pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Interest of Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia
NCT Number: NCT06584461
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Upper Respiratory Tract Infections|Perioperative Respiratory Complications
Sponsor: Tunis University
Sex: ALL
Age: CHILD
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2023-01-02
Completion Date: 2024-02-05

Summary:
The goal of this clinical trial is to determine whether intravenous (IV) lidocaine reduces the incidence of perioperative respiratory complications (PRCs) in children with upper respiratory tract infections undergoing general anesthesia. The study will also evaluate the safety of IV lidocaine in this population. The main questions it aims to answer are:

1. Does IV lidocaine lower the incidence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation) compared to a placebo?
2. What are the side effects associated with the administration of IV lidocaine in these children? Researchers will compare IV lidocaine to a placebo to assess its effectiveness in reducing PRCs.

Primary Outcome Measures: Incidence of Perioperative Respiratory Complications, Measure the occurrence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation, bronchospasm) from the induction of anesthesia until discharge from the recovery room., Within the first 2 hours post-operation.
Secondary Outcome Measures: Incidence of Side Effects Related to IV Lidocaine, Measure the occurrence of side effects such as nausea, vomiting, cardiac or neurological toxicity, and signs of anaphylaxis following the administration of IV lidocaine., Within the first 24 hours post-operation.
A Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer Tumors
NCT Number: NCT06584435
Acronym: TUOAD-RCC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: High-risk Renal Cell Carcinoma
Interventions: DRUG: Tremelimumab
Sponsor: Tianjin Medical University Second Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-10-01
Completion Date: 2025-03-03
Locations: Changyi Quan, Tianjin, Tianjin, 300211, China

Summary:
This is a phase II study to investigate the effect of treprolizumab on tumor control and survival in high-risk renal cancer after radical nephrectomy. Patients will be treated with treprolizumab, which will be administered every 3 weeks until tumor recurrence or intolerable toxicities

Primary Outcome Measures: PFS, Duration from patient enrollment to disease progression, assessed up to 3 years|OS, Duration from the start of randomization until death due to any cause, assessed up to 3 years
Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks, the EMPOWER Study
NCT Number: NCT06584396
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Carcinoma
Sponsor: M.D. Anderson Cancer Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-20
Completion Date: 2025-08-30

Summary:
This study evaluates the skin and surrounding soft tissue that is removed during an implant reconstruction after a mastectomy.

Primary Outcome Measures: Nanomechanical properties of the skin and adjacent soft tissue, The nanomechanical properties will be presented as a histogram that describes the characteristics of the sample. For each skin sample, summary statistics including mean (median), standard deviation, skewness, and range, mode, etc. will be used to describe the nanomechanical properties. Wilcoxon rank sum test or Fisher's exact test will be used to study the association between the summarized nanomechanical properties and clinical factors or outcomes. Pearson correlation coefficients will be used to assess the strength of association between any two continuous variables. Logistic regression will be conducted to examine the effect of nanomechanical properties on the risk of implant loss or any complication after adjusting other clinical factors., At time of surgery
Transatrial Pericardial Separation to Enhance Safety of Subxiphoid Pericardial Access for Left Atrial Appendage Ligation
NCT Number: NCT06584370
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Left Atrial Appendage Ligation|Pericardium|Epicardial Mapping|Heart Atria|Cardiac Surgical Procedures|Cardiac Catheterization|Pneumopericardium|Left Atrial Appendage Occlusion
Interventions: PROCEDURE: Pericardial insufflation with carbon dioxide through a transatrial microcatheter
Sponsor: Henry Ford Health System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 13
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-05
Completion Date: 2015-08
Locations: Henry Ford Health System, Detroit, Michigan, 48202, United States

Summary:
We use a tiny catheter through the heart to separate the pericardium with gas. We expect this to improve the safety of the Lariat procedure.

Primary Outcome Measures: Successful subxiphoid needle access without myocardial injury, Immediate
Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia
NCT Number: NCT06584357
Acronym: Bio-Hermes-002
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mild Cognitive Impairment|Alzheimer's Disease|Alzheimer's Disease, Early Onset|Memory Loss|Memory Disorders|Memory Impairment
Interventions: OTHER: Biomarker Data Collection|RADIATION: MK6240
Sponsor: GAP Innovations, PBC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2028-07
Locations: JEM Research Institute, Atlantis, Florida, 33462, United States|Visionary Investigators Network, Aventura, Florida, 33180, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Axiom Brain Health, Tampa, Florida, 33609, United States

Summary:
Bio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective. Digital biomarkers and blood-based biomarkers will be tested to determine whether a meaningful relationship exists between biomarkers alone or in combination with tau or amyloid brain pathology identified through PET images.

Primary Outcome Measures: Study-wide Amyloid Positivity, Increase study-wide amyloid positivity by assessing participants' likelihood of amyloid positivity utilizing the LucentAD blood test. The Sponsor retains the option to begin excluding those who have a low likelihood and/or intermediate likelihood of being amyloid PET positive during the course of the study based on the LucentAD blood test, which assesses the likelihood of amyloid pathology consistent with AD., Through study completion, an average of 18 months|Biomarkers and PET, Measure Aβ 42/40, p-tau 181, p-tau 217, p-tau 231, total tau, and NFL to see if it will predict the extent of tau and amyloid brain pathology as measured by PET brain imaging in participants shown to be cognitively normal (CN), have mild cognitive impairment (MCI), or have mild-to-moderate AD dementia., Through study completion, an average of 3 years
Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer
NCT Number: NCT06584318
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Cancer
Interventions: OTHER: Intermittent hypoxia intervention
Sponsor: Capital Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-03-01
Completion Date: 2025-04-30
Locations: Xuanwu Hospital, Capital Medical University, Beijing, Beijing, 100000, China

Summary:
This study aims to explore the safety and efficacy of intermittent hypoxia intervention on patients with colorectal cancer.

Primary Outcome Measures: Incidence of adverse reactions, Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness and insomnia., During the 7-day treatment
Secondary Outcome Measures: Tumor Markers, Blood tumor markers will be detected by the immunochemiluminescence method., The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)|Tumor Change, Tumor Change will be detected by tumor cell HIF-1α and HIF-2α through immunohistochemistry., The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)|Cytokines, Cytokines will be detected by immune-related cytokines in peripheral blood., The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)|Immune Cell Infiltration, Immune Cell Infiltration will be detected by observatiion of immune cell infiltration in tumor tissue., The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)|Symptoms, It is evaluated by completing the follow-up form., The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery
AI Screening for BDD in Aesthetic Surgery: Enhancing Safety and Outcomes
NCT Number: NCT06584305
Acronym: AI
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Body Dysmorphic Disorder
Interventions: PROCEDURE: AI-Powered Body Dysmorphic Disorder Screening Procedure
Sponsor: Bukret Plastic Surgery
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3722
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-02
Completion Date: 2024-08-23
Locations: Bukret Plastic Surgery, Buenos Aires, 1107, Argentina

Summary:
The goal of this observational study is to evaluate the effectiveness of an AI-powered screening tool for Body Dysmorphic Disorder (BDD) among patients seeking aesthetic surgery. The study aims to determine if the AI system can effectively identify patients at risk for BDD and assess the impact of early psychological intervention on surgical decision-making and outcomes. Participants will complete a comprehensive AI-based risk assessment, which includes the Body Dysmorphic Disorder Questionnaire (BDDQ). The study will track the correlation between BDD, age, stress levels, and gender to better understand the prevalence and implications of BDD in cosmetic surgery.

Primary Outcome Measures: Prevalence of Body Dysmorphic Disorder (BDD) Among Cosmetic Surgery Patients, This outcome measure assesses the prevalence of BDD among patients undergoing cosmetic surgery, as identified through the AI-powered screening tool., From 1 to 43 months post-surgery (January 2021 to August 2024)
Secondary Outcome Measures: Correlation Between Positive BDD Screening and Risk Factors, This measure evaluates the correlation between a positive Body Dysmorphic Disorder (BDD) screening result and various risk factors, including demographic factors (age, gender), psychological stress levels, and previous psychiatric history. The goal is to identify patterns that could inform better patient selection and management in cosmetic surgery., From 1 to 43 months post-surgery (January 2021 to August 2024)
Comparison of Caudal Block and Retrolaminar Block for Circumcision
NCT Number: NCT06584292
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Regional Anesthesia
Interventions: PROCEDURE: caudal block|PROCEDURE: Retrolaminar block
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: MALE
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-09-27
Completion Date: 2024-09-30
Locations: Health Science University İstanbul Prof Dr Cemil Taşcıoğlu City Hospital, Istanbul, Okmeydanı, Turkey

Summary:
Primary Outcome:

Analgesic Efficiency: The primary outcome is the comparison of the analgesic efficacy of the retrolaminar block (RL) versus caudal block (CB) based on postoperative pain scores measured by the FLACC score. This outcome aims to evaluate how effectively each block controls postoperative pain.

Secondary Outcomes:

Analgesic Requirements:

The amount of analgesic required within the first 24 hours postoperatively. The time to the first analgesic requirement. These will be recorded during postoperative follow-up visits at 30 minutes, 1, 2, 4, 6, 12, and 24 hours by an anesthesiologist who is blinded to the study groups.

Postoperative Complications:

Urinary Retention: Defined as a distended palpable bladder associated with pain.

Motor Block: The presence of lower extremity motor block will be evaluated using the modified Bromage scale (0: No motor block; 1: Able to move the legs; 2: Unable to move the legs).

Ecchymosis and Hematoma: The presence of ecchymosis (discoloration of the skin due to blood infiltration in the subcutaneous tissues) and hematoma (abnormal swelling or hardening caused by the accumulation of blood) at the injection site will be assessed.

Primary Outcome Measures: Analgesic Efficiency, The primary outcome is the comparison of the analgesic efficacy of the retrolaminar block (RL) versus caudal block (CB) based on postoperative pain scores measured by the FLACC score. This outcome aims to evaluate how effectively each block controls postoperative pain., 1 day
Secondary Outcome Measures: Analgesic Requirements:, The amount of analgesic required within the first 24 hours postoperatively. The time to the first analgesic requirement. These will be recorded during postoperative follow-up visits at 30 minutes, 1, 2, 4, 6, 12, and 24 hours by an anesthesiologist who is blinded to the study groups., 1 day|Postoperative Complications:, Urinary Retention: Defined as a distended palpable bladder associated with pain.

Motor Block: The presence of lower extremity motor block will be evaluated using the modified Bromage scale (0: No motor block; 1: Able to move the legs; 2: Unable to move the legs).

Ecchymosis and Hematoma: The presence of ecchymosis (discoloration of the skin due to blood infiltration in the subcutaneous tissues) and hematoma (abnormal swelling or hardening caused by the accumulation of blood) at the injection site will be assessed., 1 day
Diagnostic Value of MRI-targeted Plus Index-lesion-ipsilaterally Systematic Biopsy for Biopsy-naive Men at Risk of Prostate Cancer: a Prospective, Multicenter, Paired, Non-inferiority Trial
NCT Number: NCT06584279
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: DIAGNOSTIC_TEST: Biopsy of the prostate and pathological diagnosis
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 740
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-04-01
Locations: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, China

Summary:
Targeted and systematic biopsy stands as the prevalent diagnostic approach for prostate cancer. Despite its widespread use, this method is characterized by a high volume of needle biopsies. A refined approach, termed targeted and index-lesion-ipsilateral systematic biopsy, as one of targeted and regional systematic biopsy methods, aim to reduce the number of biopsy cores while maintaining an adequate positive rate. However, the absence of robust evidence necessitates further investigation. This study employs a prospective, multicenter, paired, non-inferiority design to assess the diagnostic efficacy of targeted and index-lesion-ipsilateral systematic prostate biopsy in comparison with the conventional targeted and systematic biopsy for the detection of clinically significant prostate cancer (csPCa). Eligible participants were identified as those with target lesions on prostate MRI, who subsequently underwent targeted and systematic prostate biopsies. The index lesion was defined as the one with the highest Prostate Imaging Reporting and Data System (PI-RADS) score; in cases of multiple lesions with identical PI-RADS scores, the lesion with the greatest diameter was prioritized. Post-biopsy pathological data were collected and evaluated using the International Society of Urological Pathology (ISUP) grading system, which classifies patients with a grade of 2 or higher as having csPCa. The study's primary outcome was to calculate the confidence interval for the difference in csPCa detection rates between the two biopsy methods under a paired design. This interval was then compared against a pre-specified non-inferiority margin to determine whether the targeted and index-lesion-ipsilateral systematic biopsy method is non-inferior to the standard targeted and systematic biopsy in detecting csPCa.

Primary Outcome Measures: Confidence interval for the difference in csPCa detection rate between targeted + index-lesion-ipsilaterally systematic biopsy and targeted + systematic biopsy for biopsy-naive men at risk of prostate cancer, 0.5-1 years
Secondary Outcome Measures: additional value of index-lesion-contralaterally systematic biopsy, 0.5-1 years|pathological upgrade after radical prostatectomy, 0.5-1 years
Multimodal Cardiac Imaging Registry in Patients with Atrial Fibrillation
NCT Number: NCT06584266
Acronym: IMAGE-AF
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation and Flutter|Heart Failure|Artificial Intelligence (AI)|Echocardiography
Sponsor: University in Zielona Góra
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2027-09

Summary:
The goal of this observational registry is to collect a curated dataset of multimodal imaging data that will serve for development of artificial-intelligence based solutions for prediction of risk and outcomes in patients with atrial fribrillation.

Type of study: observational study

Study Participants: Patients with atrial fibrillation or atrial flutter who undergo clinically indicated transesophageal echocardiography before catheter ablation or cardioversion.

We hypothesize, that automatic analysis of video images of transthoracic echocardiography with deep learning combined with clinical data can predict the presence of left atrial appendage thrombus (LAT). Therefore, our main aim is to create and validate an artificial intelligence model to predict the presence of LAT based on automatic analysis of transthoracic echocardiography with artificial intelligence.

Primary Outcome Measures: Assessment of the presence of left atrial appendage thrombus in patients with atrial fibrillation or atrial flutter, in whom tranesophageal is performed before cardioversion or catheter ablation ablation., We will asses the left atrial appendage in transesophageal echocardiography (TEEO for the presence of the left atrial appendage thrombus. During TEE we will record multiple projections of the left atrial appendage and we will measure laeft atrial appendage flows as listed below:

1. Projection on LAA (Left Atrial Appendage): 0, 45, 90, 135 degrees, and other projections that are necessary to correctly image the entire LAA according to the investigator/ echocardiographer.
2. 3D acquisition of the volume that contains LAA (multi-beat-optimized).
3. Measurement of maximum emptying velocity of LAA 1cm from the LAA ostium - at least three measurements in two different scanning angles, averaged.
4. Acquisition of spectral Doppler image of LAA emptying (three images from two or more scanning angles) (still images)., One day
Secondary Outcome Measures: Follow up for adverse outcomes, Follow-up for death, stroke, myocardial infarction, new onset or worsening of heart failure or acute limb ischemia. This will be obtained trough telephone interview., 1 year|Follow up for ablation recurrence, If possible, we will follow up the patients for AF recurrence., 1 year
Other Outcome Measures: Electroanatomical data, In patients who undergo catheter ablation with elepctroanatomical mapping we will collect and analyze data acquired during the procedure., One Day
A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of JHM03 in Adult Patients with Upper Limb Spasticity
NCT Number: NCT06584240
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Upper Limb Spasticity
Sponsor: JHM BioPharma (Tonghua) Co. , Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-02

Summary:
This is a phase Ib/II clinical study to evaluate the safety and efficacy of recombinant botulinum toxin type A（JHM03）in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo in adult patients with upper limb spasticity.

Primary Outcome Measures: Phase1b, The incidence rate of adverse events and severe adverse events within 12 weeks after injection;, Within 12 weeks|Phase2, Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale)., Within 4 weeks
Adebrelimab and Chidamide for Pancreatic Cancer
NCT Number: NCT06584227
Acronym: ACPC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Cancer, Adult
Sponsor: Liu Xiufeng
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 77
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2026-07-10

Summary:
Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. The primary treatment regimen for advanced pancreatic cancer remains chemotherapy, which results in a median survival time of only 8 to 12 months. Therefore, there is an urgent need to explore new combination therapies to extend survival. Therefore, this study aims to evaluate the efficacy and safety of Adebrelimab and Chidamide in Combination with Gemcitabine and S1 as first-line treatment for locally advanced or metastatic pancreatic cancer.

Primary Outcome Measures: Progression free survival, From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months, 24 months
Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.
NCT Number: NCT06584214
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Syphilis Infection
Interventions: DIAGNOSTIC_TEST: Diagnostic test: Determine™ Syphilis Advanced test
Sponsor: Abbott Rapid Dx
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2024-12
Locations: Uganda Virus Research Institute, Entebbe, Uganda

Summary:
This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test. The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff. The study will also have a retrospective study arm. The Determine™ Syphilis Advanced validation will be conducted in accordance with the World Health Organization\&#39;s TSS-6 guidance on Syphilis rapid diagnostic tests, ISO 20916 (In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice), the study protocol, Good Clinical Practice and the respective local medical device laws.

Primary Outcome Measures: To determine the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test results using fingerstick capillary whole blood, venous whole blood, serum and venous plasma, when the test is performed by professional users., The diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test will be evaluated versus laboratory reference testing., 4 months|To compare the performance of the Determine™ Syphilis Advanced test with two commercially available similar tests, The Determine™ Syphilis Advanced test will be compared with two commercially available tests. These tests are the TPPA test (SERODIA-TPPA, Fujirebio) and the Determine™ Syphilis TP (Abbott) test., 4 months
Secondary Outcome Measures: To evaluate the usability through completion of a user experience questionnaire., A user experience questionnaire will be completed by study healthcare staff. The users will evaluate the ease of use, and confidence in correct performance, of various test steps and result interpretation. The response options are ranked on a scale of 1-5. where option 1 stands for Very easy, or Very confident as applicable, and 5 stands for Very Difficult, or Very unsure as applicable., 4 months|To determine the stability of venous whole blood, serum and plasma samples for use with Determine™ Syphilis Advanced, after refrigeration ., Venous whole blood, serum and plasma will be stored at 2-8 degrees Celsius during 7 days before testing with Determine™ Syphilis Advanced., 4 months
The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients with Symptomatic Irreversible Pulpitis and Apical Periodontitis.
NCT Number: NCT06584188
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Postoperative Pain
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2025-09-30

Summary:
* The aim of this study is comparative between:

  1. Intra-radicular cryotherapy using cold anti-inflammatory {ketorolac tromethamine at 2-5C}.
  2. Intra-radicular final flush anti-inflammatory {ketorolac tromethamine at room temperature}.
* In terms of:

C. Level of post-operative pain {POP} using a visual analog scale {VAS}. D. Level of substance P in periapical fluid will be analyzed by enzyme-linked immunosorbent assay (ELISA) kit.

Outcomes :

* Primary outcomes: Level of Post-operative pain.
* Secondary outcomes: Level of substance P expression

Primary Outcome Measures: Level of Post-operative pain., measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10), After 12 hours|Level of Post-operative pain., measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10), After 24 hours|Level of Post-operative pain., measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10), After 48 hours
Secondary Outcome Measures: Level of substance P expression., Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab., After 15 minutes from access cavity preparation.|Level of substance P expression., Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab., After 30 minutes from access cavity preparation.|Level of substance P expression., Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab., After 24 hour
BAR As a Mortality Predictor in Septic AKI
NCT Number: NCT06584149
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury|Sepsis
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-25
Completion Date: 2024-09-25

Summary:
The aim of this study is to investigate the prognostic value of Blood Urea Nitrogen to serum Albumin ratio in septic Acute Kidney Injury patients Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.

Primary Outcome Measures: mortality, number of cases of mortality, 30 days
Secondary Outcome Measures: mechanical ventilation, number of participants who needed mechanical ventilation, 30 days|stage-3 AKI, number of participants who developed stage-3 AKI, 30 days|renal replacement therapy, number of participants who needed renal replacement therapy, 30 days|septic shock, number of participants who developed septic shock, 30 days|length of ICU stay, length of ICU stay in days, 30 days
Lagged Relationships Between Sleep, Balance, and Cognition in Older Adults
NCT Number: NCT06584136
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aging
Sponsor: University of Florida
Sex: ALL
Age: OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2025-06
Locations: University of Florida, Gainesville, Florida, 32603, United States

Summary:
This study investigates the use of wearable devices and a sleep diary for tracking sleep and its impact on cognition and balance in older adults over six weeks. It will include routine mobility, balance assessment, and cognitive evaluations, focusing on analyzing the relationships between sleep, mobility, balance, and cognition.

Primary Outcome Measures: Total Sleep Time, Total Sleep Time will be monitored using the OURA ring, calculated as the sum of all sleep stages in minutes each night. Data will be aggregated to provide a daily and weekly average for each participant., 6-week daily assessments|Sleep Onset Latency, Sleep Onset Latency, defined as the time taken to transition from wakefulness to sleep, will be recorded by the OURA ring each night. Data will be shown in daily and weekly for each participant., Daily assessments over 6 weeks|Sleep Efficiency, Sleep Efficiency will be measured as the ratio of total sleep time to time in bed, expressed as a percentage. The OURA ring will track this nightly, and the data will be summarized as daily data points and a weekly average., Daily assessments over 6 weeks|Cognitive Function, Evaluated using the NIH Toolbox Cognitive Battery, with attention to memory, attention, and processing speed., 6 weeks weekly assessments
Secondary Outcome Measures: Berg Balance Scale (BBS) Score, The Berg Balance Scale (BBS) will be administered twice, at baseline and at the end of the study period (Week 6), to assess changes in balance performance. The Berg Balance Scale (or BBS) is a widely used clinical test of a person\&amp;amp;amp;amp;amp;amp;amp;#39;s static and dynamic balance abilities., Pre-intervention (Baseline) and Post-intervention (Week 6)|Mini-BESTest Score, The Mini-BESTest will be conducted weekly throughout the 6-week study period to evaluate changes in balance performance over time. This test measures dynamic balance, functional mobility, and gait., Weekly assessments over 6 weeks|Daily Step Count, Daily step count will be monitored using the OURA ring. The data will be aggregated daily and weekly for each participant to assess overall physical activity levels., Daily assessments over 6 weeks recorded by Oura ring|Toe Strength from ToeScale, Measured using the ToeScale for both flexion and extension strength, comparing baseline and post-intervention data., 6 weeks weekly assessments
Other Outcome Measures: Demographic Variables, Demographic data, including age, gender, pre-existing conditions, and medical history, will be collected at the baseline (before the intervention begins). This data will be used to analyze participant characteristics and potential correlations with outcome measures., Week 1 one time measured
Molecular Pituitary Imaging Using 18F-FET PET
NCT Number: NCT06584123
Acronym: FET-pit-PET
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pituitary Adenoma
Interventions: DIAGNOSTIC_TEST: 18F-Fluoro-ethyl-tyrosine (FET) PET
Sponsor: University of Cambridge
Collaborators: Cambridge University Hospitals NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-03
Completion Date: 2026-12-31

Summary:
The goal of this single centre pilot study is to explore whether 18F-fluoro-ethyl-tyrosine PET (FET-PET) yields comparable findings to 11C-methionine PET (Met-PET) for the localisation of pituitary tumours.

Primary Outcome Measures: Maximum Standardized Uptake Values (SUVmax) over pituitary tumour on each of 11C-methionine and 18F-fluoroethyltyrosine PET scans, Comparison of maximum Standardized Uptake Values (SUVmax) measured over pituitary tumours on each type of PET scan., 1 day
Secondary Outcome Measures: Maximum Standardized Uptake Values (SUVmax) over normal pituitary gland and parasellar structures (e.g. cavernous sinuses) on each of 11C-methionine and 18F-fluoroethyltyrosine PET scans, Comparison of maximum Standardized Uptake Values (SUVmax) measured over normal pituitary gland and parasellar structures (e.g. cavernous sinuses) on each type of PET scan., 1 day
COMparative Performance of General Purpose Models
NCT Number: NCT06584097
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neurosurgical Patients
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators: University Medical Center Groningen
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-12-31
Locations: Fondazione IRCCS Istituto Neurologico C. Besta, Milano, 20133, Italy

Summary:
To compare the performance of the Eleveld models for propofol and remifentanil on neurosurgery patients admitted to intensive care with their intraoperative performance.

Primary Outcome Measures: MdAPE difference for propofol, The difference in MdAPE will be measured when comparing the model performance for propofol in the ICU to the intraoperative phase., october 2024|MdAPE difference for remifentanil, The difference in MdAPE will be measured when comparing the model performance for remifentanil in the ICU to the intraoperative phase., october 2024
Secondary Outcome Measures: Propofol and remifentanil metabolites, Metabolites of propofol and remifentanil (4-hydroxy propofol and remifentanil acid) during infusion, october 2024|BIS profile, Bispectral index monitor profile during infusion (min = 0, max = 100), october 2024|NOL profile, NOL (Nociceptive Level) value (min = 0, max = 100), Oct 2024|RASS, RASS measurements during infusion (min = -5, max = +4)., october 2024
Technical and Clinical Validation of the WPM-SEMG Prototype
NCT Number: NCT06584084
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neuron Disease, Motor
Interventions: DEVICE: WPM-SEMG prototype
Sponsor: Alain Kaelin
Collaborators: University of Applied Sciences and Arts of Southern Switzerland|Clinical Trial Unit Ente Ospedaliero Cantonale
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2018-01-19
Completion Date: 2026-04-30
Locations: Neurocentro della Svizzera Italiana, Lugano, 6900, Switzerland

Summary:
Validation study designed to demonstrate the technical and clinical performance, and the safety of a new medical device in healthy volunteers and patients with myopathy or neuropathy. The medical device is the WPM-SEMG prototype designed for recording electrophysiological signals of muscles.

Primary Outcome Measures: Technical and clinical assessment, Correlation between the properties of the final electrophysiological output identified from sEMG signals acquired with the WPM-SEMG device prototype and the properties of the final electrophysiological output identified from EMG signals acquired using needle EMG. \[Time Frame: Intervention (day0)\]

The following properties will be extracted: Amplitude (microVolts), phases/turns (ratio), signal frequency (Hz) and duration (seconds)., Intervention (day0)
Secondary Outcome Measures: Pain assessment, Pain assessment during the measurements done with a pain scale from 1 to 10 (VAS), Intervention (day0)
A Clinical Trial to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC
NCT Number: NCT06584071
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: HCC|Liver Cancer
Interventions: DRUG: PM8002|DRUG: PM1009|DRUG: atezolizumab|DRUG: bevacizumab
Sponsor: Biotheus Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-12

Summary:
This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.

Primary Outcome Measures: Objective response rate(ORR), ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1., Up to approximately 2 years|Optimal dosing regimen of PM8002 in combination with PM1009, To determine the dosing regimen of PM8002 in combination with PM1009, Up to approximately 2 years|Treatment related adverse events (TRAEs), The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0, Up to 30 days after last treatment
Secondary Outcome Measures: Objective response rate(ORR)(mRECIST), ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on mRECIST, Up to approximately 2 years|Disease control rate (DCR), DCR is defined as the proportion of subjects with complete response (CR), partial response (PR) or stable disease (SD) based on RECIST v1.1 and mRECIST, Up to approximately 2 years|Duration of response (DOR), DOR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first, Up to approximately 2 years|Progression free survival (PFS), PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first, Up to approximately 2 years|Overall survival (OS), OS is the time from the date of randomization or first dosing date to death due to any cause, Up to approximately 2 years|Maximum observed concentration [Cmax], To evaluate the Cmax of Combination regimen ., Up to 30 days after last treatment|Time to Cmax [Tmax], To evaluate the Tmax of Combination regimen ., Up to 30 days after last treatment|Minimum observed concentration [Cmin], To evaluate the Cmin of Combination regimen ., Up to 30 days after last treatment|Area under the concentration-time curve [AUC0-last], To evaluate the AUC0-last of Combination regimen ., Up to 30 days after last treatment|AUC to the end of the dosing period(AUC0-tau), To evaluate the AUC0-tau of Combination regimen ., Up to 30 days after last treatment|Apparent terminal elimination half-life (t1/2), To evaluate the t1/2 of Combination regimen ., Up to 30 days after last treatment|Anti-drug antibody (ADA), To evaluate the incidence of ADA to PM8002, Up to 30 days after last treatment
HPP737 Substance Balance Study in Human
NCT Number: NCT06584058
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psoriasis
Interventions: DRUG: HPP737
Sponsor: Newsoara Biopharma Co., Ltd.
Sex: MALE
Age: ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-30
Completion Date: 2025-08-30
Locations: The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215000, China

Summary:
Main research purpose

1. Quantitative analysis of the total amount of radioactivity in excreta (urine and feces) of male healthy subjects after oral administration of \[14C\]HPP737, to obtain the cumulative excretion rate and main excretion routes of human radioactivity;
2. To identify the main metabolites in the offspring of \[14C\]HPP737 in healthy male subjects, and to determine the main biotransformation pathway and main metabolite structure;
3. To investigate the distribution of total radioactivity in whole blood and plasma and the pharmacokinetics of total plasma radioactivity in healthy male subjects after a single oral administration of \[14C\]HPP737.

Participants will:

1. Take Investigational product once
2. Stay in the clinic about 7 days for checkups and tests
3. Report their symptoms

Primary Outcome Measures: Cmax (peak concentration), radiation pharmacokinetic parameter, Up to 12 months|Tmax (peak time), radiation pharmacokinetic parameter, Up to 12 months|AUC0-T (area under drug time curve), radiation pharmacokinetic parameter, Up to 12 months|AUC0-∞ (area under drug time curve), radiation pharmacokinetic parameter, Up to 12 months|t1/2 (elimination half-life), radiation pharmacokinetic parameter, Up to 12 months|CL/F (apparent clearance), radiation pharmacokinetic parameter, Up to 12 months|Vd/F (apparent volume of distribution), radiation pharmacokinetic parameter, Up to 12 months|MRT (mean residence time), radiation pharmacokinetic parameter, Up to 12 months|Cumulative drug excretion(Urine), Radioactive excretion corresponding to urine samples, Up to 12 months|Cumulative drug excretion(stool), Radioactive excretion corresponding to stool samples, Up to 12 months|Major metabolite, The main metabolites in plasma, urine and fecal samples were identified by liquid chromatography-mass spectrometry (LC-MS), and radioisotope metabolites were analyzed to provide the main biotransformation pathway of HPP737 in human body., Up to 12 months
Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer
NCT Number: NCT06584032
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Advanced Endometrial Cancer
Sponsor: Hutchmed
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 412
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-06
Completion Date: 2029-06-09

Summary:
The goal of this study is to evaluate whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC).

Primary Outcome Measures: Progression-Free Survival (PFS) as assessed by IRC, Progression-free survival (PFS) is defined as the time from randomization to disease progression assessed by IRC or death due to any cause, whichever occurs first., Up to approximately 4 years|Overall Survival (OS), Overall Survival (OS) is defined as the time from randomization to death due to any cause., Up to approximately 4 years
Secondary Outcome Measures: Objective Response Rate (ORR), Objective Response Rate (ORR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR) , as assessed by IRC and investigator., Up to approximately 4 years|Duration of Response (DoR), For patients who reached complete response (CR) or partial response (PR), Duration of Response (DoR) is defined as the time from the first CR or PR until disease progression or death due to any cause, whichever occurs first ,as assessed by IRC and investigator., Up to approximately 4 years|Disease Control Rate (DCR), Disease Control Rate (DCR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR) or maintained a stable disease, as assessed by IRC and investigator., Up to approximately 4 years|Time To Response (TTR), Time To Response (TTR) is defined as the time from the start of treatment to the first objective response rate (ORR) ,as assessed by IRC and investigator., Up to approximately 4 years|Progression-Free Survival (PFS) as assessed by investigator, Progression-Free Survival is defined as the time from randomization to disease progression assessed by investigator or death due to any cause, whichever occurs first., Up to approximately 4 years|Incidence and severity of Treatment-emergent Adverse Events (TEAE), Adverse events classified according to NCI CTCAE version 5.0, Up to approximately 4 years|Blood concentration of fruquintinib, Steady-state blood concentration of fruquintinib, At the end of cycle 4 day 14 (each cycle is 21 days)|Health-related quality of life (using EORTC QLQ-C30), Changes in EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) scores from baseline, Up to approximately 4 years|Health-related quality of life (using EORTC QLQ-EN24), Changes in EORTC QLQ-EN24 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module) scores from baseline, Up to approximately 4 years
The Effect of Range of Motion (ROM) exercıses on Comfort Level and vıtal sıgns
NCT Number: NCT06584019
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Children With Cancer
Interventions: OTHER: Range Of Motion applied group
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-05-01
Completion Date: 2024-07-01
Locations: Medipol University, Istanbul, Beykoz, 34810, Turkey

Summary:
This experimental study aims to examine the effects of ROM (Range of Motion) exercises on comfort level and vital signs in children diagnosed with cancer.

Primary Outcome Measures: Body temperature, For 5 days, children's body temperature was taken 2 times before and after 20 minutes of Range Of Motion., For 5 days/ 2 times a day/ before and after a 20 minute range of motion.|Pulse, For 5 days, children's pulse was taken 2 times before and after 20 minutes of Range Of Motion., For 5 days/ 2 times a day/ before and after a 20 minute range of motion.|Respiration, For 5 days, children's Respiration was taken 2 times before and after 20 minutes of Range Of Motion., For 5 days/ 2 times a day/ before and after a 20 minute range of motion.|Blood pressure, For 5 days, children's Blood pressure was taken 2 times before and after 20 minutes of Range Of Motion., For 5 days/ 2 times a day/ before and after a 20 minute range of motion.|Comfort, For 5 days, children's comfort level was taken 2 times before and after 20 minutes of Range Of Motion.

Pediatric Comfort Assessment Scale was used for measurement. It evaluates 5 parameters: sounds, motor movements, performance, facial expressions and other. Each item is evaluated on a 5-point Likert scale from 0 to 4 (0/Not Available, 1/No, 2/Somewhat, 3/Moderate, 4/Strong) from bad to good. Higher scores indicate a higher level of comfort., For 5 days/ 2 times a day/ before and after a 20 minute range of motion.