pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Comparison of Clinical Parameters in Individuals With Different Physical Activity Levels During the COVID-19 Pandemic Period
NCT Number: NCT06551025
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Physical Activity
Sponsor: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-03-27
Completion Date: 2021-08-30
Locations: Hacettepe University, Ankara, 06230, Turkey

Summary:
The COVID-19 pandemic started in China towards the end of 2019 and soon affected the whole world. Restriction and isolation measures have been taken to prevent the spread of this disease caused by a new type of coronavirus, coronavirus-2. These measures have changed people's physical activity levels and have also affected other parameters that physical activity affects. This study aims comparison of clinical parameters in with different physical activity levels during the COVID-19 pandemic period.

Primary Outcome Measures: Exercise Capacity, The 1 minute sit-to-stand test is one of the tests that evaluates exercise capacity.In this test, the number of sitting and standing repetitions in a chair for 1 minute is recorded. Heart rate, shortness of breath, and fatigue perceptions will be recorded before and after the test., March,2021- August,2021|Physical Activity, The International Physical Activity Questionnare (IPAQ)- Short form assesses the level of physical activity.The short form consists of seven questions. It provides information on sitting, walking, moderately vigorous activities, and time spent in vigorous activities., March,2021- August,2021|Cognitive Function, The standardized mini mental test is a test that evaluates the suitability of individuals' cognitive functions for tele-assessment. It consists of eleven items gathered under five main headings: orientation, recording memory, attention and calculation, recall and language., March,2021- August,2021|Coronavirus Phobia, The Coronavirus 19 Phobia Scale (C19P-S) is a scale that evaluates coronavirus phobia. C19P-S is a five-point Likert-type self-assessment scale developed to measure phobia against coronavirus. The test has psychological, somatic, social and economic sub-dimensions., March,2021- August,2021|Sleep Quality, The Pittsburgh Sleep Quality Scale (PSQI) is one of the scales that evaluates sleep quality. PSQI is a self-reported screening and evaluation test that provides information about the type and severity of sleep quality disturbances and sleep structure problems., March,2021- August,2021|Health Literacy, Turkish Health Literacy Scale-32 (TSOY-32) is a scale consisting of 32 questions and evaluating health literacy. The scale, based on the conceptual framework developed by the European Health Literacy Research Consortium, was developed by Okyay et al. to assess health literacy among literate people over the age of 15., March,2021- August,2021|Balance, Berg Balance Scale is a scale used to evaluate dynamic and static balance skills. It consists of 14 activities that require balance skills in different positions such as standing, sitting, and standing on one leg., March,2021- August,2021
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
NCT Number: NCT06550986
Acronym: FLAGSHIP_NZL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Dissection
Interventions: DEVICE: False Lumen Embolization System
Sponsor: Shape Memory Medical, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-07-01

Summary:
To determine the safety and feasibility of the False Lumen Embolization System implant to reduce aortic dissection false lumen perfusion.

Primary Outcome Measures: Technical success, Delivery and implantation of the False Lumen Embolization System implant to the false lumen, Immediately after the intervention|Major adverse events, Incidence of device/procedure-related major adverse events, 30 days
Secondary Outcome Measures: All-cause mortality and dissection-related mortality, Incidence of all-cause mortality and dissection-related mortality, 2 years|Serious adverse events, Incidence of device/procedure-related serious adverse events, 2 years|Change in false lumen thrombosis from baseline, Change in false lumen thrombosis from baseline, 2 years|Change in true lumen/aorta size ratio from baseline, Change in true lumen/aorta size ratio from baseline, 2 years|Change in aorta size from baseline, Change in aorta size from baseline, 2 years|Rate of dissection-related reinterventions, Rate of dissection-related reinterventions, 2 years
Evaluation of SureCore Plus Biopsy System
NCT Number: NCT06550960
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: BPH
Interventions: DEVICE: Evaluation of two biopsy systems
Sponsor: Uro-1 Medical
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-05
Completion Date: 2025-02-01

Summary:
This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.

Primary Outcome Measures: Procedure success, \> 3 mm/cc of tissue collected in each biopsy, During the procedure|Quality of biopsy tissue, Ranking by pathologist on scale of 0=unable to read to 5=all tissue complete for reading. The higher scores mean a better outcome., During the procedure
Secondary Outcome Measures: Performance of the study device, Ranking by MD using scale of 1=difficult to use to 5=outperformed SOC needles. The higher scores equate to better outcome., During the procedure
ALDOA Expression in Bladder Urothelial Carcinoma
NCT Number: NCT06550947
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bladder Urothelial Carcinoma
Interventions: GENETIC: Immunohistochemistry
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-08

Summary:
1. Study the immunohistochemical expression of ALDOA in bladder urothelial cancer.
2. Correlate between ALDOA expression in specimens and different cilnicopathological factors.
3. Correlate between ALDOA expression and urothelial cancer prognosis and survival.

Primary Outcome Measures: Evaluate the immunohistochemical expression of ALDOA in bladder urothelial carcinoma., Microscopic examination of bladder urothelial carcinoma spicemens and staining them with ALDOA marker, Baseline
Secondary Outcome Measures: Evaluate relation between ALDOA expression and cilnicopathological features and patient survival., Correlate between ALDOA expression and the different clinicopathological factors of patients and their survival., Baseline
Surgical Treatment of Pelvis in Fragility Fracture in Germany (TOP)
NCT Number: NCT06550934
Acronym: TOP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pelvis; Fracture
Interventions: PROCEDURE: Fracture stabilization
Sponsor: AO Innovation Translation Center
Collaborators: AO Trauma Deutschland|AUC - Akademie der Unfallchirurgie
Sex: ALL
Age: OLDER_ADULT
Enrollment: 420
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2027-10

Summary:
Over a period of approximately two years, patients above the age of 65 who have suffered from an FFP equal to or higher than type IIc FFP, according to Rommens and Hofmann, will be eligible for inclusion. At least 420 patients will be included and followed up up for 12 months. Treatment and postoperative care, will be as per standard of care at the participating institution, with a free choice of isolated posterior or combined anterior-posterior surgical treatment.

Pain levels, quality of life, level of mobility and independence will be assessed at different time points. Furthermore, both clinical and radiographic outcomes, complications, morbidity and mortality associated with interventions will be evaluated. Assessment and evaluation will be performed at defined time points during FU according to standard of care.

Primary Outcome Measures: Pain rating, Perception of pain will be assessed using Numeric Rating Scale (NRS) from 1-10, where patient reports pain due to his/her pelvis fracture. A higher value correlates with greater pain., Numeric Rating Scale (NRS) 3 month after surgical fixation of the fragility fracture of the pelvis
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma
NCT Number: NCT06550921
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Advanced Hepatocellular Carcinoma|Oligometastasis|Ablation|Anti-PD1 Antibody|Lenvatinib
Interventions: PROCEDURE: ablation of oligometastasis
Sponsor: Sun Yat-sen University
Collaborators: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-08-30
Locations: Chinese PLA General hospital, Beijing, None Selected, 100853, China

Summary:
Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.

Primary Outcome Measures: Progression-Free-Survival (PFS), Progression-Free-Survival (PFS), 24 months
Secondary Outcome Measures: Overall survival (OS), OS is the length of time from the date of inclusion until death from any cause., 24 months|Objective response rate (ORR), ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response., 12 months|Adverse events, Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations, 24 months
Training Physicians to Differentiate the Paris Classification Using Artificial Colon Polyp Images
NCT Number: NCT06550908
Acronym: LUTETIA2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colonic Polyp|Colon Adenoma
Interventions: OTHER: Lutetia Training Plattform
Sponsor: Wuerzburg University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-07

Summary:
Training in endoscopy is essential for the early detection of precursors of colorectal cancer. Up to now, this training has been carried out with image collections of findings and in practice when working on patients. We want to use artificial intelligence (AI) to better train doctors to recognise these precursors. By using generative AI, we were able to create realistic images that comply with data protection regulations and whose content can be predefined. Parts of the image can also be regenerated so that it is possible to create different precancerous stages in the same place in the image.

In this study we want to train physicians using real images or artificial images in order to compare which version helps classify polyps better.

Primary Outcome Measures: Accuracy for Paris classification, Ability to correctly classify colonic polyps using the Paris classification, 9 months
Secondary Outcome Measures: Range of misclassifications for Paris classification, Number of misclassification categorizes (eg 1-4), 9 months|Influence of endoscopy experience on accuracy for correct Paris classification, Influence of endoscopy experience measured in number of perfomed colonoscopies on accuracy for correct Paris classification, 9 months|Influence of time to complete course on accuracy for correct Paris classification, Influence of time to complete course measured in days on accuracy for correct Paris classification, 9 months|Influence regular usage of Paris classification on accuracy for correct Paris classification, Influence regular usage of Paris classification (yes/no) on accuracy for correct Paris classification, 9 months
SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER
NCT Number: NCT06550856
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Perforated Peptic Ulcer
Interventions: PROCEDURE: SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER|PROCEDURE: OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-05-01
Locations: Sohag university Hospital, Sohag, Egypt

Summary:
The present study will be conducted to assess whether there is a direct benefit associated with modified-Graham's omentopexy (MGO), above and beyond the benefit associated with Graham's omentopexy (GO) in the treatment of perforated duodenal ulcers. We attempted to answer the question whether primary closure of the perforation in MGO will affect the outcome of surgery. Complication rates will be compared for the two alternative surgical procedures.

Primary Outcome Measures: Early postoperative follow up for repair of perforated peptic ulcer, resumption of oral intake, Three days after the operation
Mesentery Guide Identify Microscopic Clean Resection and Reduces Crohn's Endoscopic Recurrence
NCT Number: NCT06550843
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Crohn Disease|Recurrence
Interventions: PROCEDURE: mesentery-guided division
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2013-02-01
Completion Date: 2021-07-01

Summary:
Microscopic clean margin is associated with reduced endoscopic recurrence after bowel resection for ileocolic Crohn's disease (CD). We aimed to investigate whether the extent of creeping fat could help indicate microscopic inflammation beyond naked eye assessment of the bowel wall and reduce endoscopic recurrence after ileocolic resection.

Primary Outcome Measures: Crohn's Endoscopic Recurrence, 12 months
Phase Ia Clinical Trial of PCV24 in Children Aged 2-17 Years
NCT Number: NCT06550830
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pneumococcal Infectious Disease
Interventions: BIOLOGICAL: Sinovac PCV24 formulation 1|BIOLOGICAL: Sinovac PCV24 formulation 2|BIOLOGICAL: Prevenar13®
Sponsor: Sinovac Life Sciences Co., Ltd.
Sex: ALL
Age: CHILD
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-28
Completion Date: 2025-03-28

Summary:
A Phase Ia clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2-17 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled combined with open-label phase Ia clinical trial.

Primary Outcome Measures: Incidence of adverse reactions, Incidence of adverse reactions within 30 days after vaccination, 0-30 days after vaccination
Secondary Outcome Measures: Incidence of adverse reactions, Incidence of adverse reactions within 7 days after vaccination, 0-7 days after vaccination|Incidence of serious adverse events (SAE), Incidence of SAE during the period of safety monitoring, 0-6 months after vaccination|Incidence of clinically significant abnormality in laboratory examination tests, Incidence of clinically significant abnormality in blood routine, blood biochemistry and urine routine test results within 3 days after vaccination, 0-3 days after vaccination|Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC), IgG GMC 30 days after vaccination, 30 days after vaccination|Proportion of Pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate), Proportion of IgG antibody concentration ≥0.35 μg/ml, 30 days after vaccination|Proportion of Pneumococcal serotype-specific IgG antibody concentration ≥1.0 μg/ml, Proportion of IgG antibody concentration ≥1.0 μg/ml, 30 days after vaccination|Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI), IgG GMI 30 days after vaccination, 30 days after vaccination|Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4, Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination, 30 days after vaccination|Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMTs), OPA GMT 30 days after vaccination, 30 days after vaccination|Pneumococcal serotype-specific OPA GMI, OPA GMI 30 days after vaccination, 30 days after vaccination|Proportion of Pneumococcal serotype-specific OPA GMT≥1:8, Proportion of Pneumococcal serotype-specific OPA GMT≥1:8 30 days after vaccination, 30 days after vaccination|Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4, Proportion of OPA antibody titer increase≥four folds 30 days after vaccination, 30 days after vaccination
Growth Mindset Intervention for Older Adults With Chronic Disease
NCT Number: NCT06550817
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Disease
Interventions: OTHER: Growth mindset intervention|OTHER: E-health Program
Sponsor: Huzhou University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 77
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2021-09-01
Completion Date: 2022-10-31
Locations: School of Medicine and Nursing， Huzhou University, Huzhou, Zhejiang, 313000, China|School of Nursing Huzhou University, Huzhou, Zhejiang, 313000, China

Summary:
This study was conducted to develop and investigate the effectiveness of a growth mindset intervention based on growth mindset theory.

Primary Outcome Measures: Implicit Theories of Intelligence Scale-6, The Implicit Theories of Intelligence Scale-6 (ITIS-6) is a validated, self-reported instrument assessing participants' level of growth mindset. A mean score of greater than or equal to 4 on all items indicates that the individual has a growth mindset, and vice versa for a fixed mindset., Baseline,Week 6, and Week 12|Questionnaire of Knowledge, Willingness, Confidence, and Practice of Smart Medicine (KWCP-SM), The Questionnaire of Knowledge, Willingness, Confidence, and Practice of Smart Medicine (KWCP-SM) is a validated, self-reported instrument assessing participants' level of knowledge, willingness, confidence, and practice of smart medicine. The questionnaire adopted the Likert-5 scoring method. The higher score indicated a higher level of knowledge, willingness, confidence, and practice of smart medicine., Baseline,Week 6, and Week 12
Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
NCT Number: NCT06550804
Acronym: A-TEAM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: HIV Infections|Adherence, Medication
Interventions: BEHAVIORAL: A-TEAM
Sponsor: University of Illinois at Chicago
Collaborators: Massachusetts General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2026-07

Summary:
The investigators propose using an electronic adherence device that is basically a pill container that can alert when it is not opened at a scheduled time. The investigators will use this device to alert the medication user at the time when medication is supposed to be taken if the device did not get opened and a pre-identified social support person or case manager when 2 or 7 consecutive days of nonadherence are detected, respectively. The investigators call our approach "A-Team" (Antiretroviral Therapy Electronic Adherence Monitoring). The aims of this application are to determine the acceptability and feasibility of real-time adherence monitoring in support persons and case managers of African American Men who have sex with Men and to test this approach for these men in a 6-month randomized controlled trial among 54 of these men living with HIV and measure ART adherence and viral suppression (the primary outcome).

Primary Outcome Measures: Viral load suppression, We measure HIV viral load, At 6 months after introduction of the intervention.
Secondary Outcome Measures: Adherence, Real-time and self-reported adherence, At the end of month 1, month 2, month 3, month 4, month 5 and at 6 months
Erectile Dysfunction Treatment Using Stem Cells
NCT Number: NCT06550752
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Erectile Dysfunction
Interventions: COMBINATION_PRODUCT: UC-MSCs and PRP
Sponsor: COR clinic of Regenerative Medicine
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2024-12-30
Locations: COR clinic for Regenerative Medicine, Beirut, 0000, Lebanon

Summary:
A prospective clinical study to investigate the safety and efficacy of intracavernosal injections of umbilical cord stem cells (UCSCs) combined with platelet-rich plasma (PRP) for erectile dysfunction

Primary Outcome Measures: Penile Doppler ultrasonography for assessment of erectile function, Penile Doppler ultrasonography will be used to evaluate erectile function by measuring peak systolic velocity (PSV) in the penile arteries. This parameter will be assessed before the initiation of the treatment and after 4 months of treatment to evaluate blood flow in the penile arteries. The primary outcome will focus on changes in PSV, which will be compared between the baseline and post-treatment assessments to determine the efficacy of the intervention., before treatment and after 4 months
Secondary Outcome Measures: Adverse effects, patients will be asked to report any adverse effects related to the injected product or procedure, Directly after the injection and after two weeks
Comprehensive Prognostic Model: The Study Introduces a Novel Prognostic Model That Incorporates a Wide Range of Clinical and Laboratory Variables, Providing a More Holistic Approach to Predicting Overall Survival in HCC Patients
NCT Number: NCT06550739
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma
Interventions: OTHER: Randomization
Sponsor: Haike Lei
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1053
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-01
Completion Date: 2024-04-30
Locations: Chongqing University Cancer Hospital, Chongqing, China

Summary:
Background: Hepatocellular carcinoma (HCC) is a significant health problem in China, with high incidence and mortality rates. This study aimed to identify the prognostic factors of elderly HCC patients in southwest China and construct a new prognostic model for predicting overall survival (OS).

Methods: This retrospective cohort study collected clinical data from 958 patients with liver cancer on January 1, 2019, and December 12, 2020. The Cox regression model was used to test the significance of all available variables as prognostic factors of OS. Independent prognostic factors were identified based on multivariable analysis to model nomograms. The concordance index (C-index), the area under the receiver operating characteristic (AUC), the Time-dependent C-index, the Time-dependent AUC, the calibration curve, and decision curve analysis (DCA) were measured to assess the model performance of the nomogram.

Conclusions: The comprehensive risk prediction model for OS in HCC patients developed through this retrospective cohort study offers a promising avenue for improving clinical outcomes and patient care.

Primary Outcome Measures: Survival status, Patient survival or death, April 31, 2024
High-resolution Multi-parametric Magnetic Resonance Imaging for Focal Epilepsy
NCT Number: NCT06550726
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Epilepsies, Partial
Interventions: DIAGNOSTIC_TEST: Magnetic Resonance Imaging
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2027-08-31

Summary:
Patients with focal epilepsy often have diagnostic difficulties as their culprit for seizures are difficult to be picked up using conventional imaging. The current study is to investigate the utility of advanced MRI sequences on detection of subtle lesions accountable for focal epilepsy.

Primary Outcome Measures: Accuracy of high resolution MRI in diagnosis, the sensitivity and specificity of the baseline MRI (bMRI) and the high-resolution MRI (hrMRI) studies, based on the standard of surgical findings on patients who underwent either intracranial EEG or surgical resection, At the time of MRI scanning, typically 1 day
The Outcomes of Laparoscopic Hybrid Surgery Versus Totally Open Surgery
NCT Number: NCT06550700
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Resectable Simultaneous Colorectal Cancer Liver Metastasis
Interventions: PROCEDURE: laparoscopic hybrid surgery (LHS)
Sponsor: Changhai Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 266
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-06-01
Locations: Department of Colorectal Surgery in Changhai Hospital, Shanghai, Shanghai, 200433, China

Summary:
Simultaneous colorectal cancer liver metastasis (SCRLM) is one of the risk factors for poor prognosis in colorectal cancer. Surgical resection of primary and metastatic lesions is the first choice of treatment for patients with resectable SCRLM. Simultaneous resection of colorectal cancer liver metastases by totally open surgery (TOS) has been widely used. However, we propose that laparoscopic hybrid surgery (LHS) may have better short and long-term outcomes. This study aimed to compare the safety, short-term, and long-term efficacy of LHS versus TOS for patients with resectable SCRLMs.

Primary Outcome Measures: short-term outcome: Operative time, Time taken for surgery, Within one week of the patient undergoing surgery|short-term outcome: Blood loss, Patient haemorrhage during surgery, Within one week of the patient undergoing surgery|short-term outcome: Time of liquid diet, Time for patients to eat fluids for the first time after surgery, Within one week of the patient undergoing surgery|short-term outcome: Postoperative hospital stay, Length of stay of patients after surgery, Within one week of the patient undergoing surgery|short-term outcome: Surgical complications, Complications that occur in patients after surgery, Within one week of the patient undergoing surgery
Secondary Outcome Measures: overall survival (OS), the time after surgical treatment until death for any reason, 3years|disease-free survival (DFS), the time after surgical treatment until the first observation of tumor recurrence or death for any reason, 3years
Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis.
NCT Number: NCT06550687
Acronym: INFOGENE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: All Types of Metastatic Solid Malignancy|1st-line Treatment|Exome Analysis|Active File EXOMA2 Study
Interventions: OTHER: Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis
Sponsor: Centre Georges Francois Leclerc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2026-11-01
Locations: Centre Georges-François Leclerc, Dijon, 21000, France|CHU François Mitterand, Dijon, 21000, France

Summary:
Currently, the EXOMA2 study (NCT04614480) offers earlier and more comprehensive exome analysis in the management of cancer patients than EXOMA. Based on the active EXOMA2 patient file, the INFOGene study offers the opportunity to study patient-physician communication, to assess patient preferences with regard to different information modalities concerning theranostic exome analysis, and to reflect on information modalities to ensure optimal patient comprehension of the information provided.

The qualitative cross-sectional study includes a dual observational and interventional component involving cancer patients. The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.

Primary Outcome Measures: Concepts of communication and preferences., The various interviews (phases 1 and 3) will provide an insight into patients' level of health literacy, which may explain the ease or difficulty of exchanges with the doctor (phase 1), as well as patients' preferences for one type of information over another (phase 3)., Through study completion, an average of 21 months.
Identification of New Candidate Genes for Hereditary Predisposition to Uveal Melanoma
NCT Number: NCT06550674
Acronym: IGCMU
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uveal Melanoma
Interventions: GENETIC: Constitutional exome analysis
Sponsor: Centre Jean Perrin
Collaborators: Association Nationale des Patients atteints de cancers de l'oeil (A.N.P.A.C.O.)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-20
Completion Date: 2025-02-28
Locations: Centre Jean PERRIN, Clermont-Ferrand, Puy-de-Dôme, 63011, France

Summary:
Only 20% of familial uveal melanomas are explained by a hereditary predisposition, implying the presence of as yet unknown hereditary predispositions. This hypothesis is reinforced by epidemiological studies revealing an excess risk of prostate cancer, thyroid cancer and leukemia in patients who have developed uveal melanoma, even though these cancers are not part of the tumor spectrum of known hereditary predispositions to uveal melanoma (BAP1, MBD4). The identification of new candidate genes, once validated, would enable us to offer these families appropriate surveillance.

Primary Outcome Measures: Identify new candidate genes for hereditary cancer predisposition in patients with uveal melanoma by constitutional exome analysis, Variants of interest are selected from the data using the following filter:

* Variant with frequency \< 1% (GnomAD)
* Shared by at least 2 sufferers in the cohort
* Truncating (nonsense, with frame shift, on a canonical splice site -2, -1 and +1 +2)
* Missense from a list of "cancer" genes and Combined Annotation Dependent Depletion (CADD) score \> 20 (COSMIC Tier1 and Tier2)

Variants will be interpreted using various databases and prediction tools:

* Functions: genecards, pubmed, uniprot
* Expression profiles: cbioportal, GEPIA
* For splice variants: CADD, Splice AI
* For exonic variants: CADD, SIFT, Polyphene, At baseline
Secondary Outcome Measures: Explore genes known to be involved in other cancer predisposition already described in the occurrence of uveal melanoma, but whose association has not yet been established with certainty., Number of patients with a mutation on BRCA1, BRCA2, CHEK2, PALB2, POT1, MSH6 or MLH1, At baseline
Effects of Ba Duan Jin Training for Older People
NCT Number: NCT06550661
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exercise|Old Age
Interventions: BEHAVIORAL: Ba duan jin
Sponsor: Central Taiwan University of Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-05-03
Completion Date: 2025-12-31
Locations: Show Chwan Memorial Hospital, Taichung, Taiwan

Summary:
Baduanjin is one of the widely circulated fitness methods. The Ministry of Health, the Ministry of Education and the General Administration of Sports of China have vigorously promoted it as one of the contents of health and physical education classes, and promoted it as a health Qigong method throughout mainland China. It can be seen that Baduanjin's gentle and non-aggressive movements are suitable for physical training for people of all ages.

Primary Outcome Measures: Chang in muscle strength from baseline to 12 weeks, pinch, grip and quadriceps strength. A Higher score means a better outcome., Baseline and 12 weeks|Chang in weight of muscle and fat from baseline to 12 weeks, muscle mass(kg/%), fat mass (kg/%), Baseline and 12 weeks|Chang in Activities of Daily Living from baseline to 12 weeks, This is a scale of physical function. The range for total score is 0-100. A Higher score means a worse outcome., Baseline and 12 weeks|Chang in Instrumental activities of daily living from baseline to 12 weeks, This is a scale of physical function. The range for total score is 0-24. A Higher score means a better outcome., Baseline and 12 weeks|Chang in short form Berg balance scale from baseline to 12 weeks, Balance Assessment. The range is 0-4. A Higher score means a better outcome., Baseline and 12 weeks|Chang in Gait analyses from wearable sensors from baseline to 12 weeks, MTC mean magnitude and variability, as well as the stride-to-stride variability, stride time and length, lower limb peak angular velocity, and foot forward linear speed, Baseline and 12 weeks|Chang in EQ5D from baseline to 12 weeks, This is a scale of quality of life. The range for total is 0-20. A higher score means a worse outcome., Baseline and 12 weeks|Chang in WHOBREF from baseline to 12 weeks, This is a scale of quality of life. A higher score means a better outcome., Baseline and 12 weeks
Secondary Outcome Measures: age, gender, married, religion, sleep, fall, disease status, education, Demographic basic data, Baseline|height, weight, height(cm), weight(kg), Baseline|Clinical Dementia Rating, Mental Function Assessment. The range is 0-3. A Higher score means a worse outcome., Baseline|Chang in Cumulative Illness Rating Scale, A Higher score means a worse outcome. Range Min and Max to 0-56., Baseline
Evaluation of the Role of Epstein-Bar Virus in Patients With Pulmonary Arterial Hypertension
NCT Number: NCT06550648
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pulmonary Arterial Hypertension
Interventions: PROCEDURE: Right Heart Catheterization (Swan Ganz Catheter)
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-01
Completion Date: 2024-04-01
Locations: Cairo University- Faculty Of Medicine, Cairo, 11562, Egypt

Summary:
Evaluate the role of Epstein-Barr virus infection in PAH (Idiopathic and connective tissue disease).

This by obtaining a blood sample from the PAH patients undergoing right heart cathetrization as well as obtaining the endothelial cells from the balloon tipped catheters and extracting the EBV virus to detect its presence.

IgG, IgM and PCR for EBV tests will be done.

Primary Outcome Measures: EBV PCR and Immunoglobulins in patients with PAH test will be done, by virus detection in both blood and endothelial cells and its immunoglobulins, from may 2023 till july 2024|The percentage of EBV-positive patients to normal control subjects, Test results statically analyzed to corelate, from may 2023 till july 2024|The presence of EBV within the endothelial cell line in patients, PCR of the virus in the endothelial cell culture proving the viral invasion causing the remodeling, from may 2023 till july 2024
Secondary Outcome Measures: CAEBV-infected individual 's risk assessment compared to the risk assessment of those who are not infected., by three risk strata assessment to all patients, from may 2023 till july 2024
Joint and Hematologic Disorders of Noonan Syndrome: French Descriptive Cross-sectional Study
NCT Number: NCT06550635
Acronym: NOORHA
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Noonan Syndrome
Sponsor: University Hospital, Brest
Sex: ALL
Age: CHILD, ADULT
Enrollment: 71
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-07-02
Completion Date: 2020-03-28
Locations: CHRU de Brest, Brest, 29609, France|CHU de Caen, Caen, 14033, France|CHU de Nantes, Nantes, 44093, France|CHU de Toulouse, Toulouse, 31000, France

Summary:
Noonan's syndrome is a rare genetic disease, estimated to be between 1: 1000 to 1: 2500 and characterized by cardiothoracic malformations, sometimes mental retardation, but also by hematologic abnormalities and joint involvement. These are poorly described in the literature. The aim of this work is therefore to describe the frequency and type of these manifestations in the French pediatric population and to compare patients with and without these disorders.

Primary Outcome Measures: Description of joint and hematologic disorders in patients with Noonan syndrome clinically confirmed by Van der Burgt criteria., Joint disorders, Inclusion (Day 0)|Description of joint and hematologic disorders in patients with Noonan syndrome clinically confirmed by Van der Burgt criteria., hematologic disorders, Inclusion (Day 0)
Secondary Outcome Measures: Comparison of patients with and without joint involvement., Comparison of patients with and without joint involvement., Inclusion (Day 0), Each year|Comparison of patients with and without joint involvement., Evolution of joint damage with and without treatment., Inclusion (Day 0), Each year
Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
NCT Number: NCT06550622
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatitis B, Chronic
Sponsor: Huashan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-10
Completion Date: 2027-08-10
Locations: Fahong Li, Shanghai, Shanghai, 200040, China

Summary:
The goal of this observational study is to learn about the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay which has improved sensitivity compared to current ARCHITECT HBsAg Assay.

The main question it aims to answer is:

What's the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay? HBsAg NEXT assay technology (lower limit of detection for HBsAg is 0.005 IU/ml) and current ARCHITECT HBsAg assay (lower limit of detection for HBsAg is 0.05 IU/ml) are applied for HBsAg detection in patients achieving functional cure, and to compare the difference in HBsAg reversion rate 48 weeks off treatment under the two types of criteria.

Primary Outcome Measures: HBsAg reversion rate, HBsAg reversion rate in patients with HBsAg loss by Abbott's HBsAg next assay at week 48 off treatment, 48 weeks
Secondary Outcome Measures: Proportion of patients who were HBsAg positive, Proportion of patients who were HBsAg positive by HBsAg Next assay in those who were HBsAg negative by ARCHITECT HBsAg test., 48 weeks|HBsAg seroconversion rate, HBsAg seroconversion rate at 48 weeks off treatment follow-up in patients with HBsAg loss, 48 weeks|Surface antibody disappearing rates, Surface antibody disappearing rates at 48 Weeks off treatment Follow-up in Patients with HBsAg loss, 48 weeks|Viral reactivation rate, Viral reactivation rate (HBV DNA \> 20 IU/ml) at 48 weeks off treatment in patients with HBsAg loss, 48 weeks
Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis With Inhaled Pentamidine Plus Oral Miltefosine
NCT Number: NCT06550609
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mucosal Leishmaniasis
Interventions: DRUG: Miltefosine Oral Capsule
Sponsor: Fundacion Nacional de Dermatologia
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-10
Locations: Hospital de Clinicas, La Paz, 00000, Bolivia

Summary:
This is a phase 2 study of the combination of inhaled-pentamidine plus oral miltefosine for Bolivian mucosal leishmaniasis.

Primary Outcome Measures: Efficacy, Demonstrate a cure rate of the combination for moderate-severe ML higher than the low cure rate of historic controls treated with inhaled pentamidine alone or miltefosine alone, 25 months
Secondary Outcome Measures: Efficacy, Demonstrate a cure rate of the combination for mild ML even higher than the high cure rate of historic controls treated with inhaled pentamidine alone or miltefosine alone, 25 months|Safety, Adverse events of the combination compared to historic controls treated with inhaled pentamidine alone or miltefosine alone, 6 months
Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
NCT Number: NCT06550596
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot|Ulcer Foot|Foot Ulcer|Diabetic Foot Ulcer
Interventions: OTHER: Standard of Care|OTHER: Axolotl DualGraft + SOC
Sponsor: Axolotl Biologix
Collaborators: SerenaGroup, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08

Summary:
The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Primary Outcome Measures: Efficacy of dhAM + SOC vs SOC, To determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers over 12 weeks., 1-12 Weeks
Secondary Outcome Measures: Time to closure for the target ulcer, To determine the proportion of ulcers that heal over 12 weeks for dhAM plus SOC versus SOC alone (Time to closure)., 1-12 weeks|Percent area reduction, To determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period., 1-12 weeks|Adverse events, To demonstrate a reduction in adverse events in subjects receiving dhAM plus SOC versus SOC alone., 1-12 Weeks|Determine improvement in quality of life using Wound Quality of Life questionnaire, Quality of Life is assessed using the Wound Quality of Life (wQOL) checklist at TV1, TV3, TV7, TV11, and TV12. This assessment will be used to compare patients receiving dhAM + SOC vs SOC., 1-12 weeks|Determine improvement in quality of life using Forgotten Wound Score questionnaire, Quality of life is assessed using the Forgotten Wound Score (FWS) at TV1, TV3, TV7, TV11, and TV12. This assessment will be used to compare patients receiving dhAM + SOC vs SOC., 1-12 weeks
Other Outcome Measures: Proportion of ulcers that heal in patients 65 years and older, To determine the proportion of ulcers that heal in patients 65 years or older for dhAM plus SOC versus SOC alone., 1-12 weeks|Determine the effect of chronic inhibitory bacterial load (CIBL) on wound closure, To determine the effect of chronic inhibitory bacterial load (CIBL) as assessed by fluorescence imaging on wound closure. Fluorescent imaging will be assessed at TV1, TV4, TV8, and TV12., 1-12 weeks
Screening for Early Cervical Cancer Detection
NCT Number: NCT06550583
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cervical Cancer|Cervix Neoplasm
Interventions: DIAGNOSTIC_TEST: Pap smear /Test
Sponsor: Assiut University
Sex: FEMALE
Age: ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2024-09-30
Locations: Assiut University, Assiut, 71111, Egypt

Summary:
This study is to audit results and adherence to Cervical Screening program before and after the implementing awareness of the WHO guidelines of screening among the multidisciplinary healthcare workers and patients.

Primary Outcome Measures: Screening clinic in Women & Children Hospital, All women undergo Pap smear test according to inclusion criteria and will be adherence to screening program protocol, Baseline
Secondary Outcome Measures: Via test, Via test will be done to all patients come to screening clinic and Adherence to screening program protocol, baseline
Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum
NCT Number: NCT06550570
Acronym: PERIDEAMBU
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Childbirth|Epidural; Anesthesia
Interventions: BEHAVIORAL: QEVA questionnaire
Sponsor: Centre Hospitalier Régional Metz-Thionville
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-23
Completion Date: 2025-08-23
Locations: CHR Metz Thionville Hopital Femme Mère Enfant, Metz, 57085, France|CHR Metz-Thionville Hopital Mère Enfant, Thionville, 57100, France

Summary:
Childbirth is a special event for women. Maternal satisfaction regarding childbirth is quite important, that is why this factor has to be taken into account. A bad experience related to childbirth could lead to serious psychological and organic consequences such as postpartum depression, mother-baby bond deterioration and chronic pelvic pain. Childbirth image changed over the years to the extent that an increasingly physiological process keeping analgesia and safety is more and more desired. In this perspective, this study aims to investigate an approach so-called ambulatory epidural. Indeed, only a few studies have been conducted and the ones published in 1990s did not involve the current recommended pharmacological protocols.

Primary Outcome Measures: Obstetrical labor and delivery experience in birthgiving women, The "emotional state" dimension of the Childbirth Assessment Questionnaire (QEVA) will be evaluated.

This questionnaire is written and validated in French. It contains 26 questions covering 4 dimensions: emotional state, relations with nursing staff, first moments with the baby, and the young mother's feelings one month before delivery., at 2 days postpartum
Secondary Outcome Measures: Relations with nursing staff and first moments with the child, Other dimensions and isolated items of the QEVA questionnaire, at 2 days postpartum|Obstetrical labor and delivery experience in birthgiving women, " emotional state " dimension of the Childbirth Assessment Questionnaire (QEVA), at 4 weeks postpartum|Labor and delivery safety : time spent in the delivery room, Time spent in the delivery room (min), at 2 days postpartum|Labor and delivery safety: need for instrumental extraction, Need for instrumental extraction (yes/no), at 2 days postpartum|Labor and delivery safety : emergency caesarean sections, Emergency caesarean sections (yes/no),, at 2 days postpartum|Labor and delivery safety: ability to maintain spontaneous micturition, Ability to maintain spontaneous micturition (yes/no), at 2 days postpartum|Safety of ambulation, absence of the following events : motor block, hypotension, malaise, falls, difficulty in achieving ambulation, at 2 days postpartum