pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Clostridioides Difficile Trial of REC-3964
NCT Number: NCT06536465
Acronym: ALDER
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Recurrent Clostridioides Difficile Infection
Sponsor: Recursion Pharmaceuticals Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-10

Summary:
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of RE-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides Difficile infection (CDI)."

Primary Outcome Measures: Treatment-Emergent Adverse Events, Incidence of treatment emergent adverse events (AEs), Assessed from time of ICF signature through 28 days following the cessation of treatment or observation period)|Serious and Related Treatment Emergent Adverse Events, Safety and tolerability will be assessed by the following endpoints: incidence , severity, and relatedness of adverse events (AEs) and serious adverse advents (SAEs); and incidence of treatment-emergent adverse events (TEAEs) leading to study drug discontinuation., 56 days
Secondary Outcome Measures: Rate of recurrent Clostridioides difficile infection (rCDI), Proportion of patients with severe recurrent Clostridioides difficile infection (rCDI), recurrent Clostridioides difficile infection (rCDI) associated hospital admissions, At least 4 weeks after EOT with REC 3964 upon resolution of the initial Clostridioides difficile infection (CDI) diarrheal episode with vancomycin.|Time to recurrence, From time after treatment with REC 3964 until time of confirmed recurrence, From date of randomization until the date of recurrent Clostridioides difficile infection (rCDI) assessed up to eight weeks|Evaluation of diarrheal episodes., The number of unformed \[types 5-7 on the Bristol stool scale\] bowel movements per day, From date of randomization until the date of recurrent Clostridioides difficile infection (rCDI) assessed up to eight weeks|To characterize the pharmacokinetics (PK) of REC 3964, Plasma pharmacokinetics (PK) parameters, as appropriate, including but not limited to Cmax, Pre-dose, 1 hour, 3 hours, and 6 hours the morning dose at the Day 1, and Day 15.|To characterize the pharmacokinetics (PK) of REC 3964, Plasma pharmacokinetics (PK) parameters, as appropriate, including but not limited to Tmax, Pre-dose, 1 hour, 3 hours, and 6 hours the morning dose at the Day 1, and Day 15.|To characterize the pharmacokinetics (PK) of REC 3964, Plasma pharmacokinetics (PK) parameters, as appropriate, including but not limited to Ctrough, Pre-dose, 1 hour, 3 hours, and 6 hours the morning dose at the Day 1, and Day 15.
Hematopoiesis in MBL and CLL Versus Healthy Age-Matched Control Subjects
NCT Number: NCT06536452
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Lymphocytic Leukemia|Monoclonal B-Cell Lymphocytosis
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-11-18
Completion Date: 2026-11-18
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study evaluates hematopoiesis to determine how MBL/CLL affected bone marrow responds to fight off infections in the body.

Primary Outcome Measures: Effects of MBL on bone marrow function, Samples collected from healthy participants and participants with MBL will be compared for differences in bone marrow function (i.e., ability to fight off infection). Results will be descriptive. With participant permission, samples will be stored for future research use., Baseline|Effects of CLL on bone marrow function, Samples collected from healthy participants and participants with CLL will be compared for differences in bone marrow function (i.e., ability to fight off infection). Results will be descriptive. With participant permission, samples will be stored for future research use., Baseline
Knee Isometric Program (KIP) Home Exercise Programs (HEP) Physical Therapy (PT) Study
NCT Number: NCT06536426
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anterior Knee Pain Syndrome
Interventions: BEHAVIORAL: Knee Isometric Program (KIP)
Sponsor: The Methodist Hospital Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-02
Completion Date: 2030-08-08
Locations: Houston Methodist Research Institute, Houston, Texas, 77030, United States

Summary:
The purpose of this study is to evaluate the efficacy of a knee isometric program (KIP) as compared to the current gold standard treatment for anterior knee pain (Patellofemoral Clinical Practice Guideline \[CPG\] - Academy of Orthopedic Physical Therapy).

Primary Outcome Measures: Subjective Pain, Participants will complete the Numerical Pain Rating Scale (NPRS) in a pain and medication journal in order to subjectively rate their pain over over 4-5 days between each session, except for after session 4 in which they will document twice a day for 20 days. The NPRS rates pain on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable, and subjects will reflect pain pre and post physical therapy. Additionally, they will be asked to reflect any pain medication that they take on a given day., Baseline, 2 weeks, 4 weeks, 6 weeks, 12 weeks|Knee Function, Participants will complete the lower extremity functional scale (LEFS) at session 1 and at session 5 (one month follow up visit after completing physical therapy) in order to determine any change in knee function across those time periods. The LEFS is a 20 question survey that asks about a person's ability to perform everyday tasks and each question is scored on a scale from 0 to 4 with 0 being extreme difficulty or unable to perform activity and 4 being no difficulty. These responses are then summed to get a total score out of 80 maximum points, and the lower the score, the greater the disability., Baseline, 12 weeks|Objective Muscular Strength Performance, Participants will have their quad strength measured using a handheld dynamometer (HHD) at session 1 and session 5 of their study visits in order to determine with that data how muscular strength changes following each physical therapy regimen., Baseline, 12 weeks|Functional Stability, Functional stability will be assessed at sessions 1 and 5 to determine each participant's dynamic balance, and it will be used to assess anterior reach specifically. This test has the participant stand on one leg while reaching out in 3 different directions with the other lower extremity, and thus measures strength, stability, and balance in multiple directions. The composite score is calculated by summing the three reach directions. Higher scores reflect better outcomes., Baseline, 12 weeks
Neprilysin Inhibition to Reduce Myocardial Fibrosis in Heart Failure With Preserved Ejection Fraction
NCT Number: NCT06536309
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Heart Failure With Preserved Ejection Fraction|Myocardial Fibrosis
Interventions: DRUG: Sacubitril-valsartan|DRUG: Valsartan
Sponsor: Brigham and Women's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2029-09

Summary:
Cardiac magnetic resonance imaging (MRI) measures of myocardial interstitial fibrosis (MIF) are elevated in heart failure with preserved ejection fraction (HFpEF) patients and associated with poor prognosis. Extracellular volume (ECV) is the most reproducible and best validated cardiac MRI measure of MIF. Sacubitril/valsartan reduces histological MIF in mice and levels of some extracellular matrix regulatory proteins in humans with HFpEF. However, the effect of sacubitril/valsartan on robust measures of MIF in humans is unknown. Demonstrating reductions in ECV with sacubitril/valsartan would clarify the mechanism of this approved medication. Given the borderline reduction in heart failure hospitalizations with sacubitril/valsartan and the heterogeneity of HFpEF pathophysiology, this result would suggest that neprilysin inhibition may particularly benefit HFpEF patients with greater MIF. The investigators propose a proof-of-concept clinical trial to evaluate the effect of neprilysin inhibition (sacubitril/valsartan vs valsartan alone) on cardiac MRI measures of fibrosis (principally ECV) and circulating protein levels.

Primary Outcome Measures: Change in extracellular volume by cardiac MRI, The primary outcome is to evaluate the change in extracellular volume (ECV), measured by cardiac MRI, from baseline to one year, in the sacubitril/valsartan arm compared to the valsartan arm, 1 year
Secondary Outcome Measures: Change in left ventricular native T1 time, Measured by cardiac MRI, 1 year
Other Outcome Measures: Change in left ventricular mass, Measured by cardiac MRI, 1 year|Change in left atrial size, 1 year
Opiophobia in Postsurgical Adults With Cancer
NCT Number: NCT06536283
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Opiophobia
Interventions: OTHER: 13-item Barriers Questionnaire (BQ-13)|OTHER: Four-item Medication Adherence Questionnaire|OTHER: 14-item Hospital Anxiety and Depression Scale (HADS)
Sponsor: M.D. Anderson Cancer Center
Collaborators: Sigma Theta Tau International
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-12-14
Completion Date: 2026-12-31
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To learn how people who underwent surgery feel about their prescribed opioid medication after they leave the hospital.

Primary Outcome Measures: To explore the barriers and fears related to use of opioids among a population of adults who underwent surgery for cancer., Use of opioids among a population of adults who underwent surgery for cancer., Through study completion, an average of 1 year.
Development of a Web-Based Food Frequency Questionnaire and Diet Quality Score for Turkish Adults
NCT Number: NCT06536270
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Nutritional Assessments|Nutritional Quality
Interventions: OTHER: A validation and reproducibility study with a cross-sectional component
Sponsor: Medipol University
Collaborators: University of Reading
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-19
Completion Date: 2024-11-30
Locations: Istanbul Medipol University, İstanbul, Beykoz, 34810, Turkey

Summary:
This research aims to adapt and validate the web-based eNutri Food Frequency Questionnaire (FFQ) and Diet Quality Score (DQS) for the Turkish population, addressing the current gap in dietary assessment tools for Turkey. The study involves adapting the UK-based eNutri FFQ to reflect Turkish dietary habits, including revising the food list, capturing portion size photos, and incorporating local food composition data. The revised FFQ will be validated against three 24-hour dietary recalls and tested for reproducibility.

Primary Outcome Measures: Validity of the web-based FFQ, Assesses the validity of the adapted eNutri FFQ by comparing its results with those from three 24-hour dietary recalls. Validity is evaluated based on nutrient intake measurements., 14-day period|Reproducibility of the web-based FFQ, Measures reproducibility by administering the FFQ twice to participants and analyzing the consistency of the results. Consistency of results; statistical measures will be used for analysis., 14-day period
Secondary Outcome Measures: Usability of the web-based FFQ, Evaluates usability through participant feedback on a scale (e.g., Likert scale) on the clarity and ease of use of the FFQ and portion size images., Immediately after the first FFQ administration|Usability Comparison of 24-Hour Recall and web-based FFQ, Compares dietary intake data obtained from the 24-hour recall method (reference method) with that obtained from the FFQ administered after the second FFQ to assess usability., Immediately after the second FFQ administration
Impact of Perioperative Anesthetic Management on Renal Cancer Progression.
NCT Number: NCT06536244
Status: WITHDRAWN
Study Type: OBSERVATIONAL
Conditions: Perioperative Anesthetic|Renal Cancer
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-07-31
Completion Date: 2028-09-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
The relationship between perioperative drugs, including preoperative medications, anesthetics, and analgesics, and postoperative outcomes in cancer patients is a complex and evolving field of study. Understanding how those medications might impact outcomes such as pain, acute kidney injury, and recurrence is crucial for optimizing perioperative care in renal cancer patients.

Primary Outcome Measures: Postoperative complications, 72 hours and 30 days postoperatively
Secondary Outcome Measures: Overall survival, The length of time from surgery to last follow-up alive or death., Recurrence-free survival:The length of time from surgery to last seen without recurrence or with recurrent disease.
Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients
NCT Number: NCT06536231
Acronym: HERICA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Critical Illness
Interventions: PROCEDURE: Remote ischemic conditioning
Sponsor: Lithuanian University of Health Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-01-01
Completion Date: 2025-03-31
Locations: The Hospital of Lithuanian University of Health Sciences Kauno klinikos, department of Intensive care, Kaunas, 50161, Lithuania

Summary:
The main objectives of this study are to evaluate the changes in hemodynamics occurring during the remote ischemic conditioning (RIC) procedure and to compare the hemodynamic responses elicited by passive leg raising before and after the RIC intervention.

Primary Outcome Measures: Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure, Change in this parameter is determined during each inflation and release of the blood pressure cuff., During RIC procedure|Maximal change in cardiac index during RIC procedure, Change in this parameter is determined during each inflation and release of the blood pressure cuff., During RIC procedure|Maximal change in peripheral perfusion index during RIC procedure, Change in this parameter is determined during each inflation and release of the blood pressure cuff. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff., During RIC procedure|The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during the RIC procedure and those observed during passive leg raising (PLR)., The maximum changes in these parameters, as determined by the RIC procedure and PLR, were identified, and their correlation was subsequently calculated. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff., During RIC procedure, as well as during passive leg raising.|The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during PLR before the RIC procedure and those observed during PLR after the RIC procedure., The maximum changes in these parameters, as measured during PLR before and after the RIC procedure, were identified. Subsequently, the correlation between these changes was calculated. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff., During PLR both before and after the RIC procedure.
Secondary Outcome Measures: The correlation between the maximum perfusion index (PI), the time to reach maximum PI during cuff release and the maximal changes in stroke volume index, cardiac index and perfusion index observed during PLR., In this context, PI is measured on the arm where the blood pressure cuff is placed. Upon cuff release, both the maximum PI and the time to reach this maximum are recorded., During RIC procedure, as well as during PLR.
Sleep Disorder Mindfulness Stress Reduction Intervention
NCT Number: NCT06536218
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patients in the Sleep Clinic
Interventions: BEHAVIORAL: CONSCIOUS AWARENESS STRESS REDUCTION PROGRAM APPLICATION
Sponsor: Muş Alparlan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-01
Completion Date: 2024-09-01
Locations: Muş Alparslan University, Muş, 49100, Turkey

Summary:
Sleep problems, ranging from mild sleep disturbance to debilitating insomnia, are among the most common health problems occurring in adults, with an estimated prevalence of 35% to 48% (Morin et al., 2009; Mai and Buyss 2008). Insomnia is a fairly common sleep disorder characterized by difficulty falling asleep, difficulty staying asleep, or waking up too early despite adequate sleep opportunity, recurring at least three times a week and accompanied by significant stress or distress during the day (Morin and Jarrin, 2013). ). According to the American guidelines for the treatment of chronic insomnia published in 2017, pharmacotherapy and non-pharmacological treatment are the two main treatment methods for sleep disorders ( Sateia et al., 2017 ).Mindfulness-based stress reduction (MBSR) is an important type of non-pharmacological mindfulness-based intervention that effectively relieves insomnia by decentering (Banno et al., 2019).Regarding the effect of mindfulness intervention in sleep disorders, Ong and Moore suggest that mindfulness can improve sleep by reducing both primary and secondary arousal (Ong and Moore, 2020).Therefore, this study aims to expand the existing investigations by examining whether mindfulness meditation (MBSR) is associated with changes in objectively measured polysomnographic (PSG) sleep profiles of patients with sleep disorders who applied to the Sleep EMG department of Muş State Hospital, and to examine the changes in PSG sleep in the context of a randomized controlled trial. It aims to determine the effect on quality of life by associating it with subjectively reported sleep and stress changes.

Primary Outcome Measures: Sleep Status, Conscious Awareness Stress Reduction Program does not affect the sleep status of patients with sleep disorders., 11 WEEKS|Perceived Stress, Mindfulness Stress Reduction Program Affects the perceived stress level of patients with sleep disorders, 11 WEEKS|Life quality, Conscious Awareness Stress Reduction Program affects the quality of life of patients with sleep disorders., 11 WEEKS
Acceptance-commitment Therapy-based Psychoeducation for Individuals Experiencing Earthquakes
NCT Number: NCT06536205
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Violent Traumatic Event Having Been in an Earthquake (History)
Interventions: BEHAVIORAL: psychoeducation
Sponsor: Mustafa Kemal University
Collaborators: University of Gaziantep
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-03-21
Completion Date: 2024-08-21
Locations: Hatay Mustafa Kemal University, Hatay, Antakya, 31060, Turkey

Summary:
This research aims to reduce the stress level of individuals within the scope of acceptance and determination-based psychoeducation, to increase the individual's positive expectations for the future, to increase the sense of hope, which represents the individual's belief in the world and his thoughts that life is worth living, and to increase the individual's adaptation and coping skills after negative situations. It is aimed to increase the defined psychological resilience. The research is planned to be carried out with individuals registered in Bursa-Kütahya container city and Qatar-2 Container city in Hatay Antakya District and who experienced the earthquake centered in Kahramanmaraş on February 6, 2023. The population of the research will consist of individuals who experienced the earthquake registered in Bursa Kütahya container city and Qatar-2 container city. The sample of the research will consist of 40 people living in Bursa Kütahya container city and Qatar-2 container city and agreeing to participate in the research. The experimental group will be composed of 60 people, while 40 people will constitute the control group. In both groups, an introductory information form, Dispositional Hope Scale, The Brief Resilience Scale and Posttraumatic Diagnostic Scale will be applied to individuals with face-to-face interview technique and the answers given by the individuals will be recorded. After 8 weeks of acceptance and commitment-based psychoeducation is given to the experimental group, the forms used in the research will be re-administered to both the experimental group and the control group. Follow-up will be done 3 months after the last session of the training. The research will be conducted as a randomized controlled experimental. The research is planned between March 2024 and 20 September 2024.

Primary Outcome Measures: Acceptance-commitment therapy-based psychoeducation, Individuals living in container cities and willing to participate in the study were identified. Experimental and control groups were determined among these individuals by randomization method. Training was given to the experimental group., 2 months
Improving Gynecological Examination Skills with the Use of a Model
NCT Number: NCT06536192
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gynecologic Nursing|Training Group, Sensitivity|Gynecologic Disease
Sponsor: Karabuk University
Sex: FEMALE
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08-25
Completion Date: 2025-01-15

Summary:
Vaginal, abdominal, and breast examinations are among the essential gynecological examination skills for midwifery students and are crucial steps that need to be learned. However, due to the privacy of genital areas, there are some debates regarding the teaching of these skills. Low-fidelity mannequins and models are particularly effective and cost-efficient in acquiring basic psychomotor skills. Thus, midwifery students can gain clinical experience, make mistakes in a safe environment, and enhance their skills. The sample of this study consists of 64 midwifery students (experimental=32, control=32) using a pre-test, post-test design with an observational randomized controlled trial. Data collection instruments include a Personal Information Form (PIF), Learner's Guide (LG), Self-Confidence Scale (SCS), and Self-Confidence in Learning Scale (SSSCLS. In the experimental group, after providing theoretical knowledge, students will receive practical training on a gynecological examination model, including bimanual examination, vaginal examination with a speculum, pap smear for cervical screening, and pelvic palpation. Each student will then perform the examination individually, with approximately 15 minutes allocated per student. Two weeks later, the same students will be asked to perform all examination steps again. During the examinations, the researcher will mark complete and incomplete procedures in the learner's guide, and any deficiencies will be explained to the students for completion. The CS and SSSLS will be administered for the post-test. In the control group, after theoretical knowledge is provided, students will be shown visual and video demonstrations of the steps of a gynecological examination. The PIF and SCS will be administered for the pre-test, and two weeks later, students will be asked to perform the examination steps in a laboratory setting, followed by the post-test.

Primary Outcome Measures: Improving gynecological examination skills with the use of a model, Gynecologic Disease, Groups of 5 people receive 15 minutes of laboratory training and 15 days later, practice in the laboratory.
New Preclinical and Clinical Approaches to Mesothelioma
NCT Number: NCT06536179
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mesothelioma
Sponsor: Marco Emilio Bianchi
Collaborators: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2027-01-25
Locations: Istituto Nazionale Tumori IRCCS Fondazione G.Pascale, Napoli, Campania, 80131, Italy|IRCCS San Raffaele, Milan, Lombardia, 20132, Italy

Summary:
This study protocol involves the coordination between UO1 (IRCCS San Raffaele Hospital) and UO2 (Istituto Nazionale Tumori di Napoli - IRCCS G. Pascale) to explore the role of HMGB1 and CXCR4 in cancer treatment and metastasis. UO1 focuses on the role of HMGB1 in inflammation, mesothelioma progression, and tissue repair, as well as developing, in future, possible HMGB1 inhibitors for cancer therapy. UO2 specializes in CXCR4's role in cancer, developing CXCR4 antagonists, and tracking CXCR4-dependent metastasis. The hypothesis is that targeting HMGB1 and CXCR4 pathways will inhibit tumor progression and metastasis, enhancing anti-tumor immunity and improving therapeutic outcomes in cancer.

Primary Outcome Measures: To set up spheroids models to study and serve as a platform, Number of spheroids with infiltrated macrophages. About of 30% of macrophages infiltrated into spheroids., 0/baseline|To set up spheroids models and serve as a platform, Evaluation of macrophages polarization status M1 or M2 based on different genes and proteins expression using qPCR and Flow Cytometry., 0/baseline|To set up organoid models, Number of organoids formation. About of 30% of biopsies generated organoids., 0/baseline|Test inhibitors on spheroids and organoids and assess the response of individual patients to therapy, Rate of growth to test the efficacy of anti-CSF1R, BoxA and DFL using human mesospheres from MPM primary cell lines derived from patients and monocytes from controls., 0/baseline
Secondary Outcome Measures: To investigate inhibitors of the CXCR4-CXCL12-HMGB1 axis on the crosstalk, Percentage of migrated or invaded MPM cell lines NCI-H2052 (BAP1 WT/NF2 MUT) vs NCI-H28 (BAP1 mut/NF2 WT) with and without macrophages in presence of CDDP-Nivolumab (NIVO)-Peptide R54., 0/baseline|To investigate inhibitors of the CXCR4-CXCL12-HMGB1 axis on the crosstalk, Percentage of cell death of Tregs/Macrophages from peripheral blood and pleural effusion derived from MPM patients treated with and without R54., 0/baseline|To investigate inhibitors of the CXCR4-CXCL12-HMGB1 axis on the crosstalk, Overall survival of mice with MPM treated with CDDP-anti-PD-1/R54., In vivo experiment 3 weeks.
Other Outcome Measures: Repurposing Diflunisal as antitumor drug in MPM, Overall survival of MPM mice treated with DFL in combination with the gold-standard treatment of MM patients, i.e. checkpoint inhibitors (Nivolumab + Ipilimumab)., In vivo experiment 3 weeks.
Ruxolitinib Treatment in Inclusion Body Myositis
NCT Number: NCT06536166
Acronym: BIGTIM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Inclusion Body Myositis, Sporadic
Interventions: DRUG: Ruxolitinib|DRUG: Placebo
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2028-04-15

Summary:
Refer to the "Detailed Description" section.

Primary Outcome Measures: 6 minutes-walk distance (6MWT): A distance walked in 6 min. superior in treated patients compared to placebo group, The 6MWT is performed in a corridor, between two cones separated by a distance of 25 m., 12 months
Secondary Outcome Measures: Adverse events (safety and tolerability) of ruxolitinib in IBM patients, Adverse events collected according to the MedDRA classification, Through study completion that is to say 15 months|Therapeutic muscular efficacy of ruxolitinib on muscle strength, Quantification of muscle strength using dynamometer, Until last consultation that is to say 12 months|Therapeutic muscular efficacy of ruxolitinib on overall muscle status, Measurement of overall muscle status using scales and serum creatine kinase (CK) levels, Until last consultation that is to say 12 months|Respiratory ability, Forced vital capacity (FVC) measurement, 12 months|Evaluate swallowing using Swallowing Disturbance Questionnaire (SDQ), Measurement of the swallowing disorders via Swallowing Disturbance Questionnaire (SDQ). 15 items. Overall score from 0,5 to 44,5. The score increase with the swallowing disorders., 12 months|Quantification of fat replacement of muscle tissue at MRI, Measurement of the differences in fat fraction value calculated on thigh Dixon MRI pictures, 12 months|Evaluate quality of life using Health Assessment Questionnaire without Disability Index (HAQ-DI), Measurement of the difference in the quality of life measured by Health Assessment Questionnaire without Disability Index (HAQ-DI). 8 dimensions rated from 0 (without any difficulty) to 3 (unable to do). Overall score from 0 to 3. The higher the score, the lower the quality of life., 12 months|Evaluate quality of life using Duke health profile, Measurement of the difference in the quality of life measured by Duke health profile - The Duke. 10 dimensions. Overall score from 0 to 100. The score increase with the quality of life., 12 months
Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia
NCT Number: NCT06536153
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Maternal Anemia in Pregnancy, Before Birth|Maternal; Malnutrition, Affecting Fetus
Interventions: COMBINATION_PRODUCT: Amaranth grain flat bread
Sponsor: Hawassa University
Collaborators: Nestlé Foundation
Sex: FEMALE
Age: ADULT
Enrollment: 306
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-10
Completion Date: 2025-01-10

Summary:
Introduction: In Ethiopia, maternal malnutrition is a severe public health issue. Underweight and anaemia are the two most common nutritional problems in pregnant women, and they often coexist.

Methods: A community-based cross-sectional study will be undertaken on a sample of 528 pregnant women in their first trimester to investigate the prevalence of anemia and associated risk factors, as well as the prevalence of co-existing anemia and undernutrition. Following that, a six-month parallel-group community-based randomized controlled trial will be conducted among 306 anemic women to assess the effect of locally prepared amaranth grain flatbread on hemoglobin concentration and anemia prevalence when compared to maize bread, which is commonly consumed among pregnant women.

Primary Outcome Measures: Prevalence of anemia, In pregnancy, anemia is defined as Hemoglobin \<11 g/dl and is classified into three categories based on WHO criteria: mild (10.0-10.9 g/dl), moderate (7.0-9.9 g/dl), and severe (7.0 g/dl), Up to six months|Prevalence of under-nutrition, In this study, the MUAC measurements of pregnant mothers who fall below a cutoff point of 23 cm will be classified as undernourished, while those who measure 23 cm or more will be classified as normal., Up to six months
The Purpose of the Study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Single-ascending and Multiple-ascending Doses of GIM-407
NCT Number: NCT06536101
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: GIM-407|DRUG: Placebo
Sponsor: Georgiamune Inc
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-03
Locations: Nucleus Network Pty Ltd, Melbourne, Victoria, 3004, Australia

Summary:
This study is for the evaluation of the safety, tolerability, PK, PD, and biomarker activity of GIM-407 in healthy volunteers in the absence of any disease-related or potentially confounding factors.

Primary Outcome Measures: Evaluation of Safety, Incidence of treatment emergent AEs, Baseline through Study Completion (up to Day 14)|Evaluation of Safety, Change in laboratory safety assessments from baseline, Baseline through Study Completion (up to Day 14)|Evaluation of Safety, Number of participants with clinically significant abnormal 12-lead ECG results as assessed by the investigator, Baseline through Study Completion (up to Day 14)|Evaluation of Safety, Number of participants with abnormal physical examination findings as assessed by the investigator, Baseline through Study Completion (up to Day 14)
Secondary Outcome Measures: Area Under the Curve (AUC) will be assessed, Area under the plasma concentration versus time curve, Multiple timepoints from Baseline through Study Completion (up to Day 14)|Maximum Plasma Concentration (Cmax) will be assessed, Maximum observed plasma concentration (Cmax), Multiple timepoints from Baseline through Study Completion (up to Day 14)
The Relationship Between Gait and Severity of Femoroacetabular Impingement
NCT Number: NCT06536088
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Femoroacetabular Impingement
Interventions: OTHER: Walking assesment
Sponsor: Gazi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2024-12-30
Locations: Gazi University Hospital, Ankara, 06500, Turkey

Summary:
In this study, the spatiotemporal gait parameters of symptomatic femoroacetabular impingement (FAI) patients scheduled for hip arthroscopy are evaluated. Radiological measurements, including the Alpha angle (AA), Lateral Center-Edge Angle (LCEA), and Kellgren-Lawrence (KL) osteoarthritis classification, are recorded from patient files. The relationship between these radiological measurements and walking parameters is assessed. Additionally, the spatiotemporal gait parameters of FAI patients are compared with those of a healthy control group.

Walking assessments provide valuable insights into how Femoroacetabular Impingement (FAI) affects movement and aid in evaluating treatment outcomes. Research indicates that individuals with FAI experience reduced hip motion and slower walking speeds. By analyzing spatiotemporal gait parameters-such as gait velocity, cadence, step length, and vertical center of mass-the impact of FAI on walking can be better understood, leading to the development of targeted treatment strategies. The goal is to explore the correlation between these gait parameters and imaging-based FAI characteristics in affected individuals.

Primary Outcome Measures: Gait velocity, Gait velocity, also known as walking speed, is a crucial parameter in spatiotemporal gait analysis. It refers to the rate at which an individual walks over a given distance and is typically measured in meters per second (m/s)., Baseline|Cadence, Cadence refers to the number of steps a person takes per minute while walking., Baseline|Step length, Step length refers to the distance covered between two consecutive footfalls of opposite feet., Baseline|Vertical center of mass, The vertical center of mass refers to the vertical position of the body's center of mass during walking. It is the point where the body's mass is considered to be concentrated and it fluctuates as the person moves., Baseline
Functional Analysis of Salivary Glands and Correlation With Sialoscintigraphy in Sjogren's Syndrome
NCT Number: NCT06536075
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sjogren's Syndrome
Interventions: RADIATION: Sialoscintigraphy
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-09-01
Completion Date: 2025-08-01
Locations: National Taiwan University Hospital, Taipei, 100, Taiwan

Summary:
Sjögren's syndrome is a complex autoimmune disorder. The investigators hypothesize that striated ductal cells may function as non-professional antigen-presenting cells in Sjögren's syndrome. However, there are currently no established methods to assess the functional status of striated ductal cells or their relationship with clinical presentations. To address this knowledge gap, the investigators aim to investigate the potential of sialoscintigraphy, a non-invasive imaging technique, to evaluate the functional status of striated ductal cells. The sodium iodide symporter (NIS), predominantly expressed in striated ductal cells, facilitates the transport of technetium-99m, a radiotracer used in sialoscintigraphy. The investigators hypothesize that the expression level of NIS, as evaluated through sialoscintigraphy, may serve as an indicator of striated ductal cell function and potentially correlate with clinical manifestations in Sjögren's syndrome. However, the literature and our preliminary data lead us to hypothesize that age and the specific major salivary gland being evaluated may introduce confounding factors in the interpretation of sialoscintigraphy results. The investigators therefore proposed to 1) establish a nomogram of sialoscintigraphy stratified by age and specific salivary glands. The investigators will recruit healthy volunteers to receive sialoscintigraphy for the nomogram; 2) associate the expression level of NIS in the striated ductal cells from the major salivary glands with sialoscintigraphy, markers of antigen presentation, and disease manifestations of Sjögren's syndrome. The outcomes will help further applications of sialoscintigraphy in Sjögren's syndrome and formulate hypotheses to explore the pathological mechanisms underlying Sjögren's syndrome.

Primary Outcome Measures: Quantitative profiles of sialoscintigraphy, including accumulation velocity and secretion velocity, For establishment of sialoscintigraphy nomogram, 3 months within enrollment
Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.
NCT Number: NCT06536062
Acronym: M-CORD IV
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dry Age-related Macular Degeneration
Interventions: PROCEDURE: Intravitreal injection of CB-PRP
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2026-07-30
Locations: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, 00168, Italy

Summary:
The objective of the study will be to evaluate the efficacy of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP) in order to reduce or stabilize the atrophic progression in dry Age-related Macular Degeneration (AMD).

Primary Outcome Measures: Autofluorescence atrophy area changes in treated eyes compared with sham group, Stabilization of enlargement of hypoautofluorescent area (atrophy) or at most a maximum increase of no more than 20% compared with baseline in treated subjects compared with placebo group from baseline until follow-ups, 24 months
Secondary Outcome Measures: ETDRS visual acuity, Increase of at least two lines from baseline measurement and/or to the contralateral untreated eye at 3 and 6, 12,24 months., 24 months|Mean increase in ONL thickness and retinal volumetrics, Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months, 24 months|Mean increase in retinal volumetrics, Mean increase, measured by high-resolution quantitative OCT, of at least 20% from baseline at 3 and 6, 12, 24 months, 24 months|Stabilization of the atrophy region of the EPR, Stabilization in enface OCT with less than 20% increase from baseline, comparing it with the placebo group, at 3 and 6, 12,24 months., 24 months|Retinography of the ocular fundus, Change in ocular fundus, 24 months|Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA), Change during follow ups, 24 months|Outer retinal atrophy (iRORA), Change during follow ups, 24 months
Other Outcome Measures: Evaluation of therapy safety, Evaluation of major ocular adverse events (bacterial or fungal septic endophthalmitis, retinal detachment, vitreous proliferative-fibrotic reaction with retinal traction, secondary glaucoma, phthisis bulbs, iris rubeosis), studied at slit-lamp evaluation in the anterior and posterior chambers., 24 months
Evaluate the Effects of Food on the Pharmacokinetics of SIM0270
NCT Number: NCT06536036
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: SIM0270
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators: Nanjing Zaiming Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-23
Completion Date: 2024-12-07
Locations: The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, 250014, China

Summary:
This is a randomized, open label, single dose, two-period, crossover trial phase I study.

The purpose of this study is to evaluate the food effect on the pharmacokinetics（PK） of SIM0270 after oral administration under fasted, standard meal, or high-fat diet conditions.

Primary Outcome Measures: PK parameters: Peak Plasma Concentration (Cmax), Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions., Day1 to Day 37|PK parameters:Area under the plasma concentration versus time curve (AUC), Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions., Day1 to Day 37|PK parameters: Half-life (t1/2), Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions., Day1 to Day 37
Secondary Outcome Measures: Adverse events, The incidence and grading of adverse events, as well as abnormal indicators of vital signs, physical examination, electrocardiogram, and laboratory tests., From signing ICF until 18 days after the last dose of medication
This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity
NCT Number: NCT06536023
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Adolescents With Obesity
Interventions: DRUG: IBI362|DRUG: IBI362 placebo
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sex: ALL
Age: CHILD, ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-06
Locations: Beijing Children's Hospital, Capital Medical University Affiliated, Beijin, Beijin, 100045, China

Summary:
The study is a first-in-pediatric assessment of the safety, tolerability, and pharmacokinetic characteristics of multiple doses of IBI362 in Chinese adolescent subjects with obesity. It employs a multicenter, randomized, double-blind, and placebo-controlled trial design. The study plans to enroll 36 adolescents (aged ≥12 years and \<18 years) with obesity who have experienced less than a 5% decrease in Body Mass Index (BMI) after at least 12 weeks of diet and exercise control.

Primary Outcome Measures: Incidence of adverse events and serious adverse events, up to week 20
Secondary Outcome Measures: Area under the Curve (AUC) of multi-dose of IBI362, up to week 12|Half-life (t1/2) of multi-dose of IBI362, up to week 12|Peak serum concentration (Cmax) of multi-dose of IBI362, up to week 12|Clearance (CL) of multi-dose of IBI362, up to week 12|Evaluate changes in subjects' fasting body weight in kilograms，Body Mass Index in kg/m2（BMI, combined with weight and height） relative to baseline, up to week 12|Evaluate changes in subjects' waist-to-hip ratio（combined with waistline and hips） relative to baseline, up to week 12|Evaluate changes in subjects' blood pressure in mmHg relative to baseline, up to week 12|Evaluate changes in subjects' lipid profile in mmol/L relative to baseline, up to week 12|Evaluate changes in subjects' glycated hemoglobin（Hemoglobin A1c,HbA1c）in % relative to baseline, up to week 12|Evaluate the mental health status of subjects by Patient Health Questionnaire (PHQ-9) following administration of IBI362., up to week 20|Evaluate the mental health status of subjects by Columbia-Suicide Severity Rating Scale (C-SSRS) following administration of IBI362., up to week 20