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## Neoadjuvant SBRT in Localized Advanced HNSCC - NCT ID: NCT06306846 - Study ID: 11235794 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2026-12-31 - Lead Sponsor: Jiang Feng ### Study Description The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. This study aims to explore the efficacy and safety of PD-1 monoclonal antibody with neoadjvant SBRT and chemotherapy. The triple mode not only can Increase the effectiveness of neoadjuvant therapy，meanwhile，the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with PD-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body， reducing postoperative adjuvant radiotherapy and chemotherapy. The triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced HNSCC. ### Conditions - Head and Neck Squamous Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SBRT+immunochemotherpy - Immunochemotherapy - cetuximab+immunochemotharpy ### Outcomes Primary Outcomes - major pathology response (MPR) Secondary Outcomes ### Location - Facility: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China @@
## The Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain - NCT ID: NCT06306833 - Study ID: CLBP-sEMG-14022024 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-12 - Lead Sponsor: Amaila Fazal [afazal] ### Study Description The prevalence of chronic low back pain (CLBP) among the Pakistani population is reported to be as high as 78% leading towards different physiological and psychosocial alterations with the worst cases suffering from disabilities. CLBP is a multifactorial phenomenon in which age, gender, comorbidities, lifestyle conditions, profession, working hours, and different stressors play their roles in its causation. However, different therapeutic techniques have been determined to reduce CLBP. Thus, this study aimed to assess the effectiveness of the biofeedback surface EMG (sEMG) technique in reducing chronic low back pain among sufferers in the long run. ### Conditions - Chronic Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Surface Electromyography (sEMG) Biofeedback ### Outcomes Primary Outcomes - Pain Intensity and interference - Lower back pain related Disability - Quality of Life with chronic low back pain - Pain and Disability-related Anxiety Secondary Outcomes - Substance P - Cortisol - Beta Endorphins ### Location - Facility: Psychophysiology Lab, University of Karachi, Karachi, Sindh, 75270, Pakistan @@
## Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery - NCT ID: NCT06306820 - Study ID: 36264MS257/7/2023 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-08-01 - Lead Sponsor: Tanta University ### Study Description The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries. ### Conditions - Ultrasound Guided Recruitment Manauvere - End Expiratory Pressure - Pediatric Patients - Laparoscopic Abdominal Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Fixed PEEP - Ultrasound-guided lung recruitment - Individualized PEEP ### Outcomes Primary Outcomes - Intraoperative oxygenation Secondary Outcomes - Lung ultrasound scores - Mean arterial blood pressure (MAP) - Heart rate - Postoperative pulmonary complication ### Location - Facility: Tanta University, Tanta, El-Gharbia, 31527, Egypt @@
## Investigation of the Effectiveness of Proprioceptive Neuromuscular Facilitation Techniques in Text Neck Syndrome - NCT ID: NCT06306807 - Study ID: AtlasUmkaya02 - Status: COMPLETED - Start Date: 2023-12-31 - Completion Date: 2024-03-15 - Lead Sponsor: Atlas University ### Study Description Smartphones and tablets are increasingly widespread mobile technological devices used for many purposes such as communication, transportation, entertainment, education and security. Increasing use of mobile technology leads to various symptoms such as insomnia, difficulty concentrating and anxiety, especially musculoskeletal problems. "Text neck" is a musculoskeletal problem seen in individuals who use smartphones and tablets for a long time due to increased head and neck flexion posture. It causes neck, back, shoulder, and head pain, insomnia, tingling and numbness in the hands. Implementation of exercise programs for both preventive and therapeutic purposes is one of the main goals in this picture dominated by posture and pain problems. Proprioceptive neuromuscular facilitation (PNF) treatment technique; In the 1940s by H. Kabat and M. Knott, PNF was expressed as a means of facilitating neuromuscular responses by stimulation of proprioceptors. It is stated that it increases joint stabilization, strength, normal range of motion, endurance and circulation and is effective in improving coordination. Although PNF techniques have been used for different spinal problems, there is no study investigating PNF techniques in text neck syndrome. The study was aimed to compare the effect of a method including muscle relaxation in the anterior elevation direction and repetition techniques in the posterior depression direction from PNF neck patterns on pain intensity, neck normal range of motion, neck muscle endurance, posture and functionality in individuals with text neck syndrome with another method including ergonomic adjustments and simple cervical exercises recommended in the literature to be included in standard treatment. ### Conditions - Neck Muscle Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications - PNF exercise program ### Outcomes Primary Outcomes - Pain intensity - Cervical range of motion - Neck flexor-extensor muscle endurance test - Posture - Disability Secondary Outcomes ### Location - Facility: Istanbul Atlas University, Istanbul, N/A, N/A, Turkey @@
## Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration - NCT ID: NCT06306794 - Study ID: 2011-KAEK-25 2023/12-26 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Nurgül Tekin ### Study Description The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration.It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups.PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse.During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention. ### Conditions - Pain - Premature Baby 26 to 32 Weeks - Premature Baby 33 to 36 Weeks - Aspiration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - crochet octopus ### Outcomes Primary Outcomes - pain in the during endotracheal aspiration Secondary Outcomes - comfort in the during endotracheal aspiration ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis - NCT ID: NCT06306781 - Study ID: HI-IM-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2026-12-30 - Lead Sponsor: RenJi Hospital ### Study Description This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis. ### Conditions - Decompensated Cirrhosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HCL001 cell (homologous allogeneic hepatocytes) injection ### Outcomes Primary Outcomes - Types and incidence of treatment-related adverse events. - Dose-Limiting Toxicity (DLT) - Maximum Tolerated Dose (MTD) Secondary Outcomes - Child-Pugh grading. - Number of participants with abnormal laboratory tests results - The percentage of participants with improved liver conditions (including changes in portal vein diam ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Remote Therapeutic Monitoring Exercise Tracking - NCT ID: NCT06306768 - Study ID: STU00219979 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-03 - Lead Sponsor: Shirley Ryan AbilityLab ### Study Description The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform. ### Conditions - Parkinson Disease - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Activity Monitoring ### Outcomes Primary Outcomes - Physical Activity Metric 1 - Physical Activity Metric 2 Secondary Outcomes - Exercise Self Efficacy - Quality of Life from PROMIS 10-b - Quality of Life from PROMIS-29 ### Location - Facility: Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States @@
## Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer - NCT ID: NCT06306755 - Study ID: 2021YFC2500405 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2034-12 - Lead Sponsor: Peking University Cancer Hospital & Institute ### Study Description To evaluate the feasibility, applicability, effectiveness, and health-economic value of the risk-based sequential screening modality for esophageal and gastric cancers, the investigators aim to initiate a community-based randomized controlled trial in Xun County, Henan Province, which is a high-risk region of upper gastrointestinal cancer (UGIC) in northern China.A total of 258 target villages from all the 11 communities (townships and streets) in Xun County will be randomly selected and assigned to the sequential screening group and the universal screening group at a ratio of 2:1 and the total sample size will be 21,000.In the sequential screening group, participants in the top 50% risk level (i.e., stratified as the high-risk subgroup) will be offered a standard upper gastrointestinal endoscopic screening. In contrast, all participants in the universal screening group will receive the endoscopic examination. The surveillance strategy for participants with screening-detected premalignant lesions in the sequential screening group will be tailored based on individualized risk assessment using endoscopic characteristics, pathological diagnosis, and biomarkers. Surveillance for participants in the universal screening group will adhere to current guidelines for UGIC screening and clinical treatment.Detection rates of upper gastrointestinal malignant lesions, early-stage malignant lesions and premalignant lesions, and health-economic indicators such as the unit cost per detected malignant lesions will be compared between the two groups. ### Conditions - Esophageal Cancer - Gastric Cancer - Precision Screening - Sequential Screening - Risk Stratification ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Risk Assessment and Individualized Surveillance - Universal screening ### Outcomes Primary Outcomes - Detection rate of upper gastrointestinal (esophageal/gastric) malignant lesions Secondary Outcomes - Rate of early-stage upper gastrointestinal (esophageal/gastric) malignant lesions - Detection rate of upper gastrointestinal (esophageal/gastric) premalignant lesions - Response rate of endoscopic examination - Total screening costs - Unit cost per detected upper gastrointestinal (esophageal/gastric) malignant lesions - Unit cost per detected early-stage upper gastrointestinal (esophageal/gastric) malignant lesions - Unit cost per detected upper gastrointestinal (esophageal/gastric) premalignant lesions - Satisfaction with the risk-based sequential screening modality - Rate of timely treatment - UGIC-specific mortality - All-cause mortality - Quality of life Scale Score ### Location - Facility: Department of genetics, Peking University Cancer Hospital & Institute, Beijing, Beijing, 100142, China @@
## Open-label Placebo in Manual Therapy - NCT ID: NCT06306742 - Study ID: ct9874 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2026-06 - Lead Sponsor: Studio Osteopatico Busto Arsizio ### Study Description to investigate the effects of placebo in patients affected by low-back pain. ### Conditions - Low Back Pain, Recurrent ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Open-label placebo - Osteopathic manipulative treatment ### Outcomes Primary Outcomes - Change in Numeric Rating Scale - Adverse effects Secondary Outcomes - Change in measures of Von Frey filaments - Changes in algometer measurements ### Location - Facility: CTFO, Saronno, Varese, 21047, Italy @@
## Computational Assessment of Bioprosthetic Aortic Valve Function - NCT ID: NCT06306729 - Study ID: 316308 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust ### Study Description Bioprosthetic valves are usually made of biological tissue that are mounted to a frame and are designed to function similarly to a healthy natural valve. Edwards Magna Ease and Intuity Elite bioprosthetic valves have similar leaflets and mounting designs. However, the valves are implanted in the patient in different ways (one is stitched to the wall of the left ventricular outflow tract, and the other is held in place by the radial force of the valve skirt). The study aims to understand in more detail how the different valves interact with the left ventricular outflow tract and aortic root. ### Conditions - CFD - Valve Heart Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Computed Tomography, Magnetic Resonance Imaging ### Outcomes Primary Outcomes - blood flow velocities - Time average wall shear stress (TAWSS) Secondary Outcomes - Patient's satisfaction - Evidence of major adverse cardiac and cerebrovascular events (MACCE) - Mortality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Single Center Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds - NCT ID: NCT06306716 - Study ID: LEO.2021.10 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2025-04-30 - Lead Sponsor: Smith & Nephew, Inc. ### Study Description The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds. ### Conditions - Chronic Wounds - Acute Wounds ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - RENASYS Film with AIRLOCK Technology ### Outcomes Primary Outcomes - Wound Healing Status Secondary Outcomes - Percentage Reduction in Wound Volume from Baseline to Week 3 - Percentage Reduction in Wound Area from Baseline to Week 3 - Percentage Reduction in Wound depth from Baseline to Week 3 - Percentage Area of Wound Bed Covered with Granulation Tissue - Peri-wound Pain Scores at Dressing Removal ### Location - Facility: Lawson Health Research Institute, London, Ontario, N6C 2R5, Canada @@
## Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women - NCT ID: NCT06306703 - Study ID: PhD Thesis of Duygu Sultan Oge - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-08-30 - Lead Sponsor: Duygu Sultan Oge ### Study Description The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Women who come to the gynecology and obstetrics clinic for examination and volunteer for the study will be randomized with a computer-aided randomization program and divided into 3 groups. First of all, the pelvic floor muscles will be evaluated by ultrasonographic method and perineometer. The first group will be taught pelvic floor muscle contraction with verbal explanation, the second group will be taught with digital vaginal palpation, and the third group will be taught pelvic floor muscle contraction with the help of a perineometer. After the training, the same evaluations will be made again. The number of individuals to be included in the study will be determined by power analysis. As a result of this study, it will be decided which method can be used to teach pelvic floor muscle contraction to women accurately and effectively in clinics. The results of our study will guide clinicians in their preferences for using different teaching methods. ### Conditions - Pelvic Floor Muscle Weakness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - group1, group2, group 3 ### Outcomes Primary Outcomes - ASSESSMENT OF THE PELVIC FLOOR USING ULTRASONOGRAPHY (USG) - Pelvic Floor Muscle Strength and Endurance: - pelvic floor power, minimum and maximum muscle contraction values Secondary Outcomes - DETAILED STORIES OF THE PATIENTS - Pelvic Floor Health Knowledge Test: - Global Pelvic Floor Disorder Questionnaire(GPFDQ) - Visual Analog Scale (VAS) assessment for pelvic pain - Determining the severity of incontinence - Sensory Evaluation - Pelvic Floor Reflex Evaluation: - Evaluation of Mistakes Made During Pelvic Floor Muscle Contraction - Pelvic organ prolapse evaluation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Biomarkers in Retinitis Pigmentosa - NCT ID: NCT06306690 - Study ID: 6401 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-04 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The objective of this study is to discover biomarkers that demonstrate a correlation between the severity of retinitis pigmentosa (RP) and the thickness of the retinal pigment epithelium (RPE). These biomarkers will serve as prognostic indicators for various kinds of retinitis pigmentosa. The objective of this study is to find biomarkers that establish a correlation between the severity of retinitis pigmentosa and the thickness of the retinal pigment epithelium (RPE), which can serve as a prognostic indicator for Retinitis Pigmentosa. ### Conditions - Retinitis Pigmentosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence. ### Outcomes Primary Outcomes - Retinal pigment epithelium changes in Retinitis Pigmentosa. Secondary Outcomes - Retinitis Pigmentosa biomarkers ### Location - Facility: Maria Cristina Savastano, Roma, N/A, 00198, Italy @@
## Accuracy of an AI-clinical Knowledge-based Hybrid System for Detecting Periodontitis in OPG Images - NCT ID: NCT06306677 - Study ID: SH9H-2023-T369-1 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-12-31 - Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University ### Study Description Periodontitis is highly prevalent and rarely detected and treated in the earlier stages of the disease. Orthopantomography (OPG) is the most frequently taken dental radiograph around the world, and its systematic screening may contribute to early detection of periodontitis and access to the needed level of care. The investigators' recent study initially developed an AI-clinical knowledge-based system for automatic periodontitis diagnosis and indicated good performance for differentiating stage II-IV periodontitis. This cross-sectional diagnostic study aims to compare the diagnostic accuracy of this AI-clinical knowledge-based hybrid system (Index test) with human experts (reference test) for differentiating stage II-IV periodontitis using the OPG images obtained from different 4 centers around the world. ### Conditions - Periodontitis - Periodontal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AI-clincial-based hybrid system for radiographic image analysis ### Outcomes Primary Outcomes - Sensitivity measure - Specificity measure - The area under the receiver operating characteristic curve (AUC) measure - Diagnostic accuracy Secondary Outcomes - Assessment time ### Location - Facility: Shanghai Perio-Implant Innovation Center, Shanghai, Shanghai, 201206, China @@
## Effect of Two Different Modes of Polarized Polychromatic Non-coherent Light Therapy on Jumper's Knee - NCT ID: NCT06306664 - Study ID: PT.REC/012/004881 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-01 - Lead Sponsor: Cairo University ### Study Description The purposes of this study are:1. To examine the combined effects of Yellow CPPNLT and conventional treatment on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee.2. To examine the combined effects of Green CPPNLT and conventional treatment on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee.3 3- To compare between the effects of Yellow CPPNLT and Green CPPNLT on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee. ### Conditions - Jumper's Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bioptron - Placebo Comparator ### Outcomes Primary Outcomes - Pain (Visual analogue scale). - pain intensity (Pressure algometry) - Disability questionnaire (Victorian institute of sport assessment-patella). - Muscle strength (Hand held dynamometer) Secondary Outcomes ### Location - Facility: Physical Therapy, Giza, Dokki, 12612, Egypt @@
## High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea - NCT ID: NCT06306651 - Study ID: FMASU MD283/2023 - Status: RECRUITING - Start Date: 2024-03-16 - Completion Date: 2025-03-01 - Lead Sponsor: Ain Shams University ### Study Description This study aims to compare the effectiveness of conventional oxygen therapy oxygen and high-flow nasal cannula therapy on oxygen saturation (SpO2), measuring number of SpO2 drop \>4% of base line oxygen saturation (o2 desaturation index), length of the ICU stay, and the need of use supplemental continuous positive airway pressure (CPAP) support in any of the study groups in the postoperative ICU setting. ### Conditions - High Flow Nasal Cannula - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High flow nasal cannula therapy group - Conventional oxygen therapy group ### Outcomes Primary Outcomes - Oxygen desaturation index Secondary Outcomes - The length of Intensive care unit stay - The incidence of ventilatory support ### Location - Facility: Ain Shams University, Cairo, N/A, 11591, Egypt @@
## Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction - NCT ID: NCT06306638 - Study ID: I-3901323 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-04-01 - Lead Sponsor: Roswell Park Cancer Institute ### Study Description This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathing passages to the lung partially or completely blocked. These tumors could be due to lung cancer or other cancers (e.g., renal, breast, kidney, etc.) that spread to the lung. This blockage puts the patient at a higher risk for respiratory failure, post-obstructive pneumonia, and prolonged hospitalizations. Treatment for these patients may include bronchoscopic intervention (such as mechanical removal, stenting, laser cauterization, or ballooning), radiation therapy with and without chemotherapy. While palliative x-ray radiotherapy may help in shrinking the tumor, high dose curative radiotherapy that can ablate (a localized, nonsurgical destruction) the tumor also has high risk to cause significant toxicity, including bleeding, abnormal connections or passageways between organs or vessels and abnormal scar tissue that can also produce airway obstruction. Photodynamic therapy (PDT) is another possible treatment that can provide local control of the tumor. PDT consists of injecting a light sensitive drug (photosensitizer, PS) into the vein, waiting for the PS to accumulate in the tumor, and then activating it with a red laser light. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are associated with the typical high dose curative x-ray radiotherapy alone in patients with malignant central airway obstruction. ### Conditions - Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Computed Tomography - Endobronchial Ultrasound Bronchoscopy - Interstitial Photodynamic Therapy - Palliative Radiation Therapy - Physical Performance Testing - Questionnaire Administration - Verteporfin ### Outcomes Primary Outcomes - Incidence of >= grade 3 adverse events (Phase I) - Overall tumor response (Phase II) Secondary Outcomes - Overall tumor response (Phase I) - Quality of life (Phase I and II) - Functional lung capacity (Phase I and II) - Change in the therapeutic laser light transmission (Phase I and II) - Association between immune markers and tumor response (Phase I and II) - Progression free survival (Phase I and II) ### Location - Facility: Roswell Park Cancer Institute, Buffalo, New York, 14263, United States @@
## REmote COnditioning in Out-of-Hospital Cardiac Arrest - NCT ID: NCT06306625 - Study ID: 69HCL21_0001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-08-15 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Out-of-Hospital Cardiac Arrest remains a major public health problem, resulting in high mortality largely related to multiple organ failure and poor neurological outcomes due to brain anoxia. The pathophysiology of organ dysfunction after resuscitated out-of-hospital cardiac arrest involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy used to protect organs against the detrimental effects of ischemia-reperfusion injury.The objective of the present trial is to determine whether remote ischemic conditioning performed early after out-of-hospital cardiac arrest can decrease mortality, or multiple organ failure and/or severe neurological failure. ### Conditions - Out-Of-Hospital Cardiac Arrest ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Remote ischemic conditioning - No remote ischemic conditioning ### Outcomes Primary Outcomes - All cause of death - Multiple organ failure - Severe neurological failure Secondary Outcomes - Sepsis-related Organ Failure Assessment (SOFA) score - Sepsis-related Organ Failure Assessment (SOFA) score - Sepsis-related Organ Failure Assessment (SOFA) score - Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score - Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score - Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score - Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction - Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction - Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction - Mean Sepsis-related Organ Failure Assessment (SOFA) score - Mean Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score - Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA) - Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA) after exclusion of the neurological sub-score - Serum level of neuron-specific enolase (NSE) - Cerebral Performance Categories (CPC) scale - All-cause mortality ### Location - Facility: Hôpital Louis Pradel, Bron, N/A, 69500, France @@
## CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer - NCT ID: NCT06306612 - Study ID: IIT-2023-0165 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2028-12-31 - Lead Sponsor: RenJi Hospital ### Study Description The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are:1. To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC.2. To explore the characteristics of the subgroup of patients who could benefit more from the above treatment.3. To explore the relationship between stage efficacy and clinical prognosis.4. To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy.Participants will undergo systemic therapy combined with cytoreductive prostatectomy.Researchers will compare systemic therapy combined with cytoreductive prostatectomy with SOC to see the pros and cons of the two strategies. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Systemic Chemohormonal Therapy - Systemic Hormonal Therapy - Cytoreductive Prostatectomy - Postoperative Adjuvant Radiotherapy ### Outcomes Primary Outcomes - Castration resistant-free survival Secondary Outcomes - Overall Survival - PSA response - Symptomatic skeletal event - Pain progression - Deterioration of disease-related somatic symptoms ### Location - Facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200127, China @@
## Ultrasound Operator Influence on Diagnostics With AI for Thyroid Nodules - Clinial Trial - NCT ID: NCT06306599 - Study ID: Thyroid AI US operator exp - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2023-11-04 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description This is a prospective clinical study aiming to test how the experience of the ultrasound operator influences the performance of AI-based (artificial intelligence-based) diagnostics when analysing thyroid nodules on ultrasound scans. The investigators set up an experiment with five stations, each with a patient with a thyroid nodule and an ultrasound machine with the deep learning based system S-Detect for Thyroid installed. 20 study participants where recruited: 8 medical students of novice ultrasound skill, 3 junior ENT (ear-nose-throat) registrars of intermediate ultrasound skill, and 9 senior ENT registrars experienced in ultrasound. The participants scanned all the patients and recorded their analyses of the nodules using the EUTIRADS (European thyroid imagining reporting and data system) system in three different ways: a analysis of their own, S-Detect's analysis, and an analysis combining the two previous.The hypothesis was that the AI system would perform equally well when between the participant groups. In addition, it was expected that the experienced participants would perform better than the students without AI help, and that the doctors would gain little from AI input, but that the students would have their performance improved by AI input. ### Conditions - Thyroid Nodule ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - S-Detect for Thyroid ### Outcomes Primary Outcomes - Accuracy of S-Detect diagnosis Secondary Outcomes - Accuracy of biopsy recommendation - Nodule classification agreement - Accuracy of EUTIRADS scores - Nodule measurement - OSAUS score ### Location - Facility: Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## A Digital Treatment for Adolescents With Eating Disorders - NCT ID: NCT06306586 - Study ID: 639031 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2026-01-01 - Lead Sponsor: Haukeland University Hospital ### Study Description The goal of this feasibility study is to evaluate the feasibility and preliminary clinical outcomes of a personalized digital treatment for adolescents with eating disorders. The main objectives are to:i) Evaluate whether a personalized digital treatment for adolescents with eating disorders are feasible in a child and adolescent psychiatric outpatient clinic.ii) Evaluate who benefits from a personalized digital treatment for adolescents with eating disorders (what works for whom?) iii) Evaluate the cost-benefit of a personalized digital treatment for adolescents with eating disorders.Participants will be enrolled in a 10-week digital treatment including weekly therapist contact. They will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up. ### Conditions - Eating Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Digital Treatment for Adolescents With Eating Disorders ### Outcomes Primary Outcomes - The Credibility and Expectancy Scale (CEQ-1) - Adherence - Module evaluations - Client Satisfaction Questionnaire (CSQ-3) - Recruitment - Eating disorder symptoms - The Clinical Impairment Assessment Questionnaire (CIA) - The KIDSCREEN (KIDSCREEN-10) Secondary Outcomes - The Patient Health Questionnaire (PHQ-2) - Generalized Anxiety Disorder scale (GAD-2) - School attendance - Tme with friends - Difficulties with Emotion Regulation Scale (DERS-18) - EuroQoL 5D-5L (EQ-5D-5L) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CardioMEMS HF System Real-World Evidence Post-Approval Study - NCT ID: NCT06306573 - Study ID: CL1019613 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-12-15 - Completion Date: 2028-12-31 - Lead Sponsor: Abbott Medical Devices ### Study Description The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods. ### Conditions - Heart Failure NYHA Class II - Heart Failure NYHA Class III ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CardioMEMS HF System ### Outcomes Primary Outcomes - Two-Year Survival in the Primary Cohort (NYHA Class II subjects) Secondary Outcomes - Two-Year Survival in the Full Cohort (NYHA Class II and Class III subjects) ### Location - Facility: Abbott Medical, Atlanta, Georgia, 30313, United States @@
## A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC. - NCT ID: NCT06306560 - Study ID: MA-SCLC-II-018 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-04-15 - Lead Sponsor: Harbin Medical University ### Study Description This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer. ### Conditions - Extensive-stage Small-cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - adebrelimab - famitinib - chemotherapy ### Outcomes Primary Outcomes - 6-month progression-free survival Secondary Outcomes - 12-month progression-free survival - Objective Response Rate - Disease control rate - Overall Survival - AEs - QoL - Progression-Free-Survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Study Cohort of Idiopathic Inflammatory Myositis - NCT ID: NCT06306547 - Study ID: IIM001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2034-04-01 - Lead Sponsor: RenJi Hospital ### Study Description Idiopathic inflammatory myositis (IIM), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment responses, and prognosis. This project will build a clinical follow-up cohort for idiopathic inflammatory myositis (IIM) centered on Renji Hospital, Shanghai Jiao Tong University School of Medicine, to promote the clinical and pathogenesis of this group of diseases. ### Conditions - Idiopathic Inflammatory Myopathies ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no interventions were involved ### Outcomes Primary Outcomes - High Resolution Computed Tomography of Chest - Cutaneous Disease Area and Severity Index - Forced vital capacity - Manual Muscle Testing - Forced expiratory volume in one second Secondary Outcomes - Serum creatine kinase ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Auditory Intranerve Stimulation Study - NCT ID: NCT06306534 - Study ID: AIS-001 - Status: RECRUITING - Start Date: 2023-05-15 - Completion Date: 2024-11-15 - Lead Sponsor: Hannover Medical School ### Study Description This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve. ### Conditions - Auditory; Nerve ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Auditory Nerve Acute (ANA) Electrode Array ### Outcomes Primary Outcomes - Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms Secondary Outcomes - Collection of adverse events ### Location - Facility: Hannover Medical School, Hannover, N/A, 30625, Germany @@
## An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing - NCT ID: NCT06306521 - Study ID: 20235517 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2029-02 - Lead Sponsor: Rady Pediatric Genomics & Systems Medicine Institute ### Study Description The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Parents will be approached to provide informed consent to enroll their newborns in prenatal, postnatal, and outpatient settings. The main questions this study aims to answer are:What is the utility of BeginNGS as compared to state newborn screening? What is the acceptability and feasibility of BeginNGS as compared to state newborn screening? What is the cost effectiveness of BeginNGS as compared to state newborn screening?Enrolled newborns will have a blood sample taken and will receive the BeginNGS test. Newborns will have also had the state newborn screening test. ### Conditions - Genetic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - BeginNGS Test ### Outcomes Primary Outcomes - Comparison of the clinical utility of BeginNGS and standard of care (state NBS), defined by the proportion of enrollees likely to benefit (likely to have an improved outcome) from an indicated therapeutic intervention Secondary Outcomes - Utility secondary outcome 1 - Utility secondary outcome 2 - Utility secondary outcome 3 - Utility secondary outcome 4 - Utility secondary outcome 5 - Utility secondary outcome 6 - Utility secondary outcome 7 - Utility secondary outcome 8 - Utility secondary outcome 9 - Utility secondary outcome 10 - Acceptability outcome 1 - Acceptability outcome 2 - Acceptability outcome 3 - Acceptability outcome 4 - Feasibility (ability of the study to be undertaken as designed) outcome 1 - Feasibility (ability of the study to be undertaken as designed) outcome 2 - Feasibility (ability of the study to be undertaken as designed) outcome 3 - Feasibility (ability of the study to be undertaken as designed) outcome 4 - Feasibility (ability of the study to be undertaken as designed) outcome 5 - Cost effectiveness outcome 1 - Cost effectiveness outcome 2 - Cost effectiveness outcome 3 - Cost effectiveness outcome 4 - Accuracy outcome 1 - Accuracy outcome 2 - Utility secondary outcome 11 - Feasibility outcome 6 - Feasibility outcome 7 - Utility secondary outcome 12 ### Location - Facility: Rady Children's Hospital San Diego, San Diego, California, 92123, United States @@
## Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis - NCT ID: NCT06306508 - Study ID: HUvbayraktaroglu - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2025-02-16 - Lead Sponsor: Halic University ### Study Description Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study. ### Conditions - Cystic Fibrosis - Cystic Fibrosis in Children ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Modified shuttle walk test (MST) Secondary Outcomes - Forced expiratory volume at one second (FEV1) - Forced vital capacity (FVC) - Forced expiratory volume at one second / Forced vital capacity rate (FEV1/FVC) - Peak expiratory flow (PEF) - Maximum inspiratory pressure (MIP) - Maximum expiratory pressure (MEP) - Physical Activity Questionnaire for Children (PAQ-C) - Munich physical fitness test (MFT) - Quadriceps strength - Handgrip strength - Cystic Fibrosis Questionnaire Revised (CFQ-R) - Parental Attitude Scale (PAS) - Parent Attitude Scale - Perceived Social Support Scale (PSS) - Breathlessness Beliefs Questionnaire (BBQ) ### Location - Facility: Haliç University, Istanbul, Eyup, 34060, Turkey @@
## Insomnia, Physical Activity Level and Stress Level - NCT ID: NCT06306495 - Study ID: 26.01.2022/17 - Status: COMPLETED - Start Date: 2022-03-27 - Completion Date: 2024-01-29 - Lead Sponsor: Halic University ### Study Description Insomnia is a common, acute, intermittent, or chronic complaint of unwanted sleep difficulties characterized by sleep disturbance. Important risk factors leading to insomnia: advanced age, poor health, work stress, shift work, loss of a loved one, divorce, domestic violence, excessive anxiety, repressed personality, perfectionism, neuroticism, alcohol and substance abuse, excessive caffeine intake, excessive smoking, low socio-economic status and low physical activity level. Research shows that college students face more sleep problems than the general public. Factors that disrupt the sleep hygiene of university students; Students' excessive use of computers during lecture and exam periods, exposure to lights and screens for long periods of time, and environmental changes. The aim of this study is to determine the prevalence of insomnia in healthy individuals after the start of face-to-face education in university students after the pandemic period and to determine the physical activity associated with insomnia in this population group. Examining levels and other behavioral factors. The research was conducted on students studying at Istanbul Rumeli University, Haliç University and Yalova University between March 2022 and August 2022. It will be held online via Google Forms with students between the ages of 18-25. Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale, and Pittsburgh Sleep Quality Index. An application will be made to obtain approval from the Haliç University Non-Interventional Clinical Research Ethics Committee. Informed consent will be obtained from people participating in the research. Statistical analysis of the data will be done with IBM SPSS 23.0 software. ### Conditions - Sleep Initiation and Maintenance Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - International Physical Activity Survey ### Outcomes Primary Outcomes - Prevalence of insomnia in university students Secondary Outcomes - The effect of insomnia on physical activity level - The effect of insomnia on stress levels in university students - Effects of sleep hygiene on insomnia in university students ### Location - Facility: Halic University, Istanbul, N/A, N/A, Turkey @@
## Determination of Posture in Patients With Restrictive and Obstructive Lung Disease - NCT ID: NCT06306482 - Study ID: SBA 23/390 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-07 - Completion Date: 2026-03-07 - Lead Sponsor: Hacettepe University ### Study Description The aim of this study is to determine posture and posture related factors in patients with restrictive and obstructive lung disease. ### Conditions - Lung Diseases, Obstructive - Lung Diseases - Postural; Defect ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluation of horizontal alignment of the head anterior view - Evaluation of horizontal alignment of the trunk anterior view - Evaluation of horizontal alignment of the head lateral view - Evaluation of vertical alignment of the head lateral view - Evaluation of horizontal alignment of the trunk lateral view - Evaluation of vertical alignment of the trunk lateral view - Evaluation of horizontal asymmetry trunk in posterior view - Evaluation of scapulae - Posture Secondary Outcomes - Functional exercise capacity - Respiratory Muscle Strength - Lung function - Dyspnea - Peripheral muscle strength - Lower extremity capacity - Energy expenditure - Balance and Fall risk - Tightness of muscle - Severity of disease for patients with COPD - Severity of disease for patients with bronchiectasis - Diffusion capacity for patients with diffuse parenchymal lung diseases - Symptoms for patients with COPD ### Location - Facility: Aynur Demirel, Ankara, N/A, 06100, Turkey @@
## Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment - NCT ID: NCT06306469 - Study ID: PHRI-2022-1001 - Status: COMPLETED - Start Date: 2022-07-02 - Completion Date: 2024-01-11 - Lead Sponsor: Pranic Healing Research Institute ### Study Description The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment.This study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral and gut microbiome will shift dynamically in a short period; and (3) the overall shift resulting from the changes in the gut microbiome members will be associated with known benefits to health and well-being. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Meditation practice ### Outcomes Primary Outcomes - Assessing the changes in gut and oral microbiome profile of the participants during retreat Secondary Outcomes ### Location - Facility: Pranic Healing Research Institute, Lyndhurst, New Jersey, 07071, United States @@
## A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC - NCT ID: NCT06306456 - Study ID: GH21C201 - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2026-12-31 - Lead Sponsor: Suzhou Genhouse Bio Co., Ltd. ### Study Description This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations. ### Conditions - Non-Small Cell Lung Cancer With EGFR Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - GH21+Osimertinib ### Outcomes Primary Outcomes - Number of participants with dose limiting toxicities - Number of participants with adverse events - Progression-free survival (PFS) Secondary Outcomes - Objective response rate (ORR) - Duration of response (DOR) - Duration of response (DCR) - Overall survival (OS) - Progression-free survival (PFS) - Number of participants with adverse events - Plasma concentration (Cmax) - Time to achieve Cmax (Tmax) - Area under the plasma concentration-time curve (AUC) ### Location - Facility: Shanghai Pulmonary Hospital, Shanghai, Shanghai, 200433, China @@
## Buprenorphine for Individuals in Jail - NCT ID: NCT06306443 - Study ID: 20235453 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-12-31 - Lead Sponsor: Friends Research Institute, Inc. ### Study Description This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - extended-release buprenorphine (XR-B) ### Outcomes Primary Outcomes - urine toxicology - days of opioid use - time to opioid relapse Secondary Outcomes - retention in buprenorphine treatment - urine toxicology for other illicit substance use - days of illicit substance use - overdose events - PROMIS Patient-Reported Outcomes Measurement Information System - physical health - PROMIS Patient-Reported Outcomes Measurement Information System - mental health - HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score - HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score - criminal activity ### Location - Facility: Friends Research Institute, Baltimore, Maryland, 21201, United States @@
## Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis - NCT ID: NCT06306430 - Study ID: uLAM TB FIA - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: Ospedale San Raffaele ### Study Description Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU). ### Conditions - Tuberculosis - Diagnoses Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - STANDARDTM F TB LAM FIA ### Outcomes Primary Outcomes - Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay Secondary Outcomes - Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects) ### Location - Facility: Emerging Bacterial Pathogens Unit, Milan, N/A, 20132, Italy @@
## A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome - NCT ID: NCT06306417 - Study ID: PKUTH TCM - Status: RECRUITING - Start Date: 2023-09-28 - Completion Date: 2025-08-30 - Lead Sponsor: Peking University Third Hospital ### Study Description To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients. ### Conditions - Polycystic Ovary Syndrome (PCOS) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - lifestyle intervention - acupuncture - Sham acupuncture ### Outcomes Primary Outcomes - HOMA-IR Secondary Outcomes - Hirsutism(FG score >4）, acne and early alopecia - AUC insulin - Follicle stimulating hormone (FSH) - luteinizing hormone (LH) - Progestin (P) - Estrogen (E2) - Prolactin (PRL) - Androgen(T) - Anti-mullerian hormone (AMH) - Sex hormone-binding globulin (SHBG) - Free testosterone index (FAI) - total cholesterol - triglycerides - high density lipoprotein (HDL) - low density lipoprotein (LDL) - Bile acidomics - Metagenomics and 16S rDNA sequencing analysis - short form-36 (SF36) - Self-Rating Anxiety Scale (SAS) - Self-Rating Depress Scale (SDS) - polycystic ovary syndrome questionnaire, PCOSQ - BMI - Fat% - waist to hip ratio(WHR) - glycosylated hemoglobin level - ovarian size - number of follicles - uterine size - endometrial thickness ### Location - Facility: Peking University third hospital, Beijing, N/A, N/A, China @@
## Improving Sleep and Mood in the Peri-menopause - NCT ID: NCT06306404 - Study ID: NL86165.100.24 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-06-01 - Lead Sponsor: VU University of Amsterdam ### Study Description The perimenopause is known as a vulnerable period for some women, with noticeable somatic and psychological issues. Aside from climacteric symptoms, insomnia and depression are common. About half of women during the peri-menopausal period experience sleep problems like problems falling asleep, awakening during the night and being unable to return to sleep. This is often attributed to vasomotor symptoms, but this is not the only reason of poor sleep (Joffe et al., 2010). Also, the peri-menopausal period is a critical time for the occurrence of new onset and recurrent depressions (Cohen et al., 2006). It has been suggested that fluctuations in estradiol may increase the risk for depression by altering neuronal functions in the brain. But there are also indications that the risk for depression increases by indirect effects, such as the increase in insomnia. Poor sleep has increasingly been recognized as the key modifiable factor affecting mental issues like depression (Van Someren, 2021). While antidepressants and psychotherapies continue to be the treatments of choice for depression, and Cognitive Behavioral Therapy for sleep (CBTi) for insomnia, preclinical and clinical data support the benefits of estrogen-based therapies to improve mood, sleep and other menopause-related symptoms (Gordon et al. 2018). Transdermal estradiol patches, which provide a stable release of estradiol and lead to more stable blood levels, have been suggested to have a positive effect on sleep (Joffe et al., 2020) and depressive symptoms (Gordon et al., 2018) in randomized controlled trials. However, it is currently unclear if the relation between improvement in mood and estradiol patches is mediated by improvement in sleep problems, and if the effect of estradiol patches on sleep problems is more effective during peri-menopause than the current evidence-based sleep interventions of CBTi, preferably in combination with Circadian Rhythm Support (CRS). The aim of the study is to pinpoint the determinants of complaints about sleep and mood and how they respond to Menopausal Hormone Treatment (MHT) with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS.Measurements will be conducted at baseline (T0), 2 months (T1) and 4 months (T3), with questionnaires, sleep measurements (EEG sleepband and actigraph) and skin conductance (to measure hot flushes). Participants will be recruited via www.slaapregister.nl and via OLVG outpatient clinic population of peri-menopausal women seeking help for climacteric complaints (like hot flushes, feeling bloated, increase in weight), including sleep problems. The participants are adults between 40-55 years old, with an Insomnia Severity Index score ≥10 and Climacteric Green Scale score ≥ 13.They have the self-considered capability to complete online questionnaires and diaries in Dutch.The intervention will be MHT (estradiol transdermal patches 50 mcg (Systen), in combination with 200 mg progesterone (Utrogestan tablets for 2 weeks, adjusted to the menstrual cycle to prevent endometrium carcinoma according to the international MHT guidelines), with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS. ### Conditions - Menopause - Insomnia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Estrogens and Progestogens - Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy ### Outcomes Primary Outcomes - The primary outcome variable is the difference between the groups in the within-subject change in insomnia severity at T1 (2 months) and T2 (4 months) relative to T0 (baseline). Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers. - NCT ID: NCT06306391 - Study ID: IMIMFCTL/NLX_1 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-09 - Lead Sponsor: Parc de Salut Mar ### Study Description This is a phase I interventional clinical trial and the aim will be to characterize the PK and PD of two formulations of naloxone (intranasal and intravenous) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Intravenous naloxone - Intranasal naloxone ### Outcomes Primary Outcomes - Effects of naloxone on heart rate (HR). - Effects of naloxone on systolic and diastolic blood pressure (BP). Secondary Outcomes - Effects of naloxone on plasma cortisol at visit 1 and visit 4. ### Location - Facility: IMIM (Hospital del Mar Medical Research Institute), Barcelona, N/A, 08003, Spain @@
## The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder - NCT ID: NCT06306378 - Study ID: XJTU1AF2023LSK-481 - Status: RECRUITING - Start Date: 2023-12-04 - Completion Date: 2024-04-30 - Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University ### Study Description Research background and project basisAutism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by social disorders and repetitive stereotypical behavior. Social memory impairment is a significant feature of ASD patients, and the specific pathogenesis of social memory impairment in ASD patients is currently unclear, and there are no objective indicators to measure social memory levels. Sleep spindle wave is a special brain wave in sleep that is closely related to memory consolidation. However, no one has yet studied the impact of sleep spindles on social memory.Research purposeExploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with ASD. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - social memory levels and spindle levels ### Outcomes Primary Outcomes - Recognition accuracy - Response delay time - Sleep spindle density - Sleep spindle average duration - Sleep spindle amplitude - Sleep spindle frequency Secondary Outcomes ### Location - Facility: First Afflicated Hospital Xian Jiaotong University, Xi'an, Shaanxi, 710061, China @@
## Effects of Modern Board Games on Well Being in Older Adults - NCT ID: NCT06306365 - Study ID: PI-DOC003-WBOA - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2024-06-28 - Lead Sponsor: European University Miguel de Cervantes ### Study Description The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being. ### Conditions - Executive Functions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Modern board game-based learning ### Outcomes Primary Outcomes - Examination for Mental Disorders of the Elderly - Trail Making Test to evaluate Executive Functions - Assessment of quality of life in older adults and people with disabilities - Psychometric development and practical use Secondary Outcomes ### Location - Facility: European University Miguel of Cervante, Valladolid, N/A, 47012, Spain @@
## Vibrotactile Feedback in Exoskeletons - NCT ID: NCT06306352 - Study ID: 1070 - Status: COMPLETED - Start Date: 2023-03-06 - Completion Date: 2023-06-21 - Lead Sponsor: Sint Maartenskliniek ### Study Description This study aims to investigate the impact of providing discrete vibrotactile feedback related to weight shift and step initiation on exoskeleton use in individuals with motor-complete SCI. ### Conditions - Spinal Cord Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Vibrotactile feedback ### Outcomes Primary Outcomes - Walking distance covered Secondary Outcomes - Reach path ratio - Reach time - User experience questionnaire - Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) - only including the eight items related to user satisfaction with the assistive device ### Location - Facility: Sint Maartenskliniek, Nijmegen, N/A, N/A, Netherlands @@
## A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug) - NCT ID: NCT06306339 - Study ID: hzVSF_v13-0015 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-07 - Lead Sponsor: ImmuneMed, Inc. ### Study Description The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab (hzVSF-v13) when added to Disease-Modifying Antirheumatic Drug (DMARD) treatment as Standard of Care (SOC) in participants with moderate to severe Rheumatoid Arthritis (RA). ### Conditions - Moderate to Severe Rheumatoid Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Burfiralimab - SOC (Standard of care) - Placebo ### Outcomes Primary Outcomes - Proportion of participants achieving clinical response according to the ACR 20 criteria at Week 12 Secondary Outcomes - Clinical response at Week 12, assessed as the attainment of an LDA (Low Disease Activity) state defined - Clinical response at Week 12, assessed as remission defined - Improvement of physical function at Week 12 - Pain relief at Week 12 assessed by the (mean) change from Baseline - Health-related quality of life at Week 12, assessed as the change from Baseline ### Location - Facility: University Medical Center Urtrecht, Utrecht, GA, N/A, Netherlands @@
## 3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities - NCT ID: NCT06306326 - Study ID: pkussfatgrafting - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2029-03-01 - Lead Sponsor: Peking University ### Study Description Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. However, the instability of its treatment effect has always been a bottleneck in this field, mainly due to the uncertain absorption rate of transplanted fat. This project aims to use advanced the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology to precisely measure the facial volume changes before and after autologous fat grafting to address this issue. By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis. ### Conditions - Adipocytes - Autografts - Imaging, Three-Dimensional / Methods ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 3dMD technology ### Outcomes Primary Outcomes - Fat Retention Rate Secondary Outcomes - Patient Satisfaction ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Robot-Assisted Rehabilitation on Upper Extremity Functions in Chronic Stroke - NCT ID: NCT06306313 - Study ID: ReoGo - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2024-05-14 - Lead Sponsor: Pamukkale University ### Study Description The most common problem caused by stroke is motor activity limitation that reduces muscle movement and mobility. But stroke can also lead to sensory and cognitive impairment. Additionally, the ability to independently carry out activities of daily living and participate in social and community life is greatly reduced. Up to 85% of stroke patients experience hemiparesis immediately after stroke, while 55% to 75% of survivors continue to experience reduced quality of life with motor impairments.It requires long-term physical rehabilitation to achieve functional recovery in the upper extremity, maximum independence and the highest possible quality of life. Different methods can be used to achieve these results, but there is no clear evidence yet as to which treatment method gives the best results. Scientific evidence shows that a multifactorial approach and high-intensity treatment accelerates the motor recovery of the upper extremities in stroke rehabilitation. Passive and active upper extremity movements appear to increase motor recovery due to their effects on somatosensory input, motor planning, soft tissue properties and spasticity.In recent years, robotic devices have emerged that have been proven to improve the motor performance of the upper extremity in chronic stroke patients. There are also studies showing that robotic device-assisted upper extremity therapy can contribute to the development of sensorimotor skills in plegic patients. However, in the current literature, there is still a need for randomized controlled studies in this field. The aim of this study is to investigate the effects of robot-assisted therapy on upper extremity functions and daily living activities in the rehabilitation of chronic stroke patients. After the demographic data of the cases in both groups are obtained, evaluations will be made before the study. Then, the study group will receive conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition robot-assisted therapy with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. The initial evaluations will be repeated after the end of the treatment period. ### Conditions - Stroke - Upper Extremity Paresis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ReoGo - Conventional Physiotherapy ### Outcomes Primary Outcomes - Fugl Meyer Upper Extremity Evaluation Scale - Functional Independence Scale Secondary Outcomes ### Location - Facility: Pamukkale University, Denizli, N/A, N/A, Turkey @@
## Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil) - NCT ID: NCT06306300 - Study ID: 445957/2020-4 - Status: RECRUITING - Start Date: 2022-07-04 - Completion Date: 2025-12-31 - Lead Sponsor: Oswaldo Cruz Foundation ### Study Description Up to 650,000 people in Brazil are living with chronic hepatitis c virus (HCV) infection. Hepatitis C is a silent disease, and up to 20% of cases can progress to liver cirrhosis and its complications. Rapid tests for diagnosis of HCV infection and non-invasive methods for detecting liver cirrhosis are available in the Brazilian Public Health System. Additionally, safe and highly effective drugs (direct-acting antivirals, DAAs) have been delivered for free for hepatitis C treatment by the Brazilian Unified Health System (Sistema Único de Saúde, SUS) since 2015. Sustained virological response (SVR) rates with DAAs in studies conducted in Brazil and Latin America were higher than 90%. Despite the availability of rapid tests for early diagnosis and effective drugs, the HCV continuum of care remains deficient in Brazil. It is estimated that only 10% of individuals known to have hepatitis C achieve HCV cure (SVR). This is explained by multiple barriers from diagnosis to treatment access, such as low rates of population screening (HCVST are not available in Brazil) and few available slots in tertiary centers for hepatitis C treatment by specialists. International studies have described that SVR rates by simplified hepatitis C treatment performed by non-specialists in the Primary Care System were similar to those treated in tertiary centers by specialists (standard-of-care). However, the optimal strategy for managing hepatitis C within the Brazilian-SUS remains unclear.This project aims to evaluate the improve of the HCV continuum of care by a implementation of a test-and-treat strategy in the Primary Care System in Brazil. The project consists of two parallel studies (and a sub-study).The project consists of two parallel studies (and a sub-study). Study I is a population-based cross-sectional screening study using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (participants included in Study I). Study II is a phase IV open-label randomized clinical trial to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment ("Simplified-and-Decentralized (SD) HCV treatment"; experimental arm) compared to specialist reference treatment ("Standard-of-Care (SC) HCV treatment"; control arm) within the SUS. ### Conditions - Hepatitis C ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Specialist - Epclusa 400Mg-100Mg Tablet - Non- specialist - Epclusa 400Mg-100Mg Tablet ### Outcomes Primary Outcomes - Prevalence of HCV infection - The effectiveness of the HCV treatment with test results. - Usability of the result of a self-test HCV Secondary Outcomes - Proportion between positive and negative - Participants with fibrosis/cirrhosis - Participants who denied the treatment - cost per detected participant - Unscheduled visits during treatment - Improvement of liver fibrosis stage - Quality of life data - Cost of treatment for participant - Adherence to treatment ### Location - Facility: Evandro Chagas National Institute of Infectious Diseases, Rio de Janeiro, Rio De Janeiro/RJ, 21040-360, Brazil @@
## Adolescent Screening and Personalized Intervention Resource for Enhancement of Behavioral Health and Substance Use - NCT ID: NCT06306287 - Study ID: DA053660 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-04-30 - Lead Sponsor: Oregon Research Institute ### Study Description Only a small fraction of youth who are beginning to experience behavioral health problems and use alcohol or illicit drugs receive needed treatment services due to the lack of accessible, effective early intervention resources. The goal of this clinical trial is to compare a personalized brief web-based early intervention, eHealth Personalized Approach for Change Efficacy (ePACE), in which youth are offered choices regarding intervention content and desired level of engagement, to a "fixed", non-tailored brief intervention, eHealth Fixed Approach for Change Efficacy (eFACE) for adolescents with mild/moderate substance use and common co-occurring problems. Both ePACE and eFACE include a multi-problem screener that guides youths through a set of key integrated behavior change and counseling modules providing a cohesive focus on these four problem domains: drug abuse, interpersonal relations, negative emotions and stress. The main questions the trial aims to answer are:* Are substance use and co-occurring problem outcomes for ePACE and eFACE are superior to those for a waitlist comparison group (WC)* Are outcomes for ePACE are superior to those for eFACE* Are the direct effects of ePACE and eFACE (i.e., the improvements in substance use and co-occurring problem outcomes) associated with improvements in areas of functioning and new skills that are hypothesized to produce change -- that is, are the improvements shown in the ePACE and eFACE groups due to the mechanisms by which change is hypothesized to occur Participants in ePACE and eFACE will complete a baseline assessment prior to engaging in the intervention to which they are assigned and will complete post-intervention assessments 3 months and 6 months later. Participants in the WC group will complete three assessments: at baseline, 3-months, and 6-months. ### Conditions - Substance Use - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ePACE Personalized Intervention - eFACE Fixed Intervention ### Outcomes Primary Outcomes - Adolescent Substance Use from baseline to 3 months - Adolescent Substance Use from baseline to 6 months - Youth Report of Internalizing Problems from baseline to 3 months - Youth Report of Internalizing Problems Change from baseline to 6-months - Youth Report of Externalizing Problems from baseline to 3-months - Youth Report of Externalizing Problems from baseline to 6-months - Parent Report of Internalizing Problems from baseline to 3-months - Parent Report Internalizing Problems from baseline to 6-months - Parent Report Externalizing Problems from baseline to 3-months - Parent Report Externalizing Problems from baseline to 6-months Secondary Outcomes - Problem-Solving Inventory from baseline to 3-months - Problem-Solving Inventory from baseline to 6-months - Child Global Assessment Scale (CGAS) from baseline to 3-months - Child Global Assessment Scale (CGAS) from baseline to 6-months - Peer Encouragement and Influence from baseline to 3 months - Peer Encouragement and Influence from baseline to 6 months ### Location - Facility: Oregon Research Institute, Albuquerque, New Mexico, 87109, United States @@
## Topical Tacrolimus for Breast Cancer-related Lymphedema - NCT ID: NCT06306274 - Study ID: TACLE trial - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-11-30 - Lead Sponsor: Odense University Hospital ### Study Description The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:* How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life).* If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months. ### Conditions - Lymphedema ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tacrolimus - Placebo ### Outcomes Primary Outcomes - Lymphedema volume Secondary Outcomes ### Location - Facility: Odense University Hospital, Odense, N/A, 5000, Denmark @@
## Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis - NCT ID: NCT06306261 - Study ID: TIMAEUS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: IRCCS San Raffaele ### Study Description The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists. ### Conditions - Ulcerative Colitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - questionnaire ### Outcomes Primary Outcomes - to evaluate mental stress/health as an impacting factor on UC progression Secondary Outcomes ### Location - Facility: Irccs Ospedale San Raffaele, Milano, N/A, 20132, Italy @@
## Immune Activation, Neural Plasticity and Depression - NCT ID: NCT06306248 - Study ID: PNRR-MAD-2022-12375716 - Status: RECRUITING - Start Date: 2023-03-03 - Completion Date: 2025-05-09 - Lead Sponsor: IRCCS San Raffaele ### Study Description Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.Increasing evidence indicates a clear link between immune dysfunction and MDD.Moreover, an activation of inflammatory pathways is associated to a lack of clinical response to antidepressants. Thus, the regulation of inflammation represents a potential approach to modulate the link between the living environment and antidepressant outcome. Light therapy combined with sleep deprivation hastens recovery, with benefits that can be perceived by patients during the first week of treatment. Alteration of the sleep-wake cycle and of sleep structure are core symptoms of MDD.The aims of the present project are (i) to show that neural plasticity and the environmental context are moderating factors of the therapeutic outcome of immune modulation and (ii) to exploit their interplay to set up novel and effective therapeutic strategies for MDD.This is a observational prospective study with non-invasive add-on procedures (Magnetic Resonance without contrast). In this study, 60 patients with a depressive episode in course of MDD and treated with a chronobiological intervention including total sleep deprivation (TSD) + light therapy (LT), as performed in clinical practice, will be studied. All participants enrolled in the study will receive Treatment As Usual (TAU), i.e., pharmacotherapy, chronobiological intervention plus clinical management. Drug prescription will be performed during the clinical management sessions.The study will have a total duration of 24 months. Each subject will participate in the study for 6 months, will undergo Magnetic Resonance Imaging (MRI) and clinical evaluation at baseline, after one week of chronobiological treatment and at 6 months follow-up. ### Conditions - Mood Disorders - Major Depressive Disorder - Sleep Deprivation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Total sleep deprivation ### Outcomes Primary Outcomes - BENEFICIAL EFFECT OF total sleep deprivation in inflamed vs non inflamed patients. Secondary Outcomes - Neurobiological markers of prediction and progression of antidepressant treatment ### Location - Facility: IRCCS Ospedale San Raffaele, Milan, Mi, 20132, Italy @@
## Are Non-participants of Conventional Centre-based Cardiac Rehabilitation Willing to Participate in Cardiac Telerehabilitation? - NCT ID: NCT06306235 - Study ID: 20.84-reva20.06 - Status: COMPLETED - Start Date: 2020-10-12 - Completion Date: 2021-07-31 - Lead Sponsor: Jessa Hospital ### Study Description Patients who are eligible for cardiac rehabilitation but do not want to participate will be offered to participate in an interview (part A of the study) or a tablet questionnaire (part B of the study).Goal is to identify main barriers for conventional rehabilitation as well as to assess willingness to participate in cardiac telerehabilitation, main barriers and willingness-to-pay for cardiac telerehabilitation. ### Conditions - Cardiac Rehabilitation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - Willingness to participate in telerehabilitation Secondary Outcomes ### Location - Facility: Jessa Hospital, Hasselt, Limburg, 3500, Belgium @@
## Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease - NCT ID: NCT06306222 - Study ID: GR-2021-12375430 - Status: RECRUITING - Start Date: 2023-11-23 - Completion Date: 2026-02-23 - Lead Sponsor: IRCCS San Raffaele ### Study Description This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL. ### Conditions - Kidney Stone - Ureteral Stone ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Laser lithotripsy ### Outcomes Primary Outcomes - Lithotripsy speed Secondary Outcomes - Stone free rate ### Location - Facility: IRCCS Ospedale San Raffaele, Milan, N/A, N/A, Italy @@
## Inflammatory Control of Antidepressant Efficacy: a Pharmaco-epigenetic Approach - NCT ID: NCT06306209 - Study ID: DeFLAME - Status: RECRUITING - Start Date: 2021-05-18 - Completion Date: 2025-01-14 - Lead Sponsor: IRCCS San Raffaele ### Study Description Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.It posits that the increase in serotonin levels induced by Selective Serotonin Reuptake Inhibitors (SSRIs) does not affect mood per se, but enhances brain plasticity and thus amplifies the influence of the environment on the individual. Thus, SSRI treatment has not a univocal effect but, in a favorable environment, it would lead to a reduction of symptoms while in a stressful environment might lead to a worse prognosis.Such innovative view opens new perspectives on how to improve SSRI efficacy by controlling the environment. However, often it is not possible to act on the quality of the living environment because of constraints due to patient's personal history and unchangeable life circumstances. In these cases, the pharmacological modulation of the factors underlying the link between living environment and SSRI efficacy represents a novel and desirable strategy to improve treatment outcome even in patients living in adverse conditions, which are very common in depressed patients. Inflammatory levels are markedly affected by the socioeconomic status and thus by the quality of the living environment. The hypothesis of the present project is that inflammation mediates the influence of the environment on SSRI outcome.Therefore, the control of inflammatory levels is a promising strategy to improve treatment efficacy and overcome the limited SSRI efficacy, especially when administered in patients living in adverse conditions. A further hypothesis is that the influence of the environment on inflammation, in turn affecting SSRI efficacy, occurs through epigenetic modifications. Therefore, the project aims at developing a pharmaco-epigenetic approach as effective treatment for MDD. In addition, through neuroimaging investigations, it will provide important information about functional and structural brain modifications associated to SSRI efficacy in patients.Both males and females will be considered because MDD is twice as common in women than men, suggesting that different mechanisms may underlie the psychopathology in the two sexes. ### Conditions - Mood Disorders - Major Depressive Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Treatment as usual (TAU), i.e., pharmacotherapy plus clinical management ### Outcomes Primary Outcomes - The potential role of inflammation as the causal link between the quality of the environment and SSRI efficacy - interaction between early stress and recent stress on the response to treatment and the role of inflammation - identification of neurobiological predictors of response to treatment - identification of neurobiological predictors of response to treatment - identification of neurobiological predictors of response to treatment Secondary Outcomes - epigenetic changes in cytokine regulating genes which could mediate the effect of stress on response to treatment. ### Location - Facility: IRCCS Ospedale San Raffaele, Milan, Mi, 20132, Italy @@
## Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children - NCT ID: NCT06306196 - Study ID: IVI Hecolin S001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-01 - Lead Sponsor: International Vaccine Institute ### Study Description The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals ### Conditions - Hepatitis E Virus Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Hecolin® Recombinant Hepatitis E Vaccine - Isotonic Sodium Chloride injection ### Outcomes Primary Outcomes - Seroresponse rate - Proportion of immediate adverse events - Proportion of solicited local and systemic adverse events - Proportion of unsolicited adverse events - Proportion of SAEs, MAAEs and AESIs Secondary Outcomes - GMC of anti-HEV IgG - SR - GMC of anti-HEV IgG - SR and GMC of anti-HEV IgG - SR - GMC of anti-HEV IgG - SR - GMC of anti-HEV IgG - SR - GMC of anti-HEV IgG - SR - GMC of anti-HEV IgG - SR and GMC of anti-HEV IgG ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Vitamin C on Pain Reduction After an Emergency Department Visit - NCT ID: NCT06306183 - Study ID: 2024-2829 - Status: NOT_YET_RECRUITING - Start Date: 2024-11 - Completion Date: 2028-03 - Lead Sponsor: Hopital du Sacre-Coeur de Montreal ### Study Description Emergency department (ED) clinicians often prescribe anti-inflammatory drugs (NSAIDs) to manage acute musculoskeletal (MSK) pain (e.g.: fracture, sprain, back pain). However, even short-term NSAIDs use can have significant gastrointestinal, cardiovascular, MSK and renal adverse effects. For this reason, some patients cannot take or tolerate NSAIDs. Recent evidence has shown that vitamin C has some analgesic and anti-inflammatory properties particularly in postoperative context and prevent specific types of chronic pain. Furthermore, vitamin C is safe and associated with very few adverse events. The primary objective of this study is to determine whether vitamin C can reduce pain intensity during a seven-day period following an ED visit for acute MSK pain.The investigators propose to compare two groups of patients, one receiving 900 mg of vitamin C to another receiving a placebo, twice a day for seven days. Both groups will consume acetaminophen slow release 650 mg two pills every eight hours regularly. Naproxen 500 mg (NSAID) will be used as a rescue medication if the patient's pain is not relieved. Participants will be ≥18 years of age, treated in ED for acute MSK pain present for less than 48 hours with pain intensity at triage of ≥ 4 on a 0-10 numeric rating scale, and discharged by an ED clinician with an NSAIDs prescription without opioids. The level of pain intensity during a seven-day period will be assessed daily using an electronic or paper diary, as well as pain relief, pain medication consumption, and adverse events. Three months after the injury, participants will also be contacted to assess the presence of chronic pain. The investigators hypothesized that vitamin C will reduce pain intensity and chronic pain development at three months.This research could provide a safe alternative to patients who are unable to take NSAIDs. It may also contribute to the reduction of the burden associated with chronic pain development. ### Conditions - Pain, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Acetaminophen and Vitamin C with Naproxen rescue - Acetaminophen and Placebo with Naproxen rescue ### Outcomes Primary Outcomes - Daily pain intensity Secondary Outcomes - NSAIDs consumption - Pain relief - New analgesic prescriptions - Adverse events - Quality of life improvement at seven days - Quantity of Healthcare visits - Prevalence of chronic pain - Prevalence of complex regional pain syndromes for limb fractures - Quality of life improvement at 90 days ### Location - Facility: Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, H4J 1C5, Canada @@
## Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART) - NCT ID: NCT06306170 - Study ID: GYN-ART - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2029-02-15 - Lead Sponsor: IRCCS San Raffaele ### Study Description This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed. ### Conditions - Gynecologic Cancer - Radiotherapy Side Effect - Radiotherapy; Complications - Survivorship - Progression, Disease - Progression, Clinical ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Image Guided Radiotherapy ### Outcomes Primary Outcomes - Local Relapse Free Survival - Regional Relapse Free Survival - Distant Metastases Free Survival - Disease Free Survival - Overall Survival - Cancer Specific Survival Secondary Outcomes - Acute toxicity - Late toxicity ### Location - Facility: San Raffaele Scientific Institute, Milan, MI, 20132, Italy @@
## Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome - NCT ID: NCT06306157 - Study ID: 2023-0667 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-10 - Lead Sponsor: Hospital for Special Surgery, New York ### Study Description Complex Regional Pain Syndrome (CRPS) is a rare and often debilitating chronic pain condition whereby individuals may experience extreme sensitivity, discoloration, and swelling of the affected area -- along with numerous other painful symptoms. There are currently a limited number of treatment options available to those suffering with the condition, with various treatments including nerve blocks, neuropathic medications, and desensitization physical therapy modules. There is budding interesting in the role naltrexone, an opiate antagonist, may play in the pain management of CRPS when prescribed in very low doses. This study aims to collect preliminary data on pain scores, symptom severity, and side-effects in patients with Complex Regional Pain Syndrome randomized to receive low dose naltrexone or placebo capsules. Enrollment of 40 patients total will occur over two years from study start to study end. Each patient will be randomized to receive placebo capsules or active low dose naltrexone capsules, with both the patient and treating clinician blind to the randomization. Each patient will be actively enrolled in the study for six months and will take the medication daily at the instructed dose for the respective duration of time. Following the initial visit and study enrollment, the investigators are asking each patient to return for three (3) in-person follow-up office visits. These office visits will occur 1 month after the patient starts the medication, 3 months afterwards, and 6 months afterwards. The final 6-month office visit will mark the conclusion of the patient's active participation in the study. ### Conditions - Complex Regional Pain Syndrome - Chronic Pain - Causalgia - Complex Regional Pain Syndrome Type I - Complex Regional Pain Syndrome Type II ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Low dose naltrexone - Placebo sugar capsules ### Outcomes Primary Outcomes - Number of study patients enrolled - Number of study patients randomized - Number of study patients who received the study medication Secondary Outcomes - Incidence of side effects/adverse events - Average NRS pain - CRPS symptom severity - PROMIS-10 score - S-LANSS score - Blinding assessment ### Location - Facility: Hospital for Special Surgery, New York, New York, 10021, United States @@
## Early-phase Telecare Programs for Minor Stroke - NCT ID: NCT06306144 - Study ID: 69HCL23_0691 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-07-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Minor strokes (few acute neurological symptoms ; NIHSS score \<5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation.However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment.Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation. ### Conditions - Minor Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Psychoeducation - Computerised Cognitive Stimulation - Usual Care ### Outcomes Primary Outcomes - The primary objective of this study is to demonstrate the benefits of early management following a minor stroke on participation at 6 months post-stroke. Secondary Outcomes - to evaluate the effects on quality of life of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) - to evaluate the effects on cognitive complaint of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) - to evaluate the effects on cognitive function of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) - to evaluate the effects on mood and anxiety of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) - to evaluate the effects on fatigue of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) - to evaluate the effects on participation of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) - to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) - to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) ### Location - Facility: CHU de Bordeaux, Bordeaux, N/A, 33000, France @@
## Phase II Study of Ovulation in Obese Women - NCT ID: NCT06306131 - Study ID: IG-23-002 - Status: RECRUITING - Start Date: 2023-12-10 - Completion Date: 2025-01-31 - Lead Sponsor: InnovaGyn, Inc. ### Study Description The goal of this clinical trial is to compare the delay in ovulation between placebo to levonorgestrel plus meloxicam in obese women with normal menses. The main questions it aims to answer are:1. Ovulation will be delayed by ≥7 days following the first dose of levonorgestrel plus meloxicam compared to ovulation within 3 days following the first dose of placebo.2. There will be no difference in unscheduled vaginal bleeding or adverse events between the two treatments \[placebo versus levonorgestrel plus meloxicam\].Participants will:* undergo two treatment cycles the 1st uses placebo and the 2nd is levonorgestrel plus meloxicam,* maintain daily diary logs for adverse events, unscheduled bleeding, and onset, cessation, and amount of menstrual bleeding,* collect daily first morning voided urine from menstrual day 9 to 24,* undergo transvaginal ultrasound for ovarian follicle development on menstrual days 9, 11,13 and 14.* allow a blood sample to be drawn on days with ultrasound scans.* Take 1st placebo and levonorgestrel plus meloxicam under observation when dominant ovarian follicle is 17 ±1.0 millimeters (mm) in diameter and 2nd dose 48 hours later.Researchers will compare the placebo cycle to levonorgestrel plus meloxicam to see if ovulation is delayed, there is unscheduled vaginal bleeding, menstrual onset is delayed or there is an abnormal amount or duration of menses, there is any difference in treatment emergent side effects and any change in vital signs ### Conditions - Pregnancy Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Levonorgestrel 0.15 milligram - Meloxicam 15 milligram - calcium carbonate 750 milligram ### Outcomes Primary Outcomes - Interval from first dose to evidence of ovulation. Secondary Outcomes - Change in blood pressure - Change in Pulse ### Location - Facility: Carolina Women's Research and Wellness Center, Raleigh, North Carolina, 27713, United States @@
## Autoguide Positioning Device for Multiple Stereotactic Biopsies - NCT ID: NCT06306118 - Study ID: 35-046 ex 22/23 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-10 - Lead Sponsor: Medical University of Graz ### Study Description The purpose of this clinical study should be that, in the context of planned resections of glial brain tumors, pieces of tissue (biopsies) are removed from the tumor at several specific locations before the actual tumor resection takes place.The aim of these biopsies in advance to the actual tumor resection will be to receive tumor tissue samples not altered in such a way that it is no longer adequate for further treatment. If not adequate, a so-called "undergrading" could occur, which means that the biological structure of the tumor is misjudged and further therapy does not achieve the desired effect in the patient.On the one hand, certain tumor regions can drift due to a "brain shift" which leads to inaccurate tissue removal, and on the other hand samples are not altered by pressure or bleeding.To carry out these biopsies, a robot positioning device (AutoGuide®) will be used that has already been approved and tested for this type of intervention. The use of the AutoGuide® is intended to ensure that the tumor sample is taken with the greatest possible precision. ### Conditions - Multiple Stereotactic Tumor Biopsies During a Brain Tumor Resection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Multiple stereotactic Tumor Biopsies during a Brain Tumor Resection ### Outcomes Primary Outcomes - Biopsy Results Secondary Outcomes ### Location - Facility: Medical University of Graz, Graz, Styria, 8036, Austria @@
## Assessment of Anti-aging Efficacy of Marine Collagen Peptides - NCT ID: NCT06306105 - Study ID: 23-118-B - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-12-01 - Lead Sponsor: TCI Co., Ltd. ### Study Description To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human ### Conditions - Skin Condition - Hair Fragility - Nails, Ingrown ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Marine Collagen Peptides - placebo drink ### Outcomes Primary Outcomes - The change of skin hydation - The change of skin wrinkles - The change of skin elasticity - The change of skin collagen density - The change of hair diameters - The change of hair loss amount - The change of hair roots diameters - The change of hair density - The change of hair follicle strength - The change of thumbs nail color - The change of nails appearence - The change of nails growth - The degree of nails fragility Secondary Outcomes - The change of self-assessment skin, hair, and nails condition ### Location - Facility: Chia Nan University of Pharmacy & Science, Pingtung, N/A, 928, Taiwan @@
## Promoting Teenage Sleep for Improved Mental Health and School Performance - NCT ID: NCT06306092 - Study ID: 2023-02885-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2030-06 - Lead Sponsor: Kristianstad University ### Study Description The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group). ### Conditions - Mental Health Issue - Insomnia - Depression - Anxiety - Daytime Sleepiness - Wellness, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Sleep on Schedule - Technology restriction ### Outcomes Primary Outcomes - Change in sleep duration, hours and minutes Secondary Outcomes - Change in Hospital Anxiety and Depression Scale scores - Change in Adolescent Sleep Hygiene Scale scores - Change in Insomnia Severity Index score - Change in EuroQol Visual Analog Scale (EQ VAS) score - Change in CHU9D Child Health Utility 9D (CHU9D) scores - Change in Sleep knowledge - Change in electronic media use - Change in sleep habits - Change in meta-cognitions - Change in motivation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Using Gait Modification to Treat Knee Osteoarthritis in Saudi Arabia: Possibilities and Acceptability. - NCT ID: NCT06306079 - Study ID: KKUMC - Status: COMPLETED - Start Date: 2022-04-13 - Completion Date: 2022-12-30 - Lead Sponsor: King Khalid University ### Study Description A variety of biomechanical gait modification interventions can elevate knee loading and improve knee symptoms in knee osteoarthritis patients. However, there was a lack of acceptability and adherence regarding modification interventions without any explanation.Thus, this study investigates the feasibility and acceptability of foot insoles as a gait modification tool among Saudi Arabian knee osteoarthritis patients and physiotherapists.This study aims to answer the following:* Which gait modification intervention is most likely to be implemented in Saudi Arabia (SA) clinical practice, taking context, patients' clinical and research evidence into consideration?* In Saudi Arabia, can this proposed foot-insole intervention be implemented? Is there sufficient experience among physiotherapists regarding gait modification to deliver it, and will patients engage with it? How can KOA rehabilitation outcomes be evaluated in the future?The participants will be conducted over three phases:1. The patients' interview and therapists' focus group discussion will be used to examine KOA patients' and clinicians' perspectives on enabling and accepting gait modifications in phase 1.2. The feasibility study will explore how a small number of KOA patients tolerate gait modifications and consider the most relevant outcome measures, such as pain and function, in phase (2).3. A small group of knee osteoarthritis patients and their physiotherapists who participated in phase (2) will be asked to participate in a descriptive survey in phase (3). To examine the acceptability and feasibility of the study intervention in phase (2). ### Conditions - Osteoarthritis, Knee - Pain - Biomechanical Lesion ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Lateral Wedge insole ### Outcomes Primary Outcomes - Pain level - Western Ontario and McMaster Universities Arthritis Index-total - Likert scale - Likert scale Secondary Outcomes ### Location - Facility: King Faisal Specialist Hospital & Research Centre, Jeddah, Western, N/A, Saudi Arabia @@
## Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome - NCT ID: NCT06306066 - Study ID: 2015/962-31 - Status: COMPLETED - Start Date: 2015-09-02 - Completion Date: 2022-12-28 - Lead Sponsor: Karolinska Institutet ### Study Description Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital before the coronary anatomy is known. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the left left anterior descending artery (LAD). The patients are followed through telephone-calls and medical records at 1 and 2 years after inclusion and at completion of the study. The hypothesis is that elevated index of microcirculatory resistance (IMR),(\>25) is associated with all-cause death, myocardial infarction (MI) and hospitalization due to congestive heart failure (CHF).The primary analysis is the relationship between IMR and the composite outcome all-cause death, MI and hospitalization due to CHF. ### Conditions - Coronary Artery Disease - Microvascular Angina - Coronary Microvascular Dysfunction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of all-cause mortality, MI and/or hospitalization due to CHF Secondary Outcomes - Rate of all-cause mortality - Rate of hospitalization due to CHF. - Rate of all-cause mortality and/or MI - Rate of MI - Rate of stroke - Rate of ischemic stroke - Rate of unscheduled revascularization ### Location - Facility: Danderyd University Hospital and Karolinska Institutet Danderyds University Hospital (KI DS), Stockholm, N/A, 182 88, Sweden @@
## A New Treatment for Chronic Pain Combining Neuromodulation, Computer Assisted Training and Telemonitoring - NCT ID: NCT06306053 - Study ID: 2022/ST/217 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-30 - Lead Sponsor: ASST Santi Paolo e Carlo ### Study Description Chronic pain (CP) is a leading cause of medical disability, healthcare expenditure, and reduced psychological well-being. Given the limited mobility, travel burden, and cost, access to care can be problematic for patients suffering from this disease, driving the recent shift toward care through telehealth programs. Given the complex interrelationship of physical and psychosocial aspects related to chronic pain, in this project the investigators propose to validate and investigate the effectiveness of new integrated health interventions by combining the technique of transcranial direct current stimulation (tDCS), complementary therapies and telemonitoring. The investigators hypothesize that this novel combined approach will provide a more effective strategy to overcome the classic barriers of pharmacological treatments and access to healthcare due to lack of mobility. To do this, the investigators will rely on a previously developed integrated platform that enables effective delivery of non-pharmacological interventions and outcome assessment. Many patients do not benefit from pharmacological and invasive treatments, leading to the development of alternative therapeutic options such as non-invasive brain stimulation (e.g. tDCS) and complementary interventions to improve physical and psychological well-being. These complementary interventions reduced pain intensity and psychological distress by improving individuals' ability to manage and cope with their pain. However, due to the multiple co-occurring factors associated with chronic pain, a multidisciplinary and integrated treatment approach is challenging. Technology ecosystems can be a reliable tool to achieve such a diverse personalized approach and evaluate their results. In a previous project, the investigators developed PainRE-Life, a dynamic and integrated technology ecosystem to enable continuity of care for CP patients, including personalized applications, training tools and telemonitoring tools for outcome assessment. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - tDCS+EuleriaLab - tDCS - EuleriaLab ### Outcomes Primary Outcomes - Visual Analogue Scale (VAS) Secondary Outcomes - 12-item Short Form Survey (SF12) - Hospital Anxiety and Depression scale (HADS) - Brief Pain Inventory (BPI) - Pain Catastrophizing Scale (PCS) - Shared Decision-Making Questionnaire 9-Item (SDM-Q-9) ### Location - Facility: ASST-Santi Paolo e Carlo Hospital, Milan, N/A, N/A, Italy @@
## Effect of Intravenous Nalbuphine and Magnesium Sulfate on Emergence Agitation in Pediatric - NCT ID: NCT06306040 - Study ID: Analgesia effect as on EA - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2025-01-30 - Lead Sponsor: Assiut University ### Study Description • Primary outcome: Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.• Secondary outcome:* Therefore, we designed a prospective, randomized, double-blind, single center study to investigate whether nalbuphine and/or magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia. In addition, the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study. Post-operative extubating time, interaction time, open eye time and emergence time. incidence of post-operative vomiting (PONV), laryngospasm, breath-holding, coughing, oxygen desaturation, and cardiac arrhythmias.* Face, Legs, Activity, Cry and Consola Bility (FLACC) scale is used to determine post-operative pain score* Parental satisfaction scores ### Conditions - Emergence Delirium ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Nalbuphine Versus Magnesium Sulfate ### Outcomes Primary Outcomes - compare between analgesia effect on pediatric patient Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Impact of Web-Based Education on Self-Care Power, Self-Efficacy, and Quality of Life in Knee Arthroplasty Patients. - NCT ID: NCT06306027 - Study ID: 2023/024 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12 - Lead Sponsor: KTO Karatay University ### Study Description The knee joint, which we use actively every day, is the largest joint in our body that bears the weight, allowing various movements such as walking, running, squatting, and standing. It involves the largest load-bearing structures in the body, including bones, cartilage, surrounding muscles, and ligaments, facilitating the mobilization of the joint. Due to constant use, the knee joint is susceptible to injuries and wear. Total knee arthroplasty (TKA) surgery involves replacing a degenerated joint surface, often due to conditions like osteoarthritis or rheumatoid arthritis, with a metal or polyethylene prosthesis. TKA, a widely used and highly successful surgical intervention in recent years, reduces pain, enhances functional range of motion, and improves independence and quality of life. Severe pain following TKA surgery restricts the movement of the knee joint and daily life activities, leading to the patient's inadequacy in self-care. Patients undergoing TKA surgery often face a lack of information after discharge. This lack of knowledge, coupled with uncertainty about the disease, limits the patient's self-efficacy. As the self-care power diminishes for patients struggling with daily life activities, their self-efficacy is negatively affected. The continuity of education becomes crucial since the verbal and written instructions given after surgery may not be sustained, causing a gradual decline in an individual's self-efficacy. As seen in the literature, studies have shown that postoperative pain, swelling, joint stiffness, fear, and movement limitations negatively impact the quality of life for patients undergoing TKA. Consequently, the self-care capacity, self-efficacy levels, and quality of life for individuals who have undergone TKA are adversely affected, as indicated in the literature.Ensuring continuity of care at home is crucial not only during the early postoperative period in the clinic but also after discharge. The nurse plays a significant role as an educator/advisor after discharge. The nurse provides counseling to patients discharged after Total Knee Arthroplasty (TKA) on pain management, disease progression, rehabilitation process, exercises, and considerations during daily activities (such as walking, bathing, toileting). Additionally, the nurse offers guidance on late-stage complications that may arise at home due to surgery and situations requiring hospitalization. While web-based educational interventions have been conducted for various patient groups, a web-based education program specifically for TKA surgery has not been identified. Having web-based post-TKA patient education allows continuous monitoring, assesses attendance and effectiveness remotely, and enables individuals to convey requests and questions to researchers through live support, ultimately enhancing the effectiveness of education. This approach is believed to prevent complications, reduce patient care costs and readmissions, increase patients' self-sufficiency in self-care, and consequently elevate their self-efficacy levels and quality of life. Close monitoring of postoperative patients is expected to improve their quality of life and self-care abilities, leading to increased satisfaction with healthcare services. ### Conditions - Knee Arthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Web-based education ### Outcomes Primary Outcomes - Personal Information Form Secondary Outcomes - Self-Care Power Scale ### Location - Facility: Konya City Hospital, Konya, N/A, 42020, Turkey @@
## Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients - NCT ID: NCT06306014 - Study ID: 69HCL22_980 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-01-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is characterized by a high risk of recurrence after cure, ranging from almost 20% after a first episode to over 60% after 2 recurrences, or in the case of specific risk factors.Currently, first-line treatment of CDI is based on oral antibiotics such as fidaxomicin or vancomycin. These antibiotic treatments, which are effective in 89% and 86% of first-episode cases respectively, do not correct the microbiological imbalance underlying the onset of CDI and may, on the contrary, encourage recurrence by contributing to the maintenance of a deleterious change in the microbiota (dysbiosis) through the elimination of bacteria other than C. difficile, due to their spectrum of activity. In a number of patients, this ecological imbalance can no longer be restored after antibiotic treatment, leading to multiple recurrences of CDI.In this context, fecal microbiota transplantation (FMT) has been validated for over 10 years for the prevention of recurrence in multi-recurrent CDI. The principle of FMT is based on the use of a pharmaceutical preparation made from the stool of a healthy donor, administered within the digestive tract of a patient for therapeutic purposes.Currently, in the case of multiple recurrences, it is the recommended first-line treatment (from 2 recurrences) and the most effective, with a clinical efficacy preventing recurrence of CDI in 69% to 89% of cases at 8 weeks post-treatment, with a good safety profile.Among the microbial factors promoting CDI, the loss of the bacterial species Faecalibacterium prausnitzii constitutes a specific therapeutic target. F. prausnitzii is a commensal bacterium of the human gut, making up nearly 5% of the fecal microbiota, and has been shown to be associated with an individual's state of health. A drop in its relative abundance is associated with an increased risk of numerous diseases, such as Crohn's disease and colorectal cancer. In CDI, F prausnitzii is greatly diminished. Moreover, low abundance of F. prausnitzii is predictive of C. difficile recurrence. Its abundance in stools is increased after FMT and is also predictive of response to treatment. From a pathophysiological point of view, one of the preventive effects of F. prausnitzii on recurrence would be mediated by its ability to hydrolyze the bile acids involved in the germination of C. difficile spores.The aim of this Phase I/II trial is to assess the efficacy and safety of oral administration of EXL01, a single isolated unmodified strain of F. prausnitzii, in preventing CDI recurrence in high-risk patients at W8. The study will be conducted in 2 parts. The phase I (Part A) is planned to include 6 patients. The phase II (Part B) will include 50 patients in two arms (25 patients respectively in the placebo and EXL01 arm). ### Conditions - Clostridioides Difficile Infection - Recurrent Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EXL01 - EXL01 - Placebo ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events - Evaluation of the efficacy of EXL01 in preventing recurrence of C. difficile infection in patients at high risk of recurrence Secondary Outcomes - Evaluation of the efficacy of EXL01 in preventing recurrence of C. difficile infection in patients at high risk of recurrence - Evaluation of the safety and tolerability profile of oral EXL01 - Number of stools per day over the past 24 hours - Stool consistency, as assessed by the Bristol scale, over the past 24 hours - Abdominal discomfort assessed by a validated irritable bowel syndrome scale - Number of stools per day over the past 24 hours - Stool consistency, as assessed by the Bristol scale, over the past 24 hours - Abdominal discomfort assessed by a validated irritable bowel syndrome scale - Assessment of patient quality of life during treatment and follow-up - Assessment of recurrence of C. difficile infection - Evaluation of the presence of EXL01 in the fecal microbiota - Assessment of EXL01 persistence in the intestinal microbiota - 16S rRNA sequencing or shotgun - 16S rRNA sequencing or shotgun - Assessment of the persistence of toxigenic C. difficile in the stool of patients in clinical remission during the study. - Assessment of the persistence of toxigenic C. difficile in the stool of patients in clinical remission during the study. - Assessment of recurrences of C. difficile infection requiring hospitalization - Assessment of recurrences of C. difficile infection requiring hospitalization - Assessment of recurrences of C. difficile infection requiring surgery - Assessment of recurrences of C. difficile infection requiring surgery ### Location - Facility: Service d'hépato-gastroentérologie - CHU Estaing, Clermont-Ferrand, N/A, 63003, France @@
## Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock - NCT ID: NCT06306001 - Study ID: IIRP-2023-1820/F1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-02 - Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh ### Study Description Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:1. Whether MB treatment reduces death to any cause as compared to no MB treatment.2. Whether treatment with MB reduces the time to achieve normal blood pressure3. Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.4. Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours. ### Conditions - Neonatal Sepsis - Shock, Septic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Methylene Blue - Placebo ### Outcomes Primary Outcomes - All-cause mortality within 7 days after randomization Secondary Outcomes - Time taken to achieve therapeutic end-points within 7 days after randomization - Time taken to stop all inotrope/vasopressor treatment within 7 days after randomisation - Echocardiographic fractional shortening at 24 hour after randomization - Left ventricular end-diastolic diameter (LVEDD) by echocardiography at 24 hour after randomization - Left ventricular end-systolic diameter (LVESD) by echocardiography at 24 hour after randomization - Aortic diameter by echocardiography at 24 hour after randomization - Velocity time integral (LVI) by echocardiography at 24 hours after randomization - Echocardiographic fractional shortening at 48 hour after randomization - Left ventricular end-diastolic diameter (LVEDD) on echocardiography at 48 hour after randomization - Left ventricular end-systolic diameter (LVESD) by echocardiography at 48 hour after randomization - Aortic diameter by echocardiography at 48 hour after randomization - Velocity time integral (LVI) by echocardiography at 48 hours after randomization - Time taken to stop vasopressor treatment - Mortality during hospital stay - Serious adverse effects - Septic shock-related mortality ### Location - Facility: Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, N/A, 160012, India @@
## Neuroregulatory Effect and Mechanism of tDCS on Medial Prefrontal Cortex in ASD - NCT ID: NCT06305988 - Study ID: LYG2023021 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-07-31 - Lead Sponsor: Jian-Jun Ou ### Study Description In this proposed study, a transcranial direct current stimulator is used to intervene in the medial prefrontal cortex of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of Autism Spectrum Disorders' intervention is discussed. ### Conditions - ASD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial direct current stimulation ### Outcomes Primary Outcomes - Autism assessment assessment index Secondary Outcomes - EEG physiological detection index - Social Communication Changes index - Stereotyped behavior index - Sensory index - Abnormal behavior indicator - Sleep index ### Location - Facility: Department of Psychiatry, Xiangya Second Hospital, Central South University, Changsha, Hunan, 410000, China @@
## Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery - NCT ID: NCT06305975 - Study ID: STUDY00003169 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03-01 - Lead Sponsor: Cedars-Sinai Medical Center ### Study Description This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected.The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique.Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique.Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique. ### Conditions - Laparoscopic Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Blunt fascial abdominal entry - Veress needle abdominal entry ### Outcomes Primary Outcomes - Insufflation time - Success upon peritoneal entry Secondary Outcomes - Intraoperative complications - Postoperative complications - Patients pain scores - Analgesics use - Length of hospital stay ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer - NCT ID: NCT06305962 - Study ID: 177Lu-RAD204.2023.0001 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2025-10 - Lead Sponsor: Radiopharm Theranostics, Ltd ### Study Description This is a first-in-human, open-label study consisting of a Screening Period, an Imaging Period, and a Treatment Period in eligible non-small lung cancer patients who are positive for the biomarker PDL-1. The Screening period lasts up to 4 weeks. The Phase 0 (Imaging Period) is used to determine if patient's tumor(s) are still positive for the biomarker, as well as radiation dosimetry with low dose 177Lu-RAD204im (for a period of up to 2 weeks following the first injection of 177Lu-RAD204im), to assess the safety of the drug. Following the 2 week safety assessment, the subject is eligible to enter Phase I (Treatment Period) with gradual dose increases of 177Lu-RAD204tr. The Treatment Period lasts up to 3 cycles every 6 weeks, with additional extension to a maximum study dose interval of 12 weeks to be approved on a case-by-case basis in discussion with study Sponsor. During the Treatment Period, subjects will be assessed for both safety and treatment response using conventional images and clinical laboratory tests. ### Conditions - PDL1 Gene Mutation - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 177Lu-RAD204 ### Outcomes Primary Outcomes - Time Activity Curves (TACs) - Radiation dosimetry of Lu177-RAD204im - Pharmacokinetics of 177Lu-RAD204im - Biokinetics of 177Lu-RAD204im - Safety and tolerability of 177Lu-RAD204tr - Recommended dose(s) of 177Lu-RAD204tr for future exploration Secondary Outcomes - Safety and tolerability of a single dose of 177Lu-RAD204im - Recommended dose(s) of 177Lu-RAD204im for future exploration - Preliminary antitumor activity of 177Lu-RAD204tr - Radiation dosimetry of 177Lu-RAD204tr ### Location - Facility: Princess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia @@
## Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia - NCT ID: NCT06305949 - Study ID: XC23DDDS0098 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: NEUROPHET ### Study Description The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia. ### Conditions - Deglutition Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Personalized transcranial Direct Current Stimulation ### Outcomes Primary Outcomes - Functional Oral Intake Scale (FOIS) - Penetration-aspiration Scale (PAS) Secondary Outcomes - Functional Oral Intake Scale (FOIS) - Penetration-aspiration Scale (PAS) - Videofluoroscopic Dysphagia Scale (VDS) - Korean Mann Assessment of Swallowing Ability (K-MASA) - Speech Mechanism Screening Test (SMST) - Urimal Test of Articulation and Phonology (U-TAP) - modified Rankin Scale (mRS) - Gugging Swallowing Screen - Eating Assessment Tool-10 (EAT-10) - Iowa Oral Performance Instrument (IOPI) - Motor-Evoked Potential (MEP) - Grade, Roughness, Breathiness, Asthenia and Strain scale(GRBAS scale) - Respiratory muscle strength - Peak cough flow ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feasibility Study: Plant Based Diet to Patients With Rheumatoid Arthritis - NCT ID: NCT06305936 - Study ID: PLATE H-23042292 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-12-31 - Lead Sponsor: Bispebjerg Hospital ### Study Description In this feasibility study, our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis (RA). The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. This comprehensive investigation covers the testing of recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention.Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA. Consequently, the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible. ### Conditions - Rheumatoid Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Intervention with 100% plant-based diet ### Outcomes Primary Outcomes - Evaluation of Feasibility and Intervention Fidelity in Implementing a Plant-Based Food Diet Intervention - Evaluating the feasibilty of included objectively measured outcomes and self-administered questionnaires - Evaluation of Study Acceptance - Recruitment - Retention - Intervention adherence Secondary Outcomes - Disease Activity Score (DAS28) - Fatigue: Bristol Rheumatoid Arthritis Fatigue (BRAF MDQ) - Pain (VAS) - Sleep - Anxiety/depression - Physical function - Impact of rheumatoid arthritis (RA) - The EuroQuality of Life (EQ-5D) - Height - Weight - Waist- and hip circumference - Disease activity - Body composition - Quantification of tender and swollen joints - C-reactive Protein (CRP) - Hemoglobin - Leukocytes - Thrombocytes - Hemoglobin (HbA1c) - D-vitamin - Low-density lipoprotein (LDL) - High-density lipoprotein (HDL) - Triglyceride - Total cholesterol ### Location - Facility: Center for Clinical Research and Prevention, BispebjergH, Frederiksberg, N/A, DK 2000, Denmark @@
## The Efficacy of a Cosmetic Preparation Containing Sheep Colostrum on Mature Skin - NCT ID: NCT06305923 - Study ID: RNN/275/21/KE - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2022-07-31 - Lead Sponsor: Medical University of Lodz ### Study Description The goal of this clinical trial is to learn about colostrum as a cosmetic in mature skin. . The aim of the study was to examine the effect of a cosmetic preparation containing sheep colostrum on skin with signs of aging in mature women Participants will be given the creams and asked to apply one -two doses in the evening after nighttime facial cleaning. They were also asked to use sunscreens during the day. During the first visit and after eight weeks of everyday use of the tested cream, the skin parameters will be measured three times on both cheeks, and the results were averaged.Participants will be enrolled to the colostrum cream or base cream groups and will not be informed which group they belonged to. ### Conditions - Skin Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - colostrum cream - placebo cream ### Outcomes Primary Outcomes - hydration - transepidermal water loss - erythema and melanin content - sebum Secondary Outcomes - firmness of the skin - firmness of the skin ### Location - Facility: Medical University of Lodz, Lodz, N/A, 90-419, Poland @@
## CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults - NCT ID: NCT06305910 - Study ID: CMN-DMGVac-01 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-01-15 - Lead Sponsor: OX2 Therapeutics ### Study Description This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults.The primary objective of this study is to determine the maximum tolerated dose (MTD) of CD200AR-L when given with a fixed dose of GBM6-AD vaccine, imiquimod, and a single dose of radiation for patients with recurrent High Grade Glioma (HGG) or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG). ### Conditions - Diffuse Midline Glioma, H3 K27M-Mutant - Recurrent High Grade Glioma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Treatment with CD200AR-L ### Outcomes Primary Outcomes - Maximum Tolerated Dose (MTD) of CD200AR-L Secondary Outcomes - Incidence of serious adverse events (SAEs) - Time to progression (TTP) by 24 months - Progression free survival (PFS) by 24 months - Overall survival (OS) by 24 months ### Location - Facility: Children's Minnesota, Minneapolis, Minnesota, 55404, United States @@
## Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation) on the Face - NCT ID: NCT06305897 - Study ID: CS5_10B - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Cryonove Pharma ### Study Description The goal of this clinical trial is to compare the 3 different prototype of cyto-selective cryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are:* the tolerance of 3 prototypes of cyto-selective cryotherapy treatments* the performance of 3 prototypes of cyto-selective cryotherapy treatmentsParticipants will be treated for each spots with a definied prototype during 6 treatment visits.Researchers will compare the tolerance and performance of the 3 prototypes. ### Conditions - Lentigo - Solar Lentigo - Post Inflammatory Hyperpigmentation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CRYONOVE (EC14_4osc) - CRYONOVE (EC+05_1osc) - CRYONOVE (EC+05_2osc) ### Outcomes Primary Outcomes - Tolerance Secondary Outcomes - Performance ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study - NCT ID: NCT06305884 - Study ID: OSU-21287 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Ohio State University Comprehensive Cancer Center ### Study Description This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home. ### Conditions - Hematopoietic and Lymphoid System Neoplasm - Lymphedema - Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Bioelectric Impedance Analysis - Exercise - Photoplethysmography - Questionnaire Administration ### Outcomes Primary Outcomes - Unique signature describing photoplethysmography and bioimpedance at rest and during activity Secondary Outcomes - Patient reported outcomes - Tolerability of sensors - Likely classification for lymphedema ### Location - Facility: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States @@
## Clinical Study of Ultrasound-guided Radiofrequency Ablation in the Treatment of Refractory Hyperthyroidism - NCT ID: NCT06305871 - Study ID: 2023-NHLHCRF-YYPPLC-ZR-09 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-08-01 - Completion Date: 2025-07-31 - Lead Sponsor: Zhang Bo ### Study Description Hyperthyroidism is an endocrine disease with a high incidence rate, and some patients are difficult to effectively control the condition after long-term drug treatment, and the disease recurs, forming refractory hyperthyroidism. The search for a new safe, effective and minimally invasive treatment has become a research hotspot. Ultrasound-guided radiofrequency ablation is a hot spot in clinical research due to its advantages of low trauma, high safety, precise inactivation of lesions, and multiple ablation. However, there is no unified standard for the number and scope of ablation in the treatment of refractory hyperthyroidism by radiofrequency ablation, and there is a lack of data on the effectiveness and safety of the treatment with large samples and long-term effects. Therefore, how to establish a standardized treatment strategy and appropriate plan for ablation of refractory hyperthyroidism based on clinical practice is an urgent problem to be solved. The purpose of this study was to prospectively include refractory hyperthyroidism for ultrasound-guided radiofrequency ablation, and to evaluate the efficacy and safety of hyperthyroidism ablation by comparing the changes in symptoms and signs, serology, and imaging of patients before and after ablation. The relevant factors affecting the efficacy of ablation were analyzed and the most appropriate ablation scope was determined. Radiofrequency ablation was retrospectively compared with traditional surgery and 131I treatment, and the near- and medium-term treatment effects, incidence of adverse reactions and complications, as well as the economic benefits and sociopsychological differences of the three treatment methods were compared.The expected outcome of this study is to establish a research cohort of hyperthyroidism ablation based on a large sample population, and to establish the most appropriate and effective regimen for radiofrequency ablation of refractory hyperthyroidism compared with traditional surgery and 131I treatment with safety and near- and medium-term efficacy. The Department of Ultrasound Medicine of China-Japan Friendship Hospital has accumulated rich experience in the ablation treatment of benign and malignant thyroid nodules and hyperthyroidism, and has completed more than 200 cases of thyroid ablation in the past two years. Under the leadership of Professor Zhang Bo, the research team of this project has conducted a number of clinical studies on the ultrasound diagnosis and treatment of thyroid diseases, presided over and participated in more than 20 national, provincial and university-level scientific research courses, and the first author or corresponding author wrote more than 70 articles in related fields, which laid a solid research foundation for the conduct of this study. ### Conditions - Hyperthyroidism/Thyrotoxicosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ablation therapy ### Outcomes Primary Outcomes - Discontinuation rate - Recurrence rate Secondary Outcomes ### Location - Facility: China-Japan friendship hospital, Beijing, Beijing, 100000, China @@
## Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis (Medial and Patellofemoral): Prospective Functional Assessment Study - NCT ID: NCT06305858 - Study ID: UKA - PFJ - Status: RECRUITING - Start Date: 2022-03-01 - Completion Date: 2025-12 - Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio ### Study Description The study is, in accordance with current legislation, definable as a prospective single-center interventional randomized study.The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinical/functional scores.The primary outcome is evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B.The population consists of 48 adult patients with gonarthrosis divided into two groups:24 patients Group A experimental group: partial denture surgical procedure24 patients Group B control group: total denture surgical procedure with patellar resurfacing ### Conditions - Knee Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Prosthetic Surgical Procedure ### Outcomes Primary Outcomes - Assess the difference in score of the KSS (Knee Society Score) questionnaire, completed by the patient in group A compared to the patient in group B Secondary Outcomes ### Location - Facility: Istituto Clinico San Siro, Milan, N/A, N/A, Italy @@
## Digital Crowns Versus Prefabricated Crowns on Primary Teeth - NCT ID: NCT06305845 - Study ID: 152012023 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-09 - Lead Sponsor: National Research Centre, Egypt ### Study Description Badly decayed primary molars will be treated by performing the pulp therapy technique indicated, then the patients will be randomized into two groups to receive the restorative intervention. For the intervention group, teeth will be prepared to receive the digital crown after intraoral scanning while for the control group, teeth will be prepared to receive the prefabricated zirconia crowns. Teeth will be followed up clinically for 1 year, at 1, 6 and 12 months. ### Conditions - Dental Caries in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Digital crowns ### Outcomes Primary Outcomes - Patient and parent satisfaction Secondary Outcomes - Crown retention - Gingival inflammation - Color match ### Location - Facility: National Research Centre, Cairo, N/A, N/A, Egypt @@
## Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer - NCT ID: NCT06305832 - Study ID: IUNU-PC-120 - Status: RECRUITING - Start Date: 2023-09-07 - Completion Date: 2028-03 - Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School ### Study Description To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or SRT combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP). ### Conditions - Prostate Cancer - Biochemical Recurrence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rezvilutamide - Androgen deprivation therapy (ADT) - SRT ### Outcomes Primary Outcomes - 3-year biochemical progression-free survival Secondary Outcomes - progression-free survival (PFS) - metastasis-free survival (MFS) - percentage of undetectable PSA - ctDNA-positive rate - ctDNA clearance rate - Adverse Events ### Location - Facility: Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University, Nanjing, Jiangsu, 210000, China @@
## Effectiveness of a Self-management Program After Traumatic Injury - NCT ID: NCT06305819 - Study ID: 2023057 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2030-12-31 - Lead Sponsor: Oslo University Hospital ### Study Description Traumatic injuries, defined as a physical injury with sudden onset, are a leading cause to disability and impaired health. Persons who sustain a traumatic injury often report problems in daily life activities and reduced quality of life, which may limit participation in work/studies, leisure activities and family life. Consequently, complex rehabilitation and support is recommended in National Trauma guidelines due to the often long-lasting physical and psychological sequela of the injury.The main goal of this study is to determine the effectiveness of a self-management support program delivered to persons with a moderate or severe traumatic injury in the sub-acute phase of recovery (i.e. 3-4 months after injury). The self-management program aims to enhance patients' self-efficacy by building skills and self-management strategies to cope with injury-related consequences. The program has a group-based format and consists of eight sessions comprising psychoeducation, skill mastery and sharing of experiences. The participants who will be included in the study must be between 18 and 70 years, be residing in the southeast region of Norway, be admitted to Oslo University hospital or transferred from local hospital within 72 hours after injury, have at least a two-day hospital stay, and be able to read and understand Norwegian language. Participants will be randomly assigned to either intervention or control group. A group of patients will also be able to self-select if they want to receive the self-management support program or be in the control group. The latter is an explorative part of the study to evaluate the influence of patients' treatment-preferences on the study outcomes. Participants in the control group will receive treatment as usual. ### Conditions - Trauma Injury - Trauma, Multiple - Polytrauma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - self-management support program - Control group ### Outcomes Primary Outcomes - Trauma Coping Self-Efficacy Secondary Outcomes - Rivermead Post-Concussion Symptom Questionnaire - Fatigue Severity Scale - Insomnia Severity Index - Brief Pain Inventory -short form - International Physical Activity Questionnaire - Cognitive Failures Questionnaire - Patient Health Questionnaire-9 - Generalised Anxiety Disorder-7 - Impact of Event Scale - Revised - Return to work ### Location - Facility: Oslo University Hospital, Oslo, N/A, N/A, Norway @@
## RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine) - NCT ID: NCT06305806 - Study ID: Pro00112597_B - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-11 - Completion Date: 2026-03 - Lead Sponsor: Kanecia Obie Zimmerman ### Study Description This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. ### Conditions - Long COVID - Long Covid19 - Long Covid-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ivabradine - Ivabradine Placebo - Coordinated Care - Usual Care ### Outcomes Primary Outcomes - Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score Secondary Outcomes - Change in Composite Autonomic Symptoms Score 31 (COMPASS-31) - Change in Malmo POTS Symptom Score - Change in Active Stand Test - Change in blood pressure (BP) - Change in heart rate (HR) - Change in 6-min Walk Test - Change in PROMIS-29 + 2 Questionnaire - Change in step count as measured by a wearable device - Change in heart rate as measured by a wearable device - Proportion of participants who experience individual SAEs - Proportion who experience any one or more SAEs - Incidence of SAEs leading to discontinuation - Incidence of Events of Special Interest (ESIs) ### Location - Facility: All sites listed under NCT06305780, Durham, North Carolina, 27710, United States @@
## RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG) - NCT ID: NCT06305793 - Study ID: Pro00112597_A - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-11 - Completion Date: 2026-03 - Lead Sponsor: Kanecia Obie Zimmerman ### Study Description This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. ### Conditions - Long COVID - Long Coronavirus Disease 2019 (Covid19) - Long Covid-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IVIG (intravenous immunoglobulin) - IVIG Placebo - Coordinated Care - Usual Care ### Outcomes Primary Outcomes - Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score Secondary Outcomes - Change in Composite Autonomic Symptoms Score 31 (COMPASS-31) - Change in Malmo POTS Symptom Score - Change in Active Stand Test - Change in blood pressure - Change in heart rate (HR) - Change in 6-min Walk Test - Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) + 2 Questionnaire - Change in step count as measured by a wearable device - Change in heart rate as measured by a wearable device - Proportion of participants who experience individual (SAEs - Proportion who experience any one or more ( Serious Adverse Event) SAEs - Incidence of SAEs leading to discontinuation - Incidence of Events of Special Interest (ESIs) ### Location - Facility: All sites listed under NCT06305780, Durham, North Carolina, 27710, United States @@
## RECOVER-AUTONOMIC Platform Protocol - NCT ID: NCT06305780 - Study ID: Pro00112597 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-11 - Completion Date: 2026-03 - Lead Sponsor: Kanecia Obie Zimmerman ### Study Description This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. ### Conditions - Long COVID - Long Covid19 - Long Covid-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IVIG + Coordinated Care - IVIG Placebo + Coordinated Care - Ivabradine + Coordinated Care - Ivabradine Placebo + Coordinated Care - IVIG + Usual Care - IVIG Placebo + Usual Care - Ivabradine + Usual Care - Ivabradine Placebo + Usual Care ### Outcomes Primary Outcomes - Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score Secondary Outcomes - Change in Composite Autonomic Symptoms Score 31 (COMPASS-31) - Change in Malmo POTS Symptom Score - Change in Active Stand Test - Change in blood pressure - Change in heart rate (HR) - Change in 6-min Walk Test - Change in PROMIS-29 + 2 Questionnaire - Change in step count as measured by a wearable device - Change in heart rate as measured by a wearable device - Proportion of participants who experience individual SAEs - Proportion who experience any one or more SAEs - Incidence of SAEs leading to discontinuation - Incidence of Events of Special Interest (ESIs) ### Location - Facility: University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B, Aurora, Colorado, 80045, United States @@
## A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005) - NCT ID: NCT06305767 - Study ID: V940-005 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2031-04-08 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab - V940 - Placebo ### Outcomes Primary Outcomes - Disease Free Survival (DFS) Secondary Outcomes - Overall Survival (OS) - Distant Metastasis-Free Survival (DMFS) - Number of Participants Who Experience an Adverse Event (AE) - Number of Participants Who Discontinue Study Treatment Due to an AE ### Location - Facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102), Orlando, Florida, 32804, United States @@
## Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) - NCT ID: NCT06305754 - Study ID: 2870-009 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-03 - Completion Date: 2030-06-14 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs).The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS). ### Conditions - Non-small Cell Lung Cancer (NSCLC) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sacituzumab tirumotecan - Pemetrexed - Carboplatin - Antihistamine - H2 Receptor Antagonist - Acetaminophen (or equivalent) - Dexamethasone (or equivalent) ### Outcomes Primary Outcomes - Progression-Free Survival (PFS) - Overall Survival (OS) Secondary Outcomes - Objective Response Rate (ORR) - Duration of Response (DOR) - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30 - Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13) - Change from Baseline in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13 - Time to Deterioration (TTD) in Global Health Status/Quality of Life (Items 29 and 30) Combined Score, on the EORTC QLQ-C30 - TTD in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30 - TTD in the Cough (Item 31) Score, on the EORTC QLQ-LC13 - TTD in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13 - Number of Participants Who Experience One or More Adverse Events (AEs) - Number of Participants Who Discontinue Study Treatment Due to an AE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers - NCT ID: NCT06305741 - Study ID: 24-060 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2026-03 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers. ### Conditions - Cancer Patients - Care Givers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Managing Anxiety from Cancer (MAC) ### Outcomes Primary Outcomes - percentage of participants to complete all study procedures Secondary Outcomes ### Location - Facility: Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 07920, United States @@
## A Study of Early Cancer Detection in People at High Risk of Developing Pancreatic Ductal Adenocarcinoma (PDAC) - NCT ID: NCT06305728 - Study ID: 23-367 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2030-03-04 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts:* The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1* The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan) ### Conditions - Pancreatic Cyst ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 89Zr-DFO-HuMab-5B1 immunoPET - HP MRI - Blood assay ### Outcomes Primary Outcomes - Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma Secondary Outcomes ### Location - Facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States @@
## Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X) - NCT ID: NCT06305715 - Study ID: IIT-THOMPSON-RADIANCE-LUNG-X - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-06-15 - Lead Sponsor: Medical College of Wisconsin ### Study Description This prospective, two-part, single-arm, phase II trial is designed to evaluate whether the use of definitive radiation to the primary lung lesion prolongs progression-free survival (PFS) in treatment-naïve, metastatic, driver-mutated non-small cell lung cancers (NSCLC) patients who are subsequently placed on a tyrosine kinase inhibitor (TKI). ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radiation Therapy - Targeted TKI therapy ### Outcomes Primary Outcomes - Progression Free Survival Secondary Outcomes ### Location - Facility: Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States @@
## Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer - NCT ID: NCT06305702 - Study ID: LZRXN-001 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2024-01-31 - Lead Sponsor: Liaoning Tumor Hospital & Institute ### Study Description A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. The study aimed to estimate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with inetetamab therapy. ### Conditions - HER2-positive Metastatic Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - inetetamab ### Outcomes Primary Outcomes - Progression Free Survival(PFS) Secondary Outcomes - objective response rate (ORR) - Adverse events (AEs) ### Location - Facility: Liaoning Cancer Hospital &Institue, Shenyang, N/A, N/A, China @@
## Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking* - NCT ID: NCT06305689 - Study ID: 79144 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Shriners Hospitals for Children ### Study Description To compare and contrast the clinical, gait and parent-reported outcomes following either non-operative (casting) or operative treatment for children with idiopathic toe walking (ITW) and determine whether there are specific genes associated with ITW. ### Conditions - Idiopathic Toe Walking ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Surgery - Serial Casting ### Outcomes Primary Outcomes - Gait parameters: Velocity - Gait Paremeters:Stride Length (m) - Three dimensional Gait Analysis:Kinematics (degrees) - Dynamic Motor Control Index during Walking (Walk-DMC) - Three dimensional Gait Analysis:Kinetics (nm/kg) - Quantitative Assessment of Toe Walking - Pediatric Outcomes Data Collection Instrument Secondary Outcomes - Passive Range of Motion - Muscle Strength ### Location - Facility: Shriners Hospitals for Children, Sacramento, California, 95817, United States @@
## Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC) - NCT ID: NCT06305676 - Study ID: MCC-23073 - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2029-01 - Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute ### Study Description Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh). ### Conditions - Oropharyngeal Cancer - HPV-Related Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - combined HPV 16 DNA and host gene methylation oral biomarker panel ### Outcomes Primary Outcomes - Diagnostic Sensitivity - Diagnostic Specificity Secondary Outcomes ### Location - Facility: Moffitt Cancer Center, Tampa, Florida, 33612, United States @@
## A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children - NCT ID: NCT06305663 - Study ID: 921 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-29 - Completion Date: 2027-01-31 - Lead Sponsor: Bausch & Lomb Incorporated ### Study Description A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children ### Conditions - Myopia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic) - CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens ### Outcomes Primary Outcomes - Mean change from baseline in axial length. - Mean change from baseline in cycloplegic SERE. Secondary Outcomes ### Location - Facility: Site 105, Beijing, Beijing, 100044, China @@
## Probiotic Influence on Obesity-Related Lipidemia - NCT ID: NCT06305650 - Study ID: WK2024001 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-07-30 - Lead Sponsor: Wecare Probiotics Co., Ltd. ### Study Description This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m\^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements. ### Conditions - Overweight or Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probiotic ### Outcomes Primary Outcomes - Effect on body mass index (BMI) values. Secondary Outcomes ### Location - Facility: Henan University of Science and Technology, Luoyang, Henan, 471000, China @@
## A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor. - NCT ID: NCT06305637 - Study ID: KTCS-2302 - Status: COMPLETED - Start Date: 2023-12-04 - Completion Date: 2024-02-10 - Lead Sponsor: Taro Pharmaceuticals USA ### Study Description To demonstrate the efficacy, therapeutic equivalence and safety of Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A., Inc.) and Ketoconazole 2% Shampoo (Reference Standard) in the treatment of tinea versicolor. ### Conditions - Tinea Versicolor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ketoconazole Shampoo, 2% - Ketoconazole Shampoo, 2% (Reference Standard) - Placebo ### Outcomes Primary Outcomes - To demonstrate the therapeutic equivalence and safety of the Investigational Product Secondary Outcomes ### Location - Facility: Taro, Hawthorne, New York, 10532, United States @@
## Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease - NCT ID: NCT06305624 - Study ID: 2024-0130 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-10 - Lead Sponsor: University of Wisconsin, Madison ### Study Description This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months. ### Conditions - Alcohol Use Disorder - Alcohol-related Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Connections App ### Outcomes Primary Outcomes - Days of Alcohol Abstinence in ALD Participants - Number of Standard Drinks Consumed in ALD Participants Secondary Outcomes - Change in Patient Health Questionnaire (PHQ-8) Score - Change in PROMIS Global Health Score - Change in Generalized Anxiety Disorder (GAD-7) Score - Change in Insomnia Severity Index (ISI) Score - Change in Pain Interference (PEG) Score - Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score - Change in CHESS Bonding Scale Score - Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score - Change in Treatment Self-Regulation Questionnaire (TSRQ) Score ### Location - Facility: UM General Hepatology Clinic, Ann Arbor, Michigan, 48109, United States @@
## European and North Indian Cohort of KaWasaki dIsease - NCT ID: NCT06305611 - Study ID: KIWI - Status: RECRUITING - Start Date: 2021-07-13 - Completion Date: 2024-10-30 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unfortunately, 10-20% of KD patients results resistant to standard treatment leading to a major risk of cardiac complications. Thus, scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy. Different scoring scales developed by Kobayashi, Egami et Sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting IVIG unresponsiveness in Japanese populations. However, their predictive value was not confirmed by subsequent studies in different ethnic populations. Recently, the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study. In our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for Kobayashi and sensitivity 77% and specificity 60% for Kawanet), will be considered a success. ### Conditions - Kawasaki Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - IVIG resistance rate - percentage of IVIG-resistant patients Secondary Outcomes ### Location - Facility: Universidade Federal do Rio de Janeiro, Rio de Janeiro, N/A, N/A, Brazil @@
## Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer - NCT ID: NCT06305598 - Study ID: I-3298823 - Status: RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-04-01 - Lead Sponsor: Roswell Park Cancer Institute ### Study Description This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression. ### Conditions - Castration-Resistant Prostate Carcinoma - Metastatic Prostate Carcinoma - Stage IVB Prostate Cancer AJCC v8 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biopsy - Bone Scan - Computed Tomography - Leuprolide Acetate - Magnetic Resonance Imaging - Survey Administration - Testosterone Cypionate ### Outcomes Primary Outcomes - Androgen receptor (AR) activity Secondary Outcomes - Incidence of adverse events - Incidence of serious adverse events - Prostate specific antigen (PSA) 50 - Measurable disease response - Progression free survival - Overall survival - Assess Quality of life - Assess Quality of Life - Assess Fatigue - Assess change in Fatigue ### Location - Facility: Roswell Park Cancer Institute, Buffalo, New York, 14263, United States @@
## Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response - NCT ID: NCT06305585 - Study ID: IRB# 23-214 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: University of Idaho ### Study Description Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs. ### Conditions - Psychological Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Primal Reflex Release Technique (PRRT) ### Outcomes Primary Outcomes - ECG Data - ICG Data - Depression Anxiety Stress Scale-21 (DASS-21) - Depression - Depression Anxiety Stress Scale-21 (DASS-21) - Anxiety - Depression Anxiety Stress Scale-21 (DASS-21) - Stress - Simple Physical Activity Questionnaire (SIMPAQ) - Self Assessment Manikin (SAM) - Valence - Self Assessment Manikin (SAM) - Arousal Secondary Outcomes ### Location - Facility: ISMaRT Clinic, Moscow, Idaho, 83843, United States @@
## Diagnostic Accuracy of Quantitative Flow Ratio - NCT ID: NCT06305572 - Study ID: H-1903-013-1014 - Status: COMPLETED - Start Date: 2019-07-30 - Completion Date: 2023-09-26 - Lead Sponsor: Seoul National University Hospital ### Study Description The aim of this study was to investigate the accuracy of quantitative flow ratio (QFR) for predicting fractional flow reserve (FFR) ≤0.80 in an independent core laboratory. ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - QFR ### Outcomes Primary Outcomes - Diagnostic accuracy of QFR Secondary Outcomes - Sensitivity of QFR - Specificity of QFR - Correlation ### Location - Facility: Seoul National University Hospital, Seoul, N/A, 03080, Korea, Republic of @@
## A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque - NCT ID: NCT06305559 - Study ID: OBEZ-302 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-03 - Lead Sponsor: NewAmsterdam Pharma ### Study Description This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA). ### Conditions - Lipidemia - Coronary Artery Disease - Plaque, Atherosclerotic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - obicetrapib 10 mg + ezetimibe 10 mg FDC daily - Placebo ### Outcomes Primary Outcomes - • To evaluate the effect of obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) daily on total non-calcified coronary atherosclerotic plaque volume (NCPV) at 18 months. Secondary Outcomes - Absolute change from baseline to 18 months in total NCPV in all major epicardial coronary arteries, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo. - Percent change from baseline to 18 months in LDL-C in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared to placebo. - Percent change from baseline to 18 months in non-calcified coronary atherosclerotic plaque volume in the most diseased coronary segment (NCPVMD), as measured by CCTA, in participants treated with FDC therapy vs placebo - Absolute change from baseline to 18 months in NCPVMD, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo. - Change in perivascular fat attenuation index (FAI), FAI score and its age- and gender specific centile in the principal epicardial coronary arteries as measured by CCTA in participants treated with FDC therapy compared with placebo. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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