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<|newrecord|> nctId: NCT06365567 id: CE209/2023 briefTitle: Dietary Fructose: a Metabolic Switch in Pediatric Obesity-related Disease. acronym: EO2022 overallStatus: RECRUITING date: 2024-03-04 date: 2025-03-05 date: 2026-03-02 date: 2024-04-15 date: 2024-04-15 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER name: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari briefSummary: The increase in childhood obesity is a multifactorial phenomenon influenced by dietary patterns, commercial factors, and social determinants; it has long-term consequences for both individual health and society as a whole. Despite recommendations for maintaining good health throughout life and promoting the Mediterranean Diet, due to the increased availability of ultra-processed and more appealing foods, children and adolescents are shifting towards a "Western" diet. One in four children consumes sugary and carbonated drinks every day, which contributes to a high intake of fructose in the diet, while fruits and vegetables are consumed less, and legumes are included in the diet of only 38% of children less than once a week.
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Fructose is a monosaccharide naturally found in fruits, vegetables, and honey; due to its high sweetness and taste-enhancing properties, fructose is widely used in the food industry. High-fructose corn syrup, in particular, is one of the most widely used ingredients in the production of soft drinks, jams, breakfast cereals, and bakery products. Non-alcoholic fatty liver disease (NAFLD), now also called metabolic dysfunction-associated fatty liver disease (MAFLD), is considered the hepatic manifestation of metabolic syndrome and currently represents the most common chronic liver disease in pediatric age in Western countries. Recent studies suggest that fructose consumption is implicated in the development of NAFLD both directly by providing metabolites that can be used for triglyceride and free fatty acid synthesis, and indirectly through increased uric acid production. High-fructose foods also appear to be a risk factor for bone loss. Numerous studies conducted over the past 25 years, during which fructose consumption has exponentially increased, have shown that this sweetener tends to increase the incidence of fractures and osteoarthritis and decrease bone mineral density (BMD) and new bone tissue deposition.
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The objective of this study is to understand the effect of fructose on the molecular events that contribute to the evolution of the pediatric age, and its effective relationship with the onset of liver and osteoarticular complications in this population. Understanding the mechanisms of fructose regulation and its effects on the body could be an important target to address the clinical and social problems arising from its spread in children. conditions: Pediatric Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: assessment of fructose intake with questionnaires measure: correlation of fructose consumption with hepatic complications, detected trough echo-abdomen and blood analysis measure: Correlation of fructose consumption with bone metabolism, detected through QUS measure: Characterization of the concentration of intestinal microorganisms measure: Evaluate sociodemographic and cultural determinants with questionnaires ( questions with multiple answers) sex: ALL minimumAge: 3 Years maximumAge: 16 Years stdAges: CHILD facility: SCDU Pediatria, AOU Ospedale Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Flavia Prodam, MD PHD role: CONTACT lat: 45.44694 lon: 8.62118 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-21 uploadDate: 2024-04-11T05:17 filename: Prot_SAP_000.pdf size: 972421 hasResults: False
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<|newrecord|> nctId: NCT06365554 id: 2 briefTitle: On-Premise and Remote Robotic Neurointervention overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-01-01 date: 2025-06-01 date: 2024-04-15 date: 2024-04-15 name: Remedy Robotics, Inc. class: INDUSTRY name: Unity Health Toronto briefSummary: This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention. conditions: Cerebrovascular Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Remedy Robot measure: Procedural safety measure: Procedural Technical Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06365541 id: GYLLPJ-2024006 briefTitle: The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients overallStatus: RECRUITING date: 2024-03-01 date: 2024-08-31 date: 2024-08-31 date: 2024-04-15 date: 2024-04-15 name: The People's Hospital of Gaozhou class: OTHER briefSummary: Dialysis patients have a higher incidence of cardiovascular events and require more effective measures to delay the progression of heart failure. Many studies have shown that dapagliflozin has cardioprotective effect, but most studies focus on non-dialysis patients with eGFR more than 20ml/min/1.73m2. However, the data on patients with eGFR less than 20ml/min/1.73m2 or dialysis patients, especially peritoneal dialysis patients, is less. Exploring the efficacy and safety of Dapagliflozin in improving heart failure in dialysis patients is of great clinical significance. conditions: The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Exploring the efficacy and safety of dapagliflozin in improving heart failure in dialysis patients by the analysis and comparison of patients' own data before and after dapagliflozin treatment primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Dapagliflozin measure: N-terminal B-type natriuretic peptide precursor (NT-proBNP) measure: Left ventricular ejection fraction (LVEF) sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The People's Hospital of Gaozhou status: RECRUITING city: Maoming state: Guangdong zip: 525200 country: China name: Mingsheng Zhu role: CONTACT phone: 15016656405 email: ms160@163.com lat: 21.65 lon: 110.9 hasResults: False
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<|newrecord|> nctId: NCT06365528 id: 2023-0232 briefTitle: Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-12-31 date: 2026-07-31 date: 2024-04-15 date: 2024-04-15 name: Hospital de Clinicas de Porto Alegre class: OTHER name: Hospital Moinhos de Vento name: Irmandade Santa Casa de Misericórdia de Porto Alegre briefSummary: The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days. conditions: CLABSI - Central Line Associated Bloodstream Infection conditions: Deep Vein Thrombosis conditions: Dislodged Catheter conditions: Occlusion conditions: Catheter Rupture conditions: Catheter (Other); Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Prospective Randomized Open, Blinded End-point (PROBE Study) whoMasked: OUTCOMES_ASSESSOR count: 840 type: ESTIMATED name: Subcutaneous tunnelling name: Non-tunnelling measure: End of therapy or catheter removal free from complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital de Clínicas de Porto Alegre city: Porto Alegre country: Brazil name: Eneida R Rabelo da Silva, ScD role: CONTACT lat: -30.03306 lon: -51.23 hasResults: False
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<|newrecord|> nctId: NCT06365515 id: TUE010_IRTG_P5 briefTitle: Dopamine, Reward Learning and Sex Hormones overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-15 date: 2024-04-15 name: University Hospital Tuebingen class: OTHER name: German Research Foundation name: Uppsala University briefSummary: Hormonal transition periods during the menstrual cycle may predispose women to mental disorders. Hormonal fluctuations provide specific neuroendocrine conditions that modulate brain structure and function and these actions affect cognitive and emotional behaviors and affect energy and mood homeostasis. It is thought that these changes are driven by altered dopamine transmission. Here, we aim to examine (1) how sex hormones and dopamine are linked and also (2) how hormonal changes affect motivation, mood, and energy homeostasis.
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To this end, dopamine intervention will be tested on effort-based decision-making and motivational circuits in three hormonal stages (i.e., women in early-follicular phase (EF), women in mid-luteal phase (ML), and men). Additionally, we are testing the effects of hormonal status on metabolic indices and its effects on mood fluctuations in a period of a month.
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The investigator hypothesizes that women in EF cycle phase (1) have naturally less dopamine and show less effort, and (2) they show greater improvement in effort-based decision-making after Levodopa administration. We have exploratory outcomes about (3) sex differences in reward-learning with and without Levodopa administration and explore if these differences correlate with elevated female sex hormone levels. Moreover, it is hypothesized that (4) hormonal fluctuations affect energy homeostasis, thus women in their EF cycle phase have higher energy expenditure and (5) they report more negative mood than in their mid-luteal (ML) cycle phase. conditions: Hormonal Changes conditions: Menstrual Cycle studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The investigators will assess the effects of Levodopa administration on reward-learning using a double-blind randomized cross-over design. In a within-subject design, participants will get both conditions (Levodopa/placebo) at different time points (a few days apart). After drug/placebo administration we will assess cerebral blood flow and functional connectivity at rest (via functional MR imaging) during effort-based decision making task. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Neither participants nor investigators will know at which time point the participant will receive Levodopa and placebo tablets. The tablets will be prepared by independent members of the university hospital. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Levodopa administration name: Placebo administration measure: Motivation to work for rewards: force of pressing grip force device (GFD) to gain food and monetary rewards circuitry during effort-based decision-making measure: Reward-related brain responses in the reward network during effort-based decision-making measure: Reward anticipation on a neural level measure: Execution of effort on a neural level measure: Resting-state functional connectivity measure: Changes in reinforcement learning measure: Menstrual cycle induced changes in mood and food cravings measure: Changes in resting energy expenditure measure: Changes in metabolic hormone levels during the menstrual cycle sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Department of Psychiatry & Psychotherapy, University of Tübingen city: Tübingen state: BW zip: 72076 country: Germany name: Andrea Heberle role: CONTACT email: Andrea.Heberle@med.uni-tuebingen.de lat: 48.52266 lon: 9.05222 hasResults: False
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<|newrecord|> nctId: NCT06365502 id: KY2023-156 briefTitle: Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-12 date: 2030-12 date: 2024-04-15 date: 2024-04-15 name: Harbin Medical University class: OTHER name: Shanghai Shenqi Medical Technology Co., Ltd briefSummary: The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome. conditions: Acute Coronary Syndrome (ACS) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 1860 type: ESTIMATED name: Drug-coated balloon name: Guideline-directed medical treatment measure: Target lesion failure (TLF) measure: Target lesion failure (TLF) measure: Target lesion failure (TLF) measure: Target lesion failure (TLF) measure: Major cardiac adverse event (MACE) measure: Major cardiac adverse event (MACE) measure: Major cardiac adverse event (MACE) measure: Major cardiac adverse event (MACE) measure: All-cause death measure: All-cause death measure: All-cause death measure: All-cause death measure: Cardiac death and target lesion MI measure: Cardiac death and target lesion MI measure: Cardiac death and target lesion MI measure: Cardiac death and target lesion MI measure: Cardiac death measure: Cardiac death measure: Cardiac death measure: Cardiac death measure: Target lesion myocardial infarction measure: Target lesion myocardial infarction measure: Target lesion myocardial infarction measure: Target lesion myocardial infarction measure: Periprocedural myocardial infarction measure: Periprocedural myocardial infarction measure: Periprocedural myocardial infarction measure: Periprocedural myocardial infarction measure: Periprocedural and non-periprocedural myocardial infarction measure: Periprocedural and non-periprocedural myocardial infarction measure: Periprocedural and non-periprocedural myocardial infarction measure: Periprocedural and non-periprocedural myocardial infarction measure: Target vessel failure (TVF) measure: Target vessel failure (TVF) measure: Target vessel failure (TVF) measure: Target vessel failure (TVF) measure: Minimal lumen area after DCB treatment measure: Plaque burden after DCB treatment measure: FCT after DCB treatment measure: Lipid arc after DCB treatment measure: FCT <75 μm after DCB treatment measure: PB >65% after DCB treatment measure: PB >70% after DCB treatment measure: MLA <3.5 mm^2 after DCB treatment measure: Maximal lipid arc >180° after DCB treatment measure: Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Beijing Luhe Hospital of Capital Medical University city: Beijin state: Beijing zip: 101149 country: China name: Guangyao zhai role: CONTACT name: Guangyao zhai role: PRINCIPAL_INVESTIGATOR facility: Affiliated Hospital of Zunyi Medical University city: Zunyi state: Guizhou zip: 563000 country: China lat: 27.68667 lon: 106.90722 facility: Daqing Oilfield General Hospital city: Daqing state: Heilongjiang zip: 150000 country: China lat: 46.58333 lon: 125.0 facility: The Second Affiliated Hospital of Harbin Medical University city: Harbin state: Heilongjiang zip: 150000 country: China name: Haibo Jia, PhD role: CONTACT name: Bo Yu, PhD role: PRINCIPAL_INVESTIGATOR name: Haibo Jia, PhD role: SUB_INVESTIGATOR lat: 45.75 lon: 126.65 facility: The First Affiliated Hospital of Jiamusi University city: Jiamusi state: Heilongjiang zip: 150000 country: China name: Guangyuan Yang role: CONTACT name: Guangyuan Yang role: PRINCIPAL_INVESTIGATOR lat: 46.79927 lon: 130.31633 facility: Mudanjiang Cardiovascular Hospital city: Mudanjiang state: Heilongjiang zip: 150000 country: China name: Kai Liu role: CONTACT name: Kai Liu role: PRINCIPAL_INVESTIGATOR lat: 44.58333 lon: 129.6 facility: Fuwai Central China Cardiovascular Hospital city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 facility: The First Affiliated Hospital of Zhengzhou University city: Zhengzhou state: Henan zip: 450000 country: China name: Chunguang Qiu role: CONTACT name: Chunguang Qiu role: PRINCIPAL_INVESTIGATOR lat: 34.75778 lon: 113.64861 facility: Tongji Hospital Tongji Medical College of HUST city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: The Third Second Hospital of Jilin University city: Changchun state: Jilin zip: 132000 country: China name: Bin Liu role: CONTACT name: Bin Liu role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: Dalian Municipal Central Hospital city: Dalian state: Liaoning zip: 116000 country: China name: Xiaoqun Zheng role: CONTACT name: Xiaoqun Zheng role: PRINCIPAL_INVESTIGATOR lat: 38.91222 lon: 121.60222 facility: The First Affiliated Hospital of Dalian Medical University city: Dalian state: Liaoning zip: 116000 country: China name: Bo Zhang role: CONTACT name: Bo Zhang role: PRINCIPAL_INVESTIGATOR lat: 38.91222 lon: 121.60222 facility: The People's Hospital of Liaoning Province city: Shengyang state: Liaoning zip: 132000 country: China facility: The Affiliated Hospital of Neimenggu Medical University city: Hohhot state: Neimenggu zip: 011500 country: China name: Fengying Chen role: CONTACT name: Fengying Chen role: PRINCIPAL_INVESTIGATOR lat: 40.81056 lon: 111.65222 facility: Shandong Provincial Hospital city: Jinan state: Shandong zip: 250000 country: China name: Haitao Yuan role: CONTACT name: Haitao Yuan role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: Affiliated Hospital of Jining Medical University city: Jining state: Shandong zip: 250000 country: China name: Lijun Gan role: CONTACT name: Lijun Gan role: PRINCIPAL_INVESTIGATOR lat: 35.405 lon: 116.58139 facility: The Affiliated Hospital of Qingdao University city: Qingdao state: Shandong zip: 250000 country: China name: Peng Li role: CONTACT name: Peng Li role: PRINCIPAL_INVESTIGATOR lat: 36.06488 lon: 120.38042 facility: Yantai Yuhuangding Hospital city: Yantai state: Shandong zip: 250000 country: China name: Lin Zhong role: CONTACT name: Lin Zhong role: PRINCIPAL_INVESTIGATOR lat: 37.47649 lon: 121.44081 hasResults: False
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<|newrecord|> nctId: NCT06365489 id: 113293 briefTitle: Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-11 date: 2023-02-20 date: 2024-09 date: 2024-04-15 date: 2024-04-15 name: Golestan University of Medical sciences class: OTHER briefSummary: Arterio-Venous Fistula (AVF) is the most recommended vascular access for hemodialysis. Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. Measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of Steal syndrome. In this study, the ratio of wrist to arm pressure and its relationship with Steal syndrome symptoms before and after fistula implantation are investigated. conditions: Vascular Access Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 78 type: ACTUAL measure: Early post operative WBI changes following AVF implantation measure: Two-week post operative WBI changes following AVF implantation measure: Three-month post operative WBI changes following AVF implantation measure: Correlation between WBI changes following AVF implantation with age measure: Correlation between WBI changes following AVF implantation with sex measure: Correlation between WBI changes following AVF implantation with co-morbidities measure: Correlation between WBI changes following AVF implantation with steal syndrome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pezhman Kharazm, MD city: Gorgan state: Golestan zip: 4917956808 country: Iran, Islamic Republic of lat: 36.8427 lon: 54.44391 hasResults: False
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<|newrecord|> nctId: NCT06365476 id: 202309126RIND briefTitle: FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity overallStatus: RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2027-04-15 date: 2024-04-15 date: 2024-04-22 name: National Taiwan University Hospital class: OTHER briefSummary: Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity. conditions: Stroke conditions: Spasticity, Muscle studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: focused extracorporeal shock wave therapy (ESWT) measure: passive range of motion for the wrist and finger joints measure: hand grip strength measure: Visual Analogue Scale (VAS) measure: modified Ashworth scale (MAS) measure: modified Tardieu scale (MTS) measure: Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) measure: Action Research Arm Test (ARAT) measure: Barthel index measure: Functional Independence Measure (FIM) measure: ultrasound assessment measure: Box and Block Test measure: Wolf Motor Function Test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100 country: Taiwan name: Shu-mei Yang, MD role: CONTACT phone: 886-2- 23123456 email: b99401109@gmail.com name: Shu-mei Yang, MD role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06365463 id: URIS202401 briefTitle: Telerehabilitation to Improve Balance and Mobility in Patients After Stroke acronym: TeleHome overallStatus: RECRUITING date: 2024-04-09 date: 2024-05-31 date: 2024-05-31 date: 2024-04-15 date: 2024-04-23 name: University Rehabilitation Institute, Republic of Slovenia class: OTHER briefSummary: Telerehabilitation is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions. conditions: Hemorrhagic Stroke conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Telerehabilitation measure: Change in balance measure: Change in limits of stability measure: Change in weight-bearing symmetry measure: Change in mobility measure: Change in walking speed measure: Satisfaction with the remote training sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Rehabilitation Institute, Republic of Slovenia status: RECRUITING city: Ljubljana zip: 1000 country: Slovenia name: Urška Puh, PT, PhD role: CONTACT phone: +386 1 4758152 email: urska.puh@ir-rs.si lat: 46.05108 lon: 14.50513 hasResults: False
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<|newrecord|> nctId: NCT06365450 id: IRB00315481 briefTitle: Breast and Cervical Cancer Education Program acronym: OCEAP overallStatus: COMPLETED date: 2022-09-22 date: 2024-02-28 date: 2024-04-05 date: 2024-04-15 date: 2024-04-15 name: Johns Hopkins University class: OTHER name: Older Women Embracing Life name: The John G. Bartlett Specialty Practice briefSummary: The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference. conditions: Cervical Cancer conditions: Breast Cancer conditions: Health Behavior studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Each participant is required to attend (in person or virtually via Zoom) two educational sessions one on breast cancer and the other on cervical cancer. primaryPurpose: OTHER masking: NONE count: 60 type: ACTUAL name: Educational Intervention measure: Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool. measure: Number of participants recruited from each community partner measure: Number of participants who preferred virtual or in person sessions measure: Number of participants who were lost of follow up measure: Number of participants who needed help redeeming their gift codes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins University School of Nursing city: Baltimore state: Maryland zip: 21205 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06365437 id: TCD601B101 briefTitle: A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation overallStatus: RECRUITING date: 2021-06-06 date: 2025-08 date: 2025-08 date: 2024-04-15 date: 2024-04-15 name: ITB-Med LLC class: INDUSTRY briefSummary: The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients. conditions: Kidney Transplantation studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: TCD601 name: Tacrolimus (TAC) name: Corticosteroids (CS) name: Mycophenolate Mofetil (MMF) name: ATG measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. measure: Measure Peak Plasma Concentration (Cmax) over time. measure: Measure the Area under the plasma concentration versus time curve (AUC). measure: Assess changes in peripheral immunophenotype, including T-, B-, and NK-cells, via Fluorescence-activated Cell Sorter (FACS) over time. measure: Measure anti-TCD601 antibodies in serum via Enzyme-linked Immunosorbent (ELISA) assay over time. measure: Measure peripheral CD2-receptor occupancy following TCD601 administration Receptor Occupancy will be reported as the % of target saturation. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Innsbruck Medical University status: RECRUITING city: Innsbruck zip: A-6020 country: Austria name: Research Coordinator role: CONTACT lat: 47.26266 lon: 11.39454 facility: University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Research Coordinator role: CONTACT lat: 48.20849 lon: 16.37208 facility: Hospital Clinic de Barcelona status: RECRUITING city: Barcelona zip: 08036 country: Spain name: Research Coordinator role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Universitari de Bellvitge status: RECRUITING city: Barcelona zip: 08907 country: Spain name: Research Coordinator role: CONTACT lat: 41.38879 lon: 2.15899 facility: Karolinska University Hospital status: RECRUITING city: Stockholm state: Huddinge zip: 14157 country: Sweden name: Research Coordinator role: CONTACT lat: 59.33258 lon: 18.0649 facility: Sahlgrenska University Hospital status: RECRUITING city: Göteborg zip: 41345 country: Sweden name: Research Coordinator role: CONTACT lat: 57.70716 lon: 11.96679 facility: Skåne University Hospital status: RECRUITING city: Malmö zip: 20502 country: Sweden name: Research Coordinator role: CONTACT lat: 55.60587 lon: 13.00073 hasResults: False
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<|newrecord|> nctId: NCT06365424 id: KY20151230-5-1 briefTitle: Fenofibrate in Patients With Primary Biliary Cholangitis (PBC) overallStatus: RECRUITING date: 2017-04-08 date: 2027-04 date: 2027-04 date: 2024-04-15 date: 2024-04-15 name: Xijing Hospital of Digestive Diseases class: OTHER briefSummary: An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC) conditions: Primary Biliary Cholangitis studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 117 type: ESTIMATED name: Fenofibrate name: UDCA measure: Treatment emergent adverse events (TEAEs) measure: Percentage of patients with biochemical response sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital status: RECRUITING city: Xi'an state: Shaanxi country: China name: Ying Han role: CONTACT lat: 34.25833 lon: 108.92861 hasResults: False
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<|newrecord|> nctId: NCT06365411 id: GEM-KiT briefTitle: GEnomic Medicine in Kidney Transplantation Study acronym: GEM-KiT overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2030-01-01 date: 2035-01-01 date: 2024-04-15 date: 2024-04-24 name: Western Sydney Local Health District class: OTHER briefSummary: Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.
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1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation
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2. Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction
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3. Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction conditions: Transplant Complication conditions: Kidney Transplant Rejection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Biomarker discovery and validation - with focus on genomic biomarkers measure: Death censored graft loss (DCGL) measure: Biopsy proven rejection (BPAR) measure: All cause graft loss measure: Death measure: Treatment resistant rejection measure: Hospital admission or emergency attendance measure: Delayed Graft Function (DGF) measure: Kidney function measure: Albuminuria measure: Surrogate end-point markers measure: Borderline rejeciton measure: chronic rejection; chronic transplant glomerulopathy; and interstitial fibrosis and tubular atrophy (IFTA) scores measure: Recurrent disease measure: BK virus complications measure: Major cardiovascular complications measure: Major infectious complications measure: Malignancy post transplantation measure: Kidney biopsy transcriptomic signature measure: Kidney cell type composition measure: Proteinomic signature sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06365398 id: SELECT id: XWHL-2018010 type: OTHER_GRANT domain: Xuanwu Hospital, Capital Medical University briefTitle: Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy acronym: SELECT overallStatus: COMPLETED date: 2018-01-01 date: 2021-06-01 date: 2022-01-01 date: 2024-04-15 date: 2024-04-15 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of micro-dose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases.
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Methods: A prospective, single-blind, randomized controlled study on patients who experienced transient ischemic attacks (TIAs) or acute ischemic strokes and underwent DSA is performed. Participants are randomized into three groups: regular-dose systemic heparinization, micro-dose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores is collected. Safety endpoints are defined as cerebral ischemic events and local complications of puncture site. Efficacy endpoints were defined as the recovery of the patients. conditions: Cerebral Angiography conditions: Heparinization studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All patients enrolled are randomly divided into three groups according to the random number principle, which includes conventional systemic heparinization group, micro-dose systemic heparinization, and heparin-free angiography. It is carried out with a 1:1:1 ratio and variable block sizes. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 180 type: ACTUAL name: Heparin name: Heparin Sodium Injection name: No heparinization measure: postoperative cerebral infarction measure: Numerical Rating Scale (NRS) for back pain measure: the incidence of paralysis of surgical limb measure: the incidence of pain of surgical limb measure: the incidence of postoperative urethral catheterization sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Xuanwu Hospital, Capital Medical University. city: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06365385 id: FOODSEQ-MARS briefTitle: Postprandial Metabolic and Appetite Responses to Different Food Intake Sequences in Athletes overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-10 date: 2024-04-15 date: 2024-04-15 name: Universidade do Porto class: OTHER name: Federação Portuguesa de Futebol name: Fundação para a Ciência e a Tecnologia briefSummary: Emerging evidence suggests that following a 'carbohydrate-last meal pattern', wherein foods rich in protein, fat, fiber, and/or polyphenols are consumed before sources of simple carbohydrate (CHO) in a meal, results in reduced postprandial glycaemic responses than the reverse food order or a co-ingestion pattern. This effect has been observed across the spectrum of glucose tolerance, from patients with diabetes to individuals with normal glucose tolerance (Kuwata et al., 2016; Nishino et al., 2018; Lu et al., 2019; Sun et al., 2020). Furthermore, reduced glucose excursions have been linked to decreased subsequent hunger and energy intake (Lu et al., 2019; Wyatt et al., 2021).
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However, to date, no studies on food intake sequence have targeted athletes, despite their increased CHO demands (Thomas et al., 2016) which could expose them to repeated episodes of hyperglycaemia and high glycaemic variability, known to increase the risk of adverse cardiovascular outcomes and all-cause mortality (Loader et al., 2015; Cavero-Redondo et al., 2017; Faerch et al., 2018). Additionally, athletes often face pressure to meet body composition standards and may benefit from strategies that enhance satiety and craving control. Finally, there is reason to believe that better glycaemic control could lead to improved performance, given that enhancements in endurance activities have been observed with a low-glycemic-index diet compared to a high-glycemic-index diet (Heung-Sang Wong et al., 2017).
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Therefore, this randomised crossover trial is part of a wider project which seeks to explore the impact of food intake sequence on metabolic health and performance in athletes. Specifically, this trial aims to investigate the acute, postprandial metabolic and appetite responses to consuming an identical meal in two intake sequences (CHO-last versus CHO-first) in athletes, while in the resting state. conditions: Healthy conditions: Nutrition, Healthy conditions: Postprandial Hyperglycemia conditions: Hunger conditions: Craving studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study is a randomised controlled trial with a counterbalanced crossover design. Block randomisation will be performed by an external researcher, and allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed envelopes. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: This is a non-blind trial, since both participants and the investigator delivering the test-meal will be able to see the ingredients and the order in which they are consumed. However, outcome assessors will be blinded to the intervention sequence. whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: Carbohydrate-last meal pattern name: Carbohydrate-first meal pattern measure: Postprandial blood glucose concentrations measure: Postprandial subjective appetite ratings measure: Prospective ad libitum energy intake measure: Prospective ad libitum nutritional intake measure: Postprandial serum insulin concentrations measure: Postprandial plasma total GLP-1 concentrations measure: Postprandial plasma total GIP concentrations measure: Postprandial serum total ghrelin concentrations measure: Postprandial plasma total PYY concentrations measure: Postprandial serum triglyceride concentrations measure: Postprandial serum NEFA concentrations sex: MALE minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06365372 id: MrgD and PAH briefTitle: Circulating MrgD in Pulmonary Hypertension overallStatus: RECRUITING date: 2024-04-10 date: 2024-05-10 date: 2024-06-01 date: 2024-04-15 date: 2024-04-15 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The aim of the study is to observe the change of the circulating MrgD level in patients with pulmonary hypertension compared with subjects without pulmonary hypertension. conditions: Pulmonary Hypertension studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED name: Western blot measure: Circulating MrgD level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: Panpan Hao, MD, PHD role: CONTACT email: panda.how@126.com name: Hongyu Zhong, MD role: SUB_INVESTIGATOR lat: 36.66833 lon: 116.99722 hasResults: False
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<|newrecord|> nctId: NCT06365359 id: 23_RIPH2-12 briefTitle: Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique acronym: LUNEK overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-10-15 date: 2025-11-15 date: 2024-04-15 date: 2024-04-15 name: University Hospital Center of Martinique class: OTHER name: Institut Pasteur de Guadeloupe name: Centre de Ressources Biologiques de la Martinique (CeRBiM) briefSummary: Chlordecone, an organochlorine pesticide, was widely used on banana farms in the French West Indies. Studies by Inserm and health authorities have confirmed the contamination of the food chain and the majority of the population of the French West Indies by chlordecone.
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Epidemiological studies conducted in the French West Indies have shown that exposure to chlordecone at the levels observed is associated with an increased risk of developing several diseases, including premature birth and prostate cancer. Many of the adverse effects associated with chlordecone could be explained by its estrogenic hormonal properties, and systemic lupus erythematosus (SLE) is an autoimmune disease whose sensitivity to estrogen is well known and is reflected by 1) its clear predominance in women, 2) its predominance in women of childbearing age, 3) its risk of exacerbation in the event of pregnancy.
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Chlordecone has the potential to modify the activity of SLE through mechanisms other than its pro-estrogenic effects. In rats, chlordecone was observed to induce alterations such as a reduction in lymphocyte count, thymic atrophy, and a decrease in splenic germinal centers and NK cells.
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In a mouse model of systemic lupus erythematosus (SLE), exposure to chlordecone results in increased production of immune complexes and anti-DNA antibodies, which are markers of disease activity and monitoring.
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Chlordecone also has a cellular effect that reduces the apoptosis of potentially auto-reactive lymphocytes and stimulates the production of GM-CSF, IL-2, TNF-alpha, and IFN-gamma. The latter is central to the pathophysiology of SLE. While experimental studies suggest a potential impact of chlordecone on SLE, no human studies have been conducted to date, and the chlordecone impregnation of lupus patients in Martinique remains unknown.
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The most serious and feared complication of SLE is kidney damage. Kidney damage from the disease and the necessary immunosuppressive treatments can lead to significant morbidity and mortality, including death and end-stage chronic renal failure. Therefore, it is important to manage the disease carefully. Suspected lupus nephritis is confirmed by a renal biopsy, which allows for formal diagnosis and categorization into several classes. Suspected cases are identified by a proteinuria to creatininuria ratio greater than 0.5 g/g (or 24-hour proteinuria greater than 0.5g).
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The objective of this project is to determine whether there is a positive association between lupus nephritis occurrence in patients followed by the internal medicine department of the Martinique University Hospital and organochlorine pesticide chlordecone impregnation. conditions: Systemic Lupus Erythematosus conditions: Renal Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Blood sample for analysis of plasma of organochlorine pesticides concentration name: Blood sample for cell collection measure: To estimate the risk of presenting a renal complication of lupus disease based on the level of impregnation with chlordecone in the lupus patients seen at the Martinique University Hospital. measure: To compare the activity of lupus according to the level of impregnation with chlordecone. measure: To compare the after-effects of lupus according to the level of impregnation with chlordecone. measure: To describe the distribution of the plasma concentration of chlordecone in lupus patients followed by the internal medicine department of the Martinique University Hospital. measure: To describe the distribution of the plasma concentration of p,p'-DDE in lupus patients followed by the internal medicine department of the Martinique University Hospital. measure: To describe the distribution of the plasma concentration of βHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital. measure: To describe the distribution of the plasma concentration of γHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital. measure: To describe the distribution of the plasma concentration of PCB 153 in lupus patients followed by the internal medicine department of the Martinique University Hospital. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Center of Martinique city: Fort-de-France zip: 97261 country: France hasResults: False
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<|newrecord|> nctId: NCT06365346 id: 2024.075-T briefTitle: Music Breathing Therapy for Children With Attention-deficit Hyperactivity Disorder and Their Caregivers overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-05-31 date: 2025-08-31 date: 2024-04-15 date: 2024-04-15 name: Chinese University of Hong Kong class: OTHER briefSummary: This pilot randomized controlled trial aims to evaluate the feasibility (in terms of rates of recruitment, retention, and attendance), acceptability, and potential effects of the dyadic video-assisted gamified music breathing therapy on dyads' resilience, children's emotional and behavioral symptoms, parents' parenting stress, and psychological distress. conditions: Resilience studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Dyadic video-assisted gamified group-based music breathing therapy name: Online educational modules measure: Resilience levels of children measure: Resilience levels of parents measure: Children's emotional and behavioral symptoms measure: Parenting stress measure: Parents' psychological distress (i.e., depression, anxiety and stress) measure: Feasibility outcomes - recruitment rate measure: Feasibility outcomes - retention rate measure: Feasibility outcomes - attendance measure: Acceptability of the intervention - level of satisfaction measure: Acceptability of the intervention sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: The Chinese University of Hong Kong city: Hong Kong country: Hong Kong name: Ankie Tan Cheung, PhD role: CONTACT phone: 852 39430515 email: ankiecheung@cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06365333 id: 1451_04/BVNTW-VNCSKTE briefTitle: Pneumatic Reduction For Intussusception In Children: A Retrospective Cohort Study overallStatus: COMPLETED date: 2016-01 date: 2017-12 date: 2024-04 date: 2024-04-15 date: 2024-04-15 name: National Children's Hospital, Vietnam class: OTHER name: Vinmec Research Institute of Stem Cell and Gene Technology briefSummary: In pediatric patients, intussusception predominantly occurs in the ileocecal region, with over 90% of cases lacking identifiable causative factors, initiating through peristalsis-driven invagination of bowel segments leading to compromised blood flow and subsequent bowel edema. Persistent obstruction may progress to bowel ischemia and infarction. Vietnam exhibits a higher incidence of intussusception compared to other countries, albeit with similar clinical presentations and anatomical locations, hinting at shared pathophysiology. Despite evidence supporting the safety and efficacy of non-surgical reduction techniques, many medical centers in low- to middle-income countries (LMICs) have not adopted these methods, resulting in unnecessary surgical interventions. The Vietnam National Hospital of Pediatrics (NCH) has employed air enema reduction since the early 2000s but lacks a comprehensive study on fluoroscopic-guided air-enema reduction (FGAR) techniques or success rates. Thus, this study aims to evaluate the long-term outcomes of pneumatic reduction for intussusception at NCH, a high-volume institution in a lower-middle-income country. conditions: Intussusception studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3562 type: ACTUAL name: Fluoroscopic-guided air-enema reduction (FGAR) measure: Complicated intussusception measure: ICU admission measure: Death measure: Failed FGAR measure: Recurrence sex: ALL minimumAge: 2 Months maximumAge: 30 Months stdAges: CHILD facility: The National Hospital of Pediatrics city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 facility: Vinmec Research Institute of Stem Cell and Gene Technology city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False
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<|newrecord|> nctId: NCT06365320 id: PROTEOMET briefTitle: Association Between Training Load and Lactate and Other Metabolites Analyzed by Metabolomic and Proteomic Techniques acronym: PROTEOMET overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-15 date: 2024-04-15 name: Fundació Eurecat class: OTHER name: University Rovira i Virgili briefSummary: Physical exercise induces numerous changes in the body in a complex signalling network caused by or in response to increased metabolic activity of contracting skeletal muscles.
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The application of omics analytical techniques such as proteomics and metabolomics in the field of sport allows us to understand how the human body responds to exercise and how sports results can be improved by optimising nutrition and training. Both omics techniques offer a quantitative measurement of the metabolic profiles associated with exercise and are able to identify metabolic signatures of athletes from different sports disciplines.
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Basketball is a high-intensity exercise modality interspersed with low-intensity. The performance requirements of basketball include aerobic and anaerobic metabolism, with anaerobic metabolism being considered the main energy system. Therefore, basketball players need great athletic ability to produce a successful performance during competition.
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For optimal sports performance it is important to adjust the training load, i.e. the degree of effort that the player can withstand in a single training session. Coaches require effective and objective load monitoring tools that allow them to make decisions about training plans based on the needs of each player.
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Microsampling systems emerge as an alternative to venipuncture by facilitating self-sampling, which can be carried out outside healthcare centres, in a comfortable and precise way from a small finger prick that the user can perform. These systems are less expensive and can be effective in measuring the levels of glucose metabolism products, such as lactate, through the application of metabolomics and proteomics. On the other hand, the use of non-invasive methods of measuring lactate levels is becoming increasingly popular in sports medicine. The use of saliva as an alternative fluid to the blood shows promise for identifying the concentrations of metabolites that occur during and after sports training. conditions: Lactate conditions: Sports Performance conditions: Metabolomics conditions: Proteomics studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-group pretest-posttest design (quasi- experimental) primaryPurpose: OTHER masking: NONE maskingDescription: Given the nature of the study (pretest-posttest design), masking will not be possible. count: 70 type: ESTIMATED name: Single basketball training measure: Correlation between blood lactate levels and the subjective sensation of perceived effort measure: Change in saliva lactate levels measure: Change in blood lactate levels measure: Change in levels of lipid metabolic markers determined in capillary blood samples measure: Change in levels of other lipid metabolic markers determined in capillary blood samples measure: Change in levels of polar metabolites determined in capillary blood samples measure: Change in levels of lipid metabolic markers determined in saliva samples measure: Change in levels of other lipid metabolic markers determined in saliva samples measure: Change in levels of polar metabolites determined in saliva samples measure: Change in levels of proteomic markers determined in capillary blood samples measure: Change in levels of proteomic markers determined in saliva samples measure: Pittsburgh Sleep Quality Index measure: Heart rate variations measure: Sociodemographic data: age and birth date measure: Sociodemographic data: sex measure: Lifestyle data: weekly training load measure: Lifestyle data: playing position measure: Clinical data: use of supplementation measure: Clinical data: use of medication measure: Clinical data: previous muscle injuries measure: Physiological data measure: Anthropometric data: weight measure: Anthropometric data: height measure: Anthropometric data: body mass index measure: Anthropometric data: fat mass percentage measure: Anthropometric data: muscle mass percentage sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Fundació Eurecat, Center for Omic Sciences city: Reus state: Tarragona zip: 43204 country: Spain name: Nuria Canela, PhD role: CONTACT phone: +34977300431 email: nuria.canela@eurecat.org name: Anna Crescenti, PhD role: CONTACT phone: +34977770958 phoneExt: 4832 email: anna.crescenti@eurecat.org lat: 41.15612 lon: 1.10687 hasResults: False
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<|newrecord|> nctId: NCT06365307 id: Histograft-SF-2023 briefTitle: Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion overallStatus: RECRUITING date: 2023-11-13 date: 2024-04 date: 2025-04 date: 2024-04-15 date: 2024-04-15 name: Histograft Co., Ltd. class: INDUSTRY name: Petrovsky National Research Center of Surgery briefSummary: The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion prosedure in comparison with bone autografts and synthetic material based on β-TCP conditions: Cervical Disc Disorder With Radiculopathy conditions: Spinal Stenosis conditions: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy conditions: Biomechanical Lesion, Unspecified studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: During the preliminary screening and indication for surgical treatment, patients are divided into 2 groups depending on the location of the pathological process: 1 - cervical spine, 2 - lumbar spine. During independent sequential randomization in a 1:1 ratio, patients in each of these groups are divided into clinical (A) and control (B) groups.
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Distribution of treatment methods by groups:
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1A - use of "Histograft" for spinal fusion of the cervical spine, 50 patients
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1. B - use of synthetic osteoplastic material based on β-TCP for spinal fusion of the cervical spine, 50 patients
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2. A - use of "Histograft" for spinal fusion of the lumbar spine, 100 patients
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2B - use of bone autograft for spinal fusion of the lumbar spine, 100 patients primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft") name: Synthetic osteoplastic material based on β-TCP or bone autograft measure: Spinal fusion measure: Adverse events and Severe Adverse Events measure: SF- 36 score (The Short Form-36) measure: Unexpected Adverse Drug Reaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V.Petrovsky" status: RECRUITING city: Moscow state: Moscow Oblast zip: 117588 country: Russian Federation name: Renat Nurmukhametov role: CONTACT email: ethic@med.ru name: Mark Aleksanyan role: CONTACT name: Renat Nurmukhametov, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False
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<|newrecord|> nctId: NCT06365294 id: REVET Study briefTitle: Rescue Extracranial Vertebral Stenting in Tandem Occlusions acronym: REVET overallStatus: RECRUITING date: 2020-12-31 date: 2024-04-30 date: 2024-05-31 date: 2024-04-15 date: 2024-04-16 name: Dr. Cuong Tran Chi class: OTHER briefSummary: The acute vertebrobasilar occlusion associated with the poor prognosis, particularly tandem occlusion. However, few data on the efficacy of the endovascular therapy was indicated in this occlusion. The investigators reported whether the additional rescue extracranial stenting improved clinical outcome by modified Rankin Scale (mRS) score within 3 months after the procedure conditions: Acute Stroke conditions: Ischemic Stroke, Acute conditions: Vertebro Basilar Ischemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: Rescue extracranial stenting measure: The good 3-month outcome rate sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Can Tho SIS Hospital status: RECRUITING city: Cần Thơ zip: 900000 country: Vietnam name: Cuong Tran Chi, Doctor role: CONTACT phone: +84886559911 email: drcuongtran@dotquy.vn lat: 10.03711 lon: 105.78825 hasResults: False
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<|newrecord|> nctId: NCT06365281 id: CARIES PREVALENCE briefTitle: Caries Prevalence, Experience and Risk Related Factors Among Early Middle-aged Patients Attending Cairo University overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-08 date: 2024-04-15 date: 2024-04-15 name: Cairo University class: OTHER briefSummary: Dental caries, a widespread oral health issue, results from a complex interplay of factors including behavior, hygiene, diet, and socio-demographic aspects. While preventive measures are available, it remains prevalent globally, affecting numerous teeth per individual. Improved oral hygiene practices and increased awareness have led to a reduction in caries prevalence. However, rising sugar consumption exceeds dietary guidelines, contributing to the problem. Despite limited epidemiological studies in Egypt, addressing individual-level factors is crucial. Surveillance of oral health in the early middle age group is standard, allowing decision-makers to assess the impact of caries and oral health care provision. Stratifying data by age, geography, and gender aids in understanding prevalence and planning effective prevention strategies. Overall, promoting awareness of dietary habits and preventive practices is vital for improving oral health outcome So, The purpose of this study is to assess the prevalence of dental caries among early middle age patients attending dental hospital in Faculty of Dentistry, Cairo university and to analyze the related risk factors utilizing WHO Oral Health Questionnaire for Adults. conditions: Dental Caries conditions: Caries,Dental studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 350 type: ESTIMATED measure: Prevalence of dental caries measure: Caries experience measure: Caries risk related factors sex: ALL minimumAge: 35 Years maximumAge: 44 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06365268 id: APHP231139 briefTitle: Perinatal Thoraco-abdomino-pelvic Tumors Study acronym: CONTRAST overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-09 date: 2024-04-15 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Congenital tumors are a rare diagnosis in the fetus and newborn. They differ from those of children and adults in terms of the nature, location and evolution of the tumor.
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Indeed, some histologically benign tumors may have lethal potential in utero (e.g. sacrococcygeal teratomas) or even undergo malignant transformation if left untreated. In contrast, other tumors that are malignant by histological criteria may have a very good prognosis, regressing spontaneously within the first year of life (e.g. neuroblastoma).
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Despite advances in imaging, benign and malignant solid tumors remain a major diagnostic and prognostic challenge in the antenatal context.
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The management of congenital tumors requires multidisciplinary expertise, taking into account the perinatal context, which poses specific problems, particularly in terms of therapeutic aspects, but also the frequent existence of associated malformations and/or genetic predisposition syndromes.
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This study focuses on solid tumors of the thoraco-abdomino-pelvic region, the main objective being to investigate the correlation between antenatal clinical and radiological analysis and confirmed postnatal diagnosis of congenital solid truncal tumors, as well as the developmental spectrum in which they fit. conditions: Perinatal Solid Tumors of the Thoraco-abdomino-pelvic Region studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Collection of data from the patient's medical file measure: Correlation between antenatal clinico-radiological analysis and postnatal diagnosis of solid congenital truncal tumors measure: Description of the developmental spectrum of solid congenital truncal tumors measure: Characteristics and location of the tumor on pre- and post-natal imaging measure: Ile-de-France epidemiology of perinatal tumors measure: Evolution of solid congenital truncal tumors measure: Associated genetic abnormalities and malformations measure: Intercurrent obstetric events and obstetric outcomes based on the diagnoses made measure: Development of a management algorithm based on prenatal findings sex: ALL maximumAge: 3 Months stdAges: CHILD facility: Hôpital Necker-Enfants Malades city: Paris zip: 75015 country: France name: Sabine SARNACKI, MD, PhD role: CONTACT phone: 1 44 49 41 94 phoneExt: +33 email: sabine.sarnacki@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06365255 id: 2022-A01453-40 briefTitle: National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes acronym: EPISTRESS2 overallStatus: COMPLETED date: 2023-01-17 date: 2024-02-28 date: 2024-02-28 date: 2024-04-15 date: 2024-04-17 name: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète class: OTHER briefSummary: The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres.
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In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres. conditions: Diabetes Type 1 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 1344 type: ACTUAL name: questionnaires measure: The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps. measure: Identify sub-populations of patients who feel stressed measure: Establish and categorise the different stress factors measure: Establishing a relationship between personality type and the impact of stress measure: Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Angers University Hospital city: Angers zip: 49100 country: France lat: 47.46667 lon: -0.55 facility: Avignon Hospital city: Avignon zip: 84000 country: France lat: 43.94834 lon: 4.80892 facility: St André Hospital city: Bordeaux zip: 33076 country: France lat: 44.84044 lon: -0.5805 facility: Brest University Hospital city: Brest zip: 29200 country: France lat: 48.3903 lon: -4.48628 facility: Dijon University Hospital city: Dijon zip: 21079 country: France lat: 47.31667 lon: 5.01667 facility: CERITD city: Evry zip: 91058 country: France lat: 48.63333 lon: 2.45 facility: Grenoble University Hospital city: Grenoble zip: 38043 country: France lat: 45.16667 lon: 5.71667 facility: Lille University Hospital city: Lille zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: APHM- La Conception Hospital city: Marseille zip: 13000 country: France lat: 43.29551 lon: 5.38958 facility: Private practice in endocrinology and metabolic diseases city: Mérignac zip: 33700 country: France lat: 44.83248 lon: -0.63381 facility: Srasbourg University Hospital city: Strasbourg zip: 67091 country: France lat: 48.58392 lon: 7.74553 hasResults: False
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<|newrecord|> nctId: NCT06365242 id: DOACS1_2024 briefTitle: Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study. acronym: DOACS_1 overallStatus: COMPLETED date: 2020-07-23 date: 2021-07-27 date: 2022-12-23 date: 2024-04-15 date: 2024-04-15 name: University of Pisa class: OTHER briefSummary: Evaluation of DOACs treatment on post-extraction bleeding conditions: Post Operative Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 49 type: ACTUAL measure: Peri-operative hemorrhage measure: Post-operative bleeding sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: U.O. Odontostomatologia e Chirurgia del Cavo Orale city: Pisa zip: 56126 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False
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<|newrecord|> nctId: NCT06365229 id: 2022-P2-336-02 briefTitle: Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: Beijing Friendship Hospital class: OTHER briefSummary: A prospective study aimed to compare the efficacy and safety of Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique for treating patients with lumbar spinal stenosis (LSS). conditions: Lumbar Spinal Stenosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Oswestry Disability Index (ODI) measure: Magnetic resonance imaging (MRI) measure: Computed tomography (CT) scans measure: Creatine kinase (CK) measure: Erythrocyte sedimentation rate (ESR) measure: Surgical complication measure: VAS (visual analogue scale) for leg pain measure: VAS (visual analogue scale) for lower back pain measure: Japanese Orthopaedic Association (JOA) score measure: Modified MacNab criteria measure: Operation time measure: Blood loss measure: Postoperative hospital stays measure: Age measure: Gender measure: Body mass index (BMI) measure: Medical comorbidity measure: Smoking status measure: Alcohol status measure: Symptoms duration measure: Physical examination finding measure: Previous spinal surgery measure: Affected level measure: Stenosis grade measure: Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06365216 id: AXO-CLI-210c-03 id: 2023-508895-13-00 type: CTIS briefTitle: ALS Phase II Study of NX210c acronym: SEALS overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-02-01 date: 2026-02-01 date: 2024-04-15 date: 2024-04-15 name: Axoltis Pharma class: INDUSTRY name: ACT4ALS network briefSummary: This study will investigate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple intravenous infusions of NX210c, at two dose levels, in patients with Amyotrophic lateral sclerosis (ALS). conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, randomized, placebo-controlled, multicentric, phase II study in adult patients with ALS to assess efficacy, safety, tolerability and pharmacokinetics of multiple intravenous infusions of NX210c.
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Two doses of NX210c (5 mg/kg and 10 mg/Kg) will be investigated, along with a placebo group which will serve as a reference. Patients will be randomized to one of 3 arms in an allocation ratio of 3:3:2.
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Patients will participate up to approximately 20 weeks: up to 30 days for screening, 26 days of treatment and 3 months of follow-up. Lumbar punctures will assess cerebrospinal fluid (CSF) NfL and other key CSF biomarkers related to ALS and drug mechanism of action. Blood sampling will be drawn for safety, PK and biomarkers testing. Urine will equally be collected for biomarkers. A comprehensive assessment of the disease, including the ALS Functional Rating Scale (ALSFRS-R) will be performed. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: NX210c name: Placebo measure: The effect of NX210c on blood neurofilament light chain (NfL) or on a blood and cerebrospinal fluid (CSF) biomarker of BBB integrity. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Lyon HCL city: Bron zip: 69500 country: France name: Emilien Bernard, MD role: CONTACT phone: 0033 (0)4 72 35 72 18 email: emilien.bernard@chu-lyon.fr lat: 45.73333 lon: 4.91667 hasResults: False
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<|newrecord|> nctId: NCT06365203 id: Through knee amputation briefTitle: Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-04 date: 2024-04-15 date: 2024-04-15 name: Assiut University class: OTHER briefSummary: The aim of this study is to search and compare outcomes of through knee amputation (TKA) and above knee amputation (AKA) in terms of Technique ,wound healing ,infection rate , function and ambulation conditions: Amputation of Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Through knee amputation name: Above knee Amputation measure: Wound healing rate measure: Incidence of infection measure: Function of the limb Rehabilitation Quality of life measure: Mortality rate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06365190 id: AHMU-PD-rTMS briefTitle: Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease overallStatus: ACTIVE_NOT_RECRUITING date: 2020-04-06 date: 2024-07-31 date: 2024-07-31 date: 2024-04-15 date: 2024-04-16 name: Anhui Medical University class: OTHER briefSummary: Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD. conditions: Transcranial Magnetic Stimulation conditions: Parkinson's Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 47 type: ACTUAL name: transcranial magnetic stimulation name: Pharmacotherapy（antiparkinsonian drugs） measure: Unified Parkinson's Disease Rating Scale III scores measure: Hoehn-Yahr(H-Y) stage measure: Levodopa equivalent dose sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cognitive Neuropsychology Lab Anhui Medical University city: Hefei state: Anhui zip: 230022 country: China lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06365177 id: 29BRC22.0243 briefTitle: Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation acronym: TELETEST overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-15 date: 2024-04-19 name: University Hospital, Brest class: OTHER briefSummary: This study concerns elderly person aged more than 65 years with autonomous mobility.
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It is a multicentric randomized trial in two arms :
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Arm one : remote consultation then physical consultation Arm two : physical consultation then remote consultation
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Consultations consist to take a Five Times Sit To Stand test, in physical consultation with physiotherapist in the same room and in remote consultation with a physiotherapist in the next room to the patient. conditions: Rehabilitation conditions: Elderly Person conditions: Teleconsultation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Cross-sectional interventional multicenter study primaryPurpose: OTHER masking: NONE count: 108 type: ESTIMATED name: Physical consultation name: Teleconsultation measure: Five Time Sit To Stand test completion time in teleconsultation measure: Five Time Sit To Stand test completion time in face-to-face consultation measure: Satisfaction questionnaire measure: Five Time Sit To Stand test completion time in teleconsultation measure: Five Time Sit To Stand test completion time in face-to-face consultation measure: Presence or absence of falls measure: Number of falls sex: ALL minimumAge: 65 Years maximumAge: 110 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06365164 id: 38RC23.0354 briefTitle: Study of the Emergence of Sensory Self-awareness in Premature Newborns Using the Rooting Reflex acronym: PREMATACT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-11 date: 2025-11 date: 2024-04-15 date: 2024-04-15 name: University Hospital, Grenoble class: OTHER name: Faculty of Psychology and Educational Sciences,University of Geneva briefSummary: The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness.
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The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness.
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The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn. conditions: Premature conditions: Development, Child conditions: Rooting Reflex studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 19 type: ESTIMATED name: Tactile stimulation measure: The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening. measure: The secondary objective is to show a longitudinal progression in the emergence of the rooting reflex by repeated inclusions (seven days minimum) at different terms for the same newborn. sex: ALL minimumAge: 28 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: University Hospital Grenoble city: Grenoble state: Isere zip: 38 000 country: France lat: 45.16667 lon: 5.71667 hasResults: False
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<|newrecord|> nctId: NCT06365151 id: TMDs fibromyalgia briefTitle: An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia overallStatus: RECRUITING date: 2024-04-05 date: 2025-04-05 date: 2026-04-05 date: 2024-04-15 date: 2024-04-15 name: Universitat de Lleida class: OTHER briefSummary: Nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. Among the comorbidities it presents, one of the most frequent is temporomandibular disorders. A randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders. conditions: Fibromyalgia conditions: Temporomandibular Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 114 type: ESTIMATED name: Osteopathic manual therapy name: Sham osteopathic manual therapy measure: catastrophizing measure: functional limitation measure: functional status, disability and pain measure: pain and tinnitus measure: myofascial trigger points measure: Range of motion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Osteopatia i Fisioteràpia Cornellà status: RECRUITING city: Cornella de Llobregat state: Barcelona zip: 08940 country: Spain name: Llanos de la Iglesia, MsC role: CONTACT phone: +34679536992 email: llanos.delaiglesia@gmail.com lat: 41.35 lon: 2.08333 hasResults: False
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<|newrecord|> nctId: NCT06365138 id: Aortic Rupture briefTitle: Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms overallStatus: RECRUITING date: 2024-01-01 date: 2029-12-01 date: 2030-12-01 date: 2024-04-15 date: 2024-04-15 name: University Hospital Augsburg class: OTHER name: Epidemiology, Medical Faculty, University Augsburg briefSummary: It is currently unclear what activities aneurysms are involved in at the time of rupture. The aim of the study is to determine the activity performed at the time of aneurysm rupture. conditions: Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 500 type: ESTIMATED name: Bahaviour at the time of an aortic aneurysm rupture measure: Occupation at the time of the aortic aneurysm rupture sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Augsburg status: RECRUITING city: Augsburg zip: 86156 country: Germany name: Tobias Warm, MD role: CONTACT phone: +49821400161068 email: tobias.warm@uk-augsburg.de lat: 48.37154 lon: 10.89851 hasResults: False
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<|newrecord|> nctId: NCT06365125 id: 7313E briefTitle: College Student Daily Life and Alcohol Use Study overallStatus: RECRUITING date: 2024-03-22 date: 2025-05-01 date: 2025-05-01 date: 2024-04-15 date: 2024-04-15 name: Boston University Charles River Campus class: OTHER briefSummary: Heavy alcohol use among college students is associated with a range of negative consequences. However, college students rarely seek resources or treatment to change their alcohol use. Brief alcohol interventions (BAIs) have been developed as an alternative method to address heavy alcohol use among college students and show promise in reducing hazardous alcohol use in college students. Despite the established efficacy of BAIs, effects are often small and short-lived, and additional research is needed to investigate how BAIs can become more efficacious and endure for longer periods of time, particularly for computer-delivered interventions to improve accessibility and scalability of these interventions to a wider range of college students. Boosters or adjunctive components to BAIs have been suggested as a method to enhance the magnitude and duration of intervention effects. However, there remains a need to identify and test booster approaches that are both appealing and engaging to college students and effective in reducing heavy/hazardous alcohol use above and beyond the magnitude and duration seen by BAIs alone. The purpose of the study is to develop and test a novel, text-messaging booster as an adjunct to a current, evidence-based brief intervention, eCHECKUP TO GO, aimed at reducing college student heavy/hazardous alcohol use. Participants will complete baseline measures and will then be randomized to 1 of 3 conditions, stratified by sex at birth: 1) assessment only, 2) BAI only, and 3) Enhanced Intervention (BAI + four weeks of text messaging boosters). It is hypothesized that those randomized to the enhanced intervention condition will show a greater reduction in heavy/hazardous alcohol use at 3-month follow-up compared to the BAI and assessment only groups. conditions: Drinking, College conditions: Drinking Heavy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 129 type: ESTIMATED name: eCHECKUP TO GO name: Text messaging boosters measure: Heavy drinking episodes measure: Alcohol-related negative consequences sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Boston University Charles River Campus status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Bonnie Rowland, MA role: CONTACT phone: 617-906-6645 email: browland@bu.edu name: Tibor Palfai, PhD role: CONTACT email: palfai@bu.edu name: Bonnie Rowland, MA role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06365112 id: R21154 briefTitle: Endoscopic Acetabulum Surgery overallStatus: RECRUITING date: 2024-04 date: 2026-01 date: 2028-01 date: 2024-04-15 date: 2024-04-24 name: Tampere University Hospital class: OTHER briefSummary: Try to develop an endoscopic surgical technique to treat acetabulum fractures conditions: Acetabulum Fracture studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 13 type: ESTIMATED name: Endoscopy assisted measure: Number of patients with major complications measure: Number of patients with minor complications measure: Operation time measure: Patient satisfaction using EQ5D sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tampere University hospital status: RECRUITING city: Tampere zip: 33521 country: Finland name: Piia Suomalainen role: CONTACT lat: 61.49911 lon: 23.78712 hasResults: False
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<|newrecord|> nctId: NCT06365099 id: STUDY00000896_Exp2 briefTitle: Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke overallStatus: RECRUITING date: 2024-02-02 date: 2026-03-31 date: 2026-03-31 date: 2024-04-15 date: 2024-04-15 name: University of Texas at Austin class: OTHER name: Emory University briefSummary: Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and promote poststroke hand motor recovery. To maximize the effects of such interventions, they must be delivered during brain activity patterns during which TMS best activates the residual CST and enhances its neural transmission. This approach is termed brain state-dependent TMS. The investigators have recently developed a machine learning framework that identifies personalized brain activity patterns reflecting strong CST activation in neurotypical adults. In this study, the investigators will apply this framework to the poststroke brain for the first time. They will also evaluate relationships between this framework's ability to detect strong and weak CST activation states and measures of CST pathway integrity.
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Participants will visit the laboratory for two days of testing that are separated by at least one night of sleep. On Day 1, participants will provide their informed consent. The MacArthur Competence Assessment Tool and the Frenchay Aphasia Screening Test will be used to evaluate consent capacity and confirm the presence of expressive aphasia as needed. Afterwards, participants will complete eligibility screening and clinical assessment of upper extremity motor impairment, motor function, and disability using the Upper Extremity Fugl-Meyer Assessment, the Wolf Motor Function Test, and the Modified Rankin Scale. Participants will then be screened for the presence of residual CST connections from the lesioned hemisphere to the affected first dorsal interosseous muscle. Recording electrodes will be attached to this muscle in order to record TMS-evoked twitches in these muscles. During this procedure, single-pulse TMS will be applied to each point of a 1 cm resolution grid covering primary and secondary motor areas of the lesioned hemisphere at maximum stimulator output. If TMS reliably elicits a muscle twitch in the affected first dorsal interosseous, that participant will be considered to have residual CST connections and will be eligible for the full study. If no muscle twitch is observed, the participant will not be eligible for the full study. Afterwards, recording electrodes will be removed and the participant will leave the laboratory.
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On Day 2, participants will return to the laboratory. The investigators will confirm continued eligibility and place recording electrodes on the scalp using a swim-type cap. The investigators will also place recording electrodes on the affected first dorsal interosseous as well as the affected abductor pollicis brevis and extensor digitorum communis muscles. After identifying the scalp location at which TMS best elicits muscle twitches in the affected first dorsal interosseous muscle, the investigators will determine the lowest possible TMS intensity that such evokes muscle twitches at least half of the time. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while participants rest quietly with their eyes open. Stimulation will be delivered at an intensity that is 20% greater than the lowest possible TMS intensity that evokes muscle twitches at least half the time. Afterwards, all electrodes will be removed, participation will be complete, and participants will leave the laboratory.
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The investigators will recruit a total of 20 chronic stroke survivors for this study. conditions: Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Single-pulse TMS measure: Personalized classifier performance measure: Corticospinal tract-lesion overlap sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas at Austin status: RECRUITING city: Austin state: Texas zip: 78712 country: United States name: Sara Hussain role: CONTACT phone: 512-232-2686 email: sara.hussain@austin.utexas.edu lat: 30.26715 lon: -97.74306 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-10 uploadDate: 2024-04-05T17:22 filename: ICF_000.pdf size: 462079 hasResults: False
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<|newrecord|> nctId: NCT06365086 id: STUDY00000608 briefTitle: Targeting Personalized Brain States Reflecting Strong and Weak Corticospinal Tract Output in Real-time overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-27 date: 2025-01-01 date: 2025-01-01 date: 2024-04-15 date: 2024-04-15 name: University of Texas at Austin class: OTHER name: Emory University briefSummary: Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and enhance recovery of paretic hand function after stroke. To maximize the therapeutic effects of such interventions, they must be delivered during poststroke brain activity patterns during which TMS best activates the residual corticospinal tract and enhances neural transmission within it (i.e., brain state-dependent TMS). In this study, the investigators will test the feasibility of real-time, personalized brain state-dependent TMS in neurotypical adults.
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Participants will visit the laboratory for one day of testing. Upon arrival, participants will provide their informed consent; afterwards, they will complete eligibility screening. The investigators will then place recording electrodes on the scalp using a swim-type cap and on the left first dorsal interosseous, abductor pollicis brevis, and extensor digitorum communis muscles. After determining the location at which TMS best elicits muscle twitches in the left first dorsal interosseous, the investigators will determine the lowest possible intensity at which TMS elicits muscle twitches at least half of the time in this muscle. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while the participant rests quietly with their eyes open; stimulation will be delivered at an intensity that is 20% greater than the lowest possible intensity at which TMS elicits muscle twitches at least half of the time. Afterwards, the investigators will use the muscle and brain activity recordings acquired during these 6 blocks to build a personalized mathematical model that identifies which patterns of brain activity correspond to the largest TMS-evoked muscle twitches. The investigators will then use this model to detect the occurrence of these brain activity patterns in real-time; when these patterns are detected, single TMS pulses will be delivered. Afterwards, all recording electrodes will be removed, participation will be complete, and participants will leave the laboratory.
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The investigators will recruit a total of 16 neurotypical adults for this study. conditions: Neurotypical Adults studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: CROSSOVER interventionModelDescription: Participants will receive single-pulse TMS during personalized brain activity patterns reflecting either strong or weak corticospinal tract activation primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 16 type: ESTIMATED name: Personalized brain state-dependent single-pulse TMS measure: Motor-evoked potential (MEP) amplitudes elicited from the left first dorsal interosseous muscle during personalized strong and weak CST states measure: State-targeting accuracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas at Austin city: Austin state: Texas zip: 78712 country: United States lat: 30.26715 lon: -97.74306 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-04 uploadDate: 2024-04-05T16:56 filename: ICF_000.pdf size: 305303 hasResults: False
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<|newrecord|> nctId: NCT06365073 id: TJIRB20231276 briefTitle: A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax overallStatus: RECRUITING date: 2024-03-13 date: 2024-08-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: Qin Ning class: OTHER briefSummary: This study is a clinical, multi-center, retrospective, case-control study. Patients clinically diagnosed with severe anthrax who meet the inclusion and exclusion criteria will be included in this study for analysis. Respiratory, circulation, nerve and other vital signs of patients with severe anthrax during hospitalization were recorded, and clinical data such as blood routine, blood biochemistry, coagulation function, myocardial injury, therapeutic drug use, and survival time of patients were recorded, as well as the survival situation of patients 28 days and 90 days after discharge. conditions: Anthrax studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED measure: mortality rates of severe anthrax measure: incidence of complications measure: Peripheral blood biomarkers associated with 28-day and 90-day mortality measure: the improvement in 28-day and 90-day mortality with treatment for severe anthrax sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei country: China name: Qin Ning, PHD,MD role: CONTACT phone: +8602783662391 email: qning@vip.sina.com name: Qin Ning, PHD,MD role: PRINCIPAL_INVESTIGATOR name: Tao Chen, PHD,MD role: SUB_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06365060 id: 00003143 id: R01CA279808 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA279808 briefTitle: Screening for AL Amyloidosis in Smoldering Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-02-27 date: 2029-02-27 date: 2024-04-15 date: 2024-04-15 name: Tufts Medical Center class: OTHER name: National Cancer Institute (NCI) briefSummary: In this multicenter study, we will recruit 400 patients 40 years of age or older at 15 centers with a diagnosis of smoldering multiple myeloma (SMM), a group of patients for whom standard of care is observation not treatment. The main goal of this study is to screen for the diagnosis of light-chain amyloidosis (AL) before the onset of symptomatic disease and to develop a training set for a likelihood algorithm. conditions: Smoldering Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Creating a network to enroll patients on a collaborative study requiring marrow and blood specimens, to collect data for a training set of likelihood statistics and to plan a future validation study. measure: Validating an NGS assay that identifies IGLV genes in clonal plasma cells sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama Hospital city: Birmingham state: Alabama zip: 35233 country: United States name: Susan Bal, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: Cedars-Sinai Medical Center city: Los Angeles state: California zip: 90048 country: United States name: Robert Vescio, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: University of California, Irvine city: Orange state: California zip: 92868 country: United States name: Lisa Lee, MD role: PRINCIPAL_INVESTIGATOR lat: 33.78779 lon: -117.85311 facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Tom Martin, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Cleveland Clinic Florida, Weston Hospital city: Weston state: Florida zip: 33331 country: United States name: Chakra Chaulagain, MD role: PRINCIPAL_INVESTIGATOR lat: 26.10037 lon: -80.39977 facility: Tufts Medical Center city: Boston state: Massachusetts zip: 02111 country: United States name: Denis Toskic, BS role: CONTACT phone: 617-636-5907 email: denis.toskic@tuftsmedicine.org name: Raymond Comenzo, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Giada Bianchi, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Columbia University Medical Center city: New York state: New York zip: 10032 country: United States name: Suzanne Lentzsch, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Cancer Center city: New York state: New York zip: 10065 country: United States name: Heather Landau, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Atrium Health Levine Cancer Institute city: Charlotte state: North Carolina zip: 28204 country: United States name: Cindy Varga, MD role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 facility: UNC Lineberger Comprehensive Cancer Center city: Durham state: North Carolina zip: 27705 country: United States name: Sascha Tuchman, MD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 facility: UT Southwestern, Harold C. Simmons Comprehensive Cancer Center city: Dallas state: Texas zip: 75390 country: United States name: Gurbakhash Kaur, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: University of Utah, Huntsman Cancer Hospital city: Salt Lake City state: Utah zip: 84112 country: United States name: Amandeep Godara, MD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 facility: VCU Medical Center city: Richmond state: Virginia zip: 23219 country: United States name: Hashim Mann, MD role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False
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<|newrecord|> nctId: NCT06365047 id: STUDY00004926 briefTitle: Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2027-06-01 date: 2024-04-15 date: 2024-04-23 name: Tufts University class: OTHER name: Colgate Palmolive briefSummary: This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product. conditions: Xerostomia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: double blinded whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: 8% Arginine toothpaste name: 1000 ppm F toothpaste measure: Salivary pH Impact measure: Measuring the change in the oral microbiome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts University School of Dental Medicine city: Boston state: Massachusetts zip: 02111 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06365034 id: YKLL-KY-2024（024） briefTitle: Study on the Efficacy and Safety of Conversion Therapy in Patients With Initially Unresectable Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2025-01-31 date: 2024-04-15 date: 2024-04-15 name: Qianfoshan Hospital class: OTHER briefSummary: To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC). conditions: Carcinoma, Hepatocellular studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 92 type: ESTIMATED measure: Pathologic response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Qianfoshan Hospital status: RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: Jing Liang, Dr role: CONTACT phone: +8618663761275 email: liangjing0531@163.com lat: 36.66833 lon: 116.99722 hasResults: False
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<|newrecord|> nctId: NCT06365021 id: 88887.687583/2022-00 briefTitle: ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder overallStatus: RECRUITING date: 2024-05 date: 2025-08 date: 2026-08 date: 2024-04-15 date: 2024-04-15 name: Beny Lafer class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of Acceptance and Commitment Therapy (ACT) as a psychotherapeutic treatment for patients with Bipolar Disorder (BD). The following questions will be investigated:
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* The efficacy of ACT in reducing depressive symptoms in patients with BD.
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* The efficacy of ACT in improving the quality of life in patients with BD.
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* The efficacy of ACT in improving functionality in patients with BD.
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* The efficacy of ACT in improving sleep quality in patients with BD.
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* The efficacy of ACT in improving psychological flexibility in patients with BD
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Participants in the clinical group will undergo 12, 2 hours, weekly sessions of Acceptance and Commitment Therapy, in addition to their regular pharmacological treatment.
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Participants in the control group will undergo 3, 2 hours, weekly sessions of Bipolar Disorder Psychoeducation Therapy, in addition to their regular pharmacological treatment.
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Scales and assessments will be used to measure study outcomes on 3 different time-points: pre-intervention (month 0), post-intervention (month 3) and follow-up (month 6). Mood scales will be assessed every 2 weeks for the duration of treatment and every 4 weeks during the additional 12 week follow-up period. Psychological Flexibility scale will be assessed every week for the duration of treatment; as well as brief mood diary, which will be assessed daily for the duration of treatment.
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Results will be compared among both groups to assess the effectiveness of Acceptance and Commitment Therapy as an intervention for syndromic and sub-syndromic depression in bipolar disorder. conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Acceptance and Commitment Therapy name: Bipolar Disorder Psychoeducation Therapy measure: Montgomery-Asberg Depression Scale measure: Young Mania Rating Scale measure: Functional Assessment Staging Tool measure: World Health Organization Quality of Life Brief Scale measure: Pittsburgh Sleep Quality Index measure: Psychological Flexibility Questionnaire measure: Generalized Anxiety Disorder 7-item Scale measure: Medication Recommendation Tracking Form measure: Regulatory Satisfaction Alertness Timing Efficiency Duration measure: Adhesion and Satisfaction Questionnaire measure: Life Events Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tatiana Cohab Khafif status: RECRUITING city: São Paulo state: SP zip: 01231010 country: Brazil name: Tatiana Khafif, Master's degree role: CONTACT phone: +5511983389643 email: taticohab@gmail.com lat: -23.5475 lon: -46.63611 hasResults: False
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<|newrecord|> nctId: NCT06365008 id: SYSKY-2024-210-01 briefTitle: Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer overallStatus: RECRUITING date: 2024-04-08 date: 2027-04-08 date: 2027-09-30 date: 2024-04-15 date: 2024-04-15 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy. However, there are no standard recommendations for subsequent treatment after progression on first-line therapy. Here, the investigators conduct this open-label, monocenter, single arm phase II study to evaluate whether sintilimab in combination with irinotecan, leucovorin folinate and fluorouracil can be the salvage therapy for patients diagnosed with unresectable or metastatic gastric cancer progression on first-line therapy. Patients participated in this study will receive sintilimab 3mg/kg for patients with body weight\<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks. The primary endpoint is progression-free survival (PFS). The investigators estimated that 40 patients were necessary. Secondary endpoints include overall survival, objective response rate, disease control rate and safety for unresectable or metastatic gastric cancer. conditions: Unresectable/Metastatic Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients will receive sintilimab 3mg/kg for patients with body weight\<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Sintilimab+irinotecan+leucovorin folinate+fluorouracil measure: Progression-free survival measure: Overall survival measure: Objective response rate measure: Disease control rate measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Qiong Yang, Doctor role: CONTACT phone: 13632341201 email: yangqiong05@126.com name: Yajing Liu, Doctor role: CONTACT phone: 13631327315 email: liuyajing1030@126.com lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06364995 id: JKEUPM-2023-1364 briefTitle: Effects of Specialised Physical Education in Volleyball on Middle School Students' Physical Fitness and Performance overallStatus: RECRUITING date: 2024-01-10 date: 2024-06-28 date: 2024-07-05 date: 2024-04-15 date: 2024-04-16 name: Universiti Putra Malaysia class: OTHER briefSummary: Physical education stands as a collaborative, bilateral activity essential for the development and improvement of young people's physical qualities and plays a pivotal role in youth sports promotion. Volleyball offers a blend of aerobic and anaerobic exercises, developing muscle strength, bone density, cardiovascular health, and fine-tuning the nervous system. It is effective in improving physical attributes such as strength, speed, agility, endurance, and coordination, which are crucial for holistic student development and success in the standardized PE entrance examinations for senior high school.
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Recent trends have highlighted a decline in physical fitness among youth, as evidenced by rising obesity rates and increasing failure rates in fitness assessments. To counteract this, the Ministry of Education of the People's Republic of China 2021 has initiated a shift towards "specialised physical education," integrating health knowledge with basic and specialised motor skills training. This innovative educational model hopes to improve student physical fitness across educational tiers.
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Therefore, this study chose volleyball specialised physical education as an intervention to study the effect of physical fitness and The PE entrance examination for senior high school performance of middle school students. conditions: Physical Fitness conditions: Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: In this experiment, the experimental group used the intervention of specialised physical education teaching of volleyball. However, the control group only conducted traditional physical education teaching content primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Volleyball name: Traditional Physical Education measure: Effects of physical fitness of middle school students measure: Effects on middle school students' PE entrance examination for senior high school test performance sex: ALL minimumAge: 13 Years maximumAge: 15 Years stdAges: CHILD facility: Yimou MAO status: RECRUITING city: Chengdu state: Sichuan zip: 610044 country: China name: Yimou MAO, PHD role: CONTACT email: 912327111@qq.com lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06364982 id: PER-ECL-2023-05 briefTitle: Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease. overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: Universitat Internacional de Catalunya class: OTHER briefSummary: The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances. conditions: Peri-implant Mucositis conditions: Peri-Implantitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 180 type: ESTIMATED name: Two contiguous dental implants placed with less ≤ 3mm from each other. name: Two contiguous dental implants placed with > 3mm from each other. measure: Prevalence of peri-implant diseases. measure: FMPI measure: FMBI measure: mPI measure: mBI measure: SoP measure: PPD measure: MR measure: KM measure: Implant location measure: Implant position measure: Implant type measure: Implant brand measure: Implant roughness measure: Implant diameter measure: Implant length measure: Apico-coronal position of the implant measure: Inter-implant distances (IID) measure: Implant placement protocol measure: Bone grafting procedures (BGP) at implant placement measure: Implant-supported restorations measure: Cleansability of the prosthesis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clínica Universitaria de Odontologia city: Sant Cugat Del Vallès state: Barcelona zip: 08195 country: Spain lat: 41.47063 lon: 2.08611 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-10 uploadDate: 2024-04-10T16:21 filename: Prot_SAP_000.pdf size: 82991 hasResults: False
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<|newrecord|> nctId: NCT06364969 id: 2021-06-02 briefTitle: Investigation of the Pruritogens of Liver-related Diseases overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-08-01 date: 2025-08-01 date: 2024-04-15 date: 2024-04-16 name: Peking University class: OTHER briefSummary: This study hopes investigate the itch-inducing ability of different potential pruritogen candidates of cholestasis pruritus, especially the intrahepatic cholestasis of pregnancy (ICP). In this study, a combination of skin application and needle-free subcutaneous injection was used to investigate whether human endogenous molecules can cause itching. And a questionnaire is used to quantify the intensity of different candidates-induced itch. conditions: Cholestasis conditions: Intrahepatic Cholestasis of Pregnancy studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: Itch intensity measure: Flare areas sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Peking University city: Beijing state: Beijing zip: 100000 country: China name: Guangyi Lan role: CONTACT phone: 13176881226 email: Guangyi_lan@stu.pku.edu.cn name: Yulong Li role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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