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<|newrecord|> nctId: NCT06321198 id: iMSC-2001 briefTitle: A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD overallStatus: RECRUITING date: 2024-02-10 date: 2027-03-02 date: 2027-03-02 date: 2024-03-20 date: 2024-03-20 name: Anhui Provincial Hospital ... |
<|newrecord|> nctId: NCT06321185 id: 2024/177 briefTitle: Laparoscopic Cholecystectomy and Quality of Recovery overallStatus: RECRUITING date: 2024-03-25 date: 2024-08-25 date: 2024-08-25 date: 2024-03-20 date: 2024-03-27 name: Istanbul University class: OTHER briefSummary: This clinical trial aims to compare the Quali... |
<|newrecord|> nctId: NCT06321172 id: 785 briefTitle: Muscle and Bone Changes After 6 Months of FES Cycling acronym: FES-Bike overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-09 date: 2024-01-22 date: 2024-04-29 date: 2024-03-20 date: 2024-03-22 name: IRCCS Eugenio Medea class: OTHER name: Politecnico di Milano name: ... |
* Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling? If any, the morpho-functional improvements are maintained one month after the end of the training? |
* Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling? |
* Does the training performance improve during the training with FES cycling? |
* Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling? If yes, the changes in the vegetative nervous system are maintained one month after the end of the training? |
* Does the intestinal function change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training? |
* Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training? |
* Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training? |
* Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training? |
* Does the pilots' motivation in carrying out a sporting activity change between T1 (3 months after starting the training) and T2(6 months after starting the training)? |
Participants will train for 6 months with FES-cycling twice a week. Each session includes at most 30 minutes of stimulation. conditions: Spinal Cord Injuries studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: FES Bike m... |
<|newrecord|> nctId: NCT06321159 id: Nursing Dep. briefTitle: Investigation of the Effect of Mobile Software Use in Blood Pressure Management of Hypertensive Individuals on Quality of Life and Disease Self-Efficacy overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-11-30 date: 2026-01-30 date: 2024-03-20 dat... |
Conducted between April 2024 and January 2026, the project adopts a pre-test post-test control group experimental design in the four most earthquake-affected provinces. It involves 614 individuals diagnosed with hypertension, residing in temporary living space in Malatya, Hatay, Kahramanmaraş, and Adıyaman, with 78, 77... |
<|newrecord|> nctId: NCT06321146 id: LY2024-029-B briefTitle: Evaluation of EEG Power Spectrum in Patients With Traumatic Coma acronym: EPIC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-03-20 date: 2024-03-20 name: RenJi Hospital class: OTHER name: Beijing Tiantan Hosp... |
<|newrecord|> nctId: NCT06321133 id: 5402589 briefTitle: High Flow Nasal Cannula Weaning in Acute Bronchiolitis overallStatus: RECRUITING date: 2024-02-13 date: 2026-12-31 date: 2026-12-31 date: 2024-03-20 date: 2024-03-20 name: Kuopio University Hospital class: OTHER name: Central Finland Hospital District name: Mikke... |
<|newrecord|> nctId: NCT06321120 id: 0749-21-HMO-CTIL briefTitle: Using Chronobiology to Improve Lenvatinib Efficacy overallStatus: RECRUITING date: 2023-03-01 date: 2024-04 date: 2024-06 date: 2024-03-20 date: 2024-03-20 name: Hadassah Medical Organization class: OTHER briefSummary: The goal of this proof-of-concept c... |
Participants will use a mobile application to follow variability-based physician approved drug administration schedules. conditions: Lenvatinib Treatment studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: An open-labeled, prospective, single-cente... |
<|newrecord|> nctId: NCT06321107 id: GenSci094-304 briefTitle: Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference overallStatus: RECRUITING date: 2024-02-29 date: 2025-08-15 date: 2025-10-31 date: 2024-03-20 date: 2024-03-20 name: Changchun Gen... |
<|newrecord|> nctId: NCT06321094 id: VERI-ACS briefTitle: Effect of Vericiguat on Endpoint Events in Acute Coronary Syndrome( ACS）Patients With Ejection Fraction <45% overallStatus: RECRUITING date: 2023-10-01 date: 2025-10-01 date: 2025-12-01 date: 2024-03-20 date: 2024-03-20 name: The First Affiliated Hospital with N... |
<|newrecord|> nctId: NCT06321081 id: 2023BJYYEC-428-02 briefTitle: ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC overallStatus: RECRUITING date: 2024-03-01 date: 2026-02-14 date: 2026-08-14 date: 2024-03-20 date: 2024-03-20 name: Beijing Hospital class: OTHER_GOV n... |
<|newrecord|> nctId: NCT06321068 id: BAT-1308-003-CR briefTitle: BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer overallStatus: RECRUITING date: 2024-04-09 date: 2024-09 date: 2027-10 date: 2024-03-20 date: 2024-04-18 nam... |
<|newrecord|> nctId: NCT06321055 id: 22533 briefTitle: An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-04-28 date: 2024-04-28 date: 2024-03-20 date: 2024-03-20... |
In this observational study data are collected from participants who have private insurance or Medicare and who had started regorafenib treatment. |
Gastrointestinal stromal tumor (GIST) is a type of cancer that most commonly originates from the stomach or small intestine. Advanced means that the cancer has spread to other parts of the body. |
The study drug, regorafenib, is already approved for doctors to prescribe to people with GIST. Regorafenib works by blocking certain proteins that cause the growth of cancer cells. Regorafenib is recommended as the third choice of treatment for patients after imatinib and sunitinib have stopped working or have caused s... |
The participants in this study had started treatment with regorafenib as part of their regular care from their doctors. |
The main purpose of this study is to learn more about the use of regorafenib treatment among people with advanced GIST who have private insurance or Medicare in the United States. To do this, researchers will collect information on: |
Duration of treatment with regorafenib (also known as duration of therapy) |
The length of time it took for participants to switch to another GIST treatment after starting regorafenib (also known as time to next therapy) |
The data will come from the participants' information stored in a database, called Merative MarketScan for people in the United States. Data collected will be from April 2002 to September 2023. |
Researchers will track the data of people with GIST who started regorafenib and will follow them for at least 28 days. |
In this study, only available data are collected. No visits or tests are required as part of this study. conditions: Advanced Gastrointestinal Stromal Tumor studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 136 type: ESTIMATED name: Regorafenib (Stivarga, BAY73-4506) measure: Dura... |
<|newrecord|> nctId: NCT06321042 id: SYMPHO-EM briefTitle: Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors acronym: SYMPHO-EM overallStatus: RECRUITING date: 2023-01-13 date: 2027-01 date: 2027-03 date: 2024-03-20 date: 2024-03-20 name: Istituto Ortopedico ... |
<|newrecord|> nctId: NCT06321029 id: 4-22-ICTSHD-44 briefTitle: Electronic Diabetes Tune-Up Group (eDTU) for African Americans overallStatus: RECRUITING date: 2023-10-19 date: 2024-12-31 date: 2025-03-31 date: 2024-03-20 date: 2024-03-20 name: Indiana University class: OTHER name: Indiana University Health briefSummary... |
1. To test the acceptability and feasibility of the electronic DTU intervention (eDTU) that has been adapted for cultural relevance and online delivery compared to waitlist control and the in-person DTU (iDTU). The hypothesis is that the adapted intervention will be culturally acceptable (by participant satisfaction sc... |
2. To test differences in diabetes distress and A1c change scores between intervention (changes in T2 to T4) and waitlist control (change in T1 to T2) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control). The hypothesis is that both the eDTU and iDTU groups will show significant improvements in ... |
Secondary Objective. The secondary aim of the study is to evaluate changes in depressive symptoms, diabetes self-efficacy, and general and diabetes-specific quality of life in intervention (T2-T3 \& T4) compared to waitlist control (T1-T2). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post inte... |
<|newrecord|> nctId: NCT06321016 id: 2023111039 briefTitle: POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer acronym: PoziKids overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-06-30 date: 2026-12-30 date: 2024-03-20 date: 2024-03-20 name: Nere... |
Design: Hybrid quasi-experimental pilot trial, clinical and phase I implementation. |
Methods: The learning collaborative approach based on the Institute for Healthcare Improvement Breakthrough Series Collaborative Model will be followed through quarterly Plan-Do-Study-Act (P-D-S-A) cycles. Participants: For feasibility, at least, 45 patients will be included in 3 successive PDSA cycles of at least 15 p... |
Statistical analysis: Recruitment rates will be calculated, characteristics associated with project participation and adherence to the exercise programme will be identified. Outcome variables will be compared before and after the intervention, identifying those with the greatest validity, reliability and sensitivity to... |
<|newrecord|> nctId: NCT06321003 id: OCT01 briefTitle: SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography acronym: SYMILIS OCT overallStatus: RECRUITING date: 2024-03-13 date: 2027-04-01 date: 2027-04-01 date: 2024-03-20 date: 2024-03-20 name: University of P... |
The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on ... |
Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological ana... |
In summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice. conditions: Oral Squamous Cell Carcinoma conditions: Oral Potentially Maligna... |
<|newrecord|> nctId: NCT06320990 id: 0074-24-CB briefTitle: Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection acronym: MCN_Tam overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-11 date: 2027-05 date: 2024-03-20 date: 2024-03-20 name: University... |
<|newrecord|> nctId: NCT06320977 id: ESS/FSA-397/23-2 briefTitle: The Influence of Acute Static Stretching on the Ankle Joint-position Sense of Soccer Players overallStatus: COMPLETED date: 2024-02-12 date: 2024-03-13 date: 2024-03-29 date: 2024-03-20 date: 2024-04-09 name: University Fernando Pessoa class: OTHER brief... |
<|newrecord|> nctId: NCT06320964 id: R01HD108252_1 id: R01HD108252 type: NIH link: https://reporter.nih.gov/quickSearch/R01HD108252 briefTitle: The TARANG Intervention acronym: TARANG Pilot overallStatus: COMPLETED date: 2023-07-14 date: 2024-01-21 date: 2024-01-21 date: 2024-03-20 date: 2024-03-20 name: University of ... |
<|newrecord|> nctId: NCT06320951 id: 300012681 id: Pending type: OTHER domain: Pending briefTitle: VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway acronym: VITAL-IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-... |
<|newrecord|> nctId: NCT06320938 id: 2024/18 briefTitle: Effectiveness of Neuroscience-based Pain Education in Patients With Chronic Neck Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2024-09-15 date: 2025-03-15 date: 2024-03-20 date: 2024-03-27 name: Turkoglu Dr. Kemal Beyazit State Hospital class: OTH... |
<|newrecord|> nctId: NCT06320925 id: SYK-SM-2022-02 briefTitle: SportsPro: Post-Market Clinical Follow Up Study overallStatus: RECRUITING date: 2023-12-05 date: 2024-06-30 date: 2024-12-01 date: 2024-03-20 date: 2024-03-22 name: Stryker Endoscopy class: INDUSTRY briefSummary: Retrospective, multi-center, chart review (... |
<|newrecord|> nctId: NCT06320912 id: TIPS01 briefTitle: Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2026-06-01 date: 2026-11-01 date: 2024-03-20 date: 2024-03-20 name: Shanghai Shenqi Me... |
<|newrecord|> nctId: NCT06320899 id: SpineShape_CH_001 id: BASEC 2023-D0092 type: OTHER domain: Ethics Committee Bern briefTitle: Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2031-08-31 da... |
The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods. conditions: Degenerative Lumbar Spi... |
<|newrecord|> nctId: NCT06320886 id: Soh-Med-24-02-05MS briefTitle: Role of Ultrasonography in Acute Abdomen in Adults in Correlation to Computed Tomography Scan overallStatus: RECRUITING date: 2024-02-01 date: 2024-10-31 date: 2024-10-31 date: 2024-03-20 date: 2024-03-20 name: Sohag University class: OTHER briefSummar... |
<|newrecord|> nctId: NCT06320873 id: zselcuk1 briefTitle: The Effect of Respiratory on Sports Performance in Archers overallStatus: COMPLETED date: 2021-07-26 date: 2022-01-01 date: 2022-01-01 date: 2024-03-20 date: 2024-03-20 name: Halic University class: OTHER briefSummary: Purpose: The physical, physiological, and f... |
Methods: Our study included 46 (27 female, 19 male) professional archers registered in archery sports clubs. Sociodemographic and physical characteristics were recorded. Pulmonary function test (PFT), respiratory muscle strength, shooting performance test, Moberg-pickup collection test, Nelson hand reaction test, and F... |
<|newrecord|> nctId: NCT06320860 id: IRB231189 briefTitle: FlexStone Enabled Kidney Stone Retrieval overallStatus: ENROLLING_BY_INVITATION date: 2024-03-08 date: 2024-09-08 date: 2024-09-08 date: 2024-03-20 date: 2024-03-20 name: EndoTheia class: INDUSTRY name: Vanderbilt University Medical Center briefSummary: This st... |
<|newrecord|> nctId: NCT06320847 id: Predictbloodpressure briefTitle: Predictive Remote Photoplethysmography Algorithm for Blood Pressure Pressure Assessment and Monitoring overallStatus: RECRUITING date: 2024-01-02 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Singapore General Hospital class: OT... |
<|newrecord|> nctId: NCT06320834 id: PTL-1000294 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-20 date: 2024-03-20 name: [Redacted] hasResults: False |
<|newrecord|> nctId: NCT06320821 id: RAKT Version 1.0 briefTitle: RAKT OUTCOME ANALYSIS overallStatus: ENROLLING_BY_INVITATION date: 2021-08-21 date: 2024-05-30 date: 2024-08-30 date: 2024-03-20 date: 2024-03-20 name: Seoul National University Hospital class: OTHER briefSummary: The goal of this observational study is ... |
- comprehensively analyze our early experience of robot-assisted kidney transplant patients and compare the results with those of open kidney transplant patients conditions: Kidney Transplantation conditions: Robotic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 t... |
<|newrecord|> nctId: NCT06320808 id: STUDY2023_00000449 briefTitle: Evaluating FDA's Proposed Patient Medication Information Handout overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-03 date: 2024-04-30 date: 2025-03-03 date: 2024-03-20 date: 2024-04-24 name: Carnegie Mellon University class: OTHER name: University of... |
The main questions it aims to answer are: |
How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension? |
and |
How does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information? |
Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension. conditions: Knowledge conditions: Attitude studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Par... |
<|newrecord|> nctId: NCT06320795 id: IT-MF-000031905 briefTitle: Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device acronym: SOUNDI overallStatus: RECRUITING date: 2023-11-22 date: 2024-03-01 date: 2024-05-31 date: 2024-03-20 date: 2024-03-20 name: Biocubica srl class: INDUSTRY briefSum... |
<|newrecord|> nctId: NCT06320782 id: 4659262 briefTitle: Effects of Different Dietary Interventions on Abdominal Fat Components and Cardiometabolic Parameters. overallStatus: ENROLLING_BY_INVITATION date: 2021-08-23 date: 2023-12-26 date: 2024-08 date: 2024-03-20 date: 2024-03-20 name: University of Pernambuco class: O... |
<|newrecord|> nctId: NCT06320769 id: 24101994 briefTitle: Role of Rotational Guided Growth in Management of Increased Femoral Anteversion overallStatus: RECRUITING date: 2024-02-20 date: 2026-03-01 date: 2026-03-01 date: 2024-03-20 date: 2024-03-20 name: Ain Shams University class: OTHER briefSummary: Efficacy of guide... |
This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods. |
This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs. conditions: Increased Femoral Anteversion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 t... |
<|newrecord|> nctId: NCT06320756 id: 24-WYSA-101 briefTitle: Examining the Feasibility of Wysa in Hindi overallStatus: RECRUITING date: 2024-02-23 date: 2024-05 date: 2024-05-31 date: 2024-03-20 date: 2024-03-20 name: Wysa class: INDUSTRY name: Udaan briefSummary: The principal objective of this study is to investigate... |
<|newrecord|> nctId: NCT06320743 id: Low Flow Anaesthesia And NIRS briefTitle: Cerebral and Peripheral Near Infrared Spectroscopy Monitoring in Low and High Flow Anaesthesia in Pediatric overallStatus: RECRUITING date: 2024-03-20 date: 2024-08-19 date: 2024-09-19 date: 2024-03-20 date: 2024-03-21 name: Ankara City Hosp... |
<|newrecord|> nctId: NCT06320730 id: 2020-0675 briefTitle: Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation overallStatus: COMPLETED date: 2020-08-25 date: 2020-08-29 date: 2021-03-01 date: 2024-03-20 date: 2024-03-20 name: Asan Medical Center class: OTHER briefS... |
<|newrecord|> nctId: NCT06320717 id: I-3574823 briefTitle: AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma overallStatus: RECRUITING date: 2024-01-02 date: 2026-07-02 date: 2026-07-02 date: 2024-03-20 date: 2024-03-20 name: Roswell Park Cancer Institute cl... |
The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers. conditions: Pancreatic Ductal Adenocarcinoma s... |
<|newrecord|> nctId: NCT06320704 id: 01067485392 briefTitle: Occlusal Balance Effect on Mandibular Bone Density by Using Fractal Analysis in Complete Denture Patients (Split-Mouth Study) overallStatus: RECRUITING date: 2024-03-21 date: 2024-09-21 date: 2024-09-21 date: 2024-03-20 date: 2024-03-20 name: Badr University ... |
<|newrecord|> nctId: NCT06320691 id: BezmialemVU 1 briefTitle: General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study overallStatus: COMPLETED date: 2014-01-10 date: 2017-01-10 date: 2017-05-25 date: 2024-03-20 date: 2024-03-20 name: Bezmialem Vakif Univers... |
<|newrecord|> nctId: NCT06320678 id: Aysun Acun 5 briefTitle: Parenteral Drug Administration Training for Nursing Students overallStatus: RECRUITING date: 2024-02-29 date: 2024-03-20 date: 2024-04 date: 2024-03-20 date: 2024-03-20 name: Bilecik Seyh Edebali Universitesi class: OTHER briefSummary: This study aims to eva... |
<|newrecord|> nctId: NCT06320665 id: 2024PI003 briefTitle: Assessment of Sagittal and Vertical Pattern in Correlation With Third Molar Inclusion : A 3D CBCT Analysis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-30 date: 2025-09-30 date: 2024-03-20 date: 2024-04-24 name: Central Hospital, Nancy, Fran... |
Patients will be analyzed according to their skeletal characteristics: skeletal class (sagittal direction) and facial skeletal typology (vertical direction). |
The inclusion characteristics of third molars will also be analyzed, to see the links between typology and inclusion. The principal hypothesis is no significant difference in third molar inclusion patterns in relation to skeletal divergence. conditions: Impacted Third Molar Tooth studyType: OBSERVATIONAL observationalM... |
<|newrecord|> nctId: NCT06320652 id: CUHospital briefTitle: Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2027-08-31 date: 2024-03-20 date: 2024-04-19 name: Copenhagen University Hospital, Hvidovre class: OTHER name: Hvi... |
<|newrecord|> nctId: NCT06320639 id: UGustaveEiffel briefTitle: DRIVing Simulator and People With NeuroCognitive Disorders acronym: DRIVS-NCD overallStatus: RECRUITING date: 2023-10-03 date: 2026-10-10 date: 2026-10-10 date: 2024-03-20 date: 2024-03-20 name: University Gustave Eiffel class: OTHER name: Hospices Civils ... |
Despite their loss of autonomy and medical advice, 22% of people with major NCD continue to drive. In addition, the presence of minor NCD also puts people at a higher risk of road accidents. |
However, several studies demonstrated that an NCD does not lead to a systematic and immediate impairment of driving ability and abruptly stopping driving leads to health problems, such as the risk of depression and greatly reduces quality of life. |
It is therefore relevant to focus research on driving with people with NCD in order to have a reliable indicator of the person's abilities and the impact of their cognitive impairment on driving activity. The proposed study seeks to meet this need by studying the performance of people with NCD on a driving station (min... |
To achieve this goal, people with NCDs will perform tasks on a driving simulator. In addition, after each task on the driving simulator, they will answer questions about how they evaluate their own driving. Two assessors will observe the participants' driving and will estimate their driving performance. By comparing th... |
Another project already underway aims to collect similar data from people without a diagnosis of NCDs (control group). |
The principal objective of the present study is to compare the driving performance in a simulator and the awareness of driving ability of people with NCDs with those of a control group. Secondary objectives are : |
1. to measure driving performance in a simulator and awareness of driving abilities (i.e. self-assessment skills) of people with NCDs. |
2. to analyse driving performance and awareness of driving abilities according to the diagnosis and severity of the disorder (i.e. minor or major neurocognitive disorders). |
3. to establish a methodology to identify a driver at risk of dangerous driving. |
It is mainly an exploratory study however some hypotheses can be made : |
* The driving performance and awareness of driving skills of people with NCDs are poorer compared to those of older, control individuals. |
* Individuals' driving performance and awareness of driving ability are lower in the presence of major NCDs compared to minor NCDs. conditions: Neurocognitive Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED measure: Awareness score of driving abi... |
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