text
stringlengths 0
197k
|
|---|
We aim to 1) quantify the impact of PERSEVERE on caregiver knowledge, attitudes, mastery, and strain; 2) identify the intervention and mentor factors determining implementation fidelity; and 3) test the effects of PERSEVERE on PLBD quality of life and healthcare utilization. This will be accomplished in an NIH Behavioral Model Stage II national, randomized, attention-controlled, 12-week trial of PERSEVERE in 502 LBD caregivers in partnership with the Lewy Body Dementia Association, Parkinson's Foundation, and LBD Caregiver Advisors. We will match intervention arm caregivers with a trained peer mentor who will coach them through a modular, theory-based curriculum on LBD knowledge and social support. Attention-control participants will receive weekly, curated links to educational materials. We will identify immediate and delayed intervention effects, including mediators of strain at 12 weeks, and caregiver strain and PLBD outcomes at nine months. Implementation fidelity and PLBD healthcare utilization will be tracked biweekly. Qualitative methods will explore the intervention- and mentor-specific factors predicting fidelity, mentee outcomes, and retention. Remote recruitment, mentoring, and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups. Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD outcomes. These results will inform future adaptation and dissemination of this model for other conditions. conditions: Lewy Body Dementia conditions: Parkinson Disease Dementia conditions: Dementia With Lewy Bodies conditions: Lewy Body Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 622 type: ESTIMATED name: Peer Mentor Support and Caregiver Education name: Caregiver Education measure: Multidimensional Caregiver Strain Index (MCSI) measure: Quality of Life in Alzheimer's Disease ( QoL-AD) measure: Dementia Attitudes Scale (DAS) measure: LBD Knowledge Test ( LBDK) measure: Baseline PLBD Fall Frequency and Healthcare Utilization Questionnaire measure: Fortinsky Caregiver Self-Efficacy Score measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: Pearlin Mastery Scale measure: Frequency and Duration of Mentoring Calls measure: Study adherence of Mentors and Mentees measure: Coverage of target topics; additional topics discussed sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University Medical Center city: Chicago state: Illinois zip: 60612 country: United States name: Persevere Study Team role: CONTACT phone: 312-563-3300 email: [email protected] name: Dr. Jori Fleisher, MD MSCE role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False |
<|newrecord|> nctId: NCT06389019 id: BLCA_CMUFH id: K2024-187-01 type: OTHER domain: The First Affiliated Hospital of Chongqing Medical University briefTitle: Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Bladder Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-01 date: 2024-10-01 date: 2024-04-29 date: 2024-04-29 name: Mingzhao Xiao class: OTHER briefSummary: Bladder cancer (BLCA), with its diverse histopathological features and varying patient outcomes, poses significant challenges in diagnosis and prognosis. Postoperative survival stratification based on radiomics feature and whole slide image feature may be useful for treatment decisions to improve prognosis. In this research, we aim to develop a deep learning-based prognostic-stratification system for automatic prediction of overall and cancer-specific survival in patients with BLCA. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Deep learning system for prognostication prediction in bladder cancer measure: Overall survival measure: Recurrence free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology, The First Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400016 country: China name: QuanHao He, PHD role: CONTACT phone: 800-555-5555 email: [email protected] name: Mingzhao Xiao, PHD role: CONTACT phone: 023-89012557 email: [email protected] lat: 29.56278 lon: 106.55278 hasResults: False |
<|newrecord|> nctId: NCT06389006 id: RC48-C025 briefTitle: To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-06-01 date: 2026-12-31 date: 2024-04-29 date: 2024-04-29 name: RemeGen Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer conditions: HR-positive, HER2-low Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 79 type: ESTIMATED name: Disitamab Vedotin for Injection name: Toripalimab name: Epirubicin name: Cyclophosphamide measure: Total pathological complete response (tpCR) rate measure: Breast pathological complete response（bpCR） measure: Event free survival (EFS) measure: Disease-free survival (DFS) measure: Objective Response Rate (ORR) measure: Adverse events (AEs) measure: Change in cluster of differentiation 8 (CD8) measure: Health-related quality of life - EORTC-QLQ-C30 measure: Residual cancer burden score measure: Change in tumor-infiltrating lymphocytes (TILs) measure: Change in programmed cell death protein L1 (PD-L1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiong Wu city: Shanghai state: Fudan University Shanghai Cancer Center zip: 200032 country: China name: Jiong Wu, Ph.D role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06388993 id: 2023H0351 briefTitle: Marrow Cellution™ vs. Traditional BMA Harvest Project overallStatus: RECRUITING date: 2024-03-25 date: 2024-12-31 date: 2025-03-31 date: 2024-04-29 date: 2024-04-29 name: Ohio State University class: OTHER briefSummary: Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research, conditions: Hip Arthropathy conditions: Avascular Necrosis of Bone conditions: Subchondral Cysts studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Bone Marrow Collection measure: Assess overall number of stem cells collected from each aspiration method measure: Assess overall number of cytokines collected from each aspiration method measure: Assess overall number of growth factors collected from each aspiration method sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Jameson Crane Sports Medicine Institute status: RECRUITING city: Columbus state: Ohio zip: 43202 country: United States name: Michael Keller role: CONTACT phone: 614-293-2410 email: [email protected] name: Karen Persons role: CONTACT email: [email protected] name: William K Vasileff, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False |
<|newrecord|> nctId: NCT06388980 id: UFCIN1_2022 briefTitle: Knowledge and Needs of Nursing in Relation to the Treatment Complex Wounds overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-01 date: 2023-06-01 date: 2024-06-01 date: 2024-04-29 date: 2024-04-29 name: Corporacion Parc Tauli class: OTHER briefSummary: Study with cross-sectional and descriptive mixed methodology. With questionnaires with likert-type questions (0-10) being the 10 with the highest score, and open questions in relation to knowledge in wound care; include all Corporaciló Sanitària Parc Taulí (CCSPT) nurses who voluntarily want to participate in a pseudo-anonymized surv conditions: Nurse's Role conditions: Knowledge, Attitudes, Practice conditions: Wound studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Validated questionnaires and ad hoc questions measure: "What not to do in chronic wounds?" measure: ReAc-PUKT (Renobato-Acosta Pressure Ulcer Knowledge Test) measure: Ad hoc open questions sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Corporació Sanitària Parc Taulí city: Sabadell state: Barcelona zip: 08208 country: Spain lat: 41.54329 lon: 2.10942 hasResults: False |
<|newrecord|> nctId: NCT06388967 id: 19288/PCDC briefTitle: Pancreatic Cancer Detection Consortium acronym: PCDC overallStatus: RECRUITING date: 2023-03-15 date: 2025-11-21 date: 2025-11-21 date: 2024-04-29 date: 2024-04-29 name: City of Hope Medical Center class: OTHER briefSummary: This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma. conditions: Pancreatic Cancer conditions: Pancreatic Carcinoma conditions: Pancreatic Adenocarcinoma conditions: Pancreatic Ductal Adenocarcinoma conditions: Pancreatic Neoplasms conditions: Pancreatic Cancer Stage I conditions: Pancreatic Cancer Stage conditions: Pancreatic Cancer Resectable conditions: Pancreatic Cancer Stage 0 conditions: Pancreatic Cancer Stage II conditions: Pancreatic Cancer Stage III conditions: Pancreatic Cancer, Adult conditions: Pancreatic Cancer Non-resectable studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: PANcreatic cancer Exosome Early detectiON (PANXEON) measure: Sensitivity measure: Specificity measure: Accuracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Translational Genomics Research Institute status: RECRUITING city: Phoenix state: Arizona zip: 85004 country: United States name: Daniel Von Hoff role: CONTACT email: [email protected] name: Daniel Von Hoff role: PRINCIPAL_INVESTIGATOR name: Haiyong Han role: SUB_INVESTIGATOR name: Derek Cridebring role: SUB_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Honorhealth status: RECRUITING city: Scottsdale state: Arizona zip: 85258 country: United States name: Erkut Borazanci role: CONTACT email: [email protected] name: Erkut Borazanci role: SUB_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: City of Hope Medical Center status: RECRUITING city: Monrovia state: California zip: 91016 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: [email protected] name: Ajay Goel role: PRINCIPAL_INVESTIGATOR name: Stanley Hamilton role: SUB_INVESTIGATOR name: Vincent Chung role: SUB_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR name: Alessandro Mannucci role: SUB_INVESTIGATOR lat: 34.14806 lon: -117.99895 facility: Hoag Center status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States name: Michael Demeure role: CONTACT email: [email protected] name: Michael Demeure role: SUB_INVESTIGATOR lat: 33.61891 lon: -117.92895 facility: OSF HealthCare status: RECRUITING city: Peoria state: Illinois zip: 61637 country: United States name: Chandler Wilfong role: CONTACT email: [email protected] name: Chandler Wilfong role: SUB_INVESTIGATOR lat: 40.69365 lon: -89.58899 facility: Ochsner Medical Center status: RECRUITING city: Jefferson state: Louisiana zip: 70121 country: United States name: John Bolton role: CONTACT email: [email protected] name: John Bolton role: SUB_INVESTIGATOR lat: 29.96604 lon: -90.15313 facility: Atlantic Health System status: RECRUITING city: Morristown state: New Jersey zip: 07960 country: United States name: Angela Alistar role: CONTACT email: [email protected] name: Angela Alistar role: SUB_INVESTIGATOR name: Eric Whitman role: SUB_INVESTIGATOR lat: 40.79677 lon: -74.48154 facility: Piedmont Medical Center status: RECRUITING city: Rock Hill state: South Carolina zip: 29732 country: United States name: Andrew Page role: CONTACT email: [email protected] name: Andrew Page role: SUB_INVESTIGATOR name: Eyal Meiri role: SUB_INVESTIGATOR lat: 34.92487 lon: -81.02508 facility: Medical College of Wisconsin status: RECRUITING city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Douglas Evans role: CONTACT email: [email protected] name: Douglas Evans role: SUB_INVESTIGATOR lat: 43.0389 lon: -87.90647 facility: Nagoya University status: RECRUITING city: Nagoya country: Japan name: Yasuhiro Kodera role: CONTACT email: [email protected] name: Yasuhiro Kodera role: SUB_INVESTIGATOR name: Masamichi Hayashi role: SUB_INVESTIGATOR lat: 35.18147 lon: 136.90641 facility: Asan Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Song Cheol Kim role: CONTACT email: [email protected] name: Song Cheol Kim role: SUB_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False |
<|newrecord|> nctId: NCT06388954 id: P.T.REC/012/005107 briefTitle: Plasticity Biomarkers,Interleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke overallStatus: RECRUITING date: 2024-02-21 date: 2024-04-23 date: 2024-05-09 date: 2024-04-29 date: 2024-04-29 name: Cairo University class: OTHER briefSummary: Forty-eight clinically verified Egyptian patients from both sexes with ischemic stroke that occurred at least 6 months to 2 years before inclusion will be randomly assigned into 2 groups, control group (GA) and the experimental group (GB). Patients will be randomly assigned into two equal groups: the control group (GA) and the experimental group (GB). Patients in the control group (GA) will be treated with sham Vagus nerve stimulation (taVNS) immediately before a selected physical therapy program, while in the experimental group (GB), patients will receive real transcutaneous auricular Vagus nerve stimulation (taVNS) followed by the same selected physical therapy program as (GA). Plasma level of Brain-Derived Neurotrophic Factors (BDNF) and Interleukin-6 (IL-6), Box and Blocks Test (BBT), and modified Ashworth scale (MAS) will be assessed at baseline and immediately post-treatment. conditions: Stroke conditions: Motor Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-blind, randomized controlled study. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients participated will be masked about the type of intervention, where (GA) patients will receive physical therapy program + sham transcutaneous auricular Vagus nerve stimulation, while patients in (GB) will receive true transcutaneous auricular Vagus nerve stimulation in addition to the same physical therapy program as (GA). whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: True Transcutaneous auricular Vagus Nerve Stimulation (TaVNS) name: Sham Trancutaneous auricular Vagus Nerve Stimulation measure: Muscle tone of the upper limb measure: Gross hand dexterity measure: Level of Plasma brain-derived Derived factor (BDNF) measure: Level of Serum Interleukin IL-6 sex: ALL minimumAge: 55 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Therapy, Cairo University status: RECRUITING city: Giza state: Ad Doqi, Giza District, Giza Governorate zip: 11432 country: Egypt name: Engy BadrEldin S Moustafa, PhD role: CONTACT phone: 00201099445112 email: [email protected] name: Moshera H. Darwish, PhD role: CONTACT phone: 00201015163617 email: [email protected] lat: 30.00808 lon: 31.21093 hasResults: False |
<|newrecord|> nctId: NCT06388941 id: CLNP023R12201 briefTitle: Iptacopan in Patients With ANCA Associated Vasculitis overallStatus: NOT_YET_RECRUITING date: 2024-08-28 date: 2027-08-27 date: 2027-09-22 date: 2024-04-29 date: 2024-04-29 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL. conditions: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Iptacopan name: Placebo name: Rituximab measure: Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48. measure: B cell counts measure: Total IgG levels measure: Complete remission at week 24 measure: Time to reach BVAS=0 measure: Time to major relapse measure: Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks measure: Cumulative dose of glucocorticoid (GC) measure: Glucocorticoid toxicity index over 48 weeks measure: 36-Item short form survey (SF-36) measure: Patient's Global Assessment (PtGA) measure: Physician's global assessment (PhGA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388928 id: P.T.REC/012/004596 briefTitle: Effect of Menstrual Cycle on the Manual Dexterity of Female Dentists overallStatus: COMPLETED date: 2023-07-09 date: 2023-12-26 date: 2023-12-26 date: 2024-04-29 date: 2024-04-29 name: Cairo University class: OTHER briefSummary: The aim of this observational study was to investigate the effect of the menstrual cycle on the manual dexterity of female dentists. |
This study was conducted to answer the following question: |
- Is there any effect of the menstrual cycle on the manual dexterity of female dentists? conditions: Menstrual Cycle conditions: Manual Dexterity studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 45 type: ACTUAL measure: Manual dexterity assessment sex: FEMALE minimumAge: 25 Years maximumAge: 35 Years stdAges: ADULT facility: Horus University city: Damietta country: Egypt lat: 31.41648 lon: 31.81332 hasResults: False |
<|newrecord|> nctId: NCT06388915 id: K2202403004 briefTitle: A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion overallStatus: COMPLETED date: 2024-03-12 date: 2024-03-20 date: 2024-03-23 date: 2024-04-29 date: 2024-04-29 name: Weikang Chen class: OTHER briefSummary: Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries. conditions: Pelvic Fracture conditions: Morel-Lavallee Lesion studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 15 type: ACTUAL measure: Site of MLL measure: Site of injury and Classification of pelvic fracture measure: Time to treatment measure: Drainage volume sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Provincial Hospital city: Fuzhou state: Fujian zip: 350000 country: China lat: 26.06139 lon: 119.30611 hasResults: False |
<|newrecord|> nctId: NCT06388902 id: BR115-101 briefTitle: A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-08 date: 2028-12 date: 2024-04-29 date: 2024-04-29 name: BioRay Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR115 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR115 for injection in patients with advanced solid malignancies. |
Patients will receive two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study. conditions: Advanced Solid Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: BR115 for injection measure: Treatment-emergent Adverse Events Following Treatment With BR115 measure: Objective Response Rate measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Disease control rate (DCR) measure: Duration of response (DOR). measure: Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) measure: Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) measure: The anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China name: Rui Xu, MD role: CONTACT phone: 86-20-87343468 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06388889 id: AR-DEX-22-04 briefTitle: Phase III Long-Term Extension Study With Dexpramipexole acronym: EXHALE-5 overallStatus: ENROLLING_BY_INVITATION date: 2024-05-08 date: 2027-06-01 date: 2027-06-01 date: 2024-04-29 date: 2024-04-29 name: Areteia Therapeutics class: INDUSTRY briefSummary: The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥12 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3. conditions: Eosinophilic Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1600 type: ESTIMATED name: Dexpramipexole Dihydrochloride measure: Number and Percentage of Participants with a Treatment Emergent Adverse Event measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight measure: Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters measure: Severe Asthma Exacerbations measure: Change in Asthma Control Questionnaire-6 (ACQ-6) measure: Change in absolute eosinophil counts (AEC) sex: ALL minimumAge: 12 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site 20001-004 city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 hasResults: False |
<|newrecord|> nctId: NCT06388876 id: AnkaraYBUbk briefTitle: The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes overallStatus: COMPLETED date: 2023-04-01 date: 2023-06-15 date: 2023-07-30 date: 2024-04-29 date: 2024-04-29 name: Ankara Yildirim Beyazıt University class: OTHER name: TÜBİTAK briefSummary: Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye. conditions: Earthquake conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: there are 2 groups; exercise and control primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Exercise name: lifestyle advice measure: Post-traumatic Stress Disorder Short Scale measure: Pittsburgh Sleep Quality Index sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Ankara Yildirim Beyazıt University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06388863 id: B2024-002 briefTitle: Evaluation of the Efficacy and Safety of FMT for Constipation in Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-31 date: 2026-05-31 date: 2024-04-29 date: 2024-04-29 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. During visitpoints, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Healthy donor-derived FMT capsule name: Placebo capsule measure: Response rate of constipation in Parkinson's Disease (PD) measure: Change from baseline PD symptoms at week 5, week 13 and week 24 measure: Change from baseline anxiety at week 5, week 13 and week 24 measure: Change from baseline depression at week 5, week 13 and week 24 measure: Change from baseline quality of life at week 5, week 13 and week 24 measure: Change from baseline drug concentration of levodopa in peripheral blood at week 13 and week 24 measure: Change from baseline fecal microbiota at week 5, week 13 and week 24 measure: Change from baseline fecal metabolites at week 5, week 13 and week 24 sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 180 Fenglin Road city: Shanghai state: Shanghai zip: 200032 country: China name: Shengdi Wu role: CONTACT phone: (86)13817923359 email: [email protected] name: Shengdi Wu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06388850 id: 5U01CE003393-03 type: NIH link: https://reporter.nih.gov/quickSearch/5U01CE003393-03 briefTitle: Evaluation of HRP Among Pre-K Through 5th Grade overallStatus: ENROLLING_BY_INVITATION date: 2023-03-23 date: 2025-09-30 date: 2025-09-30 date: 2024-04-29 date: 2024-04-29 name: Northeastern University class: OTHER briefSummary: This study is a rigorous experimental evaluation of an existing manualized universal child sexual abuse primary prevention program with a history of 30+ years of implementation across 30 states and robust pilot data. conditions: Child Sexual Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: A stepped wedge cluster randomized clinical trial design will be used to assess the efficacy of two linked curricula of the Healthy Relationships Project (HRP): Care for Kids (Pre-K through 2nd Grade) and We Care Elementary (3rd through 5th Grade). The HRP includes a 1.5 hour training for school staff prior to implementation, six 30-minute classroom lessons delivered to students once per week for 6 weeks, and 3 caregiver workshops. primaryPurpose: PREVENTION masking: NONE count: 16 type: ESTIMATED name: Healthy Relationships Project measure: Reports of child sexual abuse measure: The Parental Knowledge Scale (PKS) measure: The Parental Discussions about Sex Abuse Scale (PDSAS) measure: The adapted Parenting Self Agency (PSAM) measure: The Parent Knowledge Questionnaire (PKQ) measure: HRP evaluation measure: The CSA Myths Scale measure: The Teachers' Reporting Attitudes Scale for Child Sexual Abuse (TRAS-CSA) sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD facility: Safe Shores city: Washington state: District of Columbia zip: 20001 country: United States lat: 38.89511 lon: -77.03637 hasResults: False |
<|newrecord|> nctId: NCT06388837 id: RECO6U/20- 2021 briefTitle: Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone overallStatus: COMPLETED date: 2021-02-20 date: 2023-03-01 date: 2023-03-01 date: 2024-04-29 date: 2024-04-29 name: October 6 University class: OTHER briefSummary: The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft conditions: Symphysis Onlay Bone Graft conditions: Platelet Rich Fibrin conditions: Xenograft conditions: Horizontal Alveolar Ridge Augmentation conditions: Esthetic Zone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 12 type: ACTUAL name: Injectable Platelet Rich Fibrin name: Xenograft measure: Alveolar ridge width measure: Bone density sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: October 6 University city: Giza zip: 12511 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False |
<|newrecord|> nctId: NCT06388824 id: GWang028 briefTitle: The Effect of Esketamine on Sleep Disturbance overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-09-30 date: 2024-10-10 date: 2024-04-29 date: 2024-04-29 name: Tianjin Medical University General Hospital class: OTHER briefSummary: To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: normal saline name: Esketamine measure: The incidence of sleep disturbance on the first night after surgery measure: The incidence of sleep disturbance on the second and third postoperative nights measure: The incidence of sleep disturbance on the seventh postoperative nights measure: Postoperative anxiety measure: Postoperative depression measure: Pain intensity measure: Adverse event measure: preoperative hemoglobin concentration measure: Human Chorionic Gonadotropin level measure: The incidence of sleep disturbance on the day before surgery measure: The incidence of sleep disturbance before surgery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University General Hospital city: Tianjin zip: 300052 country: China lat: 39.14222 lon: 117.17667 hasResults: False |
<|newrecord|> nctId: NCT06388811 id: 2023/1162 briefTitle: Validity and Reliability Study of the Turkish Version of the Early Osteoarthritis Questionnaire overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-11-15 date: 2024-12-15 date: 2024-04-29 date: 2024-04-29 name: Istanbul University class: OTHER briefSummary: The symptoms of early osteoarthritis (OA) are quite similar to established knee OA, they differ, particularly in frequency, intensity, and severity. For this reason, in 2023, the International Symposium of intra-articular treatment (ISIAT) technical experts panel (TEP-technical experts panel) published for the first time a questionnaire designed to assess and monitor the follow-up and clinical progression of patients affected by early knee OA. Early management of knee OA is recommended by various guidelines because this approach may alter the course and clinical features of the disease, especially when considering disease-modifying agents that may delay disease progression. |
Therefore, the assessment of early knee OA with a questionnaire may facilitate the follow-up of OA in the early stages of the disease when treatment is likely to be more effective. This approach will allow to reduce disability and improve patients' quality of life. While creating the Early Osteoarthritis Questionnaire (EOAQ), it was aimed to have a complete, short and easy-to-understand questionnaire and to ensure that the respondents could complete the questionnaire easily and in a short time. The EOAQ consists of 11 questions. The questions were divided into two different groups. While the first two questions were related with clinical characteristics, the other nine questions aimed to investigate the results reported by the patient. For each question, there are three responses depending on the number of episodes: Never, rarely (between one and three episodes) and frequently (more than three episodes) within a 6-month period. Turkish validity and reliability study of the EOAQ has not been conducted yet. |
For the translation of the questionnaire, the guide recommended by Beaton et al. for the cultural adaptation of questionnaires will be used. According to this guideline the original EOAQ will be translated into Turkish by two experts independently of each other, and then a single Turkish version will be created by two experts working together. This Turkish version will then be translated back into English by an expert who can speak both languages at an advanced level. The experts will then evaluate the translation and adapt the questionnaire accordingly. After the completion of the translated form, 110 patients and 110 control group participants who applied to Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation and met the inclusion criteria will be included. The participants will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Voluntary Consent Form" after their consent is obtained. Participants will fill in the Turkish version of the questionnaire. Along with the questionnaire, knee pain will be questioned with the Numeric Rating Scale (0=no pain, 10=the most severe pain you experience) and disability will be questioned with the WOMAC Questionnaire, whose Turkish validity and reliability study has been conducted. Test-retest method will be applied for reliability analyses; therefore, at least 30 patients among the patients included in the study will complete the questionnaire twice (the second evaluation will be 2 weeks after the first evaluation). conditions: Early Knee Osteoarthritis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 220 type: ESTIMATED name: Early Osteoarthritis Questionnaire measure: Numeric Rating Scale measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388798 id: Ankara Etlik city hospital briefTitle: Evaluation of the Effectiveness of Psychoeducational Training Given to Nurses Working in a Psychiatric Clinic overallStatus: COMPLETED date: 2023-05-30 date: 2023-07-30 date: 2023-07-30 date: 2024-04-29 date: 2024-04-29 name: Ankara Etlik City Hospital class: OTHER_GOV briefSummary: Summary: |
Background One of the most important roles of psychiatric nurses, who help individuals, families and society in promoting health, preventing diseases and coping with problems, is their educational role. With its educational role, the nurse can help the patient and their family function at the best level in biopsychosocial integrity in preventing and coping with diseases through psychoeducation. |
Goals This research was conducted to evaluate the effectiveness of psychoeducational training given to nurses working in a psychiatric clinic. |
Design This research is a randomized controlled experimental study. Participants Participants were determined using simple randomization. The sample of the study consisted of 78 nurses (intervention = 39; control = 39) working in a psychiatric clinic in a city hospital in Turkey. |
Methods Groups were determined using the simple randomization method. Psychoeducational training was given to the intervention group, nurses working in the Psychiatry clinic, for a total of 4 sessions, with two sessions of 50 minutes each. The data of the research were collected with the ;Personal Information Form; Form for evaluating the knowledge level of nurses working in the psychiatry clinic regarding psychoeducation and Perception of Adequacy Scale in Psychoeducation Program Development and Implementation. Data were analyzed using independent samples t test and two-way repeated measures analysis of variance (ANOVA). conditions: Nursing Education conditions: Psychoeducation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 78 type: ACTUAL name: Education measure: Psychoeducation program development and implementation competence perception scale. Data will be collected before and after the training program in the intervention group, and at parallel times to the intervention group in the control group. measure: Form for evaluating the knowledge level of nurses working in a psychiatric clinic regarding psychoeducation sex: ALL minimumAge: 23 Years maximumAge: 45 Years stdAges: ADULT facility: Ankara Etlik City Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2023-05-05 uploadDate: 2024-03-04T06:15 filename: Prot_SAP_ICF_000.pdf size: 163176 hasResults: False |
<|newrecord|> nctId: NCT06388785 id: TAK-003-5001 briefTitle: A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia acronym: PRIME-Q overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-09-01 date: 2027-09-01 date: 2024-04-29 date: 2024-04-29 name: Takeda class: INDUSTRY briefSummary: The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever. |
No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate. conditions: Dengue Fever studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED name: No Intervention measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP) sex: ALL minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universiti Putra Malaysia city: Serdang state: Selangor zip: 43400 country: Malaysia name: Study Contact role: CONTACT phone: +603-9769 1000 email: [email protected] name: Zamberi Sekawi, Dr role: PRINCIPAL_INVESTIGATOR facility: Universiti Malaya city: Kuala Lumpur state: Wilayah Persekutuan Kuala Lumpur zip: 50603 country: Malaysia name: Study Contact role: CONTACT phone: +60379493641 email: [email protected] name: Sharifah Faridah binti Syed Omar, Dr role: PRINCIPAL_INVESTIGATOR lat: 3.1412 lon: 101.68653 hasResults: False |
<|newrecord|> nctId: NCT06388772 id: HJG-CZQH-QHRD106 briefTitle: Study to Assess PK, Safety and Tolerability Early in Healthy Subjects overallStatus: COMPLETED date: 2021-07-05 date: 2022-07-22 date: 2023-01-06 date: 2024-04-29 date: 2024-04-29 name: Changzhou Qianhong Bio-pharma Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ACTUAL name: QHRD106 Injection name: placebo measure: Safety as assessed by incidence, severity, and causality of adverse events measure: Plasma measurements of QHRD106 sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Nanjing Drum Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China lat: 32.06167 lon: 118.77778 hasResults: False |
<|newrecord|> nctId: NCT06388759 id: TQ05105-Ib-03 briefTitle: TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2022-08-01 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis. conditions: Myelofibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ACTUAL name: TQ05105 Tablets measure: Spleen volume reduction (SVR35)≥35% from baseline measure: Optimum effective rate measure: Onset time of splenic response measure: Duration of maintenance of spleen response (DoMSR) ≥35% reduction measure: Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline measure: The total symptom score of MPN-SAF TSS decreased compared with baseline measure: Progression-free survival (PFS) measure: Leukemia free survival (LFS) measure: Overall Survival (OS) measure: Incidence of adverse events (AEs) measure: Severity of AEs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital city: Hefei state: Anhui zip: 230001 country: China lat: 31.86389 lon: 117.28083 facility: The First Affiliated Hospital of Wannan Medical College city: Wuhu state: Anhui zip: 241001 country: China lat: 31.33728 lon: 118.37351 facility: Union Hospital Tongji College Huazhong University of Science And Technology city: Wuhan state: Hubei zip: 430071 country: China lat: 30.58333 lon: 114.26667 facility: The Affiliated Hospital of Xuzhou Medical University city: Xuzhou state: Jiangsu zip: 221000 country: China lat: 34.18045 lon: 117.15707 facility: The First Hospital of Jilin University city: Changchun state: Jilin zip: 130021 country: China lat: 43.88 lon: 125.32278 facility: Shanghai Sixth People's Hospital city: Shanghai state: Shanghai zip: 200233 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06388746 id: NKUA briefTitle: Arresting Carious Lesions With Minimal Intervention Techniques overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-12 date: 2024-04-29 date: 2024-04-29 name: National and Kapodistrian University of Athens class: OTHER briefSummary: A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars. conditions: Caries,Dental studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: BRIX3000® name: Riva Star Aqua, SDI Limited, Australia measure: clinical success measure: radiographic success measure: Longevity and the quality of the final restoration measure: Patient's acceptance sex: ALL minimumAge: 4 Years maximumAge: 8 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06388733 id: IVY P3-24-021 briefTitle: A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2028-03 date: 2024-04-29 date: 2024-04-29 name: Ivy Brain Tumor Center class: OTHER name: GlaxoSmithKline briefSummary: The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are: |
Does niraparib improve progression-free survival (PFS) compared to TMZ? |
Does niraparib improve overall survival (OS) compared to TMZ? |
Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ. |
* study drug (Niraparib) or |
* comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma). |
The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks. |
Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study. |
Participants' tasks will include: |
* Complete study visits as scheduled |
* Complete a diary to record study medication conditions: Glioblastoma conditions: GBM conditions: Brain Neoplasms, Adult, Malignant conditions: Brain Tumor studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Blinded Independent Central Review is composed of independent radiologists and will be utilized to assess progression of disease count: 450 type: ESTIMATED name: Niraparib name: Temozolomide measure: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) measure: Overall survival measure: Overall response rate measure: Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale) measure: Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-BN20-item Core module (EORTC QLQ-BN20) (Scores on a scale) measure: Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning Test measure: Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association measure: Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B measure: Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) measure: Number of treatment discontinuations, dose interruptions, and dose reductions due to AEs, SAEs, or AESIs, changes in Karnofsky performance status, changes in clinical laboratory results, and vital sign measurements measure: Frequency and severity of symptomatic AEs based on PRO-CTCAE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388720 id: NCC2024-0026 briefTitle: The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy acronym: IMGeS overallStatus: RECRUITING date: 2024-04-30 date: 2025-06-30 date: 2027-12-31 date: 2024-04-29 date: 2024-04-29 name: National Cancer Center, Korea class: OTHER_GOV briefSummary: The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 82 type: ESTIMATED name: Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml measure: Recurrent free survival in sequential treatment group. measure: Progression free survival in sequential treatment group. measure: Cystectomy free survival in sequential treatment group. measure: cancer specific survival in sequential treatment group. measure: Overall survival in sequential treatment group. measure: Safety of sequential treatment. sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center status: RECRUITING city: Goyang-si country: Korea, Republic of name: Ho Kyung Seo role: CONTACT phone: 82-31-920-1678 email: [email protected] name: Ho Kyung Seo, MD role: PRINCIPAL_INVESTIGATOR name: Eui Hyun Jung, Ph.D role: SUB_INVESTIGATOR lat: 37.65639 lon: 126.835 hasResults: False |
<|newrecord|> nctId: NCT06388707 id: NF-2022-01 briefTitle: A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-07-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: NaviFUS Corporation class: INDUSTRY name: NaviFUS US LLC briefSummary: This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE). conditions: Drug Resistant Epilepsy conditions: Epilepsy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: NaviFUS System measure: Adverse events (AEs) measure: Change from baseline in seizure frequency measure: Change from baseline in electroencephalography (EEG) epileptiform discharges measure: Days of seizure-free measure: Changes from baseline in Beck Anxiety Inventory (BAI) measure: Changes from baseline in Beck Depression Inventory (BDI-II) measure: Changes from baseline in Personal Impact of Epilepsy Scale (PIES) measure: Change from baseline in subjective seizure strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University School of Medicine city: Palo Alto state: California zip: 94305 country: United States name: Robert Fisher, M.D., Ph.D. role: CONTACT lat: 37.44188 lon: -122.14302 facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Ellen Bubrick, M.D. role: CONTACT lat: 42.35843 lon: -71.05977 facility: University of Virginia School of Medicine city: Charlottesville state: Virginia zip: 22903 country: United States name: Nathan Fountain, M.D. role: CONTACT lat: 38.02931 lon: -78.47668 hasResults: False |
<|newrecord|> nctId: NCT06388694 id: RDO KPNC 24-056 briefTitle: Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-06-28 date: 2024-07-31 date: 2024-04-29 date: 2024-04-29 name: Kaiser Permanente class: OTHER briefSummary: This cluster randomized trial will compare pharmacist management of secure message requests for refills of attention deficit hyperactivity medications with primary care physician management regarding quality of care, timeliness of service, and parent care experience. conditions: Attention-deficit Hyperactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: INVESTIGATOR count: 315 type: ESTIMATED name: Pharmacist Care name: Primary Care Physician Care measure: Percentage of participants appropriately referred for a follow-up weight check measure: Timeliness of care measure: Parent perception of effectiveness of care sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Kaiser Permanente Northern California city: Oakland state: California zip: 94612 country: United States lat: 37.80437 lon: -122.2708 hasResults: False |
<|newrecord|> nctId: NCT06388681 id: HMKU-KMY-SA-02 briefTitle: Stress Ball Use in Patients Undergoing Coronary Angiography overallStatus: RECRUITING date: 2024-04-24 date: 2024-04-26 date: 2024-06-26 date: 2024-04-29 date: 2024-04-29 name: Mustafa Kemal University class: OTHER briefSummary: One of the nonpharmacologic interventions included in the NIC-Nursing Interventions Classification is the use of stress balls. Stress balls are one of the cognitive distraction methods used especially in reducing pain and increasing the comfort level of patients. On the other hand, there are studies showing that stress balls have a positive effect not only on pain but also on vital signs, anxiety and comfort level of the patient. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 72 type: ESTIMATED name: The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography measure: Patient Identifying Information Form measure: Immobilization Comfort Scale measure: Visual Benchmarking Scale measure: Vital Signs Monitoring Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hatay Mustafa Kemal University status: RECRUITING city: Hatay country: Turkey name: SÜMEYYE AKÇOBAN role: CONTACT lat: 38.40227 lon: 27.10486 hasResults: False |
<|newrecord|> nctId: NCT06388668 id: ICM 2025-3428 briefTitle: Lipid Testing After Myocardial Infarction at the Montreal Heart Institute overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2025-09 date: 2024-04-29 date: 2024-04-29 name: Montreal Heart Institute class: OTHER name: Novartis Pharmaceuticals briefSummary: Because treatment decisions are usually based on a single measurement of the lipid panel at the time of an admission for an MI, the overarching objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization. |
It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute. |
Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission. |
Thereafter, the levels of the different lipid values from the panel will be compared between day 0, day 2, and 4-6 weeks after discharge. conditions: Dyslipidemias conditions: Lipid Testing conditions: Myocardial Infarction studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Lipid panel measure: Variation in LDL measure: Variation in non-HDL and apoB measure: Evaluation of intensification threshold measure: Repeat lipid panel after discharge measure: Evaluation of intensification threshold after discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montreal Heart Institute city: Montréal state: Quebec zip: H1T 1C8 country: Canada name: Guillaume Marquis-Gravel, MD, MSc role: CONTACT phone: (514) 376-3330 email: [email protected] name: Guillaume Marquis-Gravel, MD, MSc role: PRINCIPAL_INVESTIGATOR name: Jean Grégoire, MD role: SUB_INVESTIGATOR name: François Simard, MD role: SUB_INVESTIGATOR name: Rafaël Monet-Alarcia, MD role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False |
<|newrecord|> nctId: NCT06388655 id: MDCR-19-007 briefTitle: The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent overallStatus: COMPLETED date: 2019-06-10 date: 2022-06-30 date: 2022-06-30 date: 2024-04-29 date: 2024-04-29 name: Daegu Catholic University Medical Center class: OTHER briefSummary: The objective of this study was to ascertain the therapeutic impact of mobile neurofeedback (MNF) in neurotypical children when compared to sham MNF. Clinical assessments were conducted both before and after the MNF intervention, and the effectiveness of the intervention was to be validated through these evaluations. conditions: Internet Addiction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 61 type: ACTUAL name: mobile neurofeedback name: sham mobile neurofeedback measure: Comparisons of the means of children's self-scale variables measure: Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II) measure: Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI) measure: Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV) measure: Comparisons of the means of children's Stroop measure: Comparisons of the means of children's ATA(Advanced Test of Attention) measure: Comparisons of the means of children's CCTT(Children's Color Trails Test) sex: ALL minimumAge: 8 Years maximumAge: 15 Years stdAges: CHILD facility: Daegu Catholic University Medical Center city: Daegu state: Nam-gu zip: 42471 country: Korea, Republic of lat: 35.87028 lon: 128.59111 hasResults: False |
<|newrecord|> nctId: NCT06388642 id: CUV052 briefTitle: Pharmacokinetics of Afamelanotide in EPP Patients overallStatus: RECRUITING date: 2024-03-07 date: 2024-07-01 date: 2024-10-01 date: 2024-04-29 date: 2024-04-29 name: Clinuvel Europe Limited class: INDUSTRY briefSummary: The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients. conditions: Erythropoietic Protoporphyria studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 28 type: ESTIMATED name: Afamelanotide 16mg implant measure: Cmax (maximum Plasma Concentration) measure: AUC(0-t) (area under the curve from administration to last observed concentration at time t) measure: AUC(0-∞) (area under the curve extrapolated to infinite time) sex: ALL minimumAge: 12 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Center status: RECRUITING city: Rotterdam country: Netherlands name: Erasmus Medical Centre role: CONTACT lat: 51.9225 lon: 4.47917 hasResults: False |
<|newrecord|> nctId: NCT06388629 id: M064-066 Rev 00 briefTitle: Epicardial Access Study With Rook acronym: EASY-R overallStatus: RECRUITING date: 2023-12-17 date: 2024-05 date: 2024-05 date: 2024-04-29 date: 2024-04-29 name: Circa Scientific, Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access. |
Participants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure. conditions: Arrythmia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, non-randomized primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Rook Epicardial Access Kit measure: Successful Epicardial Access measure: Speed of Access measure: Rate of Use Errors measure: Rate of Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Na Homolce Hospital status: RECRUITING city: Prague zip: 15030 country: Czechia name: Petr Neuzil, MD, PhD role: CONTACT phone: +420257272211 lat: 50.08804 lon: 14.42076 hasResults: False |
<|newrecord|> nctId: NCT06388616 id: D6402C00013 briefTitle: Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-11-15 date: 2024-11-15 date: 2024-04-29 date: 2024-04-29 name: AstraZeneca class: INDUSTRY briefSummary: This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group. conditions: Hepatic Impairment studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three cohorts (two hepatic impairment cohorts and controls with normal hepatic function) will be enrolled into this study. |
All subjects will receive the study intervention: |
* Cohort 1 will enroll 8 participants with mild hepatic impairment |
* Cohort 2 will enroll 8 participants with moderate hepatic impairment |
* Cohort 3 will enroll 8-12 healthy participants matched on a group level regarding age, BMI and sex primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Balcinrenone measure: Area under plasma concentration-time curve from time zero to the last measurable concentration (AUClast) measure: Area under plasma concentration-time curve from zero to infinity (AUCinf) measure: Maximum observed plasma concentration (Cmax) measure: AEs and SAEs up to the follow-up telephone call (Day 10 [± 3 days]) measure: Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings measure: Number of participants with abnormal laboratory tests results sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Hialeah state: Florida zip: 33014 country: United States lat: 25.8576 lon: -80.27811 facility: Research Site city: Orlando state: Florida zip: 32809 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site city: San Antonio state: Texas zip: 78215 country: United States lat: 29.42412 lon: -98.49363 hasResults: False |
<|newrecord|> nctId: NCT06388603 id: DFORCT012023 briefTitle: RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT) acronym: DFORCT overallStatus: RECRUITING date: 2024-03-21 date: 2026-09-30 date: 2026-12-30 date: 2024-04-29 date: 2024-04-29 name: ASST Ovest Milanese class: OTHER name: Hippocrates Research name: Bonalive Biomaterials Ltd briefSummary: The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers. |
Participants will randomized into two groups: |
* Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice. |
* Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible. conditions: Osteomyelitis - Foot studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: Bioactive Glass name: Standard of Care measure: healing rate measure: Duration of antibiotic therapy measure: Rate of recurrences measure: Number of re-interventions because of the same lesion measure: Timing of re-interventions because of the same lesion measure: Proportion of patients undergoing amputations measure: Patients' Quality of Life measure: Patients' Quality of Life measure: Time back to walk measure: Characteristics of surgery measure: Length of surgery sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone status: NOT_YET_RECRUITING city: Monfalcone state: Gorizia zip: 34074 country: Italy name: Dr. Roberto Da Ros, Med Doctor role: CONTACT phone: +39 3470606008 email: [email protected] name: Dr. Roberto Da Ros, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 45.80463 lon: 13.53292 facility: ASST Ovest Milanese - Ospedale di Abbiategrasso status: RECRUITING city: Abbiategrasso state: Milano zip: 20081 country: Italy name: Dr. Roberto De Giglio, Med Doctor role: CONTACT phone: +39 331 6989775 email: [email protected] name: Dr. Roberto De Giglio, Med Doctor role: PRINCIPAL_INVESTIGATOR name: Dr. Ilaria Formenti, Med Doctor role: SUB_INVESTIGATOR name: Dr. Vincenzo Curci, Med Doctor role: SUB_INVESTIGATOR lat: 45.39821 lon: 8.91678 facility: Casa di Cura Abano Terme - POLICLINICO ABANO TERME status: NOT_YET_RECRUITING city: Abano Terme state: Padova zip: 35031 country: Italy name: Dr. Christine Whisstock, Med Doctor role: CONTACT phone: +39 338 8924624 email: [email protected] name: Dr. Christine Whisstock, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 45.35753 lon: 11.78725 facility: USL Sud Est Toscana - Ospedale San Donato status: NOT_YET_RECRUITING city: Arezzo zip: 52100 country: Italy name: Dr. Alessia Scatena, Med Doctor role: CONTACT phone: +39 328 3281501 email: [email protected] name: Dr. Alessia Scatena, Med Doctor role: PRINCIPAL_INVESTIGATOR name: Dr. Matteo Apicella, Med Doctor role: SUB_INVESTIGATOR lat: 43.46276 lon: 11.88068 facility: AUSL Romagna - Ospedale Morgagni Pierantoni status: NOT_YET_RECRUITING city: Forlì zip: 47121 country: Italy name: Dr. Silvia Acquati, Med Doctor role: CONTACT phone: +39 335 1239344 email: [email protected] name: Dr. Silvia Acquati, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 44.22177 lon: 12.04144 facility: Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte status: NOT_YET_RECRUITING city: Lucca zip: 55100 country: Italy name: Dr. Ilaria Casadidio, Med. Doctor role: CONTACT phone: +39 3284882078 email: [email protected] name: Dr. Ilaria Casadidio, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 43.84369 lon: 10.50447 facility: AOU Pisana - Ospedale di Cisanello status: NOT_YET_RECRUITING city: Pisa zip: 5612 country: Italy name: Prof. Alberto Piaggesi, Med Doctor role: CONTACT phone: +39 3473331949 email: [email protected] name: Dr. Chiara Goretti, Med Doctor role: CONTACT phone: +39 3294125791 email: [email protected] name: Prof. Alberto Piaggesi, Med Doctor role: PRINCIPAL_INVESTIGATOR name: Dr. Chiara Goretti, Med Doctor role: SUB_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False |
<|newrecord|> nctId: NCT06388590 id: MOMMC.2024.0029 briefTitle: Acupuncture for Chronic Pelvic Pain overallStatus: RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-29 date: 2024-04-29 name: David Moss class: FED briefSummary: The objective of this study is to determine if alternative pain management strategies, namely acupuncture, may help reduce intensity of female pelvic pain compared to other pain control modalities. This research study will focus specifically on the Dragon's protocol of acupuncture which will seek to alleviate chronic non-endometriosis pelvic pain for women both with and without a history of sexual assault. |
This study may support evidence for an inexpensive alternative means of treatment for patients with or without traumatic sexual history and chronic pelvic pain. conditions: Pelvic Pain conditions: Acupuncture conditions: Gynecology studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patient sample will be both control and treatment groups. Individuals will not be divided into distinct groups. Patients will serve as their own controls. Control patients will be participating in standard of care therapies including physical therapy, psychotherapy, behavioral health, typical primary care management, etc. as deemed appropriate by the primary care provider for 4 weeks prior to study intervention. The same patients will then be re-evaluated and will be offered Acupuncture with Dragon technique (see attachment Protocol for Needle Insertion) as a means of pain control once per week for 4 weeks. primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Dragons name: Standard of Care measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) sex: FEMALE minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mike O'Callaghan Military Medical Center status: RECRUITING city: Nellis Air Force Base state: Nevada zip: 89191 country: United States name: Amanda J Crawford, MSHS role: CONTACT phone: 702-653-3583 email: [email protected] lat: 36.24607 lon: -115.05721 hasResults: False |
<|newrecord|> nctId: NCT06388577 id: MEU-HEM-SY-189 briefTitle: The Effect of the Training Programme Based on the Health Promotion Model Given to Parents overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2024-06-13 date: 2024-09-13 date: 2024-04-29 date: 2024-04-29 name: Mersin University class: OTHER briefSummary: This randomised controlled study evaluates the effect of a training programme based on the Health Promotion Model developed for parents of children diagnosed with epilepsy on parents' level of knowledge about epilepsy, parents' general self-efficacy level, parents' health promoting and protective behaviours and the number of hospital admissions of their children. The hypothesis of this study is that education has an effect on these. conditions: Parents conditions: Epilepsy in Children conditions: Disease Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, single-centre, randomised controlled, single-blind interventional study in parallel groups primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participants and the person who will perform the statistical analysis will be blinded. Participants will be assigned to intervention and control groups coded as A and B. Afterwards, it will be determined which of the A and B groups belong to the control and intervention groups by drawing lots.It will not be explained to the parents which group they are in, and it will be stated that education about epilepsy will be given. While entering the data, the researcher will enter the data encrypted as A and B in order to prevent measurement bias, the statistical analysis of the data will be carried out according to this encryption and the report of the study will be written in encrypted form. After the statistical analyses of the research are carried out and the research report is written as a result of the data found, it will be explained which of the groups the individuals are included in. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Education measure: Parents' level of knowledge about epilepsy evaluated using the Form for the Evaluation of Parents' Level of Knowledge about Epilepsy measure: Self-efficacy evaluated using the General Self-Efficacy Scale measure: Health Promoting and Protective Behaviors evaluated using the Health Promoting and Protective Behaviors Scale measure: Number of Hospital Admissions for Children evaluated using the Evaluation Form for the Number of Hospital Admissions sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Turkey, Mersin University city: Mersin country: Turkey name: Sümerya YASTI, MASTER role: CONTACT email: [email protected] name: Hacer ÇETİN, PROFESSOR role: PRINCIPAL_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False |
<|newrecord|> nctId: NCT06388564 id: INCA34176-254 id: 2022-502168-19-00 type: REGISTRY domain: EU CT Number briefTitle: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease overallStatus: NOT_YET_RECRUITING date: 2024-07-08 date: 2027-03-05 date: 2028-09-05 date: 2024-04-29 date: 2024-04-29 name: Incyte Corporation class: INDUSTRY briefSummary: This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD. conditions: Chronic Graft-versus-host-disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Axatilimab name: Ruxolitinib name: Corticosteroids measure: Objective Response Rate measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Duration of Response measure: Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score measure: Best overall response in the first 6 months measure: OR at 12 months, defined as CR or PR at 12 months (C14D1) in the absence of new systemic therapy for cGVHD. measure: Proportion of participants who remain corticosteroid-free measure: Organ-specific response in the first 6 cycles and on study, based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD. measure: Failure-free Survival (FFS) measure: Axatilimab pharmacokinetic (PK) in Plasma measure: Ruxolitinib PK in Plasma sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388551 id: LY03017/CT-CHN-101 briefTitle: A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017 overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-03-30 date: 2025-03-30 date: 2024-04-29 date: 2024-04-29 name: Luye Pharma Group Ltd. class: INDUSTRY briefSummary: This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects. conditions: Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis conditions: Hallucinations and Delusions Associated With Parkinson Disease Psychosis conditions: Negative Symptoms of Schizophrenia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: LY03017 name: LY03017-Placebo measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) measure: Maximum observed concentration (Cmax) of LPM526000133 in plasma measure: Time to maximum observed concentration (Tmax) of LPM526000133 in plasma measure: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma measure: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma measure: Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Shanghai Mental Health Center city: Shanghai country: China name: Huafang Li role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06388538 id: Carlo Bergamini briefTitle: The COLD2B Multicenter, Two-arm Prospective Cohort Study acronym: COLD2B overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-01 date: 2025-06-01 date: 2024-04-29 date: 2024-04-29 name: Azienda Sanitaria di Firenze class: OTHER briefSummary: Since it is still debated whether 2b acute diverticulitis (AD), according to the World Society of Emergency Surgery (WSES) classification, should be initially treated surgically or conservatively, we launched the COLD2B study to compare the clinical results of both therapeutic regimens in a multi-institutional cohort of prospectively enrolled patients. |
The primary aim of the COLD2B (Conservative vs surgical (either Open or Laparoscopic) approach in the emergency management of acute Diverticulitis WSES 2B) study is to develop a model able to predict the length of hospitalization, comparing the management of WSES 2b AD in the emergency setting (conservative versus surgical approach) (primary endpoint of the first arm of the study). |