pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma
NCT Number: NCT06580223
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Multiple Myeloma|Venous Thromboembolism
Interventions: DRUG: Aspirin 100mg|DRUG: Rivaroxaban 10mg
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 530
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2027-09-01
Locations: Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hu Bei, 430022, China

Summary:
The aim of this study is to evaluate the efficacy and safety of aspirin and rivaroxaban in thromboprophylaxis in Chinese MM patients at high risk for MM-associated VTE.

Primary Outcome Measures: Incidence of VTE within 6 months, Participants will receive a chest X-ray (or lung CT scan) and a color Doppler ultrasound of the limb blood vessels before the study begins, and then once monthly for the next six months., 6 months
Secondary Outcome Measures: Side effects of aspirin and rivaroxaban within 6 months, Testing indicators, including blood routine, urine routine, stool routine, liver and kidney function tests, electrolytes, blood glucose, and blood lipids, will be recorded before the study begins and then once weekly for the next six months. Other observational indicators, such as hemorrhagic events, nausea, vomiting, diarrhea, and abdominal distension, will also be recorded., 6 months
The Role of AAT on DGE After Abdominal Surgery Based on RWS
NCT Number: NCT06580197
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acupuncture, Ear|Gastroparesis
Interventions: OTHER: Auricular Acupoint Therapy
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 159
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-12-01

Summary:
Delayed gastric emptying (DGE) after surgery mainly occurs after gastrointestinal surgery A functional gastric emptying disorder, clinically characterized by weak or absent gastric peristalsis, gastric motility disorders, or gastric emptying Gastric retention, fullness, nausea and other uncomfortable symptoms caused by delay.This study is based on clinical diagnosis and treatment practice, observing, collecting, and analyzing Whipple surgery, pancreatectomy, and gastric cancer Perioperative data of subtotal resection surgery, mainly observing the diagnosis and treatment of ear acupoints in Whipple surgery, pancreatectomy, and subtotal gastrectomy.The application effect of DGE after resection surgery, exploring the diagnosis and treatment of ear acupoints in Whipple surgery, pancreatic body and tail resection surgery, and Diagnostic value of perioperative related diseases in abdominal surgery such as subtotal gastrectomy, and collection of health records.By comparing and analyzing the ear acupoint information of patients with abdominal tumors, we aim to explore the ear acupoints of the volunteers. The possible relationship between image and resistance specificity and common tumors in the abdominal cavity.

Primary Outcome Measures: Clinical total effective rate, The clinical total effective rate of ear acupuncture treatment for postoperative DGE in the abdomen, including Whipple surgery, pancreatectomy, and subtotal gastrectomy.

Efficacy evaluation criteria: Measure the subjective symptom score (Gastroparesis Cardinal Symptom Index, GCSI score) of patients with gastroparesis on the third day after surgery, and calculate the clinical efficacy index of ear acupuncture treatment using the following formula (efficacy index=\[(total score of symptoms before treatment - total score of symptoms after treatment) ÷ total score of symptoms before treatment × 100%\]). Among them, significant effect: efficacy index\>75%; Effective: Efficacy index of 25% to 75%; Invalid: Efficacy index\<25%. Total effective rate=(number of significantly effective cases+number of effective cases)/total number of cases x 100%., On the third day after surgery
Validation of Walking and Remembering Test
NCT Number: NCT06580171
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Individuals
Interventions: OTHER: Walking and Remembering Test
Sponsor: Emre Şenocak
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-07-29
Completion Date: 2025-01-29
Locations: Marmara University, Department of Physiotherapy and Rehabilitation, Biomechanics and Performance Analysis Laboratory, İstanbul, 34840, Turkey

Summary:
In this study, the usability of the Walking and Remembering Test will be examined using the remote interview method. The study will be carried out with a single group. First, the WART test will be performed face-to-face at Marmara University Biomechanics Laboratory. The second evaluation will be carried out using a remote method. From the participants;

* He/she will first be asked to walk freely within a line that is 8 meters long and 19 cm wide. Later;
* He will be asked to walk once at average speed and three times as fast as possible in the same line. Later;
* The participant is given a Counting Test. This test includes number sequences from 4 digits to 9 digits. Participants are told these number strings and asked to repeat them with the same speed and tone of voice. The longest sequence of numbers is recorded. Later;
* The participant is walked on the same line again and asked to repeat the longest number sequence he remembers and the test is completed. Cognitive performance with the counting test reflects walking speed during 4 walks, and the number of incorrect steps reflects walking performance.

Primary Outcome Measures: Walking and Remembering Test (WART), WART is a clinical measure of dual-task ability involving individual and simultaneous motor and cognitive task performance. In the test, walking and memory are observed independently and under dual-task conditions., Baseline of the study (Face-to-Face)|Walking and Remembering Test (WART), WART is a clinical measure of dual-task ability involving individual and simultaneous motor and cognitive task performance. In the test, walking and memory are observed independently and under dual-task conditions., First day after the Baseline Assessment (Remote Assessment)
Secondary Outcome Measures: Demographic Data Form, This form was created by researchers and it consist of personal informations such as gender, dominant extremity, history of sport, age, body mass index, Baseline of the study
AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction
NCT Number: NCT06580158
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aortic Stenosis|Diastolic Dysfunction
Interventions: DEVICE: AI-ECG Dashboard|DIAGNOSTIC_TEST: Point of care ultrasound (POCUS)
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-03
Locations: Mayo Clinic, Rochester, Minnesota, 55905, United States

Summary:
Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.

Primary Outcome Measures: Number of patients with positive AI-ECG, Positive AI-ECG will be determined by the sensitivity, specificity, positive predictive value, and negative predictive value., Baseline|Number of studies with reasonable image quality in patients with positive AI-ECG, Image quality will be determined by sonographers at the time of imaging and will be scored on a scale from 1-4:

1. Excellent , sufficient for publication
2. Good, sufficient for data analysis
3. Fair, just enough for data analysis without complete views
4. Poor, not usable for data analysis, Baseline
Secondary Outcome Measures: Number of times the AI ECG and TTE (transthoracic echocardiogram) are statistically comparative, Will be compared using parametric (2-sample t-test) and non-parametric tests (Wilcoxon rank sum test) for continuous variables, and the χ2 test or Fisher exact test for nominal variables. A p-value of \< 0.05 will be categorized as significant for the statistical analysis, Baseline
Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML
NCT Number: NCT06580106
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Leukemia, Myeloid, Acute
Interventions: OTHER: Biospecimen samples
Sponsor: Wake Forest University Health Sciences
Collaborators: Atrium Health Levine Cancer Institute|Swim Across America
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2030-01
Locations: Levine Cancer Institute, Charlotte, North Carolina, 28204, United States

Summary:
The purpose of this research is to see how certain genetic variations relate to side effects and outcomes experienced while receiving treatment with azacitidine and venetoclax.

Primary Outcome Measures: Toxicity side effect, Defined as a binary variable indicating whether a participant experienced a Grade 3 or higher of specific side effects (including infections, anemia, thrombocytopenia, febrile neutropenia, neutropenia, nausea, diarrhea), From initiation of venetoclax through 30 days after last dose
Secondary Outcome Measures: Dose Modification, A binary variable indicating whether a participant experienced a dose modification, including delay or reduction, Approximately 6 months or until last dose of Venetoclax, whichever came first|Disease Response, For participants diagnosed with AML, response will be defined as a binary variable indicating if they had a Complete Remission (CR), Complete Remission with partial hematologic recovery (CRh), Complete Remission with incomplete hematologic recovery (CRi), Morphologic Leukemia-free state (MLFS), or partial response (PR) to induction therapy using the European LeukemiaNet (ELN 2022) criteria. Otherwise they will be considered a non-responder, Up to 3 years|Venetoclax levels, Will be defined as the maximum concentration of Venetoclax and is measured at 6 months if the participant is still receiving venetoclax, Approx 6 months|Overall survival, Duration of time from date of enrollment to death. Participants who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive, Approx 3 years|Dose modification due to nausea or diarrhea, A binary variable indicating whether a participant experienced a dose modification, including delay or reduction due to nausea or diarrhea, Approximately 6 months or until last dose of Venetoclax, whichever came first|Metabolizer status checklist, A categorical variable indicating whether a participant is a high, normal or low metabolizer based on pharmacogenomics analysis of SNP data, Approximately 6 months or until last dose of Venetoclax, whichever came first
Nutritional Status in Patients With Chronic Kidney Disease
NCT Number: NCT06580093
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Malnutrition
Sponsor: Umeå University
Collaborators: Uppsala University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-21
Completion Date: 2028-12
Locations: Uppsala University hospital, Uppsala, Sweden

Summary:
The goal of this observational study is to investigate how the GLIM criteria\* for the diagnosis of malnutrition should be operationalized in patients with chronic kidney disease (CKD) treated with hemodialysis. The main questions it aims to answer are:

* How can malnutrition be defined when applying different combinations and operationalization strategies of the GLIM criteria?
* How can information from other nutrition assessment tools be used in the operationalization of GLIM?
* Which combinations and operationalization strategies of the GLIM criteria can best predict deterioration in quality of life, muscle strength, and increased mortality? An observational study on patients with CKD in hemodialysis will be performed. Variables will be extracted from the Swedish renal registry, SNR and medical records at two hemodialysis units at one university hospital in Sweden. With start in the fall of 2024, data will be collected during two timepoints (baseline and follow-up) when wanted variables for this study are routinely measured at the units.

  * The Global Leadership Initiative on Malnutrition (GLIM) criteria to diagnose malnutrition in adults

Primary Outcome Measures: Malnutrition diagnosis, Malnutition diagnosis according to GLIM, From Aug/Sept 2024 to May 2025
Secondary Outcome Measures: Overall survival, Overall survival, From Aug/Sept 2024 to Dec 28|Muscle strength, Hand grip muscle strength, From Aug/Sept 2024 to May 2025|Health related quality of life, Health related quality of life according to RAND36, Aug/Sept 2024 (baseline)|Muscle mass, Muscle mass according to Bioimpedance Spectroscopy and Calf circumference, From Aug/Sept 2024 to May 2025
Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma
NCT Number: NCT06580054
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck|Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck|Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Interventions: PROCEDURE: Computed Tomography|OTHER: Digital Photography|PROCEDURE: Magnetic Resonance Imaging|BIOLOGICAL: Pembrolizumab
Sponsor: University of Michigan Rogel Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-10-01
Locations: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States

Summary:
This phase II trial studies how well pembrolizumab works in treating patients with orbital (eye socket) and/or periorbital (surrounding the eye socket) cutaneous squamous cell cancer (cSCC) that has spread to nearby tissue or lymph nodes (locally advanced) or has come back after a period of improvement (recurrent). Skin cancers that are close to the eye or on the eyelid often have more genetic (heredity) changes than other types of cancers. This means that the deoxyribonucleic acid (DNA) (the building blocks of the body that determine such things as the color of the hair) in tumor tissue has been altered compared to normal tissue. It is thought cancer cells with these DNA changes are more likely to respond to a type of drug called immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for patients with recurrent or metastatic cSCC not amenable (responsive) to cure by surgery or radiation. Giving pembrolizumab may work better in treating patients with locally advanced or recurrent orbital and/or periorbital cSCC.

Primary Outcome Measures: Objective response rate, Will be calculated from the tumor partial and complete responses based on immune-related Response Evaluation Criteria In Solid Tumors. Will be reported with exact 95% binomial confidence intervals., Up to 2 years
Secondary Outcome Measures: Globe preservation, To assess the globe preservation rate among patients. External and slit lamp photography will be obtained during the Ophthalmic exams, Up to 2 years|Time to progression, Up to 2 years
Precision Care for Major Depressive Disorder
NCT Number: NCT06580041
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Major Depressive Disorder|Depression|Depressive Disorder, Major
Interventions: DRUG: Pramipexole|DRUG: Methylphenidate|DRUG: Phenelzine|BEHAVIORAL: Mindfulness-based Stress Sensitivity Therapy (MBSST)|BEHAVIORAL: Complicated Grief Treatment (CGT)|OTHER: Care as usual (CAU) plan
Sponsor: University of California, San Francisco
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-09-01
Locations: Nancy Friend Pritzker Psychiatry Building, University of California, San Francisco, San Francisco, California, 94107, United States

Summary:
This study aims to assess whether phenotyping-guided intervention selection is superior to intervention selection without phenotyping guidance (i.e., routine clinician and patient judgment regarding treatment selection) for depression.

Primary Outcome Measures: Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score, Within-phenotype and across-phenotype contrasts., Up to 24 weeks after randomization.
Secondary Outcome Measures: Snaith-Hamilton Pleasure Scale (SHAPS) score, For anhedonia phenotype only., Up to 24 weeks after randomization.|Clinically Useful Depression Outcome Scale Anxious Distress Specifier Subscale (CUDOS-A) score, For anxious distress phenotype only., Up to 24 weeks after randomization.|Generalized Anxiety Disorder 7-item (GAD-7) score, For anxious distress phenotype only., Up to 24 weeks after randomization.|Inventory of Complicated Grief (ICG) score, For grief phenotype only., Up to 24 weeks after randomization.|Perceived Deficits Questionnaire - Depression (PDQ-D) score, For cognitive deficits phenotype only., Up to 24 weeks after randomization.|Patient Health Questionnaire - 8 (PHQ-8) score, Within-phenotype and across-phenotype contrasts., Up to 24 weeks after randomization.|WHO Disability Assessment Schedule (WHODAS 2.0), Within-phenotype and across-phenotype contrasts., Up to 24 weeks after randomization.|Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) response, 50% reduction from baseline score. Within-phenotype and across-phenotype contrasts., Up to 24 weeks after randomization.|Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) remission, Score \< 6. Within-phenotype and across-phenotype contrasts., Up to 24 weeks after randomization.
Repurposing Riluzole for Cancer-Related Cognitive Impairment: a Pilot Trial
NCT Number: NCT06580002
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Sponsor: University of California, Irvine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09

Summary:
This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels of breast cancer survivors with cancer related cognitive impairment.

Primary Outcome Measures: Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in breast cancer survivors experiencing cognitive impairment (CRCI), Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at the midpoint, and at the endpoint of the study., 8 weeks
Secondary Outcome Measures: Cognitive Function Scores (FACT-Cog), Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) scores, including both cumulative and perceived cognitive impairment scores. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes., 8 weeks|Cognitive Function Scores (CANTAB), The study will assess the effects of riluzole on cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB) scores across five cognitive domains. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes., 8 weeks
Multimodal High-frequency Ultrasound-based Study of Plaque Psoriasis Severity Index
NCT Number: NCT06579976
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Plaque Psoriasis
Interventions: OTHER: No intervention
Sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-05-01
Locations: Shanghai Yueyang Integrated Medicine Hospital, Shanghai, Shanghai, 200080, China

Summary:
Psoriasis (PsO) is a common chronic relapsing inflammatory disease, induced by a combination of genetic and environmental effects, which seriously affects the quality of life of patients.Psoriasis Area and Severity Index（PASI score ） ，as the most common method used by clinicians to assess the severity of psoriasis and the effectiveness of treatment, has the disadvantage of being subjective and superficial.We are therefore committed to establishing an objective, real-time, repeatable, non-invasive, microscopic assessment using high-frequency ultrasound. This study will use high-frequency ultrasound to detect the patient's lesion site and the 2cm site next to the lesion once, and the study will continue to recruit for 6 months.

Primary Outcome Measures: High Frequency Ultrasound, epidermal thickness (unit mm) detected by Grayscale ultrasound, Measurement of the patient's lesion and non-lesion areas were taken once 1 day|High Frequency Ultrasound, dermal thickness (unit mm) detected by Grayscale ultrasound, Measurement of the patient's lesion and non-lesion areas were taken once 1 day|High Frequency Ultrasound, hypoechoic cord thickness between epidermis and dermis (unit mm) detected by Grayscale ultrasound, Measurement of the patient's lesion and non-lesion areas were taken once 1 day|High Frequency Ultrasound, epidermal echo intensity detected by Grayscale ultrasound, Measurement of the patient's lesion and non-lesion areas were taken once 1 day|High Frequency Ultrasound, dermal echo intensity detected by Grayscale ultrasound, Measurement of the patient's lesion and non-lesion areas were taken once 1 day|High Frequency Ultrasound, clarity of the boundary between dermis and subcutaneous tissue detected by Grayscale ultrasound, Measurement of the patient's lesion and non-lesion areas were taken once 1 day|High Frequency Ultrasound, blood flow signal (pcs) detected by Color Doppler imaging, Measurement of the patient's lesion and non-lesion areas were taken once 1 day|High Frequency Ultrasound, blood flow signal (pcs) detected by Power doppler imaging, Measurement of the patient's lesion and non-lesion areas were taken once 1 day
Secondary Outcome Measures: Localized PASI, Same scoring criteria as PASI scores without area factors., Measurement of the patient's lesion areas were taken once 1 day
Disposable Versus Disposable Nephroscope During PCNLs: a Feasibility RCT
NCT Number: NCT06579924
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stone, Kidney
Interventions: PROCEDURE: Disposable mini-PCNL|PROCEDURE: Re-usable mini-PCNL
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-04-30
Locations: Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510230, China

Summary:
A feasibility randomised controlled trials comparing re-usable versus disposable nephroscope when treating kidney stones during mini-PCNLs

Primary Outcome Measures: Stone free rate, ability of used scope in determining a complete stone clearance, or absence of clinically significant residual fragments, 90 days post-op
Secondary Outcome Measures: complication rate, presence of post-operative complications according to Calvin-Dindo classification system, 30 days post-op|adequacy of used instrument, adequacy of instruments (including failure, quality of view, handling) will be tested, intra-operative assessment
Combining High-frequency Micro-ultrasound and Multiparametric MRI Target Biopsy for Detecting Prostate Cancer
NCT Number: NCT06579911
Acronym: Biopsy29
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostatic Neoplasm of Uncertain Behavior
Sponsor: Salzburger Landeskliniken
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-11-01
Completion Date: 2026-01-01

Summary:
\*\*Study Goal:\*\* The purpose of this clinical trial is to determine if combining high-frequency micro-ultrasound with multiparametric MRI biopsy and a systematic biopsy can better detect clinically significant prostate cancer compared to current standard methods. This study is aimed at men who may have prostate cancer.

\*\*Main Questions the Study Aims to Answer:\*\*

1. Does the combination of new biopsy methods detect more clinically significant prostate cancers than the current standard method?
2. Does the new method not increase the detection of less serious forms of cancer beyond what the standard method detects?

\*\*Participation in the Study:\*\*

Participants in this study will undergo the following procedures:

* A high-frequency micro-ultrasound examination of the prostate.
* A multiparametric MRI-targeted biopsy of the prostate.
* A systematic biopsy of the prostate.

\*\*Comparison Group:\*\* Researchers will compare the new combination method with the current standard method to see if the new approach is more effective.

\*\*Participants will:\*\*

* Undergo several exams and biopsies depending on the results of previous tests.
* Attend regular follow-up appointments to monitor potential side effects and evaluate prostate health.
* Record their experiences and any symptoms in a diary.

Primary Outcome Measures: Detection of Clinically Significant Prostate Cancer via Prostate Biopsy, This measure assesses whether participants have clinically significant prostate cancer (Gleason Score Sum ≥ ISUP 2) based on biopsy results, recorded as "yes" or "no"., 2 Weeks
Secondary Outcome Measures: Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy, This measure evaluates whether participants have clinically insignificant prostate cancer (Gleason Score Sum = ISUP 1) based on biopsy results, also recorded as "yes" or "no"., 2 Weeks
Ocular Complications of Mpox in the DRC
NCT Number: NCT06579885
Acronym: MPOX-EYE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Monkeypox|Mpox (Monkeypox)
Sponsor: Institute of Tropical Medicine, Belgium
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-06-29

Summary:
This is an observational study in which patients diagnosed with mpox will be enrolled, will undergo standard ophthalmological examinations of their eyes to see if there are any complications of mpox. The study will primarily assess the presence of ophthalmological signs and symptoms at enrollment.

Primary Outcome Measures: Composite presence or absence of eye disease and visual deficiencies at presentation, Composite presence of

* orbital lesions (exophthalmos, enophthalmos, oculomotor paralysis...)
* affection of the adnexa
* affection of the anterior segment
* affection of the posterior segment
* affection of the optic nerve, At enrollment
Secondary Outcome Measures: Ocular signs & symptoms at presentation and during follow-up, Presence or absence of individual symptoms and signs over time, From enrollment until last follow-up|Visual acuity at presentation and during follow-up, Result of Optotype letters/numbers and/or E test over time, From enrollment until last follow-up|presence of MPXV in tear fluid at presentation and during follow-up, Result of MPXV-PCR on conjunctival swabs over time, From enrollment until last follow-up
Association Between Cardiopulmonary Function, Mobility in Patients With Chronic Obstructive Pulmonary Disease
NCT Number: NCT06579872
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: OTHER: plantar pressure
Sponsor: Fu Jen Catholic University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2024-12-31
Locations: Fu Jen Catholic University Hospital, Fu Jen Catholic University, New Taipei City, 24352, Taiwan

Summary:
It aims to understand the differences in everyday mobility and activity capabilities among patients with varying disease progression and severity, to serve as reference indicators for evaluating the effectiveness of pulmonary rehabilitation exercise training.

Primary Outcome Measures: plantar pressure, The correlation between foot pressure indices and functional tests, 20 minutes
Secondary Outcome Measures: cardiopulmonary function, The correlation between foot pressure indices and cardiopulmonary function, 20 minutes|self-feedback questionnaires, The correlation between foot pressure indices and self-feedback questionnaires, 20 minutes
Development of a Registry to Assess Natural History in Duchenne Muscular Dystrophy
NCT Number: NCT06579859
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Duchenne Muscular Dystrophy
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2026-11-01
Locations: ASL LANCIANO VASTO CHIETI, Laboratorio di Patologie Neuromuscolari del Centro di Riferimento Regionale per le Malattie Neuromuscolari, Chieti, Ch, 66100, Italy|ASST Grande Ospedale Metropolitano Niguarda, Centro Clinico Nemo Milano, Milano, MI, 20162, Italy|Azienda Ospedaliera Universitaria "G. Martino"UOC di Neurologia e Malattie Neuromuscolari, Messina, 98125, Italy|Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC NEMO Pediatrico, Roma, 00168, Italy

Summary:
Duchenne muscular dystrophy is a rare progressive X-linked neuromuscular disease, caused by mutation in the dystrophin gene, leading to progressive muscle degeneration, loss of specific functional milestones, severe respiratory and cardiac impairment. Improved standards of care and the regular early use of glucocorticoid treatment have changed the natural history of the disease, affecting both survival and the time of loss of functional milestones. More recently, there has been increasing evidence of an additional benefit from new therapeutical approaches based on mechanisms targeting specific type of mutation; therefore, it has become mandatory to obtain more detailed long-term information about the patterns of progression related to different genotypes. The aim of this project is to better define the natural history of Duchenne musculare Dystrophy patients and to understand clinical and motor functional trajectories defining a more specific genotype/phenotype characterization according to the type of mutation.

Primary Outcome Measures: integrate existing datasets, To integrate the existing datasets including 3 year follow up data of ambulant Duchenne patients with new patients having at least 3 year follow up and with further follow up achieved after the study was completed. The dataset will also include data on non ambulant patients, 3 years|Develop structurate Case Report Form, To develop a structured electronic Case Report Form that will include all the functional data such as 6 Minute Walking Test ( no scaled) , North Star Ambulatory Assesment ( scale 0-34), timed items ( not scaled) , Performance Upper Limb (0-42) collected as part of the clinical routine and other clinical and genetic variables routinely collected and available from clinical notes.

To transfer the existing data to the newly developed Case report form, 3 years|analyse clinical data, To analyse 3 years data follow up in the original cohort and in all those who have more than 3 year follow up

In patients who lost ambulation during the study, their retrospective functional data will be analysed looking for possible prognostic indicators at one, two and three years before loss of ambulation, 3 years
Histotripsy (HistoSonics®) for Liver Tumours
NCT Number: NCT06579833
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Liver Tumour
Interventions: RADIATION: Histotripsy
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2028-09-01
Locations: The University of Hong Kong, Hong Kong, 0000, Hong Kong

Summary:
Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue. This study will enrol 20 patients with liver tumours (be it primary or secondary liver tumours), monitor their post-operative adverse events, and study the changes in tumour size and volume after treatment. Histotripsy will be performed under general anaesthesia, with real-time monitoring by ultrasound, and deliver high-intensity ultrasound waves in single session or multiple sessions. Similar to other minimal invasive treatments, patients will be admitted 1 day prior, then receive Histotripsy on the next day and stay overnight for observation. Patients will be discharged on the 3rd day if unremarkable. During the hospital stay, blood samplings will be taken for evaluation around 2-4 times in total depending on the length of hospital stay.

Primary Outcome Measures: Changes in tumour features, Changes in tumour size and volume before and after intervention, up to 36 months|Post procedure adverse events and complication, Post procedure adverse events and complication, The whole duration of hospital stay, normally 3 days on average
Effect of Tubular Bandage Application on Peripheral Intravenous Catheter Usage Time and Infiltration in Children
NCT Number: NCT06579820
Acronym: chıldren
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child, Only
Interventions: COMBINATION_PRODUCT: tubular bandage
Sponsor: Istanbul University
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-02-10
Completion Date: 2024-12-30
Locations: Istanbul University, Istanbul, Fatih, Turkey|Istanbul Unıversity, Istanbul, Turkey

Summary:
In pediatric patients, placement of peripheral intravenous catheters is the most commonly performed invasive medical procedure. In addition to the administration of medications, parenteral nutrition, intravenous fluids, and blood products, peripheral intravenous catheters are placed prophylactically before procedures and for emergency use in unstable patients.

One of the most common complications of peripheral intravenous catheters is infiltration. Infiltration is a vascular trauma resulting from a lesion in the vascular layers and subsequent perforation, resulting in the leakage of medications or non-vesicant solutions into the tissues surrounding the site of placement of the peripheral venous catheter.

In pediatric patients, physical factors (e.g. hyperactivity, sweating), tight fixation (may affect blood circulation and iatrogenic skin injury), loose fixation (may cause peripheral intravenous catheter displacement and infection), poor-quality fixation (may cause unplanned removal and skin injuries due to pressure), etc. causes more peripheral intravenous catheter fixation problems in pediatric patients than in adult patients Additional fixation products may be effective in preventing dislocation and micromotion in an active pediatric patient. However, limited recommendations regarding medical adhesive tapes and additional fixation products are guided only by low-evidence studies. The purpose of this study was to determine the effect of tubular bandage use on the duration of pediatric peripheral intravenous catheter use and the incidence of infiltration.

Primary Outcome Measures: pediatric peripheral infiltration scale, information collection form, The effect of tubular bandage on infiltration and catheter use time in children will be analyzed., about a year
Radiomics for Preoperative Jaw Cyst Differentiation: A Multicenter ML Study
NCT Number: NCT06579768
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Jawbone Cysitc Lesion
Interventions: DIAGNOSTIC_TEST: different types of computed tomography (CT) scans
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators: Hospital of Stomatology, Wuhan University|Stomatological Hospital, Southern Medical University|Second Affiliated Hospital, School of Medicine, Zhejiang University|Xiangya Hospital of Central South University|Air Force Military Medical University, China|The People's Hospital Of QianNan|Central South University|Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University|Hospital of Stomatology, Sun Yat-Sen University|First Affiliated Hospital of Xinjiang Medical University|Guangxi Medical University College of Stomatology
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-01-01
Locations: Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Guangzhou, Guangdong, 510120, China

Summary:
This study focuses on jawbone cystic lesions, including odontogenic tumors like ameloblastoma and various cysts. Treatment approaches differ; ameloblastomas often require surgical excision due to potential recurrence and metastasis, while cystic lesions may be treated with curettage and marsupialization. Accurate preoperative diagnosis is crucial for optimal treatment outcomes, as inappropriate choices can lead to delayed treatment or overtreatment, affecting patient quality of life. Currently, there is no standard protocol for differential diagnosis, highlighting the need for a predictive diagnostic model.

The study will be a multicenter, prospective machine learning research involving 300 patients across 12 centers. It aims to enhance a previously developed predictive model that integrates machine learning with CT radiomics. Patients will be grouped based on imaging modalities, with data processed uniformly to improve diagnostic predictions. Inclusion criteria ensure comprehensive preoperative data, while exclusion criteria eliminate incomplete or previously treated cases. The study seeks to optimize the model's performance and provide valuable clinical insights.

Primary Outcome Measures: Statistical Analysis Metrics for Machine Learning Model Predictions, Area Under the ROC Curve，Accuracy，Sentivity，Specificity..., 2025.06-2026.01
A Clinical Trial to Examine the Efficacy of a Supplement to Support Healthy Hair and Skin
NCT Number: NCT06579742
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hair Thinning|Hair Loss
Interventions: DIETARY_SUPPLEMENT: Live Conscious Beyond Collagen|DIETARY_SUPPLEMENT: Placebo
Sponsor: Scale Media Inc
Collaborators: Citruslabs
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-07
Completion Date: 2024-12-31
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This is a triple-blinded, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of Scale Media's Live Conscious Beyond Collagen supplement on overall hair and skin health. The study will involve 50 male or female participants aged 40 and over who have self-perceived hair thinning and shedding. The trial will last for 24 weeks and includes the completion of questionnaires and photo submissions at specific time points.

Primary Outcome Measures: Change in Hair Density and Hair Volume, Hair health will be assessed through expert dermatologist grading and participant questionnaires to measure changes in hair density and hair volume over the course of the study., Baseline, Month 3, and Month 6
Secondary Outcome Measures: Change in Skin Health (Fine Lines, Wrinkles, Texture, and Elasticity), Skin health will be evaluated using participant self-reported questionnaires and expert dermatologist grading to assess changes in fine lines, wrinkles, skin texture, elasticity, brightness, radiance, firmness, and roughness over the course of the study., Baseline, Month 3, and Month 6
Dietary Intervention for Low Free Sugars in Children With Non-alcoholic Fatty Liver Disease
NCT Number: NCT06579729
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: NAFLD|Low-free Sugar Dietary|Child Obesity
Interventions: BEHAVIORAL: Dietary intervention for low free sugars
Sponsor: China Medical University, China
Sex: ALL
Age: CHILD
Enrollment: 146
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2018-10-01
Completion Date: 2022-04-01
Locations: China Medical University, Shenyang, China

Summary:
A 48-week dietary intervention program was conducted in children aged 5-14 years with a diagnosis of NAFLD, who were randomized into a low free sugar diet group and a regular diet group. The primary objective of this study is to determine whether a low free sugar dietary intervention program improves liver function, fasting glucose, fasting insulin, lipid profile and hepatic steatosis in children with NAFLD. The effects of the intervention will be analyzed and compared at weeks 12, 24 and 48.

Primary Outcome Measures: NAFLD, NAFLD was diagnosed using liver ultrasonography with a Phillip IU Elite color Doppler ultrasound after a fasting period to reduce gastrointestinal interference., At weeks 1, 12 and 24|Dietary, The dietary habits of the subjects were evaluated by a semi-quantitative Food Frequency Questionnaire (FFQ), which was recalled over the past month and included food items, frequency, and amount of intake. The FFQ used in this study covered 72 food items from 11 food groups and 4 frequency categories, including 'average daily, weekly, monthly intake or hardly eat'., At weeks 1, 12 and 24|Physical activity level, Physical Activity Questionnaire for Children (PAQ-C) was answered by subjects. The PAQ-C reflects the overall physical activity level of children in the past 7 days.The scale consists of 10 items, .and a 1-5 scale was used to obtain a total score by summing the scores of the individual items. The PAQ-C scale scores \< 2.33 defined as low physical activity levels, 2.33-3.66 as moderate physical activity levels, and \>3.66 as high physical activity levels., At weeks 1, 12 and 24
Secondary Outcome Measures: Height, Height was measured using Height Measuring Ruler (Selcom, Germany) ., At weeks 1, 12 and 24|Body weight, Body weight was measured using Body Composition Analyzer (DC-13, Parade, Japan)., At weeks 1, 12 and 24|BMI, BMI (kg/m2) = body weight (kg)/height2 (m2)., At weeks 1, 12 and 24|Waist circumference, Waist circumference was measured with circumference measuring tape., At weeks 1, 12 and 24|Waist-to-height ratio, Waist-to-height ratio (WHtR) = waist circumference (cm)/height (cm)., At weeks 1, 12 and 24|Blood pressure, Blood pressure was measured using an Omron electronic blood pressure monitor (HBP-1300)., At weeks 1, 12 and 24
Ketorolac for Acute Vaso-Occlusive Crisis in Pediatric Sickle Cell Disease
NCT Number: NCT06579703
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Sickle Cell Disease|Sickle Cell Crisis|Veno-occlusive Disease
Interventions: DRUG: Ketorolac
Sponsor: Children's Blood and Cancer Center at Dell Children's Medical Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2028-02-15

Summary:
Pediatric patients who present with acute vaso-occlusive pain crisis may have equivalent pain reduction scores at lower dosing of intravenous Ketorolac compared to standard dosing of 0.5 mg/kg/dose IV (\<16yo max 15mg, \>16yo max 30mg) x 1 dose.

Primary Outcome Measures: FACES Pain Scale-Revised(FPS-R), Has a range from 0 to 10 possible. 0 to 3 mild pain, 4 to 6 moderate pain, 7 to 10 severe pain., Assessed before dose of pain medication and 30 minutes post-dose
Use of Preoperative Sodium Bicarbonate Among Women With Obstructed Labor
NCT Number: NCT06579690
Acronym: SoBicOL-II
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Obstructed Labor
Interventions: DRUG: 8.4% sodium bicarbonate solution|OTHER: 0.9% Normal Saline
Sponsor: Busitema University
Collaborators: University of Liverpool|Oslo University Hospital|Cures Within Reach|Open Philanthropy
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 280
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-06-30

Summary:
The goal of this clinical trial is to determine a universal safe and effective dose of sodium bicarbonate for use among women with Obstructed labour to treat acidosis. It will also learn about the safety of sodium bicarbonate drug among women with Obstructed labour.

Researchers will compare sodium bicarbonate drug to normal saline (a look-alike solution) to see if sodium bicarbonate works to treat acidosis.

Participants will receive sodium bicarbonate solution or a placebo up to two doses, four hours apart.

Primary Outcome Measures: Mean change in maternal pH from baseline in each group, At baseline, 30, 60, 90, 120 and 150 minutes|Mean umbilical blood pH in each arm of the study, At baseline, 30, 60, 90, 120 and 150 minutes
Secondary Outcome Measures: Mean lactate in maternal and umbilical blood,, At baseline and at birth.|Number of early neonatal deaths, Within 7 days|Safety of sodium bicarbonate (comparison of the proportion of participants that get side effects in each arm), Within 24 hours after administration of the drug|Number of mothers that get primary postpartum hemorrhage, Within 24 after birth
Nailfold Capillaroscopic Pattern Changes and Its Correlation with Interstitial Lung Disease (ILD) in Systemic Sclerosis (SSc) Patients.
NCT Number: NCT06579651
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Systemic Sclerosis (SSc)
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-11

Summary:
Detection of different pattern of nail fold capillary changes in SSc patients. Correlation of nail fold capillary changes in SSc patients with ILD.

Primary Outcome Measures: Nail fold capillary pattern changes in SSc patients, baseline