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* at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study
* on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2
* once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up
During the study, the doctors and their study team will:
* perform physical examinations
* collect blood samples from the participants to measure the levels of BAY2927088
* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. conditions: Advanced Non-small Cell Lung Cancer conditions: EGFR Mutation conditions: HER2 Mutation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: BAY2927088 name: Itraconazole name: Carbamazepine measure: AUC of BAY2927088 with and without itraconazole measure: Cmax of BAY2927088 with and without itraconazole measure: AUC of BAY2927088 with and without carbamazepine measure: Cmax of BAY2927088 with and without carbamazepine measure: Number of participants with TEAEs measure: Severity of TEAEs sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06348875 id: CLN-PLAN-102v1 briefTitle: Clinical Evaluation of Radiation Reduction for Optimized Safety acronym: CERROS overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-07-15 date: 2024-07-31 date: 2024-04-05 date: 2024-04-05 name: Angiowave Imaging class: INDUSTRY briefSummary: The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques. conditions: Coronary Artery Disease conditions: Myocardial Infarction conditions: Coronary Disease conditions: Coronary Stenosis conditions: Angina Pectoris conditions: Chest Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Segment-level percent diameter stenosis (%DS) measure: Stenosis severity measure: Diagnostic quality measure: Radiation dose - SOC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Corewell Health West city: Grand Rapids state: Michigan zip: 49503 country: United States name: Ryan Madder, MD role: CONTACT phone: 616-391-4327 email: [email protected] name: Timothy Joseph, MD role: CONTACT phone: 616-391-4327 email: [email protected] name: Ryan Madder, MD role: PRINCIPAL_INVESTIGATOR name: Timothy Joseph, MD role: PRINCIPAL_INVESTIGATOR lat: 42.96336 lon: -85.66809 hasResults: False
<|newrecord|> nctId: NCT06348862 id: 323/REC/2023 briefTitle: Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-06-30 date: 2024-06-30 date: 2024-04-05 date: 2024-04-05 name: Al-Quds University class: OTHER briefSummary: The aim of the current study is to analyze the effect of listening to Quran or music or natural sounds on anxiety and stress level among patients undergoing MRI. conditions: Anxiety conditions: Stress conditions: MRI Contrast Media Adverse Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double blinded whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 400 type: ESTIMATED name: Listening to either Quran, Music, and or Natural sound measure: Level of Anxiety among patients who underwent MRI measure: Level of Stress measure: Sociodemographic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06348849 id: 0797-11/2023 briefTitle: The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-05 name: Alexandria University class: OTHER briefSummary: The aim of the current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy. conditions: Molar Incisor Hypomineralization conditions: Hypersensitivity studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED measure: Desensitising effect in hypersensitive MIH molars measure: Change in the plaque index scores measure: Change in children's frequency of toothbrushing sex: ALL minimumAge: 7 Years maximumAge: 10 Years stdAges: CHILD hasResults: False
<|newrecord|> nctId: NCT06348836 id: 2123624-1/2 briefTitle: The Effects of Open Chain Versus Closed Chain Strengthening on Dynamic Valgus During a Step Down Test overallStatus: RECRUITING date: 2024-03-22 date: 2025-02-28 date: 2025-02-28 date: 2024-04-05 date: 2024-04-05 name: Alvernia University class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of different exercises programs in individuals with abnormal knee motion. The main question it aims to answer are:
* In individuals with abnormal knee motion and without knee pain, does a weight-bearing exercise program reduce abnormal knee motion during a step-down test better than a non weight-bearing exercise program? Participants will
* Perform a stepdown test while undergoing motion analysis and electromyograph (EMG) recording.
* Participants will then be placed either into a weight-bearing or non weight-bearing exercise group. Exercises will be performed 3 times per week for 6 weeks.
* Further motion analysis and EMG data will be collected to test for differences. Researchers will compare individual results before and after exercise, and between-group results before and after exercise to see if one exercise program helps improved abnormal knee motion more than the other. conditions: Dynamic Knee Valgus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to either a closed-chain (weightbearing) exercise group or an open-chain (non-weightbearing) exercise group primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Exercise measure: Electromyographic activity of gluteus medius muscle during step-down test measure: Electromyographic activity of quadriceps muscle during step-down test measure: Electromyographic activity of hamstring muscles during step-down test measure: Amount of dynamic knee valgus during step-down test measured with motion analysis sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alvernia University status: RECRUITING city: Reading state: Pennsylvania zip: 19607 country: United States name: James M O'Donohue, DPT role: CONTACT phone: 610-334-1162 email: [email protected] lat: 40.33565 lon: -75.92687 hasResults: False
<|newrecord|> nctId: NCT06348823 id: BritishUE briefTitle: Relationship Between Soft Tissue Volume and Gingival Phenotype: A Novel Classification System overallStatus: RECRUITING date: 2024-02-25 date: 2024-06 date: 2024-10 date: 2024-04-05 date: 2024-04-09 name: Ain Shams University class: OTHER name: British University In Egypt briefSummary: Different classifications to describe alveolar ridge defects have been published over the past years but no single classification has been developed concerning soft tissue volume around teeth or dental implants. Moreover, while several studies investigated the effect of various augmentation techniques and materials on soft tissue volume change and volume stability there is a real gap of knowledge regarding how to evaluate the available soft tissue volume and when to consider it sufficient or deficient which would definitely improve clinical decision making and treatment planing. Therefore, our primary aim was to assess the application of a novel classification system based on the correlation between buccal soft tissue volume and gingival biotypes and, also to assess the sensitivity of such novel method. conditions: Gingival Biotype conditions: Soft Tissue studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 56 type: ESTIMATED name: volume survey measure: soft tissue volume - biotype correlation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahmed Hamdy status: RECRUITING city: Cairo zip: 11234 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06348810 id: DTT2024 briefTitle: Dual-Task Training for People With Mild Cognitive Impairment and Mild Dementia acronym: DTT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-15 date: 2025-01-15 date: 2024-04-05 date: 2024-04-05 name: Taipei Medical University class: OTHER briefSummary: Evidence shows that people with dementia have a higher prevalence of sleep disturbance, cognitive decline, behavioral disturbance, and experience motor dysfunction. These symptoms are interrelated. However, few randomized controlled trial (RCT) studies implement dual-task training for mild cognitive impairment and mild dementia, especially for those who experience sleep problems and behavioral disturbances.
Therefore, this study aims to analyze the effect of dual-task training in improving global cognitive function, executive function, working memory, sleep, behavioral disturbances, balance, and flexibility among people with mild cognitive impairment and mild dementia.
The main questions it aims to answer are:
1. . Does dual-task training affect primary outcomes (global cognitive function, executive function, and working memory)
2. . Does dual-task training affect secondary outcomes (including sleep quality, behavioral disturbances, balance, and flexibility) for people with mild cognitive impairment and mild dementia?"
The length of dual-task training is 6 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 18. While the control group receives the usual care. Researchers will compare the experiment and control groups to see the effect of the dual-task training. conditions: Dementia conditions: Mild Cognitive Impairment conditions: Older Adult studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: eksperimental group receive dual-task training, while control group receive usual care and both conduct at the same time primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Outcomes Assessor will be blind, so they didnt know which is intervention group or control group whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dual-task training name: Usual care measure: Global cognitive function measure: Executive function measure: Working memory measure: Sleep Quality measure: Behavioral disturbance measure: Balance measure: Flexibility sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nursing Home city: Malang state: Jawa Timur zip: 65216 country: Indonesia name: Nur Aini, MSc role: CONTACT phone: +6285234727354 email: [email protected] lat: -7.9797 lon: 112.6304 hasResults: False
<|newrecord|> nctId: NCT06348797 id: BHP01-01 briefTitle: Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-07-31 date: 2026-12-31 date: 2024-04-05 date: 2024-04-05 name: Sichuan University class: OTHER name: Chengdu Brilliant Pharmaceutical Co., Ltd. briefSummary: A study to evaluate the safety and feasibility of α-PD-L1/4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with/without bridge radiotherapy. conditions: Small Cell Lung Cancer Extensive Stage studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: α-PD-L1/4-1BB DLL3 CAR-T (BHP01) measure: Dose-limiting toxicity (DLT) measure: Objective Response Rate (ORR) measure: Progression-free survival (PFS) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Overall-Survival (OS) measure: CAR-T cell numbers sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06348784 id: 11 briefTitle: Screening for Ovarian Malignancy overallStatus: COMPLETED date: 2022-01-01 date: 2023-01-01 date: 2023-01-01 date: 2024-04-05 date: 2024-04-05 name: Ain Shams Maternity Hospital class: OTHER briefSummary: Ovarian cancer is the second most common gynecologic malignancy. In 2008, it was the seventh leading cause of cancer deaths in women worldwide. Estimating the risk of malignancy is essential in the management of adnexal masses and several mathematical models and scoring systems have been developed to be used for discrimination between benign and malignant adnexal masses. Knowledge of the specific type of adnexal pathology before surgery is likely to improve patient triage with high accuracy, and it also makes it possible to optimize treatment. The correct identification of stage I cancer is particularly important conditions: Early Detection of Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ACTUAL name: Assesment of Different NEoplasias in the adenexa model name: Risk of malignancy index name: Histopathologic examination measure: Sensitivity, specificity, positive predictive, and negative predictive value of Assessment of Different NEoplasias in the adneXa model for differentiating between benign and malignant ovarian tumors sex: FEMALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AinShams university maternity hospital city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06348771 id: Pro2023001579 briefTitle: Postprandial Inflammation and Nuts (PIN) in Older Adults acronym: PIN overallStatus: RECRUITING date: 2024-03-25 date: 2024-10-30 date: 2025-01-30 date: 2024-04-05 date: 2024-04-05 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice, but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain and inflammation. Given these findings, this study will examine the postprandial effects of meals with 2 levels of saturated fatty acids (SFA) on metabolic endotoxemia, inflammation and satiety, using a randomized cross-over design. The low SFA meal includes peanuts that are high in monounsaturated fatty acids (MUFA) and this will be compared to a high SFA meal. The results of this study have the potential to provide valuable insights into the role of peanuts in promoting health and preventing disease in at-risk older adults. conditions: Healthy Aging conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Higher SFA meal vs higher MUFA (nut) meal in individuals with overweight and obese primaryPurpose: PREVENTION masking: NONE count: 18 type: ESTIMATED name: monounsaturated fatty acids (MUFA) peanut meal measure: Concentration of Endotoxin measure: Concentration of Interleukin-6 measure: Concentration of Glucose and Insulin measure: Concentration of Triglyceride measure: Appetite measure: Concentration of Inflammatory markers measure: Concentration of zonulin measure: Lipid Profile measure: Characterization of the Microbiome measure: Concentration of incretin hormones measure: Concentration of Bone regulating markers sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foran Hall status: RECRUITING city: New Brunswick state: New Jersey zip: 08901 country: United States name: Sue Shapses, PhD role: CONTACT phone: 848-932-9403 email: [email protected] name: Rebecca Serrano, RD MPH role: CONTACT phone: 848-932-9403 email: [email protected] lat: 40.48622 lon: -74.45182 facility: Rutgers University - NJ Inst Food Nutrition & Health status: RECRUITING city: New Brunswick state: New Jersey zip: 08901 country: United States name: Sue A Shapses role: CONTACT phone: 848-932-9403 email: [email protected] lat: 40.48622 lon: -74.45182 hasResults: False
<|newrecord|> nctId: NCT06348758 id: KAP towards AI briefTitle: Knowledge, Attitudes, And Perceptions of a Group of Egyptian Dental Students Towards Artificial Intelligence acronym: AIKnowledge overallStatus: ENROLLING_BY_INVITATION date: 2024-02-11 date: 2024-06-07 date: 2024-08-07 date: 2024-04-05 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: In the context of this ongoing AI revolution, it is essential to ensure that current and future clinical practitioners are up to date regarding this technology's current state and potential. It is valuable to assess the current attitude of clinical dentists and undergraduate students in dentistry regarding the future role of AI.
To the best of the author's knowledge, there is no study about Egyptian dental students' views and attitudes regarding the application of AI in dental practice. Therefore, this study aimed to evaluate the attitudes and perceptions of a group of dental students in Egypt towards AI. conditions: Health Knowledge, Attitudes, Practice studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 384 type: ESTIMATED name: questionnaire measure: knowledge, attitudes, and perceptions about artificial intelligence in Dentistry sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Cairo University- Faculty of Dentistry city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06348745 id: diaphragmatic ultrasound briefTitle: Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-05-01 date: 2024-04-05 date: 2024-04-08 name: Assiut University class: OTHER briefSummary: * Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.
* Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function.
* Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator. conditions: Diaphragm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: ultrasound measure: diaphragmatic function measure: pulmonary function . sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06348732 id: biomarkers in cardiomyopathy briefTitle: Diagnostic and Prognostic Role of Troponin and Brain Natriuretic Peptide in Pediatric Patients With Cardiomyopathy in Correlation to Echocardiography Findings overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-09 date: 2025-11 date: 2024-04-05 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: This study aims to assess the the role of cardiac biomarkers (troponin and ProBNP) in pediatric Patients with all types of cardiomyopathy in correlation with echocardiography findings . conditions: Cardiomyopathies studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 65 type: ESTIMATED measure: Diagnostic and Prognostic Role of Troponin and Pro BNP in Pediatric Patients with Cardiomyopathy in correlation to Echocardiography findings . sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06348719 id: 35RC21_9732_ROBOT-ECO-GYN briefTitle: Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer. acronym: ROBOT-ECO-GYN overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-10 date: 2027-10 date: 2024-04-05 date: 2024-04-05 name: Rennes University Hospital class: OTHER briefSummary: The standard treatment for endometrial cancer is surgery, as long as the stage of the disease and the patient's condition allow. It consists of hysterectomy (TSH) with bilateral adnexectomy. The recommended surgical approach is the minimally invasive or laparoscopic route, whose oncological safety has been demonstrated by the LAP2 study.
Since 2010 and the arrival of robotic surgery in gynaecology, the robot-assisted laparoscopic approach has gradually been used for endometrial cancer Hysterectomy.
Several studies have suggested that the cost and effectiveness of laparoscopy may vary according to the age and body mass index of the patient.
The investigators therefore hypothesise that robot-assisted laparoscopy may be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France.
The investigators therefore hypothesise that robot-assisted laparoscopy could be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France. The investigators will also test the efficiency of the surgical technique as a function of age and Body mass Index. conditions: Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: As part of this project, we are proposing an original approach by combining a randomized controlled trial with a prospective observational cohort and a retrospective cohort.
This research will therefore consist of 3 complementary studies :
A multicenter, parallel-group, open-label, randomized controlled superiority trial (ratio 1:1) comparing two groups:
* Group 1: laparoscopic robot-assisted hysterectomy
* Group 2: conventional laparoscopic hysterectomy A prospective cohort based on the randomized controlled trial A retrospective cohort primaryPurpose: OTHER masking: NONE count: 1680 type: ESTIMATED name: Robot-assisted laparoscopy name: conventional laparoscopy name: Prospective cohort study name: Retrospective cohort study name: information and consent name: randomization name: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence name: Surgical data collection name: Biological data collection name: Collection of histological data from the surgical specimen name: Phone calls name: Pain assessment name: Collect of data on non-reimbursed transport name: Collect of everyday help name: Collection of the business resumption date name: SF36 questionnaire name: Questionnaire EQ5D-5L name: FIGO Stadium name: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.) name: Collection of adjuvant treatments name: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one name: Collection of data measure: Cost-utility ratio expressed in terms of costs / QALY measure: Operating time measure: Conversion rate measure: Rate and nature of intraoperative complications measure: Post-operative complication rate and nature at D42 (Clavien-Dindo classification) measure: Post-operative complication rate and nature at M6 (Clavien-Dindo classification) measure: Volume of intraoperative blood loss measure: Number of RBC, FFP, PC transfused during hospital stay measure: Visual analogue scale (VAS) of pain 6h after surgery measure: Visual analogue scale (VAS) of pain 24h after surgery measure: Visual analogue scale (VAS) of pain D3 after surgery measure: Analgesic consumption at D1 after surgery measure: Analgesic consumption at D3 after surgery measure: Analgesic consumption at D7 after surgery measure: Analgesic consumption at D42 after surgery measure: EQ-5D-5L at inclusion after surgery measure: EQ-5D-5L at D1 after surgery measure: EQ-5D-5L at D3 after surgery measure: EQ-5D-5L at D7 after surgery measure: EQ-5D-5L at D14 after surgery measure: EQ-5D-5L at D21 after surgery measure: EQ-5D-5L at D42 after surgery measure: EQ-5D-5L at M3 after surgery measure: EQ-5D-5L at M6 after surgery measure: SF-36 at baseline after surgery measure: SF-36 at D3 after surgery measure: SF-36 at D7 after surgery measure: SF-36 at D42 after surgery measure: SF-36 at M6 after surgery measure: Consumption of care: average length of hospital stay measure: Consumption of care: average of number of re-hospitalizations, measure: Consumption of care: average of emergency room visits measure: Consumption of care: average of number of gynecologist consultations measure: Consumption of care: quantity of analgesic(s) measure: Consumption of care: measure: Consumption of care: average of number of work stoppage(s). measure: Time to initiate adjuvant treatment when indicated measure: Vital status at 6 months measure: Gas recovery time measure: QALYs from a collective perspective at D42 measure: QALYs from a collective perspective at M6. measure: Number of patients who underwent each approach measure: QALYs and average costs in relation to care consumption of patients included in the prospective cohort and in the randomized controlled trial according to the approach used and subgroups defined by age (<or> to 75 years) and BMI <or> to 30 kg/m2). measure: Surgical teams' perception of the benefits and limitations of robotic surgery in this indication, as well as perceived barriers and levers to the deployment of robot-assisted surgery in low- or intermediate-risk endometrial cancer. measure: Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale measure: Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX measure: Total annual costs of the foreseeable spread of robot-assisted surgery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Lille, Hôpital Jeanne de Flandre city: Lille zip: 59000 country: France name: Yohan Kerbage role: CONTACT lat: 50.63297 lon: 3.05858 facility: CHU LIMOGES, Hôpital Mère-Enfant city: Limoges zip: 87042 country: France lat: 45.83153 lon: 1.25781 facility: Hôpital Lariboisière/Hôpital Saint Louis city: Paris zip: 75010 country: France name: Cyrille Huchon role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Cochin city: Paris zip: 75014 country: France name: Bruno Borghese role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Européen Georges Pompidou city: Paris zip: 75015 country: France name: Henri Azaïs role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Bichat city: Paris zip: 75018 country: France name: Martin Koskas role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Tenon AP-HP city: Paris zip: 75020 country: France name: Yohann Dabi role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Pitié Salpêtrière city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Lyon Sud - Hospices Civils de Lyon city: Pierre-Bénite zip: 69495 country: France name: Pierre-Adrien Bolze role: CONTACT lat: 45.7009 lon: 4.82511 facility: Hôpital privé des côtes d'Armor city: Plerin zip: 22190 country: France name: Isabelle Jaffré role: CONTACT lat: 48.54249 lon: -2.77983 facility: CHU de Rennes, Hôpital Sud city: Rennes zip: 35200 country: France name: Vincent Lavoue role: CONTACT lat: 48.11198 lon: -1.67429 facility: CHU de Rouen city: Rouen zip: 76031 country: France name: Morgane Perrin role: CONTACT lat: 49.44313 lon: 1.09932 facility: CHU de Saint Etienne city: Saint Etienne zip: 42055 country: France name: Céline Chauleur role: CONTACT lat: 45.43389 lon: 4.39 facility: CHU de Strasbourg - Hôpital de Hautepierre city: Strasbourg zip: 67200 country: France lat: 48.58392 lon: 7.74553 facility: CHU de Tours - Hôpital Bretonneau city: Tours zip: 37044 country: France name: Lobna OULDAMER role: CONTACT lat: 47.38333 lon: 0.68333 hasResults: False
<|newrecord|> nctId: NCT06348706 id: Ain Shams University25032024 briefTitle: Effect of Dipeptidyl Peptidase- 4 Inhibitors on Non-Alcoholic Steatohepatitis and Type 1 Diabetes overallStatus: COMPLETED date: 2022-11-10 date: 2023-12-01 date: 2024-01-15 date: 2024-04-05 date: 2024-04-05 name: Ain Shams University class: OTHER briefSummary: Background: Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD) that can precipitate to advanced fibrosis and leads to cardiovascular morbidity and mortality. Many patients with type 1 diabetes mellitus (T1DM) had histological evidence of steatosis and met the histological criteria for NASH. Matrix metalloproteinase-14 (MMP-14) is a type 1 transmembrane proteinase expressed in liver fibrosis and is involved in the development of atherosclerosis and cardiovascular disease. Hepatic dipeptidyl peptidase-4 (DPP-4) expression in NAFLD may be directly associated with hepatic lipogenesis and liver injury. Some studies showed the beneficial effect of dipeptidyl peptidase-4 (DDP-4) inhibitors in NAFLD/NASH for their role in improving hepatic glucose metabolism. Vildagliptin, a DPP-4 inhibitor, could be promising therapeutic agents for NAFLD/NASH.
To the best of our knowledge, no previous study assessed the role of DPP-4 inhibitors in adolescent patients with T1DM and NASH.
Objectives: This randomized-controlled clinical trial assessed the impact of the oral DPP-4 inhibitor, vildagliptin, as an add-on therapy on NASH in adolescents with T1DM as well as its effect on glycemic control, lipid profile, MMP-14 levels and CIMT as a marker for subclinical atherosclerosis.
Methods: This study included 60 adolescents with T1DM and NASH with a mean age 15.6 ± 2.08 years and disease duration ≥ 5 years. Forty age- and sex-matched healthy subjects with a mean age 14.9 ± 3.2 years were enrolled as healthy controls to compare MMP-14 levels. T1DM patients were randomly assigned to receive oral vildagliptin (50 mg daily) with lunch meal for six months or not. Fasting and 2 hours post-prandial blood glucose levels, HbA1c, liver function tests, fasting lipid profile, hepatic steatosis index and triglyceride glucose (TyG) index were assessed. MMP-14 levels were measured by enzyme-linked immunosorbent assay among all patients and healthy controls. CIMT was assessed using Doppler ultrasound and transient elastography with controlled attenuation parameter (CAP) was performed to assess liver stiffness and steatosis stage. conditions: Diabetes Mellitus, Type 1 conditions: NASH studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Dipeptidyl peptidase 4 (DPP-4) inhibitor measure: Number of participants with treatment-related effect on NASH status in adolescents with type 1 diabetes mellitus measure: Number of participants with treatment-related Matrix metalloproteinase-14 (MMP-14) level change measure: Number of participants with treatment-related Glycemic control (HbA1c%) level change sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Nancy Elbarbary city: Cairo zip: 11361 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06348693 id: Gliotherapy briefTitle: Development of Therapeutic Approaches Modulating Molecular Targets Implicated on Cancer Stem Cell-related Aggressiveness overallStatus: RECRUITING date: 2017-04-19 date: 2025-11-21 date: 2025-11-21 date: 2024-04-05 date: 2024-04-05 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Experimental evidence suggests that cancer stem cells (CSCs) may play a key role in the malignancy of these tumors. In fact, due to the hypoxic tumor microenvironment, these cells are able to create compensatory pathways that confer stem-like, angiogenic and pro-tumoral functions. Furthermore, it has been demonstrated that brain tumor stem cells are radio- and chemo-resistant and therefore not treatable with the therapeutic protocols currently in use. To date, in fact, there are no definitive treatments for the eradication of brain tumors. In this scenario, sphingolips, a class of lipid deputized to several physiological functions, are also involved in tumor onset, progression, drug resistance, and aggressiveness. In hypoxic tumor microenvironment, CSCs present a modified rheostat in the metabolism of sphingolipid, in favor of Sphingosine-1-phosphate (S1P).
S1P is an intermediate of sphingolipid metabolism, formed from sphingosine through the action of sphingosine kinases (SK). Increasing evidence suggests that S1P acts as a tumor-promoting signal, predominantly in the extracellular environment, regulating important cellular properties correlated with tumor potential.
The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment. conditions: Glioblastoma conditions: Glioma conditions: Glioma Glioblastoma Multiforme studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: cell isolation from tumor biopsies and biomarker investigation measure: Investigation of molecular and metabolic signature of cancer stem cells to assess specific markers related to gliomagenesis and cancerogenesis. measure: Biomarker investigation measure: Cellular response to pharmacological treatments sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Stefania E Navone, PhD role: CONTACT phone: 0255034268 phoneExt: +39 email: [email protected] name: Giovanni Marfia, MD, PhD role: CONTACT phone: 0255034268 phoneExt: +39 email: [email protected] name: Stefania Navone, PhD role: PRINCIPAL_INVESTIGATOR name: Giovanni Marfia, MD, PhD role: SUB_INVESTIGATOR name: Laura Guarnaccia, PhD role: SUB_INVESTIGATOR name: Laura Begani, MSc role: SUB_INVESTIGATOR name: Marco Locatelli, Md, PhD role: SUB_INVESTIGATOR name: Claudia Fanizzi, MD role: SUB_INVESTIGATOR name: Luigi Schisano, MD role: SUB_INVESTIGATOR name: Antonella Ampollini, MD role: SUB_INVESTIGATOR name: Manuela Caroli, MD role: SUB_INVESTIGATOR name: Giulio Bertani, MD role: SUB_INVESTIGATOR name: Giorgio Fiore, MD role: SUB_INVESTIGATOR name: Antonio D Ammando, MD role: SUB_INVESTIGATOR name: Elena Scagliotti, MSc role: SUB_INVESTIGATOR name: Giorgia Abete Fornara, MSc role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
<|newrecord|> nctId: NCT06348680 id: AmasyaU-betuluzun-004 briefTitle: The Effect of Video-assisted Episiotomy Repair Training on Anxiety and Self-efficacy Levels in Midwifery Students overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-04-05 date: 2024-05-15 date: 2024-04-05 date: 2024-04-05 name: Amasya University class: OTHER briefSummary: The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training. conditions: Episiotomy Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 31 type: ESTIMATED name: Video assisted episiotomy repair training measure: State Anxiety Scale measure: Episiotomy Skills Self-Efficacy Scale sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06348667 id: 3184794 briefTitle: Effects of a Short- and Long-term 'Blackboard' Intervention on Ankle Stability in Older Adults overallStatus: RECRUITING date: 2024-03-07 date: 2024-06-10 date: 2024-06-10 date: 2024-04-05 date: 2024-04-05 name: University of Valencia class: OTHER briefSummary: The goal of this clinical trial is to assess the effectiveness of adding specific Blackboard Training (BB) exercises to conventional physiotherapy in improving foot and ankle parameters essential for fall prevention among older adults.
The main questions it aims to answer are:
1. Can the addition of BB exercises improve ankle dorsiflexion mobility?
2. Can the addition of BB exercises enhance single-leg stability and control of mediolateral displacement of the center of pressure?
Participants will be divided into control and intervention groups. Both groups will receive their usual conventional physiotherapy exercises. The intervention group will undergo a 5-week program comprising 10 sessions of BB exercises targeting ankle mobility and balance.
Participants will be asked to:
* Perform 3 sets of 15 repetitions for assisted ankle dorsiflexion mobility.
* Engage in 5 rounds of 40-second balance exercises using the BB.
Researchers will compare the intervention group's outcomes with those of the control group to determine the effectiveness of adding BB exercises in improving foot and ankle parameters related to fall prevention. conditions: Fall studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Specific ankle stability exercises name: Conventional physiotherapy exercises program measure: Foot and ankle pain measure: Foot and ankle strength measure: Foot and ankle ROM measure: Ankle dorsiflexion under load measure: Center of pressures variations (anteroposterior and mediolateral center of pressure displacement, velocity, and total surface) measure: Monopodal stability measure: Functional stability sex: ALL minimumAge: 75 Years maximumAge: 95 Years stdAges: OLDER_ADULT facility: Rodrigo Martin-San Agustin status: RECRUITING city: Valencia country: Spain name: Rodrigo Martin-San Agustin role: CONTACT phone: +34 963 983 853 email: [email protected] lat: 39.46975 lon: -0.37739 hasResults: False
<|newrecord|> nctId: NCT06348654 id: 6392 briefTitle: New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer acronym: InPERSON overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-12-01 date: 2025-01-01 date: 2024-04-05 date: 2024-04-05 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The goal of the InPerson study is to employ all resources in a digital listening platform to benefit the quality of life of patients (QoL) with advanced HER2-negative breast cancer.
The care pathway of patients with this type of disease represents an optimal setting for the implementation of an innovative narrative medicine pathway that, aided by integrative therapies, aims to support and accompain them in their treatment journey with a continuum of care. Moreover, the narrative medicine platform will implement the actual "static" way to define QoL with the classic Patient-Reported Outcomes (PROs) questionnaires, that reflect the patient status at a certain time point and not as a dinamic entity. It is on the basis of these assumptions that the present application project on the use of the DNMLAB digital narrative diary in the oncology department of the Fondazione Policlinico Gemelli was born. conditions: Breast Cancer conditions: Narrative Medicine conditions: HER2-negative Breast Cancer conditions: Patient Satisfaction studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: introduction of digital listening may improve the quality of life of patients withe breast cancer measure: Standardized quality-of-life measurement measure: Perceived quality of life measure: Personalization of the care pathway measure: Quality of the patient-physician relationship. measure: Interaction between multidisciplinary teams measure: Patient involvement and compliance in the care pathway measure: lifestyles best suited to positively affect quality of life measure: Awareness of disease condition sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06348641 id: 2011-KAEK-25 2022/12-11 briefTitle: Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-04-20 date: 2025-04-20 date: 2024-04-05 date: 2024-04-05 name: Nurgül Tekin class: OTHER briefSummary: The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn.
This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups.
Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist.
The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.
Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant.
The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines. conditions: Pain conditions: Retinopathy of Prematurity conditions: Premature Baby 26 to 32 Weeks conditions: Premature Baby 33 to 36 Weeks studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: baby massage measure: Pain during examination for retinopathy of prematurity measure: Comfort during retinopathy of prematurity examination sex: ALL minimumAge: 1 Day maximumAge: 40 Days stdAges: CHILD hasResults: False
<|newrecord|> nctId: NCT06348628 id: P/38/04/2021 briefTitle: Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease overallStatus: ACTIVE_NOT_RECRUITING date: 2022-05-31 date: 2025-01 date: 2025-07 date: 2024-04-05 date: 2024-04-05 name: Madunil Anuk Niriella class: OTHER briefSummary: The goal of this study is to assess if motivational counselling works to reduce the weight in participants with Non Alcoholic Fatty Liver Disease (NAFLD). conditions: Non-Alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 231 type: ACTUAL name: Motivational Interview name: Placebo measure: Change in weight after 1 year compared to baseline measure: Change in Aspartate aminotransferase (AST) level and Alanine aminotransferase (ALT) level after 1 year compared to baseline measure: Change in platelet count after 1 year compared to baseline measure: Change in waist circumference and hip circumference after 1 year compared to baseline measure: Change in total fat percentage and visceral fat percentage after 1 year compared to baseline measure: Change in motivation for weight loss after 1 year compared to baseline measure: Change in depression, anxiety and stress after 1 year compared to baseline measure: Change in quality of life after 1 year compared to baseline sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Medicine, University of Kelaniya city: Ragama state: Western Province zip: 11010 country: Sri Lanka lat: 7.0292 lon: 79.917 hasResults: False
<|newrecord|> nctId: NCT06348615 id: DEFBODY briefTitle: Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medical Device acronym: DEFBODY overallStatus: RECRUITING date: 2024-01-23 date: 2024-04-23 date: 2024-06-07 date: 2024-04-05 date: 2024-04-08 name: ICIM International S.r.l. a socio unico class: INDUSTRY briefSummary: Post-marketing clinical study conducted on a CE medical device, named Defense Body, cellulite treatment, edematous fibrosclerotic panniculopathy (2nd and 3rd stage pathology), reducing draining cream-gel, to verify its effectiveness and tolerability on a panel of 56 subjects females affected by 2nd and 3rd degree PEF. The effectiveness of the device is measured in terms of reduction in thigh circumference, improvement in the appearance of the skin with reduction of the orange peel appearance and improvement in skin smoothness. conditions: Cellulite studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Anti-cellulite cream-gel Medical Device (DEFBODY) measure: First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments measure: First day of study initiation: BMI measure: First day of study initiation: Measurement of waist circumference, hip circumference and thigh circumference measure: First day of study initiation: digital photographs of the area to be treated measure: First day of study initiation: skin profilemetry of the thigh measure: First day of study initiation: pinch test measure: After 28 days of treatment: recording of any concomitant pharmacological treatments that have occurred. measure: After 28 days of treatment: BMI measure: After 28 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference measure: After 28 days of treatment: digital photographs of the area to be treated measure: After 28 days of treatment: skin profilemetry of the thigh measure: After 28 days of treatment: pinch test measure: After 28 days of treatment: AE or AED or Drop-off measure: After 28 days of treatment: satisfaction evaluation and compliance measure: After 56 days of treatment: recording of any concomitant pharmacological treatments that have occurred. measure: After 56 days of treatment: BMI measure: After 56 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference measure: After 56 days of treatment: digital photographs of the area to be treated measure: After 56 days of treatment: skin profilemetry of the thigh measure: After 56 days of treatment: pinch test measure: After 56 days of treatment: AE or AED or Drop-off measure: After 56 days of treatment: evaluation of compliance measure: After 56 days of treatment: overall rating of product satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Dermatology Unit - I.R.C.C.S. Ospedale San Raffaele status: RECRUITING city: Milano country: Italy name: Santo Raffaele Mercuri role: CONTACT name: Vittoria Giulia Bianchi role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False