pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Unleashing Unpredictability: The Batman Project and Its Impact on Prosocial Behavior and Awareness
NCT Number: NCT06481748
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Social Behavior
Interventions: OTHER: Batman
Sponsor: Catholic University of the Sacred Heart
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-21
Completion Date: 2024-10-08

Summary:
The proposed study is an observational investigation that aims to examine the impact of an unexpected and unusual event on prosociality within the Milan metro. The event is the simple presence, in the underground car, of a student wearing a Batman suit. The main objective is to assess whether or not the presence of the unusual event influences prosocial behaviour towards a student pretending to be pregnant. During the study, the student, equipped with a sponge prosthesis to simulate a pregnancy will board the underground. She will be asked not to interact with anyone, but to simply look at her phone. In the experimental condition, an individual dressed as Batman will enter the carriage (through a different door than the one used by the student). In the control condition, on the other hand, no one will show up in costume. In addition, the observer will try to gather information on the reason for this prosocial behaviour, noting down the answer given.

Primary Outcome Measures: Prosocial behavior, A person in the metro leave their spot to the pregnant lady, 5 minutes
Secondary Outcome Measures: Awareness, A person dressed as batman enters the metro, 5 minutes
Knee Joint Angle Affect Muscle Architecture in Children With Cerebral Palsy
NCT Number: NCT06481722
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Spastic Cerebral Palsy
Interventions: OTHER: cerebral palsy
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-10
Completion Date: 2024-03-20
Locations: Mostafa S Ali, Giza, Married, 12668, Egypt

Summary:
To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy

Primary Outcome Measures: Fascicle length, Fascicle length will be measured by ultrasonography, 3 months|knee joint angle will be measured by digital Goniometer, knee joint angle will be measured by digital Goniometer, 3 months|pennation angle, pennation angle will be measured by ultrasonography, 3 months
Maternal Serum Stathmin-1 Levels in Preeclampsia
NCT Number: NCT06481683
Acronym: MSSLP
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Preeclampsia
Sponsor: Burak Yücel Special Clinic
Collaborators: Saglik Bilimleri Universitesi
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2023-08-15
Locations: Basaksehir Cam and Sakura City Hospital Perinatology Clinic, Istanbul, 34480, Turkey

Summary:
The goal of this observational study is to investigate maternal serum Stathmin-1 levels in pregnancies affected by preeclampsia compared to healthy gestations.

The main questions it aims to answer are:

1. What are the maternal serum Stathmin-1 levels in pregnancies with preeclampsia?
2. How do Stathmin-1 levels differ between preeclampsia with severe features and uncomplicated pregnancies?

Researchers will compare Stathmin-1 levels in pregnancies with preeclampsia and preeclampsia with severe features to those in a control group of healthy pregnancies to assess differences in biomarker levels.

Participants will undergo blood sample collection at 32-34 weeks of gestation. Have their blood samples processed for Stathmin-1 level measurement using ELISA.

Primary Outcome Measures: Maternal Serum Stathmin-1 Levels, To identify and compare Maternal Serum Stathmin-1 Levels levels between the pre-eclampsia group, severe pre-eclampsia group, and the control group. This will help in understanding the biochemical environment associated with pre-eclampsia and its severity., Measured at the time of diagnosis and followed up until delivery.
Asia Pediatric Intensive Care Epidemiology and Outcomes Study
NCT Number: NCT06481644
Acronym: AsiaPedIC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pediatrics|Intensive Care Unit|Critical Illness
Sponsor: KK Women's and Children's Hospital
Collaborators: King Chulalongkorn Memorial Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: K K Women's and Children's Hospital, Singapore, Singapore|King Chulalongkorn Memorial Hospital, Bangkok, Thailand

Summary:
The overall objective of this study is to improve the standard of care of critically ill pediatric patients. The specific aims are to describe the clinical profile and outcomes of all admissions to Asian pediatric ICUs, determine the risk factors associated with poor outcomes, determine quality indicators for benchmarking ICU performance across sites and develop and train artificial intelligence algorithms to predict mortality, length of ICU stay and resource utilization.

Primary Outcome Measures: Mortality, ICU mortality and time based mortality, Including 28-days and 60-days
Secondary Outcome Measures: Ventilator duration, Ventilator duration and ventilator free days to account for mortality as competing outcome, Including 28-days and 60-days|ICU duration, ICU duration and ICU free days to account for mortality as competing outcome, Including 28-days and 60-days|Nosocomial infections, Including catheter related blood stream infection, catheter associated urinary tract infection hospital/ventilator associated pneumonia, Throughout ICU stay including 28-days and 60-days|Accidental extubations, Unplanned extubations, Throughout ICU stay including 28-days and 60-days|Line associated thrombosis, Including venous or arterial clots related or unrelated to the presence of invasive catheters, Throughout ICU stay including 28-days and 60-days|Unplanned ICU readmissions, Non-elective ICU readmissions, Including readmissions within 24hour
Other Outcome Measures: Resource utilisation, Including ICU bed, ventilator and other ICU support utilisation. Hospital costs., Throughout ICU stay including 28-days and 60-days
Impact of Stress on Management of BAVU Ventilation (Self-filling Bag With One-way Valve) by Healthcare Professionals.
NCT Number: NCT06481618
Acronym: SIMBAVU 2
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Any Healthcare Professional|Agreement to Participate|Who May be Required to Perform Manual Ventilation
Sponsor: University Hospital, Clermont-Ferrand
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-24
Completion Date: 2024-10
Locations: CHU de Clermont-Ferrand, Clermont-Ferrand, France

Summary:
The goal of this observational study is to learn about the impact of stress on the manual ventilation through Self-filling Bag With One-way Valve. The main question it aims to answer :

how does the ocurence of a stressfull event modify the ventilation delivered in term of pressure, frequency, volume.

Volunter healthcare professionals will take part in a simulation where they will manually ventilate a manikin and ventilation datas will be recorded.

Primary Outcome Measures: ventilation quality, Quality of ventilation under stress conditions in terms of frequency, pressure and volume delivered compared to the standards of the protective ventilation initially delivered, 1 hour
A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection
NCT Number: NCT06481605
Acronym: NOVA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Neoplasms
Interventions: DEVICE: C-REX
Sponsor: Istituto Clinico Humanitas
Collaborators: Carponovum AB
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-31
Completion Date: 2025-08-31
Locations: IRCCS Humanitas Research Hospital, Rozzano, MI, 20089, Italy

Summary:
The C-REX device is design to help colorectal anastomoses construction and reduce the risk of anastomotic leak. This study aims to collect preliminary evidence on the effectiveness of C-REX a real-word setting.

Primary Outcome Measures: Radiological anastomotic leaks, Assess the rate of radiologically confirmed anastomotic leak in the C-REX arm, 90 days after surgery
Secondary Outcome Measures: Severity of anastomotic leaks, Assess the severity of the anastomotic leaks, classifying the events according to the International Study Group of Rectal Cancer (ISGR) criteria in the C-REX arm, 90 days after surgery|Positive leak tests, Assess the rate of intraoperative positive leak tests in the C-REX arm, Intraoperative|Positive C-REX integrity tests, Assess the rate of intraoperative positive C-REX integrity tests in the C-REX arm, Intraoperative|Time of anastomosis construction, Assess the median time of anastomosis construction in the C-REX arm, Intraoperative|Anastomotic stenosis, Assess the rate of anastomosis stenosis, as assessed by the 90-day endoscopic evaluation in the C-REX arm, 90 days after surgery|Postoperative complications, Assess the median Comprehensive Complication Index (CCI) in the C-REX arm, 90 days after surgery|Helathcare costs, Evaluate the median healthcare costs (direct and indirect) in the C-REX arm, 90 days after surgery|Low Anterior Resection Syndrome, Assess the median Low Anterior Resection Syndrome (LARS) score (ranging from 0 to 40, with 21 indicating significant symtpoms) in the C-REX arm., 90 days after surgery|Investigator's satisfaction, Evaluate the grade of investigator's satisfaction in using the C-REX device by using a simple likert scale ranging from 0 (completely unsatisfaid) to 5 (completely satisfaid)., Intraoperative
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
NCT Number: NCT06481592
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Endometrial Cancer
Interventions: BIOLOGICAL: Lifileucel
Sponsor: Iovance Biotherapeutics, Inc.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2029-11

Summary:
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.

Primary Outcome Measures: Objective Response Rate, To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1., Up to 5 Years
Secondary Outcome Measures: Complete Response Rate, To evaluate the proportion of participants who have a confirmed complete response (CR) per RECIST v1.1., Up to 5 Years|Duration of Response, To measure from the first time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1., Up to 5 Years|Disease Control Rate, To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RICIST v1.1., Up to 5 Years|Progression-Free Survival, To evaluate the time from the date of the lifileucel infusion until disease progression per RECIST v1.1., Up to 5 Years|Overall Survival, To measure the time from the date of lifileucel infusion to death due to any cause., Up to 5 Years|Adverse Events, To characterize the safety and tolerability profile of lifileucel in participants with advanced endometrial cancer., Up to 5 Years
A Study of IVX-A12 in Adults Participants
NCT Number: NCT06481579
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Healthy Participants
Interventions: BIOLOGICAL: IVX-A12|BIOLOGICAL: Licensed RSV Vaccine
Sponsor: Icosavax, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 143
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06-10
Completion Date: 2024-12-25
Locations: Icosavax Investigational Site US022, Anaheim, California, 92801, United States|Icosavax Investigational Site US021, Rolling Hills Estates, California, 90274, United States|Icosavax Investigational Site US002, Hollywood, Florida, 33024, United States|Icosavax Investigational Site US011, Lenexa, Kansas, 66219, United States|Icosavax Investigational Site US016, North Charleston, South Carolina, 29405, United States

Summary:
The primary purpose of this study is to assess the immunogenicity and safety of IVX-A12 in adults 60 years of age and older.

Primary Outcome Measures: Geometric Mean Titers (GMT) for RSV/A Neutralizing Antibodies (NAb), Geometric mean titer (GMT) is calculated as the anti-logarithm of sum of (log2 transformed titer)/n., Day 29|Geometric Mean Fold Rise (GMFR) in RSV/A NAb Titers, GMFR is defined as the geometric mean of the ratio of concentration of antibodies at specified timepoints after vaccination divided by concentration at baseline (Day 1)., From Day 0 (pre-vaccination) up to Day 29 post-vaccination|Number of Participants With Immediate Unsolicited Adverse Events (AEs), Day 1 within 30 minutes post-vaccination|Number of Participants With Injection Site and Systemic Solicited Adverse reactions (ARs), Day 1 through 7 post-vaccination|Number of Participants With Unsolicited Adverse Events (AEs), Day 1 through 28 post-vaccination|Number of Participants With Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), and Adverse Events of Special Interests (AESIs), Through 6 months post-vaccination
Efficacy and Safety of Almonertinib Combined With Stereotactic Body Radiotherapy (SBRT) in the Treatment of Non-small Cell Lung Cancer With EGFR Sensitive Mutation: a Single-arm, Open-label Clinical Trial
NCT Number: NCT06481566
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-small Cell Lung Cancer
Interventions: RADIATION: stereotactic ablative body radiotherapy
Sponsor: Chongqing University Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-21
Completion Date: 2026-06-30
Locations: Chongqing University Cancer Hospital, Chongqing, Chongqing, 400030, China

Summary:
The goal of this clinical trial is to learn if first-line Almonertinib plus upfront stereotactic ablative body radiotherapy (SABR) works to treat EGFR-mutated advanced non-small cell lung cancer. The main questions it aims to answer are:

Does first-line Almonertinib plus upfront stereotactic ablative body radiotherapy to residual primary lung lesions prolong the progression-free survival of EGFR-mutated advanced non-small cell lung cancer.

Participants will:

Take first-line Almonertinib for 2-4 months, then deliver SABR to residual primary lung lesions, after that go on Almonertinib maintenance treatment； Visit the hospital once every 3 months for checkups and tests； Keep a diary of their symptoms ；

Primary Outcome Measures: PFS, PFS was defined from the date of starting Almonertinib treatment to the date of disease progression or death from any cause., Time Frame: 18 months
Secondary Outcome Measures: OS, OS was defined from the date of starting Almonertinib treatment to the date of death or last follow-up., Time Frame: 18 months
RWS of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody
NCT Number: NCT06481553
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Stage IV
Interventions: DRUG: first line treatment
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 480
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-01
Completion Date: 2024-07-31
Locations: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China

Summary:
This is a retrospective, single-arm real-world study based on the National Anticancer Drug Clinical Application Monitoring Network database.The aim of this study is to evaluate the efficacy and safety of paclitaxel liposome combined with anti-HER-2 monoclonal antibody as first-line salvage treatment for HER-2 positive advanced breast cancer. It seeks to understand the application patterns, efficacy, and safety of paclitaxel liposome combined with anti-HER-2 monoclonal antibody in real-world settings, providing patients with safer treatment options.

Primary Outcome Measures: Overall Survival (OS), The time from the initiation of drug treatment until death due to any cause, 5-year|real world progress free survival（rwPFS）, The time from the initiation of drug treatment until disease progression (as evaluated by medical records or imaging records) or death, whichever comes first, can be considered as the time to event endpoint in the study. This endpoint can be represented as the time to treatment change in case PFS data is missing., 5-year
Secondary Outcome Measures: Time To Progression, The time from the initiation of drug treatment until disease progression (as evaluated by medical records or imaging records)，Excluding death, 5-year|Time to Treatment Failure, The time from the initiation of drug treatment until termination of treatment for any reason (including disease progression, unacceptable toxicity, and death), 5-year
SpiroGym App-Aided Cough Rehabilitation
NCT Number: NCT06481540
Acronym: ESApp PD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease|Voluntary Peak Cough Strength|mHealth
Interventions: DEVICE: Expiratory muscle strength training + SpiroGym application|DEVICE: Expiratory muscle strength training
Sponsor: General University Hospital, Prague
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: 2024-01-01
Completion Date: 2025-05
Locations: General University Hospital, Prague, 120 00, Czechia

Summary:
The pilot study by Srp et al. (2021) proved that the SpiroGym app was feasible for supporting expiratory muscle strength training (EMST) in Parkinson's disease (PD) patients. Two weeks of intensive EMST coupled with SpiroGym were sufficient to significantly improve the participants' voluntary peak cough flow (PCF). The improvement was quantitatively comparable to the results of other intensive EMST studies with longer durations. When interpreting such rapid improvement, the impact of SpiroGym's visual feedback was considered. It was assumed that visual feedback increased training effort compared to regular training without immediate control. However, comparative studies were required to verify the possible additional effects of visual feedback on voluntary PCF compared to EMST without feedback.

Primary Outcome Measures: Voluntary peak cough flow, Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines., 1 week before baseline, baseline, 8 weeks
Seen and Be Heard: Ensuring Fair Cancer Care for All Children
NCT Number: NCT06481527
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer|Oncology|Haematological Malignancy
Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators: University College London Hospitals
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-02
Completion Date: 2026-03-01

Summary:
Introduction:

Research has routinely been conducted into the experiences and well-being of children and young people with cancer and their families. However, there is little research that directly involves those with learning disabilities (LD) and or who are autistic. This is despite some cancers being more far more prevalent in some syndromes associated with learning disabilities, for example Downs Syndrome. More generally paediatric hospital care, recent research has highlighted inequity for children with LD, compared with children and young people without LD. Staff often feel less capable and confident to deliver care to those with learning disabilities, as well as having less capacity. Still less is known about cancer care for autistic children and young people, for example relating to symptom management. We aim to explore how inequity might present in cancer care for children and young people aged 5-15 years with and without LD and or who are autistic to see what inequities exist, for whom, why and in what circumstances.

Methods and analysis:

A transformative mixed methods design will be used, comprising an individual staff and organisational level survey, retrospective case note review, ethnographic observations of clinical care, family and staff interviews, and participatory workshops. The ethnographer will follow and observe individual children and their families. A 'toolbox' of creative participatory methods will be employed, including providing a co-designed research data collection journal to support elicitation of the child's perspective.

Ethics and Dissemination: The study will run from September 2024 to January 2026. Health Research Authority approval is granted (REC Reference no. 24/LO/0410 \| IRAS Project ID: 335623) for work package 2 and 3 involving the ethnography, with interviews and workshops.

Primary Outcome Measures: Cross-sectional Staff Survey, Purpose designed survey to provide staff perspectives around capacity, capability and confidence in delivering cancer care to children and young people with and without learning disabilities and or who are autistic., 6 months|Length of hospital stay, Relevant to retrospective electronic case note review, 2017-2023|Mortality, Relevant to retrospective electronic case note review, 2017-2023|Symptom management profiles: e.g. pain, constipation, nausea and vomiting, Relevant to retrospective electronic case note review, 2017-2023|Cross-sectional Organisational Survey, Purpose designed survey to explore organisational level policies, training and implementation of interventions including making reasonable adjustments., 6 months
FRI a Method of Reading Cardiotocography (CTG) in Labor
NCT Number: NCT06481514
Acronym: FINIS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Labor Complication
Interventions: OTHER: Interpretation of the CTG using FRI score|OTHER: Classic interpretation of the CTG
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 290
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2025-12
Locations: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, 00168, Italy

Summary:
The objective of the study is to investigate the FRI's ability to identify cases requiring urgent intervention which will present an adverse perinatal outcome (respiratory acidosis, metabolic acidosis, Apgar index, etc.) compared to the classical interpretation of CTG.

Patients whose CTG in labor will be considered non-reassuring will be enrolled and randomized into two groups. The "Fetal Reserve Index" algorithm will be applied to the first group of patients.

The second group of patients will, however, be managed according to the usual protocols internal management.

Primary Outcome Measures: number of cases requiring urgent intervention, number of cases requiring urgent intervention (vaginal operative delivery / urgent cesarean section) identified by the FRI, 12 MONTHS
Secondary Outcome Measures: number of cases that will present a perinatal outcome adverse events, number of cases that will present a perinatal outcome adverse events (respiratory acidosis, metabolic acidosis, Apgar index, etc.) identified through the application of the FRI compared to the classical interpretation of the CTG., 12 MONTHS
A Study to Investigate the Safety and Efficacy of YY003 in Adults With Moderate to Severe Glabellar Lines
NCT Number: NCT06481475
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Moderate to Severe Glabellar Lines
Interventions: BIOLOGICAL: YY003|BIOLOGICAL: Vehicle Control
Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 174
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2025-09

Summary:
The study is a two-part (Part A and Part B) randomized double-blind vehicle-controlled multi-center study in a total of 174 participants with moderate to severe glabellar lines. The objective of this study is to test the safety, efficacy, immunogenicity of YY003, and compare to vehicel control, in improving the appearance of moderate to severe glabellar lines.

Primary Outcome Measures: Satety: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESI), and serious adverse events (SAEs), within 4 weeks post-treatment|Efficacy: The proportion of participants achieving a score of 0 or 1 and at least a two-grade improvement from baseline, on both the investigator's assessment and the participant's self-assessmenti of glabellar line severity at maximum frown, at Week 4 post-treatment visit
Secondary Outcome Measures: Incidence of anti-drug antibodies and neutralizing antibodies, Within 12 Weeks
Intrathecal Morphine vs. US-Guided Bilateral Posterior Quadratus Lumborum Block in Cesarean Section
NCT Number: NCT06481462
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anesthesia|Postoperative Pain
Interventions: PROCEDURE: Intrathecal Morphine (ITM)|PROCEDURE: Quadratus Lumborum II (QLB-II) Block
Sponsor: Ondokuz Mayıs University
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-03
Completion Date: 2024-11-20
Locations: Ondokuz Mayıs University, Samsun, Turkey

Summary:
In this study, it was aimed to evaluate the effects of intrathecal morphine and posterior quadratus lumborum block (QLB2) on postoperative acute pain scores and opioid consumption in the first 24 hours after cesarean section.

Primary Outcome Measures: Morphine consumption in the first 24 hours after surgery, Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 4, Postoperative day 1
Secondary Outcome Measures: Postoperative pain scores, Pain status at rest and while coughing will be assessed by NRS scores at 0, 3, 6, 12, and 24 hours after operation.The NRS is an 11-point numeric scale which ranges from 0 to 10., Postoperative day 1|Postoperative nausea and vomiting (PONV) scores, The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once., Postoperative Day 1|The number of patient required rescue analgesic, The number of patient requires rescue analgesic will be recorded at 0, 3, 6, 18, and 24 hours after operation, Postoperative Day 1|Postoperative pruritus score, Pruritus score: 0 = no pruritus; 1 = sensation of itching, but not scratching, just a rubbing sensation (mild); 2 = sensation of itching and scratching (moderate); 3 = sensation of pruritus, scratching, and requiring treatment (severe)., Postoperative Day 1|Patients' satisfaction and quality of pain management, Patients' pain management satisfaction and quality will be evaluated using the QoR-11 score. ObsQoR-11 is an 11-item questionnaire that is used to evaluate the recovery of parturient women after elective CS. ObsQoR-11 is evaluated in terms of the degree of post-operative pain, nausea, vomiting, activity, baby care, hygiene,and emotional control. Each item was scored using an 11-point system, with minimum and maximum scores of 0 and 110, respectively. A high score reflects good recovery.

QoR-11 Turkish Version will be used for assessment., Postoperative Day 1
Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study
NCT Number: NCT06481449
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Esophageal Neoplasm
Sponsor: Hebei Medical University Fourth Hospital
Collaborators: Tianjin Medical University Cancer Institute and Hospital|Cancer Institute and Hospital, Chinese Academy of Medical Sciences|Fujian Cancer Hospital|Fudan University|Shandong Cancer Hospital and Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2000-01-01
Completion Date: 2024-12-01
Locations: Because this study is a response to real-world patient treatment and outcomes, Shijiazhuang, Hebei, 050000, China

Summary:
Cervical and upper thoracic esophageal cancer (ESCA) presents treatment challenges due to limited clinical evidence. This multi-center study (ChC\&UES) explores radical radio(chemo)therapy efficacy and safety

Primary Outcome Measures: Overall survival time (OS), Compared the differences in overall survival (OS) between low dose radiation and high dose radiation group after definitive radiotherapy. OS is defined as time from start of enrollment to death from any cause., 2000.1.1-2024.6.20|progression-free survival (PFS), Progression-free survival (PFS) is defined as the time from the start of enrollment until tumor progression or death from any cause., 2000.1.1-2024.6.20
Secondary Outcome Measures: Objective response rate (ORR), The Objective Response Rate (ORR) is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Measures the effectiveness of a cancer treatment by showing the percentage of patients whose tumors shrink significantly within a specified time. ORR includes: Complete Response (CR): All target tumors disappear, and no new tumors appear.Partial Response (PR): The size of target tumors decreases by at least 30%, and no new tumors appear. The proportion of patients who achieve CR+PR was ORR., 2000.1.1-2024.6.20
Other Outcome Measures: Side effect, The investigators employed the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, to assess treatment-related adverse effects during and after the course of treatmen, 2000.1.1-2024.6.20
Digital Management of Sleep Health
NCT Number: NCT06481423
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Insomnia
Interventions: BEHAVIORAL: dCBT-I|BEHAVIORAL: Relaxing music
Sponsor: Jia Xiu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-09-01
Completion Date: 2025-11-01
Locations: Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University, Shanghai, Shanghai, 200433, China

Summary:
The goal of this clinical trial is to explore whether cognitive behavioral intervention for insomnia(CBT-I) realized through audio, video, and articles on smartphone apps("ForSleep" developed by the investigators) can improve the sleep quality of insomnia patients. The main question it aims to answer is:

Does CBT-I delivered via smartphone apps improve sleep quality evaluated by scales in patients with insomnia?

Investigators will compare the treatment group receiving the CBT-I intervention via smartphone apps to a control group receiving relaxation training to see if there are significant improvements in sleep quality.

Participants will be asked to:

Use an app("ForSleep") designed for CBT-I to follow a structured therapy program.

Complete daily sleep diaries and periodic scales to track their sleep quality.

Primary Outcome Measures: The Insomnia Severity Index Scale(ISI), A scale that evaluates the severity of insomnia, the scale scores range from 0 to 28, and lower scores mean a better outcome, baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)|Pittsburgh Sleep Quality Index Scale(PSQI), A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome, baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
Secondary Outcome Measures: Dysfunctional Beliefs and Attitudes about Sleep Scale(DBAS), A scale that evaluates the sleep attitude, the scale scores range from 0 to 64, and lower scores mean a better outcome, baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)|Sleep Hygiene Index Scale(SHI), A scale that evaluates sleep hygiene, the scale scores range from 0 to 52, and lower scores mean a better outcome, baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)|Epworth Sleepiness Scale(ESS), A scale that evaluates sleepiness, the scale scores range from 0 to 24, and lower scores mean a better outcome, baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
OSCAR I STUDY - The ONCObind CTC Removal Study
NCT Number: NCT06481397
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
Interventions: DEVICE: ONCObind (Onco-Seraph) 100 Filter
Sponsor: ExThera Medical Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-06
Locations: OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, 73104, United States

Summary:
This study is a Prospective Single Arm Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood purification (EBP) procedure in metastatic PDAC refractory to systemic therapy. Site selection will be dependent upon the site's familiarity with extracorporeal blood purification platforms as well as the diagnosis and management of PDAC. Adults (18 years old and older, ECOG PS of equal or less than 2) with a diagnosis of PDAC as defined histologically (microscopically) as a "pancreatobiliary type" adenocarcinoma with at least 5 U/mL CTCs in peripheral blood and/or portal vein.

Primary Outcome Measures: Incidence of Procedure-Emergent Adverse Events Assessed by NCI CTCAE v5.0, Incidence of treatment-emergent adverse events (AEs), graded using the NCI CTCAE Version 5.0., [Time Frame 30 days]|Incidence of Procedure-Emergent Serious Adverse Events Assessed by NCI CTCAE v5.0, Incidence of treatment-emergent serious adverse events (SAEs), graded using the NCI CTCAE Version 5.0., [Time Frame 30 days]|Survival Follow-Up, Survival Follow-Up (vital status), [Time Frame 60 days]|Change in CTC Concentration, The change in CTC concentration from baseline to the end of the induction series of Extracorporeal Procedure (ECPs) with Onco-Seraph 100., [Time Frame 30 days]|Capacity for the Onco-Seraph 100 Filter to Remove Circulating Tumor Cells, Capacity for the Onco-Seraph 100 filter to remove circulating tumor cells (CTCs) when compared to baseline., [Time Frame 60 days]
Secondary Outcome Measures: Incidence of Procedure-Emergent Adverse Events Assessed by NCI CTCAE v5.0, Incidence of treatment-emergent adverse events (AEs), graded using the NCI CTCAE Version 5.0, [Time Frame 60 days]|Incidence of Procedure-Emergent Serious Adverse Events Assessed by NCI CTCAE v5.0, Incidence of treatment-emergent serious adverse events (SAEs), graded using the NCI CTCAE Version 5.0, [Time Frame 60 days]|Capacity for the Onco-Seraph 100 Filter to Remove Circulating Tumor Cells, Capacity for the Onco-Seraph 100 filter to remove circulating tumor cells., [Time Frame 30 days]
Validity and Reliability of the Self-administered Timed Up and Go Test: a Promising Telehealth Resource for Monitoring the Risk of Falls in Community-dwelling Older Adults
NCT Number: NCT06481384
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Telehealth
Sponsor: Anabela Correia Martins
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-10
Completion Date: 2024-05-25
Locations: Escola Superior de Tecnologia da Saúde de Coimbra, Coimbra, 3046-854, Portugal

Summary:
Digital health is an effective solution to overcome logistical and access challenges in urban and rural areas. Telephysiotherapy can play a vital role in tracking and monitoring health and risk factors in older adults.The aim of this study was to determinate the validity and the reliability of the self-administered Timed Up and Go (TUG) test, a gold standard test for fall risk screening, when compared to the traditional face-to-face assessment carried out by a physiotherapist. The protocol included sociodemographic and history of falls questions, the Self-Efficacy for Exercise questionnaire, the Activities and Participation Profile Related to Mobility (PAPM) and three functional tests, namely the 10-Meter Walking Speed (10-MWS) test, TUG test and 30 Seconds Sit to Stand (30s STS) test. Within an interval of 18-24 hours after the face-to-face moment, the participants were invited and instructed to self-administer the TUG test at home.

Primary Outcome Measures: Time Up and Go Test face-to-face, Seconds, Day 0|Time Up and Go test self-administered, Seconds, 18-24 hours after the first measurement
Secondary Outcome Measures: Fear of falling, "Are you afraid of falling?", Day 0|History of falls, Falls occurrence 12 months prior to screening. "Did you fall in the past 12 months?", Day 0|Sedentary behaviours, "Do you spend more than 4 hours sitting, 5 days a week?", Day 0|Education Level, "Basic education (4-9 years)" or "High school (10-12 years)" or "University education", Day 0|Health self-perception, "Very good" or "Good" or "Satisfactory" or "Poor", Day 0|Self-Efficacy for Exercise, Score 5 to 20 points, Day 0|Activities and Participation Profile Related to Mobility (PAPM), Classification: 0, meaning "no limitation or restriction," to 4, meaning "complete limitation or restriction." In between, 1 indicates "mild limitation or restriction," 2 indicates "moderate limitation or restriction," and 3 indicates "severe limitation or restriction", Day 0|10- Meter Walking Speed Test, meters per second, Day 0|30 Seconds Sit to Stand, number os stands, Day 0
Zuojin Wan Combined With Rabeprazole or Mosapride for the Treatment of Functional Dyspepsia Combined With Depression
NCT Number: NCT06481371
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Functional Dyspepsia|Depression
Interventions: DRUG: zuojinwan|DRUG: Rabeprazole sodium enteric-coated tablets|DRUG: mosapride citrate
Sponsor: Nanjing First Hospital, Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-30
Completion Date: 2025-04-30

Summary:
To evaluate the symptom improvement of Zuojinwan combined with rabeprazole or Zuojinwan combined with a mosapride regimen in patients with functional dyspepsia combined with depression (liver-stomach depression-heat type) using rabeprazole or mosapride regimen as a control, and to compare the patients' adherence to the medication and the adverse effects between the two groups.

Primary Outcome Measures: Depressionsymptom scale, Hamilton Depression Scale is assessed patients' depressive symptoms pre- and post-treatment., Pre-treatment and 4 weeks of treatment|FD symptom scale, The overall score method for the main symptoms was used, and the overall symptoms included postprandial fullness and discomfort, early satiety, mid-upper abdominal pain, and burning sensation in the mid-upper abdomen. The degree and frequency of symptoms were observed before and after treatment, Pre-treatment and 4 weeks of treatment|Chinese Medicine Symptoms, Evaluation of Chinese medicine symptoms before and after treatment using the Chinese Medicine Symptoms Score Scale, Pre-treatment and 4 weeks of treatment
Secondary Outcome Measures: Adverse events during treatment, Ask patients about the occurrence of adverse events during treatment, Pre-treatment and 4 weeks of treatment
Deep Learning-based Artificial Intelligence for the Diagnosis of Small Bowel Obstruction
NCT Number: NCT06481358
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bowel Obstruction|Artificial Intelligence
Interventions: DIAGNOSTIC_TEST: Artificial intelligence
Sponsor: Nagoya University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 17
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-01
Completion Date: 2024-10-31
Locations: Nagoya University Graduate School of Medicine, Nagoya, Aichi, 4668560, Japan

Summary:
The study will compare the diagnostic accuracy and time to diagnosis of computed tomography images of patients with suspected intestinal obstruction seen in the emergency room by residents and surgeons, with and without artificial intelligence.

Primary Outcome Measures: The diagnosis of the obstruction site, Accuracy of diagnosis of the obstruction site, September, 2024
Characterization of Myeloproliferative Neoplasia With a Mutated IDH, SRSF2 or SF3B1 Allele (CARPEDIEM)
NCT Number: NCT06481345
Acronym: CARPEDIEM
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myeloproliferative Disorders
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-25
Completion Date: 2026-05-31
Locations: Chu Brest, Brest, 29609, France

Summary:
Retrospective study assessing the impact of IDH1/2, SRSF2 or SF3B1 mutations on event free survival of MPN patients

Primary Outcome Measures: Event free survival, 3 years
Diagnostic Characterization and Evolution of "Triple Negative" Thrombocytosis (CASTETTE)
NCT Number: NCT06481332
Acronym: CASTETTE
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myeloproliferative Neoplasm
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-25
Completion Date: 2024-12-31
Locations: Chu Brest, Brest, 29609, France

Summary:
Evaluation of Event free survival in patients with triple-negative thrombocytosis

Primary Outcome Measures: Event-free survival, 3 years
Tackling Dry Socket Via Laser Therapy in Smokers
NCT Number: NCT06481293
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alveolar Osteitis
Interventions: DEVICE: Diode laser therapy|COMBINATION_PRODUCT: Alveogyl dressing
Sponsor: Badr University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-30
Completion Date: 2024-10
Locations: Badr University in Cairo, Cairo, 11837, Egypt

Summary:
This study examines the efficiency of diode laser therapy to manage dry sockets after tooth extraction.

Primary Outcome Measures: Socket volume, measured through the volumetric measurement method using a syringe filled with saline, 2 weeks
Secondary Outcome Measures: Pain level, measured by the visual analogue scale(VAS). It include score from 0 to 10 in which 10 indicates the worst pain level and 0 indicates no pain, 2 weeks
Effect of Hawthorn Vinegar, Black Mulberry Syrup and Green Tea on Oral Mucositis
NCT Number: NCT06481254
Acronym: Oral Mucositis
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mucositis|Quality of Life
Interventions: OTHER: Hawthorn Vinegar Group|OTHER: Black Mulberry Syrup Group|OTHER: Green Tea Group
Sponsor: Karadeniz Technical University
Collaborators: Bayburt University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-02-06
Completion Date: 2024-02-20
Locations: Gümüşhane University, Gümüşhane, 29600, Turkey

Summary:
In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.

Primary Outcome Measures: Oral Assessment Guide (OAG), The "OAG" is useful for assessing and recording the individual's daily oral condition, as well as detecting the presence of mucositis and evaluating the effectiveness of treatment. The "OAG" consists of 8 categories including voice, dysphagia, lips, tongue, saliva, mucous membranes, gums and teeth/prostheses.

"OAG" was administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test)., 14 Days|Oral Health Related Quality of Life Scale (OHQoL-UK), The 5-point Likert-type scale, which consists of a total of 16 items to determine the degree of impact of teeth, gums, mouth or prosthesis, consists of 4 dimensions: "symptom" (items 1-2), "physical condition" (items 3-7), "psychological condition" (items 8-12) and "social condition" (items 13-16). Each item in the scale is scored as "Very bad effect-1, bad effect-2, no effect-3, good effect-4, very good effect-5". The total score of the scale varies between 16-80, and a high score indicates a high level of oral and dental health-related quality of life. The Cronbach alpha value of the scale was reported as 0.94.

"OHQoL-UK" was administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test)., 14 Days