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The aim of the study is to assess if the insole under study allows the patient to reach a better mobility and a faster return to the normal everyday life. conditions: Plantar Fascitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: TAP insole measure: Change in pain severity according to visual analog scale measure: Change in pain severity according to visual analog scale measure: Subjective functional recovery based on the Foot Function Index (FFI) score [ measure: Quality of life and foot general health through the assessment of the Foot Health Status Questionnaire (FHSQ) measure: Patient satisfaction on a 0-10 numeric rating scale (NRS) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: EOC status: RECRUITING city: Lugano zip: 6900 country: Switzerland name: Martin Riegger, Dr.med role: CONTACT phone: +41 (0) 91 811 70 29 email: [email protected] lat: 46.01008 lon: 8.96004 hasResults: False |
<|newrecord|> nctId: NCT06386393 id: HHSP233201500048I-75P00120F370 briefTitle: Survey on Where Parents Look for and Find Information and How They Use Information When Selecting Child Care overallStatus: ENROLLING_BY_INVITATION date: 2024-03-28 date: 2024-06-30 date: 2024-06-30 date: 2024-04-26 date: 2024-04-29 name: National Opinion Research Center class: OTHER name: Office of Planning, Research & Evaluation name: Urban Institute briefSummary: The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is contracting with NORC at the University of Chicago to collect nationally representative survey data to learn more about where parents look for and find information about Child Care and Early Education (CCEE); how parents assess the people, places, or things that may offer CCEE information; what types of CCEE information parents look for; and how parents use information to make CCEE selections. The study aims to gather information that may be used by Child Care Lead Agencies to inform their consumer education efforts. This study is part of the Consumer Education and Parental Choice in Early Care and Education (CEPC) project. |
The study will select a nationally representative sample from NORC's probability-based AmeriSpeak panel. The AmeriSpeak panel provides sample coverage of approximately 97 percent of the U.S. population. It currently contains 48,900 panel members age 13 and over residing in over 40,000 households. U.S. households are randomly selected with a known, non-zero probability from the NORC National Frame, and then recruited by mail, telephone, and by field interviewers face-to-face. NORC's in-person recruitment enhances representativeness for young adults, lower socio-economic households, non-internet households, and other households that are typically hard to reach for statistical surveys of the population. |
The survey respondents are AmeriSpeak panelists of at least 18 years of age who have indicated that they have a young child in the household (under the age of 6 years, but not in kindergarten). If a household has two or more panel members who reside in a household with a young child, one will be selected at random to complete the survey, with preference given to parents/legal guardians. Selected panelists will be asked questions to confirm eligibility for the survey, including that the household has at least one child under the age of 6 but not in kindergarten. The study is designed to include parents and legal guardians across race/ethnicity, education level, and gender from the full spectrum of geographic locations. To include families who may not have English as a preferred language, a Spanish version of the survey will be provided. The survey will include parents and legal guardians using many kinds of CCEE and those who use parental care only to see if there are differences in how information is used depending on care type. In addition, the study will include understudied subgroups, such as parents who speak a language other than English, to help inform consumer education efforts. The survey is intended to produce findings that are generalizable to the larger population of parents with children under the age of 6, but not in kindergarten. conditions: Searching for and Selecting Child Care in the US studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 2196 type: ESTIMATED measure: Primary sources of information about child care measure: How parents assess the people, places, or things that may offer CCEE information measure: What types of CCEE related information parents look for measure: Information about the last time parents made a decision about CCEE and what information they tried to learn about at that time measure: Characteristics and experiences of the household and types of CCEE being used sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NORC at the University of Chicago city: Chicago state: Illinois zip: 60603 country: United States lat: 41.85003 lon: -87.65005 hasResults: False |
<|newrecord|> nctId: NCT06386380 id: IRE-4906 briefTitle: Adversity and Its Association With the Development and Expression of Rheumatic Diseases acronym: RD overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-01-01 date: 2026-02-01 date: 2024-04-26 date: 2024-04-26 name: National Institute of Medical Sciences and Nutrition, Salvador Zubiran class: OTHER briefSummary: Epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. In the field of rheumatic diseases, traumatic events, not only in childhood, have been associated with hospitalization, chronic pain, inflammation, worse outcomes, severity of the disease, and mortality. Some mechanisms proposed to explain the association between the experience of adversity and the development of chronic diseases include an impact on the physiology of immune system cells, gene expression due to DNA modification, and cellular senescence. |
With this background, we wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness. conditions: RhA - Rheumatoid Arthritis studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 110 type: ESTIMATED name: Rheumatic diseases Mistreatment Scale (RDMS) name: Routine assessment of patient index data 3 (RAPID-3) name: Health Assessment Questionnaire (HAQ) name: WHOQOL-BREF name: Depression, Anxiety and Stress Scale (DASS-21) name: Brief Resilient Coping Scale name: Expression of CDKN2A /p16INK4a name: Immunophenotype of leukocyte subpopulations name: Telomere length name: Cellular senescence measure: Adversity and senescence in patients with rheumatoid arthritis measure: Eexpression of the p16INK4a gene in CD3+ measure: Telomere length sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386367 id: MHNO-001 briefTitle: Health Education by Buddhist Monks to Promote Malaria Knowledge and Preventive Practices in Rural Myanmar overallStatus: COMPLETED date: 2022-07-01 date: 2023-03-31 date: 2024-03-30 date: 2024-04-26 date: 2024-04-29 name: Myanmar Health Network Organization class: OTHER name: Chulalongkorn University name: Ministry of Health and Sports, Myanmar briefSummary: Malaria is still a leading public health concern in Myanmar. However, people living in rural areas usually showed poor prevention practice despite residing in malaria hotspots. The majority in Myanmar are Buddhists who frequently visit the monastery and receive the speech delivered by the monks. In a malaria high burden township of the Sagaing Region from northern Myanmar, current study will first explore the difference in malaria preventive practices among people residing in different malaria-endemic villages through a mixed-methods approach. Next, this research will address the knowledge gaps by a monastery-based health education delivered by trained Buddhist monks using standardized health messages instruction for six consecutive months between August 2022 to January 2023. To test whether the intervention could balance those gaps among different groups, quantitative data of baseline, 3-month, and 6-month will be compared using descriptive statistics, chi-square test, T-test or repeated ANOVA, and the Difference-In-Differences (DID) analysis, as applicable. conditions: Buddhist Monks conditions: Health Education conditions: Malaria conditions: Monastery-based conditions: Myanmar conditions: Preventive Practice studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 501 type: ACTUAL name: Monastery-based health education by Buddhist monks measure: Malaria knowledge and preventive practices sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Myanmar Health Network Organization city: Yangon zip: 11091 country: Myanmar lat: 16.80528 lon: 96.15611 hasResults: False |
<|newrecord|> nctId: NCT06386354 id: 2023-464-1 briefTitle: Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications acronym: Porcerito overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-30 date: 2024-06-30 date: 2024-04-26 date: 2024-04-26 name: Dr. Negrin University Hospital class: OTHER briefSummary: The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient. conditions: Postoperative Neuromuscular Block conditions: Postoperative Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Train-of-four measure: Residual Neuromuscular Block measure: Residual Neuromuscular Block measure: Postoperative complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ángel Becerra city: Las Palmas De Gran Canaria state: Las Palmas zip: 35019 country: Spain lat: 28.09973 lon: -15.41343 hasResults: False |
<|newrecord|> nctId: NCT06386341 id: W23.154 briefTitle: QoL in OSA patiënts Treated With MMA Surgery. acronym: QOMAS overallStatus: RECRUITING date: 2023-08-02 date: 2026-08-02 date: 2026-08-02 date: 2024-04-26 date: 2024-04-26 name: Diakonessenhuis, Utrecht class: OTHER briefSummary: The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea. |
The main question it aims to answer is: |
Does MMA surgery in OSA patiënts improve their quality of life? |
Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure. conditions: Sleep Apnea, Obstructive conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Maxillomandibular Advancement Surgery measure: SF-36 measure: OHIP-14 measure: ESS measure: FOSQ measure: EQ-5D-3L measure: OQLQ sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Diakonessenhuis status: RECRUITING city: Utrecht zip: 3582KE country: Netherlands name: Susanne Leij role: CONTACT phone: 088-250 6172 email: [email protected] name: Maurits de Ruiter, MD, DDS, PHD role: PRINCIPAL_INVESTIGATOR name: Haya Al-Bayyati role: SUB_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False |
<|newrecord|> nctId: NCT06386328 id: A129_03FDI2317 briefTitle: A Clinical Trial to Evaluate the Food Effect of CKD-378 overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-06-03 date: 2024-06-11 date: 2024-04-26 date: 2024-04-26 name: Chong Kun Dang Pharmaceutical class: INDUSTRY briefSummary: A clinical trial to evaluate the food effect of CKD-378 conditions: Type II Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CKD-378, QD, PO measure: AUCt of CKD-378 measure: Cmax of CKD-378 sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386315 id: MC230808 id: NCI-2024-03242 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-010273 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230808 type: OTHER domain: Mayo Clinic briefTitle: Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-30 date: 2024-05-30 date: 2024-04-26 date: 2024-04-29 name: Mayo Clinic class: OTHER briefSummary: This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma. conditions: Indolent B-Cell Non-Hodgkin Lymphoma conditions: Recurrent Indolent B-Cell Non-Hodgkin Lymphoma conditions: Refractory Indolent B-Cell Non-Hodgkin Lymphoma conditions: Recurrent Indolent Non-Hodgkin Lymphoma conditions: Refractory Indolent Non-Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: Computed Tomography name: Endoscopic Procedure name: Involved-site Radiation Therapy (3 Fractions) name: Involved-site Radiation Therapy (12 Fractions) name: Positron Emission Tomography name: Questionnaire Administration measure: Incidence of grade 2 or higher acute adverse events (AEs) measure: Response rate measure: Time to progression rate measure: Patient reported quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona city: Scottsdale state: Arizona zip: 85259 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: William G. Rule, MD role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Bradford S. Hoppe, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Scott C. Lester, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False |
<|newrecord|> nctId: NCT06386302 id: CSIIT-A36 briefTitle: Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2027-12-30 date: 2027-12-30 date: 2024-04-26 date: 2024-04-26 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy. conditions: AML conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 184 type: ESTIMATED name: Chidamide name: Venetoclax name: azacitidine measure: Composite complete remission rate measure: Overall response rate (ORR) measure: Overall survival (OS) measure: MRD response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386289 id: CNV202202 briefTitle: Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke acronym: SPLENDID overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-02-28 date: 2026-06-30 date: 2024-04-26 date: 2024-04-26 name: Cerenovus, Part of DePuy Synthes Products, Inc. class: INDUSTRY briefSummary: The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 172 type: ESTIMATED name: Cereglide 92 measure: First pass reperfusion sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Iowa Hospital & Clinics city: Iowa City state: Iowa zip: 52242 country: United States lat: 41.66113 lon: -91.53017 facility: JFK Medical Center city: Edison state: New Jersey zip: 08820 country: United States lat: 40.51872 lon: -74.4121 facility: Westchester Medical Center city: Valhalla state: New York zip: 10595 country: United States lat: 41.07482 lon: -73.77513 facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37232 country: United States lat: 36.16589 lon: -86.78444 facility: University of Utah city: Salt Lake City state: Utah zip: 84132 country: United States lat: 40.76078 lon: -111.89105 facility: West Virginia University city: Morgantown state: West Virginia zip: 26506 country: United States lat: 39.62953 lon: -79.9559 hasResults: False |
<|newrecord|> nctId: NCT06386276 id: 00025986 briefTitle: Surgical TReatment of Women With Deep ENDometriosis acronym: TrEnd overallStatus: RECRUITING date: 2023-10-11 date: 2028-06-30 date: 2029-06-30 date: 2024-04-26 date: 2024-04-26 name: Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A. class: OTHER briefSummary: TrEnd trial is aimed to collect data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis. The main purpose of this project is to gather a large series of cases treated using standardized surgical procedures, allowing a precise evaluation of complications and long-term outcomes. conditions: Deep Endometriosis conditions: Surgery studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 250 type: ESTIMATED name: Colorectal bowel resection measure: To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection measure: To assess the rate of complications measure: To assess the rate of conversion to open surgery measure: To assess the rate of endometriosis-free bowel resection margins measure: To assess the rate of recurrence measure: To assess the intraoperative blood loss measure: To assess the operating time measure: To assess the gastrointestinal function recovery measure: To assess the duration of hospital stay measure: To assess the reproductive outcomes sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Casa Di Cura Malzoni Villa Platani Spa status: RECRUITING city: Avellino state: Campania zip: 83100 country: Italy name: Francesca Falcone, MD role: CONTACT email: [email protected] name: Mario Malzoni, MD role: PRINCIPAL_INVESTIGATOR name: Francesca Falcone, MD role: PRINCIPAL_INVESTIGATOR lat: 40.91494 lon: 14.79103 hasResults: False |
<|newrecord|> nctId: NCT06386263 id: D9673R00032 briefTitle: HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada acronym: HER-TEMPO overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2025-04-04 date: 2025-04-04 date: 2024-04-26 date: 2024-04-26 name: AstraZeneca class: INDUSTRY name: Daiichi Sankyo briefSummary: Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively. |
Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related outcomes in order to better represent the effectiveness of therapies in routine care settings. conditions: Unresectable Breast Cancer conditions: Metastatic Breast Cancer conditions: HER2-low Expressing Breast Cancer conditions: HER2-positive Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 75 type: ESTIMATED name: Trastuzumab deruxtecan measure: Early treatment discontinuation rates measure: Dose modifications measure: Real world time to treatment discontinuation (rwTTD) measure: Reasons for treatment discontinuations measure: Median treatment duration and dose intensity sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NavieGo Patient ProgramsLtd & Affiliate city: Oakville state: Ontario zip: L6H 1A7 country: Canada lat: 43.45011 lon: -79.68292 hasResults: False |
<|newrecord|> nctId: NCT06386250 id: 0005 briefTitle: Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy acronym: Painseverity overallStatus: COMPLETED date: 2019-01-05 date: 2020-01-06 date: 2020-01-06 date: 2024-04-26 date: 2024-04-26 name: King Edward Medical University class: OTHER briefSummary: Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known. |
Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C) primaryPurpose: PREVENTION masking: NONE count: 300 type: ACTUAL name: regional block name: Caudal block name: Epidural measure: Postoperative pain intensity measure: postoperative pain intesity sex: ALL minimumAge: 3 Years maximumAge: 12 Years stdAges: CHILD facility: Muhammad Sharif city: Lahore state: Punjab zip: 53711 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False |
<|newrecord|> nctId: NCT06386237 id: UVienna_NDNL_1 briefTitle: Nutritional Modulation of Cognition and Brain Activity overallStatus: RECRUITING date: 2024-04-08 date: 2025-02-28 date: 2025-02-28 date: 2024-04-26 date: 2024-04-26 name: University of Vienna class: OTHER name: Medical University of Vienna briefSummary: The aim of the present study is to investigate the effects of different meal interventions on cognition (i.e., learning and decision making) and brain activity in healthy participants. conditions: Nutrition, Healthy conditions: Cognitive Change conditions: Brain Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios) measure: Changes in cognition/behavior I measure: Changes in cognition/behavior II measure: Changes in brain activity measure: Changes in metabolic parameters I measure: Changes in metabolic parameters II measure: Changes in metabolic parameters III measure: Changes in metabolic parameters IV measure: Changes in subjective affective state measure: Changes in experienced hunger sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Stefan Schulreich, Prof. Dr. role: CONTACT phone: +4314277 phoneExt: 54960 email: [email protected] lat: 48.20849 lon: 16.37208 hasResults: False |
<|newrecord|> nctId: NCT06386224 id: 1R01DK137520-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DK137520-01 briefTitle: Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain acronym: IMPACT-2 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2026-09-30 date: 2024-04-26 date: 2024-04-26 name: Seattle Children's Hospital class: OTHER name: University of Kentucky briefSummary: Severe and disabling abdominal pain is common in individuals with chronic pancreatitis. Although pain is associated with reduced quality of life and high economic and societal costs, there are limited effective options for pain management in this population. This study proposes an evidence-based psychological intervention approach using an internet-delivered pain self-management program to minimize the impact of pain and improve quality of life. The ultimate goal is to maximize the public health impact of the intervention with successful implementation and dissemination to pancreas clinics and to the community. conditions: Pancreatitis conditions: Chronic Pancreatitis conditions: Acute Recurrent Pancreatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants randomized to the active intervention arm will receive access to the Pancreatitis Pain Course to learn cognitive-behavioral (CBT) pain self-management skills (e.g., changing negative thoughts, relaxation, activity pacing, goal setting). Participants randomized to the control arm will receive access to an education website. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Participants are not informed of their condition assignment and both receive online programs for chronic pancreatitis. Investigators are blinded \& masked to study condition, and all outcomes are assessed via self-reported REDCap surveys. Care providers are not involved in the study (N/A). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 280 type: ESTIMATED name: Internet-delivered pain self-management (CBT Condition) name: Education Program measure: Change in pain severity and pain interference measure: Change in disease-specific pain measure: Change in physical functioning measure: Change in psychological functioning measure: Change in pain catastrophizing measure: Change in sleep disturbance measure: Change in disease specific health-related quality of life measure: Change in patient global impression of change measure: Change in opioid use measure: Treatment acceptability measure: Change in substance use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seattle Children's Hospital city: Seattle state: Washington zip: 98105 country: United States name: Tonya Palermo, PhD role: CONTACT phone: 206-884-4208 email: [email protected] name: Tonya M Palermo, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False |
<|newrecord|> nctId: NCT06386211 id: BDR17228 id: BDR17228 type: OTHER domain: Sanofi Identifier briefTitle: Bioavailability Study of Magne-B6 New Formulation overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2024-06-15 date: 2024-06-15 date: 2024-04-26 date: 2024-04-26 name: Opella Healthcare Group SAS, a Sanofi Company class: INDUSTRY briefSummary: The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: MAGNE-B6 Oral Solution name: MAGNE-B6 New Formulation Tablet measure: Maximal Observed Concentration (Cmax) of Magnesium in Plasma measure: Area Under the Concentration-time Curve from Time Zero Until time 12 hour (h) (AUC0-12) of Magnesium in Plasma measure: Area Under the Concentration-time Curve from Time Zero Until time 24 h (AUC0-24) of Magnesium in Plasma measure: Maximal Observed Concentration (Cmax) of Pyridoxine in Plasma measure: Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUClast) of Pyridoxine in Plasma measure: Area Under the Concentration-time Curve from Time Zero to Infinity (extrapolated) (AUC0-infinity) of Pyridoxine in Plasma measure: Time When the Maximal Concentration is Observed (Tmax) of Magnesium in Plasma measure: Time When the Maximal Concentration is Observed (Tmax) of Pyridoxine in Plasma measure: Cumulative Amount of Unchanged Drug Excreted into the Urine From Time Zero to the Time Point 24 hours (Ae0-24) of Magnesium in Urine measure: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06386198 id: 23-40699 briefTitle: HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients acronym: HEAL-Tx:ToC overallStatus: RECRUITING date: 2024-03-03 date: 2026-06-30 date: 2026-06-30 date: 2024-04-26 date: 2024-04-26 name: University of California, San Francisco class: OTHER name: American Society of Transplantation briefSummary: The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM. conditions: Liver Transplant; Complications conditions: Pediatric ALL studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Health Advocate measure: Changes in patient experience measure: Change in medication adherence using MLVI measure: The quality of health advocate interactions with the participants, healthcare team, and community-based resources. measure: A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention. sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: University of California San Francisco status: RECRUITING city: San Francisco state: California zip: 94158 country: United States name: Emily Stekol role: CONTACT phone: 415-502-3190 email: [email protected] name: Sharad Wadhwani, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Children's Healthcare of Atlanta status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30345 country: United States name: Nitika Gupta role: CONTACT name: Nitika Gupta role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False |
<|newrecord|> nctId: NCT06386185 id: DRAPE briefTitle: Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography acronym: DRAPE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-07-01 date: 2026-11-01 date: 2024-04-26 date: 2024-04-26 name: Royal United Hospitals Bath NHS Foundation Trust class: OTHER name: Sheffield Teaching Hospitals NHS Foundation Trust name: Royal Free Hospital NHS Foundation Trust name: Golden Jubilee National Hospital name: Papworth Hospital NHS Foundation Trust name: University of Bath briefSummary: The goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (RV) function in echocardiography, and ECG have in detecting pulmonary hypertension. |
The main questions it aims to answer are: |
Can novel markers in ECG and echocardiography suggest the presence of PH? Can existing screening guidelines be improved with the addition of these markers? conditions: Pulmonary Hypertension studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 2500 type: ESTIMATED name: Electrocardiogram name: Transthoracic echocardiogram name: Right heart catheter measure: Distinguish between patients with and without pulmonary hypertension measure: Distinguish between patients with pre-capillary hypertension and post-capillary hypertension measure: Assess the impact of the severity of pulmonary hypertension measure: Assess the impact of additional ECG markers on existing PH probability stratification sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal United Hospital NHS Foundation Trust city: Bath state: Banes zip: BA1 3NG country: United Kingdom lat: 51.3751 lon: -2.36172 facility: Golden Jubilee Hospital city: Glasgow state: Lanarkshire zip: G81 4DY country: United Kingdom lat: 55.86515 lon: -4.25763 facility: Sheffield Teaching Hospitals NHS Foundation Trust city: Sheffield state: South Yorkshire zip: S10 2JF country: United Kingdom lat: 53.38297 lon: -1.4659 facility: Royal Papworth Hospital city: Cambridge zip: CB2 0AY country: United Kingdom lat: 52.2 lon: 0.11667 facility: Royal Free NHS Foundation Trust city: London zip: NW3 2QG country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False |
<|newrecord|> nctId: NCT06386172 id: 2023-03537-01 id: FoUI-986028 type: OTHER_GRANT domain: ALF Medicin, Region Stockholm briefTitle: Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm acronym: ALMA-CKD overallStatus: RECRUITING date: 2023-09-09 date: 2025-04 date: 2026-12 date: 2024-04-26 date: 2024-04-26 name: Karolinska Institutet class: OTHER name: Danderyd Hospital name: Region Stockholm briefSummary: One in 10 adults in Region Stockholm have chronic kidney disease (CKD), which dramatically increases healthcare costs and the risk of medication errors or adverse health outcomes, including cardiovascular disease and death. Identification and early management of these patients is done in primary care settings. However, most adults with CKD in our region are under detected, undiagnosed and undertreated, with low rates of referral to nephrology-specialist care. |
This is a pragmatic cluster randomized controlled trial (RCT) involving 66 primary healthcare centers in Region Stockholm, and testing the effect of an electronic clinical decision support (CDS) triggering system to assist general practitioners through the guideline-recommended processes of CKD care. |
The centers, providing healthcare to approximately 780.000 citizens, will be randomized 50:50 to this CDS trigger (vs basic advice) for 18 months. Study outcomes will consider the improvement in the indicators of CKD care. |
As a pragmatic trial there is no active recruitment or active data collection. The trial is embedded into the ongoing Stockholm CREAtinine Measurements (SCREAM) project, a database collection of healthcare use for the complete population of Stockholm. Using this real-world healthcare data collection, the investigators will be able to measure with precision the impact of our CDS trigger and its potential to improve clinical care. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The primary healthcare network system of the region of Stockholm coordinates 66 public primary healthcare centers. Collectively, these centers offer care to an estimated population of 780.000. Since November 2022, a new platform for CDS (clinical decision support) triggers called ALMA has been implemented in these centers. ALMA is connected to patient records and uses CDS triggers to identify medical problems, issue alerts and propose solutions. |
Using the ALMA platform, this project has the following objectives: |
Objective 1: to develop a CDS trigger connected with the electronic healthcare records specific to the processes of screening, diagnosis, and nephrologist referral of patients with CKD, including individualized CKD management optimization, in primary care. |
Objective 2: to evaluate the effectiveness of this CDS trigger (versus current basic advice) through a 2-arm pragmatic cluster RCT. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 780000 type: ESTIMATED name: Clinical decision support trigger measure: Number of participants screened for creatinine and albuminuria measure: Number of screened participants with retesting for creatinine and albuminuria measure: Number of participants with laboratory-determined CKD receiving a clinical diagnosis measure: Number of participants receiving CKD-modifying agents measure: Number of participants referred to nephrologist care sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Institutet status: RECRUITING city: Stockholm country: Sweden name: Juan J Carrero, Prof role: CONTACT phone: 0046739636948 email: [email protected] lat: 59.33258 lon: 18.0649 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-04-01 uploadDate: 2024-04-23T02:35 filename: SAP_000.pdf size: 292236 hasResults: False |
<|newrecord|> nctId: NCT06386159 id: 2023-1178 briefTitle: Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism overallStatus: RECRUITING date: 2024-03-15 date: 2025-04-30 date: 2025-07-30 date: 2024-04-26 date: 2024-04-26 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application. conditions: Post-extubation Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 69 type: ESTIMATED name: Electrical vagus nerve stimulation measure: functional oral intake scale（FOIS） measure: standardized Swallowing Assessment（SSA） measure: Rate of total oral feeding after the intervention measure: Duration of Enteral Nutrition Tube Indwelling measure: Rate of Re-intubation after Endotracheal Intubation measure: Incidence of aspiration within one week after extubation measure: The incidence of aspiration pneumonia within one week after extubation measure: Inflammation-related indicators: serum C-reactive protein (CRP) measure: Inflammation-related indicators: serum interleukin-6 (IL-6) measure: Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh) measure: Inflammation-related indicators: high mobility group box-1 protein (HMGB1) measure: Days of ICU hospitalization measure: Total days of hospitalization measure: In-hospital survival rate sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Feng Xiuqin status: RECRUITING city: Hangzhou zip: 310000 country: China name: Feng Feng, Xiuqin role: CONTACT phone: 13757119151 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06386146 id: JAB-30355-1001 briefTitle: JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-01 date: 2027-07 date: 2024-04-26 date: 2024-04-26 name: Jacobio Pharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation. conditions: Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: JAB-30355 name: JAB-30355 measure: Dose limiting toxicity (DLT) measure: Number of participants with adverse events measure: Peak Plasma Concentration (Cmax) measure: Time to reach the observed maximum (peak) concentration (Tmax) measure: Terminal half-life (t1/2) measure: Objective response rate (ORR) measure: Duration of response (DOR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386133 id: MS Boost briefTitle: Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care acronym: MSBoost overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-07-01 date: 2026-04-01 date: 2024-04-26 date: 2024-04-26 name: Ad scientiam class: OTHER name: Assistance Publique - Hôpitaux de Paris briefSummary: The main objective of the MS Boost study is to demonstrate the superiority of MSCopilot Boost over standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (MS). |
The secondary objectives include validating MSCopilot Boost clinical performance in reducing fatigue and its impact as well as evaluating its functional tests performance and its safety of use. The investigation team will also investigate the effects of MSCopilot Boost on patient symptoms, functional parameters and physical activity levels. The investigation team will evaluate patients and healthcare professionals' perceived clinical benefit as well as adherence, satisfaction and user experience related to the mobile application and the web portal. Ultimately, the investigation team will define the medico-economic and organizational impact of the MSCopilot Boost solution. |
Patients' expected benefits are the access to additional clinical tests not routinely performed, covering dimensions not addressed by standard tests like the EDSS for example; a remote monitoring of functional tests similar to those of the modified MSFC with the possibility of adding an evaluation of fatigue through digital questionnaires; improvement of symptoms related to MS fatigue through access to a personalised tele-rehabilitation program. |
Healthcare professionals' expected benefits are to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients' management and to gain time by providing a "big picture" of the patient's condition over time. conditions: Multiple Sclerosis conditions: Fatigue Syndrome, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Boost group: Use of MSCopilot Boost and wear of an actimeter during the whole study participation duration. |
Control group: Standard practice and wear of an actimeter during the whole study participation duration. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 208 type: ESTIMATED name: MS Boost name: Standard of care measure: To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis measure: To evaluate the impact of fatigue in both groups. measure: To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term) measure: To compare the fatigue impact between the two groups. measure: To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home. measure: To assess the number of adverse events of using MSCopilot Boost. measure: To compare the effect of MSCopilot Boost on walking compared to standard practice: -Assessed by the functional standard test performed at the hospital -Assessed at home measure: To compare the proportion of patients whose symptoms improved in both groups on Fatigue impact. measure: To compare the proportion of patients whose symptoms improved in both groups on anxiety and depression. measure: To compare the proportion of patients whose symptoms improved in both groups on Depression. measure: To compare the proportion of patients whose symptoms improved in both groups on Fatigue. measure: To compare the proportion of patients whose symptoms improved in both groups on Walking. measure: To compare the proportion of patients whose symptoms improved in both groups on Dexterity. measure: To compare the proportion of patients whose symptoms improved in both groups on Cognition. measure: To compare the proportion of patients whose symptoms improved in both groups on the Low-contrast Vision. measure: To compare the effect of MSCopilot Boost on quality of life compared to standard practice. measure: To compare the effect of MSCopilot Boost on the mean overall physical activity compared to standard practice. measure: To evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost. measure: To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals. measure: To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals. measure: To assess user compliance with MSCopilot Boost throughout the follow-up period. measure: To evaluate the link between MSCopilot Boost use compliance and fatigue improvement. measure: To assess the relationship between self-reported and objectively measured physical activity. measure: To explore the factors that might influence the effect of MSCopilot Boost on fatigue and its impact. measure: To assess the changes in sleep patterns and areas of life impacted by fatigue, as measured with MSCopilot Boost at home. measure: To assess the evolution of overall physical activity reported by patients. measure: To explore the correlation between overall physical activity and the change in : -Fatigue impact -Fatigue measure: Calculation of cost-effectiveness in reducing fatigue at 1, 3, 6 and 9 months using MSCopilot Boost as an intervention, compared to standard care. measure: To assess the impact of MSCopilot Boost on work-related factors (duration without working, absenteeism from work, return-to-work time, presenteeism) at 3, 6 and 9 months, compared to baseline (Day 0), in both groups. measure: To evaluate behavioral changes in terms of physical activity and energy management. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386120 id: 2024-z033 briefTitle: Respiratory Function Monitoring of Mechanical Ventilation in Patients With Chest Blunt Injury overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-07 date: 2024-04-26 date: 2024-04-26 name: Peking University People's Hospital class: OTHER briefSummary: The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. The main question it aims to answer is: |
Can lung protective ventilation strategies improve respiratory function in patients with severe chest contusion? We will collect clinical data of participants who already taking lung protective ventilation strategies as part of their regular medical care. conditions: Lung Contusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: PEEP setting strategy measure: ventilation blood flow ratio measure: oxygenation index measure: 28-day mortality measure: Mechanical ventilation-free from day 1 to 28 measure: Length of ICU stay measure: Length of hospital stay measure: The rate of successful weaning sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386107 id: 23PH188 id: 2023-A02175-40 type: OTHER domain: ANSM briefTitle: Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis acronym: CATforCAT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-08 date: 2024-04-26 date: 2024-04-26 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER name: Diagnostica Stago name: LEO Pharma name: Ligue contre le cancer, France briefSummary: Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment. conditions: Cancer conditions: Pulmonary Embolism conditions: Thrombosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective cohort of consecutive patients initiating full-dose anticoagulant therapy for an episode of CAT, followed up until the 6th month of treatment to assess the risk of clinically relevant adjunctive bleeding events and any other adverse event during anticoagulant therapy (recurrence of CAT, death). |
TGT measurement is fully automated and calibrated with quality control. primaryPurpose: OTHER masking: NONE count: 212 type: ESTIMATED name: Thrombin Generation Assay (TGA) measure: The measurement of the area under the curve ( endogenious thrombin potential) nMxmin measure: the measurement of the lag time unit = seconds measure: the measurement of the peak height unit = nm measure: the measurement of the time to peak unit = seconds measure: Effect of adding TGT results on the performance of bleeding risk prediction scores measure: Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT measure: Occurrence of an event of interest under treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Clermont-Ferrand city: Clermont-Ferrand zip: 63003 country: France name: Jeannot SCHMIDT, MD PHD role: CONTACT name: Jeannot SCHMIDT, MD PHD role: PRINCIPAL_INVESTIGATOR name: Aurélien LEBRETON, MD PHD role: SUB_INVESTIGATOR name: Fares MOUSTAFA, MD PHD role: SUB_INVESTIGATOR name: Nicolas DUBLANCHET, MD role: SUB_INVESTIGATOR name: Dorian TEISSANDIER, MD role: SUB_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: CHU de Grenoble city: Grenoble zip: 38043 country: France name: Gilles PERNOD, MD PHD role: CONTACT phone: 04 76 76 57 17 phoneExt: +33 email: [email protected] name: Gilles PERNOD, MD PHD role: PRINCIPAL_INVESTIGATOR name: Raphaël MARLU, MD PHD role: SUB_INVESTIGATOR lat: 45.16667 lon: 5.71667 facility: HCL city: Lyon country: France name: Yesim DARGAUD, MD PHD role: CONTACT name: Judith CATELLA, MD role: PRINCIPAL_INVESTIGATOR name: Claire GRANGE, MD role: SUB_INVESTIGATOR name: Yesim DARGAUD, MD PHD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Chu St-Etienne city: Saint-Étienne zip: 42055 country: France name: Géraldine POENOU, MD PHD role: CONTACT email: [email protected] name: Laurent BERTOLETTI, MD PHD role: SUB_INVESTIGATOR name: Xavier DELAVENNE, MD PHD role: SUB_INVESTIGATOR name: Coline LEGENDRE, MD role: SUB_INVESTIGATOR name: Pauline NOYEL, MD role: SUB_INVESTIGATOR name: Brigitte TARDY, MD PHD role: SUB_INVESTIGATOR name: Géraldine POENOU, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False |
<|newrecord|> nctId: NCT06386094 id: INT/IEC/2023/SPL-902 briefTitle: Cardiac Dysfunction in Patients With Non-alcoholic Fatty Liver Disease overallStatus: RECRUITING date: 2023-07-15 date: 2025-08-15 date: 2025-11-15 date: 2024-04-26 date: 2024-04-26 name: Post Graduate Institute of Medical Education and Research, Chandigarh class: OTHER briefSummary: Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality. conditions: NAFLD conditions: Cardiac Disease conditions: Fatty Liver studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Echocardiographic assessment measure: To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease measure: Presence of myocardial abnormalities in CCM dysfunction measure: Presence of perfusion abnormalities in CCM dysfunction measure: All cause mortality in NAFLD measure: Cardiac event related mortality in NAFLD measure: To determine the severity of cardiac dysfunction in patients with non-alcoholic fatty liver disease sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Madhumita Premkumar status: RECRUITING city: Chandigarh zip: 160012 country: India name: Dr. Madhumita Premkumar, MD role: CONTACT phone: +9101722754777 email: [email protected] lat: 30.73629 lon: 76.7884 hasResults: False |
<|newrecord|> nctId: NCT06386081 id: AC18/00031 briefTitle: Dietary Intervention in Food Allergy acronym: AC18/00031 overallStatus: COMPLETED date: 2021-01-01 date: 2023-01-31 date: 2023-06-30 date: 2024-04-26 date: 2024-04-26 name: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud class: OTHER briefSummary: The goal of this randomized double-blind placebo-controlled clinical study is to determine whether the dietary intervention with pectins leads to food immunomodulation in non-specific lipid transfer proteins (nsLTP) allergic patients. The main question it aims to answer is if the microbiome is a target of intervention against food allergy through the use of prebiotics such as pectins. |
Participants will be enrolled to receive a two-month dietary intervention with either two different pectins (citrus or apple pectin) or placebo. Increase in oral tolerance to the peach nsLTP will be measured through a double-blind placebo-controlled food challenge (DBPCFC). Microbiome, proteomic and metabolomic studies will also be performed in blood and stool samples. conditions: Food Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Treatment will be blinded to the participants and research team. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 51 type: ACTUAL name: Citrus pectin with low DE name: Apple pectin with high DE name: Placebo measure: Clinical efficacy of pectin dietary intervention in nsLTP allergic patients measure: Changes in Pru p 3 (nsLTP of peach) specific IgE production induced by pectin intervention measure: Pru p 3-specific maturational changes of dendritics cells induced by pectin intervention measure: Pru p 3-specific proliferative response of different lymphocytes cell subpopulations after pectin intervention measure: Changes in Pru p 3-specific basophil activation induced by pectin intervention measure: Changes induced in the taxonomic diversity of gut microbiota measure: Changes in feaces metabolome induced by pectin dietary intervention measure: Changes in serum metabolome induced by the pectin dietary intervention measure: Epigenomic changes induced by the pectin dietary intervention measure: Pectin safety profile sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hospital Regional Universitario de Málaga city: Malaga country: Spain lat: 36.72016 lon: -4.42034 hasResults: False |
<|newrecord|> nctId: NCT06386068 id: 2110041 briefTitle: Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Persistent Whiplash Associated Disorders. acronym: VALIANT overallStatus: RECRUITING date: 2024-01-23 date: 2024-06 date: 2024-06 date: 2024-04-26 date: 2024-04-26 name: University of Southern Denmark class: OTHER briefSummary: The goal of this clinical trial is to address the critical need for effective interventions by developing and testing an interdisciplinary values-based cognitive behavioral therapy (V-CBT) program for individuals with persistent whiplash. The main question it aims to answer are: |
* What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with persistent whiplash? |
* What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program? |
Participants will undergo a replicated multiple baselines single-case experimental design (SCED). Twelve participants who meet specific eligibility criteria will be block-randomized to a 1, 2, or 3-week baseline phase, serving as their own controls. The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions, focusing on psychological and physical rehabilitation. Participants will be required to attend these sessions as part of the treatment protocol. Data collection includes daily online self-reports and comprehensive measurements at pre-treatment, post-treatment, and a three-month follow-up. conditions: Whiplash Injuries studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Values-based Cognitive Behavioral Therapy (V-CBT) measure: Value-based living measure: Pain interference measure: Value-based living measure: Pain interference measure: Pain catastrophizing measure: Positive affect measure: Negative affect measure: Stress measure: Fatigue measure: Pain-related acceptance measure: Pain-related self-efficacy measure: Pain severity measure: Neck Disability measure: Depression measure: Anxiety measure: Stress measure: Health-related quality of life measure: Pain-related acceptance measure: Pain-related self-efficacy measure: Sleep quality measure: Pain severity measure: Self-perceived improvement measure: Satisfaction with treatment measure: Pain Disability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Specialized Hospital for Polio and Accident Victims status: RECRUITING city: Rødovre state: Capital Region Of Denmark zip: 2610 country: Denmark name: Anders O Aaby, PhD role: CONTACT email: [email protected] lat: 55.68062 lon: 12.45373 hasResults: False |
<|newrecord|> nctId: NCT06386055 id: STUDY00007545 briefTitle: Air Pollution and Physical Activity: A Randomized Controlled Trial acronym: PARC overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-10-15 date: 2024-12-01 date: 2024-04-26 date: 2024-04-26 name: State University of New York at Buffalo class: OTHER briefSummary: This is a small pilot intervention trial in which we will collect preliminary data to demonstrate the feasibility of an intervention study. conditions: Physical Inactivity conditions: Pollution; Exposure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: Active exercise measure: blood pressure measure: Self-report questionnaire sex: ALL minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: University at Buffalo city: Buffalo state: New York zip: 14214 country: United States lat: 42.88645 lon: -78.87837 hasResults: False |
<|newrecord|> nctId: NCT06386042 id: MEC-2022-0252 briefTitle: Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry acronym: TITRATE-HF overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-05 date: 2029-02-14 date: 2029-04 date: 2024-04-26 date: 2024-04-26 name: Erasmus Medical Center class: OTHER name: Netherlands Heart Institute briefSummary: SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice. |
Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society of Cardiology (ESC) HF 2021 guideline recommendations for patients with heart failure (HF) reduced ejection fraction (HFrEF), and mildly reduced ejection fraction (HFmrEF). |
Study design: The current study is a prospective multi-center national quality of care registry (longitudinal) of regular HF care (as given). |
Study population: The study population consists of patients with heart failure (de novo HF, chronic HF and worsening HF). Study setting is outpatient or inpatient (during admission). Patient sample is set at a minimum of 4000 patients, but can be expanded during the course of the registry project. |
Participating sites: all hospitals with dedicated HF outpatient clinic in the Netherlands can participate. |
Data: aggregated data |
Intervention: none / no |
Main study parameters/endpoints: The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage (%) drug prescription, percentage (%) target dose (order, speed) and reason not to adhere to the guideline (intolerance, side-effects, maximum tolerated dose). The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up. |
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk in participation, no intervention and no active involvement of patients for specific activities in the study. The project is a registration of care as given (standard care) to the participating subject with heart failure. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4289 type: ESTIMATED name: no intervention, observational study measure: Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF measure: All-cause mortality measure: Hospital admission due to heart failure related event and/or urgent visit with necessity of furosemide iv. measure: Hospital admission due to non heart failure related event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC city: Rotterdam state: Zuid-Holland zip: 3015CE country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False |
<|newrecord|> nctId: NCT06386029 id: STUDY24010191 briefTitle: The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-26 date: 2024-04-26 name: University of Pittsburgh class: OTHER briefSummary: The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are: |
1. Is the Power Down feasible for caregivers to do each night? |
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