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## How Does Pianistic Musical Training Influence the Development of Alzheimer's Disease? - NCT ID: NCT06378372 - Study ID: ETICA-ULE-064-2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: David Franco Castellanos ### Study Description The goal of this clinical trial is to learn about and describe how pianistic training influences the development of Alzheimer's disease.The key question is: Can pianistic practice influence the development of Alzheimer's disease?Participants will receive piano lessons for 4 weeks (20 sessions) and we will evaluate the evolution of the different parameters described by the tests carried out. ### Conditions - Dementia of Alzheimer Type - Dementia - Dementia, Vascular - Dementia, Mixed - Dementia Frontal - Dementia With Lewy Bodies - Cognitive Decline - Neurologic Disorder - Neurologic Dysfunction - Neurologic Deficits ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Music therapy based on piano learning ### Outcomes Primary Outcomes - State of global deterioration - Minimental Test - RDRS-2 Rapid Disability Assessment Scale - MONTREAL COGNITIVE ASSESSMENT (MOCA) - WAIS-IV - Behavioral disorders: BEHAVE-AD - NPI - CUMMINGS - Evaluation of the caregiver's burden (Zarit test) Secondary Outcomes ### Location - Facility: Universidad de León, León, Castilla Y León, 24004, Spain @@
## Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients - NCT ID: NCT06378359 - Study ID: IDIM-2023-32364 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2026-12-31 - Lead Sponsor: University of Minnesota ### Study Description The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent.The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap.The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome. ### Conditions - Staphylococcus Aureus Colonization - Surgical Site Infections - Healthcare Associated Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Screening and decolonization for SA carriers with the 3 drug bundle - No screening for SA - no screening - Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening. - Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening ### Outcomes Primary Outcomes - Efficacy in eradicating Staphylococcus aureus (SA) Secondary Outcomes ### Location - Facility: University of Minnesota Medical Center and Clinics, Minneapolis, Minnesota, 55414, United States @@
## GU-01: Glycyrrhizin in Prostate Cancer - NCT ID: NCT06378346 - Study ID: 2023-077 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2026-03 - Lead Sponsor: University of Illinois at Chicago ### Study Description This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer (PCa) who are candidates for surgery (radical prostatectomy) ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Glycyrrhizin - Glycyrrhizin - Observation ### Outcomes Primary Outcomes - Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration - Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy Secondary Outcomes - The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). - Assessment of plasma GLY levels after GLY administration - Assessment of blood sodium levels after GLY administration - Assessment of blood potassium after GLY administration - Assessment of serum creatinine after GLY administration - Assessment of serum testosterone levels after GLY administration - Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration - Assessment of interleukin-1β (IL-1β) after GLY administration - Assessment of Tumor necrosis factor α (TNFα) after GLY administration - Assessment of interleukin 6 (IL-6) after GLY administration - Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration - Assessment of Hepatocyte Growth Factor (HGF) after GLY - Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY - Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration - Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration - Gene expression analysis in tumor specimens obtained before administration of GLY - Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY ### Location - Facility: University of Illinois, Chicago, Illinois, 60612, United States @@
## Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area. - NCT ID: NCT06378333 - Study ID: 2024-01-023 - Status: COMPLETED - Start Date: 2022-11-27 - Completion Date: 2024-04-15 - Lead Sponsor: University Hospital, Montpellier ### Study Description The study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with UA defined using T hs-cTn measurements The study includes all patients admitted in 2 French university centers with the confirmed diagnostic of UA defined with clinical ischemic symptoms and T hs-cTn concentrations \< 99 percentile (undetectable: \<5ng/l or non-elevated: \<14ng/l), or ≥ 99 percentile but mildly elevated (14-50ng/l) .The primary end-point included major events at 1-year follow-up (total mortality, new ACS, hospitalization for cardiac causes). ### Conditions - Unstable Angina ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - patients who underwent coronary angiography ### Outcomes Primary Outcomes - Hospitalisation for of unstable Angina Secondary Outcomes ### Location - Facility: University Hospital of Montpellier, Montpellier, N/A, 34295, France @@
## eHealth for Breastfeeding Support - the HOTSPOT Trial - NCT ID: NCT06378320 - Study ID: STUDY20240287 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: University Hospitals Cleveland Medical Center ### Study Description This is a voluntary research study to test use of a phone app that is intended to support breastfeeding specifically for African American and Black people. This is called a "pilot" study because the app is still in development. The goal of this research is to see if mothers use the app more when they receive text "nudges" to look at it compared to not getting those "nudges". The research project is being conducted by Lydia Furman MD.The purpose of the app (which is currently in clickable "wireframe" status, a "pre" app phase) is to support and promote breastfeeding specifically for mothers and fathers/partners who are African American or Black. Other breastfeeding apps have pictures mainly of White or Asian mothers and information that is not oriented toward African American mothers. This app aims to provide accurate and needed breastfeeding information that is culturally attuned.Up to 24 participants will be enrolled at UHCMC, including up to 20 mothers. Other participants will include up to 4 African American or Black fathers/partners whose partners are interested in breastfeeding. ### Conditions - Breast Feeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - App access and Text message - App access only ### Outcomes Primary Outcomes - Maternal participants app usability score - Father/partner participants app usability score - Maternal participants app engagement score - Father/partner participants app engagement score Secondary Outcomes - Maternal participants breastfeeding knowledge at enrollment - Maternal participants breastfeeding knowledge after app exposure - Father/partner participants breastfeeding knowledge at enrollment - Father/partner participants breastfeeding knowledge after app exposure ### Location - Facility: Ahuja Rainbow Center for Women and Children, Cleveland, Ohio, 44103, United States @@
## A Transferability Study on the Conditions for a Successful Inclusive Education - NCT ID: NCT06378307 - Study ID: CHUBX2022-06 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-06-30 - Lead Sponsor: University Hospital, Bordeaux ### Study Description The investigators are conducting a realist evaluation study with a multi-case and qualitative design. The study aims to identify the conditions that promote successful students with disabilities inclusive education at school. This study is nested in the TIAP research (Research to explore the conditions transfer of innovations in the field of disability, with a view to developing a transfer framework). ### Conditions - Inclusive Education ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Effect of inclusive education on children with disabilities autonomy and social participation at school - Effect of inclusive education on children with disabilities autonomy and social participation in their proximal living environment (leisures participation) - Effect of inclusive education on social participation of families with children with disabilities Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA) - NCT ID: NCT06378294 - Study ID: UHACoruna - Status: RECRUITING - Start Date: 2021-04-20 - Completion Date: 2029-12-31 - Lead Sponsor: University Hospital A Coruña ### Study Description Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (IBC) patients undergoing upfront surgery.The ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (ALND) in early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial did not included patients treated with mastectomy, and the AMAROS trial only included 17% of mastectomy patients.The investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Mastectomy ### Outcomes Primary Outcomes - Disease-free survival - Axillary recurrence rate Secondary Outcomes - Overall survival ### Location - Facility: Hospital Universitario Ferrol, Ferrol, A Coruña, 15402, Spain @@
## Testing a New Method to Improve Informed Consent in Prison Research - NCT ID: NCT06378281 - Study ID: CRSK-3_221381 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-09-30 - Lead Sponsor: Stéphanie Baggio ### Study Description Understanding of informed consent is often limited in prison, due to unique challenges faced by detained people. This study will test a modified "teach-to-goal" informed consent process compared to standard procedures. Conducted within a larger study on psychiatric outcomes, it aims to enhance ethical practices for vulnerable populations. ### Conditions - ADHD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Modified teach-to-goal informed consent ### Outcomes Primary Outcomes - Understanding of the informed consent (binary) Secondary Outcomes - Understanding of the informed consent (continuous) - Evaluation of the informed consent ### Location - Facility: Geneva University Hospitals, Geneva, N/A, 1211, Switzerland @@
## PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study) - NCT ID: NCT06378268 - Study ID: 05/24/DD-BVMD - Status: RECRUITING - Start Date: 2024-04-24 - Completion Date: 2026-09-30 - Lead Sponsor: Mỹ Đức Hospital ### Study Description This non-inferiority randomized controlled trial will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam.This study compares the effectiveness of Progestin-Primed Ovarian stimulation versus GnRH protocol for ovarian stimulation in IVF treatment. Participants will be randomly assigned in a 1:1 ratio to receive Progestins or GnRH antagonists. ### Conditions - Progestins Primed Ovarian Stimulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dydrogesterone 10 mg - Cetrorelix 0.25 mg ### Outcomes Primary Outcomes - Ongoing pregnancy Secondary Outcomes - The incidence of premature LH surge - The incidence of premature progesterone elevation - Number of oocytes retrieved - Number of mature oocytes - Number of day 3 embryos - Number of day 5 embryos - Number of good quality day 3 embryos - Number of good quality day 5 embryos - Number of frozen embryos - Incidence of Ovarian hyperstimulation syndrome - Positive ß-hCG test - Clinical pregnancy - Ectopic pregnancy - Early miscarriage <12 weeks - Late miscariage 12-< 22 weeks - Live birth rate - Gestational age at birth - Mode of delivery - Birth weight - Very low birth weight - Low birth weight - High birth weight - Very high birth weight - Preterm birth - Gestational diabetes mellitus - Hypertensive disorders of pregnancy - Maternal mortality - Major congenital abnormalities - NICU admission - Reason for NICU admission - Neonatal mortality ### Location - Facility: My Duc Hospital, Ho Chi Minh City, N/A, 70000, Vietnam @@
## Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity - NCT ID: NCT06378255 - Study ID: PKUSSNCT-23A04 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-09-01 - Lead Sponsor: Peking University Hospital of Stomatology ### Study Description Evaluate the safety and clinical efficacy of new dental desensitizers in the treatment of dentin sensitivity, including the relief of sensitivity symptoms and the duration of efficacy. ### Conditions - Dentin Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Polycation-based new dentinal desensitizer - GLUMA desensitizer ### Outcomes Primary Outcomes - Improvement of dentin sensitivity induced by probe pressure stimulation Secondary Outcomes - Improvement of dentin sensitivity induced by air temperature stimulation ### Location - Facility: Peking University School and Hospital of Stomatology, Beijing, Beijing, 100081, China @@
## To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2 - NCT ID: NCT06378242 - Study ID: RC48-C029 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-23 - Completion Date: 2029-12-31 - Lead Sponsor: RemeGen Co., Ltd. ### Study Description The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2 ### Conditions - High-risk Non-muscle Invasive Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Disitamab Vedotin for injection ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicity(DLT) (Phase I) - Incidence of Adverse event (Phase I) - Recommended Phase II Dose(RP2D) - Maximum Tolerated Dosage(MTD) Secondary Outcomes - Disease-free survival (DFS) rates - Duration of response (DOR) - Disitamab Vedotin anti-drug antibody (ADA) - PK of enfortumab vedotin: Maximum concentration (Cmax) - PK of enfortumab vedotin: Trough concentration (Ctrough) ### Location - Facility: Sun Yat-sen Memorial Hospital,SunYat-sen University, Guangzhou, Guangdong, N/A, China @@
## Psilocybin for Hospitalized Patients With Treatment-resistant Depression - NCT ID: NCT06378229 - Study ID: ONZ-2023-0157 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12-31 - Lead Sponsor: University Hospital, Ghent ### Study Description The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression. ### Conditions - Treatment Resistant Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Psilocybin ### Outcomes Primary Outcomes - Incidence and type of Treatment-Emergent Adverse Events - Columbia-Suicide Severity Rating Scale (C-SSRS) Secondary Outcomes - Recruitment and retention rates. - Qualitative data from the semi-structured interviews with the subjects and their partners. ### Location - Facility: Ghent University Hospital, Gent, Oost-Vlaanderen, 9000, Belgium @@
## Myotonic Dystrophy Type 1 Congenital and Juvenile Form: From Diagnosis to Rehabilitation [MDCJ-NeuBeRe] - NCT ID: NCT06378216 - Study ID: MEDEA 975 - Status: RECRUITING - Start Date: 2022-09-15 - Completion Date: 2024-12-30 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description The rationale of the study is to collect structured data in the neuropsychological, clinical neuroradiologic and neurorehabilitation fields in children/young people affected by congenital and juvenile myotonic dystrophy. Children affected by the congenital form (CDM1) present important brain alterations present since birth while, on the contrary, patients with the adult form of DM1 often present a degenerative, slowly progressive neurocognitive picture. Promising therapies that aim to correct the molecular mechanism underlying the symptoms of adult forms of DM1 are under development, but their potential role at the level of the nervous system and in particular in forms of CDM1 (which appears to be a distinct disorder of neuronal development) is also to be clarified.To this end, a better definition of neurocognitive profiles and their evolution is essential for the purposes of evaluating the effectiveness of experimental therapies. ### Conditions - Myotonic Dystrophy 1 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - neurocognitive evaluations ### Outcomes Primary Outcomes - Motor function evaluation by Muscular Impairment Rating Scale - cognitive evaluation by Wechsler Intelligence scale - cognitive evaluation by Raven Matrices - cognitive evaluation by Continous Performance Test 3 - cognitive evaluation by Trail Making Test A-B - cognitive evaluation by Digit Span and CORSI Test - cognitive evaluation by Rey Figure test Secondary Outcomes - clinical evaluation by Epworth Sleepiness Scale - cognitive evaluation by Wisconsin Card Sorting Test - cognitive evaluation by Tower of London test - cognitive and behavioral evaluation by Minnesota Multiphasic Personality Inventory - cognitive and behavioral evaluation by Vineland Adaptive Behavior Scales ### Location - Facility: Maria Grazia D'Angelo, Bosisio Parini, Lecco, 23842, Italy @@
## Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home: Pilot Project [RIMUDI] - NCT ID: NCT06378203 - Study ID: MEDEA 1013 - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2025-04-15 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description Until twenty years ago physical exercise in muscular dystrophies was considered harmful to the muscle cells, inducing an acceleration of cell necrosis. In fact, it is now certain and validated that an active lifestyle and the practice of controlled and regular physical activity are to be considered therapeutic in neuromuscular pathologies with the aim of optimizing muscular and cardio-respiratory function and preventing atrophy In particular, it seems that the optimal care is extensive and can be carried out in a safe and controlled manner even at home.It is well documented that exercise has beneficial effects on muscle with increased strength and muscular endurance. ### Conditions - Muscular Dystrophies - Limb Girdle Muscular Dystrophy - Facio-Scapulo-Humeral Dystrophy - Becker Muscular Dystrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA) ### Outcomes Primary Outcomes - 6 minute walk test (6MWT) - Motor Function Measure scale (MFM) - Performance of Upper Limb (PUL) - Time up and go (TUG) Secondary Outcomes - Modification of fatigue and quality of life scales from T0 to T6 - Short Form 36 (SF36) ### Location - Facility: Scientific Institute IRCCS Eugenio Medea, Bosisio Parini, Lecco, 23842, Italy @@
## Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology - NCT ID: NCT06378190 - Study ID: TranspoCART19 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2028-10 - Lead Sponsor: Instituto de Investigación Biomédica de Salamanca ### Study Description The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are:Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months. ### Conditions - Refractory B-Cell Lymphoma - B-cell Lymphoma Recurrent ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CAR-T cells therapy ### Outcomes Primary Outcomes - Maximum tolerated dose (MTD) - Efficiency Secondary Outcomes - Procedure-related mortality (PRM) - Toxicity assessment - Response (overall and complete) - Duration of response - Progression-free survival (PFS) - Overall survival (OS) - Perceived general well-being ### Location - Facility: Institut Català d'Oncologia Hospital, Hospitalet de Llobregat, Barcelona, N/A, Spain @@
## A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC) - NCT ID: NCT06378177 - Study ID: LVGN6051-0402-HNSCC - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2027-10-31 - Lead Sponsor: Lyvgen Biopharma Holdings Limited ### Study Description The purpose of this study is to assess the safety and efficacy of LVGN6051 (4-1BB agonistic antibody) combined with toripalimab (anti-PD-1 antibody) and paclitaxel (anti-tubulin chemotherapy) in patients with recurrent/metastatic head and neck squamous cell carcinoma who rapidly progress from previous neoadjuvant, curative, or adjuvant platinum-containing therapy, or who are currently contraindicated for platinum-containing treatment. ### Conditions - Head and Neck Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - LVGN6051 Monoclonal Antibody Injection - toripalimab Injection - Paclitaxel injection ### Outcomes Primary Outcomes - to determine treatment-related adverse events (TRAEs, the safety and tolerability of two preset dose levels ) - to determine objective response rate (ORR) Secondary Outcomes ### Location - Facility: Anhui Cancer Hospital, Hefei, Anhui, 230000, China @@
## The Effect of Combined Volitional and Reactive Step Training in Reducing Falls Risk in Older Fallers - NCT ID: NCT06378164 - Study ID: P0041406 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2026-04 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers. ### Conditions - Older Adults With a History of Falls ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Exercise - Active Control ### Outcomes Primary Outcomes - Choice Stepping Reaction Times - Spring Scale Test Secondary Outcomes - Mini Balance Evaluation System Test - Motor Control Test - Falls Efficacy Scale - International - Trail-Making Test - Programme Adherence - Prospective Falls - Adverse Events ### Location - Facility: The Hong Kong Polytechnic University, Hong Kong, N/A, N/A, Hong Kong @@
## Time-limited Trials in the Emergency Department - NCT ID: NCT06378151 - Study ID: 2023P002243 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-09-30 - Lead Sponsor: Brigham and Women's Hospital ### Study Description A randomized controlled trial of a structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use in seriously ill older adults being admitted to the intensive care unit from the emergency department. ### Conditions - Emergencies ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - TLT training ### Outcomes Primary Outcomes - Time to complete TLT conversations - Patient-reported acceptability of TLT conversations Secondary Outcomes - Intervention fidelity - Clinician-reported feasibility - Clinician-reported satisfaction - EHR documentation by inpatient clinicians - Heard and understood - Patient-reported end-of-life quality of communication - Decisional regret scale - The number of days to the first family meeting in ICU - ICU length of stay (LOS) - Hospital LOS - The number of family meetings - ICU procedures (e.g., CPR, pressors, etc.) - ICU mortality - Patterns of hospital disposition - Rate of hospice utilization ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma - NCT ID: NCT06378138 - Study ID: ICP-CL-01203 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2031-07-25 - Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. ### Study Description Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma ### Conditions - Hematologic Malignancies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ICP-248 - Orelabrutinib ### Outcomes Primary Outcomes - Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria - Changes from baseline in pulse. - Changes from baseline in blood pressure. - Changes from baseline in ECG QRS interval. - Changes from baseline in ECG QT interval. Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China @@
## Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes - NCT ID: NCT06378125 - Study ID: CIR-NA I - Status: RECRUITING - Start Date: 2022-12-19 - Completion Date: 2025-06-01 - Lead Sponsor: University Hospital Schleswig-Holstein ### Study Description A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes. ### Conditions - Safety Issues - Pharmacokinetic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD) - immediate-release nicotinic acid (SAD) - Placebo controlled-ileal-release nicotinic acid (SAD/MAD) - Placebo immediate-release nicotinic acid (SAD) ### Outcomes Primary Outcomes - Treatment-Emergent Adverse Events [Safety and Tolerability] - Treatment-Emergent Serious Adverse Events [Safety and Tolerability] - Haemoglobin - White blood cells - Blood creatinine - Blood urea - Blood uric acid - Glomerular filtration rate - Blood ALT - Blood AST - Blood GGT Secondary Outcomes ### Location - Facility: University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Schleswig-Holstein, 24105, Germany @@
## Extraction Socket Augmentation. A Clinical Study - NCT ID: NCT06378112 - Study ID: 2734/CEIH/2022 - Status: RECRUITING - Start Date: 2022-05-20 - Completion Date: 2025-12-30 - Lead Sponsor: Universidad de Granada ### Study Description Extraction socket preservation is defined as alveolar ridge preservation within the bone envelope remaining after tooth extraction, meanwhile ridge augmentation is defined as increasing the volume of alveolar ridge beyond the bony envelope at the time of tooth extraction. It is recommended to use in cases where extraction socket anatomy is intact. In contrast definition "extraction socket augmentation" defines alveolar ridge restoration when bony walls of the socket are partly or completely lost. In the case of severe loss (\> 50%) of the buccal bone plate, preservation of hard tissue with a prolonged healing time before implant placement has been suggested.The null hypothesis of this experimental work states that: (i) the two different bone graft materials gained the same amount of bone following horizontal ridge augmentation procedure; (i) the two different bone graft materials exhibit similar histological and histomorphometric results Therefore, the main purpose of the current study is to compare two different biomaterials using guided bone regeneration procedures in the ridge preservation/ augmentation (hard-tissue preservation). ### Conditions - Edentulous Alveolar Ridge With Labial Resorption ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GTO® ### Outcomes Primary Outcomes - Dimensional bone changes Secondary Outcomes ### Location - Facility: Dental School, Granada, N/A, E18071, Spain @@
## Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments - NCT ID: NCT06378099 - Study ID: InFaPro - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-08 - Lead Sponsor: Universidad de Antioquia ### Study Description Minor ailments are non-serious, short-term health problems, not related to the patient's pathologies or to the desired or undesired effects of the medications they are taking. Pharmaceutical indication is the service provided in response to a patient's request, who comes to the pharmacy asking for a medication recommendation for a health problem; for this purpose, over-the-counter medications are used, which are pharmacological agents that can be acquired without a prescription. The practice of pharmaceutical indication turns self-medication into a safe and responsible practice, but it requires agreed-upon protocols. ### Conditions - Community Pharmacy Services ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Patient guided and followed by the pharmacist ### Outcomes Primary Outcomes - Resolution time of the MA and the frequency of referral to a physician. Secondary Outcomes - Characterization of the population visiting drugstore or drugstore/pharmacy - Identification of the presence and classification of the MA - Need to acquire an OTC medication to treat the MA ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS) - NCT ID: NCT06378086 - Study ID: TEO-PAS-2302 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-05 - Lead Sponsor: Teoxane SA ### Study Description This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection.At screening, the Principal Investigator (PI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement.At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the PI injecting study devices were blinded.Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant.Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection.Subjects attended Visit 2 (30 days post-injection) where effectiveness and safety assessments were conducted.Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2.If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary. ### Conditions - Pain - Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RHA® Redensity with new anesthetic agent - RHA® Redensity with lidocaine ### Outcomes Primary Outcomes - Non-inferiority of RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in terms of reducing pain during device injection into the upper perioral rhytids. Secondary Outcomes - Difference between RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in term of reducing pain at 15, 30, 45 and 60 minutes post-injection in each side of the mouth. ### Location - Facility: United States, New York, New York, New York, 10028, United States @@
## Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery - NCT ID: NCT06378073 - Study ID: DPT/Batch-Fall19/557 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2024-09-01 - Lead Sponsor: Superior University ### Study Description "A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups.In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS" ### Conditions - Surgery-Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Incentive Spirometer - Numeric Pain Rating Scale ### Outcomes Primary Outcomes - Incentive Spirometer - Incentive Spirometer Secondary Outcomes ### Location - Facility: Azra Naheed Medical College, Superior University, Lahore, Punjab, N/A, Pakistan @@
## Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia - NCT ID: NCT06378060 - Study ID: KM04 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-04-01 - Lead Sponsor: Hematology department of the 920th hospital ### Study Description The aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia. ### Conditions - Severe Aplastic Anemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Modified transplantation system ### Outcomes Primary Outcomes - overall survival (OS) - Acute graft-versus-host disease incidence Secondary Outcomes - Transplantation-related motality - Chronic graft-versus-host disease incidence - incidence of Intensive fungal disease - EB virus reactivation rate - CMV reactivation rate ### Location - Facility: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Kunming, Yunnan, 650000, China @@
## Irreversible Electroporation & Pembro Immunotherapy in Locally Advanced Pancreatic Cancer - NCT ID: NCT06378047 - Study ID: MCC-22325 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2027-04 - Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute ### Study Description This study aims to determine the safety and tolerability of combining sequential therapy of Irreversible Electroporation (IRE) and Immunotherapy (IO) for patients with locally advanced unresectable pancreas cancer following first-line treatment with chemotherapy and ablative stereotactic magnetic resonance image-guided adaptive radiation therapy (A-SMART). ### Conditions - Pancreatic Cancer - Locally Advanced Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab - Irreversible Electroporation ### Outcomes Primary Outcomes - Safety and Tolerability Secondary Outcomes - Progression-Free Survival (PFS) - Overall Survival (OS) - Objective Response Rate (ORR) ### Location - Facility: Moffitt Cancer Center, Tampa, Florida, 33612, United States @@
## Effect of Lactium on Sleep Disorders in Healthy Volunteers With Persistent Subclinical Insomnia - NCT ID: NCT06378034 - Study ID: 2023-A01926-39 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-10 - Completion Date: 2026-09-30 - Lead Sponsor: Ingredia S.A. ### Study Description The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia. ### Conditions - Sleep Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Lactium - Placebo ### Outcomes Primary Outcomes - Sleep efficiency Secondary Outcomes - Sleep diary - Insomnia Severity Index - PSQI - Sleep quality by cctigraphy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG - NCT ID: NCT06378021 - Study ID: Calcium chloride in CABG - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2025-04 - Lead Sponsor: Helwan University ### Study Description This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study two armed RCT for on pump CABG patient.The intervention arm will be injected with Calcium chloride in the four major atrial ganglionic plexus The control arm will be injected with sodium chloride to determine the effect of Calcium chloride on Post CABG Atrial fibrillation ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Calcium Chloride - Sodium Chloride 0.9% Inj ### Outcomes Primary Outcomes - Change in number of patients who developed Atrial fibrillation Secondary Outcomes - Change in length of hospital stay ### Location - Facility: Ain shams university, Cairo, Abassia Cairo, 02, Egypt @@
## A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity Sufferers - NCT ID: NCT06378008 - Study ID: 300100 - Status: RECRUITING - Start Date: 2024-04-16 - Completion Date: 2024-09-13 - Lead Sponsor: HALEON ### Study Description The aim of this study is to confirm the clinical dentin hypersensitivity (DH) efficacy of a 5 percent (%) calcium sodium phosphosilicate (CSPS) toothpaste. ### Conditions - Dentin Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CSPS toothpaste - Regular fluoride toothpaste (Crest Cavity Protection) ### Outcomes Primary Outcomes - Change from Baseline in Schiff Sensitivity Score at Day 56 Secondary Outcomes - Change from Baseline in Tactile Threshold at Day 56 - Change from Baseline in Schiff Sensitivity Score at Days 3, 7, 14 and 28 - Change from Baseline in Tactile Threshold at Days 3, 7, 14 and 28 - Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 - Change from Baseline in DHEQ Total Score (Section 2, Question Q1-34) at Days 28 and 56 - Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 - Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 - Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 - Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 - Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 - Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56 - Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56 ### Location - Facility: All Sum Research, Mississauga, Ontario, L5N 6J2, Canada @@
## Effectiveness of an Intervention Plan Aimed at the Diaphragm in Chronic Non-specific Neck Pain - NCT ID: NCT06377995 - Study ID: OST1_013 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2024-12-31 - Lead Sponsor: Escola Superior de Tecnologia da Saúde do Porto ### Study Description The aim of this study is to analyse the effectiveness of an intervention plan targeting the diaphragm, namely stretching technique, neuromuscular diaphragm and phrenic centre inhibition, in the treatment of chronic non-specific neck pain. ### Conditions - Chronic Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo technique - Diaphragm protocol ### Outcomes Primary Outcomes - Change in the intensity of pain in the cervical spine after applying the diaphragm intervention plan - Changes in range of motion after applying the diaphragm targeted protocol Secondary Outcomes - Changes in pain level one week after the intervention - Changes in range of motion one week later ### Location - Facility: Escola Superior de Saúde do Porto, Porto, N/A, 4200-072, Portugal @@
## Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy - NCT ID: NCT06377982 - Study ID: SCCP001 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2026-12 - Lead Sponsor: StemCyte Taiwan Co., Ltd. ### Study Description A phase I, randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of allogeneic human umbilical cord blood infusion in children with cerebral palsy ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - hUCB ### Outcomes Primary Outcomes - safety-TEAE Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain - NCT ID: NCT06377969 - Study ID: 75269 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-06-30 - Lead Sponsor: Stanford University ### Study Description Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord. ### Conditions - Chronic Pelvic Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation ### Outcomes Primary Outcomes - Change in Pain Intensity Secondary Outcomes - Change in Disability - Patient Global Impression Change - Change in Quality of Life - Change in Pain Catastrophizing Scale - Change in sleep quality - Change in Social Functioning ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Associations Between Gut Length, Gut Microbiota and Food Assimilation - NCT ID: NCT06377956 - Study ID: XRGao - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-01 - Lead Sponsor: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences ### Study Description The purpose of this observational study is to explore the correlation between human gut length and food absorption rates. This will include characterization of gut length, total food intake energy, fecal calories, urinary calories, body composition, food intake behavior, genetics and gut microbiota in the small intestine. Researchers expect to recruit up to 100 healthy volunteers. ### Conditions - Gut Length - Food Assimilation Efficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observation without intervention ### Outcomes Primary Outcomes - Gut length - Energy intake - Fecal calorie - Urine calorie - Weight - Height - Waist circumferences - Hip circumferences - Bone mass - Fat mass - Fat free mass - Blood pressure - Heart rate - Resting energy expenditure - Thermic effect of food - Body shape - Microbiome - Metabolites - Gut transit time - Food macronutrient content - Feces macronutrient content - Total daily water volume - Total daily urine volume - Physical activity - Bristol Stool Scale Secondary Outcomes ### Location - Facility: Shenzhen Institute of Advanced Technology, Shenzhen, Guangdong, 518055, China @@
## The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females - NCT ID: NCT06377943 - Study ID: SIAT-IRB-240415-H0718 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-10-31 - Lead Sponsor: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences ### Study Description This Study is focused on the interaction between resting metabolic rate (RMR), physical activity (PA), and thyroid hormones (TH). TH controls almost all the cell activities of the body so, it is known as one of the major regulatory hormones. This is the reason for individuals who suffer from thyroid disorders show abnormal metabolism. Recently it was suggested that interindividual variations in thyroid hormone levels also influence daily physical activity. ### Conditions - Thyroid - Physical Activities - Resting Energy Expenditure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Body weight - Height - Waist and Hip circumferences - Fat mass - Far free mass - Bone mass - Resting Metabolism - Physical activity - Thyroid hormone Secondary Outcomes - Total energy expenditure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy - NCT ID: NCT06377930 - Study ID: RAP-219-FOS-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Rapport Therapeutics Inc. ### Study Description This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy. ### Conditions - Focal Onset Seizures ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - RAP-219 ### Outcomes Primary Outcomes - Efficacy in reducing frequency of RNS-recorded long episodes in participants with FOS Secondary Outcomes - Measurement of estimated electrographic seizure frequency from available RNS-recorded episodes - Measurement of Clinical Seizure Frequency - Change in seizure severity - Global Impression of Change - Pharmacokinetic parameters ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigating Micro-Manipulation Procedures for Assisted Hatching Timing - NCT ID: NCT06377917 - Study ID: 2304-BRG-057-JF - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Reproductive Medicine Associates of New Jersey ### Study Description This study aims to assess the clinical significance of cleavage stage (Day 3) assisted hatching compared to assisted hatching at the blastocyst stage (Day 5,6,7) of embryo development at the time of trophectoderm (TE) biopsy for patients undergoing in vitro fertilization (IVF) and preimplantation genetic testing for aneuploidy (PGT-A) for treatment of their infertility. ### Conditions - Infertility ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Laser Assisted Hatching ### Outcomes Primary Outcomes - Blastulation Rate Secondary Outcomes - Embryo morphologic grade - Timing of blastulation - Aneuploidy rate - Positive pregnancy rate - Sustained implantation rate - Pregnancy loss rate - Live birth rate ### Location - Facility: Reproductive Medicine Associates of New Jersey, Marlton, New Jersey, 08053, United States @@
## Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure (AGING HF Study (AGe and Heart Failure IN Geriatrics)) - NCT ID: NCT06377904 - Study ID: 2023-A02125-40 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: Gérond'if ### Study Description This retrospective (between April 2020 and December 2023) then prospective (between January 2024 and August 2026), non-interventional cohort study has as its main objective to evaluate the clinical and therapeutic characteristics of patients aged 75 and over hospitalized in geriatrics for heart failure and also to evaluate the clinical characteristics and triggering factor(s) of acute heart failure. ### Conditions - Patients Hospitalized in Geriatrics for Heart Failure - Patients Aged 75 and Over ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure Secondary Outcomes - Factors associated with patients hospitalization or rehospitalization ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Emotional Resilience Training on Fear of Birth and Depression in Primiparous Pregnant Women - NCT ID: NCT06377891 - Study ID: TDK-2024-13563 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-16 - Completion Date: 2024-12-30 - Lead Sponsor: Ataturk University ### Study Description Although birth has a great place in a woman's life, factors such as the woman's education level, personal experiences, social support status, whether the pregnancy is planned or not, the family's attitude towards pregnancy, and socioeconomic status increase the burden of pregnancy and can create a stressful situation for the woman. While the pain that may be experienced during birth, thoughts about the baby's health and postpartum baby care further increase this fear, primiparous women who will give birth for the first time experience many emotions that they cannot define and cannot predict the situations they will encounter during birth. The most important situation that will cause pain during birth is fear. So much so that fear of birth may cause women to avoid pregnancy and increase optional abortions.In particular, fear of birth may increase cesarean delivery rates and also lead to negative maternal outcomes such as poor mental health after birth. Fear experienced during the antenatal period can lead to difficult births, mother-baby attachment problems, and depression. While fear of birth causes depression and anxiety disorders in the postpartum period, it is stated that depression experienced during pregnancy may increase the fear of birth, or fear of birth may be a hidden symptom of depression. It is noted that emotional regulation skills and resilience in pregnant women can be effective strategies in minimizing and managing fear, anxiety, stress, and anxiety. Emotional resilience is defined as the style of coping with stress, the ability to repair oneself, the ability to recover from adverse events quickly, and the state of adapting to a new environment. In particular, individuals with high emotional resilience can protect their physical and mental health and increase their life satisfaction by reducing the negative consequences they experience. With the emotional resilience training given during pregnancy, pregnant women's stress, fear, and anxiety will be reduced, and they will be able to cope better with the difficulties they experience. This research will be conducted to examine the effect of emotional resilience training given to primiparous pregnant women on fear of childbirth and depression. ### Conditions - Fear of Childbirth - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Emotional Resilience training ### Outcomes Primary Outcomes - The effect of emotional resilience on fear of birth and depression in primiparous pregnant women. Secondary Outcomes ### Location - Facility: Bayburt State Hospital, Bayburt, N/A, 69000, Turkey @@
## The Preeclampsia Registry - NCT ID: NCT06377878 - Study ID: Pro00008369 - Status: RECRUITING - Start Date: 2013-09-01 - Completion Date: 2040-05 - Lead Sponsor: Preeclampsia Foundation ### Study Description The purpose of The Preeclampsia Registry is to collect and store medical and other information from women who have been medically diagnosed with preeclampsia or a related hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome, their family members, and women who have not had preeclampsia to serve as controls. Information from participants will be used for medical research to try to understand why preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of new treatments. The Registry will consist of a web-based survey and mechanism for collecting and reviewing medical records. This data will be utilized for immediate investigator-driven cross-sectional research projects (after proposal review by the Registry's scientific advisory board and as directed by the PI). Participants may also choose to be contacted regarding possible participation in future studies, about providing a biospecimen, as well as investigator-driven clinical trials. The Registry is anticipated to exist long-term and to serve as a foundation of participants from which to draw for studies of preeclampsia, anticipated to evolve as our scientific understanding of preeclampsia evolves. ### Conditions - Preeclampsia - Eclampsia - HELLP Syndrome - Toxemia - Hypertensive Disorder of Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records Secondary Outcomes ### Location - Facility: Preeclampsia Foundation, Melbourne, Florida, 32940, United States @@
## Thyroid Function , HbA1c in Relation to Ferritin Level in Adullt Patient e B Thalassemia - NCT ID: NCT06377865 - Study ID: endocrine dis & B thalassemia - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Assiut University ### Study Description to evaluate thyroid function ,HbA1C,\&lipid profile in thalassemic patient to correlate thyroid function , Hba1c , lipid profile e ferritin level in thalassemic patient ### Conditions - B Thalassemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study - NCT ID: NCT06377852 - Study ID: Pro00075309 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-28 - Completion Date: 2028-09-01 - Lead Sponsor: American Society of Clinical Oncology ### Study Description The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with MBC (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs.The primary objective of the CDK Study is to compare TTD on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (AI or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors.Together with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing). ### Conditions - Metastatic Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Palbociclib - Ribociclib ### Outcomes Primary Outcomes - Time to Treatment Discontinuation (TTD) Secondary Outcomes - Toxicity (grade 3-4 AEs) - Event-Free survival (EFS) - Quality of life assessed by patient reported outcomes - Time to dose reduction and escalation - Reason for not escalating - Treatment received (missed doses, cumulative dose, etc.) - Healthcare utilization (ED visits, hospital admissions, etc.) - Body Mass Index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pain After Removal of Mandibular Third Molars With or Without Advanced Platelet-rich Fibrin - NCT ID: NCT06377839 - Study ID: N-20230048 - Status: RECRUITING - Start Date: 2024-01-10 - Completion Date: 2025-12-01 - Lead Sponsor: Aalborg University Hospital ### Study Description Pain is the most common complication following surgical removal of an impacted mandibular third molar. Several risk factors may increase the intensity and duration of pain following removal of mandibular third molars. Acute postoperative pain can transcript into postoperative chronic pain without an explainable reason or a specific risk factor. The use of advanced platelet-rich fibrin in the extraction socket following surgical removal of mandibular third molar have diminished the intensity and duration of acute postoperative pain and facilitated improved wound healing. The objective of the present study is therefore to identified specific risk factors and predictors for developing postoperative chronic pain following surgical removal of mandibular third molars with or without advanced platelet-rich fibrin applied in the extraction socket using epigenetic modulation. ### Conditions - Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Advanced platelet-rich fibrin in the ekstraction socket ### Outcomes Primary Outcomes - Assessment of postoperative pain by using Visual Analoque scale Secondary Outcomes - Assessment of quality of life ### Location - Facility: Department of Oral and Maxillofacial surgery, Aalborg University Hospital, Aalborg, Nordjylland, 9000, Denmark @@
## Comparison of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism. - NCT ID: NCT06377826 - Study ID: RCRAHS-ISB/REC/MS-PT/01813 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-01 - Lead Sponsor: Riphah International University ### Study Description the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data. ### Conditions - Comparison of Aerobic Exercise and Resistance Training ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - aerobic exercises - resistance training - medication ### Outcomes Primary Outcomes - 6 Minute Walk Test - The Beck Depression Inventory Scale - SF- 36 SF-36 Secondary Outcomes ### Location - Facility: Abbottabad medical complex, Abbottābād, Khyber Pakhtunkhwa, 21300, Pakistan @@
## Combined Mode-Kinetic Chain Exercise With and Without Core Stability Exercises on Patients With Knee Osteoarthritis - NCT ID: NCT06377813 - Study ID: REC/RCR& AHS/23/01100/Maryam - Status: RECRUITING - Start Date: 2023-11-20 - Completion Date: 2024-06-01 - Lead Sponsor: Riphah International University ### Study Description The goal of this \[type of study: Randomized control trial\] is to \[ see the effects of Combined Mode Kinetic Chain Exercises along with or without core stability exercises on pain, range of motion and disability \] in \[ in patients with Knee Osteoarthritis\].The main question it aims to answer is:Wether core stability exercises is effective if performed along with Combined chain kinetic exercises to improves the condition of Knee Osteoarthritis? Group A will receive Core Stability Exercises along with Combined Chain Kinetic Exercises and Group B will receive combined Chain Kinetic Exercises. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mode-Kinetic Chain Exercise With Core Stability Exercises - Mode-Kinetic Chain Exercise ### Outcomes Primary Outcomes - Numeric pain rating scale - Kellgren and Lawrence system for classification of Osteoarthritis - Knee Injury and Osteoarthritic outcome score (KOOS) - Goniometer Secondary Outcomes ### Location - Facility: Riphah International University, Lahore, Punjab, 54000, Pakistan @@
## Effects Of Navicular Mobilization In Patients With Planter Fasciitis - NCT ID: NCT06377800 - Study ID: REC 01801 Kainat Fatima - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-07 - Lead Sponsor: Riphah International University ### Study Description The significance of studying the effects of navicular mobilization in patients suffering from plantar fasciitis lies in its potential to provide valuable insights into non-invasive treatment approaches for a common and debilitating foot condition such as flat foot. Understanding how this therapy impacts navicular height, pain and disability of the foot can lead to improved clinical outcomes and a better understanding of the biomechanical factors contributing to plantar fasciitis. Ultimately, this research may help refine treatment strategies and enhance the quality of life for individuals suffering from this condition ### Conditions - Plantar Fascitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - navicular mobilization along conventional therapy. - conventional therapy ### Outcomes Primary Outcomes - Numeric Pain Rating Scale - (Foot Function Index) - Navicular drop test - Foot print analysis Secondary Outcomes ### Location - Facility: DHQ Hospital, Faisalābad, Punjab, N/A, Pakistan @@
## Effects of ELDOA in Patients With Cervicogenic Headache - NCT ID: NCT06377787 - Study ID: REC 01732 Aneeqa Zaheer - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-07 - Lead Sponsor: Riphah International University ### Study Description The aim of our study is to determine the effect of ELDOA in relieving pain, improving ROM and functional disability in patients with cervicogenic headache. This study will add to the growing body of knowledge that if this technique yields comparable outcomes, it would be the alternative therapy. Moreover, it would add to the society as no literature is available on the effect of ELDOA technique in the management of Cervicogenic headache. ### Conditions - Cervicogenic Headache ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ELDOA and conventional therapy - conventional therapy ### Outcomes Primary Outcomes - (Numeric Pain Rating Scale). - NDI (U) (Neck Disability Index) - Inclinometer Secondary Outcomes ### Location - Facility: Alkhidmat Raazi Hospital CBR Town, Islamabad, Punjab, 46000, Pakistan @@
## To Optimize Therapeutic Procedures of DPMAS in ACLF Patients: a Prospective, Sigle Arm and Multicenter Study - NCT ID: NCT06377774 - Study ID: NFEC-2024-096 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-02-01 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description Acute-on-chronic liver failure (ACLF) is a life-threaten syndrome carrying high-short-term mortality raging 40% to 60% within 90 days in patients with chronic liver disease. Double plasma molecular adsorption system (DPMAS) is one of the available artificial liver support systems, which combines plasma filtration and two specific adsorption membranes dedicating to remove bilirubin and the middle molecular toxins respectively. The efficiency of DMPAS treatment in liver failure patients remains controversial. Previous study indicate that liver failure patients with DPMAS therapy improve the short-term mortality and prevent the diseases progression within 28 days (PADSTONE Study). Thus, this single-arm, multicenter and prospective study is to further validate and optimize the therapeutic procedures of DPMAS therapy in ACLF patients. ### Conditions - Acute-On-Chronic Liver Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention in this study ### Outcomes Primary Outcomes - 28-day transplantation-free mortality - The disease progression rate Secondary Outcomes - the 90-day transplantation-free mortality - the disease progression ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study on Heart Failure With Preserved Ejection Fraction With Qishen Granules - NCT ID: NCT06377761 - Study ID: BF-2022-121 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine ### Study Description With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine. ### Conditions - Heart Failure With Preserved Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Qishen Granules - Placebo ### Outcomes Primary Outcomes - Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90 Secondary Outcomes - Changes in Mitral valve diastolic blood flow velocity (E) and Mitral annulus lateral and septal motion velocity (e') compared to baseline on day 90 - Changes in E/e' ratio compared to baseline on day 90 - Changes in Left Atrial Volume index (LAVI) compared to baseline on day 90 - Changes in Left ventricular mass index (LVMI) compared to baseline on day 90 - Changes in Score of Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline on day 90 - Changes in blood N terminal pro B type natriuretic peptide(NT-proBNP) compared to baseline on day 90 - Changes in blood Growth STimulation expressed gene 2(ST2) compared to baseline on day 90 - Changes in blood urea compared to baseline on day 90 - Changes in blood creatinine compared to baseline on day 90 ### Location - Facility: Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, 510120, China @@
## The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants - NCT ID: NCT06377748 - Study ID: 2023/02 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-07-30 - Lead Sponsor: Istanbul Medeniyet University ### Study Description This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants. ### Conditions - Procedural Pain - Pain, Acute - Nursing Caries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Facilitated tucking position - ShotBlocker - Combined facilitated tucking and ShotBlocker ### Outcomes Primary Outcomes - Neonatal Infant Pain Scale Secondary Outcomes - Crying time during the procedure - Procedure time ### Location - Facility: Istanbul Medeniyet University, Istanbul, Kadıköy, 34720, Turkey @@
## BAI-BACE for Advanced Lung Squamous Cell Carcinoma - NCT ID: NCT06377735 - Study ID: CHEST-001 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-30 - Lead Sponsor: Sun Yat-sen University ### Study Description Bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) has been reported as non-first-line therapy to treat lung cancer in many hospitals in China. BAI, which uses chemotherapeutic drugs directly injected into the tumor and achieved a high concentration in a short time to kill the tumor. Then BACE could seal off the tumor vessels. In this study, we aim to describe the efficacy and safety of BAI-BACE as non-first-line for advanced lung squamous cell carcinoma. ### Conditions - Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BAI-BACE ### Outcomes Primary Outcomes - Progression-Free-Survival (PFS) Secondary Outcomes - Overall survival (OS) - Objective response rate (ORR) - Adverse events ### Location - Facility: Chinese PLA General hospital, Beijing, Beijing, 100853, China @@
## Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer - NCT ID: NCT06377722 - Study ID: CABOPRE - Status: TERMINATED - Start Date: 2018-11-01 - Completion Date: 2022-08-09 - Lead Sponsor: Fundacion Oncosur ### Study Description Phase II, multicenter, national, uncontrolled, multicenter, uncontrolled, phase II clinical trial for the evaluation of cabozantinib treatment prior to cytoreductive nephrectomy in patients with advanced or metastatic renal cell cancer candidates for primary tumor cytoreductive nephrectomy (NC). ### Conditions - Renal Cell Carcinoma Metastatic - Renal Cell Carcinoma Stage IV - Renal Cell Carcinoma Stage III ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cabozantinib ### Outcomes Primary Outcomes - Radiological response rate prior to cytoreductive nephrectomy Secondary Outcomes ### Location - Facility: Hospital Universitario Central de Asturias, Oviedo, Asturias, N/A, Spain @@
## A Mixed-methods Acceptability Study of ProACTive™ to Help Burns Patients Adjust to Changes to Appearance - NCT ID: NCT06377709 - Study ID: 24CP001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Nottingham University Hospitals NHS Trust ### Study Description This mixed-methods acceptability study aims to investigate whether an early acceptance and commitment therapy (ACT) based intervention called ProACTive™, aimed at supporting burns patients' adjustment to a changed appearance and preventing distress, is acceptable. This will be measured by descriptive data, questionnaire data and semi-structured interviews.Preliminary data on the potential clinical effectiveness of the intervention will also be gathered. This will be measured by scores on standardised questionnaires. ### Conditions - Burn Injuries - Burns - Emotional Distress - Adjustment ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - ProACTive™ ### Outcomes Primary Outcomes - Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A) Secondary Outcomes - Positive and Negative Affect Schedule (PANAS-GEN) - Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT) - Self-Compassion Scale - Short Form (SCS-SF) - Helpful Aspects of Therapy Form (HAT) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy - NCT ID: NCT06377696 - Study ID: MC230713 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-04-30 - Lead Sponsor: Mayo Clinic ### Study Description This phase III trial evaluates whether patient care can be done remotely for patients having cranial (skull) radiation or who have previously had cranial radiation. In addition, this trial compares study outcomes between patients who get metformin and those who do not. Cranial radiation, an essential component of brain tumor treatment, can result in significant negative effects on cognitive (the ability to clearly think, learn, and remember) function. Wearable devices have been used in the field of neurology for seizure detection and assessment of patients with movement disorders. Wearable device technology has also been implemented for remote monitoring of cancer patients and for cancer clinical trials. Metformin is the active ingredient in a drug used to treat type 2 diabetes mellitus (a condition in which the body cannot control the level of sugar in the blood). It is also being studied in the treatment of cancer. Use of metformin may reduce risk of cognitive decline following radiation therapy within the skull (intracranial). These effects may be further strengthen by addition of device-based physical activity promotion. Mayo Test Drive is a web-based platform for remote self-administered cognitive assessment. Using Mayo Test Drive may help determine whether patient care can be done remotely, while simultaneously evaluating benefits of health promotion through use of a wearable watch device and metformin in preventing radiation-related cognitive decline. ### Conditions - Malignant Brain Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Best Practice - Medical Device Usage and Evaluation - Metformin - Neurocognitive Assessment - Questionnaire Administration ### Outcomes Primary Outcomes - Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility) Secondary Outcomes - Overall completion rates and compliance (Feasibility) - Overall satisfaction - Adherence (Feasibility) - Neurocognitive scores - Incidence of adverse events (AEs) ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer - NCT ID: NCT06377683 - Study ID: XMYY-2023KY122 - Status: RECRUITING - Start Date: 2024-04-05 - Completion Date: 2026-12-30 - Lead Sponsor: The First Affiliated Hospital of Xiamen University ### Study Description Ten to 20% of patients with prostate cancer (PC) experience progression in their disease, even after undergoing pharmaceutical or surgical castration, leading to metastatic CRPC (mCRPC). Prostate-specific membrane antigen (PSMA) is a membrane-bound glycoprotein mostly specific to the prostate. While PSMA is expressed at low levels in normal prostate, this expression increased by 100-1000-fold in PC, which makes it a favorable target for therapy. This study was designed to evaluate the safety, tolerability, and maximum tolerated dose of a long-lasting radiolabeled ligand 177Lu-Dansyl-PSMA in mCRPC patients. ### Conditions - Metastatic Castration-resistant Prostate Cancer, mCRPC ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 177Lu-Dansyl-PSMA radioligand therapy ### Outcomes Primary Outcomes - Incidence of treatment-related adverse events (safety and tolerability) - To determine the maximum tolerated dose (MTD) Secondary Outcomes - Dosimetry ### Location - Facility: The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, China @@
## Study of Functional and Aesthetic Outcomes After Wassel IV Thumb Duplication Surgery in Pediatric Population, With a Follow-up of at Least One Year - NCT ID: NCT06377670 - Study ID: 38RC24.0012 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-05-15 - Lead Sponsor: University Hospital, Grenoble ### Study Description The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication ### Conditions - Wassel IV Thumb Duplication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Wassel IV Thumb Duplication Surgery ### Outcomes Primary Outcomes - Functional and Aesthetic Outcomes Secondary Outcomes - Comparison of Surgical Techniques - Efficacy of Skin Flap Types - Immobilization Method Analysis - Preoperative Angle Decision Model ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With T2DM - NCT ID: NCT06377657 - Study ID: DONT4GET - Status: COMPLETED - Start Date: 2022-01-15 - Completion Date: 2024-02-19 - Lead Sponsor: University of Nis ### Study Description Diabetes is a prevalent metabolic disease that leads to increased blood sugar levels due to insulin shortage or resistance. Type 2 diabetes is often linked to obesity, which can increase insulin resistance. Meteorin-like protein (METRNL) is a new secreted protein that affects insulin sensitivity and has been found to be negatively related to serum glucose levels in people with diabetes.Oxidative stress in diabetics can stimulate the production of inflammatory mediators, increasing the activity of the antioxidant system. Aloe vera, a widely used plant, has been used for treating diabetes, wound healing, tumors, and inflammatory bowel disease. It has anti-inflammatory, antioxidant, neuroprotective, antidepressant, and memory-enhancing effects.Exercise can improve diabetic patients' conditions by increasing the expression of GLUT4 protein and skeletal muscle. High-intensity interval training has been shown to increase the expression of the METORIN gene in human subjects and decrease MDA in type 2 diabetic patients. However, no studies have examined the simultaneous effect of exercise and Aloe vera on diabetes indicators.The present study aims to investigate the response of METRNL and some oxidative and antioxidant plasma indicators to high-intensity interval training and Aloe vera supplementation in type 2 diabetic men. The findings indicate that exercise and consumption of plants with anti-inflammatory and antioxidant properties can be effective in modulating the pathological effects of diabetes and increasing insulin sensitivity. ### Conditions - Diabetes Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise - Aloe vera ### Outcomes Primary Outcomes - METRNL - Meteorin Like, Glial Cell Differentiation Regulator Secondary Outcomes - Glutathione peroxidase (GPx) - Serum superoxide dismutase (SOD) - Total antioxidant blood capacity (TAD) - Plasma malondialdehyde (MDA) ### Location - Facility: Department of Sport Physiology, Faculty of Sport and Physical education, Islamic Azad University of Ayatollah Amoli, Amol, Iran, Amol, N/A, N/A, Iran, Islamic Republic of @@
## Comparing the Efficacy of KT vs DN With Conventional Treatment for Improving QOL and Alleviating Pain in Frozen Shoulder - NCT ID: NCT06377644 - Study ID: DPT/Batch-Fall19/560 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-07-05 - Lead Sponsor: Superior University ### Study Description "Randomized control trial is our study design, we will make 2 groups group A ( 15 patients of frozen shoulder) and Group B (15 patients of frozen shoulder). we will apply interventions by this way For group A KT (kinesiology taping) will be applied on frozen shoulder patients by a professional physiotherapist or certified physiotherapist according to their pain pattern in muscles (supraspinatus, infraspinatus, teres minor, deltoid, subscapularis) with conventional physiotherapy of frozen shoulder also continues on 15 patients (group A). KT will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week. And for group B Dry needling with conventional physical therapy. ### Conditions - Frozen Shoulder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Kinesio taping - Dry Needling ### Outcomes Primary Outcomes - VAS - SPADI Secondary Outcomes ### Location - Facility: Pain away Physical Therapy, Lahore, Punjab, N/A, Pakistan @@
## Effect of Multi-ingredient on Visceral Adiposity & Non-alcoholic Fatty Liver Disease in Postmenopausal Women With Abdominal Obesity - NCT ID: NCT06377631 - Study ID: FATHIS+ - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Fundació Eurecat ### Study Description This study aims to evaluate the effect of daily intake of a specific combination of different natural histidine-related amino acids in combination with dietary recommendations, in the reduction of visceral fat, as well as their associated comorbidities, in postmenopausal women with abdominal obesity. ### Conditions - Visceral Obesity - Non-alcoholic Fatty Liver - Postmenopausal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine - Placebo ### Outcomes Primary Outcomes - Change in Visceral Adiposity Secondary Outcomes - Height (cm) - Age - Ethnicity - Change in Body Weight (kg) - Change in Body Mass Index (BMI) (Kg/m^2) - Change in Neck circumference (cm) - Change in Arm circumference (cm) - Change in Waist circumference (cm) - Change in Hip circumference (cm) - Change in Conicity Index - Change in Waist-to-Hip ratio - Change in Lipid Accumulation Product (LAP) - Change in Systolic Blood Pressure (mm Hg) - Change in Diastolic Blood Pressure (mm Hg) - Change in heart rate (bpm) - Change in serum glucose levels (mg/dL) - Change in serum total cholesterol (mg/dL) - Change in serum high-density lipoprotein cholesterol (HDL-C,mg/dL) - Change in serum low-density lipoprotein cholesterol (LDL-C, mg/dL) - Change in serum triglycerides (TG, mg/dL) - Change in serum alanine aminotransferase (ALT, U/L) - Change in serum aspartate aminotransferase (AST, U/L) - Change in serum gamma glutamyl transferase (GGT, U/L) - Change in serum insulin levels (mU/L) - Change in serum leptin levels (pg/mL) - Change in serum adiponectin levels (ng/mL) - Change in Adiponectin/Leptin ratio (numerical ratio) - Change in serum Monocyte chemoattractant protein-1 (MCP-1) levels (pg/mL) - Change in plasma tumor necrosis factor alpha (TNF-alpha) levels (pg/mL) - Change in plasma Interleukin 6 (IL-6) levels (pg/mL) - Change in plasma Interleukin 10 (IL-10) levels (pg/mL) - Change in plasma Intercellular Adhesion Molecule 1 (ICAM-1) levels (ng/mL) - Change in plasma Cluster of Differentiation 14 (CD14) levels (pg/mL) - Change in plasma oxidized low density lipoproteins (LDLox) levels (mU/L) - Change in serum C-Reactive protein levels (mg/L) - Change in Histidine levels in blood (umol/L) - Change in Acylcarnitine levels in blood (umol/L) - Change in 17-beta-estradiol (E2) levels in blood (pg/mL) - Change in Follicle-stimulating hormone (FSH) levels in blood (mU/mL) - Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR) - Change in Fatty Liver Index (FLI) - Change in Triglyceride glucose index (TyG) - Change in Plasma atherogenic index - Change in lipidomic profile - Change in intestinal microbiota composition - Change in the expression of lipid-metabolism genes in PBMC - Change in Dietary habits - Change in Physical activity - Concomitant medication - Consumption of dietary supplements - Change in the Supraclavicular skin temperature - Change in postmenopausal symptoms - Adverse events ### Location - Facility: Anna Crescenti, Reus, Catalonia. Spain, 43204, Spain @@
## Comparison Of Resistance Training And Core Strengthening Exercises Vitamin D In Postmenopausal Women With Low Back Pain - NCT ID: NCT06377618 - Study ID: DPT/Batch-Fall19/556 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-06-20 - Lead Sponsor: Superior University ### Study Description This study aims to evaluate the effectiveness of resistance training, core strengthening exercises, and vitamin D supplementation in reducing low back pain (LBP) among postmenopausal women. ### Conditions - Menopausal - Pain, Low Back ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Resistance Training and Core Strengthening Exercises Group - Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) - Oswestry Disability Index (ODI) Secondary Outcomes ### Location - Facility: Azra Naheed Medical College, Superior University, Lahore, Punjab, N/A, Pakistan @@
## The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients: Randomized Controlled Trial. - NCT ID: NCT06377605 - Study ID: MD-15-2024 - Status: RECRUITING - Start Date: 2023-03-10 - Completion Date: 2024-08-30 - Lead Sponsor: Amany Ahmed Eissa ### Study Description The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world. \[1\] Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing \[2\].Postoperative analgesia presents various challenges in vulnerable patient groups suffering from obesity. With the high potential risk of respiratory depression and postoperative pulmonary complications associated with opioid use, such as atelectasis and pneumonia, the availability of other pain management modalities is essential \[14\].Ultrasound-guided erector spinae plane block (ESPB) is a regional anesthesia technique where local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and allowed to diffuse caudally and cranially. It is supposed to provide both visceral and somatic abdominal analgesia \[3\].ESPB is effective, easy to perform, and can be performed in a short time. \[4\] It has been shown efficacy in different conditions such as thoracic surgery, trauma, cardiac surgery, breast surgery, and abdominal surgery \[5\]. However, the main concern with the ESPB block is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity.Peripheral nerve blocks in the obese may pose challenges, like difficulties in proper patient positioning and landmark identification. However, Ultrasound guidance may help overcome many difficulties in regional techniques. But as expected, targets are more deeply situated in obese patients and the ultrasound beams are attenuated as they travel a greater distance through tissue layers. Additionally, when crossing a tissue boundary, a portion is reflected back to the transducer creating artifacts like speckling and clutter which are particular problems in the obese patient. \[15\] Few studies examined the use of ESPB in bariatric surgery \[3,6,7\], all indicating potential benefits of the technique in terms of opioid sparing and pain control. To date, the efficacy of ESPB has not been examined in superobese patient.So we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB with controls, Local bupivacaine infiltration to the trocar sites, in super obese patients undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of perioperative analgesia for superobese patients undergoing bariatric surgeries. ### Conditions - Erector Spinae Plane Block - Super Obese Patients - Bariatric Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ESPB - local anaesthetic infiltration - midazolam and lidocaine - Bupivacain ### Outcomes Primary Outcomes - Total opioid consumption Secondary Outcomes - VAS score during first 24 hour postoperative ### Location - Facility: Kasr Al Ainy Hospitals, Cairo, N/A, N/A, Egypt @@
## Development and Accuracy Evaluation of Gram Staining Analysis AI - NCT ID: NCT06377592 - Study ID: G22396 - Status: RECRUITING - Start Date: 2023-05-10 - Completion Date: 2027-03-31 - Lead Sponsor: GramEye ### Study Description The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI ### Conditions - Bacterial Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sample collection without intervention ### Outcomes Primary Outcomes - Advanced level of blood culture Gram stain analysis AI accuracy - Ordinary level of blood culture Gram stain analysis AI accuracy Secondary Outcomes ### Location - Facility: Osaka University Hospital, Suita, Osaka, 5650871, Japan @@
## OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia - NCT ID: NCT06377579 - Study ID: FILObsLAM_IVOOBS - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-03-15 - Lead Sponsor: French Innovative Leukemia Organisation ### Study Description Mutations in IDH genes are found in numerous cancers and more specifically in acute myeloid leukemia (AML). These mutations target specific amino acids, at positions 140 or 172 of IDH2, and 132 of IDH1. Mutant IDH proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αKG) into D-2 hydroxyglutarate (D-2HG), an oncometabolite which massively accumulates in IDH-mutated cells. At high levels, D-2HG behaves as a competitive inhibitor of αKG and affects the activity of Fe(II)/αKG-dependent dioxygenases. This enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (JHDM histone demethylases) or DNA (methylcytosine hydroxylases of the TET family). As a result, IDH-mutated cells show altered survival, motility, invasiveness and cell differentiation. In AML, IDH1 mutations might be present in 10-15% at diagnosisIvosidenib (IVO) a first-in-class, oral, irreversible inhibitor of mutant IDH1 has shown clinical activity as a single agent in studies involving patients with IDH1 mutated relapsed or refractory (R/R) AML (DiNardo et al. 2018) and in front line settings (Montesinos et al. 2022). In phase II clinical trials, IVO yielded 30-35% of complete response rates both in frontline and R/R settings, with long lasting responses. Based on these results, the FDA (Food and Drug Agency) gave its approval for newly-diagnosed AML IDH1mut patients who are ≥ 75 years old or who have comorbidities and in R/R. However, European Medicines Agency (EMA)'s did not approved IVO due to lack of evidences to support the application. Agios Netherlands B.V. (the company that previously own the drug before Servier Laboratories) withdrew its EMA application. Nevertheless, IVO has been available in France through a compassionate use program (CUP), since February 2020 for R/R patients and March 2022 for first line treatment.In this multicentric retrospective study, we aim to evaluate the efficacy and safety of Ivo in two cohorts of IDH1mut AML patients treated within the CUP. The first cohort will concern patients treated in first line setting and the second cohort those treated in R/R disease. Our results might provide new insights regarding IVO in real life settings and support signs of efficacy. This could provide new data for the haematologist community and for another appliance to grant EMA approval of IVO in the setting of R/R IDH1mut AML. ### Conditions - AML, Adult ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - characterize the Overall survival (OS) in the both cohort : 1st line and Relapsed/Refractory (R/R) Secondary Outcomes - characterize the composite response rate (CRc) at any time during follow-up, for the both cohort : 1st line and Relapsed/Refractory (R/R) - characterize the Event Free Survival (EFS) in both cohorts : 1st line and Relapsed/Refractory (R/R) - characterize the incidence and relatedness of serious adverse events (SAE), for patients treated by Ivosidenib, for both cohorts : 1st line and Relapsed/Refractory (R/R) - describe the management of treatment by Ivosidenib in both cohorts : 1st line and Relapsed/Refractory (R/R) ### Location - Facility: Amiens CHU, Amiens, N/A, N/A, France @@
## A Study of BV-AVD in People With Bulky Hodgkin Lymphoma - NCT ID: NCT06377566 - Study ID: 24-039 - Status: RECRUITING - Start Date: 2024-04-17 - Completion Date: 2027-04 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease.BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer. ### Conditions - Hodgkin Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Brentuximab vedotin - Doxorubicin - Vinblastine - Dacarbazine - Pembrolizumab - Gemcitabine - Vinorelbine - FDG-PET/CT scan ### Outcomes Primary Outcomes - progression-free survival Secondary Outcomes - overall survival ### Location - Facility: University of Miami, Miami, Florida, 33136, United States @@
## PET/MRI for Evaluation of Endometriosis - NCT ID: NCT06377553 - Study ID: 2023P000955 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-03 - Completion Date: 2026-05-03 - Lead Sponsor: Massachusetts General Hospital ### Study Description This study aims to determine if PET/MRI can detect endometriosis and potentially improve upon currently available non-invasive diagnostic capabilities. Specifically, the authors will investigate the ability of PET/MRI to detect and quantify endometriosis, as well as differentiate among subcategories such as inflammatory peritoneal lesions, fibrotic deep infiltrating endometriosis lesions (DIE), and ovarian endometriomas. The authors will compare \[68Ga\]CBP8 or \[18F\]-FAPI-74 PET/MRI imaging versus the current gold standard diagnostic methods, including laparoscopic surgery, clinical follow-up, and follow-up imaging. ### Conditions - Endometriosis - Endometrioma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Radiotracer Injection - Imaging - Rectal Ultrasound Gel Injection ### Outcomes Primary Outcomes - Diagnostic Accuracy of PET/MR in Preoperative Endometriosis Detection - Diagnostic Performance of PET/MRI vs. Conventional Imaging Secondary Outcomes - Impact of [18F]-FAPI-74 and [68Ga]CBP8 PET/MRI on Diagnosis and Management in Endometriosis - Correlation of Pre-Treatment PET Uptake and Post-Treatment Response in Endometriosis ### Location - Facility: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, Massachusetts, 02129, United States @@
## MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma - NCT ID: NCT06377540 - Study ID: 2022LS174 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2027-09-01 - Lead Sponsor: Masonic Cancer Center, University of Minnesota ### Study Description This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant. ### Conditions - Autologous Stem Cell Transplant - Classic Hodgkin Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab - Autologous stem cell transplant - Carmustine - Etoposide - Cytarabine - Melphalan ### Outcomes Primary Outcomes - Progression free survival (PFS) Secondary Outcomes - Overall survival (OS) - Progression-free survival (PFS) - Non-relapse mortality (NRM) - Overall Survival (OS) - Rate of Complete Metabolic Response ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA) - NCT ID: NCT06377527 - Study ID: 2023-0945 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-31 - Completion Date: 2037-12-28 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To develop a database of medical information about patients with MLA in an effort to increase our understanding of the characteristics of MLA, which is the rarest form of endometrial carcinoma. ### Conditions - Mesonephric-like Adenocarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Tumor Registry Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens - NCT ID: NCT06377514 - Study ID: PCOL109PHNG - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-10-31 - Lead Sponsor: Johnson & Johnson Surgical Vision, Inc. ### Study Description Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial. ### Conditions - Cataracts ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Test IOL Model DEN00V - Control IOL Model DCB00 ### Outcomes Primary Outcomes - Monocular photopic DCIVA (first eyes) at 66 cm - Monocular Depth of Focus - Monocular Photopic BCDVA at 4m - Monocular Photopic DCVA at 100 cm Secondary Outcomes - Monocular photopic DCNVA at 40 cm (first eyes) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL) - NCT ID: NCT06377501 - Study ID: 804687 - Status: RECRUITING - Start Date: 2023-03-07 - Completion Date: 2024-07 - Lead Sponsor: University of California, San Diego ### Study Description This study will evaluate the feasibility of an 8-week vegan whole-food, plant-based dietary intervention in subjects with low risk CLL who are undergoing observation. Over the course of 8 weeks, participants will attend weekly group cooking classes via Zoom lead by a RD. Participants will also attend weekly individual meetings with a health coaches to assist with adherence to the dietary intervention. ### Conditions - Chronic Lymphocytic Leukemia Stage A(0) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Whole-food, plant-based diet ### Outcomes Primary Outcomes - Adherence to the Dietary Intervention - Satisfaction with the Dietary Intervention - Cooking Class Adherence - Recruitment - Retention Secondary Outcomes - White blood cell count - Absolute lymphocyte count - Anthropometric Measures (height, weight, body mass index) - Anthropometric Measures (waist circumference) - Biomarkers of cardiometabolic health (complete metabolic panel) - Biomarkers of cardiometabolic health (hemoglobin A1c) - Biomarkers of cardiometabolic health (cholesterol and triglycerides) - Concentration of vitamin B12 - Concentration of vitamin B9 - Concentration of iron - Concentration of ferritin - Blood pressure ### Location - Facility: UC San Diego, San Diego, California, 92093, United States @@
## Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses - NCT ID: NCT06377488 - Study ID: CR-6542 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-06-24 - Lead Sponsor: Johnson & Johnson Vision Care, Inc. ### Study Description This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity. ### Conditions - Visual Acuity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter ### Outcomes Primary Outcomes - High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at distance 4m - High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at intermediate distance 64cm - High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at near distance 40cm - Subjective Vision CLUE Scores - Rotational Stability - Absolute Rotation Error - Incidence of Unacceptable Lens Fit - Slit Lamp Findings Secondary Outcomes - Subjective Handling Scores - Subjective Comfort Scores - Subjective Vision Scores - Lens Fit Success ### Location - Facility: Dr. James Weber & Associates, PA - City Square Blvd, Jacksonville, Florida, 32218, United States @@
## Fabrication and Insertion of Michigan Splints by Dental Students - NCT ID: NCT06377475 - Study ID: 2024-00148 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-08 - Completion Date: 2025-12 - Lead Sponsor: Juliana Marotti Großhausen ### Study Description The aim of this study is to investigate the potential effects of different jaw relation determination (KRB) techniques on the fabrication of Michigan splints, in particular by comparing conventional methods with a wax plate and the use of an anterior jig. All materials and methods for the fabrication of the Michigan splint are already part of the curriculum of the Clinic for Dental Prosthodontics for first-year Master-students. Therefore, we intend to conduct a retrospective study (for the 2023 cohort) and a prospective analysis of the data (for the 2024 and 2025 cohorts). Questionnaires, models and intraoral scans will be used to evaluate the efficacy and precision of the different KRB methods as well as the fabrication process of the Michigan splint. ### Conditions - Impression Technic, Dental - Jaw Relationship - Bruxism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Jaw relation - Questionnaire ### Outcomes Primary Outcomes - Wax vs JIG Registration Secondary Outcomes - Questionnaire ### Location - Facility: UZB, Basel, N/A, 4058, Switzerland @@
## Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection - NCT ID: NCT06377462 - Study ID: VEXAS-Registry - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2030-12-31 - Lead Sponsor: Technische Universität Dresden ### Study Description The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers ### Conditions - VEXAS Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Collection of epidemiological data on VEXAS - Collection and monitoring of initial disease manifestations - Documentation of the treatment approaches and therapy sequences - Analysis of clinical-relevant clinical endpoints Secondary Outcomes - Describe disease cluster - Laboratory diagnostics - Correlation clinical endpoints with treatment approaches - Quality of life data (QoL), fatigue questionnaire (Facit-F) - Accompanying translational research - Collection of Biospecimens ### Location - Facility: Universitätsklinikum Carl Gustav Carus, Dresden, N/A, 01307, Germany @@
## Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients - NCT ID: NCT06377449 - Study ID: UIL-CSP-18052023 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2026-01-01 - Lead Sponsor: Saint Petersburg State University, Russia ### Study Description The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\[s\] it aims to answer are:* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients. ### Conditions - Ischemic Heart Disease - Aortic Stenosis, Severe - Aortic Insufficiency - Mitral Stenosis - Mitral Insufficiency - Mitral Stenosis With Insufficiency - Tricuspid Insufficiency - Ascending Aortic Aneurysm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ultrasound examination of the lungs ### Outcomes Primary Outcomes - The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination Secondary Outcomes - Postoperative pulmonary complications - Cumulative dosage of diuretics - Number of nights at home after hospital discharge ### Location - Facility: Saint Petersburg State University Clinic, Saint Petersburg, N/A, 190020, Russian Federation @@
## Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme - NCT ID: NCT06377436 - Study ID: PRAISE - Status: RECRUITING - Start Date: 2023-03-20 - Completion Date: 2024-12-31 - Lead Sponsor: University of Milan ### Study Description The goal of this clinical trial is to implement a personalized training program to prevent functional decline in frail subjects but not yet disable. The purpose of the project is to test the training in a subject at particularly high risk of entering the disabled condition. A total of 80 frail subjects, divide the participants into two groups "Divida Senso Group" (experimental group) and "Standard of care Group" (Control group) will be recruited.The expected outcome is to slow down a functional decline not only in isolation in the domains trained by the program. ### Conditions - Frailty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Experimental training ### Outcomes Primary Outcomes - Changes in the Functional decline - Intrinsic Capacity (IC) - Intreaction between IC and cardiac autonomic control (CAC) Secondary Outcomes ### Location - Facility: Gabriella CERRI, Milano, N/A, 20100, Italy @@
## Comparison Between Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases - NCT ID: NCT06377423 - Study ID: A54678775 - Status: COMPLETED - Start Date: 2021-08-01 - Completion Date: 2024-01-10 - Lead Sponsor: Prince Sattam Bin Abdulaziz University ### Study Description Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. The formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years. ### Conditions - Dental Leakage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Direct technique - Indirect technique ### Outcomes Primary Outcomes - Percentage % of patients with marginal staining Secondary Outcomes ### Location - Facility: Ali Elkaffas, Al Kharj, N/A, N/A, Saudi Arabia @@
## Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients - NCT ID: NCT06377410 - Study ID: FF-2023-433 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-11-30 - Lead Sponsor: National University of Malaysia ### Study Description As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial.Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation.Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency . ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Syrup Prospan - N-Acetylcysteine ### Outcomes Primary Outcomes - To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact. Secondary Outcomes - to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life. - to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry - to determine change of Forced Vital Capacity in litres/minute using spirometry - to determine adverse effects of Syrup Prospan (in %) - to determine adverse effects of N-Acetylcysteine (in %) - To assess satisfaction of treatment using the 5 point Likert Scale (1- Not Satisfied, 5 - Most Satisfied) ### Location - Facility: National University of Malaysia, Cheras, Kuala Lumpur, 56000, Malaysia @@
## Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates - NCT ID: NCT06377397 - Study ID: IIRPIG-2023-0000070 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-04-14 - Lead Sponsor: Indian Council of Medical Research ### Study Description Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis.The goal of this research study is to find out:1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life.2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life.3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes"). ### Conditions - Sepsis - PROM, Preterm (Pregnancy) - Early-Onset Neonatal Sepsis - Preterm Premature Rupture of Membrane - Preterm Birth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Antibiotics ### Outcomes Primary Outcomes - Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomization - Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization Secondary Outcomes - All-cause Mortality within 1st 7 days after randomization - Blood culture-positive sepsis of any severity within 1st 7 days after randomization - Episode of severe sepsis within 1st 7 days after randomization - Composite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomization - Individual components of composite outcome within 1st 72 hours after randomization - Composite of mortality/blood culture positive sepsis/severe sepsis during hospital stay - Individual components of composite outcome during hospital stay - Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay - Composite of mortality/blood culture positive sepsis/severe sepsis during 1st 30 days after randomization - Individual components of composite outcome during 1st 30 days - Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria - Sepsis-related mortality within 1st 72 hours after randomization - Sepsis-related mortality within 7 day after randomization - Sepsis-related mortality during hospital stay after randomization - Sepsis-related mortality during 1st 30 days after randomization - Clinical sepsis within 1st 72 hours after randomization - Clinical sepsis within 7 days after randomization - Clinical sepsis during hospital stay - Clinical sepsis within 1st 30 days after randomization - Episode of Probable EONS within 72 hours after randomization - Episode of Probable EONS within 7 days after randomization - Episode of asymptomatic proven EONS within 72 hours after randomization - Need for sepsis workup during 1st 72 hours after randomization - Need for sepsis workup during 1st 7 days after randomization - Need for sepsis workup during 1st 30 days after randomization - Need for sepsis workup during hospital stay - Cumulative duration of antibiotic therapy during 1st 7 days after randomization - Cumulative duration of antibiotic therapy during 1st 72 hrs after randomization - Cumulative duration of antibiotic therapy during hospital stay - Duration of hospitalization - Episodes of healthcare associated infection during hospital stay. - Adverse effects until day 30 after randomization - Serious adverse effects until day 30 after randomization ### Location - Facility: Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, N/A, 160012, India @@
## FLIGHT Study for Childhood Chronic Illness - NCT ID: NCT06377384 - Study ID: DHP-33-FLIGHT - Status: RECRUITING - Start Date: 2022-04-20 - Completion Date: 2025-09 - Lead Sponsor: Documenting Hope Project ### Study Description The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care for children with chronic illness. A mixed methods outcomes evaluation will be performed. The primary goal of this study is to evaluate the most feasible and promising strategies to inform a more streamlined and scalable intervention in the future. Up to 14 participants may be enrolled, but fewer are expected to achieve the primary goal of the study. ### Conditions - Chronic Illnesses, Multiple ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - FLIGHT Intervention ### Outcomes Primary Outcomes - Total Load Index (TLI) Secondary Outcomes - Child Health Inventory for Resilience and Prevention (CHIRP) - Children's Sleep Habits Questionnaire (CSHQ) - Vineland Adaptive Behavior Scale - Sensory Profile 2 - Quick Environmental Exposure and Sensitivity Inventory (QEESI) - Hayward Environmental Illness Severity Scale - Parenting Stress Index, 4th edition (PSI-4) - Beck Anxiety Inventory (BAI) ### Location - Facility: Epidemic Answers, Windsor, Connecticut, 06095, United States @@
## Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE - NCT ID: NCT06377371 - Study ID: 23-03025815 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-01 - Lead Sponsor: Weill Medical College of Cornell University ### Study Description The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device. ### Conditions - Meningioma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Brain Imaging with [Cu64]DOTATATE - Radio-guided Surgery With Neoprobe Utilization ### Outcomes Primary Outcomes - Preoperative [Cu64]DOTATATE PET SUV - 1st Post-operative [Cu64]DOTATATE PET SUV - 2nd Post-operative [Cu64]DOTATATE PET SUV - MRI Size Measurements - GTR vs STR Assessment - MRI Progression Assessment - Target Lesion Neoprobe Count - Subtotal Neoprobe Count - Reference Background Neoprobe Count Secondary Outcomes - SSTR2 expression - WHO grade - Ki67 Proliferation Index - ER/PR expression ### Location - Facility: New York-Presbyterian/Weill Cornell Medical Center, New York, New York, 10021, United States @@
## Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy. - NCT ID: NCT06377358 - Study ID: CEEAH CA31 - Status: COMPLETED - Start Date: 2022-05-09 - Completion Date: 2023-06-22 - Lead Sponsor: CAPENERGY MEDICAL, SL ### Study Description The Scope of this study is to assess the visceral and subcutaneous fat loss in patients having Tecar (Radiofrequency) Therapy and its effects on other anthropometric variables, adipokines and inflammation.20 obese patients will be treated with Tecar Therapy (Radiofrequency). Each patient will have 4 active, automatic plates placed on the abdomen (200 cm2 per plate), two on the right side of the midline and two on the left side. Energy will be applied for 50 minutes, controlling the temperature. Subsequently, 15 minutes of Capacitive and Resistive manual electrodes will be applied to the abdomen, simultaneously, 20 minutes of Lymphatic Drainage placing one active plate in the foot and the other in the lumbo-dorsal area. Patients will be informed that they will only feel comfortable warmth. Five sessions will be applied from Monday to Friday resting Saturday and Sunday, for 2 weeks. Total 10 sessions.Subcutaneous and visceral fat will be measured by MRI. Anthropometric variables (Body Mass Index, Waist to Hip ratio and skinfold) will be also measured.Metabolic and inflammatory effects of the RF treatment will be evaluated measuring adipokines (Leptin, adiponectin and resistin) as well as citokines (IL-6, TNF-a and C reactive Protein).Results will be analyzed using the SPSS statistics package. A Kolmogorov-Smirnov test will be applied, if the data behaves normally, parametric tests will be applied. If not, non-parametric tests will be performed. The differences between proportions will be analyzed using Fischer's exact test. The differences between the medians will be assessed using the Student's t-test for paired samples and independent samples. ### Conditions - Obesity, Visceral - Obesity; Endocrine ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tecar Therapy ### Outcomes Primary Outcomes - Visceral fat loss (cm3) - Visceral fat loss (g) - Subcutaneous fat loss (cm3) - Subcutaneous fat loss (g) - Tumor Necrosis Factor alfa - Interleukin 6 levels - C reactive Protein levels - Leptin levels - Adiponectin levels - Resistin levels - Total cholesterol changes - Total triglycerides changes - LDL Cholesterol changes - HDL Cholesterol changes - Glucose Secondary Outcomes - Body Mass Index loss - Waist to Hip Index loss - Skinfold Thickness (cm) ### Location - Facility: Inneo Terapia Despi, Barcelona, N/A, N/A, Spain @@
## Remote Patient Monitoring Solution for Chronic Respiratory Disease Management - NCT ID: NCT06377345 - Study ID: 202312-00011 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-03-30 - Lead Sponsor: SingHealth Polyclinics ### Study Description Aim: To evaluate the use of AeviceMD Monitoring System (AeviceMD) asthma in reducing acute exacerbation.Methodology: Using a randomized controlled trial design, this project aims evaluate the effectiveness of AeviceMD in improving patients' outcomes in terms of reducing exacerbation, healthcare utilization, improving quality of life, self-efficacy, and cost effectiveness. Paediatric patients above age 7 and adults will be recruited. The data follow-up period is 3 months. It will also evaluate the usability of the device from both patients' and clinicians' perspective. 180 patients (124 adults, 56 pediatrics) and 120 clinicians will be recruited.Importance of study: This study will evaluate if the AeviceMD can help improve disease management and reduce recurrence of asthma exacerbation.Potential benefits and risk: AeviceMD allows for remote monitoring and tracking of patients' lung sounds, which could be used by patients to monitor their lung condition and prevent an episode of exacerbation or worsening exacerbations culminating in an admission which who further utilize already limited healthcare resources. An exacerbation is an episode of severe shortness of breath, cough, and chest tightening which warrants a visit to a healthcare institution. Through self-monitoring, patients can be empowered to self-manage their asthma, with aid of the asthma action plan which is given to all patients with asthma. AeviceMD can also help provide clinicians with patients' objective lung data. In the primary care setting, care is also fragmented as patients are often followed-up by a different doctor or healthcare providers. Clinicians have no objective data to track patients, and is dependent on patients' self-report and possible recall bias. There is no expected risk with the use of the device. ### Conditions - Asthma - Asthma Attack - Asthma in Children - Asthma Acute - Asthma Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - AeviceMD device - Standard care ### Outcomes Primary Outcomes - Rescue therapy - Dose of oral Prednisolone use - Visit to hospital emergency department - Hospitalisation - Euro Quality of Life 5 dimensions (EQ5D) - Asthma quality of life questionnaire (AQLQ) - Pediatric asthma quality of life questionnaire (PAQLQ) Secondary Outcomes - Self-efficacy - Usability - Heart rate - Respiratory rate - Wheeze detection trend - Medication log - Duration of device usage - Payment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Biomarkers of Dementia in Chronic Sleep and Breathing Disorders - NCT ID: NCT06377332 - Study ID: X23-0330 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2025-07-01 - Lead Sponsor: Woolcock Institute of Medical Research ### Study Description Chronic obstructive pulmonary disease (COPD), obstructive sleep apnoea (OSA) and overlap syndrome are associated with obstructions in breathing and disturbed sleep.Chronic breathing disruptions and poor sleep may lead to cognitive impairment and brain changes linked with early neurodegenerative processes. As such, identifying early markers of cognitive impairment and dementia risk in individuals with chronic respiratory and sleep breathing disorders is crucial for understanding how these diseases may contribute to accelerated brain ageing. This study will comprehensively measure sleep, lung function, cognitive performance and blood-based markers of dementia risk and inflammation. The investigators will use innovative technologies to identify biomarkers of cognitive impairment and dementia risk in people with chronic sleep and breathing disorders. The investigators will also investigate the relationships between disrupted sleep and abnormal breathing and the brain. This research may also inform future early interventions to improve cognition and brain health in chronic sleep and respiratory disease. ### Conditions - COPD - Overlap Syndrome - OSA ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - High density electroencephalogram (HdEEG) - Functional near infrared spectroscopy (fNIRS) - Magnetic resonance imaging (MRI) - Blood collection - Neuropsychological battery - Questionnaires - Pulmonary Function Test (PFT) - Cognitive Assessment - Polysomnogram (PSG) ### Outcomes Primary Outcomes - Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk. - Blood levels of amyloid beta (Aβ40/Aβ42 ratio). Secondary Outcomes - Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep. - Brain tissue oxygenation during cognitive tasks and sleep. - Hypoxemia as measured by pulse oximetry. - Sleep Fragmentation - Assessment of premorbid functioning and preinjury through the Test of Premorbid Functioning (TOPF). - Assessment of verbal learning and memory through the Rey Auditory Verbal Learning Test (RAVLT). - Assessment of mild forms of cognitive dysfunction through Delis Kaplan Executive Functioning System (D-CEFS) neuropsychological assessment. - Assessment of speed of processing and executive functioning through the Trail Making Test (TMT). - Assessment of verbal fluency through the Controlled Oral Word Association Test (COWAT). - Assessment of attention, perceptual speed, motor speed and visual scanning through the Symbol Digits Modalities Test (SDMT). - Blood levels of fibrinogen. - Blood levels of clusterin. - Blood levels of 8-isoprostane - Blood levels of C-reactive protein (CRP) - Blood levels of erythrocyte sedimentation rate (ESR). - Blood levels of plasma tau. - Blood levels of neurofilament light chain (NFL). - Blood levels of Glial fibrillary acidic protein (GFAP). - Blood levels of Apolipoprotein E gene (APOE-4). - Blood levels of interleukin-8 (IL-8). - Blood levels of interleukin-6 (IL-6). - Blood levels of tumor necrosis factor alpha (TNFα). - Blood levels of amyloid beta (Aβ40/Aβ42 ratio). - Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk. ### Location - Facility: The Woolcock Institute of Medical Research, Sydney, New South Wales, 2113, Australia @@
## Decision Support System for Diagnosis and Progression of Heart Failure - NCT ID: NCT06377319 - Study ID: 101080905 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-07-31 - Lead Sponsor: Coventry University ### Study Description Heart failure (HF) is a complex clinical syndrome associated with impaired heart function, poor quality of life for patients and high healthcare costs. Accurate risk stratification and early diagnosis in HF are challenging as signs and symptoms are non-specific. Here the investigators propose to address this global challenge by developing novel analytic methods for HF (STRATIFYHF). A prospective clinical study will collect patient-specific data related to medical history, a physical examination for signs and symptoms, blood tests including natriuretic peptides, an electrocardiogram (ECG), an echocardiogram (ultrasound of the heart), cardiovascular magnetic resonance imaging (MRI), demographic, socio-economic and lifestyle data along with novel technologies (cardiac output response to stress (CORS) test and voice recognition biomarkers) from individuals at-risk of developing HF and those with a confirmed diagnosis of HF. STRATIFYHF will use these data to support clinical validation of an artificial intelligence (AI)-driven decision support system (DSS) and mobile application for risk prediction, diagnosis, and progression of HF to enhance patients' quality of life and lead to more cost-effective health care. ### Conditions - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cardiac Output Response to Stress (CORS) test ### Outcomes Primary Outcomes - Diagnostic accuracy of the DSS Secondary Outcomes - Demographic and clinical predictors of risk, diagnosis, and progression of heart failure. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes - NCT ID: NCT06377306 - Study ID: MC study - Status: RECRUITING - Start Date: 2023-11-05 - Completion Date: 2027-01-30 - Lead Sponsor: Wingate Institute ### Study Description Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential "noise" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking.The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes.200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC.Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment. ### Conditions - Menstrual Cycle - Athletes - Physical Activity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Effect of training loads and sport performance level on health and sport performance ### Outcomes Primary Outcomes - Stool Microbiome - Serum metabolomics - VO2max - Countermovement jump - Flexibility - Grip Strength - Lower leg Strength - Blood tests - Knee valgus Secondary Outcomes - Anthropometric (Height) - Psychological questionnaire (Positive-Affect Negative-Affect scale - PANAS) - Anthropometric (Weight) - Percentage body fat (%) ### Location - Facility: Wingate Institute, Netanya, N/A, N/A, Israel @@
## Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients - NCT ID: NCT06377293 - Study ID: FEMH-IRB-TSAI2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-11 - Completion Date: 2029-06 - Lead Sponsor: Far Eastern Memorial Hospital ### Study Description In patients with kidney failure, disturbances in bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial metabolites are frequent. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, inflammation, protein-energy wasting and dysbiosis. The investigators hypothesize that therapeutic diet intervention reverses these uremic complications and thereby reduces cardiovascular risk in patients with kidney failure. In this study, the investigators crafted 4-week dialysis-specific therapeutic diet to illustrate the clinical implications of therapeutic diet for dialysis patients. ### Conditions - End-Stage Kidney Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Dialysis-specific therapeutic diet ### Outcomes Primary Outcomes - Concentrations of intact fibroblast growth factor 23 (pg/mL) Secondary Outcomes - Concentrations of C-terminal fibroblast growth factor 23 (RU/mL) - Concentrations of phosphate (mg/dL) - Concentrations of calcium (mg/dL) - Concentrations of intact parathyroid hormone (pg/mL) - Concentrations of bone-specific alkaline phosphatase (μg/L) - Concentrations of procollagen-type 1 N-terminal-propeptide (P1NP) (ng/mL) - Concentrations of tartrate resistance acid phosphatase-5b (TRACP-5b) (mIU/ml) - Concentrations of alkaline phosphatase (ALP) (IU/L) - Concentrations of free indoxyl sulfate (mg/L) - Concentrations of free p-cresol sulfate (mg/L) - Concentrations of pre-albumin (g/dL) - Concentrations of albumin (g/dL) - Concentrations of C-reactive protein (mg/dL) - Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells - Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells - Absolute number (per μl blood) of monocytes - Concentrations of fetuin-A (μg/ml) - Concentrations of trimethylamine-N-oxide (TMAO) (μM) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device. - NCT ID: NCT06377280 - Study ID: NAV-0011 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2024-12 - Lead Sponsor: Wellspect HealthCare ### Study Description This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks.Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact. ### Conditions - Bowel Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Navina Mini ### Outcomes Primary Outcomes - Patient satisfaction Secondary Outcomes - Assessment of clinical benefit - Ease of handling - Safety Outcome ### Location - Facility: Skåne University Hospital, Malmö, N/A, N/A, Sweden @@
## Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial) - NCT ID: NCT06377267 - Study ID: ESR-20-21103 - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2025-09 - Lead Sponsor: Vall d'Hebron Institute of Oncology ### Study Description Background:The study aims to address the challenge of accurately identifying patients with ovarian cancer who would benefit from poly-ADP ribose inhibitors (PARPi) as first-line maintenance therapy. While BRCA1/2-mutated epithelial ovarian cancer (EOC) patients have shown significant benefits from PARPi treatment, the efficacy in homologous recombination deficient (HRD) patients remains inconclusive. Current assays used to estimate HR status do not effectively differentiate between patients who benefit most from PARPi and those who do not, making it inefficient to treat all patients. There is a need for a more accurate HR status testing method to optimize PARPi benefit. This study aims to assess the performance of the VHIO-CARD-300 test in determining HR status compared to SOPHiA DDM™ Dx HRD Solution.Summary:The study is a prospective, non-randomized trial designed to evaluate the concordance of the VHIO-CARD-300 test in establishing HR status compared to SOPHiA DDM™ Dx HRD Solution. Additionally, it aims to assess the association between HRD status determined by the VHIO-CARD-300 test and treatment efficacy. Patients with advanced FIGO stage III-IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer will be invited to participate. Those eligible will undergo testing with both VHIO-CARD-300 and SOPHiA DDM™ Dx HRD Solution. Patients classified as HRD positive will receive olaparib in combination with bevacizumab, while others will receive bevacizumab alone. Treatment will be administered according to approved doses, with follow-up evaluations conducted until RECIST progression. ### Conditions - Ovarian Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bevacizumab - Olaparib ### Outcomes Primary Outcomes - Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution Secondary Outcomes - Performance Assessment of VHIO-CARD-300 Test for HR Status Identification - Association Between VHIO-CARD-300 Test Groups and Efficacy Outcomes(i.e., HRD positive and HRD negative) and efficacy outcomes. - Analysis of Progression-Free Survival (PFS) and Overall Survival (OS) in Discrepant HRD Cases - Safety and Tolerability of Olaparib Plus Bevacizumab - To evaluate the failure rate for the VHIOCARD-300 test and SOPHiA DD Dx HRD Solution. ### Location - Facility: Vall d'Hebron Institute of Oncology, Barcelona, N/A, N/A, Spain @@
## Multi-organ Responses to CHronic Physical Activity and INactivity - NCT ID: NCT06377254 - Study ID: BB/X015173/1 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2028-10-31 - Lead Sponsor: University of Nottingham ### Study Description Life expectancy has been increasing for the last 150 years, but the maintenance of health has not kept pace with increased lifespan, and on average, UK adults spend the last decade of life in poor-health, with major consequences for society and the individual.Persistent physical inactivity is thought to be a key contributing factor to the risk of poor health and functional decline occurring in middle-aged and older adults. It is therefore concerning that most middle-aged adults spend \>8hrs/day being sedentary, with average step count of 3000-4000 steps/day.To be able to holistically assess the effectiveness of future strategies to address age-related decline in health, and devise public health messages to help individuals reach older age in better health, it is essential that the complex physiological effects that activity and inactivity have across biological systems are characterised.The goal of this intervention study is to compare the impact of physical activity and inactivity on body functioning. Twenty moderately active participants will decrease their physical activity for six months to match the average amount carried out by middle-aged people in the UK. They will then undertake 3-months of reconditioning training to restore their fitness. In addition, twenty sedentary participants will increase their physical activity to UK recommended levels for six months.Before and at points during the intervention period, participants will be asked to make some measurements at home and attend the University of Nottingham to have multiple assessments made. These include;* fitness, muscle strength and function tests,* completion of questionnaires and computer-based brain puzzles* having muscle and fat tissue biopsies and blood samples taken.* The study also involves having MRI scans.This 5-year study will commence in January 2024, with participant recruitment starting in March 2024 and finishing in May 2027. ### Conditions - Sedentary Behavior - Metabolic Syndrome - Age-related Cognitive Decline - Age-Related Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Decreased Physical Activity - Increased Physical activity ### Outcomes Primary Outcomes - Change in Cardiorespiratory fitness (VO2 max) Secondary Outcomes - Change in Isometric leg strength - Change in time to leg fatigue - Change in incremental area under the curve (iAUC) for blood glucose concentration - Change in iAUC for serum insulin concentration - Change in fasting glucose oxidation rate - Change in 'fed' glucose oxidation rate - Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score - Change in Short Form Health Survey (SF36) Questionnaire aggregated and normalised 'mental' score - Change in World Health Organisation Quality of Life (WHOQoL) score - Change in Pittsburgh Sleep Quality Index (PSQI) - Change in Stroop test; % Accuracy - Change in Stroop test; reaction time - Change in four-choice reaction time test; % Accuracy - Change in four-choice reaction time test; reaction time - Change in card sort test; % Accuracy - Change in card sort test; reaction time - Change in Logical reasoning test; % accuracy - Change in Logical reasoning test; reaction time - Change in serial subtractions test; number of responses in 2 minutes - Change in Corsi blocks test; score - Change in Muscle protein synthesis rate - Change in Muscle protein breakdown rate - Change in whole body fat volumes - Change in liver fat volumes - Change in thigh muscle fat volumes - Change in whole body muscle volumes - Change in muscle phosphocreatine synthesis rate - Change in cerebral volume - Change in cortical thickness - Change in plasma metabolome ### Location - Facility: David Greenfield Human Physiology Unit, Nottingham, Notts, NG72UH, United Kingdom @@
## ScentAware and OCT in MCI vs HC - NCT ID: NCT06377241 - Study ID: 2023-1436 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-06 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The goal of this clinical trial is to learn whether a new smell test works as well as the standard clinical smell test, if there is a link between sense of smell and variations in the retina, and if these results could be used as a way to identify early stages of Alzheimer's disease. The main questions it aims to answer are:* Whether the test is as effective and reliable as the standard test* Whether there is a link between the results of the smell test and the structure of the back of the eyeParticipants will:* complete a short questionnaire* have pictures of the inside of their eyes taken* perform two smell tests ### Conditions - Alzheimer Disease, Early Onset ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ScentAware - UPSIT ### Outcomes Primary Outcomes - Compare test scores of ScentAware olfactory test to the scores of the University of Pennsylvania Smell Identification Test (UPSIT) olfactory test in a clinical setting - Compare ScentAware test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently - Compare UPSIT test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently Secondary Outcomes - Compare baseline ScentAware test scores between cohorts - Compare baseline UPSIT test scores between cohorts - Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness - Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness - Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness - Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness ### Location - Facility: University of Wisconsin, Madison, Wisconsin, 53705, United States @@
## A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) - NCT ID: NCT06377228 - Study ID: TAK-007-1001 - Status: NOT_YET_RECRUITING - Start Date: 2024-11-01 - Completion Date: 2029-04-23 - Lead Sponsor: Takeda ### Study Description The main aim of the study is to learn how well adults with refractory lupus nephritis (LN) tolerate TAK-007 and to check for side effects (adverse events).Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007. ### Conditions - Refractory Lupus Nephritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TAK-007 - Chemotherapy Agents ### Outcomes Primary Outcomes - Number of Participants With Treatment-Emergent Adverse Events (TEAEs) - Number of Participants With Dose Limiting Toxicities (DLTs) Secondary Outcomes - Cmax: Maximum Observed Plasma Concentration for TAK-007 - Tmax: Time to Reach the Cmax for TAK-007 - Tlast: Time of Last Measurable Concentration Above the Lower Limit of Quantitation for TAK-007 - AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-007 - Change From Baseline in CD19+ B Cell Counts - Duration of B Cell Depletion - Change From Baseline in Plasma Cytokine Levels - Change From Baseline in Physician's Global Assessment (PGA) Score - Percentage of Participants Achieving a Reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Relative to Baseline - Percentage of Participants Achieving Complete Renal Response (CRR) - Time to CRR - Duration of CRR - Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) - Time to LLDAS - Duration of LLDAS - Percentage of Participants Meeting the Definition of Remission in SLE (DORIS) Criteria - Time to DORIS Remission - Duration of DORIS Remission - Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Levels - Change From Baseline in Antinuclear Antibody (ANA) Levels - Change From Baseline in Proteinuria Levels - Change From Baseline in Creatinine Levels - Change From Baseline in eGFR - Change From Baseline in Complement (C3, C4) Levels - Percentage of Participants With Antidrug Antibodies Categorized as Anti-Human Leukocyte Antigen (HLA) and Anti- Chimeric Antigen Receptor (CAR) - Percentage of Participants With Replication Competent Retrovirus (RCR) in Blood ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Understanding Aided Speech Perception in Noise - NCT ID: NCT06377215 - Study ID: Pro00041729 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-03-01 - Lead Sponsor: University of South Florida ### Study Description The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention. ### Conditions - Hearing Impairment, Sensorineural - Spatial Perception - Aging - Hearing Aids ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Open-source master hearing aid ### Outcomes Primary Outcomes - Digit Identification - Neural Segregation Secondary Outcomes - Minimum Audible Angle (MAA) - Speech Localization Error - Fixed Spatial Release from Masking ### Location - Facility: USF Research Park BPB, 3802 Spectrum Boulevard, Suite 210C, Tampa, Florida, 33612, United States @@
## Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies - NCT ID: NCT06377202 - Study ID: SynKIR-110 LTFU - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2038-12-15 - Lead Sponsor: Verismo Therapeutics ### Study Description The primary objective of this study is to evaluate the long-term safety of SynKIR- 110 administered to adult subjects with solid tumors expressing mesothelin. ### Conditions - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of subjects with treatment related adverse events as assessed by CTCAE v5.0 Secondary Outcomes - Number of subjects with persistence of SynKIR-110 modified cells - Number of subjects with potential/suspected RCL ### Location - Facility: University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States @@
## Psychiatric Consultation-Liaison Intervention in Primary Care: A Pilot Study - NCT ID: NCT06377189 - Study ID: 2023-01910 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-01 - Lead Sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland ### Study Description The pilot study on the impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French-speaking Switzerland (PLIMeC-P), is a mixed method randomized controlled trial. The investigated health-related intervention is a brief Consultation-Liaison (CL) psychiatry intervention in primary care.Primary Care Physicians (PCPs) have a key role in preventing, detecting, and managing mental disorders. Therefore, the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges. It is well demonstrated that multidisciplinary interventions improve the efficacy of mental health care, CL psychiatry being one such type of intervention. Therefore, community CL-psychiatry, for example in private primary care group practices, are rare. The impact of such community, primary care CL-psychiatry interventions, should be investigated.The mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings, for newly reported mental illness, versus a Treatment As Usual (TAU) control arm. The intervention consists of a CL-psychiatric intervention into private medical practices, provided to patients suffering from mental health problems, a group of patients generally under-treated. The CL-psychiatrist will receive and discuss PCPs' referrals for patients with mental distress, who don't have a psychiatric follow-up. After a brief intervention (1-4 sessions), feedback conjoint (PCP-psychiatrist) session will be organized, to complete the intervention and provide proposals.The pilot study (PLIMeC-P) will determine whether the main planned study (PLIMeC) is feasible and practicable. It will be conducted on two sites, the Neuchâtel Psychiatry Centre (CNP) and the North-west Adult Psychiatry Service (SPANO), Department of Psychiatry of CHUV, Yverdon. For the pilot study (PLIMeC-P), 15 eligible participants are expected for each group, 30 participants in total. They will be recruited in three private primary care group practices. After eligibility and randomization 15 participants will be included for the intervention arm (brief CL-psychiatric intervention) and 15 for the control arm (TAU). The expected number of participants for the main trial (PLIMeC) will be estimated through analysis of the initial results of the PLIMeC-P. ### Conditions - Mental Health Issue - Depression/Anxiety - Quality of Life - Psychosomatic Disorders - Patients Lived Experiences - Doctor-Patient Relation - Collaboration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Intervention arm - Consultation-Liaison (CL) brief psychiatric intervention in primary care settings - Control Arm - Treatment As Usual (TAU) ### Outcomes Primary Outcomes - Evaluate the feasibility of the main PLIMeC study - Mental health - psychiatric symptoms - Mental health - Quality of life - Mental health - Self-report questionnaire Secondary Outcomes - The lived experience of the participants - The lived experience of the implicated clinicians ### Location - Facility: Center for Primary Care and Public Health (Unisanté) - Sponsorship / Not recruiting site, Lausanne, Vaud, 1010, Switzerland @@
## Postpartum Massage Therapy for Women and Infants: The Effect on Maternal Depression, Stress, Fatigue and Infant Temperament - NCT ID: NCT06377176 - Study ID: NTUNHSEN - Status: COMPLETED - Start Date: 2021-06-16 - Completion Date: 2021-10-03 - Lead Sponsor: National Taipei University of Nursing and Health Sciences ### Study Description Mother and infant massage, a type of complementary therapy, possesses the capacity to ameliorate maternal depression, stress, fatigue, and also infant temperaments and convert them into more manageable ones. The objective of this study was to determine the effect of mother and infant massage therapy on maternal depression, stress, fatigue, and infant temperament. In this quasi-experimental study, a total of 102 participants were allocated into two groups based on a pretest and posttest. During a period of five weeks, the experimental groups were subjected to ten massages per week, twice every week. On the data, a generalized estimating equation (GEE) was implemented. This study's hypothesis was an improvement in maternal depression, stress, fatigue, and infant temperament. ### Conditions - Postpartum Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Massage therapy ### Outcomes Primary Outcomes - Depression Secondary Outcomes - Stress - Fatigue - Infant temperament ### Location - Facility: Community Health Center, Sleman, Yogyakarta, 55584, Indonesia @@
## Bacterial Pathogens Associated With Community-acquired Pneumonia in Children - NCT ID: NCT06377163 - Study ID: acquired pneumonia in children - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2021-08-31 - Lead Sponsor: Delta University for Science and Technology ### Study Description Pediatric community acquired pneumonia (CAP) is one of the most common reasons for hospital admission, there is no reliable way of distinguishing the causative organism based on clinical features.This study examined common pathogens of community-acquired pneumonia from 28 days up to 10 years in Dakahlia Governorate. ### Conditions - Children Pneumonia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Complete blood count - C-reactive protein (CRP) - Blood culture and sensitivity on admission - Gastric lavage culture or sputum culture on admission Secondary Outcomes ### Location - Facility: Amira Hussin Mohammed, Gamasa, N/A, 35712, Egypt @@
## Stargardt Disease in Childhood - NCT ID: NCT06377150 - Study ID: ABCA4-1382022BO2 - Status: COMPLETED - Start Date: 2022-04-01 - Completion Date: 2024-03-31 - Lead Sponsor: University Hospital Tuebingen ### Study Description Retrospective chart review study to elucidate the phenotype and genotype of children with ABCA4-associated Stargardt disease. ### Conditions - Stargardt Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Best Corrected Visual Acuity (BCVA) - Visual Field (VF) - Fundus Photography (FP) - Fundus Autofluorescence (AF) - Optical Coherence Tomography (OCT) - Full-Field Electroretinography (ff-ERG) Secondary Outcomes ### Location - Facility: University Hospital Tuebingen, Tuebingen, Baden-Wuerttemberg, Germany, 72076, Germany @@
## High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction - NCT ID: NCT06377137 - Study ID: University of the Porto - Status: COMPLETED - Start Date: 2023-03-10 - Completion Date: 2023-09-01 - Lead Sponsor: Universidade do Porto ### Study Description Pediatric obesity is considered one of the most important public health problems worldwide due to its high prevalence and associated comorbidities. Physical exercise has been shown to have an important role in the treatment of obesity and associated cardiometabolic dysfunction. Small-sided soccer games (SSSG) have been explored as a promising way of increasing physical exercise due to its benefits on cardiometabolic health and high degree of enjoyment, which favors long-term adherence.The objective of this research is to determine the effects of a 16-week high-intensity SSSG-based exercise intervention on cardiometabolic risk factors, physical fitness, adherence to 24-hour movement patterns, enjoyment and adherence to the intervention in adolescents with metabolic dysfunction and compare them to the effects of a traditional soccer intervention.The investigators hypothesize that high-intensity SSSG are more effective in improving the obesity-related cardiometabolic risk profile in adolescents with cardiometabolic dysfunction compared to traditional soccer training.A parallel 3-arm randomized controlled trial will be conducted in adolescents with overweight and metabolic dysfunction between 11 and 15 years of age. The inclusion criteria are: (i) age between 11-15 years at the time of intervention start; (ii) overweight or obesity (BMI\> 85th percentile); (iii) Abdominal obesity ≥90th percentile as assessed by waist circumference or a waist-to-height ratio ≥ 0.5; (iv) willing to participate in the study regardless of possible group allocation; (v) informed consent given by participant and legal representatives. Exclusion criteria: (i) health condition not compatible with participation in physical exercise; (ii) history of recent musculoskeletal injury hindering exercise participation; (iii) concurrent participation in a structured weight loss or exercise program.Those eligible to participate in the study will be randomly assigned to one of three groups: i) SSSG group, ii) traditional soccer play group (TSG), or, iii) non-exercise intervention control group (CG). Participants in both exercise intervention groups will undergo a 16-week intervention. The SSSG group will participate in a high-intensity small-sided soccer games training, while the TSG will undergo a technical and tactical skills training program and traditional soccer training. The CG participants will continue with regular school physical education classes without any additional intervention. Before and after the intervention, all participants will be assessed for cardiometabolic and hepatic biochemical markers, physical fitness, anthropometry and body composition, blood pressure, objective daily physical activity and sleep quality, and perceived enjoyment of participation in SSSG and TSG. The primary outcomes of the study will be waist circumference and cardiorespiratory fitness.The study protocol was approved by the Ethics Committee of the Faculty of Sport of the University of Porto and by the Scientific Ethics Committee of the Adventist University of Chile. ### Conditions - Obesity, Adolescent - Metabolic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Small-sided soccer games groups (SSSG) - Traditional soccer training groups (TSG) ### Outcomes Primary Outcomes - Waist circumference - Cardiorespiratory fitness Secondary Outcomes - Variation in fasting blood glucose concentration (mg/dL) - Variation in serum insulin concentration (mU/L) - Variation in HOMA-IR - Variation in glycosylated hemoglobin concentration (mg/dL) - Variation in high-density lipoprotein cholesterol concentration (mg/dL) - Variation in low-density lipoprotein cholesterol concentration (mg/dL) - Variation in total cholesterol concentration (mg/dL) - Variation in blood triglycerides concentration (mg/dL) - Variation in blood Alanine aminotransferase concentration (U/L) - Variation in blood Aspartate aminotransferase concentration (U/L) - Variation in blood Gamma glutamyl transferase concentration (U/L) - 6-minute walk test - Hand grip strength - Lower limb strength - Body composition - Body mass index - Neck circumference - Blood Pressure (mmHg) - Physical activity - Sleep quality - Perceived enjoyment of physical activity ### Location - Facility: Faculty of Sport of the University of Porto, Porto, N/A, 4200-450, Portugal @@
## A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients - NCT ID: NCT06377124 - Study ID: UW21-507 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2026-06-30 - Lead Sponsor: The University of Hong Kong ### Study Description Lung cancers patients often experience multiple symptoms (e.g. fatigue, dyspnea, distress, depression, sleep disturbance). The current study attempts to explore the efficacy of the Smart Self-Management Support Programme (3S) in improving quality of life of patients using self-management support programme with mobile devices. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - 3S intervention - GH information ### Outcomes Primary Outcomes - Change in health-related quality of life Secondary Outcomes - Change in health-related quality of life - Change in patient activation - Change in general self-efficacy - Change in acceptance of illness - Change in physical activity level - Change in diet habit - Change in smoking and drinking habits - Change in health status - Change in anxiety symptoms of patients - Change in depression symptoms of patients - Change in social and family support - Change in adherence to agreed preset health-related goals - Change in symptom severity - Change in functional exercise capacity - Change in lower limb strength - Change in hand grip strength - Change in flexibility - Change in balance - Change in body composition - Change in objective physical activity level - Change in objective sleep quality - Change in burden of family caregivers (For FCGs) - Change in quality of life of family caregivers (For FCGs) - Change in anxiety symptoms of family caregivers (For FCGs) - Change in depression symptoms of family caregivers (For FCGs) ### Location - Facility: Queen Mary Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma - NCT ID: NCT06377111 - Study ID: PANTHEON-IO - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: University Health Network, Toronto ### Study Description This study is open to patients with a type of cancer called melanoma. Patients can join the study if their tumor cannot be removed by surgery or has spread to other organs, and are planned to receive immunotherapy as treatment for their cancer. This study is looking at whether taking calcium pantothenate supplement (a type of Vitamin B5) can increase its levels in the blood and have an effect in the immune system, when its used in combination with the immunotherapy. ### Conditions - Melanoma (Skin) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - C-PAN - Nivolumab - Ipilimumab ### Outcomes Primary Outcomes - To determine if the dose of 2000 mg daily of pantothenic acid achieves an increase in plasmatic concentration of pantothenic acid by at least a 50% between baseline and week 9, in 9 or more of the patients treated with combined ICI. Secondary Outcomes - Evaluate the overall response rate (ORR) of the enrolled cohort. - Evaluate the progression free survival (PFS) of the enrolled cohort. - Incidence of immune-related colitis. - Correlation between baseline intestinal microbiome composition to the development of immune-related colitis. - Correlation between the early changes in composition of intestinal microbiome and the development of immune-related colitis. - The incidence of treatment-related adverse events. - The incidence of treatment-related adverse events - Correlation between change in plasmatic pantothenic acid level between baseline and at first day of ICI, and ORR. ### Location - Facility: University Health Network- Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada @@
## Intrapartum Sildenafil in Laboring Mothers - NCT ID: NCT06377098 - Study ID: UAB-300010901 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-01-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources.The main questions it aims to answer are:* What are the fetal heart rate monitoring practices in a low-resource setting?* What are the indications for operative delivery in a low-resource?* What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil?* What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting?Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected.Participants will:* Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor* Have the (mothers \& babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag \& mask ventilation, Apgar scores, and seizures.* Have a neonatal neurological assessment prior to discharge* Have phone call assessments for re-hospitalization or mortality 7 days post-delivery* Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone callThe results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia. ### Conditions - Neonatal Asphyxia - Intrapartum Fetal Distress - Development, Infant - Intrapartum Asphyxia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sildenafil 50 mg Oral Tablet - Placebo Oral Tablet ### Outcomes Primary Outcomes - Percentage of perinatal mortality - Percentage of operative delivery - Indication for operative delivery Secondary Outcomes - Percentage of mothers who received fetal heart rate monitoring - Indication for fetal heart rate monitoring - Apgar Score - Percentage of use of bag and mask ventilation in neonates - Percentage of neonates with neonatal encephalopathy - Percentage of neonates with neonatal encephalopathy - Percentage of neonates with hypoxemia - Percentage of infants with neonatal hypoxic-ischemic encephalopathy - Percentage of neonatal ICU admissions - Percentage of maternal rehospitalization - Percentage of neonatal rehospitalization - Infant/child developmental assessment ### Location - Facility: Cameroon Baptist Convention Health Services, Douala, N/A, N/A, Cameroon @@
## Repurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy - NCT ID: NCT06377085 - Study ID: 809325 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Shirley Ryan AbilityLab ### Study Description In this controlled dose-escalation study, we will study the initial safety, biological properties, and potential efficacy of 5-azacytidine (AZA). Our overarching aspiration is for AZA to evolve into an approved pharmacological treatment, fostering muscle growth and enhancing body movement, ultimately contributing to an improved quality of life in children with CP.The main questions this study aims to answer are:1. What is the optimal dose of AZA injection that can be used safely in children with CP?2. Can the optimal safe dose of AZA improve the function of muscle-generating stem cells in children with CP?Each participant will have up to five research visits over the course of the study duration, in which they will participate in: blood draws, pregnancy test(s) (if applicable), medical assessments, and a muscle biopsy during a surgery for muscle contractures.Researchers will compare participants with four different dosages of AZA injections to those with four different dosages of placebo injections. A placebo is a look-alike substance that contains no active drug. They will see if a single injection of AZA at a standard concentration currently approved by the FDA to treat myelodysplastic syndromes, can also safely improve muscle growth and function in children with CP. ### Conditions - Cerebral Palsy - Contracture ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Placebo for the AZA 10mg/m^2 - Placebo for the AZA 20mg/m^2 - Placebo for the AZA 35mg/m^2 - Placebo for the AZA 75mg/m^2 - 5-Azacytidine 10mg/m^2 - 5-Azacytidine 20mg/m^2 - 5-Azacytidine 35mg/m^2 - 5-Azacytidine 75mg/m^2 ### Outcomes Primary Outcomes - Dose-limiting toxicity (DLT). Secondary Outcomes - Satellite Cell Fusion Index. - DNA methylation quantification in Satellite Cells and Blood Mononucleated Cells. - DNA methylation profiling in Satellite Cells. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@