pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Low-level Laser Therapy Versus Shock Wave Therapy on Pain and Function in Patients With Chronic Non-specific Low Back Pain
NCT Number: NCT06487338
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain
Interventions: OTHER: Low-level laser therapy|OTHER: Shock wave Therapy
Sponsor: October 6 University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-04-25
Completion Date: 2024-09
Locations: October 6 University, Giza, 11742, Egypt

Summary:
A significant global source of disability is low back pain. Maladaptive variations in the level of activity in the lumbar musculature are one thing that could possibly contribute to persistent pain.

Primary Outcome Measures: Oswestry low back disability questionnaire, The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome toolsFor each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32%

If one section is missed or not applicable the score is calculated:

16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement), 30 minutes|Back pain functional scale, The Back Pain Functional Scale (BPFS) is a subjective scale used to measure the patient's physical function after low back painThis scale consists of a total score of 60. Moreover, the patient's score can be measured from the responses obtained on the Likert scale (0 to 5), and accordingly, a total score is summed up out of 60. Furthermore, the maximum score obtained indicates the maximum physical abilities of the patients. In addition, this scale also has an 'Adjusted score' ranging from 0 (0%)-unable to perform any activity to 60 (100%)-no difficulty in any activity, 20 minutes|Visual analogue scale, Visual analogue scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions.

Visual analogue scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end.48 Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain, 5 minutes
A Clinical Study of Ultrasound-derived Fat Fraction to Assess Metabolic Dysfunction-Associated Steatotic Liver Disease
NCT Number: NCT06487325
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Fatty Liver Disease
Sponsor: Ma Zhe
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-29
Completion Date: 2024-05-01
Locations: QianfoshanH, Jinan, Shandong, 250014, China

Summary:
Aims: To evaluate the diagnostic performance of ultrasound-derived fat fraction (UDFF) in assessing the degree of hepatic steatosis in an obese population, with liver biopsy as reference standard.

Materials and methods: Obese individuals, who were found to have fatty liver by B-mode ultrasound and underwent UDFF measurement, along with liver biopsy results, were retrospectively selected from The First Affiliated Hospital of Shandong First Medical University.The inclusion criteria were as follows: (1) BMI over 30 kg/m²; (2) diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional B-mode ultrasound; (3) serologic test results were available. The exclusion criteria include: (1) patients who have undergone liver resection or have liver space-occupying lesions; (2) pregnant women; (3) patients with incomplete medical history data.

Primary Outcome Measures: UDFF values, During the examination, the DAX probe was positioned in the right intercostal space, and the UDFF mode was selected to place a fixed-size region of interest (ROI) vertically in the right lobe of the liver, 1.5 cm away from the liver capsule, avoiding the intrahepatic duct structure. Measurements were acquired after the patient maintained a calm breathing pattern, and the system automatically determined the shear wave velocity (Vs), elastic modulus (E), and UDFF values., up to 1 year
Secondary Outcome Measures: SWE values, The auto-SWE values were collected simultaneously when using UDFF mode, and the SWE and pSWE values were collected 10 times with 5C1 and DAX probes, respectively, up to 1 year
Clinical Trial to Evaluate the Effectiveness and Safety of a Remote Automated Ultrasound Diagnostic System for Automated Ultrasound Examinations: a Prospective, Multicenter Study
NCT Number: NCT06487312
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Ultrasound|Thyroid|Carotid Artery|Liver|Gallbladder|Spleen|Pancreas|Kidney
Interventions: DEVICE: Test equipment: Name: Remote automatic ultrasound diagnostic system (Wuhan Cooper Technology Co., Ltd.) Model: CORUS-A30
Sponsor: Tongji Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2027-07-30
Locations: Xin-Wu Cui, Wuhan, Hubei, 430030, China

Summary:
The purpose of this clinical trial is to verify the safety and effectiveness of the remote automatic ultrasound diagnosis system produced by Wuhan Cooper Technology Co., Ltd. for automatic ultrasound examination. It aims to answer the main questions:

Can the robot complete automatic ultrasound scanning of multiple systems and organs such as liver, gallbladder, spleen, pancreas, kidney, thyroid, carotid artery, etc.? Will there be medical safety issues during the robot\&#39;s scanning process?

Primary Outcome Measures: Image scanning pass rate, Each subject is subjected to ultrasound examination using the corresponding probe using the test device. The image quality of each part is evaluated according to the examination site and the image evaluation standards of each part (see Appendix 1); whether it meets the doctor's diagnostic needs is determined according to the scan completeness evaluation standards (see Appendix 2). The examination sites include: abdomen (liver, gallbladder, pancreas, spleen and kidney), superficial small organs (thyroid) and peripheral blood vessels (carotid artery). Each subject can undergo examination of all parts or some parts on the same day. If the subject has a history of organ resection surgery, ultrasound examination of the corresponding part will not be performed. The expert group consists of three researchers. The three expert group researchers evaluate the ultrasound image video and standard cross-section diagram collected by the test device back to back. When the results are inconsistent, t, 12 months
Iron Administration Via Colonic TET Combined With WMT for ID
NCT Number: NCT06487299
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Iron Deficiency Anemia in Childbirth
Interventions: DRUG: Ferrous Lactate|DRUG: Iron sucrose|DRUG: 0.9% NaCl solution
Sponsor: The Second Hospital of Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2026-06-01
Locations: Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Summary:
The colon can absorb iron.We propose an integrated approach utilizing colonic transendoscopic enteral tubing to deliver iron in different valence states, coupled with washed microbiota transplantation . This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for the treatment of iron deficiency.

Primary Outcome Measures: Reticulocyte haemoglobin values in blood, To compare the level of reticulocyte haemoglobin in the blood before and after administration of iron lactate, iron sucrose and saline., Baseline; Day 4
Secondary Outcome Measures: Serum ferritin levels, To compare the level of ferritin in the serum before and after administration of iron lactate, iron sucrose and saline., Baseline; Day 4
Other Outcome Measures: Incidence of Treatment-Emergent Adverse Events, The number of adverse reactions that are associated with iron medicine reported by subjects from the start of treatment to the end of follow-up., Baseline; Day 4
Levels of Visfatin/NAMPT in Human Milk
NCT Number: NCT06487286
Acronym: VISFAMILK
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Measure Visfatin Levels in Maternal Milk Samples Collected in Three Different Moments After Birth 48 Hours 7 Days and 30 Days|Measure Visfatin Levels in Maternal Plasma/Serum Collected After 1-2 Days Post-partum|Correlate the Values of Visfatin to Different Demographic and Clinical Characteristics of the Lactating Mothers|Correlate the Values of Visfatin to Different Biological/Clinical Features of the Newborns
Interventions: OTHER: observational study
Sponsor: Paolo Manzoni Study Group
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-02
Completion Date: 2025-03-01

Summary:
Visfatin, released in maternal milk at different concentrations related to the maternal conditions, could act as a biomarker with a prognostic/predictive value to determine different newborn clinical conditions, particularly the weight loss of the neonate.

Primary Outcome Measures: Visfatin levels, Visfatin levels in maternal milk samples, 48 hours, 7 days and 30 days|Visfatin levels, Visfatin levels in maternal plasma/serum, 1-2 days post-partum
Secondary Outcome Measures: values of Visfatin, correlate the values of Visfatin to different demographic and clinical characteristics of the lactating mothers, 6 months|values of Visfatin, correlate the values of Visfatin to different biological/clinical features of the newborns; in particular, we will focus attention on the weight loss of the neonate, 6 months
Effect of Acute ObeEnd Exposure on Factors Regulating Appetite
NCT Number: NCT06487234
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity
Interventions: DEVICE: Functional band|DEVICE: Placebo band
Sponsor: Concordia University, Montreal
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2025-04-01
Locations: Concordia University, Montreal, Quebec, H4B1R6, Canada

Summary:
n Canada, over 60% of adults are classified as overweight and obese resulting in a public health crisis including increasing health care costs and negatively impacting the well-being of many Canadians. To overcome these barriers, the ObeEnd device, manufactured by WAT Medical Enterprise, is a new and innovative wellness technology that uses electrical pulses to stimulate acupressure point PC6 to help control appetite. PC6 stimulation could potentially modulate appetite and restore gastric dysfunction, which are important factors that contribute to obesity. If PC6 electrostimulation facilitates the normalization of appetite and restoration of gastric dysfunction in those with obesity, then the device could be a potentially helpful aid to weight loss.

To measure the change of appetite hormones and enzymes related to appetite regulation after using the ObeEnd device. The investigators hypothesize that, compared to placebo, acute electrostimulation of PC6 an acupuncture spot on the wrist for a 1 hour period will result in changes in enterogastric hormones in a direction that decreases appetite. This study will provide the first evidence of the acute effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.

Primary Outcome Measures: Appetite assessment, Perceived appetite as reported based on the Visual Analog Scale after a standardized mixed meal. Appetite will be assessed every 30 minutes over a 2 hour period post meal consumption, at 30, 60, 90 and 120 minutes. The Visual Analog Scale is a measure of appetite based on a 10 cm line. Participants are asked a question on how they feel about a specific aspect of appetite (e.g. hunger). Participants then place a mark on the line. A mark closer to the left indicates fullness and satiation and a mark closer to the right indicates hunger., Baseline to 4 hours|Blood Hormones, Fasting blood hormone levels will be measured prior to stimulation, and every 30 minutes over a 2 hour period post meal consumption, (at 30, 60, 90 and 120 minutes). Blood hormones involved in appetite and motility such as ghrelin, glucagon-like peptide 1, motilin, and pepsinogen-1 will be measured via ELISA., Baseline to 4 hours
Secondary Outcome Measures: Blood Pressure, Blood pressure will be measured (mmHg), Baseline to after stimulation, on average 1 hour|Heart rate, Heart rate will be measured (beats per minute), Baseline to after stimulation, on average 1 hour
Impact of a Hand-held Digital Cognitive Aid to Anticipated a Simulated Crisis Situation for Resident
NCT Number: NCT06487208
Acronym: AnticipaMax
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: Use of a digital cognitive aid in order to anticipate a critical situation|OTHER: Placebo
Sponsor: Claude Bernard University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-03-07
Completion Date: 2024-10-12
Locations: HENKEME Mathieu, Lyon, Rhone Alpes, 69008, France

Summary:
The objective of this study is to demonstrate that the systematic anticipation of major potential per operative complications using a digital cognitive aid and visualizing the appropriate actions in such cases leads to an improvement in overall performance during an immediate critical situation in simulation, particularly through the regular reassessment of the initial hypothesis

Primary Outcome Measures: Global performance composite score, The primary outcome measure is a composite score of overall performance, based on both technical performance and non-technical performance, assessed by a validated scale (Ottawa Crisis Resource Management) demonstrated by the included subject during the full-scale simulation after the implementation of the intervention.

Composite score of technical performance on a scale of 100 + non-technical performance on a scale of 0 minimum to a maximum of 100, therefore a total from zero minimum to 200 hundred maximum.

To obtain this composite score, we will sum the technical performance score out of 100 points and the non-technical performance score out of 100 points (Ottawa scale / 42 points, converted to a score out of 100)., one day after simulation
Secondary Outcome Measures: Technical performance, performance score from 0 minimum to a maximum of 100, One day after simulation|Non technical performance, performance score from 0 minimum to a maximum of 100, One day after simulation|Stress level, self-evaluated, Visual analog scale from 0 minimum to 100 maximum, 2 minutes before simulation|Stress level, self-evaluated, Visual analog scale from 0 minimum to 100 maximum, 2 minutes after simulation|Self confidence level, Visual analog scale from 0 minimum to 100 maximum, 2 minutes after simulation|Difference between the required competency level and the level that participant estimates have, Visual analog scale from 0 minimum to 100 maximum, 2 minutes after simulation
The Effect of Reiki on the Anxiety Level of Mothers
NCT Number: NCT06487182
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety
Interventions: OTHER: reiki|OTHER: placebo reiki
Sponsor: Ondokuz Mayıs University
Sex: FEMALE
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-30
Completion Date: 2024-08-30
Locations: Ondokuz Mayis University, Samsun, 55200, Turkey

Summary:
The aim of this study is to determine the effect of Reiki applied to mothers whose children were treated in the hospital on the anxiety level.

Primary Outcome Measures: anxiety, The State Anxiety Scale assesses feelings of fear, tension, irritability, and anxiety that increase during stress in response to physical danger and psychological stress. The 20-question test allows individuals to answer within 10 minutes.

It provides answers on a four-point Likert type scale. STAI, reliability ranging from 0.83 to 0.92 It has sufficient validity and reliability with its coefficients (Vitale 2006)., immediately before reiki application and immediately after the reiki application]
Effectivity Gas Extraction to Prevent Anesthesiologists Waste Gas Exposure of Sevofluorane During Pediatric Induction
NCT Number: NCT06487169
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Unrecognized Condition
Interventions: DIAGNOSTIC_TEST: Urine analysis to determine the presence of hexafluoroisopropanol
Sponsor: Bnai Zion Medical Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-01-31

Summary:
Inhalational anesthetics (IAs) are widely used in surgery and experimental research. IAs, in addition to their medical significance, are a major source of chemical contamination in the operating rooms (ORs).Exposure to IAs in ORs personnel results in reproductive effects, including infertility , spontaneous abortions , congenital diseases , psychological and neurological disturbances, hepatotoxicity , and genotoxicity .The metabolites of sevoflurane include hexafluoroisopropanol (HFIP) and inorganic fluoride (IF). The hospital's engineering department installed an air extractor with the objective to reduce the anesthetic gas concentrations during pediatric anesthesia induction. The investigators are interested in checking if the new technique also has an influence in decreasing the level of Sevoflurane breathed in by the anesthesiologist.The investigators purpose is to detect the presence of desfluoroisopropanolol in the urine of ten anesthesiologists who used sevoflurane to induce children with a mask during an eight-hour session in the induction room (IR) One session will be conducted without the use of the air extractor and the other with the air extractor. After 24 hours, a urine sample will be taken and sent to the Toxicology Unit.

Primary Outcome Measures: Presence of sevoflurane metabolite, hexafluoroisopropanol in urine, hexafluoroisopropanol is the metabolism of the sevofluorane, up to 24 weeks
A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT Number: NCT06487156
Acronym: FINN
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-small Cell Lung Cancer (NSCLC)
Interventions: DRUG: Nivolumab + ipilimumab
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-11
Completion Date: 2030-10-11
Locations: Istituto Nazionale Tumori - IRCCS Fondazione G.Pascale, Napoli, 80131, Italy

Summary:
The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy

Primary Outcome Measures: Overall survival (OS), Up to 5 years
Secondary Outcome Measures: Progression-free survival (PFS), Up to 5 years|Overall response rate (ORR), Up to 5 years|Best overall response (BOR), Up to 5 years|Best overall response rate (BORR), Up to 5 years|Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Up to 5 years|Duration of response (DOR), Up to 5 years|Time to response (TTR), Up to 5 years|European Quality of Life-5 Dimensions (EQ-5D) Score, Baseline and up to 5 years|Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results, Baseline and up to 5 years|Treatment regimen, Up to 5 years|Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results, Baseline|Number of participants discontinuing treatment, Up to 5 years|Management of Adverse Events (AEs), Up to 5 years|Participant socio-demographic characteristics, Baseline and up to 5 years|Participant clinical characteristics, Baseline and up to 5 years
Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients
NCT Number: NCT06487052
Acronym: ESCADlys-PE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulmonary Embolism Acute
Interventions: COMBINATION_PRODUCT: Standard Catheter-Directed Low Dose Thrombolysis|DRUG: Standard Anticoagulation
Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-10
Completion Date: 2027-12
Locations: Almazov National Medical Research Centre, Saint Petersburg, 197341, Russian Federation

Summary:
A single-center, open-label, randomized comparative study of two treatment strategies in patients with intermediate-high-risk acute pulmonary embolism (PE). Patients will be randomized in a 1:1 ratio to standard anticoagulant therapy or standard catheter-directed thrombolysis (SСDT) with a low dose of alteplase, followed by evaluation of short- and long-term efficacy and safety in each group

Primary Outcome Measures: A decrease in the ratio of RV/LV diameters, A decrease in the ratio of RV/LV diameters by 20% or more from the initial value 48 ± 6 hours after initiation of therapy, 48 ± 6 hours
Secondary Outcome Measures: Mortality, Mortality, 90 days|Cardiorespiratory decompensation or collapse, necessity of inotropic and vasopressor support; cardiac arrest or need for CPR; obstructive shock, placement on extracorporeal membrane oxygenation (ECMO), intubation, or initiation of non-invasive mechanical ventilation, 7 days|Major bleeding events, International Society on Thrombosis and Hemostasis (ISTH) major bleeding, 7 days|PE thrombus load reduction, Qanadli score by CT-scan, 48 hours|The degree of residual pulmonary artery thrombosis with perfusion deficiency, The degree of residual pulmonary artery thrombosis with perfusion deficiency by CT-scan, 180 days|Post-pulmonary embolism syndrome formation, The presence of symptomatic pulmonary artery residual thrombosis, 180 days
Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
NCT Number: NCT06487039
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neovascular Age-related Macular Degeneration (nAMD)
Interventions: DRUG: EB-203
Sponsor: EyebioKorea, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-01
Locations: Busan Paik Hospital, Inje University, Busan, 47392, Korea, Republic of|Pusan National University Hospital, Busan, 49241, Korea, Republic of|Yeungnam University Medical Center, Daegu, 42415, Korea, Republic of|Kim's Eye Hospital, Seoul, 08858, Korea, Republic of|Seoul National University Hospital, Seoul, 08858, Korea, Republic of

Summary:
Trial to Evaluate the Safety and Efficacy of EB-203 in Patients with Neovascular Age-related Macular Degeneration.

The purpose of this study is to primarily investigate the safety and tolerability of EB-203 by dose in patients with neovascular Age-related Macular Degeneration (nAMD), and to secondarily evaluate the clinical efficacy. Subject to Adults aged 50 years or older and Neovascular age-related macular degeneration (nAMD)

Primary Outcome Measures: Change in central retinal thickness (CRT), Change in central retinal thickness (CRT) measured by OCT at Week 12 compared to baseline., Week 12
Secondary Outcome Measures: Change in BCVA, Change in BCVA at Weeks 4, 8, and 12 compared to baseline., Weeks 4, 8, 12|Change Proportion (%) in BCVA, Proportion (%) of subjects showing improvement in visual acuity of ≥ 1 line (5 letters on the ETDRS chart), ≥ 2 lines (10 letters on the ETDRS chart), and ≥ 3 lines (15 letters on the ETDRS chart) at Weeks 4, 8, and 12 weeks from baseline, Weeks 4, 8, 12|Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid, Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid confirmed by OCT at Weeks 4, 8, and 12 weeks compared to baseline, Weeks 4, 8, 12|Proportion (%) of subjects who received rescue medication, Proportion (%) of subjects who received rescue medication (anti-VEGF drug) at each visit, Weeks 4, 8, 12
Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases: An Extension Study
NCT Number: NCT06487026
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bone Metastases
Interventions: DEVICE: ArcBlate Focused Ultrasound Ablation System
Sponsor: EpiSonica
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-10-31
Locations: Far Eastern Memorial Hospital, New Taipei City, 220, Taiwan|Taichung Veterans General Hospital, Taichung, 407, Taiwan|National Taiwan University Hospital, Taipei, 100, Taiwan|Chang Gung Memorial Hospital - Linkou, Taoyuan, 333, Taiwan

Summary:
An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful Bone Metastases

Primary Outcome Measures: Unanticipated adverse device effects (UADEs) from Day 0 to 90., UADEs is defined as any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects., from Day 0 to 90
Secondary Outcome Measures: Solicited events from Day 0 to 30, Major adverse events (Day 0 to 7)、Solicited adverse events (Day 0 to 30), from Day 0 to 30|Unsolicited adverse events from Day 0 to 90, Unsolicited adverse events are defined as whose nature or intensity are not consistent with the solicited AE., from Day 0 to 90
CHAMP T 2 Pilot of CIMT by Tele-Video
NCT Number: NCT06486987
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemiplegic Cerebral Palsy
Interventions: OTHER: Constraint induced movement therapy delivered by televideo
Sponsor: Warren Lo
Collaborators: Ohio State University|Virginia Polytechnic Institute and State University
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2027-06-30
Locations: The Ohio State University School of Health and Rehabilitation Sciences, Columbus, Ohio, 43210, United States|Virginia Tech-Fralin Biomedical Research Institute, Roanoke, Virginia, 24016, United States

Summary:
The CHAMP-T2 study is a pilot test of the efficacy of constraint induced movement therapy (CIMT) when delivered by tele-video in the child's home or home-like environment. This study will examine the pre-, post-intervention function a hemiparetic limb in children who have hemiplegic cerebral palsy. The purpose is to provide an effect size estimate that will inform the design of a future study that will compare tele-delivered CIMT with usual and customary care.

Primary Outcome Measures: Melbourne Assessment of Unilateral Upper Limb Function, Measures function of the impaired upper limb, At baseline pre-treatment and at the end of the 4-week intervention
Secondary Outcome Measures: Assisting Hand Assessment, Measures function of the impaired upper limb in bilateral upper limb functions, At baseline pre-treatment and at the end of the 4-week intervention|Pediatric Motor Activity Log, Parent reported assessment of upper limb motor activity, At baseline pre-treatment and at the end of the 4-week intervention|Fidelity to treatment protocol, Parent logs of numbers of hour of treatment and hours the child wears constraint, During 4 weeks of intervention
Efficacy of Manual Toothbrushes in Removing Tooth Stains
NCT Number: NCT06486974
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Tooth Discoloration
Interventions: DRUG: NaF|DRUG: Na MFP
Sponsor: Colgate Palmolive
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-22
Completion Date: 2024-10
Locations: Spa Dental, Santo Domingo, Dominican Republic

Summary:
Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.

Primary Outcome Measures: Lobene Tooth Stain Index, Each tooth will be scored separately using a 4 point area Stain Area (extent):

(0) No stain detected

1. Stain covering up to one third (1/3) of the region
2. Stain covering \> 1/3 to 2/3 of the region
3. Stain covering \> 2/3 of the region

Stain Intensity:

(0) No stain

1. Light Stain - yellow to light brown or gray
2. Moderate stain - medium brown
3. Heavy stain - dark brown to black and intensity scale ranging from: Using the Lobene Tooth Stain Index, each tooth will be scored separately using a 4 point area and intensity scale ranging from:, Baseline, and 6-weeks
Effect of Walking With Music in Obese People (BeatMove)
NCT Number: NCT06486961
Acronym: BeatMove
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Sedentary Behavior
Interventions: DEVICE: BeatMove Application|DEVICE: BeatMove Application without synchronized music|DEVICE: BeatMove Application without music
Sponsor: Clinique Beau Soleil
Collaborators: Université Montpellier
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2023-02-10
Completion Date: 2025-11-30
Locations: Clinique Beau Soleil, Montpellier, Hérault, 34070, France

Summary:
For several decades, scientists have reported encouraging effects of physical activity on functional capacities and quality of life among patients with obesity. However, regular daily physical activity remains limited in these individuals. People with obesity generally show lower adherence to physical activity, with 40% not meeting the recommendations of 2.5 to 3 hours of moderate physical activity per week set by the French National Authority for Health to be considered physically active. Since physical activity is the primary energy expenditure that can be targeted, the priority is to make it appealing through exercise programs tailored to individual needs, abilities, and preferences. To achieve this, using music to facilitate walking appears relevant. Studies show that individuals adhere to physical activity and incorporate it into their routines only if they find it enjoyable. Walking to music is more motivating and enjoyable. Moreover, the rhythm of music enhances the functioning of biological systems involved in walking. Tailored physical activity is a major preventive lever to implement for individuals with obesity. It is essential during the initial weight loss phase and during weight maintenance.

The overall objective of this study is to propose a digital tool capable of modifying the behavior of individuals with obesity to reduce sedentary behavior in their daily lives. Synchronized walking to the rhythm of music should help train obese patients towards a virtuous cycle leading to slowed weight gain, reduced associated health problems, and improvements in mental health and quality of life.

Primary Outcome Measures: Differences in average daily step count, The primary outcome measure is the variation in average daily step count across the three groups during the week (7 consecutive days) prior to the start of home-based self-rehabilitation and the final week of self-rehabilitation. These steps will be measured using "fibion sens" accelerometers under ecological conditions., Up to 3 months
An Exploratory, Double-arm, 8-week Study to Explore the Feasibility and Acceptability of Abbreviated Treatment With CT-156 for People With Schizophrenia.
NCT Number: NCT06486948
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia
Interventions: DEVICE: CT-156
Sponsor: Click Therapeutics, Inc.
Collaborators: Boehringer Ingelheim
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-06
Completion Date: 2024-08-23
Locations: Click Therapeutics, New York, New York, 10013, United States

Summary:
An exploratory, double-arm, 8-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.

Primary Outcome Measures: Number of Days Used, Number of days the Study App is opened out of total days of treatment, Day 0 to Week 8|Number of Times Study App is Opened, Number of times the Study App is opened during the treatment period, Day 0 to Week 8|Number of Medication Check-ins Completed, Number of medication check-ins completed during the treatment period out of total assigned, Day 0 to Week 8|Number of Assigned Tasks Completed, Number of assigned tasks completed during the treatment period, Day 0 to Week 8|Average Duration of Use, Average duration of each App-use session, Day 0 to Week 8
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial
NCT Number: NCT06486922
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Obesity|Breast Feeding|Feeding Behavior|Nutrition, Healthy
Sponsor: Northwell Health
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-10
Completion Date: 2025-12-30

Summary:
The goal of this intervention development study is to optimize the Starting Early to Prevent Obesity Using Telehealth (StEP OUT) intervention for feasibility and acceptability, using human-centered design and community-engaged research methods.

Primary Outcome Measures: Acceptability, We will use the Sekhon acceptability framework to assess affective attitude, burden, opportunity cost, perceived effectiveness, coherence, ethicality, self-efficacy and general acceptability., From enrollment through the end of the study after child age 4 months.|Feasibility, Feasibility assessment will include measures of recruitment (number enrolled of those eligible), retention (number who attend all scheduled sessions of those enrolled), fidelity (number of curriculun components delivered of those planned), and attendance (1. Attendance rate: number of participants who attend each sessions of those scheduled to attend; 2. Program dose: number of sessions attended for each participant), From enrollment to study completion after infant age 4 months.
Shunt-dependency After aSAH - Role of Early Hyperglycaemia in CSF and Blood
NCT Number: NCT06486909
Acronym: HCP-Glc
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aneurysm, Ruptured|Hyperglycemia|Hydrocephalus
Interventions: DIAGNOSTIC_TEST: Cerebrospinal Fluid (CSF) Sample|DIAGNOSTIC_TEST: Blood Serum Sample
Sponsor: Isabel Hostettler
Collaborators: Kantonsspital Aarau|University Hospital, Basel, Switzerland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-26
Completion Date: 2027-09
Locations: Cantonal Hospital Aarau, Aarau, 5001, Switzerland|University Hospital Basel, Basel, 4031, Switzerland|Cantonal Hospital St Gallen, Saint Gallen, 9007, Switzerland

Summary:
The goal of this study is to confirm the association of early increased glucose levels in cerebro-spinal fluid (CSF) and ventriculo-peritoneal-shunt (VPS)-dependency also evaluating the influence of blood glucose on VPS dependency in patients suffering from an aneurysmal subarachnoid haemorrhage (aSAH). The main questions we aim to answer are:

* Is there an association of glucose levels on VPS dependency in patients requiring extra-ventricular-drain (EVD) placement for aSAH?
* In addition, if there is, what is the influence the course of glucose levels has on VPS dependency?

Glucose levels in CSF and serum will be measured on admission, or in case of CSF, upon EVD placement. Glucose in CSF will then be measured every day until EVD removal together with serum glucose. Follow-up will be conducted in person after 3 and 6 months.

Primary Outcome Measures: Ventriculo-peritoneal shunt (VPS) dependency, Glucose levels in patients requiring EVD/LD placement for aSAH and its influence on VPS dependency., 6 months
Secondary Outcome Measures: Modified Ranking Scale (mRS), Modified Ranking Scale 0-6 where 0 means no symptoms and 6 death (adjusting for VPS dependency) in aSAH patients requiring EVD/LD placement, 6 months
Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus
NCT Number: NCT06486896
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaginismus
Interventions: OTHER: Pelvic floor training|DEVICE: Interferential current|BEHAVIORAL: General advice
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2024-11-20

Summary:
This study aims to determine the effect of adding interferential current to pelvic floor muscle training on vaginismus.

Primary Outcome Measures: Assessment of pain intensity., The visual analogue scale (VAS): will be used to measure pain intensity for each woman in both groups. Each woman will be asked to mark the point on the scale that represents her pain level., Eight weeks|Quantification of pressure pain threshold in the perineum., The pressure pain threshold in the perineum region will be evaluated with a pressure algometer., Eight weeks|Assessment of pelvic floor muscle tone., It will be assessed by biofeedback perineometer., Eight weeks
Secondary Outcome Measures: Measurement of cognition regarding vaginal penetration in women with lifelong vaginismus., The Vaginal Penetration Cognition Scale (VPCQ) will be used to evaluate cognition regarding to vaginal penetration for all participants in both groups before and after the end of the treatment program., Eight weeks
Accuracy Assessment of a Novel Gas Detection Approach in Dyslipidemia Diagnosis
NCT Number: NCT06486857
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dyslipidemias|Gas Detection Method
Interventions: DIAGNOSTIC_TEST: a novel gas detection method for dyslipidemia screening
Sponsor: Beijing Anzhen Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-12-30
Locations: Beijing Anzhen hospital, Beijing, Beijing, 100029, China

Summary:
This study aims to validate the feasibility and accuracy of a novel gas detection method for dyslipidemia screening by analyzing the lipid profile of human breath metabolites. It explores a simple, rapid, and non-invasive method for screening dyslipidemia. The application prospects of this method are broad; it can be used not only for early screening and monitoring of dyslipidemia in hospitals and communities, providing strong support for the prevention of cardiovascular diseases, but also for the routine monitoring and treatment effectiveness evaluation of patients with hyperlipidemia, offering a scientific basis for personalized treatment plans. This study not only has profound scientific value but also provides a theoretical basis for the development of subsequent new clinical testing methods.

Primary Outcome Measures: accuracy of cholesterol testing, within 1 week day of sample collection
The Effect of Stress Ball in Reducing Anxiety and Fear in 6-12 Year Old Children
NCT Number: NCT06486831
Acronym: TSA-2023-12759
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Plaster of Paris Injury to Skin
Interventions: OTHER: Squeeze the stress ball.
Sponsor: Ataturk University
Sex: ALL
Age: CHILD
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-20
Completion Date: 2025-03-20

Summary:
The aim of this study was to determine the effect of stress ball application on procedure-related anxiety and fear during plaster cast procedure in children aged 6-12 years.

Primary Outcome Measures: Patient Identification Form, In this form, there are questions about the child's age, gender, weight, age of the mother and father, presence of long-term illness, previous hospitalization status and reason, previous surgery status, presence of medication on continuous use, analgesic intake in the last 6 hours., baseline
Secondary Outcome Measures: Children's Fear Scale (CFS), The CFS, which was first used in 2003, is a scale with proven validity and reliability developed to assess the child's fear/anxiety and its level. The scale includes five different facial expressions, with no fear/anxiety at one end and very intense fear/anxiety at the other end, and is evaluated on a 0-4 point scale. 0: no fear/anxiety, 4: extreme fear and anxiety., baseline
Other Outcome Measures: Child Anxiety Scale-Dispositional (CAS-D), The CAS-D is shaped like a thermometer with a bulb at the bottom and horizontal lines with intervals going upwards. It is intended for children aged 4-10 years. The scale instructs children to "Imagine that all your anxious or angry feelings are at the bulb or bottom of the thermometer". Following the data collection, two members of the research team review and score the child's CAS-D scores. The score can range from 0 to 10., Baseline
Clinical Predictors of Short Term Outcomes of Ablation of Idiopathic Monomorphic PVCs
NCT Number: NCT06486818
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Arrythmia
Interventions: PROCEDURE: Ablation of idiopathic monomorphic PVCs
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-12-30
Locations: Assiut university, Assiut, Egypt

Summary:
Clinical predictors of successful Pvcs ablation

Primary Outcome Measures: Clinical predictors of short term outcomes of ablation of idiopathic monomorphic PVCs, Successful Pvcs ablation, 2 years
N-Acetyl Cysteine Effect on Liver Function After Mitral Valve Replacement
NCT Number: NCT06486805
Acronym: NAC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Oxidative Stress|Liver Dysfunction
Interventions: DRUG: N acetyl cysteine|OTHER: normal saline
Sponsor: Kasr El Aini Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-30
Completion Date: 2024-10-30
Locations: Kasralainy Faculty of Medicine, Cairo, Egypt

Summary:
This study aimed at the impact of the N-acetyl cysteine on the improvement of liver function subsequently on-pum mitral valve replacement. Following a clinical trial design, 34 candidates of on-pump MVR, aged 30 to 70 years, with normal liver and renal function were selected. The candidates were randomly divided into intervention: IV150 mg/ kg N-acetyl cysteine over 15 min, and control groups (normal saline as placebo) (n = 17 in each group).

Primary Outcome Measures: Malondialdahyde (MDA), MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation., first postoperative day
Secondary Outcome Measures: MDA, MDA is a marker of oxidative stress and one of the end-products of lipid peroxidation. MDA level reflects the degree of lipid peroxidation., preoperative and second postoperative day|liver function tests, ALT,AST,Bilirubin, preoperative ,first ,and,second post operative days|hemodunamics, MAP, HR, intraoperative|extubation time, time needed for extubation, postoperative 24 hr.|tissue perfusion, Lactate, preoperative ,first ,and,second post operative days
Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
NCT Number: NCT06486792
Acronym: SPICAF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Stroke|Ischemic Stroke|Cerebral Infarction|Atrial Fibrillation
Interventions: DRUG: Apixaban|DRUG: Aspirin
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: OLDER_ADULT
Enrollment: 1148
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-03-01

Summary:
Patients who have recently had an ischemic stroke with no clear cause might have undetected atrial fibrillation (AF) that isn't caught during their initial hospital stay. After discharge, these patients are typically monitored for AF using devices like Holter monitors or implantable loop recorders. Treatment options during this period include anticoagulants or aspirin. Anticoagulants are more effective in preventing recurrent strokes if AF is present, offering an 80% risk reduction compared to aspirin's 20%. If AF is detected, anticoagulant treatment continues; if not, patients may switch to aspirin after 6-12 months. Despite the clinical rationale for using anticoagulants during this search period, their benefit-risk ratio compared to aspirin has not been fully evaluated.

Primary Outcome Measures: Occurrence of fatal or nonfatal ischemic stroke, or peripheral emboli (even if asymptomatic) [peripheral emboli: emboli in arm or leg, new renal, splenic, hepatic, mesenteric infarction], Evaluate two commonly used antithrombotic treatment strategies in patients with recent ischemic stroke and at high risk of atrial fibrillation., During the 12 month follow-up
Secondary Outcome Measures: Sensitivity (percentage of true positives) in detecting AF, Yield and comparative rates of atrial fibrillation discovered using various tools (Holter-ECG monitoring device, loop recorder (wearing or implantable monitoring device)., long term using various tools (3 weeks)|The Occurrence of: Recurrent fatal or nonfatal ischemic stroke, any stroke, any stroke or TIA or vascular death, Evaluate two commonly used antithrombotic treatment strategies in patients with recent ischemic stroke and at high risk of atrial fibrillation., During the 12 month follow-up