text
stringlengths 0
197k
|
|---|
Experimental design:
|
The investigators will access tumor samples from matched pre-therapy (transurethral resection of the bladder tumor) and post-therapy (radical cystectomy) surgical interventions. They will also analyze the imaging analyses of combined bladder multiparametric MRI/Fluorodeoxyglucose Positron Emission Tomography (PET) scans pre-post neoadjuvant therapies, and will associate the data with the pathological response to treatment, expanding our previously reported work (PMID: 31882281).
|
Biomarker analyses will include the following: i.) multiplex immunofluorescence assays will allow the investigators defining the immune contexture of tumor lesion; ii.) multiparametric flow cytometry will allow the phenotypic and functional analysis of peripheral blood cells at single cell level; iii.) a whole transcriptome assay will enable investigators to assign specific molecular subtypes to pathological response and outcome, as previously reported (PMID: 33785257; 32165065).
|
Expected results:
|
The investigators will expect to identify the tumor characteristics and immune-profiling enabling them to delineate the selection of patients most suited for certain novel perioperative therapies, thus anticipating the developments in clinical research that are being conducted worldwide in MIBC.
|
The investigators will be also able to develop noninvasive tools for pathological complete response identification, thus enabling them to develop a next-generation of clinical trials aimed at sparing any radical local therapy on the bladder tumor.
|
Impact on cancer:
|
In principle, the present personalized strategy yields the potential to enhance the therapeutic standards achievable with RC alone as well as with single-agent immunotherapy and RC. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Post-hoc biomarker analyses of ongoing phase 2 studies primaryPurpose: OTHER masking: NONE count: 153 type: ESTIMATED name: various neoadjuvant therapies measure: Predictors of immune response to experimental combination therapies in MIBC. measure: Genomic predictors of response to experimental combination therapies in MIBC. measure: Transcriptomic predictors of response to experimental combination therapies in MIBC. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan state: Mi zip: 20132 country: Italy name: Andrea Necchi, MD role: CONTACT phone: +390226435789 email: [email protected] name: Rossella Miotti, PhD role: CONTACT email: [email protected] lat: 45.46427 lon: 9.18951 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-02-02 uploadDate: 2024-03-19T18:02 filename: Prot_000.pdf size: 1464434 hasResults: False
|
<|newrecord|> nctId: NCT06341465 id: HÜ- FTR- BD- 3 briefTitle: Investigation of the Effects of Exercise and Kinesiological Taping on Spinal Deformities and Serum Markers in Individuals With Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2024-07-04 date: 2024-07-04 date: 2024-04-02 date: 2024-04-02 name: Hacettepe University class: OTHER briefSummary: The aim of this study is to investigate the effects of Schroth exercises and kinesiological taping on spinal deformities and serum markers in young adults with scoliosis. The study will include young adults aged 18-21 with scoliosis. A total of 57 participants will be included in the study. Out of 57 participants, 38 have scoliosis, and 19 are healthy. 38 participants will be randomly divided into 2 groups. One group (n=19) will receive only Schroth exercises, and the other group (n=19) will receive both Schroth exercises and kinesiological taping. The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university. Trunk rotation will be assessed using the Adams Forward Bend Test with scoliometer, quality of life will be evaluated with the SRS-22 Quality of Life questionnaire and Quality of life profile for spinal deformities questionnaire, perception of deformity will be measured using the Walter Reed Visual Assessment Scale, and Cobb angles will be evaluated from anterior-posterior X-ray images. conditions: Scoliosis conditions: Scoliosis Idiopathic conditions: Musculoskeletal Deformity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 3 groups. Schroth exercise group (n=19), schroth exercise and kinesiological taping group (n=19), healthy people (n=19). primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: Just Exercise name: Exercise name: Taping measure: Trunk rotation measure: Cobb angles measure: Serum markers measure: Quality of life with scoliosis people measure: Body image assessment sex: ALL minimumAge: 18 Years maximumAge: 21 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06341452 id: HD-NaM-01-EU briefTitle: Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis acronym: SODIAH overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2025-12 date: 2024-04-02 date: 2024-04-02 name: Fresenius Medical Care Deutschland GmbH class: INDUSTRY briefSummary: The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing. conditions: End Stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, open, controlled, parallel, randomized, interventional, multi-center, explorative primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control measure: Interdialytic weight gain measure: Intradialytic hemodynamic stability measure: Intradialytic hemodynamic stability measure: Intradialytic morbid events measure: Fluid status measure: Fluid status measure: PRO: Thirst feeling measure: PRO: Thirst feeling measure: PRO: Fatigue measure: PRO: Hypotensive episodes measure: PRO: HRQOL measure: PRO: Health status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06341439 id: Prot. 001_2023 briefTitle: Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX® overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-18 date: 2024-01-18 date: 2024-03-30 date: 2024-04-02 date: 2024-04-02 name: University of L'Aquila class: OTHER briefSummary: The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are:
|
* Is the response to periodontal therapy better if mouthwash containing Citrox is used?
|
* What is the patients' perception?
|
Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Mouthwash with chlorhexidine 0,12% and CITROX name: Mouthwash with chlorhexidine 0,12% measure: Probing Depth (PD) measure: Gingival Index (GI) measure: Plaque Index (PI) measure: Full mouth plaque score (FMPS) measure: Full mouth bleeding score (FMBS) measure: Patient Reported Outcome Measure (PROMS) sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of L'Aquila, division of periodontology city: L'Aquila zip: 67100 country: Italy lat: 42.35055 lon: 13.39954 hasResults: False
|
<|newrecord|> nctId: NCT06341426 id: 23-5872 briefTitle: Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin acronym: PSI-1V2 overallStatus: RECRUITING date: 2024-02-05 date: 2028-02-01 date: 2028-08-01 date: 2024-04-02 date: 2024-04-02 name: University Health Network, Toronto class: OTHER name: Centre for Addiction and Mental Health briefSummary: The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered. conditions: Major Depressive Disorder conditions: Depression conditions: Treatment-Resistant Depression conditions: Mood Disorders studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to two groups for the first dosing session in a 1:1 allocation: 1) non-psychedelic/placebo dose (psilocybin 1mg) or 2) psychedelic dose (psilocybin 25mg). All participants will receive a psychedelic dose (psilocybin 25mg) for their second dosing session. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The first dose will be randomized and blinded (1mg psilocybin versus 25mg psilocybin), while the second dose will be open-label (25mg psilocybin). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Single Psychedelic Dose Psilocybin name: Two Psychedelic Doses Psilocybin measure: Antidepressant Efficacy measure: Self-Reported Depression Symptoms measure: Anxiety Symptoms measure: Self-Reported Quality of Life measure: Subjective Functioning measure: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) measure: Cognitive Dysfunction measure: Psychomotor Performance measure: Phonemic Word Fluency measure: Psychomotor Speed, Visual search, and Attention measure: Verbal Learning and Memory measure: Working Memory, Attention and Executive Function measure: Effort-Based Decision Making measure: Participant Blinding Success measure: Expectancy Effects measure: Quality of Clinician-Patient Therapeutic Relationship measure: Qualitative Narrative Feedback measure: Percentage Restarting Antidepressants measure: EEG Predictors of Response sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Toronto Western Hospital status: RECRUITING city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Danica Johnson, BScH role: CONTACT email: [email protected] name: Zoe Doyle, RN role: CONTACT email: [email protected] name: Joshua Rosenblat, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
|
<|newrecord|> nctId: NCT06341413 id: 2023-1281 id: A539500 type: OTHER domain: UW- Madison id: SMPH/SLEEP CENTER/SLEEP CTR type: OTHER domain: UW- Madison id: Protocol version 1/17/2024 type: OTHER domain: UW- Madison id: 1R01MH132221 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH132221 briefTitle: Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-10 date: 2024-10 date: 2024-04-02 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth.
|
Participants will attend 4 study visits:
|
* A clinical and trauma assessment visit
|
* A testing day that may include cognitive testing, surveys, and an MRI.
|
* An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition
|
* An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 180 type: ESTIMATED name: SmartSleep device measure: Change in Emotional Regulation - arousal measure: Change in Emotional Regulation - recall measure: Change in Slow-wave Activity (SWA) measure: Change in Positive and Negative Affect Schedule (PANAS) sex: ALL minimumAge: 15 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of Wisconsin city: Madison state: Wisconsin zip: 53705 country: United States name: Sara Heyn, JD, PhD role: CONTACT phone: 303-296-2116 email: [email protected] name: Stephanie Jones, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
|
<|newrecord|> nctId: NCT06341400 id: 2024-KY-030-01 briefTitle: RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients overallStatus: RECRUITING date: 2024-05-20 date: 2026-05-01 date: 2027-05-01 date: 2024-04-02 date: 2024-04-02 name: Zhujiang Hospital class: OTHER briefSummary: A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy. conditions: Bladder Cancer conditions: Muscle-Invasive Bladder Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 55 type: ESTIMATED name: DisitamabVedotinForIicction Toripalimab measure: PcR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Peng Xu, doctor role: CONTACT phone: 18665073650 lat: 23.11667 lon: 113.25 hasResults: False
|
<|newrecord|> nctId: NCT06341387 id: R178522-ieo1906 briefTitle: Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer overallStatus: RECRUITING date: 2023-05-05 date: 2024-05-30 date: 2024-07-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER name: University of Rome Tor Vergata briefSummary: The goal of this prospective, case-control study is to discover the specific "omics" biomarkers of early stage of lung cancer using the non-invasive samples (breath, urine and serum) in a total of 200 subjects (100 healthy controls and 100 lung cancer patient). The main questions it aims to answer are:
|
* Which are the "omics" biomarkers that characterize the early stage of lung cancer?
|
* How to Translate Laboratory Data into Clinical Data?
|
For each participant we will collected the breath, urine and blood samples. In lung cancer patients group the samples will be sample before lung cancer resection. The samples of Breath, urine and serum will be analysed using different type of analysis: eNose and the Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS). Moreover, Serum will be analyzed by mass-spectrometry-based proteomics. The purpose of these analyses will be to find biomarkers capable of distinguishing the early-stage of lung cancer from the healthy group. Followup will be performed to evaluate the possible change of the volatolomic and proteomic profile. conditions: Lung Cancer conditions: Non-small Cell Lung Cancer Stage I conditions: Non-small Cell Lung Cancer Stage II conditions: Lung Cancer Diagnosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Breath, urine and blood analysis measure: Comparison of the proteomic and volatolomic signature in samples of respiratory exhalation, serum, and urine from patients with lung cancer (stage I/II) and healthy individuals at high risk. measure: Omics-Data intagration. sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Europen insitute of Oncology- Division of Thoracic Surgery status: RECRUITING city: Milan zip: 20141 country: Italy name: Roberto Gasparri, MD, PhD role: CONTACT phone: 0257489499 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False
|
<|newrecord|> nctId: NCT06341374 id: 2023/5079 briefTitle: Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients overallStatus: RECRUITING date: 2023-11-06 date: 2024-03-30 date: 2024-09-30 date: 2024-04-02 date: 2024-04-02 name: Parc Taulí Hospital Universitari class: OTHER briefSummary: Sleep is an important modulator of the immune response, whereby sleep disturbances (ie, poor sleep quality, insufficient sleep and/or primary sleep disorder, obstructive sleep apnea (OSA)) contribute to inflammatory disease risk and dysregulation of immune response in front of infectious agents.
|
The objective of this study is to evaluate the impact of undiagnosed and non-treated sleep disorders on innate immunity in a cohort of COVID-19 patients and the role of trained immunity induced by influenza vaccination in the innate immune response. conditions: Apnea, Obstructive Sleep conditions: SARS CoV 2 Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Influvac Tetra measure: Immunological study: cytokines. measure: Innate cells: monocytes, classical dendritic cells and Natural Killer cells. measure: Epigenetic modification. measure: Diagnostic of obstructive sleep apnea in selected cohort sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Parc Tauli status: RECRUITING city: Sabadell state: Barcelona zip: 08208 country: Spain name: Andrea F Grau, Medicine role: CONTACT phone: +34608151458 email: [email protected] name: Miguel D Gallego, Medicine role: CONTACT phone: +34616315290 email: [email protected] lat: 41.54329 lon: 2.10942 hasResults: False
|
<|newrecord|> nctId: NCT06341361 id: OCT-FFR briefTitle: OCT-based Machine Learning FFR for Predicting Post-PCI FFR overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-04-30 date: 2025-10-15 date: 2024-04-02 date: 2024-04-02 name: Yonsei University class: OTHER name: Gangnam Severance Hospital name: Severance Hospital briefSummary: This study aims to compare the diagnostic accuracy of the fractional flow reserve (FFR) model derived by machine learning based on optical coherence tomography (OCT) exam after coronary artery stent implantation with the wire-based FFR. conditions: Tomography, Optical Coherence conditions: Fractional Flow Reserve, Myocardial studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 82 type: ESTIMATED name: OCT-based machine learning FFR measure: Correlation of OCT-based machine learning FFR compared to wire-based FFR measure: Diagnostic performance of OCT-based machine learning FFR compared to wire-based FFR measure: Diagnostic performance of OCT-based machine learning FFR according to the coronary artery (LAD, LCx or RCA) compared to wire-based FFR sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06341348 id: Dalin Tzuchi Hospital briefTitle: Effects of Case Management for Patients With Rheumatoid Arthritis in Taiwan overallStatus: COMPLETED date: 2016-01-01 date: 2018-06-30 date: 2018-12-31 date: 2024-04-02 date: 2024-04-02 name: Dalin Tzu Chi General Hospital class: OTHER briefSummary: Case management (CM) has been recommended as a way of inspiring measurable changes in individual behaviors and improving clinical outcomes for patients with chronic diseases. However, data on its effectiveness for Taiwanese patients with rheumatoid arthritis (RA) are limited. This study aimed to determine the long-term effectiveness of CM that focused on nurses' role among Taiwanese RA patients.
|
A quasi-experimental pre-post test, control-group study with purposive sampling recruited RA patients from a hospital in Taiwan during 2016-2017. CM program was composed of health education sessions and follow-up telephone consultations over a six-month period. A review of medical records and structured questionnaires yielded data about patient demographics and disease characteristics, and included Chinese version of the Arthritis Self-Efficacy Scale and the Taiwanese Depression Questionnaire. A comparison of the long-term effectiveness of the CM program was made using generalized estimating equation.
|
This evidence-based study may be beneficial to characterize the long-term effectiveness of CM for Taiwanese patients with RA, and may be a reference for healthcare providers in facilitating the provision of appropriate interventions to improve the adaptation processes and clinical outcomes for them. conditions: Case Management conditions: Rheumatoid Arthritis conditions: Effectiveness studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: A trained interviewer, who was blind with the study design and participants, was assigned to collect the participants' information on demographic and disease characteristics. count: 96 type: ACTUAL name: Case management measure: Depressive symptoms measure: Self-efficacy level measure: Sexual dysfunctionform-14 measure: DAS28 sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06341335 id: AK109-301 briefTitle: A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-11 date: 2027-07 date: 2024-04-02 date: 2024-04-02 name: Akeso class: INDUSTRY briefSummary: This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy. conditions: Gastric and Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 506 type: ESTIMATED name: cadonilimab name: pulocimab name: paclitaxel name: placebo measure: Progression-free survival (PFS) assessed by blinded independent central review (BICR) measure: Overall survival (OS) measure: Progression-free survival (PFS) assessed by investigator measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06341322 id: ERC0003996 briefTitle: Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia overallStatus: RECRUITING date: 2024-03-05 date: 2024-04 date: 2024-07 date: 2024-04-02 date: 2024-04-02 name: Veerle Snijders class: OTHER name: Croatian Institute of Public Health name: Andrija Štampar School of Public Health briefSummary: Colorectal cancer (CRC) is one of the leading causes of death in Croatia. An average of 3600 cases are diagnosed and an average of 2100 people die from the disease every year. Since 2007, Croatia has invited every man and woman aged 50-74 to participate in the home testing screening programme every two years. Currently only around 36% of the invited request the test-kit and 25% complete the home testing procedure, far below the target of 40-60%.
|
The Croatian Institute of Public Health with technical support from World Health Organization (WHO) Regional Office for Europe is undertaking a mixed-methods research study with the aim to increase the completion of colorectal cancer home testing and improve our knowledge of the barriers and drivers to do so. The study has a quantitative and a qualitative component:
|
1. Quantitative: testing the introduction of a reminder letter to encourage people to respond to the initial invite to participate in the CRC home test program and test which elements of a reminder letter improve response rates.
|
The quantitative component consists of a four-arm reminder letter randomized controlled trial (RCT) comparing no letter, standard letter, behaviorally informed letter, and behaviorally informed letter sent with a home testing kit to investigate the effectiveness of reminders in increasing uptake of home-testing for colorectal cancer. Recruitment and data collection for the reminder letter trial will be conducted utilizing the routine screening process and routinely collected screening data.
|
2. Qualitative: conducting in-depth interviews with people from the target population who did or did not respond to the CRC invite letter and reminder to better understand the barriers and drivers to participation.
|
The qualitative component consists of 24 in-depth interviews (IDIs) conducted with members of the target population to identify barriers and drivers to completing colorectal cancer screening home-testing. Data collection for IDIs will be face-to-face, using discussion guides, and will be audio recorded. The audio-recordings will then be analyzed using a rapid analysis approach based on by the modified Capability-Opportunity-Motivation-Behavior (COM-B) framework. conditions: Colorectal Cancer conditions: Behavior Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to either control (no reminder screening invitation) or one of three treatments (standard reminder letter, behaviorally informed reminder letter, behaviorally informed letter with home testing kit included). primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 13000 type: ESTIMATED name: Standard letter name: Behaviorally informed letter name: Home testing colorectal cancer kit measure: Home test kit ordered measure: Completed colorectal cancer screening measure: Opted out measure: Qualitative feedback sex: ALL minimumAge: 50 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Croatian Institute of Public Health status: RECRUITING city: Zagreb country: Croatia name: Ivana Brkić Biloš, MD role: CONTACT email: [email protected] name: Nataša Antoljak, Prof role: CONTACT email: [email protected] lat: 45.81444 lon: 15.97798 hasResults: False
|
<|newrecord|> nctId: NCT06341309 id: CSPC-DEY-CRC-K09 briefTitle: Exploratory Study of Irinotecan Liposomes in Maintenance Therapy of Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-08-01 date: 2024-04-02 date: 2024-04-02 name: West China Hospital class: OTHER briefSummary: To evaluate the progression-free survival (PFS1), objective response rate (ORR), disease control rate (DCR), progression-free survival from first-line treatment initiation (PFS2), overall survival (OS), and safety of irinotecan liposome combined with bevacizumab in patients with advanced metastatic colorectal cancer. conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Irinotecan Liposome name: Bevacizumab measure: Progression free survival -1 measure: Progression free survival -2 measure: Objective response rate measure: Disease control rate measure: Overall survival measure: Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06341296 id: CSPC-DEY-CRC-K07 briefTitle: Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: West China Hospital class: OTHER briefSummary: To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients. conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 86 type: ESTIMATED name: Irinotecan Liposome name: 5-FU name: LV name: Bevacizumab measure: Objective response rate measure: Disease control rate measure: Progression free survival measure: Overall survival measure: Percentage of patients undergoing surgery. measure: R0 resection measure: Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06341283 id: BCOOS2024 briefTitle: A Retrospective Real-world Study of Abemaciclib Tablets Based on HIS System in HR+ Breast Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2025-07-01 date: 2024-04-02 date: 2024-04-02 name: The Affiliated Hospital of Qingdao University class: OTHER briefSummary: The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive breast cancer. conditions: Breast Cancer conditions: Neoplasms conditions: Breast Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Abemaciclib and Letrozole/Anastrozole name: Letrozole or Anastrozole name: Abemaciclib and Fulvestrant name: Fulvestrant measure: Progression-free survival measure: Objective Remission Rate measure: Disease Control Rate measure: Toxicity rate measure: Cost-utility analysis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center city: Qingdao state: Shandong country: China lat: 36.06488 lon: 120.38042 hasResults: False
|
<|newrecord|> nctId: NCT06341270 id: 2024HX1564 briefTitle: Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2026-12-20 date: 2024-04-02 date: 2024-04-18 name: West China Hospital class: OTHER briefSummary: The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy conditions: Liver Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups using a computer-generated random number table. After the randomization, use the opaque envelope, hide each group envelope into an opaque envelope, the envelope outside the code, will be sealed to the researcher, when the study, if the inclusion criteria, then open the corresponding numbered envelope, and intervene according to the group scheme in the envelope. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinding of participants will be maintained throughout the observation period. The sham group will receive electrode attachment but without stimulation,Throughout the study, for adequate blinding, an opaque tape will be applied to the patient's skin above the electrodes, and the patient's target acupoints will be wrapped in a blanket. All patients will be informed that they might or might not feel a tingling sensation around the acupoints when the TEAS device is working. The patients should not be unblinded until the statistical analysis of the study data is completed. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 524 type: ESTIMATED name: transcutaneous electrical acupoint stimulation name: sham transcutaneous electrical acupoint stimulation measure: The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery measure: The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 48 and 72 hours after surgery measure: The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24, 48 and 72 hours after surgery measure: Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours measure: Pain scores of pain at rest at 24, 48 and 72 hours postoperatively measure: The cumulative morphine consumption at 24, 48, and 72 hours postoperatively measure: The incidence of postoperative nausea and vomiting during the first 24,48,72 hours measure: The incidence of a composite of postoperative pulmonary complications during hospitalization measure: Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery measure: Time of Bowel function recovery measure: Length of hospital stay measure: The postoperative sleep quality score measure: The anxiety and depression scores measure: The incidence of chronic postsurgical pain (CPSP) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital city: Chengdu state: Sichuan zip: 610041 country: China name: Chunling Jiang, PhD role: CONTACT phone: 18980601096 email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False
|
<|newrecord|> nctId: NCT06341257 id: VGHTCCTC_SCART001 briefTitle: Efficacy and Toxicity of SCART overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2029-12-31 date: 2024-04-02 date: 2024-04-02 name: Taichung Veterans General Hospital class: OTHER briefSummary: This study is expected to enroll patients for a period of five years, with a total of 30 participants. It is a prospective observational study involving cancer patients with tumors having a longest diameter greater than or equal to 5 cm. Systemic drug therapy may be administered concurrently. The following inclusion criteria must be met for participation in the study: age greater than or equal to 18 years, Eastern Cooperative Oncology Group (ECOG) score ≤ 2, pathological confirmation of cancer diagnosis, tumor with a maximum diameter greater than or equal to 5 cm, one or more lesions, not suitable for surgery, patient has provided informed consent, patient receives SCART, and reproductive-age women must agree to take adequate contraceptive measures during the study and for six months after discontinuation of medication. The patient will receive a dose of 21 Gy in 3 fractions, with the dose maintained at 5 Gy per fraction for the entire tumor gross target volume (GTV) boundary. For certain patients, an additional two fractions of 5 Gy each were added using Stereotactic Body Radiotherapy (SBRT), resulting in a total dose of 5 Gy × 5 for the GTV boundary. conditions: Tumor Size Greater Than or Equal to 5 cm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Stereotactic Central/Core Ablative Radiation Therapy (SCART) measure: Local Control (LC) measure: Progression-Free Survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Veterans General Hospital status: RECRUITING city: Taichung zip: 407 country: Taiwan name: Hao-Shen Cheng, MD role: CONTACT phone: 886975871151 email: [email protected] lat: 24.1469 lon: 120.6839 hasResults: False
|
<|newrecord|> nctId: NCT06341244 id: UNIFESP briefTitle: Air Stacking Technique Efficacy on Peak of Expiratory Flow and Cough Peak Flow in Non-cardiac Thoracic Surgery overallStatus: COMPLETED date: 2019-08-20 date: 2020-11-05 date: 2022-12-15 date: 2024-04-02 date: 2024-04-02 name: Universidade Cidade de Sao Paulo class: OTHER name: Federal University of São Paulo briefSummary: After thoracic surgical intervention, patients often feel intense pain with respiratory movements reduction making coughing less effective. The air stacking improves peak of expiratory flow (PEF) and cough peak flow (CPF) in neuro myopathies, thus raising the hypothesis that may also be effective in patients undergoing thoracic surgeries. Objectives: To evaluate the effectiveness, safety and feasibility of air stacking on postoperative PEF and CPF in patients undergoing thoracic surgeries. Methods: Patients undergoing thoracic surgery underwent air stacking on 3th PO. Dyspnea, pain, SpO2, maximum inspirational pressure (MIP), maximum expiratory pressure (MEP), PEF and CPF were evaluated in pre and postoperatory. conditions: Postoperative Care studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Air Stacking Technique measure: Peak of expiratory flow (PEF) measure: Cough peak flow (CPF) measure: Maximum Inspiratory Pressure ( MIP) measure: Maximun Expiratory Pressure (MEP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Luciana Chiavegato city: São Paulo zip: 04115000 country: Brazil lat: -23.5475 lon: -46.63611 hasResults: False
|
<|newrecord|> nctId: NCT06341231 id: 202400248 briefTitle: Personalized Anticoagulant Therapy for Pulmonary Thromboembolism overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-02 date: 2024-04-02 name: Xiangya Hospital of Central South University class: OTHER briefSummary: The goal of this prospective observational study is to explore the influencing factors of the efficacy and safety of anticoagulant therapy for pulmonary thromboembolism in special populations with older age, renal insufficiency or co-existing malignancy, and establish a predictive model to guide clinical practice. The main questions it aims to answer are:
|
* To analyze the influencing factors of the efficacy and safety of anticoagulant therapy for specific populations with pulmonary thromboembolism (PTE) in the real world (such as the elderly, those with impaired kidney function, and individuals with malignant tumors).
|
* Whether we can use machine-learning models to predict bleeding events and VTE recurrence in special populations following anticoagulant therapy in the real world? Participants will receive diagnostic and therapeutic measures for pulmonary thromboembolism in accordance with clinical guidelines, including anticoagulant therapy. Some patients need to have peripheral blood samples collected at the time of enrollment and 3 months after anticoagulant therapy. conditions: Pulmonary Thromboembolisms conditions: Anticoagulants; Increased studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4700 type: ESTIMATED measure: Major bleeding measure: Clinically relevant non-major bleeding measure: Recurrent VTE measure: All-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xiangya Hospital status: RECRUITING city: Changsha state: Hunan zip: 410008 country: China name: Juan Jiang, MD role: CONTACT phone: +8615388078713 email: [email protected] lat: 28.19874 lon: 112.97087 hasResults: False
|
<|newrecord|> nctId: NCT06341218 id: 21-5T/3 briefTitle: The Effect Of Simulation-Supported Pediatric CPR Training Based On CRM On Knowledge, Attitude, And Performance overallStatus: COMPLETED date: 2021-02-25 date: 2023-09-30 date: 2023-11-15 date: 2024-04-02 date: 2024-04-02 name: Zonguldak Bulent Ecevit University class: OTHER name: Ege University briefSummary: Crew Resource Management is a training system that aims to use all available resources effectively and increase safety by improving technical knowledge and skills as well as non-technical skills in risky tasks such as CPR. In safe critical patient management, the healthcare team should have interpersonal skills such as communication, stress management, teamwork, and leadership, cognitive skills such as situational awareness, task completion, planning, monitoring the situation, and rapid response to critical incidents, in addition to technical skills. To improve outcomes after pediatric cardiac arrest, many systems have been developed for performance measurement and quality improvement initiatives of the healthcare team. However, studies are needed to evaluate the effects of these systems. This study was planned to evaluate the effectiveness of simulation-supported pediatric cardiopulmonary resuscitation training based on team resource management on knowledge, attitude, and performance of the healthcare team in the pediatric intensive care unit. conditions: Cardiopulmonary Resuscitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ACTUAL name: Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource Management measure: Socio-demographic data of the healthcare team measure: Pediatric KPR knowledge level measure: Pediatric KPR team attitude level measure: Pediatric KPR team performance level sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: İzmir state: Bornova zip: 35100 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
|
<|newrecord|> nctId: NCT06341205 id: 22-APN-01 briefTitle: Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX) acronym: iRITUX overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2031-08-31 date: 2031-09-30 date: 2024-04-02 date: 2024-04-02 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Membranous nephropathy is an autoimmune disease affecting the kidney, and the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. The course of this disease is highly variable from one individual to another, ranging from spontaneous remission to progressive chronic kidney disease.
|
The identification of autoantibodies - e.g., the phospholipase A2 receptor type 1 (PLA2R1) - has promoted the use of immunosuppressive drugs such as rituximab which is now a safe and effective first-line treatment for the management of membranous nephropathy. However, up to 40% of patients do not respond to a first course of rituximab treatment. In nephrotic patients, due to urinary drug loss, rituximab blood level is lower than in other autoimmune diseases treated with rituximab without proteinuria. This high urinary drug loss decreases the drug exposure, potentially explaining why rituximab regimen with low dose infusions (375 mg/m2) did not demonstrate efficacy after month-6 compared to a non-immunosuppressive antiproteinuric treatment in a previous study. In contrast, a regimen of two 1-g infusions two weeks apart was associated with a significantly greater remission rate after 6 months.
|
Recently, the investigators have shown that after two 1-g rituximab infusions, the rituximab blood level 3 months after the first rituximab infusion, was correlated with the likelihood of remission after 6 and 12 months of the rituximab treatment. Patients with positive rituximab blood level 3 months after treatment had a higher chance of remission at month-6 and at month-12 than patients with an undetectable rituximab level at month-3.
|
Nowadays, machine learning algorithms are increasingly used in medicine, especially in pharmacology, to predict the exposure to a drug, the initial dose to administer or the interval between two infusions.
|
The objective of this study is to use a machine learning algorithm predicting the risk of having an undetectable residual level of rituximab 3 months after treatment, in order to propose a personalized treatment management with early additional doses of rituximab for the patients at risk. conditions: Membranous Nephropathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: RiTUXimab Injection measure: Clinical remission (complete or partial) after 6 months of rituximab initiation measure: Complete clinical remission after 12 months of rituximab initiation measure: Partial clinical remission after 12 months of rituximab initiation measure: Immunological remission: anti-PLA2R1 depletion measure: Change in urine protein/creatinine ratio (UPCR) measure: Change in serum creatinine measure: Change in renal function measure: Change in the immunological status of the disease measure: Appearance of anti-drug antibodies after rituximab treatment measure: Rituximab underdosed patients measure: Serious adverse events measure: Adaptation of symptomatic treatment measure: Model improvement through machine learning measure: Effect of rituximab on immune profiles sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06341192 id: ChangGungMH ALL SB DB briefTitle: Comparison Between Combined ALLR With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction acronym: ALLR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-08-31 date: 2026-10-31 date: 2024-04-02 date: 2024-04-26 name: Chang Gung Memorial Hospital class: OTHER briefSummary: The goal of this clinical trial is to test and compare different surgical techniques in patients with anterior cruciate ligament (ACL) injuries. The main questions it aims to answer are:
|
* What are the optimal criteria for selecting between single-bundle ACL reconstruction combined with anterolateral ligament (ALL) reconstruction versus double-bundle ACL reconstruction combined with ALL reconstruction?
|
* How do these two surgical techniques compare in terms of post-operative knee stability, functional outcomes, and reducing re-tear rates?
|
Participants will:
|
* Undergo pre-operative MRI imaging, ligament stability testing, and motion analysis evaluations
|
* Be randomly assigned to either:
|
* Single-bundle ACL + ALL reconstruction
|
* Double-bundle ACL + ALL reconstruction
|
* Receive the assigned surgical procedure
|
* Participate in post-operative follow-ups, ligament stability testing, and motion analysis at 6 months and 1 year
|
Researchers will compare the single-bundle ACL + ALL group and the double-bundle ACL + ALL group to see if one technique demonstrates superior knee stability, functional outcomes (e.g. return to sport ability), and lower ACL re-tear rates. conditions: Anterior Cruciate Ligament Injuries conditions: Anterior Cruciate Ligament Reconstruction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-Bundle ACL + ALL Reconstruction Group:
|
* Patients in this group will undergo reconstruction of the anterior cruciate ligament (ACL) using a single-bundle graft technique.
|
* In addition, they will have the anterolateral ligament (ALL) reconstructed using a portion of the same graft material.
|
* For the ALL reconstruction, a commonly used technique is the Sonnery-Cottet ALL reconstruction using a split graft.
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.