pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Mapping Diabetes in Quebec: Validating Medico-administrative Algorithms for Type 1 Diabetes, Type 2 Diabetes and LADA
NCT Number: NCT06573905
Acronym: VDA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes Mellitus, Type 1|Diabete Type 2|Diabetes;Adult Onset|Diabetes, Autoimmune
Interventions: OTHER: no intervention
Sponsor: Universite du Quebec en Outaouais
Collaborators: McGill University|Centre de Recherche du Centre Hospitalier de l'Université de Montréal|University Hospital, Angers
Sex: ALL
Age: CHILD, ADULT
Enrollment: 17271
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2025-06-30
Locations: Philippe Corsenac, Montréal, Quebec, J8X 3X7, Canada

Summary:
The goal of this observational study is to validate medico-administrative algorithms that classify diabetes phenotypes (Type 1, Type 2, and Latent Autoimmune Diabetes in Adults - LADA) in a population-based cohort in Quebec, including children, adolescents, and young adults up to 40 years old with diagnosed diabetes. The main questions it aims to answer are:

Can these algorithms accurately distinguish between Type 1, Type 2, and LADA across different age groups? What is the prevalence and incidence of each diabetes phenotype in Quebec? Participants will have their medical and administrative data analyzed, including data on medication usage and healthcare visits, to validate the accuracy of the algorithms. The study will involve comparing these algorithm-based classifications with clinical diagnoses or self-reported data to ensure reliability.

Primary Outcome Measures: Accuracy of Medico-Administrative Algorithm Classification, The primary outcome measure is the accuracy of the medico-administrative algorithms in correctly classifying participants into one of the following diabetes phenotypes: Type 1, Type 2, LADA, or Other Phenotypes, compared to clinical or self-reported diagnoses.

* Sensitivity (Se)
* Specificity (Sp)
* Prevalence (P)
* Positive Predictive Value (VPP)
* Negative Predictive Value (VPN)
* True Positives (VP)
* True Negatives (VN)
* False Negatives (FN)
* False Positives (FP)
* Likelihood Ratios (LR): Positive Likelihood Ratio (LR+); Negative Likelihood Ratio (LR-), Retrospective data from 1997 to 2024
Secondary Outcome Measures: Prevalence and Incidence of Each Diabetes Phenotype, The secondary outcome measure involves calculating the prevalence and incidence rates of each diabetes phenotype (Type 1, Type 2, LADA, and Other Phenotypes) within the study population.

Prevalence (P): This measure will determine the proportion of individuals in the population who have each specific diabetes phenotype at a given point in time.

Incidence: This measure will calculate the rate at which new cases of each diabetes phenotype occur in the population over the study period.

These calculations will provide insights into the distribution and emergence of different diabetes phenotypes within the Quebec population from 1997 to 2024, allowing for a better understanding of disease patterns and informing public health strategies and resource allocation., Retrospective data from 1997 to 2024
The Gut Microbiome in Chronic Heart Failure
NCT Number: NCT06573892
Acronym: GMCHF
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: DIETARY_SUPPLEMENT: Probiotic|DIETARY_SUPPLEMENT: Placebo
Sponsor: Nazarbayev University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-01
Completion Date: 2025-10-31
Locations: Heart Center, Astana, 010000, Kazakhstan

Summary:
there are numerous studies, most of which are predominantly associative in nature, investigating the association between the gut microbiota and various pathologies. However, to establish a causal relationship between microbiome composition and chronic heart failure (HF), clinical studies are needed, particularly using probiotics that can modify the composition and function of the gut microbiota. Examining their effects on HF can help understand which specific changes are associated with improvement or slowing the progression of the disease. The gut microbiome plays an important role in regulating the immune system and inflammatory processes. Investigating the impact of probiotics on these mechanisms may reveal their potential anti-inflammatory and immunomodulatory properties, which can be beneficial for controlling the inflammation characteristic of HF. Additionally, studying the interaction of probiotics with other medications, such as antihypertensive and diuretic agents, can be crucial for optimizing pharmacotherapy in HF patients. Confirming the role of the gut microbiota in the pathogenesis of HF and further developing probiotic therapy may lead to improved prognosis and treatment outcomes for HF patients. Overall, conducting a clinical study using probiotics in HF has the potential to expand our knowledge of the role of the gut microbiota in this disease and lay the groundwork for the development of new treatment strategies.

Primary Outcome Measures: Gut microbiome, Changes in gut microbiota composition \[Timepoints: baseline, after 3 months of probiotic intake\], 90 days
Secondary Outcome Measures: Frequency of hospitalizations, Frequency of hospitalizations and cardiovascular mortality \[Timepoints: baseline, after 3 months of probiotic intake\], 2 years
A Functional MRI Study: Assessing Brain Function in Post Stoke Patients
NCT Number: NCT06573840
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ischemic Stroke|Stroke|Acute Ischemic Stroke
Interventions: DEVICE: NeuroGlove
Sponsor: NeuroGlove LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-11-10
Completion Date: 2024-11-15

Summary:
This is a prospective, single center, observational clinical study containing two cohorts the healthy cohort and post stroke cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the healthy cohort. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will be enrolled in the post stroke cohort.

Primary Outcome Measures: Brain Function, Evaluate brain function through a functional MRI (fMRI) in both healthy subjects (without history of stroke) and post stroke patients., 2 hours
The Urinary Microbiome and Its Relationship to the Urinary and Serum Metabolome in Healthy Peri- and Postmenopausal Women
NCT Number: NCT06573827
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Urinary Tract Infections
Interventions: DIAGNOSTIC_TEST: Blood and urine sample evaluation
Sponsor: University Hospital Ostrava
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2028-12-31
Locations: University Hospital Ostrava, Ostrava, Moravian-Silesian Region, 70852, Czechia

Summary:
The presented project aims to characterize the microbiome of healthy peri- and postmenopausal women and its correlation with the metabolome of urine and serum.

Primary Outcome Measures: Microbiome alpha-diversity, The number of bacterial species in the urine sample will be assessed., 6 months|Microbiome beta-diversity, Inter-individual variability in the proportion of bacterial species will be assessed., 6 months
Secondary Outcome Measures: Correlation of microbiome alpha-diversity and serum metabolome, The correlation of microbiome alpha-diversity and serum metabolome will be assessed., 6 months
Evaluation of Pain Quality in Young Swimmers Suffering From Myofascial Pain Syndrome Using Lidocaine Phonophoresis
NCT Number: NCT06573775
Acronym: MPS
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain
Interventions: DEVICE: pulsed ultrasound|OTHER: myofascial release|DEVICE: lidocaine phonophoresis
Sponsor: New Ismailia National University
Sex: ALL
Age: CHILD
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-06-05
Completion Date: 2024-07-29
Locations: College of Medicine, Ismailia, 41522, Egypt

Summary:
To evaluate pain quality by pain quality assessment scale (PQAS) using lidocaine phonophoresis on myofascial pain syndrome (MPS) in athletic children.

Primary Outcome Measures: pain quality, pain quality assessment scale with zero indication of better outcome and twenty means the worst outcome, 6 weeks
Secondary Outcome Measures: serum cortisol level, measurement of serum cortisol level, 6 weeks
Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation
NCT Number: NCT06573736
Acronym: S3M-MRI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: DIAGNOSTIC_TEST: Stockholm3
Sponsor: Karolinska Institutet
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-12-31

Summary:
Men meeting local clinical standard of care to undergo a prostate MRI for suspicion of prostate cancer will be included. Blood sample will be drawn on the day of MRI or immediately prior to MRI for measurement of the prostate cancer biomarker Stockholm3. Specifically, the Stockholm3 test will be performed in a retrospective manner and no clinical decisions will be made based on the results. The patients will not receive the results of the Stockholm3 assay. A Stockholm3 score will be reported for each patient.

The primary aim is to show superior specificity of Stockholm3 (at different thresholds) for MRI selection compared to PSA (at different thresholds) (I.e., the proportion of men with a negative Stockholm3 test or a negative PSA test among those with a normal MRI).

Additional aims:

1. To show non-inferior relative sensitivity in detection of csPC of Stockholm3 compared to PSA (The proportion of men with a positive Stockholm3 test (at different thresholds) or a positive PSA test (at different thresholds) among those diagnosed with csPC will be calculated).
2. To evaluate Stockholm3 risk thresholds to determine if it can be used to further reduce MRI, biopsy and Gleason grade group 1 cancers without reducing sensitivity of csPC detection.

Primary Outcome Measures: Abnormal MRI, PIRADS ≥3, From enrollment up to 24 weeks
Secondary Outcome Measures: Clinically significant prostate cancer, Grade group ≥2 prostate cancer, From enrollment up to 24 weeks
Correlation Between Postoperative Pain and Apical Extrusion of Different Irrigation Activation Techniques
NCT Number: NCT06573710
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulpitis - Irreversible
Interventions: DEVICE: sonic activator|DEVICE: LASER activation|DEVICE: Ultrasonic activation|DEVICE: passive irrigation with Endodontic needle
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-02-01
Completion Date: 2024-11
Locations: Ain Shams University, Cairo, Egypt

Summary:
The aim of this clinical trial is :

To evaluate effect of different techniques of irrigant activation:

1. LASER activation
2. sonic activation
3. ultrasonic activation
4. passive needle irrigation

On:

1. Postoperative pain in vital teeth (Randomized controlled trial)
2. Amount of apical extrusion (In vitro study) Participants will describe their preoperative pain and postoperative pain level at fixed time interval Research will compare postoperative pain accompanied with different irrigant activation techniques and correlate it to amount of debris extrusion

Primary Outcome Measures: Evaluation of postoperative pain, visual analogue scale, 8,24,48 hours and one week
Secondary Outcome Measures: Frequency of analgesic intake, number of tablets, 8,24,48 hours and one week
Differences In The Severity Of Diabetic Neuropathy Based On Electromyography In Type 2 Diabetes Mellitus Patients With And Without Comorbidities
NCT Number: NCT06573684
Acronym: DISNEY-T2DM
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Diabetic Neuropathies
Interventions: DIAGNOSTIC_TEST: Electromyography
Sponsor: Universitas Diponegoro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-08-01
Locations: Dr. Kariadi Central General Hospital, Semarang, Central Of Java, Indonesia

Summary:
The goal of this clinical trial is to learn the differences severity level of diabetic neuropathy based on electromyelography in type II diabetic patient with and without comorbidities. The main questions of this study:

1. What is the electromyography result in type II diabetic patient who: has no comorbidities, with hypertension, with hypertension and dyslipidemia?
2. Is there any differences in electromyography result in type II diabetic patient who: has no comorbidities, with hypertension, with hypertension and dyslipidemia?
3. Is there any association between distal latency with nerve conduction velocity in type II diabetic patient with and without comorbidities?
4. Is there any association between distal latency with amplitude in type II diabetic patient with and without comorbidities?
5. Is there any differences on diabetic neuropathy severity based on age, height, and A1C levels in type II diabetic patient with and without comorbidities?

Researchers will collect information based on hospital registry as secondary data of in type II diabetic patient with and without comorbidities. The data consist of demographic data, clinical presentation, laboratory, and electromyography were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.

Primary Outcome Measures: Distal Latency, Distal latency defined as time between stimuli until deflection of Compound Muscle Action Potentials (CMAP) from baseline, Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
Secondary Outcome Measures: Nerve Conduction Velocity, Nerve Conduction Velocity defined as the measurement of axon conduction velocity by dividing space of nerve conduction with time needed, Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear|Amplitude, Amplitude define as the height of first negative deflection of Compound Muscle Action Potentials (CMAP) from baseline, Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
Histiocytosis in Injecting Drug Users
NCT Number: NCT06573671
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Histiocytosis
Interventions: DIAGNOSTIC_TEST: Chitotriosidase|DIAGNOSTIC_TEST: Mass spectrometry|DIAGNOSTIC_TEST: X-ray spectromicroscopy|DIAGNOSTIC_TEST: Fluorescence microscopy|DIAGNOSTIC_TEST: Transcriptomics
Sponsor: Tampere University Hospital
Collaborators: Tampere University|University of Oulu|University of Turku|University of Helsinki
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-29
Completion Date: 2030-12-31
Locations: Tampere University Hospital, Tampere, Pirkanmaa, 33101, Finland

Summary:
The goal of this observational study is to describe a new disease condition of histiocytosis related to injecting drug use, its preconditions, symptoms, signs, findings, and prognosis in a detailed and systematic patient series in one referral center. The main question\[s\] it aims to answer are:

* to find specific histologic features in different tissues to help the differential diagnosis from other histiocytoses
* to describe the value of chitotriosidase activity to screen this condition
* to describe the value of various tissue biopsies in confirming the diagnosis
* to describe the nature of polyvinylpyrrolidone accumulation in tissue macrophages by novel special microscopic techniques
* to find new tandem mass spectrometry methodology to prove polyvinylpyrrolidone accumulation in macrophages
* to show that polyvinylpyrrolidone treatment activates macrophages to histiocytes and causes povidone accumulation within the cells in in vitro experiments
* to evaluate the pathology of macrophage activation to histiocytes by transcriptomics

The patient history will be collected from the data produced by follow-up of cases followed up in a single center. A subgroup of participants will be given an opportunity to sign informed consent to give access to/donate blood and tissue samples to search for techniques to prove polyvinylpyrrolidone storage within histiocytes, and to search for transcriptomics signal(s) in histiocytes.

Researchers will compare blood and tissue samples from the biobank as controls.

Primary Outcome Measures: Frequency of disease manifestations, To describe phenotype, 10 years
Secondary Outcome Measures: Frequency of elevated chitotriosidase activity, Is chitotriosidase activity associated with PVP histiocytosis, 10 years|Mortality, Mortality, 10 years|Microscopic fluorescence positive tissue, Search for fluorescence signal, 10 years|X-ray spectromicroscopy, search for signal within cells, 10 years|Pyrolysis mass spectrometry, search for signal within cells, 10 years|Transcriptomics analysis, Search for abnormalities in cases compared with controls, 10 years
A Phase III Clinical Trial of High-dose Rituximab (500mg/m²) Combined With CHOP Regimen in the Treatment of Male Patient With Newly Diagnosed Advanced DLBCL
NCT Number: NCT06573645
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Lymphoma, Large B-Cell, Diffuse
Interventions: DRUG: Rituximab
Sponsor: Xia Yi
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 428
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-23
Completion Date: 2027-07-12

Summary:
Comparison of MODIFIED progression-free survival (Modified-PFS) in high-dose rituximab (500mg/m²) plus CHOP versus standard-dose rituximab plus CHOP in previously untreated (TN) stage III-IV male DLBCL patients

Primary Outcome Measures: MODIFIED-PFS, To investigate the preliminary anti-tumor efficacy, From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Secondary Outcome Measures: Overall survival (OS), To investigate the preliminary anti-tumor efficacy, From the date of enrollment until the date of death from ant cause, assessed up to 48 months|Complete response rate (CRR), To investigate the preliminary anti-tumor efficacy, Up to 8 cycles (each cycle is 21 days)|Objective response rate (ORR), To investigate the preliminary anti-tumor efficacy, Up to 8 cycles (each cycle is 21 days)
Perioperative TPN Improves Surgical Outcomes
NCT Number: NCT06573632
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Parenteral Nutrition|Major Surgery|Malnutrition
Interventions: DIETARY_SUPPLEMENT: TPN-N7 Baxter
Sponsor: Nepal Medical College and Teaching Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-01
Completion Date: 2023-01-01
Locations: Nepal Medical College Teaching Hospital, Kathmandu, Bagmati, Nepal

Summary:
Preoperative optimization of patients is a well known concept. Not all patients can tolerate feeds and as such TPN is given. TPN given preoperatively and continued postoperatively in selected group of patients can significantly improve the surgical outcomes and lower the morbidity as well as mortality. So the investigators aim to find the impact of TPN in malnutritional surgical patients.

Primary Outcome Measures: studying the effects of TPN on length of hospital stay, comparison of perioperative and postoperative TPN in terms of mean length of stay in days, through study completion, an average of 5years|studying the effects of TPN on mortality, comparison of perioperative and postoperative TPN in terms of number of mortality cases, through study completion, an average of 5years|studying the effects of TPN on complications using grades, comparison of perioperative and postoperative TPN in terms of Clavien-Dindo classification grades, through study completion, an average of 5years|studying the effect of albumin levels on length of hospital stay, comparison of low and normal albumin levels in terms of mean length of stay in days, through study completion, an average of 5years|studying the effect of albumin levels on mortality, comparison of low and normal albumin levels in terms of number of mortality cases, through study completion, an average of 5years|studying the effect of albumin levels on complication using grades, comparison of low and normal albumin levels in terms of Clavien-Dindo Classification grades, through study completion, an average of 5years
Therapeutic Adherence in Patients With Chronic Diseases
NCT Number: NCT06573619
Acronym: GMAS-MCNT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Disease
Interventions: OTHER: Validation of questionnaire
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-08
Completion Date: 2025-01
Locations: Daniele Napolitano, Rome, 00168, Italy

Summary:
Objectives of the study are:

* The validation of the GMAS questionnaire in patients with chronic disease.
* Measurement of the level of therapeutic adherence in patients with chronic illness.
* Measurement of the level of therapeutic adherence in patients with chronic disease undergoing an experimental trial.

Primary Outcome Measures: The validation of the GMAS questionnaire in patients with chronic disease., The validation of the GMAS questionnaire in patients with chronic disease., 1 year
Secondary Outcome Measures: Measurement of the level of therapeutic adherence in patients with chronic illness. Measurement of the level of therapeutic adherence in patients with chronic disease undergoing an experimental trial., Measurement of the level of therapeutic adherence in patients with chronic illness.

Measurement of the level of therapeutic adherence in patients with chronic disease undergoing an experimental trial., 1 year
Ophthalmic Solution in Diabetic Corneal Alteration
NCT Number: NCT06573606
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dry Eye Disease (DED)
Interventions: DEVICE: CX-HA and CS
Sponsor: D&V FARMA srl
Collaborators: San Giovanni Addolorata Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-09-01
Completion Date: 2022-09-01
Locations: San Giovanni-Addolorata Hospital, Rome, 00184, Italy

Summary:
Data analyses and revision of the DED symptoms in diabetic subjects. A novel ophthalmic solution containing cross-linked ha (CX-HA) and Chondroitin sulphate (CS) has been made available on the market.

Both molecules have been widely studied for their viscoelastic and hydrating properties.

Nevertheless, the use of CS in ophthalmology has been limited since, routinely, the molecule is of animal origins.

This new ophthalmic solution is the first on the market formulated with a CS of non-animal origin.

Primary Outcome Measures: TBUT, Tear Breakup Time, 3 months
Secondary Outcome Measures: OSDI, Ocular Surface Disease Index, 3 months|Corneal Sensitivity, measured via the "Luneau Cochet-Bonnet Aesthesiometer", results are expressed in cm, 3 months|Wound Healing, Scratch test performed on cell lines using the "Ibidi Culture-Inserts". The test provides hinds on the ability of a cell line to cover a "wound" created in the monolayer. Results are given as % of the area covered, 30 hours
Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study
NCT Number: NCT06573593
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alopecia Areata|Janus Kinase Inhibitors
Interventions: DRUG: Tofacitinib|DRUG: Baricitinib|DRUG: Ruxolitinib|DRUG: Upadacitinib|DRUG: Abrocitinib|DRUG: Ritlecitinib
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-29
Completion Date: 2026-12-31
Locations: Second Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, 310009, China

Summary:
The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.

Primary Outcome Measures: Mean SALT, Reduction of Severity of Alopecia Tool (SALT) score compared with baseline, at week 24|SALT50, Percentage of patient with more than 50% improvement in SALT score, at week 24|SALT75, Percentage of patient with more than 70% improvement in SALT score, at week 24
Secondary Outcome Measures: Mean SALT, Reduction of Severity of Alopecia Tool (SALT) score compared with baseline, at week 12, 36, 48, 56|SALT50, Percentage of patient with more than 75% improvement in SALT score, at week 12, 36, 48, 56|SALT75, Percentage of patient with more than 50% improvement in SALT score, at week 12, 36, 48, 56|Safety profile, Any adverse events including infection, hypohepatia, thrombus, gastrointestinal reaction and any other system events., at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56
Bioimpedance Analysis for Hemodialysis
NCT Number: NCT06573567
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemodialysis Complication
Interventions: DEVICE: Bioimpedance|DEVICE: Control
Sponsor: Cishan Hospital, Ministry of Health and Welfare
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2026-04-30

Summary:
The goal of this clinical trial is to learn if bioimpedance-guided fluid management can help decrease hemodialysis complications. The main questions it aims to answer are:

Does bioimpedance-guided fluid management decrease major cardiovascular events? Does bioimpedance-guided fluid management decrease other hemodialysis complications?

Participants will:

Take bioimpedance analysis once per month Adjust dry weight according to the analysis as possible in active group Blind the analysis results to the doctor and the patient in the control group

Primary Outcome Measures: Major adverse cardiovascular events, A composite of myocardial infarction, stroke and all-cause mortality, From first bioimpedance analysis done to 1 year later
Secondary Outcome Measures: The number of hemodialysis sessions with intradialytic hypotension, During hemodialysis, systolic blood pressures (SBP) drop to \<90mmHg, excluding those with baseline SBP \<90mmHg, From first bioimpedance analysis done to 1 year later|The number of hemodialysis sessions with intradialytic cramps or postdialytic cramps, Cramps during hemodialysis or later in the hemodialysis day, excluding those who experience cramps on non-hemodialysis day; cramps in both extremities and abdomen are counted, From first bioimpedance analysis done to 1 year later|The number of hemodialysis sessions with pitting edema, Pitting edema is defined as grade 1 or more, From first bioimpedance analysis done to 1 year later|The number of hemodialysis sessions with lung edema, Lung edema is defined as either of the followings:

1. Crackles in lungs, excluding those with overt history or signs of other diseases that cause crackles, such as pneumonia, atelectasis or pleural disease
2. Perihilar or interstitial pattern of infiltrations on chest X ray, From first bioimpedance analysis done to 1 year later|The number of hemodialysis sessions with non-function of arteriovenous shunt, Non-function means absence of thrill or bruit of the shunt, and/or needle could not be placed with adequate blood flow for dialysis; both arteriovenous fistula and graft are considered in this outcome, From first bioimpedance analysis done to 1 year later
Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy
NCT Number: NCT06573554
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Charcot Neuroarthropathy
Interventions: OTHER: Total Contact Cast|OTHER: Posterior Slab
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01
Locations: Department of Endocrinology, PGIMER, Chandigarh, 160012, India

Summary:
Charcot neuroarthropathy (CN) is a condition in diabetic patients characterized by foot swelling, redness, and a temperature difference exceeding 2˚C compared to the other foot. The study compares two treatments: a standard knee-high, non-removable total contact cast (TCC) and a non-removable knee-high walker. Both aim to immobilize and offload the foot to promote healing. The study will involve diabetic patients with specific criteria and exclude those with conditions like foot ulcers or severe kidney issues. Patients will be randomly assigned to one of the two treatments and followed for up to a year. The primary goal is to see how many patients achieve remission within six months, with secondary goals including remission within twelve months, time to remission, quality of life, and foot health. Statistical tests will be used to analyze the data and determine the effectiveness of each treatment. The study aims to improve CN treatment and provide better options for patients.

Primary Outcome Measures: Efficacy of posterior Slab, Proportion of participants achieving active CNO remission with Posterior slab compared to Total contact Cast, 26 weeks
Secondary Outcome Measures: Proportion of participants achieving remission 48 weeks, Proportion of participants achieving remission within a duration of 12 months from randomization,, 48 weeks|Time to achieve remission, Time (in weeks) to achieve remission as defined by dermal thermometry in two arms., 48 weeks|Life Quality, Quality of life (SF-36), 48 weeks|Life Quality 1, Foot Health Status Questionnaire, 48 weeks
Use of Ultrasound in the Initial Management of Patients in Shock in the Nancy Emergency Department
NCT Number: NCT06573541
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Shock
Interventions: DEVICE: Use of ultrasound
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2025-10-31
Locations: CHRU, Nancy, France

Summary:
Context: shock is a serious pathology where diagnostic and therapeutic speed determines the prognosis, ultrasound can be a valuable aid for the emergency physician to differentiate the different types of shock and allow appropriate treatment.

Hypothesis: what are the uses of ultrasound in the initial diagnostic and therapeutic management of patients in shock at the Emergency Department of Nancy? Main outcome: Describe the use of ultrasound in the initial diagnostic and therapeutic management of patients in shock at the Nancy Emergency Department Secondary outcome: Study the contribution of the use of different ultrasound techniques in the initial diagnostic and therapeutic management of patients depending on the type of shock state

Primary Outcome Measures: rate of ultrasound use, use of different types of ultrasound or not for diagnostic and therapeutic purposes depending on the type of shock state, Day 0
Secondary Outcome Measures: rate of patients with care changes, changes in initial diagnostic and therapeutic management when an ultrasound technique is used compared to patients who did not benefit from it (duration of passage to ED and treatment, time until diagnosis, vascular filling rate, catecholamine utilization rate), Day 0
Platelet Rich Plasma Combined With Platelet Rich Fibrin in Management of Temporomandibular Joint Osteoarthritis
NCT Number: NCT06573502
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis
Interventions: COMBINATION_PRODUCT: Prp with prf or prp or prf
Sponsor: Aliaa Babekir Ahmed Mohamed
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-29
Completion Date: 2025-07-23

Summary:
Studying effectiveness of prp with prf comparing with prp or prf for mangement of tmj osteoarthritis as result in pain and mandibular movement in adult pt

Primary Outcome Measures: Pain severty, Vas measure for pain most sever pain take 10 minimum pain take 0, 6 months
Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial
NCT Number: NCT06573489
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Drug Safety
Interventions: DRUG: Fospropofol|DRUG: Propofol
Sponsor: Hui Xu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 373
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2026-07-01

Summary:
This protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery. The study has three main objectives: First, to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia; Secondly, to evaluate the efficacy and safety of fospropofol disodium in the maintenance phase of general anesthesia, and to determine its effective dose range; Finally, the effects of fospropofol disodium on Bispectral Index during induction, maintenance and recovery were studied, and compared with propofol to understand its characteristic changes. The randomized, single-blind, controlled design of the study, with an expected enrollment of 373 patients, was designed to achieve its objectives through a three-phase trial design to provide important clinical information about the safety and efficacy of the use of propofol disodium.

Primary Outcome Measures: Incidence of perioperative hypotension, Incidence of hypotension throughout perioperative period, From the beginning to the end of surgery|Incidence of injection pain, Incidence of perceived injection pain during anesthesia induction, During induction of anesthesia
Secondary Outcome Measures: Glomerular filtration rate, The patients' glomerular filtration rate, First day after surgery|Eeg dual frequency exponential waveform, Eeg dual frequency index waveform during operation, From the beginning to the end of surgery|Urea nitrogen, Blood level of urea nitrogen, First day after surgery|Creatinine, Blood level of creatinine, First day after surgery
Addressing Racial Disparities in Opioid Overdose Using Peer Recovery Coach Training and mHealth Platform
NCT Number: NCT06573476
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder
Interventions: BEHAVIORAL: PRC supported text + AI driven CSDH-enhanced text|BEHAVIORAL: AI driven CSDH-enhanced text only|BEHAVIORAL: Treatment as Usual (TAU)
Sponsor: Friends Research Institute, Inc.
Collaborators: Nathan Kline Institute for Psychiatric Research|NYU Langone Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-12-01
Completion Date: 2027-06-01

Summary:
The study aims to adapt an existing Cultural Structural Humility (CSH) training into a video format for peer recovery coaches (PRCs) and refine an AI-driven texting tool to reinforce the training. After refining these tools using user-centered design, a pilot test will be conducted to assess their impact on the uptake of opioid treatment and social services. The study will also evaluate the feasibility and effectiveness of the intervention to inform future large-scale trials.

Primary Outcome Measures: Estimated Rate of PRC-PWUO Contact, The number of contacts between Peer Recovery Coaches (PRC) and People Who Use Opioids (PWUO), measured through communication logs., 3 months|Rate of AI-Driven Texting Use Among PWUO, The frequency of AI-driven text interactions initiated by PWUO, captured through software logs., 3 months|Change in Felt and/or Anticipated Stigma, The change in felt and/or anticipated stigma pre- and post-intervention, measured by a validated stigma assessment questionnaire., 3 months|Amount of time to Initial Receipt of Buprenorphine (Self-Reported), The time (in days) to the initial receipt of buprenorphine, as self-reported by participants., 3 months|The Amount of Self-Reported Social Services Use, The self-reported utilization of social services at baseline, 1 month, and 3 months, addressing social determinants of health (SDH) to assess intervention effect sizes., 3 months|Cost (Amount of Money) of Implementing and Sustaining the Multimodal Intervention, The associated cost of implementing and sustaining the multimodal intervention, including cost-per quality-adjusted life year (QALY) and cost-per opioid use disorder (OUD) treatment days., 3 months
Secondary Outcome Measures: The Amount of Participants That Retain in Treatment, The number of participants continuously retained in buprenorphine treatment over a 12-week period, assessed at the 12-week mark., 3 months
Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers
NCT Number: NCT06573463
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premature Tooth Exfoliation
Interventions: DEVICE: Prefabricated band and loop|DEVICE: Conventional Band and loop
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-12-01
Completion Date: 2025-10
Locations: Cairo university, Cairo, Egypt

Summary:
To assess the longevity of prefabricated versus conventional band and loop space maintainers in children with prematurely lost first primary molars.

A Randomized Clinical Trial

Primary Outcome Measures: Gingival Health, By using gingival index of Loe and Silness ,scores gingival inflammation from 0-3

0 = normal gingiva

1. = mild inflammation: slight change in color, slight edema, no bleeding on probing
2. = moderate inflammation: redness, edema, glazing, or bleeding on probing
3. = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, 3 month and 9 month|Cement integrity, Visual inspection of cement solution by using blunt periodontal explorer and mirror, Binary (Yes, No), 3 month and 9 month
Secondary Outcome Measures: Space loss between the abutment teeth., Change in distance measured on digital cast between the mesial midpoint of the second deciduous molar and the distal midpoint of the primary canine in mm., 0 month and 9 month|Change in arch dimension:, 1. Arch perimeter: Measured on digital cast as a sum of the incisor, canine and molar segment widths in mm.
2. Inter canine width : Measured on digital cast from cusp tip of canine on one side to cusp tip of canine on the other side in mm.
3. Intermolar width: Measured on a digital cast from central fossa of the second primary molar on one side to central fossa of the second primary molar on the other side in mm., 0 month and 9 month
Exhaled Breath Condensate Biomarkers in CARAS
NCT Number: NCT06573450
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Combined Allergic Rhinitis and Asthma Syndrome
Interventions: OTHER: questionnaire survey
Sponsor: Henan University of Traditional Chinese Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-01
Completion Date: 2025-05-30
Locations: The First Affiliated Hospital of Henan University of Chinese Medicine, Henan, Zhengzhou, China

Summary:
To explore the differences in the expression of biomarkers in different sample types between the healthy population and different subgroups of the disease, and to screen for potential biomarkers in a more simple, direct and objective way. To screen the biomarkers that can be identified by CARAS Chinese medicine symptoms and different stages, and to provide a reference basis for individualised diagnosis and treatment of the disease.

Primary Outcome Measures: Interleukin-2、4、5、13 (IL-2、4、5、13), Airway inflammation will be assessed using the IL-2、4、5、13., Basline|Interferon-γ (IFN-γ), Airway inflammation will be assessed using the IFN-γ., Basline|Tumor necrosis factor-β (TNF-β), Airway inflammation will be assessed using the TNF-β., Basline|Eosinophil cationic proteins (ECP), Airway inflammation will be assessed using the ECP., Basline|Immunoglobulin E (IgE), Airway inflammation will be assessed using the IgE., Basline
Secondary Outcome Measures: Fractional exhaled nitric oxide (FeNO), Higher FeNO values indicate higher airway inflammation., Basline|Forced expiratory volume in one second (FEV1), Lung function will be assessed using the FEV1., Basline|Forced vital capacity (FVC), Lung function will be assessed using the FEV1., Basline|FVC as the percentage of the predicted value (FVC%), Lung function will be assessed using the FVC%., Basline|Forced expiratory volume in one second / forced vital capacity (FEV1/FVC), Lung function will be assessed using the FEV1/FVC., Basline
Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC
NCT Number: NCT06573424
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colon Cancer|Immunotherapy
Interventions: COMBINATION_PRODUCT: Tislelizumab+anlotinib|DRUG: anlotinib
Sponsor: fan li
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 115
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2024-10-31
Locations: Daping Hospital, Third Military Medical University, Chongqing, 400042, China

Summary:
To compare the efficacy and safety of tirellizumab combined with anlotinib in the treatment of mss colorectal cancer. To investigate the effective biomarker of anlotinib combined with tiralizumab

Primary Outcome Measures: PFS, Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first), 36 months
Secondary Outcome Measures: OS, the time from the beginning of treatmentto death of any cause, 36 months|Multiomic molecular characterization of the response to combination immunotherapy, Including WES and RNA-seq analysis. using WES(Whole-exome sequencing) to analyse the differences in the mutational profiles between responders and non-responders. RNA-seq was used to reveal pathways and TME feature associated with the response to the combination therapy, 36 months
Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy
NCT Number: NCT06573411
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Primary Membranous Nephropathy
Interventions: DRUG: ACEI/ARB+ finerenone|DRUG: ACEI/ARB+ Placebo
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
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: 2025-10-30

Summary:
This is a prospective, randomized, multicenter, double-blinded, placebo-controlled trial. Eighty-eight patients with primary membranous nephropathy (PMN) will be randomly divided into the intervention and control groups. The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD. Control patients will be administered maximum tolerable dose of ACEI/ARB and a placebo. The primary endpoint is the relative change in urinary protein content from baseline to 6 months.

Primary Outcome Measures: Relative change in urinary protein content from baseline to 6 months., To evaluate the effects of ACEI/ARB combined with finerenone on proteinuria in patients with PMN compared to ACEI/ARB alone., 6 months
Reliability and Validity of Turkish Version of the Diabetes Education Questionnaire (DATE-Q)
NCT Number: NCT06573385
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes Mellitus
Interventions: OTHER: Questionnaire
Sponsor: Biruni University
Collaborators: Istanbul University|Istanbul Galata University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-23
Completion Date: 2024-12-31

Summary:
The Diabetes Education Questionnaire (DATE-Q) is a questionnaire that includes comprehensive care components of diabetes management and specifically questions the effect of exercise on blood glucose levels and the knowledge of the correct exercise intensity in patients with diabetes. It can be easily and rapidly applied. The aim of this study is to evaluate the translation into Turkish, validity and reliability of the DATE-Q, which questions the knowledge of diabetic patients about their disease.

Primary Outcome Measures: Diabetes Education Questionnaire (DATE-Q), The Diabetes Education Questionnaire (DATE-Q) is a questionnaire that includes comprehensive care components of diabetes management and specifically questions the effect of exercise on blood glucose levels and the knowledge of the correct exercise intensity in patients with diabetes. The questionnaire was designed to be a true/false/I don't know questionnaire, with 20 items (four in each domain). With each correct answer as 1 point, the maximum score possible is 20 overall, 4 by domain., Day 1
Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea
NCT Number: NCT06573372
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sleep Apnea, Obstructive
Sponsor: Peking University First Hospital
Collaborators: OPPO
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 295
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-29
Completion Date: 2026-07-31
Locations: Cheng Zhang, Beijing, China

Summary:
The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening. The study will be conducted in individuals suspected of having OSA. Subjects will undergo "gold standard" PSG assessment (overnight polysomnography with staff supervision) in a sleep monitoring room, while wearing a smartwatch and smartphone for monitoring. The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA.

Primary Outcome Measures: diagnostic specificity, sensitivity, The diagnostic specificity, sensitivity of OPPO smartphone and smartwatch, one monitoring night
Secondary Outcome Measures: apnea-hypopnea index (AHI), The accuracy of apnea-hypopnea index (AHI) determined by smart watch and smartphones were compared with polysomnography (PSG) ., one monitoring night