pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
PAP Systems External Clinical Studies (ECS)
NCT Number: NCT06562205
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea
Interventions: DEVICE: PAP System A (with Amalfi) then PAP System B (with CLA11)|DEVICE: PAP System B (with CLA11) then PAP System A (with Amalfi)
Sponsor: ResMed
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2025-03
Completion Date: 2025-07

Summary:
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.

Primary Outcome Measures: (usability) Comparison of the usability of an investigational component/s of the PAP system to a comparison component/s of the PAP system and/or Criterion Score of 6, Hypothesis: The investigational component/s of the PAP system will be equivalent to the comparison component/s of the PAP system and/or Criterion Score of 6

Subjective usability scores will be collected from participants on each usability item (e.g., comfort, seal, ease of use). Scores will be collected using an 11-point Likert Scale where a score of 10 is considered very favorable, and a score of 0 is very unfavorable, 6 weeks|(efficacy) Comparison of the investigational component/s of the PAP system efficacy (AHI) to a comparison component/s of the PAP system and/or clinically relevant data, Hypothesis: The investigational component/s of the PAP system will be equivalent to the comparison component/s of the PAP system and/or clinically relevant data

Objective data stored in the CPAP device will be downloaded wirelessly using a computer program (AirView or ResScan, ResMed). An Apnea hypopnea index (AHI) automatically analyzed by the program will be used. Typically, an AHI \<5 demonstrates efficacious treatment., 6 weeks
Online Adaptive Radiotherapy for Cervical Cancer
NCT Number: NCT06562166
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cervical Cancer
Interventions: RADIATION: online adaptive radiotherapy
Sponsor: Peking Union Medical College Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-05-01

Summary:
This study aims to evaluate the clinical efficacy and safety of online adaptive radiotherapy for cervical cancer patients received radical radiotherapy. By comparing with image-guided radiotherapy, the study explores the potential advantages of online adaptive radiotherapy in reducing treatment toxicity and improving local control.

Primary Outcome Measures: Acute non-hematological toxicity, Acute non-hematologic toxicities include gastrointestinal and genitourinary toxicities, which will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., From the start of treatment until 3 months later
Secondary Outcome Measures: treatment response, Treatment response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., 3 months after completion of treatment
fMRI Accelerated TMS Depression
NCT Number: NCT06562153
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Depression
Interventions: OTHER: Neuroimaging with Magnetic Resonance Imaging (MRI)
Sponsor: Medical University of South Carolina
Collaborators: Foundation for the Advancement of Clinical TMS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-26
Completion Date: 2026-08-05

Summary:
This study aims to investigate whether phenotypic-related brain states revealed by a novel INSCAPE ("Individualized Network-based Single-frame Coactivation Pattern Estimation") neuroimaging method in Major Depressive Disorder (MDD) patients can track brain recovery of MDD patients over an accelerated antidepressant transcranial magnetic stimulation (TMS) treatment.

Primary Outcome Measures: Dynamic brain state change after 5-day transcranial magnetic stimulation (TMS) treatment compared to baseline, Two magnetic resonance imaging (MRI) scans will be collected at baseline and after the course of 5-day TMS treatment. A neuroimaging analysis method called "INSCAPE" will be used to get the dynamic brain state from the MRI data. The changes in brain states between baseline and after treatment MRI data will be calculated as the outcome measure., 5 days
Multidimensional Examination of Patients With Colorectal and Anal Cancer
NCT Number: NCT06562140
Acronym: MECACP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colorectal Cancer|Anal Cancer|Physical Inactivity|Fecal Incontinence|Quality of Life
Interventions: OTHER: No intervention - cross-sectional observational study
Sponsor: University of Pecs
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-09-01
Locations: University of Pécs, Pécs, Baranya, 7621, Hungary

Summary:
The aim of our cross-sectional research is to assess changes in physical activity, functional capacity, and health status in individuals with colorectal and anal carcinoma using subjective measurement tools, with particular focus on those suffering from incontinence, through a cross-sectional study. Additionally, the research involves the Hungarian adaptation and validation of the quality of life questionnaire for colorectal cancer (EORTC QLQ-CR29), quality of life questionnaire for anal cancer (EORTC QLQ-AN27), and Fecal Incontinence Severity Index (FISI)" questionnaires.

Primary Outcome Measures: Quality of life questionnaire for cancer patients - EORTC QLQ-C30, The EORTC QLQ-C30 questionnaire examines the general impact of cancer and its treatment. The minimum value is 30, maximum 120, where higher scores means worse health-related quality of life., Baseline|Quality of life questionnaire for colorectal cancer - EORTC QLQ-CR29, The EORTC QLQ-CR29 questionnaire assesses the general impact of cancer and its treatment among colorectal cancer patients. The minimum value is 29, maximum 116, where higher scores means worse health-related quality of life, Baseline|Quality of life questionnaire for anal cancer - EORTC QLQ-AN27, The EORTC QLQ-CR29 questionnaire assesses the general impact of cancer and its treatment among anal cancer patients. The minimum value is 27, maximum 108, where higher scores means worse health-related quality of life, Baseline|Global Physical Activity Questionnaire (GPAQ), To measure physical activity patterns related to work, active transportation, leisure time activities and sitting time. The work time physical activity, active transportation, recreational activities and sitting time will be summarized as weekly minutes., 1 week|FECAL INCONTINENCE SEVERITY INDEX (FISI), The questionnaire measures the frequency of the different incontinence events and the type of stool involved. The index provides a numerical score that reflects the overall severity of a patient's fecal incontinence. A total score is the sum of all points between 0 to 61, where the higher the score means more severe fecal incontinence., Baseline
Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees
NCT Number: NCT06562101
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee
Interventions: PROCEDURE: Intra-articular Stromal Vascular Fraction Injection
Sponsor: Shu-Hao Chang, MD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-12-04
Completion Date: 2022-06-30
Locations: Fu Jen Catholic University Hospital, New Taipei City, 24352, Taiwan

Summary:
Background: Osteoarthritis (OA) is a prevalent form of arthritis worldwide. Intra-articular stromal vascular fraction (SVF) injections are a potential therapeutic option for patients with OA. This study aims to assess the effects of intra-articular SVF injections on knee OA. Methods: Ten patients with knee OA participated in this study. After being administered intra-articular SVF injections, their outcomes were evaluated using various questionnaires. MRI T2 mapping was conducted and compared before the intervention and 6 months after. All data underwent analysis using various tests.

Primary Outcome Measures: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), range from 0-96, with higher scores indicating greater OA-related disability, Baseline and at 3 and 6 months post-intervention|Knee Injury and Osteoarthritis Outcome Score (KOOS), 5 items, ranging from 0-96, with higher scores indicating worse life quality related to OA, Baseline and at 3 and 6 months post-intervention|Visual Analogue Scale (VAS), range from 0-10, with higher scores indicating increased degree of pain, Baseline and at 3 and 6 months post-intervention|Magnetic resonance imaging (MRI), included T2 mapping, Baseline and 6 months after the intervention
A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Intense Strong
NCT Number: NCT06562075
Acronym: DAG-ISJ
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Jawline Contour Deficit
Interventions: DEVICE: Decoria Intense Strong
Sponsor: Bohus Biotech AB
Collaborators: Key2Compliance AB
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-09
Locations: Inskinity, Göteborg, 411 07, Sweden|Göteborg Laser & Estetik, Göteborg, 411 08, Sweden|Svenska Hudkliniker, Karlstad, 652 25, Sweden|Inskinity, Stockholm, 111 28, Sweden|Florakliniken, Stockholm, 113 28, Sweden|The Faculty, Stockholm, 114 46, Sweden|Svenska Hudkliniker, Stockholm, Sweden

Summary:
A post-market Follow up clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile.

Primary Outcome Measures: Primary efficacy endpoint, The primary efficacy endpoint is the blinded-evaluator assessment of improvement using the Global Aesthetic Improvement Scale (GAIS). GAIS is a comparative scale, based on assessment of change since before pre-intervention, ranges from 1 (exceptional improvement) to 4 (no change) and 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in the jawline according to the GAIS grading. Each side (left and right) will be assessed independently., From pre-intervention baseline, at Visit 3 (3 months post baseline).|Primary safety endpoint, The primary safety endpoint is to assess the safety of Decoria® Intense Strong, evaluated by the incidence, intensity, duration, and time of onset of related AEs, including injection site reactions, collected during the study duration., From baseline to end of study (9 months)
Secondary Outcome Measures: Secondary endpoint, 1. Pain will be measured by numerical scale Numeric Pain Rating Scale (NRS) (11-point verbal score completed for each target region treated) for each visit involving an injection., From baseline to visit 2 (1 month optional touch-up)|Secondary endpoint, 2. GAIS score at 3 months, and 9 months post-treatment, as assessed by the treating investigator., 90 days respectively 270 days after IMD injection|Secondary endpoint, 3. GAIS score at 3 months, and 9 months post-treatment, as assessed by the subject., 90 days respectively 270 days after IMD injection|Secondary endpoint, 4. Treatment related adverse events and injection site reactions reported after touch-up should be similar to those reported after initial treatment., 30 days between visit 1 and visit 2|Secondary endpoint, 5. Change in jawline contour compared to baseline will be measured after treatment, as well as at 1-month, 3-months, and 9-months post-treatment visits., 30 days, 90 days and 270 days post-treatment
Radiological Outcomes of Modified Extra-articular LCL
NCT Number: NCT06562062
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Adult Acquired Flexible Flatfoot Deformity After Failure of Conservative Treatment
Interventions: PROCEDURE: Extra-articular Lateral Column Lengthening Procedure
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-16
Completion Date: 2028-02
Locations: Faculty of medicine assiut university, Assiut, Assiuu, Egypt

Summary:
To assess radiological and functional outcomes of modified extra-articular lateral column lengthening procedure for correction of adult acquired flexible flatfoot deformity

Primary Outcome Measures: Radiological outcome & by standard erect plain x ray after 3 months, Measurement of

1. Calcencal pitch : this angle is formed on a weight-bearing lateral foot radiograph between the calcaneal Inclination axis and the supporting horizontal surface , correction angle needed ≈ 15-25°.
2. Meary's angle: It is the angle between a line drawn along the longitudinal axis of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) , correction angle needed ≈ 0-1°.
3. lateral talocalceneal angle : the angle between the calcaneal inclination axis and the mid-talar axis correction angle ≈ 25 and 40° .
4. Talonavicular coverage angle: it is the medial angle between ( talar head articular surface and Proximal navicular articular surface, 3 months after the surgery
Secondary Outcome Measures: clinical outcome by American orthopedic foot and ankle score (hindfoot, 6 months after the surgery when the patient restore his life activities maximally
Carpal Bone Erosion in Rheumatoid Arthritis :Diagnostic Value
NCT Number: NCT06562049
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rheumatoid Arthritis
Interventions: RADIATION: musculoskeletal ultrasound
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-10-01
Locations: Sohag University hospitals, Sohag, Egypt

Summary:
Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by proliferative hyper vascularized synovitis which primarily affects synovial joints. Synovium of bursa; tendon sheaths; attachment sites of cartilage, ligament, and tendons to the bone; soft tissue; and bones can be mentioned among the other areas under influence of RA. Changes happen to be symmetrical and may present as fusiform soft tissue swelling, regional osteoporosis, marginal-central erosions, cartilage damage, joint destruction, narrowing of joint space and fibrous ankyloses. Wrist, metacarpophalangeal and metatarsophalangeal joints are the first sites to be affected .Over the past few years, an increasing number of rheumatologists have started to use US in the clinical setting of the early arthritis clinic. While US allows for an accurate and non-invasive multisite assessment of joint involvement in patients with RA, time for US examination is not infinite

Primary Outcome Measures: bone erosion, erosions in carpal bones and MCP 2,5 in both hands, max 1 year
Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children
NCT Number: NCT06562036
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Persistent Pulmonary Hypertension of the Newborn
Interventions: DRUG: Sildenafil|DRUG: Milrinone
Sponsor: Muhammad Aamir Latif
Sex: ALL
Age: CHILD
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2024-05-31
Locations: Children's Hospital and institute of Child Health, Multan, Punjab, 60000, Pakistan

Summary:
Neonates with persistent pulmonary hypertension (PPH) should be administered inhaled nitric oxide (iNO) and extracorporeal membrane oxygenation (ECMO), but these are not available in most resource-constrained settings like ours. This study was planned to compare the outcomes of Milrinone plus Sildenafil versus Sildenafil alone in the treatment of PPH in neonates.

Primary Outcome Measures: Change in pulmonary artery systolic pressure, Efficacy was labeled yes if there was adecrease in pulmonary artery systolic pressure (PASP), 72 hours
Botulinum Toxin and Mesotherapy on Enhancement of Facial Scarring
NCT Number: NCT06562023
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Facial Scars
Interventions: OTHER: Botulinum Toxin Type A|OTHER: Mesotherapy
Sponsor: Hams Hamed Abdelrahman
Sex: ALL
Age: ADULT
Enrollment: 33
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-19
Completion Date: 2024-07-20
Locations: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt

Summary:
Most of the body's tissues can undergo wound repair following a disruption of tissue integrity. Upon healing, these wounds result in scar formation. The scars widen when the overlying musculature pulls apart suture lines. Botulinum Toxin A (BTA) is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis. Also, mesotherapy is the non-invasive transdermal injection which can aid the skin to increase collagen and elastin production. Thus, both techniques are eligible for enhancement of facial scars.

Primary Outcome Measures: Change in scar appearance, The Vancouver Scar Scale (VSS) will be measured to calculate scar appearance. The VSS evaluates four indicators: vascularity, pigmentation, pliability, and height. It has a score ranging from 0-13.

* Vascularity: Normal 0, Pink 1, Red 2, Purple 3
* Pigmentation: Normal 0, Hypopigmentation 1, Hyperpigmentation 2
* Pliability: Normal 0, Supple 1, Yielding 2, Firm 3, Ropes 4, Contracture 5
* Height: Flat (0), \< 2 mm (1), 2-5 mm (2), \> 5 mm (3), Baseline, 1 month, 3 months, 6 months|Change in wound width, The mean wound width will be measured using a graduated Vernier caliper, Baseline, 1 month, 3 months, 6 months
Enhancing Thoracolumbar Burst Fracture Treatment
NCT Number: NCT06561997
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Surgery
Interventions: DEVICE: Robot-assisted|DEVICE: Free-hand
Sponsor: Peng Liu
Sex: ALL
Age: ADULT
Enrollment: 182
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-04-01
Completion Date: 2020-06-30
Locations: "Tianji" 3rd generation orthopedic robot, Chengdu, Sichuan, 610041, China

Summary:
The optimal treatment for neurologically intact thoracolumbar fractures remains controversial. Percutaneous pedicle screw fixation (PPSF) has been proposed for these fractures; however, achieving satisfactory reduction can be challenging. This study applied robot-assisted PPSF to enhance treatment outcomes.

Primary Outcome Measures: The height of sagittal kyphosis, The height of sagittal kyphosis of the injured vertebral body, One week post-surgery|The Cobb's angle of sagittal kyphosis, The Cobb's angle of sagittal kyphosis of the injured vertebral body, One week post-surgery|The height of sagittal kyphosis, The height of sagittal kyphosis of the injured vertebral body, One-year post-surgery|The Cobb's angle of sagittal kyphosis, The Cobb's angle of sagittal kyphosis of the injured vertebral body, One-year post-surgery
Secondary Outcome Measures: Visual Analogue Scale (VAS) score, Visual Analogue Scale (VAS; out of a total score of 10, 0 corresponds to no pain and 10 refers to unbearable pain), One week post-surgery|Visual Analogue Scale (VAS) score, Visual Analogue Scale (VAS; out of a total score of 10, 0 corresponds to no pain and 10 refers to unbearable pain), One-year post-surgery|Oswestry Disability Index (ODI) score, Oswestry Disability Index (ODI; the questionnaire is composed of 10 aspects for pain, self-care, extraction, walking, sitting, standing, sleeping, sexual life, social life, and tourism, with 0-5 points for each item. 0% scores corresponded to normal function and 100% corresponded to severe dysfunction), One week post-surgery|Oswestry Disability Index (ODI) score, Oswestry Disability Index (ODI; the questionnaire is composed of 10 aspects for pain, self-care, extraction, walking, sitting, standing, sleeping, sexual life, social life, and tourism, with 0-5 points for each item. 0% scores corresponded to normal function and 100% corresponded to severe dysfunction), One-year post-surgery
Effect of Antenatal Education on Knowledge,Attitude and Preferences Taward Delivery Modes
NCT Number: NCT06561984
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Antenatal Education|Modes of Delivery
Interventions: BEHAVIORAL: antenatal education
Sponsor: Mansoura University
Sex: FEMALE
Age: ADULT
Enrollment: 140
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2025-03
Locations: Mansoura University, Mansoura, Egypt

Summary:
The aim of the current study is to assess the effect of antenatal education on pregnant women's knowledge, attitude, and preferences of delivery mode.

Primary Outcome Measures: Structured Interviewing Questionnaire., This tool was designed by the researcher after an extensive review of the related national and international literature and was filled by the researcher It consists of three parts:

Part I: Studied pregnant women's general characteristics including age, educational level of the mother and husband, residence, etc...).

Part II: Obstetrical history of the studied pregnant women including gravidity, parity, history of abortion, type of previous C.S, inter-pregnancy interval, etc...).

Part III: Knowledge of the studied pregnant women toward mode of delivery., 6 months|Tool II: Attitude of the studied pregnant women toward mode of delivery questionnaire, It was developed by the researcher. Its primary objective was to assess pregnant women attitude toward delivery mode, it consists of two parts:

Part I: Attitude of the studied pregnant women toward vaginal delivery:

Part II: Attitude of the studied pregnant women toward Cesarean section:, 6 months|Tool III: Studied pregnant women's preference of delivery mode sheet., The researcher developed this tool after reviewing the relevant literature (Elgzar, Alshahrani, \& Ibrahim, 2023) to assess pregnant women preference of delivery mode. It included two items (the type of delivery mode as normal vaginal delivery or cesarean section and causes for choosing this mode of delivery, including labor pain, the cost, doctor preference, health beliefs regarding mode of delivery, the most common mode of delivery, having previous knowledge toward the mode of delivery, and having knowledge from an educational program, etc...)., 6 months
Effect of Different Centrifuge Values on Saliva High Sensitive C-Reactive Protein (Hs-CRP) Levels in Individuals With Different Smoking Amounts
NCT Number: NCT06561971
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking
Interventions: DIAGNOSTIC_TEST: saliva obtaining
Sponsor: Izmir Katip Celebi University
Sex: ALL
Age: ADULT
Enrollment: 90
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-01
Completion Date: 2024-09-22
Locations: Izmir Katip Çelebi University Department of Periodontology, Izmir, Çiğli, 35640, Turkey

Summary:
The purpose of this study; In periodontally healthy individuals, high sensitive c-reactive protein (hs-CRP) levels of non-smokers, smokers of less than 10 cigarettes per day and smokers of more than 10 cigarettes per day were measured at 15 rpm-10 min, 10 centrifuge values, which are frequently used in saliva studies. To determine the levels in saliva samples as a result of rpm-10 min and 10 rpm 6 min centrifugations and to determine the values at which a cytokine of this molecular weight should be centrifuged and to examine the possible correlation between these values and the clinical parameters of the amount of smoking. Materials and Methods: saliva samples were collected from 90 systemically healthy individuals who were non-smokers (N, n=30), light smokers \<10 cigarettes per day (L, n=30) and heavy smokers \>10 cigarettes per day (H, n=20). samples were taken. Full-mouth clinical periodontal measurements, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI), and plaque index (PI), were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine hs-CRP levels in biological samples.

Primary Outcome Measures: The total amount of hs-CRP in saliva, 24 hours after taking the clinical measurements at the first visit
Secondary Outcome Measures: Determining the ideal centrifugal value range of hs-CRP saliva level, Within 1 week after receiving the biochemical analysis results
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
NCT Number: NCT06561932
Acronym: TLC-AU
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: DEVICE: WiSE CRT System
Sponsor: EBR Systems, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2027-01-01
Locations: Patients of Sunshine Coast University Hospital, Birtinya, Queensland, 4575, Australia|Patients of Cairns Base Hospital, Cairns, Queensland, 4870, Australia|Royal Brisbane and Women's Hospital, Herston, Queensland, 4006, Australia|Patients of Gold Coast University Hospital, Southport, Queensland, 4215, Australia|Princess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia

Summary:
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.

Primary Outcome Measures: Incidence of Device and procedure related complications., Primary Safety, 1 month and 6 months|Bi-Ventricular capture on 12 lead EKG, Performance, 1 month and 6 months
Secondary Outcome Measures: Change in ejection fraction (EF) from Baseline, Secondary efficacy 1, 6 months|Change in in left ventricular end systolic volume (LVESV), Secondary efficacy 2, 6 months|Change in NYHA class, Secondary efficacy 3, 6 months|Change in Six-minute walk test, Secondary efficacy 4, 6 months
Establish Diagnostic and Prognostic Models for Preclinical AD Patients Based on Multimodal MRI, Behavioral, Genetic, and Plasma Biomarkers
NCT Number: NCT06561906
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alzheimer Disease, Late Onset|Mild Cognitive Impairment|Subjective Cognitive Decline
Interventions: OTHER: Multimodal magnetic resonance imaging scanning, behavioral, genetic and plasma biomarker testing
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-09-01
Completion Date: 2027-12
Locations: Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China

Summary:
To establish the diagnostic and prognostic models that could help the preclinical identification of subjects at higher risk of clinical progression to mild cognitive impairment and dementia based on combined features of baseline demographic, cognitive, behavioral, multimodal MRI, genetic, and plasma data.

Primary Outcome Measures: the area under the curve of the classification analysis between progressors and nonprogressors, We'll measure the area under the curve of the ROC curves based on combined features of baseline demographic, cognitive, behavioral, multimodal MRI, genetic, and plasma data in discriminating those convert to MCI or AD (progressors) from those do not convert (nonprogressors), Baseline, Year 1, Year 2, Year 3
Secondary Outcome Measures: mediation effects of MRI on the associations between gene/plasma biomarker and cognition/behavior, We'll explore whether MRI features could act as mediators between genetic factors and cognition or behavior, as well as between plasma biomarkers and cognition or behavior., Baseline
Effect of L. Plantarum Probiotic Supplementation on Broccoli Sulforaphane Bioavailability: Randomised Double-blind Placebo-controlled Crossover Study
NCT Number: NCT06561893
Acronym: PRO-BROC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nutrition, Healthy
Interventions: DIETARY_SUPPLEMENT: Broccoli sprouts extract supplementation
Sponsor: University of Exeter
Collaborators: The University of Queensland|PepsiCo, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2026-01
Locations: The Department of Public Health and Sport Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, Devon, EX1 2 LU, United Kingdom|Richard's Building, St Luke's Campus, Exeter, Devon, EX2 4TA, United Kingdom

Summary:
Broccoli has the precursor of an active compound (sulforaphane) that has shown a wide range of health promoting benefits. Sulforaphane formation depends on the conversion of glucoraphanin (precursor) by myrosinase enzyme. Thus, the bioavailability of sulforaphane is affected by myrosinase activity. Some bacteria, such as L. plantarum (probiotic), have shown they can also convert glucoraphanin to sulforaphane in vitro. This study investigates the effect of short-term L. plantarum supplementation on broccoli sulforaphane bioavailability in humans using a randomised double-blind placebo-controlled crossover trial.

Primary Outcome Measures: Bioavailability of sulforaphane, Bioavailability (%) of sulforaphane (will be estimated by dividing the cumulative amount of sulforaphane mercapturic acid excreted in urine in 24 h by the consumed amount of glucoraphanin (Vermeulen et al., 2008)) before and after chronic consumption of L. plantarum compared with placebo., From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition
Secondary Outcome Measures: Sulforaphane pharmacokinetics: Area under the curve, Measurement of the definite integral of the concentration of sulforaphane (and its metabolites) in blood plasma as a function of time., From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.|Sulforaphane pharmacokinetics: Cmax, Measurement of the maximum plasma concentration (Cmax) of sulforaphane (and its metabolites) indicating the value of the highest concentrations reached in the plasma., From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.|Sulforaphane pharmacokinetics: Tmax, Measurement of the time taken for sulforaphane (and its metabolites) to reach the maximum concentration (Cmax) after administration of the supplement that needs to be absorbed., From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.
Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone
NCT Number: NCT06561854
Acronym: FREEDOM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Multiple Myeloma|Relapse Multiple Myeloma
Interventions: DRUG: Dexamethasone
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 318
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-10
Locations: Service d'hématologie clinique et thérapie cellulaire, Saint-Antoine Hospital, Paris, 75012, France

Summary:
Patients with relapsed/refractory symptomatic multiple myeloma who meet all inclusion criteria, will be randomized 1:1 to receive either standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone until disease progression ("dexamethasone arm", arm A) or standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone with dexamethasone discontinuation from the 3rd cycle of treatment (after 8 weeks) ("dexamethasone-free arm", arm B).

In most centers, IKEMA and ICARIA schema can be adapted according to the standard of care in each center Choice between the ICARIA and IKEMA schema is at the discretion of the investigator, in compliance with each drug's SmPC, but must be performed before randomisation for the purpose of stratification.

Primary Outcome Measures: overall response rate (ORR)., Response rate will be evaluated according to the IMWG criteria, after six 28 days cycles of salvage therapy., At the end of Cycle 6 of salvage therapy (each cycle is 28 days)
Secondary Outcome Measures: best overall response rate (ORR), Response rate will be evaluated according to the IMWG criteria, during or after the study treatment at the time of data cutoff. Patients will be followed every 4 weeks (with either a medical visit or only an outpatient blood test) until disease progression and then every 12 weeks until final 2 years., 2 years|Time To Progress (TTP), Time To Progress defined as the duration from the date of randomization to progressive disease, according to the IMWG criteria, 2 years|Progression free survival (PFS), Progression free survival is defined as the duration from the date of randomization to either progressive disease, according to the IMWG critera or death, at 2 years after randomization., 2 years|Overall survival OS, which is defined as the time between randomization and death due to any cause. Patients, who die, regardless of the cause of death, will be considered to have had an event even if they were lost to follow-up for an extended time, 2 years|Quality of Life (QoL), 2 years
A Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH）
NCT Number: NCT06561841
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)
Interventions: DRUG: HSK39297
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-17
Completion Date: 2025-03-13
Locations: The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China

Summary:
This is a multicenter, randomized, open-label phase 2 study. Adult Patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HSK39297 for 24 weeks.

Primary Outcome Measures: Proportion of participants with increase in hemoglobin levels from baseline of ≥20 g/L in the absence of red blood cell transfusions, Baseline, 24 weeks
Secondary Outcome Measures: Proportion of participants with at least 60% reduction in LDH compared to baseline or LDH below the upper limit of normal, Baseline, 24 weeks|Change from baseline in hemoglobin, Baseline, 24 weeks|Change from baseline in reticulocyte count, Baseline, 24 weeks|Change from baseline in LDH, Baseline, 24 weeks|Change from baseline in Indirect bilirubin, Baseline, 24 weeks|Change from baseline in free hemoglobin, Baseline, 24 weeks|Proportion of participants without requiring red blood cells (RBC) transfusions, From week 4 to week 24|Change in the average number of RBC transfused per week, From week 4 to week 24|Change from baseline in PNH RBC clone size, Baseline, 24 weeks|Change from baseline in C3 fragment deposition on PNH RBC, Baseline, 24 weeks|Change from baseline in FACIT-Fatigue score, Baseline, 24 weeks|Incidence and severity of adverse events, 28 weeks
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
NCT Number: NCT06561828
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Normal Physiology
Interventions: DEVICE: continuous Theta Burst Stimulation (cTBS)|DEVICE: intermittent Theta Burst Stimulation (iTBS)|DEVICE: sham Theta Burst Stimulation (sham TBS)
Sponsor: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT
Enrollment: 600
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-10
Completion Date: 2044-11-02
Locations: National Institute on Drug Abuse, Baltimore, Maryland, 21224, United States

Summary:
Background:

People with substance use disorder (SUD) often have changes in brain function that can make it difficult to control drug-seeking behavior. These changes may heighten the urge to use drugs or lessen the desire to seek nondrug-related rewards. Researchers want to know how a technique called transcranial magnetic stimulation (TMS) may cause changes in brain activity that may help people with SUD.

Objective:

To test TMS in healthy volunteers.

Eligibility:

Healthy people aged 18 to 45 years who are right-handed.

Design:

Participants can volunteer for up to 5 different experiments. Each experiment requires 2 to 8 clinic visits. Each visit will last 3 to 7 hours.

Some visits will include TMS. A coil will be placed on the participant s head. A brief electrical current will pass through the coil to create a magnetic field. Participants may feel a tapping or pulling sensation on the skin under the coil. They may feel a twitch in their face, neck, arm, or leg muscles. Participants may be asked to tense certain muscles during TMS.

Some visits will include functional magnetic resonance imaging (fMRI) scans. Participants will lie on a bed that slides into a large tube. They will perform tasks on a computer inside the tube. The fMRI will show which parts of the brain are used during each task.

Participants will perform tasks on a computer. Some tasks may be done at a desk as well as during TMS and fMRI. Participants may look at images, listen to sounds, smell odors, or taste flavored liquids. Their vital signs may be monitored and their eye movements may be tracked during tasks.

Primary Outcome Measures: Task Performance, Responses on behavioral tasks, after each intervention
Body Composition Estimated by Bioelectrical Impedance Analysis in Patients with Acute Coronary Syndrome.
NCT Number: NCT06561815
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Syndrome|Obesity
Sponsor: Hospital de Clinicas José de San Martín
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-11
Completion Date: 2025-11-30

Summary:
This study addresses the critical issue of obesity and its impact on patients with acute coronary syndrome (ACS). While obesity is a known risk factor for cardiovascular diseases, emerging evidence suggests that obese patients with coronary artery disease may have better survival outcomes-a phenomenon known as the \&#34;obesity paradox.\&#34;

Our research aims to explore this paradox by examining the body composition of ACS patients using bioimpedance analysis (BIA). We will evaluate parameters such as lean mass, body fat, and fluid volume to assess their relationship with clinical outcomes, including mortality and the incidence of heart and kidney failure.

By focusing on body composition rather than just BMI, this study seeks to provide a more accurate understanding of how these factors influence patient outcomes. Conducted at a major hospital in Argentina, the study will contribute valuable insights into the role of body composition in the prognosis of ACS, potentially informing more personalized treatment strategies.

Primary Outcome Measures: cardiovascular death, Death attributed to cardiovascular conditions., 1 year
Other Outcome Measures: MACE, Ocurrence of mayor cardiovascular events (myocardial infarction, stroke, cardiovascular death)., 1 year
Evaluation of GCF And Salivary Ferritin, ALP And MMP-8 Levels of Individuals With Different Periodontal Diseases
NCT Number: NCT06561802
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontal Diseases
Interventions: DIAGNOSTIC_TEST: GCF and saliva obtaining
Sponsor: Izmir Katip Celebi University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2019-04-01
Completion Date: 2019-09-30
Locations: Izmir Katip Çelebi University Department of Periodontology, İzmir, Çiğli, 35640, Turkey

Summary:
The aim of this clinical study was to determine the levels of ferritin, alkaline phosphatase and matrix metalloproteinase-8 in the gingival crevicular fluid (GCF) and saliva samples were collected from 60 systemically healthy, non-smoker periodontitis (P group, n = 20), gingivitis (G group, n = 20) and periodontally healthy individuals (S group, n = 20) and all clinical parameters were recorded for all groups at baseline. GCF and serum samplings and clinical records were also repeated at 1st and 3rd months visitsfor only P group. Ferritin, MMP8, and ALP levels in samples were determined by enzyme-linked immunosorbent assay (ELISA).

Primary Outcome Measures: The total amount of Ferritin in GCF and saliva, 24 hours after taking the clinical measurements at the first visit|The total amount of ALP in GCF and saliva, 24 hours after taking the clinical measurements at the first visit
Secondary Outcome Measures: The total amount of MMP-8 in GCF and saliva, 24 hours after taking the clinical measurements at the first visit
Remineralization Effect of βTricalcium Phosphate Nanoparticles Versus FunctionalizedβTricalcium Phosphate Nanoparticles
NCT Number: NCT06561789
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: White Spot Lesions[Initial Caries]on Smooth Surface of Tooth
Interventions: OTHER: Functionalized Nano ᵦ tricalcium phosphate particles|OTHER: Nano ᵦ tricalcium phosphate particles|OTHER: sodium fluoride mouth wash
Sponsor: Aya Magdy Elsadany
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-03-10
Completion Date: 2023-07-01
Locations: Tanta university, Tanta, Gharbiya, 31527, Egypt

Summary:
The study collects Sixty non carious sound human permanent premolars from Tanta University's maxillofacial surgery department. The teeth are cleaned and prepared, and randomly assigned into four groups. The specimens are analyzed using an EDX analysis scanning electron microscope, and surface micro-hardness is determined using a Digital Display Vickers Micro-hardness Tester.

Primary Outcome Measures: concentration of calcium and phosphorous in demineralized enamel, Assessment of calcium and phosphorous using Energy Dispersive X-Ray (EDX)analysis scanning electron microscope, 6 weeks|enamel hardness, Surface Micro-hardness will be determined using Digital Display Vickers Micro-hardness Tester\* with a Vickers diamond indenter and a 20X objective lens. A load of 100g will be applied to the surface of the specimens for 20 seconds., 6 weeks
Investigation of Physical Impairments in Young Adults
NCT Number: NCT06561776
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Adult Children
Interventions: OTHER: Physical Evaluations of individuals
Sponsor: Izmir Democracy University
Sex: ALL
Age: ADULT
Enrollment: 51
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-11
Locations: Izmir Democracy University, İzmir, 35140, Turkey

Summary:
Physical inactivity is widespread among young adults due to different disasters like the COVID-19 and earthquakes. On the other hand, it is unknown how physical activity level affects cough strength and balance in young adults. In current study, it was aimed to investigate both cough strength, physical activity and balance status in young adults and the relationship between these parameters.

Primary Outcome Measures: Cough strength, Cough strength will be evaluated using a PEFmeter., through study completion, an average of 1 year
Secondary Outcome Measures: Physical activity score, Physical activity will be assessed using the Short Form of International Physical Activity Questionnaire. There are a total of 7 questions in the questionnaire. It provides a total physical activity score. As this score increases, physical activity level of the participant increases., through study completion, an average of 1 year|Static balance score, It was assessed with a single-leg balance test and the maximum time in this position was recorded in seconds with a stopwatch., through study completion, an average of 1 year|Dynamic balance score, I was assessed with the standing functional reach test. Participant was asked to extend their arms forward parallel to the wall, the distance between the starting point and the farthest reached point was measured. As this distance increases, the balance increases., through study completion, an average of 1 year
TPC VS. GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
NCT Number: NCT06561763
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: High Risk Locally Advanced Nasopharyngeal Carcinoma
Interventions: DRUG: Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine|DRUG: Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 416
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2031-08-20

Summary:
We expect to conduct a clinical trial in high-risk locally advanced nasopharyngeal carcinoma patients to explore the efficacy and safety of sequential radical radiotherapy treatment after induction chemotherapy (TPC vs. GP) with combination therapy of nivolumab and triprolizumab.

Primary Outcome Measures: 3-year event free survival, 3 years
Secondary Outcome Measures: adverse effects, chemotherapy side effectst, 3 years|3-year overall survival, 3 years|3-year distant disease free survival, 3 years|3-year local recurrence free survival rate, 3 years