pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Efects of FIFA 11+Warm-Up Program on Agilitiy, Balance And Proprioception Parameters in The Professional Football Players
NCT Number: NCT06472687
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sports Physical Therapy
Interventions: OTHER: FIFA 11+ warm-up exercise training|OTHER: warm-up exercise training
Sponsor: Yeditepe University
Sex: MALE
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2023-10-01
Completion Date: 2024-03-01
Locations: Elif Tuğçe, Istanbul, Maltepe, 34770, Turkey

Summary:
This study aimed to compare the effects of the FIFA 11+ warm-up program with a traditional warm-up on agility, balance, and proprioception in professional football players aged 18-30. Forty-four players were randomly assigned to either the FIFA 11+ group, which performed the program for 10 weeks, or the control group, which continued their usual warm-up routine.

Primary Outcome Measures: Agility, Agility was assessed by the Illinois T test, Baseline assesment (Begining of the warm-up program), 10th week assessment (through FIFA 11+ program is completed.)
Secondary Outcome Measures: Balance, The Y balance test is used to evaluate dynamic balance., Baseline assesment (Begining of the warm-up program), 10th week assessment (through FIFA 11+ program is completed.)|Proprioception, Proprioception was assessed the ability to reposition the knee at 30, 45, and 60 degrees for both the player's right and left leg., Baseline assesment (Begining of the warm-up program), 10th week assessment (through FIFA 11+ program is completed.)
China Healthy Aging Cohort Study
NCT Number: NCT06472674
Acronym: China-Ageing
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Age Problem|Disability|Dementia|Death
Interventions: OTHER: No intervention
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6780
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-13
Completion Date: 2063-06
Locations: Xuanwu Hospital, Capital Medical University, Beijing, 100053, China

Summary:
This is a community-based prospective cohort study in China. The study has been initialized in 2024 and included older residents. The goal of this observational study is to explore the risk factors related to disability and dementia in the elderly Chinese community population, and develop a risk prediction model for disability and dementia.

Primary Outcome Measures: The prevalence and incidence of functional disability using a population-based survey, Functional disability was measured by Activities of Daily Living, cognitive function (Mini-Mental State Examination) and movement disorder（Short Physical Performance Battery) collected by questionnaires.The minimum value of the Activities of Daily Living is 0, and the maximum value is 100, the higher the score, the better the outcome.The minimum value of the Mini-Mental State Examination is 0, and the maximum value is 30, the higher the score, the better the outcome.The minimum value of the Short Physical Performance Battery is 0, and the maximum value is 12, the higher the score, the better the outcome., An average of 1 to 2 years|The prevalence and incidence of mild cognitive impairment using a population-based survey, Mild cognitive impairment was measured using Mini-Mental State Examination collected by questionnaire.The minimum value of the Mini-Mental State Examination is 0, and the maximum value is 30, the higher the score, the better the outcome., An average of 1 to 2 years|The prevalence and incidence of dementia using a population-based survey, Dementia was determined by diagnosis of hospitalization or diagnosis of death or Clinical Dementia Rating scale. The minimum value of the Clinical Dementia Rating is 0, and the maximum value is 3, the higher the score, the worse the outcome., An average of 1 to 2 years|The conversion rate of normal to mild cognitive impairment, Percentage of enrolled population that convert from normal to mild cognitive impairment, An average of 1 to 2 years|The conversion rate of mild cognitive impairment to dementia, Percentage of enrolled population that convert from mild cognitive impairment to dementia, An average of 1 to 2 years|The prevalence and incidence of movement disorder using a population-based survey, Movement disorder was measured using Short Physical Performance Battery collected by questionnaire.The minimum value of the Short Physical Performance Battery is 0, and the maximum value is 12, the higher the score, the better the outcome., An average of 1 to 2 years
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
NCT Number: NCT06472661
Acronym: Mel 70
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Advanced Melanoma
Interventions: DEVICE: Echopulse or Echopulse HD|DRUG: PolyICLC
Sponsor: University of Virginia
Collaborators: Theraclion
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 11
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08
Locations: University of Virginia, Charlottesville, Virginia, 22908, United States

Summary:
This study is for adult patients with advanced melanoma who are receiving immunotherapy and who are planning on having surgery for their cancer. All participants in this study will receive an experimental treatment made up of focused ultrasound ablation (FUSA), a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue, and an injection in the tumor with an experimental drug that activates the immune system called polyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine). Neither the drug nor the device that are used in this study have been approved by the U.S. Food and Drug Administration (FDA).

Primary Outcome Measures: Adverse Events, Incidence and severity of adverse events (Common Terminology Criteria for Adverse Events \[CTCAE\] v5)., Collected from Day 1 up to Day 22|Pathologic ablation zone, Proportion of patients where the size of the pathologic ablation zone is within 20% of the planned zone, Day 22
Secondary Outcome Measures: Presence of Periablation Zone, Proportion of participants with a zone of tissue with live vasculature, fibrosis, and a histiocytic reaction as determined by hematoxylin and eosin (H\&E) staining and/or immunohistochemistry, Day 22
a Neo-adjuvant Chemotherapy Immunotherapy in Resectable ESCC Study
NCT Number: NCT06472635
Acronym: ANACIIRE-1
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma
Sponsor: Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 95
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-03-01
Completion Date: 2024-10-31
Locations: The first affiliated hospital of Zhejiang University, Hangzhou, Zhejiang, 3210002, China

Summary:
Research Purpose 1: To evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 2: To analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 3: To understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced ESCC in the

Primary Outcome Measures: Pathological Complete Response (pCR), pCR is defined as the ratio of residual viable tumor cells being 0 in the primary tumor and sampled lymph nodes., 12 months
Secondary Outcome Measures: Resection Rate, R0 resection refers to the complete removal of the tumor, with negative microscopic margins, indicating no residual tumor; no cancer cells are found on the cutting line under pathological examination., 12 months
Other Outcome Measures: ORR, Defined as the proportion of patients achieving complete response (CR) or partial response (PR) among all patients, with efficacy evaluation based on the RECIST 1.1 criteria., 12 months
Prospective Quality Improvement Project for High-Risk Diabetes Patients
NCT Number: NCT06472609
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus|Latent Tuberculosis Infection|Continuous Glucose Monitoring|Quality of Life
Interventions: BEHAVIORAL: enhanced interactive education
Sponsor: Taipei Medical University WanFang Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2021-07-29
Completion Date: 2024-12-31
Locations: Chih-Hsin,Lee, Taipei, 106, Taiwan

Summary:
Diabetes is the most important comorbidity of tuberculosis patients in Taiwan, and 1/4 of tuberculosis patients also It is a diabetic patient, and the treatment of latent tuberculosis infection is currently an important policy of the Taiwan Disease Control Agency One, because babies are prone to encounter difficulties in the early stages, because of the spread of Australian patients in the community, The Department of Disease Control encourages patients with diabetes to receive screening and treatment for latent tuberculosis infection.

Primary Outcome Measures: quality improvement project, After the admitted patients were involved in the quality improvement project, the glycated blood demand in the 12 weeks was tracked as the target index for purposeful control and research, and the final value was compared.

The quality of life of the case was evaluated by using the Diabetes-Related Distress Questionnaire (DRDQ) as an evaluation index to compare the differences before and after the intervention of the interdisciplinary care team., 12 weeks
Secondary Outcome Measures: Immune response to tuberculosis-specific antigen., In cases of latent tuberculosis infection, Quantiferon-Gold Plus is used to evaluate the immune response of CD8 T cell lymphocytes to tuberculosis-specific antigens before and after treatment., 12 weeks|Number of episodes of hyperglycemia or hypoglycemia in people with high-risk diabetes, For high-risk diabetic patients receiving treatment for latent tuberculosis infection, use a continuous blood glucose monitor to compare the incidence of adverse events such as hyperglycemia or hypoglycemia five days before and five days after medication., 14 weeks|quality of life measures, The quality of life of the case was evaluated by using the Diabetes-Related Distress Questionnaire (DRDQ) as an evaluation index to compare the differences before and after the intervention of the interdisciplinary care team., 12 weeks
Risk of Chronic Kidney Disease in Bronchial Asthma
NCT Number: NCT06472596
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bronchial Asthma
Interventions: DIAGNOSTIC_TEST: CBC, CRP ,ESR, ABG , interleukin 6, tumor necrotic factor alpha
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-07-11
Locations: Marihan Nazmy Shehata, Sohag, Egypt

Summary:
the study aims to determine the frequency and factors associated with chronic kidney disease among asthmatic patients in order to determine persons who are at risk of developing chronic kidney disease and require strict follow up in long run , to evaluate severity of asthma as a potential risk for developing kidney injury , to evaluate relationship between different inflammatory markers with severity of asthma and risk of deneloping chronic kidney disease

Primary Outcome Measures: change in kidney function in asthmatics, change in serum creatinine , GFR calculation, change in kidney function in asthmatics after diagnosis and start treatment through out the duration of study (an average 1 year )
Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
NCT Number: NCT06472570
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head and Neck Cancer
Interventions: RADIATION: Stereotactic radiotherapy boost
Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-10-26
Completion Date: 2030-12-31
Locations: 1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch,, Gliwice, Gliwicw, 44-102, Poland

Summary:
The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H\&N tumours.

Primary Outcome Measures: Response to treatment, Response to treatment in imaging tests and clinical examination-local control (LC) and locoregional control (LRC)., one month after the end of treatment, every 3 months in the first year, every 4 months in the second year, and every six months in the third-fifth years
Secondary Outcome Measures: Evaluation of efficacy, Evaluation of overall survival (OS) time, 5 years after the end of treatment|Evaluation of efficacy, Evaluation of progression-free survival time (PFS), 5 years after the end of treatment|Evaluation of efficacy, Evaluation of disease-free survival time (DFS), 5 years after the end of treatment|Evaluation of safety Terminology Criteria for Adverse Events (CTCAE)v4.0., Acute and late side effects according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0., 5 years after the end of treatment|Treatment tolerance, Evaluation of quality of live anf reatment tolerance using QLQ-C30 (Quality of Life Questionnaire C30)., an average of 3 months
Trauma-Informed Intervention for Rheumatoid Arthritis on Blackfeet Nation
NCT Number: NCT06472544
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rheumatoid Arthritis
Interventions: BEHAVIORAL: Culturally Grounded Intervention
Sponsor: Blackfeet Community College
Collaborators: University of Washington
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-09-01
Completion Date: 2030-09-01

Summary:
The goal of this study is to determine whether an intervention grounded in Blackfeet culture improves systemic inflammation and symptoms of arthritis in Blackfeet People with rheumatoid arthritis. The intervention is designed to increase conectedness of Blackfeet people to Blackfeet culture and community. The intervention will consist of one week of meetings in which Blackfeet Elders talk about Blackfeet historical trauma, culture, traditions and cerimonies. The second week of the intervention consists of visiting Blackfeet sacred sites, guided by Blackfeet Elders. Participants will complete surveys to determine their conectedness to Blackfeet Culture, level of stress, Adverse Childhood Experiences Score (ACES) and arthritis symptoms. Participants will also be evaluated for clinical severity of arthritis and biomarkers of systemic inflammation. Participants will be evaluated pre- and post-intervention as well as 6 months post-intervention.

Primary Outcome Measures: Rheumatoid Arthritis Disease Activity, Arthritis activity will be determined bu clinical assessments and self-reported symptom severity., Outcomes will be determined just before the intervention (day 1), just after intervention (day 14) and 6 months later.
Secondary Outcome Measures: Systemic Inflammation, Systemic inflammation determined by assessing blood levels of inflammation biomarkers CRP, IL-6 and IL-17., Systemic inflammation determined immediately before intervention (day 1), immediately after end of intervention 9Day 14), and 6 months after intervention.
Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage
NCT Number: NCT06472505
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pituitary Tumor|Cerebrospinal Fluid Leakage
Interventions: DEVICE: polyglycolic acid(Neoveil)
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2025-12-31
Locations: National Taiwan University Hospital, Taipei, 100, Taiwan

Summary:
The papers propose a new method to prevent postoperative cerebrospinal fluid leakage. Doctors use the absorbable polyglycolic acid (PGA) and fibrin glue to repair in surgery, prevent cerebrospinal fluid leakage and reduce the necessity of postoperative lumbar drainage after surgery. This study will analyze the changes in cerebrospinal fluid leakage in patients with pituitary tumors and skull base tumors after surgery, and further understand the effectiveness of Neoveil , as the basis for the development of new treatments.

Primary Outcome Measures: Mesurement CSF leakage grade change after surgery, Confirmation of change in CSF leakage grafe after surgery, 6 months
Evaluation of the Use of a Method "Radiomics" for DOPA PET in Gliomas
NCT Number: NCT06472440
Acronym: RADDOPAG-2
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Glioma
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-16
Completion Date: 2025-02-01

Summary:
: The evaluation of gliomas in imaging represents a real challenge today, at the initial diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging, through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it remains time-consuming and is not always available. At the same time, positron emission tomography (PET) with amino acids is an interesting alternative for these brain tumours. Amino acid PET has the advantage of being more specific than the abnormalities detected in MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the non-invasive staging of gliomas at initial diagnosis

Primary Outcome Measures: Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis., Accuracy of the method, Day 1
Secondary Outcome Measures: Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict glioma recurrence, Sensibility of the method, Day 1|Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the response to glioma treatments., specificity of the method, Day 1
The Effect of Butanediol Ingestion on Skeletal Muscle Angiogenesis in Hypoxia
NCT Number: NCT06472427
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ketosis|Hypoxia|Angiogenesis
Interventions: DIETARY_SUPPLEMENT: Normoxic recovery and placebo (NPL)|DIETARY_SUPPLEMENT: Normoxic recovery and ketones (NKE)|DIETARY_SUPPLEMENT: Hypoxic recovery and placebo (HPL)|DIETARY_SUPPLEMENT: Hypoxic recovery and ketones (HKE)
Sponsor: KU Leuven
Sex: ALL
Age: ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-12
Completion Date: 2024-09-06
Locations: KU Leuven, Leuven, Vlaams-Brabant, 3000, Belgium

Summary:
This study specifically aims to elucidate the effects of intermittent exogenous ketosis (IEK) as well as hypoxia on muscular pro-angiogenic factors- after a 60-min HIIT bout in normoxia. Moreover, blood and muscle oxygenation status, as well as peripheral blood flow and cognitive function will be assessed.

Primary Outcome Measures: Post-exercise muscle VEGF mRNA expression, Measured using PCR on collected muscle biopsies, Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.|Post-exercise serum EPO concentrations, Measured using ELISA on collected serum samples, Venous blood samples are collected 10 minutes after the end of training as well as 3 hours, 5 hours and 7 hours later.
Secondary Outcome Measures: Change in muscular VEGF concentration, Measured using Western Blotting on muscle biopsies, Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.|Change in serum VEGF concentration, Measured using ELISA on collected serum samples, Venous blood samples are collected immediately (5 minutes) after the end of training, as well as 3hours, 5hours and 7hours later..|Change in blood oxygenation, Measured using pulse oximetry with a sensor on the forehead, Continuously measured starting 30 minutes after the end of exerciseuntil 7.5 hours later|Change in skeletal muscle oxygenation, Measured using NIRS with a sensor on the belly of the m. vastus lateralis (skeletal muscle), Measured during resting measurements performed 30 minutes, 3hours and 30minutes as well as 6hours and 30minutes after the end of training.|Change in peripheral blood flow, Measured using duplex ultrasonography, Measured during resting measurements performed 30 minutes, 3hours and 30minutes as well as 6hours and 30minutes after the end of the training|Exercise performance, Measured as the average power output (W) during a 15 minutes all-out time trial, Performed 7hours and 30minutes after the end of training
Other Outcome Measures: Change in citrate synthase as a marker of mitochondrial density, Measured using an enzymatic essay, Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.
Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors
NCT Number: NCT06472388
Acronym: EVENET
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neuroendocrine Tumors|Progression|Neuroendocrine Tumor Grade 1|Neuroendocrine Tumor Grade 2|Neuroendocrine Tumor of Pancreas|Neuroendocrine Tumor of the Lung|Neuroendocrine Tumor Carcinoid
Interventions: DRUG: Everolimus 5 MG
Sponsor: AC Camargo Cancer Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-24
Completion Date: 2026-12-31
Locations: AC Camargo Cancer Center, São Paulo, SP, 01509010, Brazil|AC Camargo Cancer Center, Sao Paulo, 01509010, Brazil

Summary:
Everolimus is approved in many countries to treat patients with advanced/metastatic well-differentiated neuroendocrine tumors (NET), providing median progression-free survival times of approximately 12 months across different types of NET. However, it is can cause severe adverse effects. Phase I trial demonstrated that a dose of 5mg/day/week was sufficient to inhibit cell proliferation by blocking the mTOR pathway.

This is a randomized, open-label, phase II near-equivalence clinical trial of oral everolimus 5 mg vs 10 mg oral/daily and continuously in patients with Grade 1 or Grade 2 metastatic NET, with tumor progression or intolerance to at least one line of treatment and with radiological disease progression within 6 months.

Primary Outcome Measures: Progression free survival rate at 12 months, Proportion of patients without radiological progression or death at 12 months from first day of everolimus, 12 months
Secondary Outcome Measures: progression free survival, Time from first day of everolimus until radiological progression or death (time to event), 12 months|time to treatment failure, fTime from first day of everolimus until progression, treatment discontinuation for toxicity or death, 12 months
Chest CT Biomarkers as Prognostic Predictors in SSc-ILD
NCT Number: NCT06472362
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Systemic Sclerosis
Interventions: DIAGNOSTIC_TEST: HRCT biomarkers
Sponsor: Royal Brompton & Harefield NHS Foundation Trust
Collaborators: Imperial College London|Royal Free and University College Medical School|The Leeds Teaching Hospitals NHS Trust|Hannover Medical School|University of Siena|Università Politecnica delle Marche|Azienda Ospedaliero Universitaria di Sassari|Bichat Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2026-03-31
Locations: Bichat-Claude Bernard hospital, Paris, France|Hanover Medical School, Hannover, Germany|Marche Polytechnic University, Ancona, Italy|Sassari University, Sassari, Italy|Siena University Hospital, Siena, Italy|Leeds Hospital/University of Leeds, Leeds, United Kingdom|Royal Brompton Hospital, London, United Kingdom

Summary:
The goal of this retrospective observational study is to investigate whether novel imaging biomarkers of airways, vessels, and overall extent of fibrosis at baseline predict ILD progression, vasculopathy development, and survival in SSc-ILD.

Primary Outcome Measures: Survival, Transplant-free survival, 15 years|Pulmonary hypertension, Development of pulmonary hypertension, 15 years|Decline in FVC, Change in lung function measure FVC, 15 years|Decline in DLCO, Change in lung function measure DLCO, 15 years|Decline in KCO, Change in lung function measure KCO, 15 years
Continuous Glucose Monitoring in Prediabetes
NCT Number: NCT06472297
Acronym: G1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pre-diabetes
Interventions: DEVICE: The continuous glucose monitoring system
Sponsor: University of Southern California
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-01
Completion Date: 2027-06-30
Locations: Southern California Center for Latino Health SCCLH, Los Angeles, California, 90031, United States

Summary:
The objective of this project is to develop a behavioral intervention that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and educational video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with pre-diabetes. The goal is to prevent transition to type 2 diabetes.

Primary Outcome Measures: Glucose levels, Mean glucose in mg/dL with glucose variability, 20 days
Other Outcome Measures: Recorded narrative audio and video archives, Videos obtained from informal and semi-structured interviews, Daily clips recorded each day for up 20 days during the CGM wear period
TetraGraph in Rocuronium Infusions
NCT Number: NCT06472284
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery
Interventions: DEVICE: TetraGraph
Sponsor: Joseph D. Tobias
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2025-12
Locations: Nationwide Children's Hospital, Columbus, Ohio, 43205, United States

Summary:
This is a prospective, non-blinded study to evaluate rocuronium infusion requirements using the TetraGraph Neuromuscular Transmission Monitor during surgical procedures in patients less than 18 yrs. of age.

Primary Outcome Measures: EMG changes, Changes in the amplitude of the evoked response of the muscles, During the surgery (2-8 hrs.)|Maximum dose of rocuronium, The maximum dose of rocuronium administered by a continuous infusion to maintain one twitch of the train of four (TOF), During the surgery (2-8 hrs.)
Colistin Dosage Prsonalization Approach
NCT Number: NCT06472271
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colistin Adverse Reaction
Interventions: DRUG: Polymyxin e
Sponsor: Mahmoud I Mostafa
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2025-05-30
Locations: Cairo univrsity Hospitals, Cairo, 11435, Egypt

Summary:
A few studies have evaluated higher doses or the administration or a loading dose, which is routine in adults, in pediatric patients, and reported improved colistin exposure without an increased risk of nephrotoxicity The main questions it aims to answer are What is the optimal dosing strategies of intravenous colistin for the treatment of multidrug-resistant gram-negative bacterial infections in preterm neonates? What is the incidence of AKI? What is the factors increasing AKI incidence? A single center retrospective and comparative study, cohort study compare low dose 5 mg/kg/day versus 7.5mg/kg/day

Primary Outcome Measures: Clinical response, Resolving signs and symptoms with normalized acute phase reactants in clinical septic patients, 21 days
Secondary Outcome Measures: Microbiological clearance, Negative culture results following Colistin therapy, 21 days
Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative Study
NCT Number: NCT06472258
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Malaria
Interventions: DRUG: IV Artesunate|DRUG: IV Quinine Hydrochloride
Sponsor: RESnTEC, Institute of Research
Sex: ALL
Age: CHILD
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-01
Completion Date: 2023-06-30
Locations: Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Punjab, 32200, Pakistan

Summary:
The WHO recommends artesunate as the drug of choice for the treatment of severe malaria. However, the efficacy of this single drug as compared to the combined drug regimen remained questionable, and the clinical response was considered delayed or inappropriate. Therefore, this research intended to evaluate the efficacy of only IV artesunate versus IV artesunate plus IV quinine in the treatment of severe malaria in children. The findings of the study would be helpful knowing whether the two drugs, when given together, have considerable benefit over single-drug therapy when given for the same.

Primary Outcome Measures: Efficacy measurement between IV Artesunate and IV Artesunate plus IV Quinine Hydrochloride, The outcome was measured in the number of hours elapsed for an individual to become fever-free., Seven days
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
NCT Number: NCT06472245
Acronym: ARTEMIA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Patients With Non-Small Cell Lung Cancer
Interventions: DRUG: OSE2101|DRUG: Docetaxel|DEVICE: NGS HLAA2 assay
Sponsor: OSE Immunotherapeutics
Collaborators: Exystat|Genome Diagnostics (GenDx)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 363
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2028-12-15
Locations: Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, 20007, United States|Alliance for Multispecialty Research (AMR) - Kansas City Oncology, Merriam, Kansas, 66204, United States|NHO Revive Research Institute LLC, Lincoln, Nebraska, 68506, United States|Optum Medical Care - Carmel/Brewster Campus, Brewster, New York, 10509-2338, United States|Optum Medical Care - Fishkill Westage Campus, Fishkill, New York, 12524, United States|Optum Hematology Oncology - Lake Success, Lake Success, New York, 11042, United States|Optum Medical Care - Mount Kisco Campus 90, Mount Kisco, New York, 10549, United States|Optum Medical Care - Poughkeepsie, Poughkeepsie, New York, 12601, United States|Brooklyn Radiation Oncology, Richmond Hill, New York, 11418, United States|Bon Secours Hematology and Oncology, Greenville, South Carolina, 29607, United States

Summary:
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance.

Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).

Primary Outcome Measures: OS defined as time from randomization to death, OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date, From randomization date through study completion, an average of 3 years
Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia
NCT Number: NCT06472232
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Obstetric Labor
Interventions: DRUG: Chloroprocaine
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Collaborators: Beijing Obstetrics and Gynecology Hospital|International Peace Maternity and Child Health Hospital|Women's Hospital of Nanjing Medical University|Anhui Women and Children's Medical Center|Jiaxing Maternity and Child Health Care Hospital|Gansu Maternal and Child Health Center|Urumqi Maternal and Child Health Center|Shengjing Hospital|Zhongnan Hospital of Wuhan University|The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University|The Second Norman Bethune Hospital of Jilin University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 356
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-18
Completion Date: 2025-09-30

Summary:
Women requiring epidural labor analgesia were randomized into two groups, one with the local anesthetic chloroprocaine and the other with ropivacaine. The primary outcome was to observe the analgesic scores of the two groups of drugs as well as adverse reactions.

Primary Outcome Measures: Percentage of effective analgesia, Percentage of effective analgesia within 30 min after the first epidural addition at the beginning of labor analgesia in both groups, 30 min after the first epidural addition at the beginning of labor analgesia
The Utility of Shanfield Implantation Technique During Creation of Mitrofanoff Procedure in Pediatric Age Group
NCT Number: NCT06472193
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bladder Dysfunction
Interventions: PROCEDURE: Shanfield implantation technique in Mitroffanof procedure
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2025-08-01
Locations: Sohag university Hospital, Sohag, Egypt

Summary:
Management of bladder dysfunction was revolutionized by the introduction of intermittent catheterization by Lapides. Later, Mitrofanoff described a trans-appendicular continent cystostomy, launching a new concept whereby the bladder could be emptied by a route other than the urethra.

Clean intermittent catheterization (CIC) is one of the main tools for neurogenic lower urinary tract dysfunction management, as it provides adequate bladder emptying and protects the upper urinary tract from high pressures, hence preventing progressive renal damage.

Despite its important role, CIC is difficult to perform in various situations: lack of manual dexterity, female wheelchair patients, body habitus, anatomical morbidity due to extensive surgery or psychological problems. For such patients, continent urinary diversion (CUD) is a viable option for bladder emptying optimization.

Various techniques have been described to create an anti-reflux appendicovesical anastomosis in pediatric lower urinary tract reconstruction, whether performed via an extravesical or an intravesical route, all share a common denominator of creating a submucosal tunnel in an attempt to replicate the physiological anti-reflux mechanism.

Primary Outcome Measures: antireflux competence of stomal end of the Mitrofanoff conduit, The percentage of patients with whom leakage of urine occured in between CICs, 18 months
Sectional Versus Full Glass Ceramic Laminate Veneers
NCT Number: NCT06472180
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spacing of Anterior Teeth
Interventions: PROCEDURE: Glass ceramic sectional veneer|PROCEDURE: Glass ceramic laminate veneer
Sponsor: October University for Modern Sciences and Arts
Sex: ALL
Age: ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2025-05-01
Locations: October University for Modern Sciences & Arts, Giza, Giza, 6th October City, 12451, Egypt

Summary:
The aim of the study is to assess the marginal adaptation, color stability and clinical performance of glass ceramic sectional veneers compared to full laminate veneers There's two null hypotheses , the first is that there is no difference in the marginal adaptation of sectional and full glass ceramic laminate veneers.

the Second is that there is no apparent change in color stability and clinical performance of sectional and full glass ceramic laminate veneers.

Primary Outcome Measures: Marginal adaptation of sectional and full glass ceramic laminate veneer using digital device intraoral scanner, assessment of the marginal adaptation using digital device intraoral scanner software, Baseline,3,6,9,12 months
Secondary Outcome Measures: Color stability, assessment of the Color stability using intraoral scanner, Baseline,3,6,9,12 months|Clinical performance, categorical outcome of clinical performance using FDI(World Dental Federation) criteria, Baseline,3,6,9,12 months
Breathing Exercises on Lung Function
NCT Number: NCT06472167
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breathing Exercises
Interventions: BEHAVIORAL: Breathing exercises
Sponsor: Mansoura University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-11-10
Locations: Mohamed AbdElmoniem, Mansoura, 35516, Egypt

Summary:
aim of this study is to evaluate the efficacy of pulmonary rehabilitation program as a non-pharmacological treatment method to: Improve functional capacity as assessed by six-minute walking distance (6MWD) test. Improve dyspnea level as assessed by Medical Research Council (MRC) dyspnea scale. Improve pulmonary function tests and arterial blood gas.

Primary Outcome Measures: Impact of breathing exercises on Forced expiratory volume on first second (FEV1) in liter, Effect of Breathing exercises on lung function using spirometry, 6 months|Impact of breathing exercises on Forced vital capacity (FVC) in liter, Effect of Breathing exercises on lung function using spirometry, 6 months
The Effect of Chinese Five-element Music
NCT Number: NCT06472154
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Anxiety
Interventions: OTHER: Experimental|OTHER: Control
Sponsor: University of Malaya
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-01-01
Completion Date: 2023-12-31
Locations: Qinhuangdao No. 5 Hospital, Qinhuangdao, Hebei, 066000, China

Summary:
Depression and anxiety among the older adults is an issue that cannot be ignored at present. Compared to traditional pharmacological treatments and electroconvulsive therapy, non pharmacological treatments with fewer side effects, such as music-based intervention, are also effective and more easily accepted for the treatment of depression and anxiety in the older adults. In China, there have been some researches conducted Chinese five elements music as a clinical treatment for relieving depression and anxiety disorders in patients. However, there is few research on the impact of Chinese five elements music-based intervention based on midnight-noon ebb-flow theory on depression and anxiety in the older adults. This study investigated the intervention effect of Chinese five elements music-based intervention accompanied by midnight-noon ebb-flow theory on depression and anxiety in older adults.

Primary Outcome Measures: Hamilton Depression Rating Scale (HAM-D), The 17 items of the original HAM-D measure the degree of depression, feelings of guilt, suicidal thoughts, insomnia, ability to work and be active, language and cognitive retardation, agitation, anxiety (psychological and somatic), gastrointestinal, genital or general symptoms, hypochondriasis, weight loss and awareness of illness. Similar to the HAM-A, more than half of the items have values between 0 and 4. All other values are between 0 and 2, with the exception of weight loss (0-3). Individuals who score between 0 and 7 are considered normal or in remission. According to UF Health (2011b), a total score of more than 20 is considered an indication of at least moderate to severe depression, 12 months|Hamilton Anxiety Rating Scale (HAM-A), The 14 items of the HAM-A relate to psychological and somatic symptoms such as tension, insomnia, nervousness, depression and somatic symptoms. They also cover behavioral problems identified during the interview, such as restlessness or fidgeting, as well as problems with the respiratory tract, gastrointestinal tract, cardiovascular system, genitourinary system or autonomic system. With a total score of 0-56, each element is rated on a scale from 0 (not present) to 4 (extremely severe). According to UF Health (2011a), individuals who score between 0 and 7 are considered normal or in remission, a total score of less than 17 more than 7 indicates low anxiety, 18-24 indicates mild to moderate anxiety, and 25-30 indicates moderate to severe anxiety., 12 months
Effectiveness of Cervical Stabilization Exercises in Individuals With Temporomandibular Joint Disorder
NCT Number: NCT06472141
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Temporomandibular Joint Disorders
Interventions: OTHER: Cervical stabilization exercises|OTHER: Standard treatment (Education + home exercises)
Sponsor: Bitlis Eren University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2025-06-24

Summary:
It is planned to examine the effect of cervical stabilization exercises on Temporomandibular Joint (TMJ) symptoms in individuals with TMJ disorder.

Primary Outcome Measures: Numeric Rating Scale (NRS), TMJ and neck pain will be evaluated at rest, during activity and at night with the NRS scale. It is a scale scored between 0-10 points and '0 points means 'I have no pain' and '10 points means 'I have unbearable pain'. NRS score between 1-3 points indicates mild pain, between 4-6 points indicates moderate pain and between 7-10 points indicates severe pain., Change from baseline at 8 weeks|Pain Threshold, The pain threshold of the individuals will be measured with an analog algometer. Measurements will be made from the bilateral side with the algometer held perpendicular to the skin, the most bulging part of the masseter muscle, 2 cm behind the anterior border of the temporalis muscle (on the line between the upper orbital edge and the upper point of the ear) and lateral to the temporomandibular joint. Measurements will also be taken from the trapezius muscle for the neck. For this, measurements will be taken at the midpoint of the C7 spinous process and the acromion., Change from baseline at 8 weeks|TMJ Range of Motion, TMJ range of motion (maximum mouth opening, lateral deviation and protrusion) will be measured with a digital caliper., Change from baseline at 8 weeks|The Fonseka Questionnaire, It assesses TMJ disorder and its severity. The questionnaire includes three options: "yes" (10 points), "sometimes" (5 points) and "no" (0 points). A total score of 0-15 is considered as no TMJ disorder, 20-40 as mild, 45-65 as moderate, and 70-100 as severe., Change from baseline at 8 weeks|Cervical Posture, Cervical posture will be evaluated from the craniovertebral angle., Change from baseline at 8 weeks|Cervical Mobility, For cervical mobility, normal joint movements of the neck will be evaluated with a goniometer., Change from baseline at 8 weeks|Cervical Muscle Performance, Cervical muscle performance will be evaluated with the craniocervical flexion test., Change from baseline at 8 weeks
Secondary Outcome Measures: Jaw Function Limitation Scale (JFSL-20), It is a 20-question scale that evaluates the extent to which jaw functions are restricted with a score between 0-10. A high score on the scale indicates a high level of impairment., Change from baseline at 8 weeks
Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children
NCT Number: NCT06472115
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder|Autism
Interventions: BEHAVIORAL: Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS)
Sponsor: Stanford University
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-06-01

Summary:
This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.

Primary Outcome Measures: Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment., Baseline,16 week|Change from baseline in clinician rated clinical global impressions scale scores during treatment., Baseline,16 week
Secondary Outcome Measures: Change in Parent Rated Anxiety Scale scores for youth with ASD during treatment, Baseline, 16 week|Change in Emotion Regulation Checklist scores during treatment, Baseline, 16 week|Change in Daily Living Skills Scale Scores during treatment, Baseline, 16 week|Change in Open Source - Challenging Behavior scores during treatment, Baseline, 16 week
Romosozumab Versus Denosumab in GIOP: a 2-year Extension Study
NCT Number: NCT06472050
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Osteoporosis|Glucocorticoids Toxicity
Interventions: DRUG: Romosozumab|DRUG: Denosumab
Sponsor: Tuen Mun Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 63
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-03
Locations: Department of Medicine, Tuen Mun Hospital, Hong Kong, China

Summary:
The investigators conducted an open-label randomized controlled trial (RCT) in chronic glucocorticoid (GC) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (ROMO) for 12 months followed by denosumab (DEN) for 12 more months vs DEN for 24 months throughout. Superiority of ROMO/DEN to DEN/DEN in raising the spine bone mineral density (BMD) was demonstrated at month 12 and month 24. The present study was to report the further BMD changes at 48 months (2 year extension) for those participants who were maintained on DEN treatment.

Primary Outcome Measures: change in BMD at the lumbar spine, spine BMD, 24 more months after RCT completion
Secondary Outcome Measures: change in BMD at non-dominant hip and femoral neck, hip and femoral neck BMD, 24 more months after RCT completion