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## A Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) - NCT ID: NCT06276933 - Study ID: MA-NSCLC-II-039 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-22 - Completion Date: 2026-11-22 - Lead Sponsor: Tongji University ### Study Description To explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients ### Conditions - Lung Cancer - Camrelizumab ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Camrelizumab + chemotherapy+Thalidomide - Camrelizumab + chemotherapy+placebo ### Outcomes Primary Outcomes - Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP) Secondary Outcomes - Median time to RCCEP - Median time to RCCEP of level 3 or above - Incidence rate of ≥G3 grade RCCEP - Overall Response Rate (ORR) - Progression-Free Survival (PFS) - Overall Survival(OS) - Treatment-related Adverse Events (TRAE) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Joint Position Sense in Healthy Individuals - NCT ID: NCT06276920 - Study ID: 2024/5554(1) - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2024-02-29 - Lead Sponsor: Inonu University ### Study Description It was aimed to measure the elbow joint position sense in healthy individuals in the case of a closed kinetic chain and to compare it with the measurement made in the case of an open kinetic chain. ### Conditions - Proprioception ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Joint position sense measurement with universal goniometer in close kinetic chain - Joint position sense measurement with universal goniometer in open kinetic chain Secondary Outcomes ### Location - Facility: Inonu University, Malatya, N/A, 12000, Turkey @@
## An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response - NCT ID: NCT06276907 - Study ID: ILBS-ACLF-16 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-12-31 - Lead Sponsor: Institute of Liver and Biliary Sciences, India ### Study Description Rationale: Current understanding of the pathophysiology of ACLF suggests that unresolved injury, poor infection control, and liver regeneration result in persistent systemic inflammation and cytokine storm, which subsequently lead to systemic inflammatory response syndrome (SIRS) resulting in multiple organ failures, septic shock and deaths in ACLF. Nearly 74% of ACLF patients initially diagnosed without SIRS, sepsis, or organ failure developed SIRS by day 7 which increases the onset of secondary organ failure and sepsis with high short-term mortality. The emerging use of plasma exchange has shown some potential benefits in terms of dampening systemic inflammation and improvement of outcomes in some ACLF patients. However, there is currently no randomized controlled trial exploring the potential role in ameliorating secondary organ dysfunctions in patients with ACLF is not known. Hence in the current objective, we want to study the role of plasma exchange in the management of sec. organ failure in ACLF patients in a randomized controlled trial and identify the biomarker to access the treatment response to therapy. ### Conditions - Acute on Chronic Liver Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Plasma Exchange - Standard Medical Treatment ### Outcomes Primary Outcomes - The AARC grading is done by AARC score the values of which vary from 5-15 , pts are divided into 3 grades i.e AARC score 5-7- grade 1, 8-10- grade 2, and AARC 11-15 as grade 3. Improvement in 1 grade is associated with 40% improvement in 28-day survival Secondary Outcomes - Transplant-free survival at 28-days - The impact of TPE on the progression or resolution of secondary organ failures at day 7, 14 and 28 - the development of infection at day 7 and 14 in patients who had no infection - Duration of ICU and hospital stay - The proportion of patients developing adverse events will be compared between the two groups ### Location - Facility: Institute of Liver & Biliary Sciences, New Delhi, Delhi, 110070, India @@
## Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention - NCT ID: NCT06276894 - Study ID: IRB #2064530-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-01 - Lead Sponsor: Craig Hospital ### Study Description The purpose of this study is to evaluate the safety and feasibility of using a portable neuroimaging device called functional near-infrared spectroscopy (fNIRS) to successfully analyze fNIRS data in individuals with chronic TBI during treadmill training augmented with VR. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Motek C-Mill™ treadmill - training session with and without VR wearing the fNIRS cap ### Outcomes Primary Outcomes - Incidence of Treatment-Related Adverse Events (e.g., Safety and Tolerability) - Acceptability of the intervention - fNIRS Data Quality Secondary Outcomes ### Location - Facility: Craig Hospital, Englewood, Colorado, 80113, United States @@
## Visual Stimulation for Pain Relief - NCT ID: NCT06276881 - Study ID: DSC1001 - Status: COMPLETED - Start Date: 2022-06-03 - Completion Date: 2023-05-01 - Lead Sponsor: Dandelion Science ### Study Description The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Visual Stimulation ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) Score - Event-related Potential (ERP) Secondary Outcomes ### Location - Facility: Dandelion Science, Hoboken, New Jersey, 07030, United States @@
## Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer - NCT ID: NCT06276868 - Study ID: HELEN-017 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2029-06-01 - Lead Sponsor: Henan Cancer Hospital ### Study Description This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy. ### Conditions - Breast Cancer - HER2-positive Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dalcilib+letrozole+HP treatment group ### Outcomes Primary Outcomes - pathologic complete response Secondary Outcomes - Adverse event occurrence - objective response rate - Residual cancer burden - Event free survival - Disease free survival - Distant disease/recurrence free survival ### Location - Facility: Henan cacer hospital, Henan, Henan, 450008, China @@
## Sleep Hygiene Education in Individuals With Fibromyalgia; Sleep Quality, Pain and Depression - NCT ID: NCT06276855 - Study ID: CUtülay - Status: COMPLETED - Start Date: 2021-06-23 - Completion Date: 2021-12-31 - Lead Sponsor: Cumhuriyet University ### Study Description Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.Patients and methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory. ### Conditions - Fibromyalgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Sleep hygiene education ### Outcomes Primary Outcomes - Demographic Information Form (DIF). - Pittsburgh Sleep Quality Index (PSQI). - Visual Analog Scale (VAS). - Beck Depression Inventory (BDI). Secondary Outcomes ### Location - Facility: Sivas Cumhuriyet University, Sivas, Center, 58140, Turkey @@
## Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration - NCT ID: NCT06276842 - Study ID: 12345678 - Status: COMPLETED - Start Date: 2020-04-01 - Completion Date: 2020-09-30 - Lead Sponsor: CIMS Dental College ### Study Description OBJECTIVE To compare the effectiveness of using both a combined technique of an Inferior Alveolar Nerve block and buccal infiltration with that achieved by utilizing an Inferior Alveolar Nerve block alone for endodontic treatment of mandibular molars with irreversible pulpitis.STUDY DESIGN Randomized clinical trial PLACE AND DURATION OF STUDY Operative Dentistry Department of Armed Forces Institute of Dentistry Rawalpindi, from 1st April 2020 to 31st September 2020.MATERIAL AND METHODS A total of 120 patients were enrolled in the study. Sixty patients of group A received conventional Inferior Alveolar Nerve block and sixty patients of Group B received buccal infiltration along with conventional Inferior Alveolar Nerve block. ### Conditions - Pulpitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Inferior Alveolar Nerve Block - Buccal Infiltration - Inferior Alveolar Nerve Block and Buccal Infiltration ### Outcomes Primary Outcomes - Comparison of Anesthesia Effectiveness Between Combined Technique (Inferior Alveolar Nerve Block and Buccal Infiltration) and Inferior Alveolar Nerve Block Alone Secondary Outcomes ### Location - Facility: Dr Ayesha Ahmed, Multan, N/A, N/A, Pakistan @@
## Behçet and LDH/Albumin - NCT ID: NCT06276829 - Study ID: 02.05.2023/291 - Status: COMPLETED - Start Date: 2020-02-01 - Completion Date: 2023-04-01 - Lead Sponsor: Ataturk University ### Study Description ABSTRACT Objective: To investigate whether the lactate dehydrogenase to albumin ratio can be used as a parameter to determine disease severity in Behçet's disease, an inflammatory disease, by comparing it to healthy controls.Patients and Methods: In this retrospective cohort study, patients with Behçet's disease aged 18-69 years who presented to the outpatient clinic between February 2020 and April 2023 and healthy individuals of similar age and gender were enrolled. LDH, albumin levels, and LDH/albumin ratio of both groups were compared. Clinical findings and characteristics of Behçet's patients and disease severity were recorded and analyzed in relation to LDH/albumin ratio. ### Conditions - Behcet's Disease - Albumin - Lactate Dehydrogenase - Disease Severity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - LDH/albumin ratio ### Outcomes Primary Outcomes - LDH/albumin ratio Secondary Outcomes ### Location - Facility: Erdal Pala, Erzurum, N/A, 25240, Turkey @@
## Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia - NCT ID: NCT06276816 - Study ID: 2022-LC14 - Status: RECRUITING - Start Date: 2023-09-13 - Completion Date: 2024-12-30 - Lead Sponsor: China National Center for Cardiovascular Diseases ### Study Description This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia. ### Conditions - Sinus Bradycardia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of patients with postoperative recurrence of bradycardia symptoms Secondary Outcomes - The result of the atropine test - Changes in quality of life measured by Medical Outcomes Study 36- Item Short Form Health Survey (SF-36) - Changes in quality of life measured by EuroQol Five Dimensions Questionnaire Visual Analogue Scale (EQ VAS) - Changes in minmum heart rate - Changes in mean heart rate - Changes in deceleration capacity ### Location - Facility: 1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, N/A, N/A, China @@
## The LINFU® U.S. Registry for the in the General Population Without Risk Factors - NCT ID: NCT06276803 - Study ID: Adenocyte 104 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2034-06-15 - Lead Sponsor: Adenocyte, LLC ### Study Description Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions.. In this study, LINFU® will be evaluated in the general population with no risk factors and who exhibit no signs or symptoms of disease, This study will help determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3). ### Conditions - Pancreatic Cancer - Pancreatic Ductal Adenocarcinoma - Pancreatic Dysplasia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - LINFU® ### Outcomes Primary Outcomes - The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® - The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be determined long term Secondary Outcomes - Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® that require medical or surgical intervention ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Objective Analysis of Caesarean Scar Pregnancy - NCT ID: NCT06276790 - Study ID: ChengdeCentralHospital - Status: COMPLETED - Start Date: 2019-01-18 - Completion Date: 2022-12-25 - Lead Sponsor: Chengde Central Hospital ### Study Description This study uses a systematic scoring method combined with clinical and ultrasound data to comprehensively evaluate patient conditions and explore the guiding value of the ultrasound quantitative scoring system for selecting the surgical approach for caesarean scar pregnancy. ### Conditions - Caesarean Scar Pregnancy - Ultrasound Scoring System ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ultrasound-guided/hysteroscopic curettage - Procedure/Surgery: laparoscopic removal of the pregnancy lesion ### Outcomes Primary Outcomes - intraoperative blood loss - length of hospital stay - serum β-HCG levels Secondary Outcomes ### Location - Facility: Chengde Central Hospital, Chengde, N/A, 067000, China @@
## The Effect of Using Desensitizers Containing S-PRG In Treatment Of Dentin Hypersensitivity Over 6 Months: A Randomized Clinical Trial - NCT ID: NCT06276777 - Study ID: SPRG Dentin Hypersensitivity - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-01 - Lead Sponsor: Eman Omar Elfarouk ### Study Description The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups. ### Conditions - Dentin Hypersensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tooth varnish (PRG Barrier Coat from Shofu) - Tooth varnish (Clinpro white varnish 3M) ### Outcomes Primary Outcomes - Dentin hypersensitivity reduction Secondary Outcomes ### Location - Facility: Faculty of Dentistry Cairo University, Cairo, N/A, 11331, Egypt @@
## The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas) - NCT ID: NCT06276764 - Study ID: Adenocyte 103 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2034-05-01 - Lead Sponsor: Adenocyte, LLC ### Study Description In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes. ### Conditions - IPMN, Pancreatic - Pancreas Cancer - Pancreatic Cyst ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - LINFU® - Standard imaging tests ### Outcomes Primary Outcomes - The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods Secondary Outcomes - The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period - Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Diagnostic Value of End-Tidal CO2 in Patients Diagnosed With Pneumothorax - NCT ID: NCT06276751 - Study ID: E1-23-3870 ptx endtidalco2 - Status: COMPLETED - Start Date: 2023-08-15 - Completion Date: 2024-02-13 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description Pneumothorax (PTX) is defined as the accumulation of air in the pleural space. PTX can cause a disruption in the perfusion of lung tissue in the affected area and increase intrathoracic pressure, potentially leading to obstruction of venous return and, consequently, posing a life-threatening condition. Therefore, PTX requiring urgent intervention is a significant concern in emergency departments.End-tidal carbon dioxide (ETCO2) provides insight into carbon dioxide levels resulting from lung perfusion and serves as a respiratory parameter informing the prognosis of various critical illnesses. One of the most important factors determining lung perfusion is the effective lung area. Among the crucial issues for emergency departments are PTX cases, which typically regress following urgent intervention, leading to the establishment of an effective lung area. Hypotheses have been proposed in the literature suggesting that ETCO2 may be affected in PTX cases due to the relationship between effective lung area and ETCO2.In this study, investigetors aimed to investigate changes in ETCO2 levels following tube thoracostomy applied to PTX cases. ### Conditions - Pneumothorax ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - End-tidal CO2 monitor ### Outcomes Primary Outcomes - ETCO2-0 - ΔETCO2-1 - ΔETCO2-2 - ETCO2-1 - ETCO2-2 Secondary Outcomes ### Location - Facility: Ankara Bilkent Şehir Hastanesi, Ankara, Çankaya, 06170, Turkey @@
## The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease - NCT ID: NCT06276738 - Study ID: Adenocyte 102 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2034-05-01 - Lead Sponsor: Adenocyte, LLC ### Study Description Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC. ### Conditions - Pancreatic Cancer - Jaundice - Abdominal Neoplasm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas) ### Outcomes Primary Outcomes - The number of pancreatic ductal adenocarcinomas identified only with LINFU® will be compared to standard screening methods Secondary Outcomes - The change in size of pancreatic ductal adenocarcinomas identified only with LINFU® will be determined - Determine the number of patients with pancreatic ductal adenocarcinoma identified only with LINFU® that require medical or surgical intervention ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Writing Wrongs: Expressive Writing for Microaggressions - NCT ID: NCT06276725 - Study ID: 23-606 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-04-01 - Lead Sponsor: Auburn University ### Study Description Racial and ethnic based stressors, such as microaggressions, are pervasive, distressing, and result in lasting negative repercussions for minoritized students at predominantly white institutions (PWIs). These racial and ethnic based stressors are experienced in addition to the universally experienced stressors of higher education. Negative repercussions of microaggressions include increased drop out or transfer rates, distress, fatigue resulting in decreased academic performance, and depression and posttraumatic stress symptoms. Expressive writing (EW) may be a scalable intervention for addressing the negative repercussions resulting from microaggressions experienced by minoritized students at PWIs. Previous research suggests that EW for stressful life events results in benefits such as reduced depression and posttraumatic stress symptoms, improved coping strategies, and reduced activity restriction. Despite such benefits, EW was not designed to specifically address microaggressions in a minoritized student population. Informed by the ADAPT-ITT model, our research group conducted a pilot study with similar procedures. This pilot study demonstrated the acceptability of an adapted version of the EW intervention titled Writing Wrongs (WW), as well as recommended future modifications for WW. In the current study we aim to conduct a randomized-controlled trial to establish the efficacy of WW in alleviating clinical symptoms. We hypothesize that WW will improve symptoms of racial and discriminatory trauma and symptoms of depression, anxiety, and posttraumatic stress over time and compared to an assessment-only condition. We will conduct exploratory analyses to examine short-term changes in affect within and across sessions and across conditions. We will recruit minoritized students enrolled at a PWI. Participants will complete a pre-intervention assessment prior to being randomized into the two conditions. Participants in the intervention condition will engage in three sessions of WW and complete measures of clinical symptoms across multiple time points (i.e., pre-intervention, immediately after the final writing session, one week after the final session). Participants in the assessment-only condition will be administered the same measures at the same timepoints and given access to the WW after completing the study. If found to be efficacious, WW has the potential to be widely disseminated to minoritized college students who experience microaggressions. ### Conditions - Posttraumatic Stress Disorder - Discriminatory Stress - Microaggression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Writing Wrongs ### Outcomes Primary Outcomes - Racial and Discriminatory Trauma - Daily Racial and Discrimination Trauma Secondary Outcomes - Depression - Anxiety - Stress - Posttraumatic Stress - Daily Depression - Daily Anxiety - Daily Posttraumatic Stress ### Location - Facility: Auburn University, Auburn, Alabama, 368849, United States @@
## RCT Comparing KS Versus TS for Ovedenture - NCT ID: NCT06276712 - Study ID: UNISS_PHD_Osstem_5 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-01-30 - Lead Sponsor: Università degli Studi di Sassari ### Study Description To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants ### Conditions - Dental Implant - Dental Implant-Abutment Design - Edentulous Jaw ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Implant placement with 3.5 mm diameter KS implants. - Implant placement with 3.5 mm diameter TS implants. ### Outcomes Primary Outcomes - Number of implant failure - Number of prosthesis failure - Number of complications - Rate of implant stability Secondary Outcomes - Peri-implant marginal bone level changes - Patient satisfaction ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy - NCT ID: NCT06276699 - Study ID: FAHS - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-06 - Lead Sponsor: University of Peradeniya ### Study Description This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly. ### Conditions - Cervical Radiculopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 1.Isometric exercise 2.combined conservative treatment ### Outcomes Primary Outcomes - Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline. Secondary Outcomes - Difference in cervical ROM measured by Goniometry between combination of treatments and isometric exercises at 6-weeks post-baseline. - Difference in functional disability measured by Neck Disability Index between combination of treatments and isometric exercises at 6-weeks post-baseline ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer - NCT ID: NCT06276686 - Study ID: RS211 - 332296 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-02 - Lead Sponsor: University of Hull ### Study Description This is a single arm feasibility study of exercise for improving long- course neoadjuvant chemoradiotherapy (NACRT) efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patients will be provided with an 11-week course of structured aerobic exercises and resistance training in the periods before, during and after their chemoradiotherapy treatment. The patients will be followed up for 6 months post long course neoadjuvant chemoradiotherapy (NACRT), with a total of 3 assessment periods. ### Conditions - Locally Advanced Rectal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Supervised Vigorous intensity aerobic interval exercise ### Outcomes Primary Outcomes - Recruitment rate - Attendance rate - withdrawal rate Secondary Outcomes - Serum Carcinoembryonic antigen levels - Quality of life - Quality of life - Physical activity levels ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Influences of Single Chamber vs. Multi-chamber Blood Flow Restriction Cuffs - NCT ID: NCT06276673 - Study ID: 301 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-13 - Completion Date: 2024-12-10 - Lead Sponsor: Salisbury University ### Study Description The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, and participant perception. ### Conditions - Blood Vessel Disease - Muscle Edema ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Delfi ### Outcomes Primary Outcomes - Arterial Stiffness - Muscle Morphology Secondary Outcomes ### Location - Facility: Salisbury University, Salisbury, Maryland, 21801, United States @@
## Post-Concussion Differences Between Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT) Test - NCT ID: NCT06276660 - Study ID: STUDY23070079 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-12-31 - Lead Sponsor: University of Pittsburgh ### Study Description This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit. ### Conditions - Mild Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - BCTT - Dynamic ExIT ### Outcomes Primary Outcomes - Physiological response to dynamic or aerobic test (HEART RATE) Secondary Outcomes - Post Concussion Symptom Scale - Patient Health Questionnaire (PHQ-9) - Generalized Anxiety Disorder (GAD-7) - Vestibular Ocular Motor Screening (VOMS) - Clinical Profiles Screening (CP-Screen) - Blood Pressure ### Location - Facility: UPMC/Univ of Pgh Sports Medicine Concussion Research Program, Pittsburgh, Pennsylvania, 15203, United States @@
## Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk - NCT ID: NCT06276647 - Study ID: 850584 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-05-31 - Lead Sponsor: University of Pennsylvania ### Study Description The goal of this educational clinical trial is to identify Black women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for high-risk women. The main question\[s\] it aims to answer are:* How can the investigators help postpartum Black people who have poor outcomes by decreasing the number of ED visits/readmissions for postpartum people within the first 30 days postpartum?* How can the investigators increase the ability of participants to "obtain needed services" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ED visits?Participants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum. ### Conditions - Maternal Behavior - Postpartum Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - HOME ### Outcomes Primary Outcomes - Emergency Department (ED) Visits and Readmissions Secondary Outcomes - Ability to Obtain Needed Services - Depressive Symptoms - Depressive Symptoms ### Location - Facility: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States @@
## Intermittent Hypoxia in Persons With Multiple Sclerosis - NCT ID: NCT06276634 - Study ID: STU00219535 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-01 - Lead Sponsor: Shirley Ryan AbilityLab ### Study Description This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS. ### Conditions - Multiple Sclerosis - Multiple Sclerosis-Relapsing-Remitting - Multiple Sclerosis, Secondary Progressive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Acute Intermittent Hypoxia - Sham-Acute Intermittent Hypoxia ### Outcomes Primary Outcomes - Ankle Plantarflexion Strength Secondary Outcomes - Task fMRI ### Location - Facility: Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States @@
## Family Bridge Program - NCT ID: NCT06276621 - Study ID: STUDY00003564 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: Seattle Children's Hospital ### Study Description Pediatric healthcare inequities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and demands imposed by the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address inequities related to communication and system navigation in the inpatient setting; given the established links between these inequities and disparate clinical outcomes, such interventions are needed. To address this gap, the study team collaborated with parents/caregivers, staff, and providers to develop and pilot-test a novel program to improve navigation ability, communication, and hospital-to-home transition for a diverse population of children and their families, The Family Bridge Program (FBP).The FBP combines principles of effective patient navigation and communication coaching interventions into a brief and targeted inpatient program. It is designed for a broad population of low-income children of color, is not disease-specific, is not limited to English proficient families, and is less time-intensive than traditional navigation, to enable provision of support to more families. The FBP, delivered in-person by a trained lay navigator, includes: (1) hospital orientation; (2) unmet social needs screening (e.g., food insecurity); (3) parent communication and cultural preference assessment, relayed to the medical team; (4) communication coaching for parents; (5) emotional support; (6) assistance with care coordination and logistics; and (7) a phone call 2 days post-discharge. Program elements are flexibly delivered based on parent need and interest.In pilot testing, the program was feasible to deliver, acceptable to parents and providers, and significantly improved parent-reported system navigation ability. The current R01 proposes a two-site randomized controlled trial (RCT) of the effectiveness of FBP among 728 families of low-income children of color. Enrolled families will be randomized 1:1 (stratified by site and language) to FBP or usual care plus written resources. The specific aims of this clinical trial are to (1) Test the effect of the FBP on parent-reported system navigation ability, quality of hospital-to-home transition, diagnosis comprehension, observed communication quality, perceived stress and revisits for families of low-income children of color; (2) Examine whether changes in parent-reported barriers and needs mediate program effects; and (3) Identify subgroups of parents among whom the FBP is more effective. The proposed RCT will use a rigorous design to test a feasible, innovative program to address a critical national problem. If effective, the Family Bridge Program would provide a scalable model for improving health care experiences and outcomes for families of low-income children of color, including those who prefer a language other than English for their medical care. ### Conditions - Healthcare Inequities - General Pediatric Medical Conditions - Healthcare System Navigation - Patient-provider Communication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Family Bridge Program - Care as usual - resources only ### Outcomes Primary Outcomes - System Navigation Ability - Pediatric Transition Experience Measure (P-TEM) Secondary Outcomes - Diagnosis Comprehension - Perceived Stress Scale - Observed Communication: utterances in which team offers information - Observed Communication: utterances in which team offers supportive talk - Observed Communication: utterances in which parent asks questions - Observed Communication: utterances in which parent responds assertively - Observed Communication: parent talk-time - Observed Communication: global partnership rating - 30-day readmissions ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Iron Deficiency in Pediatric Heart Surgery - NCT ID: NCT06276608 - Study ID: PED_Fe_def - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-06-30 - Lead Sponsor: Queen Fabiola Children's University Hospital ### Study Description The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates. In this retrospective study, the iron status of all patients undergoing pediatric cardiac surgery at our institution between January 2019 and december 2023 will be analyzed. Together with iron status, transfusion requirements as well as complications will be recorded. Iron status will be reported with descriptive statistics, patients with or without iron deficiency will be compared using non-parametric tests. ### Conditions - Iron Deficiencies - Iron Deficiency Anemia - Cardiac Surgical Procedures - Congenital Heart Disease in Children ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Iron status ### Outcomes Primary Outcomes - Prevalence of preoperative iron deficiency (%) - Complications Secondary Outcomes ### Location - Facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola, Brussels, N/A, 1020, Belgium @@
## Telling Our Daughters Our Story - NCT ID: NCT06276595 - Study ID: IRB00009466 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2019-03-30 - Completion Date: 2024-07-30 - Lead Sponsor: Johns Hopkins Bloomberg School of Public Health ### Study Description The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female children and the children's female caregivers. This project will evaluate the impact of "Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (henceforth referred to as TODOS) on associated risk and protective factors for early substance use and sexual debut through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the TODOS program effectively reduces risk factors and improves protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use. ### Conditions - Substance Use - Sexual Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS) - Control condition - 3 Monthly Group Activities in the Community ### Outcomes Primary Outcomes - Change in child cultural knowledge score on knowledge assessment - Change in average score on risky behaviors assessment - Change in child reproductive health knowledge via a reproductive health knowledge questionnaire Secondary Outcomes ### Location - Facility: White Mountain Apache Center for Indigenous Health, Whiteriver, Arizona, 85941, United States @@
## Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico. - NCT ID: NCT06276582 - Study ID: 519379-2 - Status: RECRUITING - Start Date: 2023-01-17 - Completion Date: 2024-05-31 - Lead Sponsor: Norwegian University of Science and Technology ### Study Description The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared. ### Conditions - Jaundice, Neonatal ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Screening for neonatal jaundice with a mobile health device ### Outcomes Primary Outcomes - Enable high qualitative estimation of bilirubin levels in the blood of Mexican newborns using Picterus JP Secondary Outcomes - Correlation between bilirubin measurements with Picterus JP and total serum bilirubin ### Location - Facility: Hospital General de Zona 1, Oaxaca, N/A, 68040, Mexico @@
## Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Respiratory Distress Syndrome After Cardiac Surgery :a Single Centre Random Control Trial. - NCT ID: NCT06276569 - Study ID: 2023-LCYJ-MS-26 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-18 - Completion Date: 2026-12-31 - Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School ### Study Description The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute respiratory distress syndrome (ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application. ### Conditions - Cardiac Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Sivelestat - placebo ### Outcomes Primary Outcomes - Oxygenation index - Inflammatory index - Myocardial injury marker - Acute physiology and chronic health evaluation(APACHE II) socre - Murray socre - ICU time - In-hospital time - 30-day all-cause mortality - 90-day all-cause mortality Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Extension Study of ABP-671 in Participants With Gout - NCT ID: NCT06276556 - Study ID: ABP-671-302 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-22 - Completion Date: 2025-07-02 - Lead Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. ### Study Description The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3). ### Conditions - Gout ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ABP-671 - Allopurinol ### Outcomes Primary Outcomes - Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) - Incidence of treatment-emergent adverse events (Safety and Tolerability) Secondary Outcomes - Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) ### Location - Facility: Alliance for Multispecialty Research, Tempe, Arizona, 85281, United States @@
## Bactiseal Catheter Safety Registry Study - NCT ID: NCT06276543 - Study ID: C-BSEAL-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-12-31 - Lead Sponsor: Integra LifeSciences Corporation ### Study Description Research Purpose:This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter.Research Design:This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022.The following information will be collected from subjects' medical records or hospitals' databases (if any):1. General condition of the subjects (including previous shunting and external drainage operation)2. Intraoperative condition and catheter implantation3. Information on the shunt catheters4. Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2)5. Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done) ### Conditions - Hydrocephalus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - antibiotic-impregnated catheter ### Outcomes Primary Outcomes - Infection outcome - Safety outcome Secondary Outcomes ### Location - Facility: Beijing Children's Hospital, Capital Medical University, Beijing, Beijing, 100045, China @@
## Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling - NCT ID: NCT06276530 - Study ID: APHP231036 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-03 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description This study aims to identify physiopathologic mechanisms related to surgical approaches during lobectomies for non-small cell lung cancer which can explain the better quality of life and the decrease of of post-operative complications in minimally invasive techniques (video-assisted thoracic surgery and robotic-assisted thoracic surgery) compared to conventional thoracotomy. ### Conditions - Resectable Lung Non-Small Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - EOS imaging for musculoskeletal disorder - Movement analysis by an optoelectronic camera. - Stabilometric measurement by strength platform ### Outcomes Primary Outcomes - Thoracic kyphosis (T1- T12 angle) and vertical alignment head-pelvis and head- C7 vertebra (angle OD-HA and OD-C7) (EOS) Secondary Outcomes - Width of rib cage (EOS) - Rib cage volume (EOS) - " Umbrella "angle (EOS) - Center of Pressure displacement (Optoelectronic system) ### Location - Facility: Department of Thoracic and Vascular Surgery Tenon University Hospital, Paris, N/A, 75020, France @@
## Hidden Impairments During Subarachnoid Haemorrhage Recovery, Description and Evolution of a Newly Described Syndrom - NCT ID: NCT06276517 - Study ID: APHP220918 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2028-03 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Descriptive observational study in patients with spontaneous subarachnoid hemorrhage or following aneurysmal rupture to assess the presence of a post-HSA syndrome at 3 months, 6 months and 1 year, and its impact on functional outcome using the Rivermead questionnaire ### Conditions - Intracranial Hemorrhages ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - questionnaire - SS-QoL - SF-36 - CIQ-R - BREFF - MoCA - IADL - mMRS - PCL-5 - Brief-Cope ### Outcomes Primary Outcomes - Evaluate the presence of post SAH syndrome at 3 months and its impact on return to work using the Rivermead Post-Concussion symptoms questionnaire (RPQ), and its impact on functional outcome. Secondary Outcomes - - study the factors determining the presence of a post-HSA syndrome and an inability to return to work at 3 months, 6 months and 1 year - To study the prevalence of post-traumatic stress in this population - Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection - NCT ID: NCT06276504 - Study ID: APHP211001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description This study aims to assess the efficacy and safety of pembrolizumab in immunocompromised patients with progressive multifocal leukoencephalopathy (PML). This phase II, multicenter, single-arm study includes patients with an underlying cause of immunosuppression hardly reversible, i.e. not the patients with HIV nor those receiving biologics for chronic inflammatory diseases. Patients will receive intravenous pembrolizumab (2 mg/kg, maximum 200 mg) at month 0, 1 and 2 (total of three doses). The primary endpoint will be achieving at least one negative result of JCV viral load in cerebrospinal fluid (CSF) within the M0 to M3 period. ### Conditions - Progressive Multifocal Leukoencephalopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection ### Outcomes Primary Outcomes - Negativation of JCV viral load in the CSF as assessed by PCR: at least one JCV PCR in the CSF negative in the Day 0 to Month 3 period Secondary Outcomes - Negativation of JCV PCR viral load in the CSF: cumulative incidence of negative JCV viral load measures by PCR in CSF, with death as competing event - Evolution of the JCV viral load in the CSF (repeated measures JCV PCR in CSF) - Repositivation of JCV PCR: at least a positive result following at least a negative result - Evolution of National Institutes of Health Stroke Scale (NIHSS) score - Evolution of 6-item Modified Rankin Scale score (includes death as most severe state) - Evolution of Glasgow Outcome Scale Extended (GOS-E) score - Relapse or progression - Death (and date of death) - Cause specific death: death related to PML - Any adverse event classified by using US NCI CTCAE ### Location - Facility: Hôpital Pitié-Salpêtrière - Médecine Intensive Réanimation, Paris, N/A, 75013, France @@
## Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors - NCT ID: NCT06276491 - Study ID: XmAb541-01 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2028-12 - Lead Sponsor: Xencor, Inc. ### Study Description The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate effect of XmAb541 on tumor outcomes. ### Conditions - Ovarian Cancer - Endometrial Cancer - Germ Cell Tumor - Testicular Germ Cell Tumor - Ovarian Germ Cell Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - XmAb541 ### Outcomes Primary Outcomes - Incidence of Adverse Events - Incidence of dose-limiting toxicities (DLTs) - Incidence of cytokine release syndrome (CRS) Secondary Outcomes - Measurement of Cmax - Measurement of area under curve (AUC) - Measurement of Ctrough - Objective Response Rate - Duration of Response - Changes in Circulating Tumor DNA (ctDNA) ### Location - Facility: Montefiore Einstein Comprehensive Cancer Center, Bronx, New York, 10461, United States @@
## Positive Psychological Deconditioning of Pediatric Patients With Dental Anxiety Through Artificial Intelligence - NCT ID: NCT06276478 - Study ID: 2024-PEDOAI - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-04 - Completion Date: 2024-06 - Lead Sponsor: University of Pavia ### Study Description Pediatric patients who will be attending dental treatment at both the Orthodontics and Pediatric Dentistry Unit, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences at the University of Pavia, Pavia, Italy and a private dental practice in Genoa, Italy, will be recruited for the study.A cartoon version of a small molar will be drawn using the software Paint (version 22000.0, Microsoft Corporation, Redmond, Washington State, U.S.). The drawing will be animated using an AI-based software (Sketch MetaDemolab, Meta AI Research, Astor Place, New York city, New York, U.S.). A text will be created in collaboration with OpenAI (version 3.5, Open AI, San Francisco, California, U.S.) to be integrated into the video, utilizing terminology deemed most suitable for a patient with dental anxiety. The text will be transformed from written to spoken dialogue using an AI-based software (Flexclip, version 5.6.0, PearlMountain, Hong Kong, China), and then incorporated into the video.Children will undergo the first dental visit at the baseline (T0), in which the following indexes will be assessed: Modified Dental Anxiety Scale (MDAS), Face-Leg-Activity-Cry-Consolability Scale (FLACC), Simplified Oral Hygiene Index (OHI-S), Bleeding on Probing (BOP) and the International Caries Detection and Assessment System (ICDAS). They will be randomly divided into two group:* in the Trial group, patients will watch the the video, and then the tell-show-do technique will be used to explain the dental procedures;* in the Control group, only the "tell-show-do" technique will be used. Variables considered will include age, gender, and the presence/absence of a parent or another companion.At the second visit (T1), scheduled approximately after two weeks, the variables will be re-evaluated and professional debridement will be performed with a piezoelectric instrument (Satelect Acteon Newton p5 xs,Acteon Group, Mèrignac, France and Sonicflex Kavo, KaVo Dental, Biberach an der Riss, Germany) and manual scaler/curettes (Courette 9/10, 11/12 and 13/14 Gracey and Scaler lm 23, Hu Friedy, Europe). Values will be registered again, for the third time, after the professional debridement. ### Conditions - Dental Anxiety - Dental Phobia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - AI-video - Verbal instructions ### Outcomes Primary Outcomes - Change in Modified Dental Anxiety Scale - MDAS (Humphris GM et al. 1995) Secondary Outcomes - Change in Face, Leg, Activity, Cry, Consolability Scale - FLACC (Merkel, S. I. et al., 1997) - Change in Bleeding on Probing - BoP (Löe H. et al.,1967) - Change in Simplified Oral Hygiene Index - OHI-S (Greene JC et al, 1964) - International Caries Detection and Assessment System - ICDAS ### Location - Facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, Pavia, Lombardy, 27100, Italy @@
## Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging - NCT ID: NCT06276465 - Study ID: UC-GTG-2306 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2032-07-01 - Lead Sponsor: UNICANCER ### Study Description In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer.In the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number.An early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients.The treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs.The principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide. ### Conditions - Prostatic Cancer, Castration-Resistant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Darolutamide 300 mg - Stereotactic body radiation therapy - Androgen deprivation therapy ### Outcomes Primary Outcomes - Radiographic Progression-free survival (rPFS) Secondary Outcomes - Time to treatment failure (TTF) - Overall survival (OS) - Prostate cancer-specific survival - Time to PSA progression - Biochemical response rate - Time to next symptomatic skeletal event (SSE) - Time to pain progression - Safety/tolerance - Functional Assessment of CAncer Therapy - Prostate (FACT-P) - Brief Pain Inventory - Short Form (BP-SFI) questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Supporting Resilience Among Re-entered Seniors - NCT ID: NCT06276452 - Study ID: 23.0434 - Status: RECRUITING - Start Date: 2024-03-09 - Completion Date: 2024-11-30 - Lead Sponsor: University of Louisville ### Study Description The first goal (Aim 1) of this clinical trial is to learn about specific strengths, challenges, and desired areas of knowledge and skill-building among older adults who re-entered their communities from a period of incarceration and to then develop a new psychoeducational intervention tailored to these older adults. The second goal (Aim 2) of this clinical trial is to test if the intervention increases chronic disease management and whether the intervention is considered appropriate and acceptable by older adults who re-entered their communities from a period of incarceration.Aim 1 participants will:* complete a baseline survey* participate in a focus groupAim 2 participants will:* complete a baseline survey* participate in an 8-week once weekly intervention* complete three follow up surveys ### Conditions - Chronic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Psychoeducation ### Outcomes Primary Outcomes - Chronic disease self managment Secondary Outcomes ### Location - Facility: New Legacy Reentry, Louisville, Kentucky, 40203, United States @@
## Intraoperative Imaging of Lymph Nodes - NCT ID: NCT06276439 - Study ID: IRB23-0314 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2026-02-19 - Lead Sponsor: University of Illinois at Urbana-Champaign ### Study Description One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). Although modern surgical imaging and fluorescent probes enhance the detection of sentinel lymph nodes using near-infrared (NIR) fluorescence, their inability to precisely determine the nodes' status can result in additional surgeries, lymphedema, and a reduced quality of life for patients. Our research direction aims to harness the potential of bioinspired imaging technologies with the goal of precisely identifying SLN status and ensuring only the cancerous lymph nodes are excised during the initial procedure. To realize this objective, we're drawing inspiration from the mantis shrimp's visual system to create a single-chip multispectral camera that spans the deep ultraviolet to the near-infrared spectrum. Our pioneering sensor seamlessly combines perovskite nanocrystals, optical filters, and vertically-aligned photodetectors on a single chip, enabling concurrent imaging of external NIR fluorophores and internal UV fluorescence from tumor-specific markers. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surgical removal of breast cancer and lymph nodes ### Outcomes Primary Outcomes - Positive lymph node detection with custom sensors Secondary Outcomes ### Location - Facility: University Clinic Hospital, Skopje, N/A, 1000, North Macedonia @@
## Plants Optimizing Development Study (PODS) - NCT ID: NCT06276426 - Study ID: 24468 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2026-09-30 - Lead Sponsor: University of Illinois at Urbana-Champaign ### Study Description This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children. ### Conditions - Healthy Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Soy foods - Non-Soy Plant-Based Foods ### Outcomes Primary Outcomes - Sex steroid excretion Secondary Outcomes - Gut microbiota - Attentional Accuracy - Attentional Reaction Time - Hippocampal-dependent Relational memory - Body Composition - Metabolic Markers - Pubertal Staging - Cognitive Abilities and Academic Achievement ### Location - Facility: University of Illinois, Urbana, Illinois, 61801, United States @@
## REgistRy BRAnch goRE EndopRosthEsis - NCT ID: NCT06276413 - Study ID: REBRA - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2030-12-31 - Lead Sponsor: University Hospital Padova ### Study Description Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis ### Conditions - Aortic Aneurysm, Thoracic - Aortic Dissection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - GORE TAG Thoracic Branch Endoprosthesis ### Outcomes Primary Outcomes - early mortality - device stability - technical success Secondary Outcomes - early major adverse events ### Location - Facility: Vascular and Endovascular Clinic - Padova University, Padova, N/A, 35020, Italy @@
## LPFC Organization in Emotion-Duration Difference Estimation - NCT ID: NCT06276400 - Study ID: 4-24-0023:1 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2028-03-31 - Lead Sponsor: University of California, Santa Barbara ### Study Description To support optimal behavior in daily life, goals and responses following emotional events should ideally incorporate not only the valence and intensity of prior emotional episodes but also their temporal features, such as the relative duration of positive vs. negative attributes. However, how specific brain regions contribute to the integration of temporal and emotional information and promote goal-directed response remains unknown.The goal of this study is to examine how specific brain regions track both emotional and temporal information of dynamic emotional events to inform other related brain regions to guide goal-oriented and context-appropriate actions. The investigators will scan healthy human participants using functional MRI (fMRI) while they view emotional image sequences and track the associated emotional and temporal (duration) information, and act accordingly. The investigators will employ multivariate patterns analysis and pattern similarity analysis to identify brain regions that represent (can decode) emotion, time, and their combined signals, as well as brain regions that represent the associated action goal. In addition, to infer the causal contributions of these brain regions in forming task-relevant representations (emotion, time, and action goal), the same participants will be recruited to receive transcranial magnetic stimulation (TMS) in these regions. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Emotion valence - Time - TMS Stimulation ### Outcomes Primary Outcomes - Multivariate BOLD metrics - Behavioral response Secondary Outcomes ### Location - Facility: University of California, Santa Barbara, Santa Barbara, California, 93106, United States @@
## Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis - NCT ID: NCT06276387 - Study ID: K23AT011768-01 - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2025-12 - Lead Sponsor: University of California, San Francisco ### Study Description This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to:* Assess patient satisfaction with a mindfulness course* Identify barriers to participation in, or completion of, a mindfulness course* Gather initial information to understand how a mindfulness course impacts RA symptomsParticipants will:* Complete online questionnaires* Attend two in-person study visits, involving a brief joint exam and blood draw* Roughly half the participants will have the chance to participate in an 8-week online mindfulness course* Roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness courseResearchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA. ### Conditions - Arthritis, Rheumatoid ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Mindfulness Program ### Outcomes Primary Outcomes - Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study Secondary Outcomes - MBSR Course Attendance (Intervention Adherence) - Percent of Study Completers (Study Retention) ### Location - Facility: Osher Center for Integrative Health, San Francisco, California, 94115, United States @@
## Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients - NCT ID: NCT06276374 - Study ID: SMC 2023-12-107 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-12-31 - Lead Sponsor: Woo-Keun Seo ### Study Description To compare the safety of dual antiplatelet therapy with aspirin and clopidogrel and single antiplatelet therapy administered from 30 days to 12 months following carotid artery stenting on clinically significant bleeding and its prevention effects on net clinical events including combined cardiovascular and cerebrovascular accidents and major bleeding events in patients with carotid artery disease who are at high bleeding risk. ### Conditions - Carotid Artery Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Patients who are scheduled to undergo carotid artery stenting ### Outcomes Primary Outcomes - Clinically significant bleeding Secondary Outcomes - Combined cardiovascular and cerebrovascular accidents ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia - NCT ID: NCT06276361 - Study ID: ROV-QUAR-2023-01 - Status: RECRUITING - Start Date: 2023-09-26 - Completion Date: 2026-05 - Lead Sponsor: Rovi Pharmaceuticals Laboratories ### Study Description This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia. ### Conditions - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Oral risperidone; QUAR F1/2, Dose 1 - Gluteal - Oral risperidone; QUAR F1/2, Dose 2 - Gluteal - Oral risperidone; QUAR F1/2, Dose 3 - Gluteal - Oral risperidone; QUAR F1/2, Dose 3 - Deltoids ### Outcomes Primary Outcomes - λz - t1/2 - Tmax - Cmax - Cmin - Clast - AUC0-t - AUCinf - AUCextrap - Vd/F - Cl/F Secondary Outcomes ### Location - Facility: Investigational Site, Amman, N/A, N/A, Jordan @@
## Newborn Genomic Sequencing Pilot Study - NCT ID: NCT06276348 - Study ID: 20226892 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-13 - Completion Date: 2024-09 - 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. Newborns who are not suspected of having genetic diseases and who are admitted to the NICU at Rady Children's Hospital, San Diego, will be enrolled. The main questions this study aims to answer are:* What is the diagnostic yield of diagnostic whole genome sequencing (DWGS) in this population?* What is the diagnostic sensitivity and specificity of BeginNGS and whole exome sequencing (WES) as compared to DWGS?* What are the potential issues related to implementing DWGS in this population?Enrolled newborns will have a blood sample taken and will receive three tests:* DWGS* BeginNGS* WES ### Conditions - Genetic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Whole genome sequencing - BeginNGS test - WES ### Outcomes Primary Outcomes - Proportion of enrolled infants who are diagnosed with a genetic disease by DWGS. Secondary Outcomes - Proportion of enrolled infants who are identified with a genetic disease by BeginNGS. - Proportion of enrolled infants who are identified with a genetic disease by WES. - Proportion of enrolled infants who have a positive standard NBS test. - Proportion of parents approached who agree to participate in the study. - Parental reasons for refusal. - Time from sample arriving in lab to return of DWGS results. - Time from birth to return of DWGS results. - Results of confirmatory testing if BeginNGS or WES identifies a diagnostic finding not reported by DWGS. ### Location - Facility: Rady Children's Hospital San Diego, San Diego, California, 92123, United States @@
## Influence of Timing of Implant Placement on Early Healing Molecular Events - NCT ID: NCT06276335 - Study ID: IRAS:322440 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-30 - Lead Sponsor: Queen Mary University of London ### Study Description Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing the influence of timing of implant placement on wound healing. In addition, there is no data available on the signaling pathways and the expression of healing biomarkers involved in the early stages of osseointegration after immediate implant placement (IP) or delayed implant placement (DP).The primary objective of this study is to describe changes in the expression of inflammatory, angiogenesis and osseous biomarkers of saliva at 1, 3, 7, 15 and 30 days and of PICF at 3, 7, 15 and 30 days after immediate implant placement (IP) compared with delayed placement (DP). ### Conditions - Dental Implant - Healing Wound - Biomarkers - Saliva ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Immediate implant placement and guided bone regeneration (Test) - Late implant placement and guided bone regeneration (Control) ### Outcomes Primary Outcomes - Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva Secondary Outcomes - Blood flow changes - Soft tissue volume changes - Peri-implant bone level - Full mouth plaque score (FMPS) - Full mouth bleeding score (FMBS) - Probing pocket depth (PPD) - Gingival recession (REC) - Clinical attachment level (CAL) - Suppuration - Patient satisfaction at 6 months after loading - Changes in the pink esthetic score (PES) - Changes in the white esthetic score (WES) - Changes in the papilla fill index (PFI) - Implant survival ### Location - Facility: Centre for Oral Clinical Research, London, N/A, E1 2AD, United Kingdom @@
## Assessment of All Spine Segments ın Individuals With Low Back Pain - NCT ID: NCT06276322 - Study ID: HU-FTR-SZK-01 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-12-31 - Lead Sponsor: Hacettepe University ### Study Description The aim of the study is to evaluate the kinematics of all spine segments in 3 planes and compare them with asymptomatic controls using wearable technology while performing functional tasks that patients with chronic low back pain often describe as painful in their daily lives. ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Low back pain group - Healthy group ### Outcomes Primary Outcomes - Evaluation of the kinematics of the all spine during walking - Evaluation of the kinematics of the all spine during Bending Forward and Lifting Objects - Evaluation of the kinematics of the all spine during Standing from Sitting - Evaluation of the kinematics of the all spine during Climbing Step Secondary Outcomes - Spine Normal Joint Movement evaluation - Pain intensity: Visual Analog Scale - Oswestry Disability Index - Fear of movement: Tampa Kinesiophobia Scale ### Location - Facility: Hacettepe university, Ankara, Altındağ, 06050, Turkey @@
## Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors - NCT ID: NCT06276309 - Study ID: NECC2401 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-06-30 - Lead Sponsor: Fujian Maternity and Child Health Hospital ### Study Description The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. At the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. Protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value. ### Conditions - Neuroendocrine Neoplasm - China - Women - Cervical Cancer - Cervical Lesion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - mortality rate - Disease-free survival Secondary Outcomes ### Location - Facility: Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, 350001, China @@
## Heart Rate Variability After Ablation - NCT ID: NCT06276296 - Study ID: 0001 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2024-10-01 - Lead Sponsor: Charles University, Czech Republic ### Study Description Pulsed-field catheter ablation is a promising new treatment method for patients with atrial fibrillation. The mechanism of cell damage here is different from that of classic catheter ablation, in which the ganglion plexuses around the pulmonary veins are also damaged and thus changes in the autonomic nervous system occur. The aim of the work is to find out, using heart rate variability, whether the autonomic system is less affected during pulsed field ablation than in classic radiofrequency ablation. ### Conditions - Atrial Fibrillation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Holter EKG - 1 day before ablation - Radiofrequency ablation - Pulsed field ablation - Holter EKG - 1 month after ablation ### Outcomes Primary Outcomes - Mean RR interval (ms) - SDNN (ms) - RMSSD (ms) - pNN50 (%) - peak frequency (Hz) - power (ms2) - LF/HF ratio - SD1 (ms) - SD2 (ms) - SD2/SD1 - ApEn - Correlation dimension Secondary Outcomes ### Location - Facility: Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady, Prague, N/A, 10034, Czechia @@
## DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29) - NCT ID: NCT06276283 - Study ID: DZ2022E0006 - Status: RECRUITING - Start Date: 2023-02-15 - Completion Date: 2026-02-28 - Lead Sponsor: Dizal Pharmaceuticals ### Study Description This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - DZD9008 plus Bevacizumab ### Outcomes Primary Outcomes - Part A: 1) Dose Limiting Toxicity (DLT); 2) Treatment-Emergent Adverse Events (TEAEs); TEAEs ≥CTCAE grade 3; and Serious Adverse Events (SAEs). Part B: 1) TEAEs; TEAEs ≥CTCAE grade 3; and SAEs. Secondary Outcomes - Part A: 1) Tumor response per RECIST 1.1 and 2) Plasma concentration of DZD9008 and its metabolite. Part B:1) Tumor response per RECIST 1.1; 2) Intracranial tumor response per RECISIT 1.1; 3) Plasma concentration of DZD9008 and its metabolite. ### Location - Facility: Shanghai Chest Hospital, Shanghai, Shanghai, 200030, China @@
## Multi-centre, Open-label, First-in-man Study With Mucopad HA - NCT ID: NCT06276270 - Study ID: PT-MUC-1_05-21 - Status: RECRUITING - Start Date: 2023-12-12 - Completion Date: 2024-12-31 - Lead Sponsor: Contipro Pharma a.s. ### Study Description The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results. ### Conditions - Oral Mucositis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Mucopad HA ### Outcomes Primary Outcomes - Resolution of mucositis symptoms since completion of radiotherapy Secondary Outcomes - - Pain management (VAS scale) - Development of xerostomy - Subjective evaluation on scale 1-5 of the treatment by investigator/ patient ### Location - Facility: Masarykův onkologický ústav, Klinika radiační onkologie, Brno, Česká Republika, 56401, Czechia @@
## Paravertebral Block for Mastectomy With Immediate Reconstruction - NCT ID: NCT06276257 - Study ID: 2024-7301 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: CHU de Quebec-Universite Laval ### Study Description Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure. ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Paravertebral block - Usual analgesia ### Outcomes Primary Outcomes - Evaluation of postoperative pain using the BPI Secondary Outcomes - Total use of opioids received intraoperatively. - Use of non-opioid analgesia intraoperatively - Total dose of opioids received in the PACU - Time before first opioid - Total opioids consumed in the 48 hours following surgery - Chronic pain ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Trial Readiness and Endpoint Assessment in Congenital and Childhood Myotonic Dystrophy - NCT ID: NCT06276244 - Study ID: NM040-GUP19002 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2020-07-08 - Completion Date: 2024-04 - Lead Sponsor: Fondazione Serena Onlus - Centro Clinico NeMO Milano ### Study Description Children with congenital myotonic dystrophy (CDM) present at birth with respiratory insufficiency, talipes equinovarus, feeding difficulties and hypotonia. There is a 30% mortality rate in the first year of life. Children with childhood onset myotonic dystrophy present with symptoms later on but soon develop behavioural difficulties and learning difficulties and are at risk for autistic features and gastrointestinal symptoms. The ability to conduct a therapeutic trial in children with CDM or ChDM is directly limited by the lack of available data regarding appropriate clinical endpoints and biomarkers. Whereas there is an active Italian collaboration recruiting adults with DM1 to study muscle and multisystem aspects in this population, there is no active network in Italy involved in the pediatric population with DM1. Though the underlying mechanism is the same in adult DM1, in CDM and ChDM there are specific challenges to the pediatric population. The aim of this project is to coordinate the Italian Child Neurologist actively involved with CDM and ChDM in a common effort of standardizing protocols and procedures to be applied in the care of these patients. Specific aims are to collect functional measures and clinical information over time to define clinically meaningful endpoints and outcome measures in preparation for international therapeutic clinical trials. This project will contribute to the ongoing international study in CDM by recruiting additional patients from all over Italy and will extend the investigations to the childhood onset forms as an additional add-on pilot study in view of potential treatment options. The investigators expect that the Italian network, with Telethon support, will provide the necessary backbone for trial readiness in the pediatric population both at the national and international levels. ### Conditions - CDM - ChDM ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Physical function - Physical function - Cognitive-behavioral and Quality of Life - Cognitive-behavioral and Quality of Life - Biomarkers - Biomarkers Secondary Outcomes ### Location - Facility: Fondazione Serena Onlus - Centro Clinico NeMO Milano, Milan, N/A, 20162, Italy @@
## Nebulized Salbutamol in Acute Renal Colic - NCT ID: NCT06276231 - Study ID: SalbuEase - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-05-01 - Lead Sponsor: Oman Medical Speciality Board ### Study Description A Prospective, double blinded, Randomized efficacy and safety trial of Nebulized Salbutamol in acute renal colic.Research Summary:INTRODUCTION: Pain is a common reason for individuals to seek health care, especially emergency care. Salbutamol has an effect for smooth muscle relaxation of the ureters. The administration of Salbuatmol has been shown to be safe and effective in the treatment of asthma exacerbation, but there have been no studies evaluating the use of neublized salbutamol for the treatment of acute renal colic pain in the emergency department.METHOD: This is a double blinded randomized clinical controlled trial. Two hundred renal colic patients presenting to the emergency department will be randomized to intervention (10 mg nebulized salbutamol) and (10 ml neublized Normal saline) case groups. Both the groups will get the standard treatment (IM diclofenac 75mg) added to the intervention. Their pain before and after intervention will be measured by Numerical Rating scale (NRS pain score). Patient and attending physician will be blinded throughout the study. The Secondry outcomes are safety, need for rescue medications and time to discharge.AIM: The aim of this study is to compare analgesic effects of Nebulized Salbutamol versus Placebo in adult patients with renal colic.PRIMARY OJECTIVES: Analgesic effects of Nebulized Salbutamol on the Numerical Rating scale (NRS).SECONDARY OBJECTIVES: Adverse Events, the need of rescue pain medications and time to discharge.PATEINT POPULATION: Adults (from age 18 to 60 years) who presents to emergency department (ED) at Armed force Hospital with acute flank pain suggestive of renal colicINTERVENTION: Single dose of Nebulized Salbutamol 10mg.CLINICAL MEASURMENT: Numerical pain Analog Scale will be assessed at 0,15,30, 45 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented.OUTCOME: Decrease in pain measures by NRS pain score after Nebulized Salbutamol is given, tolerability and safety evaluation. ### Conditions - Renal Colic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Salbutamol - 0.9% Normal Saline - Diclofenac Injection ### Outcomes Primary Outcomes - Pain reduction at 60 minutes Secondary Outcomes - Adverse Event/Side Effects - Need of Rescue medications - Pain reduction rate. - ED revisits ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study - NCT ID: NCT06276218 - Study ID: PSU - Status: RECRUITING - Start Date: 2022-02-01 - Completion Date: 2024-02-16 - Lead Sponsor: Prince of Songkla University ### Study Description A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace. ### Conditions - Clavicle Fracture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Clavicular brace ### Outcomes Primary Outcomes - DASH Secondary Outcomes - Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction ### Location - Facility: Prince of Songkla University, Songkla, Hatyai, 90110, Thailand @@
## Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism - NCT ID: NCT06276205 - Study ID: 1037/RC/KEMU - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-09-30 - Lead Sponsor: King Edward Medical University ### Study Description The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.The main question it aims to answer is:• whether adding Vitamin D to standard therapy has any additional benefitsParticipants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them ### Conditions - Hypothyroidism Primary - Lipid Disorder - Dyslipidemias ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vitamin D - Levothyroxin ### Outcomes Primary Outcomes - Decline in Total Cholesterol - Decline in LDL Secondary Outcomes ### Location - Facility: King Edward Medical University, Lahore, Punjab, 54000, Pakistan @@
## Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care - NCT ID: NCT06276192 - Study ID: 2023-01882-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-26 - Completion Date: 2028-03-26 - Lead Sponsor: Region Östergötland ### Study Description The goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. continue according to usual practice.The main question this clinical trial aims to answer are:- Can the diSAID improve shoulder function and reduce pain for patients with subacromial pain in primary care? ### Conditions - Subacromial Pain Syndrome - Shoulder Pain - Rotator Cuff Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Digital Physiotherapy (diSAID) - Traditional Physiotherapy ### Outcomes Primary Outcomes - Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI) Secondary Outcomes - Mean change in shoulder pain intensity at rest, arm activity and at night measured by numeric rating scale (NRS) - Mean change in pain Self-Efficacy - Mean change of self-reported rating of improvement - Mean change of health-related quality of life ### Location - Facility: Anna Petersson, Linköping, N/A, SE 58191, Sweden @@
## Epidural Oxycodone for Pain Management for Lower Limb Amputation - NCT ID: NCT06276179 - Study ID: KFSIRB200-97 - Status: RECRUITING - Start Date: 2024-02-24 - Completion Date: 2024-08-01 - Lead Sponsor: Kafrelsheikh University ### Study Description The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation. ### Conditions - Epidural - Oxycodone - Pain - Lower Limb Amputation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oxycodone - Bupivacaine ### Outcomes Primary Outcomes - Acute postoperative pain scores Secondary Outcomes - Time to the first request for the rescue analgesia - Postoperative morphine consumption - Incidence of phantom limb pain - Adverse effects ### Location - Facility: Kafrelsheikh University, Kafr Ash Shaykh, Kafrelsheikh, 33516, Egypt @@
## Trajectory of Frailty and Cognitive Dysfunction in Older Adults - NCT ID: NCT06276166 - Study ID: 72374215 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-12-31 - Lead Sponsor: Zheng Li ### Study Description To explore the heterogeneity of the development trend of frailty and cognitive function of older adults. ### Conditions - Frailty - Cognitive Dysfunction - Community-dwelling Older Adults ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Frailty - Cognitive function Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer - NCT ID: NCT06276153 - Study ID: CRGGCext - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-02-28 - Lead Sponsor: RenJi Hospital ### Study Description The aim of the study is to establishing a standardized clinical information database for patients with malignant tumors of gallbaldder. Based on the database, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy. ### Conditions - Biliary Tract Diseases - Gallbladder Cancer - Gallbladder Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no interventions ### Outcomes Primary Outcomes - overall survival Secondary Outcomes - progression-free survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery - NCT ID: NCT06276140 - Study ID: 4/23/2-4661/2-9 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-01 - Lead Sponsor: Oncology Institute of Vojvodina ### Study Description The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are:* whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery* whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients.Blood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin.Data about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected.The researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices. ### Conditions - Iron Deficiencies - Iron Deficiency Anaemia - Postoperative Complications - Colorectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Laboratory analyses for the detection of iron deficiency anaemia ### Outcomes Primary Outcomes - Overall morbidity Secondary Outcomes - Prevalence of absolute iron deficiency, functional iron deficiency and iron deficiency anaemia in the study population - Red blood cell transfusion rate - All-cause infection rate - Days of antibiotic use - Number of different antibiotics administered - Length of Intensive care unit-stay - Length of hospital-stay - Intraoperative complications - Quality of postoperative recovery - Reoperation - Estimated total iron-deficit - Serum ferritin level - Values of different erythrocyte indices ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate. - NCT ID: NCT06276127 - Study ID: MERC301123 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-06 - Lead Sponsor: Oman Medical Speciality Board ### Study Description INTRODUCTION: The study focuses on comparing the effectiveness of oral Bisoprolol, a beta-1 adrenergic receptor blocker, against intravenous Diltiazem, a calcium channel blocker, in treating rapid atrial fibrillation or flutter with rapid ventricular response in an emergency setting. This research aims to fill the gap in empirical evidence regarding the use of oral Bisoprolol for these conditions, potentially offering a convenient, evidence-based alternative for patient management in emergency departments where established protocols are lacking.METHOD: This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention. Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects. The primary focus is on patient safety while evaluating the efficacy of the treatments.AIM: Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting.PRIMARY OJECTIVES: The primary efficacy outcome will be evaluated by achieving a HR\<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes. The primary safety outcome measures are HR \< 60 bpm and SBP \< 95 mm Hg.SECONDARY OBJECTIVES: The use of Rescue medication, proportion of patients who required hospitalization, worsening of heart failure or pulmonary oedema, side effect of medication ( dizziness, headaches, gastrointestinal symptoms)PATEINT POPULATION: Adults (18 and older) presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment.INTERVENTION: A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg) or a single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg).CLINICAL MEASURMENT: Heart rate recorded every 15 minutes up to the 90-minute mark, with a 12-lead ECG performed every 30 minutes.OUTCOME: For therapy to be considered effective, patients must achieve a ventricular rate ≤110/min or experience a drop-in ventricular rate of at least 20% at 60 minutes. ### Conditions - Atrial Fibrillation With Rapid Ventricular Response - Atrial Flutter With Rapid Ventricular Response ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oral Bisoprolol - Intravenous Diltiazem ### Outcomes Primary Outcomes - Efficacy Outcome Evaluated by Achieving the Target Heart Rate Reduction - Safety Outcome Evaluated by the Presence of serious adverse event Secondary Outcomes - The use of Rescue medication - Proportion of patients who required hospitalization - ED revisit - Number of Participants Experiencing Treatment-Related Adverse Events ### Location - Facility: Sultan Qaboos University Hospital, Muscat, Al-khod, 38, Oman @@
## IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON) - NCT ID: NCT06276114 - Study ID: 07 - Status: COMPLETED - Start Date: 2020-08-01 - Completion Date: 2023-10-31 - Lead Sponsor: Medical University of Silesia ### Study Description The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint. ### Conditions - Coronary Artery Calcification - Intravascular Lithotripsy - Excimer Laser-coronary Atherectomy - Stent Restenosis - Stent Occlusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Stent Underexpansion ### Outcomes Primary Outcomes - The primary efficacy endpoint was device success Secondary Outcomes - Device-oriented composite endpoint (DOCE) ### Location - Facility: Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital, Florence, N/A, N/A, Italy @@
## NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL - NCT ID: NCT06276101 - Study ID: NEWISH-HPV-101 - Status: RECRUITING - Start Date: 2024-01-25 - Completion Date: 2025-07-30 - Lead Sponsor: Newish Technology (Beijing) Co., Ltd. ### Study Description This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL. ### Conditions - High-grade Squamous Intraepithelial Lesion (HSIL) ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - NWRD08 administered by electroporation ### Outcomes Primary Outcomes - Safety - Dose-limiting toxicity (DLT) Secondary Outcomes - Immunogenicity - Histopathology outcome and HPV Viral clearance - The recommended phase II dose (RP2D) ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy - NCT ID: NCT06276088 - Study ID: NFEC-2024-067 - Status: RECRUITING - Start Date: 2024-02-18 - Completion Date: 2026-10-31 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description Immune checkpoint inhibitors have ushered in a new era of cancer treatment, bringing significant survival benefits to patients. However, some patients have accelerated tumor growth in the early stage of immunotherapy, called hyperprogression. The quality of life of patients with hyperprogression is seriously reduced, and there is no effective treatment at present, and the prognosis is extremely poor. Therefore, early identification of high-risk groups of hyperprogression is the key to prevent hyperprogression. However, there are no effective biomarkers to predict hyperprogression. By sequencing, proteomics and metabolomics analysis of clinical tissue and blood samples, we found that the level of SAA1 was significantly increased in patients with hyperprogression, and SAA1 was an effective marker for predicting hyperprogression in pan-cancer. We planned to conduct a multicenter, prospective cohort study to verify the reliability of SAA1 as a marker for predicting hyperprogression of immunotherapy in pan-cancer patients. ### Conditions - Immunotherapy - Hyperprogression - Biomarker ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of hyperprogression Secondary Outcomes - Event-free survival - Progression-free survival - Overall survival ### Location - Facility: Nanfang hospital, Southern medical university, Guangzhou, Guangdong, 510515, China @@
## The Impact of Erigo®Pro Therapy and Motor Imagery on the Balance of Stroke Patients. - NCT ID: NCT06276075 - Study ID: 10/KRN/2020 - Status: COMPLETED - Start Date: 2022-12-15 - Completion Date: 2023-09-10 - Lead Sponsor: Anna Olczak ### Study Description The aim of the study is to examine the impact of motor imagery, Erigo®Pro tilt table intervention, and classic rehabilitation on the balance of people after a stroke. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional rehabilitation, the Erigo®Pro table, motor imagery ### Outcomes Primary Outcomes - Trunk Control Test - Berg Balance Scale - RiabloTM device - RiabloTM device - Luna EMG - Luna EMG Secondary Outcomes ### Location - Facility: Military Institute of Medicine, Warsaw, Masovian District, 04-141, Poland @@
## Uses of Titanium Nail in Pediatric Fractures - NCT ID: NCT06276062 - Study ID: Titanium nail usage - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-10 - Lead Sponsor: Sohag University ### Study Description The aim of this study is to investigate the short term functional and radiological outcomes of using double short titanium elastic nails as treatment of pediatric distal radius fractures. ### Conditions - Trauma Injury of Upper Extremity Forearm Multiple - Fracture of Distal End of Radius ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Distal radius fracture fixation in pediatrics. ### Outcomes Primary Outcomes - Comparison between usage of titanium nail and old methods Secondary Outcomes ### Location - Facility: Sohag university, Sohag, N/A, N/A, Egypt @@
## ChatGPT Helping Advance Training for Medical Students: A Study on Self-Directed Learning Enhancement - NCT ID: NCT06276049 - Study ID: DGETRRP2023-54 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-25 - Completion Date: 2024-03-02 - Lead Sponsor: Wang Shalong ### Study Description The goal of this clinical trial is to evaluate the effect of LearnGuide, a custom GPT developed with ChatGPT for supporting self-directed learning (SDL) in medical students. The main questions it aims to answer are:How does LearnGuide influence SDL skills among medical students? Can LearnGuide improve critical thinking and learning flow as measured by Cornell Critical Thinking Test (CCTT) Level Z score and Global Flow Score (GFS)?Participants will:Undergo a two-hour introduction to LearnGuide. Engage in 12 weeks of SDL task-based training with LearnGuide\&#39;s support.If there is a comparison group: Researchers will compare the group utilizing LearnGuide for SDL and the group without this tool to see if there is a significant difference in SDL skills, critical thinking, and learning flow experiences. ### Conditions - Self-Directed Learning - Artificial Intelligence - Medical Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - custom GPT supported self-directed learning ### Outcomes Primary Outcomes - Self-Directed Learning Scale Secondary Outcomes - Cornell Critical Thinking Test (CCTT) Level Z - Flow Short Scale ### Location - Facility: Department of Geriatirc Surgery, Changsha, Hunan, 410011, China @@
## Autoimmune Cytopenias as a Sign of Primary Immunodeficiency. - NCT ID: NCT06276036 - Study ID: CAPID - Status: ACTIVE_NOT_RECRUITING - Start Date: 2019-07-23 - Completion Date: 2025-06-01 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Autoimmune cytopenias resistant to treatment are among the most common clinical manifestations observed in patients with congenital alterations of the immune system, such as primary immunodeficiencies (PI). The exact contribution of immune system alterations to the pathogenesis of autoimmune cytopenias has not yet been fully elucidated. Moreover, conventionally employed therapeutic strategies often fail, leading to increased healthcare costs, high morbidity, and even mortality. Therefore, there is a need to establish clinical guidelines for diagnosis and to identify early biomarkers capable of identifying individuals responsive to therapy. Thus, a systematic approach to the study of such pathologies will allow for the identification of early biomarkers and facilitate the development of targeted therapeutic strategies ### Conditions - Cytopenia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Identification of specific markers ### Outcomes Primary Outcomes - Identification of specific markers Secondary Outcomes ### Location - Facility: University of South Florida, Tampa, Florida, 33620, United States @@
## Supporting Our Caregivers In ADRD Learning (SOCIAL) - NCT ID: NCT06276023 - Study ID: 2023P003638 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2025-04-01 - Lead Sponsor: Massachusetts General Hospital ### Study Description Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks.The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial.Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention. ### Conditions - Alzheimer's Disease and Related Dementias - Quality of Life - Caregiver Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mindful and Self-Compassionate Care Program (MASC) - Health Education Program (HEP) ### Outcomes Primary Outcomes - Feasibility of Recruitment - Feasibility of Randomization - Feasibility of Assessment Measures - Feasibility of Quantitative Measures - Adherence to treatment - Patient's Global Impression of Change (PGIC) - Perceptions of Questionnaire Battery - Adherence to Home Practice - Perceptions of Email and Text Reminders - Credibility and Expectancy - Modified Perception of Global Improvement - Satisfaction with the Intervention - Therapist Fidelity Secondary Outcomes ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114-2524, United States @@
## Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO - NCT ID: NCT06276010 - Study ID: 2023-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: Xiaotong Hou ### Study Description The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery. ### Conditions - Extracorporeal Membrane Oxygenation Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - nafamostat mesilate - unfractionated heparin group ### Outcomes Primary Outcomes - Incidence of thrombotic complications Secondary Outcomes - Incidence of severe bleeding complications - Infusion volume of blood products - ACT qualified rate - Hospitalization mortality - The incidence of oxygenator dysfunction - Heparin-induced thrombocytopenia - Time to reach the target anticoagulant level for the first time ### Location - Facility: Beijing Anzhen Hospital, Beijing, Beijing, 100029, China @@
## GAIN Project: Gastric Cancer and Artificial Intelligence - NCT ID: NCT06275997 - Study ID: GAIN - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2028-03 - Lead Sponsor: Istituto Clinico Humanitas ### Study Description Our GAIN project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion.The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4). ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Integration of Artificial Intelligence (AI) assistance to screening gastroscopy ### Outcomes Primary Outcomes - Miss rate reduction Secondary Outcomes - Change number of Detections - patient satisfaction ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Online Training in Cardiopulmonary Resuscitation Maneuvers for a Network of Volunteers. - NCT ID: NCT06275984 - Study ID: PI23/00288 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina ### Study Description Background: Cardiorespiratory arrest (CPA) occurs when there is a cessation of cardiac mechanical activity, typically diagnosed by the absence of consciousness, pulse, and breathing. Actions taken in response to CPA include recognizing the condition and promptly notifying emergency medical services, initiating Cardiopulmonary Resuscitation (CPR) maneuvers, and employing an Automated External Defibrillator (AED). Survival rates are directly influenced by the time elapsed between CPA onset and the initiation of CPR maneuvers, as well as the quality of these interventionsHypotheses: Online education in CPR maneuvers is an effective and efficient tool for training individuals from the general population on how to respond to cardiac arrestsObjectives: The primary aim of this study is to assess the efficacy of online CPR and AED training within the general population of the province of Tarragona. Specific objectives include: 1) evaluating participants' theoretical and practical CPR skills in the short and medium term following online training, and 2) exploring the experiences of individuals who have completed the online training and simulation sessions using qualitative methodology.Methodology:This study will unfold in several phases: 1) Online CPR-AED training and assessment of theoretical knowledge acquisition; 2) Evaluation of acquired practical CPR skills (know-how) within a simulation environment, conducted on a subset of the population completing phase 1;3)Analysis of the experiences of a subset of individuals who have participated in the preceding two phases, employing qualitative methodologyVariables and determinations:The primary response variable for phase 1 will be the difference in scores obtained from the online questionnaire between the final (post-training) and initial (pre-training) assessments.In phase 2, the main variable will be the pass/fail categorization of scores in the simulation. This evaluation will be conducted by two members of the Advanced Clinical Simulation Unit at Joan XXII Hospital using a predefined checklist. Throughout the various phases of the study, socio-demographic data and course performance data will be taken into accountExpected results: The research team for this study aims to ascertain the efficacy and effectiveness of online CPR-AED training within the general population. Furthermore, the study aims to provide evidence regarding the optimal duration and frequency for repeating such training.Applicability and Relevance: This proposal advocates for a significant and innovative project, given the dearth of literature on this topic. While there are existing indications and studies on CPR-AED training among specific populations such as students and healthcare professionals, the presented proposal seeks to broaden the scope of training to encompass the general population. ### Conditions - Cardiorespiratory Arrest - Cardiopulmonary Arrest With Successful Resuscitation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - online CPR-AED training ### Outcomes Primary Outcomes - Difference between pre and post training scores in ad hoc designed scale - Percentage of participants that reach or exceed 10 out of 12 on the checklist Secondary Outcomes - Odds ratios (with 95% CI) for adjustment variables - Scores on the standard satisfaction questionnaire commonly used by the Catalan Health Institute to evaluate training activities ### Location - Facility: IDIAP Jordi Gol, Barcelona, N/A, 08007, Spain @@
## Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients - NCT ID: NCT06275971 - Study ID: KBSMC 2022-07-006 - Status: RECRUITING - Start Date: 2022-11-24 - Completion Date: 2024-08-31 - Lead Sponsor: Kangbuk Samsung Hospital ### Study Description The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring. ### Conditions - Cardiac Disease - PreDiabetes - Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexcom G6 - SMBG or venous/arterial blood glucose ### Outcomes Primary Outcomes - Time within the target range of 100-180 mg/dL Secondary Outcomes - Time within the target range of 100-140 mg/dL - Time within the target range of 70-180 mg/dL - Time to reach <70 mg/dL - Time to reach <54 mg/dL - Time to reach >180 mg/dL - Time to reach >250 mg/dL - Standard Deviation (SD) - Coefficient of variation (CV) - Mean glucose - Glucose management indicator (GMI) - Number of days of ICU hospitalization - Number of days hospitalized after surgery - Number of participants with pneumonia occurrence after surgery - Number of participants with wound infection occurrence after surgery - Number of participants who underwent CRRT implementation after surgery - Number of participants with Atrial fibrillation occurrence after surgery - Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery - Changes in concentration of serum CRP level after surgery - Mortality within 30 days of surgery ### Location - Facility: Kangbuk Samsung Hospital, Seoul, N/A, 03181, Korea, Republic of @@
## DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients With Metastatic Colorectal Cancer - NCT ID: NCT06275958 - Study ID: 2023-506115-17 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-12 - Lead Sponsor: Leiden University Medical Center ### Study Description The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between doublet chemotherapy in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between monotherapy in either full-dose or upfront dose-reduction.Primary outcome is PFS. Secondary endpoints include grade ≥3 toxicity, QoL, physical functioning, overall survival, number of treatment cycles, dose reductions, hospital admissions, cumulative received dosage and cost-effectiveness. ### Conditions - Older Patients - Colorectal Cancer - Metastatic Cancer - Candidates for Palliative Chemotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Doublet Chemotherapy, Standard Dose (100%) - Doublet Chemotherapy, Dose-reduced (75%) - Monotherapy, Standard Dose (100%) - Monotherapy, Dose-reduced (75%) ### Outcomes Primary Outcomes - Progression-Free Survival Secondary Outcomes - Quality of Life Questionnaire - Quality of Life Questionnaire - Physical functioning Questionnaire - Physical functioning Questionnaire - Grade 3-5 chemotherapy-related toxicity - Overall Survival - Number of completed treatment cycles - Dose reductions during treatment - Dose delay during treatment - Unplanned hospitalizations - Cumulative received dosage - Cost-effectiveness ### Location - Facility: Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, N/A, N/A, Netherlands @@
## Feasibility Study of A VoRo UrologIc ScaffolD (ARID) - NCT ID: NCT06275945 - Study ID: 1010073 - Status: RECRUITING - Start Date: 2023-04-03 - Completion Date: 2026-10-30 - Lead Sponsor: Levee Medical, Inc. ### Study Description The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years. ### Conditions - Stress Urinary Incontinence - Radical Prostatectomy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Voro Urologic Scaffold ### Outcomes Primary Outcomes - The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups. Secondary Outcomes - The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups. - The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups. ### Location - Facility: National Hospital, Panama City, Punta Pacifica, N/A, Panama @@
## Management of Healthy Newborn's Body Temperature at Birth - NCT ID: NCT06275932 - Study ID: TermoNeo/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-31 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description At birth, the newborn begins a process of adaptation to extrauterine life. One of the phases of this stabilization process is the maintenance of body temperature; indeed, the newborn passes from a warm environment (mother's womb) of around 37°C to an environment with a temperature lower (delivery room) and, therefore, must implement a series of physiological processes to be able to maintain body temperature constant and within ideal ranges through a balance between production and heat loss.Hypothermia at birth could cause risks or comorbidities such as an increased risk of infant mortality, hypoglycemia, sepsis, metabolic acidosis, respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH).One of the factors that affects heat loss in the delivery room is the relationship between surface area, volume and body mass of the newborn. The decrease in body temperature is directly related to gestational age and weight at birth; indeed, this problem is much more present in premature and/or low weight newborns at birth. Even if a full-term newborn has a more developed thermoregulation center than a preterm newborn, this does not mean that this type of newborns is not at risk heat dispersion.To date, the strategies that are implemented for the physiological newborn are documented in the literature are, in addition to the heat chain described by the World Health Organization (WHO), the implementation of skin-to-skin contact (skin to skin) mother-newborn.Some studies demonstrating the beneficial effect of this procedure on maintenance of the newborn's body temperature.The aim of this study is to evaluate two healthcare interventions to prevent heat loss of healthy newborns at birth. ### Conditions - Newborn, Infant - Body Temperature - Delivery Room ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Interventional group - Standard of care group ### Outcomes Primary Outcomes - Newborn's body temperature at the end of skin-to-skin contact Secondary Outcomes - Newborns' proportion with a body temperature < 36.5°C when arriving at the nursery - Newborns' proportion with temperature below 36.0°C at the end of skin-to-skin contact and at arrival in the nursery - Newborns' proportion with moderate hypothermia (temperature 36.0 - 36.4°C) at the end of skin-to-skin contact and at arrival in the nursery - Newborns' proportion with hyperthermia (temperature > 37.5°C) at the end of skin-to-skin contact and at arrival in the nursery - Newborns' average temperature one hour after arriving at the nursery - Duration of nursery stay - Duration of skin-to-skin contact - Newborns' proportion exclusively breastfed at discharge - Type of breastfeeding at discharge - Newborns' proportion with hypoglycemia during hospitalization - Newborns' proportion affected by respiratory distress syndrome - Newborns' proportion transferred to the Neonatal Intensive Care Unit (NICU) - Newborns' weight loss at discharge - Mortality before discharge from hospital ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy @@
## Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial) - NCT ID: NCT06275919 - Study ID: IOV-BT-1-2023 MIRAGE - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-03 - Lead Sponsor: Istituto Oncologico Veneto IRCCS ### Study Description The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent grade II or III meningiomas.Small trials and case series suggest clinical relevant activity of several VEGF inhibitors such as sunitinib, bevacizumab and valatinib reporting a 6m-PFS rate of 42-64%. Indeed, VEGF and VEGF receptors (VEGFR) are regularly overexpressed in meningiomas and can correlate with outcome.Regorafenib inhibits angiogenic receptor tyrosine kinases (RTKs) and is highly selective for VEGFR1/2/3; moreover Regorafenib inhibits PDGFRB, FGFR1 and oncogenic intracellular signalling cascades involving c-RAF/RAF1 and BRAF highly expressed in meningiomas.Noteworthy, Regorafenib showed antitumor activity in vitro and in vivo in a recent study; indeed, Regorafenib showed significant inhibition of meningioma cell motility and invasion and in vivo, mice with orthotopic meningioma xenografts showed a reduced volume of signal enhancement in MRI following Regorafenib therapy; this translated in a significantly increased overall survival time (p\<0.05) for Regorafenib treated mice.Moreover, Regorafenib showed good efficacy in different cancer types, such as colorectal cancer, GIST, hepatocellular carcinoma and glioblastoma (REGOMA trial) , maintainingmaintaining a good quality of life. ### Conditions - Meningioma, Malignant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Regorafenib 40 MG Oral Tablet - Local Standard of Care ### Outcomes Primary Outcomes - Progression free survival (PFS) Secondary Outcomes - Overall survival (OS) - Objective response rate (ORR) - Patient Reported Outcomes (PROs) - Patient Reported Outcomes (PROs) - Toxicity during treatment - Disease control rate (DCR) ### Location - Facility: IRST Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Forlì-Cesena, N/A, Italy @@
## Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters. - NCT ID: NCT06275906 - Study ID: NAFLD-POS5 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2026-04-08 - Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis ### Study Description The study in question is an interventional study with nutritional intervention.The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on:* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;* intestinal barrier;* body composition;* intestinal microbiota;* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD. ### Conditions - NAFLD - Obesity - IBS ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mediterranean diet and moderate intensity physical exercise (outdoor walking). ### Outcomes Primary Outcomes - The effect of intervention on CAP value - The effect of intervention on FLI value - The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, nutritional status, inflammatory status and metabolic and cardiovascular risk - The effect of the intervention on the integrity of the intestinal barrier Secondary Outcomes - The effect of the intervention on the Gastrointestinal Symptoms - The effect of the intervention on the Body Composition ### Location - Facility: Irccs Saverio de Bellis, Castellana Grotte, Bari, 70013, Italy @@
## IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy - NCT ID: NCT06275893 - Study ID: ACM01 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2025-08-01 - Lead Sponsor: Implicit Bioscience ### Study Description The goal of this clinical trial is to test IC14 (atibuclimab) in patients with arrhythmogenic cardiomyopathy (ACM) and who have an implantable cardoverter/defibrillator in place. ACM is also called arrhythmogenic right ventricular dysplasia (ARV) or arrhythmogenic right ventricular cardiomyopathy (ARVC). The main questions the study aims to answer are the effect of treatment on blood markers of inflammation, safety, and pharmacokinetics. There will also be measurements of myocardial imaging of C-C chemokine receptor type 2 (CCR2+) immune cells (optional), monitoring of cardiac arrhythmias using the patient's pre-existing intracardiac cardioverter/defibrillator (ICD) and a Holter monitor, electrocardiogram (ECG), echocardiogram (ECHO), and blood tests. Results will be compared to baseline; there is no inactive placebo treatment group.Participants will be asked to undergo screening and baseline testing, then receive 4 intravenous infusions with blood measurements before and after the infusion (including 24, 48, and 72 hours and 7, 14, and 28 days). Participants will be offered specialized scanning of the heart muscle, and will be asked to provide recordings from their ICD, undergo Holter monitoring twice, and have electrocardiograms (ECG), echocardiograms (ECHO) and blood tests. ### Conditions - Arrhythmogenic Right Ventricular Dysplasia - Arrhythmogenic Left Ventricular Cardiomyopathy - Arrhythmogenic Right Ventricular Cardiomyopathy 1 - Arrhythmogenic Cardiomyopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - IC14 ### Outcomes Primary Outcomes - Safety: Treatment-emergent adverse events and serious adverse events - Safety: Incidence of anti-drug antibodies Secondary Outcomes - Inflammatory biomarker C-reactive protein - CCR2+ Myocardial Imaging (optional) - Ventricular tachycardia - Ventricular premature contractions - Sustained and non-sustained ventricular tachycardia - Treated ventricular tachycardia - Atrial premature contractions - New York Heart Association (NYHA) Functional Class - Implantable cardioverter/defibrillator (ICD) discharges - Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire - Disease biomarker Troponin I - Disease biomarker N-terminal B-type natriuretic peptide (NT-pro-BNP) - Inflammatory biomarker interleukin (IL)1-beta - Pharmacokinetics: Serum IC14 concentration versus time curve - Pharmacokinetics: Peak serum IC14 concentration - Pharmacokinetics: Half life - Pharmacodynamics: Receptor Occupancy - Pharmacodynamics: Effective Concentration 95% ### Location - Facility: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States @@
## Intraarticular Collagen in Patients With Gonarthrosis - NCT ID: NCT06275880 - Study ID: F-2023-3201-066 - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2024-01-10 - Lead Sponsor: Instituto Mexicano del Seguro Social ### Study Description The objective of this clinical trial is to verify the effectiveness of polyvinyl pyrrolidone collagen in all patients with symptomatic gonarthrosis grades II-IV in patients over 40 years of age. The main objectives that this study aims to answer are the following:1. - Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis.2. - Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention.3. - Identify demographic, clinical and therapeutic factors that influence the effectiveness of intra-articular PVP collagen in the treatment of symptomatic gonarthrosis.Patients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service within 3 months, will be selected. Two study groups will be assigned: GROUP those who received intra-articular infiltration of PVP Collagen, GROUP B: patients who received conservative treatment. Through rehabilitation with a home program for one month, in both cases, ENA and the WOMAC scale will be evaluated at the beginning of the study and after 4 weeks. ### Conditions - Gonarthrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Intra-articular infiltration of PVP Collagen - Rehabilitation ### Outcomes Primary Outcomes - Western Ontario and McMaster Universities Osteoarthritis Index - Pain - Western Ontario and McMaster Universities Osteoarthritis Index - stiffness - Western Ontario and McMaster Universities Osteoarthritis Index - functionality - Number Analog Scale for pain Secondary Outcomes ### Location - Facility: Hospital General Regional No. 1 Lic. Ignacio García Téllez, Mérida, Yucatán, 97155, Mexico @@
## Improved Access to Quality Care and Healthcare Use - NCT ID: NCT06275867 - Study ID: SOPRIMA//T023635 - Status: RECRUITING - Start Date: 2024-01-20 - Completion Date: 2024-08-30 - Lead Sponsor: London School of Economics and Political Science ### Study Description This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT). The primary outcomes be overuse and underuse of healthcare services for children under 5 ### Conditions - Health Care Utilization - Health Knowledge, Attitudes, Practice - Health, Subjective ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Free high-quality care - Close distance - Far distance ### Outcomes Primary Outcomes - Underuse - Overuse Secondary Outcomes - Illness duration - Out-of-pocket expenditures - Health knowledge ### Location - Facility: HDSS Soweto clusters, Soweto, Gauteng, N/A, South Africa @@
## YASU Research Registry: For Young Adults With Cancer - NCT ID: NCT06275854 - Study ID: 22265 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2030-05-01 - Lead Sponsor: Young Adult Survivors United ### Study Description The goal of this observational research registry is to learn about health, wellbeing, and needs of survivors of young adult cancer (diagnosed between the ages of 18 and 39). The main question\[s\] it aims to understand are:* What are the levels of depression, anxiety, social support, and financial distress* Determine effectiveness of YASU programming by measuring changes over timeWith this registry, the investigators also plan to identify survivors who may be eligible for participation in future research studies pertaining to young adult cancer.Participants will be asked to complete electronic surveys every 6 to 12 months during participation in the registry. ### Conditions - Cancer - Leukemia - Sarcoma - Germ Cell Cancer - Lymphoma - Colorectal Cancer - Melanoma - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Anxiety - Depressive symptoms - Social Support - Financial Toxicity - Needs Assessment Secondary Outcomes - Name, address, email, phone number ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Learn If the Study Medicine Esomeprazole Changes How the Body Processes the Other Study Medicine Vepdegestrant - NCT ID: NCT06275841 - Study ID: C4891035 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-05-24 - Lead Sponsor: Pfizer ### Study Description The purpose of the study is to investigate the effect of multiple doses of a proton-pump inhibitor (PPI) esomeprazole on the PK of vepdegestrant under fed conditions in healthy adult participants.All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, everyone will receive esomeprazole by mouth once a day for multiple days. Participants will also receive one dose of vepdegestrant by mouth. The levels of vepdegestrant in Period 1 will be compared to the levels of vepdegestrant in Period 2 to determine if the PPI affects how vepdegestrant is processed differently in healthy adults. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - vepdegestrant - esomeprazole ### Outcomes Primary Outcomes - Maximum observed plasma concentration (Cmax) of vepdegestrant when vepdegestrant is administered alone - Maxium observed plasma concentration of vepdegestrant when vepdegestrant is administered with esomeprazole - Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered alone - Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered with esomeprazole Secondary Outcomes - number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs) - Number of participants with clinical laboratory abnormalities - Number of participants with electrocardiogram (ECG) abnormalities - Number of participans with clinically significant change from baseline in vital signs ### Location - Facility: Pfizer Clinical Research Unit - New Haven, New Haven, Connecticut, 06511, United States @@
## The Effect of Perioperative and Postoperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction - NCT ID: NCT06275828 - Study ID: PoliceGeneralHospiral - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-12-15 - Completion Date: 2024-02-20 - Lead Sponsor: Police General Hospital, Thailand ### Study Description study the effect of music therapy in pre-operative and post operative period and measure the out come by the visual analog scale (pain score) and analgesic drug use such as morphine and the anxiety score ### Conditions - Anterior Cruciate Ligament Tear ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - slow beat mesic listening by headphone ### Outcomes Primary Outcomes - visual analog scale Secondary Outcomes - analgesic drug use - Amsterdam Preoperative Anxiety and Information Scale ### Location - Facility: Police General Hospital, Bangkok, Pathuwam, 10330, Thailand @@
## Promoting Caregiver Implementation of an Effective Early Learning Intervention - NCT ID: NCT06275815 - Study ID: R01DC020958 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2028-07-31 - Lead Sponsor: Ohio State University ### Study Description The goal of this study is to examine the impact of a caregiver-implemented shared reading program, Sit Together and Read (STAR), on children ages 4 to 5 with developmental language disorder. The main questions it aims to answer are:* how much STAR impacts children's literacy skills in the short-term and long-term--up to two-years after completing STAR.* how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement STAR at its intended frequency of sessions per week.Caregiver participants will be assigned to either a control group or one of three STAR groups. Children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years.Researchers will determine the short term and long term impacts of STAR compared to the control group. Researchers will compare the three STAR conditions to see if the rewards or encouragement helped parents to follow through with completing more STAR sessions. ### Conditions - Developmental Language Disorder - Reading; Difficult ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Sit Together and Read (STAR) - Monetary Reward - Text Encouragement ### Outcomes Primary Outcomes - Preschool Word and Print Awareness (PWPA) - Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing - The Reading House (THR) - Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification - Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension Secondary Outcomes ### Location - Facility: Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy, Columbus, Ohio, 43201, United States @@
## The Effect of Nutrition Education Interventions for Adolescents - NCT ID: NCT06275802 - Study ID: 22-5.1T/2 - Status: RECRUITING - Start Date: 2022-06-06 - Completion Date: 2024-06-30 - Lead Sponsor: Ege University ### Study Description The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools It is planned that a total of 1000 students will be included in the study from the intervention school and 1000 students from the control school. At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken. During the study, nutrition initiatives consisting of 8 modules will be made to the intervention schools. Control schools will not be interfered with during this period.At the end of the study, the procedures applied at the beginning will be repeated. ### Conditions - Nutrition, Healthy - Nutrition Disorders in Adolescence - Eating Habit - Eating Behavior - Body Image ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Nutrition Education - nutritional status, eating habits ### Outcomes Primary Outcomes - nutrition literacy - Mediterranean Diet Quality Index (KID-MED) - Eating Attitudes Test 26 (EAT-26) - weight and height measurement - waist circumference measurement - Food Consumption Record - International Physical Activity Questionnaire (IPAQ- Short Form) Secondary Outcomes ### Location - Facility: Menemen District Directorate of National Education, İzmir, N/A, N/A, Turkey @@
## Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation? - NCT ID: NCT06275789 - Study ID: 2023-268 - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2025-06 - Lead Sponsor: Nova Southeastern University ### Study Description The purpose of the study is to compare a new grafting material for alveolar ridge preservation to a commonly used and well studied material. Alveolar ridge dimensions as well as histology will be compared. ### Conditions - Alveolar Ridge Preservation - Dental Extraction - Bone Graft ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Alveolar ridge preservation ### Outcomes Primary Outcomes - changes in horizontal dimensions of the alveolar ridge - changes in vertical dimensions of the alveolar ridge Secondary Outcomes - vital bone percentage ### Location - Facility: Nova Southeastern University, Fort Lauderdale, Florida, 33328, United States @@
## HIP-STITCH (Wound Recovery After THA) - NCT ID: NCT06275776 - Study ID: OC-2022-005 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-05-01 - Lead Sponsor: Reinier Haga Orthopedisch Centrum ### Study Description This prospective randomised trial will investigate the effect of four different suturing techniques (Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip) on the amount of aberrant wound recovery within 14 days after total hip arthroplasty at the RHOC in Zoetermeer, The Netherlands.This will be done by assessing photographs of the plaster and photographs of the operation wound with a self-developed classification model. The photographs of the plaster will be taken by the test subject at home at 3 days and 11 days postoperatively.The photographs of the operation wound will be taken by a member of the research team, and the doctor's assistant, respectively, during a visit to the outpatient clinic at 7 days and 14 days postoperatively.Hypothesis: Monocryl sutures give the highest amount of aberrant wound recovery within fourteen days after primary THA. ### Conditions - Wound Healing Disturbance of ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ethicon Monocryl Smooth Suture - Ethicon Vicryl Rapide Braided Suture - Flexifuze Indermil Topical Skin Adhesive - Dermabond Prineo Skin Closure System - Stryker Zip Skin Closure System ### Outcomes Primary Outcomes - Number of Participants with Aberrant Wound Recovery Secondary Outcomes - Number of Participants with Superficial or Deep Wound Infection - Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire) - Costs - Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire) - Patient reported outcome measure: Number of Participants with Other postoperative symptoms - Number and Type of Complications - Number of Visits to a Healthcare Professional ### Location - Facility: Reinier Haga Orthopedisch Centrum, Zoetermeer, Zuid Holland, 2725NA, Netherlands @@
## Optimal Medical Treatment of Difficult-to-treat Hypertension - NCT ID: NCT06275763 - Study ID: 2020/ABM/01/00037 - Status: RECRUITING - Start Date: 2023-10-20 - Completion Date: 2025-12-31 - Lead Sponsor: National Institute of Cardiology, Warsaw, Poland ### Study Description The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are \<65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Phase C: Eplerenone - Phase C: Spironolactone - Phase C: Torasemide - Phase B: Triplixam / Elestar HCT - Phase A: Confirmation of uncontrolled hypertension ### Outcomes Primary Outcomes - Patients with uncontrolled BP on ABPM - Patients with controlled BP after 12 weeks on triple SPC - Systolic BP reduction on 4th antihypertensive drug Secondary Outcomes - Percentage of patients with BP controlled confirmed by HBPM - Consistency of the rate of uncontrolled BP - Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM - Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM - Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM - Percentage of patients requiring an increase in the dose - Consistency of the rate of uncontrolled BP - The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks - The magnitude of changes in HBPM and ABPM derived indices after 12 weeks - Phase C - Changes of SBP on ABPM (24h mean) after 12 weeks of treatment - Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM - Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM - Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM - Phase C continuation - Phase C continuation - Changes in HBPM and ABPM derived indices after 12 weeks - comparison of treatment groups - Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against spironolactone - Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against baseline - Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by OBPM - comparison between groups - Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by HBPM - comparison between groups - Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by ABPM - comparison between groups - Consistency of the rate of controlled BP between ABPM, HBPM and OBPM after 24 weeks - Changes in SBP and DBP on OBPM, ABPM and HBPM after 24 weeks of treatment - comparison between groups - Changes in HBPM and ABPM derived indices after 24 weeks of treatment - - comparison between groups - Percentage of patients requiring an increase in the dose of drugs used after 6 and 12 weeks - comparison between groups ### Location - Facility: National Institute of Cardiology, Warsaw, Mazowieckie, 04628, Poland @@
## Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain - NCT ID: NCT06275750 - Study ID: CEI 175/23 - Status: COMPLETED - Start Date: 2023-08-21 - Completion Date: 2024-01-11 - Lead Sponsor: Hospital Civil de Guadalajara ### Study Description The goal of this quasi-experimental trial was to evaluate the effects of non-surgical spinal decompression on disability and pain in patients with chronic low back pain and sciatica throughout a two-month follow-up, and to analyze the relationship between demographic factors and clinical outcomes after a program of non-surgical spinal decompression.The main questions it aims to answer were:* Non-surgical spinal decompression is effective to reduce pain intensity and self-reported disability in patients with chronic low back pain and sciatica?* Age, level of education and work activities are related with clinical outcome in patients treated with non-surgical spinal decompression?Participants underwent eight sessions, three per week, with the BTL-6000 spinal decompression system. The study did not have a comparison group. ### Conditions - Low Back Pain - Sciatica - Lumbar Disc Herniation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.) ### Outcomes Primary Outcomes - Self-reported disability - Pain intensity Secondary Outcomes ### Location - Facility: Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco, 44280, Mexico @@
## POP-UP: a Single-arm, Two-cohort Study: Trimodal Prehab for Upper GI and Pancreatic Cancer - NCT ID: NCT06275737 - Study ID: POP-UP G-128 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-03 - Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group ### Study Description This is a multicenter, two-cohort, open-label, single-arm feasibility study. The primary objective is to assess the feasibility of the 8-week trimodal prehabilitation program alongside perioperative triplet chemotherapy in eligible patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) . ### Conditions - Pancreatic Ductal Adenocarcinoma - Esophageal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Prehabilitation program ### Outcomes Primary Outcomes - Rate of patients with successful completion of an 8-week trimodal prehabilitation program Secondary Outcomes - Success rate (as defined above) for Adapted Physical Activity (APA), nutritional, and psychological interventions measured separately. - Health-related quality of life (HRQoL) assessment - Rate of patients who start and complete post-habilitation Adapted Physical Activity (APA) sessions - Nutritional status assessment - Physical/functional test assessment - Number of patients with reduced chemotherapy tolerance - Number of patients with chemotherapy dose modification - Rate of patients who complete the strategy - Number of patients with Granulocyte-colony stimulating factor (G-CSF) prescription and grade ≥ 2 neutropenia - Rate of patients with exocrine pancreatic insufficiency and the dose of pancreatic enzyme consumption - Rate of surgical complications - Overall survival (OS) assessment - Disease-free survival (DFS) assessment - Adherence to Adapted Physical Activity (APA) program assessment - Physical activity behavior changes assessment - Nurse coordination ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Specified Drug-use Survey of Leqvio for s.c. Injection. - NCT ID: NCT06275724 - Study ID: CKJX839A11401 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2027-12-31 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice ### Conditions - Familial Hypercholesterolaemia - Hypercholesterolaemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - inclisiran ### Outcomes Primary Outcomes - Number of patients with adverse events - Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions Secondary Outcomes - Number of patients with adverse events leading to discontinuation of treatment with the product - Percent change from baseline in LDL-C levels ### Location - Facility: Novartis Investigative Site, Handa, Aichi, 475-0817, Japan @@
## The Effect of Therapeutic Communication Methods on the Psychological State of Children - NCT ID: NCT06275711 - Study ID: 223K003 - Status: COMPLETED - Start Date: 2023-11-30 - Completion Date: 2023-12-06 - Lead Sponsor: Gazi University ### Study Description Earthquake is a disaster that causes physical, psychological, social, economic and cultural losses for individuals and affects/interrupts all age groups and normal life. Children are a group that is more affected by the earthquake than other members of the society and are exposed to its long-term effects. Children who have experienced earthquakes and continue to stay in the earthquake zone experience physical, economic, and social problems. In addition, the emotional and psychological development of these children is negatively affected.Due to the earthquake that occurred on 6 February 2023 affecting 11 provinces in our country, the needs in the field vary. After the acute period (first 1 month), children need psychological support. Problems that cannot be solved in the early period may cause health and behavioural problems in children in later ages and adulthood. In this context, approaching children with appropriate therapeutic communication methods positively affects their psychological well-being and directly affected physical resilience by enabling them to express their emotions.The aim of the study was to evaluate the effect of therapeutic communication programme on state and trait anxiety levels, psychological resilience, mental health and well-being of children aged 8-12 years affected by the earthquake.Hypotheses H1. After the therapeutic communication programme, children's State Anxiety Scale scores decrease.H2. After the therapeutic communication programme, children's Continuance Anxiety Scale scores decrease.H3. After the therapeutic communication programme, children's Me and My Emotions Scale scores decrease.H4. After the therapeutic communication programme, children's scores on the Child and Adolescent Psychological Resilience Scale increase. ### Conditions - Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Therapeutic communication methods ### Outcomes Primary Outcomes - State Anxiety Scale on Children - Trait Anxiety Scale on Children - Me and My Feelings Scale on Children - Child and Youth Resilience Measure Secondary Outcomes ### Location - Facility: K-1 Container City, Adıyaman, Altınsehir, 02040, Turkey @@
## HONEY for the Treatment of POst-Tonsillectomy Pain - NCT ID: NCT06275698 - Study ID: RD2023-14 HONEY-POT - Status: RECRUITING - Start Date: 2023-09-04 - Completion Date: 2025-09-04 - Lead Sponsor: East and North Hertfordshire NHS Trust ### Study Description Double-blind, randomised, placebo controlled, single-site trial in adults to compare the effect of Manuka honey with standard of care compared to placebo with standard of care on post-tonsillectomy pain and postoperative outcomes.Main aim is to investigate a potential improvement in post-tonsillectomy pain control, with a low cost and freely available alternative to conventional analgesics. Recent systematic review and multidisciplinary consensus suggest a potential role for the inclusion of honey for this purpose. Clinical efficacy over placebo remains to be conclusively demonstrated in robust clinical trials. ### Conditions - Post Surgical Pain - Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Manuka honey MGO 1000 - Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring ### Outcomes Primary Outcomes - VAS pain scores Secondary Outcomes - Number and frequency of concurrent analgesia usage - Rate of readmission to hospital - Rate of secondary haemorrhage - Rate of infection requiring antibiotics treatment - Speed of return to work ### Location - Facility: Lister Hospital, Stevenage, N/A, SG1 4AB, United Kingdom @@
## Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking - NCT ID: NCT06275685 - Study ID: CIP-0001510 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-06 - Lead Sponsor: Empatica, Inc. ### Study Description The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.The main questions it aims to answer are:* can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.* does this tool improve the lives of people with epilepsy?Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life. ### Conditions - Epilepsy; Seizure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - SeizureWise algorithm - Multi-day Visualizations ### Outcomes Primary Outcomes - Sensitivity of SeizureWise Secondary Outcomes - Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P) - Qualitative assessment of multi-day visualizations - Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8) - Modifiable behavior change - Accuracy of SeizureWise low-likelihood forecast - Accuracy of SeizureWise high-likelihood forecast ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Implementing an Education- and Health System Task-shifting Approach for Child Mental Health Promotion in Uganda - NCT ID: NCT06275672 - Study ID: TREAT INTERACT - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2025-12 - Lead Sponsor: Norwegian Center for Violence and Traumatic Stress Studies ### Study Description This study will adapt a school version (mhGAP-IGs) of the World Health Organization´s (WHO) "Mental Health Gap Action Programme Intervention Guide" (mhGAP). Both teachers and health workers will receive training in mhGAP, and systems for collaboration between the school and health sector as well as other relevant stakeholders will be developed and integrated. The project is conducted in close collaboration with key stakeholders from the Ministry, the health and education sector, the police, and religious leaders. The aim is to increase mental health literacy among school staff, facilitate a healthy school environment, and increase detection of mental health needs among primary school aged children. ### Conditions - Mental Health Issue - Stigma, Social - Child Development - Child Abuse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - Adapted version of the mhGAP-IG ### Outcomes Primary Outcomes - Reach questionnaire, developed by the project group - The Program Sustainability tool (Finch et al., 2013) - Service measure on access to mental health care, developed by the project group - Attitudes about Child Mental Health (Perceived Discrimination-Devaluation (Link et al., 1987) questionnaire - The dimensions of discipline inventory, school (DDI; Strauss & Faucher, 2007) - Treatment at home, developed by the project group, by inspiration from our siste project "TREAT C-AUD") Secondary Outcomes - The Implementation Quality Questionnaire (Bogen, 2020) - Fidelity Scale, developed by the project group - General Health Questionnaire (GHQ; Goldberg, 1970) - Attitudes on Gender Norms (Waszak et al., 2000) questionnaire - Help-seeking behaviour, developed by the project group after inspiration from Yifeng et al., 2022 - Pediatric Symptom Checklist (PSC-17; Jellinek et al., 1998) - Teacher Support Scale (TSS; Metheny, McWhirter, & O'Neil, 2008) - Teacher violence scale (Piskin et al, 2014) - The dimensions of discipline inventory, home (DDI; Strauss & Faucher, 2007) - The Implementation Leadership Scale (Aarons, Ehrhart, et al., 2014) - Organizational Readiness for Implementing Change (Shea et al., 2014) - Teacher concerns about child mental health, developed by the project group, after inspiration from Yifeng et al., 2022 - Provider Report of Sustainment Scale (PRESS) (Moullin et al., 2021) (PRESS): development and validation (PRESS; Moullin et al., 2021) - Mental health knowledge (Evans-Lacko et al., - AUDIT scale (WHO) - Child alcohol use, developed by the project group - Child mental health - Pediatric symptoms (Jelinek et al.) - Perceived teacher support and its influence on adolescent career development (Metheny et al., 2008) - Sexual violence, developed by the project group - Dimensions of discipline inventory (DDI; Straus and Fauchier, 2007) ### Location - Facility: Nowegian Center for Violence and Traumatic Stress Studies, Oslo, N/A, 0655, Norway @@
## An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis - NCT ID: NCT06275659 - Study ID: CT-100-D-003 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-04 - Completion Date: 2024-03-18 - Lead Sponsor: Click Therapeutics, Inc. ### Study Description CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components.DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health. ### Conditions - Psoriasis - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - CT-100-004-A - CT-100-004-B ### Outcomes Primary Outcomes - Change in Peak Pruritus Numerical Rating Scale - Change in Dermatology Life Quality Index - Change in Quality of Life symptoms - Time in App - Experience with Study App - Improved global rating of change Secondary Outcomes - Frequency of Adverse Events - Severity of Adverse Events - Frequency of Serious Adverse Events - Severity of Serious Adverse Events ### Location - Facility: Click Therapeutics, New York, New York, 10013, United States @@
## Comparison Of Outcome Of Different Layers in Hypospadias Surgery - NCT ID: NCT06275646 - Study ID: Adeel2 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-04-01 - Lead Sponsor: Children Hospital and Institute of Child Health, Lahore ### Study Description To compare the outcome of applying autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery. A total of 220 patients fulfilling the selection criteria were admitted after taking informed consent. Cases were randomly divided into groups A and B using a random generator of the Excel program. In group A, dartos flap and PRP sheet layer were applied and in group B, only a preputial dartos fascial flap was applied ### Conditions - Hypospadias ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PRP layer - dartos flap ### Outcomes Primary Outcomes - wound infectiom - frequency of glans dehiscence - frequency of meatal stenosis Secondary Outcomes ### Location - Facility: The Children Hospital, Lahore, Punjab, 42000, Pakistan @@