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protocolSection identificationModule nctId: NCT06318546, orgStudyIdInfo id: FMASU MS59/2024, briefTitle: Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section, conditionsModule conditions: Post Spinal Shivering, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine Injection [Precedex],,,, interventions name: Fentanyl, outcomesModule primaryOutcomes measure: Post spinal shivering, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06318533, orgStudyIdInfo id: 2023-11-01, briefTitle: A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2025-03-13, completionDateStruct date: 2026-03-13, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: YANRU WANG, class: OTHER, collaborators name: Rui Therapeutics Co., Ltd, descriptionModule briefSummary: A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10\^9 cells, 9×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with relapsed/refractory B-cell related autoimmune diseases., conditionsModule conditions: Autoimmune Diseases, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: anti-CD19 CAR NK cells, outcomesModule primaryOutcomes measure: Incidence of Dose Limiting Toxicity (DLTs), primaryOutcomes measure: Treatment Emergent Adverse Events（TEAEs）, secondaryOutcomes measure: Disease control rate of subjects, secondaryOutcomes measure: Remission rate of subjects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Hospital of Jiangsu University, status: RECRUITING, city: Zhenjiang, state: Jiangsu, zip: 212001, country: China, contacts name: Yu Tang, role: CONTACT, phone: 086-13815153350, email: tangtang@ujs.edu, contacts name: Yu Tang, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Jiangsu University Affiliated Hospital, status: RECRUITING, city: Zhenjiang, state: Jiangsu, zip: 212001, country: China, contacts name: Yanru Wang, role: CONTACT, phone: 0511-85026079, email: tangtang@ujs.edu, contacts name: Yu Tang, Doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.21086, lon: 119.45508, hasResults: False
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protocolSection identificationModule nctId: NCT06318520, orgStudyIdInfo id: AFSU-DHF-TOPAL-001, briefTitle: Clinical Success of Stainless Steel Crowns Applied Using Different Cements, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Afyonkarahisar Health Sciences University, class: OTHER, descriptionModule briefSummary: The main question of the study was to evaluate the one-year clinical success of SSc bonded with two different cement types in MIH teeth with excessive material loss. The researchears will compare the survival rate, effect on gingival health and radiographic success of calcium silicate-based resin-containing cement and resin-modified glass ionomer cement., conditionsModule conditions: Dental Enamel Hypomineralization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Use of Calcium silicate based resin cement and resin modified glass ionomer cement, outcomesModule primaryOutcomes measure: Anatomical Integrity, primaryOutcomes measure: Marginal Compliance, primaryOutcomes measure: Proximal Contact, primaryOutcomes measure: Crown Marginal Location, primaryOutcomes measure: Restoration success, primaryOutcomes measure: Green and Vermillion's Oral Hygiene Index, secondaryOutcomes measure: Marginal Fit of the Crown (RADIOLOGICAL), eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Afyonkarahisar Health Sciences University, city: Afyonkarahisar, zip: 03030, country: Turkey, contacts name: Burcu GUCYETMEZ TOPAL, Asst.Prof, role: CONTACT, phone: +90 530 281 35 85, email: dt.burcugucyetmez@hotmail.com, contacts name: Esma ATIS, Res.Ass., role: SUB_INVESTIGATOR, geoPoint lat: 38.75667, lon: 30.54333, hasResults: False
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protocolSection identificationModule nctId: NCT06318507, orgStudyIdInfo id: PBRC 2023-014, briefTitle: The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy, acronym: IMPACT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Pennington Biomedical Research Center, class: OTHER, descriptionModule briefSummary: This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not., conditionsModule conditions: Breast Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Fecal microbial diversity, outcomesModule primaryOutcomes measure: Pathologic Complete Response (pCR), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pennington Biomedical Research Center, status: RECRUITING, city: Baton Rouge, state: Louisiana, zip: 70808, country: United States, contacts name: Justin Brown, Ph.D., role: CONTACT, phone: 225-763-2715, email: justin.brown@pbrc.edu, geoPoint lat: 30.45075, lon: -91.15455, hasResults: False
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protocolSection identificationModule nctId: NCT06318494, orgStudyIdInfo id: Ankle-optogait, briefTitle: Analysis of Jumping in Patients With Ankle Instability (Ankle-optogait), acronym: Ankle-optoga, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-04-28, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: The study is, in accordance with current legislation, definable as a single-center interventional study with evaluations carried out at a single timeframe.The objective of the study is to compare jumping performance between subjects with ankle instability and healthy volunteer subjects.In particular, the primary objective is to verify the difference in the monopodalic CMJ value of the diseased limb of subjects with ankle instability compared to the control group at time 0.The population is made up of patients suffering from ankle instability and a control group of healthy volunteers, divided as follows:25 subjects GROUP A: Study group: patients suffering from ankle instability25 subjects GROUP B: control group: healthy voluntary subjects not affected by ankle pathology, conditionsModule conditions: Ankle Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: jumping performance, outcomesModule primaryOutcomes measure: verify the difference in the monopodalic CMJ (countermovement jump test) of the diseased limb of subjects with ankle instability compared to the control group, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istituto Clinico San Siro, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06318481, orgStudyIdInfo id: IRB-80/2023, briefTitle: TADCLOT- a Double Blind Randomized Controlled Trial, acronym: TADCLOT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: National Institute of Cardiovascular Diseases, Pakistan, class: OTHER, collaborators name: PharmEvo Pvt Ltd, descriptionModule briefSummary: Compare the safety and efficacy of a twice-daily Clopidogrel regimen vs. Ticagrelor in reducing major adverse events in patients undergoing primary PCI in a double-blind randomized controlled trial., conditionsModule conditions: Stent Thrombosis, conditions: Myocardial Infarction, Acute, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Care provider and investigator are same so both are blinded in the trial., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 2200, type: ESTIMATED, armsInterventionsModule interventions name: Ticagrelor 90 MG, interventions name: Clopidogrel, outcomesModule primaryOutcomes measure: Evaluation of efficacy and safety, secondaryOutcomes measure: Secondary endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institute of Cardiovascular Diseases, status: RECRUITING, city: Karachi, state: SIndh, zip: 755000, country: Pakistan, contacts name: Abdul Hakeem, MD, role: CONTACT, phone: 6086953048, email: ahakeem@gmail.com, contacts name: Jehangir Shah, MBBS, role: CONTACT, email: jehangirshah91@gmail.com, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06318468, orgStudyIdInfo id: N202306106, briefTitle: The Effectiveness of Various Teaching Methods to Enhance the Comprehensive Nursing Assessment Skills of New Nurses, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Taipei Medical University WanFang Hospital, class: OTHER, descriptionModule briefSummary: This study is going to compare different teaching strategies for improving newly recruited nurses' comprehensive nursing assessment skills., conditionsModule conditions: Competence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Nursing health assessment teaching and discussion using humanoid diagrams, interventions name: Nursing health assessment teaching and discussion using case study, outcomesModule primaryOutcomes measure: Comprehensive health assessment questionnaire, primaryOutcomes measure: Comprehensive health assessment questionnaire, primaryOutcomes measure: Comprehensive health assessment questionnaire, primaryOutcomes measure: Confidence scale (C-scale), primaryOutcomes measure: Confidence scale (C-scale), primaryOutcomes measure: Confidence scale (C-scale), secondaryOutcomes measure: Course satisfaction questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei Medical University WanFang Hospital, city: Taipei, country: Taiwan, contacts name: Mei Fen Tang, master, role: CONTACT, phone: 0970746226, email: 5053@w.tmu.edu.tw, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06318455, orgStudyIdInfo id: İstanbul University-Cerrahpaşa, briefTitle: The Effect of Breathing Exercise on Sleep and Stress Levels in Women With Breast Cancer Receiving Chemotherapy Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Yalova, class: OTHER, descriptionModule briefSummary: Women receiving chemotherapy have poor sleep quality and high stress levels. With a method such as breathing exercise, which can be applied at any time without side effects, positive improvements in women's sleep and stress levels can be recorded., conditionsModule conditions: Women Receiving Chemotherapy, conditions: 18 Years of Age and Above, conditions: Women With High Stress Levels, conditions: Women With Poor Sleep Quality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: Breathing exercise, outcomesModule primaryOutcomes measure: anxiety state scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of İstanbul-cerrahpaşa (IUC), status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Gürcan Solmaz, PhD, role: CONTACT, phone: +90 5556287897, email: gurcansolmaz@hotmail.com, contacts name: Gürcan Solmaz, role: CONTACT, phone: +90 5556287897, email: gurcansolmaz@hotmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06318442, orgStudyIdInfo id: 22HH8018, briefTitle: The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, descriptionModule briefSummary: TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study)DESIGN: A double-blind study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily. This is a mechanistic experimental medicine study.AIMS: To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin.OUTCOME MEASURES:* Primary: Glucose tolerance in response to standardised mixed meal test (MMT) lasting for 240 minutes, measured in all participants at baseline and on day 7 DEX.* Secondary: Indices of insulin resistance (M-value), beta-cell function (acute insulin response to glucose) and disposition, as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp, performed at baseline and on day 7 DEX.* Exploratory: Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies, taken from a subset of approximately 8 individuals in each group.ELIGIBILITY: People living with pre-diabetes or lifestyle controlled diabetesSTUDY DURATION: This study will take place over 3 weeks for each partcipant. Study procedures include 10 days of baseline continuous glucose monitoring (CGM) followed by 7 days of dexamethasone with GLP-1, metformin or placebo. Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug. The study will run over a period of 3 years.ANTICIPATED IMPACT: Mechanistic evidence for the use of GLP-1 analogues, compared with metformin, in the treatment of steroid-induced diabetes., conditionsModule conditions: Steroid-Induced Diabetes, conditions: Steroid Induced Hyperglycemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Semaglutide Oral Product, interventions name: Metformin Oral Tablet, interventions name: Placebo, outcomesModule primaryOutcomes measure: Difference in Glucose tolerance, secondaryOutcomes measure: Difference in insulin secretion, secondaryOutcomes measure: Difference in insulin sensitivity, secondaryOutcomes measure: Difference in insulin sensitivity, secondaryOutcomes measure: Difference in insulin sensitivity, otherOutcomes measure: Mean glucose and glycaemic variation by continuous glucose monitoring (CGM), using a validated blinded system (Dexcom G7)., otherOutcomes measure: Changes in fasting gut hormones, otherOutcomes measure: Changes in fasting gut hormones, otherOutcomes measure: Changes in fasting gut hormones, otherOutcomes measure: Changes in fasting lipid profile, otherOutcomes measure: Changes in post prandial gut hormones, otherOutcomes measure: Changes in post prandial gut hormones, otherOutcomes measure: Changes in anthropometrics, otherOutcomes measure: Changes in anthropometrics, otherOutcomes measure: Tissue specific changes in AMPK determined from adipose and muscle biopsies, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Imperial College Healthcare NHS Trust, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06318429, orgStudyIdInfo id: diabet, briefTitle: Evaluation of the Effect of Stretching Exercises Applied to Diabetes Patients on Physiological Parameters and Compliance to Treatment: A Randomized Controlled Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Yalova, class: OTHER, descriptionModule briefSummary: This research will be carried out as a pretest-posttest randomized controlled study to determine the effect of stretching exercises performed 2 days a week for 12 weeks for one hour each session on physiological parameters and treatment compliance in individuals with diabetes., conditionsModule conditions: Individuals With Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: stretching exercise group, outcomesModule primaryOutcomes measure: blood sugar, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of İstanbul-cerrahpaşa (IUC), city: Istanbul, country: Turkey, contacts name: GÜRCAN Solmaz, PhD, role: CONTACT, phone: +90 5556287897, email: gurcansolmaz@hotmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06318416, orgStudyIdInfo id: HSR230382, briefTitle: Precision Rifampin Trial for Personalized Dosing, acronym: P-RIF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-01-30, completionDateStruct date: 2028-01-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, collaborators name: Haydom Lutheran Hospital, collaborators name: Rutgers University, descriptionModule briefSummary: Individual pharmacokinetic variability is an important driver of tuberculosis (TB) treatment failure particularly among undernourished populations, and that suboptimal serum drug concentrations are associated with delayed response to treatment, death, and acquired bacterial drug resistance. Serum drug exposures can be approximated by urine excretion as measured by spectrophotometry, replacing the need for specialized equipment for serum testing. Anti-TB pharmacokinetic variability has also been associated with enteric pathogen burden. The overall hypothesis is that urine spectrophotometry will identify people with below-target rifampin serum concentrations, which can be corrected to target levels after dose adjustment as confirmed by serum mass spectrometry. Therefore, this protocol includes a clinical trial to assess efficacy and safety of rifampin dose adjustment based on urinary excretion levels among adults and children who are being treated for drug-sensitive pulmonary TB at our longstanding collaborative research site in Haydom Lutheran Hospital, Tanzania., conditionsModule conditions: Tuberculosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: urine spectrophotometry for rifampin absorbance, outcomesModule primaryOutcomes measure: Rifampin serum area under the concentration time curve for the 24 hour dosing interval, primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Time to sputum culture conversion to negative, secondaryOutcomes measure: Weight change, eligibilityModule sex: ALL, minimumAge: 3 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06318403, orgStudyIdInfo id: 177012, briefTitle: Estradiol Supplementation and Rotator Cuff Repair, acronym: ESTRCR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: Rotator cuff tears in the shoulder are common, often cause pain and disability, often fail to heal with surgery, and both tears and failure of healing are associated with estradiol deficiency. In this study, women who have gone through menopause will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, and function when given with rotator cuff repair., conditionsModule conditions: Rotator Cuff Tears, conditions: Rotator Cuff Injuries, conditions: Rotator Cuff Syndrome, conditions: Menopause Related Conditions, conditions: Menopause, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Transdermal estrogen, interventions name: Rotator Cuff Repair Surgery, outcomesModule primaryOutcomes measure: American Shoulder and Elbow Surgeons (ASES) Score, secondaryOutcomes measure: Simple Shoulder Test (SST) Score, secondaryOutcomes measure: Visual Analogue Score (VAS) for pain, secondaryOutcomes measure: Magnetic Resonance Imaging (MRI) tendon healing, secondaryOutcomes measure: Strength Assessment, secondaryOutcomes measure: Range of motion, otherOutcomes measure: Serum Hormone Measurement, otherOutcomes measure: Patch Count, otherOutcomes measure: Averse Event Assessment, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06318390, orgStudyIdInfo id: 2023-0271, briefTitle: The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: The University of Texas at Arlington, class: OTHER, descriptionModule briefSummary: The primary objectives of this application are to 1) investigate the effect of increased daily consumption of the Keto5 XOGenius beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. And 2) to investigate the effect of daily consumption of the Keto5 XOGenius beverage on the following variables: waist circumference, body weight, and body mass index (BMI)., conditionsModule conditions: Cardiovascular Diseases, conditions: Hypertension, conditions: Cognitive Decline, conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: XO Genius, outcomesModule primaryOutcomes measure: Endothelial Function, primaryOutcomes measure: Neurocognitive Function, primaryOutcomes measure: Peripheral blood pressure (systolic, diastolic, mean), primaryOutcomes measure: Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG), primaryOutcomes measure: Arterial stiffness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: UT Arlington - Science and Engineering Innovation and Research Building, status: RECRUITING, city: Arlington, state: Texas, zip: 76019, country: United States, contacts name: Robert M Brothers, PhD, role: CONTACT, phone: 817-272-3288, email: matthew.brothers@uta.edu, contacts name: Alison Mancera, BS, role: CONTACT, phone: 8172723288, email: alison.mancera@mavs.uta.edu, geoPoint lat: 32.73569, lon: -97.10807, hasResults: False
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protocolSection identificationModule nctId: NCT06318377, orgStudyIdInfo id: 2022-0541, briefTitle: Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: The University of Texas at Arlington, class: OTHER, descriptionModule briefSummary: The overall research objective of this proposal is to determine the impact of increased daily peanut consumption on indices of neurocognitive and physiological health in BL individuals, conditionsModule conditions: Cardiovascular Diseases, conditions: Hypertension, conditions: Cognitive Decline, conditions: Diet, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Individual will be randomly assigned either an experimental or a control condittion, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Peanut group, outcomesModule primaryOutcomes measure: Endothelial Function, primaryOutcomes measure: Neurocognitive Function, primaryOutcomes measure: Peripheral blood pressure (systolic, diastolic, mean), primaryOutcomes measure: Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG), primaryOutcomes measure: Arterial stiffness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: UT Arlington - Science and Engineering Innovation and Research Building, status: RECRUITING, city: Arlington, state: Texas, zip: 76019, country: United States, contacts name: Robert M Brothers, PhD, role: CONTACT, phone: 817-232-3156, email: matthew.brothers@uta.edu, contacts name: Alison Mancera, role: CONTACT, phone: 817-232-3156, email: alison.mancera@mavs.uta.edu, geoPoint lat: 32.73569, lon: -97.10807, hasResults: False
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protocolSection identificationModule nctId: NCT06318364, orgStudyIdInfo id: TJ-IRB202402016, briefTitle: Postoperative Delirium in the Post-anesthesia Care Unit, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Qin Zhang, class: OTHER, collaborators name: National Natural Science Foundation of China, descriptionModule briefSummary: This study aims to investigate the incidence of postoperative delirium (POD) in the PACU and analyze its influencing factors, in order to provide theoretical basis for early screening and intervention for high-risk POD population. Blood samples of some study subjects will be collected and analyzed using molecular detection methods to provide a basis and insights into the pathophysiological mechanisms of POD., conditionsModule conditions: Delirium, Postoperative, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3320, type: ESTIMATED, armsInterventionsModule interventions name: NO Intervention, outcomesModule primaryOutcomes measure: Postoperative delirium, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Hospital of Harbin Medical University, status: RECRUITING, city: Harbin, state: Heilongjiang, zip: 150000, country: China, contacts name: Yuting Liu, role: CONTACT, phone: Hongyan, email: qin4298@sina.com, contacts name: Yuting Ma, role: CONTACT, phone: 3680, email: qin4298@sina.com, geoPoint lat: 45.75, lon: 126.65, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Xiao Ran, phd, role: CONTACT, phone: 15926207366, email: ranxiao1001@tjh.tjmu.edu.cn, contacts name: Qin Zhang, phd, role: CONTACT, phone: 15717154768, email: qzhang8@tjh.tjmu.edu.cn, contacts name: Qin Zhang, phd, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06318351, orgStudyIdInfo id: TJ-IRB202402015, briefTitle: Transcutaneous Acupoint Electrical Stimulation and Postoperative Delirium Delirium, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Qin Zhang, class: OTHER, collaborators name: National Natural Science Foundation of China, descriptionModule briefSummary: Investigating postoperative delirium in patients undergoing thoracoscopic lung resection surgery who have received or not received relevant transcutaneous acupoint electrical stimulation treatment preoperatively, observing postoperative recovery quality indicators, evaluating the necessity of treatment, and clarifying the potential mechanisms by which transcutaneous acupoint electrical stimulation may improve postoperative delirium., conditionsModule conditions: Delirium, Postoperative, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 476, type: ESTIMATED, armsInterventionsModule interventions name: transcutaneous acupoint electrical stimulation, outcomesModule primaryOutcomes measure: Delirium, secondaryOutcomes measure: Recovery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Hospital of Traditional Chinese Medicine, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Jiemin Deng, role: CONTACT, phone: 2780, email: qin4298@sina.com, contacts name: Jiemin Deng, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Qin Zhang, phd, role: CONTACT, phone: 15717154768, email: qzhang8@tjh.tjmu.edu.cn, contacts name: Qin Zhang, phd, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06318338, orgStudyIdInfo id: UPCC 14523, secondaryIdInfos id: 854756, type: OTHER, domain: Penn IRB, briefTitle: Virtual Reality to Promote Relaxation Prior to Simulation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Abramson Cancer Center at Penn Medicine, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the feasibility of a pre-simulation virtual reality (VR) platform designed to promote relaxation for cancer patients planned for radiation therapy (RT)., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality Program, outcomesModule primaryOutcomes measure: Feasibility of a pre-simulation VR platform prior to radiation, secondaryOutcomes measure: Patient feedback on pre-simulation VR program, secondaryOutcomes measure: Patient situational anxiety prior to and after use of VR program, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Perelman Center for Advanced Medicine, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Ching Lai, role: CONTACT, phone: 267-250-9244, email: Ching.Lai@pennmedicine.upenn.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06318325, orgStudyIdInfo id: ADINEGEV-2021_102, briefTitle: Growth Process and Development of the Musculoskeletal System in Young Gymnasts, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Haifa, class: OTHER, collaborators name: The Academic college Levinsky-Wingate at the Wingate Institute, Netanya, Israel, descriptionModule briefSummary: assessment of the musculoskeletal system will be performed twice a year, for three years of young gymnasts., conditionsModule conditions: Development, Adolescent, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: examination, outcomesModule primaryOutcomes measure: ultrasound tissue characterized, primaryOutcomes measure: muscle strength test, primaryOutcomes measure: range of motion, primaryOutcomes measure: bone strength, primaryOutcomes measure: Bone Age, eligibilityModule sex: FEMALE, minimumAge: 9 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: The Academic college Levinsky-Wingate at the Wingate Institute, status: RECRUITING, city: Netanya, country: Israel, geoPoint lat: 32.33291, lon: 34.85992, hasResults: False
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protocolSection identificationModule nctId: NCT06318312, orgStudyIdInfo id: HYP_MR_2024, briefTitle: Effects of Hypoxia on Cognitive Performance, acronym: HYPCOG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2024-04-12, completionDateStruct date: 2024-05-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Castilla-La Mancha, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to determine the effects of different hypoxia exposures (FiO2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. The main questions it aims to answer are:* What is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks?* Which hypoxia exposure causes the greatest detriments in cognitive function?, conditionsModule conditions: Hypoxia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Hypoxia, outcomesModule primaryOutcomes measure: Memory, primaryOutcomes measure: Attention, primaryOutcomes measure: Anticipation, primaryOutcomes measure: Reaction time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06318299, orgStudyIdInfo id: 109227, briefTitle: Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid, acronym: KetoBrain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, collaborators name: Aarhus University Hospital, descriptionModule briefSummary: It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies.Ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-OHB). 3-OHB is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (MCTs) across the blood-brain barrier.To our knowledge, no studies in human adults exist that concurrently measure 3-OHB concentrations in blood and cerebrospinal fluid (CSF) after ingestion or infusion of exogenous ketone supplementation, necessitating further study.Aims:* The 3-OHB CSF/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint* The window of effect: Ketone supplementation 1 h or 2 h before CSF sampling* If concentration measurements by point-of-care testing are non-inferior to mass spectrometry* If acute 3-OHB ingestion increases plasma brain-derived neurotrophic factor (BDNF) levels, conditionsModule conditions: Ketosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Ketone Ester, interventions name: Placebo, outcomesModule primaryOutcomes measure: 3-OHB CSF/blood ratio, secondaryOutcomes measure: CSF 3-OHB concentrations, POCT, secondaryOutcomes measure: CSF 3-OHB concentrations, Mass Spectrometry, secondaryOutcomes measure: CSF glucose concentrations, secondaryOutcomes measure: Blood 3-OHB concentrations, secondaryOutcomes measure: Plasma 3-OHB concentrations, secondaryOutcomes measure: Blood glucose concentrations, secondaryOutcomes measure: Plasma BDNF concentrations, secondaryOutcomes measure: Blood 3-OHB concentrations, secondaryOutcomes measure: Plasma 3-OHB concentrations, secondaryOutcomes measure: Blood glucose concentrations, secondaryOutcomes measure: Plasma BDNF concentrations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aarhus University Hospital, city: Aarhus, zip: 8200, country: Denmark, contacts name: Simon Kjær Simonsen, MD, role: CONTACT, phone: +45 28769491, email: simkjr@clin.au.dk, contacts name: Mads Vandsted Svart, PhD, role: CONTACT, phone: +45 28118221, email: mvsv@clin.au.dk, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
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protocolSection identificationModule nctId: NCT06318286, orgStudyIdInfo id: MK3475-IIT-60977, briefTitle: Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma, acronym: PENINSULA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-10-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Hyogo Medical University, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: In this Phase-II study, the investigators will investigate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma., conditionsModule conditions: Malignant Pleural Mesothelioma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a single-arm, open-label study to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma. Patients 18 years of age or older will be eligible for enrollment if they had histologically confirmed unresectable malignant pleural mesothelioma., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Lenvatinib, interventions name: Pemetrexed, interventions name: Cisplatin/Carboplatin, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Tumor shrinkage (response rate) (Physician Judgment by Medical Institution, Modified RECIST [Response Evaluation Criteria in Solid Tumors] criteria), secondaryOutcomes measure: Progression-Free survival (PFS) (Physician Judgment by Medical Institution, Modified RECIST criteria), secondaryOutcomes measure: Overall survival time (OS), secondaryOutcomes measure: Tumor shrinkage (disease control rate) (Physician Judgment by Medical Institution, Modified RECIST criteria), secondaryOutcomes measure: Duration of response (Physician Judgment by Medical Institution, Modified RECIST criteria), secondaryOutcomes measure: Best overall response (Physician Judgment by Medical Institution, Modified RECIST criteria), secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hyogo Medical University Hospital, city: Nishinomiya, state: Hyogo, zip: 6638501, country: Japan, contacts name: Kozo Kuribayashi, MD, PhD, role: CONTACT, phone: +81-798-45-6596, email: kuririn@hyo-med.ac.jp, contacts name: Tetsuya Takagawa, MD, PhD, role: CONTACT, phone: +81- 798-45-6265, email: takagawa@hyo-med.ac.jp, contacts name: Nobukazu Fujimoto, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Keisuke Aoe, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.71562, lon: 135.33199, hasResults: False
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protocolSection identificationModule nctId: NCT06318273, orgStudyIdInfo id: M24-742, briefTitle: A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2027-06-16, completionDateStruct date: 2027-06-17, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy.ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 120 adult participants will be enrolled in the study across sites worldwide.In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years.There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans., conditionsModule conditions: Metastatic Castration-Resistant Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ABBV-969, outcomesModule primaryOutcomes measure: Percentage of Participants With Adverse Events (AEs), primaryOutcomes measure: Percentage of Participants Achieving Prostate Specific Antigen (PSA) response, secondaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of ABBV-969, secondaryOutcomes measure: Time to Maximum Observed Concentration (Tmax) of ABBV-969, secondaryOutcomes measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-969, secondaryOutcomes measure: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969, secondaryOutcomes measure: Antidrug Antibody (ADA), secondaryOutcomes measure: Neutralizing Antibodies (nAbs), secondaryOutcomes measure: Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope /ID# 262059, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Carolina BioOncology Institute /ID# 261602, status: RECRUITING, city: Huntersville, state: North Carolina, zip: 28078, country: United States, geoPoint lat: 35.41069, lon: -80.84285, locations facility: NEXT Oncology /ID# 261601, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
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protocolSection identificationModule nctId: NCT06318260, orgStudyIdInfo id: 2023-508298-10-00, briefTitle: Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt), acronym: DobATTR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Steen Hvitfeldt Poulsen, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the effects of the inotropic drug named dobutamine, in patients with wild-type Transthyretin Amyoid Cardiomyopathy (ATTRwt). The main questions it aims to answer are:* What are the effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt.* Safety of dobutamine infusion in this patient population.Participants will be given increasing dosages of dobutamine infusion, and its effect on cardiac output and filling pressures will be assessed non-invasively by echocardiography, and invasively by right heart catheterization, simultaneously., conditionsModule conditions: ATTR Amyloidosis Wild Type, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, single-centre, one arm clinical explorative study, with consecutive enrolment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Dobutrex, outcomesModule primaryOutcomes measure: Cardiac output, secondaryOutcomes measure: Increase in invasively measured SVI by ≥ 20%., secondaryOutcomes measure: Reduction in mean PAWP and/or mPAP by 10 %., secondaryOutcomes measure: Increase in LVEF and LV-global longitudinal strain (LV-GLS) of absolute 10 %., secondaryOutcomes measure: Correlation between echo- and invasive measured SVI, and CO., secondaryOutcomes measure: Rate of complications (i.e. Systolic blood pressure drop < 90 mmHg, arrhythmias)/symptomatic side effects., eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Cardiology, Aarhus University Hospital, status: RECRUITING, city: Aarhus, zip: 8200, country: Denmark, contacts name: Ali Hussein Jaber Mejren, MD, role: CONTACT, phone: 0045 91 65 18 48, email: alimej@clin.au.dk, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
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protocolSection identificationModule nctId: NCT06318247, orgStudyIdInfo id: 2022-134(R), briefTitle: Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: The Dental Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: To evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars., conditionsModule conditions: Periodontal Pocket, conditions: Periodontal Bone Loss, conditions: Impacted Third Molar Tooth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: site preservation, outcomesModule primaryOutcomes measure: Probing pocket depths (PPD), primaryOutcomes measure: Distal bone wall defect (DBWD), primaryOutcomes measure: Clinical attachment lose (CAL), primaryOutcomes measure: Bleeding on probing (BOP), secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Gingival index (GI), eligibilityModule sex: ALL, minimumAge: 26 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Stomatology Hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Jue Shi, Doctor, role: CONTACT, phone: +86 13757171359, email: dentistsj@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06318234, orgStudyIdInfo id: 202435, briefTitle: PET/MR Evaluation of Regression Grading After Neoadjuvant Therapy for Rectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Xiao Chen, class: OTHER, descriptionModule briefSummary: This project aims to evaluate the role of 18F-FAPI combined with 18F-FDG PET/MRI imaging in quantitatively and accurately evaluating the grading of rectal cancer after SCRT neoadjuvant therapy in patients with advanced rectal cancer as the research object, with postoperative histopathological analysis as the reference index, and to assess the ability of patients to achieve pCR. A diagnostic model and evaluation system will also be constructed., conditionsModule conditions: Rectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: 18F-FAPI，18F-FDG, outcomesModule primaryOutcomes measure: Evaluation efficacy of tumor regression level, secondaryOutcomes measure: expression of FAP, secondaryOutcomes measure: expression of GLUT1, secondaryOutcomes measure: SUV, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University, status: RECRUITING, city: Chongqing, country: China, contacts name: Xiao Chen, Ph.D, role: CONTACT, phone: +8615922970174, email: xiaochen229@foxmail.com, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06318221, orgStudyIdInfo id: 06156930, briefTitle: Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-05-01, primaryCompletionDateStruct date: 2021-02-01, completionDateStruct date: 2021-02-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC).Five days before surgery and the postoperative day 10, immunonutrition support was given to the intervention group (n=17), and standard EN support was given to the control group (n=17). Body analyses were made, food consumption records were taken, NRS-2002 and quality of life scales were applied, and biochemical parameters were recorded., conditionsModule conditions: Head and Neck Cancer, conditions: Nutrition, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients were classified according to tumor location (oral cavity, oropharynx, larynx or hypopharynx) and body weight loss, approximately equally in both groups. Accordingly, patients were randomly assigned (by computer) into either the immunonutrition (intervention group) or standard EN (control group) groups., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: Experimental (Immunonutrition) Group, interventions name: Active Comparator Group ( Standard enteral nutrition), outcomesModule primaryOutcomes measure: Body weight, primaryOutcomes measure: Body weight loss, primaryOutcomes measure: Body mass index, primaryOutcomes measure: Resting metabolic rate, primaryOutcomes measure: Nutrition Risk Screening 2002, primaryOutcomes measure: The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30), primaryOutcomes measure: The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35), primaryOutcomes measure: Albumin, primaryOutcomes measure: C-reactive protein, primaryOutcomes measure: Prealbumin, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Complication development status, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University, city: Talas, state: Kayseri, zip: 38280, country: Turkey, geoPoint lat: 38.6908, lon: 35.5538, hasResults: False
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protocolSection identificationModule nctId: NCT06318208, orgStudyIdInfo id: C-LCI, briefTitle: Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-20, primaryCompletionDateStruct date: 2022-01-03, completionDateStruct date: 2022-01-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Rostock, class: OTHER, descriptionModule briefSummary: The study investigates whether patients with mild SARS-CoV-2 infection, who stayed at home during their infection and weren't hospitalized, have any persisting sequelae in pulmonary function.Therefore, 110 patients, aged 6-60 years, were recruited by telephone 4-12 weeks after laboratory-confirmed positive PCR and invited for a lung function testing. Every patient with abnormalities in pulmonary function was invited to a follow-up 3 months after the first appointment to assess changes in lung function values.Patients with a pre-existing lung disease and smokers within the last five years were excluded beforehand.Additionally to lung function testing we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the pulmonary function testing., conditionsModule conditions: SARS-CoV-2 Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ACTUAL, armsInterventionsModule interventions name: lung function testing, outcomesModule primaryOutcomes measure: Pulmonary function, secondaryOutcomes measure: Changes in pulmonary function, secondaryOutcomes measure: Sociodemographic factors, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Kinder- und Jugendklinik Universitätsmedizin Rostock, city: Rostock, zip: 18057, country: Germany, geoPoint lat: 54.0887, lon: 12.14049, hasResults: False
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protocolSection identificationModule nctId: NCT06318195, orgStudyIdInfo id: 2023-06821-01, briefTitle: Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care., acronym: CiPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Karolinska Universitetssjukhuset, descriptionModule briefSummary: The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment., conditionsModule conditions: Post Traumatic Stress Disorder, conditions: Acute Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prolonged exposure will be offered in a brief digital format with therapist support for three weeks. Treatment comprises of psychoeducation, rationales, in vivo exposure, imaginal exposure and relapse prevention., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Condensed Internet delivered prolonged exposure (CIPE), outcomesModule primaryOutcomes measure: Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5), secondaryOutcomes measure: Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress., otherOutcomes measure: Participants satisfaction with treatment., otherOutcomes measure: Adverse events related to treatment., otherOutcomes measure: Number of completed treatment modules, otherOutcomes measure: Number of messages sent and received in the digital platform, otherOutcomes measure: Number of completed home work assignments by the participant during the treatment period, otherOutcomes measure: The proportion of participants that conducts the weekly measures and further assessment points, otherOutcomes measure: The proportion of participants that go through the entire treatment period, otherOutcomes measure: Number of drop-outs from treatment, otherOutcomes measure: Rates of inclusion to the study, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet Medicinsk Psykologi; Sektion Beteendemedicin, city: Stockholm, country: Sweden, contacts name: Charlotte Gentili, PhD, role: CONTACT, phone: +46760482895, email: charlotte.s.gentili@regionstockholm.se, contacts name: Mike Kemani, PhD, role: CONTACT, email: mike.kemani@regionstockholm.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
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protocolSection identificationModule nctId: NCT06318182, orgStudyIdInfo id: NCT-SBF-EK-001, briefTitle: Testicular Self-Examination Awareness in Young Men, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-09, primaryCompletionDateStruct date: 2023-11-20, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Hitit University, class: OTHER, collaborators name: Ondokuz Mayıs University, descriptionModule briefSummary: This study aims to determine the effect of education based on the health belief model on testicular self-examination awareness and health beliefs in young men.H0 Hypothesis: Education based on the health belief model has no effect on the awareness of testicular self-examination and health beliefs about testicular self-examination of young men in the experimental and control groups.H1a Hypothesis: The training based on the health belief model will increase the awareness of young men in the experimental group about testicular self-examination compared to those in the control group.H1b Hypothesis: The training based on the health belief model will increase the mean scores of the sensitivity subscale of young men in the experimental group compared to those in the control group.H1c Hypothesis: The training based on the health belief model will increase the mean scores of the benefit subscale of young men in the experimental group compared to those in the control group.H1d Hypothesis: The training based on the health belief model will increase the mean scores of the seriousness subscale of young men in the experimental group compared to those in the control group.H1e Hypothesis: The training based on the health belief model will decrease the mean scores of the barriers subscale of young men in the experimental group compared to those in the control group.H1f Hypothesis: The training based on the health belief model will increase the mean scores of the health motivation subscale of young men in the experimental group compared to those in the control group.H1g Hypothesis: The training based on the health belief model will increase the mean scores of the self-efficacy subscale of young men in the experimental group compared to those in the control group., conditionsModule conditions: Testicular Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Education, outcomesModule primaryOutcomes measure: Demographic information and testicular cancer questionnaire, primaryOutcomes measure: Testicular Cancer Knowledge Test, primaryOutcomes measure: Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination, secondaryOutcomes measure: For the control group, Testicular Cancer Knowledge Test, secondaryOutcomes measure: For the control group, Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination, otherOutcomes measure: Testicular Cancer Knowledge Test, otherOutcomes measure: Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination, eligibilityModule sex: MALE, minimumAge: 15 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hitit University, city: Corum, zip: 19000, country: Turkey, geoPoint lat: 40.54889, lon: 34.95333, hasResults: False
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protocolSection identificationModule nctId: NCT06318169, orgStudyIdInfo id: BIO89-100-131, briefTitle: A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: 89bio, Inc., class: INDUSTRY, descriptionModule briefSummary: The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\])., conditionsModule conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1050, type: ESTIMATED, armsInterventionsModule interventions name: Pegozafermin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Proportion of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of MASH/NASH at Week 52, primaryOutcomes measure: Proportion of Participants With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52, secondaryOutcomes measure: Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52, secondaryOutcomes measure: Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36, secondaryOutcomes measure: Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 89bio Clinical Study Site, status: RECRUITING, city: Little Rock, state: Arkansas, zip: 72211-3859, country: United States, contacts name: 89bio Clinical Study Site, role: CONTACT, geoPoint lat: 34.74648, lon: -92.28959, locations facility: 89bio Clinical Study Site, status: RECRUITING, city: Ocala, state: Florida, zip: 34471, country: United States, contacts name: 89bio Clinical Study Site, role: CONTACT, geoPoint lat: 29.1872, lon: -82.14009, locations facility: 89bio Clinical Study Site, status: RECRUITING, city: Hermitage, state: Tennessee, zip: 37076, country: United States, contacts name: 89bio Clinical Study Site, role: CONTACT, geoPoint lat: 36.19617, lon: -86.6225, locations facility: 89bio Clinical Study Site, status: RECRUITING, city: Wichita Falls, state: Texas, zip: 76301, country: United States, contacts name: 89bio Clinical Study Site, role: CONTACT, geoPoint lat: 33.91371, lon: -98.49339, locations facility: 89bio Clinical Study Site, status: RECRUITING, city: Richmond, state: Virginia, zip: 23226-1925, country: United States, contacts name: 89bio Clinical Study Site, role: CONTACT, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
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protocolSection identificationModule nctId: NCT06318156, orgStudyIdInfo id: ZSLL-KY-2024-056-03, briefTitle: Exploring the Distribution Patterns and Infrared Characteristics of Force-sensitive Acupoints in Different Lumbar Nerve Segments in Patients With LDH Based on "Press Quickly" Theory, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Zhou Xingchen, class: OTHER, descriptionModule briefSummary: Utilizing the "responsive acupoint palpation" technique and infrared thermography, we investigated the distribution patterns of pressure-sensitive acupoints across different lumbar spinal segments in patients with lumbar disc herniation (LDH). Methodology: The Finger TPS tactile pressure measurement system was employed to conduct sensitivity examinations on the acupoints of the L1\~L5 lumbar spine in 80 LDH patients (Group 1) and 80 healthy individuals (Group 2), applying a standardized force of 60N. When a sensation of comfort was elicited, the points were marked on a human cutaneous nerve segment map. We then utilized infrared thermography to collect and compare the temperature differences of the top 10 most frequently responsive acupoint areas in the experimental group against those in the control group., conditionsModule conditions: Lumbar Disc Herniation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Infrared thermal imaging, outcomesModule primaryOutcomes measure: skin temperature, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310053, country: China, contacts name: Xingchen Zhou, Dr, role: CONTACT, phone: +86-18370133761, email: zhouxingchen0210@163.com, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06318143, orgStudyIdInfo id: U01HL168084, type: NIH, link: https://reporter.nih.gov/quickSearch/U01HL168084, briefTitle: mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria, acronym: ACCELERATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: New York University, class: OTHER, descriptionModule briefSummary: Large knowledge gaps remain regarding strategies to promote the adoption of hydroxyurea (HU), particularly in sub-Saharan African countries including Nigeria, where more than 75% of annual sickle cell anemia births occur. The vast majority of people with SCD in Africa do not receive evidenced-based health care (e.g., newborn screening, health education, prophylaxis for infection, optimal nutrition and hydration, blood transfusion, transcranial Doppler screening, and HU therapy), despite its effectiveness in reducing SCD-related adverse outcomes and mortality. The use of HU in SSA is \<1% among SCD patients. The investigators' preliminary findings indicate that provider-level barriers are significant and must be addressed to improve HU adoption. To address HU adoption, the investigators will use the NIH-funded study (e.g., Realizing Effectiveness Across Continents with Hydroxyurea (REACH) Clinical Trial (NCT01966731)) that developed an evidence-informed, clinical, practical, and easy-to-follow algorithm to 1) Screen patients for sickle cell disease (SCD), 2) Initiate HU treatment, and 3) Maintain HU dosage over time (SIM) for the improved management of SCD as our intervention. The Nigerian government released guidelines supporting the SIM intervention for HU adoption for improved SCD management, and HU is on the list of essential medicines for Nigeria. The investigators' implementation strategy for improving SCD management in Nigeria uses a practical and replicable evidence-based task-sharing strategy, TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH), adopted from the TAsk-Strengthening Strategy for Hypertension control (TASSH) trials in Ghana and Nigeria containing the essential components of i) Training healthcare workers/providers to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management. Using a sequential exploratory mixed-methods study design, the investigators will conduct this study using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework in four sequential phases to assess the effectiveness of SIM adoption by providers in the context of the TASSH TCP implementation strategy in Nigeria., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: TASSH, outcomesModule primaryOutcomes measure: Patient numbers - screening, primaryOutcomes measure: Patient numbers - proportion on HU, primaryOutcomes measure: Patient numbers - dosage, secondaryOutcomes measure: Mediators, eligibilityModule sex: ALL, minimumAge: 9 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06318130, orgStudyIdInfo id: LEAD-LBP, briefTitle: Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes, acronym: LEAD-LBP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: National University Hospital, Singapore, class: OTHER, descriptionModule briefSummary: This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (EHL) compared to the fixed helix, lumenless pacing lead (FHL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance., conditionsModule conditions: Pacemaker DDD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A target of 210 participants will be enrolled in this study consisting of two groups and randomised in a 1:1 fashion to either of two groups.Group 1: Fixed helix, lumenless pacing lead (FHL) Group 2: Extendable helix, stylet driven pacing lead (EHL), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Subjects will be blinded to the type of pacing lead received. Operators will not be blinded as they will be performing the procedure. Post-procedure, investigators and outcomes assessors will be blinded to the treatment arm during adjudication of outcomes., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Fixed helix, lumenless pacing lead., interventions name: Extendable helix, stylet-driven pacing lead., outcomesModule primaryOutcomes measure: Incidence of loss of left bundle branch capture, secondaryOutcomes measure: Incidence of acute lead failure, secondaryOutcomes measure: Serial changes in pacing thresholds (V), secondaryOutcomes measure: Serial changes in R-wave amplitude (mV), secondaryOutcomes measure: Serial changes in lead impedance (ohm), secondaryOutcomes measure: Serial changes in QRS duration (ms), secondaryOutcomes measure: Incidence of peri-procedural complications, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National University Heart Centre Singapore, status: RECRUITING, city: Singapore, country: Singapore, contacts name: Eugene Tan, MBBS, role: CONTACT, phone: +6567795555, email: esjtan@nus.edu.sg, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
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protocolSection identificationModule nctId: NCT06318117, orgStudyIdInfo id: 3398-1, briefTitle: Reason for Prescribing Rice Infant Formula, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Mead Johnson Nutrition, class: INDUSTRY, collaborators name: BioFortis, descriptionModule briefSummary: The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest., conditionsModule conditions: Infant Formula, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Rice infant formula, outcomesModule primaryOutcomes measure: Questionnaire - reason for prescribing a RIF during the 1st year of life., secondaryOutcomes measure: Questionnaire - Reason for prescribing a RIF in first 6 months of life, secondaryOutcomes measure: Questionnaire - Diet characteristics, secondaryOutcomes measure: Growth z-scores body mass index (BMI)-for-age, secondaryOutcomes measure: Growth z-score, secondaryOutcomes measure: Growth z-score, secondaryOutcomes measure: Growth z-score, secondaryOutcomes measure: Growth z-score, secondaryOutcomes measure: Questionnaire - Evolution of digestive and allergic symptoms, secondaryOutcomes measure: Socio-demographic characteristics, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 11 Months, stdAges: CHILD, contactsLocationsModule locations facility: Dr Christine REGIMBART - Private Practice, city: Bécon-les-Granits, state: Becon-les-Granits, zip: 49026, country: France, contacts name: Christine Regimbart, MD, role: CONTACT, geoPoint lat: 47.50134, lon: -0.8, locations facility: Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department, city: Auxerre, zip: 89011, country: France, contacts name: Bertrand Soto, MD, role: CONTACT, geoPoint lat: 47.8, lon: 3.56667, locations facility: Centre Hospitalier Universitaire de Nantes - Pediatric emergency department, city: Nantes, zip: 44093, country: France, contacts name: Hugues Piloquet, MD, role: CONTACT, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Hôpital NOVO - Pediatric department, city: Pontoise, zip: 95300, country: France, contacts name: Mariana Englender, MD, role: CONTACT, geoPoint lat: 49.05, lon: 2.1, hasResults: False
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protocolSection identificationModule nctId: NCT06318104, orgStudyIdInfo id: DI/24/310/03/4, briefTitle: Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2024-11-29, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Hospital General de México Dr. Eduardo Liceaga, class: OTHER_GOV, descriptionModule briefSummary: In Mexico, quadruple therapy is used to treat Helicobacter pylori (H.P.) at the expense of greater adverse effects, costs, and lower adherence to treatment. According to evidence, a competitive potassium channel blocker (P-CAB) is non-inferior to a proton pump inhibitor (PPI) and can improve the eradication rate of H.P. while maintaining triple therapy antibiotics (amoxicillin-clarithromycin) without increasing adverse effects, fewer drugs and better adherence to treatment. It is proposed to study the effect of a P-CAB in the eradication of H.P. as part of a triple therapy in Mexican patients, assuming that the efficacy and safety of a triple therapy of amoxicillin-clarithromycin-tegoprazan will be superior to amoxicillin-clarithromycin-esomeprazole., conditionsModule conditions: Helicobacter Pylori Infection, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Tegoprazan, interventions name: Esomeprazole 40mg, outcomesModule primaryOutcomes measure: Response to treatment by determining the eradication rate, primaryOutcomes measure: Compared Treatment-related adverse events, secondaryOutcomes measure: Brief Medication Questionnaire, secondaryOutcomes measure: Percentage of patients with adherence to treatment, secondaryOutcomes measure: Report all Treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06318091, orgStudyIdInfo id: MS.21.09.1640, briefTitle: Nanofat Versus Platelet Poor Plasma Gel for Infraorbital Rejuvenation, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: this study was conducted for evaluation of the clinical efficacy, safety, and potential side effects of platelet poor plasma gel versus nonfat injection in infraorbital rejuvenation, conditionsModule conditions: Tear Trough Eyelid Deformity, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: platelet poor plasma gel, interventions name: nanofat, outcomesModule primaryOutcomes measure: the degree of changes in the skin texture and homogeneity, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Manousra University, Faculty of Medicine, city: Mansoura, state: Dakahlia, zip: 35511, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06318078, orgStudyIdInfo id: UG2024001, briefTitle: Buikwe Electronic Community Health Information System Impact Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Malaria Consortium, class: OTHER, descriptionModule briefSummary: The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes., conditionsModule conditions: Malaria, conditions: Diarrhea, conditions: Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster Randomised Control Trial, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1140, type: ESTIMATED, armsInterventionsModule interventions name: eCHIS, outcomesModule primaryOutcomes measure: Out Patient Department attendance (due to malaria, pneumonia and diarrhoea), primaryOutcomes measure: Hospitalisation (due to malaria, pneumonia and diarrhoea), primaryOutcomes measure: malaria related mortality in the community and health facilities, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule locations facility: Buikwe, status: RECRUITING, city: Buikwe, country: Uganda, contacts name: John Baptist Bwanika, MD, role: CONTACT, contacts name: John Baptist Bwanika, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 0.3375, lon: 33.01056, hasResults: False
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protocolSection identificationModule nctId: NCT06318065, orgStudyIdInfo id: B-ER111-370, briefTitle: Surgical Resection Outcomes in Patients With Brain Metastasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2010-01-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: National Cheng-Kung University Hospital, class: OTHER, descriptionModule briefSummary: While many studies have investigated the prognostic factors for patients undergoing surgical resection for primary brain tumors, decision-making for patients with brain metastasis (BM) is more complex because of their higher burden of comorbidities compared to those with primary brain tumors. In addition, although various prognostic indicators have been identified to predict prognosis in several types of cancer, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), prognostic nutritional index (PNI), and systemic immune-inflammation index (SII), limited studies have yet determined which group of patients would yield beater survival outcome after surgical resection for BM. This study aimed to investigate the impact of patient and perioperative characteristics and prognostic indicators on survival outcome of patients undergoing surgical resection of BM., conditionsModule conditions: Brain Metastases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: survival outcome of patients undergoing surgery for brain metastasis, primaryOutcomes measure: Functional outcome of patients undergoing surgery for brain metastasis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jung-Shun Lee, status: RECRUITING, city: Tainan, state: None Selected, zip: 70403, country: Taiwan, contacts name: Jung-Shun Lee, M.D., role: CONTACT, phone: 886-6-2353535, phoneExt: 5181, email: nslee1218@gmail.com, geoPoint lat: 22.99083, lon: 120.21333, hasResults: False
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protocolSection identificationModule nctId: NCT06318052, orgStudyIdInfo id: LUM-ABU-CO2-FemTouch-19-01, briefTitle: The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM), statusModule overallStatus: RECRUITING, startDateStruct date: 2019-11-01, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Lumenis Be Ltd., class: INDUSTRY, descriptionModule briefSummary: Improvement in cancer therapies has led to an increase in the number of women surviving chemotherapy (and other treatments) and overcoming cancer. This patient population presents specific clinical needs as chemotherapy (and other cancer treatments) treatment side effects can lead to early appearance of menopause symptoms and conventional hormonal treatments are contraindicated for these patients. The use of CO2 laser treatment has been shown to provide relief of Genitourinary Syndrome Of Menopause (GSM) symptoms in women and might provide a significant improvement in the quality of life for cancer survivors. The current study is designed to demonstrate the safety and efficacy of CO2 laser for treatment of GSM symptoms in cancer survivors suffering from GSM symptoms, with limited access to hormonal treatment., conditionsModule conditions: Vaginal Atrophy Patients With GSM, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: The FemTouch delivery system, interventions name: Gynomunal gel treatment, outcomesModule primaryOutcomes measure: To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment, secondaryOutcomes measure: To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment, secondaryOutcomes measure: To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment., eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Frauenarztpraxis Heussweg, status: RECRUITING, city: Hamburg, zip: 20255, country: Germany, contacts name: Matthias Theden-Scow, Dr, role: CONTACT, phone: 4210613, phoneExt: 040, email: dr.theden-schow@hamburg.de, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False
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protocolSection identificationModule nctId: NCT06318039, orgStudyIdInfo id: IRB2022-06554-01, briefTitle: Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Linnaeus University, class: OTHER, descriptionModule briefSummary: Scientific Research QuestionOverall Purpose:Regarding rehabilitation after anterior cruciate ligament reconstruction (ACLR), there is a knowledge gap - a lack of evidence. Important questions such as how rehabilitation should be structured, what it should include, and how it should be evaluated are currently not clear. Therefore, the investigators plan to conduct a two-year follow-up randomized controlled trial (RCT) on post-ACLR rehabilitation.Moreover, detailed information on how/under what circumstances the ACL injury occurred is not satisfactorily described in the literature. Therefore, the investigators are planning a new survey that can identify, explain, and prevent the risk factors causing a person to suffer from an anterior cruciate ligament injury.Specific Objectives:How should guidelines for rehabilitation after ACLR be structured, what should they include, and how should they be evaluated to best restore knee function in the patient? Can a detailed and comprehensive survey identify, explain, and prevent the risk factors causing a person to suffer from an ACL injury?, conditionsModule conditions: Anterior Cruciate Ligament Reconstruction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Novel program, interventions name: Traditional program, outcomesModule primaryOutcomes measure: Isokinetic muscle strength, primaryOutcomes measure: Single-leg hop performance, secondaryOutcomes measure: Knee Injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: ACL Return to Sport after Injury scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Linnaeus University, city: Kalmar, state: Sverige, zip: 39363, country: Sweden, geoPoint lat: 56.66157, lon: 16.36163, hasResults: False
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protocolSection identificationModule nctId: NCT06318026, orgStudyIdInfo id: R01AA031231, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA031231, secondaryIdInfos id: R01AA031231, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA031231, briefTitle: Systematic Implementation of Patient-centered Care for Alcohol Use Trial: Beyond Referral to Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2029-02, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Kaiser Permanente, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), collaborators name: Kaiser Permanente Washington, collaborators name: University of Washington, descriptionModule briefSummary: The Systematic Implementation of Patient-centered Care for Alcohol Use Trial is a pragmatic, cluster-randomized, effectiveness-implementation trial testing two interventions to systematically implement shared decision-making with primary care patients with symptoms due to alcohol use: a primary care intervention and a centralized intervention. An anticipated 30 primary care clinics will be randomized to one of three conditions: usual care or the primary care or centralized interventions., conditionsModule conditions: Alcohol Use Disorder, conditions: Unhealthy Alcohol Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: EHR and survey (latter masked), whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Centralized Intervention, interventions name: Primary Care Intervention, outcomesModule primaryOutcomes measure: Documentation of alcohol or substance use disorder treatment in the electronic health record (including insurance claims)., primaryOutcomes measure: Continuous measure of change in alcohol use as documented on the AUDIT-C screening questionnaire., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaiser Permanente Washington, city: Seattle, state: Washington, zip: 98112, country: United States, contacts name: Megan Addis, role: CONTACT, phone: 206-287-2052, email: Megan.J.Addis@kp.org, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
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protocolSection identificationModule nctId: NCT06318013, orgStudyIdInfo id: 2022-KAEK-15427-04-204-2022101, briefTitle: Perineural and Systemic Dexamethasone Use in Dental Surgeries in Terms of Anesthesia Duration and Postop Complaints, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Karamanoğlu Mehmetbey University, class: OTHER, descriptionModule briefSummary: Participants will be asked to use some medications after the tooth extraction procedure. These drugs can be used in different ways. Investigators plan to monitor the pain, swelling and duration of anesthesia in the body as a result of participants use., conditionsModule conditions: Impacted Third Molar Tooth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: vitality test, outcomesModule primaryOutcomes measure: Swelling, primaryOutcomes measure: Duration of anesthesia, secondaryOutcomes measure: Pain Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry, status: RECRUITING, city: Karaman, zip: 70100, country: Turkey, contacts name: Faruk Ayhan Başçiftçi, Dr, role: CONTACT, phone: 338-226-2082, email: dis@kmu.edu.tr, contacts name: Sümeyye Çelik Özsoy, Dr, role: CONTACT, phone: 338-226-2082, email: sumeyyecelik@kmu.edu.tr, contacts name: Doğan Ilgaz Kaya, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.18111, lon: 33.215, hasResults: False
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protocolSection identificationModule nctId: NCT06318000, orgStudyIdInfo id: SN4/20/22, briefTitle: Physical Activity and Sports for People With Visual Impairments, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-03-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Józef Piłsudski University of Physical Education, class: OTHER, descriptionModule briefSummary: Purpose of this study was to assess the relationship between the visual impairment degree and the level of children's fundamental motor skills, balance and bilateral coordination., conditionsModule conditions: Blindness, conditions: Visual Impairment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 76, type: ACTUAL, armsInterventionsModule interventions name: Balance test, bilateral coordination test, fundamental motor skills test, outcomesModule primaryOutcomes measure: Center of pressure (CoP) path length was measured, primaryOutcomes measure: Surface area of stabilogram was measured, primaryOutcomes measure: Raw and scale score for each item, primaryOutcomes measure: Qualitative performance criteria (points), secondaryOutcomes measure: Body mass in kg, secondaryOutcomes measure: Body height in cm, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Physical Education, city: Warsaw, zip: 00-968, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
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protocolSection identificationModule nctId: NCT06317987, orgStudyIdInfo id: 2068557, secondaryIdInfos id: P50DA054072, type: NIH, link: https://reporter.nih.gov/quickSearch/P50DA054072, briefTitle: Addressing Barriers to Care for Substance Use Disorder Pilot Study, acronym: ABCSUD Pilot, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-02, completionDateStruct date: 2025-04-02, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Kaiser Permanente, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), collaborators name: Stanford University, descriptionModule briefSummary: The Addressing Barriers to Care for Substance Use Disorder Pilot (ABC-SUD Pilot) is a randomized pilot study that will precede a larger trial. The ABC-SUD Pilot is a parallel group, cluster-randomized pilot feasibility trial, with clinicians (care coordinators) as the unit of randomization.This study will be conducted in a mental health treatment access center within the Washington region of Kaiser Permanente. As part of usual care, patients contact the mental health access center and speak to a "care coordinator" to obtain contact information for potential venues to obtain treatment for substance use disorder.The experimental intervention, Care Navigation, will be evaluated for its potential to increase the utilization of substance use disorder treatment among patients who contact the mental health treatment access center. The investigators note that Care Navigation will be delivered by study "care navigators", who are distinct from the health system's care coordinators., conditionsModule conditions: Drug Use Disorders, conditions: Illicit Drug Use, conditions: Alcohol-Related Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Care coordinators will be randomized to two parallel groups: usual care (UC; i.e., the comparator group) and usual care plus care navigation (UC + CN; i.e., the experimental group). All care coordinators will continue offering substance use resources and treatment options to patients as usual. Clinicians randomized to UC + CN will be able to offer and refer patients to a care navigator., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: All study outcomes are extracted from secondary data including electronic health record and healthcare claims databases, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Care Navigation, outcomesModule primaryOutcomes measure: Rate of patient interest in care navigation, secondaryOutcomes measure: Feasibility of patient consent procedures, otherOutcomes measure: SUD treatment - 30 days, otherOutcomes measure: SUD treatment - 60 days, otherOutcomes measure: SUD treatment - 90 days, otherOutcomes measure: SUD treatment visits - 30 days, otherOutcomes measure: SUD treatment visits - 60 days, otherOutcomes measure: SUD treatment visits - 90 days, otherOutcomes measure: Days until SUD treatment utilization from clinical assessment appointment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317974, orgStudyIdInfo id: 2022/210, briefTitle: The Effect of Breastfeeding Education on Breast Milk Perception and Self-Efficacy in the Pregnancy Health Belief Model, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-30, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-02-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk., conditionsModule conditions: Breastfeeding Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled, experimental research design in pre-test, post-test design Made with, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ACTUAL, armsInterventionsModule interventions name: Breastfeeding education based on the Health Belief model, outcomesModule primaryOutcomes measure: Mothers' and fathers' perception of breast milk, assessed using the Adults' Breast Milk Perception Scale., secondaryOutcomes measure: Breastfeeding self-efficacy of mothers evaluated using the Breastfeeding Self-Efficacy Scale-Short Form during Pregnancy, otherOutcomes measure: Paternal breastfeeding self-efficacy assessed using the Paternal Breastfeeding Self-Efficacy Scale., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University - Cerrahpasa, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06317961, orgStudyIdInfo id: INT200-22, briefTitle: Pilot Study on the Use of iENTER, iCONSENT and iPARTICIPATE E-tools, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-05, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, class: OTHER, collaborators name: Vall d'Hebron Institute of Oncology, collaborators name: The Netherlands Cancer Institute, descriptionModule briefSummary: Precision oncology is the future of fighting cancer. Cancer Core Europe (CCE) developed a precision medicine trial, i.e. the Basket of Basket (BoB) study, to provide personalised treatment to a large number of patients by incorporating a molecular profiling platform. The EU-funded CCE_DART project, developed within the CCE Consortium, is aimed at improving efficiency and transform platform trials into data-rich translational research programmes. Within the CCE_DART project working area D "Patient involvement through information and partnership" three interconnected web e-tools were developed aimed at promoting patient information, recruitment, and involvement as well as facilitating adherence to the CCE BoB trial: 1) iENTER: informative web site addressed to potential BoB trial participants, their caregivers, patients' advocates, and the public; 2) iCONSENT: web app for remote management of the informed consent process in the CCE BoB trial.3) iPARTICIPATE: web app allowing remote access to BoB trial patients trial visits calendar, medications list and posology, to upload documents and download reports, messaging between patients and clinical staff. The main objective of this study is to carry out field testing and assess usability of the e-tools iENTER, iCONSENT and iPARTICIPATE. The study is also addressed at collecting patients' suggestions for improvements of the e-tools., conditionsModule conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: SUS questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Istituto Nazionale dei Tumori, status: RECRUITING, city: Milano, zip: 20133, country: Italy, contacts name: Rosalba Miceli, PhD, role: CONTACT, phone: +39 0223903198, email: rosalba.miceli@istitutotumori.mi.it, contacts name: Sara Iadecola, role: CONTACT, phone: +39 0223903198, email: sara.iadecola@istitutotumori.mi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06317948, orgStudyIdInfo id: IG23150, briefTitle: Improving the Quality of Radiotherapy by Multi-Institution Knowledge-Based Planning Optimization Models (Acronym: MIKAPOCo, Multi-Institutional Knowledge-based Approach in Plan Optimization for the Community), acronym: MIKAPOCo, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-10-28, primaryCompletionDateStruct date: 2022-10-28, completionDateStruct date: 2025-10-28, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: IRCCS Ospedale San Raffaele, class: OTHER, descriptionModule briefSummary: Investigators central hypothesis is that it is possible to create libraries of "consistent" Knowledge-Based plan-models derived from large Institutional experiences. These libraries can be used to guide automated RT planning and serve as tools to assist centers for plan quality assurance (QA) and plan prediction.Quantifying Inter-institute variability of RT planning and building libraries of interchangeable and validated multi-Institutional KB plan prediction models is expected to impact on the quality of planning at the national level. The project has the potential of facilitating the introduction of AI approaches in plan optimization, thus reducing intra and inter-Institute planning variability. Improving plan quality is expected to translate into better outcome after RT in terms of local control and, even more, of side effects and Quality of life. Positive impact is also expected in patient selection for advanced techniques, in plan audit and plan optimization in clinical trials, in technology comparison and cost-benefit analyses as well as in the RT educational field., conditionsModule conditions: Breast Cancer, conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: treatment plan comparison, outcomesModule primaryOutcomes measure: model interchangeability, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele, city: Milano, zip: 20133, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06317935, orgStudyIdInfo id: HU-ERG-BK-01, briefTitle: The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2024-06-29, completionDateStruct date: 2024-10-29, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, collaborators name: Ankara Bilkent City Hospital, descriptionModule briefSummary: The aim of this study is to evaluate the effect of virtual reality applications on the level of independence and upper extremity functionality perceived by children in daily life in children with hemipegic cerebral palsy.The research is a randomized controlled, cross-over study. The sample group of the research is children diagnosed with hemiplegic cerebral palsy and families who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital.Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.The upper extremity functionality of both research groups before the intervention will be evaluated with the 'Motor Activity Diary for Children' scale and the perceived independence level with the 'Children's Hand Use Experience' scale.After the initial evaluation is completed, group A, represented as the intervention group, will receive ArmeoSenso virtual reality intervention in the upper extremity hand function laboratory for 3 weeks, 5 days a week, each session for 30 minutes, in addition to traditional occupational therapy and physiotherapy rehabilitation programs. Meanwhile, group B, represented as the control group, will continue the traditional occupational therapy and physiotherapy rehabilitation program. At the end of the third week of the intervention, tests measuring upper extremity functionality and perceived independence level will be repeated.Measurement tools will be repeated at the beginning of the intervention, at the end of the 3rd week, and at the end of the intervention., conditionsModule conditions: Hemiplegic Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.Intervention group (A) will receive virtual reality application for 30 minutes, 5 days a week for 3 weeks, in addition to traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and will receive only traditional treatments between 3-6 weeks.The control group (B) will receive only traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and between 3-6 weeks, they will receive virtual reality application in addition to traditional approaches for 30 minutes, 5 days a week for 3 weeks., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: ArmeoSenso, interventions name: Traditional Rehabilitation, outcomesModule primaryOutcomes measure: The effect of virtual reality applications on perceived independence in daily life in hemiplegic CP., primaryOutcomes measure: The effect of virtual reality applications on upper extremity functionality in daily life in children with hemiplegic CP., secondaryOutcomes measure: Dosimetry of virtual reality applications, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ankara Bilkent City Hospital, city: Multiple Locations, state: Ankara, zip: 06000, country: Turkey, contacts name: Başak Karadağ, MSc, role: CONTACT, phone: +905059462128, email: basakhacettepe@hotmail.com, contacts name: Berke Aras, Ass. Prof., role: CONTACT, phone: +90365851518, email: drberkearas@gmail.com, hasResults: False
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protocolSection identificationModule nctId: NCT06317922, orgStudyIdInfo id: DRYEYE-IVT Project, briefTitle: Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections, acronym: DRYEYE-IVT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2025-05-12, completionDateStruct date: 2025-05-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Francesco Bandello, class: OTHER, descriptionModule briefSummary: The goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of Thealoz Duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections.The main questions it aims to answer are:* can ocular instillation of Thealoz Duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs?* can ocular instillation of Thealoz Duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision?Each participant will be randomized into each of two arms:1. TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day;2. CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day;The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement.In any case, the instillation of saline solution should not alter the ocular surface., conditionsModule conditions: Dry Eye Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants will be randomized in two arms (treatment arm and control arm) in a ratio of 1:1., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: There are two teams:1. MASKED TEAM: Sub-investigators and study coordinators delegated to perform the following tasks: * dispensation to the patient the Investigational medical device (Thealoz Duo) or saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate); * accountability of Investigational medical device and saline solution; * verify the compliance and therapeutic adherence of the patient; * discussion with the patient regarding the respect of the masked condition of the study;2. UNMASKED TEAMS: * informed consent process; * to perform the follow-up visit and assessments provided to test the ocular surface., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Thealoz Duo;, interventions name: sham (Hydrabak), outcomesModule primaryOutcomes measure: Administration of Ocular Surface Disease Index (OSDI) to the patient, secondaryOutcomes measure: administration of Visual Analog Scale for Pain to the patient, secondaryOutcomes measure: evaluation of matrix metalloproteinase 9 gene expression, secondaryOutcomes measure: TearLab Osmolarity, secondaryOutcomes measure: Schirmer's test, secondaryOutcomes measure: tear film Break Up Time (tBUT), secondaryOutcomes measure: conjunctival hyperemia according to Efron grading scale, secondaryOutcomes measure: fluorescein staining, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele _O.U. Ophthalmology, status: RECRUITING, city: Milan, zip: 20123, country: Italy, contacts name: Giulia Basile, MPharm, role: CONTACT, phone: +39 0226433545, email: basile.giulia@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06317909, orgStudyIdInfo id: 23-03 DONNER-2, briefTitle: Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Fraunhofer-Institute of Toxicology and Experimental Medicine, class: OTHER, descriptionModule briefSummary: The goal of this exploratory method-development study is to to establish and evaluate novel non-invasive methods to monitor airway inflammation induced by allergen challenge (both by instillation during bronchoscopy and by inhalation) in patients with mild allergic asthma.The investigator wants to further profile and develop the allergen challenge model by investigating the utility of various non-invasive monitoring methods. The hypothesis of the project is that local inflammatory changes in the lung induced by allergen can be captured by gas-enhanced magnetic resonance imaging (MRI) and analysis of exhaled breath.The validation of cellular outcome measures and non-invasive inflammometry can be used in future clinical trials for proof of concept of novel anti-inflammatory medications.Participants will undergo* methacholine challenge* 2 inhaled allergen challenges* 2 MRI with hyperpolarized xenon and gadolinium based contrast agent* 2 bronchoscopies with bronchoalveolar lavage (BAL)* segmental allergen challenge during the first bronchoscopy* spirometry* skin prick test and skin prick dilution tests* measurement of particles in exhaled air* nasal filter* nasal lavage* sputum induction* peak flow meter tests* exhaled NO (nictric oxide)* blood sampling (in total approx. 190 ml), conditionsModule conditions: Mild Allergic Asthma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: allergen challenge, outcomesModule primaryOutcomes measure: Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, INF-alpha, MMP-9, CXCL1, SP-D, albumin] in Bronchoalveolar lavage (BAL) after segmental allergen challenge, primaryOutcomes measure: Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin] in Sputum after inhalative allergen challenge, primaryOutcomes measure: Exploratory (1. priority) Changes in non-invasive exhaled particles [i.e.IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin]after inhalative allergen challenge, primaryOutcomes measure: Exploratory (1. priority) Changes in non-invasive exhaled particles [i.e.IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin]after segmental allergen challenge, primaryOutcomes measure: Exploratory (1. priority) Changes in cell analyzation in BAL [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after segmental allergen challenge, primaryOutcomes measure: Exploratory (1. priority) Changes in cell analyzation in Sputum [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after inhalative allergen challenge, secondaryOutcomes measure: Exploratory (2. priority) Detection of Ribonucleic acid (RNA) in exhaled particles, secondaryOutcomes measure: Exploratory (2. priority) Changes in Fractional exhaled nitric oxide (FeNO) after inhalative allergen challenge, secondaryOutcomes measure: Exploratory (2. priority) Changes in FeNO after segmental allergen challenge, secondaryOutcomes measure: Exploratory (2. priority) Quantification of regional ventilation, perfusion, and diffusion by magnetic resonance imaging (MRI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fraunhofer Institute for Toxicology and Experimental Medicine, status: RECRUITING, city: Hannover, state: Lower Saxony, zip: 30625, country: Germany, contacts name: Jens M Hohlfeld, role: CONTACT, email: jens.hohlfeld@item.fraunhofer.de, geoPoint lat: 52.37052, lon: 9.73322, hasResults: False
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protocolSection identificationModule nctId: NCT06317896, orgStudyIdInfo id: 2024-KY-048-01, briefTitle: Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Zhujiang Hospital, class: OTHER, descriptionModule briefSummary: On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment"., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Circulating Tumor Cell, conditions: Recurrence, conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: circulating tumor cells, outcomesModule primaryOutcomes measure: 2-year recurrence-free survival rate, secondaryOutcomes measure: Correlation between CTCs status dynamic changes and relapse, secondaryOutcomes measure: Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Sixth Affiliated Hospital of South China University of Technology, city: Foshan, state: Guangdong, country: China, contacts name: Weichao Liang, Prof., role: CONTACT, phone: 13590542927, contacts name: Weichao Liang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.02677, lon: 113.13148, locations facility: Zhujiang Hospital of Southern Medical University, city: Guangzhou, state: Guangdong, zip: 510220, country: China, contacts name: Mingxin Pan, Prof., role: CONTACT, phone: +8618928918216, email: pmxwxy@sohu.com, contacts name: Zhoubin Feng, role: CONTACT, phone: 19830551997, email: Fzbin1001@163.com, contacts name: Mingxin Pan, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Affiliated Cancer Hospital and Institute of Guangzhou Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Yinbing Wu, Prof., role: CONTACT, phone: 18620007296, contacts name: Yinbing Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06317883, orgStudyIdInfo id: CORALS, briefTitle: Childhood Obesity Risk Assessment Longitudinal Study, acronym: CORALS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-05-27, primaryCompletionDateStruct date: 2032-07-14, completionDateStruct date: 2032-07-14, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Consorcio Centro de Investigación Biomédica en Red (CIBER), class: OTHER_GOV, collaborators name: Instituto de Salud Carlos III, collaborators name: Maimónides Biomedical Research Institute of Córdoba, collaborators name: Universidad de Córdoba, collaborators name: Institut Investigacio Sanitaria Pere Virgili, collaborators name: University Rovira i Virgili, collaborators name: Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), descriptionModule briefSummary: Childhood obesity is a major public health problem worldwide. Europe has a high prevalence of obesity, which is accentuated in Mediterranean countries. Spain has a high prevalence of both overweight (percentage: 21.5 in boys and 22.2 in girls) and obesity (percentage: 10.6 in boys and 11.8 in girls) in children aged 6-9 years.From childhood, obesity is associated with an increased risk of diseases such as insulin resistance, type 2 diabetes, hypertension, metabolic syndrome, musculoskeletal problems, sleep disorders and mental health problems. Obesity is a complex, multi-causal problem involving individual risk factors such as behavior and genetics. Behavioral factors include diet, physical activity, sedentary lifestyle, sleep, and others. It is therefore important to study each of the individual risk factors for obesity. There are few large sample studies in European/Spanish children and no longitudinal studies estimating the incidence of obesity in preschool children based on exposure to different risk factors, considering not only the effect of food consumption but also dietary habits and patterns.The aim of the present study is to identify risk factors for childhood obesity through long-term longitudinal follow-up., conditionsModule conditions: Child Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1508, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Assessment of dietary intake and habits, primaryOutcomes measure: Assessment of physical activity, sedentary behavior and sleep pattern, primaryOutcomes measure: Early risk factors, primaryOutcomes measure: Body composition: Height, primaryOutcomes measure: Body composition: Weight, primaryOutcomes measure: Body composition: Body mass index, primaryOutcomes measure: Body composition: Waist circumference, primaryOutcomes measure: Psychosocial and neuropsychological behavioral assessment, primaryOutcomes measure: Verbal fluency, primaryOutcomes measure: Muscular strength, primaryOutcomes measure: Cardiorespiratory endurance, secondaryOutcomes measure: Association between genetic polymorphisms, metabolomic and metagenomic profiles with the development of obesity., secondaryOutcomes measure: Body composition: Waist height, secondaryOutcomes measure: Body composition: Fat mass, secondaryOutcomes measure: Body composition: Fat mass index, secondaryOutcomes measure: Body composition: Fat-free mass, secondaryOutcomes measure: Body composition: Total body water, secondaryOutcomes measure: Systolic blood pressure measurement, secondaryOutcomes measure: Diastolic blood pressure measurement, secondaryOutcomes measure: Heart rate measurement, secondaryOutcomes measure: Hematological analysis: Hemoglobine, secondaryOutcomes measure: Hematological analysis: Hematocrite, secondaryOutcomes measure: Hematological analysis: Erythrocytes, secondaryOutcomes measure: Hematological analysis: Mean corpuscular volume, secondaryOutcomes measure: Hematological analysis: Mean corpuscular hemoglobin, secondaryOutcomes measure: Hematological analysis: Mean corpuscular hemoglobin concentration, secondaryOutcomes measure: Hematological analysis: Red cell blood distribution width, secondaryOutcomes measure: Hematological analysis: White blood cells, secondaryOutcomes measure: Hematological analysis: Neutrophils, secondaryOutcomes measure: Hematological analysis: Lymphocytes, secondaryOutcomes measure: Hematological analysis: Monocytes, secondaryOutcomes measure: Hematological analysis: Eosinophils, secondaryOutcomes measure: Hematological analysis: Basophiles, secondaryOutcomes measure: Hematological analysis: Platelets, secondaryOutcomes measure: Hematological analysis: Mean platelet volume, secondaryOutcomes measure: Biochemical analysis: Glucose, secondaryOutcomes measure: Biochemical analysis: Bilirubin, secondaryOutcomes measure: Biochemical analysis: Creatinine, secondaryOutcomes measure: Biochemical analysis: Urate, secondaryOutcomes measure: Biochemical analysis: Urea, secondaryOutcomes measure: Biochemical analysis: Total protein, secondaryOutcomes measure: Biochemical analysis: Aspartate aminotransferase, secondaryOutcomes measure: Biochemical analysis: Alanine aminotransferase, secondaryOutcomes measure: Biochemical analysis: Gamma-glutamyl transferase, secondaryOutcomes measure: Biochemical analysis: Alkaline phosphatase, secondaryOutcomes measure: Biochemical analysis: Total cholesterol, secondaryOutcomes measure: Biochemical analysis: High density lipoproteins, secondaryOutcomes measure: Biochemical analysis: Non-HDL cholesterol, secondaryOutcomes measure: Biochemical analysis: Low density lipoproteins, secondaryOutcomes measure: Biochemical analysis: Apolipoprotein A1, secondaryOutcomes measure: Biochemical analysis: Apolipoprotein B, secondaryOutcomes measure: Biochemical analysis: Calcium, secondaryOutcomes measure: Biochemical analysis: Potassium, secondaryOutcomes measure: Biochemical analysis: Sodium, secondaryOutcomes measure: Biochemical analysis: Phosphorus, secondaryOutcomes measure: Biochemical analysis: Iron, secondaryOutcomes measure: Biochemical analysis: Magnesium, secondaryOutcomes measure: Biochemical analysis: Zinc, secondaryOutcomes measure: Biochemical analysis: Insulin, secondaryOutcomes measure: Biochemical analysis: Insulin resistance, secondaryOutcomes measure: Biochemical analysis: C-reactive protein, secondaryOutcomes measure: Biochemical analysis: Tumor necrosis factor alpha, secondaryOutcomes measure: Biochemical analysis: Adiponectin, secondaryOutcomes measure: Biochemical analysis: Energy, secondaryOutcomes measure: Biochemical analysis: Carbohydrates, secondaryOutcomes measure: Biochemical analysis: Sugars, secondaryOutcomes measure: Biochemical analysis: Fiber, secondaryOutcomes measure: Biochemical analysis: Polysaccharides, secondaryOutcomes measure: Biochemical analysis: Total fat, secondaryOutcomes measure: Biochemical analysis: Saturated fatty acids, secondaryOutcomes measure: Biochemical analysis: Monounsaturated fatty acids, secondaryOutcomes measure: Biochemical analysis: Polyunsaturated fatty acids, secondaryOutcomes measure: Biochemical analysis: Vitamin B1, secondaryOutcomes measure: Biochemical analysis: Vitamin B2, secondaryOutcomes measure: Biochemical analysis: Vitamin B3, secondaryOutcomes measure: Biochemical analysis: Vitamin B6, secondaryOutcomes measure: Biochemical analysis: Vitamin B9, secondaryOutcomes measure: Biochemical analysis: Vitamin B12, secondaryOutcomes measure: Biochemical analysis: Vitamin C, secondaryOutcomes measure: Biochemical analysis: Vitamin A, secondaryOutcomes measure: Biochemical analysis: Vitamin D, secondaryOutcomes measure: Biochemical analysis: Vitamin E, secondaryOutcomes measure: Biochemical analysis: Carotenes, secondaryOutcomes measure: Biochemical analysis: Retinol, secondaryOutcomes measure: Biochemical analysis: Water, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Santiago de Compostela, city: Santiago De Compostela, state: La Coruña, zip: 15782, country: Spain, geoPoint lat: 42.88052, lon: -8.54569, locations facility: University of Navarra, city: Pamplona, state: Navarra, zip: 31009, country: Spain, geoPoint lat: 42.81687, lon: -1.64323, locations facility: Institut Hospital del Mar d'Investigacions Mèdiques, city: Barcelona, zip: 08003, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: University of Cordoba, city: Córdoba, zip: 14071, country: Spain, geoPoint lat: 37.89155, lon: -4.77275, locations facility: Rovira i Virgili University, city: Tarragona, zip: 43002, country: Spain, geoPoint lat: 41.11667, lon: 1.25, locations facility: University of Valencia, city: Valencia, zip: 46010, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: University of Zaragoza, city: Zaragoza, zip: 50018, country: Spain, geoPoint lat: 41.65606, lon: -0.87734, hasResults: False
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protocolSection identificationModule nctId: NCT06317870, orgStudyIdInfo id: CHUV_PENGIT, briefTitle: Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty, acronym: PENGIT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire Vaudois, class: OTHER, descriptionModule briefSummary: The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block (PENG) with intrathecal morphine in patients scheduled for total hip replacement surgery. The main question to be answered is whether the PENG block is equivalent to intrathecal morphine in reducing postoperative pain.Participants will be randomised into two groups. Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic (isobaric bupivacaine) alone and a PENG block. Patients assigned to the intrathecal morphine (ITM) group will receive spinal anaesthesia with a mixture of local anaesthetic (isobaric bupivacaine) and morphine (100 mcg) and a sham PENG block to ensure patient blinding., conditionsModule conditions: Analgesia, conditions: Hip Arthropathy, conditions: Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: single centered, prospective, double blinded non inferiority trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: quadruple, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intrathecal morphine, interventions name: Pericapsular nerve group block (PENG), outcomesModule primaryOutcomes measure: Cumulative postoperative morphine consumption at day 1, secondaryOutcomes measure: Morphine consumption in the recovery room, secondaryOutcomes measure: PCA administered morphine consumption at day 2, secondaryOutcomes measure: rest and dynamic pain scores, secondaryOutcomes measure: Incidence of postoperative nausea and vomiting, secondaryOutcomes measure: Incidence of pruritus, secondaryOutcomes measure: Incidence of urinary retention requiring bladder catheterisation, secondaryOutcomes measure: Duration of analgesia, secondaryOutcomes measure: operated limb quadriceps strength, secondaryOutcomes measure: Walking test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Lausanne, city: Lausanne, state: Vaud, zip: 1011, country: Switzerland, contacts name: Marta Szyszko du Bois d'Aische, role: CONTACT, phone: +41795564002, email: marta.szyszko@chuv.ch, contacts name: Corey Kull, role: CONTACT, phone: +41795561781, email: corey.kull@chuv.ch, geoPoint lat: 46.516, lon: 6.63282, hasResults: False
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protocolSection identificationModule nctId: NCT06317857, orgStudyIdInfo id: 14422021443228, briefTitle: Clinical Performance of an Alkasite-based Restorative Material, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The evolution of restorative dental materials and technology has enabled the use of tooth-colored restorative materials in dental restorations, with all dentists hoping for the presence of materials that combine biocompatible qualities and aesthetics . Although resin composite materials' mechanical and aesthetic properties have greatly improved over the past 20 years, research is currently on to find ways to prevent secondary caries from forming beneath and at the margins of restorations. In order to circumvent these problems, there is a growing tendency towards the use of resin-based bioactive and remineralizing restorative materials to strengthen and lengthen the lifespan of bonded dental restorations., conditionsModule conditions: Caries, Dental, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Centio Forte, outcomesModule primaryOutcomes measure: Retention success rate % with modified USPH criteria, secondaryOutcomes measure: Marginal adaptation with modified USPH criteria marginal discolouration, recurrent caries, anatomic form and postoperative sensitivity., secondaryOutcomes measure: Postoperative sensitivity, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06317844, orgStudyIdInfo id: BlackHillsHealthPsych, secondaryIdInfos id: P20GM103443, type: NIH, link: https://reporter.nih.gov/quickSearch/P20GM103443, briefTitle: Examination of Psychological and Physiological Pathways Linking Gratitude and Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Black Hills State University, class: OTHER, collaborators name: National Institute of General Medical Sciences (NIGMS), descriptionModule briefSummary: The goal of this clinical trial is to compare the effects of a brief gratitude intervention on individuals' psychological and physiological responses to acute pain. Furthermore, these associations will be examined in the context of genetic variations associated with both pain and psychological processes., conditionsModule conditions: Acute Pain, conditions: Positive Thinking, conditions: Emotions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral Writing Intervention, outcomesModule primaryOutcomes measure: Change in Subjective Pain Ratings from Baseline to 10-minutes Post Cold Pressor Test, primaryOutcomes measure: Differences in Pain Tolerance to Cold Pressor Test, primaryOutcomes measure: Differences in Pain Onset to Cold Pressor Test, secondaryOutcomes measure: Differences in Pain-Related Cognition, secondaryOutcomes measure: Differences in Autonomic Nervous System Responsivity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317831, orgStudyIdInfo id: 2023.03936.BDANA, briefTitle: LetS Get fUnctional! FuNctional Status in pEople With intersTitial Lung Disease, acronym: SUNSET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2028-07-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Aveiro University, class: OTHER, collaborators name: Fundação para a Ciência e a Tecnologia, descriptionModule briefSummary: This study aims to i) To characterize the functional status and explore the determinants of functional status decline of people with IlD ii)To determine the measurement properties of functional status instruments in people with Interstitial lung diseases (ILD) iii) To identify the impact of ILD and the participants' perspectives on functional status through interviews iv) Explore the progression of functional status progression in people with ILD and v) Develop a multidimensional index, incorporating functional status parameters, to predict mortality in people with ILD.Patients with ILD will be recruited via the pulmonology services at hospitals, namely from Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV) and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up spirometric measurements and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.The assessments will be conducted at 6 time points: baseline and 1 week after for instrument validation, followed by assessments every 6 months for 2 years.It is expected that: i) Functional status limitations can be comprehensively identified and measured in individuals with ILD. ii) Some measures are valid and reliable indicators of functional status in individuals with ILD. iii) Different profiles of functional status progression will be identified in individuals with ILD, including stable, slow, and fast decline. iv) A multidimensional index incorporating functional status will improve the accuracy of predicting mortality and outperform the predictive ability of the current GAP Index., conditionsModule conditions: Interstitial Lung Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: Short physical performance battery (SPPB), secondaryOutcomes measure: Six Minute Walk Test (6MWT), secondaryOutcomes measure: The 1-minute sit-to-stand, secondaryOutcomes measure: The grocery shelving task, secondaryOutcomes measure: The Physical Performance Test (PPT), secondaryOutcomes measure: Handgrip strenght, secondaryOutcomes measure: Peripheral muscle strength, secondaryOutcomes measure: The Tilburg Frailty Indicator (TFI), secondaryOutcomes measure: The Canadian Occupational Performance Measure (COPM), secondaryOutcomes measure: Symptoms of fatigue, secondaryOutcomes measure: Symptoms of fatigue, secondaryOutcomes measure: Symptoms of dyspnoea, secondaryOutcomes measure: The Pulmonary Functional Status and Dyspnea Questionnaire Modified version (PFSDQ-M), secondaryOutcomes measure: Health-related quality of life (HRQOL), secondaryOutcomes measure: Health-related quality of life (HRQOL), secondaryOutcomes measure: London Chest Activities of Daily Living (LCADL), secondaryOutcomes measure: Daily physical activity, secondaryOutcomes measure: Qualitative data: Interviews, secondaryOutcomes measure: Number of hospitalizations, secondaryOutcomes measure: Acute exacerbations, secondaryOutcomes measure: Non-invasive ventilation, secondaryOutcomes measure: Oxygen therapy, secondaryOutcomes measure: Medication, secondaryOutcomes measure: Mortality, otherOutcomes measure: Weight, otherOutcomes measure: Height, otherOutcomes measure: Body mass index, otherOutcomes measure: Heart rate, otherOutcomes measure: Respiratory rate, otherOutcomes measure: Blood pressure, otherOutcomes measure: Peripheral Oxygen Saturation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Aveiro, city: Aveiro, zip: 3810-193, country: Portugal, geoPoint lat: 40.64427, lon: -8.64554, hasResults: False
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protocolSection identificationModule nctId: NCT06317818, orgStudyIdInfo id: TJT2301, briefTitle: Is Local Injection of Mesenchymal Stem Cells After Endoscopic Dilation Safe and Does it Improve the Outcome of Intestinal Stricture in Patients With Crohn's Disease?, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-06, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Liege, class: OTHER, descriptionModule briefSummary: This is an exploratory phase II study, to evaluate the impact of these Mesenchymal Stem Cells (MSCs) on strictures in Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation. The impact of combined treatment by endoscopic dilation and local injection of MSCs will be compared with that of a control group., conditionsModule conditions: Safety Issues, conditions: Efficacy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, controlled study, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Mesenchymal Stem Cells, interventions name: Comparative placebo, outcomesModule primaryOutcomes measure: Assessment of safety of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease., primaryOutcomes measure: Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating symptomatic clinical response, primaryOutcomes measure: Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating endoscopic response, primaryOutcomes measure: Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating radiological response, secondaryOutcomes measure: Evaluation of studying, in addition to biomarkers (CRP and fecal calprotectin),, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Liège, status: RECRUITING, city: Liège, zip: 4000, country: Belgium, contacts name: Sophie Vieujean, MD, role: CONTACT, phone: + 32 4 323 72 56, email: s.vieujean@chuliege.be, contacts name: Layla Boutaffala, role: CONTACT, phone: +32 4 323 38 10, email: lboutaffala@chuliege.be, geoPoint lat: 50.63373, lon: 5.56749, hasResults: False
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protocolSection identificationModule nctId: NCT06317805, orgStudyIdInfo id: TREV1-10P.401, secondaryIdInfos id: 2023-504351-26-01, type: CTIS, briefTitle: Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients, acronym: TripleTRE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: AOP Orphan Pharmaceuticals AG, class: INDUSTRY, collaborators name: ANOVA CRO s.r.o., collaborators name: PharmaLex Belgium, collaborators name: Aixial s.r.o., collaborators name: GCP-Service International Ltd. & Co. KG, descriptionModule briefSummary: TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH.The effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment., conditionsModule conditions: Pulmonary Arterial Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomized, two-arm, open-label, low-interventional, phase IV, multi-centre clinical trial comparing efficacy and safety of initial triple therapy including parenteral treprostinil to initial double oral therapy (background therapy with endothelin receptor antagonist - ERA and phosphodiesterase type-5 inhibitor - PDE-5i) by proportion of patients achieving low risk status according to the simplified four-strata risk-assessment tool from week 24 up to 48 weeks in 110 (55/group) treatment-naïve adult intermediate-high risk or intermediate-low risk patients with severe hemodynamic impairment with pulmonary arterial hypertension (PAH) (group I)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Generic treprostinil sodium + Standard of Care (Double Oral), interventions name: Standard of Care - Double Oral, outcomesModule primaryOutcomes measure: Patients achieving (non-)response status to the assigned treatment in terms of achievement of low-risk status, secondaryOutcomes measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - PVR, secondaryOutcomes measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - mPAP, secondaryOutcomes measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - mRAP, secondaryOutcomes measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - CI, secondaryOutcomes measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - CO, secondaryOutcomes measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - RAP, secondaryOutcomes measure: Change in right heart structure and function assessed by echocardiography - TAPSE/sPAP, secondaryOutcomes measure: Change in right heart structure and function assessed by echocardiography - RVEDA, secondaryOutcomes measure: Change in right heart structure and function assessed by echocardiography - RVESA, secondaryOutcomes measure: Change in right heart structure and function assessed by echocardiography - RVFAC, secondaryOutcomes measure: Change in right heart structure and function assessed by echocardiography - RA, secondaryOutcomes measure: Change in right heart structure and function assessed by echocardiography - Pericardial effusion, secondaryOutcomes measure: Time to achievement of low-risk status, secondaryOutcomes measure: Rate of change of risk status, secondaryOutcomes measure: Change in the number of low-risk criteria based on the French PH Network Registry (FPHR) risk assessment tool, secondaryOutcomes measure: Change in REVEAL 2.0 risk score, secondaryOutcomes measure: Rate of change in WHO-FC, secondaryOutcomes measure: Rate of change in 6MWD, secondaryOutcomes measure: Rate of change in NT-proBNP/BNP levels, secondaryOutcomes measure: Total number of clinical worsening(s), secondaryOutcomes measure: Overall and transplant free survival, secondaryOutcomes measure: Rate of change in quality of life - emPHasis-10, secondaryOutcomes measure: Rate of change in quality of life - EQ-5D-5L, otherOutcomes measure: Safety outcomes:, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ordensklinikum Linz, status: RECRUITING, city: Linz, country: Austria, contacts name: Regina Steringer-Mascherbauer, role: CONTACT, phone: +437327676, phoneExt: 4916, email: regina.steringer-mascherbauer@ordensklinikum.at, contacts name: Regina Steringer-Mascherbauer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.30639, lon: 14.28611, locations facility: Medical University Vienna, status: RECRUITING, city: Vienna, country: Austria, contacts name: Irene Lang, role: CONTACT, phone: +43140400, phoneExt: 4623, email: irene.lang@meduniwien.ac.at, contacts name: Irene Lang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Fakultní Nemocnice Olomouc, status: NOT_YET_RECRUITING, city: Olomouc, country: Czechia, contacts name: Jan Přeček, role: CONTACT, phone: +420588445102, email: jan.precek@fnol.cz, contacts name: Jan Přeček, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.59552, lon: 17.25175, locations facility: Všeobecná fakultní nemocnice v Praze, status: NOT_YET_RECRUITING, city: Praha, country: Czechia, contacts name: Pavel Jansa, role: CONTACT, phone: +420224962629, email: pavel.jansa@vfn.cz, contacts name: Pavel Jansa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris, status: NOT_YET_RECRUITING, city: Paris, country: France, contacts name: Olivier Sitbon, role: CONTACT, phone: +33145217883, email: olivier.sitbon@abc.aphp.fr, contacts name: Olivier Sitbon, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpitaux Universitaires de Strasbourg, status: NOT_YET_RECRUITING, city: Strasbourg, country: France, contacts name: Marianne Riou, role: CONTACT, phone: +330369550686, email: marianne.riou@chru-strasbourg.fr, contacts name: Marianne Riou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, locations facility: DRK Kliniken Berlin Westend, status: NOT_YET_RECRUITING, city: Berlin, country: Germany, contacts name: Christian Opitz, role: CONTACT, phone: +493030354815, email: c.opitz@drk-kliniken-berlin.de, contacts name: Christian Opitz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.52437, lon: 13.41053, locations facility: University Hospital Carl Gustav Carus of Technical University Dresden, status: NOT_YET_RECRUITING, city: Dresden, country: Germany, contacts name: Michael Halank, role: CONTACT, phone: +4935145813981, email: michael.halank@uniklinikum-dresden.de, contacts name: Michael Halank, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05089, lon: 13.73832, locations facility: Universitätsmedizin Greifswald, status: NOT_YET_RECRUITING, city: Greifswald, country: Germany, contacts name: Ralf Ewert, role: CONTACT, phone: +4938348680500, email: ewert@uni-greifswald.de, contacts name: Ralf Ewert, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.09311, lon: 13.38786, locations facility: Gottsegen National Cardiovascular lnstitute, status: NOT_YET_RECRUITING, city: Budapest, country: Hungary, contacts name: Olga Hajnalka Balint, role: CONTACT, phone: +3612152139, email: titkarsag@kardio.hu, contacts name: Olga Hajnalka Balint, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Medical University of Szeged, status: NOT_YET_RECRUITING, city: Szeged, country: Hungary, contacts name: Gergely Ágoston, role: CONTACT, phone: +3662545553, email: agoston.gergely@med.u-szeged.hu, contacts name: Gergely Ágoston, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.253, lon: 20.14824, locations facility: Sapienza University of Rome, status: RECRUITING, city: Rome, country: Italy, contacts name: Roberto Badagliacca, role: CONTACT, phone: +39064402727, email: roberto.badagliacca@uniroma1.it, contacts name: Roberto Badagliacca, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, locations facility: John Paul II Hospital Krakow, status: NOT_YET_RECRUITING, city: Kraków, country: Poland, contacts name: Grzegorz Kopeć, role: CONTACT, phone: +48126143399, contacts name: Grzegorz Kopeć, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Fryderyk Chopin Hospital in European Health Centre Otwock, status: NOT_YET_RECRUITING, city: Otwock, country: Poland, contacts name: Marcin Kurzyna, role: CONTACT, phone: +48227103052, email: marcin.kurzyna@ecz-otwock.pl, contacts name: Marcin Kurzyna, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.10577, lon: 21.26129, locations facility: Centro Hospitalar Lisboa Norte - Santa Maria University Hospital, status: NOT_YET_RECRUITING, city: Lisboa, country: Portugal, contacts name: Rui Miguel Freire Plácido, role: CONTACT, phone: +351217805306, email: rui.placido@chln.min-saude.pt, contacts name: Rui Miguel Freire Plácido, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.71667, lon: -9.13333, locations facility: Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu, status: NOT_YET_RECRUITING, city: Bucharest, country: Romania, contacts name: Ioan Mircea Coman, role: CONTACT, phone: +40213175222, contacts name: Ioan Mircea Coman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.43225, lon: 26.10626, locations facility: Emergency Clinical County Hospital of Targu Mures, status: NOT_YET_RECRUITING, city: Târgu-Mureş, country: Romania, contacts name: Ioan Tilea, role: CONTACT, phone: +40265215551, email: ioan.tilea@umfst.ro, contacts name: Ioan Tilea, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.54245, lon: 24.55747, locations facility: Hospital Clinic of Barcelona, status: NOT_YET_RECRUITING, city: Barcelona, country: Spain, contacts name: Isabel Blanco Vich, role: CONTACT, phone: +34932275779, email: iblanco2@clinic.cat, contacts name: Isabel Blanco Vich, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Ramon y Cajal, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, contacts name: Jose Andres Tenes Mayen, role: CONTACT, phone: +34913368263, email: jtenes@salud.madrid.org, contacts name: Jose Andres Tenes Mayen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06317792, orgStudyIdInfo id: 202201719B0, briefTitle: The Efficacy of Online Exergaming-Integrated Physiotherapy for Parkinson's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, collaborators name: National Science and Technology Council, descriptionModule briefSummary: To validate the efficiency of online exergaming-based physiotherapy. We will enroll patients with Parkinson's disease in postural instability and gait disturbance motor phenotype in the study and divide them into two groups in a randomized controlled study., conditionsModule conditions: Parkinsonism in Diseases Classified Elsewhere, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be divided into two groups in a randomized controlled study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: online exergaming-based physiotherapy programs, outcomesModule primaryOutcomes measure: Unified Parkinson's Disease Rating Scale score assessment, primaryOutcomes measure: Tinetti balance and gait score assessment, secondaryOutcomes measure: Fall Risk assessment using Berg Balance Scale, secondaryOutcomes measure: Depression severity assessment, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, city: Kaohsiung, zip: 83304, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False
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protocolSection identificationModule nctId: NCT06317779, orgStudyIdInfo id: abdominal laparotomy, briefTitle: Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Umbilical hernia frequently accompanies cholelithiasis. It is possible to repair these hernias after completing cholecystectomy., conditionsModule conditions: Abdominal Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Evaluation of Laparoscopic cholecystectomy and concomitant paraumbilical hernia repair, secondaryOutcomes measure: Secondary outcomes measures, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317766, orgStudyIdInfo id: UC 20-2023, briefTitle: Histological Study of the Effects of a 2910 nm Fiber Laser Technology, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: FA Corporation, class: INDUSTRY, collaborators name: University of Texas Southwestern Medical Center, descriptionModule briefSummary: The goal of this interventional clinical study is to conduct a comprehensive evaluation of the 2910 nm fiber laser focusing on its diverse energy settings. 2 subjects will be recruited for this 2 part histology study. The main This study will provide valuable insights into the device\'s capabilities and expand knowledge of its clinical utility. The first part of this study is intended to optimize treatment parameters based on observed effects at the molecular level. The second part will investigate the state of tissue at different timepoints following treatment.Part 1 Pre-Clinical Study Procedure:* 1 healthy adult (male or female)* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.* On the day of the scheduled procedure, the laser device will be applied to the skin that will be removed as part of the surgery. The treatment will be completed after induction and prior to prepping for the surgical procedure.Part 2 Clinical Study Procedure:* 1 healthy adult (male or female)* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.* The study team will utilize the specific setting based off the results of Part 1.* Subject will be asked to return to the site on days -30, -3, -2, -1 before their procedure.* At each visit, subjects will receive a single pulse treatment in areas that will be marked by the study team.* On the day of their procedure, a member of the study team will administer 1 final pulse immediately post-surgery and all 5 timepoints will be harvested for analysis., conditionsModule conditions: Skin Laxity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 2, type: ESTIMATED, armsInterventionsModule interventions name: 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation, interventions name: 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation, outcomesModule primaryOutcomes measure: TUNEL Staining, primaryOutcomes measure: Mason's Trichrome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UT Soutwestern Medical Center, city: Dallas, state: Texas, zip: 75390, country: United States, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
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protocolSection identificationModule nctId: NCT06317753, orgStudyIdInfo id: UMinho1, briefTitle: Can Exercise Rewire the Brain Addiction Circuitry?, acronym: REWIRED, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Minho, class: OTHER, descriptionModule briefSummary: The aim of the present study is to apply neuroimaging techniques to investigate how physical exercise may influence the addiction circuitry, ultimately reducing alcohol consumption and craving in youth binge drinkers. This proposal will advance knowledge on how exercise may modulate the neurocircuitry of addiction. Uncovering the neurobiological mechanisms underlying the interactive neural effects of exercise and alcohol intake may provide additional scientific insights for the development of preventive and intervention programs for youth BD and AUD., conditionsModule conditions: Physical Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The protocol includes a randomized controlled trial with a follow-up at three months involving three groups of adolescents (18-24 Y) -experimental group 1, will be enrolled in the Aerobic program, experimental group 2 will be involved in the agility program, and an active control group that will be participating in a stretching program. Participants will be randomly assigned to each group., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic Exercise, interventions name: Agility-Cognitive Exercise, interventions name: Stretching/relaxation, outcomesModule primaryOutcomes measure: Behavioral: alcohol consumption, primaryOutcomes measure: Behavioral: binge episodes, primaryOutcomes measure: Behavioral : drunkenness, primaryOutcomes measure: Psychological (craving levels), primaryOutcomes measure: Brain structure, primaryOutcomes measure: Brain structural connectivity- FA, primaryOutcomes measure: Brain structural connectivity - MD, primaryOutcomes measure: Brain structural connectivity - AD, primaryOutcomes measure: Brain structural connectivity - RD, primaryOutcomes measure: Brain function, primaryOutcomes measure: Brain function-resting state, secondaryOutcomes measure: Monetary Incentive Delay Task (included in the fMRI paradigm) - hits, secondaryOutcomes measure: Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time, secondaryOutcomes measure: Maximal oxygen consumption (VO2max), secondaryOutcomes measure: Brain-derived neurotrophic factor (BDNF), secondaryOutcomes measure: Dopamine, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317740, orgStudyIdInfo id: 0306369, briefTitle: Green Management Intervention Program For Nurse Managers, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Matrouh University, class: OTHER, descriptionModule briefSummary: Green management is the organization-wide strategy that aims to integrate environmental sustainability development into organizational management procedures for maintaining safety and striving high quality of care. The study aimed to examine the effect of a randomized trial of a green management intervention program on nurse manager outcomes., conditionsModule conditions: Intervention, conditions: Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized controlled trial using two-group pretest-posttest designs, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: The study was carried out as a randomized controlled trial using two-group pretest-posttest designs in which the intervention group received an intervention program, in contrast to the comparison group. The study design of the present work followed the CONSORT 2010statement, whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: green management intervention program, outcomesModule primaryOutcomes measure: Questionnaire to measure nurse managers' knowledge, primaryOutcomes measure: Questionnaires to measure nurse manager outcomes, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Matrouh University, city: Marsa Matruh, zip: 002, country: Egypt, geoPoint lat: 31.3529, lon: 27.23725, hasResults: False
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protocolSection identificationModule nctId: NCT06317727, orgStudyIdInfo id: IRAS 337105, briefTitle: PULSed Field ablAtion of coloRectal Polyps, acronym: PULSAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2030-05, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: King's College Hospital NHS Trust, class: OTHER, collaborators name: Mirai Medical, descriptionModule briefSummary: The goal of this observational study is to learn about the role of electroporation (the use of small electric pulses applied to tissue) in the treatment (ablation) of colorectal polyps. The main questions to answer in this pilot phase of the study are:1. The safety of pulsed field ablation (PFA) for the removal of colorectal polyps2. The efficacy and feasibility of PFA in the treatment of colorectal polyps using metrics such as treatment coverage, treatment time, post treatment fibrosis, post treatment recurrence and patient satisfaction, conditionsModule conditions: Colon Polyp, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Irreversible Electroporation using EndoVE(Endoscopic Vacuum Electrode) and electrical pulses generated using ePORE(electroporation device), outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps, secondaryOutcomes measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps, secondaryOutcomes measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps, secondaryOutcomes measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps, secondaryOutcomes measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps, secondaryOutcomes measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps, secondaryOutcomes measure: Evaluation of Quality of Life following pulsed field ablation treatment of colorectal polyps, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317714, orgStudyIdInfo id: IR-2023/0002, secondaryIdInfos id: 2023-A02233-42, type: OTHER, domain: ANSM, briefTitle: Long-term Follow-up and Quality of Life of Patients Treated With Anticancer Drugs, acronym: THERAPINNOV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2027-03-08, completionDateStruct date: 2027-03-08, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Institut Rafael, class: OTHER, descriptionModule briefSummary: Currently, aspects related to the effects of anticancer treatments and the quality of life of patients and their needs are still poorly documented at the Rafael Institute. Thus this study will meet a dual objective: (1) the establishment of a registry to collect data on the safety and effectiveness of innovative and expensive anticancer drugs when administered in real life and (2) a measurement quantitative quality of life of patients treated with these drugs., conditionsModule conditions: Oncology, conditions: Quality of Life, conditions: Symptoms and Signs, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: questionnaires, outcomesModule primaryOutcomes measure: overall survival, primaryOutcomes measure: progression free survival, primaryOutcomes measure: incidence of adverse events, primaryOutcomes measure: incidence of serious adverse events, secondaryOutcomes measure: Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score, secondaryOutcomes measure: change from baseline in quality of life measured with the EQ5D5L questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute Rafaël, status: RECRUITING, city: Levallois Perret, state: Institut Rafael, zip: 92300, country: France, contacts name: Alain Toledano, role: CONTACT, phone: 33 (0)1 47 58 05 96, geoPoint lat: 48.89389, lon: 2.28864, hasResults: False
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protocolSection identificationModule nctId: NCT06317701, orgStudyIdInfo id: IRB23-1801, briefTitle: Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine if the treatment of Obstructive sleep apnea (OSA) by hypoglossal nerve stimulation (HGNS) will alter glucose metabolism. The study team will also determine if the treatment of Obstructive sleep apnea (OSA) by (hypoglossal nerve stimulation) HGNS will alter predictors of cardiovascular outcomes., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Hypoglossal Nerve Stimulation (HGNS), outcomesModule primaryOutcomes measure: Glycemic variability, primaryOutcomes measure: Mean systolic BP (daytime and nocturnal), primaryOutcomes measure: Glycemic variability, secondaryOutcomes measure: mean blood glucose levels, secondaryOutcomes measure: mean ambulatory glucose excursions, secondaryOutcomes measure: time blocks, secondaryOutcomes measure: Morning fasting insulin, including calculated insulin resistance (HOMA-IR), secondaryOutcomes measure: Mean norepinephrine levels, secondaryOutcomes measure: Morning fasting blood glucose, secondaryOutcomes measure: Hemoglobin A1c, secondaryOutcomes measure: Insulin levels, secondaryOutcomes measure: c-peptide levels, secondaryOutcomes measure: fasting lipid profile (triglycerides), secondaryOutcomes measure: heart rate indices by activity monitor, secondaryOutcomes measure: sympathetic activity by plasma norepinephrine, secondaryOutcomes measure: Morning fasting insulin of c-peptide level, secondaryOutcomes measure: fasting lipid profile (HDL- cholesterol), secondaryOutcomes measure: fasting lipid profile ( LDL-cholesterol), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Chicago, status: RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Phillip LoSavio, MD, MS, role: CONTACT, phone: 773-702-5189, email: Phillip.Losavio@bsd.uchicago.edu, contacts name: Leila Yazdanbakhsh, role: CONTACT, phone: 773-834-5087, email: leila.yazdanbakhsh@bsd.uchicago.edu, contacts name: Phillip LoSavio, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06317688, orgStudyIdInfo id: TWU IRB-FY2023-157, briefTitle: Effectiveness of Highly Purified Anhydrous (HPA) Lanolin Versus Extra-Virgin Coconut Oil in Preventing Subacute Lactation Mastitis, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-06, primaryCompletionDateStruct date: 2024-08-14, completionDateStruct date: 2024-08-14, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Texas Woman's University, class: OTHER, collaborators name: Harris Health System (Houston, Texas), descriptionModule briefSummary: Problem of the Study This study was designed to test the effectiveness of the application of extra-virgin coconut oil versus Highly Purified Anhydrous (HPA) Lanolin in ameliorating nipple pain, cracking and eventually the prevention of subacute lactation mastitis in breastfeeding women. It is theorized that the nipple crack, nipple pain are early warning signs of subacute clinical lactation mastitis. Goal is after application of extra-virgin coconut oil comparative analysis will be done at one week, three weeks, and six weeks. These complications associated with development of subacute mastitis can be addressed early during the first six weeks of lactation., conditionsModule conditions: Lactation Mastitis, conditions: Breast Feeding, conditions: Staphylococcus Aureus Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trial- Random Assignment-Random Selection, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Extra-Virgin Coconut Oil, outcomesModule primaryOutcomes measure: Measurement of change in pain level (Numeric Pain Rating Scale McCaffery, 1989), primaryOutcomes measure: Measurement of Development of Nipple Crack (Nipple Tenderness Scale Storr 1988), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Harris Health System, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06317675, orgStudyIdInfo id: ct9873, briefTitle: Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Studio Osteopatico Busto Arsizio, class: OTHER, descriptionModule briefSummary: To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD), conditionsModule conditions: Gastro-oesophageal Reflux Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Osteopathic manipulative treatment (OMT), outcomesModule primaryOutcomes measure: Mean change in GERD-HRQL, primaryOutcomes measure: Adverse effects, secondaryOutcomes measure: Exercise adherence, secondaryOutcomes measure: Change in drugs use, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CTFO, status: RECRUITING, city: Saronno, state: Varese, zip: 21047, country: Italy, contacts name: +39 02 96701013, role: CONTACT, geoPoint lat: 45.62513, lon: 9.03517, hasResults: False
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protocolSection identificationModule nctId: NCT06317662, orgStudyIdInfo id: NCI-2024-01994, secondaryIdInfos id: NCI-2024-01994, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: AALL2321, type: OTHER, domain: Children's Oncology Group, secondaryIdInfos id: AALL2321, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180886, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180886, briefTitle: Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2027-12-21, completionDateStruct date: 2027-12-21, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \[R\]) or without a KMT2A gene rearrangement (KMT2A-germline \[G\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL., conditionsModule conditions: Acute Leukemia of Ambiguous Lineage, conditions: B Acute Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 171, type: ESTIMATED, armsInterventionsModule interventions name: Asparaginase Erwinia chrysanthemi, interventions name: Biospecimen Collection, interventions name: Blinatumomab, interventions name: Bone Marrow Aspiration, interventions name: Calaspargase Pegol, interventions name: Computed Tomography, interventions name: Cyclophosphamide, interventions name: Cytarabine, interventions name: Daunorubicin, interventions name: Dexamethasone, interventions name: Doxorubicin, interventions name: Echocardiography, interventions name: FDG-Positron Emission Tomography, interventions name: Leucovorin, interventions name: Lumbar Puncture, interventions name: Magnetic Resonance Imaging, interventions name: Mercaptopurine, interventions name: Methotrexate, interventions name: Multigated Acquisition Scan, interventions name: Pegaspargase, interventions name: Prednisolone, interventions name: Prednisone, interventions name: Therapeutic Hydrocortisone, interventions name: Thioguanine, interventions name: Venetoclax, interventions name: Vincristine, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (DLTs) (safety phase), primaryOutcomes measure: Incidence of DLTs (expansion phase), primaryOutcomes measure: Minimal residual disease (MRD)-negative remission rate, secondaryOutcomes measure: Event free survival (EFS) rates of infants with KMT2A-R acute lymphoblastic leukemia (ALL), secondaryOutcomes measure: 3-year EFS of infants with KMT2A-R ALL, secondaryOutcomes measure: Proportion of KMT2A-G patients in Arm C who are able to receive all treatment cycles before maintenance, secondaryOutcomes measure: Pharmacokinetics (PK) of venetoclax in infants, otherOutcomes measure: 3-year EFS of infants with KMT2A-R ALL treated on Arm B, otherOutcomes measure: 3-year EFS of infants with KMT2A-G ALL treated on Arm C, otherOutcomes measure: Use of high-throughput sequencing (HTS) for MRD detection in infant ALL compared to centralized flow cytometry, otherOutcomes measure: PK of calaspargase pegol in infants with ALL, otherOutcomes measure: Incidence of CD19-negative relapse and myeloid switch relapse with protocol therapy, otherOutcomes measure: Impact of venetoclax in combination with chemotherapy on T-cell subsets and function, otherOutcomes measure: Feasibility of T-cell collection and success of T-cell manufacturing for infants with KMT2A-R ALL who receive chimeric antigen receptor T-cell therapy, otherOutcomes measure: Predictors of response and resistance to venetoclax and overall protocol therapy, otherOutcomes measure: Impact of subsequent anti-cancer therapy on overall survival, eligibilityModule sex: ALL, maximumAge: 365 Days, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317649, orgStudyIdInfo id: NCI-2024-01987, secondaryIdInfos id: NCI-2024-01987, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: MM1OA-EA02, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: MM1OA-EA02, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180820, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180820, briefTitle: Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 147, type: ESTIMATED, armsInterventionsModule interventions name: Azacitidine, interventions name: Biospecimen Collection, interventions name: Bone Marrow Aspiration, interventions name: Bone Marrow Biopsy, interventions name: Gilteritinib, interventions name: Venetoclax, outcomesModule primaryOutcomes measure: Rate of measured residual disease (MRD) negative complete remission (CR), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317636, orgStudyIdInfo id: 73487, briefTitle: Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression, acronym: PEAK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare ketamine to a placebo when given as a single infusion during sedation in adults with chronic pain and depression. This study aims to:* Evaluate whether ketamine is more effective than a placebo in treating chronic pain and depression* Confirm that propofol sedation is a safe way to keep participants blinded to treatment* Assess patients' comfort with the sedation process to improve future studies* Explore whether patient expectations affects their pain and depressionParticipants will:* Need to qualify for the study based on stringent medical criteria* Undergo sedation with propofol* Randomly receive either a ketamine or a placebo (saline) infusion during sedation* Complete several study assessments over 5-7 weeks, conditionsModule conditions: Chronic Pain, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Ketamine, interventions name: Normal saline, outcomesModule primaryOutcomes measure: Pain Intensity (past 24 hours), secondaryOutcomes measure: Depression severity, secondaryOutcomes measure: Pain Intensity (current), otherOutcomes measure: Number and severity of adverse events related to sedation, otherOutcomes measure: Proportion of participants who accurately recall intra-sedation events, otherOutcomes measure: Treatment guess, otherOutcomes measure: Treatment expectancies, otherOutcomes measure: Pain interference, otherOutcomes measure: Physical function, otherOutcomes measure: Number of painful body regions, otherOutcomes measure: Change in pain medication utilization, otherOutcomes measure: Pressure pain threshold, otherOutcomes measure: Enrollment rate, otherOutcomes measure: Consent fraction, otherOutcomes measure: Participant Experience Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317623, orgStudyIdInfo id: 0292/21/2023-00590, briefTitle: Urinary Tract Dilations in Prenatal and Postnatal Life, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: SonoClinic, class: NETWORK, descriptionModule briefSummary: The goals of this study are to use a questionnaire survey to determine the state of awareness of the diagnosis and management of patients with urinary tract dilation across several medical professionals, to predict the severity of the postnatal course and surgical intervention in fetuses with urinary tract dilation detected during pregnancy, and to create a model of prenatal and postnatal care for patients with dilation of the urinary tract for multidisciplinary use., conditionsModule conditions: Urinary Tract Dilatation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Prenatal and postnatal ultrasound examination, outcomesModule primaryOutcomes measure: The goal is the prediction of severe postnatal course and surgical intervention in fetuses with dilatation of the urinary tract according to the UTD classification created in 2014., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Svetlana Jánošová, status: RECRUITING, city: Záborské, zip: 08253, country: Slovakia, contacts name: Svetlana Jánošová, role: CONTACT, phone: +421908369470, email: svetlana.janosova@gmail.com, contacts name: Róbert Dankovčík, role: CONTACT, phone: +4219051291297, email: dankovcik@gmail.com, geoPoint lat: 48.9451, lon: 21.28977, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-12-19, uploadDate: 2024-02-26T14:43, filename: Prot_000.pdf, size: 1211102, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-19, uploadDate: 2024-02-26T14:43, filename: ICF_001.pdf, size: 373557, hasResults: False
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protocolSection identificationModule nctId: NCT06317610, orgStudyIdInfo id: CQGOG0206, briefTitle: Artificial Intelligence Model for Growth Prediction of Ovarian Cancer Organoids, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Chongqing University Cancer Hospital, class: OTHER, descriptionModule briefSummary: The present study aims to collect early bright field image of patient-derived organoids with ovarian cancer. By leveraging artificial intelligence, this study will seek to construct and refine algorithms that able to predict growth of ovarian cancer organoids., conditionsModule conditions: Ovarian Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: growth prediction of ovarian cancer organoids in the frame of bright field image by leveraging AI, outcomesModule primaryOutcomes measure: AUC of growth prediction performance using deep learning model, primaryOutcomes measure: Accuracy of growth prediction using deep learning model, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chongqing Cancer Hospital, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400030, country: China, contacts name: Dongling Zou, M.D., role: CONTACT, phone: 13657690699, email: cqzl_zdl@163.com, contacts name: Dongling Zou, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06317597, orgStudyIdInfo id: OSS2024-0311, briefTitle: Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution for Colonoscopy, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, collaborators name: Peking University People's Hospital, collaborators name: Internet Hospital of Tianjin Medical University General Hospital, collaborators name: The Affiliated Suzhou Hospital of Nanjing Medical University, collaborators name: Tianjin First Central Hospital, collaborators name: Tianjin Beichen Hospital, collaborators name: ShangDong Provincial Hospital, collaborators name: The Affiliated Hospital of Qingdao University, collaborators name: First People's Hospital of Hangzhou, collaborators name: The Third People's Hospital of Chengdu, collaborators name: Ningbo Yinzhou District Second Hospital, collaborators name: Changshu Affiliated Hospital of Soochow University, collaborators name: Linyi People's Hospital, collaborators name: Shanghai East Hospital, collaborators name: Heilongjiang Province Hospital Nangang Branch, collaborators name: The Affiliated Jiangyin Hospital of Nantong University, collaborators name: West China Hospital, descriptionModule briefSummary: To evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) between the first and last dose of laxative is not inferior to a long time interval (10-12 hours) in bowel preparation quality., conditionsModule conditions: Colonoscopy: Bowel Preparation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 448, type: ESTIMATED, armsInterventionsModule interventions name: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution, interventions name: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution, outcomesModule primaryOutcomes measure: Bowel preparation adequate rate, secondaryOutcomes measure: Acceptability of bowel preparation by questionnaire survey, otherOutcomes measure: Incidence of laxative-related adverse events assessed by clinical examinations, otherOutcomes measure: Colonoscopy completion rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhai Hospital, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06317584, orgStudyIdInfo id: NMRPF3M0042, briefTitle: Empowerment-based Complementary and Alternative Medicine (ECAM), acronym: CAM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-04, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Chang Gung University of Science and Technology, class: OTHER, collaborators name: National Science and Technology Council, collaborators name: Chang Gung Memorial Hospital, descriptionModule briefSummary: This phase study will use a randomized trial method to evaluate the performance of the ECAM educational app in the promotion of CAM health literacy and communication among patients with diabetes., conditionsModule conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized trail method, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: QUADRUPLE, maskingDescription: The process of keeping the study group assignment hidden after the allocation to participant, care provider, investigator, outcomes assessor, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: Empowerment Application for CAM Health Education, interventions name: Written Paper for CAM Health Education, outcomesModule primaryOutcomes measure: Understanding the benefits-risks of complementary therapies (CTs) use scale Alternative Medicine (CAM) use questionnaire, primaryOutcomes measure: Quality of life questionnaire, primaryOutcomes measure: Diabetes Empowerment scale, secondaryOutcomes measure: Blood Glucose (GLU), secondaryOutcomes measure: Glycated Hemoglobin(HbA1c), secondaryOutcomes measure: ALanine aminoTransferase，Glutamic Pyruvic Transaminase(ALT/GPT), secondaryOutcomes measure: ASpartate aminoTransferase，Glutamic Oxaloacetic Transaminase (AST/GOT), secondaryOutcomes measure: Blood Urea Nitrogen(BUN), secondaryOutcomes measure: Creatinine(CREA), secondaryOutcomes measure: High Density Lipoprotein(HDL), secondaryOutcomes measure: Total Bilirubin(T.BIL), secondaryOutcomes measure: Serum total cholesterol(TC), secondaryOutcomes measure: Triglyceride (TG), secondaryOutcomes measure: Glomerular filtration rate(GFR), secondaryOutcomes measure: Albumin to Creatinine Ratio (ACR), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHENG GUNG MEMORIAL HOSPITAL, Linkou, city: Taoyuan City, state: Guishan District, zip: 333, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
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protocolSection identificationModule nctId: NCT06317571, orgStudyIdInfo id: CelalBayarU-SBF-OT-01, briefTitle: Evaluation of The Effect of Fertility Support Education Given to Infertile Couples, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-15, primaryCompletionDateStruct date: 2021-12-28, completionDateStruct date: 2022-08-10, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Celal Bayar University, class: OTHER, descriptionModule briefSummary: The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment., conditionsModule conditions: Infertility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups with intervention group and control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: fertility support education, outcomesModule primaryOutcomes measure: Infertility Stress Scale, primaryOutcomes measure: Infertility Self-Efficacy Scale-Short Form, primaryOutcomes measure: Fertility Readiness Scale, primaryOutcomes measure: Fertiqol Quality of Life Scale, primaryOutcomes measure: Blood cortisol level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi, city: Manisa, zip: 45060, country: Turkey, geoPoint lat: 38.61202, lon: 27.42647, hasResults: False
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protocolSection identificationModule nctId: NCT06317558, orgStudyIdInfo id: 22/492-3694, briefTitle: Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy, acronym: NeoIM-Lung, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in NSCLC patients using the real-world data. The main questions it aims to answer are:* What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?* How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data., conditionsModule conditions: NSCLC, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: Neoadjuvant immunotherapy, interventions name: Other drugs for neoadjuvant treatment, outcomesModule primaryOutcomes measure: Pathological Complete Response (pCR), primaryOutcomes measure: Disease-free survival(DFS), secondaryOutcomes measure: OS (overall survival), secondaryOutcomes measure: EFS (event-free survival), secondaryOutcomes measure: Major Pathological Response (MPR), secondaryOutcomes measure: Relapse Patterns, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shugeng Gao, status: RECRUITING, city: Beijing, state: Beijing, zip: 100020, country: China, contacts name: Shugeng Gao, Vice president, role: CONTACT, phone: 010-87788177, email: gaoshugeng@cicams.ac.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06317545, orgStudyIdInfo id: REC/RCR&AH/23/0167/shan ali, briefTitle: Effects of Nerchal Exercises on Lateral Epicondylitis., statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-03-28, completionDateStruct date: 2024-03-28, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Painful condition of lateral epicondyle of the humerus characterized by the inflammation of the tendons during loading of the wrist extensor muscles is a common musculoskeletal presentation in men and women between 35 and 54 years of age. The above symptom is associated with a clinical diagnosis of lateral elbow tendinopathy (LET), also known as tennis elbow or lateral epicondylalgia the two effective treatment approaches for lateral epicondylitis are Nirschl exercises and Mulligan taping. This study aims to evaluate the effectiveness of Nirschl exercises with or without Mulligan taping in treating lateral epicondylitis. The study design for this project employs a randomized controlled trial and a sample of individuals with lateral epicondylitis randomly assigned in one of the two groups i.e., Nirschl exercises only and Nirschl exercises with Mulligan taping. Nirschl exercises involve the eccentric strengthening of the wrist extensor muscles and forearm. The participants in both groups will receive Nirschl exercises while the second group will also receive Mulligan taping, which involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons. Different outcome measures including pain intensity, functional disability, grip strength, range of motion will be evaluated using, PRTEE Scale, Visual Analogue Scale (VAS) and Calibrated Jammer hand held dynamometer. Statistical analysis, including independent t-tests or chi-square tests, will be conducted to compare the outcomes between the two groups. The significance level will be set at p \< 0.05. This study will contribute to the evidence base regarding the efficacy of Nirschl exercises and Mulligan taping in managing lateral epicondylitis and will help the clinicians and patients in deciding the best treatment approach for lateral epicondylitis., conditionsModule conditions: Lateral Epicondylitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Mulligan Taping, outcomesModule primaryOutcomes measure: Pain intensity, primaryOutcomes measure: Grip strength, secondaryOutcomes measure: Disability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: BARKI Advanced Physiotherapy Center, city: Multan, state: Punjab, zip: 60000, country: Pakistan, geoPoint lat: 30.19679, lon: 71.47824, locations facility: KAIMS Physiotherapy and Rehabilitation Center, city: Multan, state: Punjab, zip: 60000, country: Pakistan, geoPoint lat: 30.19679, lon: 71.47824, hasResults: False
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protocolSection identificationModule nctId: NCT06317532, orgStudyIdInfo id: P.T.REC/012/004766, briefTitle: Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-05-20, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea., conditionsModule conditions: Primary Dysmenorrhea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Lifestyle modification advice, interventions name: Functional exercises, outcomesModule primaryOutcomes measure: Visual analogue scale (VAS), primaryOutcomes measure: The Menstrual Distress Questionnaire, secondaryOutcomes measure: Quality of life enjoyment and satisfaction questionnaire, secondaryOutcomes measure: Pressure pain threshold assessment, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University, city: Giza, country: Egypt, contacts name: Manar E. Al-Emary, M.Sc. Stud, role: CONTACT, phone: +20 128 660 0931, email: manaralemary@gmail.com, contacts name: Mai Mohamed Ali, PhD, role: CONTACT, contacts name: Soheir Mahmoud Elkosery, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Amr Hazem Abbassy, Assis. Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06317519, orgStudyIdInfo id: 09.2020-Oss, briefTitle: Verify the Performance in Clinical Practice of the Immersive Virtual Reality Platform GRAIL (Gait Real-time Analysis Interactive Lab), statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-12, primaryCompletionDateStruct date: 2026-04-12, completionDateStruct date: 2026-04-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: Gait pattern difficulties, balance and coordination deficits often characterize patients with congenital and acquired neuromotor disorders and have a significant impact on the quality of life of these subjects. There are various treatments used and in recent years, the advent of advanced technologies in rehabilitation and, in particular, devices based on virtual reality, has opened up new possibilities in rehabilitation. Virtual reality is a promising strategy that incorporates many principles crucial to motor learning, such as high-intensity, repetitive, goal-oriented tasks, enhanced synchronized sensory signals, and active participation. The virtual environment is also suitable for personalized treatment based on the needs of the individual patient.The GRAIL (Gait Real-time Analysis Interactive Lab) is a device that integrates immersive virtual reality with an instrumented treadmill and a motion capture system, which can be used with both rehabilitation and evaluation goals. To date, there are still few studies of this device in the pediatric field.The objective of the study is to verify the performance in clinical practice of the immersive virtual reality platform GRAIL and determine any secondary effects by evaluating whether they entail acceptable risks compared to the expected performances following the protocol defined at the IRCCS Medea by Bosisio Parini, in children and adolescents with congenital and acquired neuromotor pathology.Patients suffering from acquired and congenital brain injuries undergo a combined rehabilitation treatment consisting of 20 sessions with GRAIL and 20 physiotherapy sessions in four weeks. The same subjects undergo evaluations before and at the end of the treatmentThe study is prospective and involves the verification of performance through clinical and instrumental evaluations in the population of subjects treated with the GRAIL device at the IRCCS Medea-Bosisio Parini., conditionsModule conditions: Acquired Brain Injury, conditions: Cerebral Palsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Physical Rehabilitation, interventions name: Gait Real-time Analysis Interactive Lab, outcomesModule primaryOutcomes measure: 6 minute walking test, primaryOutcomes measure: Gross Motor Function Measure -total score, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Scientific Institute IRCCS Eugenio Medea, status: RECRUITING, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, contacts name: Elena Beretta, MD, role: CONTACT, phone: 031877851, phoneExt: +39, email: elena.beretta@lanostrafamiglia.it, geoPoint lat: 45.80075, lon: 9.29, hasResults: False
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protocolSection identificationModule nctId: NCT06317506, orgStudyIdInfo id: RC 43/2022, briefTitle: Methylation Pattern and Pain Sensation in Children With Intellectual Disability, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-30, primaryCompletionDateStruct date: 2023-10-10, completionDateStruct date: 2023-10-10, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: Previous literature data indicate that children with intellectual disability (ID) experience more severe pain and more frequently than their cognitively healthy peers, during their daily life. Repeated and chronic pain exposure triggers a vicious circle of hyperalgesia and reduction of the impaired cognitive and adaptive function. Furthermore, these children are unable to rationalize any intervention targeted to contain potentially painful actions.Epigenetics studies mechanisms responsible for a set of modifications that regulate gene expression without altering the DNA sequence itself. DNA methylation and posttranslational modification of histones are the main epigenetic mechanisms. It is widely accepted that these mechanisms can be engaged by environmental experience, such as early life trauma, pain or addiction leading to the idea of epigenetics as 'a bridge' between genes and environment.Several epigenetic studies evaluated genes coding proteins involved in recycling of neurotransmitters (SCL6A4), in transmission of painful stimuli (TRPA1) and in response to analgesics (OPRM1). In particular, some studies assessed TRPA1 gene, coding for a cationic channel responsible for the transmission of thermal-painful sensations, and SCL6A4, a serotonin-recycling transmembrane protein presents at inter-synaptic level, have highlighted the importance of methylation in a pathological experience of chronic pain and anxiety disorder in the adult population. Opioid receptor OPRM1 is involved in the endogenous and exogenous opioid-mediated analgesia and a recent work in a group of adolescents treated for idiopathic scoliosis highlights a link between greater pain post-surgery and methylation of this gene. In this context, children with ID are at greater risk of undertreatment both for the difficulty in pain recognition and for the fear of medication-adverse reactions.The epigenetic study of the aforementioned genes in children with ID associated with an evaluation of painful experiences and clinical history, could help understanding a scenario that it is still complex nowadays before the eyes of parents and caregivers and healthcare workers.The finding of a different methylation pattern in children with ID could in part explain the different pain experience., conditionsModule conditions: Intellectual Disability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Between groups differences in methylation levels, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", city: Trieste, zip: 34137, country: Italy, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06317493, orgStudyIdInfo id: RC 15/2021, briefTitle: Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-03, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient., conditionsModule conditions: Hearing Impaired Children, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Stimuli, outcomesModule primaryOutcomes measure: Sensitivity index of pupillometry test, eligibilityModule sex: ALL, minimumAge: 4 Months, maximumAge: 36 Months, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Eva Orzan, MD, role: CONTACT, phone: +39.040.3785.537, email: eva.orzan@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06317480, orgStudyIdInfo id: QH_2024, briefTitle: Outcomes Comparison Between Bone Resection and Subperiosteal Dissection for Specific Type of Soft Tissue Sarcoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2000-05-01, primaryCompletionDateStruct date: 2020-05-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: the purpose of this study is to assess whether bone resection for thigh soft tissue sarcoma with cortical involvement of the adjacent bone result in better local control and survival compared to sub-periosteal dissection. Investigators also aim to find out the prognostic factors for clinical outcomes in this group of patients., conditionsModule conditions: Soft Tissue Sarcoma, conditions: Cortical Contact, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 142, type: ACTUAL, armsInterventionsModule interventions name: bone resection, interventions name: subperiosteal excision, outcomesModule primaryOutcomes measure: survival, primaryOutcomes measure: recurrence, primaryOutcomes measure: metastasis, secondaryOutcomes measure: functional outcomes, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 85 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317467, orgStudyIdInfo id: RC 01/2023, briefTitle: Role of Anti-C1q Autoantibodies in Pregnancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-13, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: Preeclampsia (PE) is a very frequent obstetric complication. C1q, the first recognition molecule of the classical pathway of complement system (C), represents a double-edged molecule in determining pregnancy outcomes. In animal models, C1q deficiency caused the development of a dysfunctional placenta and PE-like symptoms. Conversely, lower levels of C components were detected in the sera of patients with PE due to C consumption and increased deposition of activated C components in the placenta, as well as to the binding to placental apoptotic bodies, syncytiotrophoblast microvesicles (STBM) and debris which are increased in the circulation of patients with PE.C1q is a hexameric glycoprotein of 460kDa composed by six copies of three polypeptide chains A, B and C, each made by a C-terminal globular head (gC1q) and a N-terminal collagen-like region (CLR). This molecule can be the target of an antibody response. Autoantibodies targeting C1q were first recognized in the serum of Systemic Lupus Erythematosus (SLE) patients. The presence of anti-C1q autoantibodies was also detected in patient affected by autoimmune disease (ie, kidney disorders, vasculitis, thyroiditis). Almost all of these autoimmune disorders are associated with an increased risk of developing PE during pregnancy.Anti-C1q detection mainly concerns the prediction of the onset of lupus nephritis (LN) in SLE patients. Although anti-C1q autoantibodies do not deplete circulating C1q, their presence in maternal circulation and in placenta may trigger improper C activation and impair C1q activity. In pregnancies complicated by autoimmune affection such as SLE, autoimmune thyroid disorders and Antiphospholipid syndrome (APS) the prevalence of anti-C1q appeared to be higher than in control pregnancies and associated with miscarriage. High levels of anti-C1q have been found in a group of Japanese patients suffering recurrent pregnancy loss (RPL). In a group of anti-C1q positive healthy pregnancies and LN patients was assessed whether C1q autoantigenic behaviour could vary among individuals with or without correlated manifestation. Sera from healthy pregnancies and LN patients were screened for the presence of autoantibodies against the CLR fragment and/or the gC1q: antibodies against gC1q were found in both groups, whereas anti-CLR were only detected in the LN one, suggesting that only the latter may have a pathogenic role. Despite this, the biological functions of anti-C1q remain far from clear, conditionsModule conditions: Pre-Eclampsia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Blood sampling, interventions name: Blood sampling, outcomesModule primaryOutcomes measure: Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies, primaryOutcomes measure: Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies, primaryOutcomes measure: Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies, primaryOutcomes measure: Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies, primaryOutcomes measure: Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies, primaryOutcomes measure: Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies, primaryOutcomes measure: Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies, primaryOutcomes measure: Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Chiara Agostinis, BSc, role: CONTACT, phone: 040/5588652, email: chiara.agostinis@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06317454, orgStudyIdInfo id: GR-2019-12369573, briefTitle: Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-11, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (HbA1c) patterns remain poorly understood and are likely to be genetic.While significant progress has been made in understanding of the genetic contribution to T1DM onset, very few studies have evaluated the role of genetic factors on T1DM metabolic control.This study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with T1DM and to evaluate genetic and environmental factors that might predict trajectories in glycemic control, conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Blood and saliva analysis, outcomesModule primaryOutcomes measure: Identification of environmental factors affecting T1DM metabolic control, primaryOutcomes measure: Identification of genetic factors affecting T1DM metabolic control, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Antonietta Robino, role: CONTACT, phone: +39.040.3785.470, email: antonietta.robino@burlo.trieste.it, contacts name: Silvia Tommasi, role: CONTACT, phone: +39.040.3785.863, email: silvia.tommasi@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06317441, orgStudyIdInfo id: NIMCSF137, briefTitle: The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Nimble Science Ltd., class: INDUSTRY, collaborators name: Lallemand Health Solutions, descriptionModule briefSummary: In this study, the goal is to evaluate whether a probiotic formula may reduce symptoms of bloating and abdominal distension in a population suffering from Small Intestinal Bacterial Overgrowth (SIBO) in comparison to a placebo. In addition to the incidence of SIBO, changes to other gastrointestinal symptoms will be assessed. Lastly, the associations between the SIBO status and microbiome from the small and large intestines will be explored using the SIMBA capsule., conditionsModule conditions: Small Intestinal Bacterial Overgrowth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, outcomesModule primaryOutcomes measure: Change in bloating/distension severity, secondaryOutcomes measure: Median bloating-free days, secondaryOutcomes measure: Change in median bloating/distension severity, secondaryOutcomes measure: Change in abdominal discomfort/pain, secondaryOutcomes measure: Changes in gastrointestinal symptoms, secondaryOutcomes measure: Changes in stool frequency and consistency, secondaryOutcomes measure: Changes in the quality of life, secondaryOutcomes measure: Changes in reflux incidence and severity, secondaryOutcomes measure: Changes in the severity of IBS symptoms, secondaryOutcomes measure: Recovery rate of the probiotic strain, secondaryOutcomes measure: Microbiome changes within small intestine, fecal and saliva samples, secondaryOutcomes measure: Investigation how the microbiome and SIBO associate with each other though bacterial population analyses., secondaryOutcomes measure: Change in SIBO positivity rate, otherOutcomes measure: Exploratory metabolomic analysis, otherOutcomes measure: Exploratory: Quantifying B. subtilis cell proportions, otherOutcomes measure: Safety outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nimble Science, city: Calgary, state: Alberta, zip: T2L 1Y8, country: Canada, contacts name: Gwen Duytschaever, role: CONTACT, phone: 4037032436, email: Gwen@nimblesci.com, contacts name: Christopher N Andrews, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Nimble Science, city: Calgary, state: Alberta, zip: T2L 1Y8, country: Canada, contacts name: Marsha Burnes, role: CONTACT, phone: 4037032436, email: Marsha@nimblesci.com, contacts name: Christopher N Andrews, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False
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protocolSection identificationModule nctId: NCT06317428, orgStudyIdInfo id: INRCA_001_2024, briefTitle: NT-proBNP Levels During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD., acronym: NTproBNP, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-28, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Istituto Nazionale di Ricovero e Cura per Anziani, class: OTHER, descriptionModule briefSummary: Observational prospective study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the iniation of triple inhaled formoterol/glycopyrrolate/budesonide therapy., conditionsModule conditions: COPD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 29, type: ESTIMATED, outcomesModule primaryOutcomes measure: Change in serum NT-pro-BNP levels, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: INRCA Hospital, status: RECRUITING, city: Ancona, country: Italy, contacts name: Francesco Spannella, role: CONTACT, email: f.spannella@inrca.it, contacts name: Riccardo Sarzani, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.5942, lon: 13.50337, locations facility: IRCCS INRCA Hospital, status: RECRUITING, city: Osimo, country: Italy, contacts name: Erilda Kamberi, MD, role: CONTACT, email: e.kamberi@inrca.it, contacts name: Yuri Rosati, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.48539, lon: 13.48222, hasResults: False
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protocolSection identificationModule nctId: NCT06317415, orgStudyIdInfo id: HuazhongU20240312, briefTitle: Intervention on Non-prescription Antibiotic Use Among the Public, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Huazhong University of Science and Technology, class: OTHER, collaborators name: Fuyong People's Hospital, Bao 'an District, Shenzhen City, Guangdong, descriptionModule briefSummary: The purpose of this study is to test the effectiveness of health education int led by community health workers for non-prescription antibiotic use among the public. In this two arm cluster randomised trial, In this two-arm cluster randomized controlled trial, 22 communities were randomly allocated in a 1:1 ratio to intervention and control groups. In the intervention group, family doctors will conduct WeChat-based health education on responsible use of antibiotic for the participants. In the control group, only routine public health education will be provided without any involvement in antibiotic use. The primary outcome is the incidence of antibiotic use without prescription in the past month., conditionsModule conditions: Non-Prescription Drug Misuse, conditions: Antibiotic Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1550, type: ACTUAL, armsInterventionsModule interventions name: WeChat-based health education on antibiotic use, interventions name: Regular public health education, outcomesModule primaryOutcomes measure: Rate of non-prescription antibiotic use among the public, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fuyong People's Hospital, city: Shenzhen, state: Guangdong, zip: 518103, country: China, geoPoint lat: 22.54554, lon: 114.0683, hasResults: False
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protocolSection identificationModule nctId: NCT06317402, orgStudyIdInfo id: APHP240133, briefTitle: Epidemiology and Management of Malnutrition of Patients Hospitalized at the Pitié-Salpêtrière Hospital: a One-day Survey Combined With Focus Groups (Mixed Methods), acronym: EPIDENUT_PSL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-09, primaryCompletionDateStruct date: 2025-09-09, completionDateStruct date: 2025-09-09, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay.Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS ( High Authority for Health) criteria for 2019 (if age \<70 years) and 2021 (if age ≥ 70 years)., conditionsModule conditions: Malnutrition, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 385, type: ESTIMATED, armsInterventionsModule interventions name: malnutrition questionary, outcomesModule primaryOutcomes measure: Prevalence of undernutrition diagnosed according to HAS 2019 and 2021 criteria on a given day in hospitalized PSL patients., secondaryOutcomes measure: Compare the prevalence and the severity of undernutrition in hospitalized PSL patients according to the HAS criteria of 2019 (if age <70 years) and 2021 (if age ≥ 70 years) versus those of 2003 (if age <70 years) and 2007 (if age ≥ 70 years)., secondaryOutcomes measure: Evaluate the quality of nutritional management for malnourished patients hospitalized at PSL. Using PMSI coding, assess the value of activities associated with undernutrition in undernourished patients hospitalized at PSL., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service de nutrition, Hôpital Pitié-Salpêtrière, status: RECRUITING, city: Paris, zip: 75013, country: France, contacts name: Pauline Faucher, Dr, role: CONTACT, phone: 01 42 17 57 71, phoneExt: 33, email: pauline.faucher@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06317389, orgStudyIdInfo id: 69HCL23_1237, briefTitle: PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments, acronym: PACOME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2034-11, completionDateStruct date: 2037-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: With the shift to ambulatory care and the rise of ATCO oral anticancer drugs, a growing number of cancer patients are benefiting from oral treatment in an outpatient setting, which meets their needs and preference over injectable chemotherapy with more autonomy and less time spent in the hospital. However, outside the safe hospital context, the complex pharmacological profile of ATCO exposes patients to iatrogenic drug risks. These medicinal problems or Drug Related Problems DRP linked to ATCO are sources of dosage modifications and lead to sub-therapeutic doses compared to clinical trials and consequently to a reduction, in life actual, dose-intensity and expected response. Furthermore, insufficiently controlled in an ambulatory environment and due to a lack of city-hospital coordination, DRPs lead to an increase in the consumption of care.Oncoral is the pioneering multidisciplinary city-hospital monitoring of outpatients treated with oral anticancer drugs. Set up in 2014 by the Hospices Civils de Lyon, this educational monitoring is based on a tripartite hospital intervention (oncologist, pharmacist, nurse) and a structured city-hospital link with private health professionals (attending doctor, community pharmacist and freelance nurse). Multidisciplinary interventions are focused on PROs and DRPs and combine an educational approach for the patient based on their needs and potential social vulnerabilities.The PACOME real-life database will describe the population of ambulatory patients treated by ATCO benefiting from the secure multidisciplinary city-hospital Oncoral pathway with the aim of improving knowledge on this population, on the real-life use of ATCO and on new methods of organizing ambulatory cancer care.The PACOME database collects sociodemographic, clinical and therapeutic data, and experiences in this population. Patients quality of life and other PROs (symptoms and adverse effects experienced by patients), social determinants, health care consumption, the caregiver-patient relationship, the use of digital technology in health, the organization of care, the city-hospital link (interventions of actors and their temporality).This base will make it possible to optimize the treatment of patients at the individual and population level and to generate evidence in addition to clinical trials, which are expected by health professionals and decision-makers. With patient data from the secure Oncoral pathway, PACOME brings together the three major and inseparable assets of real-life databases: quality, completeness and meaning of the data. It constitutes a basis for essential academic and private collaborations for studies on data and comparative observational or interventional studies, which will contribute to the animation of the new ecosystem of real-life health data in oncology., conditionsModule conditions: Cancer, conditions: Oncology, conditions: Oncoral Program, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaires, outcomesModule primaryOutcomes measure: Relative-Dose-Intensity (RDI) in real life with a prospective follow-up of 6 months within the limit of the duration of treatment with oral anticancer drugs by setting up a data platform for adult patients taking oral anticancer drugs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Groupement Hospitalier Sud - Unité de Pharmacie Clinique Oncologique, city: Pierre-Bénite, zip: 69495, country: France, contacts name: Catherine RIOUFOL, Pr, role: CONTACT, contacts name: Florence RANCHON, MCU-PH, role: SUB_INVESTIGATOR, contacts name: Anne-Gaëlle CAFFIN, Dr, role: SUB_INVESTIGATOR, contacts name: Marie-Anne CERFON, PH, role: SUB_INVESTIGATOR, geoPoint lat: 45.7009, lon: 4.82511, hasResults: False
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protocolSection identificationModule nctId: NCT06317376, orgStudyIdInfo id: REC/014131 Maria Haseen, briefTitle: Group-based Cardiac Rehabilitation on Patients With Coronary Artery Bypass Graft Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-01-18, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: 1. To determine the effect of Moderate intensity continuous training on Pulmonary function of CABG patients.2. To determine the effect of MICT on aerobic Capacity of CABG patients., conditionsModule conditions: Post-cardiac Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: MICT with Aerobic exercise on treadmill, interventions name: standard hospital protocol, outcomesModule primaryOutcomes measure: Borg rating of perceived exertion scale, primaryOutcomes measure: 6min walk test, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: RMI, city: Peshawar, country: Pakistan, geoPoint lat: 34.008, lon: 71.57849, hasResults: False
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protocolSection identificationModule nctId: NCT06317363, orgStudyIdInfo id: REC/RCR&AHS/23/0353, briefTitle: Effects of Acapella VS CHEST Physiotherapy in Post-Operative CABG Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-23, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Coronary artery bypass grafting (CABG) is a surgical procedure that is performed to improve blood flow to the heart by bypassing blocked or narrowed arteries. CABG is a major surgery that is associated with significant postoperative complications, including pulmonary complications such as atelectasis and pneumonia. Chest physiotherapy is commonly use to prevent and treat these complications, but its effectiveness in post-operative CABG patients is not well established.The purpose of this study is to evaluate the effects of Acapella device vs chest physiotherapy on pulmonary function, airway clearance and dyspnea in post-operative CABG patients. The group A will receive (baseline treatment aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition to using Acapella), while the group B will receive base line treatment. aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition chest physiotherapy percussing for 20 minute The primary outcome measures of the study will be pulmonary function tests, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC, and Modified Borg dyspnea scale . The secondary outcome measures will be the amount of sputum cleared. The study will be conducted over a period of 6 months after approval of synopsis.The study will be conducted in a tertiary care hospital in Lahore, Pakistan. Patients who have undergone CABG surgery will be screen for eligibility and those who meet the inclusion criteria will be enroll in the study. Patients who have a history of chronic lung disease, smoking, intubated patient or other respiratory conditions will be exclude from the study, conditionsModule conditions: CABG, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Base Line + ACEPELLA, interventions name: Base Line + Manual Chest Physiotherapy, outcomesModule primaryOutcomes measure: Modified Borg Dyspnea Scale, primaryOutcomes measure: FEV1, primaryOutcomes measure: FVC, primaryOutcomes measure: FEV1/FVC, primaryOutcomes measure: sputum volume, secondaryOutcomes measure: body temperature(degree centigrade), secondaryOutcomes measure: pulse rate (beats/minute), secondaryOutcomes measure: respiratory rate( breaths/minute), secondaryOutcomes measure: blood pressure (mmHg), secondaryOutcomes measure: SpO2 (%), secondaryOutcomes measure: SaO2 (%), secondaryOutcomes measure: PaO2 (%), secondaryOutcomes measure: PaCO2 (%), eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jinnah Hospital, city: Lahore, state: Punjab, zip: 54600, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06317350, orgStudyIdInfo id: GNS-212-E, secondaryIdInfos id: 101772, type: OTHER, domain: MFDS, briefTitle: Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy, acronym: GNS-212-E, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Gunkang Pharmaceuticals, Inc, class: INDUSTRY, descriptionModule briefSummary: This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial., conditionsModule conditions: Colonoscopy, conditions: Bowel Preparation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 318, type: ESTIMATED, armsInterventionsModule interventions name: GNS-212-E1, interventions name: GNS-212-E2, interventions name: GNS-212-ER, outcomesModule primaryOutcomes measure: To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale), secondaryOutcomes measure: Overall rate of bowel preparation, secondaryOutcomes measure: Overall patient satisfaction and compliance, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Byeong Gwan Kim, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06317337, orgStudyIdInfo id: Sana Bshir, briefTitle: Focused Ultrasound Cavitation Augmented With Aerobic Exercise, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-15, primaryCompletionDateStruct date: 2023-04-15, completionDateStruct date: 2023-07-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: This study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. This research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life., conditionsModule conditions: Central Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: focused ultrasound cavitation augmented with aerobic exercises, outcomesModule primaryOutcomes measure: Borg rating of perceived exertion scale, primaryOutcomes measure: girth, primaryOutcomes measure: 6min walk test, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Bioflex Aesthetic Clinic, city: Peshawar, state: KPK, country: Pakistan, geoPoint lat: 34.008, lon: 71.57849, hasResults: False
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protocolSection identificationModule nctId: NCT06317324, orgStudyIdInfo id: bc2023200, briefTitle: Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to compare the prognostic differences between SBRT and Surgery for NSCLC patients with interlobular fissure invasion. The main questions it aims to answer are:1. Explore the survival differences.2. Explore of the lung function changes before and after different treatments., conditionsModule conditions: NSCLC, conditions: Radiotherapy, conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Different treatments, outcomesModule primaryOutcomes measure: OS, primaryOutcomes measure: PFS, primaryOutcomes measure: MRFS, primaryOutcomes measure: LRFS, secondaryOutcomes measure: VC, secondaryOutcomes measure: FVC, secondaryOutcomes measure: FEV1, secondaryOutcomes measure: DLCO, secondaryOutcomes measure: PFR, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300060, country: China, contacts name: Zhao Yan, role: CONTACT, phone: +86-22-23340123, phoneExt: 5509, email: yanzhaotj@126.com, contacts name: Xishan Hao, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
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protocolSection identificationModule nctId: NCT06317311, orgStudyIdInfo id: 221968, briefTitle: A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer, acronym: RUBY-J, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2026-07-15, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer, conditionsModule conditions: Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Dostarlimab, interventions name: Carboplatin, interventions name: Paclitaxel, outcomesModule primaryOutcomes measure: Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR), secondaryOutcomes measure: DRR12 per RECIST 1.1, assessed by investigator, secondaryOutcomes measure: Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Overall response rate (ORR) per RECIST 1.1 assessed by BICR, secondaryOutcomes measure: ORR per RECIST 1.1 assessed by investigator, secondaryOutcomes measure: Disease control rate (DCR) per RECIST 1.1 assessed by BICR, secondaryOutcomes measure: DCR per RECIST 1.1 assessed by investigator, secondaryOutcomes measure: Duration of response (DOR) per RECIST 1.1 assessed by BICR, secondaryOutcomes measure: DOR per RECIST 1.1 assessed by investigator, secondaryOutcomes measure: Maximum concentration (Cmax) for dostarlimab, secondaryOutcomes measure: Minimum concentration (Cmin) for dostarlimab, secondaryOutcomes measure: Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity, secondaryOutcomes measure: Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation, secondaryOutcomes measure: Number of participants with AEs leading to death, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Aichi, zip: 464-8681, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Shiro Suzuki, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.51879, lon: 130.62158, locations facility: GSK Investigational Site, city: Chiba, zip: 260-8717, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Naotake Tanaka, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6, lon: 140.11667, locations facility: GSK Investigational Site, city: Ehime, zip: 791-0280, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Kazuhiro Takehara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.63163, lon: 132.76886, locations facility: GSK Investigational Site, city: Fukuoka, zip: 811-1395, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Kazuya Ariyoshi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.6, lon: 130.41667, locations facility: GSK Investigational Site, city: Fukuoka, zip: 830-0011, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Shin Nishio, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.6, lon: 130.41667, locations facility: GSK Investigational Site, city: Gunma, zip: 373-8550, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Kazuto Nakamura, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.52592, lon: 138.97142, locations facility: GSK Investigational Site, city: Hokkaido, zip: 060-8648, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Hidemichi Watari, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.41104, lon: 142.88878, locations facility: GSK Investigational Site, city: Hyogo, zip: 673-8558, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Satoshi Yamaguchi, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, city: Ibaraki, zip: 305-8576, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Toyomi Sato, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.81641, lon: 135.56828, locations facility: GSK Investigational Site, city: Iwate, zip: 028-3695, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Tsukasa Baba, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, city: Kanagawa, zip: 259-1193, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Takeshi Hirasawa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.58333, lon: 139.91667, locations facility: GSK Investigational Site, city: Okayama, zip: 700-8558, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Shoji Nagao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.65, lon: 133.93333, locations facility: GSK Investigational Site, city: Osaka, zip: 541-8567, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Shoji Kamiura, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.69374, lon: 135.50218, locations facility: GSK Investigational Site, city: Osaka, zip: 569-8686, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Satoe Fujiwara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.69374, lon: 135.50218, locations facility: GSK Investigational Site, city: Saitama, zip: 350-1298, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Kosei Hasegawa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.90807, lon: 139.65657, locations facility: GSK Investigational Site, city: Shizuoka, zip: 411-8777, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Yasuyuki Hirashima, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.98333, lon: 138.38333, locations facility: GSK Investigational Site, city: Tochigi, zip: 329-0498, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Yuji Takei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.38333, lon: 139.73333, locations facility: GSK Investigational Site, city: Tokyo, zip: 104-0045, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Kazuki Sudo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, locations facility: GSK Investigational Site, city: Tokyo, zip: 135-8550, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mayu Yunokawa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, locations facility: GSK Investigational Site, city: Tokyo, zip: 160-8582, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Wataru Yamagami, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, hasResults: False
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protocolSection identificationModule nctId: NCT06317298, orgStudyIdInfo id: 2023-013-CH01 IIT-RCC, briefTitle: Fruquintinib Plus Everolimus as 2nd Line Therapy of ccRCC Patients Progressed Post IO and TKI Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Peking University First Hospital, class: OTHER, descriptionModule briefSummary: This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor., conditionsModule conditions: Renal Cell Carcinoma, Clear Cell, Somatic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Fruquintinib and Everolimus, outcomesModule primaryOutcomes measure: MTD (Maximum Tolerated Dose), primaryOutcomes measure: ORR (Objective Response Rate), secondaryOutcomes measure: PFS (Progression Free Survival), secondaryOutcomes measure: DCR (Decease Control Rate ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University First Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Zhisong He, MD, role: CONTACT, phone: +8610-83572418, email: wyj7074@sohu.com, contacts name: Kaiwei Yang, MD, role: CONTACT, phone: 13811501435, email: 13811501435@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06317285, orgStudyIdInfo id: 220929, secondaryIdInfos id: 2023-509371-16-00, type: OTHER, domain: EU CTR, briefTitle: A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-19, completionDateStruct date: 2026-03-19, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: This will be a double-blind study with respect to allocation of GSK3915393 or placebo to participants., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: GSK3915393, interventions name: Placebo, outcomesModule primaryOutcomes measure: Absolute Change from Baseline in Forced Vital Capacity (FVC) in milliliters (mL) at Week 26, secondaryOutcomes measure: Absolute Change from Baseline in Forced Vital Capacity (mL) at Weeks 4, 8, 12 and 18, secondaryOutcomes measure: Absolute Change from Baseline in Percent Predicted Forced Vital Capacity (%) at Weeks 4, 8, 12, 18 and 26, secondaryOutcomes measure: Participants Achieving Relative Decline from Baseline in FVC (mL) Less than or Equal to (≤) 5 Percent (%) at Week 26, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of Participants with Clinically Important Findings in Vital Signs, secondaryOutcomes measure: Number of Participants with Clinically Important Findings in Electrocardiogram (ECG), secondaryOutcomes measure: Number of Participants with Clinically Important Findings in Haematology, secondaryOutcomes measure: Number of Participants with Clinically Important Findings in Hepatobiliary Parameters, secondaryOutcomes measure: Number of Participants with Clinically Important Findings in Clinical Chemistry, secondaryOutcomes measure: Maximum observed concentration (Cmax) of GSK3915393 in IPF Participants, secondaryOutcomes measure: Area under the time-concentration curve (AUC) from Zero (pre-dose) to 4 hours (h) post-dose sample [0-4 h]) of GSK3915393, secondaryOutcomes measure: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC- inf) of GSK3915393, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317272, orgStudyIdInfo id: RT2016-04-BROTHER Part 1, briefTitle: BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma, acronym: BROTHER, statusModule overallStatus: TERMINATED, startDateStruct date: 2021-02-10, primaryCompletionDateStruct date: 2023-09-19, completionDateStruct date: 2023-09-19, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, descriptionModule briefSummary: The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study., conditionsModule conditions: Esophageal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The participating patients will undergo weekly (during radiotherapy treatment) 2 CTs in DIBH; one using ABC and one using voluntary coaching (VC)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1, type: ACTUAL, armsInterventionsModule interventions name: DIBH using ABC technique, interventions name: DIBH using VC technique, outcomesModule primaryOutcomes measure: Feasibility DIBH, primaryOutcomes measure: Reproducibility DIBH, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UMC Groningen, city: Groningen, country: Netherlands, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False
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protocolSection identificationModule nctId: NCT06317259, orgStudyIdInfo id: 809163, briefTitle: Effects of Hypoxic Breathwork, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, descriptionModule briefSummary: This project will study changes that occur during a short period of intensive daily slow-paced breathing and breath hold practice (i.e., "breathwork"). On the first and last days of the week-long practice, investigators will conduct high-density EEG recordings during breathwork to evaluate spectral power, coherence, and causality dynamics of the brain when it is naïve to breathwork and after adaptation to a breathwork practice. Breath, blood, urine, saliva, stool samples, biometric data, and sleep EEG will be collected before the start of daily breathwork practice and again after 1 week of breathwork practice to examine the effect of breathwork on full body biochemistry, molecular biology, and sleep. Investigators will also use questionnaires to assess the impact of breathwork on stress and sleep quality., conditionsModule conditions: Hypoxic Breathwork With Music and Affirmative Messaging, conditions: Hypoxic Breathwork Only, conditions: Music and Affirmative Messaging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We have 3 groups running in parallel (one of each group running in the same week). Group 1 will do breathwork that includes music and positive messaging, group 2 will do breathwork alone with only guided breathing instructions, and group 3 will listen to the music and positive messaging but no breathwork which we call the "meditation" group., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Subjects will be unaware of the other conditions and will thus not know if they are in a 'control' group or not. All experimenters will know subject group assignments. Subjects will be told of all groups at the end., whoMasked: PARTICIPANT, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Hypoxic breathwork plus music and messaging, interventions name: Hypoxic breathwork only, interventions name: Music and messaging meditation, outcomesModule primaryOutcomes measure: EEG power and/or connectivity differences between groups, primaryOutcomes measure: Group differences in sleep EEG power and/or stage changes from baseline to the intervention period, secondaryOutcomes measure: Group differences between physiological changes in proteomics, microbiome, and other factors from baseline following intervention, secondaryOutcomes measure: Group differences in mood and stress from before to after the intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, hasResults: False
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