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## Bleeding After Robot-assisted Radical Prostatectomy: a Respective Study - NCT ID: NCT06299046 - Study ID: 3235 - Status: COMPLETED - Start Date: 2022-12-01 - Completion Date: 2023-01-01 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Nowadays robot-assisted radical prostatectomy (RARP) has become the standard surgical treatment for localised prostate cancer. The robotic approach has been proven superior to open retropubic prostatectomy (ORP) in terms of surgical-related morbidity: RARP has in fact been associated with significantly lower estimated blood loos (EBL), lower transfusion rate, less length of stay, shorter catheterization time, lower risk of Clavien-Dindo grade II and III complications, lower risk of vesicourethral anastomotic stricture and less post-operative pain. The optimal anatomical visualisation and the extraordinary maneuverability, along with the tamponade effect of the pneumoperitoneum, are surely to be deemed responsible of this statistically significant differences.However, to this day no study has ever investigated the prognostic significance of haematological parameters in terms of predicting perioperative bleeding risk in patients undergoing RARP.Therefore, the investigators conducted a retrospective non-interventional cohort study to gather evidence concerning the impact of anemia and thrombocytopenia on bleeding risk following this surgical procedure. Furthermore, the investigators evaluated associations between demographical, pathological and surgical factors and hemorrhagic complications.The investigators retrospectively evaluated all the patients that underwent robot-assisted radical prostatectomy in our Urology Unit from the 1st of January 2017 to the 31th of December 2020. The investigators collected demographic, clinical and pathological data from the medical records of these patients, with particular attention to other known risk-factors for RARP-associated bleeding (e.g.: volume of the prostate, body mass index, smoking status, nerve sparing technique).Complications were analyzed according to the Clavien- Dindo classification. Bleeding was assessed by considering both the hemoglobin (Hb) drop after surgery and the fluid intraoperatively collected in the suction canister, with all the due adjustments. Moreover, post-operative haemorrhagic complications were evaluated.The investigators included patients not younger than 18 years old, of which records of a pre-operative full blood count in the 30 days prior to the surgery along with a full blood count the day after were available.Criteria for exclusion were a history of congenital coagulopathies and/or congenital thrombocytopenia and patients that underwent salvage radical prostatectomy after radiation therapy.Statistics: EBL and operative time learning curve is studied. Clinical, pathological, intraoperative risk factors analysis for higher EBL is performed by linear regression modelling. Factors are evaluated independently and jointly. Association between each factor above and post-operative outcomes (i.e. post-op bleeding, need of transfusion and hematuria) is also assessed. ### Conditions - Prostate Cancer - Bleeding - Prostate Adenocarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - robot-assisted radical prostatectomy ### Outcomes Primary Outcomes - Influence of hemoglobin value on haemorrhagic complications - Influence of hematocrit value on haemorrhagic complications - Influence of platelet count on haemorrhagic complications - Influence of blood group on haemorrhagic complications Secondary Outcomes - Identification of possibile demographic and surgical predictive factors of haemorrhagic complications ### Location - Facility: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy @@
## A Safety and Tolerability Study of Human Forebrain Neural Progenitor Cells Injection (hNPC01) in Subjects With Chronic Ischemic Stroke - NCT ID: NCT06299033 - Study ID: HPS-NP1-101 - Status: RECRUITING - Start Date: 2023-11-09 - Completion Date: 2025-12-30 - Lead Sponsor: Hopstem Biotechnology Inc. ### Study Description The principal aims of the clinical investigation involve assessing the safety profile and MTD of human forebrain neural progenitor cells (hNPC01) administered at escalated doses via single-dose intracerebral injection to subjects with stable chronic ischemic stroke. ### Conditions - Chronic Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - hNPC01 ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 6 months after intracerebral injection of hNPC01 Secondary Outcomes - Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 12 months after intracerebral injection of hNPC01 ### Location - Facility: XiangYa Hospital, Changsha, Hunan, N/A, China @@
## Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency - NCT ID: NCT06299020 - Study ID: HLaRabta24 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-12 - Lead Sponsor: Hopital La Rabta ### Study Description In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for fourteen days (one week of fasting and one week of non-fasting). ### Conditions - Primary Adrenal Insufficiency - Intermittent Fasting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: DIAGNOSTIC ### Interventions - intermittent fasting ### Outcomes Primary Outcomes - hypoglycemia Secondary Outcomes - Dehydration ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Awareness of Iron Status Evaluation in UGIB - NCT ID: NCT06299007 - Study ID: HYH EC 052-66-01 - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2023-12-31 - Lead Sponsor: Hat Yai Medical Education Center ### Study Description BACKGROUND: Data on the awareness of the need to evaluate iron status and IDA prevalence in acute UGIB are limited.OBJECTIVES: This study aimed to investigate the rate of evaluation of iron status and prevalence of iron deficiency anemia (IDA) and the associated factors in patients with anemia hospitalized for acute upper gastrointestinal bleeding (UGIB). ### Conditions - Upper Gastrointestinal Bleeding ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - iron status measurement Secondary Outcomes - Iron deficiency anemia ### Location - Facility: Hatyai Hospital, Hat Yai, Songkhla, 90110, Thailand @@
## Determination of Body Awareness and the Functional Movement in Patients With COPD - NCT ID: NCT06298994 - Study ID: SBA 23/391 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-08 - Completion Date: 2026-03-08 - Lead Sponsor: Hacettepe University ### Study Description The aim of this study is to investigate body awareness and functional movement in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy controls. ### Conditions - Pulmonary Disease, Chronic Obstructive - Postural; Defect - Movement, Abnormal - Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluation of functional movement - Evaluation of Body Awareness Secondary Outcomes - Functional exercise capacity - Respiratory muscle strength - Respiratory muscle endurance - Pain Severity - Pain threshold - Posture - Daily living activities - Severity of disease - Dyspnea - Symptoms ### Location - Facility: Aynur Demirel, Ankara, N/A, 06100, Turkey @@
## Pulse Rate and Breathing Rate Accuracy - NCT ID: NCT06298981 - Study ID: 2301 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2024-06-30 - Lead Sponsor: Nuralogix Corporation ### Study Description The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis. ### Conditions - Pulse Rate and Breathing Rate ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - noninvasive and investigational NuraLogix AMC-SDK ### Outcomes Primary Outcomes - Breathing rate accuracy validation - Pulse rate accuracy validation Secondary Outcomes - Pulse rate simulation ### Location - Facility: Element Materials Technology, Louisville, Colorado, 80027, United States @@
## Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma - NCT ID: NCT06298968 - Study ID: NFEC-2024-074 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2027-02-25 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description In this phase 2 study, the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma ### Conditions - Intrahepatic Cholangiocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - The disease control rate (DCR) - Duration of response (DOR) - The median progression free survival time (mPFS) - The median overall survival time (mOS) - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 ### Location - Facility: Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, N/A, China @@
## Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria - NCT ID: NCT06298955 - Study ID: OMS906-PNH-003 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2027-04 - Lead Sponsor: Omeros Corporation ### Study Description The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH. ### Conditions - Paroxysmal Nocturnal Hemoglobinuria ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - OMS906 study drug ### Outcomes Primary Outcomes - To assess overall safety and tolerability of OMS906 administration at 8-week intervals in PNH patients. Secondary Outcomes - To assess efficacy measured by hemoglobin (Hgb). - To assess efficacy by transfusion requirements. - To assess efficacy by measurement of lactate dehydrogenase (LDH). - To assess efficacy by measurement of reticulocyte count. - To assess efficacy by measurement of clinical breakthrough hemolysis. - To assess population PK Cmax of OMS906. - To assess population PK AUC of OMS906. - To assess population PK terminal half life of OMS906. - To assess PD of OMS906 - OMS906 anti-drug antibodies (ADA). - Assess the change in Functional Assessment of Chronic Illness Therapy (FACIT) fatigue score. ### Location - Facility: Omeros Investigational Site, Aachen, N/A, N/A, Germany @@
## Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy - NCT ID: NCT06298942 - Study ID: fac.med.24.9 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-07-15 - Lead Sponsor: Minia University ### Study Description to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) ### Conditions - Obesity, Morbid ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - natural band - silicone band ### Outcomes Primary Outcomes - total cost - food intolerance Secondary Outcomes - %EWL - complications rate - improvement of comorbidities ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Medial Rectus Fenestration vs Recession for PAET - NCT ID: NCT06298929 - Study ID: 36264PR427/11/23 - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2024-10-15 - Lead Sponsor: Mansoura University ### Study Description This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET.All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration. ### Conditions - Partially Accommodative Esotropia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - medial rectus fenestration - medial rectus recession ### Outcomes Primary Outcomes - Ocular alignment (measured in prism diopters) Secondary Outcomes - ocular motility ### Location - Facility: Tanta University, Tanta, Gharbeya, N/A, Egypt @@
## 64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer - NCT ID: NCT06298916 - Study ID: FAPi-1301 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-04 - Lead Sponsor: Lantheus Medical Imaging ### Study Description This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) and to compare its imaging biodistribution with FAP expression by immunohistochemistry (IHC) in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2). ### Conditions - Metastatic Sarcoma - Esophageal Cancer - Gastric Cancer - Pancreatic Cancer - Colorectal Cancer - Sarcoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: DIAGNOSTIC ### Interventions - 64Cu-LNTH-1363S ### Outcomes Primary Outcomes - Primary Part 1 Biodistribution of 64Cu-LNTH-1363S - Primary Part 1 - Optimal dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S - Primary Part 2 - Correlation of 64Cu-LNTH-1363S biodistribution with Immunohistochemistry FAP expression Secondary Outcomes - Secondary Parts 1 and 2 Safety and Tolerability - Secondary Part 1 FAP expression profile of 64Cu-LNTH-1363S in patients with sarcoma - Secondary Part 1 and Part 2 Cardiac Safety - Secondary Part 2 Validate optimal radioactivity in patients with sarcoma or GIT cancer ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Hip Activation Compared to Hip Plus Balance Training on the Forward-Step-Down Test - NCT ID: NCT06298903 - Study ID: STUDY00002565 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-12 - Completion Date: 2024-08 - Lead Sponsor: Louisiana State University Health Sciences Center Shreveport ### Study Description The purpose of this research is to determine the impact of a hip activation home exercise program (HEP) compared to a hip activation + single leg balance HEP on performance of the Forward-Step-Down Test (FSDT) in healthy females. Participants will be assigned to the control (hip activation HEP only) or experimental (hip activation + single leg balance HEP). Following the pre-test data collection, participants will complete their HEP for 8 weeks. They will return to the lab for post-test measurements. ### Conditions - Control of Frontal Plane Biomechanics - Patellofemoral Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Hip Activation - Hip activation + Single leg balance ### Outcomes Primary Outcomes - Forward-Step-Down Test Secondary Outcomes - surface electromyography (sEMG) peak - surface electromyography (sEMG) mean - Unipedal Stance Test (UPST) - Dose-Response ### Location - Facility: LSUHSC-Shreveport, Shreveport, Louisiana, 71103, United States @@
## The Pattern of Dry Eye Disease After Cataract Surgery - NCT ID: NCT06298890 - Study ID: SASKAT - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2027-09 - Lead Sponsor: Lithuanian University of Health Sciences ### Study Description This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up. ### Conditions - Dry Eye Disease - Cataract - Ocular Surface Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Artificial tears (sodium hyaluronate 0.2%) ### Outcomes Primary Outcomes - Assessment of ocular surface changes following cataract surgery - Evaluation of the cornea morphology - Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears - Evaluation of tear osmolarity - Evaluation of tear cytokine levels - Assessment of central corneal sensitivity Secondary Outcomes - Evaluation of potential pain biomarkers in patients' saliva - Dry Eye Questionnaire-5 (DEQ5) 5-item - Ocular surface disease index (OSDI) - Visual function (VFQ-25) questionnaire - Visual acuity evaluation (LogMAR) ### Location - Facility: Lithuanian University of Health Sciences, Kaunas, N/A, LT-44307, Lithuania @@
## Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer - NCT ID: NCT06298877 - Study ID: 2023-04696-01 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2029-03-28 - Lead Sponsor: Sahar Salehi ### Study Description Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma.Unexpectedly, our results from a unique fully accounted for population demonstrate that survival was not improved when increasing the proportion of women in whom CMR was achieved and in a yet unidentified subgroup of women extensive surgery was detrimental. In these women surgical treatment should be omitted in favor of chemotherapy only. Accordingly, there is an imperative need to improve patient selection to surgical treatment.In Sweden, we treat an unselected population of women in a public healthcare system, where 30% of women with are \>75 years. Despite these circumstances guidelines on patient-selection are lacking.Age is an imprecise variable to base clinical decisions on but must be considered with an aging population. The dynamics between physiological changes of aging, comorbidity and medical condition are included in the concept of frailty, that has gained little attention in oncology, despite their potential to stratify risk and mortality.The FOLERO study is a prospective adequately powered national cohort study with aim to determine if frailty instruments may be used to select patient to surgical treatment. In addition, we test the feasibility of early stoma reversal after index cytoreductive surgery in a small phase I trial and follow our patients Health Related Quality of Life after state of the art surgical treatment. ### Conditions - Ovarian Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Frailty and Quality of Life evaluation ### Outcomes Primary Outcomes - Overall Survival Secondary Outcomes - 1-year mortality - Health related quality of life (HRQoL) (QLQ-C30) - Health related quality of life (HRQoL) (QLQ-OV28) - Health related quality of life (HRQoL) (QLQ-ELD14) - Health related quality of life (HRQoL) (EQ-5D-5L) - Low anterior resection syndrome (LARS) - Postoperative complications - Readmissions - Length of hospital stay - Extent of surgery vs survival - Sarcopenia vs post-operative outcome - Standard regimen of adjuvant chemotherapy - Time interval to adjuvant chemotherapy - Total number of hospital days and readmissions within90 days after index surgery - Health economics - Recurrence or progression free survival ### Location - Facility: Karolinska University Hospital, Stockholm, Solna, 171 76, Sweden @@
## Internet-based Behavioral Intervention Following ACS - NCT ID: NCT06298864 - Study ID: ASC-RCT 2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-01-31 - Lead Sponsor: Karolinska Institutet ### Study Description The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention. ### Conditions - Acute Coronary Syndrome - Online CBT Targeting Cardiac Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Internet-CBT - Internet-CL ### Outcomes Primary Outcomes - Cardiac anxiety questionnaire modified for weekly assessment Secondary Outcomes - Cardiac anxiety questionnaire - Cardiac anxiety questionnaire - HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment - HeartQoL Health-related Quality of Life Questionnaire - HeartQoL Health-related Quality of Life Questionnaire - Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment - Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) - Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) - University of Toronto Atrial fibrillation Severity Scale (AFSS) - University of Toronto Atrial fibrillation Severity Scale (AFSS) - University of Toronto Atrial fibrillation Severity Scale (AFSS) - Myocardial infarction behavior questionnaire - Myocardial infarction behavior questionnaire - Myocardial infarction behavior questionnaire - DOSE Non-Adherence questionnaire - DOSE Non-Adherence questionnaire - DOSE Non-Adherence questionnaire - Perceived stress scale 4-item - Perceived stress scale 4-item - Perceived stress scale 4-item - Short Fatigue questionnaire - Short Fatigue questionnaire - Short Fatigue questionnaire - Patient Health Questionnaire-9 - Patient Health Questionnaire-9 - Patient Health Questionnaire-9 - Insomnia Severity Index - Insomnia Severity Index - Insomnia Severity Index - Perceived stress scale 4-item - The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity - The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity - The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity - Lifestyle factors: The national Board of health and Welfare questionnaire - Lifestyle factors: The national Board of health and Welfare questionnaire - Lifestyle factors: The national Board of health and Welfare questionnaire - Aversive cognition to medication - Adversive cognition to medication - Adversive cognition to medication ### Location - Facility: Karolinska University Hospital, Stockholm, N/A, 11635, Sweden @@
## Comparative Effects of Lower Body Quadrant Neural Mobilization and Stretching in Collegiate Football Players - NCT ID: NCT06298851 - Study ID: E-10840098-772.02-2026 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-08 - Completion Date: 2024-03-31 - Lead Sponsor: Istanbul Medipol University Hospital ### Study Description Neural mobilizations (NM) are defined as interventions that aim to directly or indirectly affect neural structures or surrounding tissue through manual techniques or exercise. Neural mobilizations have been studied in both patients and healthy populations. In the study, individuals in the amateur football team will be divided into three groups and will be given pre-training warm-up periods, including neural mobilization, dynamic and static stretching.After the warm-up period, its effect on flexibility and performance will be examined and compared. ### Conditions - Sports Physical Therapy - Stretch - Stretch Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Neural Mobilization Group (NMG) - Dynamic Stretching Group (DSG) - Static Stretching Group (SSG) ### Outcomes Primary Outcomes - Straight Leg Raise Test Secondary Outcomes - Y Balance Test ### Location - Facility: Istanbul Medipol University, Istanbul, N/A, 34820, Turkey @@
## High-resolution Intra-operative PSMA PET-CT in Prostate Cancer - NCT ID: NCT06298838 - Study ID: XEOS study - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: IRCCS San Raffaele ### Study Description This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard. ### Conditions - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AURA10® Specimen PET/CT imager ### Outcomes Primary Outcomes - To investigate the performance characteristics (sensitivity and specificity) of a novel high-resolution perioperative PET-CT-scan for intraoperative margins and lymph node invasion assessment after 18F-PSMA using histopathology as the gold standard Secondary Outcomes - Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## S-ADHF：Sarcopenia in Patients With ADHF - NCT ID: NCT06298825 - Study ID: KY2024-148 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-01 - Lead Sponsor: Guangdong Provincial People's Hospital ### Study Description This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure. ### Conditions - Acute Decompensated Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - All-cause mortality Secondary Outcomes - All-cause mortality - Cardiovascular mortality - All-cause hospitalisation - HF hospitalisation ### Location - Facility: Huan Ma, Guangdong, N/A, N/A, China @@
## REFLECT Scoliosis System Post Approval Study - NCT ID: NCT06298812 - Study ID: Protocol Rev 0 11July2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2032-03-31 - Lead Sponsor: Globus Medical Inc ### Study Description The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval ### Conditions - Idiopathic Scoliosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - REFLECT Scoliosis Correction System ### Outcomes Primary Outcomes - Primary Probable Benefit - Primary Safety Secondary Outcomes - Curve progression - Device integrity - Composite endpoint analysis - Failure analysis - SRS score ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## GENETIC VARIABILITY TO GLP1 TREATMENT - NCT ID: NCT06298799 - Study ID: GEN-GE-001-IL - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2025-01-01 - Lead Sponsor: GENGE ### Study Description The goal of this retrospective study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after GLP-1 treatment in terms of weight loss, sugar level reduction, and adverse events.Participants will The study consists of a single visit at the diabetes unit clinic at the involved study sites. The following will be performed for every subject at the study screening enrollment visit:* Informed consent* Study eligibility (Inclusion / Exclusion criteria)* Collection of demographic data (age (date of birth), gender, ethnic origin)* General and T2DM medical history review (per subject file)* Concomitant medication review (at enrollment)* Physical attributes (Body Weight, Height, BMI)* Allocation to study cohort and study subgroup* Saliva and blood collection for genetic tests* Self-reported questionnaire for Ozempic (Semaglutide) experience ### Conditions - Type 2 Diabetes - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - DNA Sequencing and Analysis - differential expression analysis with RNA-sequencing (RNA seq) experiments ### Outcomes Primary Outcomes - Genetic variants and miRNA expressions associated with changes in BMI. Secondary Outcomes - Genetic variants and miRNA expressions associated with changes in A1c. ### Location - Facility: Rambem medical center, Haifa, N/A, N/A, Israel @@
## Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT). - NCT ID: NCT06298786 - Study ID: 6MIMATE012 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: Fundació Universitària del Bages ### Study Description Temporomandibular Disorders (TMD) encompass various conditions that affect the temporomandibular joint and associated tissues, often causing or being associated with other symptoms such as jaw pain, myofascial pain, neck pain, and headaches. TMDs are classified according to the DC/TMD instrument in which the joint and pain axes are evaluated. However, there is no evaluation of mandibular function, and TMDs can result in a decrease in jaw strength and resistance. This leads to an increase in the chewing fatigue. Reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of TMD. Chewing efficiency is essential for food preparation and nutrient absorption, and muscle fatigue is a common problem affecting chewing ability. Despite this, there is a lack of validated tests to evaluate chewing fatigue in patients with TMD, which makes its consideration unnoticed in clinical practice.The modified six-minute functional chewing test (F-6MMT) was proposed as a tool to evaluate chewing ability and fatigue in patients with TMD. This test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated; however, the subjects were not instructed to perform functional chewing during the test. In this version, modifications are added so that the test is as functional as possible, allowing chewing to be evaluated in a standardized way, and cut-off points established between healthy subjects and subjects with TMD in terms of chewing capacity in general and fatigue in particular. This study will follow standardized reporting guidelines and recruit participants from diverse clinical settings. ### Conditions - Mastication Disorder - Fatigue - Temporomandibular Disorder - Orofacial Pain - Chewing Problem ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Functional 6-minute mastication test ### Outcomes Primary Outcomes - Fatigue - Self-reported Pain Secondary Outcomes - Pain-related TMD diagnosis - Self-reported daily fatigue - Pain pressure threshold (PPT) - Taste of the gum - Difficulty in breaking the gum at the beginning of the F-6MMT - Preferred side when chewing during the F-6MMT - Kinesiofobia related to TMD - Health status - Comorbidities ### Location - Facility: Universitat de Manresa, Manresa, Barcelona, 08242, Spain @@
## Spatial Profile of Tumors - NCT ID: NCT06298773 - Study ID: 6127 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-05 - Completion Date: 2028-12-30 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The research project focuses on analyzing the spatial organization of cells within various solid tumors, utilizing advanced technologies enabling in-depth multi-parametric analysis of tumor and immune cells. The primary objective is to understand the spatial distribution of cellular subpopulations within each type of tumor, while secondary objectives include correlating these data with clinical aspects and identifying potential therapeutic targets. The study involves 1000 patients with primary or metastatic tumors and spans a duration of 5 years, from 2024 to 2028. No experimental treatments are planned; rather, only spatial imaging analyses with multiple markers will be conducted. Data analysis involves descriptive statistical methods and hypothesis testing to generate hypotheses for subsequent studies. The analyses will be performed using SPSS® version 21.0 software for Windows®. ### Conditions - Solid Tumors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Spatial analysis of paraffin samples from solid tumors ### Outcomes Primary Outcomes - Spatial analysis of cancer cells Secondary Outcomes - Comparison of clinical data - Identification of therapeutic targets ### Location - Facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, RM, 00168, Italy @@
## The Effect of Reflexology and Knee Massage With Black Cumin Oil on Pain and Fatigue - NCT ID: NCT06298760 - Study ID: çörekotu refleksoloji - Status: COMPLETED - Start Date: 2019-06-19 - Completion Date: 2020-04-19 - Lead Sponsor: Erzurum Technical University ### Study Description In this study, black cumin extract oil was used in elderly individuals with Knee Osteoarthritis (OA). The effects of foot reflexology and knee massage on pain and fatigue symptoms. It is aimed to examine and research which of these two applications is more effective.The study, planned as a randomized controlled experimental study, included a total of 150 participants.The data consists of participants who receive outpatient treatment in the Physical Therapy and Rehabilitation Unit at a university hospital, are over 65 years old, and have no problems with their perception after the Mini Mental Test. After randomization, participants were divided into five groups, with 30 participants in each group. Groups; It consisted of 1) Reflexology with Black Cumin, 2) Placebo Reflexology, 3) Knee Massage with Black Cumin, 4) Placebo Knee Massage and 5) Control groups. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Knee Massage With Black Cumin Oil Group: - Foot Reflexology Group With Black Cumin Oil - placebo group ### Outcomes Primary Outcomes - Pain Score Secondary Outcomes - fatigue severity ### Location - Facility: Ercan Bakır, Erzurum, Yakutiye, N/A, Turkey @@
## Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain - NCT ID: NCT06298747 - Study ID: Cervical root PRF - Status: COMPLETED - Start Date: 2022-11-01 - Completion Date: 2023-07-02 - Lead Sponsor: Diskapi Teaching and Research Hospital ### Study Description Chronic cervical pain is a common disorder with a prevalence of approximately 35% in adults. Cervical radicular pain is defined as radiating pain in the upper limb caused by compression or inflammation of the nerve roots ascending from the intervertebral foramen to the spinal cord, due to disc herniation or spinal stenosis. C7 and C6 are the two most commonly affected nerve roots. Various treatment modalities are available, including oral medications, physiotherapy, and epidural steroid injections. However, chronic and persistent pain that develops as a result of some patients not responding to these treatments. Ultrasound-guided selective cervical nerve root block and pulsed radiofrequency are interventional treatments used in patients with radicular cervical pain unresponsive to conservative treatments. Pulsed radiofrequency (PRF) treatment of peripheral nerves may provide long-term pain relief in patients with short-term pain relief with a local anesthetic block. Studies have shown the effectiveness of PRF therapy applied to selective cervical nerve roots in relieving cervical radicular pain. ### Conditions - Cervical Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Selective cervical nerve root pulsed radiofrequency ### Outcomes Primary Outcomes - VAS Secondary Outcomes - Neck Disability Index (NDI) - Douleur Neuropathique 4 Questions (DN4) ### Location - Facility: Ankara Etlik City Hospital, Ankara, N/A, N/A, Turkey @@
## Exercise and Diet Interventions During Immunotherapy in Melanoma Patients - NCT ID: NCT06298734 - Study ID: 23-712 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-03-31 - Lead Sponsor: Dana-Farber Cancer Institute ### Study Description The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy.The names of the groups in this research study are:* High-Intensity Exercise (EX)* High-fiber Diet (DT)* Combined High-Intensity Exercise and High-Fiber Diet (COMB)* Attention Control (AC) ### Conditions - Melanoma (Skin) - Skin Cancer - Advanced Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Exercise Program - Diet Program ### Outcomes Primary Outcomes - Change in Gut Microbiome Diversity Secondary Outcomes - Change in Systemic Immune Function - Change in Cardiopulmonary Fitness - Change in Short Physical Performance Battery (SPPB) - Change in Percent Body Fat - Change in Lean mass - Change in Hip circumference - Change in Waist circumference - Change in Health-Related Quality of life (EORTC-QLQ C30) - Change in MDASI-Immunotherapy Questionnaire Score - Change in Anxiety (HADS) - Change in Depression (HADS) - Change in Sleep Quality (PSQI) - Proportion of Participants Completing the Exercise Intervention Sessions ### Location - Facility: Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States @@
## Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes - NCT ID: NCT06298721 - Study ID: 23-885 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2027-03 - Lead Sponsor: The Cleveland Clinic ### Study Description This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care). ### Conditions - Knee Osteoarthritis - Knee Arthropathy - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Personalized outcome prediction tool + targeted interventions - Standard of Care TKA ### Outcomes Primary Outcomes - Satisfaction at 1 year Secondary Outcomes ### Location - Facility: Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States @@
## Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents - NCT ID: NCT06298708 - Study ID: PED-2566-0634 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: Chiang Mai University ### Study Description Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years. ### Conditions - HAV - Hepatitis A - Hep A - Vaccine-Preventable Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Mevac-A vaccine - Havrix 720 Junior ### Outcomes Primary Outcomes - Anti-HAV immunoglobulin G (IgG) seroconversion rate Secondary Outcomes - Geometric mean concentration (GMC) of anti-HAV IgG level ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Schema Therapy for Treatment-resistant Anxiety Disorders - NCT ID: NCT06298695 - Study ID: 2012939 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2030-12-31 - Lead Sponsor: Amsterdam UMC, location VUmc ### Study Description The aim of this study is to assess the cost-effectiveness of schema therapy compared to treatment as usual (TAU) in patients with treatment-resistant anxiety disorders. In a multicenter randomized controlled trial, patients will be assigned to receive individual schema therapy (maximum of 40 sessions) or treatment as usual (control group) within one year. The primary outcome is the difference between ST and TAU conditions in anxiety symptoms as measured with the Beck Anxiety Inventroy (BAI) at post treatment. Secondary outcomes include quality of life, societal costs, general mental health, remission from the anxiety disorders and/or comorbid affective disorders, positive and negative effects of psychotherapy, schemas and schema modes, and satisfaction. Measurements take place at baseline and after 1, 3, 6, 12, 24 and 36 months (follow-up of two years). ### Conditions - Anxiety Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Individual Schema Therapy - TAU ### Outcomes Primary Outcomes - Changes in the severity of anxiety symptoms - Health-related quality of life - Mental health quality of life - Health care utilization and productivity losses Secondary Outcomes - Remission from the primary anxiety disorder and from comorbid disorders - Screening for DSM-5 personality disorders - Assessment of DSM-5 personality disorders - Demographics - (Strength of) treatment preference - Assessment of childhood trauma - Assessment of autistic traits - Assessment of general mental health - Functioning and recovery in psychiatric patients - Early Maladaptive Schemas - Schema Modes - Positive and negative effects of psychotherapy - The level of satisfaction with the psychological treatment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Characterization of Exosomes Platelets-released - NCT ID: NCT06298682 - Study ID: CCM1421 - Status: RECRUITING - Start Date: 2021-07-08 - Completion Date: 2027-07-07 - Lead Sponsor: Centro Cardiologico Monzino ### Study Description Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited. ### Conditions - Platelet Thrombus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Characterization of exosomes released by activated platelet by Nanoparticle Tracking Analysis (NTA) and proteoma analysis - Characterization of exosomes released by activated platelet and exposed to platelet inhibitors by NTA and proteoma analysis Secondary Outcomes - Platelet exosome profile emerged by NTA and proteoma analysis will be related with the "biographical" and "anthropometric" data of the subjects. ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, N/A, Italy @@
## Biventricular Versus Right Ventricular Pacing - NCT ID: NCT06298669 - Study ID: 10652 - Status: SUSPENDED - Start Date: 2023-08-09 - Completion Date: 2025-02 - Lead Sponsor: Indiana University ### Study Description The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test. ### Conditions - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Biventricular Pacing - Right Ventricular Pacing ### Outcomes Primary Outcomes - 6 Minute Walk Test Performance Secondary Outcomes - Serum NT-PRO-BNP - EQ-5D-3L ### Location - Facility: Indiana University Health Methodist Hospital, Indianapolis, Indiana, 46202, United States @@
## Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients - NCT ID: NCT06298656 - Study ID: ILBS-ACLF-17 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2026-02-28 - Lead Sponsor: Institute of Liver and Biliary Sciences, India ### Study Description Clinically significant portal hypertension (CSPH) is defined as HVPG \>10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to \<12 mm Hg or reduction to \>20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study ### Conditions - Acute-On-Chronic Liver Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF Secondary Outcomes - Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days - Transplant-free survival rate at 90 days - Correlation with evolution of AARC score by 2 week ### Location - Facility: Institute of Liver & Biliary Sciences (ILBS), New Delhi, Delhi, 110070, India @@
## Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan - NCT ID: NCT06298643 - Study ID: CA056-1094 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-22 - Completion Date: 2024-12-31 - Lead Sponsor: Bristol-Myers Squibb ### Study Description The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan. ### Conditions - Lower-risk Myelodysplastic Syndromes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Red blood cell transfusion - Red blood cell transfusion ### Outcomes Primary Outcomes - Participant age - Participant sex - Participant weight - Participant height - Participant comorbidities calculated using the Charlson Comorbidity Index (CCI) method - Participant Eastern Cooperative Oncology Group (ECOG) score - Participant International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) risk category - Percentage of ring sideroblasts present in participants - Percentage of bone marrow blasts present in participants - Histopathology results - Number of red-blood cell transfusions received by participants - Treatment prescribed by line of therapy - Duration of treatment by line of therapy - Time between date of diagnosis and treatment - Time between date of treatment initiation to treatment discontinuation - Time between date of diagnosis to date of first red-blood cell transfusion Secondary Outcomes - Number of participants that achieved red-blood cell transfusion independence during first-line of therapy treatment - Mean hemoglobin change of participants during first-line of therapy - Number of transfusion dependant participants achieving re-blood cell transfusion independence for ≥12 weeks with associated concurrent mean hemoglobin increase of ≥1.5 g/dL during first-line of therapy - Number of non-transfusion dependant participants achieving red-blood cell transfusion independence during first-line therapy for ≥24, 48 and 72 weeks - Time to red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy - Hematologic Improvement - Erythroid (HI-E) response of transfusion dependant participants receiving first line therapy - Modified Hematologic Improvement - Erythroid (mHI-E) of transfusion dependant participants receiving first line therapy - Hematologic Improvement - Erythroid (HI-E) response of non-transfusion dependant participants receiving first line therapy - Modified Hematologic Improvement - Erythroid (mHI-E) of non-transfusion dependant participants receiving first line therapy - Time to Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy - Duration of Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy - Duration of red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy - Number of participants diagnosed with Acute Myeloid Leukemia - Time to Acute Myeloid Leukemia diagnosis - Overall survival (OS) of participants - Number of red-blood cell transfusion days per participant - Number of red-blood cell units used per transfusion - Number of outpatient visits per month - Number of hospital admissions - Length of hospitalization - Reason for hospitalization - Number of emergency department visits - Number of Intensive care unit admissions (ICU) - Number of outpatient/inpatient medication claims - Supplemental medication use: Iron chelation use - Supplemental medication use: Granulocyte-colony stimulating factors (G-CSF) - Number of hematology tests ordered - Medical costs ### Location - Facility: Mebix, Inc, Tokyo, Minato-ku, 107-0052, Japan @@
## Long-term Follow-up Study of BRL-101 for TDT - NCT ID: NCT06298630 - Study ID: 2022-LTF-BRL-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-12-08 - Completion Date: 2038-10-15 - Lead Sponsor: Bioray Laboratories ### Study Description Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects. ### Conditions - Thalassemia, Beta ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Assessments ### Outcomes Primary Outcomes - Incidence of hematologic malignancies - Frequency, grade, and relationship of SAEs Secondary Outcomes ### Location - Facility: Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510006, China @@
## Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis - NCT ID: NCT06298617 - Study ID: RC 27.1.2024 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-12-25 - Lead Sponsor: Benha University ### Study Description Endometriosis (EMs) is one of the commonest chronic inflammatory disorder affecting women and is characterized by the presence and growth of endometrial-like glandular epithelial and stromal cells outside the uterus leading to multiple clinical symptoms affecting patients quality of life and fertility with high recurrence rate . The systemic immune inflammatory index (SII) and systemic inflammatory response index (SIRI) are documented as prognostic serum biomarker in many kinds of cancer and for the need and outcomes of adjuvant therapies for various cancers . ### Conditions - Endometriosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diagnostic laparoscopy - Full Blood Count (FBC) ### Outcomes Primary Outcomes - Indices' ability to predict EM stage Secondary Outcomes ### Location - Facility: Benha University, Banhā, Al Qalyobia, 13511, Egypt @@
## Motorized Fine Needle Biopsy vs Standard Needles - NCT ID: NCT06298604 - Study ID: IECED-12112023 - Status: RECRUITING - Start Date: 2023-12-09 - Completion Date: 2024-12-09 - Lead Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas ### Study Description Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition.Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy. ### Conditions - Pancreas Disease - Liver Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - EUS-guided standard fine needle biopsy - EUS-guided motorized fine needle biopsy ### Outcomes Primary Outcomes - Endoscopic ultrasound fine needle biopsy sample quality - Diagnostic accuracy according to histological analysis Secondary Outcomes - Tissue blood contamination ### Location - Facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, N/A, 090505, Ecuador @@
## The Efficacy of Combination Therapy in Atrophic Scars - NCT ID: NCT06298591 - Study ID: atrophic scar treatment - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-03-15 - Lead Sponsor: Assiut University ### Study Description There are more than 100 million patients who develop scar formation caused by various factors, such as post-inflammatory acne and trauma (1). They often have physical, aesthetic, psychological, and social barriers. Scar tissue is naturally a stage of wound healing. Abnormal wound healing produces a spectrum of scar tissue types such as atrophic, hypertrophic, and keloid scars (2).Atrophic scars are dermal depressions, which are commonly caused by the destruction of collagen following inflammatory process. This permanent disfiguring sequelae correlates with the duration of pathology, severity of lesion, and delay in therapy (3).Treatment of atrophic acne scars remains a therapeutic challenge, yet there is no standard option as the most effective treatment (4). A range of possible options has been investigated including surgical techniques (subcision, non-ablative laser treatment, resurfacing techniques (ablative laser treatment, dermabrasion), and injection or dermal fillers or fat, and a combination of two or more modalities (5).Ultrasound is a unique non-invasive and non-radiating medical imaging tool in the investigation of dermatological diseases by providing detailed anatomic and physiologic data of skin lesions and deeper soft tissue changes. Lesion size in three dimensions-lengths, width, and depth, morphology, the detailed anatomic information provided by sonography is useful to assessment of effect of different types of treatment modality to improve atrophic scar and avoid invasive assessment tools as punch biopsy for histopathological examination (6) ### Conditions - Atrophic Scar ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - co2 laser ### Outcomes Primary Outcomes - change of dermal thickness in sonar and Vancouver scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial - NCT ID: NCT06298578 - Study ID: Mobile Based Application - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-01-01 - Lead Sponsor: Assiut University ### Study Description The primary objective of this study is to validate the feasibility of a remote patient monitoring (RPM) system using Mobile App in terms of the frequency of data interruptions and patient acceptance.The secondary objective is to Improve quality of life and early prediction of the complications. ### Conditions - Acetabular Fracture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - percentage of missed follow up data in both groups postoperatively through assessing the patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum using the Arabic validated form of (SF-36) Secondary Outcomes - Quality of life scoring (Arabic validated form of (SF-36) and early prediction of the complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa - NCT ID: NCT06298565 - Study ID: ARGX-113-PASS-2208 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2034-06 - Lead Sponsor: argenx ### Study Description This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort. ### Conditions - Myasthenia Gravis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - efgartigimod ### Outcomes Primary Outcomes - The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis - NCT ID: NCT06298552 - Study ID: ARGX-113-2308 - Status: RECRUITING - Start Date: 2024-04-16 - Completion Date: 2027-07-23 - Lead Sponsor: argenx ### Study Description The primary purpose of this study is to measure the efficacy and safety of efgartigimod intravenously (IV) compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). Other objectives are to assess long-term efficacy, safety, and tolerability of efgartigimod.Study will consist of:* Screening* Part A: participants will be randomized to receive either efgartigimod IV or placebo* Part B: participants completing part A will receive open-label efgartigimod IV ### Conditions - Generalized Myasthenia Gravis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Efgartigimod IV - Placebo IV ### Outcomes Primary Outcomes - Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline Secondary Outcomes - Quantitative myasthenia gravis (QMG) total score change from baseline - Proportion of participants who are both MG-ADL and QMG responders ### Location - Facility: First Choice Neurology Boca Raton, Boca Raton, Florida, 33428, United States @@
## Auditory Sensory Attenuation in Obesity - NCT ID: NCT06298539 - Study ID: 21C308 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women with obesity and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):i) is observed in obesity ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\'s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way. ### Conditions - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - point of subjective equality (PSE) Secondary Outcomes - cognitive empathy - interpersonal pleasure ### Location - Facility: IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital, Piancavallo, VCO, 28824, Italy @@
## Auditory Sensory Attenuation in Anorexia Nervosa - NCT ID: NCT06298526 - Study ID: 21C307 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women affected by anorexia nervosa and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):i) is observed in anorexia nervosa ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\'s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way. ### Conditions - Anorexia Nervosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - point of subjective equality (PSE) Secondary Outcomes - cognitive empathy - interpersonal pleasure ### Location - Facility: IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital, Piancavallo, VCO, 28824, Italy @@
## Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI - NCT ID: NCT06298513 - Study ID: 09C338 - Status: RECRUITING - Start Date: 2023-05-02 - Completion Date: 2025-12 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine). ### Conditions - Acute Myocardial Infarction: Rehabilitation Phase ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cardiac rehabilitation ### Outcomes Primary Outcomes - Changes in purine after rehabilitation - Changes in histidine after rehabilitation - Changes in galactose after rehabilitation Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano, Milan, N/A, 20149, Italy @@
## Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair - NCT ID: NCT06298500 - Study ID: AAG-O-H-2115 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-09 - Lead Sponsor: Aesculap AG ### Study Description The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified. ### Conditions - Inguinal Hernia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - hernia repair surgery ### Outcomes Primary Outcomes - Hernia recurrence rate Secondary Outcomes - Delayed tissue adhesive polymerization - Intraoperative bleeding requiring therapeutic measures - Organ injury - Hernia recurrence - Mesh migration - Adhesions - Erosion - Meshoma formation - Tack hernias - Surgical Site Infection (superficial, deep, intraabdominal) - Hematoma - Seroma - Hemorrhage - Orchitis - Other Adverse Event - Reintervention - Mesh repositioning or removal - Acute or chronic pain ### Location - Facility: Hospital San Juan de Dios, Santa Cruz De Tenerife, Tenerife, 38001, Spain @@
## Evaluation of the Impact of Therapeutic Education Workshops for COPD Patients in the North-West Val d'Oise Area - NCT ID: NCT06298487 - Study ID: CHRD 1023 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-09 - Lead Sponsor: Hôpital NOVO ### Study Description The aim of this study is to assess the impact of the Patient Therapeutic Education (PTE) workshops offered by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) on the follow-up and feelings of the COPD patients who take part. These workshops are organised outside the hospital environment and supervised by hospital and town professionals in the NOVO zone. ### Conditions - COPD ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Patient questionnaires ### Outcomes Primary Outcomes - Evaluation of the overall impact of the PTE workshops offered by the MPSAT on patients' knowledge, skills, attitudes and behaviours with regard to COPD management and care Secondary Outcomes - Measure of the impact of PTE workshops on quality of life (comparison of PTE group versus Control group) - Comparison of anxiety/depression levels in patients in the PTE group versus Control group - Comparison of levels of motivation towards physical activity during free time in the PTE group versus Control group - Comparison of the number of hospital admissions for COPD exacerbations in patients in the PTE group versus Control group - Comparison of the perception/feelings of patients in the PTE group versus Control group, concerning PTE workshops organised in a city/hospital setting ### Location - Facility: Pneumology, respiratory rehabilitation and follow-up and rehabilitation care department - Hôpital NOVO, Pontoise, N/A, 95300, France @@
## The BRAIN App (Phase 2 SBIR) - NCT ID: NCT06298474 - Study ID: 2R44AG071105-03 - Status: NOT_YET_RECRUITING - Start Date: 2025-02-15 - Completion Date: 2025-11-30 - Lead Sponsor: Hopeful Aging ### Study Description There are currently 6.7 million Americans living with dementia and, without significant breakthroughs, this figure will double to 12.7 million by 2050. There are about 46,000 long-term care (LTC) facilities in the U.S. More than half of LTC residents have some form of dementia (Alzheimer's Association, 2018). Responsive behaviors and dysfunction of the dementia care triad-i.e., the PLWD, professional Care Partner (CP), and Family Member (FM)-are inexorably linked. The emergence of responsive behaviors can lead to disruption of the triad's function. Thus, it is imperative to maintain positive relationships and a high quality of life (QoL) within the triad to reduce BPSD. Cognitive Stimulation Therapy (CST) has demonstrated improvements in QoL and relationships for PLWD. CST is a psychosocial intervention that promotes communication and engagement in PLWD via a structured program of meaningful and enjoyable theme. While clinical trials have shown improvement in cognition and QoL, the potential large-scale impact of CST has been hampered by low adherence, with less than 40% completing trials. One likely reason for the low adherence to CST is the reliance on generic and non-digital tools (e.g., paper-based agendas, tools, DVDs, and board games) in facilitating the intervention. That is, even though CST aims to be personalized, the specific interventions used in the field tend to be generic and not tailored to each PLWD's specific interests. The use of digital technology to implement CST would offer considerable advantages to expand and personalize the range of stimulation content and provide a means for monitoring responses, optimizing protocols, and promoting adherence.The proposed Phase II study will involve the continued development and evaluation of a multi-faceted software platform called "Building Relationships using Artificial Intelligence and Nostalgia" or BRAIN. The BRAIN Platform will be the first-ever Artificial Intelligence (AI) powered CST digital therapy platform for PLWD. The platform, which has been shown to be effective in an initial Phase I clinical trial, has three main goals: to improve the quality of life of PLWD, to reduce BPSD in PLWD, and to foster positive relationships between members of the care triad. The proposed Phase II project has the following Specific Aims: 1. Create an improved Beta version of the BRAIN Platform's eight components: (1) the Admin Management Dashboard, (2) the Annotation Dashboard, (3) the Log Viewer, (4) the Content Management System (CMS), (5) the Private CMS, (6) the Control App, (7) the Home App, and (8) the Training Dashboard. 2. Fine-tune the different classes of AI algorithms-i.e., behavioral analytics, personalized content recommendation, and personalized program generation-in the BRAIN app such that they can (a) recognize and track 12 distinct behaviors and indicators of PLWD, (b) use these behavioral traits as a basis for automatically rating the relative success of each activity, and (c) automatically recommend personalized activities that are likely to be successful for individual PLWD. 3. Conduct a Cluster Randomized Trial (CRT) of the BRAIN App to examine the app's impact on engagement/affect, quality of life, and responsive behaviors. 4. Examine satisfaction and ease of use of the app for PLWD, LTC staff, and FMs. ### Conditions - Dementia - Alzheimer Disease - Vascular Dementia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The BRAIN App ### Outcomes Primary Outcomes - Menorah Park Engagement Scale (MPES) - Menorah Park Engagement Scale (MPES) - Engagement for Persons with Dementia Scale (EPWDS) - Engagement for Persons with Dementia Scale (EPWDS) Secondary Outcomes - Dementia Related Quality of Life (DEMQOL) - Dementia Related Quality of Life (DEMQOL) - Neuropsychiatric Inventory--Nursing Home (NPI-NH) - Neuropsychiatric Inventory--Nursing Home (NPI-NH) - Quality of Carer-Patient Relationship (QCPR) - Quality of Carer-Patient Relationship (QCPR) - Mini-Mental Status Examination (MMSE) Mini-Mental Status Examination (MMSE)Mini-Mental Status Examination (MMSE) - Mini-Mental Status Examination (MMSE) Mini-Mental Status Examination (MMSE)Mini-Mental Status Examination (MMSE) ### Location - Facility: Hopeful Aging, Winchester, Massachusetts, 01890, United States @@
## Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease. - NCT ID: NCT06298461 - Study ID: BowelPrep - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: University of Manitoba ### Study Description The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis). ### Conditions - Crohn Disease - Ulcerative Colitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - KleanLyte - Bi-PegLyte ### Outcomes Primary Outcomes - Quality of bowel cleanliness - Quality of bowel cleanliness Secondary Outcomes - Volume of laxative intake - Endoscopic Outcomes - Endoscopic Outcomes - Endoscopic Outcomes - Endoscopic Outcomes - Patient experience data - Crohn's disease or ulcerative colitis flares after colonoscopy - Endoscopic Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## eGPA and Local Inflammation Within the Ear, Nose and Throat Area - NCT ID: NCT06298448 - Study ID: NL83176.042.23 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2028-12 - Lead Sponsor: University Medical Center Groningen ### Study Description Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed. ### Conditions - EGPA - Eosinophilic Granulomatosis With Polyangiitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - laboratory experiments before and after mepolizumab treatment ### Outcomes Primary Outcomes - The effect mepolizumab treatment has on the nasal microbiome profiles Secondary Outcomes ### Location - Facility: UMC Groningen, Groningen, N/A, 9700RB, Netherlands @@
## Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements - NCT ID: NCT06298435 - Study ID: 17536 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: University Medical Center Groningen ### Study Description • Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Determining optimal ventilator settings is a multifactorial problem with many possible realisations. Knowledge of the relationship of patient outcomes with mathematically identifiable integer sets of ventilator setting parameters may help to understand which effects ventilator settings have on patient outcomes. An exploratory database study can provide a basis for further, prospective, interventional studies to find the optimal combination of ventilator settings.Main research question* To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes* Design (including population, confounders/outcomes) Retrospective database study of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023. Multivariate and mixed-model analyses, where appropriate, will be corrections for patient specific characteristics such as ASA PS, age, BMI, sex.* Expected results Using mathematically identifiable integer ventilatory parameter sets improves respiratory and/or hemodynamic patient outcomes. ### Conditions - Hypoxemia - Hypercapnia - Ventilator Associated Pneumonia - Complication of Anesthesia - Postoperative Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intermittent Positive pressure ventilation ### Outcomes Primary Outcomes - SpO2/FiO2 ratio - SpO2 - etCO2 - Blood Pressure - Heart Rate - Positive end Expiratory Pressure - Plateau Pressure - Respiration rate Secondary Outcomes ### Location - Facility: UMCG, Groningen, N/A, 9700RB, Netherlands @@
## Oxygen Saturations Across Tones of Skin - NCT ID: NCT06298422 - Study ID: 806433 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-30 - Lead Sponsor: University of California, San Diego ### Study Description Pulse oximetry, or SpO2, is a vital sign used across healthcare systems to gauge how much oxygen blood is carrying as a percentage of the maximum it could carry. Recent research has suggested that current SpO2 monitors may inaccurately report high SpO2 in patients with darker skin tones when the actual oxygenation is at unsafe, low levels. Additionally, this new research suggests as the SpO2 levels decrease, the risk of occult hypoxia rises. The investigators hypothesize melanin interferes with the pulse oximetry accuracy. Investigators will use spectrophotometry to measure melanin indices and other variables to test this hypothesis. ### Conditions - Generalised Melanin Pigmentation - Pulse Oximetry ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Difference observed between SpO2 and SaO2. - Melanin Index Secondary Outcomes ### Location - Facility: UCSD Health, San Diego, California, 92103, United States @@
## Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan® - NCT ID: NCT06298409 - Study ID: EB04 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-12-15 - Lead Sponsor: Envivo Bio Inc ### Study Description We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO) ### Conditions - Small Intestinal Bacterial Overgrowth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CapScan collection capsule ### Outcomes Primary Outcomes - Sampling of gut microbiota - Sampling of gut metabolome Secondary Outcomes - Effect of rifaximin on gut microbiota - Effect of rifaximin on gut metabolome ### Location - Facility: Silicon Valley Gastroenterology, Mountain View, California, 94040, United States @@
## Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients - NCT ID: NCT06298396 - Study ID: CLTD5853 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Cochlear ### Study Description This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients. ### Conditions - Hearing Loss, Sensorineural ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Program using default MAP - Program using low-power 1 (LP1) MAP - Program using low-power 2 (LP2) MAP - Program using low-power 3 (LP3) MAP ### Outcomes Primary Outcomes - Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting - Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise Secondary Outcomes - Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting - Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise - Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting ### Location - Facility: Cochlear Macquarie, Macquarie Park, New South Wales, 2109, Australia @@
## The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain - NCT ID: NCT06298383 - Study ID: ERU1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-09-15 - Lead Sponsor: Cairo University ### Study Description Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids. ### Conditions - Symptomatic Irreversible Pulpitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Trypsin, Bromelain and Rutoside - Diclofenac Potassium - Prednisolone Oral Tablet - Placebo ### Outcomes Primary Outcomes - Success of Anesthesia - Post-operative pain Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty - NCT ID: NCT06298370 - Study ID: PENG study - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-07-08 - Lead Sponsor: Bezmialem Vakif University ### Study Description This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone. ### Conditions - Postoperative Pain Management ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pericapsular nerve group block plus intrathecal bupivacaine - Intrathecal bupivacaine and morphine - Pericapsular nerve group block plus intrathecal bupivacaine and morphine ### Outcomes Primary Outcomes - Morphine consumption Secondary Outcomes - Postoperative pain scores - The quality of recovery score ### Location - Facility: Bezmialem Vakif University, Istanbul, Fatih, 34093, Turkey @@
## Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation - NCT ID: NCT06298357 - Study ID: 300012601 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-03-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer rehabilitation patients. The program will last 8 weeks outside of the hospital. Participants will start immediately in the hospital (immediate start group) or wait 8 weeks after hospital discharge to start the program (waitlist control group). ### Conditions - Pediatric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Immediate Start - Virtual Reality - Delayed Start - Virtual Reality ### Outcomes Primary Outcomes - Physical activity Secondary Outcomes - Minutes of gameplay - Global Health - Forced Expiratory Volume in the first second (FEV1) ### Location - Facility: Children's Hospital of Alabama, Birmingham, Alabama, 35233, United States @@
## The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease - NCT ID: NCT06298344 - Study ID: 002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-01-01 - Lead Sponsor: Universitas Sumatera Utara ### Study Description Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions. ### Conditions - Congenital Heart Disease - Thiamine Deficiency - Patent Ductus Arteriosus - Ventricular Septal Defect - Atrial Septal Defect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Thiamine ### Outcomes Primary Outcomes - Correlation between transcatheter closure and left ventricular structure change after thiamine treatment Secondary Outcomes - Correlation between transcatheter closure and left ventricular function change after thiamine treatment - Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment - Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment ### Location - Facility: Universitas Sumatera Utara, Medan, North Sumatera, 20155, Indonesia @@
## Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation - NCT ID: NCT06298331 - Study ID: KA-23073 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-03-15 - Lead Sponsor: Hacettepe University ### Study Description The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation. There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation. However, to the best of our knowledge, there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects. By combining these two approaches, we believe that a higher and broader effect (local and systemic) and perhaps a cure for constipation (reaching the ideal defecation frequency or asymptomatic status) can be achieved. Therefore, this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study. This study is designed as a randomized controlled trial. ### Conditions - Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aerobic Exercise - Abdominal Massage - Patient Education ### Outcomes Primary Outcomes - Weekly defecation frequency Secondary Outcomes - Average weekly defecation time - Average weekly frequency of laxative use - Average weekly stool consistency score - The severity of constipation and associated discomfort - The severity of constipation - Gastrointestinal symptom level - Constipation-related quality of life - Patient perception of global change - Abdominal muscle strength - Functional exercise capacity ### Location - Facility: Ceren Gursen, Ankara, N/A, 06100, Turkey @@
## Metabolic Changes in Healthy Subjects With Acute Binge Drink - NCT ID: NCT06298318 - Study ID: Acute Binge Drink - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-18 - Completion Date: 2026-07-18 - Lead Sponsor: Zhejiang Chinese Medical University ### Study Description The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drink on liver function, liver fat content and lipid metabolism in healthy young subjects. The main questions it aims to answer are:1. if acute binge drink could alleviate liver injury and hepatic steatosis. ### Conditions - Binge Drinking - Liver Injury - Hepatic Steatosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - vodka - water ### Outcomes Primary Outcomes - Hepatic fibrosis change - hepatic function change - hepatic injury change - Lipid metabolism change - Laboratory markers of inflammation Secondary Outcomes - Fecal metabolites - Ethanol concentration - Acetaldehyde concentration - hangover cognition assessment tools after drinking ### Location - Facility: Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310053, China @@
## Artificial Intelligence & Prostate Cancer - NCT ID: NCT06298305 - Study ID: QUANTIB - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-09-01 - Completion Date: 2024-12 - Lead Sponsor: IRCCS San Raffaele ### Study Description This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study. A total of 200 patients with suspicious prostate cancer (PCa) who underwent, between January 2014 and January 2022, mpMRI of the prostate and subsequent prostate biopsy will identified. All mpMRI images will be retrospectively collected and evaluated using the Quantib Prostate software. In particular, 200 mpMRI with endorectal coil will be read by the expert radiologist and by the Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software, thus evaluating the predictive characteristics of Quantib Prostate for the identification of suspicious lesions. The sensitivity, specificity, negative predictive value, positive predictive value and accuracy of Quantib Prostate vs. radiologist in detecting csPCa will be evaluated using the biopsy report as reference standard. ### Conditions - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software ### Outcomes Primary Outcomes - To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in detecting csPCa of Quantib Prostate vs. traditional radiologist reading of mpMRI Secondary Outcomes - To assess the impact of Quantib Prostate in predicting pathologic outcomes in patients who received radical prostatectomy - To report time reduction in the diagnosis of suspicious PCa ### Location - Facility: IRCCS Ospedale San Raffaele, Milan, MI, 20132, Italy @@
## Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies - NCT ID: NCT06298292 - Study ID: ZerominisCT01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-30 - Lead Sponsor: metaX Institut fuer Diatetik GmbH ### Study Description The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA Type I, II, III or ALKAPTONURIA, HOMOCYSTINURIA, or MAPLE SYRUP URINE DISEASE (MSUD) over the age of 7 years. ### Conditions - Tyrosinemia, Type I - Tyrosinemia, Type II - Tyrosinemia, Type III - Alkaptonuria - Homocystine; Metabolic Disorder - MSUD (Maple Syrup Urine Disease) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Zero minis (range of protein substitutes in tablet form) ### Outcomes Primary Outcomes - Daily compliance Secondary Outcomes - Treatment-Emergent tolerability - Patient Acceptability - Metabolic control - Incidence of study product emergent events. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel - NCT ID: NCT06298279 - Study ID: 2023-436 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-12 - Completion Date: 2025-04-30 - Lead Sponsor: University of Regina ### Study Description This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources. ### Conditions - Depression - Anxiety - Stress Disorders, Post-Traumatic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Tunneled Delivery - Personalized Delivery - Standard Resources - Enhanced Social Learning Resources - Transdiagnostic Self-Guided ICBT ### Outcomes Primary Outcomes - Generalized Anxiety Disorder 7-item (GAD-7) - Patient Health Questionnaire-9 (PHQ-9) - PTSD Checklist for the DSM-5 (PCL-5) - Engagement Secondary Outcomes - Work and Social Adjustment Scale (WSAS) - Brief Resilience Scale (BRS) - Healthcare Use Questionnaire - Case Story Questionnaire - Treatment Satisfaction Questionnaire - Digital Behavior Change Interventions Engagement Scale (DCBI) ### Location - Facility: Department of Psychology, University of Regina, Regina, Saskatchewan, S4S 0A2, Canada @@
## To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma - NCT ID: NCT06298266 - Study ID: GD2H-XYK-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-29 - Completion Date: 2026-12-31 - Lead Sponsor: Guangdong Second Provincial General Hospital ### Study Description To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma ### Conditions - Relapsed or Refractory Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - infusion of GPRC5D-CD19 CAR T injection ### Outcomes Primary Outcomes - Objective Response Rate Secondary Outcomes ### Location - Facility: Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, 510317, China @@
## Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2 - NCT ID: NCT06298253 - Study ID: 2024P000832 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2028-06 - Lead Sponsor: Massachusetts General Hospital ### Study Description This is a cluster randomized controlled trial of 30 food pantries affiliated with the Greater Boston Food Bank to test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of fostering accurate use of SWAP traffic light labels on pantry shelves and increasing the healthfulness of foods chosen by pantry clients. Primary outcomes will be assessed at 6 and 12 months to compare the implementation and effectiveness of the SWAP program in the intervention vs. control pantries. ### Conditions - Food Insecurity - Implementation Science - Diet, Healthy - Behavioral Economics ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Behavioral economics-enhanced SWAP implementation - Basic SWAP implementation ### Outcomes Primary Outcomes - Pantry SWAP implementation - Percent items (by weight) ordered by pantry that are labeled green or red - Percent of pantry clients' selected food that is green or red - Client dietary quality score Secondary Outcomes - Skin carotenoid level ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Implementation of Nursing Demand Management as a Factor for Improvement in a Primary Care Emergency Center. - NCT ID: NCT06298240 - Study ID: 4R22/074 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-10-01 - Completion Date: 2024-09-01 - Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina ### Study Description Background: Nurse Demand Management was born in 2009 out of the need to address the growth of spontaneous acute demand in primary care. But it is not until 2013 that guidelines for the exercise of nursing actions in demand management were established in Catalonia, Spain. Nurses trained specifically to solve acute and low complexity health problems generate a quality of care comparable to that provided by family medicine doctors. On the other hand, it is worth highlighting the need to rationalise medical resources in primary care centres, primary care emergency centres or points of continuous care (different emergency facilities in the territory in terms of size and services) in order to give priority to doctors being able to dedicate more time to medium or high complexity pathology. Although nurse demand management has been implemented in primary care teams for years, it is being carried out in different intensities according to the needs or priorities of each health territory.The promotion of the autonomous role of nursing through the implementation of nurse demand management in the urgent spontaneous demand of low complexity can be transcendent, both in the optimisation of health resources in primary care and in the management of the demand for care.Hypothesis: The implementation of nurse demand management is a factor of improvement in the efficiency and quality of care in the Primary Care Emergency Centre of the city of Mataró (Barcelona, Spain). Objectives: The main objective of this study was to determine whether the implementation of nurse demand management is a factor in improving efficiency and quality of care in the CUAP of Mataró. Methodology: Non-randomised controlled experimental intervention study. Application of a consensual guide with 5 reasons for health consultations where demand management nursing can be applied. ### Conditions - Nurse's Role - Disease, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - nursing procedure for acute health problems of low complexity ### Outcomes Primary Outcomes - Waiting time and resolution of the visit - Number of reconsultations - patient experience Secondary Outcomes ### Location - Facility: Mataró primary care emergency center, Mataró, Barcelona, 08301, Spain @@
## Erector Spinae Plane Block vs Quadratus Lumborum Block for Laparoscopic Nephrectomy - NCT ID: NCT06298227 - Study ID: Medipol Hospital 1 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-07-30 - Lead Sponsor: Istanbul Medipol University Hospital ### Study Description Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries.US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs.This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy. ### Conditions - Kidney Diseases - Kidney Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Postoperative analgesia management with Paracerol® and IV PCA with Talinat® - Erector spinae plane block - Quadratus lumborum plane block ### Outcomes Primary Outcomes - Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively Secondary Outcomes - Pain scores (Numerical rating scale-NRS) - Need for rescue analgesia (meperidine) - Adverse events ### Location - Facility: Istanbul Medipol University Mega Hospital Complex, Istanbul, Bağcılar, N/A, Turkey @@
## Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester - NCT ID: NCT06298214 - Study ID: RP-23-019 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-01 - Lead Sponsor: Elizabeth F Sutton, PhD ### Study Description The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.The main question\[s\] the study aims to answer are:* Can the Her Health program increase access to healthcare in the first year postpartum?* Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby. ### Conditions - Postpartum - Pregnancy Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Her Health Program ### Outcomes Primary Outcomes - Postpartum visit attendance Secondary Outcomes - Medical trust - Health literacy - Self-efficacy - Healthcare costs ### Location - Facility: Woman's Hospital, Baton Rouge, Louisiana, 70817, United States @@
## E-Based Physical Exercise in Patients With Multiple Sclerosis and Comorbidity - NCT ID: NCT06298201 - Study ID: IMAGINE2024 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-07 - Lead Sponsor: University of Southern Denmark ### Study Description Background: Physical exercise (PE) improves symptoms and quality of life in patients with multiple sclerosis (pwMS). Comorbidity is prevalent among pwMS and may contribute to disease progression. Integrating and sustaining PE is challenging and E-based PE solutions have been proposed as a tool to support the integration of PE into daily life.Aims: To assess the effect of e-based PE in addition to usual care in pwMS on clinical outcome and the levels of inflammatory, metabolic, and neurodegenerative mediators. Furthermore, to determine whether PE plays a role in the modification of comorbidities with a focus on vascular comorbidity and related risk factors, i.e., type 2 diabetes mellitus.Method: This study will be prospective with longitudinal follow-up of pwMS with and without comorbidities. The physical activity of pwMS will be measured at baseline and after six months by accelerometers. In a randomized controlled trial (RCT) patients will be randomly assigned in a 1:1 ratio to receive either usual care or usual care plus an e-based PE program. The exercise program consists of resistance training with resistance bands targeting the lower extremities, including leg press, knee extension, hip flexion, hamstring curl, and hip extension. The sessions will enable participants to engage in group exercises from their homes through a secure online platform, supervised virtually by physiotherapists. The primary endpoints are walking capacity using the 6-meter walk test and the NEDA-3 scale, focusing on the absence of clinical relapses and disease progression, as indicated by an increase in the Expanded Disability Status Scale score and the absence of new disease activity on MRI (including new T2 lesions or enhancing lesions). Secondary outcomes will encompass measures of quality of life and fatigue, as well as levels of potential biomarkers like neurofilament light chain in blood and cerebrospinal fluid.Conclusion: This study will contribute to the rehabilitation and improved quality of life of pwMS particularly of patients with comorbidities. The potential for e-based PE at home to encourage sustained exercise engagement among pwMS will be evaluated, offering a significant contribution to the field of digital healthcare solutions. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - E-Based Physical Exercise Intervention ### Outcomes Primary Outcomes - 6-meters' walk test - "no evidence of disease activity" (NEDA-3) score Secondary Outcomes - Cognitive function, evaluated using the Montreal Cognitive Assessment (MoCA), - Fatigue levels, assessed using the short-form Neuro-QOL Fatigue Scale - Neurofilament Light Chain (NfL) determination ### Location - Facility: University of Southern Denmark, Odense, N/A, 5000, Denmark @@
## Risankizumab in Children With Crohn's Disease (RisaKids) - NCT ID: NCT06298188 - Study ID: RisaKids - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-10 - Lead Sponsor: Shaare Zedek Medical Center ### Study Description The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study. ### Conditions - Crohn Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Risankizumab ### Outcomes Primary Outcomes - Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions - NCT ID: NCT06298175 - Study ID: 2021-157 - Status: COMPLETED - Start Date: 2021-04-15 - Completion Date: 2021-08-15 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description The study was conducted from 15th April 2021 to 15th August 2021. It employed a pretest-posttest design with control and training groups. In this study, a pretest-posttest design including control and training groups was used. Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by the simple randomization method. The study group received 8 weeks of self-management training. The control group was informed about self-management for 1 week. Final evaluations were conducted for both groups after eight weeks. ### Conditions - Chronic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Self management training ### Outcomes Primary Outcomes - Self-Control Self-Management Scale (SCMS) Secondary Outcomes - Cognitive Emotion Regulation Questionnaire (CERQ) - The Occupational Balance Questionnaire (OBQ) ### Location - Facility: Saglik Bilimleri Universitesi, Ankara, N/A, N/A, Turkey @@
## Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass - NCT ID: NCT06298162 - Study ID: 2018-1279 - Status: COMPLETED - Start Date: 2019-07-25 - Completion Date: 2020-02-01 - Lead Sponsor: Rijnstate Hospital ### Study Description A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL\>35%) and bad responders (TWL\<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB). ### Conditions - Bariatric Surgery Candidate - Gastric Bypass - Obesity, Morbid - Pouch Emptying ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 2 years after RYGB, no intervention. MRI measurement. Observational. ### Outcomes Primary Outcomes - Pouch emptying rate measured with MRI Secondary Outcomes - subjective ratings of fullness - subjective ratings of wellbeing ### Location - Facility: Yonta Burgh, Arnhem, N/A, 6815 AD, Netherlands @@
## Reach Through Equitable Implementation of Turtle Island Tales - NCT ID: NCT06298149 - Study ID: 2023-650-EXEMPT - Status: ENROLLING_BY_INVITATION - Start Date: 2023-11-01 - Completion Date: 2028-04-30 - Lead Sponsor: Montana State University ### Study Description Reach Through Equitable Implementation of Turtle Island Tales is a family-level obesity prevention intervention that aims to reinforce AI cultural values of family interaction and holistic wellness. The long-term objective of this research program is to increase the reach of existing evidence-based interventions (EBIs) for cancer and obesity prevention among American Indian (AI) families who live in persistent poverty census tracts. ### Conditions - Obesity, Childhood - Obesity - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Turtle Island Tales ### Outcomes Primary Outcomes - 20-item Family Nutrition and Physical Activity Survey Secondary Outcomes - Food insecurity screener - Mental Health screening ### Location - Facility: Montana State University, Bozeman, Montana, 59717, United States @@
## The Effects of an Online Mindfulness-based Intervention for Children With Attention-Deficit/Hyperactivity Disorder - NCT ID: NCT06298136 - Study ID: 15610923 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-12-31 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial. ### Conditions - ADHD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - mindfulness-based intervention - child behavior management ### Outcomes Primary Outcomes - Child ADHD symptoms Secondary Outcomes - Parent depressive symptoms - Parent anxiety symptoms - Parent sleep quality - Parent well-being - Child executive functioning - Parental Stress - Expressed emotion ### Location - Facility: Herman Hay Ming Lo, Hong Kong, N/A, N/A, Hong Kong @@
## Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma: Risk Factor Analysis and Prognostic Modelling - NCT ID: NCT06298123 - Study ID: adjuvant-03 - Status: COMPLETED - Start Date: 2019-02-01 - Completion Date: 2023-02-01 - Lead Sponsor: Chen Xiaoping ### Study Description The aim of this study was to analyse the independent risk factors for hepatocellular carcinoma (HCC) patients undergoing adjuvant immunotherapy after liver resection surgery, and to develop a prognostic model based on these factors. ### Conditions - Hepatocellular Carcinoma - Adjuvant Immunotherapy - Checkpoint Inhibitor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Anti-PD-1 monoclonal antibody ### Outcomes Primary Outcomes - Recurrence-Free Survival (RFS) Secondary Outcomes - Overall Survival (OS) ### Location - Facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy - NCT ID: NCT06298110 - Study ID: PRP in Abdominal hysterectomy - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-09-25 - Lead Sponsor: Helwan University ### Study Description To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy. ### Conditions - Wound Heal - Abdominal Wound - PRP ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Platelets Rich plasma of the same patient ### Outcomes Primary Outcomes - changes in wound healing Secondary Outcomes - Vancouver scar scale changes - Visual Analog Scale changes - Hospital readmission - Infection ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Brain Connectivity Measured With High-density Electroencephalography - NCT ID: NCT06298097 - Study ID: 2019.11 - Status: RECRUITING - Start Date: 2020-06-11 - Completion Date: 2025-02-02 - Lead Sponsor: IRCCS San Camillo, Venezia, Italy ### Study Description Emerging scientific results show that disrupted functional connectivity in stroke can explain behavioral impairments and predict their recovery over time. However, no technique is yet available for widespread use in clinics to examine how neural synchronization in brain networks is altered in stroke patients. This is crucial to determine favorable prognostic factors and to define individualized rehabilitation protocols. Importantly, the investigators have successfully used high-density electroencephalography (hdEEG) in healthy individuals to measure neural synchronization in brain networks. In this project, the investigators will develop methods and tools based on hdEEG for assessing functional connectivity in stroke patients. These methods and tools will be employed to examine how neural changes occurring after brain lesions explain behavioral impairments. The project will open the way for the use of hdEEG at the patient's bedside, as a neurodiagnostic tool for stroke as well as other brain disorders. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Connectivity measures ### Outcomes Primary Outcomes - High-density electroencephalography measurements (work package 1, 2, and 3) - High-density electroencephalography measurements (work package 1, 2, and 3) - High-density electroencephalography measurements (work package 1, 2, and 3) - High-density electroencephalography measurements (work package 1, 2, and 3) - High-density electroencephalography measurements (work package 1, 2, and 3) - Magnetic Resonance Imaging measurement (work package 1, 2, and 3) - Magnetic Resonance Imaging measurement (work package 1, 2, and 3) - Magnetic Resonance Imaging measurement (work package 1, 2, and 3) - Magnetic Resonance Imaging measurement (work package 1, 2, and 3) - Magnetic Resonance Imaging measurement (work package 1, 2, and 3) Secondary Outcomes - Muscle strength measurement (work package 3) - Muscle strength measurement (work package 3) - Muscle strength measurement (work package 3) - Muscle strength measurement (work package 3) - Muscle strength measurement (work package 3) - Sensorimotor impairment measurement (work package 3) - Sensorimotor impairment measurement (work package 3) - Sensorimotor impairment measurement (work package 3) - Sensorimotor impairment measurement (work package 3) - Sensorimotor impairment measurement (work package 3) - Spasticity measurement (work package 3) - Spasticity measurement (work package 3) - Spasticity measurement (work package 3) - Spasticity measurement (work package 3) - Spasticity measurement (work package 3) - Funtional skills measurement (work package 3). - Funtional skills measurement (work package 3). - Funtional skills measurement (work package 3). - Funtional skills measurement (work package 3). - Funtional skills measurement (work package 3). - Activities of daily living measurement (work package 3) - Activities of daily living measurement (work package 3) - Activities of daily living measurement (work package 3) - Activities of daily living measurement (work package 3) - Activities of daily living measurement (work package 3) - Pain measurement (work package 3) - Pain measurement (work package 3) - Pain measurement (work package 3) - Pain measurement (work package 3) - Pain measurement (work package 3) - Cognitive performance measurements (work package 3) - Cognitive performance measurements (work package 3) - Cognitive performance measurements (work package 3) - Cognitive performance measurements (work package 3) - Cognitive performance measurements (work package 3) ### Location - Facility: IRCCS San Camillo Hospital, Venice, N/A, N/A, Italy @@
## Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd - NCT ID: NCT06298084 - Study ID: 2023-505925-15-00 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2029-06 - Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris ### Study Description ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.The first 2 modules will evaluate: i. safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd (Module 1) and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd (Module 0).The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose (RP2D) of the combination containing HER3-DXd.The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months. ### Conditions - Breast Cancer Metastatic - HER2-positive Metastatic Breast Cancer - HER2 Low Breast Carcinoma - Advanced Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Patritumab deruxtecan - Olaparib ### Outcomes Primary Outcomes - DLTs (dose-limiting toxicity) for part 1a and 1b - Frequency of safety event for part 1a and 1b - Severity of safety event for part 1a and 1b - Proportion of treatment modification due to AEs for part 1a and 1b - frequency of laboratory abnormalities for part 1a and 1b - Severity of laboratory abnormalities for part 1a and 1b - radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 1a and 1b - ORR for part 2 - DOR for part 2 - PFS for part 2 - CBR for part 2 Secondary Outcomes - ORR for part 1 - DOR for part 1 - PFS for part 1 - CBR for part 1 - PK analysis for part 1 - ADA analysis for part 1 - DLTs for part 2 - Frequency of safety event for part 2 - Severity of safety event for part 2 - proportion of treatment modification event for part 2 - frequency of laboratory abnormalities for part 2 - Severity of laboratory abnormalities for part 2 - radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 2 - PK analysis for part 2 - ADA analysis for part 2 ### Location - Facility: Gustave Roussy Institut, Villejuif, N/A, 94805, France @@
## A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout. - NCT ID: NCT06298071 - Study ID: SIBP-R002-Ib - Status: RECRUITING - Start Date: 2023-03-03 - Completion Date: 2025-12-30 - Lead Sponsor: Shanghai Institute Of Biological Products ### Study Description To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials. ### Conditions - Gout ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - SIBP-R002 - SIBP-R002 - SIBP-R002 - Methotrexate ### Outcomes Primary Outcomes - AE(Adverse Events) - SAE(Serious Adverse Events) - AUC(Area Under The Plasma Concentration Versus Time Curve) - Cmax(Peak Plasma Concentration) - Tmax(Peak Time) - T ½ (Terminal elimination half-life) - CL (Clearance Rate) - ADA (Anti-uricase Antibody, Anti-PEG Antibody, Anti-PEG-uricase Antibody) - NAb (Anti-PEG-uricase Neutralizing Antibody) Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, N/A, China @@
## A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients. - NCT ID: NCT06298058 - Study ID: SIBP-A13-I - Status: NOT_YET_RECRUITING - Start Date: 2024-03-12 - Completion Date: 2026-06-30 - Lead Sponsor: Shanghai Institute Of Biological Products ### Study Description To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D). ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SIBP-A13 formulation for injection ### Outcomes Primary Outcomes - AE (Adverse Events) - SAE (Serious Adverse Events) - AUC (Area Under The Plasma Concentration Versus Time Curve) - Cmax (Peak Plasma Concentration) - Tmax (Peak Time) - T ½ (Terminal elimination half-life) - CL (Clearance Rate) Secondary Outcomes - ORR (Objective Response Rate) - DCR (Disease control rate) - PFS (Progression-free survival) - OS (overall survival) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy - NCT ID: NCT06298045 - Study ID: DIM-06790-002 - Status: RECRUITING - Start Date: 2023-07-15 - Completion Date: 2025-03-31 - Lead Sponsor: Servier Affaires Médicales ### Study Description The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only. ### Conditions - Stable Angina ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Assessment of angina symptoms via the summary score of SAQ-7 Secondary Outcomes - CCS angina grading post-inclusion - Tolerance ( Adverse Events) - Tolerance ( Serious Adverse Events) - Adherence to the antianginal treatment combination under evaluation ### Location - Facility: Thera Card Srl, Braşov, N/A, 500091, Romania @@
## A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons - NCT ID: NCT06298032 - Study ID: 000414 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-11-12 - Lead Sponsor: Ferring Pharmaceuticals ### Study Description Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases. ### Conditions - Inflammatory Gastrointestinal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Olamkicept Part A - Olamkicept Part B - Placebo ### Outcomes Primary Outcomes - Number of treatment-emergent adverse events, including type, intensity, and causality - Change in vital signs from baseline to Day 36 after a single dose infusion - Change in vital signs from baseline to Day 64 after multiple dose infusions - Change in 12-lead electrocardiogram (ECG) from baseline to Day 36 after a single dose infusion - Change in 12-lead electrocardiogram (ECG) from baseline to Day 64 after multiple dose infusions - Change in haematology from baseline to Day 36 after a single dose infusion - Change in haematology from baseline to Day 64 after multiple dose infusions - Change in clinical chemistry from baseline to Day 36 after a single dose infusion - Change in clinical chemistry from baseline to Day 64 after multiple dose infusions - Change in haemostasis parameters from baseline to Day 36 after a single dose infusion - Change in haemostasis parameters from baseline to Day 64 after multiple dose infusions - Change in urinalysis parameters from baseline to Day 36 after a single dose infusion - Change in urinalysis parameters from baseline to Day 64 after multiple dose infusions Secondary Outcomes - Single-dose PK of FE 999301: Area under the concentration-time curve from dosing to infinity (AUCinf) - Single-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast) - Single-dose PK of FE 999301: Observed plasma concentration at end of infusion (AUCeoi) - Single-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax) - Single-dose PK of FE 999301: Time of maximum observed concentration (tmax) - Single-dose PK of FE 999301: Terminal half-life (t1/2) - Single-dose PK of FE 999301: Mean residence time (MRT) - Single-dose PK of FE 999301: Total clearance (CL) - Single-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss) - Multiple-dose PK of FE 999301: Area under concentration-time curve from dosing up to time τ, where τ is the dosing interval (AUCτ) - Multiple-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast) - Multiple-dose PK of FE 999301: Observed accumulation index (Rac) - Multiple-dose PK of FE 999301: Observed plasma concentration at end of infusion (Ceio) - Multiple-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax) - Multiple-dose PK of FE 999301: Time of maximum observed concentration (tmax) - Multiple-dose PK of FE 999301: Terminal half-life (t½) - Multiple-dose PK of FE 999301: Mean residence time (MRT) - Multiple-dose PK of FE 999301: Total clearance (CL) - Multiple-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss) - Presence of anti-FE 999301 antibodies on Days 1, 15, and 57 after multiple dose infusions ### Location - Facility: Ferring Investigational Site, Berlin, N/A, N/A, Germany @@
## Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis - NCT ID: NCT06298019 - Study ID: 73464 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2039-04 - Lead Sponsor: Stanford University ### Study Description The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body. In CAR T therapy, the patients' white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called "CD19" on its outer surface (membrane). Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte, when these "re-engineered" cytotoxic T lymphocytes are then given back to the patient (by an infusion), these cells will seek out and kill essentially all of the patient's B cells. B cells are an important part of a person's immune system and have many functions, including the production of antibodies. It is thought that, in dermatomyositis and other autoimmune diseases, a tiny subset of these B cells plays a large role in making autoantibodies (antibodies directed against the patient's own tissues) and causing disease. The idea is that the therapy will "wipe out" all/most of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease.The main questions the study intends to answer are:* Understanding how well patients tolerate undergoing this therapy in terms of side effects;* Getting an early idea if this therapy can help certain aspects of the autoimmune disease, including inflammation in the skin, muscles, and lungs; ### Conditions - Dermatomyositis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - KYV-101 ### Outcomes Primary Outcomes - Number of participants experiencing adverse events Secondary Outcomes ### Location - Facility: Stanford University, Stanford, California, 94305, United States @@
## A Two Year Longitudinal Clinical Study of Neurocognitive and Psychiatric Symptoms in Post COVID-19 Patients - NCT ID: NCT06298006 - Study ID: 275025 - Status: RECRUITING - Start Date: 2022-02-22 - Completion Date: 2027-06-30 - Lead Sponsor: Region Örebro County ### Study Description The prospective, longitudinal, open observational study monitors patients with cognitive and neuropsychological symptoms after COVID-19 infection, in a longitudinal manner to see how the disease has affected their physical, psychological and cognitive function, their ability to be active, return to work, their health-related quality of life in correlation with potential diagnostic and prognostic markers. ### Conditions - COVID-19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Follow-up ### Outcomes Primary Outcomes - Change in cognitive functions measured with Mindmore and change in cognitive profile in Mindmore. - Symptom improvement in depression - Self-reported symptom improvement in depression - Grade of self-reported mental fatigue - Rate of self-reported symptoms suggestive of post-traumatic stress disorder (PTSD) - Grade of self-reported stress - Grade of self-reported cognitive failures in everyday life Secondary Outcomes - Occurence of activity limitations and changes in health-related quality of life (QoL) - Grade of work incapacity/sick leave and time to return to work - Changes in body size - Waist size - Rate of peak expiratory flow (PEF) - Grade of physical exercise capacity - Concetration of Beta-Amyloid 42 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration. - Beta Amyloid Ratio 42/40 in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease - Concentration of neurogranin in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration linked to Alzheimer's disease - Concentration of Tau (P-Tau) protein in cerebrospinal fluid (CSF) as a CSF biomarker of cortikal damage/neurodegeneration - Concentration of phosphorylated Tau (P-Tau) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration/taupathy - Concentration of neurofilament light (NFL) in cerebrospinal fluid (CSF) as a CSF biomarker of neurodegeneration - Concentration of neurofilament light (NFL) in plasma as a blood biomarker of neurodegeneration - Occurence of APOE4 allele as biomarker of genetic predisposition to Alzheimer's disease and susceptibility to more severe course of COVID-19 infection - Brain volumes and signal abnormalities in white and gray matter - Changes in functional and structural brain connectivity - Changes in gut microbiome ### Location - Facility: Department of Geriatrics, University Hospital Örebro, Örebro, N/A, N/A, Sweden @@
## Adult Patients With Primary Sclerosing Cholangitis - NCT ID: NCT06297993 - Study ID: WIND-PSC-01 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2031-01 - Lead Sponsor: Arbor Research Collaborative for Health ### Study Description Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC. ### Conditions - PSC ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Develop interventional clinical trial external control using clinical and biomarker data. Secondary Outcomes - Identify alternative endpoints to predict clinical benefit using large clinical and biomarker data. - Changes in patient reported outcomes over time as assessed by Patient Reported Outcomes surveys. ### Location - Facility: Schiff Center for Liver Diseases / University of Miami, Miami, Florida, 33136, United States @@
## Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes - NCT ID: NCT06297980 - Study ID: 23-1513 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-10-31 - Lead Sponsor: University of Colorado, Denver ### Study Description The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity. ### Conditions - Type 1 Diabetes - Hypoglycemia - Hyperglycaemia Due to Type 1 Diabetes Mellitus - Menstruation Disturbances ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Personalized modifications to treatment to address menstrual cycle effects on glycemia ### Outcomes Primary Outcomes - Glucose time in range - Glucose standard deviation Secondary Outcomes - Mean glucose (mg/dL) pre-exercise - Mean glucose (mg/dL) while exercising - Mean glucose (mg/dL) over 24 hours after exercise - Glucose standard deviation - Glucose standard deviation ### Location - Facility: University of Colorado, Aurora, Colorado, 80045, United States @@
## Acetic Acid 2% Solution for Skin Ulcers - NCT ID: NCT06297967 - Study ID: CSAPG-33 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-06 - Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf ### Study Description The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment. ### Conditions - Ulcer, Skin ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acetic Acid - Prontosan ### Outcomes Primary Outcomes - Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment Secondary Outcomes - Percentage of participants with ulcer healing at 4 weeks from the start of treatment. - Percentage of participants with ulcer healing at 12 weeks from the start of treatment. - Time (days) to ulcer healing from the start of treatment. - Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 ("Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds" scale. - Number of adverse reactions associated with the treatment, collected from the medical record. - The healthcare expenditure associated with each branch of the study ### Location - Facility: Consorci Sanitari Alt'Pènedes i Garraf, Barcelona, Cataluña, 08810, Spain @@
## Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding - NCT ID: NCT06297954 - Study ID: GA22-00011 - Status: RECRUITING - Start Date: 2023-03-16 - Completion Date: 2024-06 - Lead Sponsor: Universidad Autonoma de Nuevo Leon ### Study Description A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 12 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale. ### Conditions - Upper Gastrointestinal Bleeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Metoclopramide - Placebo ### Outcomes Primary Outcomes - To determine the usefulness of metoclopramide in improving endoscopic visualisation in patients with upper gastrointestinal bleeding. Secondary Outcomes - To determine whether the use of metoclopramide avoids repeating the endoscopic procedure. - To determine whether the use of metoclopramide shortens the length of hospital stay. ### Location - Facility: Hospital Universitario Dr. José Eleuterio González, UANL, Monterrey, Nuevo León, 64460, Mexico @@
## Study of REM-422 in Patients With AML or Higher Risk MDS - NCT ID: NCT06297941 - Study ID: REM-422-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-06-15 - Lead Sponsor: Remix Therapeutics ### Study Description The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML ### Conditions - Myelodysplastic Syndromes - Higher Risk Myelodysplastic Syndromes - Acute Myeloid Leukemia - Acute Myeloid Leukemia Refractory ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - REM-422 ### Outcomes Primary Outcomes - Frequency and severity of Treatment Emergent Adverse Events (TEAEs) - Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) Secondary Outcomes - AML: Rate of Complete Response (remission) (CR) - AML: Rate of CR with partial hematologic recovery (CRh) - AML: Duration of CR - AML: Duration of CRh - AML: Overall response rate (ORR) (CR + CRh + CRi + PR) with incomplete hematologic recovery [CRi] + partial response [PR]) per modified IWG response criteria 2003 based on Investigator assessment - AML: Duration of response (DOR) - MDS: Rate of Compete Response (CR) - MDS: Duration of Complete Response (CR) - MDS: Overall Response Rate (ORR) - MDS: Duration of Response (DOR) - Determine pharmacokinetic profile (Cmax) of REM-422 - Determine pharmacokinetic profile (Cmin) of REM-422 - Determine pharmacokinetic profile (Tmax) of REM-422 - Determine pharmacokinetic profile (AUC) of REM-422 ### Location - Facility: City of Hope, Duarte, California, 91010, United States @@
## Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity - NCT ID: NCT06297928 - Study ID: 2023/11238/I - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Parc de Salut Mar ### Study Description The goal of this observational study is to investigate metabolic changes in individuals undergoing bariatric surgery, specifically focusing on those with obesity and varying metabolic health statuses. The main questions it aims to answer are:* Can metabolic markers predict the transition from metabolically unhealthy obesity to metabolically healthy obesity after bariatric surgery?* How do metabolic profiles change in individuals with metabolically healthy obesity after bariatric surgery?* What are the metabolic differences between individuals with metabolically healthy and unhealthy obesity before and after bariatric surgery?Participants will undergo routine evaluations and blood tests before and after bariatric surgery. These tests will include assessments of metabolic health markers and sampling of blood plasma for metabolomic analysis. The study will study changes in metabolic profiles between individuals who transition to metabolically healthy obesity and those who remain metabolically unhealthy after surgery. ### Conditions - Bariatric Surgery Candidate - Obesity, Morbid - Obesity, Metabolically Benign ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - baratric surgery ### Outcomes Primary Outcomes - Identification of Metabolic Signatures Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Analysis Predicting Transition from Metabolically Unhealthy Obesity (MUO) to Metabolically Healthy Obesity (MHO) Status Secondary Outcomes - Comparison of Metabolomic Changes Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) between Patients with Persistent Metabolically Unhealthy Obesity (MUO) and Those Transitioning to Metabolically Healthy Obesity (MHO) Status - Comparison of Baseline Metabolomic Profile and Its Evolution Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) after Surgery between Patients with Metabolically Healthy Obesity (MHO) and Metabolically Unhealthy Obesity (MUO) ### Location - Facility: Hospital del Mar, Barcelona, N/A, 08003, Spain @@
## Infusion Treatments of Chronic Peripheral Neuropathic Pain - NCT ID: NCT06297915 - Study ID: 2022/08-45 - Status: COMPLETED - Start Date: 2022-05-17 - Completion Date: 2023-08-01 - Lead Sponsor: Hacettepe University ### Study Description This study aimed to evaluate and compare the efficacy of ketamine and lidocaine infusion in patients with chronic peripheral neuropathic pain.Patients who received intravenous ketamine infusion and the other patient group who received intravenous lidocaine infusion were evaluated in the study. Pain scores and quality of life were assessed with scales before treatment at two weeks, two months, and six months after treatment. ### Conditions - Neuropathic Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ketamine - Lidocain ### Outcomes Primary Outcomes - Neuropathic Pain Scale - Pain Rating Scale Secondary Outcomes - Quality of Life Scale ### Location - Facility: Hacettepe University, Ankara, Cankaya, 06360, Turkey @@
## RAdiotherapy With FDG-PET Guided Dose-PAINTing Compared With Standard Radiotherapy for Primary Head and Neck Cancer-3 - NCT ID: NCT06297902 - Study ID: 2023_31 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2030-06 - Lead Sponsor: Oslo University Hospital ### Study Description The objective of the RADPAINT-3 trial is to investigate whether dose painting is safe compared to standard radiotherapy. RADPAINT-3 is a randomized, non-inferiority, multi-center phase II study, initiated at the Section for Head and Neck Cancer, Department of Oncology, Oslo University Hospital, accruing from first half of 2024. The primary endpoint is frequency of grade ≥ 3 (CTCAE v5.0) mucosal ulcers one year after treatment. The expected inclusion period is three years, total study duration is six years and planned inclusion number is 100 patients. The collaborating sites are St Olav´s Hospital and Haukeland University Hospital. The patients will be randomized 1:1 to either standard radiotherapy (2 Gy x 34; total dose 68 Gy) or experimental radiotherapy (dose painting). All patients will have 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission computed tomography (FDG-PET/CT) prior to radiotherapy. In the experimental arm, we will escalate the dose to the hypermetabolic part of the tumor (maximum point dose 83.3 Gy), shown in pre-treatment FDG-PET images. Dose escalation will be applied to these regions during the first half of the fractionated treatment (17 of 34 fractions). The patients in both arms will receive concomitant nimorazole (hypoxic radiosensitizer) and concomitant cisplatin if indicated according to standard treatment. The main inclusion criterion is patients with human-papillomavirus (HPV)-unrelated head and neck cancer with poor prognosis.The RADPAINT-3 trial includes a translational sub-study where we aim to elucidate underlying mechanisms related to the radiotherapy effect, by investigating blood samples. Analysis of cytokines in repetitive blood samples may predict both tumor response and toxicity. The data derived from this sub-study, will be further explored using artificial intelligence.If RADPAINT-3 shows that there is no excess toxicity, we will continue the study after a new protocol has been approved. The new primary endpoint will be local control at 1 year after radiotherapy. Power analysis show that we will need in total 182 evaluable patients including the 100 patients from RADPAINT-3. The translational sub-study will then be extended to investigate genetic expression data from pre-therapy routine tumor biopsies and correlate this with the analysis of blood samples and tumor control. ### Conditions - Head and Neck Cancer - Radiotherapy Side Effect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dose painting ### Outcomes Primary Outcomes - Late mucosal ulcer Secondary Outcomes - Early toxicity - Late toxicity - Odynophagia - Health-related quality of life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Core Strength Training on the Physical Fitness and Skills of Youth Field Hockey Players in China - NCT ID: NCT06297889 - Study ID: Ma Hucheng - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-06-15 - Lead Sponsor: Universiti Putra Malaysia ### Study Description Hockey, tracing its origins back to 2000 BC, has undergone substantial evolutionary transformations throughout the centuries. Initially known by various names, the game transitioned to its modern form approximately 50 years ago, when matches were conducted on grass fields with wooden sticks. In contemporary international hockey, there has been a notable shift towards artificial grass, cultivating a dynamic and fast-paced game that places heightened demands on individual skills, tactical acumen, and physical fitness. This evolution reflects a continuous adaptation, seamlessly blending tradition with cutting-edge equipment and hybrid playing grounds.Against this backdrop, modern-day hockey programs have metamorphosed into rigorous and demanding training regimes. Athletes engaged in these programs are required not only to demonstrate outstanding physical fitness but also exhibit a high level of proficiency in the nuanced skills essential for competitive play. As hockey continues its progressive trajectory, athletes partaking in these programs must meet elevated standards, underscoring the imperative integration of both exceptional fitness levels and precise skill execution.Despite the growing emphasis on the physical and skill dimensions of hockey, a literature review uncovered a dearth of research specifically focusing on core strength training for hockey players. While core strength training has demonstrated efficacy in improving physical fitness and skill performance among athletes in other team sports, its applicability to hockey players remains underexplored. Moreover, no studies have systematically examined the impact of core strength training on the two critical variables of physical fitness and skill performance in hockey players.To address this research gap, the present study sought to investigate the effects of core strength training on the physical fitness and skill performance of youth hockey players in Gansu Province, China. By doing so, this study not only contributes valuable insights to the existing body of literature but also furnishes theoretical support for the development of hockey sport programs. The findings are anticipated to inform targeted interventions aimed at enhancing athletes' physical fitness and skill performance, ultimately fostering the progression of hockey programs within the sporting landscape of China. ### Conditions - Player ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - core strength training 1-6weeks - core strength training 7-12weeks ### Outcomes Primary Outcomes - Power test - Speed test Secondary Outcomes ### Location - Facility: Ma Hucheng, Lanzhou, Gansu, 730000, China @@
## COVIDVaxStories: Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color - NCT ID: NCT06297876 - Study ID: H00023815 - Status: RECRUITING - Start Date: 2023-05-19 - Completion Date: 2025-05 - Lead Sponsor: University of Massachusetts, Worcester ### Study Description Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts ### Conditions - Vaccine Hesitancy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Storytelling - Learn More (Active Comparator) ### Outcomes Primary Outcomes - Change in Vaccine Hesitancy Secondary Outcomes - Vaccine Uptake ### Location - Facility: University of Massachusetts Chan Medical School, Worcester, Massachusetts, 01605, United States @@
## Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke - NCT ID: NCT06297863 - Study ID: DOWN-SUITE - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2026-12-31 - Lead Sponsor: University of Milano Bicocca ### Study Description The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy.This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment).The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°). ### Conditions - Acute Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HEAD DOWN TILT -10° to -15° ### Outcomes Primary Outcomes - Good collateral status Secondary Outcomes - Feasibility of HDT15 - Delay to thrombectomy - Vomiting - Early neurological deterioration - Symptomatic intracranial hemorrhage - Aspiration pneumonia - Neurological disability - Systolic blood pressure - Diastolic blood pressure - Oxygen saturation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study - NCT ID: NCT06297850 - Study ID: WARD-Glucose Validation v.2.2 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: University Hospital Bispebjerg and Frederiksberg ### Study Description The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment.The main questions it aims to answer are:• Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment?Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days. ### Conditions - Diabetes Mellitus - Dysglycemia - Perioperative Complication - Circulatory; Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) ### Outcomes Primary Outcomes - Agreement between glucose Secondary Outcomes - Agreement between glucose readings when at low glucose levels - Agreement between glucose readings when at normal glucose levels - Agreement between glucose readings when at high glucose levels ### Location - Facility: Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, Copenhagen, The Capital Region Of Denmark, 2100, Denmark @@
## ADAPT-AST (Adaptive Antimicrobial Susceptibility Testing) - NCT ID: NCT06297837 - Study ID: LHS0205 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust ### Study Description The goal of this study is to improve the way urinary tract infections (UTIs) are tested for antibiotic resistance. The main questions it aims to answer are:* Can the investigators use a method called Bayesian causal inference to create or check clinical prediction models that help predict if certain antibiotics will work for a urinary infection, using patient information from the National Health Service (NHS)?* Can this new ADAPT-AST method, which uses data and a smarter approach, do a better job of testing for urinary infection than the old methods? Will it help doctors make quicker decisions and save resources by being more efficient?Participants in this study will not be receiving treatments. The study will involve:Using statistical methods to predict UTI test results based on patient data. Evaluating whether this new approach can provide doctors with more timely and useful information for treating UTIs.Assessing whether it can help save money and resources in the lab and pharmacy. ### Conditions - Urinary Tract Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The number of antimicrobial susceptibility results that 'should' spur action by a clinician on Secondary Outcomes - The number of days until a result that 'should' spur action by a clinician - The number of antimicrobial susceptibility results that 'could' spur action by a clinician on - The number of days until a result that 'could' spur action by a clinician - The projected health economic cost per specimen, including laboratory (e.g., consumable cost) and patient (e.g., drug toxicity, clinical failure) measures. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm - NCT ID: NCT06297824 - Study ID: 2023-04909-01 - Status: RECRUITING - Start Date: 2023-10-10 - Completion Date: 2025-06-30 - Lead Sponsor: Karolinska Institutet ### Study Description Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present.A quantitative feasibility open trial (N=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents. ### Conditions - Self-harm - Emotion Regulation - Adolescent - Emotional Problem ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ERGT-A ### Outcomes Primary Outcomes - Feasibility measure, recruitment rate - Feasibility measures, proportion included - Feasibility measures, compliance - Feasibility measures, attrition - Feasibility measures, client satisfaction - Feasibility measures, negative effects of treatment Secondary Outcomes - Preliminary effect, self harm frequency EOT - Preliminary effect, self harm frequency 1MFU - Preliminary effect, emotion dysregulation EOT - Preliminary effect, emotion dysregulation 1MFU ### Location - Facility: Prima Barn och Vuxenpsykiatri Handen och Järva, Stockholm, Spånga, 16374, Sweden @@
## Myeloprotection With Trilaciclib in Pan-cancer Population - NCT ID: NCT06297811 - Study ID: SMA PT 001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-12-31 - Lead Sponsor: Sun Yat-sen University ### Study Description The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are:* effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy* does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor typeParticipants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy. ### Conditions - Non-Small Cell Lung Cancer - Breast Cancer - Endometrial Cancer - Cervical Cancer - Head And Neck Squamous Cell Carcinomas ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Trilaciclib Injection - Paclitaxel - Carboplatin ### Outcomes Primary Outcomes - Occurrence of grade 3/4 neutropenia within 6 cycles Secondary Outcomes ### Location - Facility: Medical Oncology,Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Effects of Telerehabilitation-Based Interventions on the Musculoskeletal System in Drivers - NCT ID: NCT06297798 - Study ID: SakaryaAppliedSciencesUPNS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-05-10 - Lead Sponsor: Sakarya Applied Sciences University ### Study Description This study is designed to examine the effect of telerehabilitation application on the musculoskeletal system of drivers.The study will include 40 voluntary participants who work as drivers on inter-district routes in Sakarya. The participants' sociodemographic information, musculoskeletal problems, and postures will be assessed. Participants will be divided into two groups: one group will receive tele-rehabilitation with posture and stabilization exercises, while the other group will serve as the control group. The exercises will be implemented for 10 weeks, followed by an 8-week tapering period, after which the groups will be crossed over. A re-evaluation will be conducted after 10 weeks, with follow-up assessments scheduled for 3 months later. ### Conditions - Drive - Musculoskeletal Diseases - Postural; Defect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Telerehabilitation ### Outcomes Primary Outcomes - MUSCLE SKELETAL SYSTEM ASSESSMENT Secondary Outcomes - Posture Measures ### Location - Facility: Sakarya University of Applied Sciences, Sakarya, N/A, 54000, Turkey @@
## Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS) - NCT ID: NCT06297785 - Study ID: 2022-03997-01 - Status: RECRUITING - Start Date: 2022-10-17 - Completion Date: 2027-04 - Lead Sponsor: Sahlgrenska University Hospital, Sweden ### Study Description Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity. ### Conditions - IBS - Irritable Bowel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Gut-directed hypnotherapy ### Outcomes Primary Outcomes - Change in gastrointestinal symptom severity Secondary Outcomes ### Location - Facility: Mag-Tarmlab, Sahlgrenska University Hospital, Gothenburg, N/A, 41345, Sweden @@
## Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR - NCT ID: NCT06297772 - Study ID: RJBMT-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-05-01 - Lead Sponsor: Ruijin Hospital ### Study Description A multicenter, randomized, controlled clinical study comparing the efficacy and safety of allogeneic hematopoietic stem cell transplantation with decitabine-Fludarabine- busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as pretreatment regimens for the treatment of acute myeloid leukemia in adults with MR gene abnormalities ### Conditions - AML, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Decitabine - Fludarabine Injection - Busulfan Injection ### Outcomes Primary Outcomes - disease-free survival Secondary Outcomes - incidence of relapse rate - Non-recurrent mortality ### Location - Facility: Ruijin Hospital, Shanghai, N/A, 200025, China @@
## The Validity and Reliability Study of Turkish Version of the Sense of Competence in Dementia Care Staff (SCIDS) Scale - NCT ID: NCT06297759 - Study ID: ATADEK-2023/16 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-09 - Lead Sponsor: Yeditepe University ### Study Description The purpose of the study is to adapt the SCIDS into the Turkish version and validate it in the social and cultural context of Turkey to assess staff competency in dementia care in the long-term care setting. ### Conditions - Dementia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - Sense of Competence in Dementia Care Staff (SCIDS) Scale Secondary Outcomes - Caring Behaviors Inventory-24 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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