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## Subvastus vs. Medial Parapatellar Approaches in Total Knee Arthroplasty With Quadriceps Muscle Elastography - NCT ID: NCT06297746 - Study ID: am7mi3VB - Status: COMPLETED - Start Date: 2023-07-10 - Completion Date: 2023-12-01 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description ABSTRACTINTRODUCTIONKnee osteoarthritis is a common joint pathology causing joint pain and ambulatory limitations. In primary total knee arthroplasty (TKA) surgeries, medial parapatellar (MP) and subvastus (SV) approaches are frequently used. The MP approach provides good exposure and is more widely used. In the SV approach, the vastus medialis muscle is preserved. Some argue that the extensor mechanism may heal earlier with the SV approach. In this study, unlike previous studies, the investigators aimed to quantitatively compare the early outcomes of MP and SV approaches, through shear wave elastography (SWE) measurements isolated over the vastus medialis and vastus lateralis muscles.MATERIALS AND METHODSThe study included 20 patients with indications for TKA due to primary osteoarthritis, divided into MP and SV groups. SWE measurements of the vastus medialis and vastus lateralis muscles were performed preoperatively and at 3-month follow-up. Clinical scores (Knee Society Score and WOMAC) and straight leg raising time were recorded both preoperatively and postoperatively. ### Conditions - Total Knee Arthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Subvastus approach - Medial Parapatellar approach ### Outcomes Primary Outcomes - Shear wave values Secondary Outcomes ### Location - Facility: Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Fatih, 34098, Turkey @@
## Turkish Adaptation, Validity and Reliability of the Approaches and Study Skills Inventory in Physiotherapy Students - NCT ID: NCT06297733 - Study ID: IstanbulBUFC3 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-01 - Lead Sponsor: Istanbul Bilgi University ### Study Description The quality and quantity of learning are determined by the learning approach adopted by the student. When learning and studying approaches are mentioned, individual differences between learners' learning intentions during a learning situation or while studying and what types of strategies are used to achieve these intentions come to mind. These learning approaches are thought to determine the quality of learning outcomes. Many measurement tools have been developed to quantitatively measure learning and studying approaches. These developed tools are mostly applied at the higher education level. Among the purposes of using measurement tools; These include identifying low-performing students through screening, evaluating and identifying areas of difficulty that require prediction or improvement plans, evaluating before and after academic improvement programs, and raising awareness and advising students on their academic strengths and weaknesses.When multidimensional measurement tools that evaluate students' study approaches and skills are examined, it is seen that the use of the Approaches and Study Skills Inventory for Students (ASSIST) tool has become widespread in recent years. This vehicle; It has been reported that it measures learning strategies and skills for different students and is sensitive enough to distinguish between learning types.The Portuguese, Norwegian and Danish versions of the survey, which was developed in English and intended to be translated into Turkish as the Study Skills and Approaches Scale, have also been translated, its psychometric properties have been demonstrated and it has been observed that it is becoming widespread in the literature. ### Conditions - Health Education ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Translating the Questionnaire into Turkish and Related Processes - Validity - Reliability ### Outcomes Primary Outcomes - Approaches and Study Skills Inventory for Students - Participant Information Form Secondary Outcomes ### Location - Facility: Marmara University, Istanbul, N/A, 34854, Turkey @@
## Early Oral Hydration After Thoracoscopic Surgery - NCT ID: NCT06297720 - Study ID: 2401110013 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-30 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description The goal of this clinical trial is to learn about the safety and feasibility of early oral hydration in patients receiving video-assisted thoracoscopic surgery after general anesthesia. The main questions aims to answer:* the safety and feasibility of oral hydration supplementation in the recovery room following general anesthesia.* the degree of improvement in sore throat and dry mouth after oral hydration.* the side effects and risks of oral hydration supplementation, such as the incidence of postoperative nausea and vomiting.* the impact of oral hydration supplementation in the recovery room following general anesthesia on hemodynamics.* patient satisfaction with oral hydration supplementation in the recovery room following general anesthesia.Participants will receive a series of oral hydration from swab moistening, and ice cube hydration to water hydration in the recovery room. Researchers will compare with the standard, no-hydration group to see if it is safe and feasible to hydrate patients in the recovery room. ### Conditions - Anesthesia - Intubation Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oral hydration ### Outcomes Primary Outcomes - sore throat level by VAS (Visual Analogue Scale) - Mouth dryness Secondary Outcomes - post-operative nausea and vomiting (PONV) - timing of post-operative nausea and vomiting (PONV) - duration of post-operative nausea and vomiting (PONV) - management of post-operative nausea and vomiting (PONV) - Heart Rate in PACU (Postanesthesia Care Unit) - Blood pressure in PACU (Postanesthesia Care Unit) - Patient's satisfaction ### Location - Facility: ChangGung MH, Taoyuan, N/A, 33380, Taiwan @@
## Effect of Aquatic High Intensity Resistive Training on Patients With Chronic Heart Failure - NCT ID: NCT06297707 - Study ID: P.T.REC/012/005044 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-12-30 - Lead Sponsor: Cairo University ### Study Description PURPOSE:to evaluate effect of aquatic high intensity resistive training on cardiac function and exercise capacity in patients with chronic heart failure.BACKGROUND:Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of \>37.7 million individuals globally. HF is a shared chronic phase of cardiac functional impairment secondary to many etiologies, and patients with HF experience numerous symptoms that affect their quality of life, including dyspnea, fatigue, poor exercise tolerance, and fluid retention. ### Conditions - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - aquatic high intensity resistive training - usual care ### Outcomes Primary Outcomes - Cardiac function Secondary Outcomes - exercise capacity - physical symptoms of heart failure ### Location - Facility: Faculty of Physical Therapy, Cairo, Dokki, 11432, Egypt @@
## Clinical Interpretation and Cutoff Scores for ABILHAND Questionnaire in Rheumatoid Arthritis - NCT ID: NCT06297694 - Study ID: PamukkaleU. - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-07 - Lead Sponsor: Pamukkale University ### Study Description In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis. ### Conditions - Rheumatoid Arthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Disease Activity Score (DAS 28) - Nine hole peg test - Hand grip strength Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease - NCT ID: NCT06297681 - Study ID: 2023-1-27-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-12-31 - Lead Sponsor: Beijing Chao Yang Hospital ### Study Description It is expected to include 40 patients with M-protein related cardiac disease. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min). ### Conditions - M-protein Related Cardiac Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Daratumumab + Bortezomib + Dexamethasone + Dapagliflozin ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - 2-year PFS rate, progression free survival (PFS) - 2-year OS rate, overall survival (OS) - Duration of Relief (DOR) - Next treatment time (TTNT) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C). - NCT ID: NCT06297668 - Study ID: D5985C00008 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2024-06-13 - Lead Sponsor: AstraZeneca ### Study Description This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer. ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Treatment A: BGF MDI HFA - Treatment B: BGF MDI HFO - Treatment C: BGF MDI HFO - AeroChamber Plus Flow-Vu spacer ### Outcomes Primary Outcomes - Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI - Maximum Observed Concentration (Cmax) of BGF MDI Secondary Outcomes - Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) - Maximum Observed Concentration (Cmax) - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) - Time to Reach Maximum Observed Concentration (tmax) - Terminal Rate Constant (λz) - Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz) - Mean Residence Time of the Unchanged Drug in the Systemic Circulation from Zero to Infinity (MRTinf) - Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) - Apparent Volume of Distribution at Steady State Following Extravascular Administration (Vz/F) - Number of Participants with Adverse Events ### Location - Facility: Research Site, Berlin, N/A, 14050, Germany @@
## A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A - NCT ID: NCT06297655 - Study ID: TQG202-III-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. ### Study Description This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of on-demand treatment in the event of new bleeding events. If evaluable surgical cases occur, the overall efficacy and safety of recombinant human coagulation factor VIII for injection as a replacement therapy for severe hemophilia A PTPs during the perioperative period will be evaluated. ### Conditions - Hemophilia A ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Recombinant human activated coagulation factor VIII for injection ### Outcomes Primary Outcomes - The proportion of on-demand treatment improvement for newly occurring bleeding events - Activity recovery Secondary Outcomes - The proportion of effective surgical hemostasis - Annualized bleeding rate (ABR) - The incidence of Less Han Expected Thermal Effect - The injection times of recombinant human coagulation factor VIII - The dosage of recombinant human coagulation factor VIII - Changes of Haemophilia Joint Health Score before and after on-demand treatment - Changes of Quality of Life Assessment before and after on-demand treatment ### Location - Facility: Anhui Provincial Hospital, Hefei, Anhui, 230002, China @@
## TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors. - NCT ID: NCT06297642 - Study ID: TQB2928-AK105-Ib-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-03 - Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Study Description This study will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors. ### Conditions - Advanced Malignant Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TQB2928 injection - Penpulimab ### Outcomes Primary Outcomes - Dose limiting toxicity (DLT) - Adverse event rate Secondary Outcomes - Objective response rate (ORR) - Complete response rate (CRR) - Disease Control Rate - Duration of Response - Progression-free Survival - Overall survival (OS) - Incidence of Anti-Drug antibody - Incidence of neutralizing antibodies - Peak time (Tmax) - Peak concentration (Cmax) - The area under the plasma concentration time curve from zero to after 24h (AUC0-24h) - Steady-state apparent volume of distribution (Vz/F) - Minimum plasma concentration at steady state (Cmin,ss) - Receptor Occupancy (RO%) ### Location - Facility: Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing, 100021, China @@
## A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation - NCT ID: NCT06297629 - Study ID: 2021-0636 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2026-08-31 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant. ### Conditions - Allogeneic Stem Cell Transplantation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ASTX727 - Donor Lymphocyte Infusion ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## A Study of LY3841136 in Japanese Participants With Obesity or Overweight - NCT ID: NCT06297616 - Study ID: 18814 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-10-12 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to learn about the side effects of LY3841136 when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last about 28 weeks and may include up to 17 visits. ### Conditions - Obesity - Overweight ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LY3841136 - Placebo ### Outcomes Primary Outcomes - Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration Secondary Outcomes - Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136 - PK: Maximum Observed Concentration (Cmax) of LY3841136 - Pharmacodynamics (PD): Change From Baseline in Body Weight ### Location - Facility: Sumida Hospital, Sumida-ku, Tokyo, 130-0004, Japan @@
## Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3) - NCT ID: NCT06297603 - Study ID: 18806 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-10-09 - Lead Sponsor: Eli Lilly and Company ### Study Description The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Retatrutide - Placebo ### Outcomes Primary Outcomes - Change from Baseline in Hemoglobin A1c (HbA1c) (%) Secondary Outcomes - Percentage of Participants Achieving HbA1c <7.0% - Percentage of Participants Achieving HbA1c ≤6.5% - Change from Baseline in Fasting Serum Glucose - Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL - Percent Change from Baseline in Body Weight - Change from Baseline in Body Weight - Percentage of Participants Achieving Weight Reduction of ≥5% - Percentage of Participants Achieving Weight Reduction of ≥10% - Percentage of Participants Achieving Weight Reduction of ≥15% - Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction - Percent Change from Baseline in Non-HDL Cholesterol - Percent Change from Baseline in Triglycerides - Change from Baseline in Systolic Blood Pressure (SBP) ### Location - Facility: Clinical Research Institute of Arizona (CRI) - Sun City West, Sun City West, Arizona, 85375, United States @@
## A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease - NCT ID: NCT06297590 - Study ID: 18795 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-02 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.The study will be comprised of two parts, A and B. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid.The study will last up to approximately 69 weeks for Part A, and, if conducted, 73 weeks for Part B. If conducted, the optional bridging period for Part A participants would last up to approximately 1 year after their completion of Part A.If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 120 weeks. ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - LY3954068 - Placebo - Flortaucipir F18 ### Outcomes Primary Outcomes - Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration - Part B: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration Secondary Outcomes - Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) - Optional Part B: PK: Cmax - Part A: PK: Area Under the Concentration Versus Time Curve (AUC) - Optional Part B: PK: AUC - Part A: PK: Cerebrospinal Fluid (CSF) concentration of LY3954068 - Optional Part B: PK: CSF concentration of LY3954068 - Part A: Pharmacodynamics (PD): Change from Baseline of CSF tau - Optional Part B: PD: Change from Baseline of CSF tau ### Location - Facility: K2 Medical Research LLC, Maitland, Florida, 32751, United States @@
## Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients - NCT ID: NCT06297577 - Study ID: MASH2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-09-30 - Lead Sponsor: Cairo University ### Study Description Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST. ### Conditions - Intrabony Periodontal Defect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST) - Platelet Rich Fibrin (PRF) combined with minimally invasive surgical technique (MIST) ### Outcomes Primary Outcomes - Clinical attachment level (CAL) Secondary Outcomes - Probing Depth (PD) - Radiographic Linear Defect Depth (RLDD) - Recession Depth (RD) - Post-operative Pain - Radiographic defect fill (RDF) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Assisted Reproductive Treatments - NCT ID: NCT06297564 - Study ID: 07/3/9-2023/4 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2024-01-01 - Lead Sponsor: New Valley University ### Study Description The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments. ### Conditions - Progesterone Primed Endometrial Protocol - Gonadotropin Releasing Hormone Antagonist Protocol - Assisted Reproductive Treatments ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Progesterone primed endometrial protocol - Gonadotropin-releasing hormone antagonist protocol ### Outcomes Primary Outcomes - The number of retrieved oocytes Secondary Outcomes - Pregnancy rate ### Location - Facility: New Valley University, New Valley, N/A, 72511, Egypt @@
## Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA) - NCT ID: NCT06297551 - Study ID: SBU-AML-LSC - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-05-31 - Lead Sponsor: Suhu Liu ### Study Description Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved. Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming. The research we are proposing here is to investigate whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. Our retrospective study have found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment. This pilot study will allow us to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Quantification of blood cells positive for CLL1 and CD45RA surface markers by flow cytometry ### Outcomes Primary Outcomes - Concordance between the relative fraction of Leukemia Stem Cells (LSC) vs Hematopoietic Stem Cells (HSC) and treatment response Secondary Outcomes ### Location - Facility: Stony Brook Cancer Center, Stony Brook, New York, 11794, United States @@
## Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation - NCT ID: NCT06297538 - Study ID: GR-2021-12372323 - Status: RECRUITING - Start Date: 2023-04-29 - Completion Date: 2026-04-29 - Lead Sponsor: Neuromed IRCCS ### Study Description Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - gamma transcranial alternating current stimulation (tACS) - sham transcranial alternating current stimulation (tACS) ### Outcomes Primary Outcomes - Changes in bradykinesia features as objectively assessed by kinematic techniques - Changes in motor learning performance as objectively assessed by kinematic techniques Secondary Outcomes ### Location - Facility: IRCCS Neuromed, Pozzilli, N/A, N/A, Italy @@
## Study of STP938 in Advanced Solid Tumours - NCT ID: NCT06297525 - Study ID: STP938-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-05 - Lead Sponsor: Step Pharma, SAS ### Study Description The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy.The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - STP938 ### Outcomes Primary Outcomes - Safety and Tolerability Secondary Outcomes - Area under the curve (AUC) of STP938 - Maximum plasma concentration (Cmax) - Time to reach maximum concentration (TMax) - Evaluation of preliminary clinical activity of STP938 - Evaluation of best overall response of STP938 - Evaluation of Duration of Response - Evaluation of Progression Free Survival - Change in serum CA125 (ovarian cancer only) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM). - NCT ID: NCT06297512 - Study ID: pGBM-WBRT/DOX2020 - Status: RECRUITING - Start Date: 2022-12-09 - Completion Date: 2028-03-09 - Lead Sponsor: Iacopo Sardi ### Study Description Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB ### Conditions - Glioblastoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radiotherapy, Temozolomide, Doxorubicin ### Outcomes Primary Outcomes - Evaluation prolonged Dox - Percentage of Withdrawal from the study rate - Percentage of SAEs - Mortality rate - Early discontinuation of dox treatment rate Secondary Outcomes - Event-free survival (EFS), disease progression (PFS), and overall survival (OS) ### Location - Facility: Meyer Children's Hospital IRCCS, Florence, N/A, N/A, Italy @@
## Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section - NCT ID: NCT06297499 - Study ID: IRB-22-07-4803 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12-01 - Lead Sponsor: Wayne State University ### Study Description Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration. ### Conditions - Pruritus Caused by Drug ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ondansetron 8mg ### Outcomes Primary Outcomes - Pruritus parameters in Post anesthesia Care Unit (PACU) - Pruritus severity in Post anesthesia Care Unit (PACU) - Pruritus parameters PACU - Pruritus severity PACU - Rescue Pruritus Treatment medication - Nausea PACU - Nausea Post PACU Secondary Outcomes - Post-operative Pain ### Location - Facility: Detroit Medical Center- Hutzel Women's Hospital, Detroit, Michigan, 48201, United States @@
## Study of a Gene Therapy Treatment for Hemophilia A - NCT ID: NCT06297486 - Study ID: SPK-8011-302 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2035-09-04 - Lead Sponsor: Spark Therapeutics, Inc. ### Study Description The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis. ### Conditions - Hemophilia A ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SPK-8011 ### Outcomes Primary Outcomes - Annualized Bleed Rate (ABR) for All Bleeds [Cohort A] Secondary Outcomes - Median FVIII: C levels [Cohort A] - ABR for treated bleeds [Cohort A] - Percentage of Participants with ABR=0 for all bleeds; treated bleeds; treated spontaneous bleeds; and treated joint and target joint bleeds [Cohort A] - ABR for treated spontaneous, joint, and target joint bleeds [Cohort A] - Annualized FVIII dosage [Cohort A] - Proportion of Resolved Target Joints [Cohort A] - Mean Change of Total Hemophilia Joint Health Score [Cohort A] - FVIII:C levels over time [Cohort A] - Mean ABR for all bleeds and treated bleeds [Cohort C] - FVIII: C levels over time from Week 26 [Cohort C] - Proportion of Participants Who Receive IV Methylprednisolone (IVMP) Prior to Week 8 (Early IVMP) [Cohorts A, B, C] - Proportion of Participants Who Receive Secondary Oral Immunomodulation [Cohorts A, B, C] - Median Time to First Immunomodulation-related Corticosteroid Dose [Cohorts A, B, C] - Median Duration of Secondary Oral Immunomodulation [Cohorts A, B, C] - Proportion of Participants with FVIII Inhibitor Development [Cohorts A, B, C] - Proportion of participants with Treatment-related AEs of ALT Elevation [Cohorts A, B, C] - Proportion of participants with treatment-related AEs of Infusion Reaction [Cohorts A, B, C] - Number of participants with abnormal physical exam findings, abnormal vital signs, and abnormal selected clinical laboratory test results [Cohorts A, B, C] - Proportion of participants with AEs and SAEs [Cohorts A, B, C] - Proportion of participants with AESIs [Cohorts A, B, C] ### Location - Facility: Orthopaedic Institute for Children/Orthopaedic Hemophilia Treatment Center, Los Angeles, California, 90007, United States @@
## Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors. - NCT ID: NCT06297473 - Study ID: SJ-1050 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-08-01 - Lead Sponsor: Zealand University Hospital ### Study Description The primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated assessment of pituitary function and imaging in patients with small pituitary tumors (microadenomas). ### Conditions - Non-Functional Pituitary Adenoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Telephone-/video follow-up - In-person follow-up ### Outcomes Primary Outcomes - Composite outcome of adverse events Secondary Outcomes - Thyroid replacement therapy - Growth hormone replacement therapy - Desmopressin replacement therapy - Hormonal replacement therapy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Adaptation of STEPPS Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers - NCT ID: NCT06297460 - Study ID: STEPPSPENITENTIARY - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-01-01 - Completion Date: 2025-12-01 - Lead Sponsor: Universitat Jaume I ### Study Description The overall objective of this study is to assess the feasibility, within the Penitentiary Centers of Catalonia, of adapting the STEPPS program for addressing and preventing emotional dysregulation and self-harming behaviors through an implementation study. ### Conditions - Self Harm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Systems Training for Emotional Predictability & Problem Solving (STEPPS) ### Outcomes Primary Outcomes - Level of emotional and behavioral disregulation of patients Secondary Outcomes - Type and levels of impulsivity of patients - Suicide risk of patients - Self-injury frequency, typology and funcionality of patients - Degree of hopeless of patients - Perceived level of feasibility by professionals - Perceived level of acceptability of the intervention by professionals - Satisfaction of the intervention by patients - Perceived level of adequacy by professionals - Barriers and facilitators detected by professionals that are influencing the implementation process - Quantitative information - Level of burnout of professionals ### Location - Facility: Rosa, Castellón De La Plana, Castellón, 12071, Spain @@
## Keeping it Simple Study (KISS) - NCT ID: NCT06297447 - Study ID: N-20230073 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2026-12 - Lead Sponsor: Bettina Eiger ### Study Description Problem: The number of patients living with chronic musculoskeletal (MSK) pain has steadily increased over the past decade with costs rising equally. Long-standing pain is associated with significant maladaptive beliefs about pain, psychological characteristics and associated behaviors which involve structural and functional neurobiological characteristics which share common pathophysiological mechanisms as chronic pain. The investigators recent priority setting partnership investigated the research priorities from 1000 patients with chronic MSK pain, relatives, and clinicians. Better pain education was rated as one of the three most important research areas.Solution: Pain science education has the potential to target maladaptive psychological and behavioral components that may contribute to the maintenance of chronic pain. The KISS project will evaluate the effect of a pain neuroscience education program (PNE4Adults) on rehabilitation outcomes in patients with chronic MSK pain. This intervention has the potential to change beliefs and behaviors surrounding pain in patients with chronic MSK pain. If this is successful in disrupting maladaptive cycles contributing to chronicity, this may improve outcomes for many thousand citizens. ### Conditions - Musculoskeletal Pain - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PNE4Adults - pain science education - Usual care ### Outcomes Primary Outcomes - Musculoskeletal Health Questionnaire (MSK-HQ) Secondary Outcomes - Mean Pain intensity - Pain interference - Concept of pain - Pain catastrophizing - Fear of movement - Patient specific functional limitation - Patient impression of change - Patient satisfaction with current symptom state - Pain Self-efficacy - Adverse events ### Location - Facility: Træningsenheden, Holbæk Municipality, Holbæk, Region Sjælland, 4300, Denmark @@
## Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH - NCT ID: NCT06297434 - Study ID: JH-221-201 - Status: RECRUITING - Start Date: 2023-02-15 - Completion Date: 2025-01-01 - Lead Sponsor: J2H Biotech ### Study Description The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH. ### Conditions - Non-alcoholic Steatohepatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - J2H-1702 - J2H-1702 - J2H-1702 - Placebo ### Outcomes Primary Outcomes - Changes from baseline in results on MRI-PDFF at week12. - Changes from baseline in results on MRE at week12. Secondary Outcomes ### Location - Facility: J2H Biotech, Suwon, Gyeonggi-do, 16684, Korea, Republic of @@
## Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young Adults - NCT ID: NCT06297421 - Study ID: SZYY20240229IBS-D - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2026-06 - Lead Sponsor: Shenzhen Hospital of Southern Medical University ### Study Description The purpose of this study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults. ### Conditions - Irritable Bowel Syndrome With Diarrhea - Fecal Microbiota Transplantation - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fecal Microbiota Transplantation - Placebo ### Outcomes Primary Outcomes - Percentage of Patients Who Were Composite Weekly Responders - Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0 Secondary Outcomes - Percentage of Patients Who Were Composite Weekly Responders - Percentage of Patients Who Were Abdominal Pain Weekly Responder - Percentage of Patients Who Were Stool Consistency Weekly Responder - Percentage of Patients Who Were Abdominal Bloating Weekly Responder - Percentage of Participants Who Were Responders in IBS Symptoms Relief Scale - Change from Baseline in the Weekly Average of Worst Abdominal Pain in the Past 24 hours - Change from Baseline in the Number of Days per Week with at Least One Stool with Consistency of Type 6 or 7 - Change from Baseline in the Number of Stools of Type 6 or 7 per Week - Change from Baseline in the Weekly Average of Worst Abdominal Bloating in the Past 24 Hours Score - Change from baseline in Irritable Bowel Syndrome Severity Scale (IBS-SSS) Scores - Change from baseline in Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL) Total Scores ### Location - Facility: Shenzhen Hospital of Southern Medical University, Shenzhen, Guangdong, 518000, China @@
## Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus - NCT ID: NCT06297408 - Study ID: JWCAR029115 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-05 - Lead Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd. ### Study Description To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China. ### Conditions - Systemic Lupus Erythematosus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Relma-cel ### Outcomes Primary Outcomes - DLT rate - determine RP2D Secondary Outcomes - SELENA-SLEDAI - BILAG -2004 - PGA (physician global assessment) score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Subaxial Cervical Traumatic Injuries - NCT ID: NCT06297395 - Study ID: Cervical Traumatic Inj - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Assiut University ### Study Description The aim of this study is to assess the mid-term outcomes of treating subaxial cervical traumatic injury cases admitted to the Trauma Unit of Assiut University Hospital. ### Conditions - Cervical Injury Spine ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Percentage of improvement Secondary Outcomes - Patient Outcomes - Complication - rehabilitation - Complication - rehabilitation - Complication - Complication - Complication ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of ChatGPT-based Nursing Process Training - NCT ID: NCT06297382 - Study ID: SBU-HEM-PSI-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-06 - Completion Date: 2025-04-25 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description The goal of this randomized controlled study is to determine the impact of ChatGPT based nursing process training on nursing students' clinical decision-making competencies and artificial intelligence anxiety.Population and Sample: The population of the research consists of senior students studying at Gülhane Faculty of Nursing, University of Health Sciences. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G\Power 3.1 program. In a similar study in the relevant literature, the effect size regarding the change in clinical decision-making level was calculated as 0.898. In order to exceed the 99% value in determining the power of the study; At the 5% significance level and 0.898 effect size, 44 people, 22 people in the groups, need to be reached (df=21; t=1.721). In the research, it was aimed to reach a total of 60 people, 30 people in the groups, considering the high power of the test and the losses. ### Conditions - Nurse-Patient Relations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - ChatGPT Based Nursing Process Training ### Outcomes Primary Outcomes* - Descriptive Information Form - Clinical Decision Making Scale in Nursing - rtificial Intelligence Anxiety Scale: Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients - NCT ID: NCT06297369 - Study ID: RHDIRB2020110301 REC #250 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-08-01 - Lead Sponsor: Ain Shams University ### Study Description Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients ### Conditions - Cisplatin Adverse Reaction - Cisplatin Nephrotoxicity - Cisplatin Induced Peripheral Neuropathy - Cancer Patients - Cisplatin Ototoxicity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - N acetyl cysteine ### Outcomes Primary Outcomes - The occurrence of cisplatin-induced ototoxicity in the form of hearing loss. Secondary Outcomes - The occurrence of cisplatin-induced nephrotoxicity. - The occurrence of cisplatin-induced peripheral neuropathy. - The occurrence of cisplatin-induced peripheral neuropathy. - The occurrence of cisplatin-induced peripheral neuropathy. ### Location - Facility: Department of Clinical Oncology and Nuclear Medicine, Ain Shams University Hospitals, Cairo, Egypt., Cairo, N/A, N/A, Egypt @@
## The Effect of Stress Ball Utilisation on Treatment Duration, Dyspnea Severity and Anxiety Level in Nebuliser Therapy - NCT ID: NCT06297356 - Study ID: YCEYHAN - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-04-01 - Lead Sponsor: Kirsehir Ahi Evran Universitesi ### Study Description Nebul Therapy is very effective in quickly improving the symptoms of respiratory system diseases. While applying this treatment, patients are expected to complete a sufficient period of time. However, this waiting and the symptoms of the disease may cause anxiety in the patient.The aim of the study was to enable patients to spend their nebul period actively by using a stress ball. Thus, it was thought that it would make a positive contribution to dyspnea severity and anxiety levels.The main questions it aims to answer are:Does using a stress ball contribute positively to nebulizer usage time? Is the use of a stress ball effective in reducing the severity of dyspnea? Is using a stress ball effective in reducing anxiety levels?For this purpose, participants will be asked to tighten and loosen the stress ball with one hand during the nebuliser therapy.They will be expected to continue this with at least two nebuliser therapy per day. A control group will be used to determine the effectiveness of the stress ball. This group will not use a stress ball while receiving nebulizer treatment. ### Conditions - Inhalation Therapy; Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Stress ball ### Outcomes Primary Outcomes - dyspnea severity - anxiety levels - treatment duration Secondary Outcomes - Vital signs: Respiratory rate - Vital signs: Pulse - Vital signs: Blood pressure - saturation ### Location - Facility: Yasemin CEYHAN, Kırşehir, Center, 40100, Turkey @@
## Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula - NCT ID: NCT06297343 - Study ID: 2023-A02491-44 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-03 - Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche ### Study Description The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation. ### Conditions - Renal Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Creation of an arteriovenous fistula ### Outcomes Primary Outcomes - Occurrence of ischaemia of the hand Secondary Outcomes ### Location - Facility: Hôpital Privé des Peupliers, Paris, N/A, 75013, France @@
## Sleep for Optimal MEdical StudentS (PROMESS) - NCT ID: NCT06297330 - Study ID: PROMESS - SLEEP - Status: RECRUITING - Start Date: 2023-11-11 - Completion Date: 2024-09-30 - Lead Sponsor: Research on Healthcare Performance Lab U1290 ### Study Description Medical students have been shown to have a greater prevalence of poor sleep leading to poorer quality of life than other groups of students. Among medical students, poor sleep quality and insomnia have been associated with higher level of stress, as well as poorer academic performance. Our field surveys carried out in 2022 and 2023 at the Lyon Est medical school make the same alarming observation. They revealed that 53% of students had significant sleep problems.They also showed that students presented high levels of physical and mental fatigue. It is expected that these disorders will significantly degrade their quality of life as well as their health. Indeed, lack of sleep is associated with serious health problems such as illnesses cardiovascular or immune system deficiencies.The PROMESS - SLEEP project aims to offer solutions to students to improve their sleep during their medical studies. It responds to a demand expressed by students: our field study showed that 40% of 4th year students declared being "very interested and/or interested" in following an intervention that aimed at improving sleep. An early knowledge of sleep optimization tools would allow students to quickly acquire the tools necessary to cope with the difficult conditions encountered during their training and lives of future doctors.The objective of this study is to determine the influence of an intervention program based on sleep improvement and fatigue reduction among medical students. ### Conditions - Health Behavior - Health-Related Behavior - Sleep - Sleep Disorder - Fatigue ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Sleep ### Outcomes Primary Outcomes - Perceived level of sleep troubles. Evolution of the score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI). Secondary Outcomes - Perceived level of sleep troubles. Score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI). - Epworth Sleepiness scale. Score obtained at the Epworth Sleepiness scale. - Multidimensional Fatigue. Score obtained at the Multidimensional Fatigue Inventory (MFI). - Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS). - Actimetry records. Time in Bed during the pre-intervention. - Actimetry records. Total sleep duration during the pre-intervention. - Actimetry records. Sleep efficiency during the pre-intervention. - Actimetry records. Sleep Onset Latency during the pre-intervention. - Actimetry records. Wake after Sleep Onset during the pre-intervention. - Actimetry records. Number of Awakenings during the pre-intervention. - Actimetry records. Bedtime during the pre-intervention. - Actimetry records. Mid-sleep point during the pre-intervention. - Actimetry records. Sleep Onset time during the pre-intervention. - Actimetry records. Sleep Inertia during the pre-intervention. - Actimetry records. Wake-up time during the pre-intervention. - Actimetry records. Sleep regularity index during the pre-intervention. - Multidimensional Fatigue. Evolution of the score obtained at the Multidimensional Fatigue Inventory (MFI) during the intervention. - Actimetry records. Evolution in Time in Bed during the intervention. - Actimetry records. Evolution in Total sleep duration during the intervention. - Actimetry records. Evolution in Sleep efficiency during the intervention. - Actimetry records. Evolution in Sleep Onset Latency during the intervention. - Actimetry records. Evolution in Wake after Sleep Onset during the intervention. - Actimetry records. Evolution in Number of Awakenings during the intervention. - Actimetry records. Evolution in Mid-sleep point during the intervention. - Actimetry records. Evolution in Bed time during the intervention. - Actimetry records. Evolution in Sleep Onset Time during the intervention. - Actimetry records. Evolution in Sleep Inertia during the intervention. - Actimetry records. Evolution in Wake-up Time during the intervention. - Actimetry records. Evolution in Sleep regularity index during the intervention. - VAS - sleep quantity: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep. - VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality. - VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue. - Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert. - Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set. - Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention. - Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5. - Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress. - Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention. ### Location - Facility: RESHAPE, Lyon, N/A, 69008, France @@
## Longitudinal Changes in Achilles Tendon and Medial Gastrocnemius Muscle Architecture During a 156-km Ultradistance Trail Running Event - NCT ID: NCT06297317 - Study ID: Trailstiff - Status: COMPLETED - Start Date: 2021-11-11 - Completion Date: 2024-02-01 - Lead Sponsor: University Hospital, Caen ### Study Description This study aimed to assess the longitudinal changes in triceps surae muscle-tendon architecture to an ultra distance trail running. Experienced trail runners (N=55, 78% men, age: 45.2 \[13.5\] years) participated in a 156-km trail run (6000m climbing) consisting in six 26-km laps. The resting architectural properties of triceps surae muscle-tendon were measured using ultrasound imaging for Achille tendon cross-sectional area (AT CSA), medial gastrocnemius muscle pennation angle, thickness, length and fiber length. Measurements were performed the day before the race (Baseline), at 52-km (T1), at 104-km (T2), at 156-km (T3) and 12 hours after the race (H12). ### Conditions - Achilles Tendinopathy - Calf Injury - Sport Injury - Lower Limb Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound measurement of triceps surae muscle-tendon architecture ### Outcomes Primary Outcomes - Achille tendon cross sectional area - Medial gastrocnemius thickness - Medial gastrocnemius pennation angle - Medial gastrocnemius fascicle length - Medial gastrocnemius muscle length Secondary Outcomes - Finisher status - Average speed ### Location - Facility: CHU Caen Normandie, Caen, N/A, 14000, France @@
## Sedentary Behaviors Reduction and Physical Activity Promotion for Optimal Medical StudentS - NCT ID: NCT06297304 - Study ID: PROMESS - PHYSICAL ACTIVITY - Status: RECRUITING - Start Date: 2023-11-11 - Completion Date: 2024-09-30 - Lead Sponsor: Research on Healthcare Performance Lab U1290 ### Study Description Medical students are under great competitive pressure throughout their studies. Our field surveys conducted in 2022 and 2023 at the Lyon Est Faculty of Medicine revealed that 78% of 482 students showed an excessive sedentary lifestyle compared to the threshold set by WHO. It is expected that a low level of physical activity and/or too high a sedentary lifestyle deteriorates significantly their quality of life and their health. In 2014, a British survey of 356 students in Medicine showed that lack of physical activity was an major predictor of burnout symptoms. Numerous studies show that regular physical activity improves the mental health of students and their cognitive performance.The PROMESS - PHYSICAL ACTIVITY project aims to offer solutions to students to decrease their sedentary behavior and to improve their physical activity level during their medical studies through an intervention program. From a long term perspective, this intervention may also prevent disorders related to inadequate levels of physical activity and/or sedentary behavior. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested and/or interested" in following an intervention that aimed at improving physical activity. The objective of this study is to determine the influence of an intervention based on sedentary behavior reduction and physical activity promotion among medical students. ### Conditions - Health Behavior - Health-Related Behavior - Physical Inactivity - Sedentary Behavior - Sedentary Time ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Sedentary and physical activity behaviors ### Outcomes Primary Outcomes - Perceived level of sedentary : Evolution of the score obtained at the Rapid Physical Activity Questionnaire (RPAQ) on sedentary behaviors. Secondary Outcomes - Perceived level of physical activity : Score obtained at the Global Physical Activity Questionnaire (GPAQ) on physical activity levels. - Perceived level of sedentary : Score obtained at the Rapid Physical Activity Questionnaire (RPAQ) on sedentary behaviors. - Actimetry records.Total activity during the pre-intervention. - Actimetry records. Moderate-to-vigorous Physical Activity (MVPA) during the pre-intervention. - Actimetry records. Light Physical Activity during the pre-intervention. - Actimetry records. Steps count during the pre-intervention. - Actimetry records. Energy expenditure during the pre-intervention. - Actimetry records. Number of sedentary breaks during the pre-intervention. - Actimetry records. Sedentary time during the pre-intervention. - Actimetry records. Number of prolonged sedentary bouts during the pre-intervention. - Actimetry records.Vector of the dynamic body acceleration (VeDBA) during the pre-intervention. - Body composition markers. Body Mass Index (BMI) during the pre-intervention. - Body composition markers. Skeletal muscle mass measured by bioimpedancemetry during the pre-intervention. - Body composition markers. Fat mass measured by bioimpedancemetry during the pre-intervention. - Body composition markers. Total body hydration measured by bioimpedancemetry during the pre-intervention. - Physical Fitness markers - Strength. The force developed during a maximal isometric contraction of the quadriceps during the pre-intervention. - Physical Fitness markers markers - Power. Height of jump during the pre-intervention. - Physical Fitness markers - Power. Time of flight during the pre-intervention. - Physical Fitness markers - Power. Relative Power during the pre-intervention. - Physical Fitness markers - Endurance. Speed through the endurance test during the pre-intervention. - Physical Fitness markers - Endurance. VO2max through the endurance test during the pre-intervention. - Physical Fitness markers - Endurance. Heart rate during the endurance test during the pre-intervention. - Perceived level of physical activity : Evolution of the score obtained at the Global Physical Activity Questionnaire (GPAQ) on physical activity level. - Actimetry records. Evolution in Total activity during the intervention. - Actimetry records. Evolution in Moderate-to-vigorous physical activity (MVPA) during the intervention. - Actimetry records. Evolution in Light physical activity measured in min/day during the intervention. - Actimetry records. Evolution in Step Count during the intervention. - Actimetry records. Evolution in Energy expenditure during the intervention. - Actimetry records. Evolution in number of sedentary breaks during the intervention. - Actimetry records. Evolution in Number of prolonged sedentary bouts during the intervention. - Actimetry records. Evolution in the vector of the dynamic body acceleration (VeDBA) during the intervention. - Body composition markers. Evolution in BMI during the intervention. - Body composition markers. Evolution in fat mass measured by bioimpedancemetry during the intervention. - Body composition markers: Impedance metric measures. Evolution in skeletal muscle mass measured by bioimpedancemetry during the intervention. - Body composition markers: Impedance metric measures. Evolution in total body hydration measured by bioimpedancemetry during the intervention. - VAS - physical fitness: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness. - VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical activity. - VAS - sedentary behaviours. Evolution of the scores obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviours. - Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert. - Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set. - Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention. - Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5. - Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress. - Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention. ### Location - Facility: RESHAPE, Lyon, N/A, 69008, France @@
## Global Paradise System US Post Approval Study - NCT ID: NCT06297291 - Study ID: CLN0984 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2031-07 - Lead Sponsor: ReCor Medical, Inc. ### Study Description The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure. ### Conditions - Hypertension - Cardiovascular Diseases - Vascular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Paradise Ultrasound Renal Denervation Treatment ### Outcomes Primary Outcomes - Co-Primary Endpoint #1: Group Mean BP reduction - Co-Primary Endpoint #2: Subject Responder Secondary Outcomes - Change in mean home systolic/diastolic BP in mmHg - Change in mean office systolic/diastolic BP in mmHg - Change in home and office pulse pressure - Change in the number and/or dosage and/or type of antihypertensive medications taken - Change in patient reported outcomes - Percentage of patients who are controlled as measured by various cut points of home BP (control to be assessed as both < 130 mmHg systolic and <135 mmHg systolic) office BP (control to also be assessed as <130 mmHg and <140 mmHg systolic) - Percentage of patients who demonstrate a reduction in home systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg - Percentage of patients who demonstrate a reduction in office systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg - Change in home and office heart rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids - NCT ID: NCT06297278 - Study ID: IRB-23-01-5444 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-04-30 - Lead Sponsor: Wayne State University ### Study Description Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth. ### Conditions - Adolescence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Moderate Intensity Exercise ### Outcomes Primary Outcomes - Skin Conductance Responding (SCR) - Unconditioned Stimulus (US) Expectancy Ratings - Fear extinction neural circuitry: Functional activation and coupling - Endocannabinoid (eCB) Concentrations Secondary Outcomes - Fear Ratings - Approach/Avoidance Behavior - Amygdala response during extinction recall ### Location - Facility: Tolan Park Medical Building, Detroit, Michigan, 48201, United States @@
## Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery - NCT ID: NCT06297265 - Study ID: 1B-23-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: University of Southern California ### Study Description This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer. ### Conditions - Anatomic Stage 0 Breast Cancer AJCC v8 - Anatomic Stage IA Breast Cancer AJCC v8 - Localized Breast Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Lymphedema Management - Questionnaire Administration - Adjuvant breast radiation therapy ### Outcomes Primary Outcomes - Rate of compliance of MLD breast massage sessions Secondary Outcomes - Assess the effect of MLD breast massage breast edema - Assess the effect of MLD breast massage on pain - Assess the effect of MLD breast massage on functional status - Assess the effect of MLD breast massage on quality of life - Assess the effect of MLD breast massage on body image ### Location - Facility: USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States @@
## Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population - NCT ID: NCT06297252 - Study ID: RECHMPL23_0189 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-09 - Lead Sponsor: University Hospital, Montpellier ### Study Description Young women represent a population at risk of psychiatric disorders, the first signs of which often appear between the ages of 15 and 25. Psychiatric disorders are a major source of disability and healthcare costs.The perinatal period is an additional period of psychological vulnerability, during which women are at increased risk of developing or worsening psychiatric disorders. Unfortunately, psychiatric disorders seem to be largely under-diagnosed during this period, and therefore under-treated.The goal of this Prospective multicenter study is to determine the prevalence of the presence of at least one characterized psychiatric disorder, as defined by the use of the Mini International Neuropsychiatric Interview (MINI), in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment.Participants will complete self-questionnaires and have a standardized psychiatric evaluation at T2 ultrasound and at 2 months postpartum. ### Conditions - Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - standardized clinical psychiatric evaluations - self-administered psychiatric questionnaire assessments - blood sampling ### Outcomes Primary Outcomes - To determine the prevalence of the presence of at least one characterized psychiatric disorder, in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment. Secondary Outcomes - To determine the prevalence of each psychiatric disorder characterized during pregnancy at the time of the second-trimester ultrasound, based on a standardized clinical assessment. - Determine comorbidity profiles across all pathologies, describing whether there are patient groups based on these profiles. - Compare the prevalence of psychiatric disorders unknown to the obstetrics team with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound. - Compare the prevalence of psychiatric disorders unknown to the patient with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound. - Compare the prevalence of psychiatric disorders unknown to the general practitioner with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound. - Assess patients' medication compliance using self-administered questionnaires (MARS). - Assess patients' treatment beliefs using self-administered questionnaires (BMQ). - Determine the sociodemographic, psychological, psychiatric, medical and obstetric factors, as well as those associated with access to care and the care pathway associated with known or unknown diagnoses during pregnancy. - Determine the properties (sensitivity) of screening questionnaires (EPDS) for psychiatric disorders in this population. - Determine the properties (specificity) of screening questionnaires (EPDS) for psychiatric disorders in this population. - Determine the properties (positive predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population. - Determine the properties (negative predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population. - Determine the properties (sensitivity) of screening questionnaires ( MDQ) for psychiatric disorders in this population. - Determine the properties (specificity) of screening questionnaires ( MDQ) for psychiatric disorders in this population. - Determine the properties (positive predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population. - Determine the properties (negative predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population. - Determine the properties (sensitivity) of screening questionnaires (PCL-5) for psychiatric disorders in this population. - Determine the properties (specificity) of screening questionnaires (PCL-5) for psychiatric disorders in this population. - Determine the properties (positive predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population. - Determine the properties (negative predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population. - Determine the properties (sensitivity) of screening questionnaires (EDEQ) for psychiatric disorders in this population. - Determine the properties (specificity) of screening questionnaires (EDEQ) for psychiatric disorders in this population. - Determine the properties (positive predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population. - Determine the properties (negative predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population. - Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (PAI). - Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (MIBS). - Describe how the study will be carried out, either in person or by teleconsultation, and the reasons for this choice. - Determine the prevalence of each psychiatric disorder at two months post-inclusion based on a standardized clinical assessment. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Argentine Registry of Lp(a) - NCT ID: NCT06297239 - Study ID: UC001 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-02-01 - Lead Sponsor: School of Medicine. National University of Cuyo ### Study Description The Argentine Registry on Lipoprotein(a) (LP(a)), orchestrated by the Argentine Group for LP(a) Study, stands as a pioneering and extensive prospective initiative. This registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health parameters to unravel the intricate associations surrounding LP(a) levels.The dataset encompasses diverse patient characteristics, ranging from standard metrics like blood pressure, weight, and race to broader factors such as diabetes, smoking habits, menopausal status, and hypothyroidism. This holistic approach enables a nuanced exploration of the interplay between LP(a) levels and various risk factors, providing invaluable insights for both clinical and public health considerations.One distinctive feature of this registry lies in its focus on medication history, shedding light on the impact of routine pharmaceutical interventions on LP(a) profiles. Additionally, it delves into the intricate web of inflammatory diseases, recognizing their potential role in LP(a) modulation.Genetic predispositions are meticulously examined, with a specific emphasis on identifying homozygous and heterozygous variants associated with hypercholesterolemia. This genetic dimension adds a layer of complexity to the understanding of LP(a) dynamics, contributing significantly to the ongoing discourse on cardiovascular risk.The prospective nature of this registry allows for dynamic analyses, fostering a continuous exploration of emerging patterns and trends. By amalgamating geographical, clinical, and genetic data, the Argentine LP(a) Registry emerges as a comprehensive platform poised to unlock novel facets of LP(a) biology and its implications for cardiovascular health. As the dataset matures, it holds the promise of guiding personalized interventions and refining risk stratification strategies, thereby advancing the landscape of preventive cardiovascular care. ### Conditions - Lp(A) - Hypercholesterolemia - Cardiovascular Diseases - Diabete Type 2 - Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - prevalence of high level of Lp(a) Secondary Outcomes ### Location - Facility: Universidad Nacional de Cuyo, Mendoza, N/A, 5500, Argentina @@
## Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma - NCT ID: NCT06297226 - Study ID: CA088-1000 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2030-06-04 - Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company ### Study Description The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma. ### Conditions - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BMS-986393 ### Outcomes Primary Outcomes - Best overall response (BOR) Secondary Outcomes - Best overall response (BOR) - BOR of partial response (PR) or better - BOR of complete response (CR) [including stringent complete response sCR] - Incidence of adverse events (AEs) - Incidence of serious adverse events (SAEs) - Incidence of adverse event of special interest (AESI) - Incidence of participants with clinical laboratory abnormalities - Minimal residual disease (MRD) negative status as determined using next generation sequencing (NGS) - Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC) - Duration of response (DOR) assessed by an IRC - Progression-free survival (PFS) - Overall survival (OS) - Overall response rate (ORR) assessed by an Investigator - Complete response rate (CRR) assessed by an Investigator - Time to response (TTR) assessed by an Investigator - Duration of response (DOR) assessed by an Investigator - Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator - Maximum observed plasma concentration (Cmax) - Area under the concentration-time curve (AUC) - Time of maximum observed plasma concentration (Tmax) - Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales - Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales - Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up ### Location - Facility: Local Institution - 0001, Birmingham, Alabama, 35294-3300, United States @@
## R-2487 in Patients With Sjogren's Syndrome (SS) - NCT ID: NCT06297213 - Study ID: R-2487-SS-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-08-30 - Lead Sponsor: Rise Therapeutics LLC ### Study Description The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured. ### Conditions - Sjogren's Syndrome - Sjögren - Sjögren Syndrome, Unspecified ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - R-2487 ### Outcomes Primary Outcomes - Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration Secondary Outcomes - Change in disease activity through Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI) - Change in Patient reported general health questionnaire Short Form Health Survey-36(SF-36) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Low-Intensity Focused Ultrasound and the Complex Patient - NCT ID: NCT06297200 - Study ID: 24-050 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: Virginia Polytechnic Institute and State University ### Study Description Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population. ### Conditions - Opioid Use Disorder - Chronic Pain - Anxiety Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Low-Intensity Focused Ultrasound - Low-Intensity Focused Ultrasound - sham ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events via a neurological examination - Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire - Changes in Heart Rate (HR) - Changes in Respiration Rate (RR) - Changes in mood via visual analog mood scale (VAMS) - Changes in Blood Pressure (BP) Secondary Outcomes ### Location - Facility: Fralin Biomedical Research Institute at VTC, Roanoke, Virginia, 24016, United States @@
## Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study - NCT ID: NCT06297187 - Study ID: C-CUSAWH-001 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-08 - Lead Sponsor: Integra LifeSciences Corporation ### Study Description The study is a single arm, retrospective, single-center, post market registry.The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata. ### Conditions - Vulvar Intraepithelial Neoplasia - Condylomata Acuminata ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CUSA (Cavitronic Ultrasonic Surgical Aspirator) ### Outcomes Primary Outcomes - Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata Secondary Outcomes - Primary Site Recurrence ### Location - Facility: The Center for Cancer and Blood Disorders, Dallas, Texas, 76014, United States @@
## Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions - NCT ID: NCT06297174 - Study ID: BE23-035 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-26 - Completion Date: 2024-09-20 - Lead Sponsor: Pharma Nueva ### Study Description Objectives:To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditionsStudy Design:An open label, randomized, two-treatment, four-period, two-sequence, replicate crossover bioequivalence study in healthy Thai volunteers under fasting conditions with at least 7 days washout period between the administrations of investigational products of each period ### Conditions - Healthy Vollunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Racecadotril 100 mg Capsules - HIDRASEC® ### Outcomes Primary Outcomes - Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril - Peak Plasma Concentration (Cmax) of Racecadotril Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML). - NCT ID: NCT06297161 - Study ID: B1871065 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-12-31 - Lead Sponsor: Pfizer ### Study Description The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice.This study is seeking for participants who are:* Adult Patients who are just confirmed to have Chronic Myeloid Leukemia (CML) defined in Local Product Document (LPD). CML is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood. LPD explains what a medicine's benefits and problems are. LPD also explains how to use the medicine correctly in Korea.* willing to take part in the study after being informed about the study. All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea.The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study. ### Conditions - Chronic Leukemia Myelogenous ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bosulif ### Outcomes Primary Outcomes - Incidence of AEs Secondary Outcomes - Hematologic response: CHR, not achieved - Cytogenetic response: CCyR, PCyR, mCyR, not achieved - Molecular response: EMR, MMR, MR4.0, MR4.5, not achieved - Relapse after Bosulif response ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The HIP Self-management Study - NCT ID: NCT06297148 - Study ID: 2023/590816 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2027-01-01 - Lead Sponsor: Oslo University Hospital ### Study Description The HIPS-study will be an observer blinded, single-centre, parallel-group randomized controlled trial (RCT).The main purpose of the study is:1. To investigate the clinical effectiveness of a self- management program versus usual care for patients with greater trochanteric pain syndrome (GTPS). * H0: There is no difference between a self-management program and usual care on pain and function in patients with GTPS. * H1: There is a difference between a self-management program and usual care on pain and function in patients with GTPS.2. To investigate if self-management is more cost-effective than usual care in the treatment of patients with GTPS.Participants will be randomly allocated into one of two groups: 1) self-management program or 2) usual care.Follow-up will be at 3-, 6- and 12-months. ### Conditions - GTPS - Greater Trochanteric Pain Syndrome - Gluteal Tendinopathy - Trochanteric Bursitis - Lateral Hip Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Self-management - Usual care ### Outcomes Primary Outcomes - Victorian Institute of Sport Assessment Gluteal Questionnaire (VISA-G) Secondary Outcomes - Numeric rating scale (NRS) - Painful sites - The Pain Self-Efficacy Questionnaire (PSEQ) - EuroQoL-5 dimensions-5 Level (Eq-5D-5L) - Hopkins Symptoms checklist-10 (HSCL-10) - iMTA Medical Consumption Questionnaire (iMCQ) - iMTA Productivity Cost Questionnaire (iPCQ) - Expectations related to VISA-G - Expectations on numeric rating scale (NRS) - Global rating of change (GROC) ### Location - Facility: Oslo University Hospital, Ullevål, Oslo, N/A, 0450, Norway @@
## A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits - NCT ID: NCT06297135 - Study ID: HSR-2023-020 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-03-31 - Lead Sponsor: Okinawa Institute of Science and Technology Graduate University ### Study Description This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges children face, a transition to a non-preferred activity. Parents with children demonstrating inattentive, hyperactive and impulsive behavior and experiencing difficulties with daily transition routines are invited to participate in the study. ### Conditions - ADHD ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Behavioral Parent Training ### Outcomes Primary Outcomes - Number of videos viewed - Percentage of completed daily ratings - Participant satisfaction Secondary Outcomes - Parent-rated child's difficulties with daily transitions - Parent-rated child's impairment related to transition difficulties - Positive parenting - Negative parenting - Parenting stress ### Location - Facility: Okinawa Institute of Science and Technology Graduate University, Onna, Okinawa, 904-0495, Japan @@
## Severe Group A Streptococcus Infections in Paris, France, 2018-2023 - NCT ID: NCT06297122 - Study ID: APHP240002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Streptococcus pyogenes, commonly referred to as Group A Streptococcus (GAS), has the ability to induce a diverse range of illnesses.In several European countries and the United States, a notable surge in invasive GAS (iGAS) infections has been documented since mid-2022. This sharp increase contrasts with the gradual rise in iGAS incidence observed among children over the past three decades. As demonstrated for several viral infections, the recent upturn in iGAS infections is potentially linked to the relaxation of mitigation measures implemented during the COVID-19 pandemic, such as face mask usage and school closures.Since November 2022, concerns have been raised by French public health authorities regarding the rise in levels of iGAS infections, and an unexpected increase in pediatric severe GAS infections was reported in a French single-center study. However, this study ended in December 2022 and could only explore short-term trends. The Necker - Enfants malades Hospital in Paris, France, represents an excellent opportunity to examine the impact of the COVID-19 pandemic and the associated non-pharmaceutical interventions on the incidence of severe GAS infections, during, and after the pandemic.This study aims to investigate trends of severe GAS infection incidence in children in the Paris area over the course of the COVID-19 pandemic. ### Conditions - Invasive Group A Beta-Haemolytic Streptococcal Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Collection of data from the patient's medical file ### Outcomes Primary Outcomes - Monthly incidence of severe Group A Streptococcus (GAS) infections per 1000 pediatric hospital admissions Secondary Outcomes - Age of children age with group A Streptococcus (GAS) infections - Proportion of children needing surgical intervention for the management of GAS infection - Proportion of cases admitted in the PICU for GAS infection - Proportion of deaths from GAS infection - Hospital length of stay for the management of GAS infection - Distribution of infection type of GAS infection - Proportion of healthcare-associated infections during the management of GAS infection ### Location - Facility: Hôpital Necker-Enfants Malades, Paris, N/A, 75015, France @@
## Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery - NCT ID: NCT06297109 - Study ID: S-20230033 - Status: RECRUITING - Start Date: 2023-09-12 - Completion Date: 2027-08-31 - Lead Sponsor: Hospital of South West Jutland ### Study Description Orthognathic surgery is a type of jaw surgery where a surgeon cuts the bones of the upper and lower jaw and places them better. There are two ways they can put the bones in the correct place and keep them in place after the surgery. One way, called the "conventional method", is to use a 3D-printed guide called a splint to set the bones in the right place and then screw the bones together using metal plates that the surgeon bends into shape to fit during the surgery. Another way is to use a patient-specific implants (PSI) that has been 3D-printed in titanium beforehand that because of its unique shape both places and keeps all the bones in the correct place after they are screwed in. Both ways of doing it are golden standards, meaning they are already approved.Measuring the accuracy of the surgery is done by comparing the positions of the bones after the surgery with the intended positions of those bones, according to the surgical plan. The closer the achieved position of each bone is to the intended position, the more accurate the result.Measuring the stability of the surgery is done by comparing the positions of the bones after the surgery with the positions of the bones two years later. The less the position is changed, the more stable the result.The goal of this clinical trial is to see how accurate and stable PSIs are in orthognathic surgery when the maxilla is split in 3 pieces, and to compare them with the conventional method in patients with overjet or overbite. The main questions it aims to answer are:* Does using PSIs provide accurate movements of the maxilla pieces?* Does using PSIs provide more accurate movements of the maxilla pieces than the conventional method?* Does using PSIs provide stable movements of the maxilla pieces after 2 years?* Does using PSIs provide more stable movements of the maxilla pieces than the conventional method?Participants will get orthognathic surgery as part of their normal orthodontic treatment.Investigators will compare the PSI and conventional groups to see if the PSIs are more accurate than the conventional method. ### Conditions - Retrognathia - Malocclusion, Angle Class II ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Patient-specific implants - Conventional mini-plates ### Outcomes Primary Outcomes - The accuracy of segmental Le Fort I bone movements - The stability of segmental Le Fort I bone movements - The stability of the upper airway Secondary Outcomes - The Diagnostic Criteria for Temporomandibular Disorders Symptom questionnaire - The Jaw Functional Limitation Scale - The STOP-BANG - Snorting, Tiredness, Observed apnea, blood Pressure, BMI, Age, Neck circumference, Gender questionnaire - The Epworth Sleepiness Scale questionnaire - The occlusion including horizontal/vertical overlap ### Location - Facility: University Hospital of Southern Denmark, Esbjerg, N/A, 6700, Denmark @@
## Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease - NCT ID: NCT06297096 - Study ID: NIGRIR_004NINTOC-TU - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-03-30 - Lead Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland ### Study Description The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks. ### Conditions - Systemic Sclerosis - Interstitial Lung Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tocilizumab - Nintedanib - Standard therapy ### Outcomes Primary Outcomes - The decrease in forced vital capacity (FVC) of the lungs Secondary Outcomes - Change in percent lung involvement - Assessment of absolute changes in DLCO - Assessment of the absolute changes in predicted FVC% - Change in the Six-minute walk test (6MWT) result - Change in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score - A change in the patient's global assessment of disease activity - A change in the physician's global assessment of disease activity - Assessment of the absolute changes from baseline in total scores in St. George's Respiratory Questionnaire (SGRQ) - Assessment of absolute changes compared to baseline values on the modified Rodnan skin Score (mRSS) - Percentage of participants with threshold improvement from baseline in modified Rodnan skin Score (mRSS) - Percentage of participants with modified Rodnan skin Score (mRSS) improvement greater than or equal to (>/=) 20%, 40%, or 60% ### Location - Facility: Centrum Wsparcia Badań Klinicznych, Warsaw, Mazowieckie, 02-637, Poland @@
## Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy - NCT ID: NCT06297083 - Study ID: 100992 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-12 - Lead Sponsor: Murdoch Childrens Research Institute ### Study Description This study will compare the effectiveness of three different treatments to treat peanut allergy ### Conditions - Peanut Allergy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Peanut Oral Powder [PEANUT POWDER] - Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin) ### Outcomes Primary Outcomes - Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment. Secondary Outcomes - Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment - Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE) - Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ). - Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size. - Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels - Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant - Difference between treatment arms in participant experience as assessed from qualitative interviews - Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) - Difference between clinical outcome groups in quality adjusted life year (QALY) will be estimated at 32 months using the Food Allergy Quality of Life Form (FAQLQ) mapped to the generic health utility instrument Assessment of Quality of Life-6D (AQoL-6D) - Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment - Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment ### Location - Facility: Womans and Childrens Hospital, Adelaide, South Australia, 5006, Australia @@
## Lifestyle Care for Fertility Outcome Evaluation - NCT ID: NCT06297070 - Study ID: STUDY20231406 - Status: RECRUITING - Start Date: 2024-01-24 - Completion Date: 2025-08-01 - Lead Sponsor: Christine Kaiser, LAc, DACM ### Study Description An observational outcome evaluation of the Lifestyle Care for Fertility program. ### Conditions - Fertility Issues ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Whole Health Lifestyle Care for Reproductive Well-being pilot program ### Outcomes Primary Outcomes - Servings of Fruit - Servings of Vegetables - Glasses of Water - Caffeinated Beverages - Aerobic Exercise - Strengthening Exercise - Stretching Exercise - Sleep Hygiene - Hours of Sleep - Self Care - Biofeedback - Self Care - Breathing Exercises - Self Care - Guided Imagery - Self Care - Mindfulness/Meditation - Self Care - Progressive Relaxation - Self Care - Journaling/Gratitude Journaling - Self Care - Tai Chi/Chi Gong - Self-Care - Massage Therapy - Self Care - Acupuncture/Acupressure - Self Care - Nature Walking Secondary Outcomes - PROMIS Sleep Disturbance 8a - Perceived Stress Scale - 4 - Infertility Self Efficacy - Chemical pregnancy - Stress Change (level of stress: none [0] to worst possible [10]) - SMA - Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA - Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA - Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA - Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA - Stress Change (level of stress: none [0] to worst possible [10]) - HWC - Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC - Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC - Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC - Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC - Recruitment Rate - Retention Rate - Pace of Accrual - Data Completeness - Helpfulness of group sessions in addressing needs - Coverage of important issues in the sessions - Helpfulness of tools presented in nutrition session - Helpfulness of tools presented in movement session - Helpfulness of tools presented in relaxation and sleep session - Helpfulness of tools presented in integrate session - Enjoyed group sessions - Enjoyed health and wellness coaching session - Group setting was beneficial - Comfortable in group setting - Helpfulness of individual health coaching sessions - Feedback questionnaire: Location Preference question 1 - Feedback questionnaire: Location Preference question 2 - Feedback questionnaire: Number of Sessions question. - Feedback questionnaire: Length of Sessions question. - Rating of level of support during each SMA - Rating of level of support during HWC - Overall level of satisfaction during each SMA - Overall level of satisfaction during each HWC ### Location - Facility: University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States @@
## Acquisition and Analysis Protocol Optimization of Neurophysiological Data Neurorehabilitation Settings - NCT ID: NCT06297057 - Study ID: 2021.07 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: IRCCS San Camillo, Venezia, Italy ### Study Description The study aims to optimize and validate protocols for acquiring neurophysiological data, specifically resting state functional connectivity, using advanced research techniques (hdEEG and MEG) and a user-friendly device (MUSE). Previous studies have extensively explored functional connectivity repeatability in resting conditions using functional MRI, yet few have focused on hdEEG and MEG data. Additionally, the impact of subjects' eye conditions (open or closed) during resting state recordings on network identification remains debated.The investigation involves assessing the effect of eye conditions on brain network identification and determining the most stable and repeatable measures of functional connectivity over time. This analysis is crucial for discerning whether observed changes in patients' functional connections are intrinsic to the methodology or indicative of genuine physiological alterations.The study aims to optimize protocols for rehabilitation by evaluating changes in functional connectivity metrics during and between experimental sessions. Furthermore, it seeks to identify the conditions (eyes closed or open) that yield more reliable and repeatable functional measurements.Following the optimization of advanced techniques, the study explores the feasibility of utilizing the MUSE EEG system in clinical settings. MUSE, known for its portability and user-friendliness, has demonstrated quality in experimental psychology and clinical research. The objective is to establish relevant functional correspondences between measurements obtained through research techniques (hdEEG and MEG) and those acquired with MUSE.The primary goal is to establish a protocol highlighting subjects' responses to acoustic stimuli or a reproducible pattern of resting state activity. The secondary objectives include investigating temporal and spatial characteristics of neurophysiological signals in healthy subjects over time and defining prognostic biomarkers for monitoring patients undergoing rehabilitation. This comprehensive approach aims to enhance the understanding of resting state functional connectivity and its applications in clinical settings.Therefore, to meet these goals, the present study will consist of multiple recordings of brain activity: by high-density electroencephalography (hdEEG), magnetoencephalography (MEG), and low-density EEG with a MUSE handheld device, during five experimental blocks on healthy subjects. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Neurophysiological Recordings ### Outcomes Primary Outcomes - Neurophysiological data acquisition protocol - resting state - Neurophysiological data acquisition protocol - resting state - Neurophysiological data acquisition protocol - auditory stimulation Secondary Outcomes ### Location - Facility: San Camillo IRCCS s.r.l., Venice-Lido, Venice, 30126, Italy @@
## Neural and Cognitive Correlates of Pragmatic Abilities - NCT ID: NCT06297044 - Study ID: 2017.20 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2018-03-29 - Completion Date: 2025-12-31 - Lead Sponsor: IRCCS San Camillo, Venezia, Italy ### Study Description Pragmatics of language refers to the set of abilities that allow one to use and interpret language according to context and, in general, to communicate effectively. Disorders in the pragmatics of language are prevalent in various clinical populations. They are a cause of social withdrawal and worse quality of life, both for patients directly affected and for their family members. Despite this, this type of disorder is rarely considered in neuropsychological assessment and rehabilitation.This study's objective is to characterize pragmatic deficits in various neurological populations, allowing for the most accurate diagnosis possible and leading to the planning of personalized and effective Rehabilitation Plans. ### Conditions - Right Hemispheric Stroke - Left Hemispheric Stroke - Traumatic Brain Injury - Right Hemispheric Brain Tumor - Left Hemispheric Brain Tumor - Mild Cognitive Impairment - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neuropsychological assessment ### Outcomes Primary Outcomes - Pragmatic Profile Secondary Outcomes - Theory of Mind - Functional Communication Abilities ### Location - Facility: San Camillo IRCCS s.r.l., Venice-Lido, Venice, 30126, Italy @@
## Heat Application to the Sacral Region and Pain Level During the First Stage of Labor - NCT ID: NCT06297031 - Study ID: 2020/20 - Status: COMPLETED - Start Date: 2020-04-01 - Completion Date: 2021-05-30 - Lead Sponsor: Istanbul Demiroglu Bilim University ### Study Description The aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process. ### Conditions - Heat Exposure - Labor Pain - Apgar Score - Duration of Labor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - heat application ### Outcomes Primary Outcomes - Change From Baseline labor Pain at three times Secondary Outcomes - Duration of the first stage of labor - Change From Baseline APGAR score after delivery - Change From Baseline Fetal Heart Rate ### Location - Facility: Demiroglu Bilim University, Istanbul, N/A, 34384, Turkey @@
## Bioenergy, Depression, Anxiety and Stress After Liver Transplantation - NCT ID: NCT06297018 - Study ID: February 18, 2024 - Status: TERMINATED - Start Date: 2024-01-01 - Completion Date: 2024-02-09 - Lead Sponsor: Istanbul Aydın University ### Study Description In this study, the investigators aimed to examine the effect of bioenergy application on depression, anxiety and stress after liver transplantation. ### Conditions - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Bioenergy application ### Outcomes Primary Outcomes - Anxiety, stress, depression: Measurement will be made with the Depression Anxiety Stress 21 Scale (DASS-21: Score range 21-63) Secondary Outcomes ### Location - Facility: Semra Bulbuloglu, Istanbul, N/A, N/A, Turkey @@
## The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study - NCT ID: NCT06297005 - Study ID: 21/FFP-P/10154 - Status: RECRUITING - Start Date: 2023-10-09 - Completion Date: 2027-08-31 - Lead Sponsor: University College Dublin ### Study Description Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy.The ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age. ### Conditions - Vaping - Pregnancy Related - Pediatric Respiratory Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of preterm birth - Incidence of low birth weight - Incidence of wheeze during the first two years of life Secondary Outcomes - Incidence of smoking and vaping - Estimated foetal weight - Trends in carbon monoxide levels - Blood pressure measurements (both diastolic and systolic) - Urine cotinine measurements - Incidence of maternal cough, wheeze and/or asthma - Maternal history of abnormal cervical screening cytology - Incidence of pre-eclampsia and/or hypertension during pregnancy - Incidence of birth complications - Edinburgh postnatal depression score - APGAR scores at 1, 5 and 10 minutes after birth - Admission to neonatal intensive care - Incidence of neonatal complications - Neonatal and paediatric anthropometric measurements over first two years of life - Neonatal body composition measurements - Incidence of respiratory illnesses - Number of attendances/admissions to hospital - Frequency of prescribed respiratory medications use - Barkely Functional Impairment score (BFIS) - Early Executive Functions Questionnaire (EEFQ) - Infant Behaviour Questionnaire (IBQ) - Child Behaviour Checklist (CBCL) - Early Childhood Behaviour Questionnaire (ECBQ) - Bayley Scales of Infant and Toddler Development (BSID) ### Location - Facility: Rotunda Hospital, Dublin, N/A, D01 P5W9, Ireland @@
## Type 1 Diabetes, Exercise and Mentoring Trial - NCT ID: NCT06296992 - Study ID: B2023:035 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-05 - Lead Sponsor: University of Manitoba ### Study Description The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D. ### Conditions - Type 1 Diabetes - Physical Activity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 12-week TEAM peer mentor program ### Outcomes Primary Outcomes - Enrollment rates - Adherence to the intervention arms - Retention for follow-up measurements Secondary Outcomes - Physical activity - Quality of Life (DQOL) - Quality of Life (PedsQL 4.0) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity. - NCT ID: NCT06296979 - Study ID: 0881-N-23 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-12-01 - Lead Sponsor: University of Seville ### Study Description Pain, particularly shoulder pain, is a social and economic problem worldwide. Although visceral pathology is not yet taken into account in the diagnosis of these pains, it is likely that on numerous occasions the hepatobiliary visceral condition causes referred pain in the metameric area belonging to the shoulder due to the involvement of the phrenic nerve. Therefore, the aim of this project is to study the response of treatment by neuromodulation of the phrenic nerve for shoulder pain in patients with associated hepatobiliary pathologies, assessing the possible visceral involvement in the symptomatology. ### Conditions - Shoulder Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Phrenic nerve neuromodulation - common Physical therapy ### Outcomes Primary Outcomes - Numeric Pain Rating Scale Secondary Outcomes - Algometry - Goniometry passive - Quick Dash questionnaire - Goniometriy active ### Location - Facility: Centro de Salud Ronda Histórica, Sevilla, N/A, 41008, Spain @@
## A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye - NCT ID: NCT06296966 - Study ID: VP-VSJ-110-2201 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-07 - Lead Sponsor: Vanda Pharmaceuticals ### Study Description The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye. ### Conditions - Dry Eye ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VSJ-110 - Placebo ### Outcomes Primary Outcomes - Schirmer's Tear Test Secondary Outcomes - Ocular Staining - Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS) ### Location - Facility: Vanda Investigational Site, Andover, Massachusetts, 01810, United States @@
## Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis - NCT ID: NCT06296953 - Study ID: PeriSaFe01 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-12-01 - Lead Sponsor: STB INN AB ### Study Description This will be an explorative, proof-of-principle, open, multi-center investigation.The investigation aims to investigate the safety of the PERIsign system and the ability of physicians to differentiate between healthy individuals and subjects with involuntary muscle defense as a sign of peritonitis by utilizing PERIsign data. The investigation will include a total of 20 subjects admitted to hospital for suspected appendicitis and planned for emergency surgery and 20 healthy volunteers. Both male and female subjects aged 18-70 years will be enrolled.All subjects will undergo PERIsign examinations. Subjects with suspected appendicitis will undergo 1-2 PERIsign examinations before their planned appendectomy surgery. For the healthy volunteers, there is only 1 PERIsign examination. During each examination, 4 PERIsign curves will be obtained, one from each quadrant of the abdomen. The attending physician will interpret the appearance of the PERIsign curves of all subjects, including those from the healthy volunteers. The duration of the PERIsign examination will be documented, and usability data will be gathered, including the need for sensor adjustments, subject perception of the examination, and any discomfort experienced. In addition, blinded physicians will evaluate all subjects' PERIsign curves and determine whether each subject has involuntary muscle defense as a sign of peritonitis. These blinded physicians will have access to all 4 PERIsign curves obtained during each examination, while other data will not be disclosed to them.Safety will be evaluated through analysis of reported adverse events and device deficiencies ### Conditions - Appendicitis Acute - Appendicitis - Abdominal Pain - Peritonitis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - PERIsign examination ### Outcomes Primary Outcomes - Proportion of subjects experiencing any adverse events during the examination - Proportion of device deficiencies during the evaluation Secondary Outcomes - To estimate the sensitivity and specificity of diagnosing pathological muscle defense when using the PERIsign system - Proportion of examinations of the PERIsign system that its performed without usability issues. ### Location - Facility: Hallands Sjukhus Halmstad, Halmstad, N/A, N/A, Sweden @@
## Written Exposure in Substance Treatment - NCT ID: NCT06296940 - Study ID: WEST 2.0 - Status: RECRUITING - Start Date: 2022-12-01 - Completion Date: 2024-12-31 - Lead Sponsor: Potomac Health Foundations ### Study Description The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone? ### Conditions - Posttraumatic Stress Disorder - Substance Use Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Written Exposure Therapy - Treatment as Usual ### Outcomes Primary Outcomes - Efficacy of WET Secondary Outcomes - Feasibility of WET delivered in residential SUD treatment context - Acceptability of WET delivered in residential SUD treatment context ### Location - Facility: Maryland Treatment Centers, Baltimore, Maryland, 21229, United States @@
## The Effect of the Emotional Freedom Technique on Perceived Pain, Situational Anxiety, Cortisol and Satisfaction Levels in Mammography Screening. - NCT ID: NCT06296927 - Study ID: SumeyyeKose-E.138186 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-03-01 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description This study was planned to determine the effect of Emotional Freedom Technique on perceived pain level, situational anxiety, salivary cortisol and satisfaction level during mammography screening. ### Conditions - Mammography Screening - Pain - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Emotional Freedom Technique ### Outcomes Primary Outcomes - Anxiety - Pain Level Secondary Outcomes - Satisfaction Level - Cortisol Level ### Location - Facility: Pendik District Health Directorate Maternal Child Health and Family Planning Center, Istanbul, N/A, N/A, Turkey @@
## A mHealth System for Patients With POTS - NCT ID: NCT06296914 - Study ID: 89776 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-12-31 - Lead Sponsor: Jami Warren ### Study Description Postural Orthostatic Tachycardia Syndrome (POTS) affects approximately 500,000 - 3 million Americans. This number will only increase due to the large number of patients experiencing POTS due to "long COVID." POTS patients experience several symptoms, including tachycardia, palpitations, dizziness, and pre-syncope or syncope, among others. POTS can be very debilitating and not only affect patients physically but also emotionally and financially. It takes an average of four years and seven doctors for POTS patients to achieve a diagnosis and it is often a frustrating and negative experience fraught with misdiagnoses, stigma, and depression and anxiety. Recent research demonstrates that mHealth technology may be one way that POTS patients can improve their experience in the healthcare system by providing objective data to their healthcare providers. Patients may also better take care of themselves through symptom monitoring and instant patient education via mHealth technology. The two study aims are: 1) Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients; and 2) Evaluate the usability and feasibility of the mHealth app and study design. To achieve these aims, researchers in this study will work with a programmer and leaders from the mHealth Application Modernization and Mobilization Alliance (MAMMA) and stakeholders (patients, caregivers, and providers) to co-design a mHealth app for POTS patients, including key educational components guided by the IDEA model, an instructional risk communication approach. A group of diagnosis-seeking POTS (n=20) patients will pilot test the app and provide feedback for improvement as well as evaluate its usability. Results from this study will allow researchers to acquire necessary data to apply for external funding to conduct a larger clinical trial to evaluate its influence on health outcomes, such as patient experience during visits with physicians, perceived stigma, and time to diagnosis. ### Conditions - POTS - Postural Orthostatic Tachycardia Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - POTSapp - Waitlist Control ### Outcomes Primary Outcomes - Change in POTSapp Usability as measured by uMARS - Change in POTSapp Usage - Change in POTSapp Usability as measured by Health-ITUES - Change in POTSapp Effectiveness as measured by Message Effectiveness scale Secondary Outcomes - Change in Participant Quality of Life - Change in Doctor Patient Communication (DPC) - Adapted IBS Perceived Stigma Scale - Cognitive Learning ### Location - Facility: University of Kentucky, Lexington, Kentucky, 40506, United States @@
## To Wipe or Not To Wipe?: That Is The Question - NCT ID: NCT06296901 - Study ID: 202310353 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: Joanna A. Orzel ### Study Description The primary aim of this randomized control trial is to characterize whether a mid-stream clean catch sample using a cleansing wipe in the setting of symptomatic UTI in a female patient is associated with a lower rate of contamination. We hypothesize that using a perineal cleansing wipe at the time of a midstream urine sample will decrease rates of contamination for female patients with a symptomatic UTI. ### Conditions - Urinary Tract Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Perineal Wipe ### Outcomes Primary Outcomes - Rate of Contamination Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Radiofrequency Balloon Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolated and Clinical Outome - NCT ID: NCT06296888 - Study ID: P-2022-673 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-10-01 - Completion Date: 2024-08-09 - Lead Sponsor: Jim Hansen ### Study Description Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult human population. AF is a disturbance in the electrical impulses of the heart - an electrical disturbance commonly originating from the pulmonary veins.Normalization of the heart rhythm with anti-arrhythmic drugs often fail and is frequently associated with side effects. Therefore, a treatment termed ablation by catheters via an inguinal vein has been devised and is increasingly being used for the treatment of AF. The cornerstone of this treatment is electrical isolation of the pulmonary veins so that the nocuous electrical impulses from the pulmonary veins cannot cause a disturbance in the heart rhythm and initiate episodes of AF. This treatment is called pulmonary vein isolation (PVI). Recent studies have shown that PVI is better than anti-arrhythmic drug treatment in the prevention of recurrence of AF, but despite substantial improvements in techniques and tools only 60-70% are cured from AF by a single PVI procedure, and in around 80% of patients who require additional catheter ablation, durable isolation of all the pulmonary veins has not been achieved. Improved tools for durable PVI are therefore required.A novel catheter to achieve PVI called the HELIOSTAR™ radiofrequency balloon ablation catheter has shown promising clinical results with a favorable safety profile, but the durability of PVI has not been evaluated. Therefore, we aim to investigate the long-term durability of PVI by the radiofrequency balloon and the clinical outcome following the procedure.In this study, patients with AF referred for catheter ablation will undergo an initial PVI treatment using the radiofrequency balloon catheter. All patients will undergo a repeat electrophysiology (EP) study after 4-6 months to determine to durability of PVI. Patients will be issued with a 48-hour heart rhythm monitor at 3 and 12 months after the initial PVI. Patients-reported effects on quality of life by AF related symptoms will be evaluated using a specialized questionnaire provided approximately every third month throughout the 12 month follow-up. ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radiofrequency balloon catheter ablation ### Outcomes Primary Outcomes - Proportion of durably isolated PVs observed at repeat EP study Secondary Outcomes - Proportion of patients with durable isolation of all PVs observed at repeat EP study - Proportion of patients remaining free from recurrence of ATA after the initial PVI - Difference in the effect of AF related symptoms on quality of life between baseline and after the initial PVI - Complications ### Location - Facility: Gentofte Hospital, Hellerup, N/A, 2820, Denmark @@
## The Krill Ageing Muscle Mechanisms (KAMM) Study - NCT ID: NCT06296875 - Study ID: KAMM - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: University of Glasgow ### Study Description This study aims to determine the mechanisms via which krill oil supplementation increases muscle strength and whether this translates to improvements in gait and functional characteristics in older adults. The studies we will carry out will establish, in healthy older adults, the effects of 6 months of supplementation with krill oilObjective 1) Muscle structure and function Hypothesis: Krill oil supplementation will increase muscle size and strength alongside positive changes in muscle architecture (pennation angle and fascicle length).Objective 2) Neuromuscular control and central nervous system (CNS) function Hypothesis: Krill oil supplementation will improve Neuromuscular Junction (NMJ) transmission stability and increase central drive and intramuscular coherence, as a measure of muscle synergy.Objective 3) Gait and functional characteristics Hypothesis: Krill oil supplementation will improve gait and functional characteristics. ### Conditions - Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Vegetable oil - Krill oil ### Outcomes Primary Outcomes - Grip strength - Neuromuscular junction transmission instability - Gait speed Secondary Outcomes - Knee extensor maximal torque - Vastus lateralis muscle cross sectional area - Vastus lateralis pennation angle - Vastus lateralis fascicle length - Erythrocyte fatty acid composition - Knee extensor force steadiness - Vastus lateralis motor unit conduction velocity - Vastus lateralis and vastus medialis intramuscular coherence - Hand flexor muscles intermuscular coherence - Cortico-muscular coherence between sensory motor cortex and hand extensor muscles - Femoral Nerve Stimulation - Transcranial Magnetic Stimulation (TMS) - TMS Inhibition - TMS Excitation - Gait characteristics during 4m walk test and the timed up and go test - Gait cycle with leg support parameters ### Location - Facility: University of Glasgow, Glasgow, N/A, N/A, United Kingdom @@
## Effect of DASH on HF Outcomes Heart Failure Status in Older Adults (DASH HF) - NCT ID: NCT06296862 - Study ID: STUDY00005563 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: University of Georgia ### Study Description The purpose of this study is to examine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet has on heart failure status in older adults. This study is important because it may provide a low-cost strategy to help reduce hospitalizations and deaths for heart failure patients. Participants will be adults age 65 and older with heart failure. They will have 4 study visits, each lasting about 2 hours, and will be in the study for 12 weeks. They will also be asked about their dietary consumption 6 times, each time lasting about 45 minutes. All in-person study visits will take place in the Emory GCRC. Participants will have physical exams, body measurements, blood tests, urinalysis, chart review, and answer surveys. They will be randomized to eat only the DASH diet provided to them for 4 weeks either at the beginning or end of their participation in the study. Participants will be recruited from heart failure patients at Emory University Hospital, Emory University Hospital Midtown, and Emory Outpatient Advanced Heart Failure Therapy Center. The total enrollment planned under Emory's oversight, accounting for screen failures and withdrawals, will be n=38 participants. The study team will obtain informed consent prior to the first study visit either in person, or, alternatively, over the phone, if requested by participants. Specimens and data obtained in this study will not be banked for future use. ### Conditions - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Dietary Approaches to Stop Hypertension Diet ### Outcomes Primary Outcomes - B-natriuretic peptide (BNP) Secondary Outcomes - N-terminal-proBNP (NT-proBNP) - Systolic and Diastolic Pulmonary Artery Pressures ### Location - Facility: Emory Clinical Cardiovascular Research Center (ECCRI), Atlanta, Georgia, 30322, United States @@
## Dyadic Financial Incentive Treatments for Dual Smoker Couples - NCT ID: NCT06296849 - Study ID: 00007344 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2028-05 - Lead Sponsor: University of Georgia ### Study Description Smokers partnered with other smokers (i.e., dual-smoker couples) represent \~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed study will systematically two versions of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these dyadic FITs for smoking abstinence in DSCs, the investigators will consider the cost and cost effectiveness of each adaptation as well as mechanisms of change to inform future implementation research. The investigators will additionally consider secondary outcomes including abstinence during treatment and long-term abstinence maintenance after end of treatment.The investigators will address these questions in a three-group randomized controlled trial (RCT). In all conditions, individuals who have smoking partners (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two conditions, participants will receive incentives for abstinence at three time points (1, 3, and 6 months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner will be offered incentives. Primary efficacy outcome is % point-prevalence abstinence at 6 months post-baseline among targets. Secondary outcomes are point-prevalence abstinence at 1 and 3 months during the treatment and 6 months post-treatment (12-months post-baseline), as well as partner outcomes. The investigators will evaluate possible mechanisms of change including partner support and individual and partner motivation to quit as well as evaluate the cost and relative cost of each abstainer within and across condition. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population. ### Conditions - Smoking, Cigarette ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Financial Incentive Treatment (FIT) ### Outcomes Primary Outcomes - Point-Prevalence Abstinence at End of Treatment Secondary Outcomes - Point-Prevalence Abstinence After Treatment - Point-Prevalence Abstinence at First Follow-up - Point-Prevalence Abstinence at Second Follow-up - Partner Point-Prevalence Abstinence - Smoking Heaviness ### Location - Facility: University of Georgia, Athens, Georgia, 30602, United States @@
## Effect of Continuing Versus Holding Metformin During Hospitalizations. - NCT ID: NCT06296836 - Study ID: 2024-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-30 - Lead Sponsor: University of Illinois at Chicago ### Study Description A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metformin ### Outcomes Primary Outcomes - Mean glucose levels Secondary Outcomes - Incidence of hyperglycemia greater than 300 mg/dl. - Incidence of hypoglycemia (Glu = 54 - 70). - Incidence of moderate hypoglycemia (Glu < 54) - Incidence of severe hypoglycemia (Glu < 54 with symptoms) - Mean lactic acid levels. - Incidence of lactic acid levels greater than 2.0. - Mean anion gap. - Incidence of anion gap > 11 - Incidence of elevated lactic acid level or anion gap. - Incidence of inadvertently not continuing metformin on discharge - GI adverse effects - Mortality ### Location - Facility: University of Illinois at Chicago, Chicago, Illinois, 60612, United States @@
## Biomarkers for Peripheral Circadian Clocks in Humans - NCT ID: NCT06296823 - Study ID: 22-0466 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2027-08-31 - Lead Sponsor: University of Colorado, Boulder ### Study Description The purpose of this project is to improve our understanding of peripheral circadian rhythms in humans. Circadian clocks are present in most tissues of the body with importance for optimal physiological function, health, and behavior. This project will utilize simulated jetlag protocols to systematically test novel hypotheses about the regulation of peripheral circadian rhythms in humans. Specifically, we will examine how changes in the time of when we are exposed to light and the timing of when we eat impacts proteins in the blood and saliva that represent rhythms from clocks in the brain (e.g., rhythms of the hormones melatonin and cortisol coordinated by the brain) and rhythms from clocks in body tissues (e.g., proteins made by immune and bone cells, and cells in the stomach and liver). We also aim to discover new blood-based biomarkers of peripheral rhythms in humans. We anticipate our findings will be the first step in developing novel circadian based treatments for aligning peripheral clocks under conditions such as jetlag, and for developing novel circadian biomarkers that will advance our scientific understanding of circadian rhythms. ### Conditions - Circadian Rhythms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Simulated jetlag protocol ### Outcomes Primary Outcomes - PYY - Ghrelin - Leptin - CRP - OMD - PAI-1 - IgE - CCL18 - PTH Secondary Outcomes - Glucose - Insulin - Proteomics ### Location - Facility: Sleep and Chronobiology Laboratory, Boulder, Colorado, 80303, United States @@
## Adaptive DBS to Offset STN Dysregulation During Exercise in PD - NCT ID: NCT06296810 - Study ID: 23-0847 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: University of Colorado, Denver ### Study Description The investigators conduct a prospective study to evaluate the effects of exercise on Parkinson's Disease brain biomarkers detected with the PerceptTM PC neurostimulator. ### Conditions - Parkinson Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - aDBS ### Outcomes Primary Outcomes - identification of L-beta frequency peak power Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Patient-centered Information on Permanent Contraception - NCT ID: NCT06296797 - Study ID: 5R18HS029432-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: University of California, San Francisco ### Study Description The goal of this study is to understand whether providing information to women with a strong desire to avoid future pregnancy about how tubal sterilization compares to long-acting reversible contraceptives improves perceived access to available contraceptives.Participants will:* Complete a baseline survey* Receive access to web-based educational resources* Complete a brief follow up survey immediately after exploring these web-based resources* Complete a follow-up survey 3 months after enrollingThe investigators will compare outcomes among participants provided with access to a new website (intervention) summarizing recent patient-centered outcomes research (PCOR) comparing interval laparoscopic tubal sterilization and long-acting reversible contraception (LARC) to control participants provided with access to the existing Planned Parenthood website on tubal sterilization. ### Conditions - Contraception - Reproductive Behavior - Contraception Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Control arm: Existing educational website - Advancing Access Website ### Outcomes Primary Outcomes - Perceived Access to Long Acting Contraceptives Secondary Outcomes - Person-Centered Contraceptive Counseling Measure - Consumer Assessment of Healthcare Providers and Systems - Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI) - Knowledge of Long-Acting Contraceptives - Use of preferred method of contraception - Would recommend website to a friend ### Location - Facility: University of California, San Francisco, San Francisco, California, 94143, United States @@
## An E-health Psychoeducation for People With Bipolar Disorders - NCT ID: NCT06296784 - Study ID: PG/2021/8551 - Status: COMPLETED - Start Date: 2021-05-26 - Completion Date: 2021-11-15 - Lead Sponsor: University of Cagliari ### Study Description This study aims to present data on the improvement of Quality of life (QoL), biological rhythms, anxiety, depressive symptoms and the correlations between QoL and biorhythms following an e-health psychoeducational intervention for Bipolar Disoirder (BD) during Covid-19 pandemic ### Conditions - Bipolar Disorder - Psychoeducation - COVID-19 Pandemic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - e-health psychoeducation ### Outcomes Primary Outcomes - Generalized Anxiety Disorder (GAD-7) - Hamilton Depression Rating Scale (HDRS21) - Short Form Health Survey (SF-12) - Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) Secondary Outcomes ### Location - Facility: San Giovanni di Dio Hospital, Cagliari, CA, 09100, Italy @@
## The Effect of a Combined Aerobic and Resistance Exercise (CARE) Training Programme on Cardiometabolic Outcomes in Individuals With Chronic Spinal Cord Injury: A Randomised Controlled Trial - NCT ID: NCT06296771 - Study ID: 12345678280233 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-22 - Completion Date: 2025-05-22 - Lead Sponsor: University of Bath ### Study Description The goal of this study is to investigate the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on the cardiometabolic health outcomes of individuals with chronic spinal cord injury. This study is a randomised controlled trial conducted at a single centre, consisting of two parallel arms. The main questions it aims to answer are:1. the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on cardiometabolic disease biomarker outcomes in individuals with chronic SCI2. the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on fitness and health outcomes.Twenty-one participants will be randomly assigned in a 2:1 allocation ratio. The participants will be assigned to either the dietary energy restriction and exercise group (D+E) group, which combines dietary energy restriction and exercise intervention, or the dietary energy restriction group (D) group, which just undergoes dietary energy restriction using sealed envelopes. ### Conditions - Spinal Cord Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dietary energy restriction group (D) - Dietary energy restriction and exercise group (D+E) ### Outcomes Primary Outcomes - Lipid profile - Fasting insulin concentration - Insulin sensitivity Secondary Outcomes - Resting matabolic rate - Body mass - Waist and hip circumference - Height - Total body fat percentage - Total Fat-Free Mass - Visceral Adipose Tissue - Total Fat Mass - Muscle, adipose and bone cross-sectional areas around the tibia and femur - Bone geometry and tissue densities around the tibia and femur - adipose tissue - Upper extremity muscle strength - Balance - Health-related quality of life - Shoulder Pain - Energy intake and dietary macronutrient composition - Energy expended in different physical activity intensities (MET categories) (kJ or kcal) ### Location - Facility: University of Bath, Bath, England, BA2 7AY, United Kingdom @@
## SiFi vs FNB Local Anesthesia for Hip Fracture Surgeries - NCT ID: NCT06296758 - Study ID: SiFi_HIP FRACTURE - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: University of Alberta ### Study Description The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question\[s\] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study. ### Conditions - Hip Fractures - Surgery - Anesthesia, Local ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Regional anesthesia ### Outcomes Primary Outcomes - Postoperative pain - Postoperative analgesics administered Secondary Outcomes - Mobilization - Time to readiness for discharge - Complications ### Location - Facility: University of Alberta Hospital, Edmonton, Alberta, t6g2b7, Canada @@
## Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib. - NCT ID: NCT06296745 - Study ID: 2024-KY-008-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-03-20 - Lead Sponsor: Guangzhou Medical University ### Study Description Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in treating non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. An international multi-center clinical study published in 2019 confirmed that double dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, the choice of treatment after resistance to targeted therapy is a hot topic in clinical practice, with 78% of patients in the study above who responded to double-dose osimertinib still showing progression at the time of follow-up. The purpose of this study was to observe the safety and efficacy of intrathecal pemetrexed for leptomeningeal metastasis from lung adenocarcinoma that progressed after a double dose of a third-generation TKI such as osimertinib. ### Conditions - Leptomeningeal Metastasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pemetrexed ### Outcomes Primary Outcomes - Clinical response rate - Neurological progression-free survival (NPFS) Secondary Outcomes - Overall survival - Incidence of treatment-related adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification - NCT ID: NCT06296732 - Study ID: NCPHOI-2024-01 - Status: RECRUITING - Start Date: 2023-10-19 - Completion Date: 2031-11-01 - Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology ### Study Description Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (\>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma. ### Conditions - Neuroblastoma - Ganglioneuroma - Ganglioneuroblastoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Duration of surgery intervention ### Outcomes Primary Outcomes - Duration of surgery intervention Secondary Outcomes - The influence of surgical risk factors - Cases of conversion from laparoscopic to cavity access - Comparison of surgeon's visual assessment of the tumor resection - 1-, 3-, 5-years local recurrence-free survival ### Location - Facility: Research Institute of Pediatric Hematology, Oncology and Immunology, Moscow, N/A, N/A, Russian Federation @@
## The Chit-Chat Educational Intervention to Promote Advance Care Planning in the Community - NCT ID: NCT06296719 - Study ID: ACP Community 2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description The purpose of this study is to estimate the effect size of the Chit-Chat intervention on ACP engagement among family members of older adults with multi-morbidity. ### Conditions - Old Age - Family Members ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Chit-Chat ### Outcomes Primary Outcomes - ACP engagement Secondary Outcomes - Knowledge of ACP ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer - NCT ID: NCT06296706 - Study ID: HB1801-010 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-06-01 - Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. ### Study Description This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure. ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Docetaxel for injection (Albumin-bound) - Taxotere (docetaxel) ### Outcomes Primary Outcomes - OS Secondary Outcomes - ORR by IRC - ORR by investigator - PFS - DCR - DoR - AE and SAE - Plasma concentration of docetaxel (free and total) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Diagnostic Accuracy of Pocket-size Lung Ultrasound in Pneumonia Etiology and Complications in Hospitalized Children - NCT ID: NCT06296693 - Study ID: 2023.062(051-DEFI/053-CE) - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-30 - Lead Sponsor: Centro Hospitalar Universitário de Santo António ### Study Description 1. Background and study aims Pneumonia is the leading infectious cause of death in children worldwide. Although the diagnosis is clinical, a chest radiograph (CXR) is often necessary to clarify it, exposing the patient to radiation. Ultrasound has been increasingly used in the evaluation of the lung parenchyma without exposing patients to radiation. The pocket-size Point-of-Care Ultrasound (POCUS) can be used at the patient's bedside proving comfort and saving time. Evidence suggests that ultrasound can detect CAP (community-acquired pneumonia) in children with similar accuracy and reliability as CXR. However, few studies evaluated the ability to distinguish the aetiology of pneumonia and none used a pocket-size POCUS device. This study aims to assess, for the first time, the diagnostic accuracy of a pocket-size POCUS device for the etiological diagnosis of CAP vs. CXR, in paediatric ages. Secondarily, the investigators intend to evaluate the correlation between CXR image vs. ultrasound, the correlation between clinical progression and ultrasound images, and the diagnostic accuracy to detect complications.2. Who can participate: The investigators will include, consecutively, all children aged \>12 months and \<18 years hospitalized to the Paediatric Department with the diagnosis of CAP on admission. The investigators will exclude children hospitalized with nosocomial pneumonia, with cystic fibrosis diagnosis or on long-term domiciliary ventilation.3. What does the study involve: The diagnostic accuracy between POCUS and CXR in differentiating the type of pneumonia will be assessed. All participants will perform a POCUS at admission, daily during hospitalization, 15 days and 1 month after discharge. All children will also undergo a CXR upon admission and whenever necessary.4. What are the possible benefits and risks of participating: Children will have a more frequent and serial assessment of CAP, which does not involve risks.5. Where is the study run from: The study if from Centro Materno Infantil do Norte - Centro Hospitalar Universitário de Santo António, a tertiary paediatric referral centre.6. When is the study starting and how long is it expected to run for:The recruitment period is expected to start in January/2024 and end in January 2025. ### Conditions - Pneumonia - Pneumonia, Viral - Pneumonia, Bacterial ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized ### Outcomes Primary Outcomes - POCUS vs. CXR for the etiological diagnosis of CAP Secondary Outcomes - CXR image vs. ultrasound - Clinical progression and ultrasound images - Complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Reiki for Cancer: Pain, Anxiety, and Stress - NCT ID: NCT06296680 - Study ID: EGE_UNI_SEVCAN_OZ_KAHVECI_0001 - Status: COMPLETED - Start Date: 2022-09-02 - Completion Date: 2023-06-30 - Lead Sponsor: Ege University ### Study Description The goal of this clinical trial is to investigate the effects of Reiki, Sham Reiki, and Progressive Relaxation Exercise on the levels of pain, anxiety, and stress in cancer patients.The main questions it aims to answer are:* Question 1: The effect of Reiki applied to cancer patients on the level of pain within the time series is higher in favor of the intervention group.* Question 2: The effect of Reiki applied to cancer patients on the level of anxiety within the time series is higher in favor of the intervention group.* Question 3: The effect of Reiki applied to cancer patients on cortisol levels within the time series is higher in favor of the intervention group.* Question 4: The effect of Reiki applied to cancer patients on the level of stress within the time series is higher in favor of the intervention group.* Participants have answered the questions in the Individual Identification Form, Visual Comparison Scale, State Anxiety Scale and Perceived Stress Scale and serum cortisol levels were evaluated in the pretest.* Afterwards, the patients in the intervention group received Reiki for four consecutive days, the patients in the placebo group received Sham Reiki, and the patients in the control group received Progressive Relaxation Exercise.* The patients in the experimental group received Reiki to the seven chakra regions and additional areas with pain for a total duration of 25-30 minutes for four days, with an average of three minutes.* The patients in the placebo group received Sham Reiki to the seven chakra regions for a total duration of 25-30 minutes for four days, with an average of three minutes.* Progressive Relaxation Exercise (PRE) group patients received PRE for four days.* On the 4th day, pain and anxiety levels (0-10 Likert-type scale) of the patients were evaluated after the last applications.* On the 21st day, the day of the next chemotherapy cycle, pain and anxiety levels were evaluated, state anxiety scale and perceived stress scale were administered, and serum cortisol level was evaluated in the morning before the start of chemotherapy.* At the 3rd month follow-up, pain and anxiety levels (0-10 Likert-type scale), state anxiety scale and perceived stress scale were evaluated. ### Conditions - Therapeutic Touch - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Reiki - Sham Reiki - Progressive Relaxation Exercise ### Outcomes Primary Outcomes - Stress levels Secondary Outcomes - Anxiety levels - Pain levels ### Location - Facility: Ege University, İzmir, N/A, 35100, Turkey @@
## Effect of Core Muscles Training On Patients With Chronic Mechanical Low Back Pain According To SALIBA'S Postural Classification System - NCT ID: NCT06296667 - Study ID: P.T.REC/012/003644 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-05-01 - Completion Date: 2024-04-01 - Lead Sponsor: Cairo University ### Study Description This study is designed as a pre and post experimental study. The purposes of this study are to evaluate the effect of core muscles training in patients with chronic mechanical low back pain according to SALIBA'S postural classification system (SPCS) in terms of pain intensity, function, and core muscles endurance. ### Conditions - Chronic Low-back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - core muscles training exercises ### Outcomes Primary Outcomes - pain intensity. - function disability - core muscles endurance Secondary Outcomes ### Location - Facility: Cairo University,Faculty of Physical Therapy, Giza, N/A, 11432, Egypt @@
## Effect of Empowerment-Based Interventions on Self-Efficacy and Self-Care Capacity Among Adults With Sickle Cell Disease - NCT ID: NCT06296654 - Study ID: 25/2021-22 dt. Dec. 12,2021 - Status: COMPLETED - Start Date: 2022-03-20 - Completion Date: 2022-10-22 - Lead Sponsor: University of Bahrain ### Study Description This study aimed to To investigate the effect of empowerment-based interventions (EBI) on self-efficacy and self-care capacity among adults with Sickle Cell Disease (SCD).The hypotheses of this study were: Adults with SCD who receive EBI exhibit higher self-efficacy, self- management capacity and HRQoL than those who do not. ### Conditions - Self-Efficacy - Self-Care ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Empowerment-Based Interventions - Standard Health Education ### Outcomes Primary Outcomes - Sickle Cell Self-Efficacy Secondary Outcomes - Self-Care Capacity ### Location - Facility: College of Health and Sport Sciences, University of Bahrain, Manama, N/A, 11511, Bahrain @@
## Needs Navigation for Caregivers of AYAs - NCT ID: NCT06296641 - Study ID: AAAU9477 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2025-05 - Lead Sponsor: Columbia University ### Study Description The overall aim of the study is to address unmet health-related social needs and reduce outcome disparities among AYA cancer survivors. Aim 1 aimed to refine a needs navigation model in partnership with expert consultants. Aim 2 and 3 will involve the deployment and pilot testing of the adapted needs navigation intervention among caregivers of younger AYAs with cancer. ### Conditions - Cancer in Adolescence ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Needs navigation intervention ### Outcomes Primary Outcomes - Number of (OR percentage of) participants who completed the intervention - Percentage of eligible participants who consented to be in study Secondary Outcomes - Personal Financial Wellness Scale (PFWS) / Comprehensive Score of Financial Toxicity (COST measure) ### Location - Facility: Columbia University Irving Medical Center, New York, New York, 10032, United States @@
## Rehabilitation Device for Hand Mirror Therapy - NCT ID: NCT06296628 - Study ID: 2000037049 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-04 - Lead Sponsor: Yale University ### Study Description This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Miraπ - Mirror Therapy ### Outcomes Primary Outcomes - Change in Jebsen-Taylor Hand Function Test score Secondary Outcomes ### Location - Facility: Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital, Bridgeport, Connecticut, 06610, United States @@
## Whether Vaginal Microbiota Affects Pregnancy Outcomes After Embryo Transfer - NCT ID: NCT06296615 - Study ID: 2020-022 - Status: COMPLETED - Start Date: 2021-04-01 - Completion Date: 2022-10-30 - Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute ### Study Description The goal of this observational study is to learn about vaginal microbial characteristics in the patients under in vitro fertilization treatment. The study aims to address the following questions: (1) Is there any difference in microbial composition between the pregnancy and non-pregnancy groups? (2) Is there any differences in specific bacterial species between the two groups? (3) What are the favorable or unfavorable profiles of vaginal microbiota associated with achieving pregnancy? Patients will be asked to complete a questionnaire regarding their basic characteristics, and vaginal secretions will be collected via vaginal swab during frozen-blastocyst transfer procedures. The study will compare vaginal microbiota between pregnant and non-pregnant patients to assess its potential influence on clinical outcomes. ### Conditions - Infertility, Female - Microbial Colonization ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of clinical pregnancy Secondary Outcomes ### Location - Facility: Shanghai Ji Ai Genetics & IVF Institute, Shanghai, N/A, N/A, China @@
## Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV) - NCT ID: NCT06296602 - Study ID: 2023/777 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-11-04 - Lead Sponsor: Centre Hospitalier Universitaire de Besancon ### Study Description This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation. ### Conditions - Pre-Exposure Prophylaxis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. ### Outcomes Primary Outcomes - prevalence HPV - typing HPV Secondary Outcomes - High risk HPV risk factors - Cytologist abnormalies ### Location - Facility: CHU Besançon, Besancon, N/A, 25000, France @@
## Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure - NCT ID: NCT06296589 - Study ID: HT94252310861 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-08 - Lead Sponsor: Veterans Medical Research Foundation ### Study Description The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction (TrIGR) Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt. The main questions it aims to answer are:Will TrIGR be comparable to PE in terms of PTSD symptom reduction? Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms? Will it be superior in improving trauma-related guilt and shame? ### Conditions - Stress Disorders, Post-Traumatic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Trauma Informed Guilt Reduction Therapy - Prolonged Exposure Therapy ### Outcomes Primary Outcomes - Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Secondary Outcomes - Patient Health Questionnaire-9 (PHQ-9) - Brief Psychosocial Functioning Inventory (B-IPF) - Trauma Related Guilt Inventory Cognitions Scale (TRGI) - Trauma Related Shame Inventory (TRSI) ### Location - Facility: Little Rock Veterans Health Care System (LRVHCS), Little Rock, Arkansas, 72205, United States @@
## Acceleration Time Assessment for Prediction of Critical Limb Ischemia - NCT ID: NCT06296576 - Study ID: CHM-2023/S49/06 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-05-01 - Lead Sponsor: Centre Hospitalier le Mans ### Study Description Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. The growing prevalence of this condition and the associated healthcare costs make it an important public health objective. Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries.Its diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and/or necrotic wounds, with a time to onset \> 2 weeks) and a haemodynamic criterion (ankle systolic pressure (ASP) \< 50mmHg or toe systolic pressure (TSP) \< 30 mmHg or transcutaneous oxygen pressure (TCPO2) \< 30 mmHg).Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery).The main aim of our study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible. ### Conditions - Critical Limb Ischemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - arterial ultrasound scan ### Outcomes Primary Outcomes - Evaluate the intrinsic diagnostic performance of the maximum systolic rise time (TASmax) in the distal arteries of the foot Secondary Outcomes ### Location - Facility: Centre Hospitalier de CHOLET, Cholet, N/A, 49300, France @@
## Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC - NCT ID: NCT06296563 - Study ID: SHR1316-ICC-SD-001 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-03-01 - Lead Sponsor: Lei ZHAO ### Study Description The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are:How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery.Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year. ### Conditions - Intrahepatic Cholangiocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HAIC - Adebrelimab - Apatinib ### Outcomes Primary Outcomes - Pathologic complete response (pCR) Secondary Outcomes - Objective response rate (ORR) - Event free survival (EFS) - Overall Survival (OS) - Disease Control Rate (DCR) ### Location - Facility: Shandong Cancer Hospital and Institute, Jinan, Shandong, 250117, China @@
## Enhancing Digitally Delivered Diabetes Education With Real-Time CGM - NCT ID: NCT06296550 - Study ID: Dulce Digital CGM - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-04-30 - Lead Sponsor: Scripps Whittier Diabetes Institute ### Study Description The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients. ### Conditions - Diabetes Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dulce Digital Text Messaging Intervention - CGM Device ### Outcomes Primary Outcomes - HbA1c Secondary Outcomes - CGM Metric Time in Range - CGM Metric Time above Range - CGM Metric Time Below Range - Summary of Diabetes Self Care Activitiers (SDSCA) Survey - Diabetes Distress Scale ### Location - Facility: Scripps Whittier Diabetes Institute, San Diego, California, 92121-1520, United States @@
## Effectiveness of Balance Training And Dynamic Neuromuscular Stabilization Training in Amateur Athletes With Chronic Ankle Instability - NCT ID: NCT06296537 - Study ID: E-10840098-202.3.02-1434 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-07 - Lead Sponsor: Medipol University ### Study Description The goal of this clinical trial is to determine and compare the effects of balance and dynamic neuromuscular stabilization training on ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance of amateur athletes with chronic ankle instability. The main questions it aims to answer are:* Do balance and dynamic neuromuscular stabilization training positively affect functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains?* Does balance training or dynamic neuromuscular stabilization training have a more positive effect on functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains?Participants will apply:* a dynamic neuromuscular stabilization training program consisting of a series of special exercises based on the developmental kinesiology steps of a healthy baby.* balance training which consist of an effective postural stability program.* conventional training program which consist of stretching, joint range of motion, strengthening and postural control exercises.Researchers will compare balance and dynamic neuromuscular stabilization training to see if effectiveness of ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance. ### Conditions - Ankle Inversion Sprain - Chronic Instability of Joint - Chronic Pain - Athlete Foot ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dynamic Neuromuscular Stabilization Training (DNS) - Balance Training - Conventional Training ### Outcomes Primary Outcomes - Star Excursion Balance Test - Balance Error Scoring System (BESS) Secondary Outcomes - Foot and Ankle Ability Measurement (FAAM) - Cumberland Ankle Instability Questionnaire - International Physical Activity Questionnaire - Short Form - Manual Muscle Strength Test with Hand Dynamometer - Single Heel Lift Test - Joint Position Sense Test - Foot Lift Test - Blazepod Reaction Time - Side Hop Test ### Location - Facility: Sevval Yeşilkır, Istanbul, Beşiktaş, 34347, Turkey @@
## Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot - NCT ID: NCT06296524 - Study ID: SPC-2022-09 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-03-30 - Lead Sponsor: Maharishi Markendeswar University (Deemed to be University) ### Study Description Pes Planus is a medical condition in which arch of the foot is flattened, causing the entire sole of the foot to contact the floor. For those with flat feet, footcore exercises might be an effective non-invasive therapy. Footcore exercises aim to strengthen the intrinsic foot muscles that maintain the foot arch, enhance foot function and reduce the risk of injury in persons with flatfoot. ### Conditions - Flatfoot ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Footcore exercises and conventional therapy - conventional therapy ### Outcomes Primary Outcomes - Navicular Drop Test - Harris Mat for Plantar Pressure Distribution Secondary Outcomes ### Location - Facility: MMIPR, Ambala, Haryana, 133207, India @@
## The Influence of Acute Moderate-intensity Continuous Exercise on Appetite Regulation - NCT ID: NCT06296511 - Study ID: Loughborough University - Status: COMPLETED - Start Date: 2023-06-23 - Completion Date: 2023-11-07 - Lead Sponsor: Loughborough University ### Study Description A key area of obesity research has focused on the link between appetite, energy balance and weight control. Within this area, several appetite-related hormones and cellular cytokines have been identified as key signals influencing appetite and food intake. This includes the appetite-suppressing hormone oxyntomodulin (OXM) and a cellular stress-induced cytokine growth differentiation factor 15 (GDF-15).The aims of this study are: (1) to investigate the effect of acute moderate-intensity continuous exercise on oxyntomodulin and GDF-15 concentrations; (2) to investigate whether exercise-induced changes in circulating OXM and GDF-15 concentrations are correlated with subjective appetite perceptions and subsequent energy intake. ### Conditions - Obesity - Overweight ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Exercise ### Outcomes Primary Outcomes - Oxyntomodulin - Growth Differentiation Factor 15 Secondary Outcomes - Visual analogue score (VAS) for subjective appetite - Energy intake ### Location - Facility: Loughborough University, Loughborough, N/A, LE11 3TU, United Kingdom @@
## Application of L-PRF in Periodontal Surgery - NCT ID: NCT06296498 - Study ID: 20230505HU - Status: RECRUITING - Start Date: 2023-08-19 - Completion Date: 2026-03 - Lead Sponsor: The University of Texas Health Science Center at San Antonio ### Study Description The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception. ### Conditions - Periodontal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Leukocyte Platelet-rich fibrin - Standard of care OFD ### Outcomes Primary Outcomes - Probing depth - Postoperative Pain (PROM) Secondary Outcomes ### Location - Facility: The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States @@
## Safer Aging With Diabetes Monitoring - NCT ID: NCT06296485 - Study ID: IRB-1996616 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2028-01-31 - Lead Sponsor: Kaiser Permanente ### Study Description Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes. ### Conditions - Diabetes Mellitus, Type 2 - Hypoglycemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - SAGE Group Sessions - SAGE Group Sessions + Diabetes Pharmacist - Usual Care ### Outcomes Primary Outcomes - Hypoglycemia aggregate outcome Secondary Outcomes - Self-reported hypoglycemia - Hypoglycemia-related utilization - Diabetes Distress - Hypoglycemia Confidence - Hypoglycemia Distress ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## De Quervain's Disease in the Acute Phase:a Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy. - NCT ID: NCT06296472 - Study ID: MDQ23 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2025-12-30 - Lead Sponsor: Istituto Ortopedico Rizzoli ### Study Description The objective of the study is to compare pain reduction and disability reduction in two groups of patients diagnosed with de Quervain syndrome who will undergo ultrasound-guided infiltrative treatment with corticosteroid as per normal clinical practice:* the control group will subsequently be subjected to a standard treatment based on the European guidelines of the HANDGUIDE group,* the experimental group will subsequently carry out a program of eccentric exercises. ### Conditions - De Quervain Disease - Hand Tenosynovitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation - Standard ### Outcomes Primary Outcomes - Numeric Pain Rating Scale - Numeric Pain Rating Scale - Numeric Pain Rating Scale - Numeric Pain Rating Scale Secondary Outcomes - Disabilities of Arm, Shoulder and Hand - Disabilities of Arm, Shoulder and Hand - Disabilities of Arm, Shoulder and Hand - Disabilities of Arm, Shoulder and Hand - Patient-Rated Wrist Evaluation - Patient-Rated Wrist Evaluation - Patient-Rated Wrist Evaluation - Patient-Rated Wrist Evaluation ### Location - Facility: Istituto Ortopedico Rizzoli, Bologna, N/A, 40136, Italy @@
## Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation - NCT ID: NCT06296459 - Study ID: 20220556HU - Status: RECRUITING - Start Date: 2022-09-21 - Completion Date: 2025-03 - Lead Sponsor: The University of Texas Health Science Center at San Antonio ### Study Description A closed sinus augmentation is performed for dental implant placement. ### Conditions - Dental Implant ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 3D R100 scanner - Conventional Radiograph ### Outcomes Primary Outcomes - Dimensional Change in augmentation at 8mm - Dimensional Change in augmentation at 10mm - Dimensional Change in augmentation at 12mm Secondary Outcomes ### Location - Facility: The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States @@

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