pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
VR for Lac Repairs in Peds Emergency Department
NCT Number: NCT06516003
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Laceration
Interventions: DEVICE: Immersive Virtual Reality Goggles|BEHAVIORAL: Standard of Care
Sponsor: Eastern Virginia Medical School
Sex: ALL
Age: CHILD
Enrollment: 91
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-02-01
Completion Date: 2023-03-30
Locations: Children's Hospital of the King's Daughters, Norfolk, Virginia, 23507, United States

Summary:
The goal of the clinical trial is to compare virtual reality to standard of care for laceration repairs in the pediatric emergency department. The main question it aims to answer is:

-Does virtual reality decrease pain and anxiety scores compared to standard of care for laceration repairs in the pediatric emergency department?

Participants who meet the age and other inclusion criteria will be enrolled by research staff. They will complete a brief paper survey along with their guardians and the provider doing the laceration repair. The surveys will be completed after the laceration repair is finished.

Primary Outcome Measures: Pain Score, Using Wong Baker Faces Pain Scale, Assessed immediately after intervention|Fear Score, Using Children's Fear Score, Assessed immediately after intervention
Secondary Outcome Measures: Satisfaction of procedure, Assessed by Likert- type scale question, Assessed immediately after intervention|Side Effects, nausea, vomiting, dizziness, headache, other, Assessed immediately after intervention|Duration of procedure, Five minute intervals up to 25 minutes, Assessed immediately after intervention|Future Use, Would they recommend use of VR for same procedure again, Assessed immediately after intervention|Physical Holding, Did patient need to be held for the procedure, Assessed immediately after intervention|Anxiolytic Use, Did patient need anxiolytics for the procedure, Assessed immediately after intervention
A Study of DM005 in Patients With Advanced Solid Tumors
NCT Number: NCT06515990
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung|Squamous Cell Carcinoma of Head and Neck|Solid Carcinoma
Interventions: DRUG: DM005
Sponsor: Doma Biopharmaceutical（Suzhou）Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 136
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-03

Summary:
The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit.

Participants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.

Primary Outcome Measures: Dose-limiting Toxicities (DLTs) of DM005, Incidence of DLTs of DM005 will be determined. A dose-limiting toxicity (DLT) was defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicity., 12 months|Maximum tolerated dose (MTD) for DM005, The MTD of DM005 will be determined. The MTD was defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose., 12 months
Secondary Outcome Measures: The MTD of DM005 will be determined. The MTD was defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose., Area under the plasma concentration-time curve from time zero extrapolated to infinity, calculated by linear up/log down trapezoidal summation., 12 months|Maximum (peak) plasma concentration (Cmax, ng/mL), Maximum concentration, obtained directly from the observed concentration versus time data., 12 months|Time to maximum (peak) concentration (Tmax, h), Time to Cmax, 12 months|Trough concentration (Ctrough, ng/mL), The lowest plasma concentration reached before the next dose., 12 months|Objective response rate (ORR), ORR is defined as the number of patients with at least a confirmed complete response (CR) or partial response (PR), based on the best objective response values while on treatment using RECIST version 1.1, 12 months
Texture and Colour Enhancement Imaging in Improving Detection and Miss Rate of Premalignant Lesions
NCT Number: NCT06515977
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adenoma|Sessile Serrated Adenoma
Interventions: PROCEDURE: TXI (Group A)|PROCEDURE: TXI followed by WLI (Group B)|PROCEDURE: WLI (Group C)|PROCEDURE: WLI followed by TXI (Group D)
Sponsor: Changhai Hospital
Collaborators: The First Affiliated Hospital of Dalian Medical University|The Second Hospital of Hebei Medical University|Second Affiliated Hospital of Guangzhou University of Chinese Medicine|Huadong Hospital|Shanghai 6th People's Hospital|Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine|The General Hospital of Eastern Theater Command|Jiangsu Provincial People's Hospital|First People's Hospital of Hangzhou|Wenzhou Central Hospital|The First Affiliated Hospital of Nanchang University|Shanxi Coal Center Hospital|Dalian Municipal Central Hospital|Seventh Medical Center of PLA Army General Hospital|Henan Provincial People's Hospital|Zunyi Medical College|Shandong Second People's Hospital|The Third People's Hospital of Chengdu|The Second Hospital of Lanzhou University|The Third People's Hospital of Jingdezhen|Fudan University Attached Tumor Hospital|Qingyuan People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2964
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-01
Completion Date: 2025-08-01

Summary:
Texture and Color Enhancement Imaging (TXI) is a newly developed image-enhancing endoscopy technology that has show potential in improving detection of colorectal lesions. This multicenter, randomized, tandem trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of diagnosis of premalignant lesions.

Primary Outcome Measures: adenoma detection rate, the number of patients with one or more adenomas detected and removed divided by the total number of patient, 1 years|sessile serrated lesion detection rate, the number of patients with one or more sessile serrated lesions detected and removed divided by the total number of patients, 1 years
Secondary Outcome Measures: adenoma miss rate, the number of adenomas detected during the second examination divided by the total number of adenomas detected during the first and second colonoscopy, 1 years|sessile serrated lesion miss rate, the number of sessile serrated lesions detected during the second examination divided by the total number of sessile serrated lesions detected during the first and second colonoscopy, 1 years
China Early Esophageal Cancer Cohort
NCT Number: NCT06515964
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Early Esophageal Cancer
Interventions: OTHER: observational study
Sponsor: Changhai Hospital
Collaborators: Lianshui People's Hospital|The second affiliated hospital of Xuzhou medical university|The second people's hospital of Nanyang|Nanchong Central Hospital|Tongliao City Hospital|Yancheng First People's Hospital|The Second Hospital of Hebei Medical University|The Second Affiliated Hospital of Baotou Medical College|Affiliated Hospital of Southwest Medical University|Sichuan Cancer Hospital and Research Institute|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School|Zhongda Hospital|The First Affiliated Hospital with Nanjing Medical University|West China Hospital|The First Affiliated Hospital of Soochow University|Jiangsu Province Hospital of Chinese Medicine|Shandong Provincial Hospital|Shanxi Provincial People's Hospital|Henan Provincial People's Hospital|Anyang Cancer Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-01
Completion Date: 2025-10-01
Locations: Changhai Hospital, Shanghai, Shanghai, 200433, China

Summary:
With the development of endoscopy, more and more patients with superficial esophageal squamous cell carcinoma (ESCC) receive endoscopic resection rather than traditional surgery. However, there is still no complete consensus on the risk factors for lymph node metastasis (LNM) and recurrence of ESCC after endoscopic resection. The existing curative resection criteria are strict to a certain extent, and a considerable number of patients are overtreated according to the current standard of additional treatment. Thus, we aim to conduct a multi-center retrospective and prospective study to construct a large cohort of ESCC based on the previously established multi-center collaborative research network and clinical big data, analyze the risk factors of LNM and recurrence in patients with early esophageal squamous cell carcinoma after ESD, establish an accurate and simple risk prediction model, and evaluate the discrimination efficiency of this model.

Primary Outcome Measures: Noncurative Resection, Noncurative resection was defined as the presence of residual tumor or lymph node metastasis at the vertical margin of the lesion confirmed by pathology after surgery, or local recurrence, lymph node metastasis, or distant metastasis attributable to the primary tumor during follow-up., 2022-12 Complete the preliminary clinical study preparation. 2023-10 Complete patient data analysis and sorting. 2024-10 Construct an accurate evaluation system. 2025-10 Conduct validation analysis of the evaluation system.
Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo
NCT Number: NCT06515951
Acronym: STANDING-M
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Vertigo
Interventions: DIAGNOSTIC_TEST: STANDING algorithm
Sponsor: Peiman Nazerian
Collaborators: Ospedale San Giuseppe di Empoli|Ospedale Santo Stefano|Azienda USL Toscana Nord Ovest|Azienda Ospedaliero-Universitaria Careggi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 456
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-06-09
Completion Date: 2023-11-01
Locations: Azienda USL Toscana Centro, Medicina d'Urgenza e Dipartimento Emergenza e Area Critica, Empoli, Firenze, 50053, Italy|Ospedale Versilia, Medicina d'Urgenza, Viareggio, Lucca, 55049, Italy|Azienda Ospedaliera Universitaria Careggi, Medicina d'Urgenza, Firenze, Tuscany, 50134, Italy|Nuovo Ospedale di Prato, Medicina d'Urgenza, Prato, 59100, Italy

Summary:
Differential diagnosis of vertigo is complex especially in emergency department, nevertheless it is crucial. The aim of this study is to assess the accuracy of STANDING algorithm for discriminate central from peripheral type of vertigo, identifying more easily the presence of ischemic stroke.

Primary Outcome Measures: Accuracy of STANDING algorithm for the diagnosis of types of vertigo., Accuracy (proportion of true positive and negative cases among the total number of cases examined) together with sensitivity, specificity, negative and positive predictive values, negative and positive likelihood ratios of STANDING algorithm performed by emergency physicians to distinguish central and peripheral vertigo., Thirty days
Secondary Outcome Measures: Change in the use of neuroimaging, Evaluation if the use of STANDING algorithm can reduce the number neuroimaging (a composite of CT of the head and brain MRI) exams performed in patients with suspected central vertigo according to the STANDING algorithm., Thirty days|Safety of hospital discharge, Evaluation if the use of STANDING algorithm allows a safe discharge of patients with diagnosis of benign vertigo. At 1 month follow-up we evaluate the composite of: number of readmissions for stroke, need for cerebral revasculation procedures, for neurosurgery or all cause death or death for stroke) in patients without suspected central vertigo according to the STANDING algorithm., Thirty days|Accuracy for diagnosis of stroke, Accuracy (proportion of true positive and negative cases of stroke among the total number of cases examined), Thirty days|Change in the use of specialist consultant, Evaluation if the use of STANDING algorithm can reduce the number of specialist medical consultations (composite of neurological and ENT consultations) performed in patients with suspected central vertigo according to the STANDING algorithm., thirty days
Study on New Strategies for Hepatitis B Virus Immunization
NCT Number: NCT06515938
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaccine Reaction
Interventions: BIOLOGICAL: 20μg Engerix-B hepatitis B vaccine|BIOLOGICAL: 20μg Kangtai hepatitis B vaccine|BIOLOGICAL: 60μg Kangtai hepatitis B vaccine|BIOLOGICAL: 20μg CHO
Sponsor: Wu Jiang
Sex: ALL
Age: ADULT
Enrollment: 1169
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2013-01-01
Completion Date: 2015-12-31
Locations: Huaibei District Center for Disease Control and Prevention, Huaibei, Anhui, 235000, China|Xuanhua District Center for Disease Control and Prevention, Xuanhua, Hebei, 075199, China

Summary:
To investigate the immunogenicity of HB vaccine with different series among primary immune adults aged 25-55, to assess potential alternative approaches for HB immunization.

Primary Outcome Measures: Anti-HBs, Titers of hepatitis B virus surface antibody, at the second month after the final injection of each arm
Our Whole Lives Gemini: Virtual Integrative Medical Group Visits for Managing Chronic Pain
NCT Number: NCT06515925
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain
Interventions: BEHAVIORAL: Our Whole Lives (OWL)|BEHAVIORAL: Low Dose Mindfulness Training
Sponsor: Cambridge Health Alliance
Collaborators: National Center for Complementary and Integrative Health (NCCIH)|BrightOutcome
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 212
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2025-11-30
Locations: Cambridge Health Alliance Center for Mindfulness and Compassion, Malden, Massachusetts, 02458, United States

Summary:
The goal of this research study is to test the efficacy of a non-prescription medicine, web-based platform solution for patients with chronic pain, to improve pain self-management and related outcomes. The main question investigators aim to answer is; would the use of this web-based intervention plus an online group visit compared to control result in better pain-related outcomes and improved pain impact?

Primary Outcome Measures: Reduced pain impact (based on PROMIS 29), The primary trial aim is to reduce pain impact., up to 24 weeks
Secondary Outcome Measures: The Patient-Reported Outcomes Measurement Information System (PROMIS 29), Depression and Anxiety in the past 7 days. Fatigue in the past 7 days. Sleep disturbance in the past 7 days. Ability to Participate in Social roles, and activities. Each item within is measured on a 5-point scale, 1 (minimum) to 5(maximum). Higher T-scores in some domains indicate better health; in others, they indicate worse symptoms., up to 24 weeks|Pain Self- Efficacy Scale (PSEQ), Self-efficacy beliefs for pain management. 10 items measured on a 6-point scale, 0 (minimum) to 6(maximum). Higher scores indicate greater pain self-efficacy., up to 24 weeks|Timeline Follow-Back (TLFB), Use of pain meds in the previous 7 days, including opioid use., up to 24 weeks
Association of Middle Molecules Clearance With HDF Volume
NCT Number: NCT06515899
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: End Stage Renal Disease
Sponsor: East and North Hertfordshire NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-19
Completion Date: 2025-07
Locations: East and North Hertfordshire NHS Trust, Stevenage, Hertfordshire, SG1 4AB, United Kingdom

Summary:
HDF is a dialysis technique which involves diffusion and convection. HDF with high convection volume has consistently shown to improve survival in dialysis patients in number of robust RCTs. The precise reason of this survival benefit remains unclear.

The investigators hypothesize that this survival benefit with high volume HDF is related to enhanced middle molecule clearance and hemodynamic stability. However, this relationship has not been studied so far.

This observational study is aimed to understand the relationship between HDF convection volume with middle molecules (Beta 2-Microglobulin) clearance during HDF.

Exploring the relationship of HDF volume with middle molecules clearance has significant clinical ramifications. Only a minority of patients are able to achieve target convection volume. Understanding these relationships can rationalize the HDF prescription from convection volume-based prescription to β2-Microglobulin clearance-based prescription which may be applicable to wider range of patients.

The relationship between pre-dialysis β2-Microglobulin levels and RKF offers the prospect of dispensing with pre- and post-dialysis urea and creatinine measurements and interdialytic urine collections, currently necessary for estimating RKF, thus simplifying its estimation.

β2-Microglobulin reduction ratio and its component pre and post-dialysis β2-Microglobulin levels could therefore provide a composite estimate of small and middle molecule clearance and RKF.

Primary Outcome Measures: The relationship between HDF convection volume and β2 Microglobulin reduction ratio during a HDF session., 18 months|The relationship between HDF convection volume and serum pre dialysis β2 Microglobulin concentration (measured in mg/L)., 18 months
Secondary Outcome Measures: The relationship of HDF convection volume with average intradialytic blood pressure (mmHg)., 18 months|The relationship of HDF convection volume with average intradialytic core body temperature (degrees centigrade), 18 months|The relationship of HDF convection volume with CRP (mg/L)., 18 months
Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity or Both?
NCT Number: NCT06515886
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dental Implant Failed|Implant Complication|Implant Site Infection|Implant Site Reaction
Interventions: DIAGNOSTIC_TEST: Clinical Examination|PROCEDURE: Peri-implant crevicular fluid
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-22
Completion Date: 2025-12-01
Locations: Montreal General Hospital - Oral & Maxillofacial Surgery Clinic, Montréal, Quebec, H3G 1A4, Canada

Summary:
The use of titanium dental implants has become a common modern treatment to restore teeth. Although the success rate of dental implants is high, inflammation around the dental implant still occurs. The current study will investigate if the inflammation around the implant is due to bacterial infection, hypersensitivity or both.

Primary Outcome Measures: Levels of cytokines in peri-implant crevicular fluid associated with hypersensitivity, Measure the levels of IL-4, IL-5, and IL-13 in the peri-implant crevicular fluid to assess hypersensitivity responses between healthy implants and inflamed implants (mucositis and peri-implantitis).

The measured unit is pg/ml., September 2022 - December 2024|Levels of cytokines in peri-implant crevicular fluid associated with bacterial infection, Measure the levels of IL-1α, IL-2, IL-6, IL-8, IL-10, IL-12, IL-17, TNF-α, GM-CSF, and IFN-γ in the peri-implant crevicular fluid to assess bacterial responses between healthy implants and inflamed implants (mucositis and peri-implantitis).

The measured unit is pg/ml., September 2022 - December 2024|Levels of Matrix Metalloproteinases in peri-implant crevicular fluid, Measure the levels of MMP-1, MMP-2, and MMP-9 in the peri-implant crevicular fluid to assess hypersensitivity responses between healthy implants and inflamed implants (mucositis and peri-implantitis).

The measured unit is pg/ml., September 2022 - December 2024|Levels of RANKL in peri-implant crevicular fluid, Measure the levels of RANKL in the peri-implant crevicular fluid to assess hypersensitivity responses between healthy implants and inflamed implants (mucositis and peri-implantitis).

The measured unit is pg/ml., September 2022 - December 2024
Neurofibromatosis Type 1 Tumor Early Detection Study
NCT Number: NCT06515860
Acronym: NF1-TED
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neurofibromatosis Type 1|Neurofibromatosis 1|Plexiform Neurofibroma|Plexiform Neurofibromas|Malignant Peripheral Nerve Sheath Tumor|Malignant Peripheral Nerve Sheath Tumors|Atypical Neurofibroma
Interventions: DIAGNOSTIC_TEST: Liquid biopsy for MPNST development
Sponsor: David Miller
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-07
Completion Date: 2030-07
Locations: Boston Children's Hospital, Boston, Massachusetts, 02115, United States

Summary:
The goal of this observational study is to determine if a liquid biopsy (i.e. blood test) is an effective clinical tool for monitoring the development of malignant peripheral nerve sheath tumor (MPNST) among adults (18 years and older) with Neurofibromatosis Type 1 (NF1), compared to the current standard of care. The main questions it aims to answer are:

How effective is liquid biopsy compared to the current standard of care (clinical surveillance and imaging) for early detection of MPNST development among people with NF1? Can liquid biopsy offer a cost-effective method for early detection of MPNST in people with NF1? Also, can liquid biopsy provide earlier detection that potentially leads to better outcomes? Also, can offering liquid biopsy improve access to care for people experiencing barriers to access (such as minority populations or people in rural areas)?

At baseline, participants will be asked to:

* Complete surveys to provide their demographic and NF1-related health information.
* Report whether or not they are experiencing MPNST-related symptoms.
* Provide blood samples (15 mL blood total between three tubes, which is approximately one tablespoon).

Every six months during the five-year follow-up period, participants will be asked to:

* Complete additional surveys to report whether or not they are experiencing MPNST-related symptoms and/or if they have been diagnosed with a new MPNST.
* Provide an additional blood sample (10 mL blood total in one tube).

If diagnosed with an MPNST by their healthcare provider during the follow-up period, participants will be asked to:

* Complete an additional survey regarding their diagnosis and symptoms.
* Provide an additional blood sample (10 mL blood in one tube).
* In parallel, the study team will request a sample of tumor tissue from the care provider, if available.

Primary Outcome Measures: Timing of MPNST detection by liquid biopsy, Comparison will be made between date of clinical diagnosis versus the date when the tumor could be detected in a liquid biopsy sample., From enrollment to the end of the five-year follow-up period
Secondary Outcome Measures: Number of participants with new MPNST, New MPNST diagnosed by healthcare provider (Yes/No). The number of participants who develop an MPNST will be compared to the overall size of the cohort., From enrollment to the end of the five-year follow-up period
Comfort and Quality of Life of Patients at the End of Life
NCT Number: NCT06515847
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: End of Life
Interventions: OTHER: End of Life Nursing Care Plan
Sponsor: Fenerbahce University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2017-09-01
Completion Date: 2018-09-01
Locations: Fenerbahce University, Istanbul, 34, Turkey

Summary:
A Research to Evaluate the Effect of Nursing Care Practices Based on Kolcaba's Comfort Theory on the Comfort Levels and Quality of Life of End-of-Life Patients.

Purpose: The study was carried out as a semi-experimental posttest with independent groups and a control group, in order to determine the effect of nursing care interventions on the patient's quality of life comfort level, based on Kolcaba's comfort theory. end-of-life patients.

Materials and Methods: This study compared 30 experimental and 30 control patients, aged between 25-70, at least primary school graduate, staying in the palliative care unit. He used the unit for at least two weeks and agreed to be part of this study. While the patients in the experimental group were cared for according to the nursing care plan based on Kolcaba's comfort theory, the patients in the control group were treated with the institution's standard care plan. The results were evaluated according to the standard comfort scale and the general quality of life scale.

Primary Outcome Measures: Kolcaba's comfort theory, The general comfort scale scores of patients who are cared for according to the care plan prepared according to Kolcaba's comfort theory will be higher than the control group.

The scale was developed by Kolcaba in 2006. Comfort includes the subscales of relief (9 items), relaxation (9 items) and overcoming problems (10 items). In evaluating the scale consisting of positive and negative items, negative items are reverse coded and summed. The average value is found by dividing the total score obtained by the number of scale items. The lowest possible value of 1 indicates low comfort, and the highest value of 6 indicates high comfort., 2 week
Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods
NCT Number: NCT06515821
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colorectal Cancer
Interventions: DIAGNOSTIC_TEST: ONCOSCREEN
Sponsor: Firalis SA
Collaborators: University Medical Center Mainz
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology., Sofia, 1797, Bulgaria|Masaryk Institute of Oncology, Brno, 656 53, Czechia|UFC: Université de Franche-Comté Oncology department CHU Besançon, Besançon, 25030, France|MKI UKSH Lübeck, Lübeck, 23538, Germany|LSMU: Lithuanian University of Health Sciences Gastroenterology Department,, Kaunas, 50161, Lithuania|IPO: Instituto Português de Oncologia, Porto, 4200-072, Portugal|IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București, Bucharest, Romania

Summary:
The primary goal is to develop easy accessible diagnostic tools for high risk subjects for colon cancer in different European populations to improve early CRC detection. These CRC screening technologies would be low cost, breakthrough and of high sensitivity and specificity.

Primary Outcome Measures: ONCO CTC expression pattern of ONCOSCREEN tools in CRC patients and healthy controls using colonoscopy as the reference method., Blood samples will be collected to assess various novel biomarkers associated with CRC., At the day of visit/sampling and through study completion, an average of 3 years|ONCO NMR expression pattern, Blood samples will be collected to assess various novel biomarkers associated with CRC., At Day1 and through study completion, an average of 3 years|ONCO CRISPR expression pattern, Blood and stool samples will be collected to assess various novel biomarkers associated with CRC., At Day1 and through study completion, an average of 3 years|ONCO VOC expression pattern, Breath samples will be collected to analyze volatile organic compounds (VOCs). By examining the electrochemical signal responses using pattern recognition algorithms, researchers can identify early indicators distinguishing between CRC-linked and healthy categories., At Day1 and through study completion, an average of 3 years|Evaluation of genetic risks associated to CRC, Buccal swabs will be collected to evaluate genetic risks associated to CRC. Analyzing buccal swab samples can identify genetic variations linked to an increased CRC risk, enhancing personalized screening accuracy., At Day1 and through study completion, an average of 3 years
Effects of Three Airway Instruments on the Incidence of Postoperative Sore Throat
NCT Number: NCT06515808
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Sore-throat
Interventions: DEVICE: Direct Laryngoscope
Sponsor: Fu Jen Catholic University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10382
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-01-01
Completion Date: 2022-12-31
Locations: Fu Jen Catholic University Hospital, New Taipei City, 24300, Taiwan

Summary:
Postoperative sore throat (POST) is a common complaint after general anesthesia. POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia. This condition may affect recovery and patient satisfaction and is associated with many factors, including intubation tools. Previous studies have reported conflicting results on POST. This retrospective cohort study, with sample size of 10,382 patients, was conducted to confirm the hypothesis that the use of video laryngoscopy (VL) is associated with a lower incidence of POST compared with direct laryngoscopy (DL).

Primary Outcome Measures: Postoperative sore throat (POST), POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia., 12 to 24 hours after general anesthesia is finished
Use of Thermography for the Prevention and Diagnosis of Rheumatic Foot
NCT Number: NCT06515769
Acronym: TG-AR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rheumatoid Arthritis|Rheumatoid Arthritis RA|Rheumatic Diseases
Interventions: DIAGNOSTIC_TEST: TERMOGRAPHY
Sponsor: University of Seville
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: University of Seville, Seville, 41008, Spain

Summary:
The aim of this observational study is to establish normal thermographic parameters in patients with rheumatoid arthritis, in order to prevent and diagnose rheumatic foot using thermography. The main question to be answered is: What are the normal thermographic parameters in rheumatic foot?

If there is a comparison group: the researchers will compare the thermography of the foot in healthy subjects and in subjects with rheumatoid arthritis to see if there are any alterations in the thermographic image.

Patients who wish to participate in the study will undergo a thermographic study of the foot, which does not entail any risk to their health.

Primary Outcome Measures: NORMAL PARAMETERS IN THERMOGRAPHY IN PATIENS WITH HEALTHY FOOT, Normal parameters of the healthy foot in thermography, One measurement will be taken at the start of the study and another measurement the following 6 month.
Secondary Outcome Measures: NORMAL PARAMETERS IN TERMOGRAPHY IN PATIENS WITH RHEUMATIC FOOT, Normal parameters in thermography in patients with rheumatic foot, One measurement will be taken at the start of the study and another measurement the following 6 month
Postoperative Pain Evaluation Of Novel Bioceramic-Based Root Canal Sealers
NCT Number: NCT06515756
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Pain, Acute
Interventions: OTHER: Post operative pain assessment after root canal treatment
Sponsor: Kırıkkale University
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-07-04
Completion Date: 2024-02-02
Locations: Ali Turkyilmaz, Yahsihan, Kirikkale, 71400, Turkey|Ali Turkyilmaz, Kırıkkale, 71400, Turkey

Summary:
Brief Summary: The purpose of this study was to evaluate the effect of MTA-Bioseal, GuttaFlow bioseal, and NeoSealer Flo calcium-silicate based root canal sealers on postobturation pain in teeth with asymptomatic irreversible pulpitis or chronic apical periodontitis undergoing single-visit root canal treatment.

The study tried to answer whether the type of sealer used altered the incidence and intensity of postobturation endodontic pain, whether pulp status affected the incidence and intensity of postobturation endodontic pain and whether there was no difference in analgesic intake by patients after a single-visit root canal treatment between the experimental groups.

Primary Outcome Measures: Change in pain from 6 th hours to 30 days between root canal sealers, All participants were asked to rate their perceived pain on the scale, with 0 indicating no pain and 10 indicating the highest possible pain. Pain levels were classified as none, mild (1 to 3), moderate (4 to 7), or severe (8 to 10)., 6, 24, and 72 hours and at 7 and 30 days
Secondary Outcome Measures: Change in pain from 6 th hours to 30 days between diffrernt pulp status, All participants were asked to rate their perceived pain on the scale, with 0 indicating no pain and 10 indicating the highest possible pain. Pain levels were classified as none, mild (1 to 3), moderate (4 to 7), or severe (8 to 10)., 6, 24, and 72 hours and at 7 and 30 days,
Rehabilitation With an Obturator in Maxillary Defects
NCT Number: NCT06515743
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mucormycosis
Interventions: OTHER: Delayed surgical obturator
Sponsor: Menoufia University
Collaborators: Mansoura University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-04
Completion Date: 2024-11-30
Locations: Mohammed A. El-Sawy, Mansoura, 12345, Egypt

Summary:
During the COVID-19 pandemic, there was a lot of reporting of COVID-19-associated mucormycosis cases. Managing this condition posed a new challenge to clinicians. Management includes therapeutic drugs and aggressive surgical debridement. Due to the unpredictability of disease prognosis and the possible recurrence of the disease, rehabilitation with delayed surgical obturators is beneficial for patients. Hence, the current study aimed to evaluate the impact of delayed surgical obturators on quality of life of COVID-19-associated mucormycosis patients post-maxillectomies

Primary Outcome Measures: Oral healthy related quality of life (oral health impact profile-49)) (OHIP-49), The OHIP-14 is a self-filled questionnaire developed by Locker and Slade that focuses on 7 dimensions of impact: functional limitation (questions #1,2), physical pain (questions #3,4), psychological discomfort (questions #5,6), physical disability (questions #7,8), psychological disability(question #9,10), social disability (question #11,12), and handicap (question #13,14), with participants being asked to respond according to the frequency of impact on a 5-point Likert scale coded as never (score 0), hardly ever (score 1), occasionally (score2), fairly often (score 3), and very often (score 4). The OHIP-14 is a shorter version of the OHIP-49 but retains the original conceptual dimensions contained in the OHIP-49., 6 months
Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
NCT Number: NCT06515730
Acronym: RESOLVE-AMI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Left Ventricular Thrombus|Acute Myocardial Infarction
Interventions: DRUG: Apixaban|DRUG: Warfarin
Sponsor: Karolinska Institutet
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 212
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-07-01

Summary:
The optimal anticoagulant for the treatment of left ventricular (LV) thrombus following acute myocardial infarction (AMI) is unclear. The aim of this multicenter randomized study is to evaluate the efficacy of apixaban versus warfarin with respect to thrombus resolution in patients with LV thrombus after AMI.

Primary Outcome Measures: Number and proportion of participants with thrombus resolution at 3 months, Thrombus resolution will be evaluated on transthoracic echocardiogram (TTE\*) at 3 months, 3 months
Secondary Outcome Measures: Clinically relevant bleeding at 3 and 12 months, Clinical relevant bleeding defined as Bleeding Academy Research Consortium (BARC) 2, 3 or 5 bleeding.

The BARC bleeding scale ranges from 0 to 5, where 0 is equal to no bleeding, with increasing severity from 1 through 5, where 5 represents fatal bleeding. Major bleeding is most often defined as BARC 3 and 5. BARC 4 bleeding is coronary artery bypass grafting (CABG) related bleeding., 3 and 12 months|Severe bleeding at 3 and 12 months, Severe bleeding defined as BARC 3 or 5. For definition of the BARC bleeding scale please see Outcome 2 above., 3 and 12 months|Separate bleeding outcomes at 3 and 12 months, Separate bleeding outcomes defined as fatal, intracranial, gastro-intestinal uro-genital or other bleeding, 3 and 12 months|Major adverse cardiovascular outcomes (MACE) at 3 and 12 months, MACE is defined as a composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death, 3 and 12 months|Stroke or systemic embolism at 3 and 12 months, Composite of ischemic stroke or systemic embolism, 3 and 12 months|LV thrombus status at 12 months, Recurrence (or in absence of resolution of LV thrombus at 3 months, persistence) of LV thrombus on TTE at 12 months, 12 months|Net adverse clinical outcomes, Composite of MACE and. BARC 2, 3 or 5 bleeding. For definition of MACE and BARC bleeding scale please see Outcome 2 and 5 above., 3 and 12 months
Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy
NCT Number: NCT06515691
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Bariatric Surgery|Laparoscopic Sleeve Gastrectomy|Acute Post Operative Pain
Interventions: PROCEDURE: M-TAPA block|PROCEDURE: Postoperative pain management
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-12-15
Locations: Istanbul Medipol University Mega Hospital Complex, Istanbul, Bagcilar, Turkey

Summary:
Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. Studies show that M-TAPA block is effective for postoperative analgesia and other abdominal surgeries, but its effect on patients undergoing LSG surgery has not yet been studied. The hypothesis is that the M-TAPA block performed in patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) Operation would reduce opioid consumption in the first 24 hours period after surgery.

Primary Outcome Measures: Opioid consumption, The primary aim is to compare postoperative opioid consumption from the PCA device., Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16, and 24 hours
Secondary Outcome Measures: Pain scores, The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the Numerical Rating Scale (NRS) (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded., Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours|Need for rescue analgesia (tramadol), The secondary aim is to compare rescue analgesia amount used in the postoperative 24 h period., Postoperative 24-hour period|Adverse events, The secondary aim is to compare the adverse events (nausea, vomiting, itching, ect) related to opioid use, Postoperative 24-hour period
Genetically Modified T Cells Treating Malignant Tumors
NCT Number: NCT06515626
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Solid Tumor
Interventions: BIOLOGICAL: CAR-T cell reinfusion
Sponsor: Yi Zhang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-12
Locations: Zhengzhou University First Affiliated Hospital, Zhengzhou, Henan, China

Summary:
To observe the safety, tolerability and initial effectiveness of gene modified T cell therapy in patients with malignant tumors in First Affiliated Hospital of Zhengzhou University, China.

Primary Outcome Measures: PFS, Progression-Free-Survival (PFS) is defined as admission to the group according to imaging specialists based on RECIST 1.1 review when disease progression or death from any cause was first recorded, whichever came first., up to 36 months
Secondary Outcome Measures: OS, Overall survival (OS) is the time from enrollment to death from any cause, up to 36 months|ORR, Objective response rate（ORR） refers to the proportion of subjects in the analysis population who achieved complete response (CR) or partial response (PR)., up to 36 months|DOR, Duration of response (DOR). For subjects with confirmed CR or PR, duration of remission is the time from first recording to evidence of CR or PR until disease 2 progression (according to RECIST 1.1) or death from any cause, whichever occurs first., up to 36 months
Other Outcome Measures: Quality of life improvement, EORTC QLQ C-30 survey, Baseline,The first day of each course (before dosing),up to 4weeks .
A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
NCT Number: NCT06515613
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Platinum-resistant Ovarian Cancer|Testicular Cancer|Endometrial Cancer
Interventions: DRUG: CTIM-76
Sponsor: Context Therapeutics Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2028-03-31
Locations: Context Investigational Site, Beverly Hills, California, 90212, United States

Summary:
This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 (study drug), a humanized T cell engaging bispecific antibody targeting CLDN6, in subjects with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).

Primary Outcome Measures: Incidence of Dose Limiting Toxicities (DLTs), Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs, From date of first dose of CTIM-76 until 28 days following the first dose|Overall response rate (ORR), ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1, From date of first dose of CTIM-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients
NCT Number: NCT06515600
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ventilator-Induced Diaphragmatic Dysfunction
Interventions: DEVICE: Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.
Sponsor: South Valley University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2024-10-15

Summary:
The study is a prospective experimental study on adult patients admitted to the Critical Care Department in Qasr Al-Ainy. This study is conducted prospectively to assess the efficiency of trigger sensitivity adjustment on patients with ventilator-induced diaphragmatic dysfunction (VIDD).

Primary Outcome Measures: Vital signs, Heart Rate (HR) b/min, one week|Respiratory rate RR/min, Respiratory rate RR/min, one week|Blood Pressure mmHg, Blood Pressure mmHg, one week|Arterial blood gases (ABG):-, PH, one week|PCO2 mmHg, PCO2 mmHg, one week|HCO3 mEQ/Liter, HCO3 mEQ/Liter, one week|PSAO2 mmHg, PSAO2 mmHg, one week
Secondary Outcome Measures: Ventilator parameters, Minute Ventilation L/min, one week|Tidal Volume L/breath, Tidal Volume L/breath, one week
Clinical Study of Lewis Antigen Assay Combined With CA19-9 Assay to Assess Prognosis in Patients With Pancreatic Cancer
NCT Number: NCT06515587
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PDAC
Interventions: DIAGNOSTIC_TEST: Lewis genotype detection reagent
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08-01
Completion Date: 2026-10-31
Locations: Shanghai General Hospital, Shanghai, Shanghai, 200040, China

Summary:
CA19-9 is an acidic glycoside containing sialic acid, called ganglioside. Lewis blood group antigen is the precursor for the synthesis of CA19-9, which is formed by the combined action of sialic acid transferase and fucosyltransferase (FUT3). The ability to produce soluble blood group substances is determined by the alpha (1,2) fucosyltransferase gene (FUT2), which can be divided into secretory Se, weakly secretory Sew, and non secretory SE. The Lewis antigen positive (Lewis+) population has normal CA19-9 secretion function, while the Lewis antigen negative (Lewis -) population (about 7%) usually shows no or low secretion of CA19-9. Therefore, when CA19-9 is used as a biomarker, the combined detection of Lewis antigen status is a marker to judge the prognosis of pancreatic cancer, which can divide pancreatic cancer patients into high/medium/low malignant phenotypes.

Primary Outcome Measures: To explore the prognosis of pancreatic cancer with the combination of the Lewis antigen test and the CA19-9 test, The phenotypes of pancreatic cancer patients were classified by Lewis antigen test combined with CA19-9 test.Monitoring patients' disease expression and assisting clinical selection of targeted treatment plan.The consistency between Lewis classification and prognosis was assessed by looking at the survival of pancreatic cancer subjects following clinical treatment regimens., Up to 12 months after the treatment