pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty
NCT Number: NCT06486298
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Abdominoplasty Surgery
Interventions: DEVICE: Vacuum Drain and Passive Drain insertion at abdominoplasty surgery
Sponsor: Sohag University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2023-12-01
Completion Date: 2024-11-01
Locations: Sohag Hospital University, Sohag, Egypt

Summary:
The aim of the present study is to:

Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery

Primary Outcome Measures: the subcutaneous collection with vaccum drain, the subcutaneous collection with Vacuum Drain at abdominoplasty surgery regarding : Incidence of postoperative complications, 10 days|the subcutaneous collection with passive drain, the subcutaneous collection with passive Drain at abdominoplasty surgery regarding : Incidence of postoperative complications, 10 days
The Financial Navigator Program
NCT Number: NCT06486272
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Financial Hardship
Interventions: OTHER: Financial Navigator
Sponsor: The Hospital for Sick Children
Collaborators: Edwin S.H. Leong Centre for Healthy Children
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09
Locations: Hospital for Sick Children, Toronto, Ontario, M5G1X8, Canada

Summary:
Over one third of caregivers with a child admitted to the Hospital for Sick Children (SickKids) reported having difficulty making ends meet. The SickKids Medical-Financial Partnership (MFP) working group conducted in-depth interviews exploring financial needs and supports with selected caregivers in the Neonatal Neurodevelopmental Follow-up Program (NNFU). Results identified financial stress (including difficulties with employment, high cost of living, poverty, food insecurity, inaccessible supports, benefit time lines, costs of therapy) as a major theme. Caregivers generally supported the idea of hospital-based financial services. In this feasibility study we will trial a Financial Navigator Program in the NNFU.

Primary Outcome Measures: Feasibility; Measured with validated questionnaire including; Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM)., Validated Questionnaires (Weiner et al, 2017), 14 months|Demand, Demand will be evaluated by calculating the percentage of families that provided consent and the number of appointments per family with the Financial Navigator., 14 months
Secondary Outcome Measures: Parenting Stress Index (PSI-Short Form), Validated Questionnaire, 14 months|Depression, Anxiety, Stress Scales (DASS), Validated Questionnaire, 14 months|Ages and Stages Questionnaire (ASQ), ASQ 4 months and ASQ 18 month version, 14 months|Economic outcomes, Standardized report: include tax filing, receipt of social assistance, Canada Tax Benefit and provincial tax benefit take up, parental leave benefits uptake, and reported uptake of other financial supports, 14 months
Regional Assessment of the Risk of Lung Injury in Ventilated Patients
NCT Number: NCT06486259
Acronym: RLY
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: ARDS, Human
Interventions: OTHER: Controlled mechanical ventilation
Sponsor: Hospital El Cruce
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2024-07-01
Locations: Hospital El Cruce, Florencio Varela, Buenos Aires, 1853, Argentina

Summary:
Specific characteristics of the lung, such as its functional capacity, heterogeneity, and recruitment potential, can influence the development of ventilator-induced lung injury even under safe ventilation conditions. Objective: To evaluate the risk of ventilator-induced lung injury at the regional level in patients with acute respiratory distress syndrome ventilated with similar tidal volumes and inspiratory pressures.

Primary Outcome Measures: comparison of regional lung volume, comparison of regional lung volume in ml, 1 hour
Secondary Outcome Measures: comparison of regional volume of hyperinflated lung, comparison of regional volume of hyperinflated lung in ml, 1 hour|comparison of regional lung deformation, comparison of regional lung deformation in percentage, 1 hour|comparison of the amount of unstable lung, comparison of the amount of unstable lung in percentage, 1 hour
Geniculate Nerve Block Versus Adductor Canal Block for ACL Reconstruction Surgery
NCT Number: NCT06486246
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ACL Tear|Pain, Postoperative
Interventions: PROCEDURE: Adductor canal block
Sponsor: Hospital Clinic of Barcelona
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-26
Completion Date: 2024-12-30
Locations: Hospital Clinic, Barcelona, 0836, Spain

Summary:
Anterior cruciate ligament repair (ACL) surgery presents moderate to severe pain during the inmediate postoperative period and the first days after surgery. In addition, due to the interest of surgeons and patients for early reinstatement, the use of blockages that decrease the strength of the quadriceps is avoided. Therefore, in recent years, the adductor canal block (ACB) has been used for postoperative analgesia with variable results.

Genicular nerve block (GNB) has been used for pain management in patients with knee osteoarthritis and recently in knee arthroplasty surgery with results similar to the local anesthetic infiltration techniques by the surgeon (LIA). Considering their good results in these patients in addition to being a 100% sensitive block without risk of motor involvement.

The investigators proposed this experimental study to evaluate tha analgesic efficacy of the genicular nerve block (GNB) compared with the adductor canal block (ACB) for the Anterior cruciate ligament (ACL) repair surgery.

Primary Outcome Measures: Pain assessed by NRS at PACU, Numerical raiting score (NRS) 0-10 (0= No pain; 10=maximum pain), up to 6 hours postoperative|Opioid consumption at PACU, Metadone consumption in mg., up to 6 hours postoperative
Secondary Outcome Measures: Pain score at home, Numerical raiting score (NRS) 0-10 (0= No pain; 10=maximum pain), up to 24 hours|Quality of rest, Sleep or wake-up during first night (Pain) (Awake because of pain: Yes / NO), First night
Studying the Effectiveness of Early Invasive Treatment in Elderly Patients With High-risk Non-ST-segment Elevation Acute Coronary Syndrome.
NCT Number: NCT06486233
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myocardial Infarction
Sponsor: Gia Dinh People Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 385
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-22
Completion Date: 2028-03-01
Locations: Gia Dinh people hospital, Ho Chi Minh City, Vietnam

Summary:
The goal of this is observational study is to compare about MACE events and predisposing factors related to MACE events in elderly patients with high-risk non-ST acute coronary syndromes receiving early versus late invasive treatment . This study will anwser two questions.

Question 1: What will factors associate with implementing a late invasive strategy in elderly patients with high-risk non-ST-segment elevation acute coronary syndrome ? Question 2: Is a meaningful difference about mortality and complication rates as re-myocardial infarction, heart failure, re-hospitalization, stroke after 12 months between two groups of patients undergoing early invasive and late invasive strategies in elderly patients with in high-risk non-ST-segment elevation acute coronary syndrome?

Primary Outcome Measures: In-hospital death, recorded when death occurs during treatment or is confirmed by in-hospital monitoring, one month
Secondary Outcome Measures: after 12 months death, determined by the patient follow-up period from hospital discharge until results were recorded, one year|MACE after 12 months include re-admission, recurrent myocardial infarction , stroke, heart failure, recorded, one year
PFLL Combined With PD-1 Antibody With or Without FMT for Oligometastatic NPC,a Phase III ,Open, Randomized Clinical Trial.
NCT Number: NCT06486220
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Nasopharyngeal Carcinoma
Interventions: DRUG: Intestinal bacteria freeze-dried powder capsules
Sponsor: Yun-fei Xia
Sex: ALL
Age: ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-07-01

Summary:
There is a correlation between gut microbiota and immunotherapy reactivity, and regulating gut microbiota through FMT can prevent primary resistance to immune checkpoint inhibitors and further improve the effectiveness of tumor immunotherapy.Therefore, on the basis of previous studies, this study intends to explore whether intestinal flora transplantation can improve the anti-tumor efficacy of low-dose long term 5-FU pumping ("old fire soup") therapy combined with immunotherapy and reduce the occurrence of toxic side effects in patients with metastatic nasopharyngeal carcinoma.

Primary Outcome Measures: PFS, Progression-free survival, 1-year PFS 40%
Secondary Outcome Measures: OS, overall survival, 24 months
Effects of Kendall Exercise VS Gong's Mobilization on Pain, Range of Motion, Function, and Strength in Cases With UCS
NCT Number: NCT06486207
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Syndrome, Down
Interventions: COMBINATION_PRODUCT: Gong's mobilization|OTHER: Kendall Exercise
Sponsor: Superior University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-01
Completion Date: 2024-10-30
Locations: Civil Hospital Khaniwal, Khānewāl, Punjab, Pakistan

Summary:
The effectiveness of kendall exercise vs. gong's mobilization for alleviating pain with improvment in range of motion, function and strength in cases with upper cross syndrome, assessed by dividing 44 patinets in two groups as Group A (n=22) was treated with Kendall exercises and Group B (n=22) managed by Gong's mobilization. VAS, NDI, SPADI, Goniometer and Dyanometer were used for assessing primary and secondary outcomes in patients.

Primary Outcome Measures: Visual Aanalogue scale, A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels., 12 Months|Range of motion, Range of motion of cervical spian and shoudler joint measured using a goniometer, 12 months
Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery
NCT Number: NCT06486168
Acronym: DYNASTY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diaphragmatic Dysfunction
Interventions: PROCEDURE: NIVATS
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-09-02
Locations: Hôpital Privé Claude Galien, Quincy-sous-Sénart, 91480, France

Summary:
The objective of this this single-center prospective longitudinal study is to evaluate the incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery (NIVATS).

Participant will be evaluated during surgery, 2 hours and 24 hours after surgery.

Primary Outcome Measures: Diaphragmatic excursion, The measurement of diaphragmatic excursion at H2 and H24 constitutes the primary evaluation criterion. Diaphragmatic excursion will be measured by ultrasound using a low-frequency probe (\< 5 MHz), either an abdominal or cardiac probe, positioned under the costal margin on the operated side and the contralateral side. To limit inter-operator variability, the patient's ultrasound evaluation will, as much as possible, be performed by the same operator. The presence of diaphragmatic dysfunction is defined by a diaphragmatic excursion of less than 1 cm., Hour 24
Secondary Outcome Measures: Pain evaluation, Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced)., Hour 2|Pain evaluation, Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced)., Hour 24|Diaphragmatic thickening evaluation, Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness, Hour 2|Diaphragmatic thickening evaluation, Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness, Hour 24|postoperative complications evaluation, The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration.

Cardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke., Hour 2|postoperative complications evaluation, The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration.

Cardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke., Hour 24
Evaluation of Axillary Lymph Node Metastasis Status of Breast Cancer Based on Pathological Images and Virtual Staining
NCT Number: NCT06486155
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Virtual Staining|Lymph Node Metastasis|Breast Cancer|Digital Pathology
Sponsor: Yunnan Cancer Hospital
Collaborators: Affiliated Cancer Hospital of Shantou University Medical College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-12

Summary:
The goal of this observational study is to develop an artificial intelligence model to transform unstained lymph node tissue slice images directly into stained images. The main questions it aims to answer are:

Can the virtual staining model generate hematoxylin and eosin (H\&E) and immunohistochemistry (IHC) images suitable for clinical diagnosis from unstained paraffin-embedded lymph node slice images, including those from breast axillary lymph nodes and other tumor lymph nodes?

Can the virtual staining model generate H\&E and IHC images suitable for clinical diagnosis from unstained frozen sentinel lymph node slice images from breast cancer patients?

Researchers will retrospectively collect paraffin-embedded lymph node slices from tumor patients and prospectively collect frozen sentinel lymph node slices from breast cancer patients.

Primary Outcome Measures: Lymph node metastasis status, Lymph node metastasis status: metastasis or non-metastasis, 2024-2025|Accuracy, Sensitivity, Specificity，Area under the curve，, The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images, 2024-2025|Positive predictive value，Negative predictive value, The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images, 2024-2025
Secondary Outcome Measures: Peak Signal-to-Noise Ratio(PSNR), Scores of the similarity between virtual and real staining of lymph nodes, with values ranging from 0 to infinity, the higher scores mean the better outcomes, 2024-2025|Multi-Scale Structural Similarity (MS-SSIM), Scores of the similarity between virtual and real staining of lymph nodes, with values ranging from 0 to 1, the higher scores mean the better outcomes, 2024-2025|Pearson correlation coefficient, Scores of the similarity between virtual and real staining of lymph nodes, with values ranging from 0 to 1, the higher scores mean the better outcomes, 2024-2025
EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study
NCT Number: NCT06486142
Acronym: ERIS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Non-Small Cell Lung Cancer
Interventions: DRUG: Afatinib/Dacomitinib|DRUG: Osimertinib
Sponsor: Region Skane
Collaborators: Swedish Lung Cancer Study Group
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-09-21
Completion Date: 2028-09
Locations: Skåne university hospital, Lund, Sweden

Summary:
The purpose of this study is to evaluate the optimal sequence of EGFR-inhibitors in lung cancer patients with EGFR-positive tumors not amenable for curative treatment. Life quality, adverse effects and tumor response will be evaluated and analyses of obtained blood and tumor samples will be performed to identify molecular profiles and biomarkers that can be used for treatment decisions.

Primary Outcome Measures: Progression-free survival (PFS), Maximum 6 years
Secondary Outcome Measures: Time on TKI-treatment, Maximum 6 years|Objective response rate, Maximum 6 years|Disease control rate, Maximum 6 years|Overall survival, Maximum 6 years|Quality of life, Points on the Lung Cancer Symptom Scale (LCSS) will be compared between the two treatment arms, Maximum 6 years|Hereditary genetic alterations, The frequency of germline DNA variants will be studiedassociated with cancer predisposition will be investigated, Within 15 years from end of study|Identification of potential blood-borne biomarkers of treatment prediction and resistance, Within 15 years from end of study
Myocardial Effects of NIV in OHS Patients
NCT Number: NCT06486129
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Failure Chronic|Obesity Hypoventilation Syndrome|Obstructive Sleep Apnea|Cardiac Output, Low
Interventions: PROCEDURE: Noninvasive ventilation volume targetted
Sponsor: Pavol Jozef Safarik University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 13
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-03-01
Completion Date: 2020-01-15
Locations: Department of respiratory medicine and tuberculosis, Pavol Jozef Safarik University, Medical Faculty and L. Pasteur University Hospital In Kosice, Košice 4, 04190, Slovakia

Summary:
Chronic effects of noninvasive ventilation on myocardial function in patients with obesity hypoventilation syndrome (OHS) are scarcely understood. The aim of the present study was to evaluate the long-term effects of volume-targeted bilevel-positive airway pressure ventilation (BiPAP) on cardiac parameters and myocardial biomarkers in patients with OHS.

Primary Outcome Measures: Impedance cardiography measured cardiac output, Impedance cardiography measured cardiac output before and after effective treatment of respiratory failure, 12 months
Secondary Outcome Measures: Impedance cardiography measured stroke volume, Impedance cardiography measured stroke volume before and after effective treatment of, 12 months
Effectiveness of Task Specific Home Exercise Program
NCT Number: NCT06486116
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis
Interventions: BEHAVIORAL: Task Specific Physical Therapy Home Program
Sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2026-01-31
Locations: New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, 11215, United States

Summary:
The purpose of this study is to compare the effectiveness of 2 different types of Home Exercise Programs (HEP) on mobility in persons with Multiple Sclerosis (MS). Specifically, we will be comparing the Standard of Care (SOC) a program based on aerobic conditioning and calisthenics to a Task Specific Program (TSP).

Primary Question: Will persons with who receive a Task Specific HEP have greater improvement in mobility than those who receive the SOC? Secondary question: Will a task specific HEP be as well tolerated as the SOC HEP by persons with MS

Primary Outcome Measures: 6 Minute Walk Test, Participant walks at best comfortable pace for 6 consecutive minutes; total distance walked and distance per minute is measured., Measured before and after each 4 weeks|The Functional Gait Assessment, A measure of walking balance assessed by participant's performance on specific task., Measured before and after each 4 weeks|The Mini Balance Evaluation Systems Test (MBEST), Assessment of participant balance during reactive anticipatory, dynamic and sensory aspects of balance tasks., Measured before and after each 4 weeks
Protocols for Magnesium Sulfate Maintenance Dose in Overweight and Obese Women Diagnosed With Preeclampsia
NCT Number: NCT06486025
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Severe Preeclampsia
Interventions: DRUG: maintenance magnesium sulphate1g/h|DRUG: maintenance magnesium sulphate2g/h
Sponsor: Ain Shams University
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-10-01

Summary:
There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level.

Primary Outcome Measures: serum magnesium level, Maternal Serum Magnesium Level after 24 hours of magnesium sulphate infusion, 24 hours
Periodontal Outcomes and Digital Volumetric Variation Following BOPT Restorations
NCT Number: NCT06485999
Acronym: BOPT
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Gingival Recession
Interventions: PROCEDURE: Biologically Oriented Preparation Technique
Sponsor: University of Valencia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-02
Completion Date: 2024-06-10
Locations: Universidad de Valencia, Valencia, 46010, Spain

Summary:
Technology is becoming increasingly essential in dentistry, and many procedures now require the use of an intraoral scanner. The goal of scanning the oral cavity is to create digital impressions, which are crucial for the fabrication of any dental prosthesis, as three-dimensional models of the dentition are needed.

Alongside technological advancements, new techniques for preparation in fixed dental prosthetics are being developed. An example is the BOPT technique, which involves vertical tooth preparation without a finishing line, associated with gingival sulcus curettage. The technique aims to improve the health and stability of gingival tissues over time.

Since it is a technique still not widely used, there is a need to intensify studies on the subject, justifying the conduct of this observational research aimed at assessing, through scanning and image overlay programs, the volumetric change of gingival tissues after the installation of ceramic prostheses with BOPT-type carving

Primary Outcome Measures: Gingival Volumetric Variation, Variation of gingival tickness following BOPT technique, May 2024
Secondary Outcome Measures: Plaque Index, Index of bacterial plaque, May 2024|Probing Depth, Depht of gingival sulcus, May 2024|Gingival Index, Index for measure the gingival inflammation, May 2024
Frontosubthalamic Networks in Parkinson's Disease.
NCT Number: NCT06485986
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease|Impulse Control Disorder
Interventions: OTHER: DBS on/off
Sponsor: University of Oxford
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-01
Completion Date: 2025-08
Locations: John Radcliffe Hospital, Oxford, OX39DU, United Kingdom

Summary:
The goal of this experimental study with is to understand the underlying mechanisms behind the increase in impulsivity seen in some patients that undergo deep brain stimulation of the subthalamic nucleus for Parkinson's Disease. The main questions it aims to answer are:

What are the distributed network effects of deep brain stimulation to the subthalamic nucleus? How does this correlate with increased impulsivity? Can alternative stimulation settings be used to minimize these?

Participants will complete decision-making tasks whilst their deep brain stimulation devices are turned on and off with simultaneous magnetoencephalography recordings (a type of non-invasive brain scan that measures brain activity in real-time)

Primary Outcome Measures: Identify effect of therapeutic STN-DBS on frontosubthalamic networks in PD related ICDs during decision making and impulse control, Correlation between response time and accuracy with electrophysiological signatures of neural activity., 12 months
Validation of the Experience Sampling Dietary Assessment Method
NCT Number: NCT06485960
Acronym: YONAS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Validation Study
Interventions: OTHER: ESDAM validation
Sponsor: KU Leuven
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 115
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-06

Summary:
A new dietary assessment method was developed based on the Experience Sampling Methodology. In order to use this newly developed Experience Sampling Dietary Assessment Method (ESDAM) in research and clinical practice as a valid and reliable method to measure dietary intake the ESDAM needs to be validated against objective biomarkers and reference methods.

Primary Outcome Measures: Daily dietary energy intake based on the Experience Sampling Dietary Assessment Method, Daily dietary energy intake estimated by the Experience Sampling Dietary Assessment Method (ESDAM) compared to the Doubly-labeled Water Method, 2 weeks|Daily dietary protein intake based on the Experience Sampling Dietary Assessment Method, Daily dietary protein intake estimated by the Experience Sampling Dietary Assessment Method (ESDAM) compared to urinary nitrogen, 2 weeks|Daily energy expenditure derived from the doubly-labeled water method, Daily energy expenditure (kcal/day) measured by the doubly-labeled water method, 2 weeks|Daily dietary protein intake based on urinary nitrogen analysis, Daily dietary protein intake based on urinary nitrogen analysis, 2 weeks
Secondary Outcome Measures: Dietary intake based on Experience Sampling Dietary Assessment Method, Daily nutrient and food group consumption estimated by the Experience Sampling Dietary Assessment Method ESDAM, 2 weeks|Dietary intake based on 24-hour dietary recalls, Energy, nutrient and food group consumption measured by the 24-hour dietary recalls, 2 weeks|Serum Beta-carotenoid concentration, Serum Beta-carotenoids as biomarker of fruit and vegetable consumption, 4 weeks|Erythrocyte membrane fatty acid composition, Erythrocyte membrane fatty acid composition as biomarker of fatty acid consumption, 4 weeks
Other Outcome Measures: Timing of glucose peaks, Timing of glucose peaks registered by Continuous Glucose Monitoring, 2 weeks
Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
NCT Number: NCT06485947
Acronym: DBPilot
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Neuroblastoma
Interventions: BIOLOGICAL: Dinutuximab beta|DRUG: chemotherapy treatment called GPOH|DRUG: chemotherapy treatment called rapid COJEC
Sponsor: Princess Maxima Center for Pediatric Oncology
Collaborators: EUSA Pharma, Inc.
Sex: ALL
Age: CHILD, ADULT
Enrollment: 38
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2031-12-01
Locations: Princess Maxima center for pediatric oncology, Utrecht, 3584 CS, Netherlands

Summary:
The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is:

• to assess the safety and tolerability and identifying the recommended phase II dose and/or the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens

Participants will receive:

* GPOH + dinutuximab beta infusion duration = 10 mg/m2 × 5 days (50 mg/m2/course) in 21-day treatment intervals.
* Rapid COJEC + dinutuximab beta infusion duration = 10 mg/m2 × 3 days (30 mg/m2/course) in 10-day treatment intervals.

Primary Outcome Measures: the incidence of dose limiting toxicities (DLTs) associated with the combination of Dinituximab Beta with GPOH chemotherapy regimen, Number of DLT's per dose level of Dinituximab Beta, Within first 63 days of treatment|the incidence of dose limiting toxicities (DLTs) associated with the combination of Dinituximab Beta with rapid COJEC chemotherapy regimen, Number of DLT's per dose level of Dinituximab Beta, Within first 50 days of treatment
Secondary Outcome Measures: overall response rate during after Dinituximab Beta with GPOH chemotherapy regimen, Tumor imaging, 126 days|metastatic response rate after Dinituximab Beta with GPOH chemotherapy regimen, Tumor imaging, 126 days|overall response rate during after Dinituximab Beta with rapid COJEC chemotherapy regimen, Tumor imaging, 80 days|metastatic response rate after Dinituximab Beta with rapid COJEC chemotherapy regimen, Tumor imaging, 80 days
Other Outcome Measures: event free survival (EFS) from the date of enrollment, exploratory endpoints, 5 years|overall survival (OS) from the date of enrollment, exploratory endpoints, 5 years
Kinesiophobia Scale for the Upper Extremity
NCT Number: NCT06485934
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Shoulder Injuries
Sponsor: Emre Şenocak
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-22
Completion Date: 2025-06-01
Locations: Clinic of İstanbul Hand-Microsurgery Rehabilitation, İstanbul, 34104, Turkey|Clinic of İstanbul Hand-Microsurgery Rehabilitation, İstanbul, Turkey

Summary:
Questionnaires/scales used to evaluate kinesiophobia in the literature are limited and are not specific to the upper extremity in existing scales. For this reason, the primary purpose and subject of the study is to develop a multi-factor kinesiophobia scale specific to shoulder problems.

The study is an observational research. Participants will be interviewed twice in total. All primary and secondary outcomes will be assessed at the first meeting. The second come will be performed within 5-7 days after the first assessment. In the second come, only the new kinesiophobia scale that is intended to be developed will be applied.

Primary Outcome Measures: Multidimensional Kinesiophobia Scale (To be developed), It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries., Baseline of the study|Multidimensional Kinesiophobia Scale (To be developed), It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries., 5-7 days after baseline assessment
Secondary Outcome Measures: Visual Analog Scale, Assesses pain severity. It scores between 0-10 points. A high score indicates high pain intensity., Baseline of the study|Tampa Kinesiophobia Scale, It consists of 17 items. Assesses the fear of movement. Total score is 68 points. A high score indicates high fear., Baseline of the study|Demographic Data Form, This form was created by researchers and it consist of personal informations such as gender, marital status, education, age, body mass index, dominant and affected extremity, name of pathology,, Baseline of the study
Axitinib and Oral Metronomic Etoposide for Pediatric Children and AYA Refractory/Relapsing Medulloblastoma and Ependymoma
NCT Number: NCT06485908
Acronym: MEPENDAX
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Medulloblastoma|Ependymoma
Interventions: DRUG: administration of axitinib in combination with etoposide
Sponsor: Assistance Publique Hopitaux De Marseille
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2030-01

Summary:
It is an open multicentric phase I/II trial with axitinib (Inlyta®) and metronomic delivery of etoposide for children, adolescent and young adults (AYA) with refractory/ relapsing solid tumors. It is a two-stage trial:

First stage: To determine the Maximum Tolerated Dose (MTD) of the combination of axitinib and oral metronomic etoposide for patient with medulloblastoma or ependymoma Second stage: Extension cohort evaluating the preliminary efficacy at the recommended dose for the phase II (RDP2) of the combination. The 2nd stage will start after a meeting of independent data monitoring committee (IDMC). Two cohorts of 9 patients with ependymoma and medulloblastoma Patients treated at first stage won't be included in the second stage.

Primary Outcome Measures: Dose-limiting toxicity (DLT), During first stage, During the first 28 days (cycle 1)|Progression-free survival (PFS), During second stage, progression-free survival (PFS) computed as the time interval from the beginning of treatment to the date of centrally-assessed with RAPNO criteria. A central review of all imaging is planned at the end of phase 1 and at the end of phase expansion to evaluate tumor response and progressions. PFS-duration of patients alive free of progression at last follow-up will be censored at the date of last visit., 3 years (from start of treatment to last follow-up visit)
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
NCT Number: NCT06485895
Acronym: TUBIGRA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: TUBERCULOSIS
Interventions: DIAGNOSTIC_TEST: test IGRA|DIAGNOSTIC_TEST: TEST QUATIFERON TB Gold Plus
Sponsor: Assistance Publique Hopitaux De Marseille
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-30
Completion Date: 2028-02-01
Locations: Assistance Publique Hopitaux de Marseille, Marseille, France

Summary:
Methodology This is a single-center study carried out as part of routine patient care.

The aim of the study is to determine the performance of the 2nd generation TB-IGRA test in the diagnosis of tuberculosis.

Primary Outcome Measures: sensitivity of TB-IGRA 2nd generation test, 24 MONTHS|specificity of TB-IGRA 2nd generation test, 24 MONTHS
ASSESSMENT OF PAIN USING A PAIN DIAGNOSTIC SYSTEM THAT MEASURS FACIAL MOVEMENT USING
NCT Number: NCT06485856
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing|Pain Assessment|Critical Care|Technology|Facial Recognition
Interventions: BEHAVIORAL: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Sponsor: Fatmagül Üstünel
Collaborators: Cukurova University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-05-15
Completion Date: 2024-12-15
Locations: Cukurova University, Adana, Turkey

Summary:
Pain is a subjectively difficult, abstract and comprehensive concept that is at the core of the whole study, emerging in relation to various advancements, and detailed description. For non-controlling, stress-free, stress-or-thickness training for thromboembolic, pulmonary and other organ modalities, re-admission from discharge, thromboembolic, pulmonary and other reasons.

The scales of use in the assessment of pain in the conscious surgical patient who cannot communicate verbally, into the pain, are physically subjective. Ekman and Friesen are planning the movements of their muscles to be performed by an Action Coding process that could be experienced in 1978. system; It has been applied in pain, in the evaluation of pain in the postoperative period and in children, in the new clinical practice, and in the new and clinical practice.

Health professionals may be biased in diagnosing pain, especially in intensive care patients, and may underestimate pain. In the literature, it is seen that the child who is made with pain in his patients in education in the field of medicine is not used in his experiences, similar to the pain that measures the tastes of the faces of the single scales. In this context, standardized, continuous, objective and scalable pain measures indicate the practice environment. The aim of these people is to evaluate the pain in our surgical patients who cannot communicate clearly and clearly with pain diagnosis that measures facial movement.

Primary Outcome Measures: Pain diagnosis in intensive care patients, Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, In the intensive care unit, the pain felt by the patient during the procedure will be evaluated. This assessment will be repeated for each patient throughout the 12 procedure procedures performed on the patient.
A Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint
NCT Number: NCT06485843
Acronym: OA-SYS-01
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Osteoarthritis|Osteo Arthritis Knee
Interventions: DRUG: OA-SYS
Sponsor: Ageless Biotech, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-05
Locations: Orthopedic & Sports Medicine Institute of Las Vegas, Las Vegas, Nevada, 89117, United States

Summary:
This study is being conducted to evaluate the safety and tolerability of OA-SYS in patients with moderate to severe OA of the knee joint.

Primary Outcome Measures: Presence of Adverse Events, Presence of adverse events in less than 5% of the study population, as a measure of safety, 52 weeks
Secondary Outcome Measures: Change in NSAIDs Use, Change in NSAIDS use, until study completion, 52 weeks|Change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC), The WOMAC score is used in clinical trials to measure the condition of patients with osteoarthritis. It's a patient-reported outcome measure where 0 represents the worst possible score and 100 represents the best possible score. A higher score indicates worse pain, stiffness, and functional limitations., 52 weeks|Change in the Visual Analog Scale (VAS), The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain". A lower scale indicates better progress, which indicates less pain., 52 weeks
Other Outcome Measures: Incidence of treatment-emergent adverse events (TEAEs), TEAEs are defined as adverse events with an onset on or after the time of first administration of the treatment., 52 weeks|Incidence of withdrawals due to adverse events (AEs), Reported withdrawals from the study due to adverse events, as a measure of safety., 52 weeks
AI Mobile App vs Self Exercises in Workers With Neck Pain
NCT Number: NCT06485804
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain|Work-Related Condition
Interventions: OTHER: Smartphone application guided exercises
Sponsor: University of Monastir
Collaborators: Sana Salah|Amr Chaabeni
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-10-31

Summary:
This study aims to compare the impact of two different methods to administer self-exercises in administrative workers with neck pain: an Artificial Intelligence embedded mobile application and written sheet.

Primary Outcome Measures: Pain intensity, Pain intensity assessed using a Visual Analog Scale on a scale from 0 to 100., Pain intensity will be assessed at baseline, and at 4, and 8 weeks of follow-up.
Secondary Outcome Measures: Function, Patient function will be assessed using the neck disability index (NDI). The scale consists of a set of questions addressing various aspects of neck pain and its influence on activities such as personal care, lifting, reading, working, and recreation, Function will be assessed at baseline, and at 4, and 8 weeks of follow-up.|Quality of life measure, The short form 12 (SF-12) will be used to measure health-related Quality of life. The SF-12 is a shorter version of the short form 36 (SF-36) and is used to assess individual's physical and mental well-being., Quality of life will be assessed at baseline, and at 4, and 8 weeks of follow-up.|Patient adherence, Adherence will be measured using a frequency-based response scale (ie; never, seldom, often, almost always, and always) adapted from the adherence scale of Sluijs et al. (Phys Ther 1993), Patient adherence will be assessed at 4, and 8 weeks of follow-up.
Other Outcome Measures: Gender, Gender: Female, Male., Assessed at baseline|Age, Age in terms of years, Assessed at baseline|Body mass index (BMI), BMI is calculated as follows: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height (in metres) squared., Assessed at baseline|Comorbidities, Comorbidities comprise: Diabetes, Hypertension, Thyroid disorders, Cardiovascular and Lung diseases, and Cancer history., Assessed at baseline|Musculoskeletal disorders, Musculoskeletal disorders comprise: Osteoarthrities, Rheumatic arthritis, Osteoporosis, and Tendinopathies., Assessed at baseline|Work seniority, Work seniority: Length of work service (years)., Assessed at baseline|Time spent in front of computer, Time spent in front of computer: average number of daily hours spent in front of computer., Assessed at baseline
Evaluation of the Variation of the Intestinal Microbiota and the Integrity of the Intestinal Barrier in Patients With M.D.R. Germ-induced Pneumonia Undergoing Enteral Nutrition
NCT Number: NCT06485791
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multi Drug Resistant|Dysphagia
Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Collaborators: Russo Francesco, MD|Rossella Donghia, Biologist|Maria Notarnicola, Clinical Pathology Director|Pasqua Letizia Pesole, Biologist|Sergio Coletta, Laboratory Technician|Anna Ancora, Laboratory Technician|Francesco Gabriele, Intensive Care Unit Director
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-07-01

Summary:
The study aims to evaluate the effects of enteral nutrition in subjects with MDR on the intestinal microbiota

Primary Outcome Measures: Composition of the microbiota, Improvement in the composition of the intestinal microbiota. Characterization of the microbiome will be carried out using a DNA metabarcoding and shotgun metatranscriptomics approach. DNA metabarcoding analysis will be conducted using the V5-V6 hypervariable regions of 16S rRNA for bacteria (MiSeq-Illumina platform). Samples found significant at DNA metabarcoding analysis will be subjected to metatracriptomic analysis (NextSeq 500 platform-Illumina). Metagenomic and metatracriptomic data will be analyzed using bioinformatics pipelines., at Baseline and after 10 days
Secondary Outcome Measures: Evaluation of the integrity of the intestinal barrier, Improved intestinal barrier function and integrity, assessed by measuring fecal zonulin and indole and skatole by elisa technique, at Baseline and after 10 days
A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
NCT Number: NCT06485778
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Oral Tongue Squamous Cell Carcinoma
Interventions: RADIATION: Photon intensity modulated radiation therapy (IMRT)|OTHER: Life questionnaire's
Sponsor: Memorial Sloan Kettering Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2026-06
Locations: Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth, Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen, Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Suffolk - Commack, Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester, Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan Kettering Nassau, Uniondale, New York, 11553, United States

Summary:
This study will test whether limiting standard photon intensity modulated radiation therapy (IMRT) to exclude the oral tongue surgical site can decrease the risk of side effects caused by oral radiation. The researchers will also find out if this approach affects the rate of disease coming back after treatment (recurrence), and will measure participants' quality of life by having them complete questionnaires.

Primary Outcome Measures: Rate of Acute Grade ≥3 Oral Mucositis, This is defined by CTCAE v 5.0 criteria, within 120 days of radiation completion
Secondary Outcome Measures: Cumulative Incidence of Local Failure, will be defined as any local failure in the oral tongue/FOM/BOT that is subsequently proven by biopsy during protocol-mandated follow-up. Competing risks will be distant or regional failure without local failure or death without progression. This will be calculated from the start of radiation., 2 years