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Previous studies had examined the relationship between emotion regulation and mental health in youth; maladaptive emotion regulation would increase the individual's depressive and anxiety symptoms. Carstensen proposed social emotion theory in 1995 Selectivity theory (SST) refers to the need for emotion regulation, which activates Social participation in late adulthood. SST assumes that young people are more interested in social interaction behaviors related to information seeking and building self-concept. characteristics of youth affected by many normative challenges such as adolescence, school transitions, and more complex social Landscape; Adaptive emotion regulation will reduce risk of clinical emotion attacks of illness, especially depression and anxiety.To explore the relationship between emotion regulation and mental health from a psychosocial developmental aspect, we focused on the interaction between individual and environment. Compared with the previous generation, most youths of this generation were participating in social activities and building up interpersonal relationships through the internet, suggesting the internet was an important social context. conditions: Major Depressive Disorder conditions: Anxiety Disorder conditions: Attention Deficit Hyperactivity Disorder (ADHD) conditions: Adjustment Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: The Difference and Similarity in Emotional Regulation Strategy Patterns between Western and Eastern Countries. sex: ALL minimumAge: 15 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: Chang-Geng Medical Foundation Chang-Geng Memorial Hospital status: RECRUITING city: Keelung zip: 204 country: Taiwan name: Tzuyu Liu role: CONTACT phone: (02)24329292 phoneExt: 2720 email: [email protected] lat: 25.12825 lon: 121.7419 hasResults: False
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<|newrecord|> nctId: NCT06271941 id: HAPC-RCT briefTitle: Prophylactic Double Thermal Ablation and Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-10-01 date: 2028-04-01 date: 2024-02-22 date: 2024-02-22 name: Centre hospitalier de l'Université de Montréal (CHUM) class: OTHER briefSummary: Large (≥20mm) colorectal polyps often harbor areas of advanced neoplasia, making them immediate colorectal cancer (CRC) precursors. Such polyps have to be completely removed to prevent CRC and to avoid surgery and/or adjuvant therapy. The laterally spreading lesions (LSLs) are removed via endoscopic mucosal resection (EMR). However, recurrence is common. Recent studies have found that the use of hybrid argon plasma coagulation (h-APC) for the ablation of the margin and base of resection post-EMR could significantly reduce the recurrence rate, and complete closure of the post-EMR defect can prevent other adverse pre- and post-procedure outcomes such as bleeding.
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We hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation post-EMR for large (≥20mm) colorectal LSLs will demonstrate a lower recurrence rate compared to Snare Tip Soft Coagulation (STSC) margin ablation. We also hypothesize that performing complete closure of the EMR defect will result in lower rates of adverse events compared to cases where no defect closure is performed. conditions: Colorectal Cancer conditions: Polyp of Colon studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 892 type: ESTIMATED name: Hybrid Argon Plasma Coagulation (h-APC) name: Snare tip soft coagulation (STSC) measure: To compare the recurrence rates after EMR colorectal between the h-APC and SSTC methods measure: To assess the potential advantages associated with a complete defect closure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de l'Université de Montréal city: Montréal state: Quebec country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06271928 id: TJ-IRB20220634-yijingkeli briefTitle: A Multicenter Clinical Study of Yijing Keli in the Treatment of Ovarian Aging overallStatus: RECRUITING date: 2021-10-01 date: 2024-01-01 date: 2025-01-01 date: 2024-02-22 date: 2024-02-22 name: Tongji Hospital class: OTHER briefSummary: Ovarian aging (OA) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating OA. We have created a new Chinese herbal combination Yijing Keli, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of Yijing Keli in therapy of OA. We aim to provide a solid evidence for TCM in therapy of OA. conditions: Ovarian Aging studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Yijing Keli measure: the recovery rate of ovarian function sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan country: China name: jinjin zhang, professor role: CONTACT phone: +8683663078 email: [email protected] name: yan zhang, MD role: CONTACT phone: +8683663078 lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06271915 id: cervical spine mobilization briefTitle: Role of Cervical Spine Mobilization on Lateral Epicondylitis overallStatus: RECRUITING date: 2024-02-15 date: 2024-05-15 date: 2024-06-15 date: 2024-02-22 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: The study's primary goal is to examine the effectiveness of Mulligan's technique in reducing hyperalgesia in lateral epicondylitis, focusing on cervical spine, while also investigating its influence on central sensitization in relation to lateral epicondylitis. conditions: Lateral Epicondylitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: SNAGs - eccentric exercise measure: Leeds assessment of neuropathic symptoms and sign (LANSS) scale measure: Pain-free hand grip test measure: The Numeric Rating Scale (NRS) sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Outpatient physical therapy, Faculty of physical therapy status: RECRUITING city: Giza zip: 2334 country: Egypt name: Ahmed ElMelhat role: CONTACT phone: 01112595022 email: [email protected] lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06271902 id: IRB-2023-531 briefTitle: Effects of the Singapore Youth Shoulder Overuse Injury Prevention Program Among Youth Volleyball Athletes in Singapore overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-02-22 date: 2024-02-22 name: Nanyang Technological University class: OTHER briefSummary: The Singapore Youth Shoulder Overuse Injury Prevention Program (YoSO-IPP) includes an exercise segment and an education segment. This study will (1) assess the effects of the exercise segment, and (2) assess the effects of the education segment among youth volleyball athletes using a randomized controlled trial over 12 weeks. Performance outcome measures of shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion will be used to assess the effects of the exercise segment. Knowledge scores via an online questionnaire will be used to assess the effects of the education segment.
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Hypothesis: The YoSO-IPP will have an effect on shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion and on knowledge scores. conditions: Sport Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized controlled trial with an intervention group and a control group to evaluate the effects of the YoSO-IPP. The intervention group will perform the exercises and attend the online educational workshop. The control group will only perform lower body stretching exercises which is considered as a sham program. primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Singapore Youth Shoulder Overuse Injury Prevention Program name: Lower body stretching program measure: Shoulder external rotation strength measure: Internal rotation range of motion measure: Thoracic rotation range of motion measure: Knowledge of overuse injuries measure: Shoulder overuse injury prevalence measure: Elbow overuse injury prevalence measure: Shoulder overuse injury severity measure: Elbow overuse injury severity sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Nanyang Technological University city: Singapore country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06271889 id: B.10.1.TKH.4.34.H.GP.0.01/330 briefTitle: The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum Bonding at the First Phase of Delivery overallStatus: RECRUITING date: 2021-11-24 date: 2024-02-24 date: 2024-11-20 date: 2024-02-22 date: 2024-02-22 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: University of Health Sciences, Istanbul Umraniye training and Research Hospital, Clinic of Obstetrics and gynecology, birth, maternity and Child Health Hospital, Aydın to the clinic, pregnant women, pregnant women in active labor act, and received acceptance to delivery to the fetal heart sound by existing tripped; fetal heart sounds of pregnant women, anxiety, pain and the birth in order to determine the effect of connecting the end of the level will be conducted. The study will guide midwives in reducing the anxiety or pain of pregnant women. conditions: Delivery Fear conditions: Labor Pain conditions: Maternal-Fetal Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized parallel controlled experimental design primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Which of the participants is the control or intervention group will be selected by randomization. whoMasked: PARTICIPANT count: 128 type: ESTIMATED name: Non-stress test measure: VİSUAL ANALOG SCALE measure: STATUS AND CONTINUOUS ANXIETY SCALE measure: Postpartum Attachment Scale (PASAS): sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Saglık Bilimleri Universitesi status: RECRUITING city: Istanbul country: Turkey name: YASEMİN AYDIN KARTAL role: CONTACT phone: +90 5432870029 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06271876 id: 0011 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength, Vertical Jump Performance and Muscle Oxygen Saturation overallStatus: NOT_YET_RECRUITING date: 2024-03-03 date: 2024-03-09 date: 2024-03-19 date: 2024-02-22 date: 2024-02-22 name: Sierra Varona SL class: OTHER name: Universidad Europea de Madrid briefSummary: Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and muscular strength in lower limbs, in both healthy and pathological subjects, as well as the association between such fatigue and other variables, including maximal inspiratory pressure and muscle tissue oxygen levels.
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According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence muscular strength, exercise capacity and muscle tissue oxygenation.
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In this study, subjects will be divided into three groups: experimental group , activation group and control group.
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Measurements of variables, such as maximal inspiratory pressure, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and vertical jump performance, will be conducted. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: Inspiratory muscle training measure: Respiratory muscle strength measure: Diaphragmatic thickness and thickening fraction measure: Diaphragm movement curve measure: Vertical jump performance sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06271863 id: Soh-Med-23-11-08MS briefTitle: Outcome of Conservative Management in Cases of Pre Mature Rupture of Membranes (PROM) Between 20 and 28 Weeks of Pregnancy in Sohag City Hospitals overallStatus: ENROLLING_BY_INVITATION date: 2023-06-01 date: 2024-06-01 date: 2024-07-01 date: 2024-02-22 date: 2024-02-22 name: Sohag University class: OTHER briefSummary: Prospective observational study conditions: PROM, Preterm (Pregnancy) studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Conservation vs termination in cases of PROM 20 to 28 weeks of pregnancy sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Sohag university hospital city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06271850 id: P.T.REC/012/004949 briefTitle: Effect of Pilates Exercises on Forward Head Posture in Breastfeeding Women overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-06-20 date: 2024-07-20 date: 2024-02-22 date: 2024-02-23 name: Cairo University class: OTHER briefSummary: Musculoskeletal postural issues stemming from infant care positions can exert a significant impact on the cervical, thoracic, and lumbar spine. These positions can induce mechanical alterations in the spine's natural curvature, potentially resulting in long-term deformities in postnatal women such as forward head posture (FHP), ultimately contributing to physical disability over the long term.so, The purpose of this study is to determine the effect of Pilates exercises on FHP in breastfeeding women. conditions: Breastfeeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Ergonomics breastfeeding training name: Pilates exercises measure: Measurement of craniovertebral angle (CVA) measure: Assessment of neck pain intensity measure: Measurement of cervical range of motion measure: Evaluation of disability due to neck pain measure: Assessment of neck muscle fatigue measure: Assessment of breastfeeding self-efficacy measure: Measurement of weight and height of baby measure: Assessment of Health-Related Quality of Life sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06271837 id: D781AC00001 briefTitle: A Study of T-DXd in Patients With Selected HER2-overexpressing Tumors overallStatus: RECRUITING date: 2024-02-18 date: 2025-10-30 date: 2026-04-17 date: 2024-02-22 date: 2024-04-23 name: AstraZeneca class: INDUSTRY name: Daiichi Sankyo Co., Ltd. briefSummary: This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressingsolid tumors which are not eligible for curative therapy. conditions: Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer) studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: This study is Open-Label Study. count: 50 type: ESTIMATED name: Trastuzumab deruxtecan measure: Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) measure: Confirmed Objective Response Rate (ORR) by investigator assessment measure: Duration of Response (DoR) by Independent Central Review (ICR) measure: Duration of Response (DoR) by investigator assessment measure: Disease control rate (DCR) by Independent Central Review (ICR) measure: Disease control rate (DCR) by investigator assessment measure: Confirmed best objective response (BOR) by Independent Central Review (ICR) measure: Confirmed best objective response (BOR) by investigator assessment measure: Progression-free survival (PFS) by Independent Central Review (ICR) measure: Progression-free survival (PFS) by investigator assessment measure: Overall survival (OS) measure: Occurrence of adverse events (AEs) and serious adverse events (SAEs) measure: Pharmacokinetics (PK) of T-DXd measure: Immunogenicity of T-DXd sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Beijing zip: 100142 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Changchun zip: 130021 country: China lat: 43.88 lon: 125.32278 facility: Research Site status: NOT_YET_RECRUITING city: Changsha zip: 410013 country: China lat: 28.19874 lon: 112.97087 facility: Research Site status: NOT_YET_RECRUITING city: Changzhou zip: 213004 country: China lat: 31.77359 lon: 119.95401 facility: Research Site status: NOT_YET_RECRUITING city: Chengdu zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Research Site status: NOT_YET_RECRUITING city: Chongqing zip: 400030 country: China lat: 29.56278 lon: 106.55278 facility: Research Site status: NOT_YET_RECRUITING city: Dongyang zip: 322100 country: China lat: 29.26778 lon: 120.22528 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510145 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510630 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: WITHDRAWN city: Haikou zip: 570311 country: China lat: 20.04583 lon: 110.34167 facility: Research Site status: NOT_YET_RECRUITING city: Hangzhou zip: 310022 country: China lat: 30.29365 lon: 120.16142 facility: Research Site status: RECRUITING city: Harbin zip: 150081 country: China lat: 45.75 lon: 126.65 facility: Research Site status: NOT_YET_RECRUITING city: Hefei zip: 230031 country: China lat: 31.86389 lon: 117.28083 facility: Research Site status: NOT_YET_RECRUITING city: Kunming zip: 650118 country: China lat: 25.03889 lon: 102.71833 facility: Research Site status: NOT_YET_RECRUITING city: Lishui zip: 323000 country: China lat: 28.46042 lon: 119.91029 facility: Research Site status: NOT_YET_RECRUITING city: Nanchang zip: 330029 country: China lat: 28.68396 lon: 115.85306 facility: Research Site status: NOT_YET_RECRUITING city: Shanghai zip: 200011 country: China lat: 31.22222 lon: 121.45806 facility: Research Site status: NOT_YET_RECRUITING city: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 facility: Research Site status: NOT_YET_RECRUITING city: Shenyang zip: 110016 country: China lat: 41.79222 lon: 123.43278 facility: Research Site status: NOT_YET_RECRUITING city: Xuzhou zip: 221009 country: China lat: 34.18045 lon: 117.15707 facility: Research Site status: NOT_YET_RECRUITING city: Yinchuan zip: 750004 country: China lat: 38.46806 lon: 106.27306 facility: Research Site status: NOT_YET_RECRUITING city: Zhengzhou zip: 450008 country: China lat: 34.75778 lon: 113.64861 hasResults: False
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<|newrecord|> nctId: NCT06271824 id: 23-1519 briefTitle: Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities overallStatus: RECRUITING date: 2024-03-21 date: 2024-06 date: 2024-06 date: 2024-02-22 date: 2024-03-26 name: University of North Carolina, Chapel Hill class: OTHER briefSummary: The goal of this clinical trial is to test the feasibility, acceptability and preliminary social/emotional well-being outcomes of a tailored, online self-compassion-based resilience course for caregivers of children with physical disabilities. The main questions it aims to answer are:
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1. Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities?
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2. Is participation in the resilience course associated with improvements in caregiver stress, anxiety, depression, burden, caregiver uplifts, self-compassion, emotion regulation and/or resilience?
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Participants will complete a screening, a verbal consent process and an electronic pre-course survey. Then, they will participate in a 6-session weekly online course with other caregivers and led by a certified Mindful Self-Compassion instructor. The course has been created with feedback from caregivers and includes skills for recognizing and coping with difficult emotions while connecting with others who have similar caregiving experiences. After the course, participants will repeat the electronic survey and will provide feedback on the course during a live, online feedback session. conditions: Stress conditions: Caregiver Burden conditions: Anxiety conditions: Depressive Symptoms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 12 type: ESTIMATED name: Self-Compassion Based Resilient Caregiving Course measure: Percentage of participants who withdraw from course measure: Percentage of participants who attend at least 4 of 6 intervention sessions measure: Percentage of participants who rate the course as "acceptable" or "completely acceptable" measure: Percentage of intervention topics covered measure: Mean Change in Perceived Stress as Measured by the Perceived Stress Scale (PSS-10 item) at 6 weeks measure: Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 6 weeks measure: Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 6 weeks measure: Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 6 weeks measure: Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 6 weeks measure: Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 6 weeks measure: Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 6 weeks measure: Mean Change in Difficulties with Emotion Regulation as measured by the Difficulties in Emotion Regulation-Short Form Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Monica Coudurier role: CONTACT email: [email protected] lat: 35.9132 lon: -79.05584 hasResults: False
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<|newrecord|> nctId: NCT06271811 id: UJAPFPS briefTitle: Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome acronym: flossing overallStatus: COMPLETED date: 2023-01-09 date: 2023-11-14 date: 2023-11-20 date: 2024-02-22 date: 2024-02-23 name: University of Jaén class: OTHER name: University of Jaen briefSummary: The goal of this clinical trial is to assess the efficacy of adding flossing band therapy to conventional physiotherapy in patients diagnosed with Patellofemoral Pain Syndrome (PFPS). The main questions it aims to answer are:
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* Does combining flossing band therapy with conventional physiotherapy lead to greater improvements in pain, strength, and function compared to conventional physiotherapy alone?
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* What are the effects of flossing band therapy on knee functionality and muscle strength in PFPS patients? Participants will be randomly assigned to either the Standard Physiotherapy group or the Flossing Band and Physiotherapy group. In addition to conventional physiotherapy, participants in the Flossing Band group will undergo sessions where a flossing band is applied around the knee joint to provide moderate compression. Researchers will compare the two groups to determine if the addition of flossing band therapy enhances treatment outcomes for PFPS. conditions: Anterior Knee Pain Syndrome conditions: Patellofemoral Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: Flossing band name: Conventional physiotherapy measure: Disability related to patellofemoral pain measure: Knee extensor muscle strength measure: Pain report measure: Self-reported function measure: Short Form-36 (SF-36) measure: Berg Balance Scale (BBS) measure: Pittsburgh Sleep Quality Index measure: Brief Pain Questionnaire measure: Perceived Stress Scale sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Jaen city: Jaen zip: 23009 country: Spain lat: 37.76922 lon: -3.79028 hasResults: False
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<|newrecord|> nctId: NCT06271798 id: P.T.REC/012/004867 briefTitle: Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women overallStatus: RECRUITING date: 2024-02-20 date: 2024-04-05 date: 2024-04-19 date: 2024-02-22 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: The purpose of this study will be to determine the effect of resistive exercises on varicose veins in postmenopausal women, the effect of aerobic exercise on varicose veins in postmenopausal women and to compare between the effect of resistive exercise versus aerobic exercise on varicose veins in post menopausal women. conditions: Varicose Veins studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: Life style modification advice name: Resistive exercise name: Aerobic exercises measure: Peak popliteal vein velocity measure: Visual analogue scale measure: Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) measure: 6-minute. walk test sex: FEMALE minimumAge: 50 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University status: RECRUITING city: Giza country: Egypt name: Mai Saif Elnasr Ghietah, M.Sc. Stud role: CONTACT name: Mai Mohamed Ali, PhD role: CONTACT name: Soheir Mahmoud Elkosery, PhD role: PRINCIPAL_INVESTIGATOR name: Hossam Aldin H. Kamel, PhD role: PRINCIPAL_INVESTIGATOR lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06271785 id: 49RC22_0354 briefTitle: Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery acronym: ISEPEE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2026-10-01 date: 2024-02-22 date: 2024-03-12 name: University Hospital, Angers class: OTHER_GOV briefSummary: This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children.
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This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues.
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Electrical sources are then fused on structural magnetic resonance imaging (MRI).
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Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI.
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Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%.
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Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data.
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Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI.
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Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected.
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To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles.
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This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG.
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The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome.
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Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure. conditions: Epilepsy in Children studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: HR-EEG recording measure: Prediction accuracy index measure: Localization of the epileptogenic zone (Baseline) measure: Localization of the epileptogenic zone (After Surgery) measure: preoperative accuracy of epileptogenic source localization measure: prognostic value of HFO measure: Impact of method of sources reconstruction, conditions of EEG recordings and sampling rate measure: health-economic modeling sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Angers university hospital, Pédiatric department city: Angers zip: 49000 country: France name: Patrick Van Bogaert, Professor role: CONTACT phone: 02 41 35 48 46 email: [email protected] lat: 47.46667 lon: -0.55 facility: Lille University Hospital, Clinical Neurophysiology Department city: Lille zip: 59000 country: France name: Philippe DERAMBURE, Professor role: CONTACT phone: 03 20 44 63 62 email: [email protected] lat: 50.63297 lon: 3.05858 facility: Civil Hospices of Lyon, Functional Neurology Department city: Lyon zip: 69677 country: France name: Julien Jung, Doctor role: CONTACT phone: 04 72 35 79 00 email: [email protected] lat: 45.74848 lon: 4.84669 facility: Marseille Timone University Hospital, Epileptology and Cerebral Rhythmology Department city: Marseille zip: 13000 country: France name: Fabrice BARTOLOMEI, Professor role: CONTACT phone: 04 91 38 46 84 email: [email protected] lat: 43.29551 lon: 5.38958 facility: Nancy University Hospital, Neurology Department city: Nancy zip: 54000 country: France name: Louis Maillard, Professor role: CONTACT phone: 03 83 85 16 09 email: [email protected] lat: 48.68439 lon: 6.18496 facility: Paris Neck University Hospital city: Paris zip: 75015 country: France lat: 48.85341 lon: 2.3488 facility: Paris Robert-Debré University Hospital, Department of Physiology, Pediatric functional explorations city: Paris zip: 75019 country: France name: François-Xavier MAUVAIS, Doctor role: CONTACT phone: 01 40 03 20 00 email: [email protected] lat: 48.85341 lon: 2.3488 facility: Rothschild Ophtalmologic Fondation, Pediatric neurosurgery Department city: Paris zip: 75019 country: France name: Emmanuel Raffo, Professor role: CONTACT phone: 01 48 03 68 17 email: [email protected] lat: 48.85341 lon: 2.3488 facility: Rennes University Hospital, Pediatric department city: Rennes zip: 35000 country: France name: Silvia Adriana NAPURI PEIRANO, Doctor role: CONTACT phone: 02 99 26 58 34 email: [email protected] lat: 48.11198 lon: -1.67429 hasResults: False
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<|newrecord|> nctId: NCT06271772 id: 18-26045-RII briefTitle: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II acronym: REAGIR II overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-12-31 date: 2025-07-31 date: 2024-02-22 date: 2024-02-22 name: University of California, San Francisco class: OTHER name: Stanford University name: Aravind Eye Care System name: Federal University of São Paulo briefSummary: Rose Bengal Electromagnetic Activation with Green light for Infection Reduction II (REAGIR II) is a randomized, double-masked feasibility study. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT).
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Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive and/or culture positive typical (I.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 of worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:
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* Group 6, RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus RB-PDT
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* Group 7, Sham RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham RB-PDT conditions: Bacterial Keratitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Difluprednate Ophthalmic name: Rose Bengal name: Moxifloxacin Ophthalmic measure: Best Spectacle-Corrected Visual Acuity measure: Best Spectacle-Corrected Visual Acuity measure: Scar size measure: Scar depth measure: Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federal University of São Paulo city: São Paulo country: Brazil name: Ana Luisa Hofling Lima, MD, PhD role: CONTACT email: [email protected] lat: -23.5475 lon: -46.63611 facility: Aravind Eye Care System city: Madurai state: Tamil Nadu country: India name: N V Prajna role: CONTACT email: [email protected] lat: 9.91769 lon: 78.11898 hasResults: False
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<|newrecord|> nctId: NCT06271759 id: PSYFRAG briefTitle: Psychological Effects of a Set of Functional Fragrances acronym: PSYFRAG overallStatus: RECRUITING date: 2024-03-15 date: 2024-08-15 date: 2024-08-15 date: 2024-02-22 date: 2024-04-09 name: University of Bucharest class: OTHER name: IFF (International Flavors & Fragrances) briefSummary: The goal of this clinical trial is to test the effectiveness of an intervention designed to improve wellness through aromatherapy. The main question it aims to answer is whether this intervention can deliver beneficial psychological effects on stress, anxiety and mood, as well as overall well-being.
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Participants will receive a bottle with a no/neutral odor or an essential oil (or a blend of essential oils) for home administration and will be asked to complete a series of scales pre and post self-administration twice one week apart. conditions: Stress conditions: Anxiety conditions: Well-Being, Psychological conditions: Mood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Fragrance inhalation measure: Affective states - relaxation measure: Affective states - contentment measure: Affective states - happiness measure: Affective states - stress measure: Affective states - motivation measure: Affective states - tension measure: Emotional changes measure: General mental health - Depression measure: General mental health - Anxiety measure: General mental health - Stress sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bucharest status: RECRUITING city: Bucharest zip: 050663 country: Romania name: Cezar Giosan, PhD role: CONTACT phone: +40730908050 email: [email protected] lat: 44.43225 lon: 26.10626 hasResults: False
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<|newrecord|> nctId: NCT06271746 id: TCH101 briefTitle: Treatment of Fibromyalgia With the FibroNova Neuromodulation Device overallStatus: RECRUITING date: 2024-03-04 date: 2025-03-01 date: 2025-06-01 date: 2024-02-22 date: 2024-04-11 name: Theranica class: INDUSTRY briefSummary: Fibromyalgia (FM) is a chronic disorder that affects the musculoskeletal system, causing widespread pain, tenderness, and fatigue. It is estimated to affect 1-5% of the population. The primary symptom of fibromyalgia is widespread pain throughout the body, accompanied by tenderness and sensitivity to pressure.
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Pharmacological treatments include drugs such as antidepressants, anticonvulsants, and painkillers. Another treatment option for fibromyalgia is the use of devices such as Quell. Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy (CBT), biofeedback, and relaxation techniques.
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Remote Electrical Neuromodulation (REN) is a non-pharmacological technology that induces subthreshold, non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation (CPM), to produce generalized pain relief in remote body areas. Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents, as well as migraine prevention.
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The current study examines the safety and efficacy of REN technology, implemented via the FibroNova device for treating fibromyalgia pain and related symptoms. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment. Randomized, double-blind, sham-controlled primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 170 type: ESTIMATED name: FibroNova (Active mode) name: FibroNova (Sham mode) measure: Mean reduction in pain level during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4) measure: Device safety (rate of adverse events and device related adverse events) measure: Mean change in the Revised Fibromyalgia Impact Questionnaire FIQR total score measure: Mean change in FIQR functionality sub-scale score measure: Mean change in FIQR pain item score measure: Mean change in Brief Pain Inventory (BPI) score measure: Improvement in patient global impression according to PGIC score measure: Mean reduction in functional disability during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4) measure: Improvement in quality of life measure: Improvement in sleep quality measure: Mean change in level of depression measure: Mean change in level of anxiety measure: Mean change in level of cognitive impairment measure: Mean change in level of cognitive presenteeism measure: Mean reduction of at least 30% in pain level measure: Rate of treatment tolerability measure: User experience measure: Patient Global Impression- change (PGI-C measure: Patient Global Impression- change (PGI-C)- mid study: sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Professionals status: RECRUITING city: Chesterfield state: Missouri zip: 63005 country: United States name: Shahmir Kahn role: CONTACT phone: 636-220-1200 email: [email protected] name: Daniel Mattson, MD role: PRINCIPAL_INVESTIGATOR lat: 38.66311 lon: -90.57707 facility: ClinVest Headlands Research status: RECRUITING city: Springfield state: Missouri zip: 65807 country: United States name: Brittni kendrick role: CONTACT phone: 417-883-7889 email: [email protected] name: David True, MD role: PRINCIPAL_INVESTIGATOR lat: 37.21533 lon: -93.29824 facility: Gershon Pain Specialists status: RECRUITING city: Virginia Beach state: Virginia zip: 23454 country: United States name: Erika Dorman role: CONTACT phone: 757-496-2050 email: [email protected] name: Steven Gershon, MD role: PRINCIPAL_INVESTIGATOR lat: 36.85293 lon: -75.97799 facility: Tel Aviv Sourasky Medical Center status: NOT_YET_RECRUITING city: Tel Aviv zip: 6423906 country: Israel name: Sara Pel role: CONTACT phone: +972-52-4266605 email: [email protected] name: Ori Elkayam, MD role: PRINCIPAL_INVESTIGATOR lat: 32.08088 lon: 34.78057 hasResults: False
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<|newrecord|> nctId: NCT06271733 id: 21110503 briefTitle: TMS for Veterans Attending a 2-week Intensive Outpatient Program for PTSD overallStatus: ENROLLING_BY_INVITATION date: 2022-01-11 date: 2026-01-31 date: 2027-01-31 date: 2024-02-22 date: 2024-02-29 name: Rush University Medical Center class: OTHER briefSummary: The goal of this study is to determine whether complementing regular intensive PTSD treatment with intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) can improve treatment response for individuals attending a 2-week intensive outpatient program (IOP) for PTSD. Specifically, the present study will compare iTBS versus a sham condition during the second week of the 2- week IOP for veterans who have not experienced PTSD symptom reductions over the course of the first week of the Road Home Program intensive PTSD treatment program. conditions: PTSD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: TMS name: Sham measure: PTSD Checklist for DSM-5 (PCL-5) measure: Patient Health Questionnaire-9 (PHQ-9) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University Medical Center city: Chicago state: Illinois zip: 60612 country: United States lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06271720 id: faculty of physical therapy briefTitle: Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-02-22 date: 2024-02-22 name: Noha Elserty class: OTHER briefSummary: This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome conditions: Shoulder Impingement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: visceral manipulation name: integrated neuromuscular inhibition measure: pain intensity measure: pain pressure threshold measure: shoulder range of motion measure: shoulder functional level sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06271707 id: ANES-2024-32720 briefTitle: Stellate Ganglion Block overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-06-30 date: 2026-09-30 date: 2024-02-22 date: 2024-04-23 name: University of Minnesota class: OTHER briefSummary: The purpose of this study is to determine if the addition of an ultrasound guided left sided stellate ganglion block with bupivacaine in patients undergoing esophagectomy, pneumonectomy, or lobectomy will result in lower rates of postoperative atrial fibrillation as compared to standard of care. conditions: Esophagectomy conditions: Pneumonectomy conditions: Lobectomy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: This is a double blind randomized prospective controlled trial. Randomization will be 1:1. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: 0.5% bupivacaine name: Saline measure: an ultrasound guided left stellate ganglion block with 5 mL of saline. measure: Atrial fibrillation; Other arrhythmias; Adverse events. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271694 id: STUDY22020027 id: 1K23DC020215-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23DC020215-01 briefTitle: Activity and Participation in Vestibular Disorders acronym: APV overallStatus: RECRUITING date: 2024-01-01 date: 2024-11-29 date: 2025-01-31 date: 2024-02-22 date: 2024-04-25 name: University of Pittsburgh class: OTHER name: National Institute on Deafness and Other Communication Disorders (NIDCD) briefSummary: This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy. Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation. conditions: Vestibular Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Vestibular Rehabilitation measure: Late-life Function and Disability Instrument measure: Dizziness Handicap Inventory sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC-Rehab Institute status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15206 country: United States name: Chelsea Behling role: CONTACT phone: 412-624-8811 email: [email protected] lat: 40.44062 lon: -79.99589 hasResults: False
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<|newrecord|> nctId: NCT06271681 id: 2120135-1 briefTitle: Evaluation of PCV15 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2025-02-01 date: 2024-02-22 date: 2024-02-22 name: VA Sierra Nevada Health Care System class: FED name: Merck Sharp & Dohme LLC briefSummary: The investigators will evaluate the immune response of immunocompromised adults, who have previously received at least 1 dose of 23-valent pneumococcal polysaccharide vaccine, to the booster series of 15-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine 8 weeks later. Immune response will be assessed by opsonophagocytic assay reactivity and IgG Geometric mean concentration changes. conditions: Pneumococcal Vaccines conditions: Immunosuppression studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: 15-valent pneumococcal conjugate vaccine name: 23-valent pneumococcal polysaccharide vaccine measure: Change in opsonophagocytic assay (OPA) geometric mean titers (GMT) measure: Change in Immunoglobulin G (IgG) geometric mean concentrations (GMC) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271668 id: 23-2356 id: R61DA057610 type: NIH link: https://reporter.nih.gov/quickSearch/R61DA057610 briefTitle: Clinical Decision Support to Improve System Naloxone Co-prescribing overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-09 date: 2024-02-22 date: 2024-02-29 name: University of Colorado, Denver class: OTHER name: National Institutes of Health (NIH) name: National Institute on Drug Abuse (NIDA) briefSummary: The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months. conditions: Medication Abuse conditions: Harm Reduction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200000 type: ESTIMATED name: Naloxone Co-prescribing Clinical Decision Support (CDS) measure: Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone measure: Clinical decision support (CDS) acceptance rate measure: Subsequent opioid overdose/poisonings rates measure: Naloxone dispensed rate sex: ALL minimumAge: 12 Years maximumAge: 89 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Hospital city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06271655 id: BFD-RST-23-004 briefTitle: Rapid Diagnosis of Viral Acute Respiratory Infection to Decrease Unnecessary Antibiotic Utilization in the Emergency Department (RADIATE) acronym: RADIATE overallStatus: RECRUITING date: 2024-03-12 date: 2024-09-30 date: 2024-09-30 date: 2024-02-22 date: 2024-04-09 name: Christopher Payette class: OTHER name: BioMérieux briefSummary: The study titled " The Effect of Definitive Identification of Viral Etiology in Emergency Department Patients with Acute Respiratory Infection on Antibiotic Utilization (RADIATE)" aims to investigate the effectiveness of a rapid diagnostic approach in reducing unnecessary antibiotic use in the emergency department (ED) for patients presenting with acute respiratory illness (ARI) due to a virus. Using a prospective design, eligible participants are individuals who visit the ED with complaints related to acute respiratory illness. The study will employ a single-arm consecutive enrollment approach. The intervention involves the implementation of a rapid point-of-care multiplex polymerase chain reaction (PCR) test to promptly identify the viral cause of the infection. By utilizing a rapid diagnostic tool to identify viral etiology, the study aims to provide healthcare professionals in the ED with more accurate information to guide treatment decisions. Ultimately, the goal is to decrease the unnecessary use of antibiotics for ARI's due to a virus, which has several negative outcomes including promotion of antibiotic resistance, exacerbating ED length of stay and encouraging unnecessary additional diagnostic tests. conditions: Acute Respiratory Infection conditions: Viral Infection conditions: Upper Respiratory Tract Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 200 type: ESTIMATED name: SPOTFIRE R Panel measure: Antibiotic Use measure: Emergency Department Length of Stay measure: Utilization of Alternative Tests measure: Patient Confidence in Diagnosis measure: Provider Confidence in Diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: George Washington University Hospital status: RECRUITING city: Washington state: District of Columbia zip: 20037 country: United States name: Ryan Heidish role: CONTACT email: [email protected] name: Christopher Payette, MD role: CONTACT email: [email protected] name: Christopher Payette, MD role: PRINCIPAL_INVESTIGATOR name: Andrew Meltzer, MD, MS role: SUB_INVESTIGATOR lat: 38.89511 lon: -77.03637 hasResults: False
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<|newrecord|> nctId: NCT06271642 id: 73822 briefTitle: Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-02-22 date: 2024-02-22 name: Stanford University class: OTHER briefSummary: This is a prospective, crossover study of healthy participants evaluating the mechanical pain threshold for weighted pinprick stimuli. conditions: Pain conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ESTIMATED name: Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only name: Bluetooth Haptic Device (Control Frequency) + Needle Sham only measure: Mechanical Pain Threshold measure: Mechanical pain sensitivity measure: Anxiety scores sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271629 id: 2204-042-1314 briefTitle: Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients overallStatus: COMPLETED date: 2022-02-26 date: 2023-11-30 date: 2024-02-29 date: 2024-02-22 date: 2024-03-26 name: Seoul National University Hospital class: OTHER name: Ministry of Health, Republic of Korea briefSummary: The preservation surgery of the anal sphincter has become a standard procedure for the treatment of rectal cancer and is now possible even when the tumor is close to the anus, thanks to the advancement of surgical techniques. This procedure allows patients to avoid a permanent artificial anus and enables them to evacuate through the anus, maintaining the continuity of the intestine, making it a highly preferred surgical option. Additionally, advancements in tumor treatments have led to improved long-term survival rates.
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However, this anal sphincter preservation surgery inevitably can cause functional abnormalities in the rectum, and around 90% of patients experience changes in bowel habits after surgery. The characteristic symptoms occurring after rectal cancer surgery, such as diarrhea, urgency of bowel movements, frequent bowel movements, and fecal incontinence, are referred to as Anterior Resection Syndrome (ARS). Particularly, symptoms following low anterior resection surgery for lower rectal cancer are termed Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, persisting up to 1-2 years, with some improvement over time. However, in many patients, LARS can remain a lifelong challenge, significantly impacting their quality of life. Currently, there is no definitive method to treat LARS, and symptom management is achieved through empirical treatment methods or medications.
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Many patients with LARS experience these symptoms predominantly at night, and it is presumed that their sleep quality is severely compromised, significantly affecting their overall quality of life. However, there is a lack of research on the prevalence of such patients and the appropriate treatments for them. conditions: Rectal Cancer conditions: Low Anterior Resection Syndrome conditions: Insomnia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ACTUAL name: Insomnia severity index measure: Impairment in the quality of sleep and quality of life in patients with Low Anterior Resection Syndrome (LARS). measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06271616 id: MC1873 id: NCI-2024-01061 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 18-008754 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-31 date: 2027-05-31 date: 2024-02-22 date: 2024-03-20 name: Mayo Clinic class: OTHER briefSummary: This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). An allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. When healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving ibrutinib after the transplant may stop that from happening. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking a protein in the blood called Bruton's tyrosine kinase (BTK). By blocking BTK, ibrutinib inhibits certain immune cells that play a role in cGVHD. Giving ibrutinib after an allo-HCT may prevent the development of chronic GVHD. conditions: Chronic Graft Versus Host Disease conditions: Hematopoietic and Lymphatic System Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Biospecimen Collection name: Echocardiography name: Ibrutinib measure: Cumulative incidence of NIH moderate/severe chronic graft-versus-host disease (GVHD) measure: Cumulative incidence of non-relapse mortality (NRM) measure: Cumulative incidence of relapse measure: Cumulative incidence of moderate/severe chronic GVHD measure: Cumulative incidence of moderate/severe chronic GVHD measure: Cumulative incidence of chronic GVHD of all grades measure: Cumulative incidence of late acute GVHD measure: Overall survival (OS) measure: NIH moderate/severe GVHD and relapse free survival (CRFS) measure: Type and duration of immune suppressive therapy measure: Cumulative incidence of complete immune suppression (IS) discontinuation measure: Incidence of adverse events (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Mohamed A. Kharfan Dabaja, M.D., M.B.A. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False
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<|newrecord|> nctId: NCT06271603 id: 23.02645.000357-MS01 id: CPP Ile de France III type: OTHER domain: 23.02645.000357-MS01 briefTitle: Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas acronym: ECOBASO overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2026-02 date: 2026-02 date: 2024-02-22 date: 2024-02-22 name: Damae Medical class: INDUSTRY briefSummary: This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas. conditions: Basal Cell Carcinoma of the Skin studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 704 type: ESTIMATED name: diagnosis based on deepLive™ LC-OCT device name: diagnosis based on skin biopsy measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management. measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management. measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management. measure: Compare, after the diagnosis announcement and at 1 year, the quality of life of patients in the LC-OCT arm versus the standard management arm. measure: Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm. measure: Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm. measure: Evaluate the performance of LC-OCT for the diagnosis and subtyping of BCC for all patients operated on or biopsied in the LC-OCT arm. measure: Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm measure: Estimate the actual cost of conducting the diagnosis with LC-OCT technology. measure: Compare healthcare consumption between the two groups at 1 year. measure: Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Ambroise Paré city: Boulogne-Billancourt zip: 92100 country: France name: Professeur Philippe SAIAG role: CONTACT phone: 800-555-5555 email: [email protected] name: Philippe SAIAG role: PRINCIPAL_INVESTIGATOR lat: 48.83333 lon: 2.25 hasResults: False
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<|newrecord|> nctId: NCT06271590 id: CM-US-R03 briefTitle: MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels acronym: MAGICAL-SV overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2031-04 date: 2024-02-22 date: 2024-02-22 name: Concept Medical Inc. class: INDUSTRY name: Cardiovascular Research Foundation, New York briefSummary: This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm).
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A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees. conditions: Coronary Artery Disease conditions: Native Coronary Artery Stenosis conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2:1 randomized trial (MagicTouchTM Sirolimus-Coated Balloon VS Drug eluting stent (ZES or EES) primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 1605 type: ESTIMATED name: Sirolimus Drug Coated Balloon name: Drug eluting stents (DES) measure: Target lesion failure (TLF) measure: Procedural success measure: Target lesion failure (TLF) measure: Ischemia driven target vessel revascularization (ID-TVR) measure: Target vessel revascularization (TVR) measure: Any revascularization measure: Target vessel failure (TVF) measure: Q-wave myocardial infarction (MI) measure: Non Q-wave myocardial infarction (MI) measure: Any myocardial infarction (MI) measure: Target vessel myocardial infarction (TV MI) measure: Spontaneous myocardial infarction (MI) measure: Procedural myocardial infarction (MI) measure: Cardiovascular mortality measure: All-cause mortality measure: Cardiovascular mortality or myocardial infarction (MI) measure: All-cause mortality or MI measure: All-cause mortality, myocardial infarction (MI) or target vessel revascularization (TVR) measure: Any probable or definite stent thrombosis measure: Probable stent thrombosis measure: Definite stent thrombosis measure: Angina as assessed by SAQ-7 (Seattle Angina Questionnaire) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271577 id: PRO-0013 briefTitle: Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II acronym: STLEUISII overallStatus: RECRUITING date: 2024-03-12 date: 2024-11 date: 2024-12 date: 2024-02-22 date: 2024-03-19 name: AliveCor class: INDUSTRY briefSummary: AliveCor (www.alivecor.com) has developed several electrocardiogram (ECG) devices that interface with iOS and Android smartphones and tablets via various Kardia apps. The current Kardia family of devices can measure single lead and six limb-lead ECGs, depending on the device. KardiaMobile, KardiaMobile 6L, and KardiaMobile Card have FDA clearance for ECG rhythm recording. A modified single-lead Kardia smartphone 12-lead ECG was previously validated in the multicenter ST LEUIS study for the diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI).
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Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it accurately generated 12-lead ECGs as compared to simultaneously acquired FDA-cleared 12-lead ECGs. The prototype version of the AliveCor 12L ECG System simultaneously measured four channels of ECG (leads I, II, V2, V4), calculated the remaining limb leads as is standard for 12-lead ECGs (Leads III, aVR, aVL, aVF) and synthesized the remaining 4 precordial ECG leads (V1, V3, V5, V6). This protocol will serve to validate the production version of the system against standard 12-Lead ECGs for the diagnosis of STEMI and NSTEMI in patients admitted to the Emergency Department or directly to the Cardiac Cath Lab for the evaluation of chest pain. It is anticipated that the waveforms for each of the 12 leads from the AC 12L ECG System will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ECG devices used at participating sites. The purpose of this study is to clinically validate that the four-channel AC 12L ECG device can enable the diagnosis of STEMI and NSTEMI in a non-inferior manner to existing 12-lead ECG devices. conditions: Myocardial Infarction conditions: Ischemia conditions: Myocardial Ischemia conditions: Heart Diseases conditions: Cardiovascular Diseases conditions: Vascular Diseases conditions: Heart Attack conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: AliveCor 12-lead ECG measure: Inter-rater variability for Standard 12-lead ECG readings measure: Inter-rater variability for AC 12L ECG readings measure: Number of standard 12-lead ECG readings requiring a consensus consultation measure: Number of AC 12L ECG readings requiring a consensus consultation measure: Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI measure: Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI measure: Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI measure: Negative predictive power of the AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI measure: Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI measure: Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI measure: Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Julianne Rumer role: CONTACT phone: 507-255-1034 email: [email protected] name: Anna Pick role: CONTACT phone: 507-775-0630 email: [email protected] name: Gregory Barsness, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06271564 id: FDASU-Rec IM012415 briefTitle: Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions overallStatus: RECRUITING date: 2024-02-29 date: 2024-07 date: 2024-12 date: 2024-02-22 date: 2024-03-05 name: Ain Shams University class: OTHER briefSummary: ZnO nanoparticles are now being widely researched for their anticancer properties. They show relatively high biocompatibility. They also show selective cytotoxicity against cancerous cells in in vitro condition compared with other nanoparticles. They can be further surface engineered to show increased selective cytotoxicity. The synthesis process of ZnO nanoparticles is relatively easy, with a wide variety of methods. Owing to these different methods of synthesis, their size and size distribution can be easily controlled. One of the novel methods of synthesis of ZnO is Magnetite ZnO-Fe3O4 Composite Nanoparticles.Magnetite ZnO-Fe3O4 conjugated NPs retained inherent selective property of ZnO and magnetic property of Fe3O4 NPs and showed preferential cytotoxicity towards breast cancer cell line MDA-MB-231, with no significant cytotoxicity towards noncancerous Mouse Fibroblast NIH 3T3 cell. conditions: Oral Potentially Malignant Lesions studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Magnetite ZnO Composite Nanoparticles name: Topical Placebo Gel measure: Change in the clinical size in Low to Moderate Dysplastic OPLs using Magnetite ZnO-Fe3O4 Composite NPs using standardized photographs of the oral marker lesion for each patient measure: Effect of Magnetite ZnO-Fe3O4 Composite NPs on the change of the degree of Dysplasia during histopathological examination using a biopsy sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry Ain shams University status: RECRUITING city: Cairo country: Egypt name: Nourhane Omara, Master's role: CONTACT lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06271551 id: ESTRACISE briefTitle: Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy acronym: ESTRACISE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-12 date: 2029-12 date: 2024-02-21 date: 2024-02-21 name: Central Finland Hospital District class: OTHER name: Tampere University name: University of Jyvaskyla name: Tampere University Hospital briefSummary: The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients.
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The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen deprivation therapy related adverse effects.
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Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supervised resistance training.
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Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are randomized in a 1:1 fashion to receive transdermal estradiol and androgen deprivation or solely androgen deprivation therapy. In addition subgroup of participants are randomized in a 1:1 fashion to perform resistance training or to be allocated in non-training control group. primaryPurpose: TREATMENT masking: NONE count: 310 type: ESTIMATED name: Transdermal estrogen name: Active Comparator: Androgen deprivation therapy name: Resistance training measure: The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy. measure: The occurrence of androgen deprivation therapy induced adverse effects. measure: Number of participants with transdermal estradiol-related adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events). measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on one repetition maximum tests of both the leg press and barbell biceps curl, and maximal hand grip strength assessed with a dynamometer. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on explosive strength of the leg extensors assessed with a countermovement jump (CMJ). measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on 6-minute walk (functional capacity). measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on loaded 10-stair climb test (functional capacity). measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on body composition. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on bone mineral density. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh muscle mass. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh fat mass. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on hormone (testosterone and estradiol) levels, and cancer (PSA) status. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on concentration of PVK, IL-6, TNF-α, AFOS, Alat, Krea, Cholesterol, LDL-C, HDL-C, and triglycerides). measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on type I and II myofibers' cross-sectional area, myonuclei, myonuclear domain, the satellite cell count, androgen receptor and myostatin content measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on muscle cellular function (e.g., HSP70, alpha B-crystallin, HSP60, cytochrome c oxidase subunit IV proteins) measure: Number of participants with resistance training induced adverse events. measure: The World Health Organization Quality of Life Brief Version (WHOQOL-BREF). measure: The Patient Health Questionnaire score (PHQ-9) overall and subdomain score. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271538 id: EP-USM-122023-001 briefTitle: Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2024-11-30 date: 2025-03-30 date: 2024-02-21 date: 2024-04-26 name: EP Plus Group Sdn Bhd class: INDUSTRY briefSummary: The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention. conditions: Irritable Bowel Syndrome conditions: Gastrointestinal Diseases conditions: Colonic Diseases, Functional conditions: Intestinal Disease conditions: Digestive System Disease conditions: Pathologic Processes conditions: Colonic Disease conditions: Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Skal Pro name: Placebo measure: Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS) measure: Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary measure: Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary measure: Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ) measure: Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire measure: Change in Visceral Sensitivity Index measure: Assessment of psychological dysfunction suing Catastrophizing Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universiti Sains Malaysia city: Kubang Kerian state: Kelantan zip: 16150 country: Malaysia name: Yeong Yeh Lee, MD, PhD role: CONTACT phone: +6097676846 phoneExt: 6845 email: [email protected] name: Yeong Yeh Lee, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Thai Hau Koo, MD role: SUB_INVESTIGATOR lat: 6.09123 lon: 102.27938 hasResults: False
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<|newrecord|> nctId: NCT06271525 id: P.T.REC/012/002532 briefTitle: Effect of Cupping Therapy on Nitric Oxide Level in Patients With Cervical Spondylosis acronym: CT overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-05-20 date: 2024-05-20 date: 2024-02-21 date: 2024-02-21 name: Shady Abdelsattar Refaat class: OTHER briefSummary: this study will be conducted to investigate the effect of cupping therapy on the nitric oxide level in patients with cervical spondylosis conditions: Cervical Spondylosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: cupping therapy primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: cupping therapy measure: the nitric oxide level measure: cervical range of motion measure: pain intensity sex: ALL minimumAge: 24 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271512 id: REG-501 briefTitle: A Study of Participants With β-Thalassemia Treated With Betibeglogene Autotemcel overallStatus: RECRUITING date: 2024-01-23 date: 2043-12 date: 2043-12 date: 2024-02-21 date: 2024-02-21 name: bluebird bio class: INDUSTRY name: Center for International Blood and Marrow Transplant Research briefSummary: The main aim of this study is to collect real-world longitudinal data on participants with β-thalassemia treated with betibeglogene autotemcel (beti-cel) in the post marketing setting. To assess the long-term safety, including the risk of newly diagnosed malignancies, after treatment with beti-cel and evaluate the long-term effectiveness of treatment with beti-cel. conditions: Beta-Thalassemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: No Intervention measure: Number of Participants who Experience Each Individual Adverse Events of Interest (AEIs) measure: Number of Participants with Serious Adverse Events (SAEs) measure: Number of Participants with beti-cel related AEs measure: Event-Free Survival measure: Percentage of Participants Achieving Transfusion Independence sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: UCSF Benioff Children's Hospitals status: RECRUITING city: Oakland state: California zip: 94609 country: United States lat: 37.80437 lon: -122.2708 hasResults: False
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<|newrecord|> nctId: NCT06271499 id: AnkaraU-Smart-cannulation briefTitle: The Effect of Using Smart Glasses Integrated Ultrasonography on Radial Artery Catheterization overallStatus: COMPLETED date: 2022-08-01 date: 2022-12-28 date: 2023-02-14 date: 2024-02-21 date: 2024-02-21 name: Ankara University class: OTHER name: Ayşegül Güven name: Bengi Safak name: Ahmet Onat Bermede briefSummary: The use of Ultrasonography (USG) in arterial catheterization, in which the comfort of the practitioner and hand-eye coordination become very important, is frequently needed by anesthesiologists in their daily practice. The aim of this study is to evaluate the success rate and anesthesiologist's satisfaction between two practitioners with different levels of experience in radial artery catheterization with smart glasses USG. conditions: Catheterization conditions: Cannulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ACTUAL name: Radial artery catheterization with USG name: Radial artery catheterization with smart glasses integrated UGG measure: The success rate measure: The anesthesiologist's satisfaction measure: The cannulation time measure: Complications sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara University Medical Faculty city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06271486 id: RC. 40.5.2023 briefTitle: Pregabalin in Treatment of Postdural Puncture Headache overallStatus: RECRUITING date: 2024-02-28 date: 2024-08-15 date: 2024-08-15 date: 2024-02-21 date: 2024-03-15 name: Al-Azhar University class: OTHER name: Benha University briefSummary: Lumbar puncture (LP), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. Pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. It has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders conditions: Postdural Puncture Headache studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Pregabalin 75mg name: An epidural blood patch (EBP) name: conservative treatment. measure: the incidence of complete relief measure: The intensity of the headache sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neveen Kohaf status: RECRUITING city: Tanta zip: 11865 country: Egypt name: Neveen Kohaf role: CONTACT phone: +201060383012 email: [email protected] name: Nahed F. Abo-Elmatey, M.D role: PRINCIPAL_INVESTIGATOR name: Hany Bauiomy, M.D role: PRINCIPAL_INVESTIGATOR name: Ahmed M. Abosakaya, M.D role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False
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<|newrecord|> nctId: NCT06271473 id: AinShamsU3 briefTitle: Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME overallStatus: RECRUITING date: 2023-08-30 date: 2024-12-30 date: 2025-06-30 date: 2024-02-21 date: 2024-02-21 name: Ain Shams University class: OTHER briefSummary: To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema. conditions: Efficacy conditions: Safety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 20 eyes of 20 patients will be divided randomly into 2 groups:
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* Group (A): 10 eyes subjecting to vitrectomy + ILM peeling only
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* Group (B): 10 eyes subjecting to vitrectomy + ILM peeling + planned foveal detachment via subretinal injection of ringer's solution. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. measure: change in CMT by OCT at final visit measure: change in BCVA at final visit measure: any surgical complication or recurrence of DME sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ain Shams university status: ACTIVE_NOT_RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 facility: Ain Shams university status: RECRUITING city: Cairo country: Egypt name: Azza MA Said, MD role: CONTACT phone: +201006228992 email: [email protected] name: David G Samuel, Msc role: CONTACT phone: +201064442469 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06271460 id: 2023-21-728 briefTitle: Disability in Patients With Non-specific Chronic Low Back Pain overallStatus: RECRUITING date: 2024-03-04 date: 2024-08 date: 2024-10 date: 2024-02-21 date: 2024-03-08 name: Acibadem University class: OTHER briefSummary: To investigate the reliability and sensitivity of the Turkish versions of the Roland-Morris Disability Questionnaire, The Quebec Back Pain Disability Scale, and the Oswestry Disability Index in patients with chronic non-specific low back pain and to increase confidence in their use in clinical practice and research by determining the most appropriate minimal clinically significant difference values for this patient population. conditions: Chronic Nonspecific Low Back Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Traditional physiotherapy measure: Visual Analog Scale measure: The Roland-Morris Disability Questionnaire measure: The Quebec Back Pain Disability Scale measure: The Oswestry Disability Index measure: The Perceived Global Impact sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Acıbadem Health Group status: RECRUITING city: Istanbul state: None Selected zip: 34752 country: Turkey name: Elif E Safran, asst. prof. role: CONTACT phone: 500 4047 phoneExt: 216 email: [email protected] name: Irmak Çavuşoğlu, asst. prof. role: CONTACT phone: 500 4184 phoneExt: 216 email: [email protected] name: Elif E Safran, asst. prof. role: PRINCIPAL_INVESTIGATOR name: Irmak Çavuşoğlu, asst. prof. role: PRINCIPAL_INVESTIGATOR name: Nuray Alaca, assoc. prof. role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06271447 id: 2023-21-705 briefTitle: Answerability and Minimal Clinical Significance of the Pain Questionnaires overallStatus: RECRUITING date: 2024-03-04 date: 2024-06 date: 2024-08 date: 2024-02-21 date: 2024-03-08 name: Acibadem University class: OTHER briefSummary: To investigate the reliability and sensitivity of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and The Pain Catastrophizing Scale in patients with chronic non-specific low back pain undergoing multidisciplinary rehabilitation. conditions: Chronic Low-back Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Traditional therapy measure: Visual Analog Scale measure: Fear-Avoidance Beliefs Questionnaire measure: Tampa Scale for Kinesiophobia measure: The Pain Catastrophizing Scale measure: The Perceived Global Impact sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elif Esma Safran status: RECRUITING city: Istanbul state: None Selected zip: 34752 country: Turkey name: Elif E Safran, asst. prof. role: CONTACT phone: 500 4047 phoneExt: 216 email: [email protected] name: Nuray N Alaca, assoc. prof. role: CONTACT phone: 500 4184 phoneExt: Safran email: [email protected] name: Elif E Safran, asst. prof. role: PRINCIPAL_INVESTIGATOR name: Irmak I Çavuşoğlu, asst. prof. role: PRINCIPAL_INVESTIGATOR name: Nuray N Alaca, assoc. prof. role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06271434 id: Olej z kryla/jelita briefTitle: Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers. overallStatus: NOT_YET_RECRUITING date: 2024-03-23 date: 2024-06-24 date: 2024-06-24 date: 2024-02-21 date: 2024-03-18 name: Poznan University of Physical Education class: OTHER briefSummary: The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.
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Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.
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Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.
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Hypotesis:
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The krill oil will infleunce the gut barier integrity. conditions: Endothelial Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All competitors will be randomly divided into two groups (double-blind):
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A. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day.
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B. control (n = 15) receiving placebo. The supplementation period will be six weeks. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Triple whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: THYROX (Atlantic krill oil name: Placebo measure: I-FABP (intestinal fatty acid binding protein) measure: CLDN-3 measure: LBP (lipopolysaccharide binding protein) measure: Catechyloamines, cortisol measure: CD14 measure: Food intake sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06271421 id: 01/24 briefTitle: NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme acronym: ANCHIALE overallStatus: RECRUITING date: 2024-01-01 date: 2027-02-01 date: 2027-09-01 date: 2024-02-21 date: 2024-02-26 name: Poznan University of Medical Sciences class: OTHER name: MagForce USA briefSummary: Glioblastoma multiforme (GBM), the most common and malignant primary brain tumor in adults is classified as a World Health Organisation (WHO) grade 4. Surgical removal of the tumor is the primary method of treatment. Unfortunately, because GBM is a disease of the entire brain, total resection is not possible. Therefore, the use of radiotherapy and/or chemotherapy is considered as Stupp protocol. Patients with recurrent GBM will be included in the ANCHIALE study.
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The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM.
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The main questions it aims to answer are:
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1. how NanoTherm therapy influences overall survival, and progression free survival;
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2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life.
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Participants will undergo:
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* initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life;
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* standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field;
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* between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be performed for routine postoperative evaluation;
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* after the first activation (10th day), the catheter will be removed;
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* subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day;
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* for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed;
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* during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted.
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Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects. conditions: Glioblastoma Multiforme studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective longitudinal study will be performed recurrent glioblastoma multiforme patients who:
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1. are included for NanoTherm therapy (group A),
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2. are included for standard Stupp protocol (surgery/chemo-radiotherapy) (group B) primaryPurpose: TREATMENT masking: NONE maskingDescription: ANCHIALE is open-label study count: 100 type: ESTIMATED name: NanoTherm therapy name: Glioma Resection name: radiotherapy according to Stupp protocol name: chemotherapy according to Stupp protocol measure: Survival following the surgery [units months 1-24] measure: Progression free survival [units months 1-24] measure: Response Assessment in Neuro-oncology [1 - complete response; 4 -progressive disease] measure: EuroQuality of Life 5-dimensions-5 levels scale (EQ-5D-5L) [arbitraty units 0- worst ; 100 - best] measure: Neurologic Assessment in Neuro-Oncology (NanoScale 2) [0-best; 23-worst] measure: modified Rankin scale [0-best; 6-worst] measure: Barthel index [range 0-100; 0-best, 100-worst] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital status: RECRUITING city: Poznań zip: 60-355 country: Poland name: Slawomir Michalak, Prof. role: CONTACT phone: +4861 8691 535 email: [email protected] name: Jakub Moskal, MD, PhD role: CONTACT phone: +4861 8691 422 email: [email protected] lat: 52.40692 lon: 16.92993 hasResults: False
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