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<|newrecord|> nctId: NCT06266273 id: SBA 23/442 briefTitle: Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-30 date: 2024-08-30 date: 2024-02-20 date: 2024-02-20 name: Hacettepe University class: OTHER briefSummary: "Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale" is crucial in determining the specific functional status of the shoulder joint, especially for overhead athletes experiencing shoulder pain, to identify which sporting activities restrict them the most and to fill the gap in the literature. Additionally, visually indicating activities through photographs will provide visual feedback, making it easier to assess functional status. Our study aims to develop a specific functional survey for the shoulder joint in overhead athletes, examine the validity and reliability of this scale, and contribute to the literature. conditions: Questionnaire conditions: Athletes conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 170 type: ESTIMATED name: No intervention measure: Investigating the Development, Validity, and Reliability of The Sports Activity Avoidance Photo Scale sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Elif Turgut status: RECRUITING city: Ankara zip: 06300 country: Turkey name: Elif Turgut, Assoc. Prof. role: CONTACT phone: +90 (544) 264 56 00 email: [email protected] name: Birgül DINGIRDAN, Master role: SUB_INVESTIGATOR name: Büşra PAKÖZ, Master role: SUB_INVESTIGATOR name: Kübra ÇAYLAN GÜRSES, Master role: SUB_INVESTIGATOR name: Pınar KUYULU HAKSAL, Master role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06266260 id: 5486 briefTitle: Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP) acronym: EVADIPP overallStatus: RECRUITING date: 2023-09-11 date: 2025-04-01 date: 2026-04-01 date: 2024-02-20 date: 2024-02-20 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: A minimally invasive procedure to directly assess portal pressure gradient under endoscopic ultrasound guidance (EUS-PPG) has become available and initial data have proved the technique to be safe. Aims of our proposal are: (i) to assess performance of EUS-PPG as compared to HVPG in evaluating hemodynamic response to non selective betablockers (NSBBs) in a large cohort of patients with CSPH;(ii) identification of markers of hemodynamic response(iii) identification of factors potentially affecting the accuracy of PPG measurement. conditions: Portal Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: EUS PPG measurement measure: Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs) measure: Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs) measure: Markers of hemodynamic response measure: Markers of hemodynamic response measure: Markers of hemodynamic response sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Policlinico Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Francesco Santopaolo, MD role: CONTACT phone: +393492754288 email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06266247 id: 06-2023/16 id: KMU-BAP type: OTHER domain: KMU briefTitle: How Sirtuin Levels Change During Behçet Disease overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-06-30 date: 2024-10-30 date: 2024-02-20 date: 2024-02-20 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: Our primary aim in our study is to evaluate the relationship between the activity, which will be evaluated by clinical and standard phase reactants, and the IL-6 and TNF-α levels, which will be measured in serum, in Behçet\'s patients. Our secondary aim was to evaluate Sirtuin-1 in Behcet\'s patients and compare it with the normal population. Our third aim is to find out whether there is a relationship between these values and organ involvement. conditions: Behçet Disease conditions: Inflammation conditions: Vasculitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 60 type: ESTIMATED name: Take blood samples measure: Our primary aim is to evaluate the relationship between the activity to be evaluated with clinical and standard acute phase reactants and the IL-6 and TNF-α levels to be measured in serum in Behçet's patients. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karamanoğlu Mehmetbey University city: Karaman country: Turkey lat: 37.18111 lon: 33.215 hasResults: False
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<|newrecord|> nctId: NCT06266234 id: APHP230600 id: 10723253 Bis type: OTHER domain: CESREES briefTitle: Characterization by Automated System on Infantile Spasmes acronym: REASSESS overallStatus: RECRUITING date: 2024-02-01 date: 2026-01 date: 2026-01 date: 2024-02-20 date: 2024-03-13 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: OSO-AI briefSummary: Infantile spasms are defined by the occurrence of epileptic episodes characterized by the appearance of very specific motor seizures, made up of rapid, repeated contractions in flexion or extension known as spasms. This syndrome is of high concern as it will lead to mental retardation if it is not early identified and treated. Most often, spasms are characterized by sudden contractions of the body in flexion. More rarely, spasms occur in extension: the neck and legs suddenly tense, and the arms move upwards or sideways. Spasms may be accompanied by eye revulsion. They are brief, lasting 0.5 to 2 seconds each. At the start of the attack, they may be isolated, but then may occur in series lasting up to several tens of minutes.
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Because of its nature and duration, infantile spasm is often difficult to identify and is often confused with benign motor manifestations in children, such as hiccups or muscular jerks. This difficulty often leads to delays in diagnosis. Indeed, patients are often seen at the stage when cognitive regression has set in.
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The gold standard for diagnosing infantile spasms is to capture them on video-EEG to confirm the ictal correlate of the seizure. Although multiple variations are known, the ictal correlation is often a diffuse slow wave of high amplitude with subsequent electrodecrement. Yet continuous video electroencephalogram is an expensive and time-consuming resource often unavailable in developing countries and in many parts of the developed world. Furthermore, in an appropriate clinical scenario, continuous video-EEG may be unnecessary. For example, a home video examination with typical spasms combined with a definitively epileptic ambulatory EEG may certainly be adequate for the diagnosis of infantile spasms
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As part of Mr. Diop's thesis, the study team have developed a system for analyzing videos acquired in 2 dimensions from a simple smartphone or webcam and highlighting the existence of spasms in a child. The principle is to use computer vision and computer learning model to identify the spasms from these videos. The first prototype of this system achieved a positive predictive value of 77%, which is very good considering the small sample used (\< 100) but quite insufficient to obtain a diagnostic prediction for medical use, for which we hope for sensitivity and specificity of around 95%.
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The aim is to achieve a sensitivity and specificity of over 95% so that we can offer this detection system to healthcare professionals and parents of children who do not have rapid access to diagnosis. The aim is to develop a system enabling broad screening at the population level so that identified children can be more rapidly directed towards the healthcare system and appropriate treatment for their disease.
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To achieve this goal, we need access to a standardized reference database that currently exists in the various pediatric electrophysiology laboratories of the Assistance Publique - Hôpitaux de Paris and the Île-de-France region. we propose using the films stored in these laboratories to teach the computer to recognize spasms that have already been formally identified by electrophysiologists and by ictal concordance. conditions: Infantile Spasm studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 5000 type: ESTIMATED measure: Automated computer detection of the spasms > 95% measure: Automated computer detection of the non spasms > 95% sex: ALL maximumAge: 3 Years stdAges: CHILD facility: Department of paediatric neurological care and intensive care unity (PICU), Raymond Poincaré hospital - APHP status: RECRUITING city: Garches zip: 92380 country: France lat: 48.84226 lon: 2.18232 hasResults: False
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<|newrecord|> nctId: NCT06266221 id: APHP200073 id: 2022-000712-59 type: EUDRACT_NUMBER briefTitle: Severe Erythema Multiforme - CORTICO acronym: SEMCORTICO overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-06-01 date: 2027-11-01 date: 2024-02-20 date: 2024-02-20 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Erythema multiforme (EM) is an acute and often recurrent mucocutaneous disease. EM is considered a hypersensitivity immune-mediated reaction. The two main known triggering factors are Herpes simplex virus (HSV) and Mycoplasma pneumoniae (MP) infections. Typical target skin lesions characterize EM, especially oral MMs. EM is in fact mainly linked to the oral MM involvement, including intense mucosal pain, impaired food intake, weight loss, hospitalization and potential risk of fibrotic sequelae (oral, ocular, genital, oesophageal, respiratory tract) and recurrences.
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The objectives of treatment for severe EM in the acute phase are to reduce the duration of lesions, prevent complications and mucosal sequelae. However, despite the lack of evidence and consensus some medical teams often use a short regimen of SCS hoping to obtain a quicker improvement of the condition. However, the use of SCS at the acute phase is not codified and remains debated according to the existent literature. Current studies are mostly retrospective and based on small cohorts or case reports. A randomized, controlled trial would be therefore essential to properly evaluate the benefit of SCS in this pathology and provide strong support to clinicians in their decision making in severe EM during the acute phase.
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This research will be a Phase III randomized, multicentric, double-blind, controlled trial with two parallel groups. The efficacy of prednisone, oral at 1 mg/kg/day for 3 days, tapered to 0.75 mg/kg/day for 3 days, 0.50 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days is compared to that of placebo, oral for 12 days or IV methylprednisolone if oral route is impossible because of the self-reported inability for the patient to swallow due to the impacts of the oral lesions, with dosage equivalence at 0.8 mg/kg/day for 3 days, tapered to 0.6 mg/kg/day for 3 days, 0.4 mg/kg/day for 3 days, 0.2 mg/kg/day for 3 days, then stopped, compared to that of placebo.
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A stratification according to the food intake classification (0,1,2 vs 3) will be performed.
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An interim analysis is planned after the inclusion of 50 patients. Results of the interim analysis will be presented to the DSMB. During the interim analysis, inclusions may continue. conditions: Erythema Multiforme studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Prednisone 20 Mg name: Oral Placebo name: Methylprednisolone 120 Mg name: IV Placebo measure: Time to success measure: Evaluation of Pain measure: Food intake measure: Rescue therapy intake measure: Time to clear or almost clear healing of all sites measure: Time to fever resolution measure: Length of hospital stay measure: Number of days of consumption of level III analgesics measure: Evaluation of pain measure: Chopped or solid food intake resumption measure: Rate of patients in the two groups with need for a rescue therapy measure: Rate of sequelae measure: Rate of adverse events during the treatment and follow-up measure: Evaluation of the quality of life sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266208 id: UCV/2021-2022/201 briefTitle: Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte overallStatus: RECRUITING date: 2024-03-20 date: 2024-04-15 date: 2024-07-15 date: 2024-02-20 date: 2024-04-23 name: Fundación Universidad Católica de Valencia San Vicente Mártir class: OTHER briefSummary: This study will evaluate the usefulness of ultrasonography in detecting dorsal osteophytes associated with claw nails compared to radiographs. The hypothesis will be that the larger the size of the osteophyte, the greater the nail curvature.
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Nail curvature and osteophyte height will be measured in patients with clamp nails. Nail-phalange distance will also be measured with radiography and ultrasonography.
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The investigators to find a positive correlation between nail curvature and osteophyte height. Furthermore, a strong agreement is expected between both imaging techniques to measure nail-phalange distance.
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Ultrasonography could constitute a safe and effective alternative to radiology for detecting dorsal osteophytes in claw nails, especially in mild cases, follow-ups or young patients. conditions: Exostosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Exostectomy name: Cut fingernail measure: Nail-phalange distance measure: Nail Curvature Index measure: Thickness of the nail plate measure: Dorsal Osteophyte Height sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Enieto podologos status: RECRUITING city: Logroño state: La Rioja zip: 26003 country: Spain name: Eduardo Nieto-Garcia, Dr role: CONTACT phone: 941 25 55 66 email: [email protected] name: eduardo Nieto-Garcia, Dr role: CONTACT phone: 941 25 55 66 email: [email protected] name: Eduardo Nieto-Garcia, Dr role: SUB_INVESTIGATOR lat: 42.46667 lon: -2.45 facility: Centro podológico Valencia status: RECRUITING city: Valencia state: València zip: 46001 country: Spain name: Martín Redón role: CONTACT phone: 96 352 63 41 email: [email protected] name: Emma Guillem-escámez role: CONTACT phone: 96 352 63 41 email: [email protected] name: emma Guillem-Escamez role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: Clinicas UCV status: RECRUITING city: Valencia state: València zip: 46001 country: Spain name: Pablo Vera-Ivars, Dr. role: CONTACT phone: 963 92 06 24 email: [email protected] name: Cristina Mico-Salcedo role: CONTACT phone: 963 92 06 24 email: [email protected] name: Javier Ferrer-Torregrosa, Dr role: PRINCIPAL_INVESTIGATOR name: Juan Vicente-Mampel, Dr. role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: Clinica Pasito a pasito status: RECRUITING city: Valencia zip: 46008 country: Spain name: Javier Ferrer-Torregrosa, Dr role: CONTACT phone: 963855535 email: [email protected] name: Javier Ferrer-Torregrosa, Dr role: CONTACT phone: 644733882 email: [email protected] name: JAVIER Ferrer- TORREGROSA, Dr role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06266195 id: 5452 briefTitle: Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared acronym: PROVEIR_1 overallStatus: RECRUITING date: 2023-03-15 date: 2023-12-31 date: 2025-02-28 date: 2024-02-20 date: 2024-02-20 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma. conditions: Vesicle studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: sierological test measure: primary endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FPGemelliIRCCS status: RECRUITING city: Roma state: Lazio zip: 00168 country: Italy name: Fabrizio Pizzolante, MD PhD role: CONTACT phone: +390630151 email: [email protected] name: Gabriele Ciasca, Professor role: CONTACT phone: +390630151 email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06266182 id: 2020/39/B/HS6/01927 briefTitle: The Effect of an Online ACT Intervention on Meaning-Making Process in Cancer Patients Following Hematopoietic Cell Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-04 date: 2024-02-20 date: 2024-02-22 name: University of Social Sciences and Humanities, Warsaw class: OTHER name: National Science Centre, Poland briefSummary: This trial aimed to test internet-based Acceptance and Commitment Therapy (ACT) intervention to induce a meaning-making process in cancer patients following hematopoietic cell transplantation (HCT). ACT includes identifying personal values and engaging in activities consistent with these values, developing acceptance, as well as focusing on the present moment or performing activities with greater awareness. In total, 192 patients following the first (autologous or allogeneic) HCT will be randomly assigned in equal numbers to either the ACT intervention or an education session. Participants in both conditions will take part in 14-day training (about 5-10 minutes a day). The outcomes will be measured at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. Moreover, 6-9 additional participants will be randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at each post-intervention measure. The researchers hypothesized that ACT intervention would foster a meaning-making process and thus reduce distress induced by the discrepancy between global and situational meaning as compared to education. conditions: Hematopoietic Cell Transplantation Recipient conditions: Acceptance and Commitment Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial is enhanced by a single-case experimental design (SCED), in which all study participants will receive the same intervention (i.e., intervention study model: single group). In SCED, there is no masking. The estimated total number of participants to be enrolled in SCED is 6-9. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 192 type: ESTIMATED name: Acceptance and Commitment Therapy name: Education measure: Distress (Global Meaning Violation Scale; GMVS) measure: Illness perception (Brief-Illness Perception Questionnaire; B-IPQ) measure: Global meaning (Meaning in Life Questionnaire; MLQ) measure: Psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-9; CompACT-9) measure: Coping self-efficacy (Coping Self-Efficacy Scale; CSE - selected items) measure: Deliberate meaning-making (Core Beliefs Inventory; CBI) measure: Automatic meaning-making (Event-Related Rumination Inventory; ERRI - intrusive ruminations subscale) measure: Post-traumatic growth (the "current standing" Post-Traumatic Growth Inventory-Short Form; C-PTGI-SF ) measure: Meanings made (Meaning of Loss Codebook; MLC) measure: Anxiety and depressive symptoms (Patient Health Questionnaire-4; PHQ-4) measure: Loneliness (The Revised UCLA Loneliness Scale; R-UCLA - selected items) measure: Loneliness (the Community Life Survey) measure: Health-related quality of life (Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer; EORTC QLQ-C3) measure: Daily subjective health (Daily Subjective Health Scale) measure: Daily affect (Daily Positive and Negative Affect Scale) measure: Daily meaning-making (Event-Related Rumination Inventory-daily form; ERRI-daily form) measure: Daily meanings made (Meaning of Loss Codebook-daily form; MCL-daily form) measure: Daily psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-daily form; CompACT-daily form) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maria Skłodowska-Curie National Research Institute of Oncology Gliwice Branch, Department of Bone Marrow Transplantation and Oncohematology city: Gliwice zip: 44-102 country: Poland name: Małgorzata Sobczyk-Kruszelnicka, MD role: CONTACT phone: 011 48 322788520 email: [email protected] name: Małgorzata Sobczyk-Kruszelnicka, MD role: SUB_INVESTIGATOR lat: 50.29761 lon: 18.67658 hasResults: False
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<|newrecord|> nctId: NCT06266169 id: fpc-2023-ivf-01 briefTitle: Application of Spectral Methods to Assess Gametes, Embryos, and Human Reproductive Capabilities overallStatus: RECRUITING date: 2023-09-20 date: 2024-02-28 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: Family Planning Center of Women's Welfare Clinic #44 of Pushkin District class: OTHER_GOV briefSummary: Relevance of the research topic: At present, in the world, a kind of "plateau" in the efficiency of assisted reproductive technologies has been achieved, which ensures a birth rate of 30% per embryo transfer. At the same time, a relatively high (15-20%) and stable rate of miscarriages is preserved. Until now, no effective methods for assessing the potential of gametes and embryos, as well as human reproductive capabilities, have been offered. In these conditions, to increase the rate of births after IVF, clinicians have to increase the number of transferred embryos at a time, however, this leads to a sharp increase in complications of IVF, such as multiple pregnancy. In addition, until today, the clinical effectiveness of assessing the potential of endometrium using gene expression determination methods has not been shown. Therefore, to ensure the effectiveness and safety of infertility treatment, it is necessary to develop methods for predicting the potential of gametes and embryos, as well as human reproductive capabilities. For this purpose, the investigators assume to use Raman spectroscopy of the environment obtained from the objects of research, as well as fluorescent spectroscopy of endometrium. The objects of the research are gametes (spermatozoa) and embryos, used culture medium, endometrium. The subject of the study is the set of factors, that exists in the objects of research and their ability to determine the outcomes of infertility treatment. conditions: Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: For the retrospective (observational) stage of the study:
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Embryos: 424 samples of the culture medium used from individually cultured blastocysts that were fresh and frozen before transferring a single embryo from the institution's internal biobank. Each sample is attributed based on the presence or absence of progressing pregnancy after transfer at 12-14 weeks.
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Semen: 340 samples of sperm from the internal biobank of couples undergoing ICSI, each sample is attributed based on the success or failure of the embryological stage.
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Endometrium: 300 samples of luminescent and visible spectra of patients' endometrium undergoing embryo transfer, each sample is attributed based on the presence or absence of ongoing pregnancy after transfer.
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For the prospective (interventional) stage of the study:
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For each object of study, the size of the dataset for prospective testing can only be determined after passing the observational part of the study. primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 1064 type: ESTIMATED name: making artificial intelligence based decisions of gamete, embryo and endometrial potential measure: Embryonic model performance measure: Gamete model performance measure: Endometrial model performance measure: Embryonic model clinical efficiency measure: Endometrial model clinical efficiency sex: ALL minimumAge: 20 Years maximumAge: 44 Years stdAges: ADULT facility: Family planning center status: RECRUITING city: Saint Petersburg state: Pushkin zip: 196608 country: Russian Federation name: Alexey Gryaznov role: CONTACT phone: +7(812)414-57-09 email: [email protected] lat: 59.93863 lon: 30.31413 hasResults: False
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<|newrecord|> nctId: NCT06266156 id: BMU-HTUNC-01 briefTitle: Evaluation of The Effect of Consecutive Dental Visits on Dental Anxiety of Paediatric Patients overallStatus: COMPLETED date: 2023-08-05 date: 2023-11-03 date: 2023-12-27 date: 2024-02-20 date: 2024-02-20 name: Burdur Mehmet Akif Ersoy University class: OTHER briefSummary: The goal of this observational study is to learn about in effect of consecutive dental visits on dental anxiety of paediatric patients.
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The main question\[s\]it aims to answer are:
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* Did the anxiety level of pediatric patients decrease in consecutive treatment sessions?
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* Were there changes in the physiological parameters related to stress level of pediatric patients in consecutive treatment sessions?
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Participants will fill out the questionnaire about dental anxiety in each dental treatment sessions before and after dental treatment.
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Researchers will compare paeditric patients have two caries on mandibular molars to see if changes dental anxiety levels and physiological parameters such as heart rates and oxygen saturations during dental treatments in consecutive dental treatment sessions. conditions: Dental Anxiety studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 240 type: ACTUAL name: Score of anxiety questionnaire name: Heart rate name: Oxygen saturation measure: Determination of sample size. measure: Inviting participants to the study. measure: Determination of dental anxiety score of participants before dental treatment in first dental session measure: Heart rate measuring in first dental session. measure: Oxygen saturation measuring in first dental session. measure: Determination of dental anxiety score of participants after dental treatment in first dental session measure: Determination of dental anxiety score of participants before dental treatment in second dental session measure: Heart rate measuring in second dental session. measure: Oxygen saturation measuring in second dental session. measure: Determination of dental anxiety score of participants after dental treatment in second dental session sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD facility: Burdur Mehmet Akif Ersoy University Faculty of Dentistry city: Burdur state: Centrum zip: 15100 country: Turkey lat: 37.72028 lon: 30.29083 hasResults: False
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<|newrecord|> nctId: NCT06266143 id: Y101D03 briefTitle: A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-08 date: 2024-07-30 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Wuhan YZY Biopharma Co., Ltd. class: INDUSTRY briefSummary: The Phase Ib/II study is an open-label, single-arm, multicenter trial designed to assess the efficacy and safety of Y101D in combination with Gemcitabine and Albumin Paclitaxel as first-line systemic treatment for advanced pancreatic cancer patients. The Phase Ib portion of the study aims to evaluate the safety of escalating doses of Y101D in combination with the standard regimen of Gemcitabine and Albumin Paclitaxel and determine the recommended phase 2 dose (RP2D). The Phase II portion of the study aims to evaluate the effectiveness of this combination treatment in a small population of patients. conditions: Advanced Pancreatic Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 71 type: ACTUAL name: Y101D measure: Dose Limiting Toxicities (DLTs) measure: RP2D measure: Objective Response Rate (ORR) measure: Peak Serum Concentration (Cmax) measure: Trough Serum Concentration (Ctrough) measure: Area under the serum concentration versus time curve (AUC) during one treatment cycle (21 days) measure: The TGF-β concentration in serum measure: The CA19-9 concentration in serum measure: The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06266130 id: EM-11-050087 briefTitle: Digital Bonding vs. Direct Bonding Study overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-08 date: 2026-08 date: 2024-02-20 date: 2024-02-20 name: 3M class: INDUSTRY briefSummary: This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets. conditions: Orthodontic Brackets studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups, treatment group (digital bonding) and control group (direct bonding). Subjects will be enrolled and randomized into treatment or control group at each orthodontic practice. primaryPurpose: OTHER masking: NONE maskingDescription: Due to the nature of the devices, Investigator blinding is not feasible for the study. count: 178 type: ESTIMATED name: Treatment Group Digital Bonding Tray name: Control Group Direct Bonding measure: Prep-and-bonding time measure: Number of adjustment visits to complete treatment measure: Overall chair time sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266117 id: SBF-HMS-GES-03 briefTitle: Pain, Anxiety, and Comfort Levels in Coronary Angiography overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-03-30 date: 2024-07-30 date: 2024-02-20 date: 2024-02-20 name: Abant Izzet Baysal University class: OTHER briefSummary: The study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit. conditions: Pain conditions: Anxiety conditions: Nursing Caries studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 216 type: ESTIMATED measure: Pain level measure: Anxiety measure: Comfort sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abant Izzet Baysal University Faculty of Health Science city: Bolu state: Merkez zip: 14100 country: Turkey lat: 40.73583 lon: 31.60611 hasResults: False
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<|newrecord|> nctId: NCT06266104 id: Protocol V1.4_04012024 briefTitle: Image Enhanced Endoscopy IBD overallStatus: RECRUITING date: 2024-04-03 date: 2025-12-31 date: 2026-03-01 date: 2024-02-20 date: 2024-04-12 name: Royal Perth Hospital class: OTHER briefSummary: Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future. conditions: Inflammatory Bowel Diseases conditions: Dysplasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: INVESTIGATOR count: 270 type: ESTIMATED name: Image Enhanced Endoscopy Filters measure: Dysplasia Detection Rate measure: Withdrawal times measure: Characterisation of lesions sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Perth Hosptial status: RECRUITING city: Perth state: Western Australia zip: 6000 country: Australia name: Sherman Picardo, MBBS role: CONTACT phone: 92242244 lat: -31.95224 lon: 115.8614 hasResults: False
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<|newrecord|> nctId: NCT06266091 id: M70102 briefTitle: Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-24 date: 2024-03-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Wuhan YZY Biopharma Co., Ltd. class: INDUSTRY briefSummary: A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 in treating Patients with Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer combined with Systemic Therapy. conditions: Malignant Ascites studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: M701 name: paracentesis measure: Puncture-free survival, PuFS measure: objective response rate (ORR) of malignant ascites measure: Progression-free Survival, PFS measure: Overall survival, OS measure: Quality of Life, QoL measure: Safety profiles measure: Positive rate of ADA and Nab in serum measure: The EpCAM expression in ascites measure: Trough serum concentration (Ctrough) measure: Peak serum concentration (Cmax) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Medical Center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100141 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06266078 id: School of Nursing briefTitle: A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-12-15 date: 2024-02-20 date: 2024-02-20 name: University of Campinas, Brazil class: OTHER briefSummary: Background: Many factors influence Personal Protective Equipment (PPE) compliance for use in health care, specifically the PPE usability and related human factors. It is known that issues related to the usability of new technologies, including professional behavioral and attitudinal patterns, the technologies adoption within the workflow and teamwork strengths can be investigated by using Simulation-Based Research (SBR) before its implemented. This study aims to develop and validate a simulation protocol for the assessment of human factors and usability of innovative PPEs used in critical care units. The ultimate goals is to define a standard method for PPEs assessment and comparison worldwide. Method: methodological study with a quantitative approach to be carried out in two phases: a) development and validation by experts of a simulation protocol; b) piloting of the simulation protocol. For the protocol validation phase, 14 experts with experience in the themes of infection prevention and control or clinical simulation will be included. The experts will be invited via email and will assess the simulation protocol content using the criteria of pertinence, clarity and relevance. To ensure that the simulation protocol is feasible and reliable, a piloting phase will take place at the simulation center in São Paulo and 36 health professionals with work experience in critical care units will be included. The health professionals will perform specific tasks assigned to them, wearing pre-defined PPEs in each simulation round. Errors and difficulties during PPE assembly, donning and doffing; performance of individual and team activities, as well as communication problems and self-contamination risk, will be observed during the tasks. At the end of the simulation round, the participants will take part in a debriefing, where they will answer questionnaires about comfort, perception of safety, thermal sensations, usability and perceived workload related to the PPE used. Content validity index (CVI) and intraclass correlation coefficient (ICC) will be calculated. This study protocol was approved by the Research Ethics Committee of the School of Nursing, University of São Paulo. The informed consent form will be applied both to the experts and to the health care workers. conditions: Personal Protective Equipment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Firstly, a minimum of 14 experts will validate the content, using the Delphi technique of two tools (A) The innovative PPE assessment tool; and B) the simulation scenario script.
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After reaching consensus among the experts, the protocol will be piloted. Two identical sessions will be conducted using the cross-over method with all participants, so that the same participant performs the tasks using the innovative PPE and the comparative PPE, allowing the participants compare characteristics of both PPE. The PPE use sequence and the PPE type will be randomized to minimize biases. Between both sessions there will a 30-minute break for the participants.
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For the purpose of the development and piloting of this simulation protocol, the innovative PPE were selected according to compliance with the specifications required by the World Health Organization. It will enrolled 36 healthcare workers in piloting test. primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 9 type: ESTIMATED name: Innovative PPE name: Traditional PPE measure: Content Validity of the items included in the "Innovative PPE assessment tool" and in the "Simulation scenario script" measure: Errors during PPE assembly/preparation, donning and doffing measure: Communication impairments while using PPE measure: Self-contamination risk in the professional while using and doffing the PPE measure: Influence of PPE on individual performance measure: Influence of PPE on team performance and behavioral changes measure: Changes in mobility and comfort while using PPE measure: Thermal sensations measure: Perception regarding safety and satisfaction of the PPE user measure: Perceived workload measure: Usability measure: Complementary Content Analysis - qualitative data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266065 id: 8.1-23/260-2;02/013AG briefTitle: Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia overallStatus: RECRUITING date: 2024-02-27 date: 2026-06 date: 2026-06 date: 2024-02-20 date: 2024-03-06 name: Clinical Hospital Centre Zagreb class: OTHER briefSummary: The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
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The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter \< 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia. conditions: Coronary Artery Disease conditions: Angina Pectoris studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-Center Prospective Study primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Coronary Sinus Reducer measure: Impact of Coronary Sinus Reducer on Coronary Microcirculation measure: Myocardial Ischemia assessment measure: Angina assessment measure: Functional capacity assessment sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Centre Zagreb status: RECRUITING city: Zagreb zip: 10000 country: Croatia name: Josko Bulum, MD, PhD role: CONTACT phone: +385981714090 email: [email protected] name: Luka Percin, MD role: CONTACT phone: +385917917252 email: [email protected] lat: 45.81444 lon: 15.97798 hasResults: False
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<|newrecord|> nctId: NCT06266052 id: 2019/04 briefTitle: Evaluation of the Effects of Four Different Flap Designs on Tissue Healing in Lower Third Molar Surgery overallStatus: ENROLLING_BY_INVITATION date: 2024-01-20 date: 2024-03-20 date: 2024-04-20 date: 2024-02-20 date: 2024-02-20 name: Recep Tayyip Erdogan University class: OTHER briefSummary: The aim of this study is to prospectively evaluate the effectiveness of 4 different flap types used during mandibular impacted wisdom teeth surgery on postoperative quality of life, soft tissue and hard tissue healing at the end of the 3rd month. conditions: Soft Tissue Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Triangular Flap name: Berwick Flap name: Saurez Flap name: Heitz Flap measure: Eudema Amount measure: Pain Level measure: Trismus Level measure: Halitosis Amount measure: bone healing condition sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: RTEU Faculty of Dentistry city: Rize country: Turkey lat: 41.02083 lon: 40.52194 hasResults: False
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<|newrecord|> nctId: NCT06266039 id: 2022-0328-01 id: 2022-A02616-37 type: OTHER domain: French National Agency for the Safety of Medicines (ANSM) briefTitle: Introduction of Long Acting Buprenorphine in France acronym: OBAP overallStatus: RECRUITING date: 2023-03-31 date: 2024-09-30 date: 2024-09-30 date: 2024-02-20 date: 2024-02-20 name: University of Bordeaux class: OTHER briefSummary: The current available pharmacological treatment formulations (i.e., daily formulations of buprenorphine or methadone) for OUD in France may have several inconveniences, such as: compliance, burden of daily intake, and risk of misuse; that may hinder their effectiveness. Long acting formulations of buprenorphine (LAB) such as Buvidal have been developed to favor retention and compliance and minimize the risk of diversion. Previous studies are promising on the advantage of LAB to treat opioid addiction, however more evidence is needed in the French healthcare context. However, in addition to randomized clinical trials, the French National Healthcare Agency (HAS "Haute Autorité de Santé") recommends conducting "real-life" studies (i.e., in naturalistic conditions) during the development of a medication and the use of "Patient Reported Outcome Measures" (PROMs) to analyze patient quality of life and/or other measures relevant to patients (e.g., severity, efficiency), without interpretation of the answers by a health professional. In this regard, our study proposes to use the Addiction Severity Index (ASI) self-report questions and several scales on treatment satisfaction and quality of life to collect the patient's opinion of perceived changes following the use of Buvidal.
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Main objectives:
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The objectives of this prospective open observational study, in naturalistic conditions, are to examine in individuals with an opioid use disorder, over a period of 6 months after LAB treatment initiation: the change in substance addiction severity and the changes in health-related quality of life, craving, opioids and other substance and non-substance uses and misuses, alcohol, tobacco and non-substance addiction severity, satisfaction with LAB treatment, severity of others domains related to addiction severity (i.e., medical, social, psychological) and psychiatric comorbidities
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Main hypotheses:
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1. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of the CS of "Drug use" (i.e., substance addiction severity) at 6 months compared to baseline.
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2. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of opioids and other substance and non-substance uses and misuses, other substances and non-substances addiction severity, craving, severity of others domains related to addiction (i.e., medical status, employment and support, family/social status, psychological status), an improvement of quality of life and a good satisfaction with treatment at follow-ups compared to baseline. conditions: Addiction Opiate studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 223 type: ESTIMATED measure: The change in the composite score of the "Drug use" section from the Addiction Severity Index (ASI) at 6 months after treatment initiation measure: The change in addiction severity at 6 months after treatment initiation measure: The change in quality of life with EuroQoL-5 Dimensions-5 Levels (EQ-5DL-5L) at 6 months after treatment initiation measure: The change in quality of life with the 12-Item Short Form Survey (SF-12) at 6 months after treatment initiation measure: The change in quality of life with nottingham health profile part 1 and part 2 (NHP1 and NHP2) at 6 months after treatment initiation measure: The change in quality of life with assisted quality of life assessment chart (TEAQV) at 6 months after treatment initiation measure: The change in other use at 6 months after treatment initiation measure: The change in craving at 6 months after treatment initiation measure: The change in other domains of addiction severity at 6 months after treatment initiation measure: The change in Treatment Satisfaction Questionnaire for Medication (TSQM) at 6 months after treatment initiation measure: Cues - craving - use links and others factors variations measure with EMA after treatment initiation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bordeaux status: RECRUITING city: Bordeaux state: Gironde zip: 33000 country: France name: Marc Auriacombe, Professor role: CONTACT phone: +33556561738 email: [email protected] lat: 44.84044 lon: -0.5805 hasResults: False
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<|newrecord|> nctId: NCT06266026 id: ThermoBreast briefTitle: ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography. acronym: ThermoBreast overallStatus: RECRUITING date: 2023-12-11 date: 2028-12 date: 2029-12 date: 2024-02-20 date: 2024-02-20 name: ThermoMind Ltd. class: INDUSTRY name: Assuta Medical Centers Ltd. name: Hospital of Lithuanian University of Health Sciences Kaunas Clinics name: Institut Gustav Roussy name: M.D. Anderson Cancer Center name: Sheba Medical Center name: The Holy Family Hospital Nazareth name: University College Cork name: Univerzitetni klinicni center Maribor name: Academisch Ziekenhuis Groningen name: Technical University of Munich name: Technion, Israel Institute of Technology name: Vrije Universiteit Brussel name: Cancer Patients Europe name: University Hospital Heidelberg briefSummary: Breast cancer is one of the most worrisome health concerns facing women. Early detection and active patient monitoring are crucial to survival. The chances of a cure are high when detected and treated in the early stages. Standard breast cancer diagnostic methods such as mammography, ultrasound, and MRI have limitations such as ionizing radiation, high false-positive rates, and/or high expenses.
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Medical Thermography might overcome these limitations: It is a non-invasive , adjunctive physiologic imaging technology that uses a high-resolution infrared camera and computer processing to produce an image (thermogram) of a patient's skin surface temperatures. It is a non-contact screening method, which does not involve radiation exposure or invasive procedures, and is safe for both the patient and the trained personnel performing the screening. While mammography and ultrasound depend primarily on structural and anatomical variation of the tumor from the surrounding breast tissue, thermography detects pathophysiological changes within the breast such as metabolic and vascular changes caused by cancer. The heat transfer in the body is conducted by the circulatory system; hence, pathologies identified by thermography are generally associated with changes in blood perfusion.
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To date, there has been no completed or ongoing large-scale, prospective, multicenter, international study that evaluates the diagnostic performance of thermal video streams coupled with advanced Artificial Intelligence algorithms for early-stage breast cancer screening and diagnosis. The proposed study will be crucial for the development of a new imaging modality that aims to be both cost-effective and to carry a minimal level of risk, facilitating screening of women of all age groups and breast densities, enabling early detection of abnormalities caused by malignant processes and improving patient monitoring. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 28000 type: ESTIMATED name: ThermoBreast - AI-based evaluation of dynamic breast thermography imaging measure: Sensitivity (true-positive rate) measure: Specificity (true-negative rate) measure: Cancer detection rate measure: Detection rate of ductal carcinoma in situ (DCIS) measure: Detection rate of tumor category pT1 measure: Recall rate measure: Sensitivity measure: Specificity measure: Positive-predictive value measure: Negative-predictive value measure: Diagnostic performance in the three trial cohorts measure: Proportion of breast quadrant localization measure: Proportion of correct histopathologic subtype identification measure: Proportion of correct tumorbiologic subtype identification measure: Proportion of correct axillary lymph node involvement identification measure: Effect of hormonal status on diagnostic performance measure: Effect of breast density on diagnostic performance measure: Effect of ethnicity on diagnostic performance measure: Timing of ThermoBreast measure: Screening time measure: Cost-effectiveness measure: Lived Experience sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Heidelberg University Hospital status: RECRUITING city: Heidelberg country: Germany name: André Pfob, MD role: CONTACT lat: 49.40768 lon: 8.69079 hasResults: False
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<|newrecord|> nctId: NCT06266013 id: 009 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength, Muscle Oxygen Saturation, and Functional Capacity overallStatus: NOT_YET_RECRUITING date: 2024-02-14 date: 2024-02-19 date: 2024-03-10 date: 2024-02-20 date: 2024-02-20 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 diaphragmatic fatigue and muscular strength in upper and lower limbs, in both healthy and pathological subjects, as well as the association between such fatigue and other variables, including maximal inspiratory pressure, functionality and muscle tissue oxygen levels.
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According to our hypothesis, the execution of a protocol inducing diaphragmatic fatigue in older adults could influence muscular strength, cardiorespiratory function, exercise capacity, and muscle tissue oxygenation.
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In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.
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Measurements of variables, such as maximal inspiratory pressure, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and functional capacity, 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: Muscle oxygen saturation (SmO2) measure: Functional mobility measure: Respiratory muscle strength measure: Diaphragmatic thickness and thickening fraction measure: Functional capacity measure: Diaphragm movement curve sex: ALL minimumAge: 60 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266000 id: PROPAL briefTitle: Comparison of 2 Extracts of Saw Palmetto Versus Placebo on BPH Symptoms overallStatus: RECRUITING date: 2024-03-01 date: 2025-01-01 date: 2025-03-01 date: 2024-02-20 date: 2024-04-04 name: RDC Clinical Pty Ltd class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on the symptoms of benign prostate hyperplasia (BPH) in 120 generally healthy participants, 45 - 80 years. conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Saw palmetto extract 320mg per day name: Commercial Saw palmetto extract 320mg per day name: Palm Oil capsule measure: International Prostate Symptom Score (IPSS) measure: Daily Urinary Frequency Diary measure: Brief Sexual Function Inventory (BSFI) measure: International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) measure: Electrolytes (E/LFT) blood test measure: Liver Function (E/LFT) blood test measure: Inflammatory marker - JM27 measure: Blood pressure measure: Pulse rate measure: Adverse event frequency measure: Adverse event severity measure: Discontinuation due to adverse events sex: MALE minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RDC Clinical Pty Ltd status: RECRUITING city: Brisbane state: Queensland zip: 4006 country: Australia name: Amanda Rao, PhD role: CONTACT phone: +61 414 488 559 email: [email protected] name: David Briskey, PhD role: CONTACT phone: +61 421 784 077 email: [email protected] lat: -27.46794 lon: 153.02809 hasResults: False
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<|newrecord|> nctId: NCT06265987 id: ECHOQUALITY2 briefTitle: Maternal and Fetal Characteristics Influencing Image Quality in Prenatal Ultrasonography overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-01 date: 2024-01-31 date: 2024-02-20 date: 2024-02-20 name: Poitiers University Hospital class: OTHER briefSummary: The objective of this observational study is to identify maternal and fetal characteristics that impact image quality in prenatal ultrasonography. The investigators have assembled a retrospective cohort of 198 patients, each contributing three ultrasound images taken between 18 and 18 weeks and 6 days of gestation. For each image, the investigators assess the quality of two distinct elements as well as the overall image through both subjective and objective evaluations.
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The primary questions the study seeks to address are:
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What maternal and fetal characteristics influence image quality in prenatal ultrasonography? conditions: Ultrasonography conditions: Obstetrics conditions: Fetus conditions: Pregnant Women studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 198 type: ACTUAL measure: Maternal and fetal characteristics can influence quality image in ultrasonography sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital La MILETRIE city: Poitiers zip: 86000 country: France lat: 46.58333 lon: 0.33333 hasResults: False
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<|newrecord|> nctId: NCT06265974 id: ECHOQUALITY briefTitle: Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-01 date: 2024-01-31 date: 2024-02-20 date: 2024-02-20 name: Poitiers University Hospital class: OTHER briefSummary: The goal of this observational study is to determine whether the subjective assessment of the quality of obstetrical ultrasonography pictures can be similar to that of an objective tool.
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The main question it aims to answer is:
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Is the subjective assessment of the quality of obstetrical ultrasonography pictures by a young practitioner and an experienced one can be similar to that of an objective tool, such as the contrast-to-noise ratio (CNR)? The contrast-to-noise ratio is commonly used in radiology to evaluate image quality by assessing the ability to distinguish differences between two elements.
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The investigators selected a retrospective cohort of 198 patients, including three pictures per fetus screened between 18 and 18 weeks and 6 days. For each picture, the investigators assessed the quality of two different elements and the entire image, and then calculated the CNR using software. The investigators will compare the three assessment between them conditions: Ultrasonography conditions: Obstetrics studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 198 type: ACTUAL measure: The comparability between a subjective and objective assessment of the contrast to noise ratio of an obstetric ultrasound image sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital La MILETRIE city: Poitiers zip: 86000 country: France lat: 46.58333 lon: 0.33333 hasResults: False
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<|newrecord|> nctId: NCT06265961 id: 02.01.2024_39 briefTitle: Efficiency of the Bibliotherapy Method in Developing Cultural Intelligence and Competencies of Nurses overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2024-05-01 date: 2024-05-31 date: 2024-02-20 date: 2024-02-20 name: Eskisehir Osmangazi University class: OTHER briefSummary: The study aims to evaluate the effectiveness of the developmental bibliotherapy method in developing the cultural intelligence and competence of nurses.
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The study will be carried out in an embedded intervention research model using a combination design (Quantitative + Qualitative) in the intervention design, which is one of the advanced mixed methods designs. In the embedded mixed research model where the quantitative approach is dominant, randomized controlled experimental research and qualitative research will be conducted simultaneously.
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1.1. Research questions for the qualitative phase 1.1.1. Research questions for the exploratory phase Q1. How successful are nurses in distinguishing the cultural differences of the individuals they care for? Q2. What are nurses\' views on cross-cultural nursing care? Q4. How do nurses approach the culturally-based behaviors of the individuals they care for? Q5. What are the cultural experiences that nurses have with the individuals they care for?
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1.1.2. Research questions for the integrative phase Q1. What are the contributions of the books read to the cultural intelligence and competence of nurses? Q2. What are the contributions of the stories read to the cultural intelligence and competence of nurses? Q3. What are the contributions of the watched movie to the cultural intelligence and competence of nurses?
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1.1.3. Research questions for the explanatory phase Q1. What effect did bibliotherapy practice have on nurses\' cultural intelligence? Q2. What impact did bibliotherapy practice have on nurses\' cultural competence?
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1.2. Research hypotheses of the quantitative phase
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1. H1. Bibliotherapy intervention will increase the cultural intelligence levels of the nurses in the study group.
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2. H1. The cultural intelligence levels of the nurses in the study group will be higher than the nurses in the control group.
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3. H1. Bibliotherapy intervention will increase the cultural competence of the nurses in the study group.
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4. H1. The cultural competence of the nurses in the study group will be higher than the nurses in the control group. conditions: Cultural Competency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Mixed methods research is defined as "a research approach used in the field of health, social and behavioral sciences in which the researcher collects both quantitative and qualitative data to understand the research problems, integrates two data sets, and then draws conclusions using the advantages of integrating these two data sets." The study will be carried out in an embedded intervention research model using a combination design (Quantitative + Qualitative) in the intervention design, which is one of the advanced mixed methods designs. In the embedded mixed research model where the quantitative approach is dominant, randomized controlled research and qualitative research will be conducted simultaneously. primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Education name: Bibliotherapy measure: Cultural intelligence measure: Cultural competence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eskisehir Osmangazi University city: Eskisehir state: Odunpazarı zip: 26040 country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False
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<|newrecord|> nctId: NCT06265948 id: comparsion drugs in cancer briefTitle: Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-05 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: ( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries ) conditions: Abdominal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: post operative pain sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265935 id: Ataturk Unıversıty - Neslihan briefTitle: Effect of Diaphragmatic Breathing Exercise on Fatigue and Quality of Life in Pregnant Women With Gestational Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-08-15 date: 2024-10-15 date: 2024-02-20 date: 2024-02-29 name: Ataturk University class: OTHER briefSummary: Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. GDM, which is in the high-risk pregnancy category, causes fatigue during pregnancy due to both hormonal changes and pregnancy complications (1). Fatigue is a general complaint that occurs in almost all physical and mental diseases. Fatigue also negatively affects an individual's well-being, daily performance, activities of daily living (ADLs) and relationships. Fatigue is one of the symptoms that, if not controlled, negatively affects the individual's daily living activities and quality of life (2). While breathing itself is a way of relaxation, it is also a part of all relaxation exercises and is an exercise that can be used in daily life. Breathing correctly and deeply is the first step in learning to relax. (3). It is important to identify fatigue, minimize it, plan daily living activities and improve quality of life in patients with GDM. This study will be conducted as a randomized controlled study to determine the fatigue and quality of life of diaphragmatic breathing exercises, one of the non-pharmacological methods, on pregnant women with gestational diabetes. conditions: Gestational Diabetes Mellitus in Pregnancy conditions: Pregnancy in Diabetic conditions: Fatigue conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomize primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The sample size was calculated as 60 pregnant women by performing GPower analysis, taking into account the tests to be used to calculate the minimum sample size to be included in the study. The sampling will include a total of 60 primiparous pregnant women, including 30 pregnant women diagnosed with gestational diabetes who meet the inclusion criteria for the study, who agree to participate in the study, and 30 pregnant women diagnosed with gestational diabetes who are applied diaphragmatic breathing exercise and who are not applied diaphragmatic breathing exercise. whoMasked: PARTICIPANT count: 2 type: ESTIMATED name: Experimental Group measure: SF-36 Quality of Life Scale: measure: Visual Similarity Scale for Fatigue sex: FEMALE minimumAge: 19 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06265922 id: P.T.REC/012/003937 briefTitle: Cerebellar rTMS in Patients With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-02-18 date: 2024-04-18 date: 2024-06-02 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis. conditions: Patients With Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participant masking as patients will be divided into two groups High frequecy cerebellar repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation by placing the coil in perpendicular way away from the cerebellum.
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Care provider masking as the physical therapist treating patients will be blind from the application of repetitive transcranial magnetic stimulation whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 40 type: ESTIMATED name: High frequency repetitive transcranial magnetic stimulation name: Sham repetitive transcranial magnetic stimulation measure: Biodex balance system measure: Berg balance scale measure: Nine-Hole Peg Test (9-HPT) measure: Four square step test (FSST) sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06265909 id: PRW001 briefTitle: Prospective Real World Study on Therapy Prediction Algorithm Training overallStatus: COMPLETED date: 2015-03-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-20 date: 2024-02-20 name: Mobio Interactive PTE LTD class: INDUSTRY briefSummary: This study examines the impact of using an algorithm to select therapy content for patients engaged with the mobile mental health platform AmDTx (Mobio Interactive). The algorithm is to be trained with three separate sources of data. Two sources of data come from self-reports by the patients themselves, provided before and after engaging with therapy content. The third source of data comes from an objective measurement of psychological stress, made possible through artificial analysis of computer vision data captured from the mobile device camera as the patient completes a 30 second selfie video before and after engaging with therapy content. conditions: Stress conditions: Emotional Wellbeing studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 67 type: ACTUAL name: AmDTx measure: Objective Stress Level (OSL) measure: Self-Reported Stress (SRS) measure: Self-Reported Mood (SRM) sex: ALL minimumAge: 18 Years maximumAge: 66 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mobio Interactive Pte Ltd city: Singapore zip: 389637 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06265896 id: P.T.REC/012/004948 briefTitle: Effect of Kinesiotaping on Activation of Abdominal Muscles in Female Patients With Stress Urinary Incontinence overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-06-01 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: This study will be conducted to evaluate the effect of kinesiotaping on activation of abdominopelvic cavity for management of stress urinary incontinence females' patients. conditions: Stress Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Kinesio taping name: Pelvic floor exercise training measure: Pelvic floor impact questionnaire- short form 7 (PFIQ-7) measure: King's Health Questionnaire (KHQ) measure: Assessment of pelvic floor muscle strength sex: FEMALE minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Cairo University city: Giza country: Egypt name: Mai N. Mamdouh, M.Sc. Student role: CONTACT phone: 01014924808 email: [email protected] name: Dalia M. Kamel, Prof. role: CONTACT phone: 01273990045 email: [email protected] name: Ahmed S. Ebrahim, Prof. role: PRINCIPAL_INVESTIGATOR lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06265883 id: MIIR-16-Retro briefTitle: Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT overallStatus: COMPLETED date: 2019-07-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-20 date: 2024-02-20 name: Second Affiliated Hospital of Guangzhou Medical University class: OTHER name: Zhongshan People's Hospital, Guangdong, China name: Affiliate Hospital of Guangdong Medical University name: Jieyang People's Hospital name: Huizhou Municipal Central Hospital name: Guangzhou Development District Hospital name: Shenzhen Traditional Chinese Medicine Hospital name: First People's Hospital of Foshan briefSummary: This multicenter retrospective study evaluated consecutive patients with large HCC and PVTT who received lenvatinib plus DEB-TACE with/without FOLFOX-HAIC between July 2019 and June 2021. Tumor response, time to progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups. conditions: Hepatocellular Carcinoma Non-resectable studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 205 type: ACTUAL name: Len+DEB-TACE+HAIC name: Len+DEB-TACE measure: Time to progression (TTP) measure: objective response rate (ORR) measure: Disease control rate (DCR) measure: overall survival measure: treatment-related adverse events (TRAEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Guangzhou Medical University city: Guangzhou state: Guangdong zip: 510260 country: China lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06265870 id: Parasite in Eosinophilia briefTitle: Specific Versus Empirical Anthelminthic Treatment in Eosinophilia acronym: Eosinophilia overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-04-03 name: Prince of Songkla University class: OTHER briefSummary: There are a few guidelines recommend about management of eosinophilia worldwide, most of guielines recommend a thorough history-taking and physical examination. Subsequently, investigations are requested based on suspected causes. In cases where parasite infection is suspected, particularly in developing countries, stool microscopy and serology are recommended. However, limitations such as low sensitivity of stool microscopy, the inconvenience of collecting multiple stool samples, and the high cost and unavailability of serology may arise. Consequently, some physicians opt for empiric anthelminthic regimens in managing eosinophilic patients, even without stool tests or if stool test results are normal. If subsequent complete blood count (CBC) results show a recovery of absolute eosinophil count, it is assumed that eosinophilia was caused by a parasite infection. While some studies demonstrate the efficacy and simplicity of this approach, there is a risk of overestimating parasite infection in eosinophilic patients, potential adverse drug reactions from unnecessary anthelminthic treatment, and the possibility of drug resistance due to inappropriate dosing. To address this gap, no study has yet compared the efficacy between specific anthelminthic treatment based on test results and empirical anthelminthic treatment in eosinophilic patients. Therefore, the investigators are conducting this study. conditions: Eosinophilia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 700 type: ESTIMATED name: Albendazole name: Ivermectin or albendazole measure: Eosinophilia recovery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265857 id: IOE-naoxiaoxueguan briefTitle: Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients overallStatus: RECRUITING date: 2024-02-28 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach. conditions: Cerebral Small Vessel Diseases conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Video Fluoroscopic Swallowing Study measure: Functional Oral Intake Scale measure: Body mass index measure: Serum albumin measure: Hemoglobin measure: Pneumonia measure: Activities of daily living measure: World Health Organization Quality of Life Assessment Instrument Brief Version sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thai Rehabilitation Community Center status: RECRUITING city: Ban Phon Ko country: Thailand name: Cop Kun role: CONTACT hasResults: False
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<|newrecord|> nctId: NCT06265844 id: IOE-Biyanai briefTitle: Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-09-30 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oral-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Hemoglobin measure: Serum albumin measure: Body Mass Index measure: Serum prealbumin measure: Depression measure: Functional Oral Intake Scale measure: Penetration-Aspiration Scale measure: Swallowing-Quality of Life questionnaire measure: Feeding amount sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Martin Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Xi Maheen, Master role: CONTACT lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06265831 id: BU-FHS-NC-03 briefTitle: The Effect of Face Hand Fan Application on Dyspnea acronym: HandfanCOPD overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2023-11-30 date: 2024-03 date: 2024-02-20 date: 2024-02-20 name: Bartın Unıversity class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: Diagnosing and managing dyspnea in patients with COPD is very important. Although pharmacological and non-pharmacological methods are used in the management of dyspnea, it is recommended that pharmacological methods be supported by non-pharmacological methods. Hand fan application, which is one of the non-pharmacological methods used in dyspnea management, provides an increase in self-efficacy in patients in addition to the stimulation of cold air flow to the trigeminal nerve branches, mucosa and skin. Although there are studies reporting that applying cold air to the face with a hand fan is effective in reducing the severity of dyspnea in different patient groups, the number of studies examining the effectiveness of applying cold air to the face with a hand fan in patients with COPD is quite limited. This project was planned to determine the effect of applying cold air to the face with a fan on the severity of dyspnea and quality of life in COPD patients. conditions: COPD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel group: two groups, an intervention group and a control group, receiving complementary therapy. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Hospitalized patients with a diagnosis of COPD will be randomized into two groups. The intervention group will have a hand fan applied to the face and be monitored for a week, and the control group will receive routine care at the clinic. Investigators will evaluate outcome measures. whoMasked: PARTICIPANT count: 61 type: ACTUAL name: Hand-fan application to the face measure: Modified Borg Scale measure: Saint George Respiratory Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Necmiye ÇÖMLEKÇİ city: Bartın zip: 74100 country: Turkey lat: 41.63583 lon: 32.3375 hasResults: False
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<|newrecord|> nctId: NCT06265818 id: 2024-KY-0126 briefTitle: The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder acronym: ABE-S overallStatus: RECRUITING date: 2024-03-01 date: 2024-05 date: 2024-05 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups. conditions: Respiratory Rhythm Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation training name: Active Breathing Exercises measure: The Penetration-Aspiration Scale measure: The Functional Oral Intake Scale measure: Yale Pharyngeal Residue Severity Rating Scale measure: Fiberoptic Endoscopic Dysphagia Severity Scale measure: Murray Secretion Scale measure: Swallowing Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Wei Liu, Master role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06265805 id: 2024-KY-0125-015 briefTitle: Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients acronym: IOE-Xinli overallStatus: RECRUITING date: 2024-02-28 date: 2024-12-30 date: 2024-12-30 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: comprehensive rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Generalized Anxiety Disorder 7 measure: Patient Health Questionnaire-9 measure: Self-made questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hsinchu Rehabilitation Hospital status: RECRUITING city: Xinzhu country: Taiwan name: Haim Liu, Master role: CONTACT lat: 22.46205 lon: 120.47335 hasResults: False
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<|newrecord|> nctId: NCT06265792 id: 2024-KY-0125 briefTitle: Efficacy of Stellate Ganglion Block in Obstructive Sleep Apnea acronym: OSA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2024-12-15 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:
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• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Stellate ganglion block measure: Epworth Sleepiness Scale measure: Apnea-Hypopnea Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06265779 id: 2024-KY-0122 briefTitle: Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia acronym: IOE+JLCJ-S overallStatus: RECRUITING date: 2024-02-29 date: 2024-11-30 date: 2024-12-15 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect. conditions: Cerebral Infarction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Comprehensive rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Transcranial direct current stimulation measure: Penetration Aspiration Scale measure: Functional Oral Intake Scale measure: Swallowing Quality of Life Questionnaire measure: Patient Health Questionnaire-9 measure: Body weight measure: Nutritional status-total protein measure: Nutritional status-albumin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Wei Liu, Master role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06265766 id: NL85511.041.24 id: 85511 type: OTHER domain: ABR number briefTitle: Brain STimulation for Arm Recovery After Stroke 2 acronym: B-STARS2 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-03-31 date: 2029-12-31 date: 2024-02-20 date: 2024-02-20 name: Jord Vink class: OTHER briefSummary: Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days.
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Objective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center.
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Study design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial.
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Study population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a Motricity Index between 9 and 99, in whom cTBS treatment can be started within 3 weeks after stroke onset.
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Intervention: 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb.
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Main study parameters/endpoints: The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days after stroke. Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test, Nine Hole Peg Test, Stroke Impact Scale, EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Sham cTBS treatment is delivered with a sham TMS-coil. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 454 type: ESTIMATED name: cTBS measure: Upper extremity section of the Fugl-Meyer Assessment measure: Upper extremity section of the Fugl-Meyer Assessment measure: Action Research Arm Test measure: modified Rankin Scale measure: Hand section of Stroke Impact Scale measure: Participation section of Stroke Impact Scale measure: EuroQol-5D measure: Nine Hole Peg Test measure: Ipsilesional corticospinal excitability measure: iMTA medical consumption and productivity cost questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Reade city: Amsterdam country: Netherlands name: Marijn Mulder-Kampen role: CONTACT lat: 52.37403 lon: 4.88969 facility: Revalidatie Friesland city: Beetsterzwaag country: Netherlands name: Wietske Rienstra role: CONTACT lat: 53.05914 lon: 6.07711 facility: Revant city: Breda country: Netherlands name: Marissa Riemens role: CONTACT lat: 51.58656 lon: 4.77596 facility: Tolbrug city: Den Bosch country: Netherlands name: Cynthia Klinkers role: CONTACT lat: 51.27 lon: 5.59167 facility: Basalt city: Den Haag country: Netherlands name: Kangdi Zhu role: CONTACT lat: 52.07667 lon: 4.29861 facility: MRC Aardenburg city: Doorn country: Netherlands name: Lisa Kruisheer role: CONTACT lat: 52.03343 lon: 5.34571 facility: Libra Blixembosch city: Eindhoven country: Netherlands name: Daphne Stranders role: CONTACT lat: 51.44083 lon: 5.47778 facility: University Medical Center Groningen city: Groesbeek country: Netherlands name: Henk Meulenbelt role: CONTACT lat: 51.77667 lon: 5.93611 facility: Merem city: Hilversum country: Netherlands name: Maijke van Bloemendaal role: CONTACT name: Karin Peek role: CONTACT lat: 52.22333 lon: 5.17639 facility: Adelante city: Hoensbroek country: Netherlands lat: 50.92387 lon: 5.92528 facility: Basalt city: Leiden country: Netherlands name: Annelies Mantje role: CONTACT lat: 52.15833 lon: 4.49306 facility: Sint Maartenskliniek city: Nijmegen country: Netherlands name: Nelleke Kooiman role: CONTACT lat: 51.8425 lon: 5.85278 facility: Libra Leijpark city: Tilburg country: Netherlands name: Iris Habets role: CONTACT lat: 51.55551 lon: 5.0913 facility: De Hoogstraat city: Utrecht country: Netherlands name: Mirjam Kouwenhoven role: CONTACT lat: 52.09083 lon: 5.12222 facility: Heliomare city: Wijk Aan Zee country: Netherlands name: Deborah Wit role: CONTACT lat: 52.4936 lon: 4.59409 facility: Vogellanden city: Zwolle country: Netherlands name: Bente Visser role: CONTACT lat: 52.5125 lon: 6.09444 hasResults: False
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<|newrecord|> nctId: NCT06265753 id: Gastrocimemius spasticity id: E-60116787-020-474196 type: REGISTRY domain: Pamukkale University Ethics Comitee briefTitle: Gastrocinemius Function Massage on Lower Extemity Spasticity acronym: Spasticity overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-23 date: 2024-06-01 date: 2024-09-01 date: 2024-02-20 date: 2024-02-20 name: Pamukkale University class: OTHER briefSummary: This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients. conditions: Stroke conditions: Stroke Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the study, 2 different groups (experimental and control) will be formed by using randomisation method. In addition to 45 minutes of classical physiotherapy exercises, 10 minutes of gastrocinemius function massage will be applied to the experimental group, while 10 minutes of sham massage and 45 minutes of classical physiotherapy exercises will be applied to the control group. The application will continue 2 days a week for 6 weeks. Spasticity, gait parameters and fall risks of the participants will be evaluated before and after the treatment with the help of various tests.
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Translated with www.DeepL.com/Translator (free version) primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: Gastrocinemius Function Massage name: Sham application measure: Spasticity measure: Gait parameters and fall risk sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Address city: Denizli state: Muş Alparslan University zip: 20100 country: Turkey lat: 37.77417 lon: 29.0875 hasResults: False
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<|newrecord|> nctId: NCT06265740 id: RBHP 2023 GALLOT (PREMABIOTE) id: 2023-A02466-39 type: OTHER domain: 2023-A02466-39 briefTitle: Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota acronym: PREMABIOTE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2025-11 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: Objectives: to assess the relevance of the "RiboTaxa" algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population.
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Study description: Longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth). conditions: Premature Birth conditions: Vaginal Flora studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: vaginal swab measure: Early diagnosis of preterm birth using vaginal microbiota analysis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont-Ferrand city: Clermont-Ferrand country: France name: Lise Laclautre role: CONTACT name: Denis Gallot role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 hasResults: False
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