pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Developing an Intervention to Help Nurses Improve Sexual Healthcare in Men With Inflammatory Bowel Disease
NCT Number: NCT06562751
Acronym: MenSH-IBD
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Inflammatory Bowel Diseases
Interventions: OTHER: Questionnaire|OTHER: Focus group|OTHER: Interview|OTHER: Workshop
Sponsor: York Teaching Hospitals NHS Foundation Trust
Collaborators: University of York|York St John University|National Institute for Health Research, United Kingdom
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 639
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-05-01

Summary:
Inflammatory Bowel Disease (IBD) is a chronic, relapsing and remitting disease that can greatly impact health and personal well-being. Sexual health, relationships and intimacy have been raised as key concerns for those living with the disease. Men's sexual health and well-being has been identified as a neglected area. This study will lead to the development of an intervention that will help nurses to improve the assessment and care of the sexual health and well-being needs of men with IBD.

Primary Outcome Measures: Prototype intervention, A prototype intervention to improve the assessment and care of the sexual health needs of men with Inflammatory bowel disease (IBD). The intervention will provide nurses with the improved understanding of the support and knowledge and skills required to effectively assess the sexual health needs of men with Inflammatory Bowel Disease and provide appropriate patient-centred care., 18 months
Secondary Outcome Measures: Survey 1 outcomes:, Determine provision of sexual healthcare, assessment and support services to men with IBD in UK National Health Services including whether these differ between male and female patients., 18 months|Survey 2 outcome, Facilitators, barriers and confidence of nurses to delivery sexual health assessment, care and advice to male patients., 18 months|Survey 3 outcome, Perceived needs, preferences and barriers in regards to sexual health in men with Inflammatory Bowel Disease., 18 months
Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia
NCT Number: NCT06562738
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Thrombocytopenia
Interventions: DRUG: Hetrombopag
Sponsor: The Third People's Hospital of Chengdu
Collaborators: Afﬁliated Hospital of North Sichuan Medical College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-03-31
Locations: Chengdu Third People's Hospital, Chengdu, Sichuan, 610000, China

Summary:
This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery

Primary Outcome Measures: Platelet elevation, Proportion of patients achieving perioperative platelet count goals (≥80×10\^9/ L for major surgery and ≥50×10\^9/ L for minor surgery) without emergency treatment, up to 14 days
Secondary Outcome Measures: Secondary Outcome, The median time to reach the platelet count target;, up to 14 days
Ventilator Settings for Bronchoscopy During Mechanical Ventilation: a Randomized Controlled Study
NCT Number: NCT06562725
Acronym: VentSetFib
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mechanical Ventilation Complication|Fiberoptic Bronchoscopy|Critical Illness|Acute Respiratory Failure
Interventions: OTHER: specific ventilator settings
Sponsor: Centre Hospitalier Arras
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-09
Locations: Arras Hospital, Arras, 62000, France

Summary:
Fiberoptic bronchoscopy (FOB) can cause a significant increase in respiratory resistances and airway pressure during mechanical ventilation (MV), which can jeopardize the delivery of the ventilatory assistance. This randomized controlled study tests the hypothesis that new ventilator settings aimed at reducing airway pressure may facilitate FOB during MV. Results of this trial should lead to propose a new ventilatory strategy for critically ill patients needing a FOB procedure under MV.

Primary Outcome Measures: Determine if the use of specific ventilator settings facilitates the performance of fiberoptic bronchoscopy (FOB) during mechanical ventilation compared to conventional ventilator settings., Occurrence of a serious adverse - ventilatory, respiratory, or circulatory - event prompting the procedure to be interrupted early in the first 5 minutes., 5 minutes after bronchoscopy initiation
Secondary Outcome Measures: determine if the specific ventilator settings prevent significant hypoventilation during FOB, Significant reduction in minute ventilation during FOB compared to its initial value, 5 minutes after bronchoscopy initiation|determine if the specific ventilator settings prevent significant arterial oxygen desaturation during FOB, Significant decrease in the "partial pressure of oxygen in arterial blood (PaO2)"/FiO2 ratio during FOB compared to its initial value, 5 minutes after bronchoscopy initiation|determine if the specific ventilator settings prevent significant hypercapnia during FOB, Significant increase in PaCO2 during FOB compared to its initial value, 5 minutes after bronchoscopy initiation|determine if the specific ventilator settings reduce the incidence of hemodynamic adverse event, Significant reduction in episodes of tachycardia, arrythmia, or circulatory instability occurring during the procedure, 5 minutes after bronchoscopy initiation
Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management
NCT Number: NCT06562712
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Internal Iliac Artery|Balloon Occlusion|Placenta Accreta Spectrum
Interventions: PROCEDURE: Conventional management|PROCEDURE: Bilateral internal iliac artery balloon occlusion
Sponsor: Tanta University
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-05-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.

Primary Outcome Measures: Amount of intraoperative blood loss, The amount of intraoperative blood loss will be calculated with reference to the contents of the suction apparatus and to weight of the surgical pads and the hemoglobin concentration difference, immediate preoperative (the morning of cesarean delivery) and postoperative (immediately after cesarean delivery) hemoglobin levels., Intraoperatively
Secondary Outcome Measures: Operation time, Operation time will be recorded from start till end of surgery., From the start till the end of surgery|Number of blood products units transfused, Number of blood products units transfused will be recorded., 24 hours postoperatively|Hospitalization length, Hospitalization length will be recorded from admission till discharge from hospital., 28 days postoperatively|Incidence of hysterectomy, Incidence of hysterectomy will be recorded., 24 hours postoperatively|Intensive Care Unit (ICU) admission rate, Intensive Care Unit (ICU) admission rate will be recorded., 24 hours postoperatively|Intraoperative complications, Intraoperative complications such as bladder injury, ureteric ligature, and uterine atony will be recorded., Intraoperatively
Buffering Capacity of Matcha Green Tea on Salivary PH After an Acidic Attack
NCT Number: NCT06562699
Acronym: ph
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diet Habit
Interventions: OTHER: Hot Matcha brew|OTHER: Water|OTHER: Cold matcha brew
Sponsor: NewGiza University
Sex: ALL
Age: ADULT
Enrollment: 63
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2024-12-01

Summary:
This study is conducted to evaluate the buffering capacity of hot matcha brew in comparison with cold matcha brew and water on salivary pH after an acidic attack using a digital pH meter.

Research Question:

Will matcha green tea beverage have similar salivary buffering effect as water after an acidic challenge on dental interns? Steps in short

1. Recruitment of the patients and clinical examination with medical and dental history taking.
2. Informed consent taking for the eligible participants to participate in the study.
3. A volume of 2 mL saliva samples will be collected before the commencement of acidic attack, baseline (T0).
4. After the acidic attack, saliva will be collected again by spitting method and their pH value will be measured (T1).
5. After 5 minutes of the acidic attack, participants will be instructed to swish either hot matcha tea, cold matcha tea, or water then swallow, and saliva samples will be collected (T2).
6. Then saliva will be collected after 10 (T3), 20 (T4), 30 (T5), and 40 (T6) minutes.

Primary Outcome Measures: Salivary pH buffering effect, PH will be assessed by a digital pH meter (AD1030, Adwa Instruments, Hungary). Calibration of the pH meter will be performed before measuring. The glass electrode will be immersed in the saliva sample, and after each measurement, it will be carefully cleaned with deionized water and dried with filter paper. The salivary pH value will be determined by 3 consecutive immersions of the pH meter glass electrode in the test tube with the sample, and the mean value will be taken as the obtained value. Measurements will be taken at baseline, 5 mins after the acidic attack, 5, 10, 20, 30, and 40 minutes after consumption of the buffering beverages., 60 minutes
Assessment of Methods Used in Evaluating Balance Rehabilitation in Parkinson's Patients
NCT Number: NCT06562686
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parkinson Disease
Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 83
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-07
Locations: Zeynep Candan, Istanbul, Turkey

Summary:
Balance rehabilitation holds an important place in the treatment of Parkinson's patients. Before and after treatment, patients are evaluated using various measurement methods. In calculations of changes post-treatment, although statistically significant changes are detected, clinical differences are often not observed. Jaeschke et al. developed the concept of minimal clinically important difference (MCID) to address this. They have worked on methods to determine the level of MCID. These measurements help clinicians understand which results can be interpreted as clinically meaningful for the patient.

Responsiveness refers to how sensitive a measurement tool is to changes, whereas MCID focuses on determining whether these changes are clinically significant. Both concepts are crucial for understanding and interpreting the performance of measurement tools.

Identifying which patients have a high risk of balance problems and falls, and screening those at risk, is important for making treatment decisions. Determining which change values are clinically significant (MCID) and identifying which tests are more sensitive in detecting changes (responsiveness) are essential in monitoring patients.

Primary Outcome Measures: Biodex, Determination of the minimal clinical important change values of balance scores (fall risk test) determined by the Biodex balance system in Parkinson's disease, One Month
Secondary Outcome Measures: International Fall Activity Scale, Determination of the minimal clinical important change values of tests assessing falls, One Month|timed up and go test, Determination of the minimal clinical important change values of functional balance assessment tests, One Month
Intra-arterial Cisplatin Plus Rh-endostatin Combined With Systematic Chemotherapy in Osteosarcoma
NCT Number: NCT06562673
Acronym: IACE-OS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Osteosarcoma|Bone Cancer
Interventions: DRUG: intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar)
Sponsor: Shanghai 6th People's Hospital
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-04-20
Locations: Shanghai Jiao Tong University School of Medicine, Shanghai Sixth People's Hospital,, Shanghai, 200233, China

Summary:
The goal of this clinical trial is to learn the efficacy and safety of intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy in osteosarcoma. The main questions it aims to answer are:

* Is it safe when rh-endostatin and cisplatin are administered intra-arterially?
* Does intra-arterial cisplatin plus rh-endostatin increase the rate of tumor necrosis compared with traditional treatment?

Researchers will treat newly diagnosed osteosarcoma patients with systematic treatment and local treatment.

For systematic treatment, regular high-dose methotrexate and adriamycin will be administered intravenously.

For local treatment, rh-endostatin was administered intra-arterially with dosage of 150 mg for a 6-h continuous infusion; then cisplatin was administered intra-arterially at 120 mg/m2 as a 6-h continuous infusion.

Local treatment is conducted by insertion of a catheter percutaneously using the Seldinger technique through the brachial or femoral artery under local anesthesia.

Participants will:

• Receive local combined with systematic treatment once every 2-3 weeks for 2-4 cycles before surgery.

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events, Safety analysis (adverse events) according to CTCAE 5.0, From enrollment to the end of treatment at 1-month|Incidence of tumor response, according to tumor cell necrosis rate (TCNR) of tumor tissue sample after surgery., From enrollment to the end of treatment at 1 month
Secondary Outcome Measures: Microvessel density, the measurement of microvessel density (MVD) detected in tumor tissue sample after surgery., From enrollment to the end of treatment at 1 month
Perioperative Challenges: Does Smoking Compromise High-Flow Nasal Oxygen Efficacy in Obese Men?
NCT Number: NCT06562660
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obese
Interventions: DEVICE: apnoeic
Sponsor: Henan Provincial People's Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-05-01
Completion Date: 2025-03-01
Locations: Wanghuabing, Zhengzhou, China

Summary:
There is a risk of airway-related incidents during anaesthesia associated with obesity. High-flow nasal oxygen is advocated for perioperative preoxygenation in obese patients to reduce airway adverse reactions. However, there have been no reports on whether smoking behaviors have an impact on obese men's Apnoeic oxygenation with high-flow nasal.This study compared the effects of smoking on the duration of safe apnoea times in obese males.

Primary Outcome Measures: the safe apnoea times, Investigators will record the time of oxygen saturation drop to 95 % during intubation., 5-minute
Secondary Outcome Measures: the Pao2 levels, the Pao2 levels after 5-minute pre oxygenation with high flow nasal oxygen in two groups of patients., 5-minute
SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
NCT Number: NCT06562647
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Treatment Related Cancer|Ovarian Cancer
Interventions: DRUG: SY001
Sponsor: Cell Origin Biotech (Hangzhou) Co., Ltd.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 2
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-12
Completion Date: 2025-04
Locations: Linyi Cancer Hospital, Linyi, China

Summary:
Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.

Primary Outcome Measures: Identification of Maximum Tolerated Dose (MTD), MTD will be determined based on DLTs observed during the first 28 days of study treatment., up to 28 days after SY001 infusion.
Secondary Outcome Measures: Objective response rate (ORR), Treatment response was assessed according to the criteria of RECIST 1.1, with PET-CT scans being the primary method used to evaluate tumor progression., 3 months|Time to Peak (Tmax), Changes in the CAR gene copy number after infusion of SY001; time to peak (Tmax) from 0 to 1 month., 1 month|Area Under the Plasma Concentration Versus Time Curve (AUC), Changes in the CAR gene copy number after infusion of SY001, area under the concentration-time curve (AUC) from 0 to 1 month, 1 month|Maximum Plasma Concentration of cytokines (Cmax), Changes in cytokines in peripheral blood after infusion of SY001., 1 month
Effectiveness of Ultrasound-Guided Erector Spinae Plane Block for Postoperative Pain Control in Open Knee Surgeries
NCT Number: NCT06562634
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Injuries
Interventions: PROCEDURE: erector spinea plane block|DRUG: Morphine Sulfate
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-13
Completion Date: 2024-09

Summary:
To estimate the efficacy of the ultrasound guided ESP block for postoperative pain control in open knee surgeries under general anesthesia.

Primary Outcome Measures: Total morphine consumption during the 1st 24 h postoperative., Total morphine consumption during the 1st 24 h postoperative., 24 hour postoperative
Secondary Outcome Measures: Intraoperative fentanyl consumption, Intraoperative|Time to first postoperative analgesic request, 24hour postoperative|Visual analogue score (0-10), 0: no pain 10:worst pain, 24hour postoperative|Hemodynamics :heart rate (bpm), baseline ,Intraoperative every 15 min, postoperative for 24 hr|Block failure rate., Intraoperative &24 hour postoperative|Incidence of complications. (Nerve injury, Hematoma formation, LA toxicity, Intravascular injection, 24hour postoperative|Hemodynamics :arterial blood pressure (systolic, diastolic and mean blood pressure) in mmhg, baseline, intraoperative every 15 min, postoperative for 24 hr
What is the Optimal Training Model for Cervical Awareness?
NCT Number: NCT06562595
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HPV Infection|Cervical Cancer|Cervical Dysplasia
Interventions: BEHAVIORAL: Education Intervention
Sponsor: Izmir City Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-15
Completion Date: 2024-09-30
Locations: Izmir City Hospital, İzmir, Turkey

Summary:
Cervical cancer represents the fourth most prevalent malignant disease and the fourth leading cause of mortality among women on a global scale. Despite screening and preventive vaccination efforts, cervical cancer remains a significant cause of morbidity and mortality in low- and middle-income countries.

Primary Outcome Measures: Test Score, Pre-Training, Participants will first take a test where they will receive a maximum of 25 points and a minimum of 0 points. Then the participants will be automatically assigned to one of the 4 training models, then the trainings will be given and the same test will be applied to the participants again.

By looking at the second test and first test scores, it will be determined which training model increases the participant's score more. Thus, we will be able to understand which form of education increases HPV and cervical awareness in our society., After completion of the 25-item assessment tests (first and second test) and training, an average of 1 month.|Test Score, Post-Training, Participants will first take a test where they will receive a maximum of 25 points and a minimum of 0 points. Then the participants will be automatically assigned to one of the 4 training models, then the trainings will be given and the same test will be applied to the participants again.

By looking at the second test and first test scores, it will be determined which training model increases the participant's score more. Thus, we will be able to understand which form of education increases HPV and cervical awareness in our society., After completion of the 25-item assessment tests (first and second test) and training, an average of 1 month.
STunning in Acute Myocardial Infarction - BAS
NCT Number: NCT06562582
Acronym: STAMI-BAS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Myocardial Infarct
Interventions: DRUG: Bisoprolol Oral Tablet|DRUG: Ramipril Oral Product|DRUG: Dapagliflozin Oral Product
Sponsor: Vastra Gotaland Region
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-12-31

Summary:
The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI)

Primary Outcome Measures: Measurement of Global longitudinal strain (GLS, %), GLS adjusted for baseline., day 7±24 hours
Secondary Outcome Measures: Measurement of Left ventricular ejection fraction (LVEF), LVEF adjusted for baseline, day 7±24 hours|Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide ), NT-proBNP adjusted for baseline, day 7±24 hours|Concentration of cardiac troponin-T, Area under the curve, Day 30|Concentration of cardiac troponin-I, Area under the curve, Day 30
Other Outcome Measures: Measurement of Infarct size, MI size assessed by CMRI (sub-study), Day 30
Non-invasive VNS for PD Gait
NCT Number: NCT06562569
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson's Disease
Interventions: DEVICE: non-invasive cervical vagal nerve stimulation ncVNS
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-05-27
Completion Date: 2027-04-01
Locations: Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, 60141-3030, United States

Summary:
More than 110,000 US Veterans living with Parkinson's disease (PD) currently receive PD-related care and services from the VA. Fall prevention is a priority for Veterans living PD. Gait disturbances are a major cause for functional dependence and the largest risk factor for falls, institutionalization, and death in PD. This SPiRE addresses the need to advance nonpharmacological rehabilitative health care of Veterans and maximizing functional outcomes by developing a non-invasive, neuromodulatory transcutaneous cervical Vagal Nerve Stimulation as an at-home intervention to improve gait and balance. This pilot clinical trial will assist with future efforts and priorities of the VA to prolong independent living and quality of life by minimizing gait and balance dysfunction experienced by Veterans living with PD.

Primary Outcome Measures: Stride Length, Quantitative gait analysis will be performed during a 15-meter instrumented 2-min walk test (2MWT) using the APDM Mobility Lab, baseline and 4 weeks
Digital Training Module for Sustainable Education of Pediatric Oncology Nurses
NCT Number: NCT06562517
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Cancer
Interventions: OTHER: Digital training module
Sponsor: Koç University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-03-01
Locations: Koc University, Istanbul, Turkey

Summary:
Pediatric oncology nurses are healthcare professionals who constantly communicate with children and their families for 24 hours, and take professional roles and responsibilities in areas such as care planning, a continuation of treatment, and symptom management.However, there is no standard undergraduate education program accepted worldwide in the field of pediatric oncology nursing. For example, undergraduate nursing education in Türkiye is carried out in line with the Nursing National Core Education Program (NNCEP), and information about pediatric oncology nursing is included in the curriculum of specific courses in undergraduate programs. In addition, nurses graduate without specializing in any field in our country. Therefore, the education of pediatric oncology nurses and the continuity of education is an essential problem in developing and low-middle-income countries like our country. This prospective study in randomized controlled pre-test-post-test design aimed to develop an online website consisting of information and support modules for the care of children with cancer for sustainable pediatric oncology nursing education in Türkiye.

Primary Outcome Measures: Pediatric Oncology Nurses' Educational Needs Scale, The scale consists of five sub-dimensions: disease, chemotherapy, and its side effects, other treatments and their side effects, palliative care, and supportive care. From the scale, a minimum of 42 points and a maximum of 210 points can be obtained. The increase in the total score of the scale and the mean score of the sub-dimensions indicate that the education needs of the nurses regarding that sub-dimension have increased., It will be applied to nurses in the experimental and control groups before (1 week before) and after (immediately after and 6 months later) the intervention.|Knowledge Levels of Pediatric Oncology Nurses on Childhood Cancers and Care, To evaluate the knowledge levels of pediatric oncology nurses on childhood cancers and care, test questions will be created by the digital education modules., It will be applied to nurses in the experimental and control groups before (1 week before) and after (immediately after and 6 months later) the intervention.|Ateşman Readability Index, To determine the readability level of the digital training booklet, the Ateşman Readability Index will be used., The data collection process will begin one day after the digital booklet is created.
Temporal Memory in Schizophrenic Patients
NCT Number: NCT06562504
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patients With Schizophrenia
Interventions: DEVICE: Transcranial direct current stimulation (tDCS)- anodal group|DEVICE: Transcranial direct current stimulation (tDCS)- sham group|DEVICE: transcranial alternating current stimulation (tACS)-tACS group
Sponsor: Xiaofeng Ma
Sex: ALL
Age: ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2024-09-30
Locations: Northwest Normal University, Lanzhou, Gansu, 730070, China

Summary:
Temporal order memory deficits are a central feature of cognitive abnormalities in schizophrenia. The dorsolateral prefrontal cortex contributes to the extraction of temporal contextual information. Transcranial direct current stimulation (tDCS) and interim testing have been shown to be external techniques that can improve temporal order memory deficits in schizophrenia patients. Transcranial alternating current stimulation (tACS) can also improve cognitive functioning in patients with schizophrenia. This study intends to investigate the learning effects of temporal order memory under two learning strategies during tDCS targeting the left dorsolateral prefrontal cortex (L-DLPFC) and transcranial direct current stimulation (tDCS) interventions in patients with schizophrenia, to investigate whether it can promote the retention of temporal order memory in patients, and to compare the differences in the effects of the two intervention modalities.

This study was planned to recruit 75 patients diagnosed with schizophrenia from the hospital.

A single online tDCS (2 mA × 20 min) and tACS (1.5 mA × 20 min, theta rhythm) intervention was conducted during which participants performed a temporal-sequence memory task for visual pictures, and test scores were compared for each stimulus type on an intermediate test and repetition of the two strategies of learning.

Primary Outcome Measures: Correctness of temporal recall, Stimulus content was presented using the Eprime experimental program, and participants pressed key responses during the test phase to record their rate of correctness.

Stimulus content was presented using the Eprime experimental program, and participants pressed key responses during the test phase to record their rate of correctness., 5mins to 24 hours|proactive interference rate, The rate of intrusion of prior information when participants recalled the current information was counted., 5mins to 24 hours
Phenotypes Associated With Constitutional EGFR Pathogenic Variants
NCT Number: NCT06562491
Acronym: EGFRench
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bronchopulmonary Cancers|Constitutional EGFR
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-09

Summary:
A small proportion of lung cancers are hereditary, i.e. caused by a constitutional pathogenic variant (PV). EGFR " Epidermal Growth Factor Receptor " is a major cancer predisposing gene, mainly via the T790M variant. The study aims to collect French national data on EGFR pathogenic variant carriers (affected and unaffected), in order to better characterise the associated phenotypes.

A retrospective, multicenter cohort study will be carried out. The study aims to include 20 to 25 patients identified as EGFR pathogenic variant carriers between 2018 and 2024. Data will be gathered from either paper or electronic patient files from the Oncogenetics clinics or laboratory. Eligible patients will be informed and given a possibility to opt out. Of note, all previously signed a consent form for genetic testing. Each participating centre will be responsible for transcribing the pseudonymised data from its patients' medical records into a secure Excel file unique to each centre. The anonymized data obtained from the patient files will be electronically stored in a secure document accessible only to the principal investigator and a maximum of two close collaborators involved in the study. Data will be sent by participating centres to investigators from the Medical Genetics Department at APHP Sorbonne via the secure national RENATER platform for analysis.

A Simple description of the cohort, e.g. mean/median age, proportion and type of somatic changes, prevalence of smoking will be done.

Primary Outcome Measures: average/median, proportion and type of somatic disorders, prevalence of smoking, Through out study 12 months
Evaluating the Effect of Injectable Platelet Rich Fibrin on Tooth Movement
NCT Number: NCT06562452
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Angle Class I
Interventions: DIAGNOSTIC_TEST: Injectable platelet rich fbirin
Sponsor: Can Tho University of Medicine and Pharmacy
Sex: ALL
Age: CHILD, ADULT
Enrollment: 31
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-08-15
Completion Date: 2024-07-02
Locations: Can Tho University of Medicine and Pharmacy, Cần Thơ, 900000, Vietnam

Summary:
Introduction: Prolonged orthodontic treatment can lead to challenges and unfavourable outcomes, including increased risk of caries, root resorption, as well as gingival and periodontal diseases. Acceleration of this step would reduce overall treatment time, improve patient cooperation, and decrease possible negative side effects. The injectable platelet - rich fibrin is second generation holds the advantages of easier preparations and longer effects that is obtained through low-speed centrifugation. The potential benefits of PRF have been widely investigated in regenerative dentistry and oral surgery such as tooth movement, implantology, oral pathology and periodontal therapy.

Objective: Our study aims to investigate the effectiveness of i PRF in accelerating maxillary canine retraction Subjects and method: This study was a split-mouth randomized clinical trial was conducted on 31 patients (9 male, 22 females age ranging 14-31 years) who were treated for Class I malocclusion with the extraction of the maxillary first premolar. After the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. Digital model were obtained at five time points: before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4) from the beginning of distalization.

Primary Outcome Measures: The purpose of this study was to investigate the efficiency of i-PRF in accelerating tooth movement., Digital models were scanned using the iTero scanner (Align Technology, Inc, USA) assessed by Medit Link software at 5 time points (5 months), Our study aims to investigate the effectiveness of i PRF in accelerating maxilary canine retraction at 5 time points (5 months): before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4)
Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments
NCT Number: NCT06562413
Acronym: SPHERA_WP1_2
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine Disorders|Chronic Migraine|Episodic Migraine
Interventions: DRUG: MAbs
Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborators: University of L'Aquila
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-10
Completion Date: 2026-05
Locations: Headache Science & Neurorehabilitation Unit, Pavia, 27100, Italy

Summary:
The investigators aim to define the neurofunctional phenotype of migraine patients who did not respond to at least 3 preventive treatments, including monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) pathway (NON-responders).

Primary aim will be to assess and compare changes in functional resting-state connectivity at baseline and after three months of mAbs treatment between patients who will achieve a reduction of monthly migraine days \>/= than 50% (namely Responders) and those who will not (namely Responders).

The 2 groups will undergo a neurofunctional profile by means of High Density-electroencephalogram (HD-EEG) and functional-magnetic resonance imaging (fMRI).

Primary Outcome Measures: RSN-FC assessed through HD-EEG, Resting state functional connectivity assessed through HD-EEG (continuous variable, without unit of measurement), Baseline (T0), and three months of mAbs treatment (T1)|RSN-FC assessed through MRI, Resting state functional connectivity assessed through MRI (continuous variable, without unit of measurement), Baseline (T0)
Secondary Outcome Measures: Comparison between baseline RSN-FC assessed through HD-EEG, Comparison between RSN-FC changes assessed through HD-EEG (continuous variable, without unit of measurement), Baseline (T0)|Comparison between baseline RSN-FC assessed through MRI, Comparison between RSN-FC changes assessed through MRI (continuous variable, without unit of measurement), Baseline (T0)
Searching for Novel Therapeutic Approaches in Migraine Patients Resistant to Treatments
NCT Number: NCT06562400
Acronym: SPHERA_WP2
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine Disorders|Chronic Migraine|Episodic Migraine
Interventions: DIETARY_SUPPLEMENT: Palmitoyl ethanolamide|BEHAVIORAL: Ketogenic diet
Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborators: University of L'Aquila
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-10
Completion Date: 2026-05
Locations: Headache Science & Neurorehabilitation Unit, Pavia, 27100, Italy

Summary:
Primary working hypothesis is that NON-responders to mAbs bear a dysfunction of the endocannabidiome system (eCBome), as suggested by pre-clinical and clinical data by our group.

They will be identified as patients showing a reduction of monthly migraine days \< 50% after three months of treatment.

The clinical, biochemical and neurofunctional impact of novel therapeutic approaches expected to interfere with eCBome will be evaluated in NON-responder patients

Primary Outcome Measures: Monthly migraine days (MMDs), MMDs during treatment with PEA or KD (continuous variable), Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
Secondary Outcome Measures: Monthly headache days (MHDs), MHDs during treatment with PEA or KD (continuous variable), Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)|Monthly days and doses of acute drug intake, Monthly days and doses of acute drug intake during treatment with PEA or KD (continuous variable), Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)|Percentage of patients with a 50% reduction in MMDs, Percentage of patients with a 50% reduction in MMDs during treatment with PEA or KD (continuous variable), Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)|Migraine related disability assessed by means of MIDAS, Migraine related disability assessed by means of MIDAS during treatment with PEA or KD (continuous variable), Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)|Headache impact assessed by means of HIT-6, Headache impact assessed by means of HIT-6 during treatment with PEA or KD (continuous variable), Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)|Quality of life assessed by means of MSQ, Quality of life assessed by means of MSQ during treatment with PEA or KD (continuous variable), Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation
NCT Number: NCT06562374
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteo Arthritis Knee|Age Related Osteoporosis|Pain|Knee Joint Contracture
Interventions: DEVICE: Low Frequency Ultrasound Therapy
Sponsor: The University of Texas Medical Branch, Galveston
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-07-31
Locations: University of Texas Medical Branch, Galveston, Galveston, Texas, 777555, United States

Summary:
The purpose of this study is to determine the safety and effectiveness (how well it works) of a new experimental ultrasound bath device that uses low frequency ultrasound (LFU) that may or may not help healing.

Primary Outcome Measures: Safety and Efficacy for non significant risk device, To determine the safety and efficacy for non-significant risk device, which will be denoted by surveys., one year
Secondary Outcome Measures: Participants with Osteoarthritic Joints Reaction to the LFU, To determine the potential impact the device may have on patients as their osteoarthritic joints react to the LFU, which will be denoted by surveys., one year
The ctDNA-RECIST Trial Part One
NCT Number: NCT06562348
Acronym: ctDNA-RECIST
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastrointestinal Neoplasm
Interventions: OTHER: Standard of care|OTHER: ctDNA-RECIST guided palliative systemic treatment
Sponsor: Karen-Lise Garm Spindler
Collaborators: Vejle Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 167
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2030-09-01
Locations: Aarhus University Hospital, Aarhus, 8000, Denmark|Department pf Oncology, Vejle Hospital, Vejle, 7100, Denmark

Summary:
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.

Primary Outcome Measures: Compliance with protocol, The fraction of participants in ARM B, who comply with the study procedures during the first 3 months after inclusion., 3 months
Secondary Outcome Measures: Number of treatment cycles, Median number of treatment cycles in the two arms during the first 12 month of stuydy participation, 1 year|Response rate Arm A, Overall best response and response rate per RECIST during first-line treatment, 1 year|ctDNA response rate Arm B, Overall best response and response rate per ctDNA-RECIST during first-line treatment, 1 year
Fecal Microbiota and Monocyte Trained Immunity in CHD Patients With Different hsCRP
NCT Number: NCT06562309
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Coronary Heart Disease|Unstable Angina
Interventions: OTHER: take feces and blood samples from patients
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-05-11
Completion Date: 2024-07-15
Locations: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Summary:
This single-center study enrolled patients aged 35-75 years who were diagnosed with unstable angina (UA), and had at least one of the three major coronary arteries with a ≥ 50% reduction in lumen diameter by angiographic visual estimation. Patients were all recruited at the Department of Cardiology, Union Hospital, Wuhan, Hubei Province, China. Feces and blood samples were collected on admission were used promptly for ex vivo studies.

Primary Outcome Measures: blood monocytes trained immunity, 1.Blood monocytes were detected by flowcytometry to evaluate the monocyte subsets and CCR2 expression; 2. monocytes were enriched from blood cells and used for ex vivo lipopolysaccharide stimulation, mRNA sequencing and ATAC sequencing; 3.The metabolic bias of monocytes was detected by Seahorse technology and metabolics., within 3 days
Secondary Outcome Measures: fecal microbiome profile, the feccal microbiota was detected by 16s rRNA sequencing, and the analyses includes alpha and beta diversity, the differential microbiota between two groups, and the correlation between microbiota and clinical characteristics including age, BMI, blood lipids, and other available continous variables., within 3 days
Development of Isthmocele Symptom Severity and Quality of Life Scale
NCT Number: NCT06562231
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Quality of Life
Interventions: OTHER: quality of life scale
Sponsor: Hilal Yuvacı
Sex: FEMALE
Age: ADULT
Enrollment: 330
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2025-12-30
Locations: Sakarya University School of Medicine, Sakarya, Turkey

Summary:
Isthmocele, also known as cesarean scar defect (CSD), is the disruption of the integrity of the myometrium in the cesarean section incision and the indentation of the opening in the myometrium towards the visceral peritoneum. Residual menstrual blood accumulating in the isthmocele sac can cause chronic endometritis, anormal uterine bleeding, infertility and chronic pelvic pain.

There is currently no quality of life scale that assesses isthmocele symptoms. A scale is needed to determine the positive effect on the patient's quality of life after the surgeries are performed. This study it is aimed to develop a scale that evaluates the severity of isthmocele symptoms and the impact on quality of life due to isthmocele.

Primary Outcome Measures: Development of isthmocele symptom severity and quality of life scale, In the literature review, there is currently no quality of life scale for isthmocele symptoms. There is a need for a scale to detect changes in patients' quality of life after surgery due to isthmocele.This study aimed to create a questionnaire that can be administered immediately before surgery and six weeks after surgery to assess the severity of isthmocele symptoms and the impact of isthmocele on quality of life., 3 year
The Effectiveness of Cross-training on an Immobilised Forearm
NCT Number: NCT06562218
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Forearm Fracture
Interventions: PROCEDURE: isokinetic strengthening exercise|PROCEDURE: conventional exercise programm
Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-26
Completion Date: 2025-08-30
Locations: Prof. Dr. Cemil Taşçıoğlu City Hospital, Istanbul, Turkey

Summary:
The cross-training phenomenon is the increase in muscle strength in the contralateral limb when one limb is exercised. Limited studies have shown that it prevents immobilisation-induced muscle weakness in healthy volunteers. The aim of this study was to evaluate the effect of strengthening the contralateral extremity on muscle strength and range of motion in the immobilised extremity in patients who had undergone immobilisation for forearm fractures.

Primary Outcome Measures: Wrist isometric flexion muscle strength, The isometric flexion strength of the fractured wrist will be measured using an isokinetic dynamometer at the first week after immobilisation has ceased., 1 year|Wrist isometric extansion muscle strength, The isometric extansion strength of the fractured wrist will be measured using an isokinetic dynamometer at the first week after immobilisation has ceased., 1 year