pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent
NCT Number: NCT06510790
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Bacterial Colonization in Double J Ureteral Stent
Interventions: DEVICE: Double J stent
Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-03-01
Completion Date: 2023-08-15
Locations: Institute of Medicine, Kathmandu, Bagmati, 44600, Nepal

Summary:
The goal of this prospective study is to identify the risk factors associated with bacterial colonization of DJS and report the common microorganisms isolated and drug susceptibility pattern.

Primary Outcome Measures: Risk factors associated with bacterial colonization of DJS., Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures., 4 weeks
Secondary Outcome Measures: The common microorganisms isolated from DJS in culture along with their drug susceptibility pattern., After removal of the DJS with sterile technique, the tips of both ends (renal end and bladder end) of the stent were cut with surgical blade number 10 and collected in a plastic screw-capped container, and sent for bacterial evaluation. The report of the culture and sensitivity pattern were collected and treated according to the sensitivity pattern with appropriate antibiotics correlating with the symptoms. Any amount of preoperative urine albumin from trace amounts and above (+,++, etc.) was considered in this study., 4 weeks
A Trial of Chinese Tradional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty
NCT Number: NCT06510764
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Precocious Puberty|Treatment|Alternative Medicine|Acupuncture
Interventions: OTHER: intradermal needles|DRUG: Ziyinxiehuo Granules of tradional Chinese Medicine
Sponsor: Children's Hospital of Fudan University
Sex: FEMALE
Age: CHILD
Enrollment: 170
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2027-07-01

Summary:
A randomized controlled study will be conducted to evaluate the therapeutic effect of traditional Chinese medicine and acupoints stimulation on children with idiopathic precocious puberty.

Primary Outcome Measures: The percentage of subjects' mammary nucleus minification or disappearance at the third month., The diameters of mammary nucleus will be measured with rulers along the median line of the breast at baselin,the third month and the sixth month. The subject numbers of mammary nucleus minification or disappearance at third month will be recorded. The percentage=the subject numbers of mammary nucleus minification or disappearance /total subject numbers in this group ×100%., from baseline to the third month.
Secondary Outcome Measures: the change in bone age／the change in chronological age after six months, The bone age will be measured with X-ray and evaluated with G-P Atlas method at baseline and the sixth month. the change in bone age= bone age after six months-bone age at baseline, the change in chronological age is six months., from baseline to the sixth month
Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P
NCT Number: NCT06510751
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Meningitis|Diagnosis|Prognosis
Interventions: OTHER: CGRP level
Sponsor: Melike Cengiz
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2025-08-30
Locations: Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey, Antalya, Turkey

Summary:
In cases of meningitis caused by external ventricular catheters (EVDs), which are the most commonly placed intracranial catheters that can lead to central nervous system infection through contamination/colonisation, the diagnosis may not be differentiated by either clinical signs and symptoms or conventional cerebrospinal fluid (CSF) tests. Therefore, due to the limitations in diagnosis and prognostic prediction of EVD-induced meningitis and the high mortality/morbidity rates of the disease, markers with high sensitivity and specificity in post-operative meningitis are needed. Calcitonin gene-related peptide (CGRP), a neuropeptide, has been shown to increase when C or Aδ sensory fibres are damaged or in the presence of inflammation in tissues adjacent to the fibres. CGRP is localised in nociceptive nerve terminals together with another neuropeptide, substance P, which has similar biological effects. There are very few studies investigating how CGRP levels in CSF and serum change in bacterial meningitis. Although it is thought that nociception and neuroimmune interactions affect meningeal antibacterial host defence, that nociceptors signal via CGRP to meningeal immune cells during infection, and that this neuroimmune axis exacerbates bacterial meningitis by weakening host defence, it is not yet clear how CGRP and substance P levels affect disease prognosis. This study will evaluate the utility of CGRP and substance P levels as biomarkers to assess diagnosis and treatment response in patients with post-operative meningitis followed in the intensive care unit.

Primary Outcome Measures: Diagnosis, The role of CGRP and substance P levels in blood and CSF samples in the diagnosis of postoperative meningitis, 16 months
Secondary Outcome Measures: Prognosis, The role of CGRP and substance P levels in blood and CSF samples in the evaluation of postoperative meningitis treatment response and prediction of patient prognosis, 16 months
Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images
NCT Number: NCT06510738
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer|Artificial Intelligence|Lymph Node Metastasis|Digital Pathology
Sponsor: Yunnan Cancer Hospital
Collaborators: Affiliated Cancer Hospital of Shantou University Medical College
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 700
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 based on pathology and magnetic resonance imaging (MRI) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. The main questions it aims to answer are:

Can an artificial intelligence model based on MRI images of breast cancer patients predict the non-sentinel lymph node metastatic status in patients with breast cancer sentinel lymph node metastasis?

Can an artificial intelligence model based on intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastasis status in patients with sentinel lymph node metastasis from breast cancer?

Can artificial intelligence models based on preoperative MRI and intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastatic status in patients with sentinel lymph node metastasis from breast cancer?

Researchers will retrospectively and prospectively collect preoperative MRI and intraoperative sentinel lymph node section images from breast cancer patients.

Primary Outcome Measures: Non-sentinel lymph node metastatic status, metastasis or non-metastasis, 2024-2025|Accuracy, Sensitivity, Specificity，Area under the curve, The performance of predicting non-sentinel lymph node metastatic status, 2024-2025|Positive predictive value，Negative predictive value, The performance of predicting non-sentinel lymph node metastatic status, 2024-2025
Effect of Multitarget tDCS for Neuropathic Pain
NCT Number: NCT06510725
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neuropathic Pain
Interventions: DEVICE: Mutitarget tDCS|DEVICE: Single-target tDCS|DEVICE: Sham tDCS
Sponsor: Xuanwu Hospital, Beijing
Collaborators: Beijing Tiantan Hospital|Second Affiliated Hospital of Tsinghua University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-01-31

Summary:
This study aims to conduct a randomized controlled trial to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) on pain, depression, anxiety, quality of life and sleep, in patients with neuropathic pain.

Primary Outcome Measures: Change in average pain intensity, Change in average pain intensity from baseline to week 2, average pain intensity corresponds to average pain over the last 24 hours on the Brief Pain Inventory, from baseline to week 2
Secondary Outcome Measures: Change in Brief Pain Inventory (BPI): Average pain over the last 24 hours, from baseline to week 6 and week 10|Change in BPI: Maximal pain over the last 24 hours, from baseline to week 2, week 6 and week 10|Change in BPI: Minimal pain over the last 24 hours, from baseline to week 2, week 6 and week 10|Change in Neuropathic Pain Symptoms Inventory (NPSI): Burning pain, from baseline to week 2, week 6 and week 10|Change in NPSI: Deep pain, from baseline to week 2, week 6 and week 10|Change in NPSI: Paroxysmal pain, from baseline to week 2, week 6 and week 10|Change in NPSI: Evoked pain, from baseline to week 2, week 6 and week 10|Change in NPSI: Paraesthesia, from baseline to week 2, week 6 and week 10|Change in Hamilton Depression Scale (HAMD), from baseline to week 2, week 6 and week 10|Change in Hamilton Anxiety Scale (HAMA), from baseline to week 2, week 6 and week 10|Change in Pittsburgh sleep quality index (PSQI), from baseline to week 6 and week 10|Change in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L): EQ-VAS, from baseline to week 2, week 6 and week 10|Change in EQ-5D-5L: Utility score, from baseline to week 2, week 6 and week 10|Proportion of participants with meaningful improvement compared with baseline (score as 1 or 2) in Patient Global Impression of Change (PGIC), PGIC includes 7 ranks ranging from 1 to7 (1= very much improved; 2= moderately improved; 3=slightly improved; 4= no change; 5= slightly worsened; 6= moderately worsened; 7= very much worsened), Week 2, Week 6, Week 10
Nutritional Risk for Hospitalized Patients With Neurology Disorders in China
NCT Number: NCT06510712
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neurological Disorder
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-06-30

Summary:
Neurology disorders are one of the major public health problems that seriously threaten human health. It often accompanied by various nutritional problems, which can aggravate the primary disease, lead to serious complications, prolong the hospitalization, lead to poor prognosis, and increase family and social economic burdens. According to the previous studies, the risk of malnutrition was approximately 58.5% of stroke patients, and 6% had moderate to severe malnutrition in China. Another study conducted in Beijing showed that the risk of malnutrition of elderly patients in the department of neurology was significantly higher than in other departments (28.5% vs. 26.4%). Strengthening nutritional supervision of patients with neurology disorders will benefit to improve patients' prognosis. Therefore, the aim of this study is to investigate the nutritional status of inpatients with neurology disorders in China, evaluate the impact of different nutritional status on patients' health outcomes, and establish a high-quality, standardized nutrition and health cohort database for neurology disorders.

Primary Outcome Measures: All-cause mortality, Mortality defined as all-cause mortality from inclusion to day 30, 30 days
Secondary Outcome Measures: ICU admission, ICU admission defined as admission to the intensive care unit from the medical ward from inclusion to day 30, 30 days|Non-elective hospital readmission, Non-elective hospital readmission defined as non-scheduled hospital readmission after discharge from the index hospital stay to day 30, 30 days|Major complications, Major complications defined as the following complications occurring from inclusion (i.e., not present at the time of inclusion) to day 30 I. Adjudicated nosocomial infection or abscess requiring antibiotic treatment II. respiratory failure with need for invasive or non-invasive ventilation III. major cardiovascular events including stroke, intracranial bleeding, cardiac arrest, myocardial infarction with and without invasive procedure and pulmonary embolism IV. acute renal failure (defined by 2x increase of baseline creatinine or new requirement of dialysis do to volume overload or electrolyte disturbance) V. gastro-intestinal events (hemorrhage, intestinal perforation), 30 days|Decline in functional status of 10% or more, decline in functional status of 10% or more from admission to day 30 measured by the Barthel's index., 30 days|length of in hospital days, Total length of in hospital days 30 days, 30 days
Other Outcome Measures: Adverse events, Each of the adverse events, 30 days
Extracorporeal Shock Wave Therapy Versus High Power LASER Therapy for the Treatment of Females With Calcaneal Spur
NCT Number: NCT06510673
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Calcaneal Spur
Interventions: DRUG: Platelet rich plasma|OTHER: High power LASER|OTHER: Shockwave therapy|OTHER: Ice application|OTHER: Sham LASER
Sponsor: Cairo University
Collaborators: Suez University|Badr University|Helwan University
Sex: ALL
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-06-01
Locations: Badr University in Cairo (BUC), Cairo, 12311, Egypt

Summary:
PURPOSE: To compare the effect of Extracorporeal shock wave therapy and high-power LASER therapy for the treatment of patients with calcaneal spur Background: Calcaneal spur is a common musculoskeletal disorder of the foot that affect the quality-of-life Conservative treatment modalities include, cold application, platelet-rich plasma therapy (PRP), shoe modification, therapeutic ultrasound, extracorporeal shock wave therapy (ESWT), laser therapy (LLLT) are commonly used in the treatment of calcaneal spur.

HYPOTHESES: There will be difference between Extracorporeal shock wave therapy and High- power LASER therapy on pain intensity in patients with calcaneal spur There will be difference between Extracorporeal shock wave therapy and High- power LASER therapy on function in patients with calcaneal spur. There will be difference between Extracorporeal shock wave therapy and High- power LASER therapy on the size of calcaneal spur in patients with calcaneal spur.

RESEARCH QUESTION: Is there any difference between the effect of Extracorporeal shock wave therapy and High-power LASER on calcaneal spur?

Primary Outcome Measures: Pain Visual Analog Scale, It is a self reported outcome which is a 10 cm line with zero at one end indicating no pain and 10 at the other end indicating maximum pain. Patient will be asked to mark the current pain on the scale and the distance from the starting point (0) will be measured, Baseline and after one month|foot function index., measure the impact of foot pathology on function in terms of pain, disability and activity restriction. it is a self-administered index, Baseline and after one month|calcaneal Spur length, Spur length will be measured by MRI, Baseline and after one month
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
NCT Number: NCT06510660
Acronym: RICE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma|Immunotherapy|Biomarkers
Interventions: DRUG: adebrelimab
Sponsor: Fujian Medical University Union Hospital
Collaborators: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-11
Completion Date: 2028-12
Locations: Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China

Summary:
To evaluate the efficacy and safety of adebrelimab with or without induction chemotherapy followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma

Primary Outcome Measures: cCR, Clinical complete response rates., Up to 6 months.
Secondary Outcome Measures: OS, Overall survival., From date of enrollment until the date of death from any cause, assessed up to 5 years.|PFS, Progression free survival., From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.|ORR, Objective response rate., Up to 6 months.|DoR, During of response., Up to 3 years.|DCR, Disease control rate., Up to 6 months.|Completion rate of concurrent radiotherapy, Calculate the percentage of patients who have completed concurrent radiochemotherapy., Up to 6 months.|AE, Adverse event,, Up to 6 months.
Other Outcome Measures: Biomarker analysis, Single-cell sequencing, whole-exome sequencing to screen effective biomarkers and explore their correlation with prognosis., Up to 6 months.
Risk Factors for Hormonal Therapy Failure in Patients With Endometriosis.
NCT Number: NCT06510647
Acronym: ENDOFAIL-01
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Endometriosis
Interventions: OTHER: Hormonal Therapy Agent
Sponsor: University of Cagliari
Sex: FEMALE
Age: ADULT
Enrollment: 247
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-26
Completion Date: 2026-05-31
Locations: Policlinico "Duilio-Casula", Monserrato, Cagliari, 09042, Italy

Summary:
The primary objective of our study is to determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 12 months and to compare the clinical and ultrasound characteristics of this group of patients (study group) with the clinical and ultrasound characteristics of patients who are responsive to medical therapy (control group).

The secondary objective of the study will be to determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 6 months and to compare the clinical and ultrasound characteristics of this group of patients (study group) with the clinical and ultrasound characteristics of patients who are responsive to medical therapy (control group).

Primary Outcome Measures: Percentage of patients with endometriosis who are non-responsive to medical therapy after 12 months, To determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 12 months and to compare the clinical and ultrasound characteristics of this group of patients (study group) with the clinical and ultrasound characteristics of patients who are responsive to medical therapy (control group)., 12 months
Secondary Outcome Measures: Percentage of patients with endometriosis who are non-responsive to medical therapy after 6 months, To determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 6 months and to compare the clinical and ultrasound characteristics of this group of patients (study group) with the clinical and ultrasound characteristics of patients who are responsive to medical therapy (control group)., 6 months
Triage of Patients Presenting Beyond 24 Hours With Ischemic Stroke Due to Vertebrobasilar Artery Occlusion
NCT Number: NCT06510634
Acronym: VBAO-LATE
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Stroke, Ischemic
Interventions: OTHER: Endovascular Therapy
Sponsor: Tianjin Huanhu Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 236
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-06-01
Completion Date: 2025-03
Locations: Tianjin Huanhu Hospital, Tianjin, Tianjin, China

Summary:
Endovascular thrombectomy (EVT) for posterior circulation occlusion is generally performed within a window of less than 24 hours from the time the patient was last known well (LKW). The efficacy and safety of EVT beyond the 24-hour window remain uncertain.

Primary Outcome Measures: proportion of patients with Modified ranking scale (mRS) (0-3) at 90 days, A 0-6 scale running from perfect health without symptoms to death., 90(±14)days
Secondary Outcome Measures: distribution of patients with Modified ranking scale (mRS) (0-3) at 90 days, A 0-6 scale running from perfect health without symptoms to death., 90(±14)days|Mortality within 90 days, mortality of any causes., 90(±14)days|Incidence of symptomatic intracranial haemorrhage, Symptomatic intracranial hemorrhage was characterized as any type of intracranial hemorrhage observed on follow-up imaging between 22 and 36 hours and 7 days after stroke onset, accompanied by an increase of at least 4 points on the NIHSS from baseline or the lowest value within 7 days, or resulting in mortality., 90(±14)days
The Preliminary Application of Socket-shield Technique in Orthodontic Extraction and Fixed Orthodontic Treatment
NCT Number: NCT06510621
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Immediate Dental Implant Loading
Interventions: PROCEDURE: Socket-Shield Technique
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-06-01

Summary:
Background This study was conducted to investigate the clinical efficacy of Socket-Shield Technique on the first premolar bone preservation in Orthodontic Extraction Treatment.

Methods 26 patients (12 males, 14 females, 36 single-jaw), from June 2018 to June 2021, who were underwent Orthodontic Extraction Treatment in the First Affiliated Hospital of Guangzhou Medical University were enrolled. Extracted teeth were paired and randomly allocated into two groups: test group (Socket-Shield Technique) and control group. Cone beam computerized tomography were utilized to access the horizontal resorption and vertical resorption at 1mm, 3mm and 5mm from a reference plane of alveolar crest, as well as tooth movement rate at four time-points: before tooth extraction (T0), three months after tooth extraction (T1), the juncture socket-shield was removed (T2) and three months after socket-shield removal (T3).

Primary Outcome Measures: Vertical alveolar bone loss, Cone beam computerized tomography were utilized to access the vertical resorption at 1mm, 3mm and 5mm from a reference plane of alveolar crest, 0 weeks, 3 months, 6 months and 9 months|Horizontal alveolar bone loss, Cone beam computerized tomography were utilized to access the horizontal resorption at 1mm, 3mm and 5mm from a reference plane of alveolar crest, 0 weeks, 3 months, 6 months and 9 months
Secondary Outcome Measures: Tooth movement rate, CBCT three-dimensional reconstruction graphics were used to measure the distance between the most convex points of the adjacent teeth in the mesial and distal distance of the orthodontic gap. Data at T1, T2, and T3 were recorded as D1, D2, and D3 respectively. Tooth movement rate can be calculated by dividing tooth movement distance (in mm) by the time taken for orthodontic gap closing (in months): (D1-D2)/(T2-T1) during T12 and (D2-D3)/(T3-T2) during T23., 3 months, 6 months and 9 months
Periodontal Disease and Salivary Mitofusin Levels
NCT Number: NCT06510608
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Periodontitis|Periodontal Diseases|Gingivitis
Interventions: DIAGNOSTIC_TEST: Biochemical analysis of saliva sample
Sponsor: Erzincan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 81
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2024-09-25

Summary:
The aim of this observational study is to find out whether there is a level difference in salivary mitofusin-1 and mitofusin-2 levels due to changes in periodontal status. The main question it aims to answer is:

* Do salivary mitofusin-1 and mitofusin-2 levels of periodontitis patients differ from healthy patients?
* Could salivary mitofusin-1 and mitofusin-2 levels be biomarkers for periodontal disease?

Biochemical analysis will be performed on saliva samples taken at once from gingivitis or periodontitis patients and healthy individuals who apply to the periodontology clinic, at the initial stage of the treatment. There is no ongoing monitoring or second sampling.

Primary Outcome Measures: Mitofusin-1 concentration, Mitofusin-1 concentration in saliva, determined as a result of biochemical analysis, Up to four weeks from start of work|Mitofusin-2 concentration, Mitofusin-2 concentration in saliva, determined as a result of biochemical analysis, Up to four weeks from start of work|IL-1B concentration, IL-1B concentration in saliva, determined as a result of biochemical analysis, Up to four weeks from start of work
Biomechanical Analysis of Distal Radius (Greenstick) Fracture Healing
NCT Number: NCT06510595
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Fractures, Bone
Interventions: OTHER: Active Treatment Arm|OTHER: Control Treatment Arm
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 2
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-16
Completion Date: 2025-06-30

Summary:
The study will be conducted to investigate the effects of electrical charges (flexoelectric effect) \& mechanical brachioradialis muscle bending force on the displacement and strain of fracture gap on children with Distal radius greenstick fracture via finite element method.

Primary Outcome Measures: Displacement and strain of fracture gap, The angle of fracture displacement will be measured and followed up by x-ray weekly for 3:6 weeks. A reference line will be determined between proximal and distal points of the radial styloid with the fracture inclination line to identify the radial inclination angle (normal angle 22 -23 degrees)., Followed up by x-ray weekly for 3:6 weeks.
3D Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding
NCT Number: NCT06510569
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pathological Resorption of External Root
Interventions: DEVICE: U lab aligners|DEVICE: oramco bracket
Sponsor: Haidy Fekry
Sex: FEMALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-04-15
Completion Date: 2024-06-01
Locations: Al Azhar Universty, Cairo, 002, Egypt|Haidy Fekry, Zagazig, 002, Egypt

Summary:
Evaluate and compare clear aligners versus fixed orthodontic treatment of lower anterior crowding with the use of cone-beam computed tomography within maximum 6 months or until correction of lower anterior crowding whichever is nearest to occur.

Primary Outcome Measures: Correction of lower anterior crowding, according to little irregularity index, 6 months
Other Outcome Measures: Root resorption, CBCT evaluation of root resorption, 6 month
Feasibility Study of the MAVERICK PFA System
NCT Number: NCT06510556
Acronym: MAVERICK
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Persistent Atrial Fibrillation
Interventions: DEVICE: Ablation Treatment
Sponsor: Boston Scientific Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-03-01
Completion Date: 2025-12-15

Summary:
The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX™ mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF).

Primary Outcome Measures: Device or procedure-related Composite Serious Adverse Events (CSAEs), the incidence of device or procedure-related Composite Serious Adverse Events (CSAEs) following the Index Procedure will be evaluated, Ablation Procedure (Day 0) - Day 7; Day 0- Day 30; Day 0- Day 360|Acute Procedural Success, The proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PV) and the posterior wall (PW) during the Index Procedure, as clinically assessed by entrance and/or exit block., At the end of the ablation procedure
Mechanical Power Versus Diaphragmatic Excursion as a Predictor for Weaning in Chronic Obstructive Pulmonary Disease Patients
NCT Number: NCT06510517
Acronym: weaning
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mechanical Power
Interventions: OTHER: Calculation of Mechanical Power.|OTHER: Measurement Diaphragmatic Excursion after first SBT
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-08-01

Summary:
The primary objective is to evaluate the mechanical power as a predictor of weaning of mechanical ventilation in COPD patients hospitalized in the respiratory intensive care unit of Assiut University Hospital.

The secondary objective is to compare between mechanical power and diaphragmatic excursion (DE) assessed by ultrasound as a predictor of weaning in these patients. Also, to investigate the association between MP and DE and mortality in these patients

Primary Outcome Measures: Calculation of Mechanical Power before first trial of extubation., Calculation of Mechanical Power before first trial of extubation for every mechanically ventilated patient before first trial of extubation., 30 days
Secondary Outcome Measures: value of Mechanical Power in died patients., Mechanical Power as a predictor of patient's mortality., 30 days|calculation of Mechanical Power in every Patients suffered from ventilator induced lung injury., calculation of Mechanical Power and the number of Patients suffered from ventilator induced lung injury so study association between value of MP and possibility of VILI to be occurred., 30 days|Calculation of other parameters of weaning as Respiratory rate, Rapid shallow breathing index and expiratory tidal volume., Correlation analysis between mechanical power and other parameters of weaning in evaluation of prognosis in COPD patients., 30 days|number of days for hospital stay and ICU stay for every Mechanically ventilated patients., calculation of mechanical power and duration of hospital stay and ICU stay for each patient., 30 days
Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
NCT Number: NCT06510504
Acronym: AFFIRM-1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Social Anxiety Disorder
Sponsor: Bionomics Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 332
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-06
Completion Date: 2025-09

Summary:
The purpose of the study is to evaluate the effect of a single, acute dose of BNC210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using the Subjective Units of Distress Scale (SUDS) in adult patients with social anxiety disorder.

Primary Outcome Measures: Subjective Units of Distress Scale (SUDS), The Subjective Units of Distress Scale (SUDS) is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress., 1 day
Secondary Outcome Measures: Clinical Global Impressions-Severity (CGI-S), The CGI-S measures overall disease severity of the participant's symptoms as scored by a clinician. Severity is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill of patients) with a higher score indicating a higher level of disease severity., 1 day|Patient Global Impressions-Improvement (PGI-I), The PGI-I is a patient self-reported counterpart of the CGI designed to assess the patient's impression of their perceived change in overall symptoms. Improvement is rated from 1 (very much improved) to 7 (very much worse) with a higher score indicating a higher level of disease severity., 1 day|State-Trait Anxiety Inventory (State Component; STAI-State), The State-Trait Anxiety Inventory (State component; STAI-State) is a self reported measure of subjective anxiety at the time of questionnaire completion. The range is 0-80 with a higher total score indicating a higher level of anxiety., 1 day
Efficacy of Group Life Skill Intervention to Enhance Well-Being Among Higher Education Students
NCT Number: NCT06510478
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psychological Distress|Mental Health Issue|Quality of Life|Well-Being, Psychological
Interventions: BEHAVIORAL: Group Life Skill Intervention|BEHAVIORAL: Treatment as Usual for Control Group
Sponsor: Fatima Jinnah Women University
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-02-01
Completion Date: 2024-05-31
Locations: University of Sahiwal, Sahiwal, Punjab, 57000, Pakistan

Summary:
The primary aim of this study is to investigate the Efficacy of Group life skills intervention designed to improve the well-being, Life skills, and Quality of life of higher education students. The study also identifies the feasibility of the Life skill intervention in the context of Pakistan. We will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment.

Primary Outcome Measures: Well Being, 14-item scale 'Warwick-Edinburgh Mental Well-being Scale' used to measure. Minimum score on this scale is 0 and maximum score is 30.Higher score would indicate higher level of well being., 2 Months
Secondary Outcome Measures: Life Skills, 14-item scale- Life skills questionnaire used to measure. The minimum score on this scale is 14 and the maximum score is 70. Scoring higher on this scale indicates higher life skills in individuals., 2 Months|Psychological Distress, Depression, Anxiety, and Stress Scale used to measure. The minimum score on this scale is 0 and the maximum score is 63. Higher scores on all subscales indicate a higher level of psychological distress., 2 Months
Antibiotic Prophylaxis in Metabolic Bariatric Surgery
NCT Number: NCT06510452
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Antibiotic Reaction|Wound Infection Superficial|Wound Infection Deep|Bariatric Surgery Candidate|Complication,Postoperative
Interventions: DRUG: 2000 mg of Cefazolin|DRUG: 500 mg of Metronidazole IV|DRUG: NACL 0.9% 100 ml
Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3352
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-10-01
Completion Date: 2026-04-01
Locations: Madina Women's Hospital, Alexandria, 21531, Egypt|WeightWorks clinics, Amersfoort, Utrecht, Netherlands

Summary:
SUMMARY Rationale: Prophylactic antibiotics in laparoscopic surgeries, including Metabolic Bariatric Surgery (MBS), are routinely provided to reduce postoperative infections, especially at wound incision sites. However, since incisional wound infections in laparoscopic MBS are rare and morbidity is very low, the benefit of antibiotic prophylaxis is questionable.

Objective: Evaluate the non-inferiority of omitting antibiotic prophylaxis in MBS. Compare postoperative outcomes between Group A (no antibiotics) and Group B (standard antibiotic care) to determine if omission increases complications, particularly wound infections.

Study Design: Randomized controlled trial (RCT), double-blind.

Study Population: Patients with obesity eligible for MBS.

Intervention:

* Group A (No Antibiotic Prophylaxis): Undergo MBS without antibiotics to test safety regarding postoperative complications, focusing on surgical site infections (SSIs).
* Group B (Standard Antibiotic Prophylaxis): Receive standard one-time antibiotics before incision.

Main Study Parameters/Endpoints: Compare the incidence of incisional and organ/space SSIs within six weeks post-surgery between Group A and Group B to determine if omitting antibiotics affects infection rates.

Primary Outcome Measures: Comparison of incidence of postoperative wound infections in both treatment arms, Aims to evaluate the non-inferiority of foregoing antibiotic prophylaxis in MBS. The study will compare postoperative outcomes between two groups: Group A, which will not receive antibiotic prophylaxis, and Group B, which will receive standard care including a one-time administration of antibiotics, to test the hypothesis that omitting antibiotic prophylaxis does not significantly increase the incidence of postoperative complications, in particular wound infections., until 6 weeks post operative
Early Interferon-beta Treatment for West-Nile Virus Infection
NCT Number: NCT06510426
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: West Nile Virus|West Nile Fever Encephalitis|West Nile Fever Myelitis|West Nile Fever With Other Complications
Interventions: DRUG: Rebif 44 MCG Per 0.5 ML Prefilled Syringe|DRUG: Saline
Sponsor: Tel-Aviv Sourasky Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-14
Completion Date: 2025-12-31
Locations: Tel-Aviv Sourasky Medical Center, Tel-Aviv, 6423906, Israel

Summary:
West Nile virus (WNV) is a mosquito-borne virus which in majority of cases causes only self-limited disease.

Despite that, in minority of cases (\~0.5%) it can infect the brain and cause severe and even life-threatening disease (neuroinvasive disease).

Recent study has shown that up to 40% of WNV patients who develop neuroinvasive disease, have antibodies against Interferons (anti-Type I interferon autoantibodies), which neutralizes interferons, and could explain the development of severe disease.

The investigators therefore assume that early treatment with interferon beta (the type of interferon against which most patients do not have neutralizing antibodies) could prevent the development of severe neuroinvasive WNV disease.

Primary Outcome Measures: Rates of death or intubation, Death or intubation within 4 weeks, 4 weeks|Modified Rankin Scale (mRS) score, Comparison of modified Rankin Scale (mRS) score at 3 and 6 months. The mRS score is a 7 point (0-6) disability scale with higher score suggesting higher level of disability., 3 and 6 months
Secondary Outcome Measures: ICU admission, Rates of ICU admission, 4 weeks|Mechanical ventilation, Rates of mechanical ventilation, 4 weeks|Modified-NIH-stroke-scale (mNIHSS), Change in modified-NIH-stroke-scale (mNIHSS) from baseline to 3 months. The scoring range is 0 to 42 points, with higher numbers indicating greater severity., 3 months|Mini-mental state examination (MMSE), Change in mini-mental state examination (MMSE) from baseline to 3 months. The MMSE has a range score of 0-30. A higher score suggests better performance. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment., 3 months|All cause mortality, All-cause mortality at 4 weeks, 3 months, 6 months and 12 months, 12 months
An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers
NCT Number: NCT06510413
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Osteoarthritis|Muscle Pain|Swelling Muscle
Interventions: DRUG: Loxoprofen Sodium Patches(reference product)|DRUG: Loxoprofen Sodium Patches(test product )
Sponsor: Frontier Biotechnologies Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-08

Summary:
This study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial.

Primary Outcome Measures: Cmax of loxoprofen and its trans-OH, Maximum plasma concentration. Analyzing AUC with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population mean with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25., 0-72 hours|AUC0-T of loxoprofen and its trans-OH, Area under the plasma concentration curve from time 0 to the last measured (AUC0-t).

Analyzing AUC with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population mean with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25., 0-72 hours|AUC0-∞ of loxoprofen and its trans-OH, Area under the plasma concentration curve from time 0 to ∞ (AUC0-∞). Analyzing AUC with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population mean with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25., 0-72 hours
Secondary Outcome Measures: Adverse Events, All of the adverse events will be reported, 0-14 days|Tmax of loxoprofen and its trans-OH, Time to reach maximum plasma concentration, 0-72 hours|t1/2 of loxoprofen and its trans-OH, Apparent terminal elimination half-life, 0-72 hours|λz, Apparent terminal elimination rate constant, 0-72 hours|AUC_%Extrap, Percentage of AUCINF(_obs, _pred) due to extrapolation from Tlast to infinity, 0-72 hours|Irritation score, A combined irritation score should be calculated by adding the "dermal response" score and the numeric equivalent for "other effects" letter score., 0-14 days
Clinical Evaluation of Color Stability of Direct Composite Resin Veneers in Vital Anterior Teeth
NCT Number: NCT06510400
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth Discoloration
Interventions: OTHER: OMNICHROMA|OTHER: Ceram. x spectra
Sponsor: Tanta University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-07-19
Completion Date: 2024-04-09
Locations: Restorative Department, Faculty of Dentistry, Tanta University, Tanta, 31527, Egypt

Summary:
Assess color stability of direct veneers over an 18-month recall periods

Primary Outcome Measures: Color stability evaluation, Two calibrated evaluators who were not engaged in the insertion of veneer restorations used VITA Easyshade V to measure the color (ΔE). The device was calibrated before reading., 18 months
Two Bedside Ultrasound Techniques and Standard Methods for Confirmation of Endotracheal Tube Insertion in Intensive Care Patients
NCT Number: NCT06510387
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Two Bedside|Ultrasound|Endotracheal Tube|Intensive Care Patients
Interventions: DEVICE: Ultrasound using suprasternal method|DEVICE: Ultrasound using subxiphoid method
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2024-09-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
This cross-sectional observational study aims to predict the sensitivity and specificity of ultrasonography using suprasternal and subxiphoid methods to confirm the correct placement of endotracheal tubes compared to standard methods in intensive care patients.

Primary Outcome Measures: Accuracy to predict correct placement, Accuracy in predicting the correct placement of the endotracheal tube will be assessed using Sensitivity and Specificity, positive predictive value (PPV), and negative predictive value (NPV) for each ultrasound technique., 5 minutes after placement of endotracheal tube
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
NCT Number: NCT06510374
Acronym: ABLE-32
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Intermediate Risk Non-Muscle Invasive Bladder Cancer
Interventions: DRUG: Nadofaragene Firadenovec
Sponsor: Ferring Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 454
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2031-01-01

Summary:
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Primary Outcome Measures: Recurrence Free survival, Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period., 24 months
Secondary Outcome Measures: Adverse Events, Frequency and intensity of adverse events will be recorded from the signed informed consent for participation in the trial up to month 24, up to 24 months|Recurrence Free Survival at 12 Months, Recurrence free survival at 12 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 12 months, 12 months|Recurrence Free Survival at 24 Months, Recurrence free survival at 24 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 24 months, 24 Months