pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Evolution of Neuroendoscopy Guided by Head-mounted Mixed Reality Technique Navigation System in Neurosurgery
NCT Number: NCT06516471
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pineal Tumor|Brainstem Tumor|Surgery
Interventions: DEVICE: Conventinal Navigation System Group
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2027-07

Summary:
The pineal region and brainstem tumors are located at the central position of the cranial cavity, surrounded by important neural structures and venous systems, leading to challenges in preoperative diagnosis, adding uncertainty and complexity to treatment. For a long time, surgical treatment of pineal region and brainstem tumors has been one of the most challenging areas in neurosurgery.

With the development of neuroendoscopy and virtual endoscopy technologies, how to convert complex three-dimensional bone, vascular, and neural images into virtual endoscopic images and how to combine virtual endoscopy with neuro-navigation for endoscopic skull base surgery to provide high-quality guidance images for surgery has become an urgent new research issue.

The project team plans to develop a neuroendoscopy combined with a wearable mixed reality glasses navigation system, integrating the advantages of wearable glasses and existing surgical navigation systems.

This study aims to evaluate the role of mixed reality navigation systems in improving total resection and reducing major complications in patients with pineal region and brainstem tumors, as well as shortening surgical times.

Primary Outcome Measures: Surgical time, From openning the dura mater to close it, immedately after surgery
Secondary Outcome Measures: Gross total resection rate, Gross total was defined as 100% of tumor resection, within 72 hours after surgery|The incidence of complications, new cranial nerve dysfunction, secondary surgery, within 1 month after surgery
Development of Camera Based Gait Quality Measure for Persons With Multiple Sclerosis
NCT Number: NCT06516458
Acronym: MS-GDI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis|Multiple Sclerosis, Secondary Progressive|Multiple Sclerosis Relapse|Multiple Sclerosis, Relapsing-Remitting
Interventions: DIAGNOSTIC_TEST: Camera Based Kinematic Analysis
Sponsor: Shirley Ryan AbilityLab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2026-07
Locations: Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States

Summary:
The purpose of this study is to develop a measurement of walking quality, called Gait Deviation Index (GDI) for people with Multiple Sclerosis (MS).

Primary Outcome Measures: Kinematics of the gait cycle, Joint position of lower limbs during a single cycle of gait, at the time of session
Secondary Outcome Measures: 6 minute walk test, you will be instructed to walk as quickly and safely as you can while being timed for 6 minutes, at the time of session
SCRT Followed by Camrelizumab Combined With Fluzoparib and Chemotherapy as Neoadjuvant Therapy for LARC
NCT Number: NCT06516445
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Colorectal Cancer
Interventions: RADIATION: SCRT|DRUG: Camrelizumab|DRUG: Fluzoparib|DRUG: CAPEOX
Sponsor: Huazhong University of Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-28
Completion Date: 2026-06-28
Locations: Tongji hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, 430079, China

Summary:
To explore the safety and efficacy of neoadjuvant therapy for locally advanced rectal cancer with short course radiotherapy followed by camrelizumab combined with fluzoparib and chemotherapy

Primary Outcome Measures: Adverse events, Incidence and grade according to NCI-CTCAE 5.0(including serious adverse events and immune-related adverse events); Surgical safety: surgical complications, 30 - and 90-day postoperative mortality, length of stay, and reoperation rate, up to 36 months|pCR (Pathological Complete Response), The proportion of subjects with no residual viable tumor cells(ypT0N0) in the primary tumor and lymph nodes, also defined as the proportion of subjects with grade 0 in the AJCC Tumor Regression Grading (TRG) scoring system(version 8.0)., up to 6 months
Secondary Outcome Measures: 3-year Event-Free Survival(EFS) rate, The percentage of patients without disease recurrence or progression or death due to any cause after 3-year follow-up, up to 36 months|Overall Survival(OS), The time from the date of randomization to the death caused by any cause, up to 36 months|R0 resection rate, The rate of negative margin microscopically, up to 6 months|Completion rate of neoadjuvant therapy, the rate of NAT completion, up to 6 months|Tumor Regression grade (TRG), Evaluated according to AJCC Version 8 TRG scoring system, up to 6 months|quality of life (QOL), The EORTC QLQ-C30 scale was used, up to 36 months
Other Outcome Measures: biomark, evaluate the relationship between potential biomarkers (including but not limited to MMR status, PD-L1 expression) and efficacy, up to 36 months
Parasternal Blockade and Serum Lactate in Cardiac Surgery
NCT Number: NCT06516432
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Elective Cardiac Surgery
Interventions: PROCEDURE: Parasternal block|PROCEDURE: Requirement of total dose regarding fentanyl
Sponsor: Instituto Mexicano del Seguro Social
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-01-01
Completion Date: 2024-12-31
Locations: Centro Médico Nacional de Occidente, Guadalajara, Jalisco, 44329, Mexico

Summary:
Serum lactate level is a key indicator of tissue perfusion. Parasternal blockade is associated with reduced postoperative inflammatory response by inhibiting stress response, leading to better outcomes. Elevated lactate levels help identify patients at risk of postoperative morbidity and mortality. This analytical cross-sectional study evaluated the association between parasternal blockade and serum lactate levels in patients undergoing elective cardiac surgery in 2022 at Specialty Hospital CMNO. Patients with and without parasternal block were compared for changes in serum lactate levels during and after anesthesia within the first 24 hours.

Primary Outcome Measures: Serum lactate measurement, Elevated serum lactate levels above 2 mmol/L, 24 hours postoperative
Kinesio Tape Application in the Treatment of Plantar Fasciitis
NCT Number: NCT06516393
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Plantar Fascitis
Interventions: DEVICE: The radial shock wave device
Sponsor: Bihter Aslanyurek
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-13
Completion Date: 2024-04-30
Locations: Bihter Akınoğlu, Ankara, Turkey

Summary:
This study is a prospective randomized clinical trial. Radial extracorporeal shock wave therapy (r-ESWT) is accepted as one of the most effective treatment modalities for plantar fasciitis (PF). Kinesio taping (KT) applied to the plantar fascia can provide patients with PF some benefits, but there no enough evidence about this topic. This study analysed the acute effect of adding KT to r-ESWT, on pain, foot function and flexibility when treating PF.

Primary Outcome Measures: Change from baseline in pain on the Visual Analog Scale (VAS) at week 5, VAS is a tool where patients indicate the level of pain they feel using a 10 cm ruler. VAS pain score "no pain" (score=0) and "worst pain" (score=10)., Baseline and week 5|Change from baseline Foot function via the Foot Function Index (FFI) at week 5, FFI is a safe and valid foot-specific assessment measure used to evaluate pain, disability, and activity limitation, filled out by the patient self-reported, Baseline and week 5|Change from baseline flexibility was evaluated through gastro-soleus and plantar fascia flexibility tests at week 5, The patient was seated on a flat surface with the knees extended and the soles of the feet touching the wall. The tests were repeated three times and the average of the three measurements was taken., Baseline and week 5
Screening Tool for Malnutrition, Sarcopenia, and Cachexia
NCT Number: NCT06516367
Acronym: ASUST-MSC
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Malnutrition|Sarcopenia|Cachexia
Interventions: OTHER: Ain Shams University Screening Tool for Malnutrition, Sarcopenia, and Cachexia (ASUST-MSC)
Sponsor: Ain Shams University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2024-04-30
Locations: Ain Shams University, Cairo, 11566, Egypt

Summary:
There is an accumulating evidence of the overlap and frequent co-occurrence of twasting conditions in older adults. Those conditions include malnutrition, sarcopenia, and cachexia, Therefore , a tool capable of simultaneously screening for all three conditions is imperative. In this study, we developed and validated a new tool for the simultaneous screening of muscle wasting diseases in older adults. The diagnostic accuracy of the new tool was compared to other validated screening tools including the Mini Nutritional Assessment-Short Form (MNA-SF), the Short Nutritional Assessment Questionnaire (SNAQ), and the Simple Questionnaire to Rapidly Diagnose Sarcopenia (SARC-F).

Primary Outcome Measures: reliability of a new tool for the simultaneous screening of muscle wasting diseases in older adults, Relaibility; Cronbach's alpha coefficient was used to evaluate the internal consistency., 10 months|validity of a new tool for the simultaneous screening of muscle wasting diseases in older adults, Validity; Spearman's correlation coefficient was used to examine construct validity of the new tool, 10 months
Secondary Outcome Measures: The diagnostic accuracy of the new tool, The Receiver operating curve was plotted to detect the area under curve of the new tool, for diagnosing muscle wasting diseases., 10 months
Evaluation of Obstructive Sleep Apnea (OSA) Using Portable Sleep Testing (PST) Devices on an Inpatient Stroke Unit
NCT Number: NCT06516354
Acronym: OSA
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea
Interventions: DEVICE: Portable sleep apnea screening
Sponsor: Advocate Health Care
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2017-08-01
Completion Date: 2019-03-31
Locations: Advocate Lutheran General Hospital, Park Ridge, Illinois, 60068, United States

Summary:
The purpose of this study is to evaluate the feasibility of testing patients for OSA within the inpatient setting. As part of this program, the investigators are proposing early access to a sleep apnea treatment plan, potentially lowering the risk for future stroke symptoms, and preventing lost to follow up of patients for treatment since sleep disordered breathing is primarily considered a disorder that is managed in an outpatient setting.

Hypothesis: Early identification of sleep apnea as a modifiable stroke risk factor (SRF) for acute ischemic stroke (AIS) and transient ischemic attack (TIA) patients using the STOP BANG questionnaire and portable sleep testing (PST) during inpatient hospitalization, will allow early identification of patients at risk for sleep disordered breathing, early diagnosis of sleep apnea, and earlier prescribed treatment prior to discharge.

Primary Outcome Measures: Feasibility of OSA screening and prescription of treatment for in-hospital pateints, Positive screening on STOP BANG tool and positive Portable Sleep Testing (PST) for sleep disordered breathing completed during inpatient hospitalization prior to discharge Diagnosis and prescribed treatment plan following positive interpretation of PST by sleep specialist for PAP device, this measures will be assessed via a questionnaire filled out with the investigator, 90 days
Secondary Outcome Measures: Follow up compliance and readmission rate, Phone call with patient to assess compliance and tolerability to treatment plan Hospital readmission due to stroke from Crimson database, 120 days
Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation
NCT Number: NCT06516341
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ulcerative Colitis|Crohn Disease
Interventions: PROCEDURE: CD patients|PROCEDURE: UC patients
Sponsor: IRCCS Ospedale San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-09
Locations: Prof. Pierpaolo Sileri, Milan, Italy

Summary:
A portion of patients with Inflammatory bowel disease often require surgical intervention since they do not respond to the current therapies. Besides this risk, patients may develop post-operative disease complications, and the factors beneath are far from being understood or predicted. The investigators hypothesize that some priming factors remain in the resection margin after surgery and act as a memory of the evolution of the disease, leading to the recurrence or complications. The following proposals are made:

1. defining and validating in humanized experimental models of intestinal inflammation the spatial and temporal dynamics of the postoperative complications-priming factors
2. integrating them into a machine-learning-driven model to determine risk indices of disease recurrence in IBD patients. This risk prediction model will not change the clinical decision-making process but will only be built for research. Consequently, patients enrolled in this study will be monitored and treated as per the standard of care.

This project will reveal possible causes and build methods predictive of postoperative complications ultimately resulting in changes in clinical management in the near future.

Primary Outcome Measures: To assess the pro-complication potential of IBD-derived samples in vivo models, The investigators aim to validate in several animal models the hypothesis that intra-tissue characteristics lead to the development of recurrent chronic inflammation and/or are per se sufficient to induce intestinal disease. One of the variables that will be considered is immune cells from the processing of the IBD mucosal surgical specimens. By understanding these variables, the investigators will be able to define the mechanical model underlying the development of post-operative recurrence of IBD., 6 months since surgery
Secondary Outcome Measures: to define inflammatory factors associated with postoperative complications in patients with IBD-derived samples in vivo models, Other variables to be considered are CD4+ T-cells from the processing of blood, 6 months since surgery|to define microbial factors associated with postoperative complications in patients with IBD-derived samples in vivo models, At the time of surgery, feces will be collected from patients. The microbial component from the IBD surgical specimens will be isolated and injected into humanized animal models., 6 months since surgery
AGE/sRAGE Ratio in Diabetic Periodontitis
NCT Number: NCT06516328
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Periodontitis, Diabetes Mellitus Type 2
Interventions: OTHER: Observational
Sponsor: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-01
Completion Date: 2023-12-10
Locations: Hacettepe University, Ankara, 06100, Turkey

Summary:
The goal of this observational study is to learn about some molecules in the disease mechanism of type 2 diabetes and periodontitis. There are end products inside the body called AGEs and their receptors binding to them especially (sRAGE, RAGE) in people with diabetes in hyperglycemic state.These molecules are important also in periodontitis (the disease of teeth that may end with exfoliation of the tooth). Diabetes and periodontitis enhance each other's disease-causing effects. Both is chronic inflammatory diseases and IL-17 is another molecule having role in this process.

Totally 64 men and women aged between 27-60 included in the study. Study groups were : 1.participants with healthy teeth and no diabetes, 2. participants with periodontitis without diabetes, 3.participants with periodontitis and controlled diabetes, 4.participants with periodontitis and uncontrolled diabetes (6.5% and fasting blood sugar levels \<200 mg/dl). Researchers got saliva and gingival crevicular fluid (GCF) samples from diseased teeth and examined AGE, sRAGE, IL-17 levels. GCF is a fluid around the crevice of the theeth with different characteristics from saliva.

As a result AGE/sRAGE ratio and IL-17 levels of diseased groups were higher than healthy group, while sRAGE levels were significantly lower in GCF samples. Researchers concluded that GCF and saliva AGE/sRAGE ratio may represent as a biomarker in periodontitis patients with uncontrolled diabetes.

Primary Outcome Measures: AGEs/RAGE ratio, IL-17 level in GCF and saliva, AGEs to RAGE ratio comparison between study groups, 3 to 6 months|AGEs/RAGE ratio, IL-17 level in GCF and saliva, IL-17 level comparison between study groups, 3 to 6 months
Feasibility Study of an Angiographic Quantitative Flow Ratio-guided Endovascular Procedure in Patients With Lower Limbs Peripheral Arterial Disease.
NCT Number: NCT06516315
Acronym: QFR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lower Limbs Peripheral Arterial Disease
Interventions: PROCEDURE: Preoperative ultrasound examination.|PROCEDURE: Peroperatoire angiography procedure and QFR analysis
Sponsor: Fondation Hôpital Saint-Joseph
Collaborators: Medis Medical Imaging Systems B.V.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-04-29
Completion Date: 2025-05-24
Locations: Hôpital Paris Saint-Joseph - 185 Rue Raymond Losserand, Paris, Ile-de-France, 750014, France

Summary:
The main objective of this study is to explore the feasibility of using the angiographic Quantitative Flow Ratio (QFR) as a tool to predict the success rate of endovascular revascularization in patients with superficial artery disease.

This is a prospective feasibility study. We aim to include 35 patients with indication for endovascular revascularization of a short stenosis of the superficial femoral artery. Intraoperative angiography will be performed immediately prior to revascularization. Quantitative analysis of angiography images will be performed post-procedure using Medis QFR®2.2 software.

Primary Outcome Measures: Preoperative systolic velocity peak and intraoperative QFR, Systolic velocity peak measured by preoperative ultrasound, performed the day before or the day of surgery, and QFR measured intraoperatively, immediately before the revascularization procedure., Day -1, Day 0
Secondary Outcome Measures: Percentage of stenosis, Percentage of stenosis measured by preoperative ultrasound, performed the day before or the day of surgery., Day -1, Day 0|Occurrence of a Major Adverse Limb Event (MALE), Occurrence of a Major Adverse Limb Event (MALE) at 1 month post-op (D30): Acute ischemia OR Major amputation OR Re-intervention on revascularized limb (excluding minor amputation)., Day 30|Re-hospitalization, Re-hospitalization for any reason at 1 month post-procedure (D30)., Day 30|Revascularization, Revascularization (endovascular or surgical) of the treated area (Target Lesion Revascularization (TLR)) defined by re-intervention on the target lesion, including 1 cm above and below the target lesion., Day 30|Rutherford classification, Rutherford classification at 1 month post-op., Day 30|Dosimetry and dose of contrast medium, Dosimetry and dose of contrast medium injected during the procedure (D0)., Day 0|Procedure envisaged by surgeon, Procedure envisaged by surgeon 1 and procedure envisaged by surgeon 2 after reading the QFR., Day 0|Creatinine levels and glomerular filtration rate, Preoperative (D0) and postoperative (D5 and D30) creatinine levels and glomerular filtration rate., Day 5, Day 30
Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis
NCT Number: NCT06516237
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ulcerative Colitis
Interventions: PROCEDURE: to determine molecular and epigenetic biomarkers
Sponsor: IRCCS San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-31
Completion Date: 2026-07-31

Summary:
Prospective multicenter interventional non-randomized cross-sectional study. Ultrasound operators will be blinded to clinical and endoscopic findings and the endoscopist will be blinded of the clinical and ultrasound findings.

This study aims to develop novel imaging and molecular biomarkers of fibrosis, through the use of intestinal ultrasound and shear wave elastography, using histologic specimens obtained by endoscopic biopsies as reference standard.

Primary Outcome Measures: To correlate ultrasound findings with histopathological elements of lesions, To correlate ultrasound findings with histopathological elements of lesions obtained by biopsies of the distal colon during routine investigations by colonoscopy or sigmoidoscopy, as the reference standard: specifically, Hematoxylin and Eosin (H\&E) staining for inflammation, Immunostaining of alfa-smooth muscle actin (aSMA) for muscular hypertrophy, and Sirius red special staining for collagen deposition, 1 day
Secondary Outcome Measures: To correlate shear wave elastography measurements with histopathological elements of lesions, To correlate shear wave elastography measurements with histopathological elements of lesions, Hematoxylin and Eosin (H\&E) staining for inflammation, Immunostaining of alfa-smooth muscle actin (aSMA) for muscular hypertrophy, and Sirius red special staining for collagen deposition, 1 day
Other Outcome Measures: To correlate ultrasound findings and shear wave elastography measurements with molecular and epigenetic characteristics at single cell resolution, To correlate ultrasound findings and shear wave elastography measurements with molecular and epigenetic characteristics at single cell resolution, 1 day
Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test
NCT Number: NCT06516211
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnancy
Interventions: DEVICE: Clara Pregnancy Test|DEVICE: Professional Marketed Pregnancy Test
Sponsor: Conceptra Biosciences, LLC
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2024-10-31
Locations: FPA Women's Health, Los Angeles, California, 90022, United States

Summary:
Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial center and provide a sample of urine from the same void for further testing.

Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.

Primary Outcome Measures: Lay-Professional Comparison, Demonstration of agreement of pregnancy test reading. The agreement between lay participant test results and those of a technician testing the same urine sample., 1 day
Secondary Outcome Measures: Predicate Comparison, Demonstration of agreement of pregnancy test reading. The agreement between the predicate device and investigational device test results performed by a technician testing the same urine sample., 1 day
Auricular Acupressure in Prehabilitation
NCT Number: NCT06516198
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Frailty|Thoracic|Prehabilitation|Lung Surgery|Wedge Resection|Segmentectomy|Lobectomy|Pneumonectomy; Status
Interventions: OTHER: Auricular Acupressure
Sponsor: University of Chicago
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2027-06-20
Locations: University of Chicago, Chicago, Illinois, 60637, United States

Summary:
Complementary medicine is recognized for its ability to enhance appetite, increase energy, reduce anxiety, decrease pain, and improve sleep, among many other benefits. Acupuncture is among the most frequent types of complementary medicine practiced in the US, and Medicare currently includes back pain as a reimbursable indication for this therapy. Acupuncture-related therapies may enhance efforts at prehabilitation in candidates for major lung resection.

Primary Outcome Measures: Number of patients enrolled, The patient will complete a form after each seed pressing confirming the pressing and the time., 2 weeks
Secondary Outcome Measures: Ease of participation in the study., The patient will complete a form after each seed pressing confirming the pressing and the time., End of Study (Week 4)
Other Outcome Measures: Accuracy of seed placement by a non-professional care partner., The care partner will place the seeds and then send a photo to the research team for correct seed placement verification or correction on a weekly basis. Accuracy of seed placement will be assessed by determining the number of corrections required to achieve seed placement each week., Weekly until Week 4|The change of the intervention prehabilitation results, Compared to the control group, the intervention will demonstrate better increases in endurance, function, mood, breathing capacity, and strength., End of Study (Week 4)
Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement
NCT Number: NCT06516185
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Crowding, Tooth|Tipped Tooth or Teeth|Rotation of Tooth|Malocclusion, Angle's Class
Interventions: DEVICE: direct-printed aligner|DEVICE: thermoformed aligner
Sponsor: Universidad Complutense de Madrid
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-06
Locations: Complutense University of Madrid, Madrid, 28040, Spain

Summary:
The purpose of this study is to evaluate the biomechanical behaviour of direct-printed and thermoformed aligners in different tooth movements, creating a biomechanical planning protocol based on a stratification of tooth movements according to the degree of predictability.

Primary Outcome Measures: Predictability for each type of tooth movement in patients with direct-printed aligners compared to a control group in which the movements are performed with thermoformed aligners., The primary outcome will be quantified through a continuous numerical variable, tooth movement efficiency or predictability (%) measured as the change between the final, intra-treatment and initial position for each of the individual movements studied, expressed as a percentage (%). The end of treatment or endpoint (E1) of this study will be established when the measurement of Little's Irregularity Index (hereafter LII) LII=0., Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.|impact on the effectiveness and predictability of biomechanics auxiliaries compared to a control group in which movements are performed without the use of auxiliaries., This will be assessed by quantifying the change between the predictability with auxiliaries and without auxiliaries for each of the individual movements studied respectively, expressed as a percentage (%)., Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
Secondary Outcome Measures: PROMs of the patient undergoing direct-printed aligner treatment compared to the control group., Participants will complete a validated pre-defined questionnaire \[Patient-reported outcome measures (PROMs)\] on treatment use and perceptions. The level of pain will be assessed using questionnaires., These should be completed five times after each visit (at 24 hours, 48 hours, 72 hours, 7 days and 14 days of aligner use) until reaching the defined endpoint (crowding resolution, LII=0), an average of 6 months.|influence on the printed orthodontic device (POD) of varying the degree of inclination of the aligner print., This will be assessed by quantifying the change between the predictability, varying the degree of inclination of the aligner print, expressed as a percentage (%)., Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
Validation of the MBI-C Scale in French
NCT Number: NCT06516159
Acronym: MBI-C
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Subjective Cognitive Complaint|Mild Cognitive Impairment|Neuropsychiatric Symptoms
Interventions: DIAGNOSTIC_TEST: MBI-C Scale in French
Sponsor: University Hospital, Toulouse
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 170
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-26
Completion Date: 2025-07-26
Locations: University Hospital Limoges, Limoges, 87042, France|University Hospital Nice, Nice, 06100, France|University Hospital Strasbourg, Strasbourg, 67091, France|University Hospital Toulouse, Toulouse, 31059, France|Univsersity Hospital Lyon, Villeurbanne, 69100, France

Summary:
This study aims to validate the French version of the Mild Behavioral Impairment-Checklist (MBI-C) scale, hypothetically effective for measuring behavioral symptoms in patients presenting with a subjective cognitive complaint or mild cognitive impairment (MCI).

Primary Outcome Measures: Consistency for Internal validity of the Mild Behavioral Impairment-Checklist score, consistency will be assessed using Cronbach's alpha and McDonald's Omega coefficients., Baseline|External validation of the Mild Behavioral Impairment-Checklist score, Comparison of differences between the scores of the five domains of the NeuroPsychiatric Inventory-Total Questionnaire (NPI-Q) and the MBI-C., Baseline
Secondary Outcome Measures: Prevalence of Mild Behavioral Impairment (MBI) in memory center patients presenting mild cognitive impairment (MCI) or a subjective cognitive complaint (SCC)., Percentage of patients having the 4 items of the MBI diagnostic criteria of the International Society to Advance Alzheimer's Research and Treatment (ISTAART), Baseline|Determination of the best threshold for the diagnosis of Mild Behavioral Impairment (MBI) in patients with mild cognitive impairment (MCI) or subjective cognitive complaint (SCC)., The best diagnostic threshold for MBI-C will be determined using the receiver operating characteristic (ROC) curve using as a reference the diagnosis by 4 items of the MBI diagnostic criteria of the ISTAART, Baseline
Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma
NCT Number: NCT06516133
Acronym: OART
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Nasopharyngeal Carcinoma
Interventions: RADIATION: Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy|DRUG: Chemotherapy|RADIATION: Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy|DRUG: Chemotherapy
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 494
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-17
Completion Date: 2030-12
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.

Primary Outcome Measures: Locoregional recurrence-free survival, locoregional progression free survival, 3-year
Secondary Outcome Measures: Overall survival, overall survival, 3-year|Distant metastasis free survival, Distant metastasis free survival, 3-year|Rate of acute radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0), Acute radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome., 3 months|Rate of late radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0)., Late radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome., 3-year|European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 Version 1.0 (EORTC QLQ-HN35 V1.0), The minimum and maximum values are 0 and 4 respectively. The higher scores mean a worse outcome., From baseline to 3 years post-radiotherapy|and National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Version 1.0 (NCI-PRO-CTCAE V1.0.), The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome., From baseline to 3 years post-radiotherapy
Kinematics of Movements Provoked by an Augmented Reality App
NCT Number: NCT06516120
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke|Healthy Aging
Interventions: BEHAVIORAL: RGS-app
Sponsor: Sint Maartenskliniek
Collaborators: Eodyne Systems S.L.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-13
Completion Date: 2024-12-01
Locations: Sint Maartenskliniek, Ubbergen, Gelderland, 6574 NA, Netherlands

Summary:
Introduction: Home-based rehabilitation has the potential to reduce healthcare costs. However, due to less supervision in the home situation, it is possible that movements are made incorrectly. Therefore it is important to gain insight in which movements are made with a home-based rehabilitation system and what effects instructions could have on these movements. The current study investigated these movements made by the Rehabilitation Gaming System (RGS) app, this app uses augmented reality to provoke upper limb movements.

Methods: 16 healthy elderly and 16 stroke survivors participate in this study. Each participant was invited to the rehabilitation clinic for a one time measurement of 1.5 hours. During this measurement, four therapy exercises and four games on the RGS-app are performed. Each game should provoke a similar movement as one of the therapy exercises. Participants start with performing the therapy exercises for two minutes each. Thereafter they receive a video instruction on how to perform one of the games of the RGS-app, and they will play this game for 2 minutes. Thereafter the group is randomized into two conditions. The first group receives the same video instruction, while the second group receives a personalized live instruction based on the first two minutes of playing. After the new instruction, participants will play the game for two minutes again. This is repeated for all four games. Both the order of the therapy exercises and RGS-app games are randomized. During the study, participants wear Inertial Measurement Units (IMU's).

Primary Outcome Measures: Average movement velocity, Average velocity of every 2-minute session. Velocity is measured at the hand relative to the sternum., Measured when using the RGS-app during the one-time measurement of 1.5 hours
Secondary Outcome Measures: Elbow mean angular velocity, Mean angular velocity in m/s of the elbow joint, Measured when using the RGS-app during the one-time measurement of 1.5 hours|Pelvis mean angular velocity, Mean angular velocity will be calculated in m/s of the pelvis joint, Measured when using the RGS-app during the one-time measurement of 1.5 hours|Elbow Range of motion, Range of motion in degrees of the elbow joint (0 degrees being fully stretched), Measured when using the RGS-app during the one-time measurement of 1.5 hours|Pelvis range of motion, Range of motion in degrees of the elbow joint (0 degrees meaning vertical), Measured when using the RGS-app during the one-time measurement of 1.5 hours
Stress and Well-being in Parents Raising Children With Diplegic Cerebral Palsy
NCT Number: NCT06516107
Acronym: CP
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stress|Diaplegia|Cerebral Palsy
Sponsor: Sinai University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-05
Completion Date: 2024-08-01
Locations: Sinai University, Ismailia, Egypt

Summary:
PURPOSE:

To estimate the relationships between the child, parents, and family factors and parent stress and QoL among parents of children with diplegic CP.

BACKGROUND:

Cerebral palsy (CP) is considered the primary reason of motor impairment among children worldwide. Compared to parents of typically developing children, parents of children with cerebral palsy (CP) experience higher levels of stress and reduced quality of life (QoL).

HYPOTHESES:

There is no relation between the level of functional impairment among children with diplegic CP and their parental stress and QOL.

RESEARCH QUESTION:

Is there a relationship between the level of functional impairment among children with diplegic CP and the degree of their parental stress and quality of life?

Primary Outcome Measures: Parental stress, Parental stress will be measured by the Arabic version of the parent stress index-short form (PSI-SF) . PSI-SF is a self-reported questionnaire with 36 items rated on a 5-point Likert scale (strongly agree or strongly disagree). The score of the measure ranged between 36 and 180, and a lower score indicates a better outcome., 1 day - one session
Secondary Outcome Measures: Quality of life of parents, Quality of life (QoL) will be measured by the family impact module (PedsQL) and quality-of-life inventory., 1 day - one session|Gross motor impairments, Gross motor impairments will be assessed via gross motor classification system, 1 day - one session
Controlling Anemia During Pregnancy: Sprinkles Versus IFA Tablets
NCT Number: NCT06516081
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anemia
Interventions: DIETARY_SUPPLEMENT: Micronutrient powder (Sprinkles®)
Sponsor: The Hospital for Sick Children
Collaborators: Heinz Endowments
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 480
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2005-09
Completion Date: 2008-08
Locations: Research and Evaluation Division, BRAC, Dhaka, 1212, Bangladesh

Summary:
'Very significant progress has been made but the job is less than half done' may summarise the efforts made to control vitamin A and iodine deficiency disorders. Unfortunately, in the case of iron deficiency, the most common nutritional deficiency in the world, the story is much worse. Among the population groups mostly affected by its associated anemia are pregnant women. In clinical trials, where the intake of daily doses of iron tablets has been ensured, it was shown that this intervention can prevent anemia. However, when this intervention has been implemented in non-research settings, it has had limited effect mainly due to associated side effects and lack of motivation bringing about low compliance. New effective strategies are thus needed to deliver iron and other micronutrients that would overcome the problem of low compliance. Micronutrient powders (MNPs) (Sprinkles®) are an innovative approach that delivers necessary micronutrients including iron and folic acid during pregnancy through home-based food fortification. The objectives of the current research proposal are to provide Sprinkles or iron and folic acid tablets to pregnant women in rural Bangladesh and compare outcomes including compliance and hematological status. If Sprinkles® are determined to be equivalent or better than the traditional iron and folic acid tablets, then the next step would be to determine the effectiveness of this new intervention.

Primary Outcome Measures: Hemoglobin concentration (g/L), Hemoglobin concentration, 24 weeks of gestation|Hemoglobin concentration (g/L), Hemoglobin concentration, 28 weeks of gestation|Hemoglobin concentration (g/L), Hemoglobin concentration, 32 weeks of gestation
Secondary Outcome Measures: Adverse effects, Questionnaire on nausea, vomiting and GI disturbances (heartburn and 'stomach' pain) and stool pattern (consistency and colour), Weekly during weeks 2-7 following study recruitment.|Adherence ., Questionnaire on adherence, Weekly during weeks 2-7 following study recruitment.|Acceptability of the interventions, Questionnaire on acceptability, Weekly during weeks 2-7 following study recruitment.
A Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
NCT Number: NCT06516068
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obstructive Hypertrophic Cardiomyopathy
Interventions: DRUG: HRS-1893
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-06
Locations: Fuwai Hospital Chinese Academy of Medical Sciences (CAMS), Beijing, Beijing, 100032, China

Summary:
The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy

Primary Outcome Measures: The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver, After 12 weeks of HRS-1893 treatment
Secondary Outcome Measures: Change in peak oxygen uptake (pVO2) and carbon dioxide ventilation equivalent (VE/VCO2), Baseline to Week 12|Change in LVEF, Baseline to Week 12|Change in LVOT-VTI, Baseline to Week 12|Change in LV-FS, Baseline to Week 12|Change in LV-GLS, Baseline to Week 12|Change in Rest LVOT-G, Baseline to Week 12|Change in Valsalva LVOT-G, Baseline to Week 12|Change in cardiac troponin, Baseline to Week 12|Change in NT-proBNP, Baseline to Week 12|Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS), Baseline to Week 12|Proportion of participants with ≥ 1 class improvement in NYHA Functional Class, Baseline to Week 12|Incidence and severity of any adverse events (AESI, SAE, TRAE, TEAE), Through study completion, an average of 68 weeks|plasma concentration of HRS-1893, Through study completion, an average of 68 weeks
Targeted Antimalarial Drug Administration for Seasonal Migrant Populations in Amhara Region, Ethiopia
NCT Number: NCT06516042
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Plasmodium Falciparum|Malaria
Interventions: DRUG: Dihydroartemisinin-piperaquine
Sponsor: PATH
Collaborators: Federal Minstry of Health of Ethiopia
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-29
Completion Date: 2024-12-31
Locations: Delello Farm Sites, Gondar, Metema District, Ethiopia

Summary:
The purpose of the study is to assess the effectiveness, feasibility, and acceptability of targeted drug administration for seasonal migrant populations in Metema District, Amhara Region, Ethiopia

Primary Outcome Measures: Plasmodium falciparum (Pf) parasite prevalence, Prevalence of Pf as determined by PCR at the end of the study, Up to 6 months|Feasibility of TDA, Feasibility of TDA measured through intervention coverage (% of participants treated among the total farm population) and cost effectiveness, Up to 6 months|Acceptability of TDA amongst farmworkers, farm-site owners, and local health authorities, Acceptability of TDA amongst farmworkers, farm-site owners, and local health authorities measured through drug adherence (% of participants completing the drugs as prescribed, as reported in the endline survey), survey response (self-reported values provided during endline survey), and qualitative interview data, Up to 6 months
Secondary Outcome Measures: Pf parasite prevalence in a subset of migrant farmworkers, Pf parasite prevalence measured in a subset of migrant farmworkers upon return to their home village in the western highlands, Up to 2 months|Safety and tolerability of TDA, Safety and tolerability of TDA measured through the incidence of adverse events and survey responses, Up to 6 months|Feasibility of enhanced case management through mobile clinics based on cost per case detected, A cost assessment of providing enhanced case management through mobile clinics, Up to 6 months|Feasibility and acceptability of enhanced case management through mobile clinics based on endline survey responses, Feasibility and acceptability of providing enhanced case management among the study team based on endline survey responses, Up to 6 months|Feasibility and acceptability of enhanced case management through mobile clinics based on qualitative interview data, Feasibility and acceptability of enhanced case management through mobile clinics based on information shared during qualitative interviews, Up to 6 months