pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting
NCT Number: NCT06543966
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Post-operative Nausea and Vomiting (PONV)
Interventions: DRUG: Aprepitant Injection|DRUG: Aprepitant Injection Placebo
Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 486
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-28
Completion Date: 2026-03-28

Summary:
A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,

Primary Outcome Measures: Complete response (CR) rates over 24 hours after the end of surgery, Complete response (defined as no emetic episodes and no use of rescue therapy), 0-24 hours after the end of surgery
Secondary Outcome Measures: Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery, No nausea（defined as a visual analogue scale (VAS) nausea score \< 1.）, 0-24 hours after the end of surgery|Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery, Significant nausea（defined as a visual analogue scale (VAS) nausea score≥4）, 0-24 hours after the end of surgery|Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery, No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）, 0-24 hours after the end of surgery|Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery, 0-24 hours after the end of surgery|Time to treatment failure in the 0 to 24 hours following the end of surgery, defined as the time to the first episode of vomiting (vomiting or retching) or the time to rescue therapy, whichever occurred first., 0-24 hours after the end of surgery|Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery, No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）, 0-48 hours after the end of surgery|The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery, 0-48 hours after the end of surgery
Other Outcome Measures: Number of participants with treatment-related adverse events as assessed by NIH, Safety was assessed by Adverse events (AEs) were recorded after administration., Day 0 to Day14
Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App
NCT Number: NCT06543953
Acronym: HCARE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hearing Loss, Sensorineural|Cochlear Implant
Interventions: DEVICE: HearCare MED-EL App
Sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2026-08

Summary:
This clinical investigation intends to assess safety and performance of the HearCare MED-EL App, a remote care option for recipients of MED-EL cochlear implants

Primary Outcome Measures: Primary Endpoint to assess performance of the HearCare MED-EL App by installing a new audio processor configuration and performing a system check with the HearCare MED-EL App, The primary endpoint is success rate of the HearCare MED-EL app in percent for both the installation of new audio processor configurations and the detection of technical issues of audio processors or implants., immediately after the intervention
Secondary Outcome Measures: Speech test in quiet, Speech test in quiet results (Freiburg Monosyllables at 65 dB SPL), immediately after the intervention|Speech test in noise, Speech test in noise results (adaptive SRT50 measured with Oldenburger Satztest (OLSA)) (optional), immediately after the intervention|Product specific questionnaire (for users), Results of the product-specific user questionnaire (use of the App and satisfaction with the App). This questionnaire has various questions with different answer options (yes/no; amount of use; Likert scale, open text). Results to each question will be analyzed descriptively., 2 months after the intervention|Product specific questionnaire (for professionals), Results of the product-specific professional user questionnaire (satisfaction, performance, safety, and off-label use) by professionals. This questionnaire has various questions with different answer options (yes/no; amount of use; Likert scale, open text). Results to each question will be analyzed descriptively., through study completion, an average of 2 years|Device parameters, Readout of device parameters stored in the devices internal memory/cloud services (e.g. log files, battery status, audio processor configurations, system check parameters, usage times), immediately after the intervention|Incidents of device related adverse events, The safety profile of the HearCare MED-EL App will be evaluated through the analysis of device-related adverse events and in particular Unanticipated Serious Adverse Device Effect (USADE) assessment., through study completion, an average of 2 years
Pharmacokinetics Vancomycin CVVHDF With oXiris Membrane
NCT Number: NCT06543940
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: AKI - Acute Kidney Injury
Interventions: DRUG: Vancomycin
Sponsor: Mahidol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-15
Completion Date: 2025-12-31
Locations: Facullty of Pharmacy Mahidol University, Bangkok, Payathi, 10400, Thailand

Summary:
This study is a general pharmacokinetic investigation of vancomycin in patients receiving continuous veno-venous hemodiafiltration (CRRT) with the oXiris membrane. This membrane offers the added benefit of absorbing inflammatory cytokines. In vitro studies show that vancomycin is reduced by around 20 percent in patients using the AN69ST membrane, which is part of the oXiris membrane's structure. However, there is currently a lack of in vivo studies demonstrating the impact of the oXiris membrane on vancomycin levels. Therefore, the hypothesis of this study is that vancomycin is also reduced by absorption in the oXiris membrane. This study measures the levels of vancomycin in these patients to determine the pharmacokinetic parameters.

Primary Outcome Measures: AUC of vancomycin, calculated AUC of vancomycin by 8 points of drug level. (at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after administration), at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin
Secondary Outcome Measures: To determine the Cmax of vancomycin, calculated Cmax of vancomycin in these patient by phoenix winnonlin software., 1 year|30-day mortality rate, monitor mortality rate at 30 days after received maintenance dose, 30 day after intervention period|percentage of patients who, receiving AUC/MIC ratio within the range of 400 to 600 mg*h/L., calculate percent sample who AUC with in target by number sample in target divide to total population., 1 years|incidence of adverse effects of vancomycin, record the incidence of adverse effects during the intervention period., 1 years|renal recovery rate at 30 days, monitor renal replacement therapy status at 30 days after received maintenance dose, 30 day after intervention period|To determine the elimination rate constant (Ke) of vancomycin, calculated Ke of vancomycin in these patient by phoenix winnonlin software., 1 years|To determine the volume of distribution (Vd) of vancomycin, calculated Vd of vancomycin in these patient by phoenix winnonlin software., 1 years|To determine the half life of vancomycin, calculated half life of vancomycin in these patient by phoenix winnonlin software., 1 years
Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine
NCT Number: NCT06543914
Acronym: CORNERSTONE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine
Sponsor: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-12-01
Completion Date: 2027-10-01

Summary:
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate the effectiveness of atogepant in treating adult participants with migraine in a real-world setting.

Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 1000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study across the world.

Participants will receive atogepant oral tablets as prescribed per standard clinical practice and will be followed for 2 years.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Primary Outcome Measures: Percentage of Participants Achieving a rating of "much better" or "very much better" as assessed by the Patient Global Impression of Change (PGI-C), PGI-C is a single item used to measure the patient's impression of overall change in migraine since the first dose of atogepant. The measure uses a 7-point rating scale with responses ranging from "very much better" to "very much worse"., Week 12
Comparative Study Between (MIPO)Submuscular Plate Fixation of Fracture Femur and Conservative Management With Thomas Splint in Children From 5 to 8 Years Old: A Randomized Clinical Study
NCT Number: NCT06543901
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Femur Fracture
Interventions: PROCEDURE: Submuscular plating|PROCEDURE: Traction and casting
Sponsor: Kasr El Aini Hospital
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2023-05-01
Locations: Kasr Alainy Hospital - Faculty of Medicine - Cairo University, Cairo, 11765, Egypt

Summary:
This randomized clinical study compares the outcomes of two treatment methods for femur fractures in children aged 5 to 8 years: Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation and conservative management using a Thomas splint. The study evaluates the efficacy, safety, and recovery outcomes of both techniques. Key parameters include healing time, functional outcomes, complication rates, and patient and caregiver satisfaction. The findings aim to provide evidence-based recommendations for the optimal management of femur fractures in young children, balancing the benefits and risks of surgical versus non-surgical approaches.

Primary Outcome Measures: Bony union, we do sequential xrays until we can see a bony union, 6 weeks and 12 weeks
Secondary Outcome Measures: Any associated complications, such as pain, infection or failure of reduction, 6 weeks and 12 weeks
ctDNA-guided Treatment of TKI Plus PD-1 Inhibitor for Advanced pMMR/MSS Colorectal Cancer
NCT Number: NCT06543836
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Colorectal Cancer
Interventions: DRUG: Sintilimab|DRUG: Fruquintinib or Regorafenib|DRUG: Fruquintinib
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2025-11-30
Locations: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, 100021, China

Summary:
The efficacy of combining TKI with PD-1 inhibitor in the treatment of advanced MSS/pMMR colorectal cancer with low levels of maxVAF in peripheral blood ctDNA failed with standard treatment was assessed, compared to standard treatment as chosen by researchers.

Primary Outcome Measures: PFS, Progression-free survival, Up to 2 years
Secondary Outcome Measures: OS, Overall survival, Up to 2 years|ORR, Objective response rate, Up to 2 years|DCR, Disease control rate, Up to 2 years
ST250 as a Therapeutic Option for Head & Neck Reconstruction
NCT Number: NCT06543823
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Tonsillitis
Interventions: DEVICE: SupraTHEL 250|OTHER: Comparator
Sponsor: Alaa Emara
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-05

Summary:
To assess the use of SupraThel 250 for mucosal reconstruction in the Head \& Neck region. The membrane will be applied after tonsillectomy procedures and compared to bare wounds' healing

Primary Outcome Measures: Pain scores, Visual Analogue Scores (0-10; 0 lowest , 10 highest), upto 5 days postoperatively
Secondary Outcome Measures: Quality of Life , Tonsillectomy Outcome Inventory - 14, assessment of patients quality of life according to a set of questions, 5 days Postoperative
Parkinson's Improvement Activated by Hula Understanding
NCT Number: NCT06543810
Acronym: PAHU
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: OTHER: Hula for Parkinson's
Sponsor: University of Hawaii
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-07

Summary:
Parkinson's improvement Activated by Hula Understanding (PAHU), a pilot study, will evaluate the feasibility of hula program on patients with Parkinson's disease (PD). Hula combines several aspects-moderate physical activity, cardiovascular risk reduction, social support opportunities, and other stress-reducing qualities that have potential to prevent further neurodegeneration, improve balance and mobility, help non-motor symptoms and quality of life of PD patients in a sustainable and relatable fashion. The investigators will create a hula program specifically to the needs of patients with PD with mobility difficulty as a non-pharmacological intervention, and conduct a pilot study to test the feasibility of such program. The investigators will learn from leaders of the Dance for PD (NYC, an internationally-acclaimed program offering a range of dance classes for PD patients), as well as other key informants. The investigators will create once a week hula program for 3 months for PD patients and assess the feasibility of such program. Participants will undergo motor testing before and after the hula program, and will be interviewed for their feedback.

Primary Outcome Measures: UPDRS-3, Unified Parkinson's Disease Rating Scale Part 3, Baseline (within 24 weeks before the hula intervention) and within 24 weeks after the intervention
A Pilot Clinical Trial Study to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator
NCT Number: NCT06543797
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Stroke
Interventions: DEVICE: wearable rTMS
Sponsor: Bundang CHA Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-20
Completion Date: 2024-12-31

Summary:
To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.

Primary Outcome Measures: Safety, All types of adverse events that occurred during clinical trials, Before and after 2 weeks of intervention / Soon after every intervention
Secondary Outcome Measures: Changes of Fugl-Meyer assessment, Fugl-Meyer assessment for motor function in score, Before and after 2 weeks of intervention|Changes of manual muscle test (MMT), Manual muscle test for strength in score, Before and after 2 weeks of intervention|Changes of box and block test (BBT), Box and block test for gross manual dexterity in number of blocks from on compartment of a box to another of equal size within 60 seconds, Before and after 2 weeks of intervention|Changes of action research arm test (ARAT), Action research arm test for functional ability of upper extremity in score, Before and after 2 weeks of intervention|Changes of Korean mini-mental state examination (K-MMSE), Korean mini mental state exam for cognitive function in score, Before and after 2 weeks of intervention|Changes of Korean version of Modified Barthel Index (K-MBI), Korean version of modified barthel index for functional status in score, Before and after 2 weeks of intervention|Changes of geriatric depression scale (GDS-d), Geriatric depression scale for depression in scale, Before and after 2 weeks of intervention|Changes of electroencephalograpy (EEG), Electroenchphalography is a test that measures EEG power in alpha band, Before and after 2 weeks of intervention|Changes of Evoked-potentials (EP), Evoked potential is an electrical potential recorded from the nervous system of a human or animal following presentation of a stimulus. In this study, motor- and sensory- evoked potentials are included., Before and after 2 weeks of intervention|Changes of motion analysis, Motion analysis with motion capture setup and data processing or streaming of patients movements. In this study, data of motion capture include kinetic and kinematic data including physiological parameter., Before and after 2 weeks of intervention|Changes of functional near-infrared spectroscopy (fNIRS), Funtional near-infrared spectroscopy meausures cortical activity in concentration of oxy- and deoxy-hemoglobin, Before and after 2 weeks of intervention|Changes of blood biomarker, Blood biomarker include expression of tumor necrosis factor (TNF)-a and interleukin (IL)-1b, Before and after 2 weeks of intervention
Preconception Carrier Screening at the Erasmus MC
NCT Number: NCT06543784
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Inherited Genetic Conditions
Sponsor: Erasmus Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2025-06-30
Locations: Erasmus MC, Rotterdam, Netherlands

Summary:
Rationale A recent advisory report by the 'Health Council' has recommended that all prospective parents should have the opportunity to undergo preconception carrier screening. Consequently,there will no longer be any prerequisites for referring a couple. It is expected that there will be an increase in the number of prospective parents seeking counseling for preconception carrier screening. This is anticipated to result in an increase in the number of referrals, leading to several points of attention.

Objective(s) The aim of the research is to gather insights, perspectives, and experiences from healthcare professionals and prospective parents in order to design a care pathway for offering preconception carrier screening at Erasmus MC and the Rotterdam region. This will also include examining the role that nurse practitioners can play in this offering.

Primary Outcome Measures: Creating a pathway for preconception carrier screening using focus groups and interviews., Using focus groups and interviews to gather insights, perspectives, and experiences from healthcare professionals and prospective parents in order to design a care pathway for offering preconception carrier screening at Erasmus MC and the Rotterdam region., 1 year
Clinical Performance Study of Safety Test ABO Device
NCT Number: NCT06543771
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transfusion Reaction
Interventions: DIAGNOSTIC_TEST: Safety Test ABO and ABTest Card®
Sponsor: Diagast
Collaborators: Soladis
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2025-01
Locations: CHU Montpellier, Montpellier, France

Summary:
The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.

Primary Outcome Measures: Concordance obtained between blood type information from medical record and patient results obtained by Safety Test ABO., Comparison of the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "patient" blood type in the medical record (A, B, AB, O)., 5 minutes.|Concordance obtained between blood bag labelling information and blood bag results obtained by Safety Test ABO., Comparison of the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "donor" blood type shown on the blood bag label (A, B, AB, O)., 5 minutes.|Concordance obtained on patient blood type between Safety Test ABO and ABTest Card® results., Comparison of the "patient" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O)., 5 minutes.|Concordance obtained on blood bag blood type between Safety Test ABO and ABTest Card® results., Comparison of the "donor" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O)., 5 minutes.|Blood compatibility between blood bag and patient for the Safety Test ABO., Comparison of the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O)., 5 minutes.|Blood compatibility between blood bag and patient for the ABTest Card®., Comparison of the "patient" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card® device (A, B, AB, O)., 5 minutes.
Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension
NCT Number: NCT06543745
Acronym: RESIST-PH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulmonary Arterial Hypertension|Frailty
Interventions: BEHAVIORAL: Low-Resistance Training
Sponsor: University of Pennsylvania
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-15
Completion Date: 2025-10-01
Locations: University of Pennsyvania, Philadelphia, Pennsylvania, 19103, United States

Summary:
The purpose of the study is to learn more about how low-resistance training impacts frailty and the quality of life of people with pulmonary arterial hypertension (PAH). Low-resistance training is an evidence-based approach that may help patients improve their functional ability.

Primary Outcome Measures: Adverse Events, Safety will be assessed by way of the incidence of serious adverse events., Between baseline and 12-week follow-up|Feasibility of Recruitment, Feasibility of recruitment will be assessed by measuring recruitment rates, Through study completion, an average of twice per year|Feasibility of Study, Feasibility of the study will be assessed by measuring retention rates., Through study completion, an average of twice per year|Short Performance Physical Battery (SPPB) and emPHasis-10 (E10) scores, Investigators will use a change in score for SPPB and E10 scores, using Wilcoxon signed-rank test., Between baseline and 12-week follow-up|Patient/ Caregiver Exit Interview, Each subject (both patients who participate in the study and their caregivers, separately) will be asked to review their experience with the study protocol, rating their satisfaction on a 5 point Likert scale (1 being Strongly Disagree, 5 being Strongly Agree) with the overall protocol, ease of exercises, acceptability of equipment and exercises. Higher scores (eg. agreement of a positive experience) mean a better outcome., Upon conclusion of the 12-week follow-up
Vital@Work: Reintegration Program for Employees With Stress-related Complaints
NCT Number: NCT06543732
Acronym: Vital@Work
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Return To Work|Mental Health
Interventions: OTHER: Return to work program
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Health Holland|Trimbos
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 208
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2026-12-01
Locations: Amsterdam UMC, Amsterdam, Netherlands|GGZ inGeest, Amsterdam, Netherlands|Transavia, Amsterdam, Netherlands|RSO, Den Haag, Netherlands

Summary:
The objective of this study, Vital@Work reintegration program, is to support sick-listed workers with stress-related complaints in their return to work based on a personalized program. Therefore, the aim of this study is test whether participants supported by a tailored eHealth program, and if needed, additionally supported by a structured and stepwise Participatory Approach (PA) involving the sick-listed worker, their direct supervisor and a neutral party, show a faster and sustainable return to work as compared to participants in the control condition. This program is investigated in four different organizations, which differ in sector, size (small and large organizations), type of organization (private or public) and type of work.

Primary Outcome Measures: Lasting return to work, Lasting return to work of at least 28 consecutive days without (partial or full) relapse, Baseline - 3 months - 6 months -12 months
Secondary Outcome Measures: Stress-related complaints, Stress-related complaints (e.g., type of disease, severity of symptoms) by means of the 4DKL (Terluin, 2008), Promis (Terwee et al. 2015)., Baseline - 3 months - 6 months -12 months|Psychosocial job characteristics, Psychosocial job characteristics (e.g., mental workload, decision latitude, social support, physical demands, job insecurity) by means of the JCQ (Karasek, Houtman et al. 1995), Baseline - 3 months - 6 months - 12 months|Behaviour change, Behaviour change (e.g., attitude, social influence, self-efficacy); by means of the ASE (Damoiseaux et al. 1998), RTW-SE (Volker et al. 2015)., Baseline - 3 months - 6 months - 12 months
Metabolic Syndrome and Related Diseases in Healthcare Workers
NCT Number: NCT06543706
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Metabolic Syndrome X|Diabetes Mellitus Type 2|Hypertension|Hyperlipidemia|Obesity|Cardiovascular Diseases|Stroke
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7432
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-18
Completion Date: 2023-11-10
Locations: Tengda Xu, Beijing, Beijing, 100730, China

Summary:
This study aims to investigate the incidence and prevalence of metabolic syndrome and metabolism-related diseases among healthcare workers, identify potential risk factors for these diseases, evaluate the control status of these conditions, and explore the significance of annual regular check-ups in improving metabolic-related health outcomes. All data for the study subjects are sourced from anonymized continuous records in hospital physical examinations and medical case files. The study does not involve any interventions. Upon obtaining the study data, researchers will use retrospective analysis methods to identify possible associations between risk factors and diseases.

Primary Outcome Measures: composite endpoint of cardiovascular and cerebrovascular diseases, The number of hospitalizations due to severe coronary heart disease, stroke, or sudden cardiac death. The outcome is determined if any of the first three discharge diagnoses include acute myocardial infarction, stroke, or sudden cardiac death, or if an emergency coronary stent placement or coronary artery bypass graft surgery is performed during hospitalization., through study completion, an average of 5 years
Secondary Outcome Measures: new-onset metabolic syndrome, The number of individuals who did not meet the criteria for metabolic syndrome at the first examination but developed the syndrome later. The diagnostic criteria for metabolic syndrome involve meeting three or more of the following conditions:

Abdominal obesity: waist circumference ≥90 (men) or ≥85 (women) cm. Hyperglycemia: fasting blood glucose ≥6.1 or 2-hour postprandial blood glucose ≥7.8 mmol/L or previously diagnosed diabetes. Hypertension: blood pressure ≥130/85 mmHg or previously diagnosed hypertension. Elevated triglycerides: fasting triglycerides ≥1.70 mmol/L or on lipid-lowering medication. Low fasting high-density lipoprotein cholesterol (HDL-C) \<1.04 mmol/L.

If waist circumference and HDL-C data are missing, abdominal obesity will be defined using the body mass index (BMI), calculated by dividing weight in kilograms by the square of height in meters (BMI ≥ 28.0 kg/m\^2). Total cholesterol ≥ 5.17 mmol/L will be used as a substitute for the HDL-C indicator., through study completion, an average of 5 years
The Core Ultrasound Applications for Nurse Practitioners
NCT Number: NCT06543693
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Immediate and 3-month Assessment of PoCUS Performance
Interventions: OTHER: ultrasound training
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-08-01
Completion Date: 2025-07-31
Locations: Wan-Ching Lien, Taipei, 100, Taiwan

Summary:
This project aims to establish point-of-care ultrasound (PoCUS) training course for nurse practitioners in Taiwan, and standardized evaluation modules. The study subjects are nurse practitioners across different hospital levels.

I

Primary Outcome Measures: written test, 10 multi-choice questionaire, 1day|hands-on performance, using 5-point Likert scale. Point 1 indicated no recognizable structures; point 2 indicated minimally recognizable structures but insufficient for diagnosis; point 3 indicated minimal criteria met for diagnosis, recognizable structures but with some technical flaws; point 4 indicated all structures imaged well and diagnosis easily supported; point 5 indicated all structures imaged with excellent image quality and diagnosis completely supported, 1 day
Secondary Outcome Measures: written test at the 3-month assessment, 10 multi-choice questionaire, 3 months|hands-on performance at the 3-month assessment, using 5-point Likert scale. Point 1 indicated no recognizable structures; point 2 indicated minimally recognizable structures but insufficient for diagnosis; point 3 indicated minimal criteria met for diagnosis, recognizable structures but with some technical flaws; point 4 indicated all structures imaged well and diagnosis easily supported; point 5 indicated all structures imaged with excellent image quality and diagnosis completely supported, 3 months
Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems
NCT Number: NCT06543680
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Secondary Caries Dental Restoration Failure of Marginal Integrity
Interventions: OTHER: Dental restoration
Sponsor: Mansoura University
Sex: ALL
Age: ADULT
Enrollment: 35
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-05-29
Completion Date: 2025-05-31
Locations: Faculty of dentistry mansoura university, Mansoura, Dakahliya, 35516, Egypt

Summary:
To evaluate and compare two-year clinical performance of commercially available resin modified glass ionomer cement, self-adhesive composite hybrid and self-adhesive flowable composite restorative materials for non-carious cervical lesions

Primary Outcome Measures: Percentage of aesthetic, functional and biological properties for each group, Percentage of aesthetic, functional and biological properties that will be clinically assessed using World Dental Federation and USPHS parameters for each restorative system group, 2 years after restoration
Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye
NCT Number: NCT06543667
Acronym: EXOIUMS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Dry Eye Syndromes
Interventions: BIOLOGICAL: Limbal Stem Cell Derived Exosomes Eye Drop
Sponsor: Iran University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-04-01
Locations: Moheb Kowsar Hospital, Tehran, Iran, Islamic Republic of

Summary:
The purpose of this study is to determine the safety and efficacy of Limbal Stem Cells derived Exosomes (LSC-Exo) in alleviation of dry eye symptoms

Primary Outcome Measures: Change in Inflammatory and Pro-inflammatory cytokines changes, Dry eye is characterized by ocular surface inflammation. Proinflammatory cytokines IL-1, IL-6, IL-8, TNF-α and IFN-γ are strongly correlated with dry eye markers, leading to ocular surface damage., 12 weeks|Change in Ocular Surface Disease Index (OSDI), The OSDI questionnaire contains 12 questions to measure dry eye symptoms. OSDI scores range from 0 to 100. The lower the score, the more alleviation of dry eye symptoms. Compared with the baseline, a reduction of more than 10 points indicates improvement, 4, 8 , and 12 weeks
Secondary Outcome Measures: Tear Secretion Test (Schirmer test), A paper strip is placed on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. A positive change from baseline indicates an improvement in each eye., 4, 8 , and 12 weeks|Tear Film Break-up Time, Time required for dry spots to appear on the surface of the eye after blinking was measured in seconds. A positive change from baseline indicates improvement in each eye., 4, 8 , and 12 weeks
Evaluation of Template Assisted Monochromatic Structural Colored Versus Universal Multi-Shade Direct Composite Veneers
NCT Number: NCT06543654
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth Discoloration
Interventions: OTHER: Omnichroma|OTHER: Ceram. X Spectra
Sponsor: Tanta University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-07-19
Completion Date: 2024-04-09
Locations: Faculty of Dentistry, Tanta, Egypt

Summary:
The aim of this study was to conduct a clinical trial utilizing a modified split-mouth, double-blinded, randomized strategy to clinically assess template assisted one shade structural colored versus universal multi-shade direct composite veneers

Primary Outcome Measures: Clinical evaluation was performed at baseline, six, nine, twelve, and eighteen months by two calibrated examiners using modified United States Public Health Service (USPHS) criteria, The perfect clinical scenario was represented by a score of 0, clinically acceptable by a score of 1, dubious by a score of 2, and clinically unsatisfactory by a score of 3 and 4., eighteen months
Evaluation of Tadalafil Combined With LIPUS for Treating Erectile Dysfunction
NCT Number: NCT06543628
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Erectile Dysfunction
Interventions: DRUG: Tadalafil 5mg|DEVICE: LIPUS (Low Intensity Pulsed Ultrasound)
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-02

Summary:
This study aims to evaluate the clinical efficacy and histological changes of tadalafil combined with low-intensity pulsed ultrasound (LIPUS) in patients with erectile dysfunction (ED) through a randomized controlled trial.

Primary Outcome Measures: MCID based on IIEF-5, The primary outcome measure is the Minimum Clinically Important Difference (MCID) based on the International Index of Erectile Function-5 (IIEF-5) scores. MCID will be determined by the change in IIEF-5 scores at 0 months, 2 months, 4 months, and 6 months., 0 months, 2 months, 4 months, 6 months
Secondary Outcome Measures: IIEF-5 Score, The secondary outcome measure is the change in the International Index of Erectile Function-5 (IIEF-5) scores at 0 months, 2 months, 4 months, and 6 months., 0 months, 2 months, 4 months, 6 months|EHS, The change in Erection Hardness Score (EHS) at 0 months, 2 months, 4 months, and 6 months., 0 months, 2 months, 4 months, 6 months|PSV, The change in Peak Systolic Velocity (PSV) measured by Doppler ultrasound at 0 months and 6 months., 0 months, 6 months|EDV, The change in End-Diastolic Velocity (EDV) measured by Doppler ultrasound at 0 months and 6 months., 0 months, 6 months|YMtip Value, The change in Young's Modulus (YM) value measured by elastography at 0 months and 6 months., 0 months, 6 months|YMbase Value, The change in Young's Modulus (YM) value measured by elastography at 0 months and 6 months., 0 months, 6 months
Preoperative Ultrasound Evaluation of Fasting Residual Gastric Volume in Patients With Previous Sleeve Gastrectomy : Comparative Study With Patients Without History of Bariatric Surgeries
NCT Number: NCT06543615
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Fasting
Interventions: DEVICE: Ultrasonography
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-07
Locations: Faculty of medicine ain shams university, Cairo, Egypt

Summary:
Preoperative US assessment of residual gastric volume in both; patients with previous laparoscopic sleeve gastrectomy and those without history of bariatric surgeries, undergoing elective laparoscopic cholecystectomy, aiming to develop a step for recommendations for fasting guidelines

Primary Outcome Measures: residual gastric volume, Measurement of residual gastric volume immediately preoperative in right lateral decubitus after fasting 8 hours, After fasting 8 hours immediately preoperative
Secondary Outcome Measures: incidence of aspiration, Documentation of aspiration incidence immediately preoperative, intraoperative or during recovery from anesthesia post operative, Perioperative ( immediately preoperative, intraoperative or during recovery from anesthesia post operative
the Multi-modal Evaluation of Agitation in Critically Ill Patients Based on Remote Video-Ultra-sensitive Detection Wave
NCT Number: NCT06543602
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Critically Ill Patients
Interventions: DIAGNOSTIC_TEST: multi-model monitoring and alert
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: People's Hospital of Quzhou|The Second Affiliated Hospital of Jiaxing University|Zhoushan Hospital of Zhejiang|Longquan People's Hospital|Fuyang District First People's Hospital of Hangzhou|The Third Affiliated Hospital of Wenzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 580
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2027-04-30
Locations: the second affiliated hospital, Zhejiang University school of medicine, Hangzhou, Zhejiang, 310009, China|SAHZU, Hanzhou, Zhejiang, 310009, China

Summary:
The goal of this observational study is to learn about the effectiveness of the multi-modal evaluation for agitation behavior in critically ill patients based on remote video-Ultra-sensitive detection wave.

The main question it aims to answer is: evaluate the effectiveness of multi-modal evaluation monitoring system for agitated critically ill patients Participants already taking multi-modal evaluation monitoring system as part of their regular medical care for agitated critically ill patients will compare their effectiveness for agitation for 3 years.

Primary Outcome Measures: the correct rate for alerting agitated critically ill patients, 10-15 seconds every agitated patients during stay in ICU
Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants
NCT Number: NCT06543589
Acronym: SIMPLSAFE3
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premature; Infant
Interventions: DEVICE: High-flow-nasal-cannula
Sponsor: Charles University, Czech Republic
Sex: ALL
Age: CHILD
Enrollment: 443
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-12
Completion Date: 2026-09

Summary:
Non-invasive continuous positive airway pressure (CPAP) stabilizes premature newborns, but its optimal pressure is unknown. High-flow nasal cannula (HFNC) is an alternative that minimizes trigeminal stimulation but lacks precise pressure control. Initial studies show HFNC's feasibility and effectiveness. This study hypothesizes that HFNC can deliver adequate pressure, reduce the need for positive pressure ventilation, and support safe stabilization of very premature infants. The trial compares the effectiveness and safety of HFNC versus CPAP in the delivery room and during transport to the neonatal intensive care unit in very premature infants. The primary objective is to compare HFNC and CPAP in reducing the need for positive pressure ventilation in very premature infants immediately after birth. The study includes very premature infants delivered between 28+0 and 31+6 weeks gestation in 10 tertiary referral centers (nine in the Czech Republic, one in Slovakia). Approximately 443 patients are required to detect a 15% relative decrease in the need for positive pressure ventilation between trial groups. Centers will be randomized to either CPAP or HFNC at each time period, with parental consent obtained before birth. The primary endpoint is the proportion of neonates requiring positive pressure ventilation within the first 10 minutes post-birth.

Primary Outcome Measures: Positive pressure ventilation (PPV), The primary endpoint of the trial is to demonstrate a difference in the proportion of neonates requiring PPV administration in the delivery room during the first 10 minutes post-birth, 10 minutes after delivery
Secondary Outcome Measures: SpO2 >80% within the first 5 minutes of life, Achieving SpO2 \>80% within the first 5 minutes of life, regardless of FiO2 without the need of PPV administration, 5 minutes after delivery|SpO2 >90% with FiO2 ≤ 0.40 within the first 10 minutes of life, Achieving SpO2 \>90% with FiO2 ≤ 0.40 within the first 10 minutes of life without the need for PPV, 10 minutes after delivery|Stabilization on selected ventilatory support, Stabilization on selected ventilatory support with FiO2 ≤ 0.35 without the use of PPV at 3h of life, 3 hours after delivery
Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye: Turkish Neonatal Society SECRETS-TR Study
NCT Number: NCT06543524
Acronym: TNS-SECRETS
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Morbidity;Infant
Interventions: OTHER: Care of premature infants
Sponsor: Başakşehir Çam & Sakura City Hospital
Collaborators: Turkish Neonatal Society
Sex: ALL
Age: CHILD
Enrollment: 3150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-04-28
Completion Date: 2023-09-28
Locations: BasaksehirCamSakuraSehirH, İstanbul, Please Select, 34552, Turkey

Summary:
The aim of this multi-center study was to evaluate the mortality rate and early neonatal outcomes of very low birth weight (VLBW) infants hospitalized in neonatal intensive care units (NICUs) in Türkiye. It was promoted by the Turkish Neonatology Society (TNS) and research was approved by the Cam and Sakura City Hospital Ethical Committee.

It was conducted between 28 April 2021 and 02 January 2023 and written informed consents from the families of included patients were obtained.

A total of 74 level III and IV NICUs participated to the study. All the centers had an oppurtunity to follow-up these high risk premature infants in terms of their medical staff, equipment and other neonatology sources.

The inclusion criteria consisted of preterm infants with birth weight (BW)≤1500 grams and with gestational age (GA) of 24 0/7 weeks to 31 6/7 weeks, all inborn and outborn infants admitted to NICU within the first 24 hours of life and approval of parental consent.The survival status, maternal, perinatal and neonatal characteristics, risk factors and early neonatal outcomes of all infants were recorded.

Primary Outcome Measures: mortality rate, mortality rate of infants participated to the study, during hospitalization period, with an average of 6 months.|rate of prematurity-related morbidities, rates of prematurity-related morbidities in infants participated to the study, during hospitalization period or at the time of discharge whichever came first, assessed through study completion, an average of 6 months
Secondary Outcome Measures: Duration of hospitalization, Length of hospitalization as day, at the time of discharge of the Neonatal Intensive Care Unit (NICU), an average of 1 year.
Headless Screw Fixation for Metacarpal Fractures in Adults.
NCT Number: NCT06543485
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metacarpal Fractures in Adults
Interventions: PROCEDURE: intramedullary screw fixation of metacarpal fractures
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-25
Completion Date: 2025-03-20
Locations: Faculty of Medicine Sohag University, Sohag, Select A State Or Province, 02, Egypt

Summary:
The goal of this study is to evaluate results of intramedullary screw fixation of metacarpal fractures while summarizing the pearls and pitfalls to maximize successful surgical outcomes in adults, Metacarpal fractures are third most common upper extremity fractures, Intramedullary screw Fixation is a fixation option that offers rigid stability, early active range of motion, and simplicity of insertion,

Primary Outcome Measures: early active range of motion, QuickDASH score ( Disabilities of the Arm, Shoulder and Hand questionnaire ), 3 days-12 weeks after surgery