Datasets:

hackint0sh
/

md_dataset

Dataset card Data Studio Files Files and versions Community

Split (1)

train · 10k rows

record stringlengths 560 23.9k
## OCTA Changes in Choroidal Neovascularization in High Myopia - NCT ID: NCT06357559 - Study ID: OCTA in Myopic CNV - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-12-01 - Lead Sponsor: Sohag University ### Study Description To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV.. ### Conditions - Myopic Choroidal Neovascularisation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OCTA ### Outcomes Primary Outcomes - Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section - NCT ID: NCT06357546 - Study ID: RECHMPL23_0411 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-09-01 - Lead Sponsor: University Hospital, Montpellier ### Study Description The hypothesis of this trial is that the absence of systematic bladder catheterization in patients performing spontaneous urination in the hour preceding the planned cesarean section under spinal anesthesia would not lead to more bladder heterocatheterization for postpartum urinary retention (RUPP) in the 24 hours post-cesarean section than systematic intraoperative bladder catheterization up to 2 hours post-surgery. ### Conditions - Pregnant Women - Cesarean Section ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Spontaneous urination during the hour before caesarean section. - Systematic bladder catherization during caesarean section. ### Outcomes Primary Outcomes - Necessity of heterocatheterization within 24 hours following the cesarean section. - Experience of childbirth - Duration of preoperative preparation - Operating time - Duration of post-operative hospitalization - Time to resume ambulation - First urination - Pain during the first urination or the first heterocatheterization - Discomfort during the first urination or the first heterocatheterization - Additional prescription for painkillers - Urinary infection detection - Occurrence of surgical difficulties - Occurrence of operative complications - Amount of bleeding - Presence of symptoms suggestive of a urinary infection - Presence of functional signs (dysuria, incontinence, delayed bleeding or others) - Time before resuming spontaneous urination Secondary Outcomes ### Location - Facility: Montpellier University Hospital, Montpellier, N/A, 34295, France @@
## Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations - NCT ID: NCT06357533 - Study ID: D7632C00001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2030-05-24 - Lead Sponsor: AstraZeneca ### Study Description The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations. ### Conditions - Non-Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Datopotamab Deruxtecan - Rilvegostomig - Pembrolizumab ### Outcomes Primary Outcomes - Progression-Free Survival (PFS) in TROP2 biomarker positive participants. - Overall Survival (OS) in TROP2 biomarker positive participants. Secondary Outcomes - Progression-Free Survival (PFS) in the intent-to-treat (ITT) population. - Overall Survival (OS) in the intent-to-treat (ITT) population. - Objective Response Rate (ORR) - Duration of Response (DoR) - Participant-reported lung cancer symptoms of NSCLC in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab. - Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab. - Participant-reported GHS/QoL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab. - Pharmacokinetics (PK) - Immunogenicity - Second Progression-Free Survival (PFS2). ### Location - Facility: Research Site, Clayton, N/A, 3168, Australia @@
## A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants - NCT ID: NCT06357520 - Study ID: D6970C00005 - Status: RECRUITING - Start Date: 2024-04-16 - Completion Date: 2024-06-06 - Lead Sponsor: AstraZeneca ### Study Description The main purpose of this study is to assess the effect of itraconazole on the pharmacokinetic (PK) of baxdrostat. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Baxdrostat - Itraconazole ### Outcomes Primary Outcomes - Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) - Maximum Observed Plasma Drug Concentration (Cmax) Secondary Outcomes - Extrapolated Area Under The Curve From Tlast to Infinity (AUCextr) - Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) - Apparent Total Body Clearance (CL/F) - Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F) - Terminal Elimination Half-life (t1/2λz) - Terminal Rate Constant (λz) - Mean Residence Time (MRTinf) - Time To Reach Maximum Observed Concentration (tmax) - Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on Maximum Plasma Concentration (RCmax) - Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUClast (RAUClast) - Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUCinf (RAUCinf) - Number of Participants with Adverse Events ### Location - Facility: Research Site, Brooklyn, Maryland, 21225, United States @@
## Molecular Characterization of Moraxella Catarrhalis From Pneumonic Children at Pediatric Assiut University Hospital - NCT ID: NCT06357507 - Study ID: hayam hamdy - Status: NOT_YET_RECRUITING - Start Date: 2024-12-01 - Completion Date: 2027-12-20 - Lead Sponsor: Assiut University ### Study Description moraxella catarrhalis is responsible for respiratory tract infection in children and adults with streptococcus pneumonia and haemophilus influenza.Moraxella catarrhalis is gram negative diplococci, non-motile and non spore bearing bacteria. Until, 1995 it was considered as a non pathogenic respiratory tract flora.This bacteria is an important pathogen and a common cause of both upper and lower respiratory tract infections, pneumonia, sinusitis and conjunctivitis in infants, children and in elderly patients. In adults, M. catarrhalis also causes chronic obstructive pulmonary disease (COPD) and pneumonia. However, it is associated with a number of respiratory infections affecting both children and adults, including laryngitis, bronchitis and pneumonia . ### Conditions - Respiratory Tract Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - isolation of moraxella catarrhalis Secondary Outcomes - detection of virulence genes of moraxella catarrhalis - detetion of antibiotic resistance ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of Thyroid Doppler Ultrasound in Followup of Pediatric Graves' Disease - NCT ID: NCT06357494 - Study ID: Thyroid Doppler in Graves' - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2028-04-05 - Lead Sponsor: Assiut University ### Study Description All cases of the study will be diagnosed as Graves' by History, examination, laboratory (FT3, FT4, TSH \& TRAbs), X-ray on left wrist for bone age, neck grey scale ultrasonography for thyroid gland size, shape, echotexture, vascularity and nodule characters if present with TIRAD score calculation.Then Color flow doppler ultrasound will be done to asses thyroid volume, number of vessels per square cm and inferior thyroid artery peak systolic velocity, end diastolic velocity and resistive index. Patients then will receive carbimazole antithyroid drug at dose 0.25-0.5 mg/kg/day PO \& the dose will be titrated according to thyroid function test after 4-6 weeks.Beta-adrenergic blockade will be added to all symptomatic cases. Regular follow up will be done every month of first 3 months of diagnosis and then every 3 months for 2 years by clinical and thyroid function test to asses response, compliance, complications, drug side effects, remission and relapses.Doppler ultrasound will be done at 0, 12 and 24 months. ### Conditions - Doppler Ultrasound in Follow up of Graves' Patients ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To make follow up of graves disease easier and improve patients adherence to treatment and follow up plan. Secondary Outcomes - better control of disease in our patients, less complications, less mortality and better prognosis. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Postoperative Pain After Single Visit Retreatment of Symptomatic and Asymptomatic Teeth - NCT ID: NCT06357481 - Study ID: SaglikBilimleriU-22-122 - Status: COMPLETED - Start Date: 2023-01-26 - Completion Date: 2024-01-28 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description Introduction: The aim of this study comparing the post operative pain after the retreatment of asymptomatic and symptomatic teeth that during single visit treatment with rotary and reciprocal nickel titanium files.Methods: One hundred and forty one patients scheduled for non-surgical endodontic retreatment were included for evaluation. Eighty five patients who needed endodontic retreatment were assingned to 2 groups according to semptomatic or asemptomatic teeth and 4 subgroups with rotary and resiprocal files. Endodontic filling material was removed with One Flare and MicroMega REMOVER files in the retreatment kit. Patients then recorded their postoperative pain on a VAS scale at 24h, 48h, 72h, 7 days and 14 days post-treatment. Results were analyzed using the Shapiro-Wilk, Mann-Whitney U, Kruskal-Wallis, Dunn-Bonferroni and Pearson Chi-square tests. ### Conditions - Post-operative Pain - Retreatment - Symptomatic Periapical Periodontitis - Endodontic Disease - Asymptomatic Periapical Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Endodontic Retreatment ### Outcomes Primary Outcomes - Post-operative pain Secondary Outcomes ### Location - Facility: Hüseyin Gürkan Güneç, Istanbul, Uskudar, 34450, Turkey @@
## Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women With Vaginal Births in Difference Between Physician-led and Midwife-led Birth - NCT ID: NCT06357468 - Study ID: UKGEB003 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg ### Study Description The aim of the analysis is to describe the differences and similarities in obstetric pain management and pain perception intrapartum and postpartum in women with vaginal births in contrast to physician-led births and midwife-led births ### Conditions - Pain, Labor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - midwife-led births in low risk women in pregnancy ### Outcomes Primary Outcomes - Pain perception Secondary Outcomes - Satisfaction with pain therapy - Pain perception in women with perineal tear grade III ### Location - Facility: University Hospital of Halle, Halle, Saxony Anhalt, 06120, Germany @@
## Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery - NCT ID: NCT06357455 - Study ID: Platelet CellSaver Liver trnsp - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Eduardo Schiffer ### Study Description Intraoperative cell salvage is commonly used in surgeries that carry a major hemorrhagic risk to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation status after these types of surgeries, especially liver transplantation.There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are re-transfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the liver transplant surgery population.The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function. ### Conditions - Liver Transplant - Hemorrhage, Surgical ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cell Salvage Autotransfusion: SAME™ device - Cell Salvage Autotransfusion: Autolog™ device ### Outcomes Primary Outcomes - Platelet number Secondary Outcomes - Platelet function - Platelet function - Platelet function - Platelet function - Platelet function - Platelet function - Blood plasma albumin level - Blood hemoglobin level - Blood lactate level - Free hemoglobin level - Anti-Xa activity - Number of allogeneic blood products used - Number of coagulation concentrates used - Amount of autologous blood at the end of the liver transplantation ### Location - Facility: Geneva University Hospitals, Geneva, N/A, 1211, Switzerland @@
## Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant. - NCT ID: NCT06357442 - Study ID: 23-2305 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: University of Colorado, Denver ### Study Description The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult (AYA) patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection.The main questions it aims to answer are:Aim 1: Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapyAim 2: Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesteroneAim 3: Assess satisfaction, side effects, bleeding patterns, any progesterone modifications, and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesteroneParticipants will be asked to:* Get two pelvic ultrasounds* Fill out two surveys* Continue their current hormone replacement therapy* Initiate one of two progesterone therapies (prometrium 100mg daily or Nexplanon)Researchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups. ### Conditions - Primary Ovarian Insufficiency - Hypogonadotropic Hypogonadism - Hormone Replacement Therapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Mean change in endometrial thickness after 6 months of progesterone therapy Secondary Outcomes - Measure the mean endometrial thickness on estrogen replacement therapy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Effect of the LI4 Cold Application - NCT ID: NCT06357429 - Study ID: 171002100 - Status: COMPLETED - Start Date: 2022-02-23 - Completion Date: 2022-11-18 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description It is an experimental study conducted to evaluate the effectiveness of cold application to the LI4 point of the hand to reduce/eliminate pain, nausea and anxiety in postoperative patients. The population of the study consisted of 116 individuals who underwent abdominal surgery with the open surgery method in a state hospital between February 2022 and November 2022 and were followed up in the inpatient ward. The study was completed with 80 individuals constituting the experimental group (n=40) and the control group (n=40). Patient information form, Mcgill Melzack short pain form, Visual Analog Scale, STAI - TX and Cold Application Evaluation Form were used to collect data. Patients in the experimental group underwent cold application with ice cubes for a total of 20 minutes as 2 minutes of cold application and 15 seconds of waiting 4-6 hours after the patient was admitted to the clinic after surgical intervention. Follow-up was performed before cold application, immediately after cold application, 30 minutes after the end of cold application, 1 hour and 2 hours after the end of cold application. ### Conditions - Pain - Nausea - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cold Application ### Outcomes Primary Outcomes - Pain Level - Nausea Level - Anxiety Level - Sensory characteristics, intensity and impact of pain Secondary Outcomes ### Location - Facility: Saglik Bilimleri University, Istanbul, Uskudar, 34674, Turkey @@
## The Man Van Project - NCT ID: NCT06357416 - Study ID: CCR5573 - Status: RECRUITING - Start Date: 2022-04-13 - Completion Date: 2026-12-01 - Lead Sponsor: Royal Marsden NHS Foundation Trust ### Study Description National Health Service (NHS) England has commissioned The Royal Marsden Hospital NHS Foundation Trust to run a novel mobile clinical outreach service called 'Man Van' with the aim of enabling male patients' easy access to care at the site of their work and in their communities. The initial focus of this new standard of care clinic is to access workplaces with large manual workforces where large scale working from home is not possible. These will include logistics firms and bus companies. These companies employ large numbers of black and minority ethnic men who also have poorer outcomes with a range of other diseases, including Coronavirus disease (COVID)-19. The novel clinical service will collaborate with Unite (and other unions) as well as employers in order to reach our target groups effectively. There is also the opportunity to target higher risk groups e.g. Afro Caribbean communities whose rates of prostate cancer are 1 in 41 as well as occupational higher risk categories. The Man Van has the potential to swing the balance of evidence in favour of Prostate-Specific Antigen (PSA) screening, with a targeted screening program directed at high-risk groups including ethnic minorities and manual workers. Reasons for poorer outcomes amongst these groups are multi-factorial and complex. Levels of education are often a factor which can impact the understanding of the disease and how to seek assistance. Distrust of medical organisations has also been cited as a factor.The aim of the Man Van mobile outreach service is to enable men access to a specific men's health service - focusing on general health and wellbeing (including BMI assessment, blood pressure, blood sugar/diabetes checks etc) and a prostate check for those who raise concerns. This will include a PSA test where relevant. This will be the core data gathered from the project.Patients will receive PSA results in the 'Man Van' by a clinical nurse specialist with patients with raised PSA levels being referred into the standard rapid referral cancer pathways. Similar considerations will apply to men with haematuria detected on dip stick testing or who present with a testicular mass or penile lesion (both rare but important).The clinical data generated from each routine health screening appointment will be analysed to determine the effectiveness of the Man Van mobile outreach model in identifying prostate and other male cancers and other co-morbidities much earlier than if patients had waited to present to their General Practitioner (GP) or other healthcare provider.Patients who receive an early diagnosis of clinically significant prostate cancer will have access to early curative treatments, which are typically less invasive and shorter in timescales. Similar interventions have shown large scale success in particular with breast and cervical cancer.The NHS sees many patients accessing cancer care at a late stage. Reducing this trend is a key objective of the NHS Long Term Plan. The COVID-19 pandemic has further exacerbated health inequalities and mobile clinics can potentially be a model for alleviating this. To enable patients access to medical treatment earlier there is a need to make the 'seeking advice on men's health and prostate issues' less daunting, more normal and easily accessible. The 'Man Van' has the ability to do just that and it is anticipated that the findings of this research, using the data generated from each patient's routine health screening, will demonstrate that a mobile outreach model is more effective in identifying cancers at an earlier stage than 'traditional' diagnostic pathways.We also hope to evaluate the Man Van with a qualitative study looking at the patient perspectives from those who utilise the Man Van.The reasons for high risk in prostate cancer are heavily linked to genetics. This is an issue as there is less recruitment of high risk groups to studies. We hope to gather genetic data from a higher proportion of genetically susceptible men via the Man Van, which can be used in future to further genetic knowledge of prostate cancer. ### Conditions - Prostate Cancer - Urologic Cancer - Urologic Diseases - Bladder Cancer - Diabetes - Hypertension - Mental Health Issue - Alcoholism - Smoking - Renal Cancer - Testis Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - MV-POCT Sub-study - Main Man Van Group Sub-study - MV-QualQ Sub-study - MV-PRS Sub-study - MV-DNA and MV-UctDNA Sub-study - Man Van patients ### Outcomes Primary Outcomes - Cancer detection rates - Detection rates of other diseases Secondary Outcomes ### Location - Facility: Royal Marsden Hospital NHS Foundation Trust, London, N/A, SW3 6JJ, United Kingdom @@
## Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients - NCT ID: NCT06357403 - Study ID: AntiXa-ICU 1881/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-08 - Lead Sponsor: Medical University of Vienna ### Study Description The goal of this observational study is to analyse the association between anti-factor Xa activity (antiXa) and the occurence of venous thromboembolism (VTE; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. The main questions it aims to answer are:* What is the association between antiXa and VTE?* What is the association between antiXa and symptomatic, respectively incidental, VTE?* How is pharmacological anticoagulation with enoxaparin related to measured antiXa?* What is the association between antiXa and bleeding complications.* What is the incidence of venous thromboembolism in patients treated at an intensive care unit?* How is the occurence of VTE related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital. ### Conditions - Thrombosis - Pulmonary Embolism - Enoxaparin ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Anti-factor Xa activity calibrated for enoxaparin ### Outcomes Primary Outcomes - Number of patients with new-onset venous thromboembolism Secondary Outcomes - Number of patients with new-onset upper extremity deep vein thrombosis - Number of patients with new-onset lower extremity deep vein thrombosis - Number of patients with new-onset central vein thrombosis - Number of patients with new-onset symptomatic upper extremity deep vein thrombosis - Number of patients with new-onset symptomatic lower extremity deep vein thrombosis - Number of patients with new-onset incidental upper extremity deep vein thrombosis - Number of patients with new-onset incidental lower extremity deep vein thrombosis - Number of patients with new-onset pulmonary embolism - Number of patients with new-onset symptomatic pulmonary embolism - Number of patients with new-onset incidental pulmonary embolism - Number of patients with venous thromboembolism - Number of patients with deep vein thrombosis - Number of patients with pulmonary embolism - Number of patients with new-onset venous thromboembolism - Number of days with any bleeding - Number of days with major and/or fatal bleeding - Number of red blood cell concentrates administered - Number of days on which either procoagulant medication, platelet transfusion or fresh frozen plasma was administered - Length of stay in the intensive care unit - Length of stay in the hospital - Death - Days alive and out of the intensive care unit - Days alive and out of the hospital - European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) index value - European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) visual analogue scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Physiologic and Clinical Effect of High-flow Oxygen Therapy in Tracheostomized Patients With Prolonged Mechanical Ventilation Undergoing Weaning Trials - NCT ID: NCT06357390 - Study ID: 202106174RINB - Status: COMPLETED - Start Date: 2021-10-07 - Completion Date: 2024-02-15 - Lead Sponsor: National Taiwan University Hospital ### Study Description This study is aimed at patients who have been admitted to the respiratory care center of this hospital who meet the PMV conditions (defined as continuous use of the ventilator for at least ten days) who are about to receive the ventilator out of training. After obtaining the explanatory consent, they will undergo continuous complete Before and after spontaneous breathing training, collect various relevant physiological data of lung volume and ventilation perfusion distribution, and analyze and predict the correlation of ventilator detachment. ### Conditions - High Flow Oxygen Therapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - ventilation perfusion distribution measurement Secondary Outcomes ### Location - Facility: National Taiwan University Hospital, Taipei, N/A, N/A, Taiwan @@
## A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors - NCT ID: NCT06357377 - Study ID: NEO100-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-10-31 - Lead Sponsor: Neonc Technologies, Inc. ### Study Description This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas. Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid). ### Conditions - Pediatric Tumor of CNS - Pediatric Tumor of Brain - Diffuse Midline Glioma, H3 K27M-Mutant - Pediatric Tumor of Brain Stem - Pineocytoma - Choroid Plexus Carcinoma, Childhood - Spinal Cord Tumor - High Grade Glioma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NEO100 ### Outcomes Primary Outcomes - Nature and severity of adverse events Secondary Outcomes - Identify the maximum tolerated dose (MTD) of NEO100 - Determine the recommended Phase 2 dose (RP2D) of NEO100 - Measurement of NEO100 and its metabolite perillic acid in brain tumor tissue - Blood brain barrier penetration - Characterize the pharmacokinetics (PK) of NEO100 as measured by Peak Plasma Concentration - Characterize the pharmacokinetics (PK) of NEO100 as measured by the Time to Peak Plasma Concentration - Characterize the pharmacokinetics (PK) of NEO100 as measured by Area Under the Curve - To assess efficacy of NEO100 based on objective response rate (ORR). - To assess efficacy of NEO100 based on progression free survival (PFS). - To assess efficacy of NEO100 based on overall survival (OS). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neural Changes Following Cognitive Behavior Therapy for Procrastination - NCT ID: NCT06357364 - Study ID: CBT_Procrastination_Neuro - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2026-01-15 - Lead Sponsor: Nencki Institute of Experimental Biology of the Polish Academy of Sciences ### Study Description The aim of this study is to compare the efficacy of and the neural changes following two cognitive behavior therapy (CBT) protocols for procrastination with a wait-list control group. The interventions will be delivered online in group settings. Both protocols include identical psychoeducation and cognitive modules aiming at identification and modification of dysfunctional automatic thoughts related to procrastination but will differ in the behavioral modules. The behavioral module in the first protocol is focused on timely beginning and realistic planning. The second protocol implements working time restriction. The wait-list control group will receive one of the CBT protocols after a waiting period that will last as long as the CBT intervention and the assessments performed directly after treatment. It is assumed that the interventions will be superior to the wait-list control. Primary (procrastination) and secondary (depression and anxiety) measures will be collected prior to and after the interventions (or waiting period in the wait-list group) and after 6 months in the two active condition groups. Additionally, neuroimaging measurements will be conducted before and after the interventions (or waiting period in the wait-list group). Approximately half of the participants will undergo functional Magnetic Resonance Imaging (fMRI), and another half will undergo electroencephalography (EEG). Both methods are aimed at exploring neural correlates of the expected improvements in participants' self-regulation abilities. ### Conditions - Procrastination ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Psychoeducation and cognitive modules - Behavioral module: Starting on Time and Planning Realistically - Behavioral module: Working Time Restriction ### Outcomes Primary Outcomes - Change in Polish version of the Pure Procrastination Scale (PPS) - Change in Polish version of the Aitken Procrastination Inventory (API) Secondary Outcomes - Change in Polish version of the Patient Health Questionnaire (PHQ-9) - Change in Polish version of the Generalized Anxiety Disorder Questionnaire-7 (GAD-7) - Percentage of completion of a particular project that the participant decided to work on during the training (e.g. a thesis, an essay, a report). ### Location - Facility: Nencki Institute of Experimental Biology, Polish Academy of Sciences, Warsaw, N/A, 02-093, Poland @@
## Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment - NCT ID: NCT06357351 - Study ID: VISTA in gingival recession - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-07-01 - Completion Date: 2024-05 - Lead Sponsor: Mansoura University ### Study Description To assess the efficacy of minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) with collagen membrane and Advanced Platelet-rich Fibrin (A-PRF) in the treatment of multiple buccal gingival recession type 1(RT1) Cairo Classification. ### Conditions - Gingival Recession ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - vestibular incision sub periosteal tunnel access ( VISTA) technique. ### Outcomes Primary Outcomes - Measuring the recession width in millimeter - Measuring the recession depth in millimeter - Measuring the width of keratinized gingiva in millimeter - Mean of root coverage Secondary Outcomes - Measuring the probing depth - Measuring the plaque index - Measuring the gingival index - Clinical attachment level ### Location - Facility: Mansoura university, Mansoura, N/A, N/A, Egypt @@
## Differential Expression and Potential Value of c-MYC in Non-Invasive and Invasive Mammary Carcinoma - NCT ID: NCT06357338 - Study ID: Soh-Med-24-03-15MS - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-19 - Completion Date: 2026-04-01 - Lead Sponsor: Marwa Mahmoud Hassan ### Study Description Retrospective observational study to evaluate c-MYC expression in non invasive and invasive mammry carcinoma ### Conditions - Invasive Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - role of c-MYC in breast cancer Secondary Outcomes ### Location - Facility: Sohag university, Sohag, N/A, N/A, Egypt @@
## 2023 Problems Faced by Women Earthquake Survivors in Kahramanmaraş - NCT ID: NCT06357325 - Study ID: E-74555795-050.01.04-52290 - Status: COMPLETED - Start Date: 2023-06-22 - Completion Date: 2023-12-01 - Lead Sponsor: Maltepe University ### Study Description Objective:This study was conducted to evaluate the opinions of earthquake victims about the problems affecting women's health physically and psychosocially after the 2023 Kahramanmaraş earthquake.Method:The study was designed in a qualitative type (semi-structured). The population of the study consisted of women affected by the 2023 Kahramanmaraş-Pazarcık earthquake. 15 women were interviewed. ### Conditions - Psychosocial Problem - Nurse-Patient Relations - Disaster; Personality - Gender ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - a qualitative study. ### Outcomes Primary Outcomes - Personal Information Form - A semi-structured interview form - consists of questions about changes experienced after the earthquake Secondary Outcomes ### Location - Facility: Ozeninam, Istanbul, Maltepe, 34857, Turkey @@
## Influence of Static Distal Locking of a Short Proximal Femoral Nail - NCT ID: NCT06357312 - Study ID: 2023/11P - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-04-01 - Lead Sponsor: Elda University Hospital ### Study Description Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw. ### Conditions - Hip Fracture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - hip trochanteric nail ### Outcomes Primary Outcomes - Evaluation of functional status using the Barthel index Secondary Outcomes - Postoperative mechanical complications - Parker mobility scale ### Location - Facility: Elda University Hospital, Elda, Comunidad Valenciana, 03600, Spain @@
## Assessing Better Bottles for Babies - NCT ID: NCT06357299 - Study ID: Pro00115060 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-02-01 - Lead Sponsor: Duke University ### Study Description This study will use a 2 x 2 factorial design to test impact of two intervention strategies (bottle size and bottle opacity) on infant weight gain. ### Conditions - Pediatric Obesity - Weight Gain Trajectory - Infant Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Small Bottle Size - Standard Bottle Size - Clear Bottle - Opaque Bottle ### Outcomes Primary Outcomes - Conditional weight gain z-score changes (CWGz) Secondary Outcomes - Formula volume per feed - Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Income Volatility and Mental Health, Pilot Study - NCT ID: NCT06357286 - Study ID: IRB0148156 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-10-10 - Lead Sponsor: Cornell University ### Study Description Income instability is a defining aspect of the lives of the poor, who also disproportionately suffer from poor mental and physical health. Our research is the first to assess the causal effects of predictable and unpredictable income instability on the psychological and physical health of the poor. It will advance the scientific knowledge on the effects of economic instability as well as our understanding of health disparities. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Work opportunities ### Outcomes Primary Outcomes - Depression Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of White Tea Consumption on Obesity - NCT ID: NCT06357273 - Study ID: WhiteTeaAY - Status: COMPLETED - Start Date: 2023-07-01 - Completion Date: 2023-12-15 - Lead Sponsor: Recep Tayyip Erdogan University ### Study Description Obesity is an increasing global public health issue. In general, tea consumption have been shown to offer benefit to obese patients. However, the potential of white tea (WT) to treat and protect from the adverse effects of obesity have not been addressed so far. The aim of this study was to examine the efficacy and impact WT consumption highest in catechins on levels of anthropometric and biochemical values in obese patients. ### Conditions - Obesity - Obesity; Endocrine - Obesity Adult Onset ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Weight loss - Waist Circumference - Body Mass Index Secondary Outcomes - Tumor Necrosis Factor - alpha - Total cholesterol - Low-Density Lipoprotein cholesterol - High-Density Lipoprotein cholesterol ### Location - Facility: Recep Tayyip Erdogan University, Rize, N/A, 53100, Turkey @@
## Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients - NCT ID: NCT06357260 - Study ID: Shifa OMR - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak ### Study Description Trigeminal neuralgia is a very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic enzymes, renal dysfunction. Pregabalin which is an established drug in neuropathic pain has better pharmacokinetic nature which allows for easy management and rapid dose escalation to therapeutic doses. There have been only few trials evaluating efficacy of Pregabalin in classical trigeminal neuralgia. Thus, the present study is designed to evaluate the efficacy of Pregabalin as an add-on therapy to carbamazepine in patients suffering from Trigeminal Neuralgia. In present trial 50 patients fulfilling the exclusion and inclusion criteria will be recruited in two arms that is test group and the control group. The test group will be prescribed carbamazepine along with fixed dose of Pregabalin 75mg twice daily while the control group will be prescribed carbamazepine only. The dose of carbamazepine will be titrated in both groups as per patients need. The outcome regarding pain relief, quality of life and adverse effects and mean dose of carbamazepine required in both groups will be evaluated. ### Conditions - Trigeminal Neuralgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pregabalin and Carbamazepine - Carbamazepine ### Outcomes Primary Outcomes - VAS score - Brief pain inventory ● Brief pain inventory assessment of pain. ● Brief pain inventory assessment of pain. Brief pain inventory Secondary Outcomes - Patient Global Impression of change(PGI) - mean dose of carbamazepine - Liverpool scale ### Location - Facility: PGIDS, Rohtak, Haryana, 124001, India @@
## The Effect of SRS on Hemiplegia in Stroke Survivors - NCT ID: NCT06357247 - Study ID: HM20027093 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-08 - Lead Sponsor: Virginia Commonwealth University ### Study Description Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Many stroke survivors have difficulty completing dexterous hand movements and manipulating objects due brain damage in the sensorimotor cortex. Damage to these areas can cause decreased motor movements and tactile sensation on the affected side. Research shows that tactile sensation is necessary for maintaining grip, grading grip forces and decreasing object slippage. Therefore, it is important to address tactile sensation with motor performance during stroke rehabilitation to improve performance outcomes among stroke survivors. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Sensory Threshold - Nine Hole Peg Test - Semmes Weinstein Monofilament Assessment ### Outcomes Primary Outcomes - Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients Secondary Outcomes - Optimal level of stochastic resonance vibration ### Location - Facility: Virginia Commonwealth University, Richmond, Virginia, 232398, United States @@
## Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery - NCT ID: NCT06357234 - Study ID: APRE-2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-04 - Lead Sponsor: IWK Health Centre ### Study Description This research trial will measure how useful Aprepitant is in preventing nausea and vomiting in children having surgery to correct scoliosis (curvature of the spine). ### Conditions - Spinal Fusion - Nausea and Vomiting, Postoperative - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Aprepitant - Placebo ### Outcomes Primary Outcomes - Anti-Nausea Rescue Medication Secondary Outcomes - Anti-nausea rescue medication administered by post-operative day - Emesis (Yes/No) - Baxter Retching Faces score - Pain score - Headache (yes/no) - Flatus (yes/no) - Bowel Motility (yes/no) - Sensation of Itch - Treatment of emergent adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients - NCT ID: NCT06357221 - Study ID: GLI.04.US.SL.035 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-07-31 - Lead Sponsor: Galderma R&D ### Study Description Subjects having mild-to-severe plaque psoriasis, with active target lesion plaques, and currently on or starting a prescription treatment for plaque psoriasis will apply a topical skincare regimen to one side of the body. Evaluations of the regimen's efficacy will be conducted at 2 weeks, 4 weeks, and 8 weeks post-baseline. ### Conditions - Plaque Psoriasis - Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cetaphil ### Outcomes Primary Outcomes - Change in psoriatic Body Surface Area compared to baseline - Change in target lesion severity compared to baseline - Change of Physician Global Assessment compared to baseline - Change in skin quality measured by macroscopic imaging - Subject treatment satisfaction - Incidence of psoratic irritation [tolerability assessment] Secondary Outcomes - Subject Quality of Life Satisfaction ### Location - Facility: Southeast Dermatology Specialists, LLC, Columbus, Georgia, 31904, United States @@
## IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION BREATH HOLD TO BREATH BETTER PROGRAM - NCT ID: NCT06357208 - Study ID: 23-AOI-06 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-01 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description we propose for patient in the course of Medically Assisted Reproduction a study with to arm: one arm active "Breathing Control and Retention" and the other arm control ### Conditions - Reproductive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Breathing Control and Retention ### Outcomes Primary Outcomes - Rate of stressed patients Secondary Outcomes - STAI Y-A (anxiety state) scale ### Location - Facility: Chu de Nice, Nice, N/A, 06003, France @@
## DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients - NCT ID: NCT06357195 - Study ID: 2024H0075 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-01 - Lead Sponsor: Ohio State University ### Study Description The goal of this observational study is to learn about current practices for the acute neuropsychiatric management of older adults during emergency department (ED) visits. Researchers will compare current standard of care practices with implemented guideline practice to see if standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations. The main questions this study aims to answer are:* How many older adults are receiving antipsychotics or benzodiazepines during emergency department visits?* Why are older adults receiving antipsychotics or benzodiazepines during emergency department visits?* How many older adults who receive antipsychotics or benzodiazepines during emergency department visits have an underlying cognitive or movement disorder?* What effects does administration of antipsychotics or benzodiazepines during emergency department visits have on patient outcomes in older adults and adults with neurocognitive disorders?* Does implementation of standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations? ### Conditions - Emergency Psychiatric - Cognition Disorder - Movement Disorders - Antipsychotics and Neuroleptics Toxicity - Dementia With Lewy Bodies - Alteration in Mental Status - Behavior - Aging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Antipsychotic/Benzodiazepine - Clinical Indication Secondary Outcomes - Length of Stay - Disposition - Code Status ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia - NCT ID: NCT06357182 - Study ID: STUDY00026136 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-08 - Completion Date: 2026-05-29 - Lead Sponsor: OHSU Knight Cancer Institute ### Study Description This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe, tolerable and/or effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy. ### Conditions - Acute Myeloid Leukemia - Myelodysplastic Syndrome/Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Azacitidine - Biospecimen Collection - Bone Marrow Biopsy - Echocardiography - Iadademstat - Multigated Acquisition Scan - Questionnaire Administration - Venetoclax ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicities (DLTs) within specific iadademstat (IADA) dose levels Secondary Outcomes - Percentage of efficacy-evaluable participants achieving composite complete remission (cCR) - Percentage of efficacy-evaluable participants achieving an overall response (ORR) - Incidence of treatment-emergent grade ≥ 3 adverse events (AEs) ### Location - Facility: OHSU Knight Cancer Institute, Portland, Oregon, 97239, United States @@
## Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias - NCT ID: NCT06357169 - Study ID: Venus Glow - Status: COMPLETED - Start Date: 2023-01-13 - Completion Date: 2024-01-13 - Lead Sponsor: University of Minnesota ### Study Description The objective of this study is to assess the effect of standardized scalp care, specifically mechanical cleansing with the Venus Glow™ Device and water, on the scalp microbiome. This study also seeks to characterize the microbiome of the normal, healthy scalp, thereby providing a baseline for which the scalp affected by hair and scalp disease can be compared. ### Conditions - Lichen Planopilaris of Scalp - Alopecia Areata ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Venus Glow ### Outcomes Primary Outcomes - scalp microbiome composition Secondary Outcomes - scalp health ### Location - Facility: University of Minnesota, Minneapolis, Minnesota, 55455, United States @@
## Evaluating the Topographic and Quantitative Differences of the Mandibular Symphysis Area Between Males and Females Egyptians Using CBCT Scans: a Cross-sectional Study - NCT ID: NCT06357156 - Study ID: ORAD-621 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-03-30 - Lead Sponsor: Cairo University ### Study Description Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.* Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations).* Images showing lower anterior mandibular teeth with 0.2 -0.4 voxel sizes will be reviewed.* The topography and the quantity of the mandibular symphysis area will be assessed through the different planes: sagittal, coronal and axial cuts as well as assessing the prevalence of MIC and its distance from inferior border of the mandible if detected. Correlation of results according to gender and age (3 age sub-groups per gender:18-35, 36- 55, 56-75).* CBCT images will be interpreted by oral and maxillofacial radiologist; blinded from demographic data of the patients.* radiologist (Principle investigator) will evaluate the images for assessing the topography and quantity of bone in symphysial area through measuring dimensions of mandibular symphysis. Then will re-evaluate twice with a time lag of two weeks between the two reading sessions. The assistant supervisor will evaluate percentage of the scans. Any disagreement will be solved by consensus between the two observers.* The measurements will be carried out by the principle observer (PY) and will be repeated 2 weeks later for intra-observer reliability assessment.* Mandibular scans will be collected from planmeca machine, with 0.2-0.4 voxel size to be viewed on Romexis software to do the measurements of mandibular symphysis. Vertical height will be measured from the apices of anterior teeth to inferior border of the mandible from the sagittal and coronal cuts with the orientation lines parallel to the buccal cortical plate. Also, the sagittal cuts will be used to determine the depth of the labial bone, from the apices of anterior teeth the labial cortical plate with the orientation lines parallel to the buccal cortical plate (Safi, Yaser et al.,2021) Whilst horizontal dimension (width) will be measured along the outer surface of the labial cortical bone, which is determined from the inter-foraminal distance. 3D slicer software will be used for this curved measurement on the axial plane, since Romexis software can only do the linear and angular measurements (Lee , Kim et al, 2014).Also, the sagittal reformatted cuts will be used for the determination of the topography of bone in symphysial area; either class I, II or III (Jussara Constantino, et al., 2018) Radiographs showing the different topographic types Radiograph A: Type I, B: Type II and C: Type III• Through scrolling in sagittal, coronal cuts and the reformatted panoramic view the prevalence of mandibular incisive nerve will be detected (Borghesi, Andrea et al., 2022).After collecting the whole data, statistically will be correlated to the age and gender. ### Conditions - Mandibular Symphysis, Block Bone Graft, Mandibular Incisive Canal, and CBCT ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CBCT ### Outcomes Primary Outcomes - Effect of gender on the mean height of basal bone in the symphysial area Secondary Outcomes - Effect of gender on quantity of the bone in symphysial area: depth of the bone width of the bone - Effect of gender on topography of the bone in symphysial area - Effect of age on quantity of the bone in the symphysial area - Effect of age on topography of the bone in symphysial area - Prevalence of mandibular incisive canal ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis - NCT ID: NCT06357143 - Study ID: REMOVE - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2027-12 - Lead Sponsor: University of Malaga ### Study Description The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients. ### Conditions - Shoulder Fractures - Prosthesis User ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - REMOVE - CONTROL ### Outcomes Primary Outcomes - Functionality Secondary Outcomes - Muscle mass - Kinematics - Strength - Range of movement ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Gynaecological Care for Transgender People in France in 2024. - NCT ID: NCT06357130 - Study ID: CHUBX 2023/75 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: University Hospital, Bordeaux ### Study Description To date, the transgender population, still poorly characterized, tends to increase. The impact of gender-affirming hormone therapy (GAHT) in this population remains poorly understood, and few data are published on the gynecological repercussions of such therapy. A recent literature review by a French team suggests gynecological follow-up procedures for transgender people. ### Conditions - Transgender Management Care ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - Percentage of people aware of gynaecological recommendations. Secondary Outcomes - Percentage of people aware of cancer risks - Percentage of people aware of contraception in transgender male population - Percentage of people aware of fertility and the impact of hormone treatments - Percentage of people aware of gynaecological repercussions of masculinizing hormone treatment in transgender male population ### Location - Facility: Hopital Haut-Lévêque, Pessac, N/A, 33604, France @@
## Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma - NCT ID: NCT06357117 - Study ID: A01263 - Status: COMPLETED - Start Date: 2018-04-13 - Completion Date: 2021-12-22 - Lead Sponsor: Beijing Tsinghua Chang Gung Hospital ### Study Description The extent of intrahepatic infiltration of perihilar cholangiocarcinoma (PHCC) remains unclear. This research aimed to explore the pattern and extent of intrahepatic infiltration of PHCC to guide surgical treatment and pathological research. This prospective study included 62 participants diagnosed with PHCC who underwent major hepatectomy. A whole-mount digital liver pathology system (WDLPS) for hepatectomy specimens greater than 10 × 10 cm was used to panoramically assess the intrahepatic infiltration extent of PHCC. ### Conditions - Perihilar Cholangiocarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Relapse-free survival (RFS). Secondary Outcomes - Overall survival (OS). ### Location - Facility: Beijing Tsinghua Chang Gung Hospital, Beijing, Beijing, 102218, China @@
## Detoxification From the Lipid Tract - NCT ID: NCT06357104 - Study ID: SCI-CT-0001 - Status: COMPLETED - Start Date: 2024-02-26 - Completion Date: 2024-03-20 - Lead Sponsor: Pachankis, Yang I., M.D. ### Study Description Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study. ### Conditions - COVID-19 Vaccine Adverse Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - electroencephalogram biofeedback - electrical brain stimulation - ultra-low frequency transcranial magnetic stimulation - Sertraline Hydrochloride - Clonazepam - Alprazolam - Metoprolol - Olanzapine - Pravastatin Sodium 20 MG - Sacubitril Valsartan Sodium Hydrate ### Outcomes Primary Outcomes - Changes in Leukocyte and Components' Quantities - Changes in Leukocyte Components' Ratios - Quantity Changes in Megakaryocyte-Erythroid Progenitor - Changes in Hemoglobin Distribution - Changes in Mean Corpuscular Hemoglobin - Changes in Hematocrit - Changes in Plateletcrit - Red cell Distribution Width Coefficient of Variation - Changes in Particulate Matter Sizes - Changes in Total Lipid Quantities - Changes in Apolipoproteina - Changes in Lipoprotein (a) Secondary Outcomes - Blood Pressure Changes - Heart Rate Changes ### Location - Facility: Residential Address, Chongqing, Chongqing, 402762, China @@
## ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws - NCT ID: NCT06357091 - Study ID: 1097/2023 ACL-Shark Screw® - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2031-06-01 - Lead Sponsor: Bezirkskrankenhaus Schwaz ### Study Description The goal of this clinical trial is to compare the outcome of 2 different screws for Anterior cruciate ligament reconstruction. The main question is if the human allogeneic cortical bone screw reduces tunnel widening in comparison to conventional treatment with a biocomposite screw. Additional the re-rupture rate will be evaluated and knee scores will be recorded before surgery and after surgery. Participants will have MRI before and after surgery, 3, 6, 12, and 24 months after surgery and Computertomography after surgery, 3, 6 and 24 months after surgery. Questionnaires (Knee-scores) will be recorded before surgery, 6, 12, 24 months after surgery.the investigators hope that with the human cortical bone screw the tunnel widening is reduced and the re-rupture rate is low ### Conditions - Anterior Cruciate Ligament Rupture - Anterior Cruciate Ligament Reconstruction - Anterior Cruciate Ligament Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ACL reconstruction with Shark Screw ACL® - ACL reconstruction with biocomposite screw (Mecta) ### Outcomes Primary Outcomes - bone tunnel widening will be measured by CT and/or MRI and measured in mm Secondary Outcomes - International Knee Documentation Committee (IKDC) Scores - Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores - Lysholm Knee Score - Tegner Activity Score ### Location - Facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H., Schwaz, Tirol, 6130, Austria @@
## Art Therapy and Caregivers Stress - NCT ID: NCT06357078 - Study ID: AmasyaU-NU-679 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2024-07-31 - Lead Sponsor: Amasya University ### Study Description This research will be conducted to determine the effect of art therapy on the stress, anxiety and well-being of caregivers in the palliative care service. ### Conditions - Caregiver Stress Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Art Therapy ### Outcomes Primary Outcomes - Distress Thermometer - The State Anxiety Inventory - Personal Well-Being Index Secondary Outcomes ### Location - Facility: Neşe Uysal, Amasya, N/A, 0500, Turkey @@
## Active Transport Educational Program Based on the Ecological Model on Improving the Physical and Mental Health: MOV-ES Project - NCT ID: NCT06357065 - Study ID: UCatolicaMaule - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-20 - Lead Sponsor: Universidad Católica del Maule ### Study Description The epidemic of physical inactivity affects the entire world and is responsible for more than 5 million deaths per year. The call of the United Nations, through the 2030 Agenda and the Sustainable Development Goals, encourages the creation of favorable environments for physical activity based on the ecological model of physical activity. Given this context, active transportation can be an accessible, economical, and sustainable method to increase daily physical activity. The rate of school children who use active transport has decreased, being replaced by motorized transport, causing congestion and high levels of pollution in cities. In the Chilean context, there are studies of active transportation in the Chilean population; however, they are scarce in the school population and none of them is an intervention study, demonstrating the incipient development of this area in the country. The benefits of promoting active transportation not only favor the lifestyles of school children but also include additional co-benefits such as the improvement of mental health and better academic performance, in addition to the reduction of exhaust and greenhouse gas emissions.Objectives. This proposal consists of three phases with the following objectives: Phase I: i) to synthesize the evidence about interventions aimed at estimating the effect on health of active transport in the secondary students; and ii), using qualitative techniques, to explore, from the basis of grounded theory, barriers and facilitators perceived by professors, students and parents about the development and implementation of the MOV-ES intervention. Phase II. Pilot and feasibility trial: a) to test the effect of MOV-ES intervention on improving body composition (body fat percentage and muscle mass), physical fitness (aerobic capacity and muscular strength), executive function and mental fitness (mood disorders, cognitive functioning) in the secondary students; and b), to examine the acceptability by professors, parents and students of the intervention by using ad hoc questionnaires. Phase III: to test the effectiveness of the MOV-ES intervention on physical activity, physical fitness, cognition and mental health through a cluster randomized controlled trial.Expected results: This project will give rise to the following master\'s and doctoral theses, with their corresponding articles of high scientific impact: 1) Barriers and facilitators of teachers, parents and students for active transport from a qualitative approach; 2) Association between the built environment, urban features, and active transportation in high school students, 3) Effectiveness of an active transportation educational intervention on physical fitness and body composition, 4) Effectiveness of an active transportation educational intervention on the cognition of schoolchildren. It is expected that the results of the MOV-ES Project will transcend the physical health of schoolchildren and will have an impact on the school community, especially by decongesting the school environment. Through these results, the Ministry of Education, regional DAEM, municipalities, and educational establishments will be able to propose public policies that favor the practice of physical activity and the acquisition of healthy habits at school age. All of the above is based on quality indicators proposed by the Education Quality Agency. ### Conditions - Physical Inactivity in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Active transport educational program based on the ecological model ### Outcomes Primary Outcomes - Body composition change (fat mass) by bioimpedance at 16 weeks - Change from Body Composition (fat-free mass) by bioimpedance at 16 weeks - Changes in Executive Function (inhibition) at 16 weeks - Changes in Executive Function (cognitive flexibility) at 16 weeks - Changes in executive function (working memory) at 16 weeks Secondary Outcomes - Change from Anthropometric measurements at 16 weeks - Changes in objective physical activity at 16 week - Change from Physical Fitness (Aptitud cardiorrespiratoria (VO2 máx) at 16 weeks - Change from Physical Fitness (lower body strength) at 16 weeks - Change from Physical-Functional Fitness (strenght on the upper body) at 16 weeks - Change from mental health (depression) at 16 weeks - Change from mental health (Anxiety) at 16 weeks - Change from mental health (Stress) at 16 weeks - Changes in overall academic performance once the intervention is completed - Changes in health-related quality of life at 16 weeks - Changes in the Perception of urban environmental characteristics at 16 weeks - Changes in physical activity barriers at 16 weeks - Changes in adherence to physical activity at 16 weeks - Changes in the form of Transportation to and from School (Active Transportation) at 16 weeks. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Study of Lithogenesis Processes in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) - NCT ID: NCT06357052 - Study ID: 2701 - Status: COMPLETED - Start Date: 2019-07-19 - Completion Date: 2022-11-30 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. In order to study the association between NAFLD and nephrolithiasis while minimizing the confounding effect of metabolic syndrome, we investigated the impact of different degrees of NAFLD severity on potential risk factors for stone formation. ### Conditions - NAFLD - Urinary Lithiasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - the analysis of the correlation between the degree of severity of NAFLD And urinary lithogenic profilecharacterized by reduced urinary magnesium and altered urinary ammonium excretion. Secondary Outcomes ### Location - Facility: Fondazione Policlinico A.Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## Validation Study of Sleep Tracking Devices - NCT ID: NCT06357039 - Study ID: 09.2023.422 - Status: COMPLETED - Start Date: 2023-03-21 - Completion Date: 2023-07-17 - Lead Sponsor: PNAPS Health Informatics and Space Technologies Inc. ### Study Description In this study, a two-part recursive convolutional neural networks model was developed, extracting features for each epoch window independently from before and after sleep onset (epoch encoder), and then trained in the context of long-term relationships in the sleep process (sequence encoder), using an approach similar to human expert classification based on information from single-channel forehead EEG and PPG (IR, Green, Red). The classification is based on guidelines from the American Academy of Sleep Medicine and calculated six parameters: total sleep duration (TST), wake (W), N1, N2, N3, and REM.The validation study of the developed model and the device was conducted at the Sleep Disorders Centre of the Istanbul Medical Faculty using concurrent polysomnographic data from 305 male and female patients aged 18 to 65 years. ### Conditions - Sleep - Sleep Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sleep tracking device ### Outcomes Primary Outcomes - Sleep Stages Classification Accuracy - Interoception analysis from PPG data collected from facial skin Secondary Outcomes ### Location - Facility: Pnaps Health Informatics and Space Technologies Inc, Istanbul, Başıbüyük, Maltepe, 34854, Turkey @@
## Phitys I™ Percutaneous Left Ventricular Assist System Study - NCT ID: NCT06357026 - Study ID: Phitys I -2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Shanghai NewMed Medical Co., Ltd. ### Study Description The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI. ### Conditions - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Percutaneous Ventricular Assist System（Phigine Medical） - intra-aortic balloon pump (IABP) ### Outcomes Primary Outcomes - Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) Secondary Outcomes - Incidence of death - Incidence of myocardial infarction - Incidence of stroke - Incidence of target vessel revascularization - Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia - Incidence of acute kidney injury - Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion - Incidence of increasing in aortic insufficiency by more than one grade - Incidence of severe hypotension - Incidence of failure to achieve angiographic success - Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) - Hemodynamic support success rate during PCI procedure - Technical success rate - Procedural success rate - Change in LVEF compared to baseline - Improvement in cardiac function - Evaluation of Experimental device performance ### Location - Facility: The Second Hospital of Jilin University, Jilin, Changchun, N/A, China @@
## Postoperative Analgesia in Bilateral Knee Arthroplasties - NCT ID: NCT06357013 - Study ID: 2023-40 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-05-30 - Lead Sponsor: Kocaeli City Hospital ### Study Description To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period. ### Conditions - Knee Arthroplasty, Total - Peripheral Nerve Block - Pain, Postoperative ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bilateral Suprainguinal fascia iliaca compartment block - Local infiltration analgesia ### Outcomes Primary Outcomes - Suprainguinal fascia iliaca compartment block (S-FICB) produces adequate analgesic effect in knee arthroplasty. Secondary Outcomes ### Location - Facility: Kocaeli City Hospital, Kocaeli, N/A, N/A, Turkey @@
## Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes - NCT ID: NCT06357000 - Study ID: Time from PCI to surgery - Status: COMPLETED - Start Date: 2008-01-01 - Completion Date: 2018-12-31 - Lead Sponsor: Samsung Medical Center ### Study Description To evaluate the association between time from PCI to cancer surgery and cardiovascular and oncologic outcomes in early-stage cancer patients, A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database. ### Conditions - Coronary Artery Disease - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Occurence of Bleeding Secondary Outcomes - Occurence of Spontaneous myocardial infarction - Occurence of Repeat revascularization - Occurence of Cancer recurrence - Occurence of All cause death ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children - NCT ID: NCT06356987 - Study ID: 0002 - Status: COMPLETED - Start Date: 2021-06-01 - Completion Date: 2021-12-31 - Lead Sponsor: King Edward Medical University ### Study Description All patients of age 6 month to 12 years with inguinal hernia were included in study.Data was collected on detailed proforma regarding age, sex, side ,operative time, cosmesis , and postoperative complications ### Conditions - Inguinal Hernia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Herniotomy ### Outcomes Primary Outcomes - Operative time - Recurrence Secondary Outcomes ### Location - Facility: Muhammad Sharif, Lahore, Punjab, 53711, Pakistan @@
## Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT) - NCT ID: NCT06356974 - Study ID: STROgHAT - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2027-12-30 - Lead Sponsor: Drugs for Neglected Diseases ### Study Description This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested clinical study aimed at generating further evidence on safety of acoziborole in gambiense human African trypanosomiasis (gHAT) seropositives individuals. The overall coordinator will be ITM. ITM will be fully responsible for the epidemiological study (study Part A), including cost effectiveness and evaluation of diagnostic tests. DNDi will be the legal sponsor of the nested safety clinical study (study Part B) and will ensure compliance with regulatory requirements and good clinical practices (GCP) for this part of the study.The investigators hypothesize that by systematically screening the populations of all endemic villages in a well-defined HAT focus and by expanding gHAT treatment to all seropositives, that it will be able to arrive at a zero prevalence over a three-year period.The objectives are to evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b.gambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative. ### Conditions - Human African Trypanosomiasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Treatment of seropositive individuals (positive serology test, but parasitology not confirmed) ### Outcomes Primary Outcomes - Interruption of transmission of T.b. gambiense - Assessment of safety Secondary Outcomes - Economic evaluation - assessment of the performance of several diagnostic tests ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Routine Outcome Monitoring and Feedback Informed Therapy in Italy - NCT ID: NCT06356961 - Study ID: 2022Z4BB82 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-10-05 - Lead Sponsor: University of Bergamo ### Study Description The research project OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study, represents the first Italian randomised controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) to improve patients mental health outcomes and psychotherapy processes through the use of the digital platform Mindy.The following project was awarded PRIN 2022 funding by the Ministry of University and Research (MUR). This project has the University of Bergamo as lead partner, with the auxiliary participation of the University of Palermo and the Polytechnic University of Milan.Given the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist/psychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following:I) Being of legal age II) Not having a diagnosis of psychosis and/or neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision/coaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.Recruitment of therapists will take place with the strategic participation of a pool of MIUR-recognised Schools of Specialisation in Psychotherapy (https://www.miur.it/ElencoSSPWeb/).Professionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), and who are in active practice. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables. ### Conditions - Feedback, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - (Feedback Informed Therapy) with Clinical Support Tools and ah hoc training - Feedback and ROM (basic) ### Outcomes Primary Outcomes - Change from baseline in Symptom severity (GAD7-PHQ9) in OPM-F,OPM and TAU conditions at T2 (up to 6 months), and follow up (3 months) - Clinical Outcomes in Routine Evaluation-10 (Change in Session by session) - Working Alliance Inventory-Short Revised-Client (Change in session by session) Secondary Outcomes - Impact of Usability of MINDY platform with Post-Study System Usability Questionnaire (PSSUQ) and Net Promoter Score (NPS) on patient outcomes - Change from baseline of The Reflective Functioning Questionnaire (RFQ)-7 ### Location - Facility: University of Bergamo (DSUS), Bergamo, Ita (bg), 24125, Italy @@
## Rate of Tranexamic Acid Administration on Blood Pressure (RateTXA) Study. - NCT ID: NCT06356948 - Study ID: H23-02918 - Status: RECRUITING - Start Date: 2024-03-30 - Completion Date: 2027-12-30 - Lead Sponsor: University of British Columbia ### Study Description Tranexamic acid is a well-established treatment for post-partum hemorrhage. This study aims to examine the effect of tranexamic acid administration rates on blood pressure changes over 1 minute compared to 10 minutes in healthy pregnant patients scheduled for cesarean delivery. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Tranexamic Acid (TXA) ### Outcomes Primary Outcomes - Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups. Secondary Outcomes - Incidence of nausea - Incidence of vomiting - Incidence of hypotension - Incidence of hypertension - Incidence of central nervous system side effects ### Location - Facility: BC Women's Hospital, Vancouver, British Columbia, V6H3N1, Canada @@
## Effects of Heavy-load Resistance Training - NCT ID: NCT06356935 - Study ID: HP2024 - Status: COMPLETED - Start Date: 2023-03-17 - Completion Date: 2023-08-03 - Lead Sponsor: University of Southern Denmark ### Study Description The study aims to investigate effects of 8-weeks of heavy-load resistance training on mechanical muscle function and functional performance in elite female team handball players from the Danish Women's Handball League. Players will be randomly assigned to either a resistance training group (RT) or serves as training-as-usual controls (CON). ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RT - CON ### Outcomes Primary Outcomes - Explosive muscle strength - Acceleration capacity - Agility performance - Jump ability Secondary Outcomes ### Location - Facility: University of Southern Denmark, Odense, N/A, 5230, Denmark @@
## Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia. - NCT ID: NCT06356922 - Study ID: RC20_0123 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2027-05-15 - Lead Sponsor: Nantes University Hospital ### Study Description CXCR4 inhibition may represent a new therapeutic strategy in acute leukemia (AL) patients, not only by increasing chemosensitivity but also by preventing relapse of the disease by disruption of the interaction of residual leukemic cells with the bone marrow niche. Radiolabeled CXCR4 ligands have been developed for PET imaging (68Ga-PentixaFor; INN: Gallium (68Ga) boclatixafortide) and radioligand therapy (RLT) (\[177Lu\]Lu-PentixaTher/\[90Y\]Y-PentixaTher). \[177Lu\]Lu and \[90Y\]Y-PentixaTher have been tested in three multiple myeloma patients in named-patient use with a remarkable efficacy in 2 patients (Herrmann, 2016). Moreover, feasibility of CXCR4 PET imaging in AML was reported, providing a framework for future theranostic approaches targeting the CXCR4/CXCL12-defined leukemia-initiating cell niche (Herhaus, 2016).Here a Phase I/II study to determine maximal tolerated dose (MTD) of a RLT using \[177Lu\]Lu-PentixaTher in relapsed/refractory AL was designed. This will be a standard phase I/II 3+3 dose escalation study. Five dose levels will be tested, so 6 to 21 patients have to be included in the study. ### Conditions - Acute Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Experimental drug [177Lu]Lu-PentixaTher ### Outcomes Primary Outcomes - Safety of RLT using one injection of [177Lu]Lu-PentixaTher - Tolerance Secondary Outcomes - Overall response rate - Complete response rate - Overall survival - Leukemia-free survival - Minimal residual disease - Whole-body biodistribution - Serum uptake - Radiation dosimetry - Renal safety - Renal safety - Renal safety - Renal safety - Correlation between different cytokines and toxicity - Factors associated response - Exploratory outcome measure = Identification of biological biomarkers ### Location - Facility: CHU de Bordeaux, Bordeaux, Gironde, 33604, France @@
## Study of PREMEdication Before Laryngoscopy in Neonates in France - NCT ID: NCT06356909 - Study ID: SUPREMEneo - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-04-07 - Lead Sponsor: Centre Hospitalier Intercommunal Creteil ### Study Description This study is a national prospective survey on practices of premedication before laryngoscopy in neonates. The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units (agents, dosing, efficacy, safety) ### Conditions - Neonatal Respiratory Distress ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Survey of sedo-analgesia practices before laryngoscopy ### Outcomes Primary Outcomes - Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placement Secondary Outcomes - Molecules used for sedo-analgesia - Cumulative doses of sedo-analgesia used - Questionnaire for the operator describing reasons for non-compliance with best practice guidelines - Numeric rating scale for pain (by operator and assistant) - TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment) - Side effects related to the premedication ### Location - Facility: Centre Hospitalier Intercommunal de Creteil, Creteil, N/A, 94000, France @@
## The Effect of Diaphragmatic Breathing Exercise on Symptom Severity, Sleep Quality and Anxiety in CABG Patients. - NCT ID: NCT06356896 - Study ID: 2023/034 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-09-01 - Lead Sponsor: KTO Karatay University ### Study Description Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the patients' heart muscle. However, after CABC, patients may experience symptoms arising from the effect of the operation. These symptoms include shortness of breath, chest pain, sleep problems and a general feeling of restlessness. These symptoms occur as a result of the operation and can limit patients' daily activities, negatively affect their quality of life, and make the rehabilitation process difficult. Diaphragmatic breathing exercise can be an effective strategy for managing symptoms after CABC. This exercise involves deep and controlled breathing and aims to strengthen respiratory muscles, increase lung capacity and improve respiratory efficiency. Diaphragmatic breathing exercise helps breathing occur more efficiently by reducing the movement of the chest wall and can reduce patients' breathing difficulties. Diaphragmatic breathing exercise provides relaxation in the body by calming the sympathetic nervous system and can reduce stress during the sleep process. In this way, patients can experience a deeper and more restful sleep and feel more energetic when they wake up. At the same time, diaphragmatic breathing exercise improves mental state and reduces the effects of stress by providing focus and mental relaxation. This thesis study aims to investigate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. The importance of this study is that it has great potential for managing symptoms after CABC and improving patients' quality of life. Diaphragmatic breathing exercise is expected to be effective in reducing symptoms after CABC, allowing patients to improve their respiratory functions and general health status. Additionally, investigating the effects of this exercise on patients' sleep quality and anxiety may help nurses adopt a more holistic approach in healthcare delivery. ### Conditions - Coronary Artery - Anxiety - Symptom - Sleep ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - diaphragmatic breathing exercise ### Outcomes Primary Outcomes - cardiovascular surgery symptom inventory Secondary Outcomes - richards champbell sleep quality scale ### Location - Facility: Konya City Hospital, Konya, Karatay, 42020, Turkey @@
## Intraarterial Carboplatin + Caelyx Compared to Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma - NCT ID: NCT06356883 - Study ID: 2024-4938 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: Université de Sherbrooke ### Study Description The standard of care for glioblastoma (GBM) treatment involves maximal resection followed by concomitant radiotherapy and temozolomide. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is inevitable. At relapse, there is no consensus regarding the optimal therapeutic strategy. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which impedes drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, can produce responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival (OS) 23 months. How can the OS and PFS be improved? By combining chemotherapeutic agents with different mechanisms of action.Study design: In this phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg/m\^2) + IA Cealyx (30 mg/m\^2) or IA carboplatin (400 mg/m\^2) + IA etoposide phosphate (400 mg/m\^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered.Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. Primary outcome will PFS and tumor response. Secondary outcome will include median OS, toxicity, quality of life (QOL), neurocognition (NC).Putting together these data will allow to correlate clinical and radiological response to QOL and NC. ### Conditions - Glioblastoma Multiforme - Relapse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IA Carboplatin + IA Caelyx - IA Carboplatin + IA Etoposide Phosphate ### Outcomes Primary Outcomes - Tumor Response on MRI using the RANO Criteria - Progression-free Survival Secondary Outcomes - Median overall survival - Treatment-related toxicity - Per treatment quality of life assessment - Incidence of treatment related Neurocognitive decline ### Location - Facility: CHUS, Sherbrooke, Quebec, J1H 5N4, Canada @@
## Alveolar Cleft Reconstruction Using Bone Marrow Aspirate Concentrate and Allograft vs Iliac Cancellous Bone. - NCT ID: NCT06356870 - Study ID: BUE - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-06-01 - Lead Sponsor: Cairo University ### Study Description radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting ### Conditions - Alveolar Cleft Grafting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BMAC MIXED WITH ALLOGRAFT - Cancellous bone from anterior iliac crest ### Outcomes Primary Outcomes - bone density Secondary Outcomes - Bone gain - Postoperative donor site morbidity ### Location - Facility: Cairo university, Cairo, N/A, N/A, Egypt @@
## Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging - NCT ID: NCT06356857 - Study ID: H-23070312 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: Peter Hovind ### Study Description This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with \[O15\]H2O-PET-MPI. ### Conditions - Myocardial Blood Flow ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT ### Outcomes Primary Outcomes - [O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice Secondary Outcomes ### Location - Facility: Bispebjerg Hospital, Copenhagen, RegionH, 2400, Denmark @@
## The Effect of Resolvins on the Resolve of Inflammatory Low Back Pain - NCT ID: NCT06356844 - Study ID: 27.02.2023-E.142568 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-12 - Lead Sponsor: Bezmialem Vakif University ### Study Description Brief Summary: Inflammatory back pain is a chronic condition localized in the axial spine and sacroiliac joints.1 It often accompanies mechanical issues like lumbar disc herniation. While non-surgical interventions such as medication, physiotherapy, and epidural steroid injections are typically the initial approach, surgical options may be considered if these prove ineffective.2 Resolvins, derived from omega-3 fatty acids, have shown promise in reducing inflammation and pain. They help to resolve inflammatory responses, promote tissue repair, and decrease disc size, potentially reducing the need for surgery.3,4 This clinical trial aims to evaluate the efficacy of adding oral resolvins to transforaminal epidural steroid injections for treating lumbar disc herniation (LDH) The control group (Group C: n=25) will receive epidural steroids, while the study group (Group R: n=25) will receive both oral omega-3 supplementation and epidural steroids on the same day. Additionally, the study group will continue taking oral omega-3 supplements for six months.The primary outcome measure will be changes in protruded/extruded disc size assessed via MRI, with secondary outcomes including pain levels measured by the Numeric Rating Scale (NRS) and serum cytokine levels (IL-6, IL-17, IL-1 beta, TNF-alpha) over the study period.Discussion: This trial anticipates that combining the anti-inflammatory properties of resolvins with epidural steroid injection will provide a beneficial treatment for patients suffering from inflammatory low back pain. ### Conditions - Low Back Pain - Inflammatory Response - Lumbar Disc Herniation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Resolvin supplement ### Outcomes Primary Outcomes - changes in protruded/extruded disc size Secondary Outcomes - Pain intensity score - Cytokine markers ### Location - Facility: Aylin Ceren Şanlı, Istanbul, N/A, N/A, Turkey @@
## National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis - NCT ID: NCT06356831 - Study ID: Endomecryo - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-01-31 - Lead Sponsor: Centre Hospitalier Intercommunal Creteil ### Study Description National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team ### Conditions - Endometriosis - Cryotherapy Effect - Surgical - Radiology ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis Secondary Outcomes - Characterize the epidemiology of parietal endometriosis nodules - Characterize the epidemiology of parietal endometriosis nodules - To assess the impact of hormone treatment on parietal endometriosis - Assess the demographic distribution of parietal endometriosis - Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis - Evaluate the aesthetic impact of the treatments - Assess the complication rate between the two groups - Assess the Severity of Complications according to Society (SIR) of Interventional Radiology or Cardiovascular and Interventional Radiological Society of Europe ( CIRSE) for Radiologists - Assess the Severity of Complications according to Clavien Dindo for the surgeon - Assess the recidivism rate at 3 years - Assess the quality of life between the two groups with PGIC-7 questionnaire - Assess the quality of life between the two groups with asses EHP-5 questionnaire - Assess the quality of life between the two groups with asses EVA questionnaire - Evaluate signal and morphology changes on imaging MRI of parietal endometriosis nodules after cryoablation treatment - Evaluate signal and morphology changes on ultrasound imaging of parietal endometriosis nodules after cryoablation treatment ### Location - Facility: Clinique Tivoli, Bordeaux, N/A, N/A, France @@
## Comparison of Virtual Reality and Motor Imagery Applications in Patients With Ankle Instability - NCT ID: NCT06356818 - Study ID: E-74555795-050.04-941155 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-09 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description In this study, the effects of different treatment methods for ankle instability patients are being compared aiming to find the optimal treatment. Via comparing virtual reality, motor imagery, and classic rehabilitation programs to clarify their effects on ankle static and dynamic balance, proprioception, range of motion, muscle strength, pain, function and patient satisfaction. ### Conditions - Ankle Sprains ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional physiotherapy program - Virtual reality (VR) - Motor imagery (MI) ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) - Pressure Pain Threshold (PPT) - Star Excursion Balance Test (SEBT) - Single Leg Balance Test (SLBT) - Joint position sense (JPS) - Range of Motion (ROM) - Muscle strength Secondary Outcomes - Cumberland ankle instability questionnaire (CAIT) - Patient satisfaction ### Location - Facility: Istanbul University-Cerrahpasa (IUC), Istanbul, N/A, N/A, Turkey @@
## rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia - NCT ID: NCT06356805 - Study ID: rTMS in Fibromyalgia - Status: COMPLETED - Start Date: 2023-01-10 - Completion Date: 2024-02-20 - Lead Sponsor: Assiut University ### Study Description the aim of this work was to evaluate the effect of low frequency rTMS over the right dorsolateral prefrontal area (DLPFC) on Fibromyalgia patients. Fibromyalgia Impact Questionnaire (FIQ), Hamilton depression and Anxiety scale and different cognitive rating scales were evaluated pre-1 month post sessions and pre -post 3 months later. all eligible patients with fibromyalgia (FM) were randomized to have 20 sessions of active or sham rTMS over right DLPFC. The improvement changes in groups were compared in each rating scale. ### Conditions - Treatment Resistant Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - repetitive transcranial magnetic stimulation ### Outcomes Primary Outcomes - 1- Assessment of Fibromyalgia Impact Questionnaire (FIQ) Secondary Outcomes - 1-Assessment of Hamilton depression (HDRS) and Hamilton Anxiety scales (HARS) (pre- post sessions and pre post three months) - Assessment of different cognitive rating scales (Montreal cognitive Assessment scale (MoCa), and Rey Auditory Verbal Learning Test [RAVLT], ### Location - Facility: Eman Khedr, Assiut, N/A, 11517, Egypt @@
## Obstetrics , Prenatal Outcomes in Recurrent Miscarriage - NCT ID: NCT06356792 - Study ID: Obstetrics outcome in Abortion - Status: RECRUITING - Start Date: 2024-04-21 - Completion Date: 2025-03-21 - Lead Sponsor: Assiut University ### Study Description The effect of recurrent miscarriage on the outcome of the current pregnancy and if there's a relation between it and adverse out come ### Conditions - Recurrent Miscarriage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - If there's relation between recurrent abortion and having a medical disorder during current pregnancy Secondary Outcomes ### Location - Facility: Assiut University, Assiut, N/A, N/A, Egypt @@
## Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease - NCT ID: NCT06356779 - Study ID: H-23066725 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2035-12-31 - Lead Sponsor: Gitte Fredberg Persson MD PhD ### Study Description This prospective national multicenter observational and interventional study aims to assess the longitudinal disease trajectory of patients with oligometastatic disease (OMD) who receive local metastasis-directed therapy. Patients with any category of OMD from any non-hematological cancer are eligible for inclusion. Local ablative therapy (LAT) includes surgical metastasectomy, radiotherapy, thermal ablation, and electroporations.The primary objective is to assess the time to failure of LAT strategy in patients with OMD from any primary cancer treated with all LAT modalities. ### Conditions - Oligometastatic Disease - Metastases - Ablation Techniques - Radiotherapy - Stereotactic Radiation - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Local ablative therapy (LAT) ### Outcomes Primary Outcomes - Time to failure of local ablative therapy (LAT) strategy Secondary Outcomes - Progression-free survival - Time to widespread progression - Freedom from systemic treatment - Overall survival - Time to progression - Time to local progression - Local lesion control rate at 1- and 3-years post-local ablative therapy - Time to distant progression - Investigator reported grade 3-5 CTCAE (v.5.0) LAT related toxicity - Harms ### Location - Facility: Copenhagen University Hospital Rigshospitalet, Copenhagen, Capital Region Of Denmark, 2100, Denmark @@
## Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand - NCT ID: NCT06356766 - Study ID: 30.01.2024/009 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-04-08 - Lead Sponsor: Istanbul University ### Study Description The treatment process following Zone 2 flexor tendon injuries, which are particularly controversial for hand surgery, is challenging. There are various rehabilitation methods for Zone 2 flexor tendon injuries, one of which is the Modified Duran Protocol. Disruptions in the physiotherapy process lead to joint contractures, tendon adhesions, and limitations in daily life activities for patients. Due to global issues such as socioeconomic factors, physical barriers, distance, and pandemics, patients who cannot actively participate in physiotherapy miss out on the rehabilitation process.The aim of the present study is to investigate the effectiveness of the Modified Duran protocol applied through telerehabilitation following Zone 2 flexor tendon repair. Between April and October 2024, a total of 42 adults aged 18-55 who underwent Zone 2 flexor tendon repair at Istanbul University Istanbul Faculty of Medicine will be recruited, with 21 participants in face-to-face clinic group and 21 in telerehabilitation group. Rehabilitation process will be followed for 12 weeks. The telerehabilitation group will receive exercise training on the third day. After the first training session, patients will be discharged and called to the clinic once a week for dressing changes, monitoring, exercises and if necessary, revision of the protective splint. Patients will be contacted three times a week to implement the planned program using telerehabilitation.The face-to-face rehabilitation group will receive face-to-face clinic rehabilitation three times a week under the supervision of a physiotherapist for the first 12 weeks.Patients will be evaluated at the end of the 5th, 6th, and 12th weeks. Data collection tools will include a 'Sociodemographic Form', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Visual Analog Scale (VAS)', 'Jamar Hand Dynamometer', and 'Goniometer (Joint Range of Motion)'.SPSS (Statistical Package for the Social Sciences) Statistics will be used for the statistical analysis of all data, with a significance level of p \<0.05 considered significant in all assessments, and accepted as two-tailed. ### Conditions - Zone 2 Flexor Tendon Injuries of the Hand ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Telerehabilitation - Face-to-face rehabilitation ### Outcomes Primary Outcomes - Range of Motion Secondary Outcomes - DASH - Pain of the affected hand - Muscle Strength ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## EndoxOmics : Exposome, Endometriosis and Fertility - NCT ID: NCT06356753 - Study ID: RC19_0203 - Status: COMPLETED - Start Date: 2019-09-01 - Completion Date: 2021-03-31 - Lead Sponsor: Nantes University Hospital ### Study Description For several years, the effects of environmental pollution on human health have been a growing concern for the scientific community and public authorities. Among the many known chemical contaminants, persistent organic pollutants (POPs) are of particular concern because of their properties as endocrine disrupters, bioaccumulation and biomagnification. The associations between environmental pollutants, endometriosis and infertility remains poorly understood. The objective of this exploratory non interventional monocentric study conducted in the University Hospital of Nantes, is to identify endogenous molecular profiles associated with endometriosis and related infertility. This project implements an exploratory approach combining exposure and metabolomics approaches based on high-resolution mass spectrometry to identify exposure and metabolomics profiles associated with infertility, and biomarkers for potential prognostic application. ### Conditions - Endometriosis - Infertility, Female ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Identify endogenous molecular profiles of patients with infertile endometriosis Secondary Outcomes - Characterize the internal chemical exposure profiles and metabolomic profiles in the different groups. - Compare the distribution of contaminant concentration levels and metabolomic profiles according to the media measured. ### Location - Facility: Nantes University Hospital, Nantes, Loire-Atlantique, 44093, France @@
## Efficacy and Tolerance of Abacavir/Lamivudine Treatment in Patients With Systemic Lupus Erythematosus - NCT ID: NCT06356740 - Study ID: 69HCL22_0878 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2029-06-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Systemic lupus (SL) is a rare chronic autoimmune disease characterized by the production of autoantibodies directed against nuclear antigens, particularly native double-stranded deoxyribonucleic acid (DNA), and excessive production of antiviral cytokines: type I interferons, particularly interferon alpha (IFN-α). IFN-α production results from the excessive detection of nucleic acids (DNA or Ribonucleic Acid (RNA)) by endosomal or intracytoplasmic receptors that are capable of inducing interferon production. The precise mechanisms of cytoplasmic sensor activation remain unknown; however, recent work in the field of interferonopathies suggests a role for human endogenous retroviruses (HERVs). HERVs are remnants of ancient infections caused by exogenous retroviruses integrated into the genome during evolution and represent 8% of the human genome.Several studies have suggested a role for HERVs in the development and maintenance of an excessive immune response in lupus patients and other autoimmune diseases by affecting the type I interferons (I IFN) signalling pathway.To date, none of the approved immunosuppressive drugs for Systemic Lupus Erythematosus (SLE) have been shown to be effective in the background treatment of SL or in preventing relapse. Consequently, there is an urgent need to identify new molecules and therapeutic avenues for disease-modifying therapies.In this study, an innovative therapeutic strategy using a combination of nucleoside reverse transcriptase inhibitors (NRTIs), abacavir/lamivudine, is proposed to treat SLE. Thus, we propose a pilot Phase II, randomized, open-label study using NRTIs in patients with SL in remission or with low clinical activity, and evaluating a biological endpoint (IFN signature), which is a direct proxy for the drug's expected effect.The main objective is to compare the addition of Abacavir/Lamivudine (Add-on) to standard care for 6 months, on the value of the interferon (IFN) transcriptomic signature of patients with systemic lupus with low activity as defined by the Lupus Low Disease Activity State (LLDAS). ### Conditions - Systemic Lupus Erythematosus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Blood sample - Treatment :Abacavir 600 mg/lamivudine 300 mg - Lupus Impact Tracker questionnaire ### Outcomes Primary Outcomes - Absolute variation in interferon signature (IFN) Secondary Outcomes - percentage of patients maintaining LLDAS criteria - number of relapses - anti-native double-stranded DNA quantification - anti-extractable nuclear antigens (anti-ENA) quantification - interferon-α production quantification - Number of successful patients - Cumulative dose of intravenous (IV) corticosteroids - Lupus Impact Tracker questionnaire score - number of missed treatment - number of adverse event (AE) - number of serious adverse event (SAE) - HERVs transcription quantification ### Location - Facility: Groupe Hospitalier Pellegrin-CHU de Bordeaux, Bordeaux, N/A, 33076, France @@
## Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling - NCT ID: NCT06356727 - Study ID: 121CET-MICROREV-DCM - Status: RECRUITING - Start Date: 2024-01-03 - Completion Date: 2030-01-31 - Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona ### Study Description Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF \<40%), naive of anti-remodeling cardiac medical therapy, will undergo invasive coronary microvascular assessment based on thermodilution. The primary endpoint, namely the left ventricle reverse remodeling, will be assessed after 12 months of optimal medical therapy based on transthoracic echocardiography. The primary endpoint will be evaluated by an independent central core lab. Patients enrolled in the study will be followed for a period of 5 years to monitor their clinical status. During the study period participants may undergo multimodality diagnostic tests including ECG telemetry monitoring, cardiopulmonary exercise testing, cardiovascular cardiac magnetic resonance. ### Conditions - Heart Failure - Left Ventricular Dysfunction - Idiopathic Dilated Cardiomyopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Thermodilution based assessment of coronary microcirculation ### Outcomes Primary Outcomes - Rate of Left ventricular reverse remodeling (LVRR) Secondary Outcomes - Adverse clinical events - Rate of LVRR at cardiac magnetic resonance - Changes in functional capacity at cardiopulmonary exercise test - Prevalence of different CMD endotypes and their correlation with the severity of adverse cardiac remodeling. - Left ventricle adverse cardiac remodeling at cardiovascular magnetic resonance. ### Location - Facility: Azienda Ospedaliera Universitaria di Ferrara, Ferrara, N/A, N/A, Italy @@
## Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD Status - NCT ID: NCT06356714 - Study ID: 13914704179 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08-01 - Lead Sponsor: Sun Jing ### Study Description Evaluate the efficacy and safety of Nocardia rubra cell wall skeleton in combination with prior second- or third-line regimens for the treatment of potentially hazardous colorectal cancer SD(Stable Disease) status in the real world. ### Conditions - Colorectal Cancer - Colorectal Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens ### Outcomes Primary Outcomes - Progression-free survival(PFS) Secondary Outcomes - Overall survival (OS) - Objective remission rate (ORR) - Disease Control Rate (DCR) - Incidence and extent of major security incidents - Quality of Life Score (QoL) for tumor patients ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Tumor Nutritional Therapy in the First-line Treatment of Stage IV NSCLC - NCT ID: NCT06356701 - Study ID: dongyandl - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-12-31 - Lead Sponsor: The First Affiliated Hospital of Dalian Medical University ### Study Description A Single-center, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Tumor Nutritional Therapy Combined With Immune Checkpoint Inhibitors and Chemotherapy in the First-line Treatment of Stage IV NSCLC Without Driver Gene Mutations ### Conditions - Long-Term Effects Secondary to Cancer Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules) ### Outcomes Primary Outcomes - PFS - Assessment of global disorders in patients with cancer - ORR Secondary Outcomes ### Location - Facility: DongYan, Dalian City, Liaoning, 116000, China @@
## A Clinical Study on the Efficacy and Safety of Paclitaxel Polymer Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma - NCT ID: NCT06356688 - Study ID: 13914704178 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-06-20 - Lead Sponsor: Sun Jing ### Study Description The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (cadonilimab) in combination with platinum-containing chemotherapy (paclitaxel polymer micelles combined with cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with cadonilimab combined with chemotherapy. ### Conditions - Locally Advanced Esophageal Squamous Cell Carcinoma - Neoadjuvant Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - paclitaxel polymer micelles and cisplatin combined with Cadonilimab ### Outcomes Primary Outcomes - Pathological complete response (pCR) rates Secondary Outcomes - Objective Rate of Effectiveness (ORR) - R0 Removal Rate - 2-year overall survival rate - 2-year disease free survival rate - major pathological response (MPR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy - NCT ID: NCT06356675 - Study ID: A single-arm pilot - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2028-07-01 - Lead Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine ### Study Description Immune resistance after treatment, there is no standard treatment, one of the most important and the most effective measures is immune to combination therapy。Targeted angiogenesis therapy has always been the focus of research on the treatment of NSCLC patients with progressive disease after immunotherapy. From the mechanism of action, angiogenesis and immunosuppression are interrelated processes. ### Conditions - Advanced NSCLC ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tislelizumab - Anlotinib ### Outcomes Primary Outcomes - objective response rate Secondary Outcomes - progression free survival time - over survival time - disease control rate - safety including any grade adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease - NCT ID: NCT06356662 - Study ID: KY-2023-198 - Status: RECRUITING - Start Date: 2024-01-23 - Completion Date: 2024-12-31 - Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine ### Study Description To evaluate the efficacy and safety of tenofovir disoproxil fumarate in the treatment of Parkinson's disease. The changes of motor symptoms and the occurrence of adverse reactions in early Parkinson's disease patients who took tenofovir disoproxil fumarate and did not take Tenofovir disoproxil fumarate at different time points were compared. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tenofovir Disoproxil Fumarate ### Outcomes Primary Outcomes - UPDRS III（Unified Parkinson's Disease Rating Scale part 3） Secondary Outcomes - Non-Motor Symptom Scale（NMSS） - creatinine(μmoI/L) ### Location - Facility: Guohua Zhao, Hangzhou, Zhejiang, N/A, China @@
## Investigation of the Effects of Pressure Support Ventilation and Positive Airway Pressure Modes During Extubation - NCT ID: NCT06356649 - Study ID: ESOGU2 - Status: COMPLETED - Start Date: 2023-03-15 - Completion Date: 2024-01-20 - Lead Sponsor: Eskisehir Osmangazi University ### Study Description Controlled ventilation is applied to patients intubated for general anesthesia. Additionally, positive end-expiratory pressure (PEEP) and pressure support are mechanical ventilation modes that have been used in general anesthesia practice for many years. When the recovery-extubation phase is reached, intermittent bag-mask ventilation is usually used and the patient is allowed to breathe spontaneously and is extubated when an adequate respiratory level is reached. It has been shown in previous studies that the use of intermittent mask ventilation causes postoperative atelectasis. Different methods have been used to prevent postoperative atelectasis. In our study, we aimed to observe the effect of terminating general anesthesia at the end of the operation and using PEEP and pressure-supported ventilation during the extubation phase on early complications. ### Conditions - Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - extubation ### Outcomes Primary Outcomes - Complications developing during recovery-extubation Secondary Outcomes - hemodynamic changes - hemodynamic data ### Location - Facility: Eskisehir Osmangazi University Medical Faculty, Eskisehir, Odunpazarı, 26040, Turkey @@
## Impact of the Financial Inclusion Improves Sanitation and Health - NCT ID: NCT06356636 - Study ID: P1216/2022 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Amref Health Africa ### Study Description The goal of this interventional study is to evaluate the impacts of Financial Inclusion improvement sanitation and Health (FINISH) interventions in Kenya's Homa Bay County and Uganda's Kamwenge District among children under five. The main questions it aims to answer are:1. What is the estimated impact of the FINISH model on health outcomes (diarrhoea occurrence and hygienic behaviour) as well as social (school attendance and sanitation) in the intervention groups?2. What are the perspectives, attitudes, and practices of various stakeholders (communities, governments, entrepreneurs, and financiers) regarding the FINISH model?3. What is the cost-effectiveness of the FINISH model, including the amount of leverage funds generated?The FINISH model postulates that countries will be supported to improve the enabling business environment for sanitation, markets to offer improved safely managed services and products at an affordable price, and formal and informal financial institutions will offer more funding to businesses and households for satiation and hygiene.Researchers will then compare intervention areas (Homa Bay in Kenya and Kamwenge in Uganda) with control areas (Siaya and Bushenyi in Kenya and Uganda, respectively) to see if the FINISH intervention leads to improved sanitation, health outcomes, and economic benefits. ### Conditions - Health Knowledge, Attitudes, Practice ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Financial Inclusion Improves Sanitation and Health ### Outcomes Primary Outcomes - Health outcome, measured as, Proportion of households with diarrhoea occurrence in children under five years, and social outcome measured as proportion of households whose children missed school due to diarrhoea occurrence Secondary Outcomes ### Location - Facility: Homa Bay county, Homa Bay, N/A, N/A, Kenya @@
## A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer - NCT ID: NCT06356623 - Study ID: SHDC2202020401 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-05 - Completion Date: 2024-08-06 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description PONV management has been recommended as a necessary part of enhanced recovery protocols during the perioperative period, and PONV risk assessment is, therefore, a necessary first step in determining the number of medications or strategies for prophylaxis and treatment by considering the number of modifiable and non-modifiable risk factors. However, the external validity of two commonly-used PONV prediction models for patients undergoing liver surgery is unsatisfied, and need to be updated for liver cancer populations to better inform personalized perioperative care regime and individualized decision-making in clinical practice. ### Conditions - Nausea and Vomiting, Postoperative - Liver Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 1 ### Outcomes Primary Outcomes - Postoperative nausea and vomiting Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pharmacokinetic and Subjective Effects of Heated Tobacco Products - NCT ID: NCT06356610 - Study ID: ALCS-REG-23-08-HT - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2025-06 - Lead Sponsor: Altria Client Services LLC ### Study Description This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK (pharmacokinetic) and subjective effects of HTPs (Heated Tobacco Products) comprised of 2 menthol varieties and 2 tobacco flavor varieties (Ploom® HTPs, Japan Tobacco Inc.) in adult menthol and non-menthol combustible cigarette smokers (males and females between the ages of 22 and 65). The study will include participants' UBCC (Usual Brand Combustible Cigarette) and a nicotine gum (Nicorette®) as high and low abuse liability reference products, respectively, to the HTP. Study participation is expected to last up to 34 days, including a 28-day screening period (that includes a 5-day at-home HTP product trial period), and a 6-day in-clinic confinement period (from Check-in \[Day -1\] through the end-of-study \[EOS\] visit on Day 6). ### Conditions - Tobacco Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Test Product A - Test Product B - Test Product C - Test Product D - Reference Product E - Reference Product F ### Outcomes Primary Outcomes - Plasma Nicotine Concentration Pharmacokinetic (PK) Measurement - Product Liking of Heated Tobacco Products (HTP) - Tobacco Nicotine Withdrawal Questionnaire - Direct Effects of Product Questionnaire - Use the Product Again Questionnaire - Modified Cigarette Evaluation Questionnaire (mCEQ) - Cigarette - Modified Cigarette Evaluation Questionnaire - HTP - Modified Cigarette Evaluation Questionnaire-NRT - Product Use for HTP-Units Dispensed - Product Use for UBCC-Units Dispensed - Product Use for Nicotine Gum-Units Dispensed - Product Use for HTP-Puff Count - Product Use for UBCC-Puff Count - Physiological Heart Rate (HR) Assessment-HTP - Physiological Heart Rate (HR) Assessment-UBCC - Physiological Heart Rate (HR) Assessment-Nicotine Gum Secondary Outcomes ### Location - Facility: Alliance for Multispecialty Research, LLC, Lexington, Kentucky, 40509, United States @@
## Tislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial - NCT ID: NCT06356597 - Study ID: KY2024-004-A - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-12-12 - Lead Sponsor: Jing-yuan Fang, MD, Ph. D ### Study Description The aim of this study is to evaluate the efficacy and safety of Tislelizumab with Fruquintinib, Metronidazole treatment in MSS/MSI-L advanced colorectal cancer patients with high abundance of Fusobacterium nucleatum in a single arm Phase II clinical. ### Conditions - Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tislelizumab with Fruquintinib, Metronidazole ### Outcomes Primary Outcomes - objective response rate Secondary Outcomes ### Location - Facility: Shanghai First People's Hospital, Shanghai, N/A, N/A, China @@
## Sintilimab Combined With Fruquintinib/Regorafenib ± Radiotherapy for Third-line Treatment of Advanced Metastatic Colorectal Cancer - NCT ID: NCT06356584 - Study ID: SDZLEC2024-078-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-10-01 - Lead Sponsor: Shandong Cancer Hospital and Institute ### Study Description Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. Despite advancements in first- and second-line treatments, third-line therapies for advanced CRC remain limited, emphasizing the need for novel strategies. This prospective study evaluates the efficacy of combined therapy involving Sintilimab, Fruquintinib/Regorafenib, and radiotherapy in advanced CRC. The study cohort comprises patients with non-liver metastatic advanced CRC and those with liver metastases, each receiving tailored treatment protocols. The primary objectives are to assess progression-free survival (PFS), overall survival (OS), and treatment response rates. Subgroup analyses will focus on liver metastases to delineate their impact on treatment outcomes. The rationale for this study stems from the intricate interplay between immunotherapy, targeted therapy, and radiotherapy in CRC management. Previous data suggest a negative correlation between liver metastases and immunotherapy efficacy, necessitating a comprehensive approach integrating multiple treatment modalities. Radiotherapy, particularly stereotactic body radiation therapy (SBRT), has shown promise in controlling liver tumors and modulating the tumor microenvironment, potentially enhancing immunotherapy responses. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for advanced CRC by elucidating the efficacy and safety of this combined treatment approach. The findings may pave the way for personalized treatment strategies tailored to individual patient characteristics, ultimately improving clinical outcomes in this challenging disease setting. ### Conditions - Colorectal Cancer - Immunotherapy - Radiotherapy - Targeted Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sintilimab ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Overall response rate (ORR) - Disease control rate (DCR) - Overall survival (OS) ### Location - Facility: Jinbo Yue, Jinan, Shandong, 250000, China @@
## A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma - NCT ID: NCT06356571 - Study ID: LPS18183 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-11 - Completion Date: 2027-07-15 - Lead Sponsor: Sanofi ### Study Description The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy. ### Conditions - Plasma Cell Myeloma Refractory ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Isatuximab SC-OBDS - Montelukast - Dexamethasone - Acetaminophen - Diphenhydramine - Methylprednisolone - Carfilzomib ### Outcomes Primary Outcomes - Overall response rate (ORR) Secondary Outcomes - Number of participants with infusion reactions (IRs) - Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable) - Number of participants with injection site reactions (ISRs) - CR or better - VGPR or better - Duration of response (DOR) - Time to first response (TT1R) - Time to best response (TTBR) - Patient experience and Satisfaction Questionnaire v2 (PESQ v2) - Positivity titer of anti-drug antibodies (ADA) in a subset of 15 participants - Maximum observed concentration (Cmax) of isatuximab in a subset of 15 participants - Cumulative area under the curve over the first 4 weeks of isatuximab treatment (AUC4 weeks) in a subset of 15 participants ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Adapting Enhanced Recovery Programs for Low Health Literacy Patients - NCT ID: NCT06356558 - Study ID: IRB-300010279 - Status: NOT_YET_RECRUITING - Start Date: 2026-05 - Completion Date: 2028-05 - Lead Sponsor: University of Alabama at Birmingham ### Study Description Low health literacy patients are a vulnerable population at high-risk for surgical disparities including longer hospital stays, more complications, and more readmissions. This study will adapt enhanced recovery programs (ERPs) to low health literacy patients with a multilevel, health literacy-based implementation strategy (called VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) to improve ERP fidelity and thereby outcomes. In the final aim of this project (Specific Aim 3), the VISACT intervention will be tested in a pilot trial. Findings from this study will lay the foundation for a multi-institutional stepped-wedge trial and establish key principles for adapting interventions to eliminate disparities. ### Conditions - Surgery - Health Knowledge, Attitudes, Practice - Colorectal Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Educational intervention (VISACT) ### Outcomes Primary Outcomes - Reach - the primary outcome will be to assess the reach of the intervention (VISACT) on patients and providers. Secondary Outcomes - Efficacy - Length-of-stay of index surgical hospitalization - Adoption - Completion rate of the intervention (VISACT) by participants per month - Implementation - Fidelity rate of patients with components of the Enhanced Recovery Program - Maintenance - Long-term adoption rate of the intervention (VISACT) per year - Efficacy - Readmission rate - Efficacy - Complications rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China - NCT ID: NCT06356545 - Study ID: OMICS_CODE_01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-10 - Lead Sponsor: Children's Hospital of Fudan University ### Study Description This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model. ### Conditions - Diarrhea Infantile ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Clinical phenotype of congenital diarrhea and enteropathy in China Secondary Outcomes - Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features - Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## the Intensive Care Unit Diary for Liver Transplant Recipients - NCT ID: NCT06356532 - Study ID: 202312197544 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description the purpose of this study is to assess the effectiveness of the intensive care unit diary for intensive care unit liver transplant recipients. ### Conditions - Liver Transplant Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - intensive care unit diary ### Outcomes Primary Outcomes - change from baseline in depression on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 - change from baseline in anxiety on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 - change from baseline in stress on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 - change from baseline in sense of coherence on the Sense of Coherence Scale at post operation day 7 and day 14 - change from baseline in emotional stress on the Brief Symptom Rating Scale at post operation day 7 and day 14 Secondary Outcomes - change from baseline in delirium on the intensive care delirium screening checklist at post operation day 1 and day 14 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer - NCT ID: NCT06356519 - Study ID: YOUNGBC-29 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: Fudan University ### Study Description The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sacituzumab Govitecan ### Outcomes Primary Outcomes - PFS Secondary Outcomes - ORR - OS - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## A Study on Factors of Biochemical Response in Autoimmune Hepatitis - NCT ID: NCT06356506 - Study ID: 2022-P2-338-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2034-05-01 - Lead Sponsor: Beijing Friendship Hospital ### Study Description The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up. ### Conditions - Autoimmune Hepatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Alanine aminotransferase (ALT) recovery - Aspartate transaminase (AST) recovery - Immunoglobulin G (IgG) recovery - Death - Liver transplantaiton - Progression to hepatocellular carcinoma (HCC) Secondary Outcomes ### Location - Facility: Beijing Friendship Hospital, Capital Medical University, Beijing, N/A, 100050, China @@
## Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD - NCT ID: NCT06356493 - Study ID: OBIIA CMNT - Status: COMPLETED - Start Date: 2020-01-02 - Completion Date: 2022-12-31 - Lead Sponsor: Tunis University ### Study Description The placenta accreta spectrum is a heterogeneous disorder due to abnormal placental invasion into the uterine wall putting at risk the lives of the patients by causing a massive hemorrhage. Its incidence is increasing due to the rise of the cesarean section. The management of this spectrum is multidisciplinary but not yet codified. Hysterectomy-caesarean, though hemostatic surgery, remains the standard Gold. Several adjuvant treatments have emerged in recent years to minimize the risk of bleeding and morbidity of these disorders including the internal-iliac prophylactic occlusion balloons.The aim of the study is to demonstrate the effect of prophylactic occlusion balloons in both uterine iliac arteries in the management of placental accreta spectrum disorders. ### Conditions - Hemorrhage - Placenta Accreta Spectrum - Cesarean Section Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries - caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries ### Outcomes Primary Outcomes - calculated blood loss - Transfusion peroperatively - Duration of surgery - Postoperative hospital stay - Postoperative transfer to the intensive care unit Secondary Outcomes - Morbidity ### Location - Facility: Haithem Aloui, Manouba, Nabeul, 2010, Tunisia @@
## 1% Acetic Acid vs Normal Saline Dressing inManagement of Diabetic Foot - NCT ID: NCT06356480 - Study ID: 266 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-04 - Lead Sponsor: Dr. Muhammad Naeem ### Study Description Chronic diabetic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic diabetic wounds ### Conditions - Granulation of Chronic Diabetic Wounds - Diabetic Wounds ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 1% Acetic acid dressing ### Outcomes Primary Outcomes - Early epithelialization and granulation Secondary Outcomes ### Location - Facility: Pak Emirates military hospital, Rawalpindi, Punjab, N/A, Pakistan @@
## Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs - NCT ID: NCT06356467 - Study ID: FARINET - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-21 - Completion Date: 2024-12-31 - Lead Sponsor: IRCCS San Raffaele ### Study Description Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated. ### Conditions - Neuroendocrine Tumors - GEP-NET ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Global Progression Free Survival (PFS) Secondary Outcomes ### Location - Facility: IRCCS OSpedale San Raffaele, Milan, N/A, 20132, Italy @@
## Knowledge, Attitudes and Practices of Paediatric Cardiologists About Cardiac Rehabilitation in Children With Congenital Heart Disease - NCT ID: NCT06356454 - Study ID: KAPCON-CR - Status: NOT_YET_RECRUITING - Start Date: 2024-06-02 - Completion Date: 2025-12-02 - Lead Sponsor: Karamanoğlu Mehmetbey University ### Study Description Despite significant clinical benefits and recommendations of clinical practice guidelines to refer patients for exercise and physical activity counselling in the capacity of cardiac rehabilitation (CR), CR is largely underutilised and not implemented effectively. Studies have reported that the reasons for the low implementation of CR are multifactorial at the healthcare system, physician and patient levels. Therefore, the aim of this study was to investigate the knowledge, attitudes and practical applications of paediatric cardiologists regarding cardiac rehabilitation and specifically exercise and physical activity in children with congenital heart disease (CHD). ### Conditions - Physician's Role ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease ### Outcomes Primary Outcomes - The score of Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Artificial Intelligence-supported Reading Versus Standard Double Reading for the Interpretation of Magnetic Resonance Imaging in the Detection of Local Recurrence for Nasopharyngeal Carcinoma: a Randomised Controlled Multicenter Study - NCT ID: NCT06356441 - Study ID: B2024-039-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Sun Yat-sen University ### Study Description The aim of this randomized controlled study is to investigate whether the previously developed artificial intelligence model can triage post-radiotherapy magnetic resonance images of patients with nasopharyngeal carcinoma and assist radiologists in their interpretation. ### Conditions - Artificial Intelligence Supported Image Reviewing ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AI ### Outcomes Primary Outcomes - sensitivity Secondary Outcomes - specificity - positive predictive value - negative predictive value - total time of interpretation for all the MR images - the rate of discussion with a third radiologist - the detection rate of local recurrence in the AI-supported reading group - the sensitivity in the subgroups of different rT-stage - the incidence of cases whose recurrent risks and contours cannot be provided by the AI model ### Location - Facility: Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Psychometric Properties and Cross-cultural Adaptation of the Turkish Version of Physcian Attitudes Toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R) - NCT ID: NCT06356428 - Study ID: KARYÖN-DR - Status: NOT_YET_RECRUITING - Start Date: 2024-05-13 - Completion Date: 2025-08-13 - Lead Sponsor: Karamanoğlu Mehmetbey University ### Study Description Research has reported that the reasons for low implementation of CR are multifactorial at the health system, physician and patient levels. It has also been found that patients are more likely to initiate CR if physicians strongly and positively promote the importance of CR participation. Unfortunately, there are insufficient and ineffective data on CR, referral to CR and both clinical and cost-effectiveness outcomes of CR in Turkey. In this context, it is important to examine more objectively from the perspective of physicians who play a key role in referring patients to CR. However, in our country, there is no relatively objective measurement tool to evaluate physicians' attitudes towards CR. Therefore, this study aims to adapt the original "Physician Attitudes towards Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R)" into Turkish and to examine its psychometric properties. ### Conditions - Physician's Role ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Physcian Attitudes toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R) ### Outcomes Primary Outcomes - Physician Attitudes toward Cardiac Rehabilitation and Referral (PACRR)-Revised Scale Score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Infraclavicular Brachial Plexus Block With Bupivacaine Alone or With Both Dexmedetomidine and Dexamethasone - NCT ID: NCT06356415 - Study ID: Dex Dex in infraclavicular - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-09-30 - Lead Sponsor: Suez Canal University ### Study Description Upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. Many medications have been investigated to extend and enhance long-acting local anesthetics' (LA) analgesic effects. Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. In general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects. ### Conditions - Upper Extremity Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bupivacaine injection - Bupivacaine+ Dexamethasone+ Dexmedetomidine ### Outcomes Primary Outcomes - Onset of sensory block Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Investigation of the Efficacy of OHEM for Improving Oral Hygiene in Children - NCT ID: NCT06356402 - Study ID: 8510224SMCPD - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Ziauddin University ### Study Description This pilot study evaluates the feasibility of conducting a larger Randomized Controlled Trial to compare three oral health education delivery methods to a control group. Except for the control group, mothers in the three intervention groups will receive the same oral health education based on the OHEM module but differ in the delivery methods, namely lecture, exhibition, and demonstration. All groups will receive a booklet and oral hygiene kits and be instructed to educate their children at home. Pre- and post-intervention assessments include the satisfaction of participants, the researchers' evaluation and cost of the trial, oral hygiene status, and the knowledge of the parents and children. ### Conditions - Dental Plaque - Gingivitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Oral Health Educational Module for Mothers (OHEM) lecture - Oral Health Educational Module for Mothers (OHEM) exhibition - Oral Health Educational Module for Mothers (OHEM) demonstration ### Outcomes Primary Outcomes - Satisfaction of participants: - Recruitment and participation of participants in the study - Cost of the trial Secondary Outcomes - Dental plaque scores - Gingival scores - Oral health KAP scores - Oral health behaviors - Oral health-related quality of life using Oral health impact profile-14 ### Location - Facility: Primary Healthcare Center Gulshan-e-Sikandarabad Shireen Jinnah Colony, Karachi, N/A, N/A, Pakistan @@
## A Clinical Trial to Evaluate Safety, Tolerance and Pharmacokinetics of JX11502MA Capsule in Patients With Schizophrenia. - NCT ID: NCT06356389 - Study ID: JX11502MA-Ib-II - Status: COMPLETED - Start Date: 2022-03-02 - Completion Date: 2023-01-28 - Lead Sponsor: Zhejiang Jingxin Pharmaceutical Co., Ltd. ### Study Description A multicenter, randomized, double-blind, placebo-controlled, dose-increasing phase Ib/II clinical trial to evaluate the safety, tolerance and pharmacokinetic characteristics of JX11502MA capsules administered multiple times in patients with schizophrenia ### Conditions - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - JX11502MA - Placebo ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events (TEAEs) Secondary Outcomes - Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 28 - Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Day 28 - Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Day 28 - Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 - Tmax - Css_min - Css_max - Css_av - AUC0-t,ss - AUC0-∞,ss - AUCtau,ss - t1/2 ### Location - Facility: Shanghai Mental Health Center, Shanghai, Shanghai, 201109, China @@
## The Effects of Pain and Pain Relief on Peripheral Nerve Excitability - NCT ID: NCT06356376 - Study ID: UAarhus_AGK_MNG_2 - Status: RECRUITING - Start Date: 2023-12-20 - Completion Date: 2024-04-30 - Lead Sponsor: University of Aarhus ### Study Description This study will assess changes in nerve excitability of C-fibers, and changes in sympathetic or parasympathetic tone, when the subject experiences pain and pain relief.The investigators will continuously measure blood pressure, heart rate, respiration rate, gastric motility, sympathetic skin response and C-fiber excitability while using thermal stimuli before and after an analgesic. ### Conditions - Analgesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Heat Stimulation ### Outcomes Primary Outcomes - C-fiber excitability Secondary Outcomes - Action potential duration (ms) - Action potential amplitude (V) - Heart-rate variability (ms) - Blood pressure variability (mmHg) - Sympathetic Skin Response (V) ### Location - Facility: Danish Pain Research Center, Aarhus N, N/A, 8200, Denmark @@
## Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway (Onco-PREMs) - NCT ID: NCT06356363 - Study ID: 2023_RIPH_005_OncoPREMs - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-11-01 - Lead Sponsor: Institut Jean-Godinot ### Study Description Healthcare systems are evolving, giving increasing prominence to the patient-centered model, accompanied by objective and perceived outcomes.PREMs (Patient Reported Experience Measures) are used to assess how patients feel about their experience of care. PREMs enable patients to take an active role in their own care, and enable healthcare establishments to identify areas for improvement that can be incorporated into their quality processes.In oncology, the collection of patient-perceived quality regarding their care pathway would enable better coordination of their care. While a few initiatives have emerged in the field of PREMs, the development of a reliable questionnaire assessing patient perception of their care pathway in oncology remains a challenge. ### Conditions - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Data collection ### Outcomes Primary Outcomes - Psychometric validation Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exercise Programs on Gait in Children With Scoliosis Diagnosed JIA - NCT ID: NCT06356350 - Study ID: IUC_jia_scoliosis_gait - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-11-01 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk (1). These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA (2, 3). All these situations can lead to scoliosis, which we often encounter in children with JIA. Current studies describing various 3-dimension (3D) exercise methods (SEAS, Schroth, Dobomed, BSPTS, Side-shift, Lyon, etc.) effective on scoliosis (4). However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children with scoliosis diagnosed JIA. ### Conditions - Scoliosis Idiopathic - Juvenile Idiopathic Arthritis - Gait, Frontal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional exercises - 3D exercises ### Outcomes Primary Outcomes - ATR - Cobb angle - Maximum Loading - Center of mass displacement - Walking speed Secondary Outcomes ### Location - Facility: Istanbul University-Cerrahpasa, Istanbul, N/A, N/A, Turkey @@
## A Light Exposure Tracker Designed to Improve Circadian Rhythms - Aim 1 - NCT ID: NCT06356337 - Study ID: STUDY-22-01199 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2025-08-31 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description The purpose of this research study is to investigate the relationship between light and circadian rhythms. Twenty healthy older adults will be recruited to participate in a randomized, cross-over study, where an active lighting intervention designed to maintain entrainment and a control intervention designed not to entrain will be tested. ### Conditions - Alzheimer's Disease - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Light goggles - Orange glasses ### Outcomes Primary Outcomes - Saliva samples for melatonin levels Secondary Outcomes - Light exposure using the Speck - Sleep time using actigraphy ### Location - Facility: Light and Health Research Center, Menands, New York, 12204, United States @@
## The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery - NCT ID: NCT06356324 - Study ID: 2021-13347 - Status: COMPLETED - Start Date: 2021-10-18 - Completion Date: 2024-04-01 - Lead Sponsor: Montefiore Medical Center ### Study Description This study investigates whether television viewing or music listening can reduce pre-operative anxiety and improve surgical outcomes for patients undergoing cataract surgery. It aims to determine the effectiveness of these interventions compared to a control group and assess their impact on physiological markers of anxiety as well as the incidence of intra-operative hypertensive events.The key questions that are to be answered are:1. Does watching television before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?2. Does listening to music before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients? ### Conditions - Anxiety - Intraoperative Hypertension - Cataract ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Music Intervention - Television Intervention ### Outcomes Primary Outcomes - Intraoperative hypertensive event Secondary Outcomes - Change in VAS-A measurements for Anxiety - Change in Heart Rate measurements for Anxiety - Change in Blood pressure measurements for Anxiety ### Location - Facility: Montefiore Medical Center, New York, New York, 10467, United States @@
## A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) - NCT ID: NCT06356311 - Study ID: 2870-015 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-08 - Completion Date: 2028-05-05 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS). ### Conditions - Gastroesophageal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sacituzumab tirumotecan - Trifluridine-Tipiracil - Irinotecan - Paclitaxel - Docetaxel ### Outcomes Primary Outcomes - Overall Survival (OS) Secondary Outcomes - Progression-free survival (PFS) - Objective Response Rate (ORR) - Duration of Response (DOR) - Number of Participants Who Experience an Adverse Event (AE) - Number of Participants Who Discontinue Study Intervention Due to an AE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy - NCT ID: NCT06356298 - Study ID: MCHH_004 - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2023-12-31 - Lead Sponsor: Maternal and Child Health Hospital of Hubei Province ### Study Description The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy.Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia .The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA. ### Conditions - Anesthesia Intubation Complication - Airway - Adenotonsillectomy - Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Airway Management: Flexible Reinforced Laryngeal Mask Airway - Airway Management: Endotracheal Tube ### Outcomes Primary Outcomes - Peak airway pressure - Petco2 - Ventilation leakage or not Secondary Outcomes - Mean arterial pressure (MAP) - Heart rate (HR) - Recovery time - Extubation time - Dosage of anesthetic - Success of FLMA or ETT - Surgeon satisfaction - Adverse events ### Location - Facility: Maternal and Child Health Hospital of Hubei Province, Wuhan, Hubei, 430000, China @@
## Testing New Ways to Name Antimicrobial Resistance - NCT ID: NCT06356285 - Study ID: 6995049 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-06-01 - Lead Sponsor: Imperial College London ### Study Description This study aims to investigate the public's views on antibiotics and the impact of different ways to name the potential consequences of antibiotics not working in the future. It is known that current ways to name this don't resonate well with the public, and the study team have worked with members of the public through focus groups and community workshops to develop new ways of describing this in a process of co-design. This study aims to test four different ways of presenting this potential crisis to the public, some of which are new communication strategies designed by the public themselves, to evaluate which are the most memorable and investigate the impact on behaviour change.Adults aged over 18, living in the United Kingdom, who have already signed up to a market panel research company will be eligible to participate in this study.Participants will be invited to complete a short online survey (this should take around five minutes), advertised to them by the market research panel they have already signed up to. This survey is completely anonymous, and contains some multiple-choice questions, and some that require a short free text response. At the start of the survey one of the four ways to name AMR will be presented to participants in the form of a poster.This study aims to result in an improved understanding regarding the general public's understanding of antibiotic use and investigate the impact of communication on behaviour change. The data from this study may be used to inform future public health campaigns on this topic and improve the use of antibiotics.This study will be conducted online using the Predictiv platform, an online platform built by the Behavioural Insights Team. The study is being run in collaboration between the Behavioural Insights Team and the Institute of Global Health Innovation at Imperial College London.Is it anticipated that the survey will open in April 2024 and be open until recruitment of 4000 participants is complete. This is expected to take 4-6 weeks. ### Conditions - Antimicrobial Resistance - Attitude to Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Presentation of Antimicrobial Resistance ### Outcomes Primary Outcomes - Attitudes towards Antimicrobial Resistance (Sentiment) Secondary Outcomes - Comprehension - Intent - Recall ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oropharynx (OPX) Biomarker Trial - NCT ID: NCT06356272 - Study ID: 19-006036 - Status: RECRUITING - Start Date: 2019-11-15 - Completion Date: 2025-12-15 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this research is to identify a biomarker that is exists when human papillomavirus (HPV) mediated oropharyngeal squamous cell carcinoma is present and does not exist when HPV mediated oropharyngeal squamous cell carcinoma is absent. ### Conditions - Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 - Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 - Metastatic Oropharyngeal Squamous Cell Carcinoma - Oropharyngeal Squamous Cell Carcinoma - Recurrent Oropharyngeal Squamous Cell Carcinoma - Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 - Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Change in biomarkers - Oncologic outcomes associated with biomarkers - Genetic alterations - Immunologic biomarkers for predicting progression free survival Secondary Outcomes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.