pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Clinical Study on Exercise Guided by CPET to Reduce the Risk of Metabolic Cardiovascular Diseases（C-MET Trial）
NCT Number: NCT06528639
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Syndrome
Interventions: BEHAVIORAL: HIIT
Sponsor: Peking University Third Hospital
Collaborators: Beijing Chao Yang Hospital|Guangdong Provincial People's Hospital|Peking University Shenzhen Hospital|The First Affiliated Hospital of Shanxi Medical University|Qingdao Municipal Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-05-21
Completion Date: 2025-12-31
Locations: Peking University Third Hospital, Beijing, Beijing, 100191, China

Summary:
The main purpose of this study is to validate the effect of an individualized exercise prescription developed based on cardiopulmonary exercise testing (CPET) in subjects with metabolic syndrome. This study aims to assess the improvement in cardiovascular metabolic risk associated with the personalized exercise regimen,known as individualized HIIT.

Primary Outcome Measures: Change in composite cardiovascular disease risk score (z-score), The primary outcome is the change from baseline in the composite cardiovascular disease risk score (z-score) calculated using resting blood pressure, high-density lipoprotein cholesterol, fasting glucose, waist circumference and triglyceride. Each risk factor will be individually standardized and expressed as sex-specific z-score by using the formula = (value - mean)/standard deviation for each participant., through study completion, an average of 2 year
Secondary Outcome Measures: Biochemical and metabolic indicators, Biochemical indicators including GLU(mmol/L),CHO(mmol/L),TG(mmol/L),LDL-C(mmol/L),HDL-C(mmol/L) etc., through study completion, an average of 2 year|CPET (Cardiopulmonary Exercise Testing) related indicators, Peak oxygen uptake（ml/min）, through study completion, an average of 2 year|calf circumference, waist circumference, and hip circumference, Indicators in terms of length include: calf circumference, waist circumference, and hip circumference, through study completion, an average of 2 year|Oral Glucose Tolerance Test (OGTT) Related Indicators, Fasting Blood Glucose and Insulin, 30-minute Postprandial Blood Glucose and Insulin, 120-minute Postprandial Blood Glucose and Insulin., through study completion, an average of 2 year
Tools to Identify People at Risk or Already Infected With HIV and HCV
NCT Number: NCT06528626
Acronym: ATENEA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV/AIDS|STD|HCV
Interventions: DIAGNOSTIC_TEST: rapid HIV and HCV serological tests
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators: Consorcio Centro de Investigación Biomédica en Red (CIBER)|European Union
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 240000
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2023-07-01
Completion Date: 2025-12-01
Locations: Maria J. Vivancos-Gallego, Madrid, 28034, Spain

Summary:
Wedge-Shaped Clusterded Randomizad Trial to Evaluate Two Tools to identify People at Risk or already Infected with HIV and HCV

Primary Outcome Measures: Implementation of a risk and indicator conditions self-questionnaire SQ-R&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests, Number of Participants With the implementation of a risk and indicator conditions self-questionnaire SQ-R\&IC for HIV and HCV infection, in addition to rapid HIV and HCV serological tests, Change From Baseline in hidden and incident HIV and HCV infection at 3 Years, 3 years
Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants
NCT Number: NCT06528587
Acronym: IDR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Implant Complication
Interventions: PROCEDURE: narrow diameter implant
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-11-01
Locations: Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Roma, 00168, Italy

Summary:
The scientific literature does not provide scientific evidence on how to manage patients suffering from monoedentulism with ridges having a reduced bone thickness or a reduced mesio-distal space. Narrow diameter implants could be a solution to rehabilitate patients suffering from these clinical conditions while avoiding longer, more complex and sometimes even multidisciplinary therapies. However, there is a lack of clinical studies analyzing the outcomes of rehabilitation with narrow diameter implants.

Primary Outcome Measures: peri-implant marginal bone loss in millimeters, evaluation of the peri-implant marginal bone loss in millimeters, 12 months from implant placement
Secondary Outcome Measures: soft tissue evaluation in millimeters, evaluation of marginal soft tissues levels in millimeters, 12 months from implant placement|biological complication rate in percentage, evaluation of biological complications in percentage, 12 months from implant placement|esthetics, evaluation of the esthetics using the PES score, 12 months from implant placement|mechanical complication rate in percentage, evaluation of mechanical complications in percentage, 12 months from implant placement
Postoperative Pain After Activation of Irrigant
NCT Number: NCT06528574
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain
Interventions: DEVICE: Conventional root canal treatment|DEVICE: Ultrasonic|DEVICE: Apical negative pressure|DEVICE: Combined Ultrasonic and negative pressure
Sponsor: Cleveland Dental Institute
Sex: ALL
Age: ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-08-01
Completion Date: 2025-04-30
Locations: Cleveland Dental Institute, Cleveland, Ohio, 44128, United States

Summary:
The purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC irrigation approach, and those who are treated with ultrasonic irrigation techniques, negative pressure irrigation technique and traditional irrigation techniques.

PICOTS Question:

Does the new Dent's iVac irrigation protocol has an effect on reduction of postoperative pain

By enlisting at least 84 suitable individuals who are undergoing the identical endodontic procedure.

pain will be measures by assessing pain levels through a standardized numerical rate scale (NRS) at certain time intervals after root canal treatment, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours.

Primary Outcome Measures: Numerical Pain Scale (NRS), Pain will be assessed during the numerical rate scale (NRS) which has a scale from 0 to 10, where 0 is no pain while 10 is most unbearable one., Preoperative, 6 hours, 12 hours, 24 hours, 48 hours and 72 hour post-procedure.
Secondary Outcome Measures: Analgesics intake, The patient will be advised to take analgesics in case of unbearable pain and record this. Number of tablets and the time will be recorded

● The satisfaction of patients regarding the pain management intervention at the follow-up, 6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.
Genetic Newborn Screening for Rare Diseases Within the Screen4Care Project: The French Participation
NCT Number: NCT06528548
Acronym: S4C France
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Genetic Predisposition to Disease
Interventions: DIAGNOSTIC_TEST: DBS card|BIOLOGICAL: Blood samples
Sponsor: Centre Hospitalier Universitaire Dijon
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1060
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-05
Locations: Chu Dijon Bourgogne, Dijon, 21000, France

Summary:
Newborn screening (NBS) programs are established to screen infants shortly after birth for conditions that are treatable, but not always clinically evident in the newborn period. Traditionally metabolic markers in dried blood spots (DBS) are used to diagnose these diseases. NBS detects diseases for which early diagnosis and treatment reduce long-term complications and mortality. The screening programs vary widely across Europe: Italy currently screens for 48 diseases, whereas Germany screens for 19 diseases and France screens for 14.

Through advances of genetic testing technologies, it is nowadays also possible to use DNA sequencing from DBS to test for genetic diseases. In parallel, the number of diseases, for which treatments are available are constantly increasing.

This study aims to explore the use of more extensive genetic testing by panel-based next generation sequencing to screen newborns for treatable genetic diseases. Genetic newborn screening (gNBS) is one of the pillars and the "core" of WP3 of S4C European Innovative Medicines Innitiative (IMI).

project; indeed, this work package (WP3) aims to explore the use of gNBS in newborns as a gateway to shorten the diagnostic path and offer the opportunity for early treatment. gNBS will adopt different strategies interrogating currently treatable rare diseases (RDs) (TREAT-panel-approach) (Step1). The TREAT-panel will include 245 disease genes that are related to treatable genetic disorders, prioritising those with early onset and where natural history key elements are known.

Genome sequencing (GS) will be offered to symptomatic patients to identify known gNBS-escaped RDs and novel genes/phenotypes (Step 2). More rarely, it could identify a candidate gene not yet known in human pathology.

Primary Outcome Measures: Number of couples who will accept to participate to the TREAT-panel gNBS, Through study completion, on average of 9 months|Number of newborns in whom a pathogenic or likely pathogenic variant in appropriate inheritance model will be identified through TREAT-panel, Through study completion, on average of 9 months|Number of child resulted negative at the TREAT-panel gNBS who develop early symptoms leading to the diagnosis a rare genetic disease by GS, Through study completion, on average of 26 months
Evaluation of a Health Promotion Intervention on Food Safety in Women During Pregnancy
NCT Number: NCT06528535
Acronym: NPTM2
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Food Safety|Pregnancy Related|Health Promotion
Interventions: OTHER: Health promotion intervention
Sponsor: Centre Hospitalier de Cayenne
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-22
Completion Date: 2025-09
Locations: Centre Hospitalier de Cayenne, Cayenne, 97300, French Guiana

Summary:
This is a comparative, observational study aiming to compare the diversity of the diet during pregnancy of women who have benefited from a health promotion intervention and who have not

Primary Outcome Measures: Description of diet during pregancy, To describe the diet of pregnant women among women who benefited from the health promotion intervention and those who didn't from a questionnaire, At inclusion
Secondary Outcome Measures: Prevalence of food insecurity, To estimate food insecurity of pregnant women monitored in PMI using the Minimum Dietary Diversity for Women (MDD-W) score, At inclusion|Description of socio-demographic characteristics of participants, To compare the socio-demographic characteristics of pregnant women who benefited from the intervention with those who didn't, At inclusion|Description of pregnancy outcomes, To describe pregnancy outcomes (gestational diabetis, foetal cardiac rhythm abnormalities, pre-eclampsia/eclampsia, foetal weight abnormalities) of pregnant women who benefited from the intervention with those who didn't, documented from medical file, At inclusion|Description of immediate post-partum outcomes, To describe immediate post-partum outcomes (vaginal delivery, C-section, post partum bleeding) of pregnant women who benefited from the intervention with those who didn't, documented from medical file, At inclusion|Concentration of micronutrients, To measure concentration of micronutrients (iron, iodine, zinc, magnesium, vitamins...) of pregnant women, At inclusion|Concentration of heavy metal, To measure concentration of heavy metal (mercury, lead) of pregnant women, At inclusion|Description of self-esteem, To describe the self-esteem of pregnant women using the Rosenberg self esteem questionnaire, At inclusion|Description of knowledge of pregnant women on diet, To describe the level of knowledge on diet of pregant women who benefited from the helath promotion intervention, At inclusion
N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
NCT Number: NCT06528496
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: High-risk Neuroblastoma|Neuroblastoma|Childhood Neuroblastoma
Interventions: BIOLOGICAL: DANYELZA|BIOLOGICAL: Sargramostim|DRUG: Cytoxan|DRUG: Topotecan|DRUG: Vincristine|DRUG: Doxorubicin|DRUG: Ifosfamide|DRUG: Etoposide|DRUG: Carboplatin|DRUG: Irinotecan|DRUG: Temozolomide
Sponsor: Memorial Sloan Kettering Cancer Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2029-07-22
Locations: Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States

Summary:
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.

Primary Outcome Measures: Evaluate participant response, To assess the early Complete Response/CR rate in newly-diagnosed HR-NB patients., After 2 cycles of mAb-based therapy (each cycle is 21 days)
Posterior Tibial Nerve Stimulation for Children With Pelvic Floor Dyssynergia
NCT Number: NCT06528470
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Constipation|Fecal Incontinence in Children|Pelvic Floor Dyssynergia
Interventions: DEVICE: Posterior Tibial Nerve Stimulation (PTNS)|DEVICE: Sham Stimulation
Sponsor: Nationwide Children's Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2020-01-09
Completion Date: 2024-12-30
Locations: Nationwide Children's Hospital, Columbus, Ohio, 43220, United States

Summary:
The overall objective of this study is to determine the effect of posterior tibial nerve stimulation (PTNS) on children with constipation due to pelvic floor dyssynergia. Our main hypothesis is that PTNS effectively treats children with constipation secondary to pelvic floor dyssynergia through modulation of anorectal function. We will perform a single-center, randomized controlled pilot study comparing PTNS to sham stimulation in children with constipation secondary to pelvic floor dyssynergia.

Primary Outcome Measures: Cleveland Clinic Constipation Score (CCCS), We will use the Cleveland Clinic Constipation Score (CCCS) to measure constipation severity., 4 weeks after starting treatment|Fecal Incontinence Severity Index (FISI), We will use the Fecal Incontinence Severity Index (FISI) to measure fecal incontinence severity., 4 weeks after starting treatment
Secondary Outcome Measures: Cleveland Clinic Constipation Score (CCCS), We will use the Cleveland Clinic Constipation Score (CCCS) to measure constipation severity., 5 weeks after starting treatment|Cleveland Clinic Constipation Score (CCCS), We will use the Cleveland Clinic Constipation Score (CCCS) to measure constipation severity., 8 weeks after starting treatment|Fecal Incontinence Severity Index (FISI), We will use the Fecal Incontinence Severity Index (FISI) to measure fecal incontinence severity., 5 weeks after starting treatment|Fecal Incontinence Severity Index (FISI), We will use the Fecal Incontinence Severity Index (FISI) to measure fecal incontinence severity., 8 weeks after starting treatment
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
NCT Number: NCT06528431
Acronym: MONITORA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Arthritis, Rheumatoid
Interventions: DRUG: Clinical tapering strategy|DRUG: Step Wedge trial
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Collaborators: AAP MESSIDOR
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2026-06
Locations: Infirmerie Protestante, Caluire-et-Cuire, 69300, France|Chd Vendee, La Roche-sur-Yon, 85925, France|Hopital Philibert, Lomme, 59160, France|Chu Montpellier, Montpellier, 34295, France|Ap-Hp Pitie Salpetriere, Paris, 75013, France|Chu Saint Etienne, Saint-Étienne, 42055, France

Summary:
Rheumatoid arthritis (RA) is the most common inflammatory joint disorder. Since twenty year and the use of synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biological (b)DMARD, remission can be reached. When remission is obtained, the physician has no recommendations for managing a step-down, and future guidelines will be useful to assist the clinician. Recent data suggest that tapering is feasible, but with high risk of flares. Flares are less frequent when bDMARD blood concentration is high. But, the optimal adalimumab concentration to keep before a step of tapering no targeting personal is unknown.

Primary Outcome Measures: Rheumatoid arthritis activity, Rheumatoid arthritis activity will be measured by :

- disease activity score (DAS)28 score : DAS28 is calculated according to the formula that is composed of the number of tender joints (TJC) and swollen joints (SJC), patient's global assessment of disease activity on a visual analogue scale (PGA, 0-10), and C-reactive protein (CRP).

Formula for calculating DAS28 using C-reactive protein (CRP) :

DAS28-CRP=(0.56 × √TJC) + (0.28 × √SJC) + (0.014 × PGA \[mm\]) + (0.36 × ln(CRP in mg/L+1) + 0.96,, 15 Months
Secondary Outcome Measures: Infection, Number of infection, 15 months
Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath
NCT Number: NCT06528418
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer|Lung Infection|COPD|Bronchitis|Pulmonary Fibrosis|Pulmonary Embolism|Pulmonary Arterial Hypertension|Pulmonary Tuberculosis|Pulmonary Abscess|Emphysema|Lung Injury|Cystic Fibrosis of the Lung|Bronchial Asthma|Bronchiectasis|Interstitial Lung Disease|Preserved Ratio Impaired Spirometry
Interventions: OTHER: Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system
Sponsor: ChromX Health
Collaborators: The First Affiliated Hospital of Guangzhou Medical University|First People's Hospital of Foshan|Sichuan Cancer Hospital and Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-30
Completion Date: 2027-06-30
Locations: The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510140, China

Summary:
The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) marker molecules. This model aims to accurately diagnose mutiple pulmonary diseases. The primary objectives it strives to accomplish are:

1. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose several common pulmonary diseases.
2. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose more pulmonary diseases.

Primary Outcome Measures: The diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in the diagnosis of several common pulmonary diseases., The diagnostic performance of the exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model will be compared with clinical diagnosis and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)., 2 years
Secondary Outcome Measures: The diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in the diagnosis of more pulmonary diseases., The diagnostic performance of the exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model will be compared with clinical diagnosis and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)., 2 years
Other Outcome Measures: Establish an exhaled breath VOC model for predicting specific gene mutations in some lung diseases., Establish an exhaled breath VOC model for predicting specific gene mutations in some lung diseases. And evaluate the prediction accuracy by comparing the results of specific gene testing, 2 years
The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
NCT Number: NCT06528405
Acronym: ESS-AKD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Kidney Injury
Interventions: DRUG: dapagliflozin|OTHER: Other anti-diabetic drug or no anti-diabetic drug|DRUG: empagliflozin|DRUG: canagliflozin
Sponsor: National Taiwan University Hospital
Collaborators: Chang Gung Memorial Hospital|China Medical University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 264
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-12

Summary:
Acute kidney disease (AKD) happens between 7 and 90 days after an initial kidney injury (AKI). This period is crucial because it can determine whether the condition worsens into chronic kidney disease (CKD). Despite knowing this, there is no proven treatment to improve outcomes for people with AKD.

Recent studies have shown that drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors can slow down the worsening of chronic kidney disease, help with heart failure, and reduce the risk of death. Now, researchers are looking into whether these drugs can also help prevent acute kidney injury (AKI) and improve outcomes for AKD patients.

Our project will explore the use of SGLT2 inhibitors in patients with AKD, with the belief that these drugs can safely reduce the amount of protein (albumin) in the urine and improve kidney health. To address this, investigators plan to conduct a large, multicenter study in Taiwan. This study will be randomized and placebo-controlled, meaning some patients will receive the SGLT2 inhibitors while others will receive a placebo (a harmless, inactive substance). Investigators will include AKD patients with and without diabetes, focusing on reducing the protein in their urine and monitoring for any serious side effects.

The goal of this trial is to provide strong evidence on whether SGLT2 inhibitors can be an effective treatment for AKD. If successful, this could offer a new strategy to prevent the progression from AKI to CKD and improve the health and outcomes of patients with kidney disease.

Primary Outcome Measures: Albuminuria, The changes in albuminuria compared with baseline, Day 28 and Day 90|Discontinuation of SGLT2i, Development of adverse events leading to discontinuation of SGLT2i, Day 0 to Day 90
Secondary Outcome Measures: eGFR, The changes in eGFR, Day 28 to Day 84 or Day 28 to Day 168|Major adverse kidney events, eGFR reduction \>50%, dialysis, or death, Day 0 to Day 180|Major adverse cardiovascular events, hospitalization due to heart failure or death, Day 0 to Day 180|Death, All-cause mortality, Day 0 to Day 180|Amputation, Any amputation event, Day 0 to Day 180
Efgartigimod for Stiff Person Syndrome (ESPS)
NCT Number: NCT06528392
Acronym: ESPS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Stiff-Person Syndrome
Interventions: BIOLOGICAL: Efgartigimod
Sponsor: University of South Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-06-30
Locations: University of South Florida, Carol and Frank Morsani Center for Advanced Healthcare, Tampa, Florida, 33612, United States

Summary:
The goal of this clinical trial is to examine the proportion of patients with stiff person syndrome with no worsening in stiffness and/or spasms while on efgartigimod-hyaluronidase (EFD) when compared to their current treatment. The main questions it aims to answer are:

* proportion of patients with stiff person syndrome with no worsening in DSI and HSS scores
* whether there are changes in laboratory values, vital signs, electrocardiogram, or depression, and suicide risk during the trial, as well as the incidence of any adverse events.

Participants will come to the clinic up to 18 times and have up to 5 phone call visits during the course of the trial. During these visits a variety of measures will be collected, including blood samples, neurological and physical exams, patient reported outcomes on stiffness, spasms, depression, and suicide risk.

Primary Outcome Measures: Distribution of Stiffness Index (DSI), DSI is a validated indicator or stiffness. Scores range from 0 to 6 and reflect the extent of stiffness. One point is given for stiffness in each of the following areas: lower trunk, upper trunk, legs, arms, face and abdomen., From enrollment to the end of treatment at week 13|heightened sensitivity score (HSS), HSS measures changes in the frequency of spasms. Scores range from 1 to 7; one point given for each source or type of spasm: unexpected noises, visual stimuli, somatosensory stimuli, voluntary activities, emotional upset or stress, no specific stimuli, or nocturnal spasms., From enrollment to end of treatment at week 13
Secondary Outcome Measures: Proportion of patients with SPS who are treatment responders, Proportion of patients with SPS who are treatment responders, defined as: \>= 2 points reduction in the distribution of stiffness index (DSI) AND \>= 1 point reduction in heightened sensitivity score (HSS), enrollment to end of 13 weeks|The duration of time patients maintain responder status, A responder is defined as one having \>= 2 points reduction in the distribution of stiffness index (DSI) AND \>= 1 point reduction in heightened sensitivity score (HSS), from enrollment to end of treatment at week 13|Modified Rankin Scale, From enrollment to end of treatment at week 13
Blood Biomarkers Based Screening for HPV-driven OPC
NCT Number: NCT06528353
Acronym: SCREEN-HPV
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head and Neck Squamous Cell Carcinoma|Anal Cancer|Human Papilloma Virus
Interventions: DIAGNOSTIC_TEST: HPV16-E6 serology and HPV ctDNA
Sponsor: UNICANCER
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2025-07
Completion Date: 2031-07

Summary:
The objective of our study is to demonstrate that it is possible to detect and treat human papilloma virus (HPV)-related oropharyngeal cancers (OPC) early using simple blood tests. The success of this strategy will be evaluated by the number of participants positive for both HPV16-E6 serology and HPV circulating tumor DNA (ctDNA) whose early management has allowed the detection of a cancerous lesion and/or whose HPV ctDNA results have normalized after surgical intervention. If this study is conclusive, it could pave the way for the implementation of a national screening strategy for HPV-related OPC.

Primary Outcome Measures: Early identification of HPV-driven OPC lesions, The efficacy of this stepwise, biomarker-based screening approach to identify and treat early HPV-driven OPC lesions in asymptomatic individuals at high risk is determined by the number (and percentage) of participants who are positive for both HPV EA serology and HPV ctDNA, AND who have a successful identification of a tumor lesion., 3 months following last prophylactic surgery
Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible
NCT Number: NCT06528327
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implant|Diabetes Mellitus, Type 2
Interventions: OTHER: Pre coated impants|OTHER: Non coated implant surface
Sponsor: Hams Hamed Abdelrahman
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-06-26
Completion Date: 2024-02-12
Locations: Alexandria Faculty of Dentistry, Alexandria, Egypt

Summary:
Dental implant's surface properties significantly influence both biological and mechanical integration. Surface bio-treatment could accelerate and enhance bone regeneration, ensuring successful implantation. therefore, this study compares bone densification, primary and secondary stability, wound healing, and pain intensity between pre-coated antimicrobial surfaces of dental implants versus non-coated surfaces in controlled type 2 diabetic patients.

Primary Outcome Measures: change in implant stability, implant stability will be assessed using Osstell device, up to 4 months|change in pain intensity, pain was assessed using visual analogue scale that ranges from 0 (No pain) to 10 (untolerated pain), 1st,3rd, and 7th days|Wound Healing score, Landry healing index was used;

1. Very poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue:Present, Incision margin: Not epithelialized, with loss ofepithelium beyond incision margin, Suppuration: Present
2. Poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue: Present, Incision margin: Not epithelialized, with connective tissue exposed
3. Good Tissue colour: ≥25% and\<50% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed
4. Very good Tissue colour: \<25% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed
5. Excellent Tissue color: All tissues pink, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue expose, 1st,3rd, and 7th days,14th day
Secondary Outcome Measures: Post operative complications, Occurence of infection was assessed, 6 months|Change in bone density, CBCT was used to measure bone density, up to 4 months
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
NCT Number: NCT06528301
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Lymphoma, B-Cell|Lymphoma, Non-Hodgkin (NHL)|Lymphoma, Large B-Cell, Diffuse (DLBCL)|Chronic Lymphocytic Leukemia (CLL)
Interventions: GENETIC: UB-VV111|DRUG: rapamycin
Sponsor: Umoja Biopharma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 106
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2029-03

Summary:
This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).

Primary Outcome Measures: Percentage of participants with common adverse events (AEs), Percentage of participants with commonly reported AEs overall and by severity, Up to 2 years after UB-VV111 administration
Secondary Outcome Measures: Overall response rate (ORR), Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), Up to 2 years after UB-VV111 administration
Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery
NCT Number: NCT06528288
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fusion of Spine, Lumbar Region|Anesthesia, Local|Pain, Postoperative|Opioid Use
Interventions: PROCEDURE: Erector Spinae Plane Block|PROCEDURE: Subcutaneous Anesthesia
Sponsor: Raj Gala
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-07-01

Summary:
The purpose of this study is to determine if the method for injecting local anesthesia affects patients' pain and opioid usage after surgery. The investigators will compare subcutaneous anesthesia, injections of anesthesia under the skin, to a method called erector spinae plane block (ESPB). An ESPB injection involves placing local anesthesia along the muscles and bones in the back, using a special type of x-ray called fluoroscopy for guidance. The Investigators will use patient reported outcomes (PROs) and track subjects' opioid usage to find out if there is a difference between ESPB and subcutaneous anesthesia. The investigators hypothesize that patients who get ESPB injections will use less opioids and report less pain after lumbar fusion surgery compared to patients who receive subcutaneous anesthesia injections.

Primary Outcome Measures: MOS 36 Item Short Form Health Status Survey (SF-36), Questionnaire related to a patient's general health, bodily pain, physical function, and mental health. Scoring includes eight scaled scores, which are the weighted sums of the questions in their section. Scales are converted into a 0-100 scale. The lower the score the more disability. The higher the score the more functionality and therefore indicating better outcome., 3 months|Oswestry Disability Index, Questionnaire related to a patient's back pain and its impact on their day-to-day activities. There are 10 questions, each weighted from 0-5 points. The point total of each question is added together to give a final scaled score ranging from 0-50. Lower scores near 0 are indicative of better outcome and less disability, while higher scores near 50 indicate worse outcomes and more disability., 3 months|Postoperative Opioid Usage, This is a tracking sheet for the amount of opioid medications used in the first 2 weeks of postoperative recovery., 2 weeks
Infant Feeding in French Guiana
NCT Number: NCT06528275
Acronym: ANJE Nutri
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Food Insecurity|Pregnancy Related
Interventions: OTHER: Health promotion intervention
Sponsor: Centre Hospitalier de Cayenne
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 380
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-14
Completion Date: 2026-08
Locations: Centre Hospitalier de Cayenne, Cayenne, 97300, French Guiana

Summary:
This is a comparative, observal study among the population of pregant women who participated to the study "Nutri Pou Ti Moun" on food insecurity during pregnancy in French Guiana

Primary Outcome Measures: Prevalence of exclusive breastfeeding at 3 months of age in French Guiana, To estimate the prevalence of exlusive breastfeeding at 3 months of age in French Guiana in the group control and the group intervention, At inclusion
Secondary Outcome Measures: Description of exclusive breastfeeding practices, To describe exclusive breasfeeding practices by questionnaire, At inclusion|Description of artificial breastfeeding practices, To describe artificial breastfeeding practices by questionnaire, At inclusion|Description of dietary diversity in infants, To describe dietary diversity in infants by questionnaire, At inclusion|Description of the minimal dietary diversity, To describe the minimal dietary diversity for children 6-23 months (MDD-IYCF) at 12 months of age by questionnaire, 12 months|Description of the minimal dietary diversity of mothers, To describe the minimal dietary diversity of mothers (MDD-W) at 12 months of age of the baby by questionnaire, 12 months|Description of staturo-ponderal and psychomotor development indicators, Prevalence of staturo-ponderal and psychomotor development indicators among infants during their 1st year of age, 12 months|Breastfeeding rate, exclusive and artificial breastfeeding duration, dietary diversity between groups, Comparison of breastfeeding rate, exclusive and artificial breastfeeding duration, dietary diversity and age at diversity between the 2 groups, 12 months|Description of breastfeeding practices from mothers point of view, To describe views on breastfeeding practices in intervention group by semi-structured interview, At inclusion|Description of breastfeeding practices from professionals point of view, To describe views on breastfeeding practices in professionals by semi-structured interview, At inclusion
Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate in Patients With Advanced Malignancies
NCT Number: NCT06528249
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Cancer|Solid Tumor|Hematologic Malignancy
Interventions: DRUG: Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes
Sponsor: Zhejiang Provincial People's Hospital
Collaborators: Westlake Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2026-12-31

Summary:
This is an investigator-initiated, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of Erythrocyte-αPD-1 conjugates in patients with advanced malignancies

Primary Outcome Measures: Incidence of adverse events, The incidence of adverse events (AE), treatment related adverse events (TRAE), and severe adverse events (SAE) during the treatment of engineered erythrocytes, through study completion, an average of 1 year
Secondary Outcome Measures: Pharmacodynamics characteristics Peak Plasma Concentration(Cmax), The occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after infusion,including Peak Plasma Concentration(Cmax), through study completion, an average of 1 year|Pharmacodynamics characteristics Area under the plasma concentration versus time curve（AUC）, The occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after infusion,including Area under the plasma concentration versus time curve (AUC)., through study completion, an average of 1 year|Efficacy of Erythrocyte-αPD-1 Conjugate, According to RECIST 1.1, the effectiveness of Erythrocyte-αPD-1 Conjugate injection in the treatment of patients with unresectable or metastatic advanced solid tumors was evaluated. The evaluation indicators included objective response rate (ORR),etc., per 6 weeks
Other Outcome Measures: Anti-drug antibody (ADA), Describe the number of anti-drug antibodies (ADA) produced by subjects at each time point after treatment., through study completion, an average of 1 year|Peripheral immune response assessment, Immune cell alterations(number of T-cell,etc) in the peripheral are analyzed by flow cytometry., through study completion, an average of 1 year
Research and Application of Ultrasonic Intelligent Diagnosis System for Ovarian Mass
NCT Number: NCT06528236
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Neoplasms|Adnexal Mass
Interventions: DIAGNOSTIC_TEST: Artificial intelligence model
Sponsor: Zhejiang Provincial People's Hospital
Collaborators: The Second Affiliated Hospital of Harbin Medical University|Sichuan provincial maternity and child health care hospital|The Affiliated Hospital of Qingdao University|Aksu First People's Hospital|Women's Hospital School Of Medicine Zhejiang University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2029-07-30

Summary:
Research on automatic detection of ovarian mass and intelligent auxiliary diagnosis system based on multimodal ultrasound images.

Primary Outcome Measures: Area under the curve, AUC (Area Under the Curve) is a common index used to evaluate the performance of binary classification model., Through study completion, an average of 1 year
Secondary Outcome Measures: Sensitivity, Sensitivity refers to the ability of the test to correctly identify a positive result in an individual who actually has the disease. It represents the proportion of cases in which the test is able to detect a positive for the disease, Through study completion, an average of 1 year
Other Outcome Measures: Specificity, Specificity refers to the ability of the test to correctly identify a negative result in an individual who does not actually have the disease. It represents the proportion of cases where the disease is negative that the test is able to detect., Through study completion, an average of 1 year|Accuracy, Accuracy refers to the degree to which the results of the diagnostic test are consistent with the actual situation, Through study completion, an average of 1 year|Positive predicative value, Positive Predictive Value indicates the probability that a test result will be true if it is positive. In other words, it represents the proportion of individuals who are diagnosed as positive when the test result is positive who actually have the disease, Through study completion, an average of 1 year|Negative predictive value, Negative Predictive Value refers to the probability that if a test result is negative, the result will be true negative. It represents the proportion of individuals who are diagnosed as negative when the test results are negative that are truly free of the disease, Through study completion, an average of 1 year
Research of the Application of Artificial Intelligence Model "PANDA"
NCT Number: NCT06528223
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Cancer
Interventions: DIAGNOSTIC_TEST: biopsy or operation
Sponsor: Zhejiang University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-15
Completion Date: 2027-12-31
Locations: the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310003, China|the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, China

Summary:
The research objective of this project is to conduct a large-scale and prospective real-world validation of the Pancreatic Cancer Screening Model PANDA, which was developed based on deep learning and plain CT scans in previous studies. This validation will be carried out across different scenarios at the First Affiliated Hospital of Zhejiang University, leveraging clinical big data. The goal is to verify the model's role in suggesting and supplementing the diagnosis of PDAC in clinical practice, thereby laying the groundwork for large-scale opportunistic screening of PDAC.

Primary Outcome Measures: OS, overall survival, From diagnosis of PDAC to 3 years later
Secondary Outcome Measures: TNM stage, Staging of pancreatic cancer, 1 day (evaluate through CT imaging before surgery)|Resectability grading, Resectability grading of pancreatic cancer, 1 day (evaluate through CT imaging before surgery)|Tumor markers, Characteristic presence in malignant tumor cells or substances produced abnormally by malignant tumor cells，like CA199, Immediately after recall
Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese and Western Medicine
NCT Number: NCT06528197
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Primary Sjögren Syndrome
Sponsor: China-Japan Friendship Hospital
Collaborators: Xiyuan Hospital of China Academy of Chinese Medical Sciences|Beijing Hospital of Traditional Chinese Medicine|Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-04
Completion Date: 2026-12-31
Locations: Jiaqi Chen, Beijing, Beijing, 100029, China

Summary:
This study aims to establish a large sample cohort of patients with primary sjogren's syndrome, collect multi-omics information of patients with primary sjogren's syndrome, and construct disease diagnosis model and disease prognosis prediction model.

Primary Outcome Measures: Number of participants with system involvement, System involvement determined from clinical diagnosis, Baseline , 6 months follow-up
Secondary Outcome Measures: Mortality, All-cause mortality, Baseline , 6 months follow-up|Number of participants with tumor, Tumor determined from clinical diagnosis, Baseline , 6 months follow-up|Number of participants with connective tissue disease, Connective tissue disease determined from clinical diagnosis, Baseline , 6 months follow-up
Covid-19 Long Immunité IMagerie (CLIIM)
NCT Number: NCT06528171
Acronym: CLIIM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COVID Long-Haul
Interventions: PROCEDURE: Brain MRI|BIOLOGICAL: Specific blood samples
Sponsor: Centre Hospitalier Universitaire de Nice
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-15
Completion Date: 2026-09
Locations: CHU de NICE, Nice, 06200, France

Summary:
Covid-long pathology affects a large number of patients, and represents a major medical, economic and societal challenge. To date, we have no objective criterion for a definitive diagnosis, nor any predictive tool for monitoring the evolution of Covid-long. Based on recruitment from the infectious diseases department of Nice University Hospital, the investigator's team wants to conduct an innovative pathophysiological study to better define the disease and identify specific biomarkers that could subsequently be used as a diagnostic tool for Covid-long. 120 participants will be initially included for the model learning phase: 60 controls in the CL- cohort and 60 patients in the CL+ cohort. Then 80 patients (40 CL+ and 40 Cl-) will be enrolled for the model validation phase.

Primary Outcome Measures: Predictive model of Covid-long, Build and validate a multivariate predictive model of Covid-long considering immunological, inflammatory and brain imaging markers., 24 months
Secondary Outcome Measures: Evolution of these markers over time, Comparison of data over time between cohorts (CL+ vs. CL-), 24 months