pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
3D Printed Implant for Management of Gummy Smile Through VISTA Technique
NCT Number: NCT06473805
Acronym: VISTA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Management of Gummy Smile
Interventions: PROCEDURE: VISTA technique and 3D printed PMMA implant|PROCEDURE: VISTA technique and 3D printed PEEK implant
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-01-01
Locations: Faculty of Dentistry-Ain Shams University, Cairo, Egypt

Summary:
the most important esthetic concern for dental patients is excessive display of gingiva during smiling due to multiple causes e.g. hyperplasia of gingival, skeletal overgrowth of the anterior maxilla, altered passive eruption, maxillary alveolar tooth extrusion, short lip and lip hypermobility therefore accurate diagnosis of these factors is essential before treatment to ensure the most suitable approach is chosen. Maxillary overgrowth may cause sub nasal skeletal depression that lead to retraction of upper lip during smiling, causing gingiva display. The aim of this study is to describe an alternative technique to treat gingival smile with minimally invasive vestibular incision subperiosteal tunnel access (VISTA) to place 3D printed polymethylmethacrylate (PMMA)-based bone cement versus polyether ether ketone (PEEK) for lip repositioning.

Primary Outcome Measures: To measure amount of gingival display in different follow-up intervals, To measure amount of gingival display in millimeters in different follow-up intervals., at 1, 3, 6 and 12 months postoperatively
Secondary Outcome Measures: To evaluate patient satisfaction, To evaluate patient satisfaction by filling questionnaire, at 1, 3, 6 and 12 months postoperatively|to evaluate postoperative pain, to evaluate postoperative pain by visual analogue scale (from 0 to 10 score), at 1, 3, 6 and 12 months postoperatively
Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic Patients
NCT Number: NCT06473792
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Plaque
Interventions: OTHER: Probiotic Toothpaste
Sponsor: Kanza Tahir
Sex: ALL
Age: ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-04
Completion Date: 2024-07-15
Locations: Aga Khan University, Karachi, Sindh, 24700, Pakistan

Summary:
This study is set to determine the improvement in plaque levels utilizing Plaque Index Simplified scores in orthodontic patients using probiotic toothpaste and regular toothpaste.

It will further analyze the mean difference in oral hygiene scores between metal and ceramic brackets in regular toothpaste and probiotic toothpaste groups.

Primary Outcome Measures: Plaque Index Simplified, Number of sites with plaque/ Number of sites evaluated x 100, Before and three weeks after bonding|Gingival Index, Gingival Index measures gingival condition of the marginal and interproximal tissues (mesial, lingual, distal, facial) separately on the basis of 0 to 3 with 0=Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding., Before and three weeks after bonding
Ultrasound RF Data for Discriminating Between Benign and Malignant Ovarian Masses
NCT Number: NCT06473766
Acronym: RFDATA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ovarian Cancer
Interventions: DIAGNOSTIC_TEST: RF data extraction
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators: Samsung Medison
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-19
Completion Date: 2025-09-30
Locations: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, 00168, Italy

Summary:
Ultrasound imaging provides useful information for the characterization of ovarian masses as benign or malignant. The most accurate mathematical model to categorize ovarian masses is the IOTA ADNEX model.This model estimates the risk of malignancy and performs similarly to subjective assessment by an experienced ultrasound examiner for discriminating between benign and malignant adnexal masses. The ability of IOTA ADNEX to discriminate between benign and malignant masses is very good (area under the receiver operator characteristic curve 0.937 (95% CI: 0.915-0.954). The ADNEX model maintains its accuracy even in the hands of operators with different experience and training.

According to IOTA terminology, 13% of ovarian masses detected on ultrasound examination are classified as solid. Solid ovarian masses have a risk of malignancy of 60%-75%2 and the discrimination between benign and malignant in this morphological category is challenging. Additionally, it has been estimated that 30% (25/84; 95% CI 18 to 44%) of solid malignant ovarian masses are metastases from non-ovarian tumors. The discrimination between primary ovarian cancer and metastatic tumors in the ovary is also clinically important for planning adequate therapeutic procedures. It is worth exploring the predictive performance of the diagnostic tools in identifying ovarian masses with ultrasound solid morphology.

Preliminary data (unpublished) on radiomics analysis and ovarian masses provided that benign and malignant ovarian masses with solid morphology have different radiomics features in a monocentric retrospective study. However, no statistically significant differences have been observed between primary ovarian cancer and metastases to the ovary.

A new technology is emerging in engineering ultrasound field: the analysis of ultrasound summed RF data- raw data generated by the interface of ultrasound beams with human tissues. To date, raw data are not utilized for conventional imaging and their eventual role in clinical practice is unknown. Indeed, summed RF data could better correlate with biological parameters then parameters identifiable in B-mode images. Summed RF data could also improve radiomic analysis.

Primary Outcome Measures: number of examinations readable, Feasibility measured as number of examinations readable, (i.e. number of patients with successful process with diagnosed solid ovarian masses, and acquisition of readable RF data), 30 minutes
Pelvic Floor Disorders in Multiple Sclerosis Patients
NCT Number: NCT06473753
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-10-01

Summary:
Primary objective

1. Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS
2. Impact of sphincter disorders on quality of life in patients with MS by using correlation between Extended Disability Status Scale (EDSS)and The Incontinence Quality of Life Questionnaire (IQOL)

Secondary objectives

-Studying the effect of low frequency rTMS on bladder symptoms in patients with MS.

Primary Outcome Measures: Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS though applying specific related scales, Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS though applying specific related scales, Baseline
Secondary Outcome Measures: Motor evoked potential using TMS with parameters gained using single pulse paradigm, Motor evoked potential using TMS with parameters gained using single pulse paradigm effect on sphincter distrubance in multiple sclerosis., Baseline
The Endovascular Plus GENe Therapy Versus Only EndoVascular Therapy for Severe Limb ischaemiA Trial
NCT Number: NCT06473740
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Severe Lower Limb Ischemia
Interventions: DRUG: Deoxyribonucleic acid supercoiled plasmid pCMV-VEGF165 (Neovasculgen)
Sponsor: Amur State Medical Academy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 386
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2029-05-19
Locations: Amur State Medical Academy, Blagoveshchensk, Amur, 675001, Russian Federation

Summary:
GENEVA is the world's first multicenter, randomized, prospective, controlled trial of the clinical effectiveness of best endovascular treatment versus best endovascular treatment combined with gene therapy for severe lower limb ischemia (Rutherford categories 4 and 5). The researchers hypothesized that the combination treatment would significantly reduce the number of re-interventions on the operated segment and high amputations, and also significantly increase the time interval between re-interventions.

Primary Outcome Measures: Numper of participants with freedom from repeated interventions on the operated segment, the need for re-intervention on the operated segment will be determined based on the clinical data (return of severe ischemia of the operated limb) together with ultrasound and/or computed tomography data; counting the number of re-interventions in the study group, within 2 years after the intervention|Numper of participants with freedom from high amputations, amputations will be performed in patients with the development of gangrene of the lower limb; counting the number of high amputations in each study group, within 2 years after the intervention
Secondary Outcome Measures: amputation-free survival, database data, within 2 years after the intervention|overall survival, database data, within 2 years after the intervention|time to major amputation, database data, within 2 years after the intervention|time to MALE (Major adverse limb event ), database data, within 2 years after the intervention|time to MACE (Major adverse cardiovascular event ), database data, within 2 years after the intervention|change time in pain-free walking distance, database data, within 2 years after the intervention|safety assessment - monitoring for serious adverse events throughout the study after the first drug administration, according to the researchers and the monitor, within 2 years after the intervention|Number of participants with mortality, database data, within 30 days after the first revascularization|VAS(Visual Pain System) pain reduction from 0 to 10, where 0 - no pain and 10 - very strong pain, database data, within 2 years after the intervention|Dynamics of ulcerchealing in diabetic foot syndrome according to the PEDIS classification (Perfusion, Extent, Depth, Infection, Sensation), database data, within 2 years after the intervention|Hemodynamic measurements (ankle brachial index changes), database data, within 2 years after the intervention
Evaluation of the Initial Color Match of Different Single-shade Composites
NCT Number: NCT06473727
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Diseases
Interventions: OTHER: Omnichoroma|OTHER: Charisma Topaz One
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-05-24
Completion Date: 2024-06-16
Locations: Faculty of Dentistry, Erciyes University, Kayseri, 38280, Turkey

Summary:
The aim of this study was to evaluate the initial colour match of anterior non-carious cervical lesions restored with different single-shade resin composites, namely Omnichroma (Tokuyama) and Charisma Topaz One (Kulzer).

Primary Outcome Measures: Color assesment, The color match of all restorations was evaluated with a spectrophotometer.The values of the coordinates L\*, a\* and b\* in the middle third of the tooth before the restorations and after 24 hours in the middle third of the restorations were evaluated using a digital spectrophotometer. The colour difference (ΔE00) was calculated using an Excel spreadsheet with parametric factors set to 1., 24 hours
Effects of Transcranial Direct Current Stimulation (tDCS) on Inhibition and Brain Function in Primary Progressive Aphasia
NCT Number: NCT06473714
Acronym: Stim-APHA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aphasia, Primary Progressive
Interventions: DEVICE: tDCS|DEVICE: SHAM
Sponsor: Centre Hospitalier Universitaire de Nice
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-01

Summary:
Primary progressive aphasia (PPA) is a focal dementia characterized by primary impairment of language abilities and functional disturbances associated with language.

Although PPA is a progressive disorder, new techniques are being proposed to try to activate parts of the brain previously thought to be potentially inactive, due to the possibility of "neuroplasticity". This concept refers to our brain's modularity and learning potential. Transcranial direct current stimulation is a powerful neuromodulatory technique, in which a small current is applied to the participant's scalp through the targeted positioning of an anode and a cathode. The positive or anodal stimulation of tDCS is supposed to increase neuronal activity under the electrode, while cathodal stimulation is supposed to do the opposite.

This project will provide new insights into the nature of the neural activity underlying executive functions in people with primary progressive aphasia compared to those without. The investigators expect to find reduced amplitude of electrophysiological responses and lower accuracy in people with primary progressive aphasia compared with healthy controls. Given the results of previous studies showing the efficacy of tDCS protocols in the treatment of aphasia, the investigators might expect them to improve executive functions. If so, the investigators expect significantly greater electrophysiological responses after stimulation sessions compared with sham conditions. This project is of great clinical relevance. This research will improve current therapeutic protocols used in the treatment of PPA by providing critical findings on whether and how the use of tDCS improves executive functions. Crucially, the research will advance knowledge of executive function decline as a sensitive marker of PPA, informing us about the possibility of early detection of this disorder. At the same time, the investigators will analyze the possibility of controlling symptomatological evolution via the analysis of acoustic and vocal markers. This will enable us to observe the evolution of sensory markers such as acoustic markers according to symptomatological evolution. This will enable us to check whether acoustic markers correlate with the patient's level of symptomatological impairment and/or pathological physiological data.

Primary Outcome Measures: Flanker task, 6 week|Stroop task, 6 week
The DEXTER-assisted Non-Emergent and Acute cholecyStecTomy Study (The NEST Study)
NCT Number: NCT06473688
Acronym: NEST
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cholecystectomy
Interventions: PROCEDURE: Cholecystectomy
Sponsor: Distalmotion SA
Collaborators: confinis AG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-21
Completion Date: 2024-11
Locations: Groupe Hospitalier Saintes - Saint-Jean-d'Angély, Saintes, 17100, France|Universitätsklinikum Bonn, Bonn, 53127, Germany|Kantonsspital Winterthur, Winterthur, 8401, Switzerland|Klinik Hirslanden Zürich, Zürich, 8032, Switzerland

Summary:
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic cholecystectomy.

Primary Outcome Measures: primary safety endpoint, occurrence of Clavien - Dindo grades III-V adverse events, up to 30 days|primary performance endpoint, successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach, intraoperative
Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System (The HYPER Study)
NCT Number: NCT06473675
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hysterectomy
Interventions: PROCEDURE: Hysterectomy with adnexal surgery
Sponsor: Distalmotion SA
Collaborators: confinis AG
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2025-01
Locations: Groupe Hospitalier Saintes - Saint-Jean-d'Angély, Saintes, 17100, France|Inselspital Bern, Bern, Switzerland

Summary:
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.

Primary Outcome Measures: primary safety endpoint, occurrence of Clavien - Dindo grades III-V adverse events, up to 42 days|primary performance endpoint, successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach, intraoperative
Study to Evaluate the Safety and Efficacy of Oral Insulin Formulation in Type 2 Diabetes Mellitus Subjects
NCT Number: NCT06473662
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Type 2 Diabetes Treated With Insulin
Interventions: DRUG: Oral insulin
Sponsor: Roger New
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-10-22
Completion Date: 2020-07-11
Locations: Diabetology, London, NW1 0NH, United Kingdom

Summary:
The aim of the study was to compare the pharmacodynamic properties of different doses of regular human insulin administered in capsule form twice daily in a randomised twelve-week open-label trial.

Primary Outcome Measures: Fall in HbA1c, Fall in HbA1c, 12 weeks
Secondary Outcome Measures: Change in Fasting Plasma Glucose, Change in Fasting Plasma Glucose, 12 weeks|Change in Post-Prandial Glucose, Change in Post-Prandial Glucose, 12 weeks|Changes in Lipids, Change in plasma cholesterol and triglyceride, 12 weeks
Mindfulness Training Improves Emotions Among Female Abdominal Cancer Patients
NCT Number: NCT06473636
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mindfulness Training
Interventions: BEHAVIORAL: Mindfulness training
Sponsor: Zunyi Medical College
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2021-08-01
Completion Date: 2024-05-30
Locations: Zunyi Medical University, Zunyi, Guizhou, 563000, China

Summary:
We first explored the effect of mindfulness training on depression in patients with abdominal cancer. Then the effects of cognitive emotion regulation and emotional state in the training effect were examined. Sixty patients with abdominal cancer were recruited from a hospital and divided into two groups: the mindfulness group (n=30) who received a four-week mindfulness training program, and the control group (n=30) who received only one mindfulness lecture. All participants were assessed using the Mindful Attention Awareness Scale, Cognitive Emotion Regulation Strategy Questionnaire, Positive and Negative Affect Scale, and depression subscale of the Patient Health Questionnaire before and after the mindfulness training program.

Primary Outcome Measures: The change from baseline Mindful Attention Awareness Scale at post-training, It contains 15 items in a single dimension. All of the items are rated on a 7-point Likert scale from 1 ("strongly agree") to 7 ("strongly disagree"). Higher scores reflect a higher level of trait mindfulness and awareness of the present moment., Baseline (Day 0)/Post-training (Month 1)|The change from baseline Patient Health Questionnaire at post-training, Its depression subscale consists of 9 items. All of the items are rated on a 4-point Likert scale from 1 ("strongly disagree") to 4 ("strongly agree"). Higher scores indicate a greater level of depression., Baseline (Day 0)/Post-training (Month 1)|The change from baseline Cognitive Emotion Regulation Questionnaire at post-training, It consists of 36 items and nine subscales. These subscales assess various strategies employed in cognitive emotion regulation, such as self-blame, blaming others, acceptance, refocus on planning, positive refocusing, rumination or focus on thought, positive reappraisal, putting into perspective, and catastrophizing. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). Higher scores on each subscale indicate a greater likelihood of utilizing that particular cognitive emotion regulation strategy in the face of negative events., Baseline (Day 0)/Post-training (Month 1)|The change from baseline Positive and Negative Affect Scale at post-training, It contains 20 items and consists of two self-report subscales including positive emotions and negative emotions. All of the items are rated on a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). The higher the score, the stronger the emotions in a certain dimension., Baseline (Day 0)/Post-training (Month 1)
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder
NCT Number: NCT06473623
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder
Interventions: DEVICE: vagus nerve stimulation
Sponsor: Neuropix
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-09
Completion Date: 2025-09

Summary:
Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder

Primary Outcome Measures: Feasibility for completed treatments and stimulation intensity tolerance, Completion success and neurostimulation tolerance, 1 month
Secondary Outcome Measures: Clinician Global Clinical Impression (CGI-I), For core social impairment and overall level of cognitive, adaptive and social functioning, 1 month|Clinician Global Impression Severity (CGI-S), For assessment of anxiety, gastrointestinal symptoms and social interactions and overall ASD, 1 month|Parent-Rated Anxiety Scale for ASD (PRAS-ASD), For anxiety assessment consisting of 25 questions related to anxiety ranging from 0 (none) to 3 (severe), 1 month|Autistic Behavior Checklist (ABC) scores, For measurements of 5 behavioral domains including irritability, social withdrawal, stereotypy, hyperactivity and inappropriate speech, 1 month
Residual Embolism Evaluated With Single Photon Emission Computed Tomography
NCT Number: NCT06473610
Acronym: RESPECT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulmonary Circulation Obstruction
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 358
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-27
Completion Date: 2026-04
Locations: Centre Hospitalier Universitaire, Saint-Étienne, 42055, France

Summary:
Major progress achieved in diagnostic and therapeutic strategies has substantially improved the short-term prognosis of patients with pulmonary embolism (PE). These improvements have led to a shift from an acute to a chronic condition of venous thromboembolism, justifying the recent development of Chronic Thrombo-embolic Disease (CTED). In most of the situations, it is due to a residual pulmonary vascular obstruction (RPVO) which can be assessed by pulmonary scintigraphy.

Primary Outcome Measures: RPVO (%), Evaluation of the RPVO establish with Meyer score (planar scintigraphy, 2D). The higher the percentage, the greater the obstruction of the lung, At inclusion|Segmental visual score, Evaluation of segmental visual score (SPECT-CT , 3D) The higher the percentage, the greater the obstruction of the lung, At inclusion
Study of the Prevalence of Diabetes and Pre-diabetes in Réunion Island
NCT Number: NCT06473584
Acronym: PREVADIABRUN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes
Interventions: DIAGNOSTIC_TEST: Diabetes detection
Sponsor: Centre Hospitalier Universitaire de la Réunion
Collaborators: Agence Régionale de Santé de La Réunion
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2025-12

Summary:
In view of the new priority given to diabetes in Réunion and the implementation of an ambitious plan to combat the disease at regional level, which includes the identification and management of pre-diabetes, the need for up-to-date data on the extent of these 2 diseases (diabetes and pre-diabetes) has become essential.

These two diseases have known risk factors: age, overweight, obesity, high waist circumference, family history, hypertension, eating habits and physical activity, all of which form part of a risk score for developing diabetes: the Findrisk recommended by the Haute Autorité de Santé for identifying people at risk of diabetes. Given the specific population characteristics of Réunion compared with Finland, where this score has been validated, it would seem important to be able to measure these risk indicators in the population as a function of carbohydrate status in order to check that the proposed thresholds are appropriate for the population of Réunion.

Finally, cardiovascular risk has been described as early as the pre-diabetes stage. Given the young age of onset of diabetes in Réunion and the high proportion of diagnoses of diabetes made following the occurrence of a cardiovascular complication, the study of the prognosis of carbohydrate status on the occurrence of complications using the social security information system will be offered on a voluntary basis to study subjects (via a probabilistic social security link).

Primary Outcome Measures: Estimating the prevalence of glycaemic abnormalities (diabetes and pre-diabetes) in Réunion, Measurement of fasting blood glucose and blood glucose 2 hours after ingesting 75g of glucose (HGPO test) according to Haute Autorite de Sante (HAS) recommendations used in France for diagnosing diabetes and pre-diabetes in people with unknown diabetes, Day 1
Retrospective Evaluation of a Novel Biomimetic Synthetic Bone Substitute (Creos® Syntogain)
NCT Number: NCT06473545
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Tooth Loss|Partial-edentulism|Tooth Fracture|Edentulous Alveolar Ridge
Sponsor: International dentistry Research Group
Collaborators: Nobel Biocare
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 173
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-01
Completion Date: 2023-12-20
Locations: Cairó Franch Clinica Dental, Barberà del Vallès, Barcelona, 08210, Spain|Clínica Dental Altes Mesquida, Palma de Mallorca, Illes Balears, 07004, Spain

Summary:
Guided bone regeneration (GBR) is a commonly performed technique, using autogenous grafts, allografts, xenografts, or synthetic bone grafts (SBG). Advantages of an "off the shelf" substitute, available anytime with limitless fabrication capacity that avoids human, or animal associated morbidity provides SBG with a very positive future perspective. This data collection is to retrospectively evaluate the long-term clinical performance of a CE marked biomimetic SBG substitute in patients with implant placement related bone regeneration treatments up to 72 months of follow-up. The study hypothesis states that a biomimetic SBG is a verified graft choice to be used clinically in patients with implant placement related bone regeneration treatments such as socket preservation with a delayed implant placement, GBR simultaneous with immediate implant placement, and sinus lift elevation with lateral approach.

Primary Outcome Measures: Implant survival, Implant in place at any follow up visit, From final prosthesis delivery through study completion, up to 72 months.|Prosthesis survival, Prosthesis survival at any follow up visit, From final prosthesis delivery through study completion, up to 72 months.
Secondary Outcome Measures: Complications, Biological or technical complications related to implant or prosthetic function, From initial surgical procedure date (GBR or implant placement) through study completion, up to 72 months|Peri-implant evaluation, marginal bone loss, Peri-implant stability parameters evaluation (marginal bone loss) when available, From final prosthesis delivery through study completion, up to 72 months.|Peri-implant evaluation, soft tissue evaluation PES-WES score, Pink esthetic score, white esthetic score, when available, From final prosthesis delivery through study completion, up to 72 months.
Group A Streptococcus Saliva Study
NCT Number: NCT06473506
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Group A Streptococcal Infections
Interventions: DIAGNOSTIC_TEST: Saliva collection
Sponsor: The Hospital for Sick Children
Sex: ALL
Age: CHILD, ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-10
Completion Date: 2024-09-30
Locations: Siobhan Doria, Toronto, Ontario (ON), M5G1X8, Canada|The Hospital for Sick Children, Toronto, Ontario (ON), Canada

Summary:
This study is being done to evaluate whether saliva can be used to diagnose GAS infection and also to compare different testing methods in the microbiology lab. The saliva sample testing will be compared to the throat swab testing to see if saliva testing works as well. The lab will also try different testing methods to see if a faster type of testing (e.g. molecular testing) works as well as the regular method, which takes 48 hours to get results.

This is important because throat swabs can be challenging to collect in some children, and saliva is often much easier and more acceptable by children to collect. This could improve our ability to accurately diagnose and treat GAS infections.

Primary Outcome Measures: Rate and sensitivity of GAS detection, compare the rate and sensitivity of GAS detection by throat bacterial culture, throat molecular detection and saliva molecular detection according to a semi-quantitative value (quantified growth on bacterial culture or CT value for molecular assays), Within 24 hours of collection
Socioeconomic Behavior Changes During the Pandemic
NCT Number: NCT06473467
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pandemic, COVID-19|Sedentary Behavior
Sponsor: Istanbul University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 765
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-10
Completion Date: 2024-03-10
Locations: Şensu Dinçer, Istanbul, 34093, Turkey

Summary:
The goal of this observational study was to determine the changing shopping and movement habits of people during the period of March 2020- June 2021, when full and partial lockdown measures were in force due to the covid 19 outbreak in our country. in 500 adult participants. The main questions were:

* whether the increase in sedentaryism that occurred during the pandemic will persist after the pandemic ended?
* whether the socioeconomic behavior patterns that emerged during the pandemic period will persist after the pandemic?

Primary Outcome Measures: shopping habit (type), what type of shopping the participants did face to face and online.Shopping types are listed as Daily Materials (Grocery Shopping), Clothing, Electronics, Cosmetics - Personal Care products, Household goods - Furniture, Ready-made food (Food ordering at home) and Gifts - Toys., before the closure period (before March 2020), during the closure period up to 2 years (March 2020- June 2021) and after the closure period (June 2021-June 2023)|shopping habit (frequency), A 5-point Likert scale was used to determine shopping frequency, with questions ranging from 1 for Never; and 5 for always., before the closure period (before March 2020), during the closure period (March 2020- June 2021) and after the closure period up to 2 years (June 2021-June 2023)|sedantary score, Participants were asked about their weekly active exercise times, weekly non-exercise activity times and daily step counts, and after the evaluation and scoring made in line with the answers given, it was determined which of the participants were closer to the sedentary lifestyle and which were farther away from the sedentary lifestyle.It was evaluated that participants with a total score of "5" and below were more prone to sedentary life, while participants with a score of "7" and above were more prone to active life., before the closure period (before March 2020), during the closure period (March 2020- June 2021) and after the closure period up to 2 years (June 2021-June 2023)
Effects of Manual Therapy Techniques on Hamstring
NCT Number: NCT06473402
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Muscle Tightness|Muscle Spasm
Interventions: DIAGNOSTIC_TEST: Muscle Strength Test|DIAGNOSTIC_TEST: Hamstring Flexibility|DIAGNOSTIC_TEST: Knee Range of Motion|DEVICE: Percussion Therapy|OTHER: Manual Therapy Technique
Sponsor: Bezmialem Vakif University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-16
Completion Date: 2024-06-04
Locations: Bezmialem Vakif University, Istanbul, Turkey

Summary:
Hamstring shortness occurs in almost all populations worldwide, in both symptomatic and asymptomatic individuals. The causes of hamstring shortness include genetic factors, adaptation of the muscle to acute or chronic injury, sitting in a sitting position for a long time, etc. countable. Some studies have stated that decreased hamstring flexibility may cause patellar tendinopathy, patellofemoral pain, hamstring strain, and muscle damage after eccentric exercise.Therefore, the flexibility of the hamstring muscles must be maintained. The objective of current research is to contrast the immediate consequences of two distinct manual therapy methods applied to individuals with a short hamstring muscle on the said muscle.

Primary Outcome Measures: Hamstring Flexibility, Hamstring flexibility was measured with sit and reach test, Change from baseline to final examination immediate after 6 minutes of manual therapy
Secondary Outcome Measures: Hamstring Strength, Hamstring strength was measured with dynamometer, Change from baseline to final examination immediate after 6 minutes of manual therapy|Range of Motion, Knee flexion range of motion was measured with goniometer, Change from baseline to final examination immediate after 6 minutes of manual therapy
Comparison Between Hegab Splint, Arthrocentesis, and Arthroscopy in Treatment of TMJ Closed Lock
NCT Number: NCT06473376
Acronym: arthroscopy
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: TMJ Disorder|TMJ Disc Disorder
Interventions: PROCEDURE: arthrocentesis
Sponsor: Al-Azhar University
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-01-14
Completion Date: 2023-12-30
Locations: Al-Azhar UNIVERSITY, Cairo, Egypt|Prof.Hegab, Cairo, Egypt

Summary:
This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders.

Primary Outcome Measures: change in pain using a visual analog scale,, The primary outcome variable was the change in pain using a visual analog scale (VAS), with 0 indicating the absence of pain and 10 indicating the worst pain possible, one year|improvement of maximum voluntary mouth opening, improvement of maximum voluntary (non-assisted) mouth opening (MVMO) in millimetres., one year
Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability
NCT Number: NCT06473337
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Vitamin D Deficiency|Carotid Artery Diseases
Interventions: DIAGNOSTIC_TEST: Blood sample
Sponsor: Medical University of Vienna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 332
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-03-01
Completion Date: 2024-03-01
Locations: Department of General Surgery, Division of Vascular Surgery, Vienna, 1090, Austria

Summary:
Role of vitamin D in cardiovascular disease is controversial. Here the investigators aimed to investigate the association of vitamin D deficiency and carotid plaque morphology as well as outcome of participants with high-grade carotid artery stenosis undergoing carotid endarterectomy.

332 consecutive participants undergoing carotid endarterectomy for symptomatic or asymptomatic carotid artery stenosis, were prospectively included in the study, and vitamin D levels were determined prior to surgery using chemiluminescence-immunoassay.

Primary Outcome Measures: Vitamin D levels and its correlation with plaque vulnerability, Vitamin D levels and its correlation with plaque vulnerability is the primary outcome measurement. Serum 25-hydroxy-vitamin D is measured by the Liaison Total 25-Hydroxy-Vitamin D chemiluminescence immunoassay (CLIA) on Liaison XL immunology analyzers (DiaSorin, Saluggia, Italy., through study completion, an average of 1 year
Secondary Outcome Measures: Vitamin D levels and its correlation with cardiac outcome, Vitamin D levels and its correlation with cardia outcome is the secondary outcome measurement. Serum 25-hydroxy-vitamin D is measured by the Liaison Total 25-Hydroxy-Vitamin D chemiluminescence immunoassay (CLIA) on Liaison XL immunology analyzers (DiaSorin, Saluggia, Italy., through study completion, an average of 1 year
Association Between Preoperative Hyperglycemia and Postoperative Delirium in Geriatric Hip Fracture Patients
NCT Number: NCT06473324
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Postoperative Delirium|Hip Fractures|Hyperglycemia
Sponsor: Wenbo Ding
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2031
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-21
Completion Date: 2024-01-03
Locations: Dandong Central Hospital, Dandong, Liaoning, 118002, China

Summary:
This retrospective study aims to collect electronic medical record data from Dandong central hospital spanning from January 2013 to November 2023. The collected data does not contain any personally identifiable information or breach privacy. Additionally, this study design does not involve active intervention measures or patient recruitment. The research aims to investigate the correlation between preoperative blood glucose levels in elderly hip fracture patients and postoperative delirium.

Primary Outcome Measures: Number of Participants with Postoperative Delirium, Postoperative Delirium (POD) manifests as acute cognitive dysfunction and consciousness disorder, characterized by changes in attention or consciousness that cannot be attributed to pre-existing cognitive impairments. Typical symptoms include hallucinations, delusions, agitated behavior, disordered speech, decreased attention, confusion, unclear consciousness, and disrupted sleep-wake cycles. Moreover, POD typically occurs within the first five days after surgery, particularly within the initial 48 hours, and exhibits significant fluctuations., up to 2 months
Whole Body Vibration and Virtual Reailtry on Quadriceps Strength and Activity of Daily Living in Children With Burn
NCT Number: NCT06473311
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Whole Body Vibration|Virtual Reality
Interventions: DEVICE: whole bady vibration and virtual reality
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-10
Completion Date: 2024-06-17
Locations: Mostafa S Ali, Giza, Married, 12668, Egypt

Summary:
Burns are injuries that can have both local and systemic effects and are brought on by biological, chemical, electrical, and physical factors. Mobility is a significant problem for burn patients in terms of their quality of life since the burn injury affects their capacity to participate in activities of daily living. The immobility of the patient has a major impact on their physical health. The aim of current study was to compare between the effect of virtual reality and whole body vibration as two methods of proprioceptive stimulation on quadriceps strength and activity of daily living in children with burn.

Primary Outcome Measures: quadriceps strength, measurement of quadriceps power by Baseline Economy Mechanical Push/Pull, 2 months|activities of daily living, measurement od ADL by Physical Self Maintenance Scale. the score is 1 and zero the better score is 1, 2 MONTHS
Role of Light Tracking Intervention in Children With Spastic Hemiplegia
NCT Number: NCT06473298
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spastic Hemiplegic Cerebral Palsy
Interventions: OTHER: Visual Light Tracking
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-04-01
Locations: Cairo University, Cairo, 12613, Egypt

Summary:
The study aims to investigate the effect of visual light tracking on gait, selective motor control and sensory processing in children with spastic hemiplegic cerebral palsy.

Primary Outcome Measures: Effect of Visual light tracking intervention on quality of walking, selective motor control and sensory processing of the study group compared to control group with different intervention., The quality of walking as step length will be assessed using Kinovea software. Selective motor control will be assessed using Selective Control Assessment of the Lower Extremity (points).

Sensory processing will be assessed using the Sensory Proﬁle Caregiver Questionnaire(points)., Baseline
Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness
NCT Number: NCT06473285
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prolonged Disorders of Consciousness
Interventions: DRUG: Drug: Esketamine (Continuous infusion)
Sponsor: Beijing Tiantan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-01
Completion Date: 2025-05-30
Locations: Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China

Summary:
Prolonged disorders of consciousness (pDoC) are pathologies in which there is a loss of consciousness for more than 28 days. The number of patients with pDoC is increasing as the level of critical care treatment and monitoring improves. However, clinical trials for patients with pDoC are limited by small sample sizes, lack of placebo groups, and use of heterogeneous outcome measures. As a result, few therapies have strong evidence to support their use. In recent years, ketamine has been used with remarkable success in the treatment of neuropsychiatric disorders by inducing neuroplasticity, increasing neurophysiologic complexity, and expanding functional brain connectivity states. Considering increased brain plasticity as well as brain complexity, it may be beneficial for consciousness recovery. In this study, the investigators aimed to explore the effects of esketamine on brain networks and level of consciousness in patients with pDoC, and to discuss its possible use as a wakefulness-promoting treatment for patients with pDoC.

Primary Outcome Measures: Entropy index., A higher entropy index indicates a higher brain complexity., During the trial(up to 3 hours for each subject).|Lempel Ziv complexity., Higher Lempel Ziv complexity indicates higher brain complexity., During the trial(up to 3 hours for each subject).
Secondary Outcome Measures: EEG Spectral Characteristics, EEG power spectrum characteristics of pDoC patients under esketamine. administration, including the δ, θ, α, β, and γ frequency bands., During the trial(up to 3 hours for each subject).|Cortical Connectivity, Characteristics of the weighted phase lag index(WPLI) in patients with pDoC. 0 ≤ WPLI ≤ 1, where 0 represents asynchronous and 1 represents synchronous., During the trial(up to 3 hours for each subject.|Rate of patients recovered consciousness after surgery, Rate of patients recovered consciousness 30 days, 90 days, 180 days after surgery., During the trial(through study completion, 180 days).
Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients
NCT Number: NCT06473259
Acronym: ECHOS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer|Hormone Sensitive Prostate Cancer|Metastatic Tumor
Interventions: DRUG: Docetaxel|DRUG: Apalutamide Oral Tablet|DRUG: Enzalutamide Oral Tablet|DRUG: Abiraterone acetate tablets|DRUG: Darolutamide Oral Tablet|RADIATION: radiotherapy|DRUG: Triptorelin
Sponsor: Santa Chiara Hospital
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-12-16
Completion Date: 2028-12
Locations: Azienda Ospedaliera San Luigi, Orbassano, Torino, 10043, Italy|Istituto Oncologico Veneto, Padova, 35128, Italy|Santa Chiara Hospital, Trento, 38122, Italy

Summary:
The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical practice

Primary Outcome Measures: progression free survival, the projected rate over the time of patients without progressive disease, From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Secondary Outcome Measures: overall survival, the projected rate over the time of alive patients, From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Other Outcome Measures: rate of patients with an objective response, rate of patients who experienced a reduction of at least 30% of measurable lesions, through study completion, an average of 2 year