pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluation of a Perceptual Learning Module on Spinal Ultrasound Among Residents.
NCT Number: NCT06533488
Acronym: MAP-Rachis
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Anesthesia Skill|Ultrasound Imaging of Anatomical Structures|Medical Education
Interventions: OTHER: Perceptual learning module|OTHER: Control
Sponsor: Maisonneuve-Rosemont Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-03-26
Completion Date: 2025-04
Locations: Maisonneuve-Rosemont Hospital, Montreal, Quebec, H1T 2M4, Canada

Summary:
This medical education research project aims to evaluate the impact of a directed perceptual learning module (PLM) on spinal sonoanatomy. Following a demographic questionnaire, participants will be exposed to a tutorial explaining the necessary theoretical foundations for the PLM as well as the functioning of the PLM interface. A pre-test involving selecting the best image from a video sequence depicting spinal sonoanatomy will be administered to all participants. Participants will then be randomized into two groups and exposed to video sequences in the same manner as during the pre-test, with immediate feedback in the intervention group and no feedback in the control group. The video sequences presented will be the same between the two groups. Finally, a post-test will be administered immediately and remotely after exposure to the PLM. The time window corresponding to the best image will be predefined by an expert and compared to the resident\&#39;s value. The difference in feedback exposure between the two groups will not be revealed to limit biases.

Primary Outcome Measures: Improvement in the concordance of identifying the best image on the video within the interval specified by the expert in seconds, between the pre-test and the post-test., Between the pre-test and the immediate post-test, as well as the post-test at 1 month.
Secondary Outcome Measures: Improvement over time in the concordance of identifying the best image on the video within the interval specified by the expert in seconds, During the intervention phase
Using the Chinese Indigenization FS Scale in the Diagnosis of Fibromyalgia： Specificity and Sensitivity in Clinical Practice
NCT Number: NCT06533410
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fibromyalgia
Interventions: DIAGNOSTIC_TEST: The FM Diagnosis and Assessment Scale will be filled out, and there will be no other interventions beyond that
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators: Hebei Provincial Hospital of Traditional Chinese Medicine|BAODING NO.1 HOSPITAL OF TCM|Inner Mongolia Hospital of Traditional Chinese Medicine|Shenzhen Hospital of Traditional Chinese Medicine|Suzhou Hospital of Traditional Chinese Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-21
Completion Date: 2025-05-31
Locations: Guang'anmen Hospital, Beijing, Beijing, 100053, China

Summary:
This study aimed to evaluate the specificity and sensitivity of the diagnostic criteria for fibromyalgia after conducting local validation in China.

Primary Outcome Measures: Diagnosis of fibromyalgia with the Polysymptomatic Distress Scale(PDS), up to 1 week
Secondary Outcome Measures: QOL as measured by Short Form-36 Health Status Questionnaire(SF-36), up to 1 week|Fibromyalgia symptoms severity as measured by the Rebised Fibromyalgia Impact Questionnaire(FIQR), up to 1 week|Depression scores as measured by Beck depression inventory(BDI), up to 1 week|Stress scores as measured by Perceived Stress Scale(PSS), up to 1 week|Sleep scores as measured by Pittsburgh sleep quality index(PSQI), up to 1 week|Fatigue was measured by the Multidimensional Fatigue Inventory(MFI-20), up to 1 week
PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC
NCT Number: NCT06533384
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Triple-negative Breast Cancer
Interventions: DRUG: As per the germline BRCA1/2 mutation status, the selection of either Fluzopalil or capecitabine in combination with Camrelizumab is made for adjuvant therapy.
Sponsor: Guangdong Provincial People's Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 310
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2030-12-31
Locations: Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong, 510080, China

Summary:
In TNBC patients who have completed neoadjuvant immunotherapy and local treatment, a 9-cycle regimen of PD-1 inhibitor adjuvant immunotherapy is currently considered the standard approach. Based on the classification according to their BRCA mutation status, patients with BRCA mutations choose the PD-1 inhibitor + PARPi regimen, while patients without BRCA mutations opt for the PD-1 inhibitor + capecitabine regimen. Compared to monotherapy with PD-1 inhibitors, these combination regimens may offer improved efficacy and acceptable tolerability. This study is designed as a prospective, randomized, controlled, open-label, single-center phase III trial aimed at assessing the efficacy and safety of selecting PARPi or capecitabine in combination with PD-1 inhibitors based on germline BRCA1/2 mutations as adjuvant therapy in high-risk TNBC patients who have achieved non-pCR after completion of neoadjuvant immunotherapy in conjunction with chemotherapy and local treatment.

Primary Outcome Measures: IDFS, invasive disease free survival, Up to approximately 5 years
Secondary Outcome Measures: OS, Overall survival, Up to approximately 5 years|DDFS, Distant Disease Free Survival, Up to approximately 5 years|Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, Up to approximately 5 years
Clinical-ultrasonographic Assessment of Pulmonary Emphysema
NCT Number: NCT06533371
Acronym: ESCULAPIO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emphysema|Pulmonary Emphysema
Interventions: DIAGNOSTIC_TEST: Relationship between lung ultrasound and computed tomographic scan
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators: Miulli General Hospital|Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli|Università degli Studi di Trento
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1628
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-31
Completion Date: 2026-08-31
Locations: Ente Ecclesiastico, Ospedale Generale Regionale "F. Miulli", Acquaviva Delle Fonti, 70021, Italy|A.O.R.N. "A. Cardarelli", Napoli, 80131, Italy|Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, 00168, Italy|University of Trento, Trento, 38123, Italy

Summary:
The goal of this clinical trial is to identify correlations among data deriving from lung ultrasonographic (LUS) and tomographic evaluations of patients with panlobular or paraseptal emphysema, to improve the comprehension of acoustic information derived from ultrasound evaluation.

The main question it aims to answer is: what are the correlations between thoracic ultrasonographic patterns and peripheral parenchymal changes evaluated by high resolution computed tomography (HRCT) of the chest, in patients affected with variable degree of panlobular or paraseptal emphysema? Researchers will compare LUS patterns observed in: 1) COPD patients with CT evidence of panlobular or paraseptal emphysema, 2) subjects participating in the screening program for lung cancer with CT evidence of panlobular or paraseptal emphysema, and 3) patients with suspected/known lung cancer undergoing with CT evidence of panlobular or paraseptal emphysema, with the ones obtained from healthy volunteers and subjects who participate in the screening program for lung cancer with no evidence of emphysema.

Participants will undergo LUS evaluation with both clinical and research scanners. Patients will be assessed in supine position with the arms extended above the head. The position is the same in which chest CT scans will be performed. LUS assessment will be performed using commercially available linear probes.

Finally, all COPD patients and subjects who participate in the screening program for lung cancer with CT evidence of paraseptal or panlobular emphysema will undergo respiratory oscillometry. Tidal breathing analysis with impulse oscillometry (IOS) has proven to be an informative and meaningful tool used in the early detection and follow up of pulmonary diseases like COPD.

Primary Outcome Measures: Number of participants with ultrasonographic pattern of emphysema., To characterize ultrasonographic signs of paraseptal or panlobular emphysema, the measurement of the ultrasound backscattering-index, as a function of the transmitted frequency, will be perform., through study completion, an average of 2 year
A Clinical Study of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI
NCT Number: NCT06533358
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Coronary Syndrome
Interventions: DRUG: MT1002 Injection
Sponsor: Shaanxi Micot Technology Limited Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-27
Completion Date: 2025-07
Locations: Beijing Anzhen Hospital Affiliated to Capital Medical University, Beijing, Beijing, 100029, China|Xianyang Hospital, Yan'an University, Xi'an, Shaanxi, 712000, China

Summary:
An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI.

Primary Outcome Measures: percentage of subjects who achieved target ACT (200-300 s), percentage of subjects achieving target ACT (200-300 s) among subjects receiving MT1002 (not switching to standard care) pre/intraoperatively and after successful PCI, Day 1, 24 hours （Day 2） to Day 30±2 after intravenous injection on Day 1|Major bleeding events, Adverse events (AEs): Major bleeding events (Bleeding Academic Research Consortium \[BARC\] type 3-5), Day 1 to end of follow-up period (Day 30±2)
MERCI Chronic Pain Research Clinic
NCT Number: NCT06533345
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain
Interventions: BEHAVIORAL: Behavior Change Coaching|BEHAVIORAL: Nutrition|OTHER: Autonomic Recalibration|PROCEDURE: Dry Needling|OTHER: Osteopathic Manipulative Treatment|BEHAVIORAL: Counseling Psychology|OTHER: Multiple Treatments
Sponsor: Edward Via Virginia College of Osteopathic Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-02
Completion Date: 2027-08-01
Locations: Edward Via College of Osteopathic Medicine-Auburn, Auburn, Alabama, 36832, United States

Summary:
Studies estimate that 30% of people worldwide experience chronic pain. The mechanisms causing this pain can vary: a neuropathic offender, such as nerve compression; a structural offender, such as long-term effects of soft tissue damage and repair; or nociplastic, dysfunctional offenders, such as fibromyalgia. The type of pain experienced influences diagnostic and treatment choice. In theory, there's a significant blending of these pain types within individuals and across patients, leading many specialists to view pain classification as a spectrum. Multidisciplinary pain management (MPM) is a standard model for addressing and treating different mechanisms of chronic pain using multiple interventions from different disciplines. Although many clinics employing these strategies have resulted in positive and clinically effective outcomes, the creation and implementation of such facilities have not been widespread. With increasing focus on psychosocial factors that impact pain in conjunction with structural and biomechanical offenders, a need for a whole-person, integrated approach to chronic pain management is needed. We propose an observational study to gather data that will inform the design, implementation, and operation of such a chronic pain research clinic.

Primary Outcome Measures: Pain Intensity (NRS Pain Scale), 0-10 Pain Rating. 0=no pain to 10=pain as intense as you can imagine, Beginning of each Visit through study completion, an average (anticipated) of 6 months|PROMIS (Pain Interference, SF4a), Pain interference survey. Answers range from "Not at all" to "Very Much" when relating to the impact of pain on daily life., Beginning of each Visit through study completion, an average (anticipated) of 6 months|Use of analgesics (QAQ-Quantitative Analgesic Questionnaire), Survey listing all medications taken for pain. All types are converted in equivalent doses of morphine and scored., Beginning of each Visit through study completion, an average (anticipated) of 6 months|Human Flourishing (Secure Flourishing Index), Measure of Human Flourishing across 6 Domains. Scores range from 0-10 with lower scores indicating lower flourishing and higher scores indicating higher flourishing., Beginning of each Visit through study completion, an average (anticipated) of 6 months
Hepatitis C Treatment in Idaho County Jails
NCT Number: NCT06533319
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatitis C
Interventions: DRUG: sofosbuvir/velpatasvir
Sponsor: Eastern Idaho Public Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-08-01

Summary:
To explore the feasibility of opt in Hepatitis C Virus (HCV) screening and initiation of HCV treatment during incarceration in county jails including;

1. incarcerated persons positive for HCV who remain in jail for duration of 12 weeks of treatment and
2. incarcerated persons positive for HCV in jails less than the duration of 12 weeks of treatment who receive remaining supply of study drug on discharge with appropriate linkage to care.

Assess quality of life measures in participants being treated for their HCV through the validated questionnaire EuroQol-5D at baseline and post-treatment.

Primary Outcome Measures: Sustained Virologic Response, Undetectable hepatitis C RNA, 12 weeks after treatment
Secondary Outcome Measures: Quality of life improvement, Improvement in quality of life measures after treatment of hepatitis C as measured by SF-12 tool, At study enrollment and 12 weeks after treatment
Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.
NCT Number: NCT06533306
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cryptorchidism
Interventions: PROCEDURE: Surgery for cryptorchidism.
Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2024-05-30
Locations: Consorci Sanitari Alt Penedès-Garraf, Vilafranca Del Penedès, Barcelona, 08720, Spain

Summary:
The present study aims to calculate the risk of a patient with a history of cryptorchidism developing cryptorchidism on the contralateral side.

Primary Outcome Measures: Contralateral Cryptorchidism, Proportion of patients previously operated on for cryptorchidism in whom acquired contralateral cryptorchidism is detected., Up to 1 month
Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.
NCT Number: NCT06533267
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nasopharyngeal Carcinoma|Intensity Modulated Radiotherapy|Surgery
Interventions: PROCEDURE: Endoscopic nasopharyngectomy followed close follow-up|RADIATION: Intensity-modulated Radiotherapy
Sponsor: Sun Yat-sen University
Collaborators: Fifth Affiliated Hospital, Sun Yat-Sen University|Fifth Affiliated Hospital of Guangzhou Medical University|Huazhong University of Science and Technology Union ShenZhen Hospital (Nanshan Hospital)|First Affiliated Hospital, Sun Yat-Sen University|Nanfang Hospital, Southern Medical University|First People's Hospital of Foshan|Zhongshan People's Hospital, Guangdong, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 442
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-25
Completion Date: 2034-03-25
Locations: The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, 519000, China

Summary:
The goal of this clinical trial is to compare the survival and adverse reactions differences between endoscopic surgery and intensity modulated radiotherapy for patients with newly diagnosed stage Ⅰ nasopharyngeal carcinoma, aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal carcinoma.

Primary Outcome Measures: Overall Survival (OS), Defined as the time interval from randomization to death due to any cause., 5 years|Incidence of ≥3 grade adverse events, The proportion of patients with ≥3 grade adverse events according to CTCAE 5.0/RTOG criteria., 5 years
Secondary Outcome Measures: Local Regional Relapse-Free Survival (LRRFS), Defined as the time from randomisation to the date of first locoregional relapse., 5 years|Distant Metastasis-Free Survival (DMFS), Defined as the time interval from randomisation to the date of first distant metastases., 5 years|Progress-Free Survival (PFS), Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first., 5 years|The proportion of patients with treatment related complications, The proportion of patients with treatment related complications according to NCI-CTC5.0 criteria and RTOG criteria., 5 years|Objective response rate (ORR), Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment. (according to tumor imaging examinations 3 months after the end of treatment/supplementary treatment), 3 months|Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0), Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment., 5 years|Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35), Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment., 5 years
Behavioral AI to Predict and Increase Peritoneal Dialysis Uptake
NCT Number: NCT06533254
Acronym: AI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Kidney Disease
Interventions: OTHER: Predicting choice of dialysis|BEHAVIORAL: Behavioral nudges
Sponsor: Scaled Insights
Collaborators: Dallas Renal Group|The Leeds Teaching Hospitals NHS Trust|Suffolk and North East Essex NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2025-12-31

Summary:
Scaled Insights Behavioral AI will be used to improve clinicians ability to detect and understand: The likelihood of patients with kidney failure opting for peritoneal dialysis and to select the right personalized nudge to get CKD patients to choose peritoneal dialysis

Scaled Insights' can utilize the data from this study to develop individualized nudges for healthcare professionals that can be broadly deployed within a digital platform so that clinics across the English speaking world can use it as a means of supporting patients with CKD in selecting peritoneal dialysis treatment.

Using Scaled Insights novel Behavioral Artificial Intelligence solution, the proposed project has two aims:

1. to identify personality attributes of patients with Chronic Kidney Disease and correlating their personality attributes with their subsequent choice of dialysis. Once correlated into personality based clusters, the AI Model will then be able will determine which personality cluster each net new patient will fall into and therefore predict their specific likelihood of opting for peritoneal dialysis or hemodialysis
2. once prediction is possible, customized nudges towards the selection of PD will be developed and tested to improve the likelihood that patients will opt for peritoneal dialysis

Hypotheses:

1. Scaled Insights Behavioral AI will identify the personality characteristics of patients with Chronic Kidney Disease who are likely to opt for both peritoneal dialysis and hemodialysis (Phase 1)
2. Scaled Insights Behavioral AI will identify the nudges that are most effective in encouraging or supporting patients with Chronic Kidney Disease in choosing peritoneal dialysis over hemodialysis (Phase 2)

Primary Outcome Measures: Choice of Dyalysis, The Investigators will use AI to predict patients choice of dialysis. This choice will be recorded by their clinical provider as per normal routine care., From August 2024 to August 2025
Trends of Renal Biopsy in Pediatric Patients at Tanta University Hospital for 10 Years From 2012 to 2022.
NCT Number: NCT06533241
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Renal Diseases
Interventions: PROCEDURE: renal biopsy
Sponsor: Tanta University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-28
Completion Date: 2024-09
Locations: Sara Mabrouk Mohamed Elghoul, Tanta, Tanta, Qism 1, 31511, Egypt

Summary:
This study will be conducted on pediatric patients less than 18 years' old who underwent renal biopsy at Tanta University Hospital from 2012 to 2022.

Primary Outcome Measures: the indications of renal biopsy, investigate the indications of renal biopsy in pediatric patients at Tanta University Hospital for 10 years from 2012 to 2022, 3 months
Secondary Outcome Measures: light , electron microscope and immunofluorescence results of renal biopsy, investigate the results of renal biopsy in pediatric patients at Tanta University Hospital for 10 years from 2012 to 2022, 3 months
Helmsley 3.0: Abbreviated MRE
NCT Number: NCT06533228
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn's Disease
Interventions: DIAGNOSTIC_TEST: Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)
Sponsor: Children's Hospital Medical Center, Cincinnati
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2028-02
Locations: Mayo Clinic, Rochester, Minnesota, 55905, United States|NYU Langone, New York, New York, 10016, United States

Summary:
The purpose of our study is to compare an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) protocol to a conventional, standard of care MRE in children and adults with Crohn's Disease.

Primary Outcome Measures: Compare clinical MRE with research MRE, Our abbreviated magnetic resonance enterography (MRE) will be non-inferior to a standard clinical MRE in detecting small bowel inflammation, strictures and penetrating disease associated with Crohn's Disease., 3 years
Secondary Outcome Measures: Patient experiences and preferences between the abbreviated MRE and the standard clinical MRE., Patients/patients parents will answer a survey to determine if the abbreviated magnetic resonance enterography (MRE) or the clinical MRE is preferred., 3 years|Willingness to trade diagnostic performance for patient experience, We will ask patients a series of questions to determine their tolerance for trading diagnostic performance for a better patient experience., 3 years
Antimicrobial Efficacy of Nano-Based ICM on E.F
NCT Number: NCT06533215
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Enterococcus Faecalis Infection|Endodontically Treated Teeth|Endodontic Disease
Interventions: OTHER: antimicrobial efficacy of nano based intracanal medications on Enterococcus faecalis count reduction in secondary endodontic infection cases.
Sponsor: Tanta University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-01-02
Completion Date: 2025-03-02
Locations: Faculty of Dentistry, Tanta, Egypt

Summary:
This in-vivo study aims to evaluate the antimicrobial effect of nano based intracanal medications (Triple antibiotic-loaded chitosan nanoparticles and chlorohexidine loaded by silver nanoparticles) on Enterococcus faecalis count reduction in secondary endodontic infection cases.

Primary Outcome Measures: the total numbers of Enterococcus Faecalis bacteria on bile esculin agar, colony forming units (CFU/ml)., one weak after application of intracanal medication
Secondary Outcome Measures: Post operative pain, pain on his own words, one weak after application of intracanal medication
Developing a Whole-body MRI and Diffusion-weighted Imaging State-of-the-art Protocol: a Pilot Study
NCT Number: NCT06533189
Acronym: WANDA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Whole Body Imaging|Cancer|Genetic Predisposition
Interventions: DEVICE: Enhanced Diffusion Software
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators: GE Healthcare
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-02-28
Locations: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Radiologia, Roma, 00168, Italy|Advanced Radiology Center, Rome, 00168, Italy

Summary:
Whole-body magnetic resonance imaging (WB-MRI) is a non-ionizing imaging method that can provide WB coverage using essential imaging contrasts with the possibility to include sequences focusing in specific body-regions as needed per case. WB-MRI is increasingly being used for the management of cancer patients, especially metastatic ones. An integral part of WB-MRI is becoming whole-body diffusion-weighted MRI (WB-DWI) which is a non-invasive tool used for staging and response evaluation in oncologic practice. WB-DWI is an inherently noisy technique, resulting in it accounting for more than 50% of the acquisition time of conventional whole-body MRI studies with overall duration at least 1-hour. Reducing acquisition times, without compromising image or diagnostic quality would facilitate the wider adoption of clinical WBDWI, reducing costs, and improving the patient experience

Primary Outcome Measures: Radiologists' satisfaction of the quality of images, Radiologists' satisfaction of the quality of images after applying noise reduction methods, in terms of mean overall response rate ≥4 at the questionnaires' items, 18 months
Secondary Outcome Measures: Diagnostic accuracy of the de-noised WB-MRI in detecting lesions, Comparison of diagnostic accuracy for lesion detection after applying noise reduction methods with that of standard reference imaging modalities,, 18 months|Diagnostic accuracy of the de-noised WB-MRI in detecting staging metastatic oncologic patients., Comparison of diagnostic accuracy for staging neoplasms according to the reference staging system with that of standard reference imaging modalities., 18 months
Real-time Personalized Brain State-dependent TMS After Stroke
NCT Number: NCT06533176
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Stroke
Interventions: DEVICE: Personalized brain state-dependent single-pulse TMS
Sponsor: University of Texas at Austin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2026-08-31
Locations: University of Texas at Austin, Austin, Texas, 78712, United States

Summary:
Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal connections and enhance recovery of paretic hand function after stroke. This project will test whether personalized brain state-dependent TMS can activate the residual corticospinal tract better than standard TMS, and evaluate the relationship between this activation and hand motor impairment.

Primary Outcome Measures: MEP amplitudes, Peak-to-peak MEP amplitudes elicited by single TMS pulses delivered during personalized strong and random CST states will be measured. At the individual participant level, all MEP amplitudes will be normalized to the mean MEP amplitude observed in that participant. Mean normalized MEP amplitudes will be used to calculate the percentage MEP amplitude difference between personalized strong and random states., 1 week|Upper Extremity Fugl-Meyer Assessment Summed Hand and Wrist Subscores, Hand and wrist subscores obtained for each participant during the Upper Extremity Fugl-Meyer Assessment will be calculated. Hand and wrist subscores will then be summed for each participant. This will provide a single impairment score that will be correlated with the percentage MEP amplitude difference between personalized strong and random states., 1 week
Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial
NCT Number: NCT06533163
Acronym: OMX-EFS-01
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glioblastoma Multiforme
Interventions: DEVICE: Oncomagnetic device
Sponsor: BioTex, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2027-11

Summary:
The clinical investigation is a non-randomized, multicenter, open-label, prospective, exposure-time escalation clinical investigation. The clinical investigation is designed to assess the clinical safety and performance of the Oncomagnetic Device.

Primary Outcome Measures: To assess the safety of the Oncomagnetic device., • Incidence of device-related adverse events (as per CTCAE v.5) at 6 months following surgery., 6 months
Secondary Outcome Measures: To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM., Response of Index Lesion:

• Via radiographic assessment (MRI), 6 months|To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM., Median Progression-Free Survival at 6 months (PFS-6) following surgery:

• Changes in tumor volume via radiographic assessment (MRI) analyzed via independent reviewer using mRANO criteria., 6 months|To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM., Median Overall Survival (OS):

• Measured by the length of time from initial diagnosis until subject expiration., 3 years|To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM., Quality of Life (QOL):

• Assessed using the validated quality of life scale (QLQ-C30) by the EORTC as well as the module for brain tumors, BN 20., 6 months
Other Outcome Measures: To assess imaging data for exploratory analyses and to support potential future research endeavors., • Via radiographic assessment (MRI), 3 years
Improving Surgical Patient Outcomes Through Implementation of a SemiStructured Intraoperative Anesthesia Handoff Tool
NCT Number: NCT06533111
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post-operative Complications
Interventions: OTHER: Epic Health Record cognitive aid|OTHER: Standard of Care
Sponsor: The University of Texas Health Science Center, Houston
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-11-01
Completion Date: 2026-05-31
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States

Summary:
The purpose of this study is to assess the impact of a semi-structured intraoperative anesthesia handoff tool on patient outcomes and to assess the validity of the 5-Factor Perceived Shared Mental Model Scale (5-PSMMS) in a healthcare setting and whether the perception of Shared Mental Model (SMM) mediates the effect of the intraoperative handoff tool on postoperative outcomes

Primary Outcome Measures: Number of participants that show post-operative complications that have been associated with intraoperative handoffs, Post operative complications will be a composite comprised of bleeding, pneumonia, acute renal failure requiring dialysis, myocardial infarction, pulmonary embolism, deep vein thrombosis, sepsis, unplanned ICU admission, and unplanned return to the operating room as documented in physician notes., 30 days after surgery
Secondary Outcome Measures: Number of participants that die after surgery, 30 days after surgery|Hospital length of stay, At time of discharge or 30 days whichever comes first
Comparison Ultrasound-Guided Adductor Canal Block and Surgeon-Performed Block for Pain Management After Total Knee Arthroplasty
NCT Number: NCT06533085
Acronym: ACB
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthrosis Knee Arthroplasty Analgesia Pain Management
Interventions: PROCEDURE: Adductor canal block by surgeon
Sponsor: Kirsehir Ahi Evran Universitesi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-05-01
Completion Date: 2022-05-30
Locations: Ahievran university, Kirşehi̇r, 40100, Turkey

Summary:
Objective: Adductor canal block (ACB) is widely performed for postoperative analgesia for total knee arthroplasty (TKA). The aim of this study is to compare surgeon-assisted and anesthesiologist-assisted (ultrasound-guided) adductor blocks in terms of postoperative analgesic efficacy.

Methods: This study was designed as a double-blind, prospective and randomized trial. A total of 240 participants were randomly allocated to three groups: one where the surgeon performed the adductor canal block (ACBs), another where it was conducted by an anesthetist with ultrasound guidance (ACBa), and a third group without the adductor block. The follow-up management after the Total Knee Arthroplasty (TKA) procedure occurred on the first, third, and tenth days, as well as the twelfth week. Outcome measures comprised pain assessment using the Visual Analog Scale (VAS) and monitoring opioid analgesic consumption.

Primary Outcome Measures: Pain Intensity, Evaluation of Pain; Visual analog scale (VAS) was used for pain assessment. VAS is in the form of a 10-point Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level., immediately before surgery and postoperative at hour 3, postoperative at hour 12, postoperative day 1, postoperative day 3, postoperative day 10 and week 12 after surgery.|Pain Managment, consumption of opioids (single dose (2 ml) containing 100 mg of tramadol hydrochloride was administered), Postoperative Day 1 Opioid Usage, Postoperative Day 2 Opioid Usage, Postoperative Day 3 Opioid Usage
Secondary Outcome Measures: Functionality, Knee scoiety score(KSS) (The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.Turkish validity and reliability has been established.), preoperatively and at week 12 post-operatively
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
NCT Number: NCT06533059
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Cancer|Breast Cancer|Endometrial Cancer|Metastatic Cancer|Advanced Solid Tumor
Interventions: DRUG: ALTA2618
Sponsor: Alterome Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-22
Completion Date: 2027-12-29
Locations: Research Site, San Antonio, Texas, 78229, United States|Research Site, Fairfax, Virginia, 22031, United States

Summary:
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.

Primary Outcome Measures: Adverse Events, Number of participants that experience treatment-emergent adverse events (TEAEs)., Up to 39 months|Dose Limiting Toxicities, Number of participants with Dose Limiting Toxicities (DLTs)., 21 days
Secondary Outcome Measures: Maximum Observed Plasma Concentration (Cmax), Cmax, Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose|Time to Reach Maximum Observed Plasma Concentration (Tmax), Tmax, Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose|Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt), AUCt, Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose|Terminal Half-Life (t1/2), t1/2, Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose|Overall Response Rate (ORR), Assess per RECIST 1.1, Up to 39 months|Duration of Response (DOR), Assess per RECIST 1.1, Up to 39 months|Progression-Free Survival (PFS), Assess per RECIST 1.1, Up to 39 months|Overall Survival (OS), Assess per RECIST 1.1, Up to 39 months
Ultrasound Estimation of Gastric Volumes in Patients With Previous Gastric Sleeve
NCT Number: NCT06533046
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aspiration
Sponsor: University of North Carolina, Chapel Hill
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-02
Completion Date: 2024-12-31
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27514, United States

Summary:
The goal of this observational study is to determine whether the existing model for calculating gastric volume based on an ultrasound-measured cross sectional area is accurate in adults who have had a previous gastric sleeve procedure. The main questions it aims to answer are:

Can the existing model accurately calculate gastric volume in patients who have had a previous gastric sleeve procedure?

If the existing model is not accurate in this population, can a model be developed to predict gastric volume in these patients based on ultrasound-measured cross section area?

Participants will be asked to fast prior to presenting for a gastric ultrasound scan. Following a fasted scan, patients will drink a small volume of water and undergo a second gastric scan.

Primary Outcome Measures: Accuracy of existing gastric volume equation, Calculated gastric volumes from after participants ingestion of a known quantity of water during the study will be compared to the known volumes of water that the subjects ingested using a mean squared error analysis., 5 minutes after ingestion
Secondary Outcome Measures: Equation for calculating gastric volume in patients with previous gastric sleeve, Should the existing model prove to be inaccurate, LASSO regression will be performed to identify a more accurate model in this population based on comparing the known volumes of water ingested and the measured cross sectional gastric area., through study completion, an average of one year|Gastric emptying time, The thirty-minute interval scans following ingestion will be used to determine the approximate time at which each patient is able to fully empty the volume of water they have ingested., 2 hours after ingestion
PDE3B in Metabolic Regulation
NCT Number: NCT06533007
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 2 Diabetes|Cardiometabolic Syndrome|Cardiovascular Diseases
Sponsor: Cambridge University Hospitals NHS Foundation Trust
Collaborators: University of Cambridge
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2029-09

Summary:
Phosphodiesterase 3B (PDE3B), an enzyme responsible for the degradation of cyclic AMP and GMP (two important second messengers used for intracellular signal transduction), has been associated with cardiometabolic outcomes. Results from animal studies indicate that abolishing PDE3B function may be associated with unfavourable metabolic profile; however, preliminary human studies suggest that heterozygous loss of function (LoF) variants in the PDE3B gene have been associated with cardiometabolic improvements. Therefore, the effect of PDE3B on human adipose tissue metabolic pathways remains poorly understood.

Accordingly, the investigators propose to conduct a recall-by-genotype, case-control study in a group of people with LoF variants in the PDE3B gene and a matched group without the variant (wild type, WT) to determine differences on key metabolic features: 1) adipose tissue biology (i.e., mitochondrial function, adipocyte morphology, gene expression and in vivo lipolysis in the basal and/or the insulin-stimulated state); 2) systemic lipid and glucose metabolism using the hyperinsulinemic-euglycemic clamp procedure.

The proposed investigations will elucidate the role of PDE3B on adipose tissue and systemic glucose and lipid metabolism in humans and whether modulating PDE3B activity constitutes a target for the prevention and treatment of cardiometabolic disease.

Primary Outcome Measures: Lipolysis, Lipolysis will be assessed as the palmitate rate of appearance by using infusion of stable isotope tracers., baseline
Secondary Outcome Measures: Adipose tissue gene expression, Changes in the expression of genes will be assessed by using RNA sequencing, baseline|Insulin sensitivity, Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers., baseline|Insulin secretion, Insulin sensitivity will be assessed by using an oral glucose tolerance test, baseline
Predictive Algorithms for Critical Rehabilitation Outcomes
NCT Number: NCT06532994
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intensive Care|Mechanical Ventilation|Rehabilitation|Algorithms
Interventions: OTHER: Early rehabilitation intervention
Sponsor: Wuhan University
Collaborators: Wuhan No.1 Hospital|General Hospital of the Yangtze River Shipping/Wuhan Brain Hospital|Wuhan No.6 Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-09-30

Summary:
An increasing amount of evidence from evidence-based medicine indicates that early rehabilitation intervention for patients receiving mechanical ventilation is safe and feasible, and can promote functional recovery and reduce hospital stay. However, the conscious state, respiratory function, and daily living activities of these patients after being discharged from the ICU vary greatly, and some patients do not show obvious benefits. How to identify which patients may have benefit from early rehabilitation is a key issue that needs to be addressed in critical care rehabilitation. This study aims to investigate the clinical data related to the disease of the ICU survivors who received mechanical ventilation as the research object, by collecting their clinical data when receiving early rehabilitation intervention, and constructing a clinical prediction model for the efficacy of early rehabilitation intervention in the ICU through the selection of optimal regression equation or machine learning algorithm. The application of this model can effectively determine whether ICU inpatients need early rehabilitation intervention, thereby reducing complication rates and improving their quality of life.

Primary Outcome Measures: Functional Independence Measure (FIM) scale, The Functional Independence Measure (FIM) scale is a widely used tool designed to assess an individual's level of disability and functional independence in activities of daily living (ADLs).

The FIM scale consists of 18 items divided into two main categories: \*\*self-care\*\* and \*\*mobility\*\*, each evaluating specific tasks such as eating, bathing, dressing, and transferring. Each item is scored on a scale from 1 to 7, where:

* 1 indicates total dependence (the individual requires assistance),
* 7 indicates complete independence (the individual performs the task safely and independently).

The total FIM score can range from 18 to 126, with higher scores representing greater functional independence levels., From date of enrollment until the date of ADL improvement (FIM increase ≥ 5) or date of participants are transferred out of the ICU. FIM score was assessed every other day after treatment starts and up to 6 weeks.
The Effect of AFOs on the EMG of Children With CP
NCT Number: NCT06532981
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Spastic Cerebral Palsy
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-06
Completion Date: 2025-07-31
Locations: UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium

Summary:
Children with cerebral palsy (CP) have altered gait patterns as a result of primary and secondary symptoms. Ankle-foot orthoses (AFOs) are frequently used to improve their gait. Despite evidence of AFO-effects on gait kinetics and -kinematics, the effects on muscle activity remain unclear.

This study will investigate the effect of AFOs on the amplitude and timing, as well as the co-activation of lower limb muscle activity in children with spastic CP.

Primary Outcome Measures: EMG-waveform amplitude & timing, The averaged time-normalized continuous EMG-waveforms for each walking condition (i.e., barefoot, AFO, overground and on the treadmill) the following muscles: the quadriceps (m. rectus femoris, m. vastus lateralis), the hamstrings (m. semitendinosus, m. biceps femoris) and the shank (m. gastrocnemius medialis, m. tibialis anterior)., One measurement of 150 minutes|EMG co-activation, The co-activation was calculated by defining the synchronised activations of the agonist and antagonist muscles. To quantify the co-activation, the on- and off-timing of the muscle activity needed to be defined for the rectus femoris, the medial hamstrings, the gastrocnemius and the tibialis anterior., One measurement of 150 minutes