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## A Safety Study of Single and Multiple Doses of AG-181 in Healthy Participants - NCT ID: NCT06286033 - Study ID: AG181-C-001 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-06-01 - Lead Sponsor: Agios Pharmaceuticals, Inc. ### Study Description The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181 in healthy participants in Part 3. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - AG-181 - Placebo ### Outcomes Primary Outcomes - SAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug - MAD: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug - Food Effect: Maximum Observed Plasma Concentration (Cmax) of AG-181 - Food Effect: Area Under the Concentration-time Curves (AUCs) of AG-181 - Food Effect: Time to Reach Maximum Observed Concentration (tmax) of AG-181 - Food Effect: Terminal Elimination Rate Constant (Kel) of AG-181 - Food Effect: Terminal Elimination Half-Life (t1/2) of AG-181 - Food Effect: Apparent Oral Clearance (CL/F) of AG-181 - Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 Secondary Outcomes - SAD: Maximum Observed Plasma Concentration (Cmax) of AG-181 - SAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181 - SAD: Terminal Elimination Rate Constant (Kel) of AG-181 - SAD: Terminal Elimination Half-Life (t1/2) of AG-181 - SAD: Area Under the Concentration-time Curves (AUCs) of AG-181 - SAD: Apparent Oral Clearance (CL/F) of AG-181 - SAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 - SAD: Renal Clearance (CLR) of AG-181 - SAD: Total Percent of AG-181 Dose Excreted Unchanged in Urine (Fet%) - SAD: Percent of AG-181 Dose Excreted Unchanged in Urine Between Time 1 and Time 2 (Fet1-t2%) - SAD: Cumulative Amount of AG-181 Drug Excreted in Urine (Ae0-t) - SAD: Amount of AG-181 Drug Excreted in Urine Between Time 1 and Time 2 (Aet1-t2) - MAD: Maximum Observed Plasma Concentration (Cmax) of AG-181 - MAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181 - MAD: Terminal Elimination Rate Constant (Kel) of AG-181 - MAD: Terminal Elimination Half-Life (t1/2) of AG-181 - MAD: Area Under the Concentration-time Curve (AUC) of AG-181 - MAD: Apparent Oral Clearance (CL/F) of AG-181 - MAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181 - MAD: Time to Maximum Observed Plasma Concentration at Steady State (Cmax_ss) of AG-181 - MAD: Accumulation Ratio for Cmax (RA_Cmax) of AG-181 - MAD: Accumulation Ratio for Area Under the Concentration-time Curve (RA_AUC) of AG-181 - Food Effect: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug ### Location - Facility: ICON 1255 East 3900 South, Salt Lake City, Utah, 84124, United States @@
## Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome - NCT ID: NCT06286020 - Study ID: VR-Zhenqiu - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-07 - Lead Sponsor: Zeng Changhao ### Study Description The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy. ### Conditions - Wallenberg Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual Reality Therapy - Conventional dysphagia treatment ### Outcomes Primary Outcomes - standardized swallowing assessment Secondary Outcomes - Murray secretion scale - Rosenbek penetration-aspiration scale - swallowing-quality of life ### Location - Facility: Xinzhu Rehabilitation Hospital, Xinzhu, N/A, N/A, Taiwan @@
## Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control - NCT ID: NCT06286007 - Study ID: PRIPASCO-2023 - Status: RECRUITING - Start Date: 2023-12-21 - Completion Date: 2026-07-01 - Lead Sponsor: Hospital Clinico Universitario de Santiago ### Study Description The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI).A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up ### Conditions - Asthma - Pertussis - RSV Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PCR ### Outcomes Primary Outcomes - Incidence of Bordetella pertussis and RSV infections in adult patients with asthma, Secondary Outcomes - To describe the seroprevalence of Bordetella pertussis in adult patients with asthma - To describe the seroprevalence of RSV in adult patients with asthma - To evaluate the severity and control of the asthma caused by either BP or RSV infection ### Location - Facility: Hospital Clínico Universitario de Santiago de Compostela, Santiago De Compostela, A Coruña, 15706, Spain @@
## Complications of High Frequency Jet Ventilation - NCT ID: NCT06285994 - Study ID: SRB2024016 - Status: RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-10-31 - Lead Sponsor: Erasme University Hospital ### Study Description High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as:* Hypoxia: SpO2 \< 90% for 1 min* Severe hypoxia: SpO2 \< 85% for 1 min* Hemodynamic instability, defined as Arterial pressure \< 90/60* Cardiac arrhythmia* Laryngospasm or bronchospasm* Barotrauma or volutrauma* Need for ICU admissionA model predicting the risk for developing any complication will be developped using 2 mathematical methods:* a multivariate analysis* a data mining approachFor both approaches, the following variables will be included in the model:* Age* Gender* Weight* Height* BMI* Smoking* Alcohol consumption* Consumption of Other drugs* ASA class* Obstructive pulmonary disease* Restrictive lung disease* COPD status (1, 2, 3, 4)* Interstitial lung disease* Lung tumor * Trachea location * Carina location * Bronchial location* Pulmonary or tracheal stenosis* Presence of stridor* Severe stenosis (\< 6 mm)* Baseline SpO2 (pre-intervention)* Pre-intervention oxygen requirement Procedure* Duration (min)* Stent placement* Dilation* Laser treatment* Length of hospital stay Lung function tests* FEV1 (forced expiratory volume)* VC (Vital Capacity)* FEV1/VC (Tiffeneau ratio)* CPT (total lung capacity)* DLCO (carbon monoxide diffusion) ### Conditions - High-Frequency Jet Ventilation - Bronchoscopy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - High frequency jet ventilation ### Outcomes Primary Outcomes - Occurence of complications Secondary Outcomes - Prediction model of complications ### Location - Facility: Hôpital Universitaire de Bruxelles - Hôpital erasme, Brussels, N/A, 1070, Belgium @@
## Retrospective Study Chimaera Long Nail in Adult Patient - NCT ID: NCT06285981 - Study ID: OCI_2206 - Status: RECRUITING - Start Date: 2023-11-27 - Completion Date: 2024-06-30 - Lead Sponsor: Orthofix s.r.l. ### Study Description The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice. ### Conditions - Pertrochanteric Fracture of Femur - Intertrochanteric Fracture of Femur - Subtrochanteric Fracture of Femur ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Chimaera Long Nail ### Outcomes Primary Outcomes - percent of patients in wich bone union has been achieved Secondary Outcomes - percent of patients that required a reoperation ### Location - Facility: AORN Sant'Anna e San Sebastiano, Caserta, CE, 81100, Italy @@
## The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing Cardiometabolic Health Inequities - NCT ID: NCT06285968 - Study ID: AAAU8937 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2027-03-31 - Lead Sponsor: Columbia University ### Study Description The purpose of this randomized controlled trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in Hispanic/Latina/o/x adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention. ### Conditions - Blood Pressure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Multidimensional Sleep Health Promotion Intervention ### Outcomes Primary Outcomes - Change in office systolic blood pressure Secondary Outcomes - Change in office systolic blood pressure (sustained effect at 24 weeks) - Change in office diastolic blood pressure - Change in out-of-office blood pressure - Change in fasting glucose - Change in body weight - Change in waist circumference - Change in diet quality - Change in sleep health - Acceptability of Implementation - Feasibility of Implementation - Appropriateness of Implementation ### Location - Facility: Columbia University Irving Medical Center, Mailman School of Public Health, New York, New York, 10032, United States @@
## Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips - NCT ID: NCT06285955 - Study ID: 307-reinforced teeth - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-08-31 - Lead Sponsor: Beijing 302 Hospital ### Study Description Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. The technical limitations of traditional endoscopic hemoclips restrict their application. Although endoscopic suturing techniques are emerging, most are still in the exploratory phase. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcomes are the technical success rate and the clinical success rate. ### Conditions - Pilot Study - Clips ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Clinical success rate Secondary Outcomes - Technical success rate - Delayed bleeding rate - Delayed perforation rate ### Location - Facility: The fifth Medical Center of Chinese PLA General Hospital, Beijing, Beijing, 100071, China @@
## EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation - NCT ID: NCT06285942 - Study ID: 277.535 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-01-31 - Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita ### Study Description The goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy. One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH.Once enrolled, patients will be treated with a single daily dose of Edoxaban (60 or 30 mg according to specific indications). At day 4 after enrollment (steady state), evaluation of anti-FXa activity and thrombin generation assay will be performed on peripheral whole blood samples. At months 6 and 12 patients will be asked to complete the ACTS (Anti-Clot treatment scale) questionnaire specific for anticoagulation.The main endpoint will be: the difference in the results of the Anti-Clot treatment scale questionnaire between the two groups evaluated at 12 months. ### Conditions - Atrial Fibrillation - Fragility ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Edoxaban - No Edoxaban ### Outcomes Primary Outcomes - Difference in Anti-Clot treatment scale (ACTS) questionnaire results among the two groups assessed at 6 and 12 months. Secondary Outcomes - Number of cardio-embolic events at 6 and12 months - Number of bleeding events - Assessment of drugs efficacy by measuring the anti-factor Xa activity - Assessment of drugs efficacy by measuring the thrombin generation - Assess the quality of life - Cost-effectiveness analysis ### Location - Facility: Ospedale Policlinico San Martino, Genova, N/A, 16132, Italy @@
## ACS Community Access to Resources Education and Support - NCT ID: NCT06285929 - Study ID: 2013209-1 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-09-01 - Completion Date: 2025-12-31 - Lead Sponsor: American Cancer Society, Inc. ### Study Description The goal of this study is to evaluate the pilot phase of ACS Cares to identify key implementation outcomes and assess effectiveness of the program to improve distress, enhance communication, and reduce missed appointments and healthcare utilization. ### Conditions - Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ACS CARES Student Navigation ### Outcomes Primary Outcomes - Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers - Measure the impact of ACS CARES on patient-reported outcomes: Information Needs - Measure the impact of ACS CARES on patient-reported outcomes: Distress needs - Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program - Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs - Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication - Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge - Measure the impact of ACS CARES on patient-reported outcomes: Patient activation - Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity - Measure the impact of ACS CARES on patient-reported outcomes: Quality of life - Context, Training, and Process Measures: Service Penetrance and Process Measures: Service Penetrance Secondary Outcomes - Sociodemographic differences between ACS CARES supported and non-ACS CAREs supported patients - Impact of ACS CARES on treatment adherence and healthcare - Context, Training, and Process Measures: Volunteer Satisfaction ### Location - Facility: UCLA Health, Los Angeles, California, 90024, United States @@
## A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression - NCT ID: NCT06285916 - Study ID: NORA520-PT-US-1a - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-03 - Lead Sponsor: Gerbera Therapeutics, Inc. ### Study Description The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine:* How well NORA520 is tolerated and what side effects it may cause* If NORA520 reduces depressive symptoms in subjects with severe PPD* The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken* In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days. ### Conditions - Depression, Postpartum - Postpartum Depression - Post-partum Depression - Postnatal Depression - Post-Natal Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NORA520 Dose 1 - NORA520 Dose 2 - Placebo ### Outcomes Primary Outcomes - Incidence, severity, and causality of AEs, SAEs, and AESIs - Change from baseline in HAM-D17 total score compared to placebo Secondary Outcomes - Change from baseline in HAM-D17 total score - HAM-D17 response - HAM-D17 remission - Change from baseline in HAM-D17 subscale and individual item scores - Change from baseline in Clinical Global Impression - Severity (CGI-S) score - Clinical Global Impression - Improvement (CGI-I) scale positive response - Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score - Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score - Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score - Number of patients who start any new antidepressant or anti-anxiety medication ### Location - Facility: Gerbera site, Canoga Park, California, 91304, United States @@
## Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing - NCT ID: NCT06285903 - Study ID: AUAREC20220002-11 - Status: COMPLETED - Start Date: 2022-09-02 - Completion Date: 2023-12-30 - Lead Sponsor: Al-Azhar University ### Study Description Successful osseointegration considered the cornerstone in implant stability which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone sur-rounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain ### Conditions - Bone Density, Low ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - internal sinus lift surgery ### Outcomes Primary Outcomes - Implant stability using the Osstell device by percentage Secondary Outcomes - Modified sulcus bleeding index,Peri-implant pocket depth (PPD)by mm ### Location - Facility: Alazhar university ,Assuit branch ,Egypt, Assiut, Assuit, 0000, Egypt @@
## Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia - NCT ID: NCT06285890 - Study ID: 2023-1016 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2029-12-31 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To find a recommended dose of HC-7366 that can be given in combination with azacitidine and venetoclax to patients with AML. The safety and effects of this drug combination will also be studied. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HC-7366 - Azacitidine - Venetoclax ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury - NCT ID: NCT06285877 - Study ID: 291120234382023 - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2025-01 - Lead Sponsor: Universidad Rey Juan Carlos ### Study Description Purpose: to observe the possible benefits produced by conventional therapy through virtual reality with the Nintendo Switch to try to improve motivation and increase the degree of care satisfaction. The aim is to improve postural control in both seated and standing positions and to maintain and improve cognitive capacity.Material and methods: one group (experimental group) will receive a total of 8 one-hour sessions or 16 half-hour sessions, depending on their individual needs, for 8 weeks using the Nintendo Switch. The other group (control group) will continue to receive their conventional scheduled therapy.Measures: Abilhand, MEC-Lobo, FIST, Fugl-Meyer, Berg Balance Scale and CSQ-8. ### Conditions - Occupational Therapy - Acquired Brain Injury - Adults ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional therapy sessions - Conventional therapy sessions plus Nintendo Switch ### Outcomes Primary Outcomes - Abilhand - MEC-Lobo - Function in Sitting Test (FIST) - Fugl-Meyer - Berg Balance Scale (BBS) Secondary Outcomes - Client Satisfaction Questionnaire (CSQ-8) ### Location - Facility: Universidad Rey Juan Carlos, Móstoles, Madrid, 28933, Spain @@
## Sense to Act: An Interoceptive Sensibility Intervention for Musculoskeletal Pain - NCT ID: NCT06285864 - Study ID: 122/2023 - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2024-12 - Lead Sponsor: Iscte-University Institute of Lisbon ### Study Description The ability to be connected and act according to bodily information is fundamental in chronic pain adjustment. This study aims to test the feasibility of an intervention designed to improve interoceptive sensibility, i.e., the ability to sense, interpret, and regulate bodily sensations in chronic musculoskeletal pain patients. ### Conditions - Musculoskeletal Pain - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Interoception-based intervention ### Outcomes Primary Outcomes - Feasibility - Sessions' acceptability - Feasibility - Program acceptability, appropriateness, and feasibility - Feasibility - Recruitment, retention, and attendance rates - Feasibility - safety/unexpected events - Feasibility - Treatment Fidelity Check Secondary Outcomes - Interoceptive sensibility - Psychological flexibility - Emotion regulation - Pain-related self-efficacy - Pain catastrophizing - Activity patterns - Affective distress (depression and anxiety) - Pain severity - Physical function and Vitality ### Location - Facility: Iscte - University Institute of Lisbon, Lisbon, N/A, 1649-026, Portugal @@
## A Novel Iron Supplement for Athletes: Phase I - NCT ID: NCT06285851 - Study ID: 23-0825 - Status: COMPLETED - Start Date: 2023-11-23 - Completion Date: 2023-12-12 - Lead Sponsor: University of Calgary ### Study Description Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study is a pilot trial to assess the tolerability of a novel iron supplement prior to conducting a clinical trial on the efficacy of the developed novel iron supplement on iron status and performance. ### Conditions - Constipation - Diarrhea - Cramp, Abdominal - Bleeding Gastric ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - FeSC ### Outcomes Primary Outcomes - GI Symptoms - Gastrointestinal symptoms Secondary Outcomes - Supplement Tolerability and Preferences Questionnaire - Recovery ### Location - Facility: University of Calgary, Calgary, Alberta, N/A, Canada @@
## Impact of Measures Taken to Contain COVID-19 on Hospital Surgical Care Services and Clinical Outcomes - NCT ID: NCT06285838 - Study ID: 2020/2706 - Status: COMPLETED - Start Date: 2020-07-17 - Completion Date: 2024-01-20 - Lead Sponsor: Singapore Health Services ### Study Description Swift and decisive actions on the part of healthcare and hospital authorities are required to effectively contain the current COVID-19 pandemic. These measures firstly allow personnel and facilities leeway to provide surge capabilities to meet anticipated increased demands on the healthcare service. In addition, by deferring none urgent hospital visits, admissions and investigations, such measures support social distancing and aid attempts to control disease transmission. Deferring perceived non-urgent patient services may however lead to unintended delayed diagnoses and exacerbation of current patient conditions and lead to increased emergency admissions and surgeries.A policy decision was made that essential surgical services pertaining to cancer and urgent cardiovascular surgery were allowed but that surgeons had the option to postpone what is assessed to be less urgent cases. Increasingly patients also postpone their surgeries or visits because of anxieties over the developing situation. Elective surgical services at the Outram Campus were thus significantly reduced from January 2020 as part of the measures to contain the COVID-19 outbreak.The surgical philosophy during this period was that a judicious policy that allowed surgeons to proceed with surgery deemed critical but to postpone those deemed less so will at the system level, avoid poor outcomes for patients who required surgery and yet successfully re-allocate resources required to address the unfolding pandemic. ### Conditions - COVID-19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Impact of measures taken to contain COVID-19 on hospital surgical care services and clinical outcomes Secondary Outcomes ### Location - Facility: Singapore Health Services Pte ltd, Singapore, N/A, 169856, Singapore @@
## A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia - NCT ID: NCT06285825 - Study ID: 2023-0864 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2028-08-22 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART. ### Conditions - Cytopenia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Emapalumab ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children - NCT ID: NCT06285812 - Study ID: 000003 - Status: RECRUITING - Start Date: 2023-01-10 - Completion Date: 2024-05-30 - Lead Sponsor: PhotoniCare, Inc. ### Study Description A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs. ### Conditions - Otitis Media Acute ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OtoSight Middle Ear Scope ### Outcomes Primary Outcomes - Change the clinician rate of antibiotic prescriptions - Change the number of antibiotic rounds per patient - Change costs associated with management of pediatric patients presenting with ear-related pain Secondary Outcomes - Change in unnecessary antibiotic prescriptions - Change in prescription adherence - Change in antibiotic prescription rate when fluid not present - Improve patient outcomes - Change medical resource utilization - Change unnecessary medical intervention - Impact clinician confidence - Impact caregiver satisfaction - Change in Health-related Quality of Life (HQoL) ### Location - Facility: Children's National Hospital, Washington, District of Columbia, 20010, United States @@
## Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women - NCT ID: NCT06285799 - Study ID: IHAT_ID_2024 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-12-31 - Lead Sponsor: Nemysis Ltd ### Study Description This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks. ### Conditions - Iron-deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Low Dose IHAT - High Dose IHAT - Carob Flour ### Outcomes Primary Outcomes - Percentage of women recovering from iron deficiency at week 12 Secondary Outcomes - Time to reach normalisation of ferritin levels - Change in iron status - Change in fatigue - Incidence and prevalence of gastrointestinal side effects - Iron deficiency symptoms ### Location - Facility: RDC Clinical Pty Ltd, Brisbane, Queensland, 4006, Australia @@
## Patient Handling Techniques and New Technology for Health Care Workers - NCT ID: NCT06285786 - Study ID: REB 2023-109 - Status: RECRUITING - Start Date: 2023-09-20 - Completion Date: 2024-04-20 - Lead Sponsor: University of New Brunswick ### Study Description Patient handling is a major risk-factor for the development of musculoskeletal injuries in healthcare providers. To have a significant impact on injury reduction related to patient handling will require the incorporation of technology. This project is to investigate a piece of technology that has been designed to facilitate in-bed patient handling: The Vendlet.The purpose of this research project is to assess the ability of the Vendlet system outfitted on a Span-America Medical Systems (SAMS) bed to reduce the physical load on healthcare providers performing patient handling tasks. This evidence-based outcomes will be used to support the mitigation of the Vendlet from the European market into the Canadian market. The SAMS bed is currently available in North America and has several adjustable features to support patient transfer activities.The project will provide a biomechanical comparison of commonly used patient handling techniques performed using a SAMS bed outfitted with and without a Vendlet patient transfer device. This Vendlet technology has the potential to significantly reduce the musculoskeletal and joint strain of healthcare providers while handling patients. ### Conditions - Work-related Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Ergonomic Training on Patient Handling Techniques ### Outcomes Primary Outcomes - Neuromuscular Activity - Average muscle activation - Neuromuscular Activity - Peak muscle activation - Motion Capture: To assess postural changes in patient handling technique. - Motion Capture: To assess cumulative load forces - Motion Capture: To assess joint angles - Foot Pressure Distribution: Peak pressure will be the outcome measure of interest to assess postural balance and stability of the participant performing the patient handling technique. - Foot Pressure Distribution: Contact area will be the outcome measure of interest to assess postural balance and stability of the participant performing the patient handling technique. - Bed Pressure Distribution: Average pressure distribution will be outcome measures to assess the safe placement of the patient. - Bed Pressure Distribution: Peak pressure distribution will be outcome measures to assess the safe placement of the patient. Secondary Outcomes - Self Reported Questionnaires - Exit Survey - Rating of Perceived Exertion (RPE) ### Location - Facility: Universite de Moncton, Moncton, New Brunswick, E1A 3E9, Canada @@
## Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery - NCT ID: NCT06285773 - Study ID: Medipol Hospital 36 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-11-10 - Lead Sponsor: Medipol University ### Study Description In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy. ### Conditions - Cardiac Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RIFPB block - Postoperative analgesia management - PIFPB block ### Outcomes Primary Outcomes - Global recovery scoring system / Quality of Recovery 15 questionairre Secondary Outcomes - Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable") - The use of rescue analgesia - The use of rescue analgesia ### Location - Facility: Istanbul Medipol University Hospital, Istanbul, Bagcilar, 34070, Turkey @@
## Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY) - NCT ID: NCT06285760 - Study ID: 135/23 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-02 - Lead Sponsor: Puerta de Hierro University Hospital ### Study Description The goal of this observational study is to assess the natriuretic effect of intravenous acetazolamide in patients admitted with heart failure and persistent congestion despite treatment with intravenous furosemide and sodium-glucose cotransporter type 2 (iSGLT2) inhibitors.The main question it aims to answer is whether there is a difference in natriuresis 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2). ### Conditions - Heart Failure - Persistent Congestion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Standarized diuretic therapy ### Outcomes Primary Outcomes - Change in natriuresis 48 hours after acetazolamide Secondary Outcomes - Increase in diuresis 48 hours after acetazolamide administration - Weight difference 48 hours after acetazolamide administration - Difference in congestion score 48 hours after acetazolamide administration. - Difference in ultrasound measurements 48 hours after acetazolamide administration. ### Location - Facility: Julia González González, Madrid, N/A, 28222, Spain @@
## A Correlational Study: Breast Cancer-related Chest Wall Lymphedema, Quality of Life, and Shoulder Function - NCT ID: NCT06285747 - Study ID: 23-004117 - Status: RECRUITING - Start Date: 2023-07-28 - Completion Date: 2025-08-01 - Lead Sponsor: Mayo Clinic ### Study Description This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function. ### Conditions - Breast Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Chest wall lymphedema - Quality of life - Limb Lymphoedema Quality of Life (LymQOL) - Disability of the shoulder - Disabilities of the Arm, Shoulder and Hand (DASH) Secondary Outcomes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals With Abdominal Distention - NCT ID: NCT06285734 - Study ID: KYLL-202312-049 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-01-07 - Lead Sponsor: Shandong University ### Study Description Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention. ### Conditions - Abdominal Distention ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Breath test ### Outcomes Primary Outcomes - Positive rate of SIBO in patients with abdominal distension Secondary Outcomes - Positive rate of abnormal OCTT in patients with abdominal distension - Correlation between clinical features of patients with abdominal distension and SIBO - Correlation between clinical features of patients with abdominal distension and OCTT ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Delirium Treatment With Transcranial Electrical Stimulation - NCT ID: NCT06285721 - Study ID: DELTES - Status: NOT_YET_RECRUITING - Start Date: 2024-02-26 - Completion Date: 2027-03-31 - Lead Sponsor: A.J.C. Slooter ### Study Description The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with postoperative delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial.To test the safety and feasibility of tACS in delirious patients, the first 30 patients will be randomized to receive either active or sham tACS treatment in a 1:1 ratio through a pilot study. For the main phase of the study, patients will be randomized, resulting in an overall 1:1:1 allocation to standardized tACS, personalized tACS or sham treatment.Electroencephalogram (EEG) will be measured directly before and directly after the first stimulation session to assess whether tACS can reduce relative delta power. tACS or sham treatment will be given once daily for a maximum of 14 days, or until resolution of delirium or discharge (whichever comes first). During the treatment phase, presence and severity of delirium will be assessed daily. After the treatment phase, an additional EEG will be measured. Cognitive status will be assessed three months postoperative. ### Conditions - Delirium ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transcranial alternating current stimulation (tACS) - Sham transcranial alternating current stimulation (tACS) ### Outcomes Primary Outcomes - Relative delta power Secondary Outcomes - Duration of delirium - Severity of delirium - Length of hospital stay - Cognitive status three months post delirium - Subjective sensations during treatment - Average peak frequency - Phase Lag Index - Corrected Amplitude Envelope Correlation (AECc) - Relative power ### Location - Facility: Radboudumc, Nijmegen, Gelderland, 6525 GA, Netherlands @@
## Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD - NCT ID: NCT06285708 - Study ID: 2023B0193 - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2026-01 - Lead Sponsor: Ohio State University ### Study Description The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD. ### Conditions - PTSD - Suicidal Ideation - Suicide, Attempted - Trauma, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Prolonged exposure ### Outcomes Primary Outcomes - Beck Scale for Suicidal Ideation (SSI) - Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) - PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Secondary Outcomes - Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom Measure - Interpersonal Needs Questionnaire (INQ) - Abbreviated - Beck Hopelessness Scale (BHS) - Abbreviated - Brief Suicide Cognitions Scale (SCS) - Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) - Monetary Choice Questionnaire (MCQ) - Behavioral Inhibition Scale (BIS) - Behavioral Activation Scale (BAS) - Patient-Reported Outcomes Measurement Information System (PROMIS) Measures - Patient-Reported Outcomes Measurement Information System (PROMIS) Measures - Patient-Reported Outcomes Measurement Information System (PROMIS) Measures - Patient-Reported Outcomes Measurement Information System (PROMIS) Measures - Patient-Reported Outcomes Measurement Information System (PROMIS) Measures - Patient-Reported Outcomes Measurement Information System (PROMIS) Measures - Patient-Reported Outcomes Measurement Information System (PROMIS) Measures ### Location - Facility: The Ohio State University, Columbus, Ohio, 43210, United States @@
## Clareon Toric Study (T2-T9) - NCT ID: NCT06285695 - Study ID: ILS241-I001 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2028-04 - Lead Sponsor: Alcon Research ### Study Description The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs). ### Conditions - Aphakia - Corneal Astigmatism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Clareon Toric IOL - Cataract surgery ### Outcomes Primary Outcomes - Mean monocular best corrected distance visual acuity (BCDVA) Secondary Outcomes - Mean monocular absolute residual refractive cylinder - Mean absolute IOL rotation from previous visit - Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit ### Location - Facility: Gimbel Eye Centre, Calgary, Alberta, T3B 0M3, Canada @@
## Bioavailability of Hydroxytyrosol in Healthy Adult Humans - NCT ID: NCT06285682 - Study ID: ETH2324-2826 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-03 - Completion Date: 2024-05-01 - Lead Sponsor: Anglia Ruskin University ### Study Description Brief summary: There is current scientific interest in hydroxytyrosol due to its anti-inflammatory and antioxidant properties, efficient protection of vascular tissue and ability to neutralise free radicals via hydrogen donation. Recognised as the potent polyphenol within a commercially available olive-fruit water (OliPhenolia®), data from this research will determine the dose of OliPhenolia® required for the optimum absorption and metabolism of hydroxytyrosol. The primary aim of this research is to identify the dose of hydroxytyrosol (0.5, 1.0 or 1.5 mg∙kg-1) within OliPhenolia® that demonstrates the greatest area under the plasma concentration curve for hydroxytyrosol over a four-hour period. A secondary aim is to assess maximum concentration (CMAX) and time to maximum concentration (TMAX) of total hydroxytyrosol and secondary metabolites (Tyrosol, HT-3-glucoronide, HT-3-sulphate, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein) following consumption of 3 randomised doses of OliPhenolia® on separate occasions with healthy adult volunteers. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - OliPhenolia®) ### Outcomes Primary Outcomes - Hydroxytyrosol bioavailability - Bioavailability of hydroxytyrosol metabolites. Secondary Outcomes - Hydroxytyrosol CMax - Hydroxytyrosol TMAX - CMAX of hydroxytyrosol secondary metabolites - TMAX of hydroxytyrosol secondary metabolites ### Location - Facility: Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University, Cambridge, N/A, CB5 8DZ, United Kingdom @@
## Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants - NCT ID: NCT06285669 - Study ID: KA18/35 - Status: COMPLETED - Start Date: 2018-01-01 - Completion Date: 2020-06-30 - Lead Sponsor: Ondokuz Mayıs University ### Study Description This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV. It is hypothesized that the application of kinesio taping to the chest area of preterm infants may improve respiratory functions and oxygenation at the alveolar level, leading to decreased work of breathing, reduced respiratory rate, and improved neonatal stability by promoting respiratory mechanics and enhancing chest expansion. ### Conditions - Preterm - Premature - Infant, Newborn, Diseases - Respiratory Distress Syndrome - Neonatal Respiratory Distress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - kinesiotaping application ### Outcomes Primary Outcomes - Level of pH Secondary Outcomes ### Location - Facility: Nilay Çömük Balci, Samsun, Atakum, 55139, Turkey @@
## Femoral Blood Gas and Prediction of Postoperative Bleeding - NCT ID: NCT06285656 - Study ID: ASH-KG - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10-03 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description Postoperative bleeding is still an important concern after major abdominal surgery. Postoperative bleeding is the most important determinant of morbidity and death. It results in longer hospital stays, the necessity for extra radiological tests, interventional radiology treatments, and the possibility of reoperation. Early detection of postoperative bleeding reduces morbidity and mortality with appropriate intervention.Simultaneous arterial and venous blood gas measurements can be used to quickly identify the degree of bleeding and the need for replacement in serious trauma patients brought to the emergency room.Lactate levels, venous oxygen saturation, and the differential in partial pressure of carbon dioxide between arterial and venous blood can all be used to indicate the requirement for replacement, as demonstrated in several studies. The purpose of this study is to evaluate lactate levels, venous oxygen saturation, and arterial-venous partial pressure of carbon dioxide difference in blood gas analysis in order to assess the severity of bleeding in patients undergoing major abdominal surgery as early as possible and perform replacement as soon as possible. ### Conditions - Postoperative Hemorrhage - Blood Transfusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Eritrocyte replacement Secondary Outcomes - Postoperative Hemmorhagea ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD) - NCT ID: NCT06285643 - Study ID: ASK-PD5-CS201 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-11-30 - Lead Sponsor: Asklepios Biopharmaceutical, Inc. ### Study Description The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AAV2-GDNF Gene therapy - Control Surgery ### Outcomes Primary Outcomes - Motor symptoms-MDS-UPDRS parts 2 and 3 - PD Motor Diary Non-Motor symptoms-MDS-UPDRS part1 - PDQ39 Levodopa Equivalent Daily Dose Secondary Outcomes - Change from baseline in the MDS-UPDRS parts 2 and 3, and the PD Motor Diary - Change from baseline in the MDS-UPDRS part 1 and PDQ-39 - Change in Levodopa equivalent daily dose ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Development and Health of the Intestinal Flora During the First Year of Life - NCT ID: NCT06285630 - Study ID: Alba101 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-26 - Completion Date: 2024-12-20 - Lead Sponsor: Alba Health AB ### Study Description In this research study (PREVENT 1), Alba Health, in collaboration with academic institutions (Uppsala University, COPSAC and University of Antwerp) is investigating the association between the developing gut microbiota (collection of microbes present in the human gut) in the first year of life and lifestyle, wellbeing and health in a Swedish population. The study is the first of its kind in a Swedish population to collect and associate microbiome composition to an extensive family history and health questionnaire, stool colour and crying type, building on learnings from previous studies performed in other countries, such as the HELMI and COPSAC studies (HELMI - Finnish Health and Early Life Microbiota cohort from the University of Helsinki in Finland; COPSAC - Copenhagen Prospective Studies on Asthma in Childhood in Denmark).The PREVENT 1 study is an observational research study led by Alba Health involving 300 families in Sweden with children between 0 and 12 months of age at the time of the study's start. After providing informed consent, the participating families will be asked to provide three stool samples from their child (the sample collection is not invasive and does not cause discomfort) and will be asked to answer questionnaires on lifestyle, well-being and family health. The participating families will not be asked to change their lifestyle beyond sample and data collection.From the collected stool samples, we will extract microbial DNA and subject this to deep metagenomic sequence analysis. The study will only analyze microbial DNA, any human related material will be discarded. The stool samples will be destroyed within one month of sequencing (maximum 3 months from collection). The data will be stored according to GDPR and Swedish law, with informed consent in Sweden and with appropriate security measures. All research will be carried out in Sweden. ### Conditions - Healthy - Microbial Colonization ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational, no intervation will be made ### Outcomes Primary Outcomes - Microbiome composition of infants in variable age ranges Secondary Outcomes - Is the composition associated with and gastrointestinal issues ### Location - Facility: Alba Health AB, Stockholm, N/A, N/A, Sweden @@
## Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis - NCT ID: NCT06285617 - Study ID: 2022GDRC016 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-30 - Lead Sponsor: Xinqiao Hospital of Chongqing ### Study Description The goal of this clinical trial is to compare the efficacy and safety of short-term versus 6-week prednisone in the treatment of moderate-to-severe subacute thyroiditis. The main questions it aims to answer are: Does the short-term medication regimen reduce glucocorticoid side effects while achieving similar efficacy as the guideline treatment group? Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/day prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy in the control group. ### Conditions - Subacute Thyroiditis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 1-week predisone+1-week celecoxib - 6-weeks predisone ### Outcomes Primary Outcomes - The difference in efficacy between the two groups at the completion. Secondary Outcomes - Thyroid function - Total cholesterol (TC) - Triglycerides (TG) - Systolic blood pressure (SBP) - Diastolic blood pressure (DBP) - Parathyroid hormone (PTH) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia - NCT ID: NCT06285604 - Study ID: IRB-20230398-R - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2025-12-31 - Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University ### Study Description The goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. The main questions it aims to answer are:* Objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy.* To provide objective basis for clinical rational use of blood in the selection of blood products.Participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators. ### Conditions - Neonatal Anemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood transfusion ### Outcomes Primary Outcomes - Clinical efficacy of different red blood cell products transfusion in anemic neonates - The changes of inflammatory response before and after transfusion in anemic neonates Secondary Outcomes ### Location - Facility: Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, 310006, China @@
## Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors - NCT ID: NCT06285591 - Study ID: 2023-1801 - Status: RECRUITING - Start Date: 2023-11-10 - Completion Date: 2025-03-31 - Lead Sponsor: West China Hospital ### Study Description Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients. Lactobacillus Reuteri is a natural flora of the human body that can be found in the gastrointestinal tract, skin, etc. Among them, Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can be isolated from healthy mammals as well as poultry, and are common Lactobacillus strains marketed for the production of oral probiotics, which are commonly used in infant formulas, among others. In oral inflammatory diseases, it has been reported in the literature that Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can reduce gingival and periodontal inflammation, mainly through the mechanisms of modulating the host inflammatory response and displacing pathogenic bacteria. In terms of safety, oral Lactobacillus Reuteri has good stability, very low pathogenic potential, and is not toxic to humans. Therefore, this study is a placebo-controlled, multi-center, open, randomized controlled clinical study to evaluate the efficacy of Lactobacillus Reuteri for the prevention of radioactive oral mucosal reactions in intensity-modulated radiotherapy for head and neck tumors, including nasopharyngeal carcinoma. ### Conditions - Oral Mucositis (Ulcerative) Due to Radiation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Lactobacillus Reuteri Tablets - Placebo-containing tablets - Radiotherapy ### Outcomes Primary Outcomes - The incidence of Severe Oral mucositis (WHO grade ≥3) - The time to onset of Severe Oral mucositis (WHO grade ≥3) - The duration of Severe Oral mucositis (WHO grade ≥3) Secondary Outcomes - Taste function - Xerostomia summated xerostomia inventory (SXI) - Functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire - Adverse events - Oral activities scores - Mouth and throat soreness (MTS) scores ### Location - Facility: West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China @@
## Effects of Probiotic and HIIT in Obese Women - NCT ID: NCT06285578 - Study ID: MOST 107-2410-H-277-003 - Status: COMPLETED - Start Date: 2018-10-01 - Completion Date: 2019-03-01 - Lead Sponsor: University of Taipei ### Study Description The aim of this study is to investigate whether there are the additive effects when implementing both high-intensity interval training (HIIT) and probiotics simultaneously on improving cardiorespiratory endurance and metabolism in middle-aged women. ### Conditions - Cardiorespiratory Fitness - Metabolism - Anthropometry ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Probiotics supplementation - HIIT training - Placebo supplementation ### Outcomes Primary Outcomes - Height - Body weight - Body mass index (BMI) - Body fat percentage - Waist circumference - Hip circumference - Maximum oxygen uptake (VO2max) - Time to exhaustion (TTE) - Running economy (RE) - Fasting blood glucose (FBG) - Total cholesterol (TC) - Triglyceride (TG) - High-density lipoprotein cholesterol (HDL-C) - Low-density lipoprotein cholesterol (LDL-C) Secondary Outcomes - Muscle mass - Fat mass - Bone mineral density (BMD) - Caloric intake ### Location - Facility: University of Taipei, Taipei, N/A, N/A, Taiwan @@
## A Nurse-led Coaching Programme With Telemonitoring in Heart Failure - NCT ID: NCT06285565 - Study ID: CE390/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Alberto Dal Molin ### Study Description The goal of this pilot interventional study is to assess the feasibility and acceptability of a supportive intervention for patients affected by heart failure. The main questions it aims to answer are:* Are implementation strategies effective in facilitating participant fidelity?* What factors contribute to patients' satisfaction with the designed intervention, and how can these be optimized for improved patient experience and adherence?* Are the methods and tools established the most appropriate to ensure the completeness of the data collection?Participants will follow a combined intervention consisting of:1. pre-discharge educational meeting;2. telephone nurse-led coaching sessions;3. home telemonitoring of vital signs.In the main trial, researchers will compare data from the intervention group with a control group to assess whether it reduces hospitalization rates and improves self-care capabilities ### Conditions - Heart Failure - Telemonitoring - Hospitalizations - Feasibility - Mentoring ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Nurse-led telephone coaching intervention with home telemonitoring of vital signs ### Outcomes Primary Outcomes - Recruitment rate - Retention rate - Adherence to the coaching intervention - Adherence to telemonitoring program - Completeness of data collection Secondary Outcomes - 90- and 180-day all-cause hospital readmissions - 90- and 180-day heart failure-related hospital readmissions - 90- and 180-day Emergency Departments visits - 90- and 180-day General Practioner visits - 90- and 180-day oupatient visits - Self-care capacity (Self-Care of Heart Failure Index ) - Self Care - Self-Efficacy Scale - Quality of life (SF-12 scale) - Anxiety (Hamilton Anxiety Scale ) - Depression (Geriatric Depression Scale) - Heart Failure Somatic Perception Scale v.3 (HFSPS) - Mortality ### Location - Facility: Università del Piemonte Orientale Amedeo Avogadro, Novara, N/A, 28100, Italy @@
## Evaluation of the Comprehensive Family Support Program (PAIF) - NCT ID: NCT06285552 - Study ID: 4792/0842 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2026-07 - Lead Sponsor: University of Seville ### Study Description The goal of this study is to evaluate the effectiveness of positive parenting programs targeted to parents of toddlers, children and adolescents carried out in Cantabria (Spain).We will collect information from the participants before the intervention, in the last session of the program and some months after, to verify if there have been some changes in the family dynamics of these parents, and if these changes continue after some time. Besides, we will compare these results with information from other families that are not taking part in the program. The main caregivers of the participating families and the practitioners in charge of the intervention will provide the information for the study.We expect that families participating in the programs will improve their parenting competencies and their family dynamics, and that these change will stay after the program. ### Conditions - Parenting ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Positive parenting PAIF program ### Outcomes Primary Outcomes - Perception of the parental role - Parenting practices (Authoritative parenting style: Warmth and Support, Reasoning/Induction, Democratic Participation) - Parenting practices (Overreactivity and Laxness) Secondary Outcomes - Satisfaction with the intervention - Children adjustment - Social support - Satisfaction with Family Life ### Location - Facility: Consejería de Inclusión Social, Juventud, Familias E Igualdad, Santander, Cantabria, 39004, Spain @@
## Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases - NCT ID: NCT06285539 - Study ID: 2022-502968-20 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: UMC Utrecht ### Study Description Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations. Patients with Behçet's disease (BD), idiopathic inflammatory myopathy (IIM, also known as myositis) and IgG4-related disease (IgG4-RD) are treated with high-dosed glucocorticoids, methotrexate, azathioprine and mycophenolate mofetil, mostly for long periods of time with attendant risks of long-term toxicity, including infections. Therefore, there is an urgent need for new, more specific anti-inflammatory therapies such as targeted synthetic and biological disease-modifying antirheumatic drugs. Due to the role of type 1 interferon in both BD, IIM and IgG4-RD, JAK-STAT inhibition may be a promising treatment strategy in these conditions, because JAK1 is critical for the signal transduction of pro-inflammatory cytokine receptors. Previous research showed that JAK1 inhibition reduces activation of type 1 interferon-regulated proteins and key chemokines that control tissue inflammation. ### Conditions - Behcet's Disease - Idiopathic Inflammatory Myopathies - IgG4-related Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Filgotinib ### Outcomes Primary Outcomes - EQ-5D-5L - Disease activity in Behcet's patients - Disease activity in myositis patients - Disease activity in IgG4-RD patients Secondary Outcomes - Corticosteroid toxicity - Corticosteroid dosage - VAS score of pain - Fatigue - Treatment-related adverse events ### Location - Facility: Amsterdam UMC, Amsterdam, N/A, N/A, Netherlands @@
## Glycocalyx Monitoring in Major Abdominal Surgery - NCT ID: NCT06285526 - Study ID: 2023/0046/OB - Status: RECRUITING - Start Date: 2022-07-05 - Completion Date: 2025-01-05 - Lead Sponsor: University Hospital, Rouen ### Study Description The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters. ### Conditions - Major Abdominal Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy - Cephalic DuodenoPancreatectomy ### Outcomes Primary Outcomes - Glycocalyx thickness Secondary Outcomes - Glycocalyx thickness and a biological marker of tissue hypoperfusion - Glycocalyx thickness and a biological marker of tissue hypoxia - Blood cell velocity and macrocirculatory function - Perfused capillary density and macrocirculatory function - Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1 ### Location - Facility: Rouen University Hospital, Rouen, N/A, 76000, France @@
## Cardiovascular Metabolic Remodeling in Shock - NCT ID: NCT06285513 - Study ID: 2021/387/OB - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-02 - Lead Sponsor: University Hospital, Rouen ### Study Description The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved. ### Conditions - Shock ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cardiac ultrasound ### Outcomes Primary Outcomes - Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock Secondary Outcomes ### Location - Facility: University Hospital of Rouen, Rouen, N/A, N/A, France @@
## Umbrella Study for Single Patient Treatments in Oncology - NCT ID: NCT06285500 - Study ID: UNIQUE - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2029-02-01 - Lead Sponsor: University Health Network, Toronto ### Study Description The purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments. ### Conditions - Advanced Cancer - Rare Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patient-specific treatments ### Outcomes Primary Outcomes - Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy Secondary Outcomes - Overall survival rate - Progression-free survival rate - Number of participants with adverse events as assessed by CTCAE v5.0 ### Location - Facility: University Health Network, Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada @@
## Depression in Youth Onset Type 2 Diabetes - NCT ID: NCT06285487 - Study ID: 23-1600 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-06 - Lead Sponsor: University of Colorado, Denver ### Study Description The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes. ### Conditions - Type 2 Diabetes - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Group Program ### Outcomes Primary Outcomes - Acceptability of IPT-T2D - Depression Changes - Changes in Glycemic Control Secondary Outcomes ### Location - Facility: Children's Hospital Colorado, Aurora, Colorado, 80045, United States @@
## Investigating LIFUP in Anhedonic Depression - NCT ID: NCT06285474 - Study ID: 22-001323 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-10-27 - Completion Date: 2024-04-30 - Lead Sponsor: University of California, Los Angeles ### Study Description This study will observe changes in brain imaging, behavior, and symptom measures following intervention with low intensity focused ultrasound pulsation (LIFUP) targeting reward circuitry in individuals who are depressed and anhedonic. ### Conditions - Depression - Anhedonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Low Intensity Focused Ultrasound Pulsation (LIFUP) ### Outcomes Primary Outcomes - Change in Patient health questionnaire-14 self report measure (PHQ-14) from baseline - Change in Positive valence systems scale-21 self report measure (PVSS-21) from baseline - Changes in MRI images from Pre-scan to week 5 - Change in Ecological momentary assessment (EMA) from W0/Baseline Secondary Outcomes - Changes in digital behavioral phenotype sleep measurement - Changes in digital behavioral phenotype physical activity measurement - Changes in heart rate - Changes in heart rate variability - Changes in respiratory rate - changes in World Health Organization (WHO) -5 Wellbeing index score from W0/Baseline to end of study - changes in Pittsburgh Sleep Quality Index (PSQI) score from W0/Baseline to end of study ### Location - Facility: University of California Los Angeles, Los Angeles, California, 90095-1563, United States @@
## Food Intake, Endocrine Factors and Brown Fat - NCT ID: NCT06285461 - Study ID: T2566/2023 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2026-06-30 - Lead Sponsor: Turku University Hospital ### Study Description This study will investigate how the acute intake of foods with high and low hedonic reward differentially affects brown adipose tissue and the interplay between gut peptides, brown fat, and the brain (gut-BAT-brain axis). ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Non-palatable meal - Palatable meal ### Outcomes Primary Outcomes - Brown adipose tissue metabolism - Changes in gut peptides - Differences in μ-opioid receptors in the human brain Secondary Outcomes - Energy expenditure/Meal-induced thermogenesis - Visual Analogue scale (VAS) ### Location - Facility: Turku PET Centre, Turku, N/A, 20520, Finland @@
## Feasibility of Lecanemab Registry and Clinical Outcome Measures - NCT ID: NCT06285448 - Study ID: A24-028 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-02 - Completion Date: 2026-06-30 - Lead Sponsor: HealthPartners Institute ### Study Description Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners. ### Conditions - Alzheimer Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lecanemab ### Outcomes Primary Outcomes - Feasibility of enrollment - Feasibility of completing visits - Qualitative experience at 3 months - Qualitative experience at 12 months Secondary Outcomes ### Location - Facility: HealthPartners Neuroscience Center, Saint Paul, Minnesota, 55130, United States @@
## Coagulation Activation in Patients With Pemphigus - NCT ID: NCT06285435 - Study ID: coagulation activation in PV - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-02 - Lead Sponsor: Assiut University ### Study Description Aim of work:1. To evaluate the plasma markers of coagulation activation: prothrombin F1+2 and d-dimer levels in pemphigus patients with active disease and compare them with age and sex-matched controls.2. To evaluate the correlation of these markers with disease severity score by using Pemphigus Disease Area Index (PDAI) and with disease activity by measurement of anti-desmoglein 1 and 3 antibody titers. ### Conditions - Pemphigus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - prothrombin fragment 1+2 ### Outcomes Primary Outcomes - Comparison of coagulation activation markers in pemphigus patients with controls Secondary Outcomes - Correlation of markers with disease severity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study Evaluating SC262 in Subjects With r/r B-cell Malignancies (VIVID) - NCT ID: NCT06285422 - Study ID: SC262-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-03 - Lead Sponsor: Sana Biotechnology ### Study Description SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers. ### Conditions - Non Hodgkin's Lymphoma - Large B-cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SC262 ### Outcomes Primary Outcomes - Evaluate safety and tolerability of SC262 Secondary Outcomes - Evaluate preliminary anti-tumor activity of SC262 - Evaluate cellular kinetics and persistence of SC262 - Evaluate cellular kinetics and persistence of SC262 - Evaluate cellular kinetics and persistence of SC262 - Evaluate host immunogenicity to SC262 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium - NCT ID: NCT06285409 - Study ID: 24-02 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2024-10 - Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital ### Study Description This study will investigate the effects of drugs called "uterotonics" that help with the contraction of the uterus after a baby is born. This uterine contraction is very important to stop the bleeding after delivery. An uncontracted uterine state is called "uterine atony", which can lead to an excessive amount of post-delivery bleeding. Carbetocin is an uterotonic drug that works well to prevent post-delivery bleeding. In some cases, carbetocin is not enough to contract the uterus, and ongoing bleeding continues. When that happens, there are other uterotonic medications that can be used. In this study, we aim to find which uterotonic drug, amongst those available (oxytocin, carbetocin, ergometrine or carboprost), is more effective to lower the risk of post-delivery bleeding once carbetocin has already been administered.This study will be done by using a very small sample of uterine tissue, taken from the incision site, following delivery by cesarean section. The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs. The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further. ### Conditions - Postpartum Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Carbetocin - Oxytocin - Carbetocin - Oxytocin - Ergonovine - Carboprost ### Outcomes Primary Outcomes - Motility index Secondary Outcomes - Amplitude of contraction - Frequency of contraction - Integrated area under response curve (AUC) ### Location - Facility: Mount Sinai Hospital, Toronto, Ontario, M5G1X5, Canada @@
## Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study - NCT ID: NCT06285396 - Study ID: 24-01 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-07 - Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital ### Study Description The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes.Spinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH.It is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory. ### Conditions - Postpartum Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ephedrine - Phenylephrine - Norepinephrine - Oxytocin ### Outcomes Primary Outcomes - Motility index Secondary Outcomes - Amplitude of contraction - Frequency of contraction - Integrated area under response curve (AUC) ### Location - Facility: Mount Sinai Hospital, Toronto, Ontario, M5G1X5, Canada @@
## The Effects of Music on Neck Pain - NCT ID: NCT06285383 - Study ID: Kar.neck - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-04-15 - Lead Sponsor: KTO Karatay University ### Study Description The effects of passive music listening on pain, anxiety and quality of life in patients with chronic neck pain in addition to physical therapy will be examined. ### Conditions - Pain, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Music listening - classic physical therapy ### Outcomes Primary Outcomes - Beck anxiety inventory - Visual Analogue Scale - Short form-36 Secondary Outcomes ### Location - Facility: Mustafa Savaş Torlak, Karatay, Eyalet/Yerleşke, 42000, Turkey @@
## A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy - NCT ID: NCT06285370 - Study ID: 0761-CN001 - Status: RECRUITING - Start Date: 2023-05-29 - Completion Date: 2026-01-31 - Lead Sponsor: Kyowa Kirin China Pharmaceutical Co., Ltd. ### Study Description The purpose of the study is to evaluate the efficacy and safety of mogamulizumab (KW-0761) in chinese subjects with mycosis fungoides or sézary syndrome previously treated with systemic therapy ### Conditions - Cutaneous T-Cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Mogamulizumab ### Outcomes Primary Outcomes - Overall Response Rate Secondary Outcomes - Skin disease response rate; - Lymth nodes response rate - Visceral metastases response rate; - Blood disease response rate; - Progression Free Survival - Duration of response (DOR) - Time to response (TTR) - Response rate of lymph node evaluated by Lugano 2014. - Response rate of viscera evaluated by Lugano 2014 criteria. ### Location - Facility: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China @@
## The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection. - NCT ID: NCT06285357 - Study ID: EPISTOP_22 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2025-12 - Lead Sponsor: Lo.Li.Pharma s.r.l ### Study Description The purpose of the study is to test the effect of the administration of a dietary supplement consisting of epigallocatechin gallate (EGCG), vitamin B12 and folic acid in the treatment of infections with papilloma virus of the cervix. ### Conditions - HPV Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EGCG + folic acid + B12 ### Outcomes Primary Outcomes - HPV DNA test negativity Secondary Outcomes ### Location - Facility: Azienda Ospedaliero-Universitaria di Modena, Modena, N/A, 41124, Italy @@
## Impact of Workload and Fatigue on Sleep in OR Nurses - NCT ID: NCT06285344 - Study ID: kilis_3 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-01 - Lead Sponsor: Kilis 7 Aralik University ### Study Description This study aims to explore the impact of individual workload and fatigue levels on the sleep quality of operating room (OR) nurses, highlighting a critical aspect of healthcare professionals' well-being that directly affects patient safety and care quality. Operating room nurses face unique challenges due to the high-stress, fast-paced environment of surgical settings, which can lead to increased stress levels, emotional challenges, and a higher incidence of fatigue compared to other nursing specialties. Factors contributing to this fatigue include the demanding nature of surgical procedures, the need for constant vigilance, and the irregular hours associated with shift work, all of which can impair sleep quality.The literature review suggests that while the relationship between workload, fatigue, and sleep quality has been extensively studied in general nursing populations, there is a lack of specific focus on operating room nurses. These professionals work under distinct conditions that may exacerbate the effects of workload and fatigue on sleep quality, yet comprehensive studies targeting this group are limited. Understanding the nuances of how workload and fatigue specifically impact the sleep quality of OR nurses is crucial for developing targeted interventions aimed at improving their health and job performance, thereby enhancing patient care and safety.This cross-sectional and correlational study seeks to fill the gap in the literature by examining the specific effects of workload and fatigue on sleep perception among OR nurses. By identifying these relationships, the study aims to contribute valuable insights into strategies for mitigating fatigue and improving sleep among this critical group of healthcare workers, with the ultimate goal of ensuring both nurse well-being and patient safety. ### Conditions - Shift Work - Sleep Perception ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Demographic Information Form - Individual Workload Perception Scale (IWPS) - Chalder Fatigue Scale (CFS) - Richard-Campbell Sleep Questionnaire (RCSQ) Secondary Outcomes ### Location - Facility: Islam Elagöz, Kilis, N/A, 79100, Turkey @@
## the Impact of Manual or Mechanical Ways to Perform PLR on the Accuracy of Evaluation of Fluid Responsiveness - NCT ID: NCT06285331 - Study ID: 2023ZDSYLL483-P01 - Status: RECRUITING - Start Date: 2023-11-06 - Completion Date: 2025-12-31 - Lead Sponsor: Southeast University, China ### Study Description Our goal was to study the impact of different ways to perform passive leg raising (PLR) on the accuracy of evaluation of fluid responsiveness. ### Conditions - Circulatory Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Automatic Bed - Manual ### Outcomes Primary Outcomes - Accuracy of fluid responsiveness evaluation Secondary Outcomes - Mortality ### Location - Facility: Zhongda Hospital Southeast University, Nanjing, Jiangsu, 210009, China @@
## A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials - NCT ID: NCT06285318 - Study ID: 64007957MMY4004 - Status: RECRUITING - Start Date: 2023-12-18 - Completion Date: 2026-01-28 - Lead Sponsor: Janssen-Cilag Ltd. ### Study Description The purpose of this study is to describe the use of teclistamab in the treatment of patients with RRMM outside of clinical trials. ### Conditions - Relapsed/Refractory Multiple Myeloma (RRMM) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - teclistamab ### Outcomes Primary Outcomes - Describe Baseline Characteristics of Patients with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab Outside of Clinical Trials Secondary Outcomes - Describe the Use of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials - Describe the Safety Management of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials - Describe the Clinical Outcomes of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials ### Location - Facility: Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## Surgical ICU Nurses' Attitudes on End-of-Life Care - NCT ID: NCT06285305 - Study ID: kilis_2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-01 - Lead Sponsor: Kilis 7 Aralik University ### Study Description This study aims to explore the attitudes and behaviors of nurses working in surgical intensive care units (ICUs) towards end-of-life care, alongside identifying the barriers they face in providing such care. Despite the universal need for end-of-life care, with an estimated 56.8 million people requiring it annually, only a fraction receive adequate services. The concept of a "good death" has evolved, now emphasizing patient and family wishes, and aligning with clinical, cultural, and ethical standards. In the U.S., a significant portion of deaths occur in hospitals, often involving surgical interventions in the final stages of life. Nurses in ICUs play a crucial role in delivering end-of-life care, making their attitudes and behaviors pivotal to the quality of care provided. Previous studies have indicated a positive correlation between nurses' attitudes towards end-of-life care and their ethical conduct in care delivery. However, research specifically focusing on surgical ICU nurses and the challenges they encounter in end-of-life care is limited. This study seeks to fill that gap, enhancing understanding of the factors that influence end-of-life care in surgical ICUs and potentially guiding improvements in care practices and policy. ### Conditions - PATİENT CARE - Intensive Care Unit ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Descriptive Information Form - Attitudes and Behaviors Towards End-of-Life Care Scale for Intensive Care Nurses - Barriers to End-of-Life Care in Surgical Intensive Care Form Secondary Outcomes ### Location - Facility: Islam, Kilis, N/A, 79100, Turkey @@
## Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence. - NCT ID: NCT06285292 - Study ID: RC24_0097 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: Nantes University Hospital ### Study Description Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Innovative devices offer self-training exercises for the pelvicfloor, thus promoting motivation and adherence to treatment. The hypothesis of this study is to prove that the use of a pelvicfloor medical device combined with 2 rehabilitation sessions is not inferior to pelvic-perineal rehabilitation. ### Conditions - Urinary Incontinence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EMY ### Outcomes Primary Outcomes - Urinary symptoms using the ICIQ-UI SF questionnaire Secondary Outcomes - Quality of life using the I-QoL questionnaire - Urinary symptoms using the ICIQ-UI SF questionnaire - Cost-utility ratio using the EQ-5D questionnaire - Qualitative component ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## FKC288 in Participants With Autoimmune Kidney Diseases - NCT ID: NCT06285279 - Study ID: NJCT-2401 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2028-12-31 - Lead Sponsor: Nanjing University School of Medicine ### Study Description This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10\^6 cells/kg, 1.0×10\^6 cells/kg, 3.0×10\^6 cells/kg, and an alternative dose of 0.1×10\^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases). ### Conditions - Lupus Nephritis - ANCA-associated Vasculitis - Membranous Nephropathy - PLA2R Induced - IgG4-Related Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - FKC288 ### Outcomes Primary Outcomes - The proportion of subjects with dose-limiting toxicity - The proportion of subjects with adverse events Secondary Outcomes - Proportion of subjects achieving renal response - Duration of response (DoR) of all subjects - Progression-free survival (PFS) of all subjects - Overall survival (OS) of all subjects ### Location - Facility: Jinling Hospital, Nanjing, Jiangsu, 210016, China @@
## Nursing Students' Perceptions and Participation in Surgical Clinical Learning - NCT ID: NCT06285266 - Study ID: kilis_1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-06-01 - Lead Sponsor: Kilis 7 Aralik University ### Study Description This cross-sectional study investigates the perceptions of nursing students regarding the clinical learning environment (CLE) in surgical services and their participation in clinical practices. Surgical services present a complex, dynamic, and intense learning environment crucial for the development of nursing students' professional competencies. The study explores the challenges nursing students face in these settings, including limited opportunities for participation in intraoperative processes and intensive care units, and the impact of these challenges on their learning outcomes and professional development.Previous research has highlighted various factors that can either facilitate or hinder nursing students' ability to engage effectively in clinical practices, such as the learning atmosphere, support from nurse educators, peer support, and effective communication. However, there is a noted gap in understanding the specific difficulties encountered in surgical services, the adequacy of students' clinical skills and knowledge, and their ability to apply theoretical knowledge in practice.By examining nursing students' experiences, this study aims to shed light on the suitability and quality of CLEs in surgical services, contributing valuable insights for optimizing clinical learning and enhancing nursing education programs. The hypotheses tested whether nursing students' perceptions of CLEs in surgical services and their participation in clinical practices are influenced by their descriptive characteristics.Keywords: Nursing Student, Surgical Services, Clinical Practice, Clinical Learning Environment ### Conditions - Clinical Practice ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Descriptive Characteristics Form - Clinical Learning Environment Scale (CLES): - Clinical Practice Participation Determination Form: Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial - NCT ID: NCT06285253 - Study ID: MIRO-01-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-02-28 - Lead Sponsor: Miromatrix Medical Inc. ### Study Description The clinical trail will assess the safety of miroliverELAP for the treatment of acute liver failure without underlying chronic liver disease. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a transplantable liver. ### Conditions - Acute Liver Failure - Acute Liver Injury, Drug Induced ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - miroliverELAP treatment ### Outcomes Primary Outcomes - Survival - Adverse Events Secondary Outcomes - 21-day survival ### Location - Facility: University of California San Francisco Medical Center, San Francisco, California, 94143, United States @@
## Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007) - NCT ID: NCT06285240 - Study ID: 1167-007 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2024-07-25 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description The main purpose of this study is to assess the safety and efficacy of MK-1167 administered to participants with Alzheimer's Disease (AD) receiving stable Donepezil treatment. ### Conditions - Alzheimer's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MK-1167 - Donepezil - Placebo ### Outcomes Primary Outcomes - Number of participants experiencing an Adverse Event (AE) - Number of participants discontinuing study treatment due to an AE Secondary Outcomes - Area Under the Plasma Concentration-Time Curve from Dosing to 24 Hours Postdose (AUC0-24) of MK-1167 - Maximum Plasma Concentration (Cmax) of MK-1167 - Plasma Concentration at 24 hours postdose (C24) - Time to Reach Maximum Plasma Concentration (Tmax) of MK-1167 - Apparent Terminal Half-Life (t½) of MK-1167 - Oral Clearance (CL/F) of MK-1167 from Plasma - Apparent Volume of Distribution (Vz/F) of MK-1167 ### Location - Facility: Velocity Clinical Research, Hallandale Beach ( Site 0001), Hallandale Beach, Florida, 33009, United States @@
## Study of CM313 in Healthy Subjects - NCT ID: NCT06285227 - Study ID: CM313-100001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-04-30 - Lead Sponsor: Keymed Biosciences Co.Ltd ### Study Description This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - CM313 injection ### Outcomes Primary Outcomes - Adverse event Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome - NCT ID: NCT06285214 - Study ID: OAG1050 - Status: RECRUITING - Start Date: 2022-05-26 - Completion Date: 2026-06 - Lead Sponsor: Imbrium Therapeutics ### Study Description The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo. ### Conditions - Interstitial Cystitis/Bladder Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - V117957 - Placebo ### Outcomes Primary Outcomes - Change from baseline for bladder pain/discomfort scores over last 12 hours (morning and evening). Secondary Outcomes - Change from baseline in mean number of micturitions per 12 hours (morning and evening) - Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS) - Change from baseline in Bladder Pain / Interstitial Cystitis Symptom Score (BPIC-SS) - Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) - Change from baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) - Change from baseline in Subject Global Response Assessment (SGRA) - Change from baseline in Symptom Impact Sleep Questionnaire (SISQ) ### Location - Facility: Urology Centers of Alabama, PC, Homewood, Alabama, 35209, United States @@
## Study of Felzartamab in Healthy Adult Subjects - NCT ID: NCT06285201 - Study ID: TJ202001BE104 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2024-12-31 - Lead Sponsor: TJ Biopharma Co., Ltd. ### Study Description A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design) ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - T - R ### Outcomes Primary Outcomes - Primary PK Endpoint Secondary Outcomes ### Location - Facility: The First Hospital of Jilin University, Jilin, Changchun, N/A, China @@
## Immunomonitoring of Mold Invasive Infections - NCT ID: NCT06285188 - Study ID: APHP221174 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Mold invasive infections are associated with an important mortality despite optimization of the antifungal treatment. In a few case reports, immune checkpoints inhibitors, initially developed for neoplastic diseases, have shown a potential beneficial effect in such devastating infections by restoring an efficient immune response. The investigators propose a longitudinal monitoring of the adaptative immune response, notably immune checkpoint expression on T cells, during mold invasive infections to help identify the patients who could benefit from the adjunction of immunotherapy and the optimal timing of such strategy. ### Conditions - Invasive Fungal Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Immune checkpoint expression on T cells Secondary Outcomes - Aspergillus/Mucorales FLUOROSPOT - T cell proliferation - Immune checkpoint expression on monocytes ### Location - Facility: Hôpital Necker Enfants Malades, Paris, N/A, 75015, France @@
## REINVENT: A Brain and Muscle Computer Interface for Stroke - NCT ID: NCT06285175 - Study ID: APP-22-04497 - Status: COMPLETED - Start Date: 2021-06-01 - Completion Date: 2024-02-15 - Lead Sponsor: University of Southern California ### Study Description Stroke is a leading cause of adult disability in the United States. High doses of repeated task-specific practice have shown promising results in restoring upper limb function in chronic stroke (\>6 months after onset). However, it is currently challenging to provide such doses in standard clinical practice. At-home telerehabilitation services supervised by a clinician are a potential solution to provide higher-dose interventions. However, telerehabilitation systems developed for repeated task-specific practice typically require a minimum level of active movement. Therefore, severely impaired people necessitate alternative therapeutic approaches. Measurement and feedback of electrical muscle activity via electromyography (EMG) have been previously implemented in the presence of minimal or no volitional movement to improve motor performance in people with stroke. Specifically, muscle neurofeedback training to reduce unintended co-contractions of the impaired hand may be a targeted intervention to improve motor control in severely impaired populations. In this study, we examine the effects of a low-cost, portable, and modular EMG biofeedback system (Tele-REINVENT) for supervised and unsupervised upper limb telerehabilitation after stroke during a 6-week home-based training program that reinforces activity of the wrist extensor muscles while avoiding coactivation of flexor muscles via computer games. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tele-REINVENT ### Outcomes Primary Outcomes - Fugl Meyer Assessment - Upper Extremity - Maximum EMG activity - Corticomuscular coherence Secondary Outcomes ### Location - Facility: University of Southern California, Los Angeles, California, 90033, United States @@
## Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy - NCT ID: NCT06285162 - Study ID: 69HCL23_1372 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-07 - Lead Sponsor: Hospices Civils de Lyon ### Study Description The Analgesia Nociception Index (ANI) reflects the balance between sympathetic and parasympathetic tone. It is based on a specific interpretation of the R-R interval variation. During fluid removal by net ultrafiltration in patients with fluid overload and continuous renal replacement therapy, some data suggest that haemodynamic variation could be induced by the autonomic nervous system. The study aims to investigate ANI variations in this context and their association with the haemodynamic variations observed. ### Conditions - Critically Ill - Renal Replacement Therapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Percentage of changes in ANI. Secondary Outcomes ### Location - Facility: Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel, Bron, N/A, 69500, France @@
## Tace With Icaritin in First-line Treatment of Middle and Advanced HCC in Child Grade B Patients - NCT ID: NCT06285149 - Study ID: AKLD-22 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-01 - Lead Sponsor: Henan Cancer Hospital ### Study Description Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus, TACE+Icaritin may potentially optimize treatment strategies for patients with poor liver function reserve. ### Conditions - HCC ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Icaritin ### Outcomes Primary Outcomes - ORR - PFS Secondary Outcomes - Overall survival，OS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult - NCT ID: NCT06285136 - Study ID: SHEN-PJ-KE-2024-15 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: The Second Affiliated Hospital of Kunming Medical University ### Study Description This study proposes to conduct a prospective, multicenter, single-arm study to explore the efficacy and safety of venetoclax in combination with high-dose decitabine (DEC3-VEN) in new diagnosed adult patients with AML, and to provide evidence for the optimal selection of clinical treatment regimens, which is planned to be conducted in 10 research centers across the country. ### Conditions - Acute Myeloid Leukemia, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - DEC3-VEN ### Outcomes Primary Outcomes - ORR Secondary Outcomes - Overall survival (OS) ### Location - Facility: The Second Affiliated Hospital of Kunming Medical University., Kunming, Yunnan, N/A, China @@
## Implementing the COMFORT Guidelines for Postpartum Pain Management - NCT ID: NCT06285123 - Study ID: HUM00248235 and HUM00248331 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-26 - Completion Date: 2026-04 - Lead Sponsor: University of Michigan ### Study Description A new national clinical practice guideline (CPG) for pain management after childbirth aims to mitigate peripartum opioid-related risks without compromising or exacerbating existing inequities in pain management in the United States. Standard dissemination approaches are often insufficient to change clinical practice-more active implementation efforts are generally required. Replicating Effective Programs (REP) is a theory-driven implementation intervention that is publicly available and highly scalable, but REP alone may be insufficient for effectively embedding the CPG across all maternity sites. For sites needing more support, REP can be augmented with facilitation (e.g., individualized consultation with site champions to overcome local barriers to CPG adoption, "Enhanced-REP" \[E-REP\]). Because E-REP is more expensive and difficult to scale than REP, it is essential to identify those settings where REP alone is effective versus those where REP may need augmentation, but this has not been evaluated in maternity contexts. Our objective is to determine the effect of a new postpartum pain management CPG, as implemented by REP and E-REP, on postpartum opioid prescribing (primary outcome: rate and amount of opioid prescribed within three days of childbirth), overall, by hospital, and among key subgroups.This is a non-responder randomized trial within the Obstetrics Initiative (OBI), a perinatal collaborative quality initiative funded by Blue Cross Blue Shield of Michigan that includes 68 member hospitals serving more than 120,000 postpartum people over an approximately 15-month study time period. Hospitals not initially responding to REP (defined by performance below the top 15th percentile of all OBI hospitals for a) inpatient order for opioid-sparing postpartum pain management, \[e.g., scheduled acetaminophen and ibuprofen\], or b) amount of opioid prescribed at discharge, or c) provision of non-medication pain management interventions) will be allocated, via block randomization, to either continue REP vs. augment REP with facilitation (E-REP).The primary analysis will evaluate the rate of postpartum opioid-sparing prescribing metrics at the time of discharge (primary outcome) and opioid prescription refills and high-risk prescribing (secondary outcomes) before and after CPG implementation with REP, using interrupted time series analyses. Inequities in outcomes by patient, procedure, prescriber, and hospital factors will be evaluated. Exploratory analyses will examine temporal trends in patient-reported outcomes. The effects of continued REP vs. E-REP among non-responder sites will also be examined. Finally, implementation outcomes will be characterized using clinician and patient surveys and qualitative methods. ### Conditions - Postpartum Pain - Opioid Stewardship - Maternity Care - Obstetric Care ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - REP - Facillitation ### Outcomes Primary Outcomes - Postpartum opioid prescribing - Rate - Postpartum opioid prescribing - Amount Secondary Outcomes - Refill opioid prescribing - High-risk opioid prescribing ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen - NCT ID: NCT06285110 - Study ID: DTG Resist - Status: RECRUITING - Start Date: 2022-06-13 - Completion Date: 2025-08-31 - Lead Sponsor: University of Bern ### Study Description This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of \>1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure.To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS). ### Conditions - Hiv ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Type of Integrase Drug Resistance Mutations (INSTI DRMs) at the time of failing a DTG-based regimen. - Prevalence of Integrase Drug Resistance Mutations (INSTI DRMs) at the time of failing a DTG-based regimen. - Time to virologic failure - Number of INSTI DRMs per patient - DTG drug resistance - Phenotypic resistance levels of novel DRMs Secondary Outcomes ### Location - Facility: Centro Medico Huesped, Buenos Aires, N/A, N/A, Argentina @@
## A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors - NCT ID: NCT06285097 - Study ID: C5391001 - Status: RECRUITING - Start Date: 2024-02-08 - Completion Date: 2028-01-31 - Lead Sponsor: Pfizer ### Study Description This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors. ### Conditions - Neoplasms - Non-small-cell Lung Cancer - Melanoma - Squamous Cell Carcinoma of the Head and Neck - Renal Cell Carcinoma - Urothelial Carcinoma - Colorectal Carcinoma - Ovarian Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - PF-07820435 - Sasanlimab ### Outcomes Primary Outcomes - Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B) - Number of patients with adverse events (AEs) - Number of patients with clinically significant lab abnormalities - Objective response rate (ORR) in Part 2 Expansion Secondary Outcomes - Objective response rate (ORR) in dose escalation (Part 1A and Part 1B) - Duration of tumor response - Progression free survival (PFS) - Cmax (maximum concentration) of PF-07820435 and its active metabolite - Tmax (time to maximal plasma concentration) of PF-07820435 and its active metabolite - AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite - Cmin (minimum concentration) of PF-07820435 and its active metabolite after multiple dosing only - Change from baseline of immune markers within biopsied tumor tissue - Pre-dose trough concentrations of sasanlimab (Part 1B and Part 2) - Incidence and titers of ADA and NAb against sasanlimab (Part 1B and Part 2) - Cmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 - Tmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 - AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 ### Location - Facility: Corewell Health (reference non-engagement letter), Grand Rapids, Michigan, 49503, United States @@
## Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility - NCT ID: NCT06285084 - Study ID: VALETUDO Trial (L4195) - Status: RECRUITING - Start Date: 2024-02-02 - Completion Date: 2027-02-02 - Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio ### Study Description The goal of this observationl study is to evaluate the possibility of building a Deep Learning (DL) model capable of analyzing electrocardiographic traces of athletes and providing information in the form of a probability stratification of cardiovascular disease.Researchers will enroll a training cohort of 455 participants, evaluated following standard clinical practice for eligibility in competitive sports. The response of the clinical evaluation and ECG traces will be recorded to build a DL model.Researchers will subsequently enroll a validation cohort of 76 participants. ECG traces will be analyzed to evaluate the accuracy of the model to discriminate participants cleared for sports eligibility versus participants who need further medical tests ### Conditions - Sports Cardiology - Preventive Cardiology - Electrocardiogram - Artificial Intelligence ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - DL model accuracy Secondary Outcomes ### Location - Facility: Ospedale Galeazzi-Sant'Ambrogio, Milano, Lombardy, 20157, Italy @@
## Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors - NCT ID: NCT06285071 - Study ID: NN7415-7557 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-30 - Completion Date: 2030-04-30 - Lead Sponsor: Novo Nordisk A/S ### Study Description The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years. ### Conditions - Haemophilia A - Haemophilia B ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Concizumab ### Outcomes Primary Outcomes - Number of adverse reaction (AR) Secondary Outcomes - Number of serious adverse reaction (SAR) - Number of serious adverse event (SAE) - Number of thromboembolic adverse event (AE) - Number of shock/anaphylaxis AE - Number of treated spontaneous and traumatic bleeding episodes - Number of treated spontaneous and traumatic target joint bleeding episodes - Number of all treatment requiring bleeding episode ### Location - Facility: Novo Nordisk Investigational Site, Toshima, Tokyo, N/A, Japan @@
## Deep Learning Model Predicts Pathological Complete Response of Lung Cancer Following Neoadjuvant Immunochemotherapy - NCT ID: NCT06285058 - Study ID: LUNAI - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description This study presents the development and validation of an artificial intelligence (AI) prediction system that utilizes pre-neoadjuvant immunotherapy plain scans and enhanced multimodal CT scans to extract deep learning features. The aim is to predict the occurrence of pathological complete response in non-small cell lung cancer patients undergoing neoadjuvant immunochemotherapyy. ### Conditions - Deep Learning Model - Pathological Complete Response - Non-small Cell Lung Cancer - Neoadjuvant Chemoimmunotherapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No interventions ### Outcomes Primary Outcomes - the accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of predicting model Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression - NCT ID: NCT06285045 - Study ID: 2060302-1703-05 - Status: COMPLETED - Start Date: 2018-10-01 - Completion Date: 2019-08-31 - Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences ### Study Description To evaluate the efficacy and safety of Roujin Formula in the treatment of fibromyalgia syndrome(FMS)patients with blood deficiency and liver depression through a randomized,single-blind,placebo-parallel controlled exploratory clinical trial study,and to provide reliable clinical evidence for the treatment of fibromyalgia syndrome with Roujin Formula. 48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data. ### Conditions - Fibromyalgia Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Roujin Formula ### Outcomes Primary Outcomes - The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline - The change of the Visual Analogue Scale (VAS) for pain from baseline Secondary Outcomes - The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline - The change of the Beck depression inventory(BDI) from baseline - The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline ### Location - Facility: Juan Jiao, Beijing, Beijing, 100053, China @@
## Decreasing Loneliness to Optimize Pain Care - NCT ID: NCT06285032 - Study ID: STUDY00017244 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-05 - Lead Sponsor: University of Washington ### Study Description Loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. The study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse. ### Conditions - Loneliness - Opioid Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Cognitive Behavior Therapy (CBT) - Social Navigation Group - Controlled Group ### Outcomes Primary Outcomes - Opioid Misuse Secondary Outcomes - Determine Functional Outcome ### Location - Facility: University of Washington, Seattle, Washington, 98105, United States @@
## Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma - NCT ID: NCT06285019 - Study ID: GWK-2023-004 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2025-12-31 - Lead Sponsor: Fudan University ### Study Description This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TOMOX-HAIC - Sintilimab - Bevacizumab ### Outcomes Primary Outcomes - objective response rate (ORR) Secondary Outcomes - disease control rate (DCR) - Progression-Free Survival (PFS) - Time to progression (TTP) - Duration of response (DOR) - overall survival (OS) - adverse event (AE) ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200062, China @@
## Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis - NCT ID: NCT06285006 - Study ID: MScAZASTPED025/23/202/12/2021 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-05-12 - Lead Sponsor: Al-Azhar University ### Study Description Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis. ### Conditions - Nocturnal Enuresis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Desmopressin ### Outcomes Primary Outcomes - The number of episodes per week after desmopressin treatment Secondary Outcomes ### Location - Facility: Alazhar university, Assiut, N/A, 11884, Egypt @@
## Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis - NCT ID: NCT06284993 - Study ID: 2023-214-KY - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2026-12-30 - Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences ### Study Description Plantar fasciitis (PF) is one of the most common causes of heel pain, typically characterized by a sharp pain in the plantar aponeurosis, specifically near the insertion site close to the medial process of the calcaneal tuberosity. It has been reported that 1 in 10 people are expected to be affected by PF in their lifetime. A comprehensive internet-panel survey conducted among the adult United States population revealed the population-based prevalence of self-reported PF with pain in the last month was 0.85 percent. Approximately 1 million patients are diagnosed with this disease each year in the United States. PF was believed to be an acute inflammatory disease, but patient samples show it is actually a chronic degenerative process caused by various factors such as repetitive stresses, vascular and metabolic disorders, excess free radicals, high temperatures, genetic factors, and conditions like rheumatoid arthritis and spondyloarthropathies. PF may be associated with impaired health-related quality of life, including reduced life functioning, poor perceived health status and social isolation. Additionally, a recent study indicates that the annual cost associated with PF is $284 million.The first-line treatments recommended by guidelines for PF encompass physical therapy (including manual therapy, stretching, and others), pharmacological therapy (involving corticosteroids or platelet-rich plasma), and surgical treatment. However, the definite effects of physical therapy still require confirmation. Pharmacological treatments, such as local corticosteroid injections, exhibit a short maintenance period. Some studies indicate that the relief provided by corticosteroid injections lasts up to one month, yet its efficacy diminishes after 6 months. Surgical treatment is generally advised 6 to 12 months after unsuccessful conservative treatment, albeit with the drawback of higher costs, post-surgery recovery time, and patient apprehension.Acupuncture is one of the most common complementary alternative therapy for the treatment of pain-related diseases such as musculoskeletal muscle, and recent guidelines recommend dry needling as a treatment for relief of plantar fasciitis, with a level of evidence of B. Dry acupuncture is different from acupuncture in terms of theoretical basis, therapeutic apparatus, technical operation and scope of indications, however, the American Alliance for Professional Acupuncture Safety also believes that dry needling falls under the umbrella of acupuncture, but under a different name. In addition, there are systematic evaluations that suggest acupuncture can be a safe and effective treatment for PF, and most of the trials in the systematic evaluations used 4-week treatment courses. Our prior study demonstrated that a 4-week intervention of both electroacupuncture and manual acupuncture resulted in improved pain outcomes among patients with PF.The frequency of acupuncture stands as a crucial factor influencing its efficacy. A study revealed that needling trials with negative results had a significantly lower frequency compared to those yielding positive results. Furthermore, several studies indicate that acupuncture once a week can be help in conditions such as simple obesity, functional dyspepsia, and overactive bladder in women. There is no universally accepted standard of frequency of treatment for many conditions, including PF. In China, patients with chronic diseases usually receive 3-5 acupuncture treatments per week. However, in most previous trials, individuals with chronic diseases received 1-2 needling sessions per week. An increase in the frequency of acupuncture means an increase in the pain, time, and financial investment associated with the acupuncture process. Therefore, it is critical to optimize the frequency of acupuncture to ensure the effectiveness and feasibility of the treatment while avoiding increasing the burden on the patient. Accordingly, we designed the current trial to compare the effects of different acupuncture sessions (1 session per week versus 3 sessions per week) in a randomized controlled trial (RCT) of chronic PF. The hypothesis is that 1 session per week compared with 3 sessions per week of electroacupuncture treatment over a total of 4 weeks of treatment will provide a similar effect on pain relief in chronic PF. ### Conditions - Plantar Fasciitis, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - electroacupuncture(more frequent) - electroacupuncture(less frequent) ### Outcomes Primary Outcomes - The response rate Secondary Outcomes - The response rate - Change from baseline in the VAS score for worst pain intensity during the first steps in the morning - Change from baseline in the VAS score for mean pain intensity during the day - Change from baseline in the duration of heel pain during the day - Change from baseline in heel pressure pain threshold (PPT) - Change from baseline in ankle range of motion (AROM) - Change from baseline in Foot and Ankle Ability Measure (FAAM) total score and subscale scores - Participant global assessment of improvement ### Location - Facility: Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital, Beijing, N/A, N/A, China @@
## Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study - NCT ID: NCT06284980 - Study ID: 2369 - Status: RECRUITING - Start Date: 2019-01-24 - Completion Date: 2025-12-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Gestational trophoblast diseases are characterized by abnormal proliferation of trophoblastic tissue, which can occur consequent to any pregnancy event. Pre-malignant forms (partial hydatiform mola and complete mola) and malignant forms are distinguished, the latter also known as gestational trophoblast neoplasms (invasive hydatiform mola, choriocarcinoma, placental site trophoblastic tumor, and epithelioid trophoblastic tumor).These are neoplasms associated with good prognosis, amenable to conservative treatment and highly sensitive to chemotherapy.The identification of ultrasonographic and echofluximetric features typical of malignant forms as well as the identification of ultrasonographic parameters predictive of chemoresistance to single-drug treatments could help improve their management. ### Conditions - Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination - To Assess if There Are Differences at the Baseline US Scan Between Low-risk and High-risk Patients - To Identify Ultrasound Predictors of Resistance to First-line Single Drug Chemotherapy in Low-risk GTN Patients - To Investigate if Machine Learning (ML) Algorithms (Radiomics, Deep Neural Networks (DNN), and Other Machine Learning Algorithms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - typical features of Gestational Trophoblastic Neoplasia Secondary Outcomes - differences at the baseline US scan between low-risk and high-risk patients ### Location - Facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, N/A, 00168, Italy @@
## Association Of Serum Vitamin D Level With Isthmic Spondylolysis - NCT ID: NCT06284967 - Study ID: Vitamin D In Spondylolysis - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-09-01 - Lead Sponsor: Assiut University ### Study Description The aim of this study is to compare vitamin D level between young adults with isthmic spondylolysis and a matched healthy control group. ### Conditions - Spondylolysis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Mean serum vitamin D in both groups. Secondary Outcomes - Mean serum calcium level ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis - NCT ID: NCT06284954 - Study ID: ARGX-117-2301 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2028-01-20 - Lead Sponsor: argenx ### Study Description This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). ### Conditions - Dermatomyositis - Myositis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Empasiprubart IV - Placebo IV ### Outcomes Primary Outcomes - Incidence and severity of adverse events (AEs) - Percentage of participants discontinuing investigational medicinal product (IMP) due to an adverse event (AE) Secondary Outcomes - Mean TIS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty - NCT ID: NCT06284941 - Study ID: KY 2023-001-001 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-06-20 - Completion Date: 2024-06-20 - Lead Sponsor: Wang wanxia ### Study Description Total hip arthroplasty is currently the most effective method for treating hip joint lesions and improving quality of life, but postoperative severe pain is not conducive to rapid recovery of patients. In recent years, the widespread application of ultrasound has achieved good clinical results in iliac fascia block for postoperative analgesia in THA. However, the use of high-dose local anesthetics can increase the risk of local anesthetic poisoning, and the single block analgesia time is generally less than 24 hours. Methylene blue, as a long-acting analgesic drug, can block the pain transmission of nerve fibers for a long time, achieving analgesic effects without damaging neurons. This study used ultrasound-guided ropivacaine combined with methylene blue to perform iliac fascia block on patients undergoing total hip replacement, with the aim of prolonging pain relief time, reducing complications, and promoting postoperative recovery on the basis of traditional methods. ### Conditions - Femoral Neck Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Ropivacaine combined with methylene blue for iliac fascia block ### Outcomes Primary Outcomes - Neutrophil lymphocyte ratio - visual analogue scale（VAS） - Procalcitonin - Hypersensitive C-reactive protein Secondary Outcomes - Mean arterial pressure - Heart rate - Duration of surgery - Number of postoperative salvage analgesia - Walking distance for the first time getting out of bed - The number of activities of getting out of bed 48 hours after surgery ### Location - Facility: Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine, Taizhou, Jiang Su, 225500, China @@
## Gut Microbiota and New Hypertension - NCT ID: NCT06284928 - Study ID: 20240104-01 - Status: COMPLETED - Start Date: 2019-12-01 - Completion Date: 2020-12-01 - Lead Sponsor: Xinjiang Medical University ### Study Description This study aims to explore the gut microbiota patterns in patients newly diagnosed with hypertension, comparing them to those in non-hypertensive individuals. Utilizing cross-sectional analysis, it seeks to identify specific microbial profiles associated with hypertension, which could provide insights into the disease's pathogenesis and potential new avenues for treatment. The research focuses on analyzing fecal samples collected from both groups, using advanced genomic techniques to assess the diversity and abundance of gut bacteria. This investigation could contribute significantly to our understanding of the role gut microbiota plays in cardiovascular health and disease. ### Conditions - Hypertension - Gut Microbiota ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gut Microbiota Analysis ### Outcomes Primary Outcomes - Change in Gut Microbiota Composition Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, 630000, China @@
## Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers - NCT ID: NCT06284915 - Study ID: MEQ00089 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2025-03-11 - Lead Sponsor: Sanofi Pasteur, a Sanofi Company ### Study Description This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants. ### Conditions - Meningococcal Immunisation - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - MenACYW conjugate vaccine - MenACYW conjugate vaccine ### Outcomes Primary Outcomes - Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, Y and W Secondary Outcomes - hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W - hSBA antibody titers against meningococcal serogroups A, C, W, and Y - hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W - Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA - hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse - Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y - rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W - Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA - rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse - Number of participants with immediate adverse events (AEs) - Number of participants with solicited injection site reactions or systemic reactions - Number of participants with unsolicited AEs - Number of participants with serious adverse events (SAEs) ### Location - Facility: Investigational Site Number: 2030001, Ceske Budejovice, N/A, N/A, Czechia @@
## Bioavailability Study of Fexofenadine HCl New Formulation Tablet - NCT ID: NCT06284902 - Study ID: BDR17987 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-05-23 - Lead Sponsor: Opella Healthcare Group SAS, a Sanofi Company ### Study Description The purpose of the study is to assess the relative bioavailability of a new galenic form of fexofenadine HCl new formulation tablet (test drug) taken with or without water compared to fexofenadine HCl film-coated tablets (reference form) taken with water under fasting conditions. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Fexofenadine HCl Coated tablet - Fexofenadine HCl New Formulation Tablet ### Outcomes Primary Outcomes - Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) of Fexofenadine - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf) of Fexofenadine - Maximal Observed Concentration (Cmax) of Fexofenadine Secondary Outcomes - Time When the Maximal Concentration is Observed (Tmax) of Fexofenadine - Time of Observation Prior to the First Observation with a Measurable (non-zero) Concentration (Tlag) of Fexofenadine - Terminal Half-life Associated with the Terminal Slope (T1/2z) of Fexofenadine - Terminal Elimination Rate Constant (Kel) of Fexofenadine - Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) ### Location - Facility: Syneos Health Clinic inc., Quebec, N/A, G1P 0A2, Canada @@
## Behavioral Activation for the Treatment of Depression in Older Adults - NCT ID: NCT06284889 - Study ID: DepActive - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2028-12-31 - Lead Sponsor: Uppsala University ### Study Description Depression affects between 5-15% of adults ≥ 65 years in Sweden. Depression in older adults reduces functional ability and quality of life, and increases the risk for morbidity, loneliness, and suicide. Psychological treatment is recommended as a first-line treatment for depression, which about 3% of older adults with depression in Sweden report receiving. One effective psychological treatment is behavioral activation, which reduces depressive symptoms by increasing enjoyable, meaningful and important activities, for example exercise and social activities. The research group conducted a pilot study of telephone based behavioral activation for isolated older adults with depression during the COVID-19 pandemic. The intervention consisted of four telephone calls, and the results showed a significant decrease in depressive symptoms, with maintained effects for six months.250 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving treatment as usual at their respective primary care center. Participants will be asked to fill in questionnaires before, after treatment. Questionnaires will also be sent 3- and 6 months after treatment to follow up on the results. Patients will be asked to wear an accelerometer for 5-7 days to record their activity level at baseline, post-intervention and after 3-months. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Behavioural activation - Treatment as usual (TAU) ### Outcomes Primary Outcomes - Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S Secondary Outcomes - Change from baseline in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI - Change from baseline in Physical Activity level - Change from baseline in anxiety symptoms using the Geriatric Anxiety Scale - 10 item (GAS-10) is a self-rating scale designed to capture anxiety specifically in older adults, with items reflecting affective-, cognitive- and somatic anxiety symptoms. - Change from baseline in health and disability using The WHO Disability Assessment Schedule 12-item, WHODAS - Change from baseline in self rated quality of life using the EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L - Changes from baseline in Self Efficacy measured with the New General Self-Efficacy Scale, S-GSE. - Changes from baseline in loneliness measured with the UCLA Loneliness Scale version 3, UCLA-LS-3. - Diagnostic accuracy ### Location - Facility: Uppsala university, Uppsala, Uppland, 753 10, Sweden @@
## Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer - NCT ID: NCT06284876 - Study ID: IY-NTNS03 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-30 - Completion Date: 2027-02-28 - Lead Sponsor: Il-Yang Pharm. Co., Ltd. ### Study Description To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24 ### Conditions - Peptic Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ilaprazole - Lansoprazole - Ilaprazole Placebo - Lansoprazole Placebo ### Outcomes Primary Outcomes - Ilaprazole, Lansoprazole peptic ulcer Secondary Outcomes - Ilaprazole, Lansoprazole peptic ulcer - Ilaprazole, Lansoprazole GI bleeding ### Location - Facility: Chung Ang University Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Impact Of Nutritional Education Program In Hemodialysis Patients - NCT ID: NCT06284863 - Study ID: 04-2023-200315 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-04 - Lead Sponsor: Assiut University ### Study Description The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program ### Conditions - Hemodialysis Complication ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Natritional Education Program In Hemodialysis Patients ### Outcomes Primary Outcomes - The percentage patients responded to nutritional education program on hemodialysis patients. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels - NCT ID: NCT06284850 - Study ID: Christina Trakatelli - Status: RECRUITING - Start Date: 2023-11-30 - Completion Date: 2025-11 - Lead Sponsor: Aristotle University Of Thessaloniki ### Study Description The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors. ### Conditions - Hematocrit Change - Cardiovascular Prevention - Empagliflozin - SGLT2-Inhibitors - Tissue Oxygenation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Empagliflozin10Mg Tab ### Outcomes Primary Outcomes - Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml) Secondary Outcomes - Mean change in Hct (%) - Hb (mg/dl) - RBC (x1000000/μl) - MCV (fl), - HbA1c (%, mmol/mol), - erythropoietin (mU/ml) - eGFR (ml/min/1.73m2), - Urine Albumin to Creatinine Ratio (mg/g) ### Location - Facility: Papageorgiou General Hospital, Thessaloniki, Central Macedonia, 56403, Greece @@
## Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation? - NCT ID: NCT06284837 - Study ID: HREC/99382/Alfred-2023 - Status: RECRUITING - Start Date: 2023-12-04 - Completion Date: 2025-08 - Lead Sponsor: The Alfred ### Study Description Transcatheter aortic valve implantation (TAVI) is a well known safe treatment for severe aortic stenosis. To perform TAVI safely, there is a need for two vascular entry (access) sites: the primary and secondary access sites. While the femoral approach remains the most common site for primary access, secondary access (which is needed for guidance during the procedure) has drawn little attention in trials of TAVI. The two secondary access sites most commonly used are the radial (through an artery in the wrist) and femoral (through an artery in the groin) access sites. Observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access, but there are no randomized controlled data to confirm these findings. Accordingly, investigators aim to undertake a multicenter, randomized controlled trial among patients who are undergoing transfemoral TAVI, to assess if radial access is superior to femoral access as a secondary access site. ### Conditions - Valve Stenoses, Aortic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Access site ### Outcomes Primary Outcomes - All bleeding and vascular complications Secondary Outcomes - All bleeding - All vascular complications - All-cause death - Stroke - Myocardial infarction - Major adverse cardiovascular events - Length of stay post-procedure - Overall procedure duration - Radiation dose - Conversion rate to alternative vascular access site - Tertiary site utilised to treat vascular complication - Failure to perform angiogram of primary access site at completion of TAVI ### Location - Facility: Alfred Health, Melbourne, Victoria, 3004, Australia @@
## Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems - NCT ID: NCT06284824 - Study ID: DPS-JMP-2022-040 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-05 - Lead Sponsor: Southeast Orthopedic Specialists ### Study Description The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:* Will the patient reported outcomes differ between the two groups?* Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken. ### Conditions - Knee Osteoarthritis - Knee Arthritis - Knee Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Stryker Triathlon with MAKO Robotic-Arm - DePuy Attune with VELYS Robotic-Assistance ### Outcomes Primary Outcomes - KSS - KSS - KSS - KSS - KOOS JR - KOOS JR - KOOS JR - KOOS JR - FJS-12 Knee - FJS-12 Knee - FJS-12 Knee Secondary Outcomes - Operative step time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Massage and Percussion Therapy on Muscle and Performance Parameters - NCT ID: NCT06284811 - Study ID: 050.06.04/155 - Status: RECRUITING - Start Date: 2023-12-31 - Completion Date: 2024-04-20 - Lead Sponsor: Acibadem University ### Study Description DOMS, muscle viscoelastic properties, quadriceps strength and vertical jump performance will be evaluated in physically active individuals before the exercise and after the exercise and intervention which is either Swedish massage or Percussion therapy ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise program focusing on quadriceps ### Outcomes Primary Outcomes - Muscle tone/tension(Hz) - Muscle dynamic stiffness (N/m) - Muscle elasticity (log) - DOMS - Vertical Jump Performance - Quadriceps isometric strength Secondary Outcomes ### Location - Facility: Acibadem University, Istanbul, Ataşehir, 34752, Turkey @@
## A Research Study of a New Medicine (NNC0650-0013) in Healthy Men - NCT ID: NCT06284798 - Study ID: NN9650-5027 - Status: RECRUITING - Start Date: 2024-01-30 - Completion Date: 2025-03-22 - Lead Sponsor: Novo Nordisk A/S ### Study Description This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - NNC0650-0013 A - Placebo ### Outcomes Primary Outcomes - S.C. Cohort: Number of treatment emergent adverse events (TEAEs) Secondary Outcomes - S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose - S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose - S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose - S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose - S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose - S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose - I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose - I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose - I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose - S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered ### Location - Facility: Profil Institut für Stoffwechselforschung GmbH, Neuss, N/A, 41460, Germany @@
## The Effects of Bariatric Surgery on Kidney Oxygenation in Obese Adults With Type 2 Diabetes and Hyperfiltration - NCT ID: NCT06284785 - Study ID: 2023.0121 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2026-03-01 - Lead Sponsor: Amsterdam UMC, location VUmc ### Study Description In this study the investigators will examine the effects of VAT reduction by bariatric surgery on kidney hypoxia and compare kidney oxygenation before- and after surgery in both sexes using BOLD-MRI and measures of kidney hemodynamic function. Furthermore, the investigators will assess whether kidney oxygenation is reduced in obese T2D men and women versus various controls as described below. This will determine whether kidney hypoxia can be appointed as a modifiable pathogenic factor in early DKD and non-surgical interventions targeting kidney hypoxia can be designed to slow DKD progression. ### Conditions - Kidney Hypoxia - Diabetes Mellitus, Type 2 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bariatric surgery ### Outcomes Primary Outcomes - Difference in kidney oxygenation before and after bariatric surgery Secondary Outcomes - Difference in kidney oxygenation between men and women - Difference in kidney oxygenation between obese, hyperfiltering men and women with T2D versus non-diabetic lean controls ### Location - Facility: VU University Medical Center, Amsterdam, Noord-Holland, 1081HV, Netherlands @@
## FINRISK 2002 Re-examination - NCT ID: NCT06284772 - Study ID: 4457/2023 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-11-13 - Completion Date: 2024-06-25 - Lead Sponsor: University of Turku ### Study Description The project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut microbiome, microbial metabolites, and their long-term changes are prospectively related to the risk factors, surrogate markers, and overt outcomes of CMD. To achieve this goal, repeat stool samples will be collected of \~2300 Finnish individuals who gave stool samples in the year 2002. In addition, \~300 individuals will undergo a in-depth health examination in 2024. ### Conditions - Cardiometabolic Syndrome - Cardiovascular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire and fecal sampling - Health examination ### Outcomes Primary Outcomes - Gut microbiome change between 2002-2024 Secondary Outcomes - Correlates of gut microbiome change between 2002-2024 ### Location - Facility: University of Turku, Turku, N/A, 20100, Finland @@
## The Effect of Tele-Nursing Application on Self-Care Ability and Daily Living Activities in Fracture Surgery Patients - NCT ID: NCT06284759 - Study ID: E-77082166-302.08.01-380534 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-15 - Completion Date: 2024-03-28 - Lead Sponsor: Gazi University ### Study Description This study aims to determine the effect of tele-nursing application based on Orem's Self-care Theory on self-care agency and daily living activities in trauma-related lower extremity fracture surgery patients. ### Conditions - Lower Extremity Fracture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - post-discharge telenursing intervention ### Outcomes Primary Outcomes - Self Care, Assessed using the Self-Care Agency scale. - Activities of daily living, Assessed using the Katz index of independence in activities of daily living (ADL) scale. - Instrumental activities of daily living, Assessed using the The Lawton instrumental activities of daily living scale. Secondary Outcomes ### Location - Facility: Lokman Hekim University, Ankara, N/A, 06510, Turkey @@
## Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer - NCT ID: NCT06284746 - Study ID: 301Qiaoz - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2025-07-30 - Lead Sponsor: Lin Chen ### Study Description This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research. ### Conditions - Locally Advanced Gastric Carcinoma - HER2 Negative - Efficacy - Safety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tirolizumab+SOX/XELOX - SOX/XELOX ### Outcomes Primary Outcomes - Pathological complete response (pCR) - Objective Response Rate（ORR） Secondary Outcomes - Disease-free survival（DFS） - Overall survival（OS） - Major Pathologic Response（MPR） - The incidence of adverse events during treatment ### Location - Facility: General Surgery Institute, China PLA General Hospital, Beijing, Beijing, 100853, China @@