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The control arm won't receive any intervention. conditions: Obstetric Complication conditions: Woman's Role studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women measure: Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women. measure: Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women measure: Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness sex: FEMALE minimumAge: 15 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT facility: University of Dodoma city: Dodoma zip: 259 country: Tanzania name: Alex P Sanga, MSc. PH role: CONTACT phone: 0762144082 email: sanga.alex@gmail.com name: Stephen Kibusi, PhD role: CONTACT phone: 0712600966 email: skibusi@gmail.com lat: -6.17221 lon: 35.73947 hasResults: False
<\|newrecord\|> nctId: NCT06325306 id: 2023/392 id: B7072023000102 type: OTHER domain: Comité d'Ethique Hospitalo-Facultaire Universitaire de Liège briefTitle: Physical Literacy-Based Intervention for Chronic Disease Management overallStatus: RECRUITING date: 2024-03-04 date: 2024-10-30 date: 2024-10-30 date: 2024-03-22 date: 2024-03-22 name: University of Liege class: OTHER name: Centre Hospitalier Universitaire de Liege briefSummary: The goal of this quasi-experimental study is to evaluate the effectiveness of a physical literacy-based intervention for chronic disease management in adults with chronic diseases participating in adapted physical activity group sessions in Belgium. The main questions it aims to answer are:
* How does incorporating physical literacy elements in adapted physical activity sessions affect participants overall physical literacy levels?
* Can a physical literacy-oriented adapted physical activity program enhance long-term engagement in physical activities and improve health outcomes for chronic disease patients?
Participants will:
* Undergo assessments for physical literacy levels and health outcomes at the beginning, after three months, and at the end of the six-month period.
* Engage, in intervention groups, in adapted physical activity sessions, which may include physical fitness exercises and educational components on physical literacy.
Researchers will compare 3 groups: a control group, a traditional Adapted Physical Activity (APA) group, and a Physical Literacy Oriented APA (APA+PL) group to see if integrating physical literacy components results in improved physical literacy levels, better sustained engagement in physical activities, and enhanced health outcomes. conditions: Chronic Disease conditions: Chronic Disease Management conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 195 type: ESTIMATED name: Traditional APA name: APA+PL measure: Global Physical Literacy Score measure: Physical Activity Behavior and Engagement measure: Motivation and Confidence in Physical Activity measure: Physical Competence measure: Knowledge and Understanding of Physical Activity measure: Environment interactions measure: Meaningful and Purposeful Activities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Sportif du Sart-Tilman status: RECRUITING city: Liège zip: 4000 country: Belgium name: Jean-Pierre Weerts, M.A. role: CONTACT phone: +32 4366 3818 email: jpweerts@uliege.be name: Cédric Lehance, M.A. role: CONTACT phone: +32 477490055 email: clehance@chuliege.be name: Jean-Pierre Weerts, M.A. role: PRINCIPAL_INVESTIGATOR lat: 50.63373 lon: 5.56749 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-02 uploadDate: 2024-03-08T06:13 filename: ICF_000.pdf size: 334181 hasResults: False
<\|newrecord\|> nctId: NCT06325293 id: 2023-01295 id: 207286 type: OTHER_GRANT domain: Swiss National Science Foundation briefTitle: A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study acronym: MYTHIC overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-06-30 date: 2028-06-30 date: 2024-03-22 date: 2024-03-22 name: Christoph Berger class: OTHER briefSummary: The goal of this clinical trial is to compare a placebo (a look-alike substance that contains no active drug) with a commonly used antibiotic in children with Mycoplasma pneumoniae (a specific bacterium) induced community-acquired pneumonia. The main question it aims to answer is:
Is antibiotic treatment needed in Mycoplasma pneumoniae (a specific bacterium) induced pneumonia?
Participants will receive either a placebo or a antibiotic treatment and track their symptoms and vital signs until they are healthy.
Researchers will then compare the length of symptoms between the placebo and the antibiotic group. conditions: Community Acquired Pneumonia in Children conditions: Mycoplasma Pneumoniae conditions: Mycoplasma Pneumoniae Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, double-blind, placebo-controlled, multicenter, non-inferiority trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 376 type: ESTIMATED name: Azithromycin Pfizer® name: Placebo measure: Co-primary outcome: days to normalization of all vital signs measure: Co-primary outcome: community-acquired pneumonia(CAP)-related change in patient care status measure: Overall clinical outcome measure: Time (days) to normalization of CAP-related symptoms measure: Quality of Life (QoL) Assessment assessing impact of the child's pneumonia on the family's social and health-related well-being measure: Time (days) to return to daily routine measure: Incidence of Mp-associated extrapulmonary manifestations development in patients assessed by clinical examination and/or parent report measure: Length of hospital stay (LOS) measure: Number of unscheduled medical visits measure: Proportion of patients (re-)treated with antibiotics for any reason measure: Side effects/AEs/serious AE (SAE)s of investigational medicinal product (IMP) measure: Microbiological indicators sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD facility: Children's Hospital Aarau, Switzerland city: Aarau state: Aargau zip: 5001 country: Switzerland name: Henrik Köhler, Prof. Dr. med. role: CONTACT phone: 0041 62 838 41 41 email: Henrik.Koehler@ksa.ch name: Henrik Köhler, Prof. Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.39254 lon: 8.04422 facility: University of Basel Children's Hospital, Switzerland city: Basel state: Basel-Stadt zip: 4056 country: Switzerland name: Julia A Bielicki, PD Dr. Dr. med. role: CONTACT phone: 0041 61 704 12 12 email: julia.bielicki@ukbb.ch name: Julia A Bielicki, PD Dr. Dr. med. role: PRINCIPAL_INVESTIGATOR name: Ulrich Heiniger, Prof. Dr. med. role: SUB_INVESTIGATOR lat: 47.55839 lon: 7.57327 facility: Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland city: Chur state: Graubünden zip: 7000 country: Switzerland name: Beate Deubzer, Dr. med. role: CONTACT phone: 0041 81 256 61 11 email: beate.deubzer@ksgr.ch name: Beate Deubzer, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 46.84986 lon: 9.53287 facility: Children's Hospital of Eastern Switzerland St. Gallen city: St. Gallen state: Saint Gallen zip: 9006 country: Switzerland name: Anita Niederer-Loher, Dr. med. role: CONTACT phone: 0041 71 243 71 11 email: anita.niederer@kispisg.ch name: Anita Niederer-Loher, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.42391 lon: 9.37477 facility: Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland city: Bellinzona state: Ticino zip: 6500 country: Switzerland name: Lisa Kottanattu, Dr. med. role: CONTACT phone: 0041 91 811 91 11 email: Lisa.Kottanattu@eoc.ch name: Lisa Kottanattu, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 46.19278 lon: 9.01703 facility: Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland city: Lausanne state: Vaud zip: 1011 country: Switzerland name: Ludivine Coulon, Dr. med. role: CONTACT phone: 0041 21 314 11 11 email: Ludivine.Coulon@chuv.ch name: Ludivine Coulon, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 46.516 lon: 6.63282 facility: Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland city: Winterthur state: Zurich zip: 8401 country: Switzerland name: Andreas Jung, Dr. med. role: CONTACT phone: 0041 52 266 41 44 email: andreas.jung@ksw.ch name: Andreas Jung, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.50564 lon: 8.72413 facility: University Children's Hospital Bern, Switzerland city: Bern zip: 3010 country: Switzerland name: Philipp Agyeman, PD Dr. med. role: CONTACT phone: 0041 31 632 21 11 email: Philipp.Agyeman@insel.ch name: Philipp Agyeman, PD Dr. med. role: PRINCIPAL_INVESTIGATOR name: Kristina Keitel, PD Dr. Dr. med. role: SUB_INVESTIGATOR lat: 46.94809 lon: 7.44744 facility: Department of Pediatrics, Fribourg Hospital, Switzerland city: Fribourg zip: 1708 country: Switzerland name: Petra Zimmermann, PD Dr. Dr. med. role: CONTACT phone: 0041 26 306 00 00 email: petra.zimmermann@unifr.ch name: Petra Zimmermann, PD Dr. Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 46.80237 lon: 7.15128 facility: Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland city: Geneva zip: 1205 country: Switzerland name: Noémie Wagner, Dr. med. role: CONTACT phone: 0041 22 372 40 00 email: Noemie.Wagner@hcuge.ch name: Noémie Wagner, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 46.20222 lon: 6.14569 facility: Children's Hospital of Central Switzerland, Switzerland city: Luzern zip: 6000 country: Switzerland name: Alex Donas, Dr. med. role: CONTACT phone: 0041 41 205 31 66 email: alex.donas@luks.ch name: Alex Donas, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.05048 lon: 8.30635 facility: University Children's Hospital Zurich, Switzerland city: Zurich zip: 8032 country: Switzerland name: Michelle Seiler, PD Dr. med role: CONTACT phone: 0041 44 266 71 11 email: Michelle.Seiler@kispi.uzh.ch name: Michelle Seiler, PD Dr. med role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 facility: Department of Pediatrics, Triemli Hospital Zurich, Switzerland city: Zurich zip: 8063 country: Switzerland name: Maren Tomaske, Prof. Dr. med. role: CONTACT phone: 0041 44 416 11 11 email: Maren.Tomaske@stadtspital.ch name: Maren Tomaske, Prof. Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False
<\|newrecord\|> nctId: NCT06325280 id: Pro00132542 briefTitle: Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2027-12-31 date: 2024-03-22 date: 2024-03-22 name: University of Alberta class: OTHER briefSummary: There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function. conditions: Pediatric ALL conditions: Congenital Heart Disease conditions: Heart Transplantation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Exercise cardiac MRI Assessment name: Cardiopulmonary Exercise Test measure: MRI assessment of cardiac structure at rest measure: MRI assessment of cardiac function at rest measure: Maximal exercise MRI assessment of cardiac structure measure: Cardioplumonary Exercise Test sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of Alberta city: Edmonton state: Alberta zip: T6G 2B7 country: Canada name: Rae Foshaug role: CONTACT phone: 780-407-7499 email: rae.foshaug@albertahealthservices.ca name: Michael Khoury, MD role: CONTACT phone: 780-492-0103 email: khoury1@ualberta.ca name: Michael Khoury, MD role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 hasResults: False
<\|newrecord\|> nctId: NCT06325267 id: PLC briefTitle: Clinical Characteristics of Primary Liver Cancer overallStatus: RECRUITING date: 2010-01-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-22 date: 2024-03-27 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: Primary liver cancer (PLC) is the sixth most common malignancy in the world and the third most common cause of malignancy death. In 2020, there were about 905,677 new cases of PLC worldwide, and 830,180 deaths. Despite the availability of a variety of treatments for PLC, the 5-year net survival rate is still only 5% to 30%. How to effectively reduce the disease burden of PLC is a major public health problem that needs to be solved worldwide. The clinical characteristics and prognosis of PLC caused by different pathogenic factors are different. Therefore, it is of great significance to fully identify the risk factors of PLC, be familiar with the clinical characteristics and prognosis of disease development, and understand the relevant monitoring and follow-up strategies for the prevention and treatment of PLC. conditions: Primary Liver Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Epidemiological characteristics of overall cohort by liver disease etiology measure: Clinical characteristics of overall cohort by liver disease etiology measure: Survival rates of overall cohort and different etiologies measure: Risk factors of prognosis in overall cohort and different etiologies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Drum Tower Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Jie Li, M.D., Ph.D role: CONTACT phone: 15863787910 email: lijier@nju.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06325254 id: MAFLD briefTitle: Clinical Characteristics of Metabolic Associated Fatty Liver Disease overallStatus: RECRUITING date: 2010-01-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-22 date: 2024-03-26 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: Metabolic associated fatty liver disease (MAFLD), which can lead to liver fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma, poses a significant burden on society. With the improvement of living standards and changes in dietary habits, MAFLD patients show a younger and increasing trend, but there is still no specific drug. The clinical features and prognosis of MAFLD may be different with different metabolic disorder phenotypes and treatment measures. Therefore, further systematic study of the clinical characteristics and prognosis of MAFLD patients will be of great significance for the formulation of corresponding clinical prevention and treatment strategies. conditions: Metabolic Associated Fatty Liver Disease conditions: Clinical Features studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED measure: Clinical characteristics and follow-up outcomes of MAFLD patients measure: Clinical characteristics and follow-up outcomes of MAFLD patients under different subgroups measure: Baseline clinical characteristics MAFLD patients measure: Risk factors for progression to cirrhosis and hepatocellular carcinoma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Drum Tower Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Jie Li, M.D.,Ph.D role: CONTACT phone: 15863787910 email: lijier@nju.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06325241 id: 20200048-01H briefTitle: Validating the Use of Frailty Measurements to Predict Care & Quality of Life overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-12 date: 2025-03-31 date: 2025-03-31 date: 2024-03-22 date: 2024-04-24 name: Ottawa Hospital Research Institute class: OTHER briefSummary: The aim of this research program is to validate frailty measurements as a risk stratification tool to predict deteriorations in patient-reported outcomes, to gain a better understanding of patient preferences for care within varying degrees of frailty, and to assess differences in frailty measurement between patients and their clinicians.
This work will provide a foundation in the development of customized interventions for people with COPD and varying degrees of frailty, with the goal of improving quality of life and optimizing health system service delivery for patients and their care givers. conditions: Chronic Obstructive Pulmonary Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 123 type: ACTUAL name: No intervention measure: Respiratory Health Related Quality of Life measure: Burden of symptoms - COPD Assessment measure: Burden of symptoms - Dyspnea measure: Psycho-social well being - Anxiety measure: Psycho-social well being - Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ottawa Hospital, General Campus city: Ottawa state: Ontario zip: K1J 0J2 country: Canada lat: 45.41117 lon: -75.69812 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-09-22 uploadDate: 2022-11-29T13:05 filename: Prot_SAP_000.pdf size: 617838 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form: Verbal consent date: 2022-11-09 uploadDate: 2022-11-29T13:08 filename: ICF_001.pdf size: 317754 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form: English Information Sheet date: 2022-11-09 uploadDate: 2022-11-29T13:11 filename: ICF_002.pdf size: 161773 hasResults: False
<\|newrecord\|> nctId: NCT06325228 id: NKBBN/241/2023 id: SONP/SP/549693/2022 type: OTHER_GRANT domain: Minister of Education and Science briefTitle: Musculoskeletal Injuries, Sports Performance, Sports Specialization, and Quality of Life in Young Athletes overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-01 date: 2025-05-01 date: 2025-09-01 date: 2024-03-22 date: 2024-04-24 name: Medical University of Gdansk class: OTHER name: Ministry of Science and Higher Education, Poland briefSummary: The primary aim of this observational cohort study is to assess sports specialization, sports performance, history of injuries (prevalence, types, areas, duration) and quality of life in young healthy athletes aged 8-16 from Poland. Athlete profiles will be created based on the variables (explained in detailed description) examined. Furthermore, the investigators will perform one-year injury follow-up.
The main questions it aims to answer are:
* Do athletes with a specific profile (lower values in athletic performance tests, low values in quality of life) evaluated at one time point, suffer injury in the future in annual observation?
* Do athletes with high sports specialization will sustain injury in one-year follow-up?
* Does sports specialization have a relationship with sports performance tests, and quality of life?
* Does sport specialisation, training volume, geographical factor relate to injury history?
* Does sports specialisation, injury history differ between sports (individual and team sports)?
* Does value of the specific muscle (lower limb) isometric strength will be associated with the dynamic balance scores in young healthy athletes? conditions: Sport Injury conditions: Healthy conditions: Injury;Sports conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 373 type: ACTUAL measure: Number of Participants with sports injury after one-year follow-up measure: Type, location, duration, and return to sports in participants with injury at one-year follow up measure: Sports Specialization measure: History of sports-related injuries measure: Health-related quality of life: EQ-5D-Y measure: Y-Balance Test - dynamic balance test measure: Functional Movement Screen (FMS) measure: Hand-Held Dynamometer (HHD) measurement - Isometric Strength of the lower extremities muscle measure: Sport workload (hours per trainings or competition) measure: Peak Height Velocity measure: Sports discipline and position measure: Participants characteristics - Body Mass Index measure: Sports experience sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD facility: Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk city: Gdańsk zip: 80-211 country: Poland lat: 54.35205 lon: 18.64637 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-01-15 uploadDate: 2024-04-22T03:58 filename: ICF_000.pdf size: 183809 hasResults: False
<\|newrecord\|> nctId: NCT06325215 id: SCaglar briefTitle: The Effect of Hydrocolloid to Prevent Nasal Injuries in Preterm Infants overallStatus: COMPLETED date: 2022-05-05 date: 2022-10-29 date: 2022-11-05 date: 2024-03-22 date: 2024-03-22 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: The aim of this study is to evaluate the effect of using hydrocolloid tapes in preventing pressure injuries on the nose and columella regions caused by non-invasive mechanical ventilation (NIMV) in preterm infants. conditions: Pressure Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Experimantal primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: After providing information about the study to the parents of preterm newborns who met the inclusion criteria, informed consent forms were obtained without disclosing which group their babies would be assigned to. The research outcome measurements were recorded by two nurses working at NICU. Prior to the study, necessary training and information about the form and process were provided to the nurses. The data analysis was conducted by an independent statistician. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 56 type: ACTUAL name: Hidrocolloid Bant measure: Neonatal Skin Condition Score measure: Pressure İnjury Staging Scale measure: Neonatal Skin Risk Assessment Scale sex: ALL minimumAge: 24 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: Abide-i Hurriyet Cad. Istanbul University-Cerrahpaşa, Florence Nightingale Faculty of Nursing city: Istanbul zip: 34381 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06325202 id: STUDY00020946 id: 1U01DK135126 type: NIH link: https://reporter.nih.gov/quickSearch/1U01DK135126 briefTitle: Closed Loop and Education for Hypoglycemia Awareness Restoration acronym: CLEAR overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-06-30 date: 2027-12-31 date: 2024-03-22 date: 2024-03-26 name: Milton S. Hershey Medical Center class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) name: University of Minnesota name: University of Kentucky name: University of Pennsylvania name: University of California, San Diego name: AdventHealth name: University of Leicester name: University of Sheffield name: University of Melbourne name: Jaeb Center for Health Research briefSummary: The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D. conditions: Diabetes Mellitus, Type 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Sequential Multiple Assignment Randomized Trial (SMART) design primaryPurpose: TREATMENT masking: NONE count: 324 type: ESTIMATED name: Omnipod 5 or Medtronic 780G name: My HypoCOMPaSS Education name: HARPdoc Education measure: epinephrine (pg/ml) measure: Towler questionnaire measure: geometric mean of plasma glucagon measure: geometric mean of plasma pancreatic polypeptide measure: geometric mean of plasma free fatty acids measure: glucose infusion rate measure: HbA1c measure: % of time with sensor hypoglycemia <70 mg/dL measure: % of time with sensor hypoglycemia <54 mg/dL measure: number of hypoglycemia events measure: % time with sensor glucose in range measure: sensor glucose coefficient of variation measure: sensor use as the average numbers of days per week measure: glycemia risk index measure: Trail Making Test - Part B measure: Four Choice Reaction Time measure: sleep duration measure: sleep quality measure: 24-hour step count measure: exercise bouts measure: resting heart rate measure: heart rate during exercise measure: heart rate variability measure: Hypo-METRICS questionnaire measure: Hypoglycemic Confidence Scale measure: Hypoglycemia Fear Survey-II measure: Attitudes to Awareness of Hypoglycaemia measure: Type 1 Diabetes Distress Scale measure: Diabetes Self-Management Questionnaire measure: Diabetes Management Experiences Questionnaire measure: PROMIS Sleep Disturbance - Short Form 8a measure: Hospital Anxiety and Depression Scale measure: 12-Item Hypoglycemia Impact Profile measure: EQ-5D-5L measure: device-related adverse events measure: severe hypoglycemic events, self-reported on a CLEAR data collection form measure: diabetic ketoacidosis (DKA) events measure: number of participants with hospitalizations measure: number of participants with emergency room (ER) visits measure: major adverse cardiovascular events (MACE) measure: all-cause mortality sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Diego city: La Jolla state: California zip: 92037 country: United States name: Jeremy H Pettus, MD role: CONTACT phone: 858-246-2160 email: jpettus@ucsd.edu name: Jeremy H Pettus, MD role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: AdventHealth city: Orlando state: Florida zip: 32804 country: United States name: Keri Whitaker role: CONTACT phone: 407-303-2519 email: keri.whitaker@adventhealth.com name: Richard E Pratley, MD role: PRINCIPAL_INVESTIGATOR name: Anna Casu, MD role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: University of Kentucky city: Lexington state: Kentucky zip: 40508 country: United States name: Simon Fisher, MD, PhD role: CONTACT phone: 859-562-0473 email: simon.fisher@uky.edu name: Simon Fisher, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Cornelia (Ginger) Dalton-Bakes role: CONTACT phone: 215-746-2085 email: corneliv@pennmedicine.upenn.edu name: Michael R Rickels, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: University of Melbourne city: Fitzroy state: Victoria zip: 3065 country: Australia name: Katrin Brown role: CONTACT phone: 61 3 9231 2574 email: katie.brown@unimelb.edu.au name: Catriona Sims role: CONTACT phone: 61 3 9231 2574 email: catriona.sims@unimelb.edu.au name: David O'Neal, MD role: PRINCIPAL_INVESTIGATOR lat: -37.79839 lon: 144.97833 facility: University of Leicester city: Leicester zip: LE5 4PW country: United Kingdom name: Andrew Kingsnorth role: CONTACT phone: 44 116-258-4874 email: a.kingsnorth@leicester.ac.uk name: Pratik Choudhary, MBBS role: PRINCIPAL_INVESTIGATOR lat: 52.6386 lon: -1.13169 facility: University of Sheffield city: Sheffield zip: S10 2RX country: United Kingdom name: Simon Heller, MD role: CONTACT phone: 44 114-215-9009 email: s.heller@sheffield.ac.uk name: Simon Heller, MD role: PRINCIPAL_INVESTIGATOR lat: 53.38297 lon: -1.4659 hasResults: False
<\|newrecord\|> nctId: NCT06325189 id: Rec-42336 briefTitle: Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients overallStatus: COMPLETED date: 2023-07-20 date: 2023-12-01 date: 2023-12-10 date: 2024-03-22 date: 2024-03-22 name: Riphah International University class: OTHER briefSummary: The goal of this randomized controlled trial is to determine the effects of aerobic interval training on levels of tiredness and functional performance in post-angioplasty patients. The main question it aims to answer is:
Does aerobic interval training reduce fatigue and improve functional performance compared to medication alone in post-angioplasty patients?
Participants will:
Be randomly assigned to either the control group (medication) or the experimental group (medication + aerobic interval training) Perform aerobic interval training for 30 minutes, three times a week, for six weeks (experimental group only) Complete pre and post-intervention assessments using the fatigue severity scale, the 6-minute walk test, and the one minute sit to stand test Researchers will compare the two groups to see if aerobic interval training leads to significant improvements in fatigue levels and functional performance. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this parallel-group randomized controlled trial (RCT), post-angioplasty patients will be assigned to either the control group (receiving standard medication) or the experimental group (receiving medication along with aerobic interval training). The study aims to evaluate the impact of aerobic interval training on fatigue levels and functional performance in these patients. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study was single-blinded, as assessors of the study were kept blind to the intervention group to which the participant was allocated. whoMasked: OUTCOMES_ASSESSOR count: 47 type: ACTUAL name: Aerobic Interval Training measure: Fatigue Severity Scale measure: Six Minute Walk Test measure: 1 minute sit to stand: sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gulab Devi Chest Hospital city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06325176 id: REC/RCR & AHS/23/0569 briefTitle: Comparative Effects of Cryotherapy and Infrared Light on Pain, Redness, and Healing of Episiotomy Wound overallStatus: RECRUITING date: 2024-03-20 date: 2024-10-01 date: 2024-10-15 date: 2024-03-22 date: 2024-04-05 name: Riphah International University class: OTHER briefSummary: The study will be a randomized clinical trial and will be conducted in Bahawalpur Victoria Hospital, Bahawalpur. The subjects (n=24) will be divided into two groups. Group A will include 12 postnatal women and for treatment, cryotherapy will be applied for 20 minutes. Group B will include 12 women and receive infrared light, an infrared lamp will be put at a distance of 45 cm from the perineum, and the heat produced with 230 volts for twenty minutes. The participant will be checked after the first five minutes to make sure that she is not being burned. This procedure will be done twice a day for 7 consecutive days. conditions: Episiotomy Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Cryotherapy name: Infrared light therapy measure: Numeric Pain Rating Scale measure: The standardized REEDA scale: sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Bahawalpur Victoria Hospital(BVH) status: RECRUITING city: Bahāwalpur state: Punjab zip: 63100 country: Pakistan name: Ghulam Fatima, PhD* role: CONTACT phone: 03034073057 email: ghulam.fatima@riphah.edu.pk lat: 29.4 lon: 71.68333 hasResults: False
<\|newrecord\|> nctId: NCT06325163 id: MIU-IRB-2223-219 briefTitle: Accuracy of Artificial Intelligence Technology in Detecting Number of Root Canals in Human Mandibular First Molars Obturated and Indicated for Retreatment: Diagnostic Accuracy Experimental Study overallStatus: COMPLETED date: 2023-01-25 date: 2023-10-02 date: 2023-10-10 date: 2024-03-22 date: 2024-03-22 name: Misr International University class: OTHER briefSummary: evaluate the accuracy of new AI technology for detecting root canals in mandibular first molars retreatment cases in comparison to dentist clinical access cavity and CBCT imaging. conditions: Missed Canals studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: DIAGNOSTIC masking: NONE count: 35 type: ACTUAL name: CBCT name: clinical examination under dental operating microscope name: canal detection AI software (diagnocat) measure: Number of canals measure: linear morphological variations in failed cases sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Misr International University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06325150 id: STUDY00008572 briefTitle: The Impact of Light Exposure on Cognitive Function in Classrooms overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02-01 date: 2028-02-01 date: 2024-03-22 date: 2024-03-22 name: Michigan State University class: OTHER briefSummary: Humans are constantly exposed to a variety of light types, created naturally or through artificial means. Light exposure captured by the eyes impacts many physiological functions in humans, including but not limited to cognitive output, fatigue levels, and mood regulation. The level of impact on cognitive learning from different types of light on undergraduate adult students remains unclear. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study will test the effect of light emitting glasses, vs placebo, vs no-glasses to attention in college students. This is a crossover study, where participants will be randomly assigned to one of three groups, and tested in random order. The students will be tested on 2 or 3 different conditions (no glasses, placebo or light emitting glasses). The assignment to each of the groups, and the order of the intervention (+/- glasses) will be randomized.
Note-light emitting glasses are not FDA regulated. Because light emitting glasses can change physiology, this is considered a phase 1 clinical trial. primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Light emitting glasses measure: Assessment of attention measure: Determine how time of day impacts attention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Michigan State University city: East Lansing state: Michigan zip: 48824 country: United States name: Hanne M Hoffmann, PhD role: CONTACT phone: 517-353-1415 email: hanne@msu.edu lat: 42.73698 lon: -84.48387 hasResults: False
<\|newrecord\|> nctId: NCT06325137 id: RC 24/2022 briefTitle: Transcriptome Analysis in Idiopathic Nephrotic Syndrome: Steroid Responsiveness overallStatus: RECRUITING date: 2023-03-16 date: 2025-03 date: 2025-03 date: 2024-03-22 date: 2024-03-22 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Idiopathic nephrotic syndrome (INS) affects the glomerular barrier by damaging the podocytes with foot process effacement, leading to a pathological increase of permeability and protein loss. INS classification is based on the clinical response to glucocorticoid (GC) therapy. When GCs treatment fails to induce remission in a four-six weeks course, patients are defined as affected with steroid-resistant nephrotic syndrome (SRNS).
The whole transcriptome sequencing could consent the INS classification at onset, prior to glucocorticoids (GCs) treatment, allowing to reduction of unuseful GCs treatment. RNA sequencing technologies allow an extensive characterization of the transcriptomic profile and permit global changes in gene expression levels between different conditions such as active and remission of the disease.
Of great interest is the research of a molecular biomarker to predict steroid resistance, a predictor that is not yet available. Among the candidate biomarkers, pharmacogenomic determinants are promising, even if available studies are still limited. Among these, some epigenetic factors have been previously suggested. Data obtained in animal models suggests that nucleotide-binding oligomerization domain-like receptors (NOD-like receptor) pyrin domain containing 3 (NLRP3) inflammasome can be deregulated in a wide variety of glomerular diseases, including those causing INS. Another potential marker involved in steroid response is the long noncoding RNA GAS5. Data reported in the literature indicate that abnormal levels of GAS5 in peripheral blood mononuclear cells (PBMCs) may alter steroid effectiveness in autoimmune diseases, such as inflammatory bowel disease.
Preliminary findings show that the study of NLRP3 promoter methylation could be reduced in the blood of SRNS compared with steroid-sensitive nephrotic syndrome (SSNS) patients. Moreover, unpublished encouraging results on the association between Growth Arrest Specific 5 (GAS5) expression and steroid response in INS in PBMCs were obtained in a preliminary study conducted on 8 patients with the first episode of INS. PBMCs were obtained and GAS5 gene expression was evaluated using TaqMan technology. Patients affected with SRNS presented significantly higher levels of GAS5 in comparison with the SSNS group. In PBMCs from SRNS patients, the GAS5 expression could reduce the availability for binding to GCs target genes of the activated GCs receptor and suppresses GC transcriptional activity. conditions: Nephrotic Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Transcriptome analyses measure: Between groups differences in molecular signature by whole transcriptome analysis sex: ALL minimumAge: 1 Year maximumAge: 12 Years stdAges: CHILD facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Marco Pennesi, MD role: CONTACT phone: +39.040-3785263 email: marco.pennesi@burlo.trieste.it name: Barbara Bonifacio role: CONTACT phone: +39.040.3785.422 email: barbara.bonifacio@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False
<\|newrecord\|> nctId: NCT06325124 id: REC/01805 MARIA NAWAZ briefTitle: Muscle Energy Technique of Lower Limb Muscles in Forward Head Posture overallStatus: RECRUITING date: 2024-03-26 date: 2025-03-20 date: 2025-04-20 date: 2024-03-22 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: The aim of this randomized controlled trial is to find the effect of muscle energy technique of muscles involved in lower limb superficial backline (hamstring and Gastro-soleus) on improving craniovertebral angle and cervical proprioception and minimizing pain among patients with forward head posture conditions: Forward Head Posture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: Muscle energy technique name: Conventional PT measure: Neck disability index (NDI) measure: Numeric Pain Rating Scale NPRS measure: Bubble inclinometer measure: FHP Mobile Application (To measure Craniovertebral angle) measure: Cervical Joint Position Error sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: We Care Physical Therapy Clinic street 13 phase 4A, Ghouri town Islamabad status: RECRUITING city: Islamabad state: Punjab country: Pakistan name: KINZA ANWAR, MS-OMPT role: CONTACT phone: +92-3239735427 email: kinza.anwar@riphah.edu.pk name: MARIA NAWAZ, MS-OMPT* role: CONTACT phone: +92-3435625466 name: MARIA NAWAZ role: SUB_INVESTIGATOR lat: 33.72148 lon: 73.04329 hasResults: False
<\|newrecord\|> nctId: NCT06325111 id: RC 06/2023 briefTitle: Determinants of Glycaemic Control in Children With Type 1 Diabetes overallStatus: RECRUITING date: 2023-05-29 date: 2026-04-30 date: 2026-04-30 date: 2024-03-22 date: 2024-03-22 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Type 1 diabetes (T1D) is a common chronic disease of childhood associated with a significantly increased risk of micro- and macro-vascular complications, including neuropathy, nephropathy and cardiovascular diseases. The risk of development T1D comorbidities is associated with glycaemic control, a complex mechanism involving biological, physiological environmental factors.
While more than 60 genetic variants were already associated with Glycated hemoglobin (HbA1c) in healthy subjects, very few genes have been identified in T1D individuals. Also, hyperglycaemia could be the cause of epigenetic changes at specific target genes, such as DNA methylation, histone modifications and microRNAs, correlated to accelerated development of diabetes-related complications. Most recently, increasing evidence also suggested that human microbiome may play a crucial role in the onset and progression of T1D and dysbiosis of the gut and oral microbiota was reported as a typical feature of hyperglycaemia.
However, potential differences among poorly and good managed T1D subjects have not been still studied. Also, the exact mechanism by long-term hyperglycaemia's acts in T1D remains poorly understood. Therefore, this project will explore an emerging area of research by the study of possible genetic, epigenetic and environmental biomarkers among T1D subjects with different glycaemic control. conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 800 type: ESTIMATED name: Determinants of T1D glycaemic control measure: Identification of genes involved in T1D glycaemic control measure: Identification of DNA methylation patterns involved in T1D glycaemic control measure: Identification of microRNAs involved in T1D glycaemic control measure: Identification of oral microbiome characteristics associated to T1D glycaemic control sex: ALL minimumAge: 6 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Eulalia Catamo, BSc role: CONTACT phone: +39 040.3785470 email: eulalia.catamo@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False
<\|newrecord\|> nctId: NCT06325098 id: PER-NEPH briefTitle: Implementation of a Diagnostic Workflow for Personalized Diagnosis of Nephrotic Syndrome overallStatus: RECRUITING date: 2022-01-26 date: 2026-01-31 date: 2026-06-30 date: 2024-03-22 date: 2024-03-22 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Nephrotic syndrome (NS) is a clinical picture common to several diseases resulting from damage to podocytes and glomerular filtration barrier. Currently, there is limited consensus regarding the diagnostic pathway and management of the specific etiology. Some patients show complete response to first-line steroid therapy (steroid-sensitive nephrotic syndrome, SSNS), especially in children and young adults. The prognosis of this group is generally favorable. In contrast, patients unresponsive to steroids (steroid-resistant NS, SRNS) frequently undergo immunosuppressive therapies, which are burdened with numerous side effects. Resistance to treatment is associated with a high likelihood of progression to chronic renal disease (CKD) and kidney failure (ESKD). Recent evidence suggests that immunological mechanisms (including permeabilizing factors) are involved in the pathogenesis of post-transplant NS recurrence and SSNS.
Providing patients with NS with a correct diagnosis is the cornerstone of personalized medicine, reducing morbidity and side effects of therapies, ensuring their appropriate prescription, and slowing or preventing progression to ESKD. conditions: Nephrotic Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with nephrotic syndrome (SSNS, SRNS) primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Anti-nephrin antibodies name: u-RPC cultures measure: Role of anti-nephrin antibodies in the pathogenesis of NS measure: Functional role of VUS in the pathogenesis of SRNS measure: Identification of potential predictive biomarkers of renal outcome. measure: Cost-effectiveness analysis sex: ALL minimumAge: 1 Month maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Paola Romagnani role: CONTACT lat: 43.77925 lon: 11.24626 hasResults: False
<\|newrecord\|> nctId: NCT06325085 id: Ayesha Saddiqa briefTitle: Compensatory and Restorative Rehabilitation Techniques in Stroke acronym: The overallStatus: RECRUITING date: 2024-04-16 date: 2025-03-20 date: 2025-04-20 date: 2024-03-22 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: The aim of this randomized controlled trial is to find the combined effects of restorative and compensatory cognitive rehabilitation techniques in mild cognitive impairment after stroke. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: compensatory and restorative rehabilitation techniques name: Traditional cognitive rehabilitation training measure: Montreal cognitive assessment test (Urdu version) measure: Cognitive assessment scale for stroke patients (CASP) measure: Stroke specific quality of life questionnaire (Urdu version) measure: Modified Rankin Scale (MRS) sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shafi Hospital Dina status: RECRUITING city: Dina state: Punjab country: Pakistan name: Dr. Aroosa Tariq, MS:NMPT role: CONTACT phone: 03161578156 email: aroosa.tariq@riphah.edu.pk name: Ayesha Saddiqa, MS:NMPT* role: CONTACT phone: 0315-5568417 email: aisha.sadeeqa23@gmail.com name: Dr. Aroosa Tariq, MS:NMPT role: PRINCIPAL_INVESTIGATOR name: Ayesha Saddiqa, MS:NMPT* role: SUB_INVESTIGATOR hasResults: False
<\|newrecord\|> nctId: NCT06325072 id: NIKE briefTitle: Set-up of a Platform for Personalized Diagnosis of Rare Kidney Diseases (NIKE) overallStatus: ACTIVE_NOT_RECRUITING date: 2021-07-09 date: 2023-06-27 date: 2024-06-30 date: 2024-03-22 date: 2024-03-22 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Chronic kidney disease (CKD) is a major health problem, with steadily increasing incidence and prevalence and the threat of a true "epidemic". Converging evidence suggests a high prevalence of genetic etiology in rare kidney diseases and the list of new disease-causing genes is constantly updated. Recent advances in next-generation sequencing (NGS) technologies have prompted a significant improvement in the diagnosis of rare kidney diseases. Notwithstanding this, NGS generates high numbers of information that need to be properly analysed by the joint efforts of geneticists, nephrologists and bioinformatics in order to integrate clinical and genetic information in a personalized manner. In addition, in selected cases, the contribution of researchers proves essential for the development of experimental models of the disease to study and understand the pathogenic features and propose a personalized therapeutic approach. Such an innovative, integrated diagnostic paradigm is currently available in few centers all over the world and cannot be easily translated in daily clinical practice.
The aim of the study is to set-up an integrated diagnostic algorithm to extend the newest personalized diagnostic and treatment strategies for rare kidney diseases to all patients in the Tuscany region, under 40 years of age with kidney disease. This algorithm will be based on a constant cross-talk between participating centers and a dedicated multidisciplinary team. Diagnostic and therapeutic performances will be validated at European level. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients selected based on the inclusion criteria will be evaluated by a multidisciplinary team of experts. All the selected patients will undergo genetic testing by clinical exome sequencing and in silico filtering for a panel of genes described as causing or in association with CKD. Identified variants will be classified according to the American College of Medical Genetics and Genomics (ACMG) guidelines. Reverse phenotyping will be performed according to the results of genetic testing. The results of the diagnostic work-up will be evaluated by a multi-disciplinary team of experts in order to establish conclusive diagnosis. primaryPurpose: DIAGNOSTIC masking: NONE count: 160 type: ESTIMATED name: Conclusive genetic testing name: Genotype-phenotype correlation for personalized diagnosis name: Personalized study of variants of uncertain clinical significance (VUS) through functional studies on 3D organ-on-a-chip measure: Validation of genetic diagnosis measure: Identification of molecular pathways measure: Explore the applicability of gene editing in rare kidney diseases sex: ALL maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Azienda Ospedaliero Universitaria Careggi city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Meyer Children's Hospital IRCCS city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: USL Toscana Centro city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero Universitaria Pisana city: Pisa country: Italy lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06325059 id: BIO-KIDNEY briefTitle: The Role of Renal Progenitors and Polyploid Tubular Cell Response in Glomerular and Tubular Diseases overallStatus: RECRUITING date: 2023-03-22 date: 2047-03-22 date: 2047-11-30 date: 2024-03-22 date: 2024-03-22 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Renal progenitors are a subset of parietal epithelial cells (PECs) localized at the urinary pole of Bowman's capsule. Experimental models of podocyte damage showed that PECs can potentially regenerate lost podocytes by migrating from Bowman's capsule to the glomerular tuft, acquiring the morphological and functional features of mature podocytes. Podocyte loss and damage, as well as the inability of PECs to replace lost podocytes, lead to glomerular scarring and chronic kidney disease (CKD) progression.
In addition, the investigators of the present study and others have recently demonstrated the existence of a specific subpopulation of tubular cells in the human kidney with a high potential for regeneration and resistance to death, thus acting as tubular progenitors. These cells are involved in tubular response to damage during acute kidney injury (AKI) trough endoreplication (polyploidization).
Kidney biopsy is the cornerstone of diagnosis in many kidney diseases leading to CKD and AKI, allowing unambiguous diagnosis in some cases and presumptive diagnosis of ongoing disease in others. Very recently, super resolution imaging techniques proved to maintain current diagnostic standards while allowing to study morphological features of pathophysiological mechanisms of glomerular and tubular diseases.
The rationale of this project is to study the role of renal progenitors (PECs and tubular progenitors) in the pathogenesis of CKD and AKI trough super resolution imaging applied to human renal biopsies, to the aim of identifying relevant connections with clinical data and markers of damage and/or disease progression. conditions: Nephropathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients affected by nephropathy primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: Study of renal progenitors measure: Evaluation of the role of renal progenitors in the progression of glomerular diseases measure: Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI) measure: Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI) trough DNA and RNA analysis sex: ALL minimumAge: 1 Month maximumAge: 17 Years stdAges: CHILD facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Paola Romagnani role: CONTACT lat: 43.77925 lon: 11.24626 hasResults: False
<\|newrecord\|> nctId: NCT06325046 id: 23-003388 id: NCI-2024-01669 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: GMROR2351 type: OTHER domain: Mayo Clinic Radiation Oncology id: 23-003388 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Evaluating Changes in Quality of Life After Near Margin-less Adaptive Radiation Therapy Compared to Standard Stereotactic Ablative Body Radiotherapy in Localized Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-06 date: 2026-06 date: 2024-03-22 date: 2024-04-01 name: Mayo Clinic class: OTHER briefSummary: This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR. conditions: Localized Prostate Adenocarcinoma conditions: Stage I Prostate Cancer AJCC v8 conditions: Stage II Prostate Cancer AJCC v8 conditions: Stage III Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: Computed Tomography name: Cone-Beam Computed Tomography name: Image-Guided Adaptive Radiation Therapy name: Magnetic Resonance Imaging name: Stereotactic Ablative Radiotherapy name: Survey Administration measure: Treatment-related, patient-reported early quality of life (QOL) changes measure: Treatment-related, patient-reported late QOL changes measure: Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events measure: Change in International Index of Erectile Function (IIEF) measure: Change in International Prostate Symptom Score (IPSS) measure: Change in financial adverse events - COST-FACIT measure: Fiducial-free treatment measure: Bladder filling measure: Biochemical recurrence measure: Prostate specific antigen (PSA) kinetics measure: Local recurrence measure: Overall survival sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Mark R. Waddle, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06325033 id: 18546 briefTitle: Prospective Validation of the Eleveld Model of Propofol for Procedural Sedation in Adults. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-03-22 date: 2024-03-22 name: University Medical Center Groningen class: OTHER briefSummary: The goal of this prospective observational study is to identify effect site concentrations (CET) of propofol using the Eleveld model for different levels of procedural sedation.
The main question it aims to answer is to identify CET propofol using the Eleveld model for different levels of procedural sedation as measured by the modified observer's assessment of alertness and sedation score (MOAAS) and EEG monitoring.
Participants vital signs will be monitored according to the departmental protocol. Sedation will be administered using Target-Controlled Infusion (TCI) of propofol (administered by effect-site TCI using the Eleveld model) and remifentanil (administered by effect site TCI using the Eleveld model). Target controlled infusion of propofol and remifentanil is according to the departmental protocol. The MOAAS score will be noted every 5 minutes or when the target effect site concentration of propofol is altered. Depth of sedation will also be monitored using a non-invasive BIS® monitor. conditions: Deep Sedation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 75 type: ESTIMATED measure: To identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels, MOAAS 3-1 and the associated BIS levels in adult patients. measure: Induction time measure: Recovery time measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-23 uploadDate: 2024-02-29T03:59 filename: Prot_000.pdf size: 454063 hasResults: False
<\|newrecord\|> nctId: NCT06325020 id: 337367 briefTitle: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology acronym: ORACLE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2025-02-28 date: 2024-03-22 date: 2024-03-22 name: University of Edinburgh class: OTHER briefSummary: The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services.
The primary objective is to determine the feasibility of delivering an objective assessment of risk for participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in a community setting using point of care and patient facing technologies within one working day of referral.
Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms.
Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured by point of care high sensitivity cardiac troponin assays as well as a core lab assay.
The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events. conditions: Angina, Stable conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: The assessment of patients with possible angina using the ORACLE pathway measure: Proportion of participants in whom a chest pain risk assessment is complete within one working day of referral. measure: Proportion of patients who can have their risk assessment completed in one, two or three or more working days from referral to service until completion of risk assessment. measure: Proportion of valid and interpretable point-of-care troponin tests measure: Proportion of personal electrocardiograms that are interpretable measure: Proportion of participants stratified as low, intermediate, or high risk using objective risk stratification. measure: Proportion of participants with and without a clinical diagnosis of angina stratified as low, intermediate, or high risk and according to triage status. measure: Proportion of participants with unscheduled Emergency Department attendance(s) at 3 months stratified as low, intermediate, or high risk and according to triage status. measure: Proportion of participants with cardiac death or non-fatal myocardial infarction at 3 months stratified as low, intermediate, or high risk and according to triage. measure: Proportion of participants reclassified as low, intermediate, or high risk using standard laboratory assays compared to point-of-care high-sensitivity cardiac troponin assay. measure: Proportion of participants reclassified as low, intermediate, or high risk using standard 12-lead compared to personal 12-lead electrocardiography sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325007 id: 293-2024-HFH briefTitle: Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous overallStatus: RECRUITING date: 2024-04-11 date: 2024-12-15 date: 2024-12-31 date: 2024-03-22 date: 2024-04-15 name: Holy Family Hospital, Nazareth, Israel class: OTHER briefSummary: The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in nulliparous women.
The main question it aims to answer are:
Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, an extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline. In the control group, a foley catheter will be inserted into cervical canal without ingestion of castor oil. conditions: Induction of Labor Affected Fetus / Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 142 type: ESTIMATED name: Induction of labor measure: time to delivery measure: balloon expulsion time measure: Bishop score after catheter expulsion measure: Fetal presentation at the delivery measure: Duration of the active phase of labor measure: Duration of second stage measure: Mode of delivery measure: Indications for cesarean or operative vaginal deliveries measure: Intrapartum fever measure: Number of patients that will require use of intrapartum use of antibiotic treatment. measure: Number of Participants with that will develop clinical signs of chorioamnionitis. measure: Number of Participants with that will develop 3rd and 4th degrees perineal lacerations. measure: Number of Participants with develop postpartrum hemorrhage. measure: Number of Participants with need blood transfusion. measure: Side effects related to castor oil use measure: Oxytocin maximal dosage measure: Number of participants with Umbilical Cord prolapse. measure: Apgar score (0 to 10). measure: pH taken from umbilical artery measure: Neonatal birthweight measure: Number of neonates with Neonatal fever ≥ 38 °C measure: The number of neonates that will develop neonatal sepsis. measure: The number of neonates that will require antibiotic treatment. measure: Neonatal complications measure: The number of neonates that will Admit to neonatal intensive care unit (NICU) measure: Length of stay in NICU. measure: neonatal death measure: Maternal hemoglobin level after delivery. measure: Number of participants that will require postpartum hysterectomy. measure: Number of participants that will require postpartum laparotomy. measure: postpartum maternal complications measure: The length of stay from birth to discharge home. measure: Maternal satisfaction from delivery process. sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Holy Family hospital, Nazareth status: NOT_YET_RECRUITING city: Nazareth country: Israel name: Wiaamk Khatib, MD role: CONTACT phone: 0549192433 email: wiaam.khatib.95@gmail.com name: Wiaam Khatib, MD role: PRINCIPAL_INVESTIGATOR lat: 32.69925 lon: 35.30483 facility: Holy Family Hospital status: RECRUITING city: Nazareth country: Israel name: Raed Salim, MD role: CONTACT email: r.salim@hfhosp.org lat: 32.69925 lon: 35.30483 hasResults: False
<\|newrecord\|> nctId: NCT06324994 id: YY-20394-BV-MCL briefTitle: Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-12-01 date: 2024-03-22 date: 2024-03-22 name: Dalian Medical University class: OTHER briefSummary: This is a single arm, open label, national multicenter clinical study included patients with relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL), aiming to evaluate the efficacy of a chemotherapy free triple therapy of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody (Obinutuzumab) and BCL-2 inhibitor (Venetoclax) in R/R BV-MCL patients. conditions: Mantle Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Linperlisib in combination with Obinutuzumab and Venetoclax measure: Objective Response Rate (ORR) according to the RECIST 1.1 measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Duration of Overall Response (DOR) measure: Adverse event (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Hospital Dalian Medical University city: Dalian state: Liaoning zip: 116000 country: China name: Xiuhua Sun, Doctor role: CONTACT phone: +86 17709873631 email: 3038668@vip.sina.com lat: 38.91222 lon: 121.60222 hasResults: False
<\|newrecord\|> nctId: NCT06324981 id: 22-2097 id: 1UG3HL168504 type: NIH link: https://reporter.nih.gov/quickSearch/1UG3HL168504 briefTitle: Using AI Text Messaging to Improve AHA's Life's Essential 8 Health Behaviors overallStatus: RECRUITING date: 2024-02-26 date: 2028-02 date: 2028-06 date: 2024-03-22 date: 2024-03-22 name: University of Colorado, Denver class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of our pragmatic clinical trial is to compare how well three different strategies might do to reduce risk factors for cardiovascular disease in patients experiencing health disparities. The three different strategies are: 1) text messages, 2) interactive chatbot messages, and 3) chatbot messages with proactive pharmacist support. To measure cardiovascular risk factors, the investigators are using the American Heart Association's Life's Essential 8 (LE8) factors-blood glucose, cholesterol, blood pressure, physical activity, body mass index, diet, and smoking.
This study focuses on improving cardiovascular risk factors for individuals facing health disparities, such as ethnic minorities, limited English proficiency, and low-income groups. These groups are more likely to be seriously affected by cardiovascular diseases. Self-management, or an individual's roles in managing their own chronic disease, includes lifestyle changes, medication adherence. Improving patients' self-management has been shown to improve health behaviors, better disease control and improved patient outcomes.
The main question this study aims to answer is if one of the strategies (texting, chatbot, or chatbot with pharmacist support) may improve patient self-management and patient outcomes.
The investigators will enroll up to 2,100 patients from three health systems that serve large populations experiencing health disparities: Denver Health, Salud Family Health Centers, and STRIDE Community Health Center.
The results might help researchers and health care systems find the best ways to involve patients with health disparities to managing their chronic cardiovascular disease. conditions: Cardiovascular Diseases conditions: Lifestyle Factors studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 2100 type: ESTIMATED name: Generic text messages name: Interactive AI chatbot text messaging name: Proactive pharmacist support measure: Change in Life's Essential 8 risk score measure: Blood pressure (Individual Life's Essential 8 components) measure: Total cholesterol (Individual Life's Essential 8 components) measure: Blood sugar (Individual Life's Essential 8 components) measure: Body Mass Index (Individual Life's Essential 8 components) measure: Physical activity (Individual Life's Essential 8 components) measure: Sleep (Individual Life's Essential 8 components) measure: Smoking habits (Individual Life's Essential 8 components) measure: Health diet pattern (Individual Life's Essential 8 components) measure: Self-Efficacy for Managing Chronic Diseases measure: Number of medication refill gaps (Medication adherence) measure: Length of refill gaps (Medication adherence) measure: Clinic events measure: Risk Score for Recurrent Coronary Heart Disease, Framingham Risk Score measure: Risk Score for Coronary Heart Disease (2-year risk) - First Event, Framingham Risk Score measure: Rate of routine clinical visits and/or other procedures associated with the clinical condition measure: Cost sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Denver Health status: RECRUITING city: Denver state: Colorado zip: 80204 country: United States name: Pamela Peterson, MD MPH role: CONTACT email: pamela.peterson@dhha.org lat: 39.73915 lon: -104.9847 facility: Salud Family Health Centers status: NOT_YET_RECRUITING city: Fort Lupton state: Colorado zip: 80621 country: United States name: Emily Kosirog, PharmD role: CONTACT email: ekosirog@saludclinic.org lat: 40.08471 lon: -104.81303 facility: STRIDE Community Health Centers status: NOT_YET_RECRUITING city: Wheat Ridge state: Colorado zip: 80033 country: United States name: Danielle Montoya, PharmD role: CONTACT email: danielle.montoya@stridechc.org lat: 39.7661 lon: -105.07721 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-11 uploadDate: 2023-12-04T16:49 filename: Prot_000.pdf size: 325640 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-02-26 uploadDate: 2024-03-04T15:41 filename: SAP_001.pdf size: 235057 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-07 uploadDate: 2024-03-04T16:34 filename: ICF_002.pdf size: 788437 hasResults: False
<\|newrecord\|> nctId: NCT06324968 id: 22-AOIP-01 briefTitle: Ro60 Expression in Macrophages in Sjogren's Disease acronym: RoMioSS overallStatus: RECRUITING date: 2024-02-09 date: 2025-02-09 date: 2026-02-09 date: 2024-03-22 date: 2024-03-22 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Context: The Ro60 protein associates with YRNAs (or RNYs) to form the RoRNP complex, which regulates RNA surveillance and maturation. It is hypothesized that its impairment by nuclear penetration of the anti-Ro60 autoantibodies, would deregulate the anti-inflammatory response in monocytes/macrophages (Mo/Mp) in patients with Sjögren's disease (SD). conditions: Sjogren's Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: Positive serology for anti-SSA measure: SSA/Ro60 interactions measure: The molecular and functional impact : inflammatory cytokine and chemokine profiles measure: The molecular and functional impact : cell apoptosis/survival and cellular polarization measure: The molecular and functional impact : clinical and biochemical phenotypes of CD14+ monocytes/macrophages sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Nice status: RECRUITING city: Nice state: Alpes-Mritimes zip: 06000 country: France name: Nihal MARTIS, MD, MSc role: CONTACT phone: 4 92035444 phoneExt: +33 email: martis.n@chu-nice.fr lat: 43.70313 lon: 7.26608 hasResults: False
<\|newrecord\|> nctId: NCT06324955 id: IRB-P00042507 briefTitle: Language During Inhalational Induction overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2024-07-01 date: 2025-03-11 date: 2024-03-22 date: 2024-03-22 name: Boston Children's Hospital class: OTHER briefSummary: The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group. conditions: Emergence Delirium conditions: Anesthesia; Adverse Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 128 type: ESTIMATED name: Standard/common language during induction name: Positive language during induction measure: Induction compliance measure: Length of induction measure: Verbal refusal of mask sex: ALL minimumAge: 5 Years maximumAge: 10 Years stdAges: CHILD facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: John Fiadjoe, MD role: CONTACT email: john.fiadjoe@childrens.harvard.edu name: Rachel Bernier, MPH role: CONTACT phone: 857-218-5348 email: rachel.bernier@childrens.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06324942 id: REB24-0349 briefTitle: Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section. overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-12 date: 2024-03-22 date: 2024-03-22 name: University of Calgary class: OTHER briefSummary: The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital. conditions: Cesarean Section Complications conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg measure: Post operative Pain measure: Time to first request for rescue analgesia in hours measure: Post operative Opioid use measure: Time from surgery to discharge from hospital sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Calgary city: Calgary state: Alberta zip: T2N 2T9 country: Canada lat: 51.05011 lon: -114.08529 hasResults: False
<\|newrecord\|> nctId: NCT06324929 id: HSR220448 id: R61AA030581-01 type: NIH link: https://reporter.nih.gov/quickSearch/R61AA030581-01 briefTitle: Optimizing a Digital AEP Risk Intervention With Native Women and Communities Aim 1 acronym: CARRII Native overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09 date: 2025-03-31 date: 2024-03-22 date: 2024-03-27 name: University of Virginia class: OTHER name: University of Minnesota name: Missouri Breaks Industries Research, Inc. name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The purpose of this aim of the ovedrall study is to gather information to inform the development of a digital app that can be used on any platform (smartphone, tablet, computer) for Native American women to help them avoid a pregnancy affected by alcohol. conditions: Alcohol Exposed Pregnancy conditions: Unplanned Pregnancies conditions: Alcohol Use, Unspecified conditions: Contraception Use conditions: Sexual Behavior studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Mixed methods research during Aim 1 will include 4 different components. They are:
1. Convene working group of Native American stakeholders.
2. Collect data using a 35-minute survey of demographics, AEP risk, device use, recommendations for recruitment methods, and interest in subsequent trial with 300 Native women respondents, targeting approximately 100-150 per region (rural Great Northern Plains), urban Denver and mountain West, and rural Southwest .
3. Conduct Iterative prototyping of existing and proposed CARRII components with 60 Native women across 10 focus group discussions. Content will be informed by Components 1 and 2, and will be added via modification request
4. Conduct User Testing of existing CARRII and candidate components with Think-Aloud methods among 20 Native women. primaryPurpose: OTHER masking: NONE count: 300 type: ESTIMATED name: Survey measure: Determine the characteristics of and rate of Native women eligible for, and interested in the CARRII intervention. sex: FEMALE minimumAge: 18 Years maximumAge: 44 Years stdAges: ADULT facility: University of Virginia Fontaine Research Park city: Charlottesville state: Virginia zip: 22908 country: United States name: Karen Ingersoll, PhD role: CONTACT phone: 804-651-6929 email: kes7a@uvahealth.org lat: 38.02931 lon: -78.47668 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-24 uploadDate: 2024-03-22T09:41 filename: Prot_SAP_000.pdf size: 558452 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-02 uploadDate: 2024-03-22T09:41 filename: ICF_001.pdf size: 242257 hasResults: False
<\|newrecord\|> nctId: NCT06324916 id: vascularized fibular graft briefTitle: Donor Site Morbidity After Free Vascularized Fibular Graft overallStatus: RECRUITING date: 2024-01-10 date: 2026-01-10 date: 2026-12-30 date: 2024-03-22 date: 2024-03-22 name: Assiut University class: OTHER briefSummary: This study was carried out at Assiut University to Asses the long-term donor site morbidity following free vascularized fibular transfer because there is a limited information regarding the long-term donor morbidity of this type of flap. conditions: Osteosarcoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: Xray measure: Donor site morbidity in contrast with surgery benifits this will be measured by point evaluation system sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut university status: RECRUITING city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06324903 id: echo cath CHD briefTitle: Role of Echocardiography in Optimization of Cardiac Catheterization in Children With Congenital Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04 date: 2025-10-30 date: 2024-03-22 date: 2024-03-22 name: Assiut University class: OTHER briefSummary: Delineate and evaluate the role of echocardiography in children with congenital heart disease undergoing cardiac catheterization in the pediatric cardiology unit of Assiut university hospitals.
1. To improve diagnostic accuracy by creating a systematic approach for image acquisition and interpretation across different procedural timepoints.
2. To promote consistent hemodynamic evaluations to reliably assess cardiac function and blood flow.
3. To enable optimized procedural planning and intraprocedural guidance via comprehensive delineation of anatomy and pathophysiology.
4. To facilitate standardized longitudinal monitoring after interventions to evaluate outcomes and detect complications. conditions: Echocardiography studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 67 type: ESTIMATED name: echocardiography and percutaneous cardiac catheterization measure: congenital heart defect dimensions in mm, measure: pressure gradient in mmHg across valve measure: cardiac function by measuring fraction shortening (FS) % in percent measure: cardiac function TAPSV in cm/sec sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06324890 id: 20240225 briefTitle: PET-CT Imaging Features of Meibomian Glands overallStatus: RECRUITING date: 2024-01-31 date: 2024-12-31 date: 2024-12-31 date: 2024-03-22 date: 2024-03-22 name: Zhongnan Hospital class: OTHER briefSummary: Analysis the results of Dry eye analysis results and PET-CT imaging comprehensively conditions: MGD-Meibomian Gland Dysfunction conditions: Positron-Emission Tomography conditions: Dry Eye studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: Lacrimal river height measure: Tear break-up time measure: Tear-film lipid layer thickness measure: Meibomian glands two-dimensional digital infrared images sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongnan Hospital of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430071 country: China name: Min Ke, Doctor role: CONTACT phone: +86-18672395959 email: keminyk@163.com lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06324877 id: HREC/24/QCHQ/106030 briefTitle: Ataxia-telangiectasia: Treating Mitochondrial Dysfunction With Nicotinamide Riboside acronym: ATNAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-10-30 date: 2025-10-30 date: 2024-03-22 date: 2024-04-18 name: The University of Queensland class: OTHER briefSummary: Study design: Single arm open-label clinical trial in ataxia-telangiectasia to test the effects of nicotinamide riboside on ataxia scales, immune function, and neurofilament light chain. Study population: 6-10 patients with Ataxia-Telangiectasia. Dose: Nicotinamide riboside 25 mg/kg/day in 3 equal divided doses.
Primary endpoint: Scales for assessment and rating of ataxia (SARA), and International Cooperative Ataxia Rating Scale (ICARS). Improvement of at least ½ standard deviation in key clinical scales which includes either; a) significant improvement in total combined scores from the SARA and ICARS scales, and /or b) significant improvements any aspects of the SARA and ICARS scales individually, especially pertaining to; Postural and gait improvements, Improved syllable speed and articulation, Improved fine motor skills.
Secondary endpoints: Serum analysis of neurofilament light chain (Nfl), Type 1 Interferon (INFs) epigenetic signature conditions: Ataxia Telangiectasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 1. Primary objective: Single arm open-label clinical trial in ataxia-telangiectasia to test the effects of nicotinamide riboside on ataxia scales, immune function, and neurofilament light chain.
2. Secondary objectives:
* Determine to what extent the beneficial effects ongoing of NR on NFl translate to clinical efficacy in patients with A-T.
* Type 1 Interferon (INFs) epigenetic signature specifically the cGAS-STING pathway. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 10 type: ESTIMATED name: Nicotinamide riboside measure: Scales for assessment and rating of ataxia measure: International Cooperative Ataxia Rating Scale measure: Serum analysis of neurofilament light chain measure: Type 1 Interferon epigenetic signature measure: Quality of Life Measures sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Queensland Children's Hospital city: Brisbane state: Queensland zip: 4101 country: Australia name: David Coman, MBBS FRACP role: CONTACT phone: +610730681111 email: david.coman@health.qld.gov.au lat: -27.46794 lon: 153.02809 hasResults: False
<\|newrecord\|> nctId: NCT06324864 id: 2024-00212 briefTitle: START NOW Adapted: Culturally Adapted Version of START NOW overallStatus: RECRUITING date: 2024-03-13 date: 2026-03 date: 2026-03 date: 2024-03-22 date: 2024-03-22 name: Prof. Christina Stadler class: NETWORK briefSummary: The goal of this clinical trial is to test the effectiveness of the culturally adapted skills-training START NOW in youth migrant populations. The main question it aims to answer is: Is the culturally adapted skills training START NOW more effective than treatment as usual (TAU) in reducing mental health problems in migrants? Participants will be randomly assigned to the intervention group receiving the skills training START NOW Adapted or the control group receiving TAU. Researchers will compare both groups to see if START NOW Adapted is more effective than TAU in reducing mental health problems in migrants. conditions: Depression conditions: Depression/Anxiety conditions: Anxiety conditions: Adolescent conditions: Emotion Recognition conditions: Mental Health conditions: Resilience,Psychological conditions: Refugee Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: START NOW Adapted measure: Change from baseline in symptoms of depression and anxiety at the end of the intervention measure: Change from baseline in symptoms of depression and anxiety at follow-up measure: Change from baseline in self-reported perceived stress at follow-up measure: Change from baseline in self-reported social-ecological resilience at the end of the intervention measure: Change from baseline in self-reported perceived stress at the end of the intervention measure: Change from baseline in self-reported social-ecological resilience at follow-up measure: Change from baseline in facial emotion recognition at the end of the intervention measure: Change from baseline in facial emotion recognition at follow-up sex: ALL minimumAge: 15 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University Psychiatric Clinics Basel status: RECRUITING city: Basel state: Basel-Stadt zip: 4002 country: Switzerland name: Donja Brunner, PhD role: CONTACT phone: +410613258031 email: donja.brunner@unibas.ch name: Janine Bacher, MSc role: CONTACT phone: +410613258048 email: janine.bacher@upk.ch name: Donja Brunner, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.55839 lon: 7.57327 hasResults: False
<\|newrecord\|> nctId: NCT06324851 id: DROVZOEFFIPREP briefTitle: The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation overallStatus: COMPLETED date: 2023-01-01 date: 2023-08-01 date: 2024-03-01 date: 2024-03-22 date: 2024-04-08 name: University of Palermo class: OTHER name: University of Roma La Sapienza briefSummary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy. conditions: Endometrial Polyp conditions: Endometrial Diseases studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ACTUAL name: Drospirenone / Estetrol name: Nomegestrol Acetate / Estradiol name: Ethinylestradiol / Dienogest measure: Quality of endometrial preparation sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Andrea Etrusco city: Palermo zip: 90123 country: Italy lat: 38.13205 lon: 13.33561 facility: Marco Monti city: Rome zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06324838 id: 248-2021-NQ briefTitle: Extended Mesenteric Resection in Ileocecal Crohn's Disease. acronym: EXCEED overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2028-12 date: 2029-06 date: 2024-03-22 date: 2024-04-04 name: Odense University Hospital class: OTHER briefSummary: The EXCEED project aims to study the role of the mesentery in disease recurrence in Crohn's disease (CD), as evidence suggests that including the mesentery when doing ileocecal resections can significantly reduce recurrence rates. The EXCEED study is a blinded randomised clinical trial with 204 participants having ileocecal Crohn's disease requiring resection. Participants will undergo either "standard" mesocolic sparing resection or extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site. The primary endpoint is endoscopic recurrence 12 months postoperatively.
Additionally, the study aims to evaluate the efficacy of different surveillance modalities in detecting anastomotic site recurrence. These examinations will be conducted pre- and postoperatively for a cohort of 20 participants.
Through this study, we seek to understand the mesentery's role in Crohn's disease recurrence and identify effective non-invasive methods for postoperative monitoring. conditions: Crohn's Disease of Terminal Ileum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Blinded multicenter randomized controlled clinical trial (RCT). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: This randomized controlled trial will incorporate blinding procedures, with the understanding that due to the nature of this interventional surgical study, the operating surgeon cannot be blinded. However, rigorous measures will be implemented to ensure blinding of both patients and all other participants involved in patient treatment. The description of the surgery within the patient chart will follow a standardized format, with the exception of the resection details. Where the two treatment methods diverge, a predefined, standardized text referencing the study will be inserted. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 204 type: ESTIMATED name: Standard laparoscopic ileocecal resection name: Extended laparoscopic ileocecal resection measure: Endoscopic recurrence measure: Early endoscopic recurrence measure: Clinical signs of recurrence / morbidity. measure: Difference in disease severity measure: Patient reported outcome 1 measure: Patient reported outcome 2 measure: Reoperations measure: Perioperative complications measure: Cost of treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06324825 id: 2022CR64 briefTitle: Fuzheng Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial overallStatus: RECRUITING date: 2022-10-24 date: 2024-12-31 date: 2024-12-31 date: 2024-03-22 date: 2024-03-22 name: Peking University First Hospital class: OTHER briefSummary: Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. This study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control Molduodan granule. conditions: Atrophic Gastritis With Low-grade Intraepithelial Neoplasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: Fuzhegn Nizeng Decoction name: Moluodan granules measure: Recovery rate of Low-grade Intraepithelial Neoplasia measure: 7-point Global Overall Symptom Scale measure: Adverse event rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Xuezhi Zhang, Doctor role: CONTACT phone: +861083572634 email: zhang.xuezhi@263.net lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06324812 id: SSGJ-611-PED-AD-Ib/II-01 briefTitle: Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-08 date: 2024-03-22 date: 2024-03-22 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis. conditions: Dermatitis, Atopic studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) measure: Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit. measure: Minimum concentration (Cmin) measure: Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) measure: Number of Participants with Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points measure: Number of Participants with Eczema Area and Severity Index (EASI) - 50 Response (>= 50% Improvement in Score From Baseline) measure: Number of Participants with Eczema Area and Severity Index (EASI) - 90 Response (>= 90% Improvement in Score From Baseline) measure: Number of Participants Who Achieved >=4 Points/ >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline measure: Percentage Change From Baseline in EASI Score measure: Change From Baseline in Percent Body Surface Area (BSA) of AD Involvement measure: Change From Baseline in Weekly Average of Pruritus NRS measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) measure: Change From Baseline in Patient Oriented Eczema Measure (POEM) sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06324799 id: 2023/51 briefTitle: The Effect of Position Change Frequency on Hyperbilirubinemia overallStatus: RECRUITING date: 2024-03-14 date: 2024-07-14 date: 2024-11-24 date: 2024-03-22 date: 2024-03-22 name: Tarsus University class: OTHER briefSummary: In our study, the effect of the frequency of position changes on hyperbilirubinemia in babies hospitalized in the Neonatal Intensive Care Unit and receiving phototherapy treatment will be investigated.
This study was planned as a single-center randomized controlled clinical trial to examine the effect of the frequency of position changes on the time it takes for hyperbilirubinemia to subside in babies receiving phototherapy treatment in the Neonatal Intensive Care Unit of Mersin City Training and Research Hospital.

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