text
stringlengths 0
197k
|
|---|
SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA. conditions: Corneal Erosion studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-Blinded, Parallel, Vehicle-Controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-Blinded, Parallel, Vehicle-Controlled whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ESTIMATED name: SHJ002 name: Vehicle measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measured by corneal fluorescein staining (CFS) score measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by central corneal fluorescein staining (cCFS) score measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Visual Analogue Scale (VAS) measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Symptom Assessment in Dry Eye (SANDE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical Chung-Ho Memorial Hospital city: Kaohsiung zip: 807 country: Taiwan name: Shiuh-Liang Hsu, MD role: CONTACT phone: +886-73121101 email: [email protected] name: Shiuh-Liang Hsu, MD role: PRINCIPAL_INVESTIGATOR name: Li-Yi Chiu, MD role: SUB_INVESTIGATOR lat: 22.61626 lon: 120.31333 hasResults: False |
<|newrecord|> nctId: NCT06381973 id: ELTGOL briefTitle: Ventilation Distribution in COPD Patients During Breathing Exercises overallStatus: RECRUITING date: 2024-04-15 date: 2024-08-01 date: 2024-08-01 date: 2024-04-24 date: 2024-04-25 name: William Poncin, PT, PhD class: OTHER briefSummary: ELTGOL (Slow Expiration with the Opened Glottis in the Lateral posture) is an airway clearance technique performed in the lateral decubitus position. This technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. Previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure. |
This study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (COPD), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during ELTGOL on ventilation distribution. conditions: Chronic Obstructive Pulmonary Disease conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: ELTGOL_Physio name: ELTGOL_Auto name: PEP name: 1L-Tidal-Breathing name: Spontaneous Breathing measure: Impedance variation using Electrical Impedance Tomography sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cliniques universitaires Saint-Luc status: RECRUITING city: Brussels state: Brussels Capital zip: 1200 country: Belgium name: William Poncin role: CONTACT phone: +320470592032 phoneExt: +320470592032 email: [email protected] lat: 50.85045 lon: 4.34878 hasResults: False |
<|newrecord|> nctId: NCT06381960 id: 2022LJ014 briefTitle: Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-24 date: 2024-04-24 name: Jianhui Tian class: OTHER briefSummary: To address the clinical challenge of postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative driver gene expression, there is a lack of effective diagnostic and therapeutic measures. Based on this, investigators propose to carry out a clinical study on the prevention and treatment of postoperative metastasis of IIA-IIIA stage lung cancer with negative driver gene expression with the formula of supporting the positive and dispelling the evil. conditions: Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 356 type: ESTIMATED name: Fuzheng Quxie Recipe measure: Disease-free survival, DFS measure: Overall survival,OS measure: Minimal residual disease, MRD measure: Circulating Tumour Cell Assay measure: Chinese Medicine Symptom Score measure: Quality of life assessment measure: Immunological indicators measure: Tumour marker measure: Peripheral blood systemic immunoinflammatory index sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: Changning state: Shanghai country: China name: Tianhui Tian role: CONTACT phone: +8613816562972 email: [email protected] name: Fan Xu role: CONTACT phone: +8618762866303 email: [email protected] facility: Shanghai General Hospital status: RECRUITING city: Hongkou state: Shanghai country: China name: Tianhui Tian role: CONTACT phone: +8613816562972 email: [email protected] name: Fan Xu role: CONTACT phone: 18762866303 email: [email protected] facility: Shanghai Traditional Chinese Medicine-Integrated Hospital status: RECRUITING city: Hongkou state: Shanghai country: China name: Tianhui Tian role: CONTACT phone: +8613816562972 email: [email protected] name: Fan Xu role: CONTACT phone: +8618762866303 email: [email protected] facility: Shanghai Municipal Hospital of Traditional Chinese Medicine status: RECRUITING city: Jing'an state: Shanghai zip: 200071 country: China name: Tianhui Tian, Professor role: CONTACT phone: +8613816562972 email: [email protected] name: Fan Xu, Dr role: CONTACT phone: 18762866303 email: [email protected] facility: Shanghai Pulmonary Hospital status: RECRUITING city: Yangpu state: Shanghai country: China name: Tianhui Tian role: CONTACT phone: +8613816562972 email: [email protected] name: Fan Xu role: CONTACT phone: +8618762866303 email: [email protected] typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2022-12-21 uploadDate: 2024-04-18T10:13 filename: Prot_000.pdf size: 825047 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-12-21 uploadDate: 2024-04-18T10:14 filename: ICF_001.pdf size: 151196 hasResults: False |
<|newrecord|> nctId: NCT06381947 id: 19092023 briefTitle: Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients acronym: BESAFE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-30 date: 2025-06-30 date: 2024-04-24 date: 2024-04-24 name: University of Salerno class: OTHER briefSummary: Statin intolerance occurs in up to 15-20% of treated patients. The combined use of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors with ezetimibe is commonly performed in these patients, and has been associated with an estimated LDL-C reduction of 65-70%. This drug combination may be insufficient to reach the LDL-C target in high- and very-high-risk patients with statin intolerance, also considering the goals recommended by the current international guidelines. Also, PCSK9 inhibitor dosage escalations frequently fail to achieve the target. Doubling the dosage of alirocumab from 75 mg to 150 mg, when administrated as monotherapy, determines a further reduction of only 3,6% of LDL-C serum level. The full dose of Evolocumab (420 mg every two weeks), was approved only in the setting of homozygous familiar hypercholesterolemia. |
Bempedoic acid is an oral, once-daily prodrug, metabolized in the liver to an active inhibitor of ATP-citrate lyase, blocking cholesterol synthesis upstream of 3-hydroxy-3-methylglutaryl-coenzyme A reductase and thereby increasing hepatic expression of the LDL receptor and decreasing circulating LDL-C levels. |
The CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Harmony trial demonstrated that bempedoic acid in addition to maximally tolerated statin therapy did not lead to a higher incidence of adverse events compared to placebo and significantly lowered LDL-C levels. In the CLEAR Serenity study, bempedoic acid showed a safe and effective profile compared with placebo in patients with statin intolerance. In the CLEAR Tranquility, it provided an oral therapeutic option complementary to ezetimibe in patients intolerant to high-dose statins who required additional LDL-C lowering. |
The synergistic effect of bempedoic acid plus PCSK9 inhibitors has been investigated by one phase 2 trial (NCT03193047), which showed a statistical superiority of bempedoic acid plus evolocumab strategy versus placebo plus evolocumab in terms of percent change in LDL-C up to 2 months. To date, no randomized phase 3 clinical trial have evaluated the effect of bempedoic acid in association with anti-PCSK9 and ezetimibe in statin-intolerant patients not attaining the recommended LDL-C target. |
The investigators hypothesized that the association of bempedoic acid with PCSK9 inhibitors and ezetimibe may be safe and effective in reducing LDL-C in statin-intolerant patients. conditions: Dyslipidemias conditions: Statin Adverse Reaction conditions: Cardiovascular Diseases conditions: Lipid Metabolism Disorders studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is an investigator-initiated, phase 4, open-label, multicentre, 2-way crossover trial primaryPurpose: PREVENTION masking: NONE count: 130 type: ESTIMATED name: Lipid-lowering therapy combination with PCSK9 inhibitors, bempedoic acid and ezetimibe name: Lipid-lowering therapy combination with PCSK9 inhibitors and ezetimibe measure: Mean percentage change in LDL-C after 12 weeks of treatment measure: Mean absolute change from baseline to week 12 in low-density lipoprotein cholesterol measure: Percentage of patients reaching the recommended LDL-C target measure: Changes in plasmatic levels of total cholesterol after 12 weeks of treatment measure: Changes in plasmatic levels of HDL cholesterol after 12 weeks of treatment measure: Changes in plasmatic levels of non-HDL cholesterol after 12 weeks of treatment measure: Changes in plasmatic levels of fasting glucose after 12 weeks of treatment measure: Changes in plasmatic levels of glycated haemoglobin after 12 weeks of treatment measure: Changes in plasmatic levels of fasting insulinemia after 12 weeks of treatment measure: Changes in plasmatic levels of HOMA index after 12 weeks of treatment measure: Changes in plasmatic levels of hs-CRP after 12 weeks of treatment measure: Changes in plasmatic levels of lipoprotein(a) after 12 weeks of treatment measure: Changes in plasmatic levels of apolipoprotein B after 12 weeks of treatment measure: Changes in PCSK9 serum levels before starting the treatment and after 12 weeks of treatment measure: Number of participants with abnormal uric acid level, abnormal AST/ALT level, ALT or AST >3x ULN, and/or unexplained creatine kinase (CK) >3x ULN measure: The number and type of adverse events measure: MACE at 12 and 28 weeks measure: Rehospitalization at 12 and 28 weeks measure: Death at 12 and 28 weeks sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-02 uploadDate: 2024-04-08T09:09 filename: Prot_SAP_000.pdf size: 452473 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-05-02 uploadDate: 2024-04-08T09:09 filename: ICF_001.pdf size: 193521 hasResults: False |
<|newrecord|> nctId: NCT06381934 id: 2024-00335; kt23ChristCrain4 briefTitle: Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-04 date: 2027-04 date: 2024-04-24 date: 2024-04-24 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: This study is looking at two new parameters, aSID and ChU, to see if these can help physicians to distinguish between different causes of low sodium levels (hyponatremia) in Patients taking a medicament against high blood pressure (thiazide). Researchers also want to see if using these new parameters to decide on treatment works just as well, or better, than the current standard treatments. conditions: Thiazide Associated Hyponatremia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 136 type: ESTIMATED name: Standard Care name: aSID/ChU Guided Therapy measure: Serum Sodium Level measure: Descriptive analyses: Changes in aSID in relation to changes in serum sodium levels measure: Descriptive analyses: Changes in ChU in relation to changes in serum sodium levels measure: Diagnostic performance analyses of: aSID and ChU measure: Diagnostic performance analyses of: aSID measured in blood gas analysis measure: Diagnostic performance analyses of: clinical volume status assessment measure: Diagnostic performance analyses of: not-invasive instrumental volume status assessment measure: Diagnostic performance analyses of: other hormones such as aldosterone, renin, arginine-vasopressin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel city: Basel zip: 4031 country: Switzerland name: Laura Potasso, Dr. med. sc. role: CONTACT phone: +41 61 328 58 76 email: [email protected] name: Mirjam Christ-Crain, Prof. Dr. med. role: CONTACT phone: +41 61 328 70 80 email: [email protected] name: Laura Potasso, Dr. med. sc. role: PRINCIPAL_INVESTIGATOR name: Mirjam Christ-Crain, Prof. Dr. med. role: SUB_INVESTIGATOR lat: 47.55839 lon: 7.57327 hasResults: False |
<|newrecord|> nctId: NCT06381921 id: B2023-0046 briefTitle: Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain acronym: OIME overallStatus: NOT_YET_RECRUITING date: 2025-05-01 date: 2027-10-31 date: 2029-02-28 date: 2024-04-24 date: 2024-04-24 name: University of Connecticut class: OTHER name: Yale University briefSummary: The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial. conditions: Abdominal Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled ambulatory trial primaryPurpose: DIAGNOSTIC masking: NONE count: 120 type: ESTIMATED name: IBS-PPSM intervention measure: Pain intensity and interference measure: IBS-related symptoms measure: Electrodermal activity (EDA) measure: Electrocardiogram (ECG) measure: Electromyogram (EMG) measure: Objective integrated multimodal electrophysiological index sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06381908 id: 1-10-72-19-24 briefTitle: The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity acronym: CHO-EX overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-15 date: 2024-12-15 date: 2024-04-24 date: 2024-04-24 name: University of Aarhus class: OTHER name: University of Southern Denmark name: University Ghent briefSummary: The effect of calorie restriction combined with low or moderate carbohydrate availability on exercise capacity, metabolism and metabolic health indicators will be measured in a randomized parallel group design. Forty overweight (BMI 25-30) and relatively inactive women (20-35 of age) will be included. These will be randomized into one of two experimental groups both receiving a calorie-restricted diet (-1000 kcal) combined with either low carbohydrate availability or moderate carbohydrate availability across a 10 day period. Laboratory-based physical capacity tests and blood and muscle sampling will be performed before and after the intervention. In addition, an additional follow-up test day will be performed after continuing the diet for another 48 h and then standardizing the pre-testing carbohydrate availability before repeating the tests of physical capacity. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is performed as a randomized single-blinded parallel group design. Randomization is performed into two groups using minimization based on a predetermined estimated VO2max middle value of 30. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The study is labelled as a single-blinded study because the investigators are blinded to the group allocation (the group allocation and diet handling is managed by a researcher not involved in other aspects of the data collection or processing). The participants are not informed about their allocated condition, however, it is conceivably possible for them to recognize this based on the food provided. However, the direction of the hypothesis will not be evident to the participants. Moreover, we include questionnaires before the post-tests related to their perceived diet allocation and their perception of the effect of the diet on the test assessments. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Calorie-restriction with low carbohydrate name: Calorie-restriction with moderate carbohydrate measure: Time to exhaustion measure: Sprint performance measure: Exercise tolerance measure: Muscle glycogen levels measure: Physical activity level measure: Maximal fat oxidation capacity measure: Muscle metabolic enzyme activity measure: Blood lipid profile measure: Continuous glucose levels measure: Fasting blood glucose and insulin measure: Long-term glycemic control (HbAc1) sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Section for Sport Science, Department of Public Health, Aarhus University status: RECRUITING city: Aarhus C zip: 8000 country: Denmark name: Mette Hansen, PhD role: CONTACT phone: +4551666551 email: [email protected] lat: 56.15674 lon: 10.21076 hasResults: False |
<|newrecord|> nctId: NCT06381895 id: SYSKY-2023-467-01 briefTitle: The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer overallStatus: COMPLETED date: 2023-05-30 date: 2024-02-01 date: 2024-02-20 date: 2024-04-24 date: 2024-04-24 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated. conditions: Bladder Cancer conditions: Radiomics conditions: Immunotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1200 type: ACTUAL measure: Tumour-infiltrating lymphocytes (TIL) measure: overall survival measure: cancer-specific survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06381882 id: MiPac briefTitle: The Role of the Human Microbiome in Patients After Pancreatic Resection. acronym: MiPac overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-11-01 date: 2024-04-24 date: 2024-04-24 name: St. Antonius Hospital class: OTHER briefSummary: The goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva, rectal/faecal, tumor, blood and/or bile microbiome profiles. |
To identify the dynamics of the microbiome, as well as the possibly related short-term and long-term complications, multiple samples at different timepoints are needed from the patients. conditions: Pancreas Cancer conditions: Pancreas Neoplasm conditions: Pancreas Adenocarcinoma conditions: Periampullary Cancer conditions: Periampullary Carcinoma conditions: Microbial Colonization studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Pancreatic resection measure: Risk stratification postoperative complications measure: Long time oncological outcomes - site of recurrence measure: Long time oncological outcomes - disease free survival measure: Long time oncological outcomes - overall survival measure: Complications neoadjuvant chemotherapy measure: Complications adjuvant chemotherapy measure: Response to neoadjuvant chemotherapy measure: Complications bile duct drainage measure: Postoperative endocrine insufficiency measure: Postoperative exocrine insufficiency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381869 id: CRNHA 2018-2 briefTitle: Bioavailability of Pea Protein in Young and Old Volunteers acronym: NUTRALYS overallStatus: COMPLETED date: 2019-01-10 date: 2019-06-13 date: 2019-06-13 date: 2024-04-24 date: 2024-04-24 name: Roquette Freres class: INDUSTRY name: CRNH Auvergne name: Université d'Auvergne briefSummary: The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal. conditions: Healthy Male Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ACTUAL name: Pea protein (NUTRALYS ® S85 plus) in water name: Pea protein (NUTRALYS ® S85 plus) within meal name: Whey protein in water name: Whey protein within meal measure: Leucine blood concentration measure: Essential amino acids blood concentration (µmol/L) measure: Non essential amino acid blood concentration (µmol/L) measure: Blood glucose concentration (g/L) measure: Blood insulin concentration (μIU/ml) measure: Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l) measure: Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml) sex: MALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne city: Clermont-Ferrand zip: 63009 country: France lat: 45.77966 lon: 3.08628 hasResults: False |
<|newrecord|> nctId: NCT06381856 id: EPM_2024-00227-01 briefTitle: Improving Participation of Autistic Children and Adolescents in the Habilitation Process acronym: IMPAC overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-05 date: 2025-12 date: 2024-04-24 date: 2024-04-24 name: Region Örebro County class: OTHER briefSummary: This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre. conditions: Autism Spectrum Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: The child's involvement measure: The Mental Health Continuum - Short Form measure: The "Your child's strengths, abilities and special needs"-questionnaire. measure: The collaboration with the neuropsychiatric team questionnaire measure: Cantril ladder measure: Individual interviews measure: Type and number of goals in the childrens' individual habilitation plans sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: University Health Care Research Center city: Örebro zip: 70182 country: Sweden lat: 59.27412 lon: 15.2066 hasResults: False |
<|newrecord|> nctId: NCT06381843 id: WSKCT004 briefTitle: A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster overallStatus: COMPLETED date: 2022-08-02 date: 2023-03-29 date: 2023-12-30 date: 2024-04-24 date: 2024-04-25 name: WestVac Biopharma Co., Ltd. class: INDUSTRY name: West China Hospital briefSummary: A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation. |
A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated. conditions: COVID-19 conditions: SARS-CoV-2 Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ACTUAL name: Recombinant COVID-19 Vaccine (Sf9 Cell) name: COVID-19 Vaccine (Vero Cell), Inactivated measure: Incidence of adverse drug reactions (ADRs) measure: Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain measure: Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant measure: Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain measure: Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant measure: GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain measure: GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant measure: GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan country: China lat: 30.66667 lon: 104.06667 hasResults: False |
<|newrecord|> nctId: NCT06381830 id: ASCT+CART briefTitle: Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma overallStatus: RECRUITING date: 2024-01-01 date: 2027-01-01 date: 2027-01-01 date: 2024-04-24 date: 2024-04-24 name: The First Affiliated Hospital of Soochow University class: OTHER name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd name: Suzhou Hongci Hematology Hospital, Suzhou, China briefSummary: The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma. conditions: Lymphoma, B-Cell conditions: Autologous Stem Cell Transplantation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Apheresis name: Autologous Stem Cell Transplantation name: CAR-T Cell Therapy measure: Overall Response Rate (ORR) measure: Progression-free Survival（PFS） measure: Duration of Response(DOR) measure: Complete Response Rate measure: Overall Survival（OS） measure: Adverse events profile sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Caixia Li, M.D. role: CONTACT phone: +86 512 67781856 email: [email protected] lat: 31.30408 lon: 120.59538 hasResults: False |
<|newrecord|> nctId: NCT06381817 id: 2024112 briefTitle: Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients overallStatus: RECRUITING date: 2024-04-01 date: 2028-03-31 date: 2028-03-31 date: 2024-04-24 date: 2024-04-26 name: The First Affiliated Hospital of Soochow University class: OTHER name: Children's Hospital of Soochow University name: Ruijin Hospital name: Nanfang Hospital, Southern Medical University name: Fujian Medical University Union Hospital name: First Affiliated Hospital Xi'an Jiaotong University name: Wuhan Union Hospital, China name: Zhejiang University briefSummary: The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are: |
Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL. |
Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion. conditions: Acute T Cell Lymphoblastic Leukemia conditions: Haploidentical Hematopoietic Stem Cell Transplantation conditions: Cord Blood studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 146 type: ESTIMATED name: Haplo-cord HCT name: Haplo-HCT measure: Progression-free survival measure: Overall survival measure: Cumulative incidence of relapse measure: Non-relapse mortality measure: Adverse events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Yang XU role: CONTACT phone: 86+051267781850 email: [email protected] name: Yang Xu role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 hasResults: False |
<|newrecord|> nctId: NCT06381804 id: 24YL9001 briefTitle: Effect of Shotblocker and Palm Stimulator overallStatus: RECRUITING date: 2024-04-19 date: 2024-05 date: 2024-05 date: 2024-04-24 date: 2024-04-24 name: Necmettin Erbakan University class: OTHER briefSummary: This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: shotblocker name: palm stimulator measure: Visual analog scale (VAS) pain Scale score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Necmettin Erbakan University status: RECRUITING city: Meram country: Turkey name: Gülden Basit role: CONTACT phone: (0 332) 320 40 29 email: [email protected] role: CONTACT phone: (0 332) 320 40 29 name: Merve Öz role: SUB_INVESTIGATOR lat: 37.82985 lon: 32.46777 hasResults: False |
<|newrecord|> nctId: NCT06381791 id: PRO00036811 briefTitle: CBD for Pain Following Orthopedic Shoulder Surgery acronym: CBD overallStatus: RECRUITING date: 2024-05-01 date: 2026-12-30 date: 2027-12-30 date: 2024-04-24 date: 2024-04-24 name: The Methodist Hospital Research Institute class: OTHER briefSummary: The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery. |
Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery. |
Participants will: |
* track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary. |
* Complete two short surveys. Once before surgery and once after. |
* Have bloodwork tested after surgery conditions: Shoulder Osteoarthritis conditions: Rotator Cuff Injuries studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is designed as a randomized, double-blinded controlled trial. Patients will be recruited in clinic preoperatively prior to their scheduled procedure. Patients and the treating physician/research study team will be blinded to the treatment arm. Patients will be randomized to either the test group, which will be prescribed Epidiolex (cannabidiol) postoperatively in addition to the standard pain regimen, or the control group, which will have a placebo provided in addition to the standard pain regimen. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Epidiolex name: Placebo oral solution measure: Primary - Pain Journal measure: Survey Data measure: Pain Disability Index (PDI) measure: Pain, Enjoyment, General Activity (PEG) Scale measure: Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety measure: Pittsburgh Sleep Quality Index (PSQI) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Houston Methodist Hospital status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Haley M Goble, MHA, CRCC role: CONTACT phone: 713-441-3930 email: [email protected] name: Patrick C McCulloch, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False |
<|newrecord|> nctId: NCT06381778 id: 112006-E briefTitle: Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis overallStatus: RECRUITING date: 2023-02-06 date: 2027-12-01 date: 2027-12-01 date: 2024-04-24 date: 2024-04-24 name: Far Eastern Memorial Hospital class: OTHER briefSummary: Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) and may present various symptoms including arrhythmia and heart failure. Mutations in the genes related to sarcomeric proteins and metabolic disorders are known causes of HCM. However, it remains required to further explore the prevalence of HCM in the context of Taiwanese' genetic background. Additionally, certain rare diseases that affect the heart, including Fabry disease, cardiac amyloidosis, may present LVH, which makes precise diagnosis among HCM and these diseases more challenging. In this TSOC multi-center registry, we aim to systematically evaluate the clinical, genetic, biochemical features,prevalence, and possible natural course of HCM and relevant rare diseases such as Fabry disease in Taiwan. In the meanwhile, we may also generate the specific "red-flag" signs of Fabry disease in Taiwan. conditions: Hypertrophic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 2600 type: ESTIMATED measure: Death measure: CV death sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Far Eastern Memorial Hospital status: RECRUITING city: New Taipei City zip: 220 country: Taiwan name: Yen-Wen Wu, MD, PhD role: CONTACT phone: 886-2-8966-7000 phoneExt: 1090 email: [email protected] name: Yen-Wen Wu, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 25.01111 lon: 121.44583 hasResults: False |
<|newrecord|> nctId: NCT06381765 id: Serratus-Pectointercostal briefTitle: Serratus Plane Block and Pectointercostal Block overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-08-01 date: 2024-04-24 date: 2024-04-24 name: Cukurova University class: OTHER briefSummary: ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . General anesthesia with sevoflurane and remifentanil will perform to the all patients. Postoperative pain scores, morphine consumption and complications will record till the 24.th hours. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Serratus plane bock and pectointercostal block measure: postoperative morphine consumption measure: postoperative visual analog scale scores sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381752 id: CPMvsPT briefTitle: Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement overallStatus: COMPLETED date: 2019-06-25 date: 2020-03-31 date: 2020-03-31 date: 2024-04-24 date: 2024-04-24 name: Johannes Gutenberg University Mainz class: OTHER briefSummary: Immediate rehabilitation after total knee arthroplasty (TKA) differs in terms of volume, intensity but also type of treatment. Continuous passive motion after TKA is so far only investigated for replacing physiotherapy. This study is conducted to investigate CPM when it partially replaces group physiotherapy in terms of functional and patient-reported outcomes. conditions: Total Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 175 type: ACTUAL name: Continuous passive motion name: standard rehabilitation measure: Staffelstein Score measure: Oxford Knee Score (OKS) measure: Range of motion (ROM) measure: Visual Analogue Scale (VAS) measure: Return to work sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitaetsmedizin der JGU Mainz city: Mainz state: Rheinland-Pfalz zip: 55131 country: Germany lat: 49.98419 lon: 8.2791 hasResults: False |
<|newrecord|> nctId: NCT06381739 id: M011 briefTitle: A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol acronym: AeroVax overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2026-07 date: 2024-04-24 date: 2024-04-25 name: McMaster University class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The goal of this clinical trial is to study the safety of a new inhaled vaccine to prevent COVID infection and learn about the immune responses that are made in the lungs and the blood after vaccination. Participants will be randomized (like the toss of a coin) to receive the experimental vaccine or a placebo (a look-alike solution that contains no vaccine). |
To be in the study participants will have to have already had three doses of a messenger ribonucleic acid (mRNA) COVID vaccine and be generally healthy. Participants are given a single dose of the vaccine by breathing in a fine mist that goes directly into the lungs. |
During follow-up participants will: |
* visit the clinic for checkups and blood tests at 2, 4 and 8 weeks after vaccination |
* report their symptoms for 24 weeks after getting the vaccine. |
In some participants, the researchers will collect cells from the lung 4 weeks after vaccination (a test known as a bronchoscopy). conditions: COVID-19 Infection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 350 type: ESTIMATED name: ChAd-triCoV/Mac name: Control measure: Antigen specific T cell responses in blood. measure: Antigen specific T cell responses in bronchoalveolar lavage (BAL). measure: Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine. measure: Confirmed COVID infection by reverse transcriptase polymerase chain reaction (RT-PCR) measure: CD4 and CD8 T cell responses specific for the spike (S1), nucleoprotein (N) and polymerase (POL) SARS-CoV-2 antigens expressed by the vaccine, including those expressing memory T cell markers, in the peripheral blood. measure: Neutralizing and total antibody levels in BAL and blood measure: Any adverse events, including grade 1 or 2 or where relationship to vaccine/placebo administration or study procedures is judged not related or unlikely. measure: Tissue-resident memory surface marker expression airway T cells sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences Centre city: Hamilton state: Ontario zip: L8S 4K1 country: Canada lat: 43.25011 lon: -79.84963 hasResults: False |
<|newrecord|> nctId: NCT06381726 id: Progetto AIRC IG-2022 ID 27184 briefTitle: Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life overallStatus: RECRUITING date: 2024-03-07 date: 2028-02-28 date: 2028-02-28 date: 2024-04-24 date: 2024-04-24 name: University of Milan class: OTHER name: University of Turin, Italy briefSummary: Background Lower-grade-gliomas affect young patients, thus the longest progression-free-survival (PFS) with a high level quality of life is crucial. Surgery most significantly impacts on tumor natural history, postponing recurrence, improving symptoms, decreasing the need of adjuvant therapies, with extent of resection, gross-total and supra-total (GTR and STR), strongly associating with longest PFS. Achievement of GTR or STR depends on the degree of functional reorganization induced by glioma. Consequently, a successful treatment fostering neural circuit reorganization before surgery, would increase the chance of GRT/STR. |
Hypothesis The plastic potential of motor system suggests that reorganization of circuits controlling hand movements could be presurgically fostered in LGG patients by enhancing plasticity with up-front motor-rehabilitation and/or by decreasing tumor infiltration with up-front chemotherapy. Advanced neuroimaging allows to infer the neuroplasticity potential. Intraoperative assessment of the motor circuits functionality will validate reliability of preoperative analyses. |
Aims The project has 4 aims, investigating: A) the presurgical functional (FC) and structural (SC) connectomics of the hand-motor network to picture the spontaneous reorganization and the influence of clinical, imaging and histomolecular variables; B) the dynamic of FC and SC after tumor resection; C) changes in FC and SC maps after personalized upfront motor rehabilitation and/or chemotherapy; D) the effect of FC and SC upfront treatment on the achievement of GTR/STR preserving hand dexterity. |
Experimental Design Resting-state fMRI and diffusion-MRI will provide FC and SC maps pre- and post-surgery; personalized up-front motor rehabilitation and/or chemotherapy will be administered; Intraoperative brain mapping procedures will generate data to validate the maps. |
Expected Results |
1. Provide a tool to render the motor functional reorganization predictive of surgical outcome. |
2. Identify demographic, clinical and imaging variables associated with functional reorganization. |
3. Describe the gain induced by up-front treatment. |
4. Distinguish "patterns" predicting chance for GTR/STR from "patterns" suggesting need for up-front treatment. |
Impact On Cancer Results will increase the achievement of GTR/STR, preserving motor integrity, with dramatic impact on LGGs natural history. conditions: Glioma conditions: Glioma, Malignant studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients immediately candidate for resection will be assessed neurologically, neuropsychologically and by functional MRI. Extent of resection will be assessed on \<48hrs and 2-month MRI. Neurological and neuropsychological assessment will be performed during regular follow-up. Patients not requiring an adjuvant treatment according to tumor board meeting will be submitted to functional MRI at 4-8 and 12 months from surgery. Patients not immediately eligible for resection will be submitted to biopsy for histomolecular definition. Patients not requiring radiation therapy will be submitted to neurological, neuropsychological, and functional MRI evaluation. Upon clinical context, patients will undergo motor rehabilitation and/or chemotherapy. After 3-6 months, patients will undergo functional MRI and evaluated for surgery. Neurological and neuropsychological evaluation will be performed at treatment initiation, every month during treatment, at admission for surgery and 1 month after surgery. primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Resting State Functional Magnetic Resonance Imaging (rs-fMRI) name: Up-front Motor Rehabilitation name: Up-front Chemotherapy measure: Muscle power measure: Motor praxia measure: Comprehensive neuropsychological assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale Galeazzi Sant'Ambrogio status: RECRUITING city: Milan state: Lombardy zip: 20157 country: Italy name: Lorenzo Bello, MD role: CONTACT phone: 0039-340-217-1453 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06381713 id: ONZ-2024-0158 briefTitle: Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-12 date: 2027-12 date: 2024-04-24 date: 2024-04-24 name: University Ghent class: OTHER name: Research Foundation Flanders briefSummary: Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice. |
Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders. conditions: Cleft Palate Children conditions: Speech Therapy conditions: Speech Disorders in Children conditions: Cleft Lip and Palate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: High intensive combined phonetic-phonological intervention name: Low intensive combined phonetic-phonological intervention measure: Consonant proficiency measure: Incremental cost-utility ratio measure: Incremental cost-effectiveness ratio measure: Intelligibility in Context measure: Health-related quality of life measure: Speech Function measure: Speech Distress measure: Communication attitudes of children aged 4 and 5 years measure: Communication attitudes of children aged 6 years and older sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06381700 id: DF CO2405/0014 (P) briefTitle: Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children: overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-06 date: 2024-04-24 date: 2024-04-24 name: University of Malaya class: OTHER briefSummary: The goal of this cluster-randomised control trial is to assess the effectiveness of the MySmile app for improving oral health in secondary school children. The main questions it aims to answer are: |
1. Will the MySmile app be more effective in improving secondary school children's dental plaque and gingival health over and above the existing school dental service (SDS)? |
2. Will the MySmile app be more effective in improving secondary school children's oral health knowledge, attitudes, and behaviours over and above the existing SDS? |
3. Is the MySmile app easy to use by secondary school children? |
4. Is the MySmile app acceptable to use from the perspective of secondary school children? |
Participants in the intervention group will receive the SDS and MySmile app. The control group will receive SDS only. Therefore the researcher will compare between the intervention and control group in terms of dental plaque, gingival health, oral health knowledge, oral health attitudes and oral health behaviours. conditions: Oral Disease conditions: Gingival Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 303 type: ESTIMATED name: MySmile app name: Control measure: The mean decrement in plaque score will be assessed using the Plaque Control Record developed by O'Leary Drake and Naylor in 1972 measure: The mean increment in gingival health will be assessed using Gingival Index developed by Silness and Loe in 1963 measure: The mean increment of oral health knowledge, attitude and practice using validated questionnaires. sex: ALL minimumAge: 15 Years maximumAge: 17 Years stdAges: CHILD facility: Muhammad Hamidie bin Saari city: Kuala Lumpur state: Wilayah Persukutuan Kuala Lumpur zip: 50480 country: Malaysia name: Zamros Yuzadi Mohd Yusof, PHD role: CONTACT name: Zamros Yuzadi Mohd Yusof, PHD role: PRINCIPAL_INVESTIGATOR name: Marhazlinda Jamaludin, Master role: PRINCIPAL_INVESTIGATOR name: Unaizah Hanum Obaidellah, PHD role: PRINCIPAL_INVESTIGATOR name: Nazirah Ab Mumin, PHD role: PRINCIPAL_INVESTIGATOR lat: 3.1412 lon: 101.68653 hasResults: False |
<|newrecord|> nctId: NCT06381687 id: 2023-3118978 id: PID2022-141095NB-I00 type: OTHER_GRANT domain: Spanish Ministry of Science, Innovation and Universities briefTitle: A Movement and Music Programme in Early Childhood Education and Care (The MoviMusi Study Protocol) acronym: MOVIMUSI overallStatus: RECRUITING date: 2024-03-20 date: 2024-07-31 date: 2025-07-31 date: 2024-04-24 date: 2024-04-24 name: University of Valencia class: OTHER briefSummary: The early childhood education and care (ECEC) environment is an important setting for providing children with daily opportunities for movement and music, supporting holistic child development in the early years. To date, there are no studies evaluating the implementation of a holistic programme in the ECEC context in the areas of movement behaviour, motor, and musical skills. The main aim is to examine the impact over time of a holistic movement and music programme on correlates of movement behaviour, gross and fine motor skills, and musical skills in young children (1-3 years). The secondary aims are to examine the impact of the movement and music programme on the perceptions of the educational community, as well as the barriers and facilitators they perceive in the process of baseline assessment, construction, and implementation of the movement and music programme in their own ECEC community. This cluster-randomised controlled trial (intervention and control groups) with public ECEC centres will be performed over a 24-month period. Baseline measurements will be taken in the first year of the project, and the longitudinal evaluation of the implementation of the movement and music programme in the second year. educational community's perceptions about the barriers and facilitators associated with the correlates of movement behaviour will be taken into account, as will the results of the assessment of gross and fine motor and musical skills identified in the first year of the project, with a special focus on the structured and unstructured opportunities for movement and music both in the ECEC settings and at home. This research project aims to fill a knowledge gap during a period of childhood that has rarely been explored, either nationally or internationally (1-3 years), and to position movement and music teaching practices as key contexts in the curriculum development of infant and toddler education. conditions: Fundamental Motor Skills conditions: Physical Activity conditions: Music Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The allocation of ECECs to the intervention versus control group will be randomised in a blinded procedure at the end of the first year, following the baseline assessment. Once ECEC centres meeting the selection criteria are identified, they will be randomised to one of the trial arms. primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 312 type: ESTIMATED name: A multi-component, multi-level programme (MoviMusi) measure: Physical activity measure: Sleep time measure: Motor skills measure: Musical skills measure: Sedentary time measure: For young children, the first secondary outcome measure is physical activity and sedentary time during unstructured and structured physical activity opportunities. measure: For young children, the second secondary outcome measure will be the play patterns during unstructured outdoor free play. measure: For ECEC educators, the first secondary outcome will be the perceived barriers and facilitators for the inclusion of movement and music as curricular practices in the ECEC institution. measure: For ECEC educators, the second secondary outcome will be the perceived impact of the implementation of the movement and music program. measure: For families, the first secondary outcome is the perceived barriers and facilitators to PA in young children. measure: For families, the second secondary outcome is the perceived barriers and facilitators to the inclusion of music at home. measure: For families, the third secondary outcome are the means of transport to ECEC settings and barriers to active comm measure: For families, the fourth secondary outcome is the habitual perceived PA and sedentary behaviour in the child's home environment. measure: For families, the fifth secondary outcome is the perceived barriers and facilitators to PA in young children. sex: ALL minimumAge: 14 Months maximumAge: 22 Months stdAges: CHILD facility: University of Valencia status: RECRUITING city: Valencia state: Comunidad Valenciana zip: 46021 country: Spain name: Vladimir Martínez-Bello, Ph.D. role: CONTACT phone: 34961625473 email: [email protected] name: María del Mar Bernabé-Villodre, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Herminia Vega-Perona, Ms.Sc. role: SUB_INVESTIGATOR name: José Díaz-Barahona, Ph.D. role: SUB_INVESTIGATOR name: Yolanda Cabrera García-Ochoa, Ph.D. role: SUB_INVESTIGATOR name: Sandra Molines-Borrás, Ph.D. role: SUB_INVESTIGATOR name: Felipe Gertrudix, Ph. D. role: SUB_INVESTIGATOR name: Juan Carlos Montoya-Rubio, Ph. D. role: SUB_INVESTIGATOR name: María Ángeles Fernández-Vilar, Ph. D. role: SUB_INVESTIGATOR name: José Manuel Azorín, Ph. D. role: SUB_INVESTIGATOR name: Nataliya Filenko, Ph. D. role: SUB_INVESTIGATOR name: Daniel Martínez-Bello, Ph.D. role: SUB_INVESTIGATOR name: Ángela Martínez, Ph.D. role: SUB_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False |
<|newrecord|> nctId: NCT06381674 id: OHSU: 25890 id: HT9425-23-1-0845 type: OTHER_GRANT domain: Department of Defense briefTitle: Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation acronym: SuBTyPE overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2028-09-30 date: 2028-09-30 date: 2024-04-24 date: 2024-04-24 name: Oregon Health and Science University class: OTHER name: United States Department of Defense briefSummary: Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy. conditions: Mild Traumatic Brain Injury, Concussion conditions: Rehabilitation conditions: Balance Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There will be two groups in this study that will be randomized concurrently into two different rehabilitation programs. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Parties that will be masked include those collecting and analyzing data before and after rehabilitation (post-doctorate fellows, research assistants, and statistician). whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback name: Vestibular therapy for mTBI measure: Patient Global Impression of Change (PGIC) measure: Concussion Clinical Profiles Screening (CP Screening) measure: Dizziness Handicap Index (DHI) measure: Quality of Life After Brain Injury (QOLIBRI) measure: The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a measure: Hospital Anxiety and Depression Scale (HADS) measure: Headache Impact Test (HIT-6) measure: Insomnia Severity Index (ISI) measure: Neck Disability Index (NDI) measure: Convergence Insufficiency Symptom Survey (CISS) measure: Vertigo Symptom Scale (VSS) measure: Concussion Symptom Subtypes Inventory (CSSI) measure: Automated Neuropsychological Assessment Metric (ANAM) measure: Dynamic Visual Acuity ( DVA-Clinical) measure: Ocular Motor Function Tests measure: Video Head Impulse Test (vHIT) measure: Functional Gait Assessment (FGA) measure: Complex Turning Course (CTC) measure: Modified Balance Error Scoring System (mBESS) measure: Modified Clinical Test for Sensory Integration on Balance (mCTSIB) measure: Instrumented One Minute Walk (Single and Dual Task) measure: Hybrid Assessment of Mobility (HAM-4) measure: Tandem Gait (Single and Dual Task) measure: Vestibular Ocular Motor Screening (VOMS) measure: Central Sensorimotor Integration Testing (CSMI) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Oregon Health & Science University city: Portland state: Oregon zip: 97239-3098 country: United States lat: 45.52345 lon: -122.67621 facility: Fort Sam Houston city: San Antonio state: Texas zip: 78234 country: United States lat: 29.42412 lon: -98.49363 facility: University of Utah city: Salt Lake City state: Utah zip: 84112 country: United States lat: 40.76078 lon: -111.89105 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol and ICF date: 2024-02-13 uploadDate: 2024-03-07T11:25 filename: Prot_SAP_ICF_000.pdf size: 1554413 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan: Updated Statistical Analysis Document date: 2024-04-02 uploadDate: 2024-04-04T19:41 filename: SAP_001.pdf size: 112584 hasResults: False |
<|newrecord|> nctId: NCT06381661 id: APHP240385 briefTitle: Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial acronym: PALETTE overallStatus: NOT_YET_RECRUITING date: 2026-04-01 date: 2029-05-01 date: 2032-04-01 date: 2024-04-24 date: 2024-04-24 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context. conditions: Sepsis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization will concern 3 specific domains (immunomodulation, coagulation, and corticosteroids); in each domain, patients will be randomly allocated between control (standard of care) and 1-4 experimental treatments using parallell arms primaryPurpose: TREATMENT masking: NONE count: 2000 type: ESTIMATED name: Tocilizumab name: Baricitinib name: Anakinra name: Hydrocortisone name: Hydrocortisone and fludrocortisone name: Heparin name: Low molecular weight heparin name: Recombinant humanThrombomodulin( rhTM) name: Sivelestat name: Fresh frozen plasma name: Usual care measure: All-cause mortality measure: Number of patients with persistent life-supportive therapies measure: Composite of the two primary outcomes measure: Overall Survival measure: Overall Survival measure: Overall Survival measure: Number of hospital free days measure: Number of hospital free days measure: Time to recover walking measure: Time to resume previous social and professional activities measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Number of adverse events measure: Incidence of new sepsis episodes measure: Incidence of new sepsis episodes measure: Incidence of new sepsis episodes measure: Incidence of new unscheduled hospitalizations measure: Incidence of new unscheduled hospitalizations measure: Incidence of new unscheduled hospitalizations measure: Incidence of sequels in neurocognitive, neuromuscular; cardiovascular, respiratory, renal, metabolic, and immune systems sex: ALL minimumAge: 37 Weeks maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06381648 id: 23228/LyMIC briefTitle: Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC) acronym: LyMIC overallStatus: RECRUITING date: 2023-04-15 date: 2026-06-18 date: 2026-06-18 date: 2024-04-24 date: 2024-04-25 name: City of Hope Medical Center class: OTHER briefSummary: Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC. |
This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients. conditions: Cholangiocarcinoma conditions: Cholangiocarcinoma, Intrahepatic conditions: Cholangiocarcinoma Resectable conditions: Cholangiocarcinoma; Liver studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91016 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: [email protected] name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR name: Takayuki Noma, MD role: SUB_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University status: RECRUITING city: Hokkaido state: Sapporo zip: 060-8648 country: Japan name: Akinobu Taketomi, PhD role: CONTACT email: [email protected] name: Kazuki Wakizaka, PhD role: SUB_INVESTIGATOR name: Akinobu Taketomi, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.41104 lon: 142.88878 facility: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University status: RECRUITING city: Fukuoka zip: 812-8582 country: Japan name: Masaki Mori, PhD role: CONTACT email: [email protected] name: Masaki Mori, PhD role: PRINCIPAL_INVESTIGATOR name: Takeo Toshima, PhD role: SUB_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: Department of Surgery, Tokushima University status: RECRUITING city: Tokushima zip: 770-8503 country: Japan name: Mitsuo Shimada, PhD role: CONTACT email: [email protected] name: Yuma Wada, PhD role: SUB_INVESTIGATOR name: Takayuki Noma, MD role: SUB_INVESTIGATOR name: Yuji Morine, PhD role: SUB_INVESTIGATOR name: Tetsuya Ikemoto, PhD role: SUB_INVESTIGATOR name: Yu Saito, PhD role: SUB_INVESTIGATOR name: Mitsuo Shimada, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.06667 lon: 134.56667 hasResults: False |
<|newrecord|> nctId: NCT06381635 id: FD-BUE-REC: IRB000124920 briefTitle: Effect of Aloe Vera Gel and Manuka Honey on Radiation Induced Oral Mucositis overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2025-01-01 date: 2024-04-24 date: 2024-04-24 name: Ain Shams University class: OTHER briefSummary: The goal of this \[ type of study: Clinical trial\] is to test effectiveness of Aloe Vera Gel and Manuka Honey in management of Radiation Induced Mucositis in head and neck cancer patients. |
The main question \[s\] \] is to \[ learn about, test, compare etc.\] it aims to answer are: |
1. Is Aloe Vera Gel and Manuka Honey effective in management of Radiation Induced Mucositis? |
2. Does Aloe Vera Gel and Manuka Honey affect the level of TGFβ1 and EGF in saliva of patients with radiation induced mucositis? participants will be asked to apply Aloe Vera Gel and Manuka Honey or saline three times daily during radiotherapy and 6 months after radiotherapy. conditions: Radiation Mucositis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Manuka honey mixed with aloe vera gel measure: Change from World Health Organization Oral Toxicity Scale Grading of Oral Mucositis measure: the level of salivary transforming growth factor beta 1 measure: the level of salivary Epidermal Growth factor (EGF) sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ain shams University status: RECRUITING city: Cairo zip: 11565 country: Egypt name: hani wlliam, MD role: CONTACT phone: +20 0001000093885 email: [email protected] lat: 30.06263 lon: 31.24967 facility: Fatma E.Sayed status: RECRUITING city: Cairo country: Egypt name: Fatma E. Hassanein, PHD role: CONTACT phone: +201000093885 email: [email protected] name: Asma Abou Bakr role: CONTACT email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06381622 id: CTA no: 2023-510028-63-00 briefTitle: Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block overallStatus: RECRUITING date: 2024-04-18 date: 2024-08-03 date: 2024-09-03 date: 2024-04-24 date: 2024-04-24 name: Nordsjaellands Hospital class: OTHER briefSummary: The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery. conditions: Nerve Block conditions: Anesthesia, Local conditions: Forearm Fracture conditions: Surgery conditions: Brachial Plexus Block studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Ropivacaine 0.5% Injectable Solution name: Lidocaine epinephrine name: Ropivacaine 0.75% Injectable Solution measure: Total time to breakthrough pain measure: The onset of sensory block measure: Total duration of sensory blockade measure: Total duration of motor blockade measure: Degree of motor blockade measure: Pain intensity at pain breakthrough measure: Duration of maximum pain intensity after the blockade has ended measure: Occurence of adverse events (AE) and serious adverse events (SAE) measure: Failed blockade measure: The patient's experience of the treatment (patient satisfaction) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nordsjælland Hospital status: RECRUITING city: Hillerød zip: 3400 country: Denmark name: Lars H Lundstrøm, PhD role: CONTACT phone: 48296512 phoneExt: 45 email: [email protected] name: Christian Rothe, PhD role: CONTACT phone: 48297459 phoneExt: 45 email: [email protected] lat: 55.92791 lon: 12.30081 hasResults: False |
<|newrecord|> nctId: NCT06381609 id: 69HCL22_0901 briefTitle: Peer Support in Alcohol Dependence acronym: PEERSIAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-11-01 date: 2027-11-01 date: 2024-04-24 date: 2024-04-24 name: Hospices Civils de Lyon class: OTHER briefSummary: Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment. |
However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome. |
Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.