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<|newrecord|> nctId: NCT06276855 id: CUtülay briefTitle: Sleep Hygiene Education in Individuals With Fibromyalgia; Sleep Quality, Pain and Depression overallStatus: COMPLETED date: 2021-06-23 date: 2021-07-01 date: 2021-12-31 date: 2024-02-26 date: 2024-02-26 name: Cumhuriyet University class: OTHER briefSummary: Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.
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Patients and methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental group Control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 70 type: ACTUAL name: Sleep hygiene education measure: Demographic Information Form (DIF). measure: Pittsburgh Sleep Quality Index (PSQI). measure: Visual Analog Scale (VAS). measure: Beck Depression Inventory (BDI). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sivas Cumhuriyet University city: Sivas state: Center zip: 58140 country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False
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<|newrecord|> nctId: NCT06276842 id: 12345678 briefTitle: Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration overallStatus: COMPLETED date: 2020-04-01 date: 2020-09-30 date: 2020-09-30 date: 2024-02-26 date: 2024-02-26 name: CIMS Dental College class: OTHER briefSummary: OBJECTIVE To compare the effectiveness of using both a combined technique of an Inferior Alveolar Nerve block and buccal infiltration with that achieved by utilizing an Inferior Alveolar Nerve block alone for endodontic treatment of mandibular molars with irreversible pulpitis.
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STUDY DESIGN Randomized clinical trial PLACE AND DURATION OF STUDY Operative Dentistry Department of Armed Forces Institute of Dentistry Rawalpindi, from 1st April 2020 to 31st September 2020.
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MATERIAL AND METHODS A total of 120 patients were enrolled in the study. Sixty patients of group A received conventional Inferior Alveolar Nerve block and sixty patients of Group B received buccal infiltration along with conventional Inferior Alveolar Nerve block. conditions: Pulpitis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 120 type: ACTUAL name: Inferior Alveolar Nerve Block name: Buccal Infiltration name: Inferior Alveolar Nerve Block and Buccal Infiltration measure: Comparison of Anesthesia Effectiveness Between Combined Technique (Inferior Alveolar Nerve Block and Buccal Infiltration) and Inferior Alveolar Nerve Block Alone sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Dr Ayesha Ahmed city: Multan country: Pakistan lat: 30.19679 lon: 71.47824 hasResults: False
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<|newrecord|> nctId: NCT06276829 id: 02.05.2023/291 briefTitle: Behçet and LDH/Albumin overallStatus: COMPLETED date: 2020-02-01 date: 2023-04-01 date: 2023-04-01 date: 2024-02-26 date: 2024-02-26 name: Ataturk University class: OTHER briefSummary: ABSTRACT Objective: To investigate whether the lactate dehydrogenase to albumin ratio can be used as a parameter to determine disease severity in Behçet's disease, an inflammatory disease, by comparing it to healthy controls.
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Patients and Methods: In this retrospective cohort study, patients with Behçet's disease aged 18-69 years who presented to the outpatient clinic between February 2020 and April 2023 and healthy individuals of similar age and gender were enrolled. LDH, albumin levels, and LDH/albumin ratio of both groups were compared. Clinical findings and characteristics of Behçet's patients and disease severity were recorded and analyzed in relation to LDH/albumin ratio. conditions: Behcet's Disease conditions: Albumin conditions: Lactate Dehydrogenase conditions: Disease Severity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1 type: ACTUAL name: LDH/albumin ratio measure: LDH/albumin ratio sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erdal Pala city: Erzurum zip: 25240 country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False
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<|newrecord|> nctId: NCT06276816 id: 2022-LC14 briefTitle: Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia overallStatus: RECRUITING date: 2023-09-13 date: 2024-09-30 date: 2024-12-30 date: 2024-02-26 date: 2024-02-26 name: China National Center for Cardiovascular Diseases class: OTHER_GOV briefSummary: This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia. conditions: Sinus Bradycardia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 88 type: ESTIMATED measure: Number of patients with postoperative recurrence of bradycardia symptoms measure: The result of the atropine test measure: Changes in quality of life measured by Medical Outcomes Study 36- Item Short Form Health Survey (SF-36) measure: Changes in quality of life measured by EuroQol Five Dimensions Questionnaire Visual Analogue Scale (EQ VAS) measure: Changes in minmum heart rate measure: Changes in mean heart rate measure: Changes in deceleration capacity sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: 1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Beijing country: China name: Yao Yan, MD PhD role: CONTACT phone: +86-1390-1121-319 email: ianyao@263.net.cn lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06276803 id: Adenocyte 104 briefTitle: The LINFU® U.S. Registry for the in the General Population Without Risk Factors overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2034-04-15 date: 2034-06-15 date: 2024-02-26 date: 2024-03-06 name: Adenocyte, LLC class: INDUSTRY briefSummary: Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions.. In this study, LINFU® will be evaluated in the general population with no risk factors and who exhibit no signs or symptoms of disease, This study will help determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3). conditions: Pancreatic Cancer conditions: Pancreatic Ductal Adenocarcinoma conditions: Pancreatic Dysplasia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: LINFU® measure: The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® measure: The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be determined long term measure: Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® that require medical or surgical intervention measure: Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified with LINFU® sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276790 id: ChengdeCentralHospital briefTitle: Objective Analysis of Caesarean Scar Pregnancy overallStatus: COMPLETED date: 2019-01-18 date: 2022-12-23 date: 2022-12-25 date: 2024-02-26 date: 2024-02-26 name: Chengde Central Hospital class: OTHER_GOV briefSummary: This study uses a systematic scoring method combined with clinical and ultrasound data to comprehensively evaluate patient conditions and explore the guiding value of the ultrasound quantitative scoring system for selecting the surgical approach for caesarean scar pregnancy. conditions: Caesarean Scar Pregnancy conditions: Ultrasound Scoring System studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 117 type: ACTUAL name: ultrasound-guided/hysteroscopic curettage name: Procedure/Surgery: laparoscopic removal of the pregnancy lesion measure: intraoperative blood loss measure: length of hospital stay measure: serum β-HCG levels sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chengde Central Hospital city: Chengde zip: 067000 country: China lat: 40.9519 lon: 117.95883 hasResults: False
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<|newrecord|> nctId: NCT06276777 id: SPRG Dentin Hypersensitivity briefTitle: The Effect of Using Desensitizers Containing S-PRG In Treatment Of Dentin Hypersensitivity Over 6 Months: A Randomized Clinical Trial acronym: S-PRG overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2024-12-01 date: 2024-02-26 date: 2024-02-26 name: Eman Omar Elfarouk class: OTHER briefSummary: The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups. conditions: Dentin Hypersensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants and both assessors will be blind to the type of material used. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Tooth varnish (PRG Barrier Coat from Shofu) name: Tooth varnish (Clinpro white varnish 3M) measure: Dentin hypersensitivity reduction sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry Cairo University city: Cairo zip: 11331 country: Egypt name: Eman Omar, bachelor role: CONTACT phone: 01156677558 email: eman.omar@dentistry.cu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06276764 id: Adenocyte 103 briefTitle: The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas) overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2034-03-30 date: 2034-05-01 date: 2024-02-26 date: 2024-02-26 name: Adenocyte, LLC class: INDUSTRY briefSummary: In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes. conditions: IPMN, Pancreatic conditions: Pancreas Cancer conditions: Pancreatic Cyst studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: LINFU® name: Standard imaging tests measure: The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods measure: The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period measure: Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention. measure: Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified only with LINFU® sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276751 id: E1-23-3870 ptx endtidalco2 briefTitle: The Diagnostic Value of End-Tidal CO2 in Patients Diagnosed With Pneumothorax overallStatus: COMPLETED date: 2023-08-15 date: 2024-02-06 date: 2024-02-13 date: 2024-02-26 date: 2024-02-26 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Pneumothorax (PTX) is defined as the accumulation of air in the pleural space. PTX can cause a disruption in the perfusion of lung tissue in the affected area and increase intrathoracic pressure, potentially leading to obstruction of venous return and, consequently, posing a life-threatening condition. Therefore, PTX requiring urgent intervention is a significant concern in emergency departments.
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End-tidal carbon dioxide (ETCO2) provides insight into carbon dioxide levels resulting from lung perfusion and serves as a respiratory parameter informing the prognosis of various critical illnesses. One of the most important factors determining lung perfusion is the effective lung area. Among the crucial issues for emergency departments are PTX cases, which typically regress following urgent intervention, leading to the establishment of an effective lung area. Hypotheses have been proposed in the literature suggesting that ETCO2 may be affected in PTX cases due to the relationship between effective lung area and ETCO2.
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In this study, investigetors aimed to investigate changes in ETCO2 levels following tube thoracostomy applied to PTX cases. conditions: Pneumothorax studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 43 type: ACTUAL name: End-tidal CO2 monitor measure: ETCO2-0 measure: ΔETCO2-1 measure: ΔETCO2-2 measure: ETCO2-1 measure: ETCO2-2 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bilkent Şehir Hastanesi city: Ankara state: Çankaya zip: 06170 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06276738 id: Adenocyte 102 briefTitle: The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2034-03-01 date: 2034-05-01 date: 2024-02-26 date: 2024-02-29 name: Adenocyte, LLC class: INDUSTRY briefSummary: Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC. conditions: Pancreatic Cancer conditions: Jaundice conditions: Abdominal Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas) measure: The number of pancreatic ductal adenocarcinomas identified only with LINFU® will be compared to standard screening methods measure: The change in size of pancreatic ductal adenocarcinomas identified only with LINFU® will be determined measure: Determine the number of patients with pancreatic ductal adenocarcinoma identified only with LINFU® that require medical or surgical intervention measure: Yearly survival rate of patients with pancreatic ductal adenocarcinomas identified only with LINFU® sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276725 id: 23-606 briefTitle: Writing Wrongs: Expressive Writing for Microaggressions acronym: WW overallStatus: RECRUITING date: 2024-03-18 date: 2024-12-01 date: 2025-04-01 date: 2024-02-26 date: 2024-03-25 name: Auburn University class: OTHER name: Medical University of South Carolina briefSummary: Racial and ethnic based stressors, such as microaggressions, are pervasive, distressing, and result in lasting negative repercussions for minoritized students at predominantly white institutions (PWIs). These racial and ethnic based stressors are experienced in addition to the universally experienced stressors of higher education. Negative repercussions of microaggressions include increased drop out or transfer rates, distress, fatigue resulting in decreased academic performance, and depression and posttraumatic stress symptoms. Expressive writing (EW) may be a scalable intervention for addressing the negative repercussions resulting from microaggressions experienced by minoritized students at PWIs. Previous research suggests that EW for stressful life events results in benefits such as reduced depression and posttraumatic stress symptoms, improved coping strategies, and reduced activity restriction. Despite such benefits, EW was not designed to specifically address microaggressions in a minoritized student population. Informed by the ADAPT-ITT model, our research group conducted a pilot study with similar procedures. This pilot study demonstrated the acceptability of an adapted version of the EW intervention titled Writing Wrongs (WW), as well as recommended future modifications for WW. In the current study we aim to conduct a randomized-controlled trial to establish the efficacy of WW in alleviating clinical symptoms. We hypothesize that WW will improve symptoms of racial and discriminatory trauma and symptoms of depression, anxiety, and posttraumatic stress over time and compared to an assessment-only condition. We will conduct exploratory analyses to examine short-term changes in affect within and across sessions and across conditions. We will recruit minoritized students enrolled at a PWI. Participants will complete a pre-intervention assessment prior to being randomized into the two conditions. Participants in the intervention condition will engage in three sessions of WW and complete measures of clinical symptoms across multiple time points (i.e., pre-intervention, immediately after the final writing session, one week after the final session). Participants in the assessment-only condition will be administered the same measures at the same timepoints and given access to the WW after completing the study. If found to be efficacious, WW has the potential to be widely disseminated to minoritized college students who experience microaggressions. conditions: Posttraumatic Stress Disorder conditions: Discriminatory Stress conditions: Microaggression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After consenting to participate in the study, participants will be randomized in a 1:1 manner into either the Writing Wrongs Intervention or the Assessment Control condition. All participants will complete a total of five online study sessions including a pre-intervention assessment, three intervention or assessment only sessions, and a one-week follow-up assessment . primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Writing Wrongs measure: Racial and Discriminatory Trauma measure: Daily Racial and Discrimination Trauma measure: Depression measure: Anxiety measure: Stress measure: Posttraumatic Stress measure: Daily Depression measure: Daily Anxiety measure: Daily Posttraumatic Stress measure: Negative Affect measure: Positive Affect measure: Acceptability of Writing Wrongs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Auburn University status: RECRUITING city: Auburn state: Alabama zip: 368849 country: United States name: Cassidy M Brydon, MS role: CONTACT phone: 954-591-5261 email: cmb0106@auburn.edu name: Tracy K Witte, PhD role: CONTACT phone: 334-844-6465 email: tracy.witte@auburn.edu lat: 32.60986 lon: -85.48078 hasResults: False
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<|newrecord|> nctId: NCT06276712 id: UNISS_PHD_Osstem_5 briefTitle: RCT Comparing KS Versus TS for Ovedenture overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-30 date: 2028-01-30 date: 2024-02-26 date: 2024-02-26 name: Università degli Studi di Sassari class: OTHER name: Dr. Dario Melodia name: Dr. Milena Pisano name: Dr. Aurea Lumbau name: Prof. Silvio Mario Meloni name: Prof. Edoardo Baldoni briefSummary: To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants conditions: Dental Implant conditions: Dental Implant-Abutment Design conditions: Edentulous Jaw studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A multicenters, randomized controlled trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A blinded (when possible) outcome assessor will evaluate all the outcomes and will take the radiogram for centralized analysis. whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Implant placement with 3.5 mm diameter KS implants. name: Implant placement with 3.5 mm diameter TS implants. measure: Number of implant failure measure: Number of prosthesis failure measure: Number of complications measure: Rate of implant stability measure: Peri-implant marginal bone level changes measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276699 id: FAHS briefTitle: Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-06 date: 2024-02-26 date: 2024-04-16 name: University of Peradeniya class: OTHER briefSummary: This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly. conditions: Cervical Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 46 type: ESTIMATED name: 1.Isometric exercise 2.combined conservative treatment measure: Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline. measure: Difference in cervical ROM measured by Goniometry between combination of treatments and isometric exercises at 6-weeks post-baseline. measure: Difference in functional disability measured by Neck Disability Index between combination of treatments and isometric exercises at 6-weeks post-baseline sex: ALL minimumAge: 35 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06276686 id: RS211 - 332296 briefTitle: Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-02 date: 2024-02-26 date: 2024-04-24 name: University of Hull class: OTHER name: Hull University Teaching Hospitals NHS Trust briefSummary: This is a single arm feasibility study of exercise for improving long- course neoadjuvant chemoradiotherapy (NACRT) efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patients will be provided with an 11-week course of structured aerobic exercises and resistance training in the periods before, during and after their chemoradiotherapy treatment. The patients will be followed up for 6 months post long course neoadjuvant chemoradiotherapy (NACRT), with a total of 3 assessment periods. conditions: Locally Advanced Rectal Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Supervised Vigorous intensity aerobic interval exercise measure: Recruitment rate measure: Attendance rate measure: withdrawal rate measure: Serum Carcinoembryonic antigen levels measure: Quality of life measure: Quality of life measure: Physical activity levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276673 id: 301 briefTitle: The Influences of Single Chamber vs. Multi-chamber Blood Flow Restriction Cuffs overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-13 date: 2024-11-10 date: 2024-12-10 date: 2024-02-26 date: 2024-02-26 name: Salisbury University class: OTHER briefSummary: The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, and participant perception. conditions: Blood Vessel Disease conditions: Muscle Edema studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will undergo three treatment sessions (control (no BFR), SC BFR, and MC BFR) in a randomized order separated by one week. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Unable to blind due to differences in cuff size and appearance. count: 35 type: ESTIMATED name: Delfi measure: Arterial Stiffness measure: Muscle Morphology sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Salisbury University city: Salisbury state: Maryland zip: 21801 country: United States lat: 38.36067 lon: -75.59937 hasResults: False
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<|newrecord|> nctId: NCT06276660 id: STUDY23070079 briefTitle: Post-Concussion Differences Between Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT) Test overallStatus: RECRUITING date: 2024-03-05 date: 2024-09 date: 2024-12-31 date: 2024-02-26 date: 2024-03-06 name: University of Pittsburgh class: OTHER briefSummary: This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit. conditions: Mild Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: BCTT name: Dynamic ExIT measure: Physiological response to dynamic or aerobic test (HEART RATE) measure: Post Concussion Symptom Scale measure: Patient Health Questionnaire (PHQ-9) measure: Generalized Anxiety Disorder (GAD-7) measure: Vestibular Ocular Motor Screening (VOMS) measure: Clinical Profiles Screening (CP-Screen) measure: Blood Pressure sex: ALL minimumAge: 14 Years maximumAge: 17 Years stdAges: CHILD facility: UPMC/Univ of Pgh Sports Medicine Concussion Research Program status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15203 country: United States name: Cynthia Holland, MPH role: CONTACT phone: 412-904-1298 email: clh197@pitt.edu lat: 40.44062 lon: -79.99589 hasResults: False
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<|newrecord|> nctId: NCT06276647 id: 850584 id: R01MD016029 type: NIH link: https://reporter.nih.gov/quickSearch/R01MD016029 briefTitle: Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk acronym: HOME overallStatus: RECRUITING date: 2024-02-20 date: 2025-02-15 date: 2025-05-31 date: 2024-02-26 date: 2024-03-01 name: University of Pennsylvania class: OTHER name: National Institutes of Health (NIH) name: Columbia University name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The goal of this educational clinical trial is to identify Black women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for high-risk women. The main question\[s\] it aims to answer are:
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* How can the investigators help postpartum Black people who have poor outcomes by decreasing the number of ED visits/readmissions for postpartum people within the first 30 days postpartum?
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* How can the investigators increase the ability of participants to "obtain needed services" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ED visits?
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Participants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum. conditions: Maternal Behavior conditions: Postpartum Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 214 type: ESTIMATED name: HOME measure: Emergency Department (ED) Visits and Readmissions measure: Ability to Obtain Needed Services measure: Depressive Symptoms measure: Depressive Symptoms sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Hospital of the University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Elizabeth Howell, MD MPP role: CONTACT email: elizabeth.howell1@pennmedicine.upenn.edu name: Micki Burdick, PhD role: CONTACT email: micki.burdick@pennmedicine.upenn.edu name: Elizabeth Howell, MD MPP role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06276634 id: STU00219535 id: R21HD108587 type: NIH link: https://reporter.nih.gov/quickSearch/R21HD108587 briefTitle: Intermittent Hypoxia in Persons With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2027-01 date: 2024-02-26 date: 2024-04-09 name: Shirley Ryan AbilityLab class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: Northwestern University briefSummary: This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS. conditions: Multiple Sclerosis conditions: Multiple Sclerosis-Relapsing-Remitting conditions: Multiple Sclerosis, Secondary Progressive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, double-blind, placebo-controlled, cross-over, repeated measures study design primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 21 type: ESTIMATED name: Acute Intermittent Hypoxia name: Sham-Acute Intermittent Hypoxia measure: Ankle Plantarflexion Strength measure: Task fMRI measure: Timed 25 Feet Walk test measure: Six-Minute Walk test measure: Stride length measure: 12-Item Multiple Sclerosis walk scale (MSWS-12) measure: Resting-State fMRI sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shirley Ryan AbilityLab city: Chicago state: Illinois zip: 60611 country: United States name: Alexander Barry, MS, CCRC role: CONTACT phone: 312-238-1435 email: abarry@sralab.org name: Milap Sandhu, PT, PhD role: PRINCIPAL_INVESTIGATOR name: Molly Bright, D.Phil. role: SUB_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06276621 id: STUDY00003564 briefTitle: Family Bridge Program overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-05 date: 2024-02-26 date: 2024-02-26 name: Seattle Children's Hospital class: OTHER name: Children's Hospital of Philadelphia briefSummary: Pediatric healthcare inequities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and demands imposed by the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address inequities related to communication and system navigation in the inpatient setting; given the established links between these inequities and disparate clinical outcomes, such interventions are needed. To address this gap, the study team collaborated with parents/caregivers, staff, and providers to develop and pilot-test a novel program to improve navigation ability, communication, and hospital-to-home transition for a diverse population of children and their families, The Family Bridge Program (FBP).
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The FBP combines principles of effective patient navigation and communication coaching interventions into a brief and targeted inpatient program. It is designed for a broad population of low-income children of color, is not disease-specific, is not limited to English proficient families, and is less time-intensive than traditional navigation, to enable provision of support to more families. The FBP, delivered in-person by a trained lay navigator, includes: (1) hospital orientation; (2) unmet social needs screening (e.g., food insecurity); (3) parent communication and cultural preference assessment, relayed to the medical team; (4) communication coaching for parents; (5) emotional support; (6) assistance with care coordination and logistics; and (7) a phone call 2 days post-discharge. Program elements are flexibly delivered based on parent need and interest.
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In pilot testing, the program was feasible to deliver, acceptable to parents and providers, and significantly improved parent-reported system navigation ability. The current R01 proposes a two-site randomized controlled trial (RCT) of the effectiveness of FBP among 728 families of low-income children of color. Enrolled families will be randomized 1:1 (stratified by site and language) to FBP or usual care plus written resources. The specific aims of this clinical trial are to (1) Test the effect of the FBP on parent-reported system navigation ability, quality of hospital-to-home transition, diagnosis comprehension, observed communication quality, perceived stress and revisits for families of low-income children of color; (2) Examine whether changes in parent-reported barriers and needs mediate program effects; and (3) Identify subgroups of parents among whom the FBP is more effective. The proposed RCT will use a rigorous design to test a feasible, innovative program to address a critical national problem. If effective, the Family Bridge Program would provide a scalable model for improving health care experiences and outcomes for families of low-income children of color, including those who prefer a language other than English for their medical care. conditions: Healthcare Inequities conditions: General Pediatric Medical Conditions conditions: Healthcare System Navigation conditions: Patient-provider Communication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 728 type: ESTIMATED name: Family Bridge Program name: Care as usual - resources only measure: System Navigation Ability measure: Pediatric Transition Experience Measure (P-TEM) measure: Diagnosis Comprehension measure: Perceived Stress Scale measure: Observed Communication: utterances in which team offers information measure: Observed Communication: utterances in which team offers supportive talk measure: Observed Communication: utterances in which parent asks questions measure: Observed Communication: utterances in which parent responds assertively measure: Observed Communication: parent talk-time measure: Observed Communication: global partnership rating measure: 30-day readmissions sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276608 id: PED_Fe_def briefTitle: Iron Deficiency in Pediatric Heart Surgery overallStatus: RECRUITING date: 2024-02-23 date: 2024-04-20 date: 2024-06-30 date: 2024-02-26 date: 2024-02-28 name: Queen Fabiola Children's University Hospital class: OTHER briefSummary: The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates. In this retrospective study, the iron status of all patients undergoing pediatric cardiac surgery at our institution between January 2019 and december 2023 will be analyzed. Together with iron status, transfusion requirements as well as complications will be recorded. Iron status will be reported with descriptive statistics, patients with or without iron deficiency will be compared using non-parametric tests. conditions: Iron Deficiencies conditions: Iron Deficiency Anemia conditions: Cardiac Surgical Procedures conditions: Congenital Heart Disease in Children studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: Iron status measure: Prevalence of preoperative iron deficiency (%) measure: Complications sex: ALL maximumAge: 16 Years stdAges: CHILD facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Denis Schmartz, MD role: CONTACT phone: +3225553919 email: denis.schmartz@hubruxelles.be lat: 50.85045 lon: 4.34878 hasResults: False
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<|newrecord|> nctId: NCT06276595 id: IRB00009466 briefTitle: Telling Our Daughters Our Story acronym: TODOS overallStatus: ACTIVE_NOT_RECRUITING date: 2019-03-30 date: 2022-03-22 date: 2024-07-30 date: 2024-02-26 date: 2024-02-26 name: Johns Hopkins Bloomberg School of Public Health class: OTHER name: White Mountain Apache Tribe name: Native American Research Centers for Health briefSummary: The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female children and the children's female caregivers. This project will evaluate the impact of "Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (henceforth referred to as TODOS) on associated risk and protective factors for early substance use and sexual debut through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the TODOS program effectively reduces risk factors and improves protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use. conditions: Substance Use conditions: Sexual Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 183 type: ACTUAL name: Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS) name: Control condition - 3 Monthly Group Activities in the Community measure: Change in child cultural knowledge score on knowledge assessment measure: Change in average score on risky behaviors assessment measure: Change in child reproductive health knowledge via a reproductive health knowledge questionnaire sex: FEMALE minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: White Mountain Apache Center for Indigenous Health city: Whiteriver state: Arizona zip: 85941 country: United States lat: 33.83699 lon: -109.96427 hasResults: False
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<|newrecord|> nctId: NCT06276582 id: 519379-2 briefTitle: Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico. overallStatus: RECRUITING date: 2023-01-17 date: 2024-05-31 date: 2024-05-31 date: 2024-02-26 date: 2024-02-26 name: Norwegian University of Science and Technology class: OTHER name: Picterus AS name: Instituto Mexicano del Seguro Social briefSummary: The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared. conditions: Jaundice, Neonatal studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 150 type: ESTIMATED name: Screening for neonatal jaundice with a mobile health device measure: Enable high qualitative estimation of bilirubin levels in the blood of Mexican newborns using Picterus JP measure: Correlation between bilirubin measurements with Picterus JP and total serum bilirubin measure: Accuracy of Picterus JP to screen for neonatal jaundice sex: ALL minimumAge: 1 Day maximumAge: 14 Days stdAges: CHILD facility: Hospital General de Zona 1 status: RECRUITING city: Oaxaca zip: 68040 country: Mexico name: Rey Manuel Silva Mendez role: CONTACT phone: +529511283520 email: reymsilvam@gmail.com lat: 17.06542 lon: -96.72365 hasResults: False
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<|newrecord|> nctId: NCT06276569 id: 2023-LCYJ-MS-26 briefTitle: Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Respiratory Distress Syndrome After Cardiac Surgery :a Single Centre Random Control Trial. overallStatus: NOT_YET_RECRUITING date: 2024-02-18 date: 2026-06-30 date: 2026-12-31 date: 2024-02-26 date: 2024-02-28 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute respiratory distress syndrome (ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application. conditions: Cardiac Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 384 type: ESTIMATED name: Sivelestat name: placebo measure: Oxygenation index measure: Inflammatory index measure: Myocardial injury marker measure: Acute physiology and chronic health evaluation(APACHE II) socre measure: Murray socre measure: ICU time measure: In-hospital time measure: 30-day all-cause mortality measure: 90-day all-cause mortality sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276556 id: ABP-671-302 briefTitle: Extension Study of ABP-671 in Participants With Gout overallStatus: ENROLLING_BY_INVITATION date: 2024-04-22 date: 2025-07-02 date: 2025-07-02 date: 2024-02-26 date: 2024-02-26 name: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3). conditions: Gout studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 580 type: ESTIMATED name: ABP-671 name: Allopurinol measure: Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) measure: Incidence of treatment-emergent adverse events (Safety and Tolerability) measure: Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alliance for Multispecialty Research city: Tempe state: Arizona zip: 85281 country: United States lat: 33.41477 lon: -111.90931 facility: Tucson Neuroscience Research, LLC city: Tucson state: Arizona zip: 85710 country: United States lat: 32.22174 lon: -110.92648 facility: Anaheim Clinical Trials (Cenexel ACT) city: Anaheim state: California zip: 92801 country: United States lat: 33.83529 lon: -117.9145 facility: Center for Clinical Trials of Sacramento city: Sacramento state: California zip: 95823 country: United States lat: 38.58157 lon: -121.4944 facility: Access Research Institute city: Brooksville state: Florida zip: 34613 country: United States lat: 28.55554 lon: -82.38991 facility: Nature Coast Clinical Reasearch city: Crystal River state: Florida zip: 34429 country: United States lat: 28.90248 lon: -82.5926 facility: JY Research Institute Inc. city: Cutler Bay state: Florida zip: 33189 country: United States lat: 25.5783 lon: -80.3377 facility: Accel Clinical Research Site city: DeLand state: Florida zip: 32720 country: United States lat: 29.02832 lon: -81.30312 facility: Jacksonville Center for Clinical Research city: Jacksonville state: Florida zip: 32216 country: United States lat: 30.33218 lon: -81.65565 facility: A & D Doctor Center city: Miami state: Florida zip: 33135 country: United States lat: 25.77427 lon: -80.19366 facility: Bioclinical Research Alliance city: Miami state: Florida zip: 33155 country: United States lat: 25.77427 lon: -80.19366 facility: Cordova Research Institute city: Miami state: Florida zip: 33155 country: United States lat: 25.77427 lon: -80.19366 facility: Century Research LLC city: Miami state: Florida zip: 33173 country: United States lat: 25.77427 lon: -80.19366 facility: ITB Research city: Miami state: Florida zip: 33173 country: United States lat: 25.77427 lon: -80.19366 facility: Combined Research Orlando Phase I-IV city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: New Horizons Research city: Palmetto Bay state: Florida zip: 33158 country: United States lat: 25.62177 lon: -80.32477 facility: Advanced Clinical Research of Atlanta city: Atlanta state: Georgia zip: 30309 country: United States lat: 33.749 lon: -84.38798 facility: Centricity Research city: Columbus state: Georgia zip: 31904 country: United States lat: 32.46098 lon: -84.98771 facility: Alliance for Multispecialty Research, LLC. city: Newton state: Kansas zip: 67114 country: United States lat: 38.04668 lon: -97.34504 facility: DelRicht Research city: New Orleans state: Louisiana zip: 70115 country: United States lat: 29.95465 lon: -90.07507 facility: AMR city: New Orleans state: Louisiana zip: 70119 country: United States lat: 29.95465 lon: -90.07507 facility: Annapolis Internal Medicine/CCT Research city: Annapolis state: Maryland zip: 21401 country: United States lat: 38.97845 lon: -76.49218 facility: DelRicht Research of Gulfport city: Gulfport state: Mississippi zip: 39501 country: United States lat: 30.36742 lon: -89.09282 facility: Quality Clinical Research, Inc city: Omaha state: Nebraska zip: 68114 country: United States lat: 41.25626 lon: -95.94043 facility: Santa Rosa Medical Center city: Las Vegas state: Nevada zip: 89119 country: United States lat: 36.17497 lon: -115.13722 facility: Inspire Santa Fe Medical Group city: Santa Fe state: New Mexico zip: 87505 country: United States lat: 35.68698 lon: -105.9378 facility: OnSite Clinical Solutions city: Salisbury state: North Carolina zip: 28144 country: United States lat: 35.67097 lon: -80.47423 facility: Altoona Center for Clinical Research city: Duncansville state: Pennsylvania zip: 16635 country: United States lat: 40.42341 lon: -78.4339 facility: ClinSearch city: Chattanooga state: Tennessee zip: 37421 country: United States lat: 35.04563 lon: -85.30968 facility: Medical Care/CCT city: Elizabethton state: Tennessee zip: 37643 country: United States lat: 36.34872 lon: -82.21069 facility: PanAmerican Clinical Research, LLC city: Brownsville state: Texas zip: 78520 country: United States lat: 25.90175 lon: -97.49748 facility: Quality Research Inc. city: San Antonio state: Texas zip: 78209 country: United States lat: 29.42412 lon: -98.49363 facility: Worldwide Clinical Trials city: San Antonio state: Texas zip: 78217 country: United States lat: 29.42412 lon: -98.49363 facility: Paratus Clinical Research Western Sydney city: Blacktown state: New South Wales zip: 2148 country: Australia lat: -33.76667 lon: 150.91667 facility: Emeritus Research Sydney city: Botany state: New South Wales zip: 2019 country: Australia lat: -33.94599 lon: 151.19591 facility: Paratus Clinical Research Central Coast city: Kanwal state: New South Wales zip: 2259 country: Australia lat: -33.253 lon: 151.4911 facility: A R Houston Medical Pty Ltd city: Kippa-Ring state: Queensland zip: 4021 country: Australia lat: -27.22586 lon: 153.0835 facility: Emeritus Research Melbourne city: Camberwell state: Victoria zip: 3124 country: Australia lat: -37.84205 lon: 145.0694 facility: Austin Health - Repatriation Hospital city: Heidelberg state: Victoria zip: 3084 country: Australia lat: -37.75 lon: 145.06667 facility: New Hospitals city: Tbilisi zip: 0114 country: Georgia lat: 41.69411 lon: 44.83368 facility: Evex Hospitals Caraps Medline city: Tbilisi zip: 0159 country: Georgia lat: 41.69411 lon: 44.83368 facility: Aversi Clini city: Tbilisi zip: 0160 country: Georgia lat: 41.69411 lon: 44.83368 facility: The First Medical Center city: Tbilisi zip: 0180 country: Georgia lat: 41.69411 lon: 44.83368 facility: Academician Vakhtang Bochorishvili Clinic city: Tbilisi zip: 0186 country: Georgia lat: 41.69411 lon: 44.83368 facility: Innova city: Tbilisi zip: 0186 country: Georgia lat: 41.69411 lon: 44.83368 facility: Clinical Research Center (CRC) city: C.p. zip: 01010 country: Guatemala facility: Clínica Médica Especializada en Medicina Interna y Reumatología (CREER) city: C.p. zip: 01010 country: Guatemala facility: Clínica Médica Especializada en Medicina Interna y Reumatología city: C.p. zip: 01010 country: Guatemala facility: Clínica Médica Especializada en Medicina Interna city: C.p. zip: 01010 country: Guatemala facility: Buddhist Dalin Tzu Chi General Hospital city: Chiayi City zip: 62247 country: Taiwan lat: 23.47917 lon: 120.44889 facility: Chang Gung Memorial Hospital CGMH city: Kaohsiung City zip: 833 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Chung Shan Medical Univ. Hospital city: Taichung zip: 402367 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Cheng-Shin General Hospital city: Taipei City zip: 112401 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Chang Gung Memorial Hospital LinKou city: Taoyuan zip: 333423 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06276543 id: C-BSEAL-002 briefTitle: Bactiseal Catheter Safety Registry Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-07-31 date: 2026-12-31 date: 2024-02-26 date: 2024-04-19 name: Integra LifeSciences Corporation class: INDUSTRY briefSummary: Research Purpose:
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This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter.
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Research Design:
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This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022.
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The following information will be collected from subjects' medical records or hospitals' databases (if any):
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1. General condition of the subjects (including previous shunting and external drainage operation)
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2. Intraoperative condition and catheter implantation
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3. Information on the shunt catheters
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4. Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2)
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5. Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done) conditions: Hydrocephalus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: antibiotic-impregnated catheter measure: Infection outcome measure: Safety outcome sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Children's Hospital, Capital Medical University city: Beijing state: Beijing zip: 100045 country: China name: Hailang Sun, MD role: CONTACT phone: 0086-10-59616408 email: et2007yy@163.com lat: 39.9075 lon: 116.39723 facility: Xuanwu Hospital, Capital Medical University city: Beijing state: Beijing zip: 100053 country: China name: Ning Wang, MD role: CONTACT phone: 010-83198899 lat: 39.9075 lon: 116.39723 facility: Beijing Hospital city: Beijing state: Beijing zip: 100730 country: China name: Cheng Sha, MD role: CONTACT phone: 0086-10-85132266 email: bjshacheng@163.com lat: 39.9075 lon: 116.39723 facility: Guangzhou Women and Children Medical Center city: Guangzhou state: Guangdong zip: 510623 country: China name: Fangcheng Li, MD role: CONTACT phone: 020-81886332 lat: 23.11667 lon: 113.25 facility: Guangdong Province People Hospital city: Guangzhou state: Guangdong zip: 519041 country: China name: Feng Wang, MD role: CONTACT phone: 0086 20 83827812 lat: 23.11667 lon: 113.25 facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Ting Lei, MD role: CONTACT phone: 0086 27 83662688 lat: 30.58333 lon: 114.26667 facility: Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai zip: 200127 country: China name: Nan Bao, MD role: CONTACT phone: 0086-21-38626161 email: baonan@scmc.com.cn lat: 31.22222 lon: 121.45806 facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610041 country: China name: Jianguo Xu, MD role: CONTACT phone: 0086 28 85422114 lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06276530 id: APHP231036 briefTitle: Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling acronym: VaPosVent overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-02 date: 2025-03 date: 2024-02-26 date: 2024-02-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: This study aims to identify physiopathologic mechanisms related to surgical approaches during lobectomies for non-small cell lung cancer which can explain the better quality of life and the decrease of of post-operative complications in minimally invasive techniques (video-assisted thoracic surgery and robotic-assisted thoracic surgery) compared to conventional thoracotomy. conditions: Resectable Lung Non-Small Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: EOS imaging for musculoskeletal disorder name: Movement analysis by an optoelectronic camera. name: Stabilometric measurement by strength platform measure: Thoracic kyphosis (T1- T12 angle) and vertical alignment head-pelvis and head- C7 vertebra (angle OD-HA and OD-C7) (EOS) measure: Width of rib cage (EOS) measure: Rib cage volume (EOS) measure: " Umbrella "angle (EOS) measure: Center of Pressure displacement (Optoelectronic system) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Thoracic and Vascular Surgery Tenon University Hospital city: Paris zip: 75020 country: France name: Harry ETIENNE, M.D., PhD role: CONTACT phone: +33 6 67 96 82 89 email: h.etienne@hotmail.fr lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06276517 id: APHP220918 id: 2022-A01739-34 type: OTHER domain: IDRCB briefTitle: Hidden Impairments During Subarachnoid Haemorrhage Recovery, Description and Evolution of a Newly Described Syndrom acronym: HIDDEN overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-03 date: 2028-03 date: 2024-02-26 date: 2024-02-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Descriptive observational study in patients with spontaneous subarachnoid hemorrhage or following aneurysmal rupture to assess the presence of a post-HSA syndrome at 3 months, 6 months and 1 year, and its impact on functional outcome using the Rivermead questionnaire conditions: Intracranial Hemorrhages studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: questionnaire name: SS-QoL name: SF-36 name: CIQ-R name: BREFF name: MoCA name: IADL name: mMRS name: PCL-5 name: Brief-Cope measure: Evaluate the presence of post SAH syndrome at 3 months and its impact on return to work using the Rivermead Post-Concussion symptoms questionnaire (RPQ), and its impact on functional outcome. measure: - study the factors determining the presence of a post-HSA syndrome and an inability to return to work at 3 months, 6 months and 1 year measure: To study the prevalence of post-traumatic stress in this population measure: Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276504 id: APHP211001 id: 2023-503520-31-00 type: OTHER domain: EU CT number briefTitle: Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection acronym: PENALTY overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-04 date: 2024-02-26 date: 2024-02-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: This study aims to assess the efficacy and safety of pembrolizumab in immunocompromised patients with progressive multifocal leukoencephalopathy (PML). This phase II, multicenter, single-arm study includes patients with an underlying cause of immunosuppression hardly reversible, i.e. not the patients with HIV nor those receiving biologics for chronic inflammatory diseases. Patients will receive intravenous pembrolizumab (2 mg/kg, maximum 200 mg) at month 0, 1 and 2 (total of three doses). The primary endpoint will be achieving at least one negative result of JCV viral load in cerebrospinal fluid (CSF) within the M0 to M3 period. conditions: Progressive Multifocal Leukoencephalopathy studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection measure: Negativation of JCV viral load in the CSF as assessed by PCR: at least one JCV PCR in the CSF negative in the Day 0 to Month 3 period measure: Negativation of JCV PCR viral load in the CSF: cumulative incidence of negative JCV viral load measures by PCR in CSF, with death as competing event measure: Evolution of the JCV viral load in the CSF (repeated measures JCV PCR in CSF) measure: Repositivation of JCV PCR: at least a positive result following at least a negative result measure: Evolution of National Institutes of Health Stroke Scale (NIHSS) score measure: Evolution of 6-item Modified Rankin Scale score (includes death as most severe state) measure: Evolution of Glasgow Outcome Scale Extended (GOS-E) score measure: Relapse or progression measure: Death (and date of death) measure: Cause specific death: death related to PML measure: Any adverse event classified by using US NCI CTCAE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Pitié-Salpêtrière - Médecine Intensive Réanimation city: Paris zip: 75013 country: France name: Nicolas WEISS, Pr role: CONTACT phone: +33 (0)1 42 16 27 70 email: nicolas.weiss@aphp.fr lat: 48.85341 lon: 2.3488 facility: Hôpital Pitié-Salpêtrière - Service d'hématologie clinique city: Paris zip: 75013 country: France name: Damien ROOS-WEIL, Dr role: CONTACT phone: +33 (0)1 42 16 15 96 email: damien.roosweil@aphp.fr lat: 48.85341 lon: 2.3488 facility: Hôpital Pitié-Salpêtrière - Service des Maladies infectieuses et tropicales city: Paris zip: 75013 country: France name: Valérie POURCHER, Pr role: CONTACT phone: +33 (0)1 42 16 02 62 email: valerie.martinez@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06276491 id: XmAb541-01 briefTitle: Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors overallStatus: RECRUITING date: 2024-04-04 date: 2027-12 date: 2028-12 date: 2024-02-26 date: 2024-04-18 name: Xencor, Inc. class: INDUSTRY briefSummary: The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate effect of XmAb541 on tumor outcomes. conditions: Ovarian Cancer conditions: Endometrial Cancer conditions: Germ Cell Tumor conditions: Testicular Germ Cell Tumor conditions: Ovarian Germ Cell Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Dose escalation and expansion study primaryPurpose: TREATMENT masking: NONE count: 212 type: ESTIMATED name: XmAb541 measure: Incidence of Adverse Events measure: Incidence of dose-limiting toxicities (DLTs) measure: Incidence of cytokine release syndrome (CRS) measure: Measurement of Cmax measure: Measurement of area under curve (AUC) measure: Measurement of Ctrough measure: Objective Response Rate measure: Duration of Response measure: Changes in Circulating Tumor DNA (ctDNA) sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Einstein Comprehensive Cancer Center status: RECRUITING city: Bronx state: New York zip: 10461 country: United States lat: 40.84985 lon: -73.86641 hasResults: False
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<|newrecord|> nctId: NCT06276478 id: 2024-PEDOAI briefTitle: Positive Psychological Deconditioning of Pediatric Patients With Dental Anxiety Through Artificial Intelligence overallStatus: ENROLLING_BY_INVITATION date: 2024-03-04 date: 2024-06 date: 2024-06 date: 2024-02-26 date: 2024-03-07 name: University of Pavia class: OTHER briefSummary: Pediatric patients who will be attending dental treatment at both the Orthodontics and Pediatric Dentistry Unit, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences at the University of Pavia, Pavia, Italy and a private dental practice in Genoa, Italy, will be recruited for the study.
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A cartoon version of a small molar will be drawn using the software Paint (version 22000.0, Microsoft Corporation, Redmond, Washington State, U.S.). The drawing will be animated using an AI-based software (Sketch MetaDemolab, Meta AI Research, Astor Place, New York city, New York, U.S.). A text will be created in collaboration with OpenAI (version 3.5, Open AI, San Francisco, California, U.S.) to be integrated into the video, utilizing terminology deemed most suitable for a patient with dental anxiety. The text will be transformed from written to spoken dialogue using an AI-based software (Flexclip, version 5.6.0, PearlMountain, Hong Kong, China), and then incorporated into the video.
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Children will undergo the first dental visit at the baseline (T0), in which the following indexes will be assessed: Modified Dental Anxiety Scale (MDAS), Face-Leg-Activity-Cry-Consolability Scale (FLACC), Simplified Oral Hygiene Index (OHI-S), Bleeding on Probing (BOP) and the International Caries Detection and Assessment System (ICDAS). They will be randomly divided into two group:
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* in the Trial group, patients will watch the the video, and then the tell-show-do technique will be used to explain the dental procedures;
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* in the Control group, only the "tell-show-do" technique will be used. Variables considered will include age, gender, and the presence/absence of a parent or another companion.
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At the second visit (T1), scheduled approximately after two weeks, the variables will be re-evaluated and professional debridement will be performed with a piezoelectric instrument (Satelect Acteon Newton p5 xs,Acteon Group, Mèrignac, France and Sonicflex Kavo, KaVo Dental, Biberach an der Riss, Germany) and manual scaler/curettes (Courette 9/10, 11/12 and 13/14 Gracey and Scaler lm 23, Hu Friedy, Europe). Values will be registered again, for the third time, after the professional debridement. conditions: Dental Anxiety conditions: Dental Phobia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: AI-video name: Verbal instructions measure: Change in Modified Dental Anxiety Scale - MDAS (Humphris GM et al. 1995) measure: Change in Face, Leg, Activity, Cry, Consolability Scale - FLACC (Merkel, S. I. et al., 1997) measure: Change in Bleeding on Probing - BoP (Löe H. et al.,1967) measure: Change in Simplified Oral Hygiene Index - OHI-S (Greene JC et al, 1964) measure: International Caries Detection and Assessment System - ICDAS sex: ALL minimumAge: 4 Years maximumAge: 8 Years stdAges: CHILD facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia city: Pavia state: Lombardy zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False
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<|newrecord|> nctId: NCT06276465 id: UC-GTG-2306 id: 2023-507482-26-00 type: OTHER domain: EU-CT briefTitle: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging acronym: PEACE8 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-07-01 date: 2032-07-01 date: 2024-02-26 date: 2024-02-26 name: UNICANCER class: OTHER name: Bayer briefSummary: In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer.
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In the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number.
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An early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients.
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The treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs.
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The principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide. conditions: Prostatic Cancer, Castration-Resistant studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible patients will be randomly allocated in a 1:1 ratio to either the:
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* Control arm: ADT + darolutamide.
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* Experimental arm: ADT + darolutamide + SBRT. primaryPurpose: TREATMENT masking: NONE count: 336 type: ESTIMATED name: Darolutamide 300 mg name: Stereotactic body radiation therapy name: Androgen deprivation therapy measure: Radiographic Progression-free survival (rPFS) measure: Time to treatment failure (TTF) measure: Overall survival (OS) measure: Prostate cancer-specific survival measure: Time to PSA progression measure: Biochemical response rate measure: Time to next symptomatic skeletal event (SSE) measure: Time to pain progression measure: Safety/tolerance measure: Functional Assessment of CAncer Therapy - Prostate (FACT-P) measure: Brief Pain Inventory - Short Form (BP-SFI) questionnaire sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276452 id: 23.0434 id: U2CDA050097 type: NIH link: https://reporter.nih.gov/quickSearch/U2CDA050097 briefTitle: Supporting Resilience Among Re-entered Seniors acronym: SRRS overallStatus: RECRUITING date: 2024-03-09 date: 2024-11-30 date: 2024-11-30 date: 2024-02-26 date: 2024-03-15 name: University of Louisville class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The first goal (Aim 1) of this clinical trial is to learn about specific strengths, challenges, and desired areas of knowledge and skill-building among older adults who re-entered their communities from a period of incarceration and to then develop a new psychoeducational intervention tailored to these older adults. The second goal (Aim 2) of this clinical trial is to test if the intervention increases chronic disease management and whether the intervention is considered appropriate and acceptable by older adults who re-entered their communities from a period of incarceration.
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Aim 1 participants will:
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* complete a baseline survey
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* participate in a focus group
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Aim 2 participants will:
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* complete a baseline survey
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* participate in an 8-week once weekly intervention
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* complete three follow up surveys conditions: Chronic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 8 type: ESTIMATED name: Psychoeducation measure: Chronic disease self managment sex: MALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New Legacy Reentry status: RECRUITING city: Louisville state: Kentucky zip: 40203 country: United States name: Stephanie Grace Prost, PhD role: CONTACT email: stephanie.prost@louisville.edu lat: 38.25424 lon: -85.75941 hasResults: False
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<|newrecord|> nctId: NCT06276439 id: IRB23-0314 briefTitle: Intraoperative Imaging of Lymph Nodes overallStatus: RECRUITING date: 2024-02-19 date: 2025-03-30 date: 2026-02-19 date: 2024-02-26 date: 2024-02-26 name: University of Illinois at Urbana-Champaign class: OTHER name: U.S. National Science Foundation name: Ss. Cyril and Methodius University of Skopje, Macedonia briefSummary: One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). Although modern surgical imaging and fluorescent probes enhance the detection of sentinel lymph nodes using near-infrared (NIR) fluorescence, their inability to precisely determine the nodes' status can result in additional surgeries, lymphedema, and a reduced quality of life for patients. Our research direction aims to harness the potential of bioinspired imaging technologies with the goal of precisely identifying SLN status and ensuring only the cancerous lymph nodes are excised during the initial procedure. To realize this objective, we're drawing inspiration from the mantis shrimp's visual system to create a single-chip multispectral camera that spans the deep ultraviolet to the near-infrared spectrum. Our pioneering sensor seamlessly combines perovskite nanocrystals, optical filters, and vertically-aligned photodetectors on a single chip, enabling concurrent imaging of external NIR fluorophores and internal UV fluorescence from tumor-specific markers. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 48 type: ESTIMATED name: Surgical removal of breast cancer and lymph nodes measure: Positive lymph node detection with custom sensors sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Clinic Hospital status: RECRUITING city: Skopje zip: 1000 country: North Macedonia name: Viktor Gruev, PhD role: CONTACT phone: +1.267.847.4020 email: vgruev@illinois.edu name: Goran Kondov, MD, PHD role: CONTACT phone: +389 70 252010 email: kondov@yahoo.com lat: 41.99646 lon: 21.43141 hasResults: False
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<|newrecord|> nctId: NCT06276426 id: 24468 briefTitle: Plants Optimizing Development Study (PODS) acronym: PODS overallStatus: RECRUITING date: 2024-03-18 date: 2026-09-30 date: 2026-09-30 date: 2024-02-26 date: 2024-04-17 name: University of Illinois at Urbana-Champaign class: OTHER name: Soy Nutrition Institute briefSummary: This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children. conditions: Healthy Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 96 type: ESTIMATED name: Soy foods name: Non-Soy Plant-Based Foods measure: Sex steroid excretion measure: Gut microbiota measure: Attentional Accuracy measure: Attentional Reaction Time measure: Hippocampal-dependent Relational memory measure: Body Composition measure: Metabolic Markers measure: Pubertal Staging measure: Cognitive Abilities and Academic Achievement sex: ALL minimumAge: 8 Years maximumAge: 11 Years stdAges: CHILD facility: University of Illinois status: RECRUITING city: Urbana state: Illinois zip: 61801 country: United States name: Naiman Khan, PhD, RD role: CONTACT phone: 217-300-2197 email: nakhan2@illinois.edu name: Naiman Khan, PhD, RD role: PRINCIPAL_INVESTIGATOR lat: 40.11059 lon: -88.20727 hasResults: False
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