data
stringlengths 358
232k
|
|---|
protocolSection identificationModule nctId: NCT06300346, orgStudyIdInfo id: Soh-Med-23-12-02MS, briefTitle: Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-18, completionDateStruct date: 2024-08-18, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia, conditionsModule conditions: Emetic Attacks During Caesarean Delivery With Spinal Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Propofol, outcomesModule primaryOutcomes measure: Incidence of nausea and vomiting with spinal anesthesia, secondaryOutcomes measure: Measurement of hemodynamics postoperative, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300333, orgStudyIdInfo id: Ectopic tubal pregnancy, briefTitle: Treatment of Ectopic Pregnancy by Low Dose of Methotrexate, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Evaluate the efficacy and safety of the use of low dose regimen of methotrexate in treatment of tubal undisturbed tubal ectopic pregnancy, conditionsModule conditions: Ectopic Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Methotrexate, outcomesModule primaryOutcomes measure: descriptive measurements of the results of using low dose methotrexate regimen in treatment of tubal undisturbed ectopic pregnancy, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300320, orgStudyIdInfo id: TQ05105-II-06, briefTitle: A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease, conditionsModule conditions: Chronic Graft Versus Host Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TQ05105 tablets, outcomesModule primaryOutcomes measure: Objective response rate (ORR) at 24 weeks, secondaryOutcomes measure: Best objective response rate (BOR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Failure-free survival (FFS), secondaryOutcomes measure: Incidence rate of malignancy relapse or recurrence, secondaryOutcomes measure: Non relapse mortality, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Adverse event rate, secondaryOutcomes measure: Severity of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, city: Hefei, state: Anhui, zip: 230001, country: China, contacts name: Lianxin Liu, PhD, role: CONTACT, phone: 15255456091, email: xiaoyuz@ustc.edu.cn, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The 940th hospital of joint logistics support force of Chinese people's liberation army, city: Lanzhou, state: Gansu, zip: 730050, country: China, contacts name: Tao Wu, PhD, role: CONTACT, phone: 13919939297, email: wutaozhen@yeah.net, geoPoint lat: 36.05701, lon: 103.83987, locations facility: Guangzhou First People's Hospital, city: Guangzhou, state: Guangdong, zip: 510180, country: China, contacts name: Shunqing Wang, PhD, role: CONTACT, phone: 13437801998, email: drwangshq@medmail.com.cn, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Guangxi Medical University, city: Nanning, state: Guangxi, zip: 530021, country: China, contacts name: Zhongming Zhang, Master, role: CONTACT, phone: 15807801369, email: zzmmissyou@126.com, geoPoint lat: 22.81667, lon: 108.31667, locations facility: The Second Hospital of Hebei Medical University, city: Shijiazhuang, state: Hebei, zip: 050000, country: China, contacts name: Xuejun Zhang, PhD, role: CONTACT, phone: 13722781112, email: zhxjhbmu@126.com, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Xiangyang Central Hospital, city: Xiangyang, state: Hubei, zip: 441021, country: China, contacts name: Guolin Yuan, PhD, role: CONTACT, phone: 18696231603, email: yuanguo1973@163.com, geoPoint lat: 32.0422, lon: 112.14479, locations facility: Tai'an Central Hospital, city: Taian, state: Shangdong, country: China, contacts name: Guanchen Bai, Bachelor, role: CONTACT, phone: 18653819776, email: bgcbgc1@163.com, geoPoint lat: 36.18528, lon: 117.12, locations facility: Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, city: Shanghai, state: Shanghai, zip: 200025, country: China, contacts name: Xiaoxia Hu, PhD, role: CONTACT, phone: 13795437259, email: hu_xiaoxia@126.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Second Affiliated Hospital of Xi'an Jiaotong University, city: Xian, state: Shannxi, zip: 710299, country: China, contacts name: Aili He, PhD, role: CONTACT, phone: 13891939962, email: heaili@xiju.edu.cn, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Hematology Hospital of the Chinese Academy of Medical Sciences, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Er lie Jiang, PhD, role: CONTACT, phone: 022-23909180, email: jiangerlie@ihcams.ac.cn, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First Affiliated Hospital, Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: He Huang, PhD, role: CONTACT, phone: 13605714822, email: hehuangyu@126.com, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The Affiliated People's Hospital of Ningbo University, city: Ningbo, state: Zhejiang, zip: 315040, country: China, contacts name: Ying Lu, Master, role: CONTACT, phone: 13486090834, email: rmluying@nbu.edu.cn, geoPoint lat: 29.87819, lon: 121.54945, hasResults: False
|
protocolSection identificationModule nctId: NCT06300307, orgStudyIdInfo id: CT-ATX-01-DM1-1.1, briefTitle: Study of ATX-01 in Participants With DM1, acronym: ArthemiR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: ARTHEx Biotech S.L., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated. The trial will compare the safety and tolerability of ATX-01 and a matching placebo.There will be a single-ascending dose part of the trial and a multiple-ascending dose part. In the single-ascending dose, participants will receive one dose of ATX-01 or placebo. In the multiple-ascending dose part, participants will receive three doses of ATX-01 or placebo.ATX-01 is a novel anti-miR (synthetic single stranded oligonucleotide) that inhibits a microRNA called miR-23b., conditionsModule conditions: Myotonic Dystrophy 1, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: ATX-01, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Incidence of clinically significant changes in laboratory assessments, electrocardiograms (ECGs), vital signs, suicidal ideation and behavior, secondaryOutcomes measure: Maximum observed plasma concentration (Cmax) of ATX-01, secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC) of ATX-01, secondaryOutcomes measure: Video hand opening time, secondaryOutcomes measure: Change from baseline in ankle dorsiflexion strength by quantitative myometry, secondaryOutcomes measure: Change from baseline in Impact on Activities of Daily Living questionnaire item scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300294, orgStudyIdInfo id: AIBU-SBF-AYN-3, briefTitle: Acute Coronary Syndrome and Acupressure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: This study aims to examine the effect of acupressure on physiological parameters and anxiety levels in individuals diagnosed with Acute Coronary Syndrome (ACS).H1-1: Acupressure applied to individuals diagnosed with ACS has an effect on the level of anxiety.H1-2: Acupressure applied to individuals diagnosed with ACS has an effect on blood pressure.H1-3: Acupressure applied to individuals diagnosed with ACS has an effect on heart rate.H1-4: Acupressure applied to individuals diagnosed with ACS has an effect on respiratory rate.H1-5: Acupressure applied to individuals diagnosed with ACS has an effect on the pain level.H1-6: Acupressure applied to individuals diagnosed with ACS has an effect on cortisol levels., conditionsModule conditions: Acute Coronary Syndrome, conditions: Nursing, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: experimental and control, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Since block randomization will be used in the study, the research director and the individuals who meet the study inclusion criteria will not know which group they will be in during the preliminary evaluation process of the study. However, the person analyzing the data will not know which group the data belongs to., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: acupressure, outcomesModule primaryOutcomes measure: means of blood pressure, primaryOutcomes measure: means of hear rate, primaryOutcomes measure: means of respiratory rate, primaryOutcomes measure: means of cortisol., secondaryOutcomes measure: means of subjective anxiety scores., secondaryOutcomes measure: means of subjective pain scores., secondaryOutcomes measure: electrocardiography evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300281, orgStudyIdInfo id: NEAEGeriatircs, briefTitle: Comparison of Neuromuscular and Aquatic Exercise Programs on Fall Risk and Physical Function in Geriatrics, acronym: NE-AEinGR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-04, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Alanya Alaaddin Keykubat University, class: OTHER, collaborators name: Pamukkale University, descriptionModule briefSummary: Objective: The aim of this study is to compare neuromuscular and aquatic Exercise programs on fall risk and physical function in geriatrics.Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (NE Group) and Group 2 (AE Group) (Randomizer.org). NE (Neuromuscular Exercise) group will participate in a 12-week exercise program consisting of sensorimotor system training, postural stability and control, global and local joint stabilization, balance training, muscle strength, breathing, and functional movement patterns.AE (Aqıuatic Exercise) Group will participate in an aquatic exercise program, which includes warm-up, mobility and strength, stretching, and cooling exercises in a 140 cm deep pool with a water temperature of 32 °. Data will be collected using the International Physical Activity Survey Short Form (IPAQ-SF), Montreal Cognitive Assessment Scale (MoCA), Geriatric Pain Measure, Optojump-next (Microgate, Bolzano, Italy), 6-minute Walk Test, 30-second-Sit-to-Stand Test, Four Step Square Test, Berg Balance Scale, Fear of Falling Avoidance Behavior Questionnaire.Practice Implications: This current study will contribute to the understanding of how neuromuscular exercises affect falls and physical function in geriatrics., conditionsModule conditions: Geriatrics, conditions: Exercise Therapy, conditions: Fall, conditions: Physical Functional Performance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study will be divided into two parallel groups: The neuromuscular exercise group and the Aquatic exercise group. Both groups will participate in exercise programs for 12 weeks., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Neuromuscular Exercise, interventions name: Aquatic Exercise, outcomesModule primaryOutcomes measure: Change in Pain, primaryOutcomes measure: Change in walking and reaction time, primaryOutcomes measure: Change in aerobic capacity, primaryOutcomes measure: Change in muscular fitness, primaryOutcomes measure: Change in s balance, primaryOutcomes measure: Change in dynamic balance, primaryOutcomes measure: Change in fear of falling, secondaryOutcomes measure: Physical activity level, secondaryOutcomes measure: Level of cognition, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300268, orgStudyIdInfo id: CSPL/PL/2023/004, briefTitle: Advapro Coronary Stent System in Coronary Artery Diseased Patients., acronym: RESTORE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Advanced MedTech Solutions Pvt. Ltd., class: OTHER, descriptionModule briefSummary: A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population.To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit.A QCA Analysis will be performed on minimum 48 patients in Indian population only.Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14., conditionsModule conditions: Coronary Artery Disease, conditions: De Novo Stenosis Lesion, conditions: Coronary Stent Implantation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pilot Study (Open Label), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: AdvaPro Sirolimus Eluting Coronary Stent System, outcomesModule primaryOutcomes measure: Composite Endpoint, secondaryOutcomes measure: Incidence of DOCE, secondaryOutcomes measure: Incidence of POCE, secondaryOutcomes measure: Incidence of MACE, secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Non-Target Vessel related Myocardial Infarction, secondaryOutcomes measure: Stent thrombosis, secondaryOutcomes measure: Device success, secondaryOutcomes measure: Procedural Success, secondaryOutcomes measure: Acute Device Success, otherOutcomes measure: For QCA Group, otherOutcomes measure: For QCA Group, otherOutcomes measure: For QCA Group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300255, orgStudyIdInfo id: IRB 00166616, briefTitle: Evaluation of the H.O.O.V.E.S. Healing Intensives Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2029-02-01, completionDateStruct date: 2029-02-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: VA Salt Lake City Health Care System, class: FED, descriptionModule briefSummary: The aim of this study is to measure the impact of these H.O.O.V.E.S. healing intensives on Veteran participants using several psychological instruments. The investigators are planning to administer the demographic questionnaires and psychological instruments to Veteran participants before the healing intensives. Psychological instruments will be administered immediately pre-intervention, pre- and post-session for each session, post-intervention, 90, 120 and 360 days post-intervention. The primary aim is to assess for statistically significant changes pre- to post session and pre- to post-intervention., conditionsModule conditions: Anxiety, conditions: PTSD, conditions: Depression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: H.O.O.V.E.S. Healing Intensives, outcomesModule primaryOutcomes measure: Mean Difference in AAQII pre- to post-session and pre- to post-intervention, primaryOutcomes measure: Mean Difference in PANAS pre- to post-session and pre- to post-intervention, primaryOutcomes measure: Mean Difference in STAI pre- to post-session and pre- to post-intervention, primaryOutcomes measure: Mean Difference in PCL pre- to post-session and pre- to post-intervention, primaryOutcomes measure: Mean Difference in BDI pre- to post-session and pre- to post-intervention, primaryOutcomes measure: Mean Difference in PTGI pre- to post-session and pre- to post-intervention, primaryOutcomes measure: Mean Difference in B-SCS pre- to post-session and pre- to post-intervention, secondaryOutcomes measure: Mean Difference in AAQII pre- to post-session, secondaryOutcomes measure: Mean Difference in PANAS pre- to post-session, secondaryOutcomes measure: Mean Difference in STAI pre- to post-session, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: George E. Wahlen Department of Veterans Affairs Medical Center, city: Salt Lake City, state: Utah, zip: 84148, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
|
protocolSection identificationModule nctId: NCT06300242, orgStudyIdInfo id: UP-23-00859, briefTitle: Incentives for Influenza Vaccination, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2024-01-24, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: J-PAL North America, descriptionModule briefSummary: In this work, we are assessing the impact of messaging with or without a $50 financial incentive on influenza vaccination rates in a county health system. Our main hypothesis is that a message with a $50 financial incentive will increase vaccination rates relative to a control/"treatment as usual" group. We further hypothesize that the financial incentive will increase vaccination rates relative to the message only arm., conditionsModule conditions: Influenza Vaccination, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 66000, type: ESTIMATED, armsInterventionsModule interventions name: Reminders, interventions name: Financial Incentive, interventions name: Placebo, outcomesModule primaryOutcomes measure: Vaccination status at 1 week, secondaryOutcomes measure: Vaccination status at 2 weeks, secondaryOutcomes measure: Vaccination status at 1 month, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Contra Costa Health Services, city: Martinez, state: California, zip: 94553, country: United States, geoPoint lat: 38.01937, lon: -122.13413, hasResults: False
|
protocolSection identificationModule nctId: NCT06300229, orgStudyIdInfo id: 2023-508325-27-00, briefTitle: NAPO - Novel Approach for Oligospermia, acronym: NAPO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Martin Blomberg Jensen, class: OTHER, descriptionModule briefSummary: This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely impaired semen quality (concentrations between 0.01 million/mL to 2 million/mL)., conditionsModule conditions: Infertility, Male, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Denosumab, interventions name: sodium chloride, outcomesModule primaryOutcomes measure: The difference in sperm concentration (million pr. mL) on day 80, secondaryOutcomes measure: The difference in semen quality (total sperm count, motile sperm, progressive motile sperm and morphologically normal sperm) between baseline and two semen samples delivered at day 80 and day 83 after inclusion, secondaryOutcomes measure: The change/differences in number of pregnancies achieved before day 180, secondaryOutcomes measure: The difference in the number of miscarriages throughout the trial before day 180, secondaryOutcomes measure: The change/difference in serum levels of follicle stimulating hormone (FSH) on day 80, secondaryOutcomes measure: The change/difference in serum levels of reproductive hormone luteinizing hormone (LH) on day 80, secondaryOutcomes measure: The change/difference in serum levels of reproductive hormone AMH on day 80, secondaryOutcomes measure: The change/difference in serum levels of reproductive hormone Inhibin B on day 80, otherOutcomes measure: The change/difference in CatSper expression on day 80, otherOutcomes measure: The change/difference in RANKL expression on day 80, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, city: Copenhagen, country: Denmark, contacts name: Sam Kafai Yahyavi, MD, role: CONTACT, phone: +45 35456360, email: sam.kafai.yahyavi.01@regionh.dk, contacts name: Mads Joon Jorsal, MD, role: CONTACT, phone: +45 38683868, email: mads.joon.jorsal@regionh.dk, contacts name: Sam Kafai Yahyavi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mads Joon Jorsal, MD, role: SUB_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
|
protocolSection identificationModule nctId: NCT06300216, orgStudyIdInfo id: KYLL-202401-034-1, briefTitle: A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2027-11-26, completionDateStruct date: 2028-05-26, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: The aim of this multicenter, open-label, observational study is to evaluate the safety and efficacy of octreotide microspheres in the treatment of advanced neuroendocrine tumors in real clinical practice, especially to evaluate the treatment of octreotide microspheres in various subgroups of neuroendocrine tumor patients., conditionsModule conditions: Neuroendocrine Tumors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Octreotide microspheres, outcomesModule primaryOutcomes measure: Treatment Emergent Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu hospital of Shandong University, city: Jinan, state: Shandong, zip: 250012, country: China, contacts name: Jian Wang, Dr., role: CONTACT, phone: 8618560088226, email: wang.jian@sdu.edu.cn, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
|
protocolSection identificationModule nctId: NCT06300203, orgStudyIdInfo id: CM310_IIS_SAR07, briefTitle: Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis, acronym: MEGREZ, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Beijing Tongren Hospital, class: OTHER, descriptionModule briefSummary: Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease., conditionsModule conditions: Seasonal Allergic Rhinitis, 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: 80, type: ESTIMATED, armsInterventionsModule interventions name: Interleukin-4 receptor responders, interventions name: Placebo, outcomesModule primaryOutcomes measure: Average change from baseline in daily retrospective total nasal symptom score (rTNSS) at week 2., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tongren Hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100000, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06300190, orgStudyIdInfo id: Treatment SLAP type IV lesion, briefTitle: Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Aim of this study is comparing results Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV, conditionsModule conditions: SLAP Lesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2 parallel groups selected by Randomisation, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Aim of this study is comparing outcome results of Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Biceps tenodesis alone, interventions name: Biceps tenodesis and labrum repair, outcomesModule primaryOutcomes measure: Clinical outcome by American shoulder elbow score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300177, orgStudyIdInfo id: D1553-III-01, briefTitle: D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this project is to evaluate progression-free survival (PFS) of D-1553 Tablet versus Docetaxel Injection in subjects with prior standard therapy failure kirsten rat sarcoma viral oncogene (KRAS) G12C mutation positive locally advanced or metastatic non small cell lung cancer (NSCLC), progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) based on RECIST 1.1 was used as the primary endpoint., conditionsModule conditions: Non Small Cell Lung Cancer, 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: 522, type: ESTIMATED, armsInterventionsModule interventions name: D-1553 Tablet, interventions name: Docetaxel injection, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective mitigation rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Time to response (TTR), secondaryOutcomes measure: Patient-reported outcome (PRO), secondaryOutcomes measure: Abnormal laboratory test indicators, secondaryOutcomes measure: Adverse event rate, secondaryOutcomes measure: Time to Maximum Plasma Concentration (Tmax), secondaryOutcomes measure: Half life (t1/2), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Province Hospital, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, zip: 230002, country: China, contacts name: Minghong Bao, Master, role: CONTACT, phone: 15255187155, email: baomh2015@163.com, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Cancer Hospital Chinese Academy of Medical Sciences, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Yan Wang, Doctor, role: CONTACT, phone: 13911793771, email: wangyanyifu@163.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Xuanwu Hospital Capital Medical University, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100053, country: China, contacts name: Yi Zhang, Doctor, role: CONTACT, phone: 13141370703, email: steven9130@sina.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Cancer Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Jian Fang, Bachelor, role: CONTACT, phone: 13701224460, email: fangjian5555@yeah.net, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Baoshan Cao, Doctor, role: CONTACT, phone: 13641093518, email: caobaoshan0711@aliyun.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Chest Hospital,Capital Medical University, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 101149, country: China, contacts name: Tongmei Zhang, Doctor, role: CONTACT, phone: 13683016715, email: tongmeibj@163.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The Fifth medical center of Chinese PLA General Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 222002, country: China, contacts name: Junxun Ma, Doctor, role: CONTACT, phone: 13699262799, email: majunxun74@126.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The Second Affiliated Hospital of Chongqing Medical University, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 400010, country: China, contacts name: Zhenzhou Yang, Doctor, role: CONTACT, phone: 13883270881, email: yangzz1970@163.com, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Chongqing Cancer Hospital, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 400032, country: China, contacts name: Jianlin Long, Doctor, role: CONTACT, phone: 17830326836, email: ga.longjianlin@163.com, geoPoint lat: 29.56278, lon: 106.55278, locations facility: The Southwest hospital of AMU, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 400038, country: China, contacts name: Jianjun Li, Doctor, role: CONTACT, phone: 13608319428, email: leejjun2007@163.com, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Army Medical Center, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 400042, country: China, contacts name: Mengxia Li, Doctor, role: CONTACT, phone: 18580408265, email: 707849603@qq.com, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Chongqing University Three Gorges Hospital, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 404100, country: China, contacts name: Wei Wang, Master, role: CONTACT, phone: 13635324483, email: 19574605@qq.com, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Fujian Medical University Union Hospital, status: NOT_YET_RECRUITING, city: Fuzhou, state: Fujian, zip: 350001, country: China, contacts name: Peifeng Hou, Doctor, role: CONTACT, phone: 13799987620, email: 717217167@qq.com, geoPoint lat: 26.06139, lon: 119.30611, locations facility: The First Affiliated Hospital Of Fujian Medical University, status: NOT_YET_RECRUITING, city: Fuzhou, state: Fujian, zip: 350005, country: China, contacts name: Rixiong Wang, Doctor, role: CONTACT, phone: 13960758357, email: 13960758357@163.com, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Fujian Cancer Hospital, status: NOT_YET_RECRUITING, city: Fuzhou, state: Fujian, zip: 350500, country: China, contacts name: Jing Zhang, Master, role: CONTACT, phone: 13809557405, email: cfcy813@sina.com, geoPoint lat: 26.06139, lon: 119.30611, locations facility: The First Affiliated Hospital of Xiamen University, status: NOT_YET_RECRUITING, city: Xiamen, state: Fujian, zip: 361003, country: China, contacts name: Feng Ye, Doctor, role: CONTACT, phone: 13860458889, email: yefengdoctor@sina.com, geoPoint lat: 24.47979, lon: 118.08187, locations facility: Lanzhou University Second Hospital, status: NOT_YET_RECRUITING, city: Lanzhou, state: Gansu, zip: 730030, country: China, contacts name: Junnian Shi, Master, role: CONTACT, phone: 13919778675, email: ldeyyzbgs@lzu.edu.cn, geoPoint lat: 36.05701, lon: 103.83987, locations facility: Gansu Provincial Cancer Hospital, status: NOT_YET_RECRUITING, city: Lanzhou, state: Gansu, zip: 730050, country: China, contacts name: Xiting Liu, Bachelor, role: CONTACT, phone: 13893296929, email: LXT-0421@163.com, geoPoint lat: 36.05701, lon: 103.83987, locations facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510399, country: China, contacts name: Minghui Wang, Doctor, role: CONTACT, phone: 13826276828, email: wmingh@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Guangdong Pharmaceutical University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 528405, country: China, contacts name: Xintian Qin, Master, role: CONTACT, phone: 13660558820, email: xintianqin@126.com, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Affiliated Hospital of Guangdong Medical University, status: NOT_YET_RECRUITING, city: Zhanjiang, state: Guangdong, zip: 524001, country: China, contacts name: Shujun Li, Master, role: CONTACT, phone: 13726913133, email: lishujun072@163.com, geoPoint lat: 21.28145, lon: 110.34271, locations facility: The Second Affiliated Hospital of Guilin Medical College, status: NOT_YET_RECRUITING, city: Guilin, state: Guangxi, zip: 541199, country: China, contacts name: Bihui Li, Master, role: CONTACT, phone: 18378316283, email: lbihui0202@163.com, geoPoint lat: 25.28194, lon: 110.28639, locations facility: The First Affiliated Hospital of Guangxi Medical University, status: NOT_YET_RECRUITING, city: Nanning, state: Guangxi, zip: 530020, country: China, contacts name: Qing Bu, Doctor, role: CONTACT, phone: 18277133566, email: 1332271797@qq.com, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Yulin First People's Hospital, status: NOT_YET_RECRUITING, city: Yulin, state: Guangxi, zip: 537000, country: China, contacts name: Haizhen Yi, Master, role: CONTACT, phone: 15807851995, email: yhz228815@168.com, geoPoint lat: 22.63333, lon: 110.15, locations facility: Guizhou Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Guiyang, state: Guizhou, zip: 550002, country: China, contacts name: Yu Zhang, Doctor, role: CONTACT, phone: 18885146684, email: 248634489@qq.com, geoPoint lat: 26.58333, lon: 106.71667, locations facility: The Second Affiliated Hospital of Zunyi Medical University, status: NOT_YET_RECRUITING, city: Zunyi, state: Guizhou, zip: 563000, country: China, contacts name: Yuju Bai, Master, role: CONTACT, phone: 13984535566, email: byj6618@163.com, geoPoint lat: 27.68667, lon: 106.90722, locations facility: Hainan Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Haikou, state: Hainan, zip: 570311, country: China, contacts name: Yongxing Chen, Master, role: CONTACT, phone: 13876825536, email: chen13876825536@163.com, geoPoint lat: 20.04583, lon: 110.34167, locations facility: Affiliated Hospital of Hebei University, status: NOT_YET_RECRUITING, city: Baoding, state: Hebei, zip: 050031, country: China, contacts name: Zizheng Song, Master, role: CONTACT, phone: 13932268911, email: 13932268911@163.com, geoPoint lat: 38.85111, lon: 115.49028, locations facility: The Affiliated Hospital of Chengde Medical College, status: NOT_YET_RECRUITING, city: Chengde, state: Hebei, zip: 067028, country: China, contacts name: Qingshan Li, Bachelor, role: CONTACT, phone: 15633142750, email: libing200865@126.com, geoPoint lat: 40.9519, lon: 117.95883, locations facility: The Fourth Hospital of Hebei Medical University, status: NOT_YET_RECRUITING, city: Shijiazhuang, state: Hebei, zip: 050011, country: China, contacts name: Yudong Wang, Doctor, role: CONTACT, phone: 15931166600, email: wyd_999@hebmu.edu.cn, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Tangshan People's Hospital, status: NOT_YET_RECRUITING, city: Tangshan, state: Hebei, zip: 063001, country: China, contacts name: Junquan Yang, Doctor, role: CONTACT, phone: 19131829092, email: 13313059092@163.com, geoPoint lat: 39.63333, lon: 118.18333, locations facility: Affiliated Cancer Hospital of Harbin Medical University, status: NOT_YET_RECRUITING, city: Harbin, state: Heilongjiang, zip: 150000, country: China, contacts name: Baogang Liu, Doctor, role: CONTACT, phone: 13804552752, email: liubaogang1962@sina.com, geoPoint lat: 45.75, lon: 126.65, locations facility: The Second Affiliated Hospital of Harbin Medical University, status: NOT_YET_RECRUITING, city: Harbin, state: Heilongjiang, zip: 150000, country: China, contacts name: Tao Xin, Doctor, role: CONTACT, phone: 13633655999, email: xintao1234@263.net, geoPoint lat: 45.75, lon: 126.65, locations facility: Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital), status: NOT_YET_RECRUITING, city: Jiamusi, state: Heilongjiang, zip: 154000, country: China, contacts name: Hongmei Sun, Bachelor, role: CONTACT, phone: 15344540000, email: SHM1357@163.com, geoPoint lat: 46.79927, lon: 130.31633, locations facility: Anyang Tumor Hospital, status: NOT_YET_RECRUITING, city: Anyang, state: Henan, zip: 455001, country: China, contacts name: Yuanyuan Ji, Master, role: CONTACT, phone: 13460856657, email: jiyuanyuan666@126.com, geoPoint lat: 36.096, lon: 114.38278, locations facility: The First Affiliated Hospital of Henan University of Science and Technology, status: NOT_YET_RECRUITING, city: Luoyang, state: Henan, zip: 471003, country: China, contacts name: Zhiye Zhang, Master, role: CONTACT, phone: 13783100985, email: 13783100985@163.com, geoPoint lat: 34.68361, lon: 112.45361, locations facility: Nanyang second general hospital, status: NOT_YET_RECRUITING, city: Nanyang, state: Henan, zip: 473000, country: China, contacts name: Qichuan Wang, Master, role: CONTACT, phone: 13838709208, email: chuan12616@126.com, geoPoint lat: 32.99472, lon: 112.53278, locations facility: The First affiliated Hospital of Nanyang Medical College, status: NOT_YET_RECRUITING, city: Nanyang, state: Henan, zip: 473007, country: China, contacts name: Peng Cheng, Master, role: CONTACT, phone: 13782042723, email: oncologist@163.com, geoPoint lat: 32.99472, lon: 112.53278, locations facility: The First Affiliated Hospital Of Xinxiang Medical Unerversity, status: NOT_YET_RECRUITING, city: Xinxiang, state: Henan, zip: 453100, country: China, contacts name: Weiwei Li, Master, role: CONTACT, phone: 13837384916, email: 13837384916@163.com, geoPoint lat: 35.19033, lon: 113.80151, locations facility: Xuchang Central Hospital, status: NOT_YET_RECRUITING, city: Xuchang, state: Henan, zip: 461000, country: China, contacts name: Pengyuan Wang, Master, role: CONTACT, phone: 13837440693, email: wangpengyuan@126.com, geoPoint lat: 34.03189, lon: 113.86299, locations facility: Henan Cancer Hospital, status: NOT_YET_RECRUITING, city: Zhengzhou, state: Henan, zip: 450008, country: China, contacts name: Yanqiu Zhao, Master, role: CONTACT, phone: 13938252350, email: 13938252350@163.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The First Affiliated Hospital Zhejiang University School of Medicine, status: NOT_YET_RECRUITING, city: Zhengzhou, state: Henan, zip: 450052, country: China, contacts name: Xingya Li, Doctor, role: CONTACT, phone: 13838253946, email: lixingyavip@163.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Henan Provincial People's Hospita, status: NOT_YET_RECRUITING, city: Zhengzhou, state: Henan, zip: 463599, country: China, contacts name: Shundong Cang, Doctor, role: CONTACT, phone: 13592675836, email: cangshundong@163.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, status: NOT_YET_RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Qian Chu, Doctor, role: CONTACT, phone: 13212760751, email: qianchu@tjh.tjmu.edu.cn, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Zhongnan hospital of Wuhan University, status: NOT_YET_RECRUITING, city: Wuhan, state: Hubei, zip: 430071, country: China, contacts name: Junhong Zhang, Bachelor, role: CONTACT, phone: 13638679004, email: Zjhzhongnan@163.com, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The Second Xiangya Hospital Of Central South University, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410011, country: China, contacts name: Fang Ma, Doctor, role: CONTACT, phone: 13975806788, email: dr_fma@126.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The Third Xiangya Hospital of Central South University, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410013, country: China, contacts name: Xuewen Liu, Doctor, role: CONTACT, phone: 18711033808, email: aveinliu@163.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Hunan Cancer Hospital, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410031, country: China, contacts name: Bolin Chen, Doctor, role: CONTACT, phone: 13787101898, email: chenbolin@hnca.org.cn, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Hunan Cancer Hospital, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410031, country: China, contacts name: Yongzhong Luo, Bachelor, role: CONTACT, phone: 13607443876, email: luoyongzhong@hnca.org.cn, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Xiangya Hospital Central South University, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410119, country: China, contacts name: Rongrong Zhou, Doctor, role: CONTACT, phone: 13875898127, email: 664990095@qq.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The first people's hospital of Changzhou, status: NOT_YET_RECRUITING, city: Changzhou, state: Jiangsu, zip: 213004, country: China, contacts name: Mei Ji, Doctor, role: CONTACT, phone: 0519-68871123, email: jimei@163.com, geoPoint lat: 31.77359, lon: 119.95401, locations facility: General Hospital of eastern theater command, status: NOT_YET_RECRUITING, city: Nanjing, state: Jiangsu, zip: 210007, country: China, contacts name: Yong Song, Doctor, role: CONTACT, phone: 13851761392, email: song_yong6310@126.com, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Jiangsu Cancer Hospital, status: NOT_YET_RECRUITING, city: Nanjing, state: Jiangsu, zip: 210009, country: China, contacts name: Guohao Xia, Doctor, role: CONTACT, phone: 13913976000, email: 13913976000@163.com, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Nantong Tumor Hospital, status: NOT_YET_RECRUITING, city: Nantong, state: Jiangsu, zip: 226006, country: China, contacts name: Junguo Liu, Bachelor, role: CONTACT, phone: 13814603295, email: jsntzlyy@126.com, geoPoint lat: 32.03028, lon: 120.87472, locations facility: Wuxi People's Hospital, status: NOT_YET_RECRUITING, city: Wuxi, state: Jiangsu, zip: 214023, country: China, contacts name: Tao Bian, Doctor, role: CONTACT, phone: 13358119859, email: biantaophd@126.com, geoPoint lat: 31.56887, lon: 120.28857, locations facility: Jiangyin People's Hospital, status: NOT_YET_RECRUITING, city: Wuxi, state: Jiangsu, zip: 214400, country: China, contacts name: Dong Shen, Doctor, role: CONTACT, phone: 15961663515, email: shendong@ntu.edu.cn, geoPoint lat: 31.56887, lon: 120.28857, locations facility: The Affiliated Hospital Of XuZhou Medical University, status: NOT_YET_RECRUITING, city: Xuzhou, state: Jiangsu, zip: 221004, country: China, contacts name: Zhengxiang Han, Doctor, role: CONTACT, phone: 18052268612, email: cnhzxyq@163.com, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Xuzhou Central Hospital, status: NOT_YET_RECRUITING, city: Xuzhou, state: Jiangsu, zip: 221009, country: China, contacts name: Xiang Wang, Master, role: CONTACT, phone: 18912007930, email: wangxiang7726@163.com, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Jiangxi Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Nanchang, state: Jiangxi, zip: 330006, country: China, contacts name: Weirong Yao, Doctor, role: CONTACT, phone: 13907002901, email: 13907002901@126.com, geoPoint lat: 28.68396, lon: 115.85306, locations facility: The First Affiliated Hospital Of Nanchang University, status: NOT_YET_RECRUITING, city: Nanchang, state: Jiangxi, zip: 330006, country: China, contacts name: Longhua Sun, Doctor, role: CONTACT, phone: 18279110112, email: 48570887@qq.com, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Jiangxi Cancer Hospital, status: NOT_YET_RECRUITING, city: Nanchang, state: Jiangxi, zip: 330029, country: China, contacts name: Zhenntian Liu, Master, role: CONTACT, phone: 15070083853, email: 345588506@qq.com, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Jilin Cancer Hospital, status: NOT_YET_RECRUITING, city: Changchun, state: Jilin, zip: 130000, country: China, contacts name: Ying Cheng, Doctor, role: CONTACT, phone: 0431-80596003, email: jl.cheng@163.com, geoPoint lat: 43.88, lon: 125.32278, locations facility: The First Affiliated Hospital of China Medical University, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, zip: 110002, country: China, contacts name: Yunpeng Liu, Doctor, role: CONTACT, phone: 13898865122, email: cmu_trial@163.com, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Shengjing hospital of China medical university, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, zip: 110022, country: China, contacts name: Caigang Liu, Doctor, role: CONTACT, phone: 18940254967, email: liucg@sj-hospital.org, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Shandong Cancer Hospitai, status: NOT_YET_RECRUITING, city: Jinan, state: Shandong, zip: 250117, country: China, contacts name: Hui Zhu, Doctor, role: CONTACT, phone: 15805310022, email: drzhuhui@163.com, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Jining First People's Hospital, status: NOT_YET_RECRUITING, city: Jining, state: Shandong, zip: 272011, country: China, contacts name: Jie Li, Doctor, role: CONTACT, phone: 13964921790, email: 13964921790@139.com, geoPoint lat: 35.405, lon: 116.58139, locations facility: Qingdao Municipal Hospital, status: NOT_YET_RECRUITING, city: Qingdao, state: Shandong, zip: 266011, country: China, contacts name: Mi Zhou, Master, role: CONTACT, phone: 18561858073, email: mi_zhou1978@163.com, geoPoint lat: 36.06488, lon: 120.38042, locations facility: The Second Affiliated Hospital of Shandong First Medical University, status: NOT_YET_RECRUITING, city: Tai'an, state: Shandong, zip: 271000, country: China, contacts name: Haiyan Liu, Master, role: CONTACT, phone: 18505387037, email: fylhy1998@163.com, geoPoint lat: 36.18528, lon: 117.12, locations facility: Weifang people's Hospital, status: NOT_YET_RECRUITING, city: Weifang, state: Shandong, zip: 261000, country: China, contacts name: Wei Tan, Master, role: CONTACT, phone: 13863659099, email: 13863659099@126.com, geoPoint lat: 36.71, lon: 119.10194, locations facility: Weihai Municipal Hospital, status: NOT_YET_RECRUITING, city: Weihai, state: Shandong, zip: 264299, country: China, contacts name: Fujun Yang, Doctor, role: CONTACT, phone: 18660377195, email: 58500775@qq.com, geoPoint lat: 37.50914, lon: 122.11356, locations facility: Ruijin Hospital, Shanghai Jiaotong University School Of Medicine, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, zip: 200025, country: China, contacts name: Min Zhou, Doctor, role: CONTACT, phone: 13681779624, email: doctor_zhou_99@163.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200030, country: China, contacts name: Shun Lu, Doctor, role: CONTACT, phone: 13601813062, email: shun_lu@hotmail.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Changzhi People's Hospital, status: NOT_YET_RECRUITING, city: Changzhi, state: Shanxi, zip: 046000, country: China, contacts name: Jun Zhao, Doctor, role: CONTACT, phone: 13835578500, email: zhaojun380@163.com, contacts name: Xianping Zhao, Bachelor, role: CONTACT, phone: 13453503966, email: ZXP13453503966@126.com, geoPoint lat: 35.20889, lon: 111.73861, locations facility: Shanxi Provincial Cancer Hospital, status: NOT_YET_RECRUITING, city: Taiyuan, state: Shanxi, zip: 030013, country: China, contacts name: Wei Guo, Master, role: CONTACT, phone: 13834563396, email: guowei812@126.com, geoPoint lat: 37.86944, lon: 112.56028, locations facility: The First Affiliated Hospital of Xi'An JiaoTong University, status: NOT_YET_RECRUITING, city: Xi'an, state: Shanxi, zip: 710061, country: China, contacts name: Xiaomin Dang, Doctor, role: CONTACT, phone: 18991232795, email: dxming112@163.com, geoPoint lat: 34.25833, lon: 108.92861, locations facility: The Second Affiliated Hospital of Air Force Medical University, status: NOT_YET_RECRUITING, city: Xian, state: Shanxi, zip: 710032, country: China, contacts name: Haichuan Su, Doctor, role: CONTACT, phone: 18629190366, email: cntdgcp@163.com, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Sichuan Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Chengdu, state: Sichuan, zip: 610072, country: China, contacts name: Haitao Lan, Doctor, role: CONTACT, phone: 18981838376, email: lanht@sina.com, geoPoint lat: 30.66667, lon: 104.06667, locations facility: The Affiliated Hospital Of Southwest Medical Unerversity, status: NOT_YET_RECRUITING, city: Luzhou, state: Sichuan, zip: 646000, country: China, contacts name: Peirong Ren, Master, role: CONTACT, phone: 15883037066, email: 1097802221@qq.com, locations facility: Mianyang Central Hospital, status: NOT_YET_RECRUITING, city: Mianyang, state: Sichuan, zip: 621099, country: China, contacts name: Gang Feng, Doctor, role: CONTACT, phone: 18141380968, email: 15520828768@163.com, geoPoint lat: 31.46784, lon: 104.68168, locations facility: The second people's hospital of neijiang, status: NOT_YET_RECRUITING, city: Neijiang, state: Sichuan, zip: 641000, country: China, contacts name: Yu Liu, Master, role: CONTACT, phone: 13698308655, email: 13278258@qq.com, geoPoint lat: 29.58354, lon: 105.06216, locations facility: Tianjin medical University cancer, status: NOT_YET_RECRUITING, city: Tianjin, state: Tianjin, zip: 300181, country: China, contacts name: Xiubao Ren, Doctor, role: CONTACT, phone: 18622221235, email: rwziyi@163.com, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The Affiliated Tumor Hospital of Xinjiang Medical University, status: NOT_YET_RECRUITING, city: Urumqi, state: Xinjiang, zip: 830054, country: China, contacts name: Chunling Liu, Master, role: CONTACT, phone: 13899931987, email: liudeyouxiang66@163.com, geoPoint lat: 43.80096, lon: 87.60046, locations facility: Yunnan Cancer Hospital, status: NOT_YET_RECRUITING, city: Kunming, state: Yunnan, zip: 650118, country: China, contacts name: Runxiang Yang, Master, role: CONTACT, phone: 13888876721, email: 13888876721@163.com, geoPoint lat: 25.03889, lon: 102.71833, locations facility: The First Affiliated Hospital Zhejiang University School of Medicine, status: NOT_YET_RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310009, country: China, contacts name: Yina Wang, Doctor, role: CONTACT, phone: 15957109041, email: sinead555@163.com, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The Second Affiliated Hospital Zhejiang University School of Medicine, status: NOT_YET_RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310009, country: China, contacts name: Pingli Wang, Doctor, role: CONTACT, phone: 13516808409, email: W_pl77@163.com, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The First Affiliated Hospital of Wenzhou Medical University, status: NOT_YET_RECRUITING, city: Wenzhou, state: Zhejiang, zip: 325000, country: China, contacts name: Yanfan Chen, Doctor, role: CONTACT, phone: 13600666600, email: chenyf2605@163.com, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False
|
protocolSection identificationModule nctId: NCT06300164, orgStudyIdInfo id: Unripecarobinceliac, briefTitle: The Effect of Unripe Carob Fruit in Celiac Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Toros University, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate the effects of the consumption of cookies produced by adding the unripe part of carob fruit, which has high insoluble fiber, polyphenol and antioxidant content, on the oxidative parameters (TAS and MDA), intestinal permeability (zonulin, GIP) and microbiota of celiac patients and to develop new products containing unripe carob fruit for celiac patients in this direction., conditionsModule conditions: Celiac Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study will conduct by using a prospective randomized double-blind clinical trial model., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Participants will not know which type of cookies to eat., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Unripre Carob, outcomesModule primaryOutcomes measure: Examination of between group differences regarding serum Total Antioxidant Capacity (TAC), primaryOutcomes measure: Examination of between group differences regarding serum Malondialdehyde (MDA), primaryOutcomes measure: Examination of between group differences regarding serum zonulin, secondaryOutcomes measure: Comparison of between group differences regarding serum Total Antioxidant Capacity (TAC), secondaryOutcomes measure: Comparison of between group differences regarding serum Malondialdehyde (MDA), secondaryOutcomes measure: Comparison of between group differences regarding serum zonulin, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 64 Years, stdAges: ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06300151, orgStudyIdInfo id: Ultrasound Real-time Guidance, briefTitle: The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Zongxun Lin, class: OTHER, descriptionModule briefSummary: Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block. At present, Doppler ultrasound is rarely used for spinal block, especially for real-time ultrasound guidance technology, which has not been widely applied in clinical practice due to its high equipment requirements, lack of mature puncture plans, complex operation, and high learning curve. If a comprehensive diagnosis and treatment plan can be developed, it will greatly improve the delivery experience of mothers., conditionsModule conditions: Labor Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia, interventions name: Dural Puncture Epidural Labor Analgesia, outcomesModule primaryOutcomes measure: Analgesic effect（onset time）, primaryOutcomes measure: Analgesic effect（block level）, primaryOutcomes measure: Analgesic effect（block effect）, primaryOutcomes measure: Analgesic effect（Visual Analogue Scale）, primaryOutcomes measure: Analgesic effect（number of Patient controlled analgesia）, primaryOutcomes measure: Analgesic effect（time of Patient controlled analgesia）, primaryOutcomes measure: Uterine contraction indicators（Frequency）, primaryOutcomes measure: Uterine contraction indicators（duration）, primaryOutcomes measure: Uterine contraction indicators（Number of pregnant women with Tachysystole）, primaryOutcomes measure: Uterine contraction indicators（Number of pregnant women with hypertonus）, primaryOutcomes measure: Fetal heart indicators（Fetal heart rate）, primaryOutcomes measure: Fetal heart indicators（NICHD classification）, primaryOutcomes measure: Fetal heart indicators（Fetal Heart Rate decelerations）, primaryOutcomes measure: Fetal heart indicators（Fetal Heart Rate Variability）, primaryOutcomes measure: Apgar score, primaryOutcomes measure: Sacral sensory block of pregnant women, primaryOutcomes measure: modified bromage score, secondaryOutcomes measure: Operation evaluation（Time）, secondaryOutcomes measure: Operation evaluation（number of times）, secondaryOutcomes measure: Operation evaluation（side effects and Complications）, secondaryOutcomes measure: Delivery mode, secondaryOutcomes measure: Concentration of Interleukin 6, secondaryOutcomes measure: Concentration of hypersensitive C-reactive protein, secondaryOutcomes measure: Concentration of cortisol, secondaryOutcomes measure: Maternal rehabilitation indicators（Postpartum hospital stay）, secondaryOutcomes measure: Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale）, secondaryOutcomes measure: Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40））, secondaryOutcomes measure: Number of pregnant women with adjust the treatment plan and adjustment method, secondaryOutcomes measure: Drug consumption, secondaryOutcomes measure: Effect of stages of labor（time）, secondaryOutcomes measure: body temperature changes, secondaryOutcomes measure: Number of pregnant women with Infection during labor, secondaryOutcomes measure: Side effects and complications of labor analgesia, secondaryOutcomes measure: The reasons and number of pregnant women with conversion of natural labor to Caesarean section, secondaryOutcomes measure: Self-Rating Anxiety Scale, secondaryOutcomes measure: Delivery fear score（numerical rating scale）, secondaryOutcomes measure: Delivery satisfaction survey, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fujian Provincial Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, zip: 350001, country: China, contacts name: Zongxun Lin, Master, role: CONTACT, phone: +8613763820916, email: 13763820916@189.cn, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
|
protocolSection identificationModule nctId: NCT06300138, orgStudyIdInfo id: 2023-631-2, briefTitle: Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: First Hospital of China Medical University, class: OTHER, descriptionModule briefSummary: Sporotrichosis is a chronic granulomatous mycosis caused by sporothrix complex. The course of sporotrichosis is always prolonged and even life-threatening, the treatment of this disease in an important scientific problem to be solved. The investigators previously found the predominance of subtype M2 macrophage which play an anti-inflammatory role in the lesions of sporotrichosis, the predominance of M2 macrophage may be responsible for the persistence of sporotrichosis; the investigators also found that local hyperthermia is effective in the treatment of sporotrichosis and hyperthermia treatment can activate the CRAC calcium channel in macrophages which triggers pro-inflammatory type M1 polarization and subsequent killing of sporothrix, however, the mechanism still calls for further investigation. The investigators hypothesize that hyperthermia leads to the activation of CRAC channels resulting in profound Ca2+ influx and Ca2+ upregulates NLRP3 inflammasome expression through inducing Nrf2 activation, then NLRP3 overexpression triggers M1 polarization and subsequent killing of sporothrix. Furthermore, the activation of Nrf2 upregulates STIM1 expression which forms a positive feedback for M1 type polarization of macrophages and further subsequent killing of sporothrix. The purpose of this project is to identify the hypothesis that hyperthermia could treat sporotrichosis by promoting pro-inflammatory type M1 polarization in macrophages, the mechanism by which hyperthermia could treat sporotrichosis is local hyperthermia could led to STIM1/CRAC calcium channel activation mediated calcium ions/Nrf2/NLRP3 induced M1 macrophages polarization and subsequent killing of sporothrix. The hypothesis will be identified at the cellular level, at the animal model level and at the clinical specimens level. The investigators believe that the project will guide the application of hyperthermia in the treatment of sporotrichosis and provide a new basis of theory and practice after the investigators achieving these goals., conditionsModule conditions: Sporotrichosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Itraconazole, interventions name: Infrared thermotherapy apparatus, interventions name: Itraconazole and Infrared thermotherapy apparatus, outcomesModule primaryOutcomes measure: the overall clinical clearance rate of skin lesions, secondaryOutcomes measure: Overall clinical clearance rate and recurrence rate, secondaryOutcomes measure: adverse reactions and incidence, secondaryOutcomes measure: the clearance rate of target skin lesions, secondaryOutcomes measure: overall lesion clearance rate, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300125, orgStudyIdInfo id: R1881/23 - L2-015, briefTitle: Percutaneous Cryoablation of Low-risk Early Breast Cancer, acronym: PRECICE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2031-03-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, collaborators name: Fondazione Umberto Veronesi, collaborators name: IceCure Medical Ltd., descriptionModule briefSummary: Expand the current evidence base regarding percutaneous cryoablation of early-stage, low-risk breast tumors, integrated into the standard therapeutic pathway with well-defined follow-up data, as well as data on quality of life. Demonstrate, therefore, that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy (when necessary). The hypothesis is that cryoablation, being simple and oncologically effective, ensures a better quality of life for the patient (reduced morbidity, no need for general anesthesia, improved cosmetic outcomes) and consequently has a lesser psychological impact, as well as a better cost-benefit ratio compared to the standard surgical approach., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 234, type: ESTIMATED, armsInterventionsModule interventions name: Cryoablation, outcomesModule primaryOutcomes measure: Procedure failure rate, secondaryOutcomes measure: Assessment of subject's quality of life in terms of evaluation of sources of distress, secondaryOutcomes measure: Assessment of subject's satisfaction, secondaryOutcomes measure: Cost-analysis - evaluation of cost of intervention, hospitalization and re-intervention (if applicable), secondaryOutcomes measure: Ipsilateral breast tumor recurrence, secondaryOutcomes measure: Distant metastasis, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Franco Orsi, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06300112, orgStudyIdInfo id: Amasya Univ_emine.akca, briefTitle: Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Amasya University, class: OTHER, descriptionModule briefSummary: The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns., conditionsModule conditions: Stress, conditions: Sexuality, conditions: Sleep, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized-controlled trial with pretest-posttest control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: YOGA, outcomesModule primaryOutcomes measure: Perceived stress level, primaryOutcomes measure: Sexual Quality of Life, otherOutcomes measure: Sleep patterns, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Amasya University, city: Amasya, zip: 05100, country: Turkey, contacts name: Emine İbici Akça, Ph.D, role: CONTACT, phone: 03582115005-4723, email: emine.akca@amasya.edu.tr, geoPoint lat: 40.65333, lon: 35.83306, hasResults: False
|
protocolSection identificationModule nctId: NCT06300099, orgStudyIdInfo id: AZAST/Research/52/20-Jan-2024, briefTitle: Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results.The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Dexamethasone, interventions name: Dexmedetomidine, outcomesModule primaryOutcomes measure: postoperative visual assessment scale for pain., eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06300086, orgStudyIdInfo id: NUDGE-CKD, briefTitle: Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease, acronym: NUDGE-CKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2034-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Tor Biering-Sørensen, class: OTHER, descriptionModule briefSummary: Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines.This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters., conditionsModule conditions: Chronic Kidney Diseases, conditions: Behavior and Behavior Mechanisms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: 2x2 factorial design, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 35000, type: ESTIMATED, armsInterventionsModule interventions name: Electronically delivered nudging letters to patients with CKD, interventions name: Electronically delivered nudging letter to associated GPs of patients with CKD, outcomesModule primaryOutcomes measure: Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, secondaryOutcomes measure: Number of participants with any prescription of renin-angiotensin system inhibition, secondaryOutcomes measure: Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors, secondaryOutcomes measure: Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, secondaryOutcomes measure: Number of participants with a new prescription of renin-angiotensin system inhibition, secondaryOutcomes measure: Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors, secondaryOutcomes measure: Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, secondaryOutcomes measure: Time from intervention delivery to a new prescription of renin-angiotensin system inhibition, secondaryOutcomes measure: Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants with an increase in baseline daily RASi dosage, otherOutcomes measure: Number of participants with any prescription of mineralocorticoid receptor antagonists, otherOutcomes measure: Number of participants with any prescription of non-steroid mineralocorticoid receptor antagonists, otherOutcomes measure: Number of participants with any prescription of cholesterol-lowering medication, otherOutcomes measure: Number of participants with any prescription of glucagon-like peptide-1 analogue, otherOutcomes measure: Number of participants with any prescription of antidiabetic medication besides SGLT2i, otherOutcomes measure: Number of participants with any prescription of antidiabetic medication, otherOutcomes measure: Number of participants with any prescription of antihypertensive medication besides renin-angiotensin system inhibition, otherOutcomes measure: Number of participants with any prescription of antihypertensive medication, otherOutcomes measure: Number of participants with a new prescription of mineralocorticoid receptor antagonists, otherOutcomes measure: Number of participants with a new prescription of non-steroid mineralocorticoid receptor antagonists, otherOutcomes measure: Number of participants with a new prescription of cholesterol-lowering medication, otherOutcomes measure: Number of participants with a new prescription of glucagon-like peptide-1 analogue, otherOutcomes measure: Number of participants with a new prescription of antidiabetic medication besides sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants with a new prescription of antidiabetic medication, otherOutcomes measure: Number of participants with a new prescription of antihypertensive medication besides renin-angiotensin system inhibition, otherOutcomes measure: Number of participants with a new prescription of antihypertensive medication, otherOutcomes measure: Change in number of antihypertensive medications, otherOutcomes measure: Number of participants referred to nephrology outpatient clinics, otherOutcomes measure: Number of participants with an assessment of urine albumine to creatine ratio, otherOutcomes measure: Number of participants with an assessment of plasma-creatinine., otherOutcomes measure: Number of participants with an assessment of estimated glomerular filtration rate by creatinine, otherOutcomes measure: Number of participants with an assessment of hemoglobin A1c, otherOutcomes measure: Number of participants with an assessment of lipids, otherOutcomes measure: Number of participants recipient of influenza vaccination, otherOutcomes measure: Number of participants recipient of COVID-19 vaccination, otherOutcomes measure: Total number of visits to general practitioners, otherOutcomes measure: Time to first phone contact to a general practice, otherOutcomes measure: Time to first visit with a general practitioner, otherOutcomes measure: Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants with any prescription of renin-angiotensin system inhibition, otherOutcomes measure: Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants with a new prescription of renin-angiotensin system inhibition, otherOutcomes measure: Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Time from intervention delivery to prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Time from randomization to prescription of renin-angiotensin system inhibition, otherOutcomes measure: Time from randomization to prescription of sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants who have discontinued renin-angiotensin system inhibition treatment., otherOutcomes measure: Number of participants who have discontinued sodium-glucose cotransporter 2 inhibition treatment., otherOutcomes measure: Rate of change in estimated glomerular filtration rate, otherOutcomes measure: Rate of change in urine albumine to creatinine ratio, otherOutcomes measure: Number of participants with any hospitalization, otherOutcomes measure: Total number of all-cause hospitalizations, otherOutcomes measure: All-cause mortality, otherOutcomes measure: Number of participants with kidney failure defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence and kidney transplantation, otherOutcomes measure: Number of participants with kidney failure (alternative definition #1) defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence, kidney transplantation and renal death, otherOutcomes measure: Number of participants with kidney failure (alternative definition #2) defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence, kidney transplantation, renal death, and cardiovascular death., otherOutcomes measure: Number of participants with acute dialysis, otherOutcomes measure: Number of participants with acute kidney insufficiency, otherOutcomes measure: Number of participants with incident heart failure, heart failure hospitalization, or cardiovascular death, otherOutcomes measure: Number of participants with major adverse cardiovascular events defined as a composite of myocardial infarction, stroke, and cardiovascular death., otherOutcomes measure: Number of participants with major adverse cardiovascular events (alternative definition) defined as a composite of myocardial infarction, revascularization, stroke, and cardiovascular death., otherOutcomes measure: Number of participants with individual components of the renal/cardiovascular composite outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, city: Hellerup, state: Hovedstaden, zip: 2900, country: Denmark, geoPoint lat: 55.73204, lon: 12.57093, hasResults: False
|
protocolSection identificationModule nctId: NCT06300073, orgStudyIdInfo id: AB-360-001-2022, briefTitle: Plaque Removal Efficacy of a U-Shaped Sonic Power Toothbrush in Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-14, primaryCompletionDateStruct date: 2023-02-17, completionDateStruct date: 2023-02-17, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Lander Enterprises, LLC, class: INDUSTRY, descriptionModule briefSummary: The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush., conditionsModule conditions: Dental Plaque, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: single-use, randomized, two-period, cross-over study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Examiner and data recorder will not have access to the room for test materials dispensing and instructions., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Experimental: U-shaped Power Toothbrush, interventions name: Placebo Comparator: Soft Manual Toothbrush, outcomesModule primaryOutcomes measure: Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all tooth surfaces of the whole mouth., eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Salus Research, Inc, city: Fort Wayne, state: Indiana, zip: 46825, country: United States, geoPoint lat: 41.1306, lon: -85.12886, hasResults: False
|
protocolSection identificationModule nctId: NCT06300060, orgStudyIdInfo id: REB23-1161, briefTitle: Synbiotic Supplementation in Cyclists, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Lallemand Health Solutions, descriptionModule briefSummary: The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance.The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health., conditionsModule conditions: Exercise Endurance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel arm. Single-site, double-blinded, placebo-controlled trial., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, maskingDescription: The synbiotic and placebo are both powders identical in taste and appearance and are equally dissolvable in cold water., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Synbiotic, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in endurance exercise performance measured during a 20km cycling distance trial, secondaryOutcomes measure: Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test, secondaryOutcomes measure: Change in peak power output (PPO) measured during a Step-Ramp-Step Test, secondaryOutcomes measure: Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP), secondaryOutcomes measure: Change in time to exhaustion measured during a cycling session at 85% of the peak power output, secondaryOutcomes measure: Change in fat and carbohydrate oxidation measured during exercise sessions, secondaryOutcomes measure: Change in blood lactate concentration measured via pinprick capillary blood test, secondaryOutcomes measure: Change in body composition measured by dual energy X-ray absorptiometry (DXA), secondaryOutcomes measure: Change in intestinal permeability markers measured in serum, secondaryOutcomes measure: Change in cytokines, secondaryOutcomes measure: Change in gastrointestinal symptoms measured by self-report, secondaryOutcomes measure: Change in fecal SCFA concentration measured by gas chromatography, secondaryOutcomes measure: Synbiotic strains quantification measured by qPCR in fecal matter, secondaryOutcomes measure: Change in fecal microbiota composition, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Calgary, city: Calgary, state: Alberta, zip: T2N 1N4, country: Canada, contacts name: Raylene A Reimer, PhD, RD, role: CONTACT, phone: 403-220-8218, email: reimer@ucalgary.ca, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False
|
protocolSection identificationModule nctId: NCT06300047, orgStudyIdInfo id: REB23-0679, briefTitle: Diabetes Transition Coordinator Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Juvenile Diabetes Research Foundation, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis.The 3 main aims are:1. To assess the effects of our transition intervention on clinical and patient-reported outcomes.2. To implement the transition intervention and evaluate the implementation outcomes.3. To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care.Researchers will compare a pre-intervention cohort to evaluate the impact of the transition coordinator intervention., conditionsModule conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The usual care group is defined as the group who receives usual care and serves as the control group. This group is defined prior to the implementation of the intervention. We include a two month wash out period between our two groups to avoid care providers 'holding on' to patients they feel may benefit from the intervention, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Non-Medical Transition Coordinator, outcomesModule primaryOutcomes measure: Lost to Followup, secondaryOutcomes measure: Patient Reported Outcome Survey 1, secondaryOutcomes measure: Patient Reported Outcome Survey 2, secondaryOutcomes measure: Patient Reported Outcome Survey 3, secondaryOutcomes measure: Clinical Outcome 1, secondaryOutcomes measure: Clinical Outcome 2, secondaryOutcomes measure: Clinical outcome 3, secondaryOutcomes measure: Clinical outcome 4, secondaryOutcomes measure: Clinical Outcome 5, secondaryOutcomes measure: Clinical Outcome 6, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Alberta Children's Hospital, city: Calgary, state: Alberta, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False
|
protocolSection identificationModule nctId: NCT06300034, orgStudyIdInfo id: bagattoni2, briefTitle: Parental Perceptions and Acceptance of Silver Diamine Fluoride in Italy, acronym: SDF, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2022-02-01, completionDateStruct date: 2022-03-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Bologna, class: OTHER, descriptionModule briefSummary: Parental perceptions on staining due to Silver Diamine Fluoride (SDF) could affect its implementation in pediatric dentistry. This study represents the second part of a wider project focused on SDF aesthetic acceptability among Italian parents., conditionsModule conditions: Perceptions, conditions: Acceptability, conditions: SDF, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 234, type: ACTUAL, outcomesModule primaryOutcomes measure: Parental overall acceptance of SDF staining on anterior and posterior teeth, secondaryOutcomes measure: Parental willingness to accept SDF treatment on anterior and posterior teeth depending on child's behavior, secondaryOutcomes measure: Parental overall acceptability of SDF staining according to demographic background, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
|
protocolSection identificationModule nctId: NCT06300021, orgStudyIdInfo id: PEC19242, secondaryIdInfos id: 2021-A00317-34, type: OTHER, domain: ID-RCB, briefTitle: Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-14, primaryCompletionDateStruct date: 2022-05-20, completionDateStruct date: 2022-05-20, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Givaudan France Naturals, class: INDUSTRY, collaborators name: BioFortis, descriptionModule briefSummary: The goal of this clinical trial is to learn about the extent to which turmeric compounds in different food matrices becomes available to the body in healthy volunteers. The main question it aims to answer is:* Is the availability to the body of a turmeric dietary supplement altered when consumed in fruit nectar, oat milk, yogurt drink, or gummies in comparison to a dietary supplement capsule?Participants will ingest a turmeric dietary supplement as a capsule or in different food matrices on six testing days (separated by at least one week). The day before testing day, a standardized dinner will be provided to the participants in the evening and participants will be instructed to not consume any foods or beverages (except water) and to arrive fasted (12 hours) at the investigation site. Participants will ingest turmeric dietary supplement formulations one by one in random order in the morning of testing days. Regular blood and urine samples will be collected before and up to 24 hours after the turmeric dietary supplement ingestion. Standardized meals will be provided during the entire testing day (lunch, mid-afternoon snack, dinner)., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Monocentric, randomized, cross-over, open-label, pharmacokinetic study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: TPG capsule, interventions name: TPG ready to drink, interventions name: TPG dairy analog, interventions name: TPG probiotic drink, interventions name: TPG gummies, interventions name: TPG sport bar, outcomesModule primaryOutcomes measure: Dose-normalized AUC0-24h of total curcuminoids, secondaryOutcomes measure: Dose-normalized AUC0-24h of curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Dose-normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Dose-normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Relative bioavailability for normalized AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Relative bioavailability for normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Relative bioavailability for normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Cmax of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Dose-normalized Cmax of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Half-life of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Tmax of total curcuminoids, curcuminoid compounds and of their metabolites, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Biofortis, city: Saint-Herblain, zip: 44800, country: France, geoPoint lat: 47.21765, lon: -1.64841, hasResults: False
|
protocolSection identificationModule nctId: NCT06300008, orgStudyIdInfo id: OrthoTU13, briefTitle: Cetylated Fatty Acid for Reducing Pain After TKA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Thammasat University, class: OTHER, descriptionModule briefSummary: To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA., conditionsModule conditions: Postoperative Pain, conditions: Postoperative Inflammation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: cetylated fatty acid, interventions name: Placebo, outcomesModule primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: inflammatory marker, primaryOutcomes measure: inflammatory marker, primaryOutcomes measure: inflammatory marker, primaryOutcomes measure: inflammatory marker, primaryOutcomes measure: Knee skin temperature, primaryOutcomes measure: Knee skin temperature, primaryOutcomes measure: Knee skin temperature, primaryOutcomes measure: Knee skin temperature, secondaryOutcomes measure: Knee circumference (cm), secondaryOutcomes measure: Knee circumference (cm), secondaryOutcomes measure: Knee circumference (cm), secondaryOutcomes measure: Knee circumference (cm), secondaryOutcomes measure: Knee Range of Motion, secondaryOutcomes measure: Knee Range of Motion, secondaryOutcomes measure: Knee Range of Motion, secondaryOutcomes measure: Knee Range of Motion, secondaryOutcomes measure: Modified WOMAC, secondaryOutcomes measure: Modified WOMAC, secondaryOutcomes measure: Modified WOMAC, secondaryOutcomes measure: Thai forgotten joint score, secondaryOutcomes measure: Thai forgotten joint score, secondaryOutcomes measure: Thai forgotten joint score, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: department of orthopaedic surgery, Faculty of medicine, Thammasat university, status: RECRUITING, city: Khlong Luang, state: Pathumthani, zip: 066, country: Thailand, contacts name: supakit kanitnate, role: CONTACT, phone: 6629260000, email: naypeng@hotmail.com, contacts name: Nattapol Tammachote, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Supakit Kanitnate, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 14.06467, lon: 100.64578, hasResults: False
|
protocolSection identificationModule nctId: NCT06299995, orgStudyIdInfo id: MFSP, briefTitle: Phenotype and Burden of a Midfacial Segment Pain, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-24, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Swiat Zdrowia, class: OTHER, descriptionModule briefSummary: The purpose of this study is to describe midfacial segment pain phenotype, burden and comorbidities in a multicentre and multidisciplinary setting. The ultimate goal is a comprehensive description of this type of pain allowing for its implementation in future classifications.This cross-sectional study is designed to describe midfacial segment pain in a clinical setting. Patients from rhinologic, headache and facial pain or oral medicine/dentistry secondary care centres will be recruited during a one year period. Individuals with other facial pain according to current classification such as sinonasal disorders, neoplasms, local infections, history of significant trauma associated with pain onset will be excluded. Data will be collected through a structured questionnaire covering pain characteristics, coexisting diagnoses, pain-related burden and consequences, physical examination and paranasal sinuses imaging., conditionsModule conditions: Facial Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Pain characteristics, secondaryOutcomes measure: Coexisting diagnoses, secondaryOutcomes measure: Pain-related burden and consequences, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Otolaryngology, University of Malta, city: Imsida, country: Malta, geoPoint lat: 35.8925, lon: 14.48278, locations facility: Athleticomed - Pain&Headache Treatment Centre, city: Bydgoszcz, country: Poland, geoPoint lat: 53.1235, lon: 18.00762, locations facility: Department of Otolaryngology, Head and Neck Surgery and Laryngological Oncology, city: Bydgoszcz, country: Poland, geoPoint lat: 53.1235, lon: 18.00762, locations facility: Department of Neurology, Jagiellonian University Medical College, city: Kraków, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Świat Zdrowia, city: Orzyny, zip: 12-120, country: Poland, geoPoint lat: 53.67846, lon: 21.06617, locations facility: Department of Neurology and Restorative Medicine, Health Institute dr Boczarska-Jedynak, city: Oświęcim, country: Poland, geoPoint lat: 50.03437, lon: 19.21037, locations facility: 4. Department of Otorhinolaryngology, National Institute of Medicine of the Ministry of the Interior and Administration, city: Warsaw, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: 5. Department of Otolaryngology, Centre of Postgraduate Medical Education, city: Warsaw, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Department of Experimental Dentistry, Wroclaw Medical University, city: Wrocław, country: Poland, geoPoint lat: 51.1, lon: 17.03333, locations facility: Department of Neurology, Wroclaw Medical University, city: Wrocław, country: Poland, geoPoint lat: 51.1, lon: 17.03333, locations facility: MIGRE Polish Migraine Center, city: Wrocław, country: Poland, geoPoint lat: 51.1, lon: 17.03333, locations facility: Pain Medicine, Liverpool University Hospitals NHS Foundation Trust, city: Liverpool, country: United Kingdom, geoPoint lat: 53.41058, lon: -2.97794, locations facility: Department of Otorhinolaryngology, Nottingham University Hospital, city: Nottingham, country: United Kingdom, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False
|
protocolSection identificationModule nctId: NCT06299982, orgStudyIdInfo id: SSGJ-608-PsO-III-02, briefTitle: An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis., conditionsModule conditions: Plaque Psoriasis Patients, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 750, type: ESTIMATED, armsInterventionsModule interventions name: 608 Q2W, interventions name: 608 Q4W, outcomesModule primaryOutcomes measure: Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75), primaryOutcomes measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement, secondaryOutcomes measure: Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90), secondaryOutcomes measure: Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100), secondaryOutcomes measure: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0), secondaryOutcomes measure: Adverse events (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299969, orgStudyIdInfo id: StBernwardH, briefTitle: Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest, acronym: FITT-OHCA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: St.Bernward Hospital, class: OTHER, collaborators name: University Medical Center Goettingen, descriptionModule briefSummary: The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA)., conditionsModule conditions: Out-Of-Hospital Cardiac Arrest, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: In-hospital mortality, secondaryOutcomes measure: CPC score, secondaryOutcomes measure: MRS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Bernward Hospital, status: RECRUITING, city: Hildesheim, state: Niedersachsen, zip: 31134, country: Germany, contacts name: Karl H Scholz, MD, role: CONTACT, phone: +4955139, phoneExt: 64940, email: k.scholz@fitt-stemi.de, contacts name: Sebastian Riedel, role: CONTACT, phone: +4955139, phoneExt: 64940, email: s.riedel@bernward-khs.de, geoPoint lat: 52.15077, lon: 9.95112, hasResults: False
|
protocolSection identificationModule nctId: NCT06299956, orgStudyIdInfo id: 2023-SFHHB-IC-001, briefTitle: Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark, acronym: StRiDE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2029-01, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Slagelse Hospital, class: OTHER, collaborators name: Region Zealand, collaborators name: Vordingborg Municipality, collaborators name: Kalundborg municipality, collaborators name: Køge Municipality, collaborators name: Næstved municipality, collaborators name: Solrød Municipality, descriptionModule briefSummary: The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication.The objective of this project is to describe:1. The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.2. The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.3. Outcomes available for assessment of benefits and harms from the SET intervention.Participants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking., conditionsModule conditions: Intermittent Claudication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Supervised exercise therapy, outcomesModule primaryOutcomes measure: Maximal Walking Distance, secondaryOutcomes measure: Pain-free walking distance, secondaryOutcomes measure: Vascular Quality of Life Questionnaire-6 (VASCUQoL-6), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PROgrez, status: RECRUITING, city: Slagelse, zip: 4700, country: Denmark, contacts name: Helle Bøgard, role: CONTACT, email: hboga@regionsjaelland.dk, contacts name: Lars Tang, role: CONTACT, email: larta@reggionsjaelland.dk, geoPoint lat: 55.40276, lon: 11.35459, hasResults: False
|
protocolSection identificationModule nctId: NCT06299943, orgStudyIdInfo id: BiofeedbackTargetGaitTraining, briefTitle: Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke, acronym: TargetGait, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-24, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health, class: OTHER, descriptionModule briefSummary: Single-blinded controlled clinical trial. Biofeedback training courses based on target biomechanical gait parameters are being studied. For targeted biofeedback training, various biomechanical parameters are used: parameters of the gait cycle, EMG or kinematics of joint movements. The number of sessions is 8-11 for each patient. Clinical gain analysis is carried out before and after a course of training. Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults., conditionsModule conditions: Stroke, conditions: Biofeedback, conditions: Gait, Hemiplegic, conditions: Gait Training, conditions: Hemiparesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel-group, single-blinded controlled clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Clinicians involved in the measurements and researchers that worked with data results did not know which group each patient was in., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Biofeedback gait training by biomechanical target parameter, outcomesModule primaryOutcomes measure: Gait cycle, primaryOutcomes measure: Foot clearance, primaryOutcomes measure: Speed of walking, primaryOutcomes measure: Stance phase, primaryOutcomes measure: Single support phase, primaryOutcomes measure: Hip joint amplitude, primaryOutcomes measure: Knee joint amplitude, primaryOutcomes measure: Ankle joint amplitude, primaryOutcomes measure: EMG amplitude of tibialis anterior muscle, primaryOutcomes measure: EMG amplitude of gastrocnemus muscle, primaryOutcomes measure: EMG amplitude of quadriceps femoris muscle, primaryOutcomes measure: EMG amplitude of Hamstring muscle, secondaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Activities of Daily Living, secondaryOutcomes measure: Modified Rankin Scale for Neurologic Disability, secondaryOutcomes measure: The Timed Up and Go Test, secondaryOutcomes measure: The Medical Research Council Weakness Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: FCCerebroPathStroke, status: RECRUITING, city: Moscow, zip: 117997, country: Russian Federation, contacts name: Dmitry Skvortsov, PhD, role: CONTACT, phone: +79166925419, email: skvortsov.biom@gmail.com, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
|
protocolSection identificationModule nctId: NCT06299930, orgStudyIdInfo id: LRR after NACT vs ACT, briefTitle: Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-22, primaryCompletionDateStruct date: 2023-08-16, completionDateStruct date: 2023-09-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 10328, type: ACTUAL, armsInterventionsModule interventions name: Neoadjuvant chemotherapy, interventions name: Adjuvant chemotherapy, outcomesModule primaryOutcomes measure: Locoregional recurrence-free survival (LRR), secondaryOutcomes measure: Distant metastasis-free survival, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, zip: 03080, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-04-22, uploadDate: 2024-03-01T20:58, filename: Prot_SAP_000.pdf, size: 151396, hasResults: False
|
protocolSection identificationModule nctId: NCT06299917, orgStudyIdInfo id: CeViG, secondaryIdInfos id: S-20232000 - 3, type: OTHER, domain: Committees on Health Research Ethics for Southern Denmark, briefTitle: WORK-ON Vocational Rehabilitation for People With Inflammatory Arthritis, acronym: WORK-ON, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-09-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: The Danish Center for Expertise in Rheumatology, class: OTHER, collaborators name: Odense Patient Data Explorative Network, collaborators name: The Danish Rheumatism Association, collaborators name: Danish Association of Occupational Therapist, collaborators name: Schaufuss foundation, descriptionModule briefSummary: People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues.Based on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline., conditionsModule conditions: Rheumatoid Arthritis, conditions: Psoriatic Arthritis, conditions: Axial Spondyloarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single center parallel randomized study, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: Statistical analyses will be blinded for group allocation, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: WORK-ON, outcomesModule primaryOutcomes measure: Work Ability Index (WAI) single item, secondaryOutcomes measure: Job loss, secondaryOutcomes measure: Work hours per week, secondaryOutcomes measure: Work Productivity and Activity Impairment questionnaire, general health (WPAI:GH), secondaryOutcomes measure: Sickness absenteeism, secondaryOutcomes measure: Work ability in relation to demands, secondaryOutcomes measure: Job insecurity, secondaryOutcomes measure: Physical activity while at work, secondaryOutcomes measure: Occupational balance, secondaryOutcomes measure: Health related quality of life, secondaryOutcomes measure: VAS Pain, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Mental well-being, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Work Ability Index (WAI) single item, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Danish Hospital for Rheumatic Diseases, status: RECRUITING, city: Sønderborg, zip: 6400, country: Denmark, contacts name: Christina MT Madsen, MSci, role: CONTACT, phone: +4528551373, email: cmadsen@danskgigthospital.dk, contacts name: Jette Primdahl, PhD, role: CONTACT, phone: +4524206692, email: jprimdahl@danskgigthospital.dk, geoPoint lat: 54.90896, lon: 9.78924, hasResults: False
|
protocolSection identificationModule nctId: NCT06299904, orgStudyIdInfo id: stroke, briefTitle: Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital of Dalian Medical University, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Modified Air-pulse Stimulation, interventions name: Conventional air-pulse stimulation, outcomesModule primaryOutcomes measure: the score of Fiberoptic endoscopic examination of swallowing (FEES), primaryOutcomes measure: the score of Murray's secretion scale (MSS), primaryOutcomes measure: the score of penetration-aspiration scale (PAS), secondaryOutcomes measure: the score of Clinical Pulmonary Infection Score (CPIS), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Second Affiliated Hospital of Dalian Medical University, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116024, country: China, contacts name: wuyao Pan, postgraduate, role: CONTACT, phone: +86-18186766836, email: 331189506@qq.com, geoPoint lat: 38.91222, lon: 121.60222, hasResults: False
|
protocolSection identificationModule nctId: NCT06299891, orgStudyIdInfo id: PhT_HypOb_Protocol_Clean_07-05, briefTitle: Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: Children's Hospital of Philadelphia, descriptionModule briefSummary: Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine/topiramate (Ph/T) that is FDA-approved for "common" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph/T-induced decrease in appetite and increase in alertness.Preliminary assessments of safety, adverse events, dosing (Aim 1), as well as of efficacy (% BMI loss, Aim 2) will be made in a 28-week parallel-arm double-blinded Phase 2 placebo-controlled clinical trial in 12-28-year-old individuals with HO., conditionsModule conditions: Hypothalamic Obesity, conditions: Hypothalamic Tumor, conditions: Craniopharyngioma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two-center, double-blind (participant and assessor), randomized, parallel-arm placebo-controlled 28-week clinical trial, comparing changes related to active drug (Qsymia®) vs. placebo (matched capsules)., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Eligible subjects will be assigned treatment using a sex-stratified permuted-block randomization (1:1) to drug vs. placebo for 27 weeks with varying block sizes constructed by the study statistician., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Phentermine / Topiramate Extended Release Oral Capsule [Qsymia], interventions name: Placebo, outcomesModule primaryOutcomes measure: Treatment-emergent adverse events, secondaryOutcomes measure: Maximum tolerated dose, secondaryOutcomes measure: % change in BMI, secondaryOutcomes measure: Proportion of individuals who experience 5% decrease in BMI, secondaryOutcomes measure: Proportion of individuals who experience 2.5% decrease in BMI, secondaryOutcomes measure: Change in body fat mass, secondaryOutcomes measure: Change in visceral fat mass, secondaryOutcomes measure: Change in hunger, secondaryOutcomes measure: Change in energy intake, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 28 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Seattle Children's, city: Seattle, state: Washington, zip: 98101, country: United States, contacts name: Clinton Elfers, role: CONTACT, phone: 513-290-5710, email: clinton.elfers@seattlechildrens.org, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
|
protocolSection identificationModule nctId: NCT06299878, orgStudyIdInfo id: MelPRO-0322, briefTitle: MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns], acronym: CRISTINA, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Russian Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are:* radiological and pathological response rate to three doses of antiPD1 agents;* do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery.After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years., conditionsModule conditions: Melanoma, Skin, conditions: Melanoma Stage Iii, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Gut microbiota analysis, outcomesModule primaryOutcomes measure: 2-year disease-free survival, secondaryOutcomes measure: pathological response rate, otherOutcomes measure: biomarker reproducibility, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: N.N. Blokhin Russian Cancer Research Center, skin tumor department, status: RECRUITING, city: Moscow, zip: 115478, country: Russian Federation, contacts name: Igor V Samoylenko, MD, PhD, role: CONTACT, phone: +7 (499) 444-24-24, email: i.samoylenko@ronc.ru, contacts name: Angelina O Kuzmenko, MD, role: CONTACT, phone: +74993249024, email: angelin.kuzmenko@gmail.com, contacts name: Igor V Samoylenko, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
|
protocolSection identificationModule nctId: NCT06299865, orgStudyIdInfo id: YXLL-KY-2023（150）, briefTitle: Comparison of Detection Rates Between Two Commonly Used Bone Density Measurement Methods, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Xiaoqian Zhang, class: OTHER, descriptionModule briefSummary: 72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient.1. Record the patient's age, gender, height, and weight; Review the patient's past medical history (especially whether there is a history of brittle fractures, whether there is a history of using drugs that affect bone metabolism, etc.).2. Retrieve the bone density values of the anterior lumbar vertebrae 1 to 4 measured by GE Healthcare Lunar Prodigy dual energy X-ray absorptiometry from the database, and take the average (DXA bone density value). According to the diagnostic criteria of the Diagnosis and Treatment Guidelines for Primary Osteoporosis (2022), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.3. Identify the lumbar spine bone density values (QCT bone density values) measured by the GE Gemstone CTHD750 CT instrument from the database. According to the diagnostic criteria of the Chinese Quantitative CT (QCT) Diagnosis Guidelines for Osteoporosis (2018), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.4. Statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by DXA and QCT respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. The data was analyzed and processed using SPSS 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, P\<0.05 indicates statistically significant difference; Explore whether the difference in detection rates between the two is related to factors such as weight; Calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis., conditionsModule conditions: Osteoporosis, conditions: Diagnosis, conditions: Dual Energy X-ray Absorptiometry, conditions: Quantitative Computed Tomography, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Ungrouped, outcomesModule primaryOutcomes measure: Comparison of the difference in detection rates of osteoporosis between dual energy X-ray and quantitative CT, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shandong Provincial Qianfoshan Hospital, city: Jinan, state: Shandong, country: China, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
|
protocolSection identificationModule nctId: NCT06299852, orgStudyIdInfo id: TK01, briefTitle: Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: N.N. Petrov National Medical Research Center of Oncology, class: OTHER, descriptionModule briefSummary: This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT.The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT.The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine, remains unexplored. This study plans to evaluate the effectiveness of combining systemic therapy and local control methods (SRT) in patients with oligometastatic HER2-positive breast cancer. It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied. This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses, long-lasting disease remissions, and potentially cure., conditionsModule conditions: HER2-positive Metastatic Breast Cancer, conditions: Oligometastatic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Trastuzumab emtansine, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Toxicity profile, secondaryOutcomes measure: Second co-primary outcome measure is quality of life, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: N.N. Petrov National Medical Research Center of Oncology, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Tatiana Semiglazova, DSc Med., Prof., role: CONTACT, email: tsemiglazova@mail.ru, contacts name: Tatiana Kudryashova, role: CONTACT, phone: +79632165730, email: tatyana-kudryashova-98@mail.ru, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False
|
protocolSection identificationModule nctId: NCT06299839, orgStudyIdInfo id: PAS-004-102, secondaryIdInfos id: 2024-510900-34, type: EUDRACT_NUMBER, briefTitle: PAS-004 in Patients With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Pasithea Therapeutics Corp., class: INDUSTRY, descriptionModule briefSummary: The main purpose of this clinical trial is to test PAS-004 in people with advanced solid tumors with rat sarcoma virus (RAS), neurofibromatosis type I (NF1), or rapidly accelerated fibrosarcoma (RAF) mutations. The main questions it aims to answer are:* How well participants are able tolerate different doses of PAS-004, and* What side effects PAS-004 might have.Study participants will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety. Everyone participating in the study will take PAS-004 by mouth as a single dose, followed by one week observation, then once a day during the study, in 28-day cycles. Participants will continue on daily PAS-004 for up to 2 years, or until:* They decide to withdraw from the study, or* They experience unacceptable side effects, or* Their disease progresses, or another illness interferes with taking the study drug, or* The sponsors stops the study., conditionsModule conditions: RAS Mutation, conditions: NF1 Mutation, conditions: RAF Mutation, conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: 3+3 dose expansion, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: PAS-004, outcomesModule primaryOutcomes measure: Evaluation of dose limiting toxicities (DLTs), primaryOutcomes measure: Evaluation of adverse events (AEs), primaryOutcomes measure: Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004., primaryOutcomes measure: Evaluation of hematology laboratory parameters, primaryOutcomes measure: Evaluation of clinical chemistry laboratory parameters, secondaryOutcomes measure: Apparent terminal elimination half-life (t1/2) in Plasma, secondaryOutcomes measure: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Plasma predose or trough concentration (Ctau/Ctrough), secondaryOutcomes measure: Time of maximum plasma concentration (Tmax), secondaryOutcomes measure: Area under the concentration versus time curve from time zero to the last sampling time with quantifiable analyte (AUC0-t), secondaryOutcomes measure: Area under the concentration versus time curve from time zero extrapolated to infinity if possible (AUC0-∞), secondaryOutcomes measure: Area under the concentration versus time curve for the dosing interval, assuming steady state has been reached and duplicating the predose concentration for the 24 hour postdose concentration (AUC0-tau), secondaryOutcomes measure: Apparent total plasma clearance if possible (CL/F), secondaryOutcomes measure: Evaluation of the percentage of extracellular signal-regulated kinase phosphorylation (pERK) inhibition from baseline, secondaryOutcomes measure: Evaluation of the objective response rate (ORR), secondaryOutcomes measure: Evaluation of progression-free survival (PFS), secondaryOutcomes measure: Evaluation of overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT Oncology, status: RECRUITING, city: Austin, state: Texas, zip: 78758, country: United States, contacts name: Erica Torres, role: CONTACT, phone: 210-610-5205, email: etorres@nextoncology.com, geoPoint lat: 30.26715, lon: -97.74306, locations facility: NEXT Oncology, status: RECRUITING, city: Irving, state: Texas, zip: 75039, country: United States, contacts name: Erica Torres, role: CONTACT, phone: 210-610-5205, email: etorres@nextoncology.com, geoPoint lat: 32.81402, lon: -96.94889, locations facility: NEXT Oncology, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Carmen Gonzalez, role: CONTACT, phone: 210-580-9521, email: cgonzalez@nextoncology.com, geoPoint lat: 29.42412, lon: -98.49363, locations facility: NEXT Oncology, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Blake Patterson, role: CONTACT, phone: 703-783-4505, email: BPatterson@nextoncology.com, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False
|
protocolSection identificationModule nctId: NCT06299826, orgStudyIdInfo id: D9090C00008, briefTitle: A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure, acronym: LUMINARA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-10, primaryCompletionDateStruct date: 2025-11-24, completionDateStruct date: 2025-11-24, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF)., conditionsModule conditions: Chronic Heart Failure, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: AZD5462, interventions name: Placebo, outcomesModule primaryOutcomes measure: Cohort A and B: Change from Baseline in Ejection Fraction, secondaryOutcomes measure: Cohort A and B: Change from Baseline in Ejection Fraction, secondaryOutcomes measure: Cohorts A and B: Change from Baseline in Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS), secondaryOutcomes measure: Cohorts A and B: Change from Baseline in New York Heart Association Functional Class (NYHA FC), secondaryOutcomes measure: Cohorts A and B: Percentage Change from Baseline in cardiac biomarkers, secondaryOutcomes measure: Cohorts A and B : Plasma Concentration of AZD5462, secondaryOutcomes measure: Cohorts A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299813, orgStudyIdInfo id: 771.284, secondaryIdInfos id: 2022-002955-20, type: EUDRACT_NUMBER, briefTitle: Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection, acronym: Adeno-beta, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: A.O.U. Città della Salute e della Scienza, class: OTHER, descriptionModule briefSummary: The goal of this double-blind, Placebo-controlled Randomized Study is to assess if a single dose of betamethasone in children with febrile adenoviral infection works well in achieving an early fever regulation.The experimentation is conducted to answer this question: "Can betamethasone help reduce fever more quickly in a child with viral adenovirus infection? "The secondary objective is to assess if the child's overall clinical conditions improve more rapidly (reduced sore throat, quicker return to regular eating) and a reduction in the incidence and duration of hospitalizations., conditionsModule conditions: Adenovirus, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A double-blind, placebo-controlled randomized study, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The nurse that will prepare and administer the treatment to the patient won't be masked, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Bentelan, interventions name: Placebo, outcomesModule primaryOutcomes measure: Proportion of patients with a sustained fever resolution at 24 hours from randomization, secondaryOutcomes measure: Pharyngeal-tonsillar pain level in patients younger than 36 months, secondaryOutcomes measure: Hospitalization, secondaryOutcomes measure: Duration of hospitalization (among those hospitalized), measured in days, secondaryOutcomes measure: Cumulative incidence of fever resolution, secondaryOutcomes measure: Fever duration, secondaryOutcomes measure: Pharyngeal-tonsillar pain level in patients older than 36 months, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ospedale Infantile Regina Margherita, status: RECRUITING, city: Torino, zip: 10126, country: Italy, contacts name: Virginia Giannone, MD, role: CONTACT, phone: +390113135063, email: vgiannone@cittadellasalute.to.it, contacts name: Marco Denina, MD, role: CONTACT, phone: +390113135064, email: mdenina@cittadellasalute.to.it, contacts name: Emanuele castagno, MD, role: SUB_INVESTIGATOR, contacts name: Giannone Virginia, MD, role: SUB_INVESTIGATOR, contacts name: Marco Denina, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.07049, lon: 7.68682, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-06-12, uploadDate: 2023-12-06T05:08, filename: Prot_SAP_000.pdf, size: 963093, hasResults: False
|
protocolSection identificationModule nctId: NCT06299800, orgStudyIdInfo id: CE385/2023, briefTitle: Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer, acronym: TCPT2023, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-04, primaryCompletionDateStruct date: 2025-02-04, completionDateStruct date: 2025-02-04, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, descriptionModule briefSummary: Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice.Primary objective of the study:- identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus;Secondary objectives of the study:* description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus;* assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes;* assess the relationship between the characteristics of patients and the time to the onset of cancer., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 779, type: ESTIMATED, armsInterventionsModule interventions name: phenotyping of patients followed at a third-level diabetes centre with cancer, outcomesModule primaryOutcomes measure: Smoking assessment at first visit, primaryOutcomes measure: Alcool consumption at first visit, primaryOutcomes measure: BMI assessment at first visit, primaryOutcomes measure: Glycated assessment at first visit, secondaryOutcomes measure: First-line therapy characteristics assessment at first visit, secondaryOutcomes measure: Primary outcomes and recurrence or presence of a secondary tumor, secondaryOutcomes measure: Relationship between patients characteristics and the time onset of cancer considering anthropometric and biochemical data, secondaryOutcomes measure: Tumour characterization in the considered population, detected at the first clinical visit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SCDU Endocrinology, AOU Ospedale Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Flavia Prodam, role: CONTACT, phone: +39 0321 660 693, email: flavia.prodam@med.uniupo.it, geoPoint lat: 45.44694, lon: 8.62118, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-09-10, uploadDate: 2024-03-01T05:46, filename: Prot_SAP_000.pdf, size: 525402, hasResults: False
|
protocolSection identificationModule nctId: NCT06299787, orgStudyIdInfo id: 058-2021, briefTitle: Cognitive Dysfunction in the Addictions Study - Project 4 (P4), acronym: CDiA-P4, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-07, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Centre for Addiction and Mental Health, class: OTHER, descriptionModule briefSummary: The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder., conditionsModule conditions: Major Depressive Disorder, conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: intermittent theta burst stimulation, interventions name: Sham stimulation, outcomesModule primaryOutcomes measure: Executive Function Index - inhibition, primaryOutcomes measure: Executive Function Index - working memory, primaryOutcomes measure: Executive Function Index - set shifting, secondaryOutcomes measure: 17-Item Hamilton Depression Rating Scale (HRSD-17), otherOutcomes measure: Columbia-Suicide Severity Rating Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centre for Addiction and Mental Health, status: RECRUITING, city: Toronto, state: Ontario, zip: M6J 1H4, country: Canada, contacts name: Daphne Voineskos, MD, role: CONTACT, phone: 416-535-8501, phoneExt: 30176, email: daphne.voineskos@camh.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
|
protocolSection identificationModule nctId: NCT06299774, orgStudyIdInfo id: 2023P003383, briefTitle: Emergency Care at Home, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2025-02-02, completionDateStruct date: 2025-03-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department., conditionsModule conditions: Emergency Medical Services, conditions: Emergency Department Visits, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Emergency care at home, interventions name: Emergency care at a brick-and-mortar emergency department, outcomesModule primaryOutcomes measure: Participant with an emergency department presentation, observation, or hospitalization within 9 days, secondaryOutcomes measure: Time to care initiation, secondaryOutcomes measure: Time spent receiving care, secondaryOutcomes measure: Number of days at home within 9 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: David Levine, MD, MPH, MA, role: CONTACT, phone: 617-732-7063, email: dmlevine@bwh.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06299761, orgStudyIdInfo id: BBI-825-101, briefTitle: Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications, acronym: STARMAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Boundless Bio, class: INDUSTRY, descriptionModule briefSummary: BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: BBI-825 single agent dose escalation, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: BBI-825, outcomesModule primaryOutcomes measure: Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825, primaryOutcomes measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825, secondaryOutcomes measure: Maximum observed plasma concentration (Cmax) of BBI-825, secondaryOutcomes measure: Trough observed plasma concentration (Ctrough) of BBI-825, secondaryOutcomes measure: Time to Cmax (Tmax) of BBI-825, secondaryOutcomes measure: Area under the concentration time curve (AUC) of BBI-825, secondaryOutcomes measure: Anti-tumor activity of BBI-825 as determined by RECISTv1.1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sarcoma Oncology Research Center, status: RECRUITING, city: Santa Monica, state: California, zip: 90403, country: United States, geoPoint lat: 34.01945, lon: -118.49119, locations facility: START Midwest, status: RECRUITING, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: NEXT Oncology, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
|
protocolSection identificationModule nctId: NCT06299748, orgStudyIdInfo id: ARGX-113-PAC-2206, briefTitle: A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2033-12, completionDateStruct date: 2033-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: argenx, class: INDUSTRY, descriptionModule briefSummary: This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the VYVGART IV or SC-exposed pregnancies were reported., conditionsModule conditions: Myasthenia Gravis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 279, type: ESTIMATED, armsInterventionsModule interventions name: Efgartigimod, outcomesModule primaryOutcomes measure: Pregnancy outcomes, secondaryOutcomes measure: Congenital malformations, secondaryOutcomes measure: The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness), secondaryOutcomes measure: Maternal complications of pregnancy, secondaryOutcomes measure: Maternal infections, secondaryOutcomes measure: The number of observed fetal growth deficiency, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299735, orgStudyIdInfo id: AsenaIremYildiz1, briefTitle: Comparison of Airway Management With Bronchial Blocker and Double-Lumen Tube in Single-Lung Ventilation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: In this study, the primary aim is to compare the impact of using a double-lumen tube and bronchial blocker for single-lung ventilation in patients undergoing minimal invasive cardiac surgeries on postoperative pulmonary functions. Secondary objectives include the comparison of application duration, success in lung collapse, and the number of repositioning attempts for both techniques., conditionsModule conditions: Heart Valvular Disease, conditions: Coronary Arteriosclerosis, conditions: One-lung Ventilation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The anesthesia method applied for both patient groups is the same. However, the airway maintenance device used will vary between two different patient groups. Group BB: A bronchial blocker will be used for this patient group, Group DLT: A double-lumen tube will be used for this patient group. The parameters to be recorded for both patient groups include: preoperative smoking history, ARISCAT score, systolic arterial pressure, diastolic arterial pressure, saturation, pulse, and the duration of airway device insertion following anesthesia induction and intubation. For the assessment of postoperative pulmonary complications in both patient groups, arterial blood gas analysis, chest X-ray, respiratory sounds, and the patient's oxygen requirement will be monitored every 6 hours for 24 hours., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Minimally Invasive Cardiac Surgery (airway management with double-lumen tube), interventions name: Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker), outcomesModule primaryOutcomes measure: Comparison of Postoperative Pulmonary Complications in Patient Groups Undergoing Single-Lung Ventilation with Double-Lumen Tube and Bronchial Blocker, secondaryOutcomes measure: Duration of insertion of the double-lumen tube / bronchial blocker, secondaryOutcomes measure: Incidence of postoperative sore throat, secondaryOutcomes measure: Incidence of postoperative hoarseness, secondaryOutcomes measure: Impact of the success of lung collapse, secondaryOutcomes measure: Satisfactory lung collapse time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara bilkent city hospital, status: RECRUITING, city: Ankara, state: Çankaya, zip: 06530, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06299722, orgStudyIdInfo id: N-20230055, briefTitle: Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents, acronym: STEEL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Aalborg University, class: OTHER, descriptionModule briefSummary: We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis)., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: STEEL, interventions name: Circuit training, outcomesModule primaryOutcomes measure: Isometric strength, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Step counts, secondaryOutcomes measure: Caloric expenditure, secondaryOutcomes measure: Maximal dynamic strength, secondaryOutcomes measure: Bone mineral density of the lumbar spine and body composition, secondaryOutcomes measure: Grip strength and rate of force development, secondaryOutcomes measure: Muscular strength, endurance, and rate of force development, secondaryOutcomes measure: Cardiorespiratory fitness and endurance, secondaryOutcomes measure: Exercise compliance and fidelity, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Movement-evoked pain, secondaryOutcomes measure: Satisfaction with the intervention, secondaryOutcomes measure: Blood glucose, secondaryOutcomes measure: Glycated hemoglobin (Hba1c), secondaryOutcomes measure: Insulin, secondaryOutcomes measure: Proinsulin c-peptide, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: High-density lipoprotein cholesterol, secondaryOutcomes measure: Low-density lipoprotein cholesterol, secondaryOutcomes measure: Very low-density lipoprotein cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Glucagon, secondaryOutcomes measure: Homeostatic Model assessment for Insulin resistance score, secondaryOutcomes measure: Body Mass Index (BMI), secondaryOutcomes measure: Lean body mass, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Android/gynoid fat distribution, secondaryOutcomes measure: Abdominal circumference, secondaryOutcomes measure: Self-reported Tanner staging, secondaryOutcomes measure: Blood pressure, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Rigshospitalet, status: RECRUITING, city: Copenhagen, country: Denmark, contacts name: Martin K Fridh, role: CONTACT, email: martin.kaj.fridh@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Aalborg University, status: RECRUITING, city: Gistrup, zip: 9260, country: Denmark, contacts name: Henrik Riel, role: CONTACT, email: hriel@dcm.aau.dk, geoPoint lat: 56.9943, lon: 9.99085, locations facility: Odense University Hospital, status: RECRUITING, city: Odense, country: Denmark, contacts name: Mathias Rathe, role: CONTACT, email: mathias.rathe@rsyd.dk, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Århus University Hospital, status: RECRUITING, city: Århus, country: Denmark, contacts name: Clara Vad, role: CONTACT, email: claravad@live.dk, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
|
protocolSection identificationModule nctId: NCT06299709, orgStudyIdInfo id: VX23-121-012, briefTitle: A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Vertex Pharmaceuticals Incorporated, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: VNZ/TEZ/D-IVA, interventions name: VNZ/TEZ/D-IVA, outcomesModule primaryOutcomes measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA, primaryOutcomes measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA, primaryOutcomes measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA, primaryOutcomes measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA, secondaryOutcomes measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion, Inc., status: RECRUITING, city: Tempe, state: Arizona, zip: 85283, country: United States, geoPoint lat: 33.41477, lon: -111.90931, hasResults: False
|
protocolSection identificationModule nctId: NCT06299696, orgStudyIdInfo id: VX23-121-011, briefTitle: A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Vertex Pharmaceuticals Incorporated, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: VNZ/TEZ/D-IVA, outcomesModule primaryOutcomes measure: Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Site 001, city: Woburn, state: Massachusetts, zip: 01801, country: United States, geoPoint lat: 42.47926, lon: -71.15228, hasResults: False
|
protocolSection identificationModule nctId: NCT06299683, orgStudyIdInfo id: 230487, secondaryIdInfos id: 1R01DK133415-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DK133415-01A1, briefTitle: Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-05, completionDateStruct date: 2028-08-04, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University Medical Center, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS., conditionsModule conditions: Chronic Interstitial Cystitis, conditions: Bladder Pain Syndrome, conditions: Painful Bladder Syndrome, conditions: Cystitis, Interstitial, conditions: Cystitis, Chronic Interstitial, conditions: Interstitial Cystitis, conditions: Interstitial Cystitis, Chronic, conditions: Interstitial Cystitis (Chronic) With Hematuria, conditions: Interstitial Cystitis (Chronic) Without Hematuria, conditions: Chronic Prostatitis, conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study involves a two group parallel design, with one group receiving individual psychosocial intervention online and another pelvic floor physical therapy., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Study assessors will be blinded to the study primary outcome but will be aware of study treatment conditions., enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Psychosocial Treatment, interventions name: Pelvic Floor Physical Therapy, outcomesModule primaryOutcomes measure: Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale., secondaryOutcomes measure: Chronic Overlapping Pain Condition-Screener (COPCS), secondaryOutcomes measure: Quantitative Sensory Testing - Tolerance Average (QST-TOL), secondaryOutcomes measure: Quantitative Sensory Testing - Threshold Average (QST-THR), secondaryOutcomes measure: Quantitative Sensory Testing - Temporal Summation (QST-TS), secondaryOutcomes measure: Urinary Nerve Growth Factor (NGF), secondaryOutcomes measure: Urinary Interleukin-6 (IL6), secondaryOutcomes measure: Interleukin-6, whole blood stimulated (IL6-LPS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299670, orgStudyIdInfo id: 939, briefTitle: Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, class: OTHER, descriptionModule briefSummary: Transfusion Dependent Thalassemia (TDT) is an emerging global public health concern. Hemopoietic stem cell transplantation (HSCT) is the only curative treatment. But its adoption is limited due to lack of HLA matched donor, experienced centers and high initial cost. So, researches are going on in search of an effective, safe, easily available treatment option. Use of fetal haemoglobin inducing agents shows promising effects in treatment of TDT patients. Thalidomide an immunomodulating and anti-angiogenic drug has been shown to induce γ-globin gene expression and increase the proliferation of erythroid cells. Furthermore Hydroxyurea (HU) is known to increase haemoglobin (Hb) by HbF induction and reduction of inflammation and hypercoagulability.Recent studies with combination of HU and Thalidomide have shown promising results in treatment of Thalassemia patients. However, most of those studies are retrospective or single arm nonrandomized trials \& The study population includes both adult and children age group . So the effectiveness of combination therapy of Thalidomide and HU needs to be established through randomized trials.This single centered non blinded quasi randomized clinical trial will be conducted at the Department of Pediatric Hematology and Oncology in Bangabandhu Sheikh Mujib Medical University (BSMMU), Bangladesh for one year of period. Thirty transfusion dependent thalassemia children of 3-18 years old will be included in each group. The objective of this study is to assess the effectiveness of combination of Thalidomide and Hydroxyurea in TDT children. It will play an important role in planning a cost effective and affordable treatment option for TDT children.This study will involve minimum physical risk to the patient. Written informed consent will be taken from parents or study subjects after brief explanation of the purpose and procedure. They will also be informed about the freedom to participate or not to participate at any time. Privacy and confidentiality will be safe guarded. History regarding age, sex, height, weight of these patients will be taken. Thorough physical examinations and laboratory investigations including CBC, Hb electrophoresis, serum Ferritin, serum creatinine, SGPT will be done. Data will be collected in a predesigned questionnaire and will be kept confidential. Statistical analysis will be done using the statistical software SPSS., conditionsModule conditions: Transfusion-dependent Thalassemia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Thalidomide, interventions name: Hydroxy Urea, interventions name: Combinations, outcomesModule primaryOutcomes measure: Change in Hb Level, primaryOutcomes measure: Change in Blood transfusion frequency, primaryOutcomes measure: Change in HbF, secondaryOutcomes measure: Change in Biochemicals, secondaryOutcomes measure: Adverse effect, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Bangabandhu Sheikh Mujib Medical University, status: RECRUITING, city: Dhaka, zip: 1000, country: Bangladesh, contacts name: Md. Anwarul Karim, MBBS, FCPS, MD, role: CONTACT, phone: +880255165814, email: drkarim1990@gmail.com, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False
|
protocolSection identificationModule nctId: NCT06299657, orgStudyIdInfo id: 2023H0286, briefTitle: Intervention for Managing Physical Reactions to Overwhelming Emotions, acronym: IMPROVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: The clinical trial aims to conduct a feasibility, acceptability, and usability clinical trial of a modular CBT-based and technologically enhanced intervention for people with an SUD and recently enrolled in IOP, probe target engagement and change in clinical outcomes, and examine attrition rates in IOP.This study will enroll 40 adults who are currently enrolled in IOP, have a substance use disorder, and experience elevated anxiety. 20 individuals will be randomized to the experimental intervention, "Intervention for Managing Physical Reactions to Overwhelming Emotions" (IMPROVE), and 20 individuals will be randomized to the active control group, "Physical Health Education Treatment" (PHET).Participants will be asked to complete a baseline assessment of mood, substance use, and psychophysiology. Participants will then completed ecological momentary assessments (EMA) via smartphone technology 4 times a day for \~ 28 days (the day following the baseline assessment until the 3rd intervention session). Participants will complete one 45 minute - 1 hour intervention each week for 3 weeks (either the IMPROVE or PHET intervention, pending randomization). Following the last intervention session, participants will return to the lab to complete a post-intervention assessment that mirrors the baseline assessment and then complete follow-up surveys 1- and 3-months post intervention., conditionsModule conditions: Anxiety, conditions: Substance Use Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to receive one of two possible interventions., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Raters completing the outcome assessments will be blind to condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: IMPROVE, interventions name: PHET, outcomesModule primaryOutcomes measure: Intolerance of Uncertainty-12 Scale, primaryOutcomes measure: Anxiety Sensitivity-3 Scale, primaryOutcomes measure: PROMIS Anxiety Short Form, primaryOutcomes measure: Timeline Followback, primaryOutcomes measure: Desire for Drug Questionnaire, primaryOutcomes measure: Penn Alcohol Craving Scale, primaryOutcomes measure: Hyperkatifeia Interference Scale - Alcohol Version., primaryOutcomes measure: Clinical Institute Withdrawal Assessment Alcohol Scale Revised., primaryOutcomes measure: Hyperkatifeia Interference Scale - Opioid Version., primaryOutcomes measure: Subjective Opiate Withdrawal Scale, primaryOutcomes measure: NPU Threat Task, primaryOutcomes measure: Straw Breathing Avoidance Task, primaryOutcomes measure: Emotion Picture Paradigm Task, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Department of Psychiatry and Behavioral Health, city: Columbus, state: Ohio, zip: 43062, country: United States, contacts name: Nicholas P Allan, PhD, role: CONTACT, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
|
protocolSection identificationModule nctId: NCT06299644, orgStudyIdInfo id: 2023P003282, briefTitle: Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-05-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Endo Tools Therapeutics S.A., descriptionModule briefSummary: The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss., conditionsModule conditions: Obesity, conditions: Obesity, Morbid, conditions: Metabolic Disease, conditions: Weight, Body, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic Sleeve Gastroplasty - Belt and Suspenders, interventions name: Endoscopic Sleeve Gastroplasty - Belt, outcomesModule primaryOutcomes measure: Percent TWL (%TWL), primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Gastric Emptying, secondaryOutcomes measure: Number of participants with improvement in fasting glucose, secondaryOutcomes measure: Number of participants with improvement in Hemoglobin A1c (HgA1c %), secondaryOutcomes measure: Improvement in fasting lipids profile, secondaryOutcomes measure: Number of participants with a change in ghrelin hormone values, secondaryOutcomes measure: Obesity-related comorbidities - hypertension, secondaryOutcomes measure: Obesity-related comorbidities - change in hypertension concomitant medications, secondaryOutcomes measure: Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications, secondaryOutcomes measure: Obesity-related comorbidities - pre-diabetes/diabetes, secondaryOutcomes measure: Obesity-related comorbidities - gastroesophageal reflux (GERD), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06299631, orgStudyIdInfo id: RECHMPL23_0187, briefTitle: Endoscopic Relapse Risks Evaluation After Ileocolic Resection for Crohn's Disease, acronym: RIC-1, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01, primaryCompletionDateStruct date: 2023-06, completionDateStruct date: 2023-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, collaborators name: Carémeau University Hospital, Nîmes, descriptionModule briefSummary: Aim of the study:To evaluate risk factors of endoscopic relapse after ileocolic resection in a cohort of Crohn's disease patients treated with anti-TNF agents.Methods:From 2014 to 2022, all consecutive patients who underwent ileocolic resection for Crohn's disease treated with anti-TNF agents in two referral tertiary center were prospectively collected.Considering exclusion criteria, data from 114 patients were analyzed. The cohort was separated into 2 groups according to study period.Short and long-term outcomes were compared between the two groups.Primary outcome:Endoscopic recurrence (defined as \> i2 lesions according to Rutgeerts classification) 6 months after surgery, conditionsModule conditions: Crohn's Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 133, type: ACTUAL, armsInterventionsModule interventions name: Ileocolic resection, outcomesModule primaryOutcomes measure: Endoscopic recurrence rate, secondaryOutcomes measure: Resection margins, secondaryOutcomes measure: Length of resected specimen, secondaryOutcomes measure: Duration of surgery, secondaryOutcomes measure: Intra-operative blood loss, secondaryOutcomes measure: Postoperative morbidity rate, secondaryOutcomes measure: Mortality rate, secondaryOutcomes measure: Myenteric plexitis, secondaryOutcomes measure: Number of inflammatory cells in myenteric plexuses, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montpellier University Hospital, city: Montpellier, zip: 34295, country: France, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False
|
protocolSection identificationModule nctId: NCT06299618, orgStudyIdInfo id: ENIGMA-I, briefTitle: Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism, acronym: ENIGMA-I, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University College Cork, class: OTHER, collaborators name: University of Southampton, collaborators name: Carol Davila University of Medicine and Pharmacy, collaborators name: Microlink PC UK LTE, collaborators name: Engineering Ingegneria Informatica SpA, collaborators name: MEDEA SRL, collaborators name: ORTHOKEY ITALIA SRL, descriptionModule briefSummary: The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism., conditionsModule conditions: Autism, conditions: Autism Spectrum Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Symptoms of anxiety, primaryOutcomes measure: Symptoms of anxiety, primaryOutcomes measure: Symptoms of depression, primaryOutcomes measure: Symptoms of depression, otherOutcomes measure: Attention-Deficit/Hyperactivity, otherOutcomes measure: Sleep disturbance, otherOutcomes measure: Physical Activity, otherOutcomes measure: Symptoms of Mental Health Disorders, otherOutcomes measure: Cognitive Assessment, otherOutcomes measure: Nutritional Assessment, otherOutcomes measure: Heart Rate, otherOutcomes measure: Respiratory Rate, otherOutcomes measure: Genotype, otherOutcomes measure: DNA Methylation, otherOutcomes measure: Hormone Levels, otherOutcomes measure: Metabolomic Profile, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: University College Cork, city: Cork, country: Ireland, contacts name: Deirdre Murray, PhD, role: CONTACT, email: enigma@ucc.ie, contacts name: Jean Conway, Masters, role: CONTACT, email: ethereal@ucc.ie, geoPoint lat: 51.89797, lon: -8.47061, locations facility: University of Medicine and Pharmacy Carol Davila Bucharest, city: Bucharest, country: Romania, geoPoint lat: 44.43225, lon: 26.10626, locations facility: University of Southampton, city: Southampton, country: United Kingdom, contacts name: Samuele Cortese, MD, role: CONTACT, contacts name: Koushik Maharatna, PhD, role: CONTACT, email: km3@ecs.soton.ac.uk, geoPoint lat: 50.90395, lon: -1.40428, hasResults: False
|
protocolSection identificationModule nctId: NCT06299605, orgStudyIdInfo id: SHARE2401, briefTitle: Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori, acronym: SHARE2401, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Shandong University, class: OTHER, collaborators name: Binzhou Maternal and Child Health Hospital, collaborators name: Zibo Maternal and Child Health Hospital, collaborators name: Zaozhuang Municipal Hospital, collaborators name: Linyi Yizhou Hospital, collaborators name: Feicheng Municipal People's Hospital, descriptionModule briefSummary: The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated., conditionsModule conditions: Helicobacter Pylori Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 375, type: ESTIMATED, armsInterventionsModule interventions name: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days, interventions name: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days, interventions name: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days, outcomesModule primaryOutcomes measure: Eradication rate, secondaryOutcomes measure: Rate of adverse reactions, secondaryOutcomes measure: Patient compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299592, orgStudyIdInfo id: 2023-1626, secondaryIdInfos id: 1RF1AG082215-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1RF1AG082215-01, secondaryIdInfos id: A538900, type: OTHER, domain: UW- Madison, secondaryIdInfos id: SMPH/PSYCHIATRY/PSYCHIATRY, type: OTHER, domain: UW- Madison, secondaryIdInfos id: Protocol Version 10/15/2023, type: OTHER, domain: UW- Madison, briefTitle: Comparison of Microglial Activation in Severe Asthma and Healthy Controls, acronym: MAIA-SC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2028-08, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are:* How airway inflammation in asthma affects the brain; and,* Whether airway inflammation in asthma is related to symptoms of depression and anxietyOver the course of 3 visits, participants will:* Complete questionnaires* Complete computer tasks* Undergo allergy skin test and breathing tests* Give two blood samples* Give a sputum sample* Complete brain imaging scansResearchers will compare results between participants with asthma, and participants who do not have asthma., conditionsModule conditions: Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: PET/MRI using [18F]FEPPA tracer, outcomesModule primaryOutcomes measure: Binding of [18F]-FEPPA, secondaryOutcomes measure: How activated microglia correspond to immune biomarkers in lung and blood, secondaryOutcomes measure: Relationship between activated microglia and cognitive function, secondaryOutcomes measure: Relationship between activated microglia and psychological symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Healthy Minds, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53703, country: United States, contacts name: Janelle Grogan, role: CONTACT, phone: 608-263-0524, email: jegrogan@medicine.wisc.edu, contacts name: Melissa Rosenkranz, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
|
protocolSection identificationModule nctId: NCT06299579, orgStudyIdInfo id: WG-GD11-III-01, briefTitle: GD-11 for Injection in the Treatment of Acute Ischemic Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-02-22, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, collaborators name: Jiangsu Wangao Pharmaceutical Co. ltd, descriptionModule briefSummary: Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study with the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours. The subject has a clinical diagnosis of acute ischemic stroke, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with mRS score ≤ 1 at 90 days after treatment., conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This trial is designed as a multicenter, randomized, double-blind, placebo-parallel controlled trial using a multicenter, randomized, double-blind, placebo-parallel controlled trial design. Subjects are randomly assigned in a 1:1 ratio and random number tables are generated using SAS（Statistics Analysis System）software., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 980, type: ESTIMATED, armsInterventionsModule interventions name: GD-11 for injection test group, interventions name: Placebo control group, outcomesModule primaryOutcomes measure: Proportion of subjects with mRS score ≤1 on 90th day of treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 81 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tiantan Hospital Capital Medical University Beijing, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Yongjun Wang, role: CONTACT, email: yongjunwang111@aliyun.com, contacts name: Yongjun Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Linfen Central Hospital, status: RECRUITING, city: Shangxi, state: Linfen City, zip: 041099, country: China, contacts name: hongguo Dai, role: CONTACT, email: daihongguo3199@163.com, hasResults: False
|
protocolSection identificationModule nctId: NCT06299566, orgStudyIdInfo id: CF NGS, briefTitle: Perceptions of the CF Screening Protocol Incorporating NGS, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-19, primaryCompletionDateStruct date: 2023-02-28, completionDateStruct date: 2023-02-28, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: University of Warwick, collaborators name: Coventry University, collaborators name: Barts & The London NHS Trust, collaborators name: Cystic Fibrosis Trust, descriptionModule briefSummary: Newborn bloodspot screening (from now on referred to as screening) for cystic fibrosis (CF) became part of the national screening programme in 2007. Screening for CF is also well established internationally. The current process works well but has some disadvantages: carrier reporting - which is not the intention of CF screening in the UK (\~200 pa); need for repeat samples which can be costly and contribute to parental worry (\~300 pa.); mutation panels not fully reflecting the ethnic diversity of the birth population; identification of children designated as CF screen positive, inconclusive diagnosis (CFSPID) which can cause uncertainty (\~20-30 pa).A trial of NGS in one centre in the UK, for one year found that it was technically feasible at reasonable cost and with an acceptable turn around time. In addition, the trial determined that using NGS could mitigate against some of the disadvantages described above.The purpose of this piece of work was to:1. Gather, compare and analyse the views of a range of stakeholders on the proposed CF screening protocol incorporating NGS.2. Use the outcomes to inform discussions and decisions by the fetal, maternal and child health (FMCH) group and UK National Screening Committee (NSC) about the proposed protocol3. Consider what generalisable information on the views of stakeholders on newborn screening could be generated from this exercise to inform other FMCH and UK NSC discussions4. Evaluate and learn from the exercise to inform future stakeholder engagement activities by the UK NSC and screening programmes., conditionsModule conditions: Cystic Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Focus groups/interviews/questionnaires exploring stakeholder views of the proposed CF screening protocol incorporating NGS., secondaryOutcomes measure: Focus groups/interviews/questionnaires exploring stakeholder views on equivocal, carrier, false positives/negatives results, late onset/uncertain conditions, secondaryOutcomes measure: Q sorts used to develop data and materials FMCH and UK NSC can use to engage stakeholders, secondaryOutcomes measure: Surveys to explore principles of engagement for stakeholders, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King's College London, city: London, zip: SE5 9RS, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
|
protocolSection identificationModule nctId: NCT06299553, orgStudyIdInfo id: INCB88888-040 PRO-MIND, briefTitle: Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Incyte Biosciences Italy S.r.l, class: INDUSTRY, descriptionModule briefSummary: The PRO-MIND study is an Italian, multicenter, prospective observational cohort study to evaluate the effectiveness and the safety of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in patient with DLBCL., conditionsModule conditions: DLBCL - Diffuse Large B Cell Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Baseline Characteristics, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Time to next treatment (TTNT), secondaryOutcomes measure: Time to response, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Event Free Survival (EFS), secondaryOutcomes measure: Progression-Free-Survival 2 (PFS2), secondaryOutcomes measure: Information of which treatment the patients will get after tafasitamab discontinuation, secondaryOutcomes measure: Safety of tafasitamab combined with lenalidomide, secondaryOutcomes measure: Safety of tafasitamab in monotherapy, secondaryOutcomes measure: Describe the treatment adherence of lenalidomide and dose reduction., secondaryOutcomes measure: Health-Related Quality of Life (HRQoL), secondaryOutcomes measure: Health-Related Quality of Life (HRQoL), secondaryOutcomes measure: Health economics - Hospitalization, secondaryOutcomes measure: Health economics - DLBCL treatment, secondaryOutcomes measure: Health economics - Concomitant Treatments, secondaryOutcomes measure: Health economics - Monitoring activities, secondaryOutcomes measure: Health economics - monitoring activities performed after patients' discharge, secondaryOutcomes measure: Health economics - Adverse event treatment, secondaryOutcomes measure: Health economics - Unplanned specialist visits, secondaryOutcomes measure: Exploratory objectives, secondaryOutcomes measure: Exploratory objectives, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Incyte Biosciences Italy S.r.l, status: RECRUITING, city: Milan, zip: 20122, country: Italy, contacts name: Nicola Battaglia, role: CONTACT, phone: +39 3429513636, email: NBattaglia@incyte.com, contacts name: Mario Lapecorella, role: CONTACT, email: MLapecorella@incyte.com, contacts name: Pier Luigi Zinzani, role: PRINCIPAL_INVESTIGATOR, contacts name: Eliana Valentina Liardo, role: PRINCIPAL_INVESTIGATOR, contacts name: Paolo Corradini, role: PRINCIPAL_INVESTIGATOR, contacts name: Enrico Derenzini, role: PRINCIPAL_INVESTIGATOR, contacts name: Francesca Gaia Rossi Dardanoni, role: PRINCIPAL_INVESTIGATOR, contacts name: Andrès Ferreri, role: PRINCIPAL_INVESTIGATOR, contacts name: Leonardo Flenghi, role: PRINCIPAL_INVESTIGATOR, contacts name: Caterina Patti, role: PRINCIPAL_INVESTIGATOR, contacts name: Maurizio Musso, role: PRINCIPAL_INVESTIGATOR, contacts name: Annalisa Chiarenza, role: PRINCIPAL_INVESTIGATOR, contacts name: Adalberto Ibatici, role: PRINCIPAL_INVESTIGATOR, contacts name: Michele Spina, role: PRINCIPAL_INVESTIGATOR, contacts name: Alice Di Rocco, role: PRINCIPAL_INVESTIGATOR, contacts name: Maria Christina Cox, role: PRINCIPAL_INVESTIGATOR, contacts name: Stefan Hohaus, role: PRINCIPAL_INVESTIGATOR, contacts name: Andrea Bernardelli, role: PRINCIPAL_INVESTIGATOR, contacts name: Francesco Piazza, role: PRINCIPAL_INVESTIGATOR, contacts name: Domenico Pastore, role: PRINCIPAL_INVESTIGATOR, contacts name: Giuseppe Tarantini, role: PRINCIPAL_INVESTIGATOR, contacts name: Daniela Dessì, role: PRINCIPAL_INVESTIGATOR, contacts name: Sofya Kovalchuk, role: PRINCIPAL_INVESTIGATOR, contacts name: Alberto Fabbri, role: PRINCIPAL_INVESTIGATOR, contacts name: Antonio Pinto, role: PRINCIPAL_INVESTIGATOR, contacts name: Ferdinando Frigeri, role: PRINCIPAL_INVESTIGATOR, contacts name: Mario Annunziata, role: PRINCIPAL_INVESTIGATOR, contacts name: Elsa Pennese, role: PRINCIPAL_INVESTIGATOR, contacts name: Caterina Cecilia Stelitano, role: PRINCIPAL_INVESTIGATOR, contacts name: Mattia Novo, role: PRINCIPAL_INVESTIGATOR, contacts name: Manuela Zanni, role: PRINCIPAL_INVESTIGATOR, contacts name: Guido Gini, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06299540, orgStudyIdInfo id: 54179060CLL4033, secondaryIdInfos id: 54179060CLL4033, type: OTHER, domain: Janssen-Cilag France, briefTitle: Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia, acronym: QOLIBRI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Janssen Cilag S.A.S., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G)., conditionsModule conditions: Leukemia, Lymphocytic, Chronic, B-Cell, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 256, type: ESTIMATED, armsInterventionsModule interventions name: Individual Physical Activity Intervention (IPAI), interventions name: Ibrutinib, outcomesModule primaryOutcomes measure: Change from Baseline in Health-related Quality of Life (HRQoL) by Using Functional Assessment of Cancer Therapy General (FACT-G) Total Score at Month 4.5, secondaryOutcomes measure: Change from Baseline in HRQoL by Using Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Total Score at Month 4.5, Month 6.5 and Month 12, secondaryOutcomes measure: Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5, secondaryOutcomes measure: Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12, secondaryOutcomes measure: Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12, secondaryOutcomes measure: Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5, secondaryOutcomes measure: Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12, secondaryOutcomes measure: Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12, secondaryOutcomes measure: Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5, secondaryOutcomes measure: Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12, secondaryOutcomes measure: Percentage of Participants Achieving a Greater Than or Equal to (>=) 5-Point Improvement in the FACT-G Total Score at Months 4.5, 6.5, and 12 as Compared to Baseline, secondaryOutcomes measure: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 4.5, Month 6.5, and Month 12, secondaryOutcomes measure: Change From Baseline in the Pittsburgh Sleep Quality Index (PSQI) Total Score and Sub Score at Month 4.5, Month 6.5, and Month 12, secondaryOutcomes measure: Change From Baseline in Total Sleep Time Using Connected Watch, secondaryOutcomes measure: Change From Baseline in Total Sleep Score Using Connected Watch, secondaryOutcomes measure: Change From Baseline in Sleep Stages Using Connected Watch, secondaryOutcomes measure: Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12, secondaryOutcomes measure: Change From Baseline in Physical Fitness as Measured by Six-Minute Walk Test (6MWT) at Month 4.5, Month 6.5, and Month 12, secondaryOutcomes measure: Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch, secondaryOutcomes measure: Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch, secondaryOutcomes measure: Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch, secondaryOutcomes measure: Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch, secondaryOutcomes measure: Percentage of Participants with Treatment-related Adverse Events, secondaryOutcomes measure: Time to Treatment Discontinuation (TTD), secondaryOutcomes measure: Reasons for Treatment Discontinuation, secondaryOutcomes measure: Percentage of Participants Who Still Wear the Connected Watch, secondaryOutcomes measure: Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch), secondaryOutcomes measure: Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment, secondaryOutcomes measure: For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI, secondaryOutcomes measure: For Group 1: Percentage of Participants Who Follow the Adapted Physical Activity (APA) Sessions, the Walking Objectives and the APA Appointment as Scheduled With the APA Among Those Who Have Started IPAI, secondaryOutcomes measure: For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study, secondaryOutcomes measure: For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study, secondaryOutcomes measure: For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study, secondaryOutcomes measure: For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299527, orgStudyIdInfo id: 01032024, briefTitle: Telerehabilitation in Patients With Fibromyalgia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-27, primaryCompletionDateStruct date: 2023-11-15, completionDateStruct date: 2024-01-27, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16)., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 66, type: ACTUAL, armsInterventionsModule interventions name: Exercise Program, outcomesModule primaryOutcomes measure: Visual Analog Scale, secondaryOutcomes measure: Revised Fibromyalgia Impact Questionnaire, secondaryOutcomes measure: Pain Catastrophizing Scale, secondaryOutcomes measure: Hospital Anxiety and Depression Scale, secondaryOutcomes measure: 6 Minute Walk Test, secondaryOutcomes measure: Arm Curl Test, secondaryOutcomes measure: Laser Cursor Assisted Angle Repetition Test (LI-RATT), secondaryOutcomes measure: Short Form - 12, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Health Sciences, city: Istanbul, state: Maltepe, zip: 1464185881, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06299514, orgStudyIdInfo id: 4754, briefTitle: RAFT-P&A Randomized Control Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, descriptionModule briefSummary: Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy., conditionsModule conditions: Atrial Fibrillation, conditions: Heart Failure, conditions: Pacemaker, conditions: Arrhythmia Atrial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: Pace and Ablate, interventions name: Medication, outcomesModule primaryOutcomes measure: Winratio, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Cardiovascular mortality, secondaryOutcomes measure: Number of heart failure events, secondaryOutcomes measure: All-cause hospitalization, secondaryOutcomes measure: Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ), secondaryOutcomes measure: Exercise, secondaryOutcomes measure: Biochemical marker, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: London Health Sciences Centre - University Hospital, city: London, state: Ontario, zip: N6A5A5, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, locations facility: London Health Sciences Research, city: London, state: Ontario, zip: N6G5A5, country: Canada, contacts name: Abbie Pardo, role: CONTACT, phone: 5196612111, phoneExt: 86459, email: abbie.pardo@lhsc.on.ca, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False
|
protocolSection identificationModule nctId: NCT06299501, orgStudyIdInfo id: LS 2015-1199 and 2017-24, briefTitle: How Can Child Health Services Identify and Respond to Family Violence, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-08-23, primaryCompletionDateStruct date: 2019-08-31, completionDateStruct date: 2019-08-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Jane and Dan Olsson Foundation for Scientific Purposes, collaborators name: Region Stockholm, descriptionModule briefSummary: Family violence has severe impacts on children's health and development. The Child Health Services (CHS) in Sweden reaches almost 100% of families with young children and provides a unique setting to facilitate identification of family violence. This study is a three-armed randomized controlled trial (RCT) conducted to assess the effectiveness of different approaches to identify family violence within CHS. Two different approaches are tested and compared to treatment as usual; 1) information about family violence at home visit when child is newborn, and questions posed to all mothers at the 6-8-week visit; 2) information about family violence at home visit when child is newborn, and questions posed to mothers on evidence based indication. Nurses who are randomized into any of the two intervention arms receive training and supervision. The outcomes of the study are related to knowledge, attitudes, and practices around identification and support in case of family violence and number of identified cases of family violence., conditionsModule conditions: Family Violence, conditions: Domestic Violence, conditions: Intimate-partner Violence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three-armed study, two intervention groups and one control group, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 85, type: ACTUAL, armsInterventionsModule interventions name: Routine questions, interventions name: Questions on evidence based indication, interventions name: Treatment as usual, outcomesModule primaryOutcomes measure: Knowledge, attitudes and practices, secondaryOutcomes measure: Number of cases of family violence, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Child Health Care (Centrala barnhälsovården), city: Stockholm, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
|
protocolSection identificationModule nctId: NCT06299488, orgStudyIdInfo id: PS03, briefTitle: Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia, acronym: Sip2Sleep, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-05, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-07-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Lakshmi Nutraceuticals LLC, class: INDUSTRY, collaborators name: People Science, Inc., descriptionModule briefSummary: Lay Summary: This study is about the effect of using a unique formula called Sip2Sleep®, a product currently available on the market which is a combination of montmorency tart cherry extract and Venetron® (Apocynum venetum leaf extract) on sleep. The purpose of this study is to evaluate the effects of taking this combination product on various aspects of sleep. This study is being conducted by People Science, and is sponsored by Lakshmi Nutraceuticals, LLC. The information we gather will help inform how people may use Sip2Sleep® to affect the quality of sleep.Participants in this study will complete a number of surveys about their difficulties falling asleep and staying asleep (insomnia), their energy level during the day and health status regarding their quality of sleep.There are no major risks associated with this study., conditionsModule conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will complete a 5-week study consisting of screening assessments, baseline scales and surveys, objective digital measure, 2 weeks of product use (1 week on - 1 week off - 1 week on), scales and surveys, and end of study assessments and surveys. This is a remote observational study that will use the People Science app-based data collection platform Consumer Health Learning and Organizing Ecosystem (CHLOE) for study participants to report their assessments and collect objective sleep data from personal wearable devices. Participants will receive the study product during the baseline period. Demographic and medical history data will be collected for the study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: This study is not blinded. Participants consume the intervention on alternating weeks. All participants receive the intervention, enrollmentInfo count: 77, type: ACTUAL, armsInterventionsModule interventions name: Sip2Sleep: Montmorency Cherry and Apocynum Venetum, outcomesModule primaryOutcomes measure: Subjective Sleep Quality, secondaryOutcomes measure: Insomnia Sleep Index, secondaryOutcomes measure: Generalized Anxiety Disorder-7 (GAD-7), secondaryOutcomes measure: Subjective Alertness, otherOutcomes measure: Exploratory: Sleep Duration, otherOutcomes measure: Exploratory: Sleep Latency, otherOutcomes measure: Participant Satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: People Science Inc., city: West Hollywood, state: California, zip: 90069, country: United States, geoPoint lat: 34.09001, lon: -118.36174, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-03-24, uploadDate: 2024-02-28T17:22, filename: Prot_SAP_000.pdf, size: 436932, hasResults: False
|
protocolSection identificationModule nctId: NCT06299475, orgStudyIdInfo id: 2023-06755-01, briefTitle: Structured Online Contraceptive Counseling (LOWE Trial) at Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC, acronym: LOWEC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: the Swedish Pharmacy Association, descriptionModule briefSummary: To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP)., conditionsModule conditions: Contraception, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A cluster randomized crossover trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Online counseling and invitation, outcomesModule primaryOutcomes measure: Use of effective contraception, secondaryOutcomes measure: Contraceptive use, secondaryOutcomes measure: Incidence of pregnancy and abortion, secondaryOutcomes measure: Satisfaction with the intervention, secondaryOutcomes measure: Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups, secondaryOutcomes measure: Process evaluation, eligibilityModule sex: FEMALE, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299462, orgStudyIdInfo id: PTCy-ATG-001, briefTitle: PTCy and ATG for MSD and MUD Transplants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-21, primaryCompletionDateStruct date: 2031-06-01, completionDateStruct date: 2031-06-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Instituto Nacional de Cancer, Brazil, class: OTHER_GOV, descriptionModule briefSummary: Hematopoietic stem cell transplantation is a curative treatment for a number of benign and malignant hematologic diseases. One of the key parts of hematopoietic stem cell transplantation is the prophylaxis of graft-versus-host disease. Since the end of the 1970s, with the introduction of cyclosporine, calcineurin inhibitors (cyclosporine and tacrolimus) have become part of almost all prophylactic regimens, even though they are a group of drugs with a poor toxicity profile that requires monitoring. constant serum level. Since 2008, post-transplant cyclophosphamide has been introduced with great success, associated with a calcineurin inhibitor and mycophenolate, in the prophylaxis of graft-versus-host disease in haploidentical transplantation (50% matched).Since then, in view of this enormous success, efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants, or with a mismatch.This is a prospective, 2-arm, non-randomized study. Arm 1, with related donors, and arm 2, with unrelated donors. Patients will be allocated in these arms according to donor availability (patients with a matched-sibling donor will receive a matched-sibling transplant; patients with no related donors but with unrelated donors, an unrelated transplant).Patients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study.The stem cell collection target will be 5E6 CD34/kg recipient weight for peripheral source. If a quantity greater than this is collected, the remainder will be cryopreserved according to the institutional protocol.Graft-versus-host disease prophylaxis will be performed on D+3 and D+4 with cyclophosphamide and with ATG on D-1 or on D-2 and D-1, depending on ATG de-escalation, for matched-sibling transplants, according to prespecified criteria based on the 3+3 approach; and on D+3 and D+4 with cyclophosphamide and with ATG on D-2 and D-1, for unrelated donors., conditionsModule conditions: Acute Myeloid Leukemia, conditions: Acute Lymphoblastic Leukemia, conditions: Myelodysplastic Syndromes, conditions: Hodgkin Lymphoma, conditions: Non-hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with a matched sibling donor will be assigned to the PTCy+ATG2.5±1.5 arm, while patients with an matched unrelated donor will be assigned to the PTCy+ATG5.0 arm, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ATG 5.0, interventions name: Cyclophosphamide injection, interventions name: ATG 2.5±1.5, outcomesModule primaryOutcomes measure: Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria, secondaryOutcomes measure: Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria, secondaryOutcomes measure: Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949, secondaryOutcomes measure: Cumulative incidence of chronic GVHD as defined by the NIH criteria, secondaryOutcomes measure: Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria, secondaryOutcomes measure: Cumulative incidence of non-relapse mortality, i.e., death not following disease relapse, secondaryOutcomes measure: Cumulative incidence of relapse, defined as > 5% blasts in bone marrow or 1% blasts in peripheral blood (acute leukemias/myelodysplasia) or biopsy proven relapse or positve PET-CT (lymphoma), secondaryOutcomes measure: Rate of overall survival, secondaryOutcomes measure: Rate of disease-free survival (death or relapse), secondaryOutcomes measure: Cumulative incidence of clinically significant CMV reactivation (which led to antiviral treatment), secondaryOutcomes measure: Cumulative incidence of posttransplant lymphoproliferative disorder (biopsy-proven or positive EBV PCR combined with clinical symptoms), secondaryOutcomes measure: Cumulative incidence CMV disease (biopsy-proven CMV disease OR suggestive CMV+ BAL), secondaryOutcomes measure: Measuremnt of quality of life using the FACT-BMT scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-03-23, uploadDate: 2023-03-23T15:38, filename: Prot_SAP_000.pdf, size: 322979, hasResults: False
|
protocolSection identificationModule nctId: NCT06299449, orgStudyIdInfo id: KFSIRB200-174, briefTitle: Artificial Intelligence Assisted Socket Shield With Computer Guided Implant Placement, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach., conditionsModule conditions: Implant Complication, conditions: Dental Implant Failed, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: free-hand socket shield, interventions name: AI/guided socket shield, outcomesModule primaryOutcomes measure: Stability Quotient of dental implant, primaryOutcomes measure: pink esthetic score, primaryOutcomes measure: Midfacial Mucosal Alterations, primaryOutcomes measure: facial marginal bone level, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: faculty of dentistry, kafrelsheikh University, status: RECRUITING, city: Kafr Ash Shaykh, state: Kafrelsheikh, zip: 214312, country: Egypt, contacts name: walid elamrousy, role: CONTACT, phone: +201005724781, email: Waled_Hammed@den.kfs.edu.eg, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
|
protocolSection identificationModule nctId: NCT06299436, orgStudyIdInfo id: IRB00426760, secondaryIdInfos id: R01HL172830, type: OTHER, domain: NHLBI/NIH, briefTitle: Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure, acronym: HALT-RHF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-03-31, completionDateStruct date: 2029-03-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: Right ventricular (RV) failure is recognized to worsen patient outcomes in the setting of heart failure with reduced ejection fraction (HFrEF)-related pulmonary hypertension (PH), yet the investigators fall short in trying to identify and treat it. The current proposal will (1) determine the best clinical indicators of intrinsic RV myocyte contractile failure in humans with HFrEF-PH, (2) clarify underlying mechanisms, and (3) test novel treatments on RV myocytes. The long-term goal of this proposal will be to better identify and treat RV failure in humans suffering from HFrEF-PH., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, conditions: Pulmonary Hypertension, conditions: Right Heart Failure Due to Left Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Diagnostic accuracy based on Area Under Curve (AUC), secondaryOutcomes measure: Percentage improvement in ex vivo right ventricular tissue sample, secondaryOutcomes measure: Predictive capacity (based on likelihood ratio), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299423, orgStudyIdInfo id: 3677, briefTitle: Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients, acronym: PeRseo, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-22, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring., conditionsModule conditions: Inflammatory Bowel Diseases, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Single-center, interventional, case-series study with a historical cohort of comparison, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Howdy Senior® device, outcomesModule primaryOutcomes measure: Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV), secondaryOutcomes measure: Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI), secondaryOutcomes measure: Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S), secondaryOutcomes measure: Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery, secondaryOutcomes measure: 90-day postoperative complications, secondaryOutcomes measure: Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV), secondaryOutcomes measure: Healthcare costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Humanitas Research Hospital, status: RECRUITING, city: Rozzano, state: MI, zip: 20089, country: Italy, contacts name: Annalisa Maroli, PhD, role: CONTACT, phone: 02 8224 7776, phoneExt: 0039, email: colorapp@humanitas.it, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False
|
protocolSection identificationModule nctId: NCT06299410, orgStudyIdInfo id: ITI-1284-008, briefTitle: PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Intra-Cellular Therapies, Inc., class: INDUSTRY, descriptionModule briefSummary: The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor in healthy subjects. Subjects will enroll in one of the 2 cohorts, will have a baseline PET/CT scan, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: ITI-1284 10 mg, interventions name: ITI-1284 20 mg, outcomesModule primaryOutcomes measure: % Receptor occupancy, secondaryOutcomes measure: Pharmacokinetics: AUC0-t, secondaryOutcomes measure: Pharmacokinetics: Cmax, secondaryOutcomes measure: Pharmacokinetics: Tmax, secondaryOutcomes measure: Percentage of subjects with treatment-emergent adverse events, secondaryOutcomes measure: Change from baseline in ECG QT interval, secondaryOutcomes measure: Change from baseline in aspartate aminotransferase, secondaryOutcomes measure: Change from baseline in alanine aminotransferase, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Site 1, city: New Haven, state: Connecticut, zip: 06520, country: United States, geoPoint lat: 41.30815, lon: -72.92816, hasResults: False
|
protocolSection identificationModule nctId: NCT06299397, orgStudyIdInfo id: Inonu-SBF-4, briefTitle: Breastfeeding Education and Humor-Based Practices on Breastfeeding, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-14, primaryCompletionDateStruct date: 2023-07-14, completionDateStruct date: 2024-02-14, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week. Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session. The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place. In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included. The training program prepared for breastfeeding education will be applied to pregnant women. Then, humor will be applied. A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month. Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'., conditionsModule conditions: Humor as Topic, conditions: Breast Feeding, conditions: Mother-Child Relations, conditions: Breastfeeding, Exclusive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants determined by the researchers before starting the study were divided into experimental and control groups by randomization method. Humor-based breastfeeding education was given to women in the experimental group for 35-45 minutes once a week for 2 weeks on specified days and hours. Breastfeeding education was given in practice. Then, humor was practiced with songs and clown costumes. An interim test was administered one month after this application and a final test was administered three months later., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: After randomization was performed by a researcher independent of the study, it was decided by lottery method which group would be the experiment and which group would be the control group., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: breastfeeding - humor training, interventions name: Control Group, outcomesModule primaryOutcomes measure: Breastfeeding Motivation Scale, secondaryOutcomes measure: Maternal Attachment Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Simge OZTURK, city: Bartin, zip: 74100, country: Turkey, geoPoint lat: 41.63583, lon: 32.3375, hasResults: False
|
protocolSection identificationModule nctId: NCT06299384, orgStudyIdInfo id: R44MH133517, type: NIH, link: https://reporter.nih.gov/quickSearch/R44MH133517, briefTitle: The Use of Voice-Based AI in 988 Crisis Counseling, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Lyssn.io, Inc., class: INDUSTRY, collaborators name: ProtoCall Services, Inc., descriptionModule briefSummary: Effective training requires repeated opportunities for skills practice with performance-based feedback, which is challenging to provide at scale. This research study focuses on developing an AI-based, coding and feedback tool ("LyssnCrisis") for implementation in a nationally utilized crisis call center, training counselors (call-takers) in suicide risk assessment skills, and evaluating LyssnCrisis to improve services and client outcomes. Our goal is to maximize the human capacity of call-takers to help assess their callers for risk of suicidality, and thus, a core aspect of the current research is developing a novel training process that supports human call-taker capacities., conditionsModule conditions: Suicide, conditions: Suicide and Self-harm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: LyssnCrisis, outcomesModule primaryOutcomes measure: Post-Call Survey, primaryOutcomes measure: Call-taker crisis counseling fidelity, primaryOutcomes measure: System Usability Scale (SUS), primaryOutcomes measure: Acceptability of Intervention Measure; AIM, primaryOutcomes measure: Intervention Appropriateness Measure; IAM, primaryOutcomes measure: Feasibility of Intervention Measure; FIM, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299371, orgStudyIdInfo id: MA-NSCLC-II-033, briefTitle: Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-04-15, completionDateStruct date: 2029-04-15, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Liaoning Tumor Hospital & Institute, class: OTHER, descriptionModule briefSummary: This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations, conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, interventions name: paclitaxel for injection (albumin bound), interventions name: Cisplatin or Carboplatin, outcomesModule primaryOutcomes measure: Pathological complete response rate, secondaryOutcomes measure: Major pathologic response rate, secondaryOutcomes measure: R0 rate, secondaryOutcomes measure: Event Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299358, orgStudyIdInfo id: KMU_MPEPE_1, briefTitle: Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-06, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Karamanoğlu Mehmetbey University, class: OTHER, descriptionModule briefSummary: Infantile colic is a developmental disorder that reduces comfort levels in infants with intense crying crises and has negative effects on the infant and family. The study is planned to measure the effect of the combination of maternal heart sound simulation, aromatic foot massage and maternal heart sound simulation and aromatic foot massage on the colic and comfort levels of infants with infantile colic. It is aimed to alleviate colic symptoms, increase comfort levels, regulate daily crying and sleep durations (increase in sleep durations, decrease in crying durations) and support the development of infants in this context by using maternal heart sound simulation, aromatic foot massage and their combined application., conditionsModule conditions: Nurse's Role, conditions: Infantile Colic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Type and Purpose of the Study The study was designed as a randomized experimental study. Sample of the Study G\* Power 3.1.9.7. program was used to calculate the sample size (Faul et al., 2007). As a result of the analysis, the sample size was calculated as 28 people for each of the three groups, and considering the possible data losses, it was decided to take 30 people for each group.In the study, computer-aided randomization (random.org) program was used to determine the groups. Stratified randomization was preferred to ensure group similarity. In stratification, the number of weeks of age, gender and feeding patterns of the babies were used. After stratification, block randomization was used to decide which group the babies would be in.SPSS 22.0 package program will be used for data analysis., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: In the study, interviews will be conducted at different times so that mothers or caregivers do not encounter mothers/caregivers in other groups. In this way, participant blinding will be ensured. Since the study will be conducted with newborns, no study will be conducted on other blinding techniques and biases. In order to prevent bias in the data evaluation process, each baby will be numbered by the researcher during the application and these numbers will be used by the statistical expert in statistical evaluations. The statistical expert will not learn the identity information of the participants and will only perform statistics according to the numbering., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Foot massage, interventions name: Mother heart sound, interventions name: Foot massage and maternal heart sound, outcomesModule primaryOutcomes measure: Changes in colic scale ratings induced by maternal heart sound, primaryOutcomes measure: Changes in comfort scale ratings as a result of maternal heart sound, primaryOutcomes measure: Changes in colic scale assessments induced by foot massage, primaryOutcomes measure: Changes in comfort scale assessments induced by foot massage, eligibilityModule sex: ALL, minimumAge: 2 Weeks, maximumAge: 16 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Karamanoglu Mehmetbey University, city: Karaman, state: Center, zip: 70100, country: Turkey, geoPoint lat: 37.18111, lon: 33.215, hasResults: False
|
protocolSection identificationModule nctId: NCT06299345, orgStudyIdInfo id: 1870394-1, briefTitle: The Effect of Motor Imagery Dosage on Motor Learning in Healthy Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2022-04-20, completionDateStruct date: 2022-04-28, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ahmed Mahmoud Kadry, class: OTHER, collaborators name: Concordia University Wisconsin, descriptionModule briefSummary: The goal of this clinical trial is to compare the effects of different durations of Motor Imagery (MI) practice and physical practice on motor performance enhancement in healthy adults. The main questions it aims to answer are:* Does Motor Imagery (MI) practice improve motor performance?* How do different doses of MI practice (low vs. high) compare to no MI practice in enhancing motor performance?Participants:* Be randomly assigned to one of three groups: no MI practice (control group), low dose MI practice (6 minutes per session), or high dose MI practice (12 minutes per session).* Complete nine sessions over three weeks, practicing a timed mirror tracing task.* Have their performance measured in each session by the time taken to complete the task and the number of errors made.Compared the control group, low dose MI group, and high dose MI group to see if there are significant differences in motor performance enhancement, aiming to determine the effectiveness of MI and the optimal dose for practice., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: The participants were blinded about which group they were allocated (control or intervention), whoMasked: PARTICIPANT, enrollmentInfo count: 27, type: ACTUAL, armsInterventionsModule interventions name: Motor imagery training, interventions name: NO motor imagery training, outcomesModule primaryOutcomes measure: Time, primaryOutcomes measure: Errors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Concordia University Wisconsin, city: Mequon, state: Wisconsin, zip: 53097, country: United States, geoPoint lat: 43.21573, lon: -88.02962, locations facility: Kafrelshaikh University, city: Kafr Ash Shaykh, zip: 12623, country: Egypt, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
|
protocolSection identificationModule nctId: NCT06299332, orgStudyIdInfo id: DO611503A, briefTitle: Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-23, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: InMode MD Ltd., class: INDUSTRY, descriptionModule briefSummary: The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED)., conditionsModule conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, open-label clinical study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Device treatment, outcomesModule primaryOutcomes measure: Change in ED symptoms, following the RF treatment, secondaryOutcomes measure: Change in sexual activity leading to optimal penetration, secondaryOutcomes measure: Evaluate efficacy of the RF treatment for erectile function, secondaryOutcomes measure: Evaluate efficacy of the RF treatment for erectile function, secondaryOutcomes measure: Evaluate efficacy of the RF treatment for erectile function, secondaryOutcomes measure: Evaluate efficacy of the RF treatment for hardness of erection, otherOutcomes measure: Measuring pain level during the procedure, eligibilityModule sex: MALE, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LC Medical 140 W 58th St, Suite A New York, NY 10019, status: RECRUITING, city: New York, state: New York, zip: 10019, country: United States, contacts name: Lanna Cheuck, role: CONTACT, phone: 929-492-2052, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Washington Heights Urology, status: RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts name: Robert Valenzuela, role: CONTACT, phone: 212-781-9696, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
|
protocolSection identificationModule nctId: NCT06299319, orgStudyIdInfo id: 149-2021, briefTitle: Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD, acronym: PAP-OCD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Centre for Addiction and Mental Health, class: OTHER, descriptionModule briefSummary: Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD).The purpose of this study is to evaluate the safety, feasibility, and clinical effects of psilocybin administration in those with OCD. Ten participants with treatment-resistant OCD will receive two doses of 25mg of psilocybin under supportive conditions, two weeks apart. The investigators hypothesize that two sessions of psilocybin 25mg administered under supportive conditions to participants with treatment-resistant OCD will lead to significant reductions in OCD symptoms., conditionsModule conditions: Obsessive-Compulsive Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, outcomesModule primaryOutcomes measure: Feasibility of administering psilocybin (25 mg) in adults with treatment-resistant OCD, primaryOutcomes measure: Incidence of adverse events (Safety and Tolerability), primaryOutcomes measure: Change in the Yale-Brown Obsessive-Compulsive Scale (YBOCS) total score from baseline, secondaryOutcomes measure: Proportion of participants who respond to treatment, secondaryOutcomes measure: Changes in Patient Health Questionnaire (PHQ-9) from Baseline to Week 3, secondaryOutcomes measure: Change in the Clinical Global Impression (CGI) scale from Baseline to Week 3, secondaryOutcomes measure: Change in the World Health Organization Quality of Life Short Version (WHOQOL-BREF) score from Baseline to Week 3, secondaryOutcomes measure: Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) from Baseline to Week 3, secondaryOutcomes measure: Change in Generalized Anxiety Disorder (GAD-7) scores from Baseline to Week 3, secondaryOutcomes measure: Changes in behavioural assessments for well-being (Warwick-Edinburgh Mental Wellbeing Scale; WEMWBS) from Baseline to Week 3, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-10-20, uploadDate: 2024-02-14T17:40, filename: Prot_SAP_000.pdf, size: 879497, hasResults: False
|
protocolSection identificationModule nctId: NCT06299306, orgStudyIdInfo id: D3250R00116, briefTitle: REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma, acronym: REACT-Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: This is a multi-center, single-country, single-arm, prospective, disease study to collect real world data of patients with severe uncontrolled asthma in Germany., conditionsModule conditions: Asthma, Bronchial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1650, type: ESTIMATED, outcomesModule primaryOutcomes measure: Proportion of severe asthma patients with an Asthma Impairment and Risk Questionnaire (AIRQ®) score at baseline, and at 6 and 12 months post enrollment., secondaryOutcomes measure: Changes in the AIRQ® total score, secondaryOutcomes measure: Bi-weekly changes in the AIRQ® total score over time, secondaryOutcomes measure: Changes in the AIRQ® impairment domain score, secondaryOutcomes measure: Changes in the AIRQ® risk domain score, secondaryOutcomes measure: Proportion of patients with prescribed use of oral corticosteroids (OCS), secondaryOutcomes measure: Proportion of patients with self-reported OCS use, secondaryOutcomes measure: Proportion of patients with a change in other asthma therapies, secondaryOutcomes measure: Treatment switches (change in prescribed therapies) over time and time on treatment., secondaryOutcomes measure: Assessment of the patient satisfaction with digital and analog healthcare, secondaryOutcomes measure: Assessment of the patient-reported 1-year prior healthcare utilization, secondaryOutcomes measure: Assessment of the healthcare provider (physician) satisfaction with digital and analog healthcare, secondaryOutcomes measure: Assessment of the provider preferences in digital versus analog healthcare monitoring., secondaryOutcomes measure: Assessment of the patient preferences towards remote monitoring and healthcare delivery., secondaryOutcomes measure: Number and type of recorded comorbidity-related events overall and in patients with self-reported OCS, secondaryOutcomes measure: Changes in laboratory parameter - IgE level, secondaryOutcomes measure: Changes in lung function parameters - Tiffenau-Index, secondaryOutcomes measure: Correlations between environmental factors and patients' asthma exacerbations, secondaryOutcomes measure: Correlation between environmental factors and changes in AIRQ® score, secondaryOutcomes measure: Changes in laboratory parameter - blood eosinophil, secondaryOutcomes measure: Changes in laboratory parameter - blood neutrophil, secondaryOutcomes measure: Changes in laboratory parameter - FeNO, secondaryOutcomes measure: Changes in laboratory parameter - C-reactive protein (CRP) level, secondaryOutcomes measure: Changes in lung function parameters - FEV1 %, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299293, orgStudyIdInfo id: 21C306, briefTitle: Facial Emotion Recognition in Anorexia Nervosa, acronym: FER_AN, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Altered emotional processing is reported in Anorexia Nervosa. However, this capability is generally measured through explicit measures, like self-report questionnaires and facial emotion recognition tasks. Instead, no previous research has investigated implicit emotional processing in this clinical condition. In the implicit facial emotion recognition task grounded on the implicit "redundant target effect", individuals generally respond faster when two identical targets are presented simultaneously rather than when presented alone; moreover, the competitive presence of a distractor (that is another emotion or a neutral expression) affects the correct recognition of the target. The ability to recognize and detect facial expressions is explored about two main emotions, fear and anger, because of their role in the intra- and interindividual psychological processing., conditionsModule conditions: Anorexia Nervosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Facial Emotion Recognition Test, outcomesModule primaryOutcomes measure: Behavioural measure relative to recognition ability, secondaryOutcomes measure: Behavioural measure relative to the detection ability, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe, city: Piancavallo, state: VCO, zip: 28824, country: Italy, hasResults: False
|
protocolSection identificationModule nctId: NCT06299280, orgStudyIdInfo id: Igdir180, briefTitle: The Effect Of Dual-Task Training On Motor And Cognitive Performance In School-Age Children, acronym: Dual-task, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Igdir University, class: OTHER, descriptionModule briefSummary: The aim of the study is to investigate the effect of dual task training on performance in school-age children. Although studies on this subject in the world are limited, a comprehensive study on school-age children is needed.MATERIAL AND METHOD:* Evaluation will begin by applying demographic information and the Physical Activity Survey for Children.* The evaluations to be made will primarily evaluate the child's performance on a single cognitive task in a supported sitting position on a chair, without a motor task.* To evaluate single motor performance, a 2-minute walk test and a 30-second sit-stand test will be applied.* Dual task evaluations will be carried out by adding a cognitive task while applying the 2-minute walk and 30-second sit-to-stand test.* Walking speed will be evaluated with the 10m walk test.* Balance parameter will be evaluated with functional reaching test.* Using the Visual Analog Scale (VAS), participating children will be asked to score the difficulty of cognitive and motor performance as a number between 0 and 10.* Walking speeds will be normalized by measuring lower extremity lengths.* The children will be randomly divided into two groups and the study group will be given dual-task training by creating dual-task situations during the activities carried out in physical education classes.* After 4 weeks, appropriate analyzes will be made with the data obtained as a result of the evaluations performed by the same evaluator.As a result of this study, motor and cognitive performance in single-task conditions in typically developing children will be revealed. Additionally, changes in this performance will be detected in dual-task situations. The gains to be obtained as a result of the training will also reveal the importance of implementing dual task training in school-age children., conditionsModule conditions: Healthy, conditions: Child, Only, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomised controlled, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: double-blind, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: dual task training, interventions name: single task training, outcomesModule primaryOutcomes measure: Physical Activity Questionnaire for Children (PAQ-C), primaryOutcomes measure: Physical Activity Questionnaire for Adolescent (PAQ-A), primaryOutcomes measure: Single cognitive task performance, primaryOutcomes measure: 2-minute walk test, primaryOutcomes measure: 30-second sit-stand test, primaryOutcomes measure: 10m walk test. (single-task conditions), primaryOutcomes measure: 10m walk test. (dual-task conditions), primaryOutcomes measure: functional reaching test., primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: lower extremity lengths assessment, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299267, orgStudyIdInfo id: Igdir181, briefTitle: The Effect of Dual Task on Manual Skill Performance in Children and Adolescents, acronym: Dual-task, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Igdir University, class: OTHER, descriptionModule briefSummary: The aim of the study is to investigate the effect of dual-task conditions on manual dexterity performance in typically developing young people and children between the ages of 7-18.MATERIAL AND METHOD:* Demographic information, dominant extremity will be noted and the evaluation will begin by applying the Physical Activity Questionnaire for Children.* The evaluations will primarily evaluate the child's performance on a single cognitive task* The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or adolescent.* Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.* the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.* Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the -9-Hole Test and writing a paragraph.* In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.As a result of this study, manual dexterity performance and cognitive performance in single-task conditions in typically developing children and adolescents will be revealed. Additionally, changes in this performance will be detected in dual-task situations., conditionsModule conditions: Child, Only, conditions: Adolescent Development, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: dual task conditions, outcomesModule primaryOutcomes measure: single cognitive task, primaryOutcomes measure: Visual Analogue Scale (VAS), primaryOutcomes measure: 9-Hole Peg Test.-Single task, primaryOutcomes measure: 9-Hole Peg Test and writing a given paragraph.-Dual task, primaryOutcomes measure: writing a given paragraph.-Single task, primaryOutcomes measure: writing a given paragraph.-Dual task, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299254, orgStudyIdInfo id: 21C305, briefTitle: Placebo Effect About Fatigue in Obesity, acronym: POF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-02-27, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, collaborators name: University of Turin, Italy, descriptionModule briefSummary: Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels., conditionsModule conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Placebo-Natural History, outcomesModule primaryOutcomes measure: Behavioural outcome of fatigue, secondaryOutcomes measure: The individual level of perceived fatigue, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe, status: RECRUITING, city: Piancavallo, state: VCO, zip: 28824, country: Italy, contacts name: Federica Scarpina, PhD, role: CONTACT, phone: +39032351, phoneExt: 4003, email: f.scarpina@auxologico.it, hasResults: False
|
protocolSection identificationModule nctId: NCT06299241, orgStudyIdInfo id: 01C313, briefTitle: Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity, acronym: PREFISAR, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-21, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The primary objectives of the present study are to estimate the sarcopenic proportion in a cohort of obese older subjects who have been hospitalized. The secondary objective is to individuate several clinical variables that differ between the sarcopenic obese patient and the not sarcopenic obese patient., conditionsModule conditions: Obesity, conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: Fat free mass, primaryOutcomes measure: Evaluation of lower limb muscle strength, primaryOutcomes measure: Senior Fitness Test (SFT), primaryOutcomes measure: Physical performance test (PPT), primaryOutcomes measure: Fat mass, secondaryOutcomes measure: Questionnaire SF-12 (Short Form Health Survey), secondaryOutcomes measure: Oswestry Disability Index questionnaire, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, Site Piancavallo, city: Oggebbio, state: Verbania, zip: 28824, country: Italy, geoPoint lat: 45.99088, lon: 8.64663, hasResults: False
|
protocolSection identificationModule nctId: NCT06299228, orgStudyIdInfo id: HSA, briefTitle: Is Sensorimotor Training Effective Following a Distal Radius Fracture?, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Hand Surgery Associates LLC, class: OTHER, collaborators name: Touro University Nevada, collaborators name: Orthopaedic Specialty Group PC, Fairfield, descriptionModule briefSummary: The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist., conditionsModule conditions: Distal Radius Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Experimental Group, interventions name: Control Group, outcomesModule primaryOutcomes measure: Active Joint Position Sense (AJPS), secondaryOutcomes measure: Patient Rated Wrist and Hand Evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hand Surgery Associates, status: RECRUITING, city: Olyphant, state: Pennsylvania, zip: 18447, country: United States, contacts name: Nancy Naughton, OTD, role: CONTACT, phone: 570-780-8681, email: nancynaughton10@gmail.com, contacts name: Lori Algar, OTD, role: CONTACT, phone: 2034514938, email: Lori.Algar@gmail.com, geoPoint lat: 41.46841, lon: -75.60297, hasResults: False
|
protocolSection identificationModule nctId: NCT06299215, orgStudyIdInfo id: APHP240044, briefTitle: Factors and Prognosis of Obstructive Pyelonephritis Patients, acronym: PYELO-OBS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit.Most of the available data on this condition comes from small, retrospective, single-centre series.To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis.The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients., conditionsModule conditions: Pyelonephritis, conditions: Prognostic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: The primary endpoint will be a combined endpoint of death, and/or stage 3 AKI ( KDIGO classification), and/or non-recovery of renal function., secondaryOutcomes measure: Death, secondaryOutcomes measure: Stage 3 Acute kidney injury (KDIGO classification), secondaryOutcomes measure: failure to recover renal function, secondaryOutcomes measure: the incidence of acute renal failure defined by KDIGO 1, secondaryOutcomes measure: the incidence of acute renal failure defined by KDIGO 2 and 3, secondaryOutcomes measure: the incidence of Renal replacement therapy, secondaryOutcomes measure: the incidence of non-recovery of renal fuction, secondaryOutcomes measure: The number of days alive without Renal replacement therapy, secondaryOutcomes measure: The number of days alive without catecholamines, secondaryOutcomes measure: The number of days alive without antibiotics, secondaryOutcomes measure: The number of days alive without, secondaryOutcomes measure: Death rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Saint Louis, city: Paris, zip: 75010, country: France, contacts name: Maxime Dr COUTROT, MD, role: CONTACT, contacts name: François DEPRET, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
|
protocolSection identificationModule nctId: NCT06299202, orgStudyIdInfo id: 69HCL23_0204, secondaryIdInfos id: ID-RCB, type: OTHER, domain: 2023-A01905-40, briefTitle: Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy, acronym: CERePred, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Some types of localised breast cancer, including stage II and III, HER2 positive (Human Epidermal Growth Factor Receptor) or triple negative cancers are treated with primary or neoadjuvant chemotherapy prior to surgical treatment (mastectomy or conservative treatment).Follow-up with neoadjuvant or primary chemotherapy is usually done by breast Magnetic Resonance Imaging (MRI).Tumour response to treatment is assessed on morphological size criteria.Angiomammography (also called CESM : Contrast Enhanced Spectral Mammography) is an innovative and validated imaging technique consisting of dual energy mammography with injection of iodinated contrast medium; two images are generated, one comparable to a standard mammography and a second image highlighting the structures enhanced by the contrast medium. The characteristic neo angiogenesis of the tumour process thus allows good visualisation of the tumour compared to the underlying mammary gland.A classical morphological analysis is therefore possible thanks to standard mammographic acquisition coupled with a quantitative functional analysis linked to the study of enhancement.During angiomammography, several images are acquired in succession, starting with the cranio caudal view and ending with the profile view. On the same examination, these acquisitions are carried out at different injection times, making it possible to study the type of enhancement of a given area (Progressive/ Plateau/ Wash out).Angiomammography has several advantages over breast MRI in the follow-up of chemotherapy: shorter examination time, shorter appointment time, better tolerated by the patients and without injection of Gadolinium chelates, which have recently been shown to cause definitive brain deposits during repeated injections. Currently, angiomammography is validated in the follow-up of breast cancers treated with neoadjuvant or primary chemotherapy, with an analysis of tumour response currently only morphological, as in breast MRI.Here, the hypothesis is that the study of tumour enhancement by angiomammography may constitute a new predictive element of histological response: indeed, the performance of an initial angiomammography before treatment (baseline) and then a second angiomammography performed early in relation to the start of chemotherapy, could allow early prediction of which patients will have a complete histological response at the time of the closing surgery. This prospective study is to compare the variation in tumour enhancement, assessed on each of the two examinations using dedicated X-ray consoles, to the final histological result after closure surgery: it is hoped that the relative variation in tumour enhancement would be greater in responding patients., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic test, outcomesModule primaryOutcomes measure: The evolution of the relative tumor enhancement (RTEe) (%) between the baseline and early re-evaluation CESM, secondaryOutcomes measure: RTEe according to the 3 categories of RCB score, secondaryOutcomes measure: The type of enhancement (TE) %, eligibilityModule sex: FEMALE, minimumAge: 35 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital de la Croix Rousse, city: Lyon, zip: 69004, country: France, contacts name: Dorothée TACONET, MD, role: CONTACT, phone: 0426109185, phoneExt: +33, email: dorothee.taconet@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False
|
protocolSection identificationModule nctId: NCT06299189, orgStudyIdInfo id: 309264, briefTitle: A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care, acronym: MinADHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Haukeland University Hospital, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:i) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program., conditionsModule conditions: ADHD, conditions: ADHD - Combined Type, conditions: ADHD Predominantly Inattentive Type, conditions: ADHD, Predominantly Hyperactive - Impulsive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: MinADHD, outcomesModule primaryOutcomes measure: The Adult ADHD Self-Rating Scale, primaryOutcomes measure: Adult ADHD Quality of Life Measure, secondaryOutcomes measure: The Patient Health Questionnaire, secondaryOutcomes measure: Generalized Anxiety Disorder-7, secondaryOutcomes measure: Personality Disorder Severity ICD-11, secondaryOutcomes measure: EuroQoL 5D-5L, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bjørgvin DPS, status: RECRUITING, city: Bergen, country: Norway, contacts name: Gunn Elise Sæthre, role: CONTACT, phone: 00000000, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False
|
protocolSection identificationModule nctId: NCT06299176, orgStudyIdInfo id: ESHF-WHRT (2024-10362), briefTitle: Whole Heart Radiotherapy for End-stage Heart Failure, acronym: ESHF-WHRT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: End-stage heart failure (ESHF) causes recurrent hospitalizations, cardiac arrhythmias, and intolerance to standard HF therapies are common as the disease progresses. Management focuses on controlling symptoms, correcting precipitants, avoiding triggers, and improving quality-of-life. The combination of recent preclinical and clinical data suggests that localized cardiac RT is relatively safe and has positive conductive and anti-proliferative effects in the "sick" heart. In this Phase 1 study, the investigators aim to assess the feasibility and safety of 5 Gy whole heart radiotherapy in six (6) ESHF participants with limited options for further medical therapy to control their disease. The investigators hypothesize that 5 Gy whole heart radiotherapy can improve LVEF and decrease blood markers of heart failure and inflammation including B-type natriuretic peptide (BNP), C-reactive protein (CRP), and troponins, while also having a very tolerable side effect profile., conditionsModule conditions: Heart Failure NYHA Class III, conditions: Heart Failure NYHA Class IV, conditions: End-stage Heart Failure, conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 6 participants with end-stage heart failure (NYHA 3 or 4, LVEF \< 30%) with no other standard of care therapy options to receive whole heart radiation therapy., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: no masking, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Whole Heart Radiation Therapy, outcomesModule primaryOutcomes measure: Change in mean left ventricle ejection fraction, primaryOutcomes measure: Acute adverse events definitely or probably related to radiation therapy at 30 days as per CTCAE v 5.0, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Hospital stays, secondaryOutcomes measure: Subacute adverse events, secondaryOutcomes measure: Late adverse events, secondaryOutcomes measure: Medication Changes - dose, secondaryOutcomes measure: Medication Changes - number, secondaryOutcomes measure: Quality of life CHFQOLQ-20, secondaryOutcomes measure: Quality of life - SF-36, secondaryOutcomes measure: Troponin changes, secondaryOutcomes measure: Lactate changes, secondaryOutcomes measure: Renal Function, secondaryOutcomes measure: b-natrurietic peptide, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299163, orgStudyIdInfo id: NB-NM032-2668-101, briefTitle: NM32-2668 in Adult Patients With Selected Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Numab Therapeutics AG, class: INDUSTRY, descriptionModule briefSummary: This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors., conditionsModule conditions: Ovarian Carcinoma, conditions: Fallopian Tube Carcinoma, conditions: Peritoneal Carcinoma, conditions: Endometrial Cancer, conditions: Adenocarcinoma of Lung, conditions: Triple Negative Breast Cancer, conditions: Liposarcoma, conditions: Leiomyosarcoma, conditions: Mesothelioma, Malignant, conditions: Adenocarcinoma - Gastroesophageal Junction (GEJ), conditions: Adenocarcinoma of the Stomach, conditions: Melanoma, Malignant, conditions: Renal Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: NM32-2668, outcomesModule primaryOutcomes measure: Incidence of Dose Limiting Toxicities (DLTs), primaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 / ASTCT (for Cytokine Release Syndrome [CRS]), primaryOutcomes measure: Frequency of dose interruptions/reductions, primaryOutcomes measure: Duration of dose interruptions/reductions, secondaryOutcomes measure: Assessment of the maximum observed serum concentration (Cmax), secondaryOutcomes measure: Assessment of the the minimum observed serum concentration (Cmin), secondaryOutcomes measure: Time from dosing at which maximum observed serum concentration is apparent (Tmax), secondaryOutcomes measure: Assessment of the terminal phase (apparent elimination) rate constant (λz), secondaryOutcomes measure: Assessment of the elimination half-life (t½), secondaryOutcomes measure: Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity]), secondaryOutcomes measure: Assessment of the area under serum concentration-time curve over dosing interval (AUCtau), secondaryOutcomes measure: Assessment of clearance (CL) of NM32-2668 in serum, secondaryOutcomes measure: Assessment of the volume of distribution (Vd) of NM32-2668 in serum, secondaryOutcomes measure: Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum, secondaryOutcomes measure: Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum, secondaryOutcomes measure: Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum, secondaryOutcomes measure: Frequency of specific anti-drug antibodies (ADAs) to NM32-2668, secondaryOutcomes measure: Concentration of specific ADAs to NM32-2668, secondaryOutcomes measure: Incidence of specific ADAs by category to NM32-2668, secondaryOutcomes measure: Best Overall Response (BOR) according to RECIST 1.1, secondaryOutcomes measure: Overall Response Rate (ORR) according to RECIST 1.1, secondaryOutcomes measure: Disease Control Rate (DCR) according to RECIST 1.1, secondaryOutcomes measure: Progression-free Survival (PFS) according to RECIST 1.1, secondaryOutcomes measure: Time to Response (TTR) according to RECIST 1.1, secondaryOutcomes measure: Duration of Response (DOR) according to RECIST 1.1, secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lifespan Cancer Institute at Rhode Island Hospital, status: RECRUITING, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Benedito A. Carneiro, MD, role: CONTACT, contacts name: Benedito A. Carneiro, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.82399, lon: -71.41283, locations facility: Mary Crowley Cancer Research, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Douglas W. Orr, MD, role: CONTACT, contacts name: Douglas W. Orr, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
|
protocolSection identificationModule nctId: NCT06299150, orgStudyIdInfo id: 2023-1, briefTitle: Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: October University for Modern Sciences and Arts, class: OTHER, descriptionModule briefSummary: Dental trauma (DT) of the incisors and their supporting tissues, which is one of the most challenging dental emergency situations, requires immediate assessment and management due to psychological and physical reasons. (8) This is especially important for young permanent teeth because of continuing development in order to minimize undesired complications. The treatment of dental trauma is sometimes neglected. (9,10) although it might lead to pain, difficulty in articulation and mastication as well as having considerable negative effects on patient's self-esteem. (11) However, aesthetics of the anterior teeth are very important aspects of human appearance and could be affected by many factors including the presence of fillings, tooth color, position, alignment, shape and number. (12)Rasmussen ST et al. discovered in 1981 that most children suffer from tooth trauma. (13) According to their research, 25% of all schoolchildren and 33% of adults have undergone trauma, with the majority of cases occurring before the age of 19. (14)As the maxillary incisors are the most commonly injured teeth due to their exposed position, a functional, aesthetic and time-efficient restoration is frequently demanded.(15) According to the current International Association of Dental Traumatology guidelines, crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment.(16) As long as the fragment is intact, reattachment is often preferred in dental practice. This technique facilitates the restoration of the tooth with its original anatomy, color and function in a minimum amount of time. (17,18) Unfortunately, clinical studies regarding the survival of reattached fragments are scarce, and results from laboratory investigations cannot be transferred to clinical settings without limitations. (19) Furthermore, longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies. (20, 21)In addition to the aforementioned restorative alternatives, the use of small partial glassy restorations-partial laminate veneers (PLVs), sectional veneers, or ceramic fragments-has become increasingly popular over the last few years. (22,23) PLVs are thin pieces of glass-matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth. As tooth preparation is not required for this type of restoration, as for conventional laminate veneers, and minimal to no prep is accepted, the maximum amount of enamel surface structure is conserved. (24) Thus, retention relies completely on adhesion, which is primarily achieved by bonding to the conditioned glassy surface. (25,26) Despite their growing popularity, available data in the literature on PLVs are limited to a few in vitro studies (27,28) and case reports (29, 30, 31), without any clinical information available at present.Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors (either conventional composite restoration, fragment reattachment or partial laminate veneers) that require minimal to no preparation depends on the type of restoration will receive and doesn't require local anesthesia., conditionsModule conditions: Composites Resins, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a randomized clinical trial (RCT) where 2 arm parallel groups with a 1:1 allocation ratio were compared. The child participants and the legal guardian of each participating child and the statistician were blinded., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: IPS e.max CAD, outcomesModule primaryOutcomes measure: Clinical success/ survival, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299137, orgStudyIdInfo id: RE2022-0000000349, secondaryIdInfos id: RE2022-0000000349, type: OTHER_GRANT, domain: Society of Academic Emergency Medicine, briefTitle: Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rhode Island Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are:* Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours.* Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours.Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures., conditionsModule conditions: Rib Fractures, conditions: Pain Acute, conditions: Regional Anesthesia, conditions: Opioid Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Research Assistants who collect the data will be blinded to which arm of the study the participants are in., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Serratus Anterior Plane Block, interventions name: Ropivacaine injection, outcomesModule primaryOutcomes measure: PIC Score, secondaryOutcomes measure: Total oral morphine equivalents over the first 24 hours, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rhode Island Hospital, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Leland K Perice, MD, role: CONTACT, phone: 401-429-3441, email: lperice@lifespan.org, contacts name: Leland K Perice, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False
|
protocolSection identificationModule nctId: NCT06299124, orgStudyIdInfo id: RGT-419B-102, briefTitle: A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-17, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Regor Pharmaceuticals Inc., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors., conditionsModule conditions: Breast Cancer, conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: RGT-419B, outcomesModule primaryOutcomes measure: Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level, secondaryOutcomes measure: Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Day 1 and steady-state pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax, secondaryOutcomes measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-TimeCurve to Infinity (AUC0-inf), secondaryOutcomes measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t1/2), secondaryOutcomes measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum ObservedPlasma Concentration (Tmax), secondaryOutcomes measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multipledoses, secondaryOutcomes measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion, secondaryOutcomes measure: Tumor Response assessed by Investigator according to RECIST v1.1, secondaryOutcomes measure: QTc Interval - Changes in corrected QT interval, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Yan Zhou, role: CONTACT, phone: 86-021-31168233, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06299111, orgStudyIdInfo id: R9933-DVT-2308, secondaryIdInfos id: 2023-508603-21-00, type: OTHER, domain: EU CT Number, briefTitle: A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC), acronym: ROXI-CATH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2026-06-08, completionDateStruct date: 2026-06-08, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in your vein, also called a 'PICC line'.The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.The study is looking at several other research questions, including:* What side effects may happen from taking the study drug* How much study drug is in your blood at different times* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects), conditionsModule conditions: Venous Thromboembolism, 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: 195, type: ESTIMATED, armsInterventionsModule interventions name: REGN9933, interventions name: REGN7508, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of confirmed VTE per central reading center (CRC) review, primaryOutcomes measure: Incidence of treatment-emergent adverse event (TEAEs), primaryOutcomes measure: Severity of TEAEs, secondaryOutcomes measure: Incidence of confirmed PICC associated venous thrombosis per CRC review, secondaryOutcomes measure: Incidence of major bleeding, secondaryOutcomes measure: Incidence of clinically relevant non-major (CRNM) bleeding, secondaryOutcomes measure: Concentrations of REGN9933 in serum, secondaryOutcomes measure: Concentrations of REGN7508 in serum, secondaryOutcomes measure: Change in activated partial thromboplastin time (aPTT), secondaryOutcomes measure: Change in prothrombin time (PT), secondaryOutcomes measure: Incidence of anti-drug antibody (ADA) to REGN9933 over time, secondaryOutcomes measure: Titer of ADA to REGN9933 over time, secondaryOutcomes measure: Incidence of ADA to REGN7508 over time, secondaryOutcomes measure: Titer of ADA to REGN7508 over time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06299098, orgStudyIdInfo id: R1033-OB-2288, briefTitle: A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss, acronym: COURAGE, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-06-24, completionDateStruct date: 2026-06-24, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). Part A of the study, the sponsor is only researching trevogrumab. Part B of the study the sponsor is researching trevogrumab, garetosmab, and Wegovy either alone or in different combinations with each other. Part A of the study is focused on healthy participants. Part B of the study is focused on participants with obesity. The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B of the study is to see how safe and effective the study drug is when combined with Wegovy.Parts A and B of the study are looking at several other research questions, including:* What side effects may happen from taking the study drug* How much study drug is in the blood at different times* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects), conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 624, type: ESTIMATED, armsInterventionsModule interventions name: Trevogrumab-Part A, interventions name: Trevogrumab-Part B, interventions name: Garetosmab, interventions name: Semaglutide, interventions name: Matching Placebo-Part A, interventions name: Matching Placebo-Trevogrumab, interventions name: Matching Placebo-Garetosmab, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Severity of TEAEs, primaryOutcomes measure: Percent body weight change, primaryOutcomes measure: Percent change in total fat mass, secondaryOutcomes measure: Concentrations of trevogrumab in serum over time, secondaryOutcomes measure: Percent body weight change, secondaryOutcomes measure: Percent change in total fat mass, secondaryOutcomes measure: Percent change in total lean mass, secondaryOutcomes measure: Change in waist circumference (cm), secondaryOutcomes measure: Percent change in body weight, secondaryOutcomes measure: Percent change in total lean mass, secondaryOutcomes measure: Percent change in regional measurements of body composition, secondaryOutcomes measure: Percent change in gynoid fat mass, secondaryOutcomes measure: Change in total lean mass:total fat mass ratio, secondaryOutcomes measure: Proportion of weight loss attributable to fat mass loss, secondaryOutcomes measure: Percent change in android (central) fat mass, secondaryOutcomes measure: Percent change in thigh muscle volume (TMV), secondaryOutcomes measure: Body weight reduction of ≥5%, secondaryOutcomes measure: Body weight reduction of ≥10%, secondaryOutcomes measure: Body weight reduction of ≥15%, secondaryOutcomes measure: Body weight reduction of ≥20%, secondaryOutcomes measure: Body weight reduction of ≥25%, secondaryOutcomes measure: Percent change in fasting serum triglycerides, secondaryOutcomes measure: Percent change in total cholesterol, secondaryOutcomes measure: Percent change in Apolipoprotein B (Apo B), secondaryOutcomes measure: Percent change in low-density lipoprotein cholesterol (LDL-C), secondaryOutcomes measure: Change in physical function domain (5 items) score of Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQoLLite- CT), secondaryOutcomes measure: Change in physical functioning domain score of SF-36, secondaryOutcomes measure: Concentrations of garetosmab in serum over time, secondaryOutcomes measure: Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time, secondaryOutcomes measure: Titer of ADAs to trevogrumab after repeated doses over time, secondaryOutcomes measure: Incidence of ADAs to garetosmab after repeated doses over time, secondaryOutcomes measure: Titer of ADAs to garetosmab after repeated doses over time, secondaryOutcomes measure: Incidence of TEAEs, secondaryOutcomes measure: Severity of TEAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ProSciento, city: Chula Vista, state: California, zip: 91911, country: United States, geoPoint lat: 32.64005, lon: -117.0842, locations facility: Tandem Clinical Research, city: Marrero, state: Louisiana, zip: 70072, country: United States, geoPoint lat: 29.89937, lon: -90.10035, locations facility: Accellacare of Wilmington, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, hasResults: False
|
protocolSection identificationModule nctId: NCT06299085, orgStudyIdInfo id: OSTEO-BS (L4191), briefTitle: Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality., conditionsModule conditions: Bariatric Surgery Candidate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The minimum sample size was determined by considering the circulating levels of gastro-entero hormones (PYY, ghrelin, GLP-1, GIP), adipokines (leptin and adiponectin) and hormones associated with the anabolism of muscle and bone tissue (insulin). as primary endpoints; the highest calculated sample size obtained for ghrelin levels was used for the purposes of this study.The calculation was performed using G\*Power software (v3.1.9.7) assuming a type I error (α error) of 0.05, a Power (1-β error) of 0.8, an effect size of 0.44.The resulting minimum sample size is 42 patients. Taking into account the presence of any drop-outs, 20% more patients will be considered, for a total of 50 patients to be enrolled., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery., outcomesModule primaryOutcomes measure: Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery., secondaryOutcomes measure: Evaluation of the bone health status of patients pre- and post-bariatric surgery using different methods., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06299072, orgStudyIdInfo id: PEP-2303, briefTitle: A Cross-sectional Online Survey Among Saudi Arabian Population in the Age Group 18-40 Years to Assess Whole Grain (WG) Awareness, Consumption Levels, and Dietary Habits Around Breakfast, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-05, primaryCompletionDateStruct date: 2023-09-19, completionDateStruct date: 2023-09-19, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: PepsiCo Global R&D, class: INDUSTRY, descriptionModule briefSummary: In this online survey conducted suing the YouGov consumer insights panel, the primary aims of this study are to provide for the first time an estimate of consumer awareness regarding wholegrains; their definitions and knowledge of potential benefits in the Saudi Arabia adult population and the he estimated consumption amongst Saudi consumers.Secondary Objectives are to assess the breakfast habit, oat consumption \& health concerns amongst Saudi consumers; identify socio-demographic and consumer characteristics associated with breakfast consumption, the types of foods consumed at breakfast, and fill gaps in knowledge regarding breakfast eating habits, commonly consumed breakfast foods., conditionsModule conditions: Diet, Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 814, type: ACTUAL, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: Consumer awareness regarding wholegrains, primaryOutcomes measure: Consumer definitions of wholegrains, primaryOutcomes measure: Consumer knowledge of potential benefits of wholegrains, primaryOutcomes measure: Wholegrain consumption, secondaryOutcomes measure: Breakfast habits, secondaryOutcomes measure: Oat consumption, secondaryOutcomes measure: Health concerns, secondaryOutcomes measure: Socio-demographics associated with breakfast consumption, secondaryOutcomes measure: Consumer characteristics associated with breakfast consumption, secondaryOutcomes measure: Types of foods consumed at breakfast, secondaryOutcomes measure: Fill gaps in knowledge regarding breakfast eating habits, secondaryOutcomes measure: Commonly consumed breakfast foods, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Remote, no facility visits, city: Riyadh, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, hasResults: False
|
protocolSection identificationModule nctId: NCT06299059, orgStudyIdInfo id: Compliance, briefTitle: Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: Rehabilitation Treatment Compliance Questionnaire, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Swallowing Quality of Life questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.