Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-29 @ 12:11 AM
Study NCT ID:
NCT06267859
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2023-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'working with children from the "frequently ill children" group'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'identification of children from the group of "frequently ill children"'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2034-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Working with archival documentation.', 'timeFrame': 'one year', 'description': "Medical and statistical analysis of data from children's medical institutions is carried out to identify common somatic diseases in children from birth to 15 years old associated with impaired immunity.\n\nEvaluation criterion:\n\n* medical archival documentation of children's clinics in the region;\n* statistical analysis of archival documentation on the morbidity of children (acute respiratory: acute bronchitis and acute pneumonia; cardiovascular diseases: congenital heart disease, congenital and acquired carditis)."}, {'measure': 'Formation of a group of patients to study immunity and the antioxidant system in venous blood.', 'timeFrame': 'one year', 'description': 'Objective: Preparations for a clinical trial are underway.\n\nWork in progress:\n\n* 400 children with diseases of the bronchopulmonary system and congenital heart defects will be selected;\n* preparation and submission to the Ethics Committee under the Ministry of Health of Uzbekistan of all necessary documentation for the planned clinical trial among children;\n\nEvaluation criterion:\n\n\\- The percentage of detection of acute bronchopulmonary and congenital heart defects in the region of residence (results of medical statistics).'}, {'measure': 'Clinical scientific research.', 'timeFrame': 'five years.', 'description': 'A clinical study of sick children (acute respiratory: acute bronchitis and acute pneumonia; cardiovascular diseases: congenital heart disease, congenital and acquired carditis) is being conducted to determine the presence of immunological and antioxidant blood parameters.\n\nWork in progress:\n\n* Screening medical examination of children (objective examination, general blood test - ELISA method);\n* Examination of venous blood for indicators of immune status (extended immunogram: CD3, CD3/4, CD3/8, CD19, and others), method: flow cytometry of venous blood, mIU/mL;\n* the study of antioxidant status in sick children (Total antioxidant status, method: venous blood PCR, mmol/L);\n* publication of the research results.\n\nEvaluation criterion:\n\n* opinion of reviewers and experts in this field (comparison of the results obtained by other scientists - immunological and antioxidant research)\n* changes in immune and antioxidant status indicators in sick children to healthy peers.'}, {'measure': 'Clinical trial evaluation.', 'timeFrame': 'three years', 'description': "The development and implementation of clinical recommendations for practicing pediatricians, pediatric pulmonologists, and cardiologists on improving children's health with acute respiratory (acute bronchitis, pneumonia) and cardiovascular (CHD, congenital and acquired carditis) diseases.\n\nWork in progress:\n\n* development and implementation of clinical recommendations for pediatricians, pediatric pulmonologists, and cardiologists;\n* assessment of the effectiveness of clinical recommendations based on repeated laboratory tests (immunological (flow cytometry, mIU/mL) and TAS (PCR, mmol/L)), after six months of implementation of the recommendations.\n\nEvaluation criterion:\n\n* opinion of reviewers and experts - review;\n* assessing the quality of life of patients (methods: PedsQLtm 4.0; HBSC), indicator: total score on the screening survey;\n* number of recurrent illnesses and complications, indicator: the number of patients as a percentage."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children', 'adolescents', 'heart diseases', 'lung diseases', 'congenital malformations'], 'conditions': ['Respiratory Diseases', 'Congenital Heart Defects']}, 'descriptionModule': {'briefSummary': 'The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.\n\nThe main questions it aims to answer:\n\n* Analysis of common congenital diseases among children;\n* Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;\n* Based on the results of the primary research, common diseases among children will be identified;\n* Analysis of existing treatment methods and their effectiveness;\n* Development of modern methods of treatment and rehabilitation of children.', 'detailedDescription': 'Children\'s health is a priority in modern medicine. Some childhood diseases are most often encountered in the practice of pediatricians and family doctors. Children with these diseases need early diagnosis, treatment, and rehabilitation.\n\nPatient selection criteria are:\n\n* children from birth to 15 years;\n* children permanently residing in the territory where the clinical examination is carried out;\n* children included in the group of "frequently ill children";\n* patients without severe chronic diseases.\n\nExclusion criteria:\n\n* Teenagers over 15 years old;\n* Patients with severe neurological and mental diseases;\n* Patients with endocrinological diseases;\n* Patients with long-term chronic somatic diseases;\n* Children without genetic pathologies.\n\nClinical research methods:\n\n* Collection of anamnestic data;\n* General examination of patients (auscultation, palpation, percussion);\n* If necessary: consultation with a geneticist and pediatric doctors of various specialties (cardiologist, surgeon, urologist, nephrologist, otolaryngologist, pulmonologist, immunologist, allergist)\n* Standard laboratory tests (general analysis of blood, urine, feces);\n* Standard biochemical studies (microelements of blood and enzymes in venous blood);\n* Instrumental studies: chest X-ray, ultrasound examination of internal organs (chest and abdominal organs), computed tomography (chest and abdominal organs);\n* Study of immunological status (cellular immunity, according to standard methods); Immunological research methods - flow cytometry, mIU/mL: immunogram - CD3, CD3/4, CD3/8, CD19, CD16/56, CD3/16/56, CD3/HLA-; and others;\n* Study of antioxidant status (TAS, using the PSR method, mmol/L);\n* Assessing the quality of life of patients (methods: PedsQLtm 4.0; HBSC, indicator: total score on the screening survey).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children from birth to 15 years;\n* children permanently residing in the territory where the clinical examination is carried out;\n* children included in the group of "frequently ill children";\n* patients without severe chronic diseases.\n\nExclusion Criteria:\n\n* Teenagers over 15 years old;\n* Patients with severe neurological and mental diseases;\n* Patients with endocrinological diseases;\n* Patients with long-term chronic somatic diseases;\n* Children without genetic pathologies.'}, 'identificationModule': {'nctId': 'NCT06267859', 'briefTitle': 'Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children', 'organization': {'class': 'OTHER', 'fullName': 'Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan'}, 'officialTitle': 'Based on Medical Statistical Analysis and Screening (Dispensary) Examination, Identification of the Most Common Somatic and Congenital Diseases in Children, With the Further Development of More Effective Methods of Treatment and Recovery', 'orgStudyIdInfo': {'id': 'No. 2 of 2023/11/7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'First stage', 'description': 'Study of children from the group of "frequently ill children", and with congenital diseases, collection of anamnesis, their examination, clinical and laboratory examination. Purpose: to identify the most frequently encountered group of diseases among children.'}, {'type': 'NO_INTERVENTION', 'label': 'Second stage', 'description': 'Study the effectiveness of treatment according to approved treatment standards'}, {'type': 'NO_INTERVENTION', 'label': 'third stage', 'description': 'Based on the research results, develop your treatment tactics. It is approved by the Ethics Committee for working with patients.'}, {'type': 'EXPERIMENTAL', 'label': 'fourth stage', 'description': 'Use your treatment tactics among a group of patients. Study the effectiveness of the proposed therapy and rehabilitation methods.', 'interventionNames': ['Combination Product: The use of a combination of microelements and vitamins against the background of physiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'fifth stage', 'description': 'Based on the research data, clinical recommendations for doctors will be developed.'}], 'interventions': [{'name': 'The use of a combination of microelements and vitamins against the background of physiotherapy', 'type': 'COMBINATION_PRODUCT', 'description': 'If necessary, necessary microelements and vitamins will be added to the treatment process. At the same time, physiotherapeutic procedures will be added at the rehabilitation stage.', 'armGroupLabels': ['fourth stage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100140', 'city': 'Tashkent', 'state': 'Yunus-obad District', 'status': 'RECRUITING', 'country': 'Uzbekistan', 'contacts': [{'name': 'Shokhida T Turdieva, M.D., D.Sc.', 'role': 'CONTACT', 'email': 'Shohidahon69@mail.ru', 'phone': '+998935872570'}, {'name': 'Kholida B Abdurashidova', 'role': 'CONTACT', 'email': 'otdel.nayka@mail.ru', 'phone': '+998935092934'}, {'name': 'Gulmira R Nasirova, Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Turdieva Shokhida Tolkunovna', 'geoPoint': {'lat': 41.26465, 'lon': 69.21627}}], 'centralContacts': [{'name': 'Shokhida T Turdieva, DSc', 'role': 'CONTACT', 'email': 'Shohidahon69@mail.ru', 'phone': '+998935872570'}, {'name': 'Kholida B Abdurashidova', 'role': 'CONTACT', 'email': 'otdel.nayka@mail.ru', 'phone': '+998935092934'}], 'overallOfficials': [{'name': 'Shokhida T Turdieva, D.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '2034/01/30', 'ipdSharing': 'YES', 'description': 'This clinical study aims to discover the course of common congenital, infectious, and non-infectious diseases among children living in Uzbekistan, to develop methods for their treatment and improvement. Several separate clinical studies by young scientists will be combined.', 'accessCriteria': 'Researchers at the Tashkent Pediatric Medical Institute.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Medical Sciences, Professor', 'investigatorFullName': 'Turdieva Shokhida Tolkunovna, MD', 'investigatorAffiliation': 'Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan'}}}}