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<|newrecord|> nctId: NCT06364878 id: 813533 briefTitle: Non-invasive Diagnostics of Microbial Keratitis overallStatus: RECRUITING date: 2023-08-23 date: 2025-03-01 date: 2028-04-08 date: 2024-04-15 date: 2024-04-15 name: Sorlandet Hospital HF class: OTHER_GOV briefSummary: Infectious keratitis is a significant cause of partial vision loss and blindness and places a large burden on eye care professionals. One of the main challenges for the ophthalmologist when presented with a case of suspected microbial keratitis is the determination of the subtype of keratitis. It must be determined whether the origin of the infection is bacterial, viral, fungal, or parasitic, in order to prescribe a correct, effective treatment aimed at the causative pathogen. In daily practice this can be challenging, and general treatments with antibiotics are prescribed. Some cases then experiences deterioration, resulting in more patients visits and further rounds of invasive treatments and progressive vision deterioration. |
This project is designed to break this cycle of nonspecific diagnosis, suboptimal treatment, and progressive worsening of vision with increased interventions. New, advanced diagnostics will be brought into the clinic to provide additional information which, if our hypothesis is correct, will result in more rapid and accurate diagnosis of the keratitis subtype. This will translate into earlier administration of a more targeted treatment, avoiding the repeated round of non-targeted treatment and progressive worsening of the patient's vision. This can directly reduce to number of clinic visits and specialist time required for treatment and follow-up of keratitis, knowledge of how the eye responds to various microbes by initiating a specific cascade of molecular inflammatory signals and changes in protein expression in the tear film. |
Using in vivo confocal microscopy (IVCM) we will document the cellular status of the cornea and identify microbes infecting the cornea in real-time. Secondly, tear samples will be obtained from patients with keratitis to evaluate and quantify the molecular cytokine signatures associated with specific microbial species, confirmed by microbiological culture. We will for the first time develop cytokine profiles for the various types of infection, identifying diagnostic cytokines which in the longer term can lead to development of rapid point-of-care biomarker diagnostics. |
The project aims are translated into the following hypotheses: |
H1: In vivo confocal microscopy imaging features detect microbial keratitis consistent with clinical assessment and outcome at a greater frequency than microbiological culture results. |
H2: Cytokine profiles (or a subset of molecules) in the eye are specific for viral, bacterial, fungal, or amoebic keratitis; and H3: A combination of in vivo confocal microscopy and molecular profiling of the tear film can yield a specific keratitis diagnosis closely matching the clinical progression and outcome of keratitis. conditions: Infectious Keratitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 125 type: ESTIMATED name: In vivo confocal microscopy name: Tear film sampling measure: IVCM findings and cytokine profile in infectious keratitis is specific for the different microbial subtypes. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sorlandet hospital status: RECRUITING city: Arendal country: Norway name: Neil Lagali role: CONTACT lat: 58.46151 lon: 8.77253 hasResults: False |
<|newrecord|> nctId: NCT06364865 id: 2022-04 briefTitle: AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study acronym: AE05ML overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-01-31 date: 2025-03-30 date: 2024-04-15 date: 2024-04-16 name: Teleflex class: INDUSTRY briefSummary: This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback. conditions: Gall Bladder Disease conditions: Bile Duct Diseases conditions: Acute Cholecystitis conditions: Kidney conditions: Liver conditions: Appendix conditions: Spleen Disease conditions: Prostate studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 161 type: ESTIMATED name: laparoscopic procedure measure: Evaluating the safety of AE05ML measure: Evaluating the performance of AE05ML measure: Evaluating device performance characteristics measure: Evaluating operator reported feedback sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364852 id: LY007C1101 briefTitle: An Evaluation of LY007 Cell Injection for r/r B-NHL acronym: r/r B-NHL overallStatus: RECRUITING date: 2021-12-25 date: 2024-08-31 date: 2026-05-31 date: 2024-04-15 date: 2024-04-15 name: Ruijin Hospital class: OTHER name: The First Affiliated Hospital with Nanjing Medical University name: Shanghai Longyao Biotechnology Inc., Ltd. briefSummary: An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research conditions: B-NHL studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: LY007 measure: Maximum tolerated dose or clinically recommended dose; measure: Dose limiting toxicity measure: Adverse Events , Serious Adverse Events , Adverse Events of Particular Concern, Including cytokine release syndrome , neurotoxicity,physical examination, vital signs, ECOG score, ECG, laboratory testing, etc. measure: PK aspect measure: PK aspect measure: PD aspect measure: therapeutic effect measure: Anti LY007 antibody measure: The titer of human anti mouse antibody measure: Exploratory study endpoint sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin hospital status: RECRUITING city: Shanghai country: China name: Weili Zhao, MD role: CONTACT phone: 13512112076 phoneExt: 610707 email: [email protected] name: Zixun Yan, MD role: CONTACT phone: +8613482056727 phoneExt: 610707 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06364839 id: CT2024-ZJU-OBS7 briefTitle: Liver Transplantation for Hepatocellular Carcinoma Arising in Non-cirrhotic Liver: a Propensity Score-matched Retrospective Cohort Study of Two National Databases overallStatus: COMPLETED date: 2024-02-20 date: 2024-03-23 date: 2024-03-25 date: 2024-04-15 date: 2024-04-15 name: Xiao Xu class: OTHER briefSummary: Background: Majority of liver transplantation (LT) recipients for hepatocellular carcinoma (HCC) were concomitant with liver cirrhosis, while few researches focusing on recipients without cirrhosis. Here we aim to investigate the prognosis of non-cirrhosis HCC recipients, expecting to provide theoretical basis for further improvement of these patients. |
Methods: This retrospective study analyze outcomes between adult HCC recipients arising in non-cirrhotic and cirrhotic liver from two national databases (CLTR and UNOS, January 2015 to December 2020). Based on important variables, 1:2 and 1:1 propensity score matching (PSM) were performed respectively. conditions: Hepatocellular Carcinoma, Non-cirrhotic Liver studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1 type: ACTUAL measure: Postoperative complications were evaluated by postoperative imaging and serological examination measure: The overall survival rate was evaluated by follow-up investigation and outpatient review measure: The tumor-free survival rate was evaluated by follow-up investigation and outpatient review sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Xiao Xu city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06364826 id: NPC-202403 briefTitle: Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-04-22 date: 2026-04-22 date: 2024-04-15 date: 2024-04-15 name: Zhejiang Cancer Hospital class: OTHER briefSummary: This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Sintilimab, bevacizumab, gemcitabine name: IMRT measure: 3-year Event-free survival rate measure: Objective Response Rate measure: Disease Control Rate measure: Progression-Free Survival measure: Overall survival measure: adverse events(AEs) measure: biomarkers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364813 id: H20-01461 briefTitle: Co-developing a Novel Intervention to Promote Wellbeing of Family Caregivers of Individuals With Spinal Cord Injury overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-04-15 date: 2024-04-23 name: University of British Columbia class: OTHER name: The Craig H. Neilsen Foundation briefSummary: Family caregivers of individuals with spinal cord injury (SCI) provide the majority of care and are at high risk of experiencing caregiver burden, which not only impacts caregivers' own wellbeing, but also their ability to respond to patients' needs. Health education using online approaches (eHealth) has the potential to improve quality of care, enhance communication between health care users and providers, reduce costs and increase access to existing knowledge and education for family caregivers. Here, the investigators propose a research study to assess the quality of the eHealth program. The findings of this study will lead to the refinement of the eHealth program. conditions: Spinal Cord Injuries conditions: Caregiver Burden studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: COMPANION eHealth Program measure: Family caregivers' subjective burden as assessed by the Zarit Burden Interview measure: Participants' objective burden as assessed by the Dutch Objective Burden Inventory measure: Participants' distress as assessed by the Depression, Anxiety and Stress Scale measure: Participants' relationship quality satisfaction as assessed by the Dyadic Adjustment Scale measure: Participants' health-related quality of life as assessed by the Veterans RAND 12-item Health Survey measure: Caregiver competence as assessed by the Caregiving Competence Scale measure: Participants' opinion regarding the usability of the implementation as assessed by the System Usability Scale measure: Participants' health care use as assessed by a bespoke questionnaire measure: Participants' experience using the implementation as assessed by a qualitative interview measure: A composite measure of recruitment rate, consent rate, retention rate, perceived benefit, and assessor masking will be evaluated as "successful" or "revise" according to expectations measure: A composite measure of treatment adherence, participant and evaluator burden during data collection, and expert burden will be evaluated as "successful" or "revise" according to expectations measure: A composite measure of internet stability, participant processing time, and treatment administration issues will be evaluated as "successful" or "revise" according to expectations measure: A measure of dose level of training time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364800 id: GDT-001-07-02 briefTitle: Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial of Hepatocellular Carcinoma Resistant to PD-1 Monoclonal Antibody overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2026-04-26 date: 2026-09-26 date: 2024-04-15 date: 2024-04-15 name: Beijing 302 Hospital class: OTHER name: Chinese Academy of Medical Sciences name: Beijing GD Initiative Cell Therapy Technology Co., Ltd. briefSummary: The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in patients with hepatocellular carcinoma resistant to PD-1 monoclonal antibody. |
Hepatocellular Carcinoma conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: γδ T cells name: PD-1 monoclonal antibody name: targeted drugs measure: Safety evaluation: Incidence of Adverse events (AEs) measure: Safety evaluation: Dose limited toxicity (DLTs) measure: Efficacy evaluation: Objective Response Rate(ORR) measure: Efficacy evaluation: Duration of Response(DOR) measure: Efficacy evaluation: Progress Free Survival(PFS) measure: Efficacy evaluation: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364787 id: GDT-001-07-01 briefTitle: Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2026-04-26 date: 2026-09-26 date: 2024-04-15 date: 2024-04-15 name: Beijing 302 Hospital class: OTHER name: Chinese Academy of Medical Sciences name: Beijing GD Initiative Cell Therapy Technology Co., Ltd. briefSummary: The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in first-line treatment of patients with hepatocellular carcinoma. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: γδ T cells name: Targeted drugs name: PD-1 monoclonal antibody measure: Safety evaluation: Incidence of Adverse events (AEs) measure: Safety evaluation: Dose limited toxicity (DLTs) measure: Safety evaluation: Maximum-tolerated dose (MTD) measure: Efficacy evaluation: Objective Response Rate(ORR) measure: Efficacy evaluation: Duration of Response(DOR) measure: Efficacy evaluation: Progress Free Survival(PFS) measure: Efficacy evaluation: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364774 id: 22-020309 briefTitle: ALS20-101 Lentiviral Gene Therapy for Beta Thalassemia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-12-31 date: 2027-12-31 date: 2024-04-15 date: 2024-04-15 name: Children's Hospital of Philadelphia class: OTHER briefSummary: The main goal of this study is to find out if the blood disorder called transfusion-dependent beta thalassemia can be safely treated by modifying blood stem cells. This is done by collecting blood stem cells from the subject, modifying those cells, adding a healthy beta globin gene, and then giving them back to the subject. It is hoped that these modified cells will decrease the need for blood transfusions. The gene modified blood stem cells are called CHOP-ALS20 ("study drug"). This experimental gene therapy has not been tried on human beings before and is not FDA approved. conditions: Beta-Thalassemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm pilot, phase I/II study of 12 subjects. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: ALS20 measure: Neutrophil Engraftment measure: Platelet Engraftment measure: Overall Survival at 2 years measure: Incidence of transplant related mortality measure: Incidence of Graft Versus Host Disease measure: Incidence of Vector-Derived Replication Competent Lentivirus measure: Insertional Oncogenesis measure: Clonal Predominance measure: maintain total hemoglobin level of 9.0 g/dL or higher sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Janet Kwiatkowski, MD role: CONTACT phone: 215-590-5286 email: [email protected] name: Jaladhikumar Patel role: CONTACT phone: 267-426-5602 email: [email protected] name: Janet Kwiatkowski, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False |
<|newrecord|> nctId: NCT06364761 id: 24103_BIL_EDOF briefTitle: Assesment of Intermediate Vision After BIL Cataract Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-15 date: 2024-04-15 name: Universitair Ziekenhuis Brussel class: OTHER briefSummary: The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens". |
The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery. |
Participants will: |
* Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters) |
* Have to fill in 2 questionnaires about visual functioning and spectacle independance |
Researchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens . conditions: Cataract studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 38 type: ESTIMATED name: Bag in the lens cataract surgery measure: Intermediate vision measure: Near vision sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364748 id: 002-2024-Shalowitz briefTitle: Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer overallStatus: RECRUITING date: 2024-03-11 date: 2025-03 date: 2025-09 date: 2024-04-15 date: 2024-04-15 name: West Michigan Cancer Center class: OTHER name: Veta Health briefSummary: A randomized trial of remote blood pressure monitoring, compared to usual care, in patients receiving bevacizumab to determine whether remote blood pressure monitoring improves the collection of blood pressure data, identification and management of clinically significant hypertension, and patient satisfaction. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ESTIMATED name: Cellular enabled blood pressure cuff name: Standard of Care Cuff measure: To determine whether remote blood pressure monitoring improves adherence to recommendations for daily systolic and diastolic blood pressure monitoring compared to usual care measure: Improvement of early identification of bevacizumab-induced hypertension with usual care blood pressure monitoring measure: Improvement of early identification of bevacizumab-induced hypertension with remote blood pressure monitoring measure: Patient satisfaction with usual care blood pressure monitoring measure: Patient satisfaction with remote blood pressure monitoring sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West Michigan Cancer Center status: RECRUITING city: Kalamazoo state: Michigan zip: 49007 country: United States name: Wendi Mitchell role: CONTACT phone: 269-373-7443 email: [email protected] name: Kathleen Allen role: CONTACT phone: 269-373-7452 email: [email protected] lat: 42.29171 lon: -85.58723 hasResults: False |
<|newrecord|> nctId: NCT06364735 id: Entità e variabili briefTitle: Entities and Variables Related to Catch-up Growth overallStatus: RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2024-12-01 date: 2024-04-15 date: 2024-04-29 name: ASST Fatebenefratelli Sacco class: OTHER briefSummary: A retrospective monocentric observational no-profit study with the aim of evaluating the entity and potential variables influencing the catch-up growth of childhood gluten-free diet patients with celiac disease during a 10-year follow-up. The only extrapolation of the data collected in anonymized form from the medical records of patients who match the necessary study criteria will be planned in order to achieve this aim. A 900-patient sample size will be planned. conditions: Celiac Disease in Children studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 900 type: ESTIMATED measure: Measure the catch-up growth degree. measure: Calculate the degree of catch-up growth measure: Exploratory objectives 1 measure: Exploratory objectives 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST Fatebenefratelli Sacco status: RECRUITING city: Milan zip: 2015 country: Italy name: Elena MD Groppali role: CONTACT email: [email protected] name: Elena MD Groppali role: CONTACT name: Elena MD Groppali role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06364722 id: ZYS2024-02 briefTitle: Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease overallStatus: COMPLETED date: 2015-05-01 date: 2023-12-31 date: 2024-03-28 date: 2024-04-15 date: 2024-04-15 name: Shanghai Institute of Acupuncture, Moxibustion and Meridian class: OTHER name: Fudan University briefSummary: Multidisciplinary techniques such as multimodal neuroimaging, microbiology, and bioinformatics were applied to study the differences in correlation characteristics between gut microbes, functional brain networks, and peripheral inflammation among patients with active Crohn's disease (CD), CD in remission, and healthy subjects. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Subjects, efficacy assessors and statisticians were blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ACTUAL name: Acupuncture treatment name: Sham acupuncture measure: Effect of Acupuncture on Crohn's Disease Activity Index (CDAI) measure: Effects of Acupuncture on Anxiety and Depression measure: Effects of Acupuncture on Quality of Life measure: Effect of acupuncture on intestinal inflammation measure: Effects of acupuncture on gut microbiota measure: Effects of acupuncture on the functional activity of brain networks measure: Effects of acupuncture on intestinal inflammation measure: Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations measure: Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment) measure: Safety evaluation (number of participants with abnormal routine blood tests) measure: Safety evaluation (number of participants with abnormal Liver function tests) measure: Safety evaluation (number of participants with abnormal Renal function tests) sex: ALL minimumAge: 16 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364709 id: 4526 id: R01DC015516 type: NIH link: https://reporter.nih.gov/quickSearch/R01DC015516 briefTitle: Criterion-learning Based Naming Treatment in Aphasia overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2028-08 date: 2028-08 date: 2024-04-15 date: 2024-04-15 name: Albert Einstein Healthcare Network class: OTHER name: Thomas Jefferson University name: National Institute on Deafness and Other Communication Disorders (NIDCD) briefSummary: Aphasia is a disorder of spoken and written language, most commonly following a stroke. It is estimated that between 2.5 and 4 million Americans are living with aphasia today. A common problem in aphasia involves difficulty retrieving known words in the course of language production and comprehension. The overarching goal of this project is to develop and test early efficacy, efficiency, and the tolerability of a lexical treatment for aphasia in multiple-session regimens that are comprised of retrieval practice, distributed practice, and training dedicated to the elicitation of correct retrievals. The aim of this work is to add to and refine the evidence base for the implementation and optimization of these elements in the treatment of production and comprehension deficits in aphasia, and make important steps towards an ultimate goal of self-administered lexical treatment grounded in retrieval practice principles (RPP) to supplement traditional speech-language therapy that is appropriate for People with Aphasia (PWA) from a broad level of severity of lexical processing deficit in naming and/or comprehension. This project cumulatively builds on prior work to develop a theory of learning for lexical processing impairment in aphasia that aims to ultimately explain why and for whom familiar lexical treatments work, and how to maximize the benefits they confer. conditions: Aphasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Criterion-learning practice measure: Trained naming items (Experiment 1) measure: Trained naming items (Experiment 2) measure: Trained naming items (Experiment 3) measure: Trained comprehension items (Experiment 4) measure: Trained naming items (Experiment 1) measure: Trained naming items (Experiment 2) measure: Untrained naming items (Experiment 2) measure: Trained naming items (Experiment 3) measure: Trained naming items (Experiment 4) measure: Trained comprehension items (Experiment 4) measure: Untrained comprehension items (Experiment 4) measure: Treatment compliance (Experiment 2) measure: Connected speech output performance sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364696 id: 4396-CL-0101 briefTitle: A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors overallStatus: RECRUITING date: 2024-04-16 date: 2027-04-30 date: 2027-04-30 date: 2024-04-15 date: 2024-04-29 name: Astellas Pharma Inc class: INDUSTRY briefSummary: Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors. |
ASP4396 is being developed as a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene. ASP4396 is not currently available as a treatment for the public. In this study, researchers will learn how ASP4396 is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from ASP4396. |
In this study, ASP4396 is being given to humans for the first time. |
People in this study will be adults with locally advanced (unresectable), or metastatic solid tumors with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies or refused to receive those treatments. |
The main aims of the study are to check the safety of ASP4396, how well people cope with medical problems during the study (how well it is tolerated), and to find a suitable dose of ASP4396. |
This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP4396. |
This study will be in 2 parts. |
Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of ASP4396. For each dose, all medical problems will be recorded. The first group will receive the lowest dose of ASP4396. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396. The panel will do this until all groups have taken ASP4396 or until suitable doses have been selected for Part 2. |
Part 2 is called Dose Expansion. Other different small groups of people will receive ASP4396 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP4396 to use in future studies. |
In both parts of the study, ASP4396 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. People will continue treatment until: they have medical problems from the treatment they can't cope with (can't tolerate); their cancer gets worse; they start other cancer treatment; or they ask to stop treatment. |
People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. The study doctors will check for any medical problems from ASP4396. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during treatment with the option of a tumor sample being taken after treatment has finished. |
People will visit the clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. |
After this, people will visit the clinic for a health check several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not. |
After treatment has finished, people in the study will be followed up for up to 45 weeks. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 175 type: ESTIMATED name: ASP4396 measure: Incidence of Dose Limiting Toxicities (DLTs) for ASP4369 measure: Number of Participants with Adverse Events (AEs) measure: Number of Participants with Serious Adverse Events (SAEs) measure: Number of Participants with laboratory value abnormalities and/or AEs measure: Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs measure: Number of Participants with vital sign abnormalities and/or AEs measure: Number of Participants with physical exam abnormalities and/or AEs measure: Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measure: Duration of Response (DOR) per RECIST v 1.1 measure: Disease Control Rate (DCR) per RECIST v 1.1 measure: Progression Free Survival (PFS) per RECIST v1.1 measure: Overall Survival (OS) measure: Pharmacokinetics (PK) of ASP4396 in plasma: area under the concentration-time curve from the time of dosing to 24 hours after dosing (AUC24h) measure: PK of ASP4396 metabolite in plasma: AUC24h measure: PK of ASP4396 in plasma: AUC168h measure: PK of ASP4396 metabolite in plasma: AUC168h measure: PK of ASP4396 in plasma: Maximum Concentration (Cmax) measure: PK of ASP4396 metabolite in plasma: Cmax measure: PK of ASP4396 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) measure: PK of ASP4396 metabolite in plasma: Ctrough measure: PK of ASP4396 in plasma: Time of maximum concentration (tmax) measure: PK of ASP4396 metabolite in plasma: tmax measure: Change from baseline of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D amino acid substitution (G12D) tumor samples sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: START Midwest status: RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: NEXT Oncology Dallas status: RECRUITING city: Irving state: Texas zip: 75039 country: United States lat: 32.81402 lon: -96.94889 facility: START Mountain Region status: RECRUITING city: West Valley City state: Utah zip: 84119 country: United States lat: 40.69161 lon: -112.00105 facility: NEXT Oncology Virginia status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States lat: 38.84622 lon: -77.30637 hasResults: False |
<|newrecord|> nctId: NCT06364683 id: AIBU-HSF-SDEMIR-04 briefTitle: Coronary Artery Disease and Exercise Adherence overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2024-11-13 date: 2025-05-13 date: 2024-04-15 date: 2024-04-15 name: Abant Izzet Baysal University class: OTHER briefSummary: This study aims to determine the factors affecting exercise adherence in patients with coronary artery disease (CAD). For this purpose, the following measurement tools will be used respectively: (1) "Patient Information Form" including sociodemographic characteristics of the patients and medical information related to the disease, (2) the Exercise Adherence Rating Scale (EARS), (3) Exercise Self-Efficacy Scale (ESE) and, (4) Turkish-Health Literacy Survey Europe-Q12 (HLS-EU-19-12Q-TR). Statistical analyses will be carried out by descriptive statistics (number, percentage, mean, standard deviation, etc.), correlation analysis and regression analysis. conditions: Adherence, Treatment conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Survey study measure: exercise adherence measure: predictors for exercise adherence sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364670 id: ZSLL-KY-2023-011-01 briefTitle: Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus overallStatus: RECRUITING date: 2024-05 date: 2026-08-31 date: 2026-12-31 date: 2024-04-15 date: 2024-04-15 name: The Third Affiliated hospital of Zhejiang Chinese Medical University class: OTHER briefSummary: This trial aims to use machine learning to analyze fNIRS imaging data of specific brain regions of tinnitus patients, thereby constructing a predictive model of the clinical efficacy of acupuncture for SNT. conditions: Tinnitus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: acupuncture measure: Change in resting-state functional connectivity (RSFC) measure: Change in hemoglobin signals measure: Change in Tinnitus Severity Grading measure: Change in Tinnitus Handicap Inventory score measure: Change in average pure-tone threshold sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: the Third Affiliated Hospital of Zhejiang Chinese Medical University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Hantong Hu, M.D role: CONTACT phone: 18667103032 phoneExt: 86 email: [email protected] name: Xiaohan Huang, M.M role: CONTACT phone: 18334334738 phoneExt: 86 email: [email protected] name: Hantong Hu, M.D role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06364657 id: IRB00439625 briefTitle: Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye acronym: IIR overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-31 date: 2027-07-31 date: 2024-04-15 date: 2024-04-15 name: Johns Hopkins University class: OTHER briefSummary: In this study the investigators plan to enroll three groups of patients: non-Sjogren's dry eye, Sjogren's dry eye and controls. The study has the following primary goals: |
1. To determine whether dry eye is associated with reduced corneal sensation |
2. To determine whether reduced corneal sensation is due to the severity of the dry eye, the type of dry eye (primarily aqueous deficient versus primarily evaporative) or entirely related to the presence of Sjogren's |
3. To determine whether corneal sensation is associated with ocular or systemic pain symptoms Additionally, the study aims to compare the novel corneal esthesiometer measurements to confocal biomicroscopy findings in determining neurotrophic keratitis (NK) and assess correlations between corneal sensation. conditions: Sjogren's Syndrome conditions: Dry Eye conditions: Neurotrophic Keratitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Eye Exam measure: Corneal Epithelium health measure: Corneal Nerve health measure: Correlations Between Corneal Staining Score measure: Correlations Between Patient Symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Hospital Wilmer Eye Institute city: Baltimore state: Maryland zip: 21287 country: United States name: Esen K Akpek, MD role: CONTACT phone: 410-955-5490 email: [email protected] name: Lee W Guo, OD role: SUB_INVESTIGATOR name: Michelle M Hessen, OD role: SUB_INVESTIGATOR name: Esen K Akpek, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False |
<|newrecord|> nctId: NCT06364644 id: IRB00336599 id: 1P50MD017348-01 type: NIH link: https://reporter.nih.gov/quickSearch/1P50MD017348-01 briefTitle: Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure acronym: UNLOAD-HF overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-09-30 date: 2027-06-30 date: 2024-04-15 date: 2024-04-15 name: Johns Hopkins University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility. conditions: Type2diabetes conditions: Heart Failure conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The design of the study is a randomized 2:1 parallel-arm clinical trial. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants and interventionists will be unblinded, while those assessing outcomes will be blinded to the randomization arm . whoMasked: OUTCOMES_ASSESSOR count: 402 type: ESTIMATED name: Community Champions name: Homegrown Heroes measure: Change in cardiorespiratory fitness measure: Change in cardiac biomarker, hs-cTnT measure: Change in hemoglobin A1c measure: Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales. measure: Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA) measure: Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test measure: Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ) measure: Change in weight (kgs) measure: Change in BMI measure: Change in hip and waist circumference (centimeters) measure: Change in Metabolic Syndrome Severity Z score measure: Change in self-management as assessed by the Patient Activation Measure (PAM-13). measure: Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 measure: Change in blood pressure (systolic and diastolic (mmHg)) measure: Change in cardiac biomarker, gal-3 measure: Change in cardiac biomarkers, NT-proBNP sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364631 id: 2023-503317-29-00 id: 2023/3764 type: OTHER domain: CSET number briefTitle: CARE1 Pragmatic Clinical Trial acronym: CARE1 overallStatus: RECRUITING date: 2024-04-12 date: 2032-05-05 date: 2032-05-05 date: 2024-04-15 date: 2024-04-19 name: Gustave Roussy, Cancer Campus, Grand Paris class: OTHER name: European Commission name: CRIS Cancer Foundation name: National Cancer Institute, France name: Rennes University Hospital name: University Hospital, Essen name: Fundació Privada Institut d'Investigació Oncològica de Vall d'Hebron name: The Netherlands Cancer Institute name: Servicio Madrileño de Salud, Madrid, Spain name: Hospital Universitario 12 de Octubre name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano name: Medical University of Vienna name: FAKULTNI NEMOCNICE OLOMOUC name: International Kidney Cancer Coalition name: Association pour la Recherche sur les Tumeurs du Rein name: Resilience name: PRIMAA name: Queen Mary University of London briefSummary: Systemic therapy for renal cell carcinoma (RCC) relies on 2 classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD1/PDL1 axis or CTLA4. Combination therapy is SOC for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI. However, no head-to-head comparison have been performed between the 2 approaches and patients are treated based on physician decision without clinical /biomarker factors to guide treatment selection. PDL1 staining is, to date, the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PDL1(+) and ICI-VEGFR TKI in PDL1(-) patients. |
Study design has been developed to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging Overall Survival (OS) for PDL1(+) patients and to demonstrate that ICI-VEGFR TKI is superior to ICI-ICI in prolonging Progression Free Survival (PFS) and OS for PDL1(-) patients. conditions: Metastatic Kidney Cancer conditions: Metastatic Kidney Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: International, multicenter, open-label, randomized, controlled Phase 3 trial - 2 arms (A and B) primaryPurpose: TREATMENT masking: NONE count: 1250 type: ESTIMATED name: Nivolumab name: Ipilimumab name: Pembrolizumab name: Cabozantinib name: Axitinib name: Lenvatinib measure: Overall Survival (OS). measure: Progression-free survival according to RECIST 1.1 measure: Objective Response Rate (ORR) according to RECIST 1.1 measure: Quality of Life via questionnaire EQ-5D-5L measure: Quality of Life via questionnaire NNCCN/FACT Kidney Cancer Symptom Index (NFKSI) measure: Quality of Life via questionnaire Kidney Symptom Index (KSI) measure: Duration of Treatment measure: Time to treatment discontinuation (TTD) measure: Treatment-free survival (TFS) measure: Time to subsequent systemic anticancer therapy (TTSST) measure: Incidence of AE's measure: Health Economic evaluation: healthcare costs [France & Netherlands only] measure: Health Economic evaluation: cost-utility [France & Netherlands only] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gustave Roussy status: RECRUITING city: Villejuif zip: 94805 country: France name: Laurence ALBIGES, MD, PhD role: CONTACT phone: +33 (0)1 42 11 66 90 email: [email protected] lat: 48.7939 lon: 2.35992 hasResults: False |
<|newrecord|> nctId: NCT06364618 id: G-24-07 briefTitle: Use of Wearables to Detect Infections in Kidney Transplant Recipients acronym: RENALERT overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-12-31 date: 2027-12 date: 2024-04-15 date: 2024-04-15 name: Institute for Clinical and Experimental Medicine class: OTHER_GOV briefSummary: The goal of this observational study is to develop a machine learning algorithm for early detection of infections in kidney transplant recipients using data recorded by wearable digital health technologies. |
The main questions it aims to answer are: |
1. What are the biometric data pattern changes in impending infections? |
2. What accuracy the machine learning algorithm can achieve? |
Participants will be given/use their own wearable device that will record biometric data. Any infection event will be recorded and an algorithm will be trained to recognize changes in biometric data preceding symptomatic infection. conditions: Kidney Transplant Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Accuracy of the algorithm at detecting infections at presymptomatic stage measure: Rate of in-patient admissions measure: Incidence of decrease/increase of Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Clinical and Experimental Medicine city: Prague zip: 14021 country: Czechia name: Tereza Metelcova, PhD role: CONTACT phone: +420261262125 email: [email protected] name: Ivan Zahradka, MD role: PRINCIPAL_INVESTIGATOR name: Vojtech Petr, MD role: SUB_INVESTIGATOR name: Katarina Jakubov, MD role: SUB_INVESTIGATOR lat: 50.08804 lon: 14.42076 hasResults: False |
<|newrecord|> nctId: NCT06364605 id: IIT_UVIP_MySpace briefTitle: MySpace: the Role of Vision in Representing Space overallStatus: ENROLLING_BY_INVITATION date: 2021-05-03 date: 2021-06-26 date: 2025-12-31 date: 2024-04-15 date: 2024-04-15 name: Istituto Italiano di Tecnologia class: OTHER briefSummary: My Space aims to identify the ontogenesis of spatial representation through cross-sectional and longitudinal studies in infants, children, and adolescents with typical and atypical development (visual impairments). The results will serve for the design and development of a novel multisensory device for sensorimotor rehabilitation in blind children from the early stages of life. conditions: Blindness conditions: Visual Impairment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 720 type: ESTIMATED name: Rehabilitation with the iReach novel multisensory medical device measure: Perceptual responses to multisensory stimuli measure: Stimuli velocity perception measure: Distance stimuli perception measure: Eye movements measure: Saccade Analysis measure: ERP evaluation and analysis measure: Power of the cortical activity sex: ALL minimumAge: 3 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unit For Visually Impaired People city: Genova zip: 16152 country: Italy lat: 44.40478 lon: 8.94438 hasResults: False |
<|newrecord|> nctId: NCT06364592 id: 2024-011-KY briefTitle: Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-05 date: 2024-04-15 date: 2024-04-15 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER briefSummary: The aim of this study is to preliminarily evaluate the is to assess the effects and safety of electroacupuncture for moderate to severe dysmenorrhea secondary to adenomyosis. conditions: Dysmenorrhea conditions: Adenomyosis conditions: Electroacupuncture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Electroacupuncture name: Sham Electroacupuncture measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain measure: The change from baseline in the numerical rating scale (NRS) score on the average pain measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain. measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain. measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain. measure: The change from baseline in the Pictorial Blood Loss Assessment Chart (PBAC) score. measure: The change from baseline in the the Cox Menstrual Symptom Scale (CMSS). measure: The change from baseline in the Short Form Endometriosis Health Profile Questionnaire (EHP-5). measure: The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS). measure: Proportion of participants with positive expectance assessment measure: Blinding assessment measure: Adherence assessment measure: The change from baseline in the dose of rescue medicine. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences city: Beijing country: China name: Zhishun Liu, PhD role: CONTACT phone: +861088002331 email: [email protected] name: Min Yang role: CONTACT phone: +8618810268077 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06364579 id: 6533 briefTitle: Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT). acronym: PROACT overallStatus: RECRUITING date: 2024-03-28 date: 2027-01-31 date: 2031-01-31 date: 2024-04-15 date: 2024-04-15 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter. However, patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal, anal sphincter and sexual level. Few studies to date have documented patient-reported outcomes (PROs) in this area. The aim of this observational study is to verify the quality of life (QOL) of the patients by means of self-completed questionnaires. conditions: Anal Cancer Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 120 type: ESTIMATED measure: QOL analysis measure: Overall survival (OS) measure: Colostomy Free Survival (CFS) measure: Loco-Regional Recurrence (LRR) measure: Disease-Free Survival (DFS) measure: Acute toxicity measure: Late toxicity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: RECRUITING city: Rome state: Lazio zip: 00168 country: Italy name: Stefania Manfrida, MD role: CONTACT phone: +3900630154434 email: [email protected] name: Stefania Mandrida role: CONTACT phone: +390630155701 name: Stefania Manfrida, MD role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False |
<|newrecord|> nctId: NCT06364566 id: time-exploring briefTitle: Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma overallStatus: COMPLETED date: 2010-10-15 date: 2016-10-15 date: 2019-10-15 date: 2024-04-15 date: 2024-04-15 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The optimal interval between neoadjuvant chemradiotherapy and esophagectomy is still a question that needs to be explored for patients with esophageal squamous cell carcinoma. In this study, based on previous studies, the investigators divided patients into two groups with a cutoff value of 50 days. By comparing the overall survival and disease-free survival of the entire population and non PCR population, the investigators ultimately obtained the optimal surgical timing suitable for clinical use conditions: Time studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 303 type: ACTUAL name: Neoadjuvant chemradiotherapy name: Minimally invasive esophagectomy measure: The overall survival of the overall population measure: The Disease-Free survival of the overall population measure: The overall survival of the non-PCR population measure: The Disease-Free survival of the non-PCR population measure: The overall survival of the PCR population measure: The Disease-Free survival of the PCR population sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital Affiliated to Fudan University city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2021-10-15 uploadDate: 2024-04-10T05:47 filename: SAP_000.pdf size: 119312 hasResults: False |
<|newrecord|> nctId: NCT06364553 id: NL86416.078.24 briefTitle: Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study acronym: ENTRANCE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-15 date: 2024-04-15 name: Erasmus Medical Center class: OTHER briefSummary: A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia. conditions: Oesophageal Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Esophageal self-expandable metal stent measure: Complication: incidence of perforation measure: Complication: incidence of hemorrhage measure: Complication: incidence of fistula formation measure: Complication: incidence of gastroesophageal reflux measure: Complication: incidence of stent migration measure: Efficacy: clinical outcome measure: Efficacy: incidence of patients receiving technical successful stent placement measure: Incidence of recurrent dysphagia measure: Pain related to esophageal stent (placement) measure: Overall survival measure: Patient characteristic: age measure: Patient characteristic: gender measure: Patient characteristic: tumor location measure: Patient characteristic: tumor histology measure: Stent characteristic: length of the stent measure: Stent characteristic: diameter of the stent measure: Patient characteristic: prior radiotherapy measure: Patient characteristic: prior chemotherapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364540 id: 2023-08-14 briefTitle: Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED acronym: KETAFEN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2026-12-31 date: 2024-04-15 date: 2024-04-15 name: Antonios Likourezos class: OTHER briefSummary: In situations where intravenous access is not readily available or is unobtainable and the intranasal route is not feasible, another non-invasive route of ketamine administration, such as inhalation via breath-actuated Nebulizer (BAN), is becoming a viable alternative. The BAN allows the controlled, patient-initiated delivery of analgesics in a measured and titratable fashion. (18) Ketamine has been studied as a nebulized drug in a lot of different settings and for a lot of different reasons, such as to treat acute pain after surgery (like a sore throat after being intubated), as a pre-medication for general anesthesia, to treat cancer pain, and as a therapy for asthmaticus. |
Our research team has published two case series of 10 adult patients who were given nebulized ketamine (via BAN) for a variety of acute traumatic and non-traumatic painful conditions. The patients showed a 60% decrease in pain and a small number of side effects. Furthermore, our group published a randomized, double-blind trial of 120 adult patients evaluating the analgesic efficacy and safety of nebulized ketamine at three different dosing regimens for acute pain in the ED (0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg), showing similar analgesic efficacy between the three different dosing regimens for short-term (up to 120 minutes) pain relief. Lastly, we recently completed a randomized, double-blind, double-dummy clinical trial comparing the analgesic efficacy and safety of nebulized ketamine and intravenous ketamine in managing acute pain in adult ED patients, with data currently being analyzed. |
Nebulized fentanyl given in the ED to adults with acute traumatic and non-traumatic pain syndromes at a dose range of 1.5-4 mcg/kg showed the same or even better pain-relieving effects than IV fentanyl and IV morphine alone. |
Our objective is to compare the analgesic efficacy and rates of side effects of a 0.75 mg/kg dose of ketamine administered via breath-actuated nebulizer (BAN) to a dose of 3 mcg/kg of fentanyl administered via breath-actuated nebulizer (BAN) in adult patients presenting to the ED with acute painful conditions. conditions: Pain, Acute studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Ketamine name: Fentanyl measure: Reduction of pain scores on the numeric rating pain scale (NRS) measure: Need for Rescue Analgesia measure: Severity of Adverse Events measure: Evaluation of Severity of agitation and/or sedation sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-18 uploadDate: 2024-04-05T12:16 filename: Prot_SAP_000.pdf size: 208117 hasResults: False |
<|newrecord|> nctId: NCT06364527 id: ADH-BSA-02-23 briefTitle: Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-04-15 date: 2024-04-15 name: CoheroHealth class: INDUSTRY name: Aptar Digital Health name: Lindus Health briefSummary: The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. With the advancement of digital health technology, there is the potential to transform patient care and improve outcomes. |
The Aptar Digital Health respiratory disease management platform, a digital therapeutic will be utilized to determine its value and how it supports: i) asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence; ii) asthma control through the use of the Asthma Control Questionnaire-5. In addition, spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines. conditions: Asthma Chronic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 118 type: ESTIMATED name: Aptar Digital Health respiratory disease management platform measure: Asthma Control Questionnaire - 5 scores measure: Mini-Asthma Quality of Life Questionnaire measure: Rescue medication usage measure: Inhaled corticosteroid steroid daily adherence measure: Step-up from inhaled corticosteroids to biologics measure: Asthma related oral corticosteroids utilization and associated cost measure: Asthma related accident and emergency department visits and associated cost measure: Asthma related unscheduled outpatient clinic visits and associated cost measure: Asthma related inpatient hospitalization, associated length of stay, and associated cost measure: Computer System Usability Questionnaire measure: Semi-structured interviews using the 2019 Rudin et al study sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06364514 id: IRB-P00047313 briefTitle: PICNIC Study - PatIent Centered aNtIbiotic Courses in Children With Medical Complexity overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-01 date: 2025-10-01 date: 2024-04-15 date: 2024-04-15 name: Boston Children's Hospital class: OTHER briefSummary: To determine if clinicians can safely reduce antibiotic exposure in children with medical complexity (CMC) who are diagnosed with pneumonia by implementing an intervention that bases total antibiotic duration on an individual's clinical stability. conditions: Pneumonia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Clinical Stability Assessment measure: Proportion of eligible patients who consent to participate in the intervention measure: Rate of persistent and worsening respiratory symptoms measured by patient's clinical status; the rate of emergency department revisit or hospital readmission within 1 week of antibiotic discontinuation measure: Median days of antibiotics received for patients in the intervention group as well as from historical control group sex: ALL minimumAge: 2 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06364501 id: KH801 briefTitle: Phase 1 Trial of KH801 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2030-05-01 date: 2024-04-15 date: 2024-04-17 name: Beijing Kanghong Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: KH801 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Or 0.9% sodium chloride Injection. |
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