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Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis \[1\]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD. |
Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi). |
Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium \> 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed conditions: Hyperkalemia conditions: Diet Modification conditions: Chronic Kidney Disease conditions: Sodium Zirconium Cyclosilicate studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Single center, cross-over randomized clinical trial with non-inferiority design primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Sodium zirconium cyclosilicate measure: The difference of serum potassium at baseline and after six weeks of treatment with potassium enriched diet (non-inferiority design) compared to the control group. With an intention to treat analysis. measure: Ambulatory blood pressure (average systolic and diastolic blood pressure over 24 hours) measure: 24 hours albuminuria measure: urinary potassium (mmol/l) measure: Plasma bicarbonate measure: Quality of life, using SF36 questionnaire measure: Effect on stool (assessed with Bristol Stool Chart) measure: Difference in serum potassium one week after start of study (SCZ free period) measure: Per protocol analysis of difference in serum potassium after six week (end of study) measure: Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia) measure: Incidence of hyperkalemia (serum potassium above 5.5 mmol/l) measure: Necessity for treatment of hyperkalemia measure: urinary sodium (mmol/l) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06365671 id: ASCT-CART briefTitle: CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2027-04 date: 2024-04-15 date: 2024-04-15 name: Ruijin Hospital class: OTHER briefSummary: Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors conditions: B-NHL, Extranodal, TP53 Alterations, Bulky Mass studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: autologous stem-cell transplantation, Relmacabtagene autoleucel (relma-cel) measure: Best Complete Response (CR) Rate in 3 months measure: Objective remission rate (ORR) in 3months measure: Duration of Response (DOR) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Adverse Events rate as assessed by CTCAE version 5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06365658 id: 2024/PTPiP/1 briefTitle: Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective overallStatus: RECRUITING date: 2023-07-03 date: 2025-03 date: 2025-12 date: 2024-04-15 date: 2024-04-22 name: Bartosz M. Radtke class: OTHER_GOV briefSummary: The goal of this observational study is to investigate cognitive functioning profiles in adults with neurologically recognized aphasic syndromes and general population. |
The study group consist of minimal 600 adults (over 18 y.o.) who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: memory, learning and language. Furthermore informations regarding past and present health condition will be collected from participants. |
The main questions it aims to answer are: |
1. What is the profile of memory and learning among polish adults? |
2. Do gender and age moderates patterns of memory and learning functioning among polish adults? |
3. What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes? |
4. Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes? |
Researchers will compare the following groups of adults: |
1. general population/control group |
2. with neurologically recognized aphasic syndromes |
3. seniors (over 60 y.o.) conditions: Aphasia conditions: Development, Human conditions: Neuropathology studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED name: Psychological assessment measure: Memory and learning measure: Language measure: Socio-demographic data measure: General mental state measure: Health related data measure: Education data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Laboratory of Psychological and Educational Tests status: RECRUITING city: Gdansk state: Pomerania zip: 80-239 country: Poland name: Rafał Nowicki, M.A. role: CONTACT phone: +48509805591 email: [email protected] name: Urszula Sajewicz-Radtke, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Bartosz M Radtke, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Ariadna Łada-Maśko, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Beata Daniluk, Ph.D. role: SUB_INVESTIGATOR name: Piotr Markiewicz, Ph.D. role: SUB_INVESTIGATOR name: Paweł Jurek, Ph.D. role: SUB_INVESTIGATOR name: Michał Olech, Ph.D. role: SUB_INVESTIGATOR name: Artur Sawicki, M.A. role: SUB_INVESTIGATOR name: Rafał Nowicki, M.A. role: SUB_INVESTIGATOR lat: 54.35205 lon: 18.64637 hasResults: False |
<|newrecord|> nctId: NCT06365645 id: 2138752 briefTitle: Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-12 date: 2024-04-15 date: 2024-04-15 name: Women and Infants Hospital of Rhode Island class: OTHER briefSummary: Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers \& Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention. conditions: Postpartum Depression conditions: Postpartum Anxiety conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Participants who consent will be unaware of the existence of another version of M.Bapp. Obstetric care providers will be aware of participant's enrollment in this trial but not of the study group and will be encouraged to provide standardized care. The research team and outcomes assessors will be blindd to the randomization group. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: M.Bapp name: App-based parenting education measure: Feasibility measure: Acceptability measure: Edinburgh Postnatal Depression Scale measure: General Anxiety Disorder-7 measure: Perceived Stress-Scale 4 measure: Dyadic Adjustment Scale measure: UCLA Loneliness Scale measure: Frequency of Mothers and Babies Skills Use measure: De novo psychiatric diagnosis measure: Screening positive on study survey sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Women & Infants Hospital of Rhode Island city: Providence state: Rhode Island zip: 02905 country: United States lat: 41.82399 lon: -71.41283 hasResults: False |
<|newrecord|> nctId: NCT06365632 id: OLTOSPAN-02 briefTitle: Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis acronym: OLTOSPAN-02 overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2024-12 date: 2024-04-15 date: 2024-04-15 name: Research Institute for Physical Chemical Problems of the Belarusian State University class: OTHER name: Unitary Enterprise UNITEHPROM BSU name: City Clinical Hospital of Emergency Medical Care of Minsk briefSummary: The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions. conditions: Abdominal Adhesions studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus name: antegrade appendectomy measure: Number of patients with acute phlegmonous appendicitis cured measure: absence of signs of adhesions measure: increase in the sliding distance of the cecum sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CITY CLINICAL EMERGENCY HOSPITAL of Minsk city: Minsk zip: 220024 country: Belarus name: Olga Svetlitskaya role: CONTACT phone: +375297752697 email: [email protected] name: Yulia Shabalina role: CONTACT phone: +375 (17) 287 00 15 email: [email protected] lat: 53.9 lon: 27.56667 facility: CITY CLINICAL EMERGENCY HOSPITAL of Minsk city: Minsk zip: 220024 country: Belarus name: Olga Svetlitskaya role: CONTACT phone: +375297752697 email: [email protected] name: Yulia Shabalina role: CONTACT phone: +375 (17) 287 00 15 email: [email protected] name: Stanislav Tretiak, Doctor of Medicine role: PRINCIPAL_INVESTIGATOR name: Alexander Zhura, Doctor of Medicine role: SUB_INVESTIGATOR lat: 53.9 lon: 27.56667 hasResults: False |
<|newrecord|> nctId: NCT06365619 id: HCI168525 briefTitle: Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma acronym: NeoRelapse overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-08 date: 2029-08 date: 2024-04-15 date: 2024-04-15 name: University of Utah class: OTHER briefSummary: The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy. |
Participants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response. conditions: Melanoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Ipilimumab name: Nivolumab measure: Rate of pathologic response rate (pCR, mCR/nCR, or pPR) at the time of surgery. measure: Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment. measure: Rate of adverse events that occur within 30 days post-surgery. measure: Rate of Event Free Survival (EFS). measure: Rate of Overall Survival (OS). measure: Objective response rate (ORR) defined as the proportion of subjects achieving a confirmed PR and CR as defined by RECIST 1.1 prior to surgical resection. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huntsman Cancer Institute city: Salt Lake City state: Utah zip: 84112 country: United States lat: 40.76078 lon: -111.89105 hasResults: False |
<|newrecord|> nctId: NCT06365606 id: CLS-015A briefTitle: Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites overallStatus: RECRUITING date: 2024-03-14 date: 2024-04-10 date: 2024-05-29 date: 2024-04-15 date: 2024-04-15 name: bioLytical Laboratories class: INDUSTRY briefSummary: This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at conditions: Syphilis Infection conditions: Syphilis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: DOUBLE maskingDescription: Participants and the healthcare providers are not aware of the syphilis status. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 4500 type: ESTIMATED name: iStatis Syphilis Ab Test measure: Sensitivity and specificity of the iStatis Syphilis Ab Test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Epicentre Health Research status: RECRUITING city: Hillcrest state: KwaZulu Natal zip: 3650 country: South Africa name: Cherie Cawood role: CONTACT phone: +27 828202955 email: [email protected] hasResults: False |
<|newrecord|> nctId: NCT06365593 id: D8450R00005 briefTitle: hATTR Polyneuropathy in Russia acronym: PRIMER overallStatus: RECRUITING date: 2023-12-29 date: 2024-05-31 date: 2024-05-31 date: 2024-04-15 date: 2024-04-15 name: AstraZeneca class: INDUSTRY briefSummary: A multicenter observational retrosPective Registry of patIents with transthyretin aMyloid polynEuropathy (hATTR-PN) and chRonic idiopathic axonal polyneuropathy (CIAP) in the population of the Russian Federation (PRIMER) There are no comprehensive epidemiological data on patients with hereditary ATTR-PN (hATTR-PN) and CIAP in the Russian Federation. Therefore, there is a need to conduct a large-scale observational study in the Russian population to obtain information on clinical, electrophysiological and demographic characteristics of patients with hATTR-PN and CIAP. Obtaining the study data will help to identify the patients with axonal polyneuropathy, who deserve TTR gene sequencing, and therefore to allow early treatment and potentially modify disease progression in patients. conditions: Hereditary Transthyretin Amyloidosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: In order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Mean age at the hATTR-PN or CIAP diagnosis information will be collected measure: In order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of women and men will be collected measure: In order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with each race and ethnicity will be collected measure: to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIA, information on Proportion of patients from each federal district of the Russian Federation will be collected measure: in order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, tha following Anthropometric characteristics will be collected: measure: In order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with underweight will be collected measure: in order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with negative lifestyle factors will be collected: measure: in order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with positive family history in close relatives will be collected measure: to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, information on Mean (or median) time from the first symptoms of neuropathy to the diagnosis of PN will be collected measure: to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, Proportion of patients with different firstly suspected etiology of PN will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, information on Mean (or median) time from first PN manifestation/diagnosis to the hATTR-PN or CIAP diagnosis will be collected measure: To describe the baseline electrophysiological and clinical characteristics of patients, Proportion of patients with chronic sensory or sensorimotor polyneuropathy and progressive chronic polyneuropathy among patients with CIAP will be calculated measure: To describe the baseline clinical characteristics of patients with hATTR-PN and CIAP, Proportion of patients with each result of TTR gene testing will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each clinical manifestation will be calculated: measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each PND score will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each score by each parameter of neurological examination will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean point by MRS will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean point by INCAT scale (total score, arm disability, leg disability) will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean left ventricular ejection fraction (LVEF) will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information Mean wall thickness of the left ventricular (LV) will be collected measure: To describe the baseline electrophysiological characteristics of patients with hATTR-PN and CIAP, information Mean variables based on the results of electrophysiological investigation, including the following (on both extremities) will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with diagnosis of HFpEF will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean NT-proBNP level will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information Mean estimated glomerular filtration rate (eGFR) will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean urine albumin-to-creatinine ratio (UACR) in a spot urine sample will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with a positive paraprotein blood test result will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean blood pressure (BP) (systolic and diastolic) and Mean heart rate (HR) measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each concomitant disease will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients underwent surgery for CTS to the moment of diagnosis will be calculated measure: To arrange a score to select patients with axonal neuropathy who deserve screening for TTR mutation. measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP in the Russian Federation during retrospective follow-up period Mean changes in BMI at visits 2, 3 will be compared to baseline measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with newly diagnosed clinical manifestations will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period, Proportion of patients with different newly diagnosed clinical manifestations will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with each PND score at visits 2, 3 will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP, Proportion of patients with worsening of PND score at visits 2, 3 compared to baseline will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with hospitalisations (one or more) will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of different reasons for hospitalisations will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with death for all causes will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients during follow-up period Proportion of patients with different causes of death will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients during retrospective follow-up period Proportion of patients with each score by each parameter of neurological examination at visits 2, 3 will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in MRS at visits 2, 3 compared to baseline will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in INCAT scale at visits 2, 3 compared to baseline will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with diagnosis of HFpEF at visits 2, 3 will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in LVEF at visits 2, 3 compared to baseline will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in wall thickness of the LV at visits 2, 3 compared to baseline will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in NT-proBNP at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in eGFR at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in UACR at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with a positive paraprotein blood test result at visits 2, 3 will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in BP at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in HR at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with new concomitant diseases will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with different new concomitant diseases will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with presence of CTS surgery will be calculated sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Kazan country: Russian Federation lat: 55.78874 lon: 49.12214 facility: Research Site status: RECRUITING city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Research Site status: RECRUITING city: Saint-Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 hasResults: False |
<|newrecord|> nctId: NCT06365580 id: Kylo-0603-I-C01 briefTitle: Dose Escalation Study of Kylo-0603 in Healthy Subjects overallStatus: RECRUITING date: 2023-05-23 date: 2024-06-30 date: 2024-06-30 date: 2024-04-15 date: 2024-04-16 name: Kylonova (Xiamen) Biopharma co., LTD. class: INDUSTRY briefSummary: This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects. conditions: Nonalcoholic Steatohepatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 124 type: ESTIMATED name: Kylo-0603 capsule name: Placebo measure: incidence of adverse events measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax) measure: PK parameter of time of maximum observed concentration (Tmax) measure: PK parameter of area under the concentration time curve (AUC) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The first affiliated hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False |
<|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. |
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. |
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 |
<|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 |
<|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: [email protected] lat: 21.65 lon: 110.9 hasResults: False |
<|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 |
<|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. |
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. |
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: [email protected] lat: 48.52266 lon: 9.05222 hasResults: False |
<|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 |
<|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 |
<|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: [email protected] name: Shu-mei Yang, MD role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 hasResults: False |
<|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: [email protected] lat: 46.05108 lon: 14.50513 hasResults: False |
<|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 |
<|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 |
<|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 |
<|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. |
1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation |
2. Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction |
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 |
<|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. |
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 |
<|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). |
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). |
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 |
<|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: [email protected] name: Hongyu Zhong, MD role: SUB_INVESTIGATOR lat: 36.66833 lon: 116.99722 hasResults: False |
<|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. |
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. |
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. |
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. |
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. |
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). |
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 |
<|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: [email protected] lat: 22.27832 lon: 114.17469 hasResults: False |
<|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 |
<|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. |
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. |
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. |
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. |
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: [email protected] name: Anna Crescenti, PhD role: CONTACT phone: +34977770958 phoneExt: 4832 email: [email protected] lat: 41.15612 lon: 1.10687 hasResults: False |
<|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. |
Distribution of treatment methods by groups: |
1A - use of "Histograft" for spinal fusion of the cervical spine, 50 patients |
1. B - use of synthetic osteoplastic material based on β-TCP for spinal fusion of the cervical spine, 50 patients |
2. A - use of "Histograft" for spinal fusion of the lumbar spine, 100 patients |
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: [email protected] name: Mark Aleksanyan role: CONTACT name: Renat Nurmukhametov, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False |
<|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: [email protected] lat: 10.03711 lon: 105.78825 hasResults: False |
<|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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