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## A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects - NCT ID: NCT06310746 - Study ID: HLX6018-FIH101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-12-30 - Lead Sponsor: Shanghai Henlius Biotech ### Study Description The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments.This is a randomized, double-blind, placebo-controlled study with single dose escalation design to assess the safety, PK, and immunogenicity of HLX6018 in healthy subjects. It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). This is the first-in-human study of the investigational product. ### Conditions - IPF ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - GARP/TGF-β1 monoclonal antibody - Placebo ### Outcomes Primary Outcomes - The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs) Secondary Outcomes - AUC0-inf - Cmax - Tmax - T1/2 - CL - λz ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders - NCT ID: NCT06310733 - Study ID: REC 66-517-1-1 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2026-02-20 - Lead Sponsor: Prince of Songkla University ### Study Description Recurrent or chronic abdominal pain is one of the common gastrointestinal problems in children. While most children do not have organic origins (so called functional abdominal pain disorders; FAPDs), the symptoms can nevertheless be severe enough to impair the patient's quality of life, growth, and development. To help rule out organic disorders and diagnose this condition, some individuals underwent multiple invasive and costly studies.Generally, the diagnosis of FAPDs is based on clinical symptoms and criteria, it can be divided into irritable bowel syndrome (IBS), abdominal migraine, functional abdominal pain (FAP) and functional dyspepsia (FD). Approximately 14% of children globally, between the ages of 4 and 18, experience functional abdominal pain issues8. In Thailand, the prevalence of FAPDs among adolescents (mean age of 16 years) was 5.3%, functional dyspepsia and irritable bowel syndrome were found to be the most prevalent subtypes.The pathogenesis of FAPDs is believed to result from disruptions in the microbiota-gut-brain axis, which may happen early in life or throughout. Hence, several studies, specifically in western countries, reported the role of probiotics, specifically Lactobacillus rhamnosus GG (LGG), in modulating abdominal symptoms in children with FAPDs.It is widely known that the diversity of gut microbiota depends on multiple factors including ethnicity, mode of delivery, dietary and environmental factors. However, the studies on the use of probiotics in pediatric patients with FAPDs have been mainly conducted in western countries. Since there are limited studies on the effectiveness of probiotics in Asian children with FAPDs, the investigators aim to evaluate the effects of probiotics, LGG, in the treatment of children who suffered from FAPDs.The secondary objectives are to measure daily pain score in children with and without FAPDs, to evaluate and compare the diversity of fecal microbiota in children with FAPDs and those without FAPDs, and to compare the diversity of fecal microbiota between children with FAPDs who took probiotics and those who did not. ### Conditions - Functional Abdominal Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LGG - Placebo ### Outcomes Primary Outcomes - The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs - The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs - The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs Secondary Outcomes - To measure daily pain score in children with and without FAPDs - To measure daily pain score in children with and without FAPDs - To measure daily pain score in children with and without FAPDs - To compare the diversity of fecal microbiota in children with FAPDs who took probiotics and those who did not ### Location - Facility: Atchariya Chanpong, Songkhla, N/A, N/A, Thailand @@
## Postpartum Video Education in High Risk Populations - NCT ID: NCT06310720 - Study ID: 23-10026618 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Weill Medical College of Cornell University ### Study Description This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery for self-identified, Black, Latinx, other with two or more self-identified races, Medicaid, and/or uninsured postpartum individuals. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs. ### Conditions - Postpartum Hemorrhage - Postpartum Depression - Postpartum Sepsis - Postpartum Preeclampsia - Patient Empowerment - Patient Education - Postpartum Care ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Video Education ### Outcomes Primary Outcomes - Change in baseline and post-education questionnaire score Secondary Outcomes - Change in post-education and post-discharge questionnaire score - Number of participants who attended 6 week postpartum visit - Healthcare utilization: Number of clinic visits - Healthcare utilization: Number of phone calls - Healthcare utilization: Number of urgent care/emergency room visits - Mean difference in patient satisfaction rating ### Location - Facility: Alexandra Cohen Hospital for Women and Newborns, New York, New York, 10065, United States @@
## Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter - NCT ID: NCT06310707 - Study ID: EU RCT: ePatch vs 24h Holter - Status: RECRUITING - Start Date: 2023-11-09 - Completion Date: 2025-08 - Lead Sponsor: Philips Clinical & Medical Affairs Global ### Study Description This study is a Multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring. ### Conditions - Arrythmia - Syncope ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - ePatch ® Extended Wear Holter (EWH) ### Outcomes Primary Outcomes - Diagnostic yield (frequency) of clinically actionable arrythmia Secondary Outcomes - Number of Atrial Fibrillation (AF) diagnoses > 30 seconds - Occurrence of symptomatic events - Number of Clinically actionable arrhythmia - Patient Quality of Life as measured by EQ-5D-5L - Patient Quality of Life as measured by Patient Experience Survey - Cost related to cardiac monitoring - Time Holter is worn/ removed ### Location - Facility: Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel, Bron, N/A, 69677 Cedex, France @@
## Additional Circular Dressing Material - NCT ID: NCT06310694 - Study ID: EGE-HEM-SL-01 - Status: COMPLETED - Start Date: 2023-04-27 - Completion Date: 2023-12-30 - Lead Sponsor: Ege University ### Study Description The study was conducted to determine the effect of fixing peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of PIVC stay and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It has been determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site. ### Conditions - Nurse's Role ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - intervention group (Elastane circular dressing on sterile transparent dressing) ### Outcomes Primary Outcomes - Skin Penetration Difficulty Rating Scale - Visual Infusion Phlebitis Diagnostic Scale - Infiltration Rating Scale - Data Collection Form for the Patient Who Had a Peripheral Intravenous Catheter Secondary Outcomes ### Location - Facility: Şeyma Turan, Turgutlu, Manisa, 45400, Turkey @@
## Pilot Testing of a Co-adapted Group Programme for Parents/Carers of Children With Complex Neurodisability - NCT ID: NCT06310681 - Study ID: ETH2223-2528 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: City, University of London ### Study Description The goal of this pilot feasibility study is to test a co-adapted community-based group programme ("Encompass") with parents/carers of children with complex neurodisability under 5 years of age in East London in the UK.The main questions it aims to answer are:* Is it feasible and acceptable to carry out this newly co-adapted programme with two groups of parents/carers of children with complex neurodisability under the age of 5?* Is it feasible to carry out an evaluation of the above programme, which could then inform a protocol for larger scale evaluation?The main activities for the parent/carer participants will include:* Attending ten "Encompass" parent/carer groups* Filling in questionnaires at the start and end of the groups* Attending an interview with the researcher to discuss their experiencesThe groups will be facilitated by a healthcare professional and a parent with lived experience. They will also be interviewed about their experiences after the groups have been completed. ### Conditions - Complex Neurodevelopmental Disorder - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - "Encompass" group programme ### Outcomes Primary Outcomes - Group Attendance - Recruitment - percentage of eligible participants who consent to take part - Follow-up response rate-self-complete outcomes questionnaire(s) - Fidelity - delivery on items described in the Fidelity Checklist Secondary Outcomes - Family Empowerment Scale (FES) - Power Ladder Question (PLQ) - Parent Patient Activation Measure (P-PAM) - Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) - Parent/carer Quality of Life - EuroQoL-5D-5-level (EQ-5D-5L) - Parent/carer Needs and Goals - Childhood Cost Calculator (C3) ### Location - Facility: Barts Health NHS Trust, Children's Occupational Therapy, Mile End Hospital, London, N/A, E1 4EH, United Kingdom @@
## Has CBT an Effect on Emotional Intelligence in Patients With Substance Use Disorder? - NCT ID: NCT06310668 - Study ID: CBT IN substance use disorder - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10 - Lead Sponsor: Egyptian Medical Syndicate ### Study Description Aim of the study: In this study, the change in emotional intelligence will be assessed before and after group CBT sessions in male patients with substance use disorder in the inpatient department of the addiction unit at Mansoura University Hospital. ### Conditions - Substance Use Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - group cognitive behavioral therapy sessions ### Outcomes Primary Outcomes - emotional intelligence Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Online Proton Adaptive Radiotherapy - NCT ID: NCT06310655 - Study ID: 202403078 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-08-31 - Lead Sponsor: Washington University School of Medicine ### Study Description This is a pilot study evaluating the feasibility of daily online adaptive planning for patients undergoing proton radiation therapy.Patients undergoing proton radiation therapy normally undergo extensive pre-planning for their treatment. However, accounting for uncertainties in treatment delivery remains a challenge for a variety of reasons, such as differences in patient anatomy from pre-planning to the day of treatment. Online adaptive planning is a process consisting of generating the original pre-plan on the patient on a treatment day, assessing the pre-plan's coverage and safety, and if changes are needed, the plan is changed in order to optimize the treatment while the patient is still on the treatment table. This study is assessing the feasibility and safety of this approach in order to gather data for a larger trial. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Proton SBRT ### Outcomes Primary Outcomes - Feasibility of online proton adaptive radiotherapy Secondary Outcomes - Safety of online proton adaptive radiotherapy as measured by the amount of grade 2 and higher radiation-related toxicities ### Location - Facility: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States @@
## Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness - NCT ID: NCT06310642 - Study ID: 2020-217 - Status: COMPLETED - Start Date: 2021-05-20 - Completion Date: 2023-03-13 - Lead Sponsor: CHRISTUS Health ### Study Description A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score. ### Conditions - AMS - Acute Mountain Sickness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Immediate descent from altitude. - Diphenhydramine - Prochlorperazine 10 mg ### Outcomes Primary Outcomes - Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups Secondary Outcomes - Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups ### Location - Facility: CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency, Corpus Christi, Texas, 78405, United States @@
## Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") - NCT ID: NCT06310629 - Study ID: CMUH112-REC3-163 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2025-05-21 - Lead Sponsor: China Medical University Hospital ### Study Description Based on early bench-testing data and subsequent clinical case studies in the U.S., "Intrinseque Health" non-rebreathing mask (IHNRM) has delivered virtual elimination of air entrainment and preferential delivery of all available oxygen first into the alveolar spaces by sequential opening of valves in its controller manifold, even at oxygen flow as low as 10 LPM, patient can attain high alveolar oxygen concentration of 75% or more-far higher than attainable with face mask or nasal cannula.Numerous intubated patients emerging from the operating room require intensive critical care specialist supervision in order to transition to the regular care. This would enable higher patient turnover and more efficient utilization of hospital resources, if patient can be transited to the regular care earlier by using a device that supports high oxygenation. This will enable a faster, safe and smooth extubation in critical care, and earlier discharge from intensive care ward.This study is anticipated to take only around 2.5 hour per patient to complete. Patients meeting the inclusion and exclusion criteria of this study are placed on IHNRM and monitored until steady state of SpO2 of 95% or higher on 7-10 LPM has been maintained for at least 2 hours, when they can be discharged from the post-anesthesia care unit (PACU) to the regular care ward.The study is the parallel design study. 60 patients will be randomly selected to use the IHNRM, and 30 subjects will be placed on HFNC. Blood oxygen concentration (SpO2), respiratory rate, end tidal CO2 concentration (EtCO2), and vital sign will be recorded in the study. The endpoint of the study is to compare the effect after using between "IHNRM" and HFNC. ### Conditions - Respiratory Disease - Respiratory Distress Syndrome - Respiratory Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - High Flow Nasal Cannula - "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") ### Outcomes Primary Outcomes - Time to reach SpO2 Criteria in Run-in - The percentage of subjects to reach SpO2 Criteria in maintenance Secondary Outcomes ### Location - Facility: Department of Internal Medicine, China Medical Univdersity Hospital, Taichung, N/A, N/A, Taiwan @@
## A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants - NCT ID: NCT06310616 - Study ID: 219888 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2024-05-28 - Lead Sponsor: ViiV Healthcare ### Study Description This study aims to assess any impact of VH4524184 on the pharmacokinetic (PK) profile of an ethinyl estradiol (EE) and norethindrone acetate (NEA) containing oral contraceptive (OC) administered to healthy adult female participants. ### Conditions - HIV Infections ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - VH4524184 - Loestrin ### Outcomes Primary Outcomes - Area under the concentration-time curve (AUC) from time zero (pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) of EE and NEA without coadministration with VH4524184 - AUC0-Tau, ss of EE and NEA with coadministration with VH4524184 - Maximum plasma concentration (Cmax) for EE and NEA without coadministration with VH4524184 - Cmax for EE and NEA with coadministration with VH4524184 Secondary Outcomes - Number of participants with adverse events (AEs) and severity of AEs - Number of participants with AEs leading to discontinuation of study intervention - Change from baseline of liver panel laboratory parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ASP) (International units per liter) - Change from baseline of liver panel laboratory parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L]) - Change from baseline of liver panel laboratory parameters: International normalized ratio (INR) (Ratio) - Number of participants with maximum toxicity grade increase from baseline of liver panel laboratory parameters: ALT, AST, alkaline phosphatase, total bilirubin, Direct bilirubin, and INR - Maximum plasma concentration at steady state (Cmax,ss) for VH4524184 - Time to maximum concentration at steady state (Tmax, ss) during dosing interval for VH4524184 - Area under the concentration-time curve from time zero(pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) for VH4524184 - Trough concentration prior to the next dose (Ctrough) for VH4524184 ### Location - Facility: GSK Investigational Site, San Antonio, Texas, 78209, United States @@
## Determinants and Outcomes of High vs. Low Ultra-processed Feeding - NCT ID: NCT06310603 - Study ID: IRB-23-42 - Status: RECRUITING - Start Date: 2023-08-09 - Completion Date: 2025-08-09 - Lead Sponsor: Oklahoma State University ### Study Description The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\[s\] it aims to answer are:• Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected.If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health. ### Conditions - Healthy Nutrition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Low-Processed Food Diet ### Outcomes Primary Outcomes - Body Weight - Body Composition - Fat Mass Percentage - Fat-Free Mass Percentage Secondary Outcomes - Triglyceride Levels - Glucose Levels - Cholesterol Levels - HDL - LDL - Alanine transaminase (ALT) - Aspartate transaminase (AST) ### Location - Facility: Laboratory for Applied Nutrition and Exercise Science (LANES), Stillwater, Oklahoma, 74075, United States @@
## Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma - NCT ID: NCT06310590 - Study ID: NRT6003-HCC-2022 - Status: RECRUITING - Start Date: 2023-08-08 - Completion Date: 2025-10-31 - Lead Sponsor: Chengdu New Radiomedicine Technology Co. LTD. ### Study Description The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003 Injection in patients with unresectable HCC. ### Conditions - Unresectable Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NRT6003 Injection ### Outcomes Primary Outcomes - Adverse events/ Severe adverse events - Localized Objective response rates (ORR) Secondary Outcomes - Hepatic time to progression (hTTP) - Duration of response (DOR) - Disease control rate (DCR) - Time to progression (TTP) - Progression Free Survival (PFS) - Concentration of Alpha fetoprotein (AFP) - Quality of life (QoL) - Yttrium-90 distribution - Resection rate of liver target lesions - Radioactivity of Yttrium-90 for 9 participants, assessed by liquid scintillation counter ### Location - Facility: Anhui Provincial Hospital, Hefei, Anhui, N/A, China @@
## Evaluation of Leak-Free Bronchoscope Adapter to Limit Ventilated Air Volume Loss During Bronchoscopy - NCT ID: NCT06310577 - Study ID: EH23-343 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-11 - Lead Sponsor: NorthShore University HealthSystem ### Study Description The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy. ### Conditions - Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Leak-free bronchoscope adapter ### Outcomes Primary Outcomes - Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter" - Heart rate (bpm) - Blood pressure (mmHg) - Oxygenation as measured by SpO2 - Assessment of adverse events Secondary Outcomes - Evaluation of bronchoscope adapter tidal volume loss efficacy - Evaluation of bronchoscope adapter aerosolization efficacy - Peak airway pressure (cmH2O) - Dynamic compliance (mL/CmH2O) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Low and Intermediate Risk oliGometastatic coloREctal cancEr patieNts Treated With Stereotactic ABlative Radiotherapy - NCT ID: NCT06310564 - Study ID: 2023-18 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2031-04 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description This is an experimental study without drug or device, randomized, open-label, non-profit, sponsored by the IRCCS Sacro Cuore Don Calabria Hospital in Negrar, which will take place at the Department of Advanced Oncological Radiotherapy and 18 other Italian centers.The reason for this research study is to evaluate whether stereotactic radiotherapy treatment (SABR), in addition to the systemic chemotherapy treatment foreseen by clinical practice for low-intermediate risk oligometastatic colorectal cancer, is able to:* delay possible local recurrence and/or distant polymetastatic progression* improve disease-free survival* reduce side effects in the short and long termthus inducing an improvement in the quality of life of patients suffering from this type of pathology.Therefore, as part of this randomized study, before starting first or second line systemic therapy for his tumor, the patient will be randomized to one of the following treatment arms:* Experimental arm: ablative stereotactic radiotherapy on all sites of oligometastatic disease (from 1 to 3 sites, performed at most within the second cycle of systemic therapy)* Control arm: no ablative stereotactic radiotherapy to sites of oligometastatic diseaseThe procedure that is intended to be tested in the experimental arm is a stereotactic radiotherapy treatment on oligometastases (up to a maximum of 3 sites), with ablative dosage (effective biological dose \>100 Gy), performed before the start of systemic therapy of I or II line (at most within the second cycle of the same).It is hoped that the addition of this type of radiotherapy will increase the potential clinical benefit of the treatment in the context of colorectal cancer. ### Conditions - Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SABR ### Outcomes Primary Outcomes - Progression-free survival (PFS). Secondary Outcomes - Time to the polymetastatic conversion (tPMC) - Local control (LC): the time between randomization to the date of radiological development of local progression after SABR. - Overall survival (OS) - Time to start of the next systemic treatment line (NEST) - Number of adverse events as assessed by CTCAE v4.0 - Number of acute side-effects - Number of Late side-effects - questionnaire QLQ-C30 ### Location - Facility: IRCCS Sacro Cuore Don Calabria di Negrar, Negrar, Verona, 37024, Italy @@
## First Time in Human Study of Long Acting VH4524184 Formulations - NCT ID: NCT06310551 - Study ID: 218804 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-14 - Completion Date: 2026-11-27 - Lead Sponsor: ViiV Healthcare ### Study Description The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection. ### Conditions - HIV Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oral VH4524184 - VH4524184 Formulation A SC - Placebo Formulation A SC - rHuPH20 - VH4524184 Formulation B SC - Placebo Formulation B SC - VH4524184 Formulation C SC - Placebo Formulation C SC - VH4524184 Formulation A IM - Placebo Formulation A IM ### Outcomes Primary Outcomes - Percentage of participants reporting AEs and related AEs - Percentage of participants with AEs by severity - Percentage of participants discontinuing the treatment due to AEs - Liver panel laboratory parameters (Alanine aminotransferase [ALT], Aspartate aminotransferase [AST] and alkaline phosphatase) change from baseline after the administration of LAI VH4524184 - Liver panel laboratory parameters (total bilirubin) change from baseline after the administration of LAI VH4524184 - Liver panel laboratory parameters (International normalized ratio) change from baseline after the administration of LAI VH4524184 - Maximum toxicity grade increase from baseline in liver panel laboratory parameters (ALT, AST and alkaline phosphatase) - Maximum toxicity grade increase from baseline in liver panel laboratory parameters (total bilirubin) - Maximum toxicity grade increase from baseline in liver panel laboratory parameters (International normalized ratio) - Percentage of participants reporting injection site reaction (ISR) AEs - Duration of injection site reaction AEs - Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity time (AUC[0-inf]) of Long-Acting Injectable (LAI) VH4524184 following single dose administration - Area under the plasma drug concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-t]) of LAI VH4524184 following multiple dose administration - Maximum observed plasma drug concentration (Cmax) of LAI VH4524184 following single dose administration - Cmax of LAI VH4524184 following multiple dose administration - Time to maximum observed plasma drug concentration (Tmax) of LAI VH4524184 following single dose administration - Tmax of LAI VH4524184 following multiple dose administration - Apparent terminal half-life (t1/2) of LAI VH4524184 following single dose administration - t1/2 of LAI VH4524184 following multiple dose administration Secondary Outcomes - Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities ### Location - Facility: GSK Investigational Site, Lenexa, Kansas, 66219, United States @@
## Clinical Study on the Treatment of Breast Hyperplasia With Kou Sha Therapy Based on Real World - NCT ID: NCT06310538 - Study ID: 2024BZYLL0110 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-05 - Lead Sponsor: Hongguo Rong ### Study Description In this study, epidemiological prospective real-world cohort study design was adopted. The Third Affiliated Hospital of Beijing University of Chinese Medicine and the First Hospital of Handan City, Hebei Province were selected. From the same time appointed before the study, all breast hyperplasia participants who met the admission criteria choosing Kou Sha therapy or routine treatment of western medicine were selected in the sample hospitals.The first 30 participants were included in the planned Kou Sha therapy group while the first 30 participants were included in the control group.Taking the change of the total score of breast pain (McGill Pain Questionnaire Short Form score+breast pain score) as the main curative effect index, and taking McGill pain questionnaire score, breast color ultrasound score, palpation lump score, quality of life, anxiety and depression symptoms, sleep and so on as the secondary curative effect indexes to observe the clinical effect of the method of Kou Sha therapy on breast hyperplasia. The research period is from March 2024 to May 2024. ### Conditions - Breast Hyperplasia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - kou sha - Hongjin Xiaojie Capsules ### Outcomes Primary Outcomes - Breast pain score - Short Form McGill Pain Inquiry Scale (SF-MPQ) Secondary Outcomes - Breast color ultrasound score - Palpation lump score - Depression symptoms - Anxiety symptoms - The quality of life rating scale (QOL) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Using Machine Learning to Optimise the Danish Drowning Formula - NCT ID: NCT06310525 - Study ID: DROWN_DDF2 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Prehospital Center, Region Zealand ### Study Description The Danish Drowning Formula (DDF) was designed to search the unstructured text fields in the Danish nationwide Prehospital Electronic Medical Record on unrestricted terms with comprehensive search criteria to identify all potential water-related incidents and achieve a high sensitivity. This was important as drowning is a rare occurrence, but it resulted in a low Positive Predictive Value for detecting drowning incidents specifically. This study aims to augment the positive predictive value of the DDF and reduce the temporal demands associated with manual validation. ### Conditions - Drowning - Drowning and Submersion While in Bath-Tub - Drowning and Submersion While in Natural Water - Drowning and Submersion While in Swimming-Pool - Drowning and Submersion Due to Fall Off Ship - Drowning and Nonfatal Submersion - Drowning, Near - Drowning; Asphyxia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Drowning incident ### Outcomes Primary Outcomes - Sensitivity of the machine learning algorithm as a drowning identification tool - Specificity of the machine learning algorithm as a drowning identification tool - PPV of the machine learning algorithm - NPV of the machine learning algorithm Secondary Outcomes ### Location - Facility: Prehospital Center, Næstved, Region Zealand, 4700, Denmark @@
## Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients" - NCT ID: NCT06310512 - Study ID: ANZHEN HOSPITOL-LY-04 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-30 - Lead Sponsor: Beijing Anzhen Hospital ### Study Description The goal of this Randomized Controlled Trial is to carry out in adult patients with primary hypertension whose blood pressure control is not up to standard. The main question it aims to answer are:To explore the effect of pharmacists' implementation of "the medication therapy management pathway in hypertensive patients"on the patients with hypertension.Participants will receive structured drug treatment management at the first diagnosis. During on-site follow-up in the first, third and sixth months, as well as telephone follow-up in the second week, second and fourth months, patients will be evaluated, corresponding information will be collected and possible interventions will be taken.Researchers will compare the non intervention group to see if patients' blood pressure will also be reduced without intervention. ### Conditions - Hypertension - Medication Therapy Management ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Structured drug therapy management ### Outcomes Primary Outcomes - systolic blood pressure Secondary Outcomes - diastolic blood pressure - Change from baseline in mean sitting systolic blood pressure at 3 months - Change from baseline in number of medication-related problems (MRP) at 6 months - Average number of medication-related problems (MRP) resolved after 6 months - The compliance rate of blood pressure after 6 months - Effective rate of blood pressure lowering after 6 months - Time to BP Attainment in Intervention and Non-Intervention Groups - Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used. - Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs ### Location - Facility: Beijing Anzhen Hospital, Beijing, Beijing, 100029, China @@
## Primary or Secondary Drowning - NCT ID: NCT06310499 - Study ID: DROWN_COD - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2025-12-31 - Lead Sponsor: Prehospital Center, Region Zealand ### Study Description According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated.Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Yet, knowing the most frequent causes of secondary drowning may provide useful information to healthcare professionals working in prehospital Emergency Medical Services, as this may affect prehospital treatment. ### Conditions - Drowning - Drowning; Anoxia - Drowning, Near - Drowning in Swimming Pool - Drowning; Asphyxia - Drowning/Diving/SCUBA Accident - Drowning or Immersion of Unknown Intent - Drowning and Submersion, Undetermined Intent - Drowning and Submersion While in Bath-Tub - Drowning and Submersion While in Natural Water - Drowning and Submersion Due to Sailboat Sinking - Drowning and Submersion Due to Fall Off Ship - Drowning and Submersion While in Swimming-Pool ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Drowning ### Outcomes Primary Outcomes - Autopsy rate - Primary fatal drowning rate - Secondary fatal drowning rate Secondary Outcomes ### Location - Facility: Prehospital Center, Næstved, Region Zealand, 4700, Denmark @@
## The Emergency Call on Drowning - NCT ID: NCT06310486 - Study ID: DROWN_CALL - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: Prehospital Center, Region Zealand ### Study Description This study aims to 1) describe patient-, setting-, and dispatcher-related characteristics in drowning-related emergency calls to the Emergency Medical Dispatch Centre (1-1-2 emergency phone) and 2) factors associated with 30-day survival. The investigators will separately analyse drowning-related out-of-hospital cardiac arrest (OHCA) and drowning-related non-OHCA. If feasible, the investigators will qualitatively analyse the calls to identify and describe potential barriers for an optimal handling strategy. ### Conditions - Drowning - Drowning; Anoxia - Drowning, Near - Drowning; Asphyxia - Drowning and Nonfatal Submersion - Drowning or Immersion of Unknown Intent - Drowning and Submersion, Undetermined Intent - Drowning and Submersion While in Bath-Tub - Drowning and Submersion While in Natural Water - Drowning and Submersion Due to Sailboat Sinking - Drowning and Submersion Due to Fall Off Ship - Drowning and Submersion While in Swimming-Pool ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Drowning-related OHCA - Drowning-related non-OHCA ### Outcomes Primary Outcomes - Patient-related characteristics influencing the 30-day survival - Setting-related characteristics influencing the 30-day survival - Caller-related characteristics influencing the 30-day survival - Dispatcher-related characteristics influencing the 30-day survival Secondary Outcomes ### Location - Facility: Prehospital Center, Næstved, Region Zealand, 4700, Denmark @@
## Neoadjuvant Cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial - NCT ID: NCT06310473 - Study ID: NFEC-2023-582 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2028-03 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description For locally advanced esophagogastric junction and gastric cancer, neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early , and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate.Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer. ### Conditions - Gastric Cancer - Esophagogastric Junction Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cadonilimab - Oxaliplatin - Capecitabine ### Outcomes Primary Outcomes - Pathologic complete remission rate (pCR) Secondary Outcomes - Major pathologic response，MPR - R0 resection rate - Objective Response Rate (ORR) - Disease Control Rate (DCR) - 3-year disease-free survival rate of 3year (DFS) - Overall Survival (OS) ### Location - Facility: Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510-515, China @@
## Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation - NCT ID: NCT06310460 - Study ID: PCP - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-02-28 - Lead Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH ### Study Description To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation. ### Conditions - Cholangiopancreatography, Endoscopic Retrograde ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Papillectomy ### Outcomes Primary Outcomes - Rate of treatment success - Adverse event rate Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Determination of Ecological Awareness and Attitudes Levels of Undergraduate Physiotherapy Students in Istanbul - NCT ID: NCT06310447 - Study ID: IstanbulBUFC2 - Status: COMPLETED - Start Date: 2024-03-18 - Completion Date: 2024-04-03 - Lead Sponsor: Istanbul Bilgi University ### Study Description The natural environment, which is the living environment of all living things; Technological advances and industrialization activities are being affected more and more negatively every day. Increasing energy demand and resource consumption due to population growth lead to negative consequences on ecological balance, such as environmental pollution, climate change and loss of natural environments. Health services have also increased resource use with the advancement of technology and caused negative effects on the environment. Health services have been slow to understand their impact on the environment. The aim of the study is to determine the environmental awareness and environmental attitude levels of physiotherapy and rehabilitation department students, to popularize the field of "Environmental Physiotherapy" and to enable the training of physiotherapist candidates with high environmental awareness. ### Conditions - Ecological and Environmental Concepts ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Ecological Footprint Awareness Scale - Environmental Awareness Scale - Environmental Attitude Scale Secondary Outcomes - Participant Information Form ### Location - Facility: Istanbul Bilgi University, Istanbul, N/A, 34440, Turkey @@
## Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes. - NCT ID: NCT06310434 - Study ID: PI23/00409 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2026-12 - Lead Sponsor: Instituto de Salud Carlos III ### Study Description The investigators want to work on compassion, understood as the recognition of the suffering of others that motivates us to try to alleviate it. The goal of this Multicenter project, with a mixed sequential transformative methodology, is to analyze the impact of a participatory process of awareness and reflection on compassion, in the face of end-of-life processes, in adolescents aged 12-23 years in 6 Spanish provinces, and to understand how the participatory process can transform and improve their compassion.As the adolescents must be the protagonists of change, the study will be conducted with students enrolled in one public secondary school and in one degree in a public University, that belongs to the same "health area" in each province. The investigators also include families' and teachers' knowledge of the context because it can support the interventions of change proposals.Compassion will be assessed using the Compassion for the Lives of Others Scale (COOLS), comprising 26 items. Similarly, adolescents' attitudes toward death are another important concept and will be explored through the Death Anxiety Scale (DAS), which has 15 questions. Both scales will be distributed to the adolescents, requesting their permission anonymously.After the survey, a second phase will start with a Participatory Action Research (PAR) with different activities. The objective is to generate awareness of the need to improve it, allowing the participants to design the interventions, based on evidence-based proposals (cinema forum, colloquiums with testimonies of volunteers accompanying palliative patients, organization of Death Cafe, artistic and literary activities, generation of grief groups, etc.).At the end of the project, the investigators will evaluate the adolescent compassion level and create discussion groups again to understand the impact of the interventions.With this project, the investigators will empower new generations of people to encourage, facilitate, support, and celebrate mutual care and family and community development in end-of-life processes. The translation and implications of the results for clinical practice will contribute to reducing inequalities in health research in a vulnerable group of special interest, especially when treatments can do nothing for their survival but with interventions such as those in this study, the investigators can ensure quality and dignity of life as long as there is life. ### Conditions - Compassion - Death Anxiety - Adolescent Behavior ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - questionnaire - Discussion group - Reflective diary ### Outcomes Primary Outcomes - Describe and improve the level of compassion of high school and university students. - Describe and improve the attitude towards death of high school and university students. Secondary Outcomes ### Location - Facility: Instituto Murciano de Investigación Biosanitaria, Murcia, MU, 30120, Spain @@
## Spinal Muscular Atrophy Neonatal Screening Program - NCT ID: NCT06310421 - Study ID: Screening_SMA - Status: RECRUITING - Start Date: 2023-10-16 - Completion Date: 2026-05-31 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description Spinal muscular atrophy (SMA) is a group of disorders caused by the degeneration of the motor neuron cells of the anterior horn of the spinal cord and, in some subtypes, of the bulbar motor neurons. Almost all cases are genetically determined. Most SMAs are autosomal recessive diseases, caused by homozygous deletions of the survival motor neuron (SMN) gene located on the long arm of chromosome 5. The estimated incidence of recessive childhood and juvenile SMA linked to deletion of the SMN gene is 1 in 6000 to 10000 live births, with a carrier frequency of 1 in 35 in the general population, making it a major genetic cause of infant mortality. Up to 95-97% of all childhood cases are due to homozygous deletions of the survival motor neuron 1 (SMN1) gene, or telomeric SMN, located on chromosome 5q11.2-13.3. The remaining 3-5% of cases are due to small mutations in SMN1 (rather than complete deletions).Until a few years ago, the prognosis of type 1 SMA was poor. In the absence of therapies, the only measures were supportive (ventilation, nutrition) and the prospect, especially in the early forms, was to accompany them towards an early end of life. There are currently three treatment options available: nusinersen, risdiplam, and gene therapy with onasemnogene abeparvovec. The three options were found to be equally effective in reducing the symptoms of the disease, making it possible to reach or safeguard fundamental stages in a child's neuromotor development, starting from the ability to remain seated. At this moment, gene therapy is probably the preferred choice. To date, in Italy, there are approximately 100 patients undergoing gene therapy.To ensure maximum benefit for affected patients, it is essential that the therapy is administered as soon as possible. Literature shows how the administration of gene therapy in pre-symptomatic subjects made it possible to achieve a better neurological outcome compared to symptomatic patients. From this perspective, the inclusion of spinal muscular atrophy in neonatal screening is of fundamental relevance. ### Conditions - Spinal Muscular Atrophy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Screening SMA test ### Outcomes Primary Outcomes - Rate of newborn screened Secondary Outcomes ### Location - Facility: SC Pediatria Gorizia - Monfalcone, Monfalcone, Gorizia, N/A, Italy @@
## Comparison Between Nasal Mask vs Nasal Prong on Pain Response in Neonate - NCT ID: NCT06310408 - Study ID: 0214022024 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-06-01 - Lead Sponsor: Indonesia University ### Study Description to determine the comparison of nasal masks and nasal prongs on the pain response of neonate ### Conditions - Nasal Mask - Nasal Prong ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - nasal mask - nasal prong ### Outcomes Primary Outcomes - pain response Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Analysis of the Acute Mesenteric Ischemia in a Single Institution Over 10 Years - NCT ID: NCT06310395 - Study ID: AMI_H.MAR - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2024-10-15 - Lead Sponsor: Hospital del Mar ### Study Description Acute mesenteric ischemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, and the aim of this study is to analyse the results of the patients admited with an AMI in Hospital de Mar. ### Conditions - Acute Mesenteric Ischemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Mortality Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase I/II Clinical Study to Evaluate The Safety, PK, PD of GH55 in Patients With MAPK Mutant Advanced Solid Tumors - NCT ID: NCT06310382 - Study ID: GH55-CRS001 - Status: RECRUITING - Start Date: 2022-12-07 - Completion Date: 2025-08-04 - Lead Sponsor: Suzhou Genhouse Bio Co., Ltd. ### Study Description This is a multi-center, open-label, dose escalation phase I and dose expansion phase II study aimed to evaluate the safety, tolerability, PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors.This study is divided into two parts, namely the dose escalation phase I study and the dose expansion phase II study. ### Conditions - Advanced Solid Tumors With MAPK Signal Pathway Mutant ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - GH55 ### Outcomes Primary Outcomes - Number of participants with dose limiting toxicities - Number of participants with adverse events - Objective response rate (ORR) Secondary Outcomes - Progression-free survival (PFS) - Duration of response (DOR) - Progression-free survival (PFS) - Number of participants with adverse events - Plasma concentration (Cmax) - Time to achieve Cmax (Tmax) - Area under the plasma concentration-time curve (AUC) ### Location - Facility: Shanghai East Hospital, Shanghai, Shanghai, 200120, China @@
## Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer - NCT ID: NCT06310369 - Study ID: EORTC 2335-GUCG - Status: NOT_YET_RECRUITING - Start Date: 2025-03-01 - Completion Date: 2030-03-01 - Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC ### Study Description We aim to investigate a possible role for radiotherapy in good prognosis bladder cancer patients has been identified as a possible alternative to cystectomy, especially for patients non-eligible for surgery but has yet to be fully explored. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - radiation therapy ### Outcomes Primary Outcomes - Proportion of patients with a CR at 6 months post-radiotherapy Secondary Outcomes - Progression-free survival - overall survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Continuous Glucose Monitoring for Women With Gestational Diabetes - NCT ID: NCT06310356 - Study ID: CORDELIA - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-02 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian open-label multi-centric RCT with 17 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance. ### Conditions - Gestational Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Freestyle Libre 3 - Glucometer ### Outcomes Primary Outcomes - a composite of pregnancy outcomes Secondary Outcomes - time in glucose range overnight between 70-95mg/dl - time in glucose range during the day between 70-95mg/dl - time in glucose range overnight between 63-140mg/dl - time in glucoserange during the day between 63-140mg/dl - time in glucose range during the day between 54-95mg/dl - time in glucose range overnight between 54-95mg/dl - time in glucose range overnight between 63-120mg/dl - time in glucose range during the day between 63-120mg/dl - hypoglycemia <54mg/dl - hypoglycemia <50mg/dl - hypoglycemia <63mg/dl - hypoglycemia <70mg/dl - standard deviation - Coefficient of Variance - mean amplitude of glycemic excursions - glucose time overnight >100mg/dl - glucose postprandial time >120mg/dl - glucose postprandial time >140mg/dl - glucose time >180mg/dl - mean HbA1c - Glucose management indicator - timing of start insulin treatment - mean insulin dose - mean gestational weight gain - rate of postpartum hemorrhage - rate of macrosomia - rate of baby >4.5Kg - rate of Small-for-gestational age infant - rate of cesarean section - rate of instrumental delivery - rate of perineal inury - rate of labor inductions - rate of preeclamspia - rate of gestational hypertension - rate of fetal malformation - rate of miscarriage - rate of polycythemia - rate of neonatal hypoglycemia - Treatment satisfaction - Quality of life based on Short Form (SF-36) score - dietary intake - Physical activity - fear for hypoglycaemia - fear for hyperglycaemia - symptoms of depression - symptoms of anxiety - user-friendliness of CGM - user-friendliness of CGM compared to oral glucose tolerance test (OGTT) - duration of breastfeeding - rate of hypercholesterolemia - night glucose time in range between 70-180mg/dl - day glucose time in range between 70-180mg/dl - day glucose time in range <70mg/dl - night glucose time in range <70mg/dl - night glucose time in range >180mg/dl - day glucose time in range >180mg/dl ### Location - Facility: OLV Aalst-Asse, Aalst, Oost-Vlaanderen, 9300, Belgium @@
## ADAs to Alemtuzumab - NCT ID: NCT06310343 - Study ID: 304993 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-04-25 - Completion Date: 2025-11-30 - Lead Sponsor: Queen Mary University of London ### Study Description The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period ### Conditions - Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Alemtuzumab ### Outcomes Primary Outcomes - To quantify the longitudinal changes in alemtuzumab ADAs Secondary Outcomes - 1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2. - 2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions. - 3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity. - 4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels - 5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity. ### Location - Facility: Barts Health NHS Trust, London, Second Floor Neurophys Dept, N/A, United Kingdom @@
## TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography - NCT ID: NCT06310330 - Study ID: 2019/1059 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2026-12-31 - Lead Sponsor: Norwegian University of Science and Technology ### Study Description TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD).Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice. ### Conditions - Breast Neoplasm Malignant Primary ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Comprehensive echocardiographic follow-up - Simplified echocardiographic follow-up ### Outcomes Primary Outcomes - Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD) Secondary Outcomes ### Location - Facility: St. Olavs hospital, Trondheim, N/A, 7491, Norway @@
## Applied Behavior Analysis With Technologies - NCT ID: NCT06310317 - Study ID: CNR-IRIB-PRO-2024-003 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-01-31 - Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica ### Study Description Applied Behavior Analysis (ABA) is a therapeutic approach for autism that is based on the principles of behavioral theory, learning, and positive reinforcement. Current research shows that early and intensive ABA intervention is effective in reducing dysfunctional behaviors and promoting learning and enactment of socially appropriate behaviors.In this context, new approaches that attempt to integrate advanced technologies can play a key role. This experimental protocol aims to test whether the use of advanced technologies, such as tablets, as part of an intervention for a group of children with autism spectrum disorder (ASD) is more effective than the traditional approach implemented in a control group of children with ASD. The experimental protocol is aimed at enhancing cognitive skills, increasing new skills and acquiring functional/adaptive behaviors. ### Conditions - Autism - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Applied Behavior Analysis protocol - Traditional intervention ### Outcomes Primary Outcomes - Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) Secondary Outcomes ### Location - Facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), Messina, N/A, 98164, Italy @@
## A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants. - NCT ID: NCT06310304 - Study ID: INCB18424-153 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2024-05-15 - Lead Sponsor: Incyte Corporation ### Study Description This study is conducted to determine the Relative Bioavailability of Ruxolitinib XR Tablets Compared With Ruxolitinib IR Tablets Administered Orally in Healthy Participants. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Ruxolitinib IR - Ruxolitinib XR ### Outcomes Primary Outcomes - INCB018424 pharmacokinetic (PK) in Plasma Secondary Outcomes - Number of participants with Treatment Emergent Adverse Events (TEAEs) - Additional INCB018424 pharmacokinetic (PK) in Plasma ### Location - Facility: Celerion, Inc, Lincoln, Nebraska, 68502, United States @@
## VTP-1000 in Adults With Celiac Disease - NCT ID: NCT06310291 - Study ID: GLU001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-08 - Lead Sponsor: Barinthus Biotherapeutics ### Study Description GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000. ### Conditions - Celiac Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - VTP-1000 - Matched Placebo ### Outcomes Primary Outcomes - Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs) - Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters - Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters - Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parameters - Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parameters - Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parameters - Changes from baseline and clinically significant abnormalities in vital signs - Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodies - Changes in physical examination findings Secondary Outcomes - PART A SAD:Maximum concentration in plasma (Cmax) rapamycin component - PART A SAD: Time corresponding to Cmax (Tmax) of rapamycin component - AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component - AUC extrapolated to infinity (AUC0-∞)of rapamycin component - Half-life of rapamycin component - Clearance of rapamycin component - Volume of distribution of rapamycin component - Part B MAD:Maximum concentration in plasma (Cmax) rapamycin component - Part B MAD:Time corresponding to Cmax (Tmax) of rapamycin component - Part B MAD:AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component - Part B MAD:AUC extrapolated to infinity (AUC0-∞)of rapamycin component - Part B MAD: Half-life of rapamycin component - Part B MAD: Clearance of rapamycin component ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ossiview Normative Mobility Data Collection Protocol - NCT ID: NCT06310278 - Study ID: 1030312 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-10-31 - Lead Sponsor: Audioptics Medical Incorporated ### Study Description The goal of this observational study is to learn about the sound-induced vibration level of certain structures in the middle ear in the normal-hearing population. The targeted structures are part of a chain of structures responsible for conducting sound within the auditory system and so their ability to vibrate normally in response to sound is relevant to the diagnosis of conductive hearing loss.The main questions the study aims to answer are:* What are the mean and variance of the normal sound-induced vibration level at two anatomical locations, the umbo of the malleus and the tip of the incus?* Are there any significant differences in these vibrational responses associated with sex or age?Participants will have their ossicular mobility measured with an investigational medical device that sends light into the middle ear and measures the motion-induced phase shift on light reflected from the target structures when a sound stimulus is presented. Standard hearing tests including audiometry and tympanometry will also be performed to confirm the normal hearing status of participants. ### Conditions - Conductive Hearing Loss, Middle Ear ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ossicular mobility measurement ### Outcomes Primary Outcomes - Umbo mobility - Incus mobility Secondary Outcomes - Dependence on age and sex ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Our Anesthesia Experiment Applied to Child Earthquake Victims in the February 6, 2023 Earthquake - NCT ID: NCT06310265 - Study ID: TABED 1-24-21 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-04-22 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description The study aimed to investigate anesthesia management of pediatric patients in the Ankara Bilkent City Hospital during the earthquake disaster of February 6. ### Conditions - Earthquake - Crush Injury - Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Retrospective observational study ### Outcomes Primary Outcomes - The anesthesia management under pediatric earthquake victims Secondary Outcomes ### Location - Facility: Ankara Bilkent City Hospital, Ankara, N/A, 06800, Turkey @@
## Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up - NCT ID: NCT06310252 - Study ID: PRO_010-2023 - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2024-09 - Lead Sponsor: Allotex, Inc. ### Study Description The objective of this clinical study is to evaluate the long term safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for providing near vision in presbyopic subjects.A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia. ### Conditions - Presbyopia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Opthalmic assessments ### Outcomes Primary Outcomes - An exploratory data collection project with no primary safety or effectiveness endpoints. Secondary Outcomes ### Location - Facility: Gemini - Oční klinika Zlín, Zlín, N/A, 760 01, Czechia @@
## Microbiome Population Adaptation Study - NCT ID: NCT06310239 - Study ID: WRNMMC-2023-0434 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2029-11-30 - Lead Sponsor: Walter Reed National Military Medical Center ### Study Description The investigators will accomplish our research aims by collecting cutaneous microbiome samples from 50 persons that have undergone the Osseointegration (OI) surgery at eight timepoints, prospectively. The investigators will also collect control samples to correct for turnovers in species compositions that may naturally occur and to compare the residual limb microbiome to the sound contralateral limb. The investigators will sequence the bacterial community using universal bacterial primers. Using these sequences, The investigators will borrow from ecological theory and calculate the alpha and beta diversity. The alpha diversity will determine the species and abundance of each species that are present, while the beata diversity will allow us to compare how species assemblages and frequencies change between time points. Then, the investigators will take a phylogenetic modeling approach to determine if particular species assemblages correlate with rates of wound healing. The investigators will construct phylogenies from the sequences at the different time points and "paint" the rate of wound healing along the phylogeny (e.g., improved, stagnated, worsened). Using Akaike and Bayesian information criterion, the investigators can determine which phylogenetic model best explains the patterns the investigators see across patients. Lastly, the investigators will quantify soft tissue stability and health and correlate this with the homeostasis of the microbial community. Specifically, the investigators will determine if redundant soft tissue leads to altered microbial communities that can impact the rate of wound healing. Finally, the investigators will further stratify these data to compare microbial communities between the sexes, upper versus lower limbs, and proximal versus distal amputations. This work will allow us to better treat infections after OI surgery and can shed light on wound healing process so that the investigators can better treat limb loss patients and the military community as a whole. ### Conditions - Amputation With Osseointegration ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Collection of biologic samples and data ### Outcomes Primary Outcomes - Determine if OI surgery causes changes in the microbiome community using phylogenies - Determine if changes in the microbiome community predicts wound healing using phylogenetic comparative methods - Quantify soft tissue health using a modified Holger Score (0 = healthy soft issue and 6 = unhealthy soft tissue) to phylogenetically correlate this with microbiome homeostasis. Secondary Outcomes - Floral profiles - Floral colonization - Clinical guidelines - Surgical site questionnaire - Post-OI hygiene guidelines - Soft tissue stability guidelines - Holger score validation ### Location - Facility: Orhopaedic Surgery Service, Walter Reed National Military Medical Center,, Bethesda, Maryland, 20889, United States @@
## Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain - NCT ID: NCT06310226 - Study ID: 23-000347 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-01 - Lead Sponsor: University of California, Los Angeles ### Study Description Chronic low back pain (CLBP) is a debilitating condition and costly to treat. Long-term drug treatment often fails due to habituation, breakthrough of pain, or adverse effects of drug treatment. Opioid use to manage this pain has contributed to the opioid epidemic. Spinal cord stimulators have emerged as a promising treatment and reduces reliance on drugs. However, response to spinal cord stimulation (SCS) is unpredictable. It is difficult to predict which patients will respond positively to SCS because the physiological mechanism for treatment responsiveness is unclear. Therefore, the aim of this study is to investigate how spinal cord stimulators affect functional measures in patients with CLBP, including functional MRI, neurophysiology, gait analysis, and questionnaires. The results of this study can lead to the widespread adoption of spinal cord stimulators as a safe and effective therapy for CLBP, reducing the reliance on opioids and mitigating the opioid epidemic's impact. ### Conditions - Chronic Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Epidural electrical spinal cord stimulator ### Outcomes Primary Outcomes - Detection of brain connectivity using functional MRI Secondary Outcomes - Detection of brain waves using electroencephalography (EEG) ### Location - Facility: University of California, Los Angeles, Los Angeles, California, 90095, United States @@
## Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus - NCT ID: NCT06310213 - Study ID: 17368 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-07-01 - Lead Sponsor: Indiana University ### Study Description The goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. The main questions it aims to answer are:* Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without* Can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments Participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable. ### Conditions - Hydrocephalus in Infants ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SCREENING ### Interventions - Non-Invasive Pressure Monitor ### Outcomes Primary Outcomes - Efficacy of modified smart soft contact lens evaluation of external intracranial pressure Secondary Outcomes ### Location - Facility: Riley Hospital for Children, Indianapolis, Indiana, 46202, United States @@
## Sphenopalatine Ganglion Block and Cold Induced Headaches - NCT ID: NCT06310200 - Study ID: IRB-2023-398 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-01 - Lead Sponsor: Wright State University ### Study Description The primary objective of this study is to determine if a sphenopalatine ganglion (SPG) block, performed through intranasal atomization of 4% lidocaine, is able to prevent cold induced cephalgia ("Brain Freeze"). Secondary objectives will be to determine the degree of decreased pain/duration of brain freeze after sphenopalatine ganglion block ### Conditions - Cold Induced Headache - Brain Freeze - Cold Induced Cephalgia - Headache ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Lidocaine Topical 4% Topical Solution - Bitrex - normal saline ### Outcomes Primary Outcomes - Does sphenopalatine ganglion (SPG) block prevent cold induced cephalgia Secondary Outcomes - Degree of pain - Duration of brain freeze - Time to onset of headache ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Little Cigar Oxidants - NCT ID: NCT06310187 - Study ID: STUDY00023967 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2029-08 - Lead Sponsor: Milton S. Hershey Medical Center ### Study Description Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 6 exposure groups. These include a high oxidant unflavored little cigar exposure condition, a low oxidant unflavored little cigar exposure condition, a high oxidant flavored exposure condition, a low oxidant flavored exposure little cigar exposure condition, their usual cigarette, and a control condition (unlit little cigar). Following the smoking of each product, exhaled breath condensate samples will be collected at baseline, 30, 60, 90, 120 and 150 minutes. Samples will be analyzed for levels of oxidant markers including hydrogen peroxide, 8-isoprostanes, and C-reactive protein, as well as nicotine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN). ### Conditions - Tobacco Use - Oxidative Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - High Oxidant Unflavored Little Cigar - Group A - Low Oxidant Unflavored Little Cigar - Group B - High Oxidant Flavored Little Cigar - Group C - Low Oxidant Flavored Little Cigar - Group D - Usual Cigarette - Group E - Unlit Little Cigar - Group F ### Outcomes Primary Outcomes - Hydrogen Peroxide Concentration in Exhaled Breath Condensate - Hydrogen Peroxide Concentration in Exhaled Breath Condensate - Hydrogen Peroxide Concentration in Exhaled Breath Condensate - Hydrogen Peroxide Concentration in Exhaled Breath Condensate - 8-isoprostanes Concentration in Exhaled Breath Condensate - 8-isoprostanes Concentration in Exhaled Breath Condensate - 8-isoprostanes Concentration in Exhaled Breath Condensate - 8-isoprostanes Concentration in Exhaled Breath Condensate - C-reactive Protein Concentration in Exhaled Breath Condensate - C-reactive Protein Concentration in Exhaled Breath Condensate - C-reactive Protein Concentration in Exhaled Breath Condensate - C-reactive Protein Concentration in Exhaled Breath Condensate - Nicotine Concentration in Exhaled Breath Condensate - Nicotine Concentration in Exhaled Breath Condensate - Nicotine Concentration in Exhaled Breath Condensate - Nicotine Concentration in Exhaled Breath Condensate - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate - N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate - N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate - N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate - N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications - NCT ID: NCT06310174 - Study ID: IRB00362883 - Status: RECRUITING - Start Date: 2023-12-22 - Completion Date: 2027-05 - Lead Sponsor: Johns Hopkins University ### Study Description The purpose of this study is to assess user satisfaction and the frequency of common central venous catheter insertion complications when using a novel cannulation knife. ### Conditions - Central Venous Catheter Exit Site Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - User satisfaction with the new cannulation knife for CVC insertion. Secondary Outcomes - Frequency of skin incision revisions. - Frequency of procedures being aborted and restarted. - Frequency of reverting to use of the scalpel normally used to make the incision. - Presence of a clean, dry dressing. ### Location - Facility: Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States @@
## Light Therapy in End Stage Kidney Disease - NCT ID: NCT06310161 - Study ID: 855161 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2025-03-01 - Lead Sponsor: University of Pennsylvania ### Study Description The goal of this clinical trial is to test light therapy in patients with end stage kidney disease who are receiving hemodialysis. The main aim is to determine if light therapy decreases fatigue severity. Participants will receive light therapy using special glasses for one hour during the dialysis sessions for four weeks of treatment. ### Conditions - End Stage Renal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bright light - Dim Light ### Outcomes Primary Outcomes - Fatigue Severity Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Chronic Disease Co-Care Pilot Scheme - NCT ID: NCT06310148 - Study ID: UW 24-019 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2026-12-31 - Lead Sponsor: The University of Hong Kong ### Study Description The Chronic Disease Co-Care (CDCC) Pilot Scheme is initiated for early screening and management of people with hypertension (HT), pre-diabetes mellitus (pre-DM) and diabetes mellitus (DM) in Hong Kong. This study will evaluate the quality of care, feasibility, acceptability, effectiveness and cost-effectiveness of the Scheme.This is a 12-month cohort study among the District Health Centre (DHC) or DHC Express, healthcare providers, CDCC participants and a comparison group of 1,886 non-participants. All the person-in charge, 2 family doctors and 1 of each allied health provider from each DHC/DHC Express will be administered with the questionnaires on quality of care and costing. All CDCC participants will be included in subject characteristics, among which a convenience sample of 548 will complete a telephone survey on experience, enablement and satisfaction of the CDCC Pilot Scheme. The health outcomes of 1,886 CDCC participants and 1,886 non-participants will be compared for evaluation of effectiveness and cost-effectiveness.Participant characteristics, enablement, compliance to the standards of care, and costing of CDCC Pilot Scheme will be summarized using descriptive statistics. Differences in the proportion of patients meeting treatment targeted for HT, pre-DM and DM after 12 months will be compared by chi-squared test and logistic regressions. The incremental cost-effectiveness ratio will be evaluated by comparing with the World Health Organization (WHO) threshold. This study will inform future healthcare planning and policy for manpower and resource allocation. ### Conditions - Diabetes Mellitus, Type 2 - Hypertension - Chronic Disease - Disease Management - Primary Healthcare ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - The Chronic Disease Co-Care (CDCC) Pilot Scheme ### Outcomes Primary Outcomes - Characteristics of the Chronic Disease Co-Care (CDCC) participants - Healthcare providers' adherence to care standards on the evaluation framework by the quality of care questionnaire - Enablement of CDCC participants by the Chinese Patient Enablement Instrument - Effectiveness of the CDCC Pilot Scheme on disease control for pre-diabetes mellitus (pre-DM) and DM in percent of Glycated Hemoglobin (HbA1c) and hypertension (HT) in millimeter of mercury of systolic blood pressure (SBP)/diastolic blood pressure (DBP) - The additional costs for delivering the CDCC Pilot Scheme by the costing questionnaire - The cost-effectiveness for delivering the CDCC Pilot Scheme on the incremental cost-effectiveness ratio Secondary Outcomes - Experience and satisfaction of CDCC participants by the experience and enablement questionnaire - Number of attendance to doctor consultation on times in comparison groups - Rate of diagnosis of HT and/or DM on dichotomous yes/no response in comparison groups - Changes in mean HbA1c/FPG in percent between two groups - Changes in mean SBP and DBP in millimeter of mercury between two groups - Changes in mean of HbA1c in percent between two groups - Changes in BMI in kilogram per square metre between two groups - Changes in the rate of smoking cessation and rate of alcohol abstinence between two groups by the Health Risk Factor Assessment - The predicted 10-year cardiovascular disease (CVD) risk between two groups - Amount of direct medical costs between two groups ### Location - Facility: Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pok Fu Lam, HONG KONG, Hong Kong, N/A, N/A, Hong Kong @@
## Filtered Eyewear to Prevent Light-induced Melatonin Suppression - Aim 1 - NCT ID: NCT06310135 - Study ID: STUDY-23-00816 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description The aim of this study is to determine the relative effectiveness of monocular and binocular light exposures, with and without selective blue-blocking filtering, on nocturnal melatonin suppression, subjective sleepiness, and visual performance of night shift workers. ### Conditions - Sleep Quality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Filtered Eyewear - Unfiltered Eyewear - No Filters ### Outcomes Primary Outcomes - Melatonin Levels Secondary Outcomes - Karolinska Sleepiness scale to measure Subjective Sleepiness - Numerical Verification Task (NVT) ### Location - Facility: Light and Health Research Center, Menands, New York, 12204, United States @@
## Effect of Extracorporeal Shockwave Therapy on Gait Parameters in Patients With Planter Fascitis - NCT ID: NCT06310122 - Study ID: ESWT on planter fascitis - Status: NOT_YET_RECRUITING - Start Date: 2024-03-12 - Completion Date: 2025-03-30 - Lead Sponsor: Cairo University ### Study Description The purpose of this study is :* to determine the effect of extracorporeal shockwave on pain intensity in patients with plantar fasciitis.* to determine the effect of extracorporeal shockwave on foot function in patients with plantar fasciitis.* to determine the effect of extracorporeal shockwave on gait parameters in patients with plantar fasciitis ### Conditions - Plantar Fascitis - Extracorporeal Shockwave Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Extracorporeal shockwave therapy - ultrasound ### Outcomes Primary Outcomes - Stride length mean distance measured by (meter) - stride time mean time measured by (second) - speed mean distance/ time measured by (meter/second) - cadence mean number of steps /times. Secondary Outcomes - pain intensity level. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Pediatric Intensive Care Unit Diaries on PICS-p - NCT ID: NCT06310109 - Study ID: 2358_OPBG 2020 - Status: RECRUITING - Start Date: 2021-07-14 - Completion Date: 2024-10-31 - Lead Sponsor: Bambino Gesù Children's Hospital IRCCS ### Study Description When children become very sick and need to stay in a Pediatric Intensive Care Unit (PICU), it can have a big impact on their recovery and their family's well-being. Sometimes kids and their families feel worried or sad even after they leave the hospital. This can have an impact on the quality of their life after hospital discharge.To help understand and improve these experiences, the investigators want to study the "PICU diaries." These are journals that families and hospital staff can write in during the child's time in the hospital. Parents, other visitors and healthcare professionals can share thoughts, experiences, and even drawings or photos related to the child's admission. The content is a narrative account of what happens during the child's hospital stay, for the family to take home at PICU discharge.The investigators believe that writing in these diaries might help children and their families feel better after leaving the hospital. It might help kids feel less worried or sad, and it might also help their parents or caregivers feel better too.The study will include children who have been in the PICU and their families. Some families will receive these special diaries to use during their time in the hospital, while others won't. We'll then see how everyone feels after they leave the hospital and compare the two groups to see if the diaries make a difference.The investigators hope that by understanding how these diaries can help, healthcare professionals can make hospital experiences better for everyone involved. ### Conditions - Post Intensive Care Syndrome - Narrative Medicine - Post Traumatic Stress Disorder - Anxiety - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - PICU diary ### Outcomes Primary Outcomes - Parent's Post Traumatic Stress Disease (PTSD) - Parent's Anxiety - Child's Strengths and difficulties - Child's Post Traumatic Stress Disease (PTSD) - Child's Anxiety - Child's Depression Secondary Outcomes - Satisfaction with PICU care - Patient's Quality of Life ### Location - Facility: Bambino Gesù Children's Hospital IRCCS, Rome, N/A, 00165, Italy @@
## Role of Thoracolumbar Fascia Stretching on Pain Parameters With Non-Specific Chronic Low Back Pain - NCT ID: NCT06310096 - Study ID: E-59394181-604.01-79277 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-03-11 - Lead Sponsor: Atılım University ### Study Description Role of Thoracolumbar Fascia Stretching on Pain Parameters with Non-Specific Chronic Low Back Pain ### Conditions - Pain - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - TLF fascial stretching exercise - conventional physiotherapy program. ### Outcomes Primary Outcomes - Pain threshold - Temporal summation - NRS(Numerical rating scales) Secondary Outcomes - Pain Sensitivity Scale (PSS) - Brief Pain Inventory (BPI) ### Location - Facility: Atılım University, Ankara, N/A, N/A, Turkey @@
## Endoscopic Submucosal Resection Turbinoplasty VS Turbinectomy - NCT ID: NCT06310083 - Study ID: SMR for Turbinate Hypertrophy - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2024-01-31 - Lead Sponsor: Ahmed Nabil Selim ### Study Description The aim of our study is to compare endoscopic submucosal resection Turbinoplasty and partial inferior turbinectomy regarding clinical and radiological evaluation and its possible complications in the treatment of Chronic inferior turbinate hypertrophy. ### Conditions - Turbinate; Hypertrophy Mucous Membrane ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy ### Outcomes Primary Outcomes - Nasal Obstruction - Nasal Discharge - Crustations Secondary Outcomes - intra operative blood loss - Duration of operation (Minutes ) - Hyposmia ### Location - Facility: Al-Azhar University Hospital of Assiut, Assiut, N/A, 17511, Egypt @@
## 3D Printed Personalized Ostomy Appliance - NCT ID: NCT06310070 - Study ID: IRB-23-1965 - Status: NOT_YET_RECRUITING - Start Date: 2025-03-05 - Completion Date: 2025-06-05 - Lead Sponsor: Carilion Clinic ### Study Description The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is:• Whether or not a 3D scan of a stoma reduces leakages and improves patient quality of life in regard to using a personalized ostomy appliance.Participants will* Spend 2 weeks with their standard of care ostomy appliance* Spend 2 weeks with their personalized ostomy appliance made from a 3D scan* Participate in daily surveys and weekly quality of life surveys conducted over the phone ### Conditions - 3D Printing - Ostomy - Leakage ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - 3D Printed Personalized Ostomy Appliance ### Outcomes Primary Outcomes - Incidence of Leaks Secondary Outcomes - Number of appliances - Overall patient satisfaction ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study - NCT ID: NCT06310057 - Study ID: 4139 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2024-03-01 - Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh ### Study Description The goal of this clinical trial is to assess the efficacy of tofacitinib in refractory axial spodyloarthritis (ax-SpA) with dose escalation from 10mg to 15mg. Patients will start on 10mg and then divided into 2 groups (10 and 15) at 3rd month according to major improvement criteria.The main question\[s\] it aims to answer are:* Efficacy and safety of tofacitinib in different doses* If escalation of tofacitinib is justified if clinical criteria is not fulfilled at 10mg ### Conditions - Axial Spondyloarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tofacitinib ### Outcomes Primary Outcomes - To assess the ASDAS CRP major improvement criteria in refractory ax-SpA patients with dose escalation from 10mg to 15mg Secondary Outcomes - Clinicodemographic characteristics of Ax-SpA, ASDAS CRP outcome rates, quality of life, adverse effects ### Location - Facility: Bangabandhu Sheikh Mujib Medical University, Dhaka, N/A, 1000, Bangladesh @@
## Effect of Commiphora Myrrh Solution as a Root Canal Irrigant on Post Operative Pain and Bacterial Load Reduction in Necrotic Tooth - NCT ID: NCT06310044 - Study ID: Commiphora Myrrh - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-01-01 - Lead Sponsor: Cairo University ### Study Description Clinically compare the post-operative pain , incidences post-operative swelling , post-operative number of analgesic tablets taken by patient and amount of bacterial load reduction after using 50% Commiphora Myrrh Chemomechanical preparation , versus 2.5% NaOCl,in asymptomatic necrotic mandibular premolar treated in single visit. ### Conditions - Necrotic Pulp ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Root canal irrigant Commiphora Myrrh 50% ### Outcomes Primary Outcomes - Post-operative pain Secondary Outcomes - incidence of Post-operative swelling ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06310031 - Study ID: CL-00545 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE - NCT ID: NCT06310018 - Study ID: 2023A070902 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2025-12-31 - Lead Sponsor: Brigham and Women's Hospital ### Study Description SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system to determine its impact on the change in RV-to-LV diameter, refined Modified Miller Score, and distal pulmonary vascular blood volume as well as to assess International Society on Thrombosis and Haemostasis (ISTH) major bleeding. ### Conditions - Pulmonary Embolism - Right Ventricular Dysfunction - Right Ventricular Failure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis ### Outcomes Primary Outcomes - Change in RV-to-LV diameter ratio as measured by chest CT from baseline to 48 ± 6 hours - Frequency of ISTH major bleeding at 72 hours Secondary Outcomes - Change in chest CT-measured blood volume in the distal pulmonary vasculature from baseline to 48 ± 6 hours - Change in refined Modified Miller Score as measured by chest CT from baseline to 48 ± 6 hours as measured by chest CT from baseline to 48 ± 6 hours ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated - NCT ID: NCT06310005 - Study ID: 1466-0003 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-18 - Lead Sponsor: Boehringer Ingelheim ### Study Description The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BI 3006337 in healthy male subjects following s.c. administration of single rising doses and multiple doses over 6 weeks. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BI 3006337 - Placebo ### Outcomes Primary Outcomes - SRD + MD part: Percentage of patients with any treatment-emergent adverse event assessed as drug-related by the investigator Secondary Outcomes - SRD part: Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf) - SRD part: Maximum measured concentration of BI 3006337 in serum (Cmax) - MD part: Area under the concentration-time curve of BI 3006337 in serum over the dosing interval tau at steady state (AUCtau, ss) after the last dose in Week 6 - MD part: Maximum measured concentration of BI 3006337 in serum at steady state (Cmax, ss) after the last dose in Week 6 ### Location - Facility: Clinical Research Hospital Tokyo, Tokyo, Shinjuku-ku, N/A, 160-0004, Japan @@
## A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight - NCT ID: NCT06309992 - Study ID: 1404-0056 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2026-03-09 - Lead Sponsor: Boehringer Ingelheim ### Study Description This study is open to adults who are at least 18 years old and have* presumed or confirmed NASH together with overweight or obesity and* a body mass index (BMI) of 30 kg/m² or more, or* a BMI of 27 kg/m² and at least one weight-related health problem.People with a history of other chronic liver diseases cannot take part in this study.The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works. ### Conditions - Obesity - Non-Alcoholic SteatoHepatitis (NASH) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Survodutide - Placebo ### Outcomes Primary Outcomes - Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) - Relative change (%) in body weight from baseline to Week 48 Secondary Outcomes - Absolute change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF - Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF - Reduction from baseline to Week 48 in Iron corrected T1 (cT1) levels of ≥80 ms (yes/no) - Absolute change from baseline to Week 48 in alanine amino transferase (ALT) levels - Relative change from baseline to Week 48 in alanine amino transferase (ALT) levels - Absolute change from baseline to Week 48 in waist circumference [cm] - Relative change from baseline to Week 48 in waist circumference [cm] - Absolute change from baseline to Week 48 in Homeostasis Model Assessment -Insulin Resistance (HOMA-IR) (Fasting Plasma Insulin (FPI) [mlU/L] · Fasting Plasma Glucose (FPG) [mmol/L]/22.5) - Absolute change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE) - Relative change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE) - Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI - Relative change in liver volume [mL] from baseline to Week 48 measured using MRI ### Location - Facility: Panax Clinical Research, Miami Lakes, Florida, 33014, United States @@
## A Study to Assess Growth in Children With Idiopathic Short Stature - NCT ID: NCT06309979 - Study ID: 111-903 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2040-12-31 - Lead Sponsor: BioMarin Pharmaceutical ### Study Description Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest. ### Conditions - Idiopathic Short Stature ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Change in annualized growth velocity (AGV) - Change in Height Z-score - Change in Standing Height - Change in BMI - Change in BMI Z-score Secondary Outcomes - Frequency of event rates of medical events of interest - Frequency of Serious Medical Events - Association between specific variants and growth velocity - Association between other health outcomes directly related to short stature ### Location - Facility: Children's National Health System, Washington, District of Columbia, 20010, United States @@
## Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy - NCT ID: NCT06309966 - Study ID: BHV7000-303 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-09 - Lead Sponsor: Biohaven Therapeutics Ltd. ### Study Description The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. ### Conditions - Focal Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BHV-7000 - BHV-7000 - Placebo ### Outcomes Primary Outcomes - Change from Baseline in 28-day average seizure frequency during Weeks 8 to 16 of Treatment Secondary Outcomes ### Location - Facility: Dm Healthworks, Kissimmee, Florida, 34741, United States @@
## A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease - NCT ID: NCT06309953 - Study ID: 937 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-06-28 - Lead Sponsor: Bausch & Lomb Incorporated ### Study Description An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease ### Conditions - Dry Eye ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Miebo ### Outcomes Primary Outcomes - Mean change from baseline (CFB) in dry eye symptom severity at Visit 3 Secondary Outcomes ### Location - Facility: Site 205, Petaluma, California, 94954, United States @@
## Prognostic Factors for Surgical Management of Large Hypertensive Basal Ganglionic Haemorrhage - NCT ID: NCT06309940 - Study ID: Basal ganglionic haemorrhage - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-04 - Lead Sponsor: Assiut University ### Study Description The aim of this study is to present current and comprehensive recommendations for surgical treatment of this hematoma and to determine the factors that may improve the survival rate ### Conditions - Basal Ganglionic Hemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Prognostic factors of surgical evacuation of basal ganglionic haemorrhage ### Outcomes Primary Outcomes - Prognostic factors of surgical evacuation of basal ganglionic haemorrhage Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage) - NCT ID: NCT06309927 - Study ID: 0025-24-ASF - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Assaf-Harofeh Medical Center ### Study Description Non-blinded prospective randomized study. 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management (after being offered the options of conservative management and medical treatment) will be recruited.Qualifying patients will sign an informed consent form and will be randomly assigned to the two arms of the study:1. Surgical uterine evacuation by the traditional ultrasound-guided suction curettage (control group)2. Surgical uterine evacuation by operative hysteroscopy using a tissue removal device (study group).The surgical procedure will be determined randomly by computer generated allocation.All surgical procedures will be performed under general anesthesia in an outpatient surgical suite. The operative time, operative blood loss and intraoperative complications will be recorded by the research team.Following the surgical procedure, the patients will be monitored and discharged home as per our department's day-surgery protocol. Immediate post-operative complications will be recorded until discharge.One week after the procedure, a telephone interview will be conducted to assess any procedure-related complications.A diagnostic hysteroscopy without anesthesia will be scheduled 6 weeks postoperatively to assess for retained products of conception and for intrauterine adhesions. The diagnostic hysteroscopy will be performed by a practitioner who will be blinded to the type of surgery performed.6 months after the procedure, a telephone questionnaire will be conducted to assess for subsequent pregnancies. ### Conditions - Early Pregnancy Loss - Intrauterine Adhesion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Operative hysteroscopy (by tissue removal device) - Suction curettage ### Outcomes Primary Outcomes - Operative complications - Intrauterine adhesions - Subsequent fertility Secondary Outcomes - Conversion from operative hysteroscopy to suction curettage ### Location - Facility: Shamir Medical Center, Be'er Ya'aqov, N/A, 70200, Israel @@
## The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States - NCT ID: NCT06309914 - Study ID: Pro00074459 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2024-05-06 - Lead Sponsor: Applied Science & Performance Institute ### Study Description This is a randomized, double-blind, placebo-controlled, 4-week intervention clinical study assessing the efficacy of Mirtoselect®, Virtiva® Plus, and Enovita® on cognitive performance and mood states, and the occurrence of adverse events in response to daily supplementation. The desired sample size for this study is 64 subjects. To account for potential dropouts, we aim to enroll up to 20% over the desired sample size. Therefore, this study will enroll up to 76 healthy men and women (25-55 years of age). Subjects will be randomly divided into four study groups: Placebo, Virtiva® ginkgo biloba extract, Mirtoselect® bilberry extract, or Enovita® grape seed extract. Blocked randomization will be deployed in which subjects are divided into blocks of 4 subjects and each subject within a block is randomly assigned to one of the four study groups. ### Conditions - Mental Processes - Cognitive Change - Mood Change ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo - Enovita Grape Seed Extract - Mirtoselect Bilberry Extract - Virtiva Plus Ginko Biloba Extract ### Outcomes Primary Outcomes - Change in Visual Memory - Change in Verbal Memory - Change in Finger Tapping Test (FTT) Results - Change in Symbol Digit Coding (SDC) Test Results - Change in Stroop Test Results - Change in Shifting Attention Test Results - Change in Continuous Performance Test Results Secondary Outcomes - Change in Abbreviated Profile of Mood States (POMS) Score ### Location - Facility: Applied Science and Performance Institute, Tampa, Florida, 33607, United States @@
## Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization Techniques - NCT ID: NCT06309901 - Study ID: ankaraYBU2019-199 - Status: COMPLETED - Start Date: 2019-06-30 - Completion Date: 2022-05-31 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description To compare the effects of facial distortion model and equipment assisted soft tissue mobilization techniques on the treatment process, which are among the applications in the rehabilitation process after meniscus repair. ### Conditions - Meniscus Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Exercise - Fascial Distortion Model - Instrument Assisted Soft Tissue Mobilisation ### Outcomes Primary Outcomes - Visual Analog Scale - environmental measurement - Power Track Manuel Muscle Tester - sit and reach test - Goniometric measurement - The Western Ontario Meniscal Evaluation Tool (WOMET ) - Lysholm Knee Score Secondary Outcomes ### Location - Facility: Yıldırım Beyazıt University Yenimahalle Training and Research Hospital, Ankara, N/A, 06010, Turkey @@
## Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury - NCT ID: NCT06309888 - Study ID: 2023-18 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-12 - Lead Sponsor: Swiss Paraplegic Research, Nottwil ### Study Description In the case of spinal cord injury, rehabilitation is particularly focused on motor skills. Non-motor impairments such as thinking difficulties did not receive a lot of attention to date.In this research project, the investigators want to find out how thinking difficulties become noticeable in the brain with spinal cord injury.Participation procedure: Participants who take part will be asked to come to an examination once. The duration of the examination is between 2 and 2.5 hours (including around 55 minutes in the magnetic resonance imaging scanner, including preparation and follow-up). ### Conditions - Spinal Cord Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Brain activity Secondary Outcomes - Behavioral performance - Behavioral performance - Behavioral performance - Behavioral performance - Behavioral performance - Brain morphometry - Level of life satisfaction - Level of anxiety - Level of pain - Quality of sleep - Level of attention and awareness - Motor symptom severity - Demographics ### Location - Facility: Swiss Paraplegic Research, Nottwil, Lucerne, 6207, Switzerland @@
## Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure - NCT ID: NCT06309875 - Study ID: ENF- 25-2018 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-11-12 - Lead Sponsor: Universidad de la Sabana ### Study Description According to the World Health Organization (WHO), by 2021 cardiovascular diseases (CVD) will be a public health problem, among them heart failure (HF), since this is a chronic disease, patients should be competent in their care. Despite the above, according to research conducted in Colombia, 59.7% of people with chronic noncommunicable diseases (NCDs) have a level of care competence considered not optimal; patients report not having sufficient knowledge of the disease or experience feelings of lack of tools for the management of symptoms and the challenges of post-hospitalization.The objective of the research is to determine the effect of the PLAN CUIDARTE on the caregiving competence of people with HFMethodology: Pre-posttest randomized clinical trial, with blinding of the participants, where the intervention "PLAN CUIDARTE" is applied and the initial and subsequent caregiving competence is evaluated in the comparison group and in the intervention group for pretest - posttest and between-group comparisons. ### Conditions - Heart Failure - Caregiver Burden - Discharge Plan - Care Transitions - Nursing ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PLAN CUIDARTE - Conventional care ### Outcomes Primary Outcomes - Care Competence Secondary Outcomes ### Location - Facility: Universidad de Caldas, Manizales, Caldas, 170004., Colombia @@
## Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy - NCT ID: NCT06309862 - Study ID: 5993 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-12-31 - Lead Sponsor: Sunnybrook Health Sciences Centre ### Study Description Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes. ### Conditions - Cardio-Oncology - Cardiomyopathy Due to Drug ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Define changes in CMR tissue and blood biomarkers during ICI treatment. - Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction. - Investigate associations between serum biomarkers and CMR-defined left ventricular ejection fraction. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of Physical Therapy Intervention in Cervical Angina Patients at Jerash University Office Employees, "Randomized Clinical Trail". - NCT ID: NCT06309849 - Study ID: Jerash University - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-06-01 - Lead Sponsor: South Valley University ### Study Description Cervicogenic angina (CA) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. Because CA mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed Nakajima H, 2006. Patients with CA may have suffered symptoms for longer periods of time and seen several clinicians due to conflicting cardiac exams. Clinicians and patients are unaware that CA symptoms are stemming from cervical spine disorders. However, the mechanism of pain occurrence in patients with CA remains unclear. ### Conditions - Cervical Radiculopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) ### Outcomes Primary Outcomes - 1-Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using Sphygmomanometer. Secondary Outcomes - 3- Range of Motion (ROM) (in degrees) of the cervical spine using Electro-Goniometer. 4- the pain using Visual Analogue Scale (VAS) from (0-10) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma - NCT ID: NCT06309836 - Study ID: SID03 - Status: RECRUITING - Start Date: 2021-06-23 - Completion Date: 2024-06-23 - Lead Sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse ### Study Description Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma. ### Conditions - Basal Cell Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - clinical evolution, treatment and prognosis Secondary Outcomes ### Location - Facility: Irccs Fondazione Policlinico Gemelli, Roma, ITA, 00168, Italy @@
## A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency - NCT ID: NCT06309823 - Study ID: 1000080330 - Status: COMPLETED - Start Date: 2023-02-08 - Completion Date: 2024-01-17 - Lead Sponsor: The Hospital for Sick Children ### Study Description MAS825 is a bi-specific IgG1 monoclonal antibody that simultaneously targets IL-1 beta and IL-18, thereby neutralizing both cytokines that are thought to be integral to the pathogenesis of XLP-2. Clinical trials are currently examining its efficacy in other diseases associated with elevations of these cytokines, including NLRC4-associated disease and hidradenitis suppurativa. This study proposes to assess the effectiveness of MAS825 in a single patient with XLP-2, who has previously demonstrated response to blockade of IL-1 beta and IL-18. Given the lack of alternative pharmaceutical options for XLP-2, this represents the only known medication option that avoids the toxicity associated with high-dose corticosteroids and the morbidity associated with hematopoietic stem cell transplantation. ### Conditions - X-linked Lymphoproliferative Syndrome Type 2 (XLP-2) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MAS825 ### Outcomes Primary Outcomes - Impact of MAS825 on Physician Global Assessment Score - Impact of MAS825 on Physician Severity Assessment of Disease Signs and Symptoms - Patient/Parent Global Assessment of Disease Activity Secondary Outcomes ### Location - Facility: The Hospital for Sick Children, Toronto, Ontario, M5G1X8, Canada @@
## Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia - NCT ID: NCT06309810 - Study ID: 2022-35 - Status: RECRUITING - Start Date: 2023-03-06 - Completion Date: 2025-08 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description This is a pilot, experimental, monocentric study. The main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view, and therefore induce an improvement in posture and quality of life in patients with malignant spasticity.The study foresees the enrollment of about 10 patients, in a period of 24 months. The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique, and a prescription dose between 45 and 60 Gy; subsequently the patients will be followed up for one year. ### Conditions - Spasticity/Paresis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radiotherapy ### Outcomes Primary Outcomes - MAS Secondary Outcomes - Acute and late toxicity (CTCAE) - Quality of life (SF-12) - Quality of nursing (VAS) - Radiological characteristics and treatment-related changes of the spinal roots ### Location - Facility: IRCCS Sacro Cuore Don Calabria di Negrar, Negrar, Verona, 37024, Italy @@
## Effects of Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Periodontitis - NCT ID: NCT06309797 - Study ID: OSATAGUN2 - Status: COMPLETED - Start Date: 2023-05-02 - Completion Date: 2024-02-05 - Lead Sponsor: Özlem SARAÇ ATAGÜN ### Study Description This study aimed to compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis. ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Interdental brush+HA - Interdental brush ### Outcomes Primary Outcomes - Gingival index (GI) - Plaque index (PI) - Papillary bleeding index (PBI) - Pocket depth (PD) - Clinical attachment loss (CAL) Secondary Outcomes ### Location - Facility: Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi, Ankara, N/A, 06010, Turkey @@
## Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling - NCT ID: NCT06309784 - Study ID: RD 2595 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2024-10-31 - Lead Sponsor: Royal United Hospitals Bath NHS Foundation Trust ### Study Description The Investigators have developed a camera based drill guidance system to improve the accuracy of surgical drilling. The aim of the study is to assess:Accuracy in vivo Safety Acceptability of use amongst surgeons and theatre staff ### Conditions - Orthopaedic Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Drill Guidance System (DGS) ### Outcomes Primary Outcomes - Accuracy of placement of a screw or K wire in scaphoid bones - Accuracy of placement of a screw or K wire in other bones Secondary Outcomes - Length of material part of the procedure - Number of fluoroscopy (perioperative X-ray) images performed - Number of patients with treatment related adverse events as assessed by CTCAE v4.0 - Immediate acceptability to surgeons and theatre staff - Initial acceptability to surgeons and theatre staff - Overall acceptability to surgeons and theatre staff ### Location - Facility: Royal United hospitals NHS Foundation Trust, Bath, N/A, N/A, United Kingdom @@
## Preventive Remediation for Optimal MEdical StudentS (PROMESS) - NCT ID: NCT06309771 - Study ID: PROMESS - QOL - Status: ENROLLING_BY_INVITATION - Start Date: 2023-11-11 - Completion Date: 2024-09-30 - Lead Sponsor: Research on Healthcare Performance Lab U1290 ### Study Description Medical students are under a great deal of competitive pressure throughout their training. During their studies, medical students experience high levels of stress, sleep disorders and excessive physical inactivity. These feelings and behaviours are expected to significantly degrade their quality of life, health and performance.The PROMESS project aims to increase students' quality of life and ultimately improve their medical performance. The project aims to improve students' ability to take care of themselves from a short and long term perspective.Encouraging physical activity, reducing sedentary behaviors, reducing stress, fatigue and sleep troubles during their curriculum can promote a healthier lifestyle and reduce the risk of chronic health conditions in the future.The study seeks to quantify the impact of a complex intervention based on 3 modules (stress, sleep, physical activity) on the quality of life and academic performance of 2nd cycle medical students. This study will also have a clear insight on the influence of the complex intervention on changes in stress, sleep, physical activity and sedentary behavior markers. ### Conditions - Health Behavior - Health-Related Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion. ### Outcomes Primary Outcomes - Quality of life. Change from pre-intervention in a composite score obtained at the Brief Quality Of Life questionnaire at the post-interventional measure at Week 27. Secondary Outcomes - Academic self-efficacy. Change from the pre-intervention in score obtained at the Academic self-efficacy questionnaire at the post-interventional measure at Week 27. - Wu self efficacy questionnaire. Change from pre-intervention in score obtained at the adapted Wu self efficacy questionnaire at the post-interventional measure at Week 27. - Academic performances. Scores and ranks obtained at all the official exams during the 2023-2024 academic year. - VAS - quality of life. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of Quality Of Life - VAS - self-confidence. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-confidence. - VAS - self-efficacy. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-efficacy. - VAS - resources. Evolution of the score obtained at the 100-mm Visual Analogue Scale assessing the perceived level of resources. - VAS - work-life balances. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the work-life balances. - VAS - stressors quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors. - VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level. - VAS - stress coping. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations. - VAS - stress quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress. - VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality. - VAS - sleep quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep. - VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue. - VAS - physical fitness. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness. - VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the level of physical activity. - VAS - sedentary behaviors. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviors. - Perceived level of stress. Change from pre-intervention in score obtained at the Perceived Stress Scale (PSS) at the post-interventional measure at Week 27. - Coping strategies.Change from pre-intervention in scores obtained at the Brief Cope Inventory (BCI) at the post-interventional measure at Week 27. - Quantity of stressors. Score obtained at the Holmes and Rahe Questionnaire Inventory during the pre-intervention. - Big-5. Scores obtained at the Big-5 questionnaire. - Perceived level of sleep troubles. Change from pre-intervention in score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI) at the post-interventional measure at Week 27. - Epworth Sleepiness scale. Change from the pre-intervention in score obtained at the Epworth Sleepiness scale at the post-interventional measure at Week 27. - Multidimensional Fatigue. Change from the pre-intervention in score obtained at the Multidimensional Fatigue Inventory (MFI) at the post-interventional measure at Week 27. - Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS). - Perceived level of physical activity. Change from the pre-intervention in score obtained at the Global Physical Activity Questionnaire (GPAQ) at the post-interventional measure at Week 27. - Perceived level of sedentary. Change from the pre-intervention in score obtained at the Rapid Physical Activity Questionnaire (RPAQ) at the post-interventional measure at Week 27. - Heart rate variability (HRV) marker. Change from pre-intervention in cardiac coherence at the post-interventional measure at Week 27. - Heart rate variability (HRV) marker. Change from pre-intervention in the SDNN score in at the post-interventional measure at Week 27. - Heart rate variability (HRV) marker. Change from pre-intervention in the RMSSD score in at the post-interventional measure at Week 27. - Heart rate variability (HRV) marker. Change from pre-intervention in the pnn50% score in at the post-interventional measure at Week 27. - Heart rate variability (HRV) markers.Change from pre-intervention in the Low frequency / High frequency ratio (LF/HF) ratio in at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Time in Bed at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Total Sleep duration at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Sleep efficiency at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Sleep Onset Latency at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Wake after Sleep Onset at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Number of Awakenings at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Mid-sleep point at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Bedtime at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Sleep Onset time at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Sleep Inertia at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Wake-up time at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Sleep regularity index at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Total activity at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Moderate-to-vigorous Physical Activity (MVPA) at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in light physical activity at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Steps count at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in energy expenditure at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in sedentary breaks at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in Sedentary time at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in prolonged sedentary bouts at the post-interventional measure at Week 27. - Actimetry records. Change from pre-intervention in vector of the dynamic body acceleration (VeDBA) at the post-interventional measure at Week 27. - Physical fitness markers - Strength. Change from pre-intervention in the force developed during a maximal isometric contraction of the quadriceps at the post-interventional measure at Week 27. - Physical fitness markers - Power. Change from pre-intervention in height of jump at the post-interventional measure at Week 27. - Physical fitness markers - Power. Change from pre-intervention in time of flight at the post-interventional measure at Week 27. - Physical fitness markers - Power. Change from pre-intervention in relative power at the post-interventional measure at Week 27. - Physical fitness markers - Endurance. Change from pre-intervention in speed through the endurance test at the post-interventional measure at Week 27. - Physical fitness markers - Endurance. Change from pre-intervention in VO2max through the endurance test at the post-interventional measure at Week 27. - Physical fitness markers - Endurance. Change from pre-intervention in heart rate during the endurance test at the post-interventional measure at Week 27. - Body composition markers. Change from the pre-intervention in Body Mass Index (BMI) at the post-interventional measure at Week 27. - Body composition markers. Change from the pre-intervention in fat mass at the post-interventional measure at Week 27. - Body composition markers. Change from the pre-intervention in Skeletal muscle mass at the post-interventional measure at Week 27. - Body composition markers.Change from the pre-intervention in total body hydration at the post-interventional measure at Week 27. - Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the stress module. - Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sedentary behaviors and physical activity module. - Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sleep module. - Question recommendation. Answer to the question "Would you recommend a friend to participate at the PROMESS project?" asked during the post-intervention. - Question Habits change. Answer to the question "Do you think that your participation at the PROMESS project has modified your health behaviors/actions?" asked during the post-intervention. - Question Habits change. Answer to the question ""For which behaviors do you think you have modified your habits/actions?" asked during the post-intervention. ### Location - Facility: RESHAPE, Lyon, N/A, 69008, France @@
## BreinZorg: Feasibility Study Into an Online Lifestyle Platform for MCI and SCD - NCT ID: NCT06309758 - Study ID: 115022 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-15 - Lead Sponsor: Radboud University Medical Center ### Study Description Dementia is the most common disease in older individuals and this century's biggest healthcare challenge. Many patients who visit the memory clinic with memory complaints do not have dementia but instead are diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD). MCI or SCD may be a pre-dementia stage. Many patients with MCI or SCD often leave their consultation with unanswered questions, and unsure what they, themselves can do to reduce dementia risk. Patients with MCI and SCD have a heightened risk of developing dementia. Therefore, this group would possibly benefit most from preventive strategies. Around 40% of dementia cases is attributable to modifiable factors. Thus, managing a healthy lifestyle may reduce dementia risk.To answer the information request many patients have when leaving the memory clinic and to fill the knowledge gap an online tool has been developed.The goal of this mixed-method feasibility study is to investigate the usability, feasibility, patient experience, and effectiveness of the personalized, multi-domain online website in older adults with MCI or SCD.The main questions it aims to answer are:* Is the new website being used by the target population?* How does the target population experience the use of the website?* What is the effect of using the website?Participants will have access to the website and are free to use the website in any way they want. ### Conditions - Mild Cognitive Impairment - Cognitive Decline ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Breinzorg ### Outcomes Primary Outcomes - Acceptability of the new online website following the theoretical framework of acceptability - Adoption / Uptake of the new online website. Website usage data. - Demand of the new online website. Website usage data. - Practicality of the new online website. - Feeling of trust in yourself and your own abilities. - Feeling of control about own life and future. - Motivation to change lifestyle for reduction of dementia risk. - Awareness about dementia risk reduction Secondary Outcomes - Change in alcohol consumption - Change in smoking behaviour - Change in physical exercise. - Change in Diet. - Change in Sleep behaviour - Change in cognitive activities. - Change in Stress levels - Change in Mental health Quality of Life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## THERApy De-escalation for TESTicular Cancer - NCT ID: NCT06309745 - Study ID: THERATEST - Status: RECRUITING - Start Date: 2024-01-25 - Completion Date: 2027-12 - Lead Sponsor: Queen Mary University of London ### Study Description THERATEST is looking to collect data from 30 patients actively receiving de-escalation treatments or other standard of care treatments in two UK hospitals. THERATEST is a feasibility study to determine whether patients are willing to be recruited, the impact of de-escalation treatments on patients' cancers and quality of life, whether we should proceed with these treatments in a larger study, and if so how the study should be conducted. A feasibility study prepares the ground for a larger study and improves the chances of the subsequent study producing valuable evidence, and helps to avoid wasting precious resources on larger trials that are unlikely to be informative. We hope that information from THERATEST will bridge the current knowledge gap and allow clinicians to design bigger trials to actively compare the different treatment strategies. ### Conditions - Seminoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - retroperitoneal lymph node dissection - Carboplatin AUC10 ### Outcomes Primary Outcomes - FEASIBILITY of recruitment and retention Secondary Outcomes - QUALITY OF LIFE assessed by difference in HRQOL scores - QUALITY OF LIFE assessed by difference in differences in sexual drive, function, and overall satisfaction - Progression free SURVIVAL - OVERALL SURVIVAL - SAFETY and complication of all treatments ### Location - Facility: Barts and London Hospital NHS Trust, London, N/A, N/A, United Kingdom @@
## GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT) - NCT ID: NCT06309732 - Study ID: 4491 - Status: COMPLETED - Start Date: 2006-07 - Completion Date: 2014-01 - Lead Sponsor: Queen Mary University of London ### Study Description St Bartholomew's hospital completed a study using the regimen GAMEC (PEG-filgrastim, actinomycin-D, methotrexate, etoposide, cisplatin). The results of this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. These results are very encouraging and compare very favourably to other treatment protocols. In reviewing this study, it became clear that of the 5 cycles of treatment which were proposed, the first 3 seemed to matter and the last 2 did not appear important. In addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal LDH (lactate dehydrogenase). LDH is a blood test which monitors cancer activity. Selecting patients which fill both these criteria, this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment. This will therefore shorten the treatment from 10 weeks to 6 weeks, thus reducing the side effects. ### Conditions - Testicular Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pegfilgrastim - Dactinomycin - Methotrexate - Etoposide - Cisplatin - Epirubicin ### Outcomes Primary Outcomes - Response rate to GAMEC-S or GAMEC-A Secondary Outcomes - Relapse-free survival - Overall survival ### Location - Facility: Barts and the London NHS Trust, London, N/A, EC1A 7BE, United Kingdom @@
## Hyaluronic Acid and Polynucleotides for Supra-bony Defects - NCT ID: NCT06309719 - Study ID: 339479 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: Queen Mary University of London ### Study Description The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel. ### Conditions - Periodontal Diseases - Wound Heal - Periodontal Inflammation - Periodontal Pocket - Periodontal Attachment Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) - Periodontal Access Flap (AF) ### Outcomes Primary Outcomes - Early wound healing molecular events through GCF - Early gingival tissue vascularization pattern when supra-bony defects are treated with AF, in association or not with PNHA Secondary Outcomes - Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the surgery - Probing pocket depth (PPD) - Gingival recession (REC) - Clinical attachment level (CAL) - Suppuration - Gingival phenotype - Keratinized tissue (KT) - Full mouth plaque score (FMPS) - Full mouth bleeding score (FMBS) - Early Healing Index (EHI) - Gingival morphometric changes - Oral impact on daily performance (OIDP) - Dentine/root sensitivity - Food impaction - Patient perception about therapy - Global ratings of Periodontal Health and Quality of Life ### Location - Facility: Barts Health NHS Trust Dental Hospital, London, N/A, E1 1BB, United Kingdom @@
## A Retrospective Cone Beam Computed Tomography Study of The Lateral Wall Bony Window - NCT ID: NCT06309706 - Study ID: JXHU - Status: COMPLETED - Start Date: 2019-09-01 - Completion Date: 2020-12-31 - Lead Sponsor: The Dental Hospital of Zhejiang University School of Medicine ### Study Description Three experienced observers were asked to screen all the CBCT images from the Stomatology Hospital,Zhejiang University School of Medicine, between September 1, 2019 and December 31, 2019, and counted 1000 maxillary sinus CBCT images that met the criteria. Later, 1000 CBCT images were further measured and analyzed, and indicators such as maxillary sinus buccal wall thickness, morphology, whether there is blood vessel or not, whether there is bone septa or not were counted. The variation rules and related factors were summarized by SPSS analysis. ### Conditions - Lateral Wall Thickness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Lateral wall thickness Secondary Outcomes ### Location - Facility: Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China @@
## Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy - NCT ID: NCT06309693 - Study ID: IRB-300011310 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-10 - Lead Sponsor: University of Alabama at Birmingham ### Study Description In the effort to reduce postoperative opioid use, there has been increasing interest in developing multimodal pain regimens to better manage postoperative pain while minimizing opioid use and their subsequent side effects that can be detrimental to the healing process. Standard of care approaches to better manage postoperative pain include the Enhanced Recovery After Surgery (ERAS) protocol and the use of peripheral and truncal nerve blocks. Truncal nerve blocks are widely used as an additional modality to provide longer lasting postoperative analgesia and have been adopted as part of the standard of care. The goal of this clinical trial is to compare the effects of ERAS alone versus the quadratus lumborum (QL) nerve block on the postoperative pain experience for women with pelvic organ prolapse undergoing robotic assisted sacrocolpopexy. Subjects will be randomized to the ERAS protocol or the QL block. The main questions the study aims to answer are: 1) does the QL block decrease patient reported pain scores postoperatively; and 2) does the QL block decrease the amount of opioid pain medications in the immediate postoperative period? The primary outcome measure will be median patient reported pain score in the post-anesthesia care unit (PACU) following surgery. ### Conditions - Pelvic Organ Prolapse - Post Operative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Quadratus Lumborum (QL) Block - Enhanced Recovery After Surgical (ERAS) Protocol ### Outcomes Primary Outcomes - Median postoperative patient reported pain score in post-anesthesia recovery unit (PACU) Secondary Outcomes - Maximum postoperative patient reported pain score in PACU - Total oral morphine equivalents (OME) required in PACU Total oral morphine equivalents (OME) required in post-anesthesia recovery unit - Rates of postoperative nausea and vomiting (PONV) in PACU - Rates of overnight admission - Total time spent in PACU - Rates of initial active voiding trial failures ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Accuracy of Metagenomic Blood Sampling to Identify Pathogen in Infective Endocarditis Patients - NCT ID: NCT06309680 - Study ID: 280992 - Status: RECRUITING - Start Date: 2023-04-24 - Completion Date: 2025-07-31 - Lead Sponsor: Queen Mary University of London ### Study Description Infective Endocarditis is an infection, usually a bacterium, which attacks the heart and can cause valves to leak and produces a bacterial mass which can break off from the valves and block the blood supply to important organs.We are very keen to improve the treatment of this disease and we are measuring the impact of the treatments that we give to patients so that we have a very clear idea of which treatments work best and also which treatments are less successful.A key part of the treatment is the accurate determination of the causative organism which allows appropriate targeted antibiotic and antifungal medication to be administered.Accurate antibiotic regimes require detection of the causative organism and its sensitivities to each antibiotic. Antibiotic choice is then based on effectiveness, toxicity, ease of use and national guidelines. The current best technique for identifying bacteria is blood culture where organisms are identified by growing them from blood samples. However, this takes up to 5 days from sampling, resulting in delays to the correct diagnosis. Until this time, treatment requires the use of generic, more toxic antibiotic regimes.New techniques are emerging to identify causative organisms from blood. Metagenomics allows the sequencing of bacterial DNA allowing precise identification of the infecting organism. ### Conditions - Infective Endocarditis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - diagnostic accuracy of CMg in blood Secondary Outcomes - to evaluate the results of Nanopore CMg in identifying the causative organism in patients with BCNIE - 1. Optimal timing of blood sampling - 3. Metagenomic Techniques ### Location - Facility: St Bartholomew's Hospital. West Smithfield, London, N/A, EC1A 7BE, United Kingdom @@
## A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers - NCT ID: NCT06309667 - Study ID: SL-MG12-P1 - Status: RECRUITING - Start Date: 2023-10-17 - Completion Date: 2024-06-26 - Lead Sponsor: ProGen. Co., Ltd. ### Study Description This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.This study will be conducted in 2 Parts (Part A and B), with up to 5 cohorts in each part (Part A; Cohorts A1 to A5 and Part B; Cohorts B1 to B5). ### Conditions - Healthy - Overweight ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PG-102(MG12) - Placebo ### Outcomes Primary Outcomes - Number of participants with treatment-emergent adverse events (TEAEs) for Part A - Number of participants with treatment-emergent adverse events (TEAEs) for Part B - Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A - Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B - Number of participants with clinically significant abnormalities in vital signs for Part A - Number of participants with clinically significant abnormalities in vital signs for Part B - Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A - Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B Secondary Outcomes - Maximum plasma concentration (Cmax) for Part A - Maximum plasma concentration (Cmax) for Part B - Time to maximum plasma concentration (tmax) for Part A - Time to maximum plasma concentration (tmax) for Part B - Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A - Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B - Terminal half-life (t1/2) for Part A - Terminal half-life (t1/2) for Part B - Apparent total clearance (CL/F) for Part A - Apparent total clearance (CL/F) for Part B ### Location - Facility: Catholic University Seoul St.Mary Hospital,, Seocho, Seoul, 06591, Korea, Republic of @@
## Home-Based Circuit Training in Overweight/Obese Older Adult Patients With Knee Osteoarthritis and Type 2 Diabetes - NCT ID: NCT06309654 - Study ID: PNU - Status: COMPLETED - Start Date: 2021-09-13 - Completion Date: 2023-12-29 - Lead Sponsor: Princess Nourah Bint Abdulrahman University ### Study Description Background: Obesity and type 2 diabetes mellitus (T2DM) are considered two of the most prevalent metabolic diseases linked to the onset of knee pain caused by osteoarthritis. Regular exercise has been documented as a principal component of a prevention, management, and treatment strategy for knee osteoarthritis (KOA) patients. However, evidence-based exercise protocols for individuals with comorbidities such as obesity, T2DM, and KOA are scarce. Thus, the present pragmatic randomized controlled trial aimed to investigate the effectiveness of a 12-week home-based circuit training (HBCT) protocol on various indicators related to KOA and cardiometabolic health among overweight/obese older adult patients with KOA and T2DM during the COVID-19 lockdown. Methods: Seventy overweight or obese patients with KOA and T2DM (62.2 ± 6.1 years; 56% female) were randomly assigned to the intervention group (n = 35, HBCT) or the no-exercise control group (n = 35, CON). HBCT performed a progressive protocol (seven exercises; 15-30 repetitions per exercise, 1 min passive rest between exercises; 2-4 rounds per session; 20-60 min total session duration). The knee injury and osteoarthritis symptoms, cardiovascular and metabolic risk factors, cardiorespiratory fitness, and renal function were assessed at baseline and following the 12-week intervention. Results: HBCT significantly improved HBCT improved the vast majority of outcomes related to cardiometabolic health and knee osteoarthritis symptoms compared to CON (p\<0.05). No significant differences were detected in total bilirubin, sodium, urea, resting heart rate, or KOOS-sport between HBCT and CON. Conclusion: These findings suggest that an injury-free HBCT program may improve several cardiometabolic health- and KOA-related indices in overweight/obese patients with T2DM and KOA. Such results may encourage clinicians and practitioners to adopt real-world exercise training approaches when prescribing physical exercise to patients characterized by impaired metabolic and musculoskeletal health. ### Conditions - Aerobic Exercise - Strength Training - Glycemic Control - Blood Pressure - Oxidative Stress - Metabolic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 12-week home-based circuit training (HBCT) - Standard of care (CONT) ### Outcomes Primary Outcomes - Blood pressure - The A1C test - blood oxygen levels - cardiorespiratory fitness - interleukin 6 (IL-6) - Superoxide dismutases (SOD) Secondary Outcomes ### Location - Facility: Princess Nourah bint Abdulrahman University, Riyadh, N/A, 11671, Saudi Arabia @@
## Methemoglobinemia Following Intravenous Iron Treatment - NCT ID: NCT06309641 - Study ID: MetHb 001 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2025-12 - Lead Sponsor: Claudia Seiler ### Study Description Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose. ### Conditions - Methemoglobinemia - Anemia - Iron Deficiencies - Side Effect ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sample after treatment - Case reports ### Outcomes Primary Outcomes - Difference in methemoglobin after ferric derisomaltose - Difference in methemoglobin after ferric carboxymaltose Secondary Outcomes - Difference in methemoglobin depending on drug dosage - Difference in methemoglobin depending on age - Difference in methemoglobin depending on sex - Difference in methemoglobin depending on hemoglobin level before treatment - Difference in methemoglobin depending on blood levels of ferritin, transferrin or iron. - Association between difference in methemoglobin and venous lactate ### Location - Facility: Center of Clinical Research Dalarna, Falun, N/A, 79182, Sweden @@
## Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy - NCT ID: NCT06309628 - Study ID: PGX-006 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-09-21 - Completion Date: 2024-12-31 - Lead Sponsor: Paragonix Technologies ### Study Description This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy. ### Conditions - Lung Transplant Rejection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Breathe sample ### Outcomes Primary Outcomes - Volatile Organic Compound profile Secondary Outcomes ### Location - Facility: Duke University, Durham, North Carolina, 27710, United States @@
## Decision Impact Study of PreciseDx Breast - NCT ID: NCT06309615 - Study ID: PDX-001_2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2029-05-30 - Lead Sponsor: Precise Dx, Inc. ### Study Description The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. The development of an artificial-intelligent (AI)-grade provides not only an objective, quantitative advancement of classical breast cancer grading but also improves upon the accuracy and utility of clinical risk. The investigator's sought to understand how such a PreciseDx Breast would be used in clinical practice post-surgical resection for women with early-stage IBC. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Standard of Care ### Outcomes Primary Outcomes - Decision Impact Study of PreciseDx Breast on treating Oncologist - Decision Impact Study of PreciseDx Breast on Diagnostic Pathologist Secondary Outcomes - Decision Impact on long term outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigation of a Free Water Protocol - NCT ID: NCT06309602 - Study ID: 22-0465 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-01-01 - Lead Sponsor: Poudre Valley Health System ### Study Description Hypothesis: Use of a Free Water Protocol (FWP) will improve patient satisfaction scores (Dysphagia Handicap Index), will not increase the risk of aspiration pneumonia/pneumonitis, and will result in improved oral hygiene (as assessed by the Oral Assessment Guide). Aim: To demonstrate that improvement in patient satisfaction and quality of life scores outweighs the potential risks of aspiration of plain water in an acute care setting; to qualitatively assess the implementation of a Free Water Protocol from the viewpoints of the patient and family/caregivers; to quantify changes in oral hygiene practices for individuals on the Free Water Protocol. ### Conditions - Oropharyngeal Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Free Water Protocol - Control / Standard Care ### Outcomes Primary Outcomes - Dysphagia Handicap Index - Oral Assessment Guide - Qualitative data Secondary Outcomes - Adverse events: Aspiration pneumonia/pneumonitis - Liquid intake ### Location - Facility: Medical Center of the Rockies, Loveland, Colorado, 80538, United States @@
## The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis - NCT ID: NCT06309589 - Study ID: YIHM - Status: COMPLETED - Start Date: 2021-05-01 - Completion Date: 2023-12-31 - Lead Sponsor: Yilihamu·Abilitifu ### Study Description The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis. ### Conditions - Primary Biliary Cholangitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vitamin D ### Outcomes Primary Outcomes - UDCA response: Paris I criteria - UDCA response: Barcelona criteria Secondary Outcomes ### Location - Facility: People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, 830001, China @@
## Experimental Approach to Test Predictions of Body Weight Regulation Models - NCT ID: NCT06309576 - Study ID: PBRC 2023-069 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-02 - Lead Sponsor: Pennington Biomedical Research Center ### Study Description The regulation of human body weight and fatness is not fully understood. Although some models of regulation have been proposed (set point, dual-intervention point, others), no studies have been designed to test their predictions. In this pilot and feasibility study, the investigators will implement an experimental approach to test the predictions of models of body weight regulation in humans. Men and women with either underweight or obesity will be exposed to a 2-day fasting followed by a 2-day ad-libitum refeeding. During the entire fasting-refeeding period, energy intake and expenditure will be accurately measured within metabolic chambers. The investigators will therefore determine the compensatory responses to fasting elicited to prevent weight loss. The results will serve to design and power future studies to better understand body weight regulation. ### Conditions - Obesity - Underweight ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Fasting-refeeding cycle ### Outcomes Primary Outcomes - Compensatory response Secondary Outcomes - Timing of the compensatory response - Protein balance - Carbohydrate balance - Lipid balance - Overall appetite - Food preference - Physical activity - Sleeping metabolic rate - Leptin - Appetite-regulating hormones - Metabolites - Gonadotrophic axis - Thyroid axis - Hypothalamic-pituitary-adrenal axis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Metabolic Effects of a Diet Replaced With Essential Amino Acids - NCT ID: NCT06309563 - Study ID: 31J301 - Status: RECRUITING - Start Date: 2023-08-30 - Completion Date: 2025-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing. ### Conditions - Obesity Morbid - Weight Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aminoacid supplementation - Placebo ### Outcomes Primary Outcomes - Muscle mass Secondary Outcomes - 6 minute walking test (6MWT) ### Location - Facility: Istituto Auxologico Italiano, Site Piancavallo, Oggebbio, Verbania, 28921, Italy @@
## Provocative Tests for HFpEF - NCT ID: NCT06309550 - Study ID: 09W002 - Status: RECRUITING - Start Date: 2023-03-10 - Completion Date: 2028-03 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Diagnosing heart failure with preserved ejection fraction (HFpEF) in patients complaining exertional breathlessness can be challenging: diagnostic algorithms and scores have low sensitivity, and ageing-associated comorbidities can complicate the interpretation of symptoms. Thus, exercise right heart catheterization (RHC) or invasive cardiopulmonary exercise test (iCPET) have been advocated as gold-standard methods for HFpEF diagnosis. However, exercise RHC and iCPET are still not widely standardized methods, with results mainly coming from US cohorts (that may differ from Italian cohorts), and other provocative tests (e.g. non-invasive CPET, passive leg raising) may offer complementary diagnostic information. ### Conditions - Heart Failure With Preserved Ejection Fraction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - exercise test ### Outcomes Primary Outcomes - Mortality - Hospitalization for heart failure - Atrial fibrillation Secondary Outcomes ### Location - Facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano, Milan, N/A, 20149, Italy @@
## Chemoreflex Sensitivity in HFpEF - NCT ID: NCT06309537 - Study ID: 09C830 - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2029-12 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Patients with heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. However, some patients may complain of exertional breathlessness which seems to be out of proportion as compared with hemodynamic abnormalities.Chemoreflex sensitivity accounts for the ventilatory responses to a variety of chemical stimuli, including carbon dioxide produced by the organism during exercise. Chemoreflex sensitivity can be augmented in heart failure with reduced left ventricular ejection fraction, and an increased chemoreflex sensitivity has been linked to symptoms, neurohumoral activation, breathing disturbances, and adverse prognosis.However, the clinical correlates and implications of chemoreflex sensitivity in HFpEF have not been accurately studied.We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics. ### Conditions - Heart Failure With Preserved Ejection Fraction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - chemoreflex evaluation ### Outcomes Primary Outcomes - difference in chemoreflex sensitivity between HFpEF and healthy controls Secondary Outcomes ### Location - Facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano, Milan, N/A, 20149, Italy @@
## Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair - NCT ID: NCT06309524 - Study ID: 09C332 - Status: RECRUITING - Start Date: 2023-02-15 - Completion Date: 2025-01-01 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. Treatment options mimic surgical techniques such as leaflet approximation, direct annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially available transcatheter TV replacement systems using orthotopic valve implantation. (5) Among leaflet approximation techniques, the Tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip™ (Abbott Vascular, Santa Clara, CA, USA) or leaflet approximation with the PASCAL systems (Edwards Lifesciences, Irvine, CA, USA) are approved in Europe for minimally invasive TV repair.The purposes of the present study are: i. to use 3DE and CCT to evaluate the effect of T-TEER on the geometry and function of the right heart chambers in patients with STR; ii. to identify the predictors of procedural success potentially related to features of both right chambers geometry and TR jet; iii. to compare the accuracy of 3DE assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same parameters obtained by CCT, in the setting of T-TEER; and iv. to assess patients' outcome. ### Conditions - Tricuspid Regurgitation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tricuspid transcatheter edge-to-edge repair ### Outcomes Primary Outcomes - Inverse remodeling of right heart chambers - Heart failure hospitalization - Death Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano, Milan, Lombardia, 20149, Italy @@
## Subendocardial Viability Ratio in Hypertension - NCT ID: NCT06309511 - Study ID: 09C218 - Status: RECRUITING - Start Date: 2022-10-01 - Completion Date: 2026-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The aim of the research is to evaluate the Subendocardial Viability Ratio (SEVR) in hypertensive patients, using non-invasive arterial tonometry, and to establish the influencing factors and the possibility of predicting cardiovascular morbidity and mortality in arterial hypertension.The SEVR will be evaluated on all patients belonging to the Arterial Hypertension Centers undergoing non-invasive arterial tonometry.The SEVR is calculated on the morphology of the central pressure wave as the ratio between the DPTI (diastolic pressure-time index), i.e. the area between the carotid pressure curve and the ventricular pressure curve during the diastolic phase, and the SPTI ( systolic pressure-time index), i.e. the area under the carotid pressure curve during the systolic phase.The SEVR will be correlated with the anthropometric and pathology variables which will be collected in an appropriate database. ### Conditions - Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Arterial tonometry ### Outcomes Primary Outcomes - Buckberg index Secondary Outcomes ### Location - Facility: Centro di Prevenzione e Cura dell'Ipertensione Arteriosa "Alessandro Filippi", Mascalucia, Catania, N/A, Italy @@
## Residual Adrenal Function in Addison's Disease - NCT ID: NCT06309498 - Study ID: 05C307 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The main aim of this study is to assess the role of 11-deoxycortisol as surrogate marker of Residual adrenal function.11-deoxycortisol levels will be assessed in all recruited patients ### Conditions - Adrenal Insufficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - blood test ### Outcomes Primary Outcomes - prevalence of RAF Secondary Outcomes - prevalence of adrenal crisis ### Location - Facility: Istituto Auxologico Italiano, Milan, N/A, 20135, Italy @@
## Phase 2 Study of WGI-0301 in Combination With Sorafenib for Advanced HCC - NCT ID: NCT06309485 - Study ID: WGI0301-P2G-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Zhejiang Haichang Biotech Co., Ltd. ### Study Description The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors. ### Conditions - Advanced Hepatocellular Carcinoma (HCC) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - WGI-0301 at MTD/RP2D dose IV infusion, QW - WGI-0301 at MTD/RP2D -1 dose IV infusion, QW - Sorafenib 400 mg PO, BID continuously - Sorafenib 400 mg PO, BID ### Outcomes Primary Outcomes - Efficacy of WGI-0301 in combination with Sorafenib based on ORR per RECIST 1.1. Secondary Outcomes - Safety of each dose group. - Tolerability of each dose group. - Anti-tumor activity if WGI-0301 in combination with Sorafenib based on ORR. - Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DCR. - Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DoR. - Anti-tumor activity if WGI-0301 in combination with Sorafenib based on PFS. - Anti-tumor activity if WGI-0301 in combination with Sorafenib based on TTP per RECIST 1.1. - Anti-tumor activity if WGI-0301 in combination with Sorafenib based on OS. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Trial of Mirtazapine for Depression in IBD - NCT ID: NCT06309472 - Study ID: NIHR302528 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-06 - Lead Sponsor: King's College London ### Study Description This study will test whether it is feasible to conduct a clinical trial of mirtazapine (an antidepressant tablet) in patients who have both depression and inflammatory bowel disease (IBD). The study design is a randomised controlled trial (a study in which people are allocated by chance to receive different interventions). The trial will compare mirtazapine against a placebo (dummy) tablet in 76 patients with both depression and IBD.The investigators will recruit outpatients aged 18 or over with a diagnosis of any IBD attending gastroenterology clinics. Either in person or remotely, patients will complete a brief screening questionnaire for depression. Those scoring positive for depression will be invited for a 15-minute interview for clinical depression. Those with clinical depression will be invited to take part. Participants will be randomly allocated by a computer to take either 1) mirtazapine tablet once at night for 12 weeks; or 2) placebo (dummy) tablet once at night for 12 weeks. The study is 'blinded', meaning neither patients nor the study team will know which medication they are taking. Throughout, participants will be able to access other treatments for depression, such as talking therapies.The investigators will measure how many people join the study; how many remain in the trial; how many complete treatment; how many tablets people take; and assess overall acceptability of the trial. Participants will complete brief questionnaires to measure their mental health and IBD symptoms after 4 weeks, 8 weeks, 12 weeks and 16 weeks. Participants will also provide blood samples and faecal samples to measure inflammation.If successful, this trial will support an application for a larger version of the study. ### Conditions - Major Depressive Disorder - Inflammatory Bowel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mirtazapine - Placebo ### Outcomes Primary Outcomes - Recruitment feasibility - Trial adherence - Treatment adherence - Study procedures acceptability and compliance - Overall acceptability Secondary Outcomes - Quick Inventory for Depressive Symptomatology-16 Questionnaire - Patient Health Questionnaire-9 questionnaire - Generalised Anxiety Disorder-7 questionnaire - Inflammatory Bowel Disease Control questionnaire - Inflammatory Bowel Disease Fatigue Assessment Scale - Chalder Fatigue Scale - Maudsley 3-item Visual Analogue Scale - Pittsburgh Sleep Quality Index - 9-item Avoidant Restrictive Food Intake Disorder Screen - Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) Questionnaire - Inflammatory Bowel Disease Resource Use Questionnaire (IBD-RUQ) items on employment and healthcare contacts - Birmingham Irritable Bowel Syndrome Symptoms Questionnaire - Harvey Bradshaw Index (Crohn's disease patients only) - Simple Clinical Colitis Activity Index (ulcerative colitis patients only) - Dietary Screener Questionnaire - Concentration of faecal calprotectin - Concentration of serum high-sensitivity C-reactive protein - Concentration of serum interleukin-23 - Concentration of serum interleukin-22 - Concentration of serum granulocyte-macrophage colony-stimulating factor - Concentration of serum interleukin-5 - Concentration of serum interleukin-13 - Concentration of serum interleukin-17A - Concentration of serum tumor necrosis factor alpha - Concentration of serum interferon-gamma ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma - NCT ID: NCT06309459 - Study ID: IRB 2023/04-34 - Status: COMPLETED - Start Date: 2018-08-01 - Completion Date: 2023-05-01 - Lead Sponsor: Kahramanmaras Sutcu Imam University ### Study Description Triple-negative breast carcinoma is characterized by the absence of estrogen receptors, progesterone receptors, and HER2/neu receptors. Carbonic anhydrase IX (CA IX) is a tumor-associated cell surface glycoprotein that is involved in adaptation to hypoxia-induced acidosis and plays a role in cancer progression. This study aimed to investigate CA IX expression in TNBC and its relationship with treatment effect. ### Conditions - Triple Negative Breast Cancer - Carbonic Anhydrase IX ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Carbonic anhydrase staining levels ### Outcomes Primary Outcomes - Poor prognostic factors in patients with TNBC - The treatment success with inhibiting the CA IX enzyme levels' effectiveness Secondary Outcomes ### Location - Facility: Kahramanmaraş Sütçü İmam University, Kahramanmaraş, N/A, 46000, Turkey @@

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