACT phone: +44(0)1158230434 email: joanne.mallinson@nottingham.ac.uk name: Paul Greenhaff, PhD role: PRINCIPAL_INVESTIGATOR name: Liz Simpson, PhD role: SUB_INVESTIGATOR name: Joanne Mallinson, PhD role: SUB_INVESTIGATOR name: Abhishek Sheth, MD role: SUB_INVESTIGATOR name: Penny Gowland, PhD role: SUB_INVESTIGATOR name: Sue Francis, PhD role: SUB_INVESTIGATOR name: Rosemary Nicholls, PhD role: SUB_INVESTIGATOR name: Aline Nixon role: SUB_INVESTIGATOR name: Sara Brown role: SUB_INVESTIGATOR name: Donald Peden, PhD role: SUB_INVESTIGATOR lat: 52.9536 lon: -1.15047 hasResults: False
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<|newrecord|> nctId: NCT06377241 id: 2023-1436 id: A536000 type: OTHER domain: UW Madison id: SMPH/OPHTHAL&VIS SCI/GEN type: OTHER domain: UW Madison id: Protocol Version 2/23/2024 type: OTHER domain: UW Madison briefTitle: ScentAware and OCT in MCI vs HC overallStatus: RECRUITING date: 2024-04-15 date: 2024-06 date: 2024-06 date: 2024-04-22 date: 2024-04-22 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this clinical trial is to learn whether a new smell test works as well as the standard clinical smell test, if there is a link between sense of smell and variations in the retina, and if these results could be used as a way to identify early stages of Alzheimer's disease. The main questions it aims to answer are:
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* Whether the test is as effective and reliable as the standard test
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* Whether there is a link between the results of the smell test and the structure of the back of the eye
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Participants will:
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* complete a short questionnaire
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* have pictures of the inside of their eyes taken
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* perform two smell tests conditions: Alzheimer Disease, Early Onset studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: ScentAware name: UPSIT measure: Compare test scores of ScentAware olfactory test to the scores of the University of Pennsylvania Smell Identification Test (UPSIT) olfactory test in a clinical setting measure: Compare ScentAware test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently measure: Compare UPSIT test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently measure: Compare baseline ScentAware test scores between cohorts measure: Compare baseline UPSIT test scores between cohorts measure: Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness measure: Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness measure: Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness measure: Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin status: RECRUITING city: Madison state: Wisconsin zip: 53705 country: United States name: Amy Remm role: CONTACT phone: 608-262-3377 email: amy.remm@wisc.edu lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06377228 id: TAK-007-1001 briefTitle: A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2029-04-23 date: 2029-04-23 date: 2024-04-22 date: 2024-04-22 name: Takeda class: INDUSTRY briefSummary: The main aim of the study is to learn how well adults with refractory lupus nephritis (LN) tolerate TAK-007 and to check for side effects (adverse events).
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Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007. conditions: Refractory Lupus Nephritis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: TAK-007 name: Chemotherapy Agents measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) measure: Number of Participants With Dose Limiting Toxicities (DLTs) measure: Cmax: Maximum Observed Plasma Concentration for TAK-007 measure: Tmax: Time to Reach the Cmax for TAK-007 measure: Tlast: Time of Last Measurable Concentration Above the Lower Limit of Quantitation for TAK-007 measure: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-007 measure: Change From Baseline in CD19+ B Cell Counts measure: Duration of B Cell Depletion measure: Change From Baseline in Plasma Cytokine Levels measure: Change From Baseline in Physician's Global Assessment (PGA) Score measure: Percentage of Participants Achieving a Reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Relative to Baseline measure: Percentage of Participants Achieving Complete Renal Response (CRR) measure: Time to CRR measure: Duration of CRR measure: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) measure: Time to LLDAS measure: Duration of LLDAS measure: Percentage of Participants Meeting the Definition of Remission in SLE (DORIS) Criteria measure: Time to DORIS Remission measure: Duration of DORIS Remission measure: Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Levels measure: Change From Baseline in Antinuclear Antibody (ANA) Levels measure: Change From Baseline in Proteinuria Levels measure: Change From Baseline in Creatinine Levels measure: Change From Baseline in eGFR measure: Change From Baseline in Complement (C3, C4) Levels measure: Percentage of Participants With Antidrug Antibodies Categorized as Anti-Human Leukocyte Antigen (HLA) and Anti- Chimeric Antigen Receptor (CAR) measure: Percentage of Participants With Replication Competent Retrovirus (RCR) in Blood sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Site Contact role: CONTACT phone: 888-229-3065 email: madisonj@med.umich.edu name: Jacqueline Madison role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: University of Rochester city: Rochester state: New York zip: 14642 country: United States name: Site Contact role: CONTACT phone: 585-486-0901 email: christopher_palma@urmc.rochester.edu name: Christopher Palma role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: UT Health Houston city: Houston state: Texas zip: 77030 country: United States name: Site Contact role: CONTACT phone: 713-486-3100 email: Meera.g.subash@uth.tmc.edu name: Meera Subash role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06377215 id: Pro00041729 id: R01DC020514 type: NIH link: https://reporter.nih.gov/quickSearch/R01DC020514 briefTitle: Understanding Aided Speech Perception in Noise overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-03-01 date: 2028-03-01 date: 2024-04-22 date: 2024-04-22 name: University of South Florida class: OTHER name: National Institute on Deafness and Other Communication Disorders (NIDCD) briefSummary: The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention. conditions: Hearing Impairment, Sensorineural conditions: Spatial Perception conditions: Aging conditions: Hearing Aids studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 121 type: ESTIMATED name: Open-source master hearing aid measure: Digit Identification measure: Neural Segregation measure: Minimum Audible Angle (MAA) measure: Speech Localization Error measure: Fixed Spatial Release from Masking measure: Pure-tone Air Threshold (PTac) measure: Bone Conduction Threshold (PTbc) measure: Wideband Tympanometry (Equivalent Ear Canal Volume) measure: Wideband Tympanometry (Static Peak Pressure) measure: Wideband Tympanometry (Resonant Frequency) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USF Research Park BPB, 3802 Spectrum Boulevard, Suite 210C city: Tampa state: Florida zip: 33612 country: United States name: Erol Ozmeral, Ph.D. role: CONTACT phone: 813-974-9778 email: eozmeral@usf.edu name: Carrie Secor, Au.D. role: CONTACT phone: 813-974-4148 email: csecor@usf.edu name: Erol Ozmeral, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False
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<|newrecord|> nctId: NCT06377202 id: SynKIR-110 LTFU briefTitle: Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies overallStatus: RECRUITING date: 2023-11-15 date: 2038-12-15 date: 2038-12-15 date: 2024-04-22 date: 2024-04-24 name: Verismo Therapeutics class: INDUSTRY briefSummary: The primary objective of this study is to evaluate the long-term safety of SynKIR- 110 administered to adult subjects with solid tumors expressing mesothelin. conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Number of subjects with treatment related adverse events as assessed by CTCAE v5.0 measure: Number of subjects with persistence of SynKIR-110 modified cells measure: Number of subjects with potential/suspected RCL sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Katie Elkins role: CONTACT phone: 215-615-6740 email: katie.elkins@pennmedicine.upenn.edu name: Janos Tanyi, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06377189 id: 2023-01910 briefTitle: Psychiatric Consultation-Liaison Intervention in Primary Care: A Pilot Study acronym: PLIMeC-P overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-22 date: 2024-04-22 name: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland class: OTHER name: Neuchâtel Psychiatry Centre (CNP) name: University of Lausanne Hospitals briefSummary: The pilot study on the impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French-speaking Switzerland (PLIMeC-P), is a mixed method randomized controlled trial. The investigated health-related intervention is a brief Consultation-Liaison (CL) psychiatry intervention in primary care.
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Primary Care Physicians (PCPs) have a key role in preventing, detecting, and managing mental disorders. Therefore, the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges. It is well demonstrated that multidisciplinary interventions improve the efficacy of mental health care, CL psychiatry being one such type of intervention. Therefore, community CL-psychiatry, for example in private primary care group practices, are rare. The impact of such community, primary care CL-psychiatry interventions, should be investigated.
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The mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings, for newly reported mental illness, versus a Treatment As Usual (TAU) control arm. The intervention consists of a CL-psychiatric intervention into private medical practices, provided to patients suffering from mental health problems, a group of patients generally under-treated. The CL-psychiatrist will receive and discuss PCPs' referrals for patients with mental distress, who don't have a psychiatric follow-up. After a brief intervention (1-4 sessions), feedback conjoint (PCP-psychiatrist) session will be organized, to complete the intervention and provide proposals.
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The pilot study (PLIMeC-P) will determine whether the main planned study (PLIMeC) is feasible and practicable. It will be conducted on two sites, the Neuchâtel Psychiatry Centre (CNP) and the North-west Adult Psychiatry Service (SPANO), Department of Psychiatry of CHUV, Yverdon. For the pilot study (PLIMeC-P), 15 eligible participants are expected for each group, 30 participants in total. They will be recruited in three private primary care group practices. After eligibility and randomization 15 participants will be included for the intervention arm (brief CL-psychiatric intervention) and 15 for the control arm (TAU). The expected number of participants for the main trial (PLIMeC) will be estimated through analysis of the initial results of the PLIMeC-P. conditions: Mental Health Issue conditions: Depression/Anxiety conditions: Quality of Life conditions: Psychosomatic Disorders conditions: Patients Lived Experiences conditions: Doctor-Patient Relation conditions: Collaboration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In order to answer the research question of the PLIMeC-P (pilot study), aiming to determine the feasibility and practicability of the main PLIMeC study, in the initial phase, the statistical procedures will be limited to questions of practicability and quality.
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For the main PLIMeC study we will use a mixed method approach, combining various data collection and analysis methods (qualitative and quantitative). Quantitative methods will be used to obtain a breadth of understanding of the phenomenon of interest, and qualitative methods will be used to explore and obtain depth of this understanding. More specifically, the combination of methods will be used for complementarity, using qualitative data to examine how the participants, patients and healthcare providers, experience this specific CL-psychiatric intervention and quantitative methods to examine the impact of such an intervention on patients. In data analysis, the priority among the two methods will be equal. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: Intervention arm - Consultation-Liaison (CL) brief psychiatric intervention in primary care settings name: Control Arm - Treatment As Usual (TAU) measure: Evaluate the feasibility of the main PLIMeC study measure: Mental health - psychiatric symptoms measure: Mental health - Quality of life measure: Mental health - Self-report questionnaire measure: The lived experience of the participants measure: The lived experience of the implicated clinicians measure: Healthcare system complexity - Quantitative assessment measure: Healthcare system complexity - qualitative assessment measure: Access to mental healthcare sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Primary Care and Public Health (Unisanté) - Sponsorship / Not recruiting site city: Lausanne state: Vaud zip: 1010 country: Switzerland lat: 46.516 lon: 6.63282 facility: Service de psychiatrie de l'adulte nord ouest (SPANO) Département de psychiatrie - CHUV (DP-CHUV) city: Yverdon-les-Bains state: Vaud zip: 1400 country: Switzerland name: Julien Elowe, MD role: CONTACT phone: 0041 21 314 54 38 email: Julien.Elowe@chuv.ch name: Julien Elowe, MD role: PRINCIPAL_INVESTIGATOR name: Gerrit Weber, MD role: SUB_INVESTIGATOR lat: 46.77852 lon: 6.64115 facility: Centre Neuchâtelois de Psychiatrie (CNP) city: Neuchâtel zip: 2000 country: Switzerland name: Stéphane Saillant, PD role: CONTACT phone: 0041 32 755 15 15 email: stephane.saillant@cnp.ch name: Stéphane Saillant, PD role: PRINCIPAL_INVESTIGATOR name: Julie Gavin-Ramain, PhD role: SUB_INVESTIGATOR lat: 46.99179 lon: 6.931 hasResults: False
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<|newrecord|> nctId: NCT06377176 id: NTUNHSEN briefTitle: Postpartum Massage Therapy for Women and Infants: The Effect on Maternal Depression, Stress, Fatigue and Infant Temperament overallStatus: COMPLETED date: 2021-06-16 date: 2021-10-03 date: 2021-10-03 date: 2024-04-22 date: 2024-04-22 name: National Taipei University of Nursing and Health Sciences class: OTHER briefSummary: Mother and infant massage, a type of complementary therapy, possesses the capacity to ameliorate maternal depression, stress, fatigue, and also infant temperaments and convert them into more manageable ones. The objective of this study was to determine the effect of mother and infant massage therapy on maternal depression, stress, fatigue, and infant temperament. In this quasi-experimental study, a total of 102 participants were allocated into two groups based on a pretest and posttest. During a period of five weeks, the experimental groups were subjected to ten massages per week, twice every week. On the data, a generalized estimating equation (GEE) was implemented. This study's hypothesis was an improvement in maternal depression, stress, fatigue, and infant temperament. conditions: Postpartum Depression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasi-experimental design was utilized in this investigation; it comprised a pre-test and a post-test administered to two distinct groups. The intervention group was subjected to pre-testing before receiving the intervention, and after the intervention, mother and infant massage treatment was delivered to the intervention group. Post-testing was performed on both groups, with the control group receiving mother and infant massage. primaryPurpose: TREATMENT masking: NONE count: 102 type: ACTUAL name: Massage therapy measure: Depression measure: Stress measure: Fatigue measure: Infant temperament sex: ALL minimumAge: 1 Month maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Community Health Center city: Sleman state: Yogyakarta zip: 55584 country: Indonesia lat: -7.71556 lon: 110.35556 hasResults: False
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<|newrecord|> nctId: NCT06377163 id: acquired pneumonia in children briefTitle: Bacterial Pathogens Associated With Community-acquired Pneumonia in Children overallStatus: COMPLETED date: 2021-01-01 date: 2021-08-31 date: 2021-08-31 date: 2024-04-22 date: 2024-04-22 name: Delta University for Science and Technology class: OTHER briefSummary: Pediatric community acquired pneumonia (CAP) is one of the most common reasons for hospital admission, there is no reliable way of distinguishing the causative organism based on clinical features.
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This study examined common pathogens of community-acquired pneumonia from 28 days up to 10 years in Dakahlia Governorate. conditions: Children Pneumonia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ACTUAL measure: Complete blood count measure: C-reactive protein (CRP) measure: Blood culture and sensitivity on admission measure: Gastric lavage culture or sputum culture on admission sex: ALL minimumAge: 28 Days maximumAge: 10 Years stdAges: CHILD facility: Amira Hussin Mohammed city: Gamasa zip: 35712 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False
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<|newrecord|> nctId: NCT06377150 id: ABCA4-1382022BO2 briefTitle: Stargardt Disease in Childhood overallStatus: COMPLETED date: 2022-04-01 date: 2024-03-31 date: 2024-03-31 date: 2024-04-22 date: 2024-04-22 name: University Hospital Tuebingen class: OTHER briefSummary: Retrospective chart review study to elucidate the phenotype and genotype of children with ABCA4-associated Stargardt disease. conditions: Stargardt Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 39 type: ACTUAL measure: Best Corrected Visual Acuity (BCVA) measure: Visual Field (VF) measure: Fundus Photography (FP) measure: Fundus Autofluorescence (AF) measure: Optical Coherence Tomography (OCT) measure: Full-Field Electroretinography (ff-ERG) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen city: Tuebingen state: Baden-Wuerttemberg, Germany zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 hasResults: False
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<|newrecord|> nctId: NCT06377137 id: University of the Porto briefTitle: High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction overallStatus: COMPLETED date: 2023-03-10 date: 2023-04-10 date: 2023-09-01 date: 2024-04-22 date: 2024-04-22 name: Universidade do Porto class: OTHER briefSummary: Pediatric obesity is considered one of the most important public health problems worldwide due to its high prevalence and associated comorbidities. Physical exercise has been shown to have an important role in the treatment of obesity and associated cardiometabolic dysfunction. Small-sided soccer games (SSSG) have been explored as a promising way of increasing physical exercise due to its benefits on cardiometabolic health and high degree of enjoyment, which favors long-term adherence.
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The objective of this research is to determine the effects of a 16-week high-intensity SSSG-based exercise intervention on cardiometabolic risk factors, physical fitness, adherence to 24-hour movement patterns, enjoyment and adherence to the intervention in adolescents with metabolic dysfunction and compare them to the effects of a traditional soccer intervention.
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The investigators hypothesize that high-intensity SSSG are more effective in improving the obesity-related cardiometabolic risk profile in adolescents with cardiometabolic dysfunction compared to traditional soccer training.
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A parallel 3-arm randomized controlled trial will be conducted in adolescents with overweight and metabolic dysfunction between 11 and 15 years of age. The inclusion criteria are: (i) age between 11-15 years at the time of intervention start; (ii) overweight or obesity (BMI\> 85th percentile); (iii) Abdominal obesity ≥90th percentile as assessed by waist circumference or a waist-to-height ratio ≥ 0.5; (iv) willing to participate in the study regardless of possible group allocation; (v) informed consent given by participant and legal representatives. Exclusion criteria: (i) health condition not compatible with participation in physical exercise; (ii) history of recent musculoskeletal injury hindering exercise participation; (iii) concurrent participation in a structured weight loss or exercise program.
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Those eligible to participate in the study will be randomly assigned to one of three groups: i) SSSG group, ii) traditional soccer play group (TSG), or, iii) non-exercise intervention control group (CG). Participants in both exercise intervention groups will undergo a 16-week intervention. The SSSG group will participate in a high-intensity small-sided soccer games training, while the TSG will undergo a technical and tactical skills training program and traditional soccer training. The CG participants will continue with regular school physical education classes without any additional intervention. Before and after the intervention, all participants will be assessed for cardiometabolic and hepatic biochemical markers, physical fitness, anthropometry and body composition, blood pressure, objective daily physical activity and sleep quality, and perceived enjoyment of participation in SSSG and TSG. The primary outcomes of the study will be waist circumference and cardiorespiratory fitness.
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The study protocol was approved by the Ethics Committee of the Faculty of Sport of the University of Porto and by the Scientific Ethics Committee of the Adventist University of Chile. conditions: Obesity, Adolescent conditions: Metabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 51 type: ACTUAL name: Small-sided soccer games groups (SSSG) name: Traditional soccer training groups (TSG) measure: Waist circumference measure: Cardiorespiratory fitness measure: Variation in fasting blood glucose concentration (mg/dL) measure: Variation in serum insulin concentration (mU/L) measure: Variation in HOMA-IR measure: Variation in glycosylated hemoglobin concentration (mg/dL) measure: Variation in high-density lipoprotein cholesterol concentration (mg/dL) measure: Variation in low-density lipoprotein cholesterol concentration (mg/dL) measure: Variation in total cholesterol concentration (mg/dL) measure: Variation in blood triglycerides concentration (mg/dL) measure: Variation in blood Alanine aminotransferase concentration (U/L) measure: Variation in blood Aspartate aminotransferase concentration (U/L) measure: Variation in blood Gamma glutamyl transferase concentration (U/L) measure: 6-minute walk test measure: Hand grip strength measure: Lower limb strength measure: Body composition measure: Body mass index measure: Neck circumference measure: Blood Pressure (mmHg) measure: Physical activity measure: Sleep quality measure: Perceived enjoyment of physical activity sex: MALE minimumAge: 11 Years maximumAge: 15 Years stdAges: CHILD facility: Faculty of Sport of the University of Porto city: Porto zip: 4200-450 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False
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<|newrecord|> nctId: NCT06377124 id: UW21-507 briefTitle: A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-03-31 date: 2026-06-30 date: 2024-04-22 date: 2024-04-22 name: The University of Hong Kong class: OTHER name: Queen Mary Hospital, Hong Kong name: The Queen Elizabeth Hospital name: United Christian Hospital briefSummary: Lung cancers patients often experience multiple symptoms (e.g. fatigue, dyspnea, distress, depression, sleep disturbance). The current study attempts to explore the efficacy of the Smart Self-Management Support Programme (3S) in improving quality of life of patients using self-management support programme with mobile devices. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The 3S intervention includes an individual session, messaging and phone contact related to lung cancer self-management, and hotline services.
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The general health information includes an individual session, messaging and phone contact related to general health information, and hotline services. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The outcome assessor was not aware of which groups the patients belonged to. whoMasked: OUTCOMES_ASSESSOR count: 320 type: ESTIMATED name: 3S intervention name: GH information measure: Change in health-related quality of life measure: Change in health-related quality of life measure: Change in patient activation measure: Change in general self-efficacy measure: Change in acceptance of illness measure: Change in physical activity level measure: Change in diet habit measure: Change in smoking and drinking habits measure: Change in health status measure: Change in anxiety symptoms of patients measure: Change in depression symptoms of patients measure: Change in social and family support measure: Change in adherence to agreed preset health-related goals measure: Change in symptom severity measure: Change in functional exercise capacity measure: Change in lower limb strength measure: Change in hand grip strength measure: Change in flexibility measure: Change in balance measure: Change in body composition measure: Change in objective physical activity level measure: Change in objective sleep quality measure: Change in burden of family caregivers (For FCGs) measure: Change in quality of life of family caregivers (For FCGs) measure: Change in anxiety symptoms of family caregivers (For FCGs) measure: Change in depression symptoms of family caregivers (For FCGs) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Mary Hospital city: Hong Kong country: Hong Kong name: Agnes YK Lai, PhD role: CONTACT phone: 3970-2903 email: ayklai@hkmu.edu.hk name: Agnes Yuen Kwan Lai, PhD role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06377111 id: PANTHEON-IO briefTitle: A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: University Health Network, Toronto class: OTHER briefSummary: This study is open to patients with a type of cancer called melanoma. Patients can join the study if their tumor cannot be removed by surgery or has spread to other organs, and are planned to receive immunotherapy as treatment for their cancer. This study is looking at whether taking calcium pantothenate supplement (a type of Vitamin B5) can increase its levels in the blood and have an effect in the immune system, when its used in combination with the immunotherapy. conditions: Melanoma (Skin) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: C-PAN name: Nivolumab name: Ipilimumab measure: To determine if the dose of 2000 mg daily of pantothenic acid achieves an increase in plasmatic concentration of pantothenic acid by at least a 50% between baseline and week 9, in 9 or more of the patients treated with combined ICI. measure: Evaluate the overall response rate (ORR) of the enrolled cohort. measure: Evaluate the progression free survival (PFS) of the enrolled cohort. measure: Incidence of immune-related colitis. measure: Correlation between baseline intestinal microbiome composition to the development of immune-related colitis. measure: Correlation between the early changes in composition of intestinal microbiome and the development of immune-related colitis. measure: The incidence of treatment-related adverse events. measure: The incidence of treatment-related adverse events measure: Correlation between change in plasmatic pantothenic acid level between baseline and at first day of ICI, and ORR. measure: Correlation between change in pantothenic acid plasmatic level in mcMol/L between baseline and first day of ICI, and ORR by RECIST and iRECIST. measure: Correlation between change in plasmatic pantothenic acid level between baseline and week 9 assessment, and immune profiling. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network- Princess Margaret Cancer Centre city: Toronto state: Ontario zip: M5G 2M9 country: Canada name: Minge Xu role: CONTACT phone: 416-946-4501 phoneExt: 7754 email: minge.xu@uhn.ca name: Samuel Saibil role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06377098 id: UAB-300010901 id: UAB Dixon Endowed Ch/3102800 type: OTHER_GRANT domain: UAB Dixon Endowed Chair briefTitle: Intrapartum Sildenafil in Laboring Mothers acronym: PRISM overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2028-01-31 date: 2024-04-22 date: 2024-04-22 name: University of Alabama at Birmingham class: OTHER name: University Teaching Hospital, Lusaka, Zambia name: Egerton University name: Cameroon Baptist Convention Health briefSummary: The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources.
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The main questions it aims to answer are:
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* What are the fetal heart rate monitoring practices in a low-resource setting?
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* What are the indications for operative delivery in a low-resource?
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* What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil?
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* What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting?
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Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected.
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Participants will:
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* Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor
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* Have the (mothers \& babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag \& mask ventilation, Apgar scores, and seizures.
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* Have a neonatal neurological assessment prior to discharge
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* Have phone call assessments for re-hospitalization or mortality 7 days post-delivery
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* Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call
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