pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluating The Efficacy Of Combined Cognitive Processing Therapy and Stellate Ganglion Blocks for PTSD: A Randomized Controlled Trial
NCT Number: NCT06570213
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: PTSD
Interventions: BEHAVIORAL: Cognitive Processing Therapy|DRUG: Stellate Ganglion Block
Sponsor: Rush University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-12-31

Summary:
The purpose of this study is to understand if we can improve the treatment for posttraumatic stress disorder (PTSD). We are looking into whether the combination of Stellate Ganglion Block (SGB) treatment and Cognitive Processing Therapy (CPT) can reduce symptoms of PTSD. CPT is a trauma-focused talk therapy that can help identify and challenge unhelpful trauma-related beliefs about oneself, others, and the world. It is known to be a highly effective talk therapy for PTSD. SGB treatment is a procedure involving an injection of local anesthetic into a bundle of nerves located in the neck that is part of the sympathetic nervous system which controls our body's response to stressful situations and blocks pain.

The proposed project will systematically test whether combining CPT with SGB produces greater PTSD symptom reductions and functional improvements in the short- and longer-term up to 6-months follow-up compared to CPT (+Placebo) or SGB (+Daily Monitoring) alone.

Primary Outcome Measures: Clinician Administered PTSD Scale for DSM-5, A clinician rated assessment of PTSD, Baseline to 6 month follow up|PTSD Checklist for DSM-5, A self-report measure of PTSD symptom severity, Baseline to 6 month follow up
Evaluation of iPRF With Vit.D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis
NCT Number: NCT06570200
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Periodontal Pocket
Interventions: PROCEDURE: PMPR+iPRF|DRUG: PMPR+iPRF+Vit.D|PROCEDURE: PMPR only
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-02

Summary:
a clinical trial will be made to investigate the effect of locally applied injectable prf (iPRF) plus vitamin D on the periodontal pockets in stage III periodontitis patients

Primary Outcome Measures: pocket depth reduction, estimate the amount of reduction of the pocket depth from baseline and after 6 months of treatment, 6 months
Secondary Outcome Measures: clinical attachment level (CAL) gain, the amount of CAL gained from baseline and after 6 months of treatment, 6 months|Plaque index, comparison of amount of plaque before and after treatment using plaque score, 6 months|Bleeding on probing (BOP), measuring the percentage of BOP using a periodontal probe before and after treatment, 6 months|Gingival Marginal Level (GML), determining the location of gingival margin in relation to the tooth before and after treatment, 6 months|Post-operative Pain, comparing the pain before and after treatment using Visual Analogue Scale(VAS) Questionnaire. A scale from 0-10 will be used with 0 means no pain and 10 means maximum pain., 6 months|Treatment time taken for each groups, a timer will be used to determine the required time of each procedure of the 3 study groups, 6 months|degree of bone fill or loss, using digital software, evaluation of the radiographic changes will be done at the area diagnosed with periodontal problem and selected for the treatment before and after the intervention., 6 months
Assessment of Fit of Novel N95 Style Transparent Face Masks
NCT Number: NCT06570161
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Disease|Infection, Coronavirus|Respiratory Tract Infections
Interventions: DEVICE: SEEUS95 Transparent mask|DEVICE: CrystalGuard Mask|DEVICE: N95 face mask
Sponsor: Brigham and Women's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-10-01
Completion Date: 2025-05-30
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

Summary:
Face masks have become a critically important public health intervention after the COVID-19 pandemic. Multiple types of masks ranging from full face filtering to cloth masks have been developed and commercialized to facilitate protection against respiratory pathogens. Most of these systems are made with opaque fabrics and may prevent individuals from expressing emotions or for those who are deaf and hard of hearing, communicating. To date, few transparent face masks which also confer respiratory pathogen protection have been developed. This study will test the feasability and acceptability of two new masks, the SEEUS-95 mask and CrystalGuard mask which are both transparent versions of N-95 filtering face masks.

Primary Outcome Measures: Acceptability, User acceptability and comfort wearing the assigned mask graded on a likert scale, immediately after mask wearing
Secondary Outcome Measures: Mask preference, Discrete choice of SEEUS-95, CrystalGuard versus standard N-95 mask selected by study participants, immediately after completion of all three arms
Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial
NCT Number: NCT06570135
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premature Ejaculation
Interventions: DIAGNOSTIC_TEST: Detecting Brain Activity with Functional Near Infrared Spectroscopy
Sponsor: Xijing Hospital
Sex: MALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-26
Completion Date: 2025-07-09

Summary:
This is a controlled study of patients with and without primary premature ejaculation. It is based on near-infrared spectroscopy (NIRS) functional brain imaging to detect and compare changes in brain activity in resting and task states (Simulated Sex) between the two groups of patients.

Primary Outcome Measures: Results of near-infrared brain functional imaging, Data on changes in oxygenated hemoglobin concentration, 1 hours
Mobile Phone-Based Smoking-Cessation Intervention for Smoking Parents
NCT Number: NCT06570122
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking Cessation
Interventions: BEHAVIORAL: 5A's/5R's advice|OTHER: Health warning leaflet|BEHAVIORAL: AI-powered chatbot support
Sponsor: Beijing Normal University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-12-30
Locations: Beijing Normal University, Zhuhai, Guangdong, 519087, China

Summary:
This study aims to explore the feasibility and preliminary effectiveness of a mobile phone-based intervention tailored specifically for smoking parents.

Primary Outcome Measures: Self-reported 7-day point prevalence quit rate, Self-reported 7-day point prevalence quit rate in the two groups, 3 and 6 months follow-up|Eligibility rate, the percentage of eligible smokers out of the total number of smokers screened, baseline
Secondary Outcome Measures: Consent rate, the percentage of eligible smokers who agree to participate out of the total number of eligible smokers, baseline|Percentage of Participant Engagement with E-Messages and Counselor Chats, This outcome measures the percentage of participants who engage with the intervention by reading e-messages and responding to counselor chat messages at least once during the 3-month follow-up period., 3 months follow-up
Frailty and Functional Ability in Alzheimers
NCT Number: NCT06570109
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alzheimer Disease
Interventions: OTHER: Frailty
Sponsor: Aalborg University Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-06
Completion Date: 2027-09-01

Summary:
The primary aim of this study is to investigate the association between frailty as defined by the Fried Frailty Phenotype and risk of functional decline in patients with Alzheimer's dementia. The hypothesis is that frailty is associated with greater functional decline in community-dwelling older people with Alzheimer's dementia compared to those without frailty.

Secondary aims include investigation of long-term risk of institutionalization (through administrative follow-up) and trajectories of assessment components in future assessment.

The study is designed as a prospective cohort study. Participants in the study will undergo an assessment battery at baseline, 1 years of follow-up, and administrative follow-up for 5 years.

Participants will be recruited from patients of the Unit of Dementia at Aalborg University Hospital within 3 months of dementia diagnosis. The time frame of 3 months after diagnosis was chosen to ensure that cognitive assessment in the Unit of Dementia was reflective of patient's cognitive level and thereby ability to consent at inclusion. Patients will be eligible for inclusion if they are 65 years or older, have a diagnosis of mild or moderate Alzheimer's or mixed (Alzheimer's and vascular) dementia, live at home, and are able to walk 5 meters independently of other people (walking aids will be allowed). The severity of dementia will be defined according to score on the Mini Mental State Examination (MMSE) as it has done in other studies. According to this definition a MMSE score between 20-30 indicates mild Alzheimer's dementia and a MMSE score from 15-19 indicates moderate dementia. People with moderately severe and severe Alzheimer's dementia defined as MMSE score below 15 will not be eligible to participate.

Primary Outcome Measures: Caregiver IADL Decline, Defined by caregiver reported ADL performance on the Functional Activities Questinnaire, 1 year|Patient IADL Decline, Defined by patient reported ADL performance on the Functional Activities Questinnaire, 1 year|Caregiver BADL Decline, Defined by caregiver reported ADL performance on Katz ADL scale, 1 year|Patient BADL Decline, Defined by Patient reported ADL performance on Katz ADL scale, 1 year
Secondary Outcome Measures: Nursing home admission, Admission to nursing home (time to event), 5 years|Mortality, Death (time to event), 5 years
Premixed vs Sequential Injections of Lidocaine and Bupivacaine for Supraclavicular Brachial Plexus Block in Patients Undergoing Arteriovenous Fistula Creation
NCT Number: NCT06570096
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premixed|Sequential|Lidocaine|Bupivacaine|Supraclavicular Brachial Plexus Block|Arteriovenous Fistula
Interventions: DRUG: Lidocaine 2% then bupivacaine 0.5%|DRUG: Lidocaine 2% and bupivacaine 0.5%
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-24
Completion Date: 2025-02-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
This study aims to compare premixed and sequential injections of lidocaine and bupivacaine for supraclavicular brachial plexus block in patients undergoing arteriovenous fistula creation.

Primary Outcome Measures: Percentage of participants with a complete four-nerve sensory block, Percentage of participants with a complete four-nerve sensory block at 10 minutes will be recorded., With in 10 minutes intraoperatively
Secondary Outcome Measures: Time of onset of sensory block, Time of onset of sensory block is defined as time interval between end of local anesthetics injection and complete loss of sensation to pin prick in all four nerve distribution areas, and the duration of sensory block is defined as the time interval between onset of sensory block and reappearance of pinprick sensation in all four nerve distribution areas., Intraoperatively|Time of onset of motor block, Time of onset of motor block is defined as the time interval between the completion of local anesthetics injection and the inability of patient to move the elbow, wrist and fingers of the operating limb., Intraoperatively|Degree of pain, Degree of pain will be recorded using numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). It will be assessed every 2 hours for 6 hours then every 4 hours for 24 hours postoperatively., 24 hours postoperatively|Time to the 1st rescue analgesia, Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated) will be recorded., 24 hours postoperatively|Degree of patient satisfaction, Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied), 24 hours postoperatively|Incidence of adverse events, Incidence of adverse events such as local anesthetics systemic toxicity, PONV, hypotension, pneumothorax, or any other complication will be recorded., 24 hours postoperatively
AI-powered Chatbot vs. Human Counselors in Smoking Cessation
NCT Number: NCT06570070
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking Cessation|Mobile Health
Interventions: BEHAVIORAL: 5A's/5R's advice|OTHER: Brief leaflet on health warning and smoking cessation|OTHER: Self-help smoking cessation booklet|BEHAVIORAL: AI-powered chatbot support|BEHAVIORAL: Counselor individual support
Sponsor: Beijing Normal University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-12-30
Locations: Beijing Normal University, Zhuhai, Guangdong, 519087, China

Summary:
This study aims to explore the feasibility and preliminary effectiveness of AI-powered chatbot support in community smokers.

Primary Outcome Measures: Biochemical validated quit rate at 6 months follow-up, The primary outcomes are biochemically validated quit rate (exhaled carbon monoxide \< 4 ppm or salivary cotinine \< 30 ng/ml), 6 months follow-up
Secondary Outcome Measures: Biochemical validated quit rate at 3 months follow-up, biochemically validated quit rate (exhaled carbon monoxide \< 4 ppm or salivary cotinine \< 30 ng/ml), 3 months follow-up|Self-reported 7-day point prevalence quit rate, Self-reported 7-day point prevalence quit rate in the two groups, 3 and 6 months follow-up|Smoking reduction rate, Rate of smoking reduction by at least half of baseline amount in the two groups, 3 and 6 months follow-up|Eligibility rate, the percentage of eligible smokers out of the total number of smokers screened, baseline|Consent rate, the percentage of eligible smokers who agree to participate out of the total number of eligible smokers, baseline|Percentage of Participant Engagement with E-Messages and Counselor Chats, This outcome measures the percentage of participants who engage with the intervention by reading e-messages and responding to counselor chat messages at least once during the 3-month follow-up period., 3 months follow-up
Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors
NCT Number: NCT06570057
Acronym: EMPOWER-D
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type II Diabetes Mellitus
Interventions: BEHAVIORAL: Participatory, learning and Action (PLA) Based intervention
Sponsor: Baqai Institute of Diabetology and Endocrinology
Collaborators: University of York|Khyber Medical University Peshawar|HealthNet TPO|National Institute for Health Research, United Kingdom|Aga Khan University Hospital, Pakistan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-24
Completion Date: 2027-10
Locations: Baqai Institute of Diabetology and Endocrinology (BIDE), Karachi, Sindh, 74600, Pakistan

Summary:
This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.

Primary Outcome Measures: Prevalence of Type II Diabetes Mellitus, HbA1c biochemical test, 18 months|Two-year cumulative incidence of Type II Diabetes Mellitus, HbA1c biochemical test, 18 months
Secondary Outcome Measures: Mean diastolic and systolic blood pressure, Digital blood pressure monitoring, 18 months|Prevalence of hypertension, Digital BP monitoring, 18 months|Abdominal obesity, Waist-to-hip circumference ratio, 18 months|Mean body mass index, Height and weight will be taken, 18 months|Health-related quality of life, World Health Organization Quality of Life (WHOQOL) BREF questionnaire, 18 months|Frequency of depression, Patient Health Questionnaire (PHQ-9), 18 months|Mean body fat percentage, Using impedance analyzer, 18 months|Prevalence of overweight and obesity, Height and weight will be taken, 18 months|Frequency of anxiety, Generalized Anxiety Disorder (GAD-7) Scale, 18 months
Etiology and Hemodynamic Instability in Brain Death
NCT Number: NCT06569992
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Brain Death
Interventions: OTHER: VIS, TIES
Sponsor: Antalya Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-30
Completion Date: 2024-12-30
Locations: University of Health Sciences, Antalya, Muratpasa, 07100, Turkey

Summary:
Brain death is a complex and irreversible condition marked by the cessation of all brain activity. This retrospective study analyzes ICU patients who progressed from initial brain injury to brain death. The research focuses on demographic profiles, pharmacological interventions, laboratory data, and imaging findings to understand these cases clinical trajectories and therapeutic responses. Central to this study is evaluating cardiovascular support using the Vasoactive-Inotropic Score (VIS) and Total Inotrope Exposure (TIE) Score. This study explores the relationship between the etiology of brain death and the pharmacologic cardiovascular support administered, as quantified by VIS and TIES scores. This study seeks to enhance the management strategies and improve outcomes for patients diagnosed with brain death

Primary Outcome Measures: Total Inotrope Exposure Score (TIES), Dopamine dose (μg/kg/min) × \[length of administration in days\] + Dobutamine dose (μg/kg/min) × \[length of administration in days\] + 10 × Milrinone dose (μg/kg/min) × \[length of administration in days\] + 100 × Epinephrine dose (μg/kg/min) × \[length of administration in days\] + 100 × Norepinephrine dose (μg/kg/min) × \[length of administration in days\] + 10,000 × Vasopressin dose (U/kg/min) × \[length of administration in days, From beginning to vasoactive-inotropic drugs infusion until diagnosis of brain death, 10 days (with intermediate measurements every hours)|Vasoactive-Inotropic Score (VIS), Dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min)., From beginning to vasoactive-inotropic drugs infusion until diagnosis of brain death, 10 days (with intermediate measurements every hours)
The Knowledge Gaps of Amputee Rehabilitation Course Content in Physiotherapy Curriculum
NCT Number: NCT06569979
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Amputation|Rehabilitation|ICF
Interventions: OTHER: Survey
Sponsor: Akdeniz University
Collaborators: Hasan Kalyoncu University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 73
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-01
Completion Date: 2024-05-30
Locations: Akdeniz University, Antalya, Turkey

Summary:
Understanding the knowledge gaps of amputee rehabilitation course content is essential for addressing these gaps. Identifying the course contents according to International Classification of Functioning, Disability and Health (ICF) can be a starting point for determining the gaps. This study aimed to investigate which amputee-specific ICF categories are underemphasized in the course content.

Primary Outcome Measures: Survey, The survey was developed using the Google Forms platform. The first part of the questionnaire consisted of descriptive information such as age, gender, duration of academic experience. In addition to this informations, the questionnaire also included information related the status of use ICF in any fields.

In the other part of the questionnaire, a total of 59 questions (16 related to body functions, 3 related to body structures, 30 related to activity and participation, 10 related to environmental factors) were asked to the academicians whether these categories are present in the amputee rehabilitation course content. Academicians were asked to answer "yes" or "no" to each question., 1 day
The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure
NCT Number: NCT06569966
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Anterior Resection Syndrome
Interventions: BEHAVIORAL: preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon
Sponsor: The Affiliated Hospital of Qingdao University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 154
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-07-01
Completion Date: 2024-12
Locations: the Affiliated Hospital of Qingdao, Qingdao, Shandong, 266000, China

Summary:
This study was a single-center RCT study to compare the effect of preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon with that of traditional treatment in patients with bowel function after stoma closure.

Primary Outcome Measures: The extent of low anterior resection syndrome, low anterior resection syndrome score（0-42，Higher scores indicate more severe symptoms）, 1 month after discharge, and 3, 6, and 12 months after surgery
Secondary Outcome Measures: the intestinal function recovery, The first postoperative exhaust and defecation time, up to 10 days after surgery|Concentration of C-reactive protein, Concentration of C-reactive protein after surgery, up to 10 days after surgery|Quality of Life Questionnaire Core 30, Quality of Life Questionnaire Core 30（0-100，standardscore，A higher score in the symptom domain indicates a worse quality of life）, 1 month after discharge, and 3, 6, and 12 months after surgery|fecal incontinence, The Cleveland clinic fecal incontinence score（0-20，Higher scores indicate more severe symptoms）, 1 month after discharge, and 3, 6, and 12 months after surgery|Weight change after rehabilitation, Weight change after rehabilitation, From date of randomization until the date of stoma closure surgery, assessments usually take up to 3 months|The number of emergency visits or rehospitalizations related to stoma closure, The number of emergency visits or rehospitalizations related to stoma closure, 1 year after surgery|the incidence of postoperative intestinal obstruction (POI), the incidence of postoperative intestinal obstruction (POI), 1 year after surgery
Sleepiz One+ vs. Capnography and Electrocardiography
NCT Number: NCT06569940
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Apnea|Asthma|COPD|Hypertension|Diabetes|Respiratory Disease|Cardiovascular Diseases
Interventions: DEVICE: Sleepiz One+
Sponsor: Sleepiz AG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-18
Completion Date: 2024-09-30
Locations: Schlaflabor Fluntern, Zürich, Zurich, 8044, Switzerland

Summary:
Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. Effective management of chronic diseases relies on detecting pathological changes early, with RR being among the most sensitive predictors of patient deterioration. Therefore, vigilant monitoring of RR and HR is vital for improving patient outcomes.

The primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ algorithms and end-tidal carbon dioxide measurement (EtCO2) Capnography for measuring respiration rate and electrocardiography (ECG) for measuring heart rate, in healthy adults and patients suffering from chronic conditions (e.g., hypertension, Chronic Obstructive Pulmonary Disease (COPD), asthma, diabetes), at rest in a clinical setting when the data is acquired with the new hardware version. Additionally, the investigators will evaluate the performance of RR estimation against the thoracic effort belt and the HR against the pulse oximetry.

Primary Outcome Measures: Instantaneous respiration rate measurement accuracy per 60s epoch, Instantaneous respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed, During 60 seconds|Instantaneous heart rate measurement accuracy per 60s epoch, Instantaneous heart rate measurement accuracy per 60s epoch against ECG R-R interval, recorded on subjects lying down and resting on a bed, During 60 seconds
Study on the Influence of Humanized Nursing Model on the Effect of Intravenous Infusion Care
NCT Number: NCT06569914
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intravenous Infusion
Interventions: BEHAVIORAL: Humanized care
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2024-09-30

Summary:
The routine nursing content is relatively simple, and nursing measures are greatly influenced by the personal experience of nursing staff, lacking a systematic approach Sexuality, scientificity, and relatively late implementation have resulted in unsatisfactory preventive effects. Early nursing intervention emphasizes the importance of patients The impact of early postoperative intervention can effectively meet the cognitive needs of patients and improve their compliance with treatment and care At the same time, early intervention can help patients avoid risks and better achieve nursing goals. This selection A study was conducted on 40 patients receiving intravenous infusion to explore the impact of humanized nursing on the effectiveness of intravenous infusion nursing.

Primary Outcome Measures: Hamilton Depression Scale, Evaluate patients' psychological changes through the four indicators in the Hamilton Depression Scale (depression, mental anxiety, sleep disorders, and physical anxiety). Each indicator ranges from 0 to 4 points, with 0 being the minimum value and 4 being the maximum value. The better the patient's mentality, the lower the score., Up to 24 hours (during intravenous infusion)|Self-made scale, Evaluate patients' satisfaction with nursing services through five indicators in a self-made scale (environmental quality, reception attitude, puncture proficiency, health education quality, communication ability). The range of each indicator is from 0 to 100 points, with 0 being the minimum value and 100 being the maximum value. The higher the patient satisfaction, the higher the rating., Up to 24 hours (during intravenous infusion)
Utility of Low Intensity Pulsed Ultrasound Stimulation (LIPUS) to Modulate the Release of Mediators Capable of Reflecting the Inflammatory State in the Affected Colonic Tract of Ulcerative Colitis Patients
NCT Number: NCT06569888
Acronym: LIPUSinVIVO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ulcerative Colitis
Interventions: DEVICE: LIPUS stimulation
Sponsor: Istituto Clinico Humanitas
Collaborators: Innovative Medicines Initiative|Ospedale San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-11-01
Completion Date: 2026-06-30

Summary:
The goal of this clinical trial is to learn whether Low Intensity Pulsed Ultrasound (LIPUS) is capable of promoting the release of extracellular vesicles from the gut into the bloodstream of Ulcerative Colitis (UC) patients, whose content may be predictive of the inflammatory state of the mucosal source to aid the monitoring of the disease status and therapy response.

The main questions it aims to answer are:

Is LIPUS effective in inducing the release of biomarker-containing micro-vesicles into the bloodstream, capable of reflecting the inflammatory state of the mucosa during active disease?

Are there any extracellular vesicle-contained biomarkers that can monitor therapy during clinical remission?

Participants who undergo endoscopy and gut biopsy collection as per Standard Of Care, will:

* undergo abdominal ultrasound to establish the distance with the target tissue and consequently set the LIPUS device to supply the optimum energy established in the protocol.
* before LIPUS stimulation and 2 hours after stimulation, patients will have blood drawn
* an extra intestinal biopsy during endoscopy will be collected
* patients will be contacted 72h after intervention for adverse events monitoring

Primary Outcome Measures: Efficiency of LIPUS in terms of target-specific extracellular vesicle release, Evaluation of LIPUS efficiency in extracellular vesicle release by measuring extracellular vesicle concentration in blood before and after LIPUS stimulation, 14 months
Secondary Outcome Measures: Accuracy of LIPUS stimulation in monitoring ulcerative colitis in terms of tissue state-specific biomarkers contained in LIPUS-induced extracellular vesicles, Identification of extracellular vesicle molecular content before and after LIPUS stimulation which correlate with intestinal inflammation in Ulcerative Colitis (active/remission states) by fluorescent miRNA microarray technology and RNA-seq, 14 months
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults
NCT Number: NCT06569823
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Shingles|Herpes Zoster|Vaccine-Preventable Diseases
Interventions: BIOLOGICAL: Z-1018|BIOLOGICAL: Shingrix
Sponsor: Dynavax Technologies Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 440
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-17
Completion Date: 2026-09
Locations: Northern Beaches Clinical Research, Brookvale, New South Wales, 2100, Australia

Summary:
This is a randomized, active-controlled, observer-blinded, dose-escalation multi-center trial of 2 doses of an investigational HZ vaccine (Z-1018) in approximately 440 healthy adults.

Primary Outcome Measures: Percentage of participants with solicited local and systemic post-injection reactions (PIRs), Solicited local and systemic post-injection reactions (PIRs), Up to 7 days following each dose|Percentage of participants with Adverse events (AEs), Adverse events (AEs), 28 days following each dose|Percentage of participants with serious adverse events (SAEs), medically-attended adverse events (MAEs), and immune-mediated adverse events of special interest (imAESIs), Serious adverse events (SAEs) Medically-attended adverse events (MAEs) Immune-mediated adverse events of special interest (imAESIs), Day 1 through 12 months after the last dose of study injection
Secondary Outcome Measures: Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE) 4 weeks after the second study injection, Geometric mean concentration (GMC) to varicella-zoster virus (VZV) gE in the Per Protocol (PP) population, 4 weeks after the second study injection|Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE, Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE in the Per Protocol (PP) population, 4 weeks after the second study injection|Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE, Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE in the Per Protocol (PP) population, 4 weeks after the second study injection|Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE, Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE in the Per Protocol (PP) population, 4 weeks after the second study injection
Real-world Registry Study of Red Light Treatment on Myopia Control: a Focus on Non-responders to Conventional Treatments
NCT Number: NCT06569810
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myopia|Repeated Low-level Red Light
Interventions: DEVICE: Repeated Low-Level Red Light (RLRL) therapy
Sponsor: The Hong Kong Polytechnic University
Sex: ALL
Age: CHILD
Enrollment: 2500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-09-01

Summary:
This real-world observational registry study aims to assess the effectiveness of Repeated Low-Level Red Light (RLRL) therapy in controlling myopia progression among children aged 8 to 16 who have not responded to conventional treatments like Orthokeratology and atropine eyedrops. The primary focus is to determine if RLRL therapy can limit axial length (AL) elongation to less than 0.1mm per year and spherical equivalent refraction (SER) progression to less than 0.25 diopter per year, while also evaluating safety and visual outcomes.

Primary Outcome Measures: The proportion of fully controlled, The proportion of the people with AL elongation of less than 0.1mm per year or SER progression of less than 0.25 diopter per year after RLRL therapy for 12 months., 12 months for each participate
Secondary Outcome Measures: BCVA changes, Best corrected visual acuity (BCVA) changes at 12 months., 12 months for each participate|Optical coherence tomography (OCT) scan changes (eg. choroidal thickness changes on OCT scans.), Optical coherence tomography (OCT) scan changes at 12 months., 12 months for each participate
Evolution of the Patient's Perception of the Use of the Upper Limb After a Stroke During Intensive Rehabilitation
NCT Number: NCT06569771
Acronym: ValetM-2024
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Upper Limb Ischemia
Interventions: DIAGNOSTIC_TEST: Functional assessments
Sponsor: Grand Hôpital de Charleroi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-11
Completion Date: 2025-12-31
Locations: Grand Hôpital de Charleroi, Charleroi, Hainaut, 6060, Belgium

Summary:
This study is being carried out in the context of rehabilitation after stroke, where persistent upper limb weakness is a major challenge. It aims to explore the relationship between observed function and patients' perceived participation in use.

Primary Outcome Measures: To assess whether the perception of use of the impaired upper limb improves during intensive rehabilitation after a stroke., various tests : computer adaptive test F-M, ARA test, MIF test, star concellation test, ACTIVLIM test, Up to 2 months|To compare the difference between perception and observed function of the upper limb during intensive multidisciplinary rehabilitation treatment., various tests : computer adaptive test F-M, ARA test, MIF test, star concellation test, ACTIVLIM test, Up to 2 months
Evaluation of Children's Oral Health Education With Different Education Methods
NCT Number: NCT06569745
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries in Children
Interventions: OTHER: Verbal Explanation|OTHER: Animation Video Display|OTHER: Peer-Led Reels Video Display
Sponsor: Tokat Gaziosmanpasa University
Sex: ALL
Age: CHILD
Enrollment: 464
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2022-01-15
Completion Date: 2022-06-30
Locations: Tokat Gaziosmanpasa University, Tokat, 60100, Turkey

Summary:
Different educational methods may play a crucial role in oral and dental health education programs.

The aim of our study is to evaluate the effects of different educational methods on the knowledge levels of primary school children regarding oral and dental health. The null hypothesis of this study is that there is no difference between education methods on the level of knowledge acquired by children about oral and dental health.

Primary Outcome Measures: After education knowledge, A questionnaire was administered to the children to measure their oral and dental health knowledge and then educations were given. After the educations, the same questionnaire was applied again to determine how effective these educations were according to the groups and their knowledge levels were evaluated.

The questionnaire was divided into two parts. The first part collected demographic data, such as age, gender, and tablet/mobile phone usage. The second part consisted of 8 questions assessing general knowledge about oral and dental health. Each correct answer was scored as 1 point, while incorrect and unanswered questions received 0 points., 1 year
Effectiveness of CDT for the Treatment of Lymphedema in Breast Cancer Patients Who Received LVA Surgery
NCT Number: NCT06569719
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Lymphedema
Interventions: OTHER: Complex decongestive therapy
Sponsor: Fundacion Universitaria Maria Cano
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2024-12-30
Locations: Fundación Universitaria María cano, Medellin, Antioquia, 05000, Colombia|Fundación Universitaria María Cano, Medellín, Antioquia, 0000, Colombia

Summary:
Breast cancer is the most common type of cancer in women worldwide. Advances in treatment have increased survival rates, so patients must live with the complications resulting from the cancer and its treatment. One of the most common side effects is lymphedema, which can occur as a secondary effect of surgical or radiotherapy treatment. Lymphatic edema is a condition characterized by an excess of lymphatic fluid, rich in proteins, in the subcutaneous tissue, causing pain, a feeling of heaviness in the affected limb, restricted range of motion, and, in some cases, progressing to the formation of ulcers and recurrent infections; inevitably affecting the quality of life of the women who suffer from it. There are various therapeutic strategies to reduce the risk of developing lymphedema or to treat it. Among the management options is complex decongestive therapy (CDT), which is a conservative treatment that includes manual lymphatic drainage (MLD), compression therapy, skin care, and lymph-reducing exercises (LRE). Surgical options include lymph node transfer and lymphovenous anastomosis; redirecting lymphatic circulation and reducing edema in the affected limb. This is why the current research is undertaken, aiming to evaluate the effectiveness of combining these two treatment approaches in terms of reducing lymphedema, the presence of cellulitis, and changes in patients' quality of life

Primary Outcome Measures: Lymphedema change, Upper and leg Extremity Lymphedema Index. The index includes 5 perimeters that are sum and divided by BMI. Classified as mild leg lymphedema \< 250, mild to severe 250-350 and severe \> 350. Classified as mild arm lymphedema \< 130, mild to severe 130-150 and severe \> 150 This outcome is compound by multiple measurements that will be aggregated to arrive at one reported., Baseline, post-intervention up to 3 weeks and 3 months follow up
Secondary Outcome Measures: Quality of life change, ARM and LEG Lymphoedema Quality of Life Tool (LYMQOL). It includes 3 domains (Function, symptoms, mood) and an overall quality of life score. Domain totals are calculated by adding the individual scores and dividing the total by the number of questions answered. A higher number means a poor quality of life., Baseline, post-intervention up to 3 weeks and 3 months follow up
Dyadic Sleep Study
NCT Number: NCT06569693
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastrointestinal Cancer
Interventions: BEHAVIORAL: My Sleep Our Sleep (MSOS) Program|BEHAVIORAL: Brief Behavioral Treatment for Insomnia (BBTI)
Sponsor: University of Miami
Collaborators: National Institute of Nursing Research (NINR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 152
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2026-10-01
Locations: University of Miami, Coral Gables, Florida, 33146, United States

Summary:
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.

Primary Outcome Measures: Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI), Change in sleep disturbance symptoms (patient-sleep-partner caregiver dyads) among participants will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-reported, 19-item questionnaire health-related quality of life (HRQOL) questionnaire which assesses sleep quality and disturbances at baseline, week 5 and week 13. Questions generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. A decrease of ≥ 5 points on the PSQI) will be considered as clinical improvement of symptoms., Baseline, Up to 13 weeks
Secondary Outcome Measures: Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI), Change in insomnia symptoms among participants (patient-sleep-partner caregiver dyads) will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the 7-item Insomnia Severity Index (ISI). The ISI is a self-reported, health-related quality of life (HRQOL) questionnaire used to assess insomnia symptoms at baseline, week 5 and week 13. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item, ranging from 0 to 4 (e.g., 0 = no problem; 4 = very severe problem). The total score ranges from 0 to 28, the lower total score indicates a lower level of insomnia. Greater than a 6-point decrease on the ISI is considered substantial reduction in insomnia symptoms., Baseline, Up to 13 weeks
Using AI and Peer Coaching to Address Racial Disparities Among People Who Use Opioids
NCT Number: NCT06569667
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder
Interventions: BEHAVIORAL: PRC supported text + AI driven SDH-enhanced text|BEHAVIORAL: AI driven SDH-enhanced text only|BEHAVIORAL: Treatment as Usual (TAU)
Sponsor: Friends Research Institute, Inc.
Collaborators: Nathan Kline Institute for Psychiatric Research|NYU Langone Health|Weill Medical College of Cornell University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 292
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-15
Completion Date: 2026-08-31

Summary:
Black and Latinx people who use opioids are disproportionately impacted by opioid overdose deaths. The proposed study assesses the efficacy of an open source, multimodal artificial intelligence-driven texting tool combined with peer recovery coach-supported text contact that delivers social services, stigma reduction, health habitus, and patient navigation content addressing social determinants of health to enhance receipt of buprenorphine in primary care among emergency department-enrolled Black / Latinx people who use opioids.

Primary Outcome Measures: Rate of self-reported linkage to OUD services, The primary outcome for this efficacy study is self-reported linkage to OUD services (i.e., time to initial buprenorphine prescription that is prescribed in OBOT programs or other OUD treatment providers per the Non-study Medical and Other Services form., 1 year
Secondary Outcome Measures: Durability of treatment, Durability of treatment effect at 52 weeks. For example, continuous retention in Office-Based Opioid Treatment with buprenorphine., 1 year|receipt of social services, Number of social services received and documented over 52 weeks., 1 year|longitudinal engagement with intervention, Total number of interactions and time spent (in minutes) engaged with the intervention over 26 weeks, 26 weeks
Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System
NCT Number: NCT06569641
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neonatal Disease|Post-Surgical Complication|Cardiac Disease
Interventions: DEVICE: Neoneur Feeding System
Sponsor: Neoneur LLC
Sex: ALL
Age: CHILD
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2026-09

Summary:
A prospective non-randomized longitudinal design of 30-40 infants from initiation of oral feeding until discharge to track feeding changes as a potential indicator of surgical recovery.

Primary Outcome Measures: To test the validity in use of feeding parameters to measure recovery progress for infants with complex CHD, A comparison of feeding patterns (oral cavity pressure changes in suck and swallow, and respiratory patterns) and changes as an infant recovers and determination if there is a greater than 60% concordance with behavioral survey measuring recovery., 12 months
Secondary Outcome Measures: Comparison of Neoneur Feeding system measurements seen in post surgical infants, to match clinical observation of suck, swallow, and breathing during oral feeding., 70% concordance between Neoneur Feeding Trace, and clinical observation, 12 months