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Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups.
Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery. conditions: Analgesic Effect studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The trial is designed as a single-center, prospective, double-blind, randomized controlled superiority trial. Patients will be randomly assigned to either the IPP-PSP block group or the sham block group (placebo). primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Neither the participant, anesthesiologist, study nurse, surgeon, nor the doctors and nurses in the Intensive Care Unit will know the participant's group assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Levobupivacaine Hydrochloride 0.25 % Injectable Solution name: Sodium chloride 0.9% measure: Cumulative opioid consumption measure: Number of episodes of postoperative pain measure: Time to need for rescue medication measure: Number of patients with respiratory complications measure: PaCO2 levels measure: Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire measure: Number of episodes of postoperative nausea and vomiting measure: Time to extubation measure: Number of hours spent in the Intensive Care Unit measure: Hospitalization duration measure: Quality of life measured by the 5 level version of the EuroQoL-5 Dimension questionnaire measure: Days alive and at home measure: Vital status (whether the patient is alive or dead) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bart Vaes city: Gent state: Oost-Vlaanderen zip: 9000 country: Belgium name: Bart Vaes, MD role: CONTACT phone: +3292461700 email: bart.vaes@mijnziekenhuis.be name: Steffi Ryckaert, MSc role: CONTACT phone: +3292461910 email: steffi.ryckaert@mijnziekenhuis.be lat: 51.05 lon: 3.71667 hasResults: False
<\|newrecord\|> nctId: NCT06369857 id: PPY briefTitle: Pectopexy for Apical Prolapse Management overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-08 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: This study was designed to evaluate the efficacy of pectopexy for treatment of apical pelvic organ prolapse at follow up at 12 months. Investigator also evaluates complications, improvement of symptoms, quality-of-life outcomes and patient satisfaction with surgery.
Assessment of restoration of normal pelvic anatomy and lower urinary tract symptoms using transperineal ultrasound conditions: Pelvic Organ Prolapse studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Case series study primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Pectopexy measure: Pelvic Organ Prolapse Quantification stage measure: Urinary Symptoms questionnaire measure: Bladder neck measurements using Transperineal US sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06369844 id: 1.2023-440 briefTitle: Pressure Injury Education Intervention for Pediatric Intensive Care Nurses: A Randomized Controlled Trial overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2024-04-03 date: 2024-04-30 date: 2024-04-17 date: 2024-04-17 name: Ankara Yildirim Beyazıt University class: OTHER name: Ankara City Hospital Bilkent briefSummary: The purpose of this observational study is to find out the impact of pressure injury education on the knowledge level of pediatric intensive care nurses and the likelihood of pediatric pressure injury occurrence. The main questions it aims to answer are:
* Does pressure injury education increase nurses knowledge level on pediatric pressure injuries?
* Does the rate of pediatric pressure injuries decrease after the education?
The researcher will compare nurses working in two separate pediatric intensive care units where similar patients are treated to see if planned education on pressure injuries affects nurses knowledge level and the rate of pediatric pressure injuries.
* Volunteer nurses participating in the study will answer pressure injury survey questions prepared by the researcher.
* Nurses in the intervention group will attend planned education sessions provided by the researcher.
* Two weeks after the completion of the education sessions, all nurses in the intervention and control groups who wish to continue participating in the study will answer the pressure injury survey questions prepared by the researcher again. conditions: Pressure Injury Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study design will be two-group and pretest-posttest design. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Pressure injury education measure: Stop Pressure Injuries" Education Evaluation Survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara yıldırım Beyazıt Üniversitesi city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06369831 id: ABS011-1 id: 2024-511419-22-00 type: CTIS briefTitle: HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011 acronym: HERMIA overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-01 date: 2025-06 date: 2024-04-17 date: 2024-04-17 name: ABSCINT NV/SA class: INDUSTRY briefSummary: This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization (ISH) and imaging tools used for treatment response follow-up including Fluorodeoxyglucose F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography (ceCT). conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Interventional, prospective, single arm radio-diagnostic study. Driven by number of biopsied lesions (and not by number of patients) primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: 68Ga-NOTA-ABSCINT-HER2 PET/CT measure: positive, negative, and overall diagnostic agreement between 68Ga-ABS011 PET/CT and the standard of care IHC (and ISH) HER2 status test. measure: Safety of 68Ga-ABS011. measure: Change in treatment management measure: reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (Early tumor shrinkage) measure: reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (metabolic response) measure: Tumor heterogeneity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OLV Aalst city: Aalst state: East-Flanders zip: 9300 country: Belgium name: G. Huygh, Dr. role: CONTACT lat: 50.93604 lon: 4.0355 facility: AZ Delta city: Brussels zip: 1070 country: Belgium name: C. Closset, Dr. role: CONTACT lat: 50.85045 lon: 4.34878 facility: Cliniques Universitaires Saint-Luc city: Brussels zip: 1070 country: Belgium name: F. Duhoux, Prof. role: CONTACT lat: 50.85045 lon: 4.34878 facility: Free University Brussels (VUB) city: Brussels zip: 1070 country: Belgium name: C. Fontaine, Dr. role: CONTACT lat: 50.85045 lon: 4.34878 facility: Institut Jules Bordet city: Brussels zip: 1070 country: Belgium name: E. De Azambuja, Prof. role: CONTACT lat: 50.85045 lon: 4.34878 hasResults: False
<\|newrecord\|> nctId: NCT06369818 id: AnIt23-02 briefTitle: Correlation of Cardiac Output Determined by Echocardiography and Indirect Calorimetry in Critically Ill Patients in Cardiogenic Shock on Extracorporeal Circulatory Life Support overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-02 date: 2024-04-17 date: 2024-04-17 name: Universität Münster class: OTHER briefSummary: This observational study investigates whether the daily measured trend of cardiac output as evaluated by indirect calorimetry correlates with the same evaluated by transthoracic echocardiography. conditions: Cardiogenic Shock studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Correlation of t two methods of determining cardiac output (determined by transthoracic echocardiography and determined by indirect calorimetry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Münster city: Münster zip: 48149 country: Germany name: Thilo von Groote, MD role: CONTACT phone: +49-251-47255 lat: 51.96236 lon: 7.62571 hasResults: False
<\|newrecord\|> nctId: NCT06369805 id: 2021-00731 briefTitle: EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION overallStatus: COMPLETED date: 2021-06-02 date: 2022-11-17 date: 2022-11-17 date: 2024-04-17 date: 2024-04-17 name: Les Toises - Psychiatry and Psychotherapy Center class: OTHER briefSummary: This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment. conditions: Depressive Disorder conditions: Bipolar Disorder conditions: Bipolar Depression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 307 type: ACTUAL name: there is no intervention measure: Psychiatric symptomatology sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Les Toises - Psychiatry and Psychotherapy Center city: Lausanne zip: 1005 country: Switzerland lat: 46.516 lon: 6.63282 hasResults: False
<\|newrecord\|> nctId: NCT06369792 id: 2020-00266 briefTitle: PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH DEPRESSION overallStatus: RECRUITING date: 2020-10-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-17 date: 2024-04-17 name: Les Toises - Psychiatry and Psychotherapy Center class: OTHER briefSummary: This is an observational (non-interventional) prospective study, carried out in drug-naïve outpatients who start a treatment with escitalopram, fluoxetine, sertraline or quetiapine. Five blood samples are collected (i.e. before initiating the drug, and then after 1, 2, 4 and 8 weeks of treatment). It does not affect the choice or the treatment dose. The primary objective of this study is to measure the association between the EDIT-B® editing signature and response to pharmacological treatment in drug-naïve patients. Results of this research could provide an aid to early diagnosis, optimize pharmacological treatment and guide clinical practice towards individualized treatment. conditions: Depressive Disorder conditions: Bipolar Disorder conditions: Bipolar Depression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: psychiatric symptomatology measure: EDIT-B profiling sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Les Toises - Psychiatry and Psychotherapy Center status: RECRUITING city: Lausanne zip: 1005 country: Switzerland name: Aurélie Reymond-Delacrétaz, PhD role: CONTACT phone: +41584580580 email: aurelie.delacretaz@lestoises.ch lat: 46.516 lon: 6.63282 hasResults: False
<\|newrecord\|> nctId: NCT06369779 id: OTCS 36406866 briefTitle: Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2030-12 date: 2024-04-17 date: 2024-04-17 name: Ivoclar Vivadent AG class: INDUSTRY briefSummary: The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months. conditions: Class I or II Cavities in Premolars or Molars studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: TM Fill and TM Flow measure: Postoperative hypersensitivity measure: evaluation of functional (e.g. fracture of the material and retention), biological (e.g. caries at restoration margins) and aesthetic (e.g. color match) properties of the restorations sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06369766 id: 2023-02144; ko23Papadopoulou4 briefTitle: REtinal Markers In Neuroinflammatory Diseases ("REMIND") overallStatus: RECRUITING date: 2024-01-31 date: 2028-12 date: 2029-02 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Basel, Switzerland class: OTHER name: University of Basel briefSummary: The goal of this observational study, including patients with Multiple Sclerosis, patients with other neuroinflammatory diseases and healthy controls, is to determine the predictive value of retinal markers in predicting disease progression. Participants complete a questionnaire and undergo various non-invasive retinal routine clinical examinations. conditions: Multiple Sclerosis conditions: Neuroinflammatory Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Optical coherence tomography (OCT) name: Static retinal vessel analyzer name: Dynamic retinal vessel analyzer name: Laser speckle flowgraphy system name: Questionnaire measure: Occurence of Progression Independent of Relapse Activity (PIRA) measure: Neuroaxonal loss in the retina (as marker of neurodegeneration in the CNS) measure: Neuroinflammation in the retina measure: Fixation instability (as marker of global neuronal dysfunction in the CNS) measure: Structural changes of the retinal vessels (as marker of systemic microvascular health) measure: (For a subgroup of participants) Functional/perfusional changes of the retinal vessels measure: Relative value of retinal markers for the prediction of PIRA compared to or combined with other biomarkers of neuroaxonal damage measure: Comparison of the examined retinal markers of Multiple Sclerosis patients with Healthy Controls and with patients with other neuroinflammatory diseases of the CNS measure: The relationship between neuroaxonal loss, functional deficits and vascular changes in Multiple Sclerosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel, Department of Neurology status: RECRUITING city: Basel zip: 4031 country: Switzerland name: Athina Papadopoulou, PD Dr. med. role: CONTACT phone: +41 61 32 85704 email: Athina.Papadopoulou@usb.ch name: Athina Papadopoulou, PD Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.55839 lon: 7.57327 hasResults: False
<\|newrecord\|> nctId: NCT06369753 id: PR(AG)459/2023B briefTitle: Visible Abdominal Distension overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-05 date: 2025-07 date: 2024-04-17 date: 2024-04-17 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.
Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers.
Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period.
Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period. conditions: Irritable Bowel Syndrome conditions: Dyspepsia conditions: Functional Bloating studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Biofeedback name: Placebo measure: Visible abdominal distension measure: Sensation of abdominal pressure/fullness measure: Sensation of abdominal discomfort/pain measure: Follow-up after biofeedback sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Vall d'Hebron city: Barcelona zip: 08035 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06369740 id: ENZ20-2024-INDIANAPOLIS briefTitle: Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia A Monitoring overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-06-04 date: 2024-06-04 date: 2024-04-17 date: 2024-04-17 name: Enzyre B.V. class: INDUSTRY name: Indiana Hemophilia & Thrombosis Center briefSummary: This observational study consists of two parts.
In part one, case scenario focus groups with hemophilia A patients and healthcare providers (HCPs) will be held. This parts aims to identify potential use scenarios of a point of care (POC) in vitro medical for patients with hemophilia A. The main questions it aims to answer are:
* How is coagulation lab testing for patients with hemophilia A currently organized?
* What is the interest and what are desired alternatives of a POC in-vitro diagnostic medical device for patients with hemophilia A?
Part two of the study consists of a use scenario study in which patients with hemophilia A and HCPs will evaluate two types of non-functional mock-ups of a POC in vitro medical device. The main goal of this part is to evaluate the usability of the current prototypes of the POC device. conditions: Hemophilia A studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 102 type: ESTIMATED name: Case scenarios - questionnaire name: Case scenarios - Focus groups name: Use scenarios - Usability test name: Use scenarios - interview measure: Current management of Hemophilia A coagulation lab testing measure: Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A measure: Usability issues of the current POC in-vitro diagnostic device prototypes measure: User preferences for the point of care in-vitro diagnostic device measure: Problems with current Hemophilia A coagulation monitoring measure: Potential benefits of a POC device for home use, near-patient use or in clinic use sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Indiana Hemophilia & Thrombosis Center city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 hasResults: False
<\|newrecord\|> nctId: NCT06369727 id: MOB015B-VI briefTitle: Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design acronym: RIPT overallStatus: COMPLETED date: 2017-10-15 date: 2018-02-15 date: 2018-02-15 date: 2024-04-17 date: 2024-04-17 name: Moberg Pharma AB class: INDUSTRY briefSummary: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design To evaluate the sensitization potential conditions: Erythema studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE maskingDescription: NA- Safety study count: 250 type: ACTUAL name: MOB015B name: MOB015B vehicle name: Negative irritant solution of 0.9% saline measure: To determine the potential of MOB015B to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions. measure: To assess safety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TKL Research, Inc city: Fair Lawn state: New Jersey zip: 07410 country: United States lat: 40.94038 lon: -74.13181 hasResults: False
<\|newrecord\|> nctId: NCT06369714 id: CHEC2023-296 briefTitle: Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children. acronym: ADHD overallStatus: RECRUITING date: 2023-02-24 date: 2025-02-24 date: 2025-02-24 date: 2024-04-17 date: 2024-04-17 name: Lei Lei, MD class: OTHER briefSummary: A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens. conditions: Attention Deficit Disorder With Hyperactivity conditions: Executive Function Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Concerta name: Digital therapeutics measure: Swanson, Nolan, and Pelham IV Rating Scale measure: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD measure: Questionnaire-Children with Difficulties measure: Behavior Rating Inventory of Executive Function measure: Continuous Performance Test measure: Digital Cancellation Test sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Changzheng Hospital, Naval Medical University status: RECRUITING city: Shanghai state: Shanghai zip: 200003 country: China name: Yujiao Wang, MBBS role: CONTACT phone: 15021500051 email: 2191916146@qq.com lat: 31.22222 lon: 121.45806 facility: Changhai Hospital, Naval Medical University status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Yuanhao Cai, MBBS role: CONTACT phone: 15001969690 email: 15552283399@163.com name: Yuanhao Cai, MBBS role: SUB_INVESTIGATOR name: Lei Lei, MD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06369701 id: C.2024.019 briefTitle: Effects Compressive Tissue Flossing on Lateral Elbow Tendinopathy in US Service Members overallStatus: RECRUITING date: 2024-02-13 date: 2024-05 date: 2024-06 date: 2024-04-17 date: 2024-04-17 name: Brooke Army Medical Center class: FED briefSummary: The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. Dependent variables will be the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements. conditions: Lateral Elbow Tendinopathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Within-subjects repeated measures design primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Compressive tissue floss band measure: Patient's report of pain on the Defense and Veteran's Pain Rating Scale measure: Patient-Rated Tennis Elbow Evaluation measure: Maximal grip strength in the affected upper extremity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brooke Army Medical Center status: RECRUITING city: Fort Sam Houston state: Texas zip: 78234 country: United States name: Carly R Cooper, PhD role: CONTACT phone: 210-808-2240 email: carly.r.cooper2.mil@health.mil name: Brian T Gregg, PhD role: CONTACT phone: (210) 808-2269 email: brian.t.gregg.mil@health.mil name: John E Elam, DSc Fellow role: PRINCIPAL_INVESTIGATOR name: Carly R Cooper, PhD role: SUB_INVESTIGATOR name: Katelyn A Culley, DSc Fellow role: SUB_INVESTIGATOR name: Tara A Haugen, DSc Fellow role: SUB_INVESTIGATOR lat: 29.45746 lon: -98.4472 hasResults: False
<\|newrecord\|> nctId: NCT06369688 id: Baqiyatallah University briefTitle: IDEAL SKIIN CARES Bundle to Prevent Pressure Injury acronym: IdealSkinCares overallStatus: NOT_YET_RECRUITING date: 2025-10-01 date: 2026-10-01 date: 2027-10-01 date: 2024-04-17 date: 2024-04-17 name: Baqiyatallah Medical Sciences University class: OTHER name: Tehran University of Medical Sciences name: Hamadan University of Medical Science name: Tabriz University of Medical Sciences briefSummary: The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training. conditions: Pressure Ulcer conditions: Pressure Injury conditions: Bed Sore conditions: Pressure Sore conditions: Decubitus Sore conditions: Decubitus Ulcer conditions: Skin Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: C-RCT will be conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group and the placebo group. The third arm will be the control group. primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: In this placebo-controlled trial, patients will be blinded to their group allocations. Additionally, WSNs, who are trained for delivering special PIP care bundles, as well as nursing staff who are responsible for measuring wounds and collecting data, and data analyst, will also be blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1620 type: ESTIMATED name: IDEAL SKIIN CARES bundles name: IDEAL SKIIN CARES bundles workshop name: Respiratory care workshop measure: Incidence of hospital-acquired pressure injury (HAPI) measure: Pressure Injury Stage measure: Patient participation in care measure: Healthcare costs measure: Self-report Patient participation in care sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06369675 id: MOB015B-V briefTitle: Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design acronym: CIPT overallStatus: COMPLETED date: 2017-10-19 date: 2017-11-14 date: 2017-11-14 date: 2024-04-17 date: 2024-04-17 name: Moberg Pharma AB class: INDUSTRY briefSummary: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design To evaluate the irritation potential of MOB015B on normal skin. Single center, randomized, controlled, evaluator blinded, within-subject comparison study conditions: Erythema studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 45 type: ACTUAL name: MOB015B name: 0.2% SLS name: 0.9% Saline name: MOB015B vehicle measure: To determine the potential of MOB015B to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions. measure: To assess safety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TKL Research, Inc city: Fair Lawn state: New Jersey zip: 07410 country: United States lat: 40.94038 lon: -74.13181 hasResults: False
<\|newrecord\|> nctId: NCT06369662 id: SECI-CD155 id: SECI-IRB-IORG0006563-545 type: OTHER domain: Scientific Research Unit briefTitle: CD155 Expression in Acute Myeloid Leukemia overallStatus: ACTIVE_NOT_RECRUITING date: 2022-07-01 date: 2023-12-31 date: 2024-08-30 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy. It is the most common form of acute leukemia among adults. In the United States, an estimated 19,940 people will be diagnosed with AML in 2020.
CD155 expression was associated with an unfavorable prognosis in solid tumors such as colon cancer, breast cancer, lung adenocarcinoma, pancreatic cancer, melanoma, and glioblastoma, as it correlated with tumor migration, development of metastases, tissue and lymph node invasion, relapse, and poorer survival. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 93 type: ACTUAL name: Flow cytometric immunophenotyping name: Complete blood count name: Bone marrow aspiration name: Cytogenetic testing name: FLT3-ITD using High resolution melting curve (HRM) analysis measure: CD155 expression level in AML patients sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: South Egypt Cancer Institute, Assiut University city: Assiut zip: 71111 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06369649 id: COOLSENSE-1 briefTitle: Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-08-31 date: 2025-12-31 date: 2024-04-17 date: 2024-04-17 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: This study aims to determine the effect of using Coolsense, which is created using the proven effect of cold application during insulin injection, and Buzzy, which is a combination of vibration and cold application, in reducing pain and anxiety in children diagnosed with Type 1 diabetes mellitus.This randomized controlled clinical study is planned to be conducted between 05.2024-12.2025 with 147 participants between the ages of 6-12. Participants will be divided into three groups according to the randomization method: buzzy group (n = 49), coolsense group (n = 49) and control group (n = 49). Participants in the Coolsense group will receive a cold application using the coolsense device for 5 seconds before the injection. Participants in the Buzzy group will be subjected to vibration and cold application 30-60 seconds before the procedure. Participants in the control group will continue the clinic's standard procedure. Changes in participants' pain score and fear level, heart rate, blood pressure, respiratory rate and oxygen saturation will be measured at three time points: immediately before and after the procedure. Data descriptive information form, application registration form, Facial Expressions Pain Scale (FPS-R) and Child Fear Scale (CFS) will be used. The collected data will be analyzed using SPSS 15 software. The main questions it aims to answer:
* Does buzzy and coolsense application have an effect the pain score of children during the insülin injection?
* Does buzzy and coolsense application have an effect the fear score of children during the insülin injection?
* Does buzzy and coolsense application have an effect the heart rate of children during the insülin injection?
* Does buzzy and coolsense application have an effect the oxygen saturation of children during the insülin injection?
* Does buzzy and coolsense application have an effect the blood pressure of children during the insülin injection?
* Does buzzy and coolsense application have an effect the respiratory rate of children during the insülin injection? conditions: Injection Fear conditions: Injection Site Coldness conditions: Pain conditions: Type 1 Diabetes Mellitus conditions: Pediatric Disease conditions: Nurse's Role studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Single blinding (participants) will be used in the research and the researchers will not have information about the other group.
While applying both scales, care will be taken to ensure that children, parents and observers do not see each other's evaluations and are not influenced by each other. In this way, the child, parent and independent observer will score blindly before and after the procedure. whoMasked: PARTICIPANT count: 147 type: ESTIMATED name: Coolsense and Buzzy measure: Faces Pain Scale- Revised (FPS-R) measure: Children's Fear Scale (CFS) measure: Heart rate measure: Oxygen saturation measure: Respiratory rate measure: Blood pressure sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06369636 id: myucesu briefTitle: Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation in Thyroid Surgery overallStatus: COMPLETED date: 2023-06-01 date: 2023-10-31 date: 2024-01-28 date: 2024-04-17 date: 2024-04-17 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The primary purpose of this prospective observational study was to compare these tests used to predict difficult intubation in patients undergoing thyroid surgery. Secondarily; By comparing these tests, we aim to find the test that best predicts difficult intubation and to determine the incidence of difficult intubation in patients who will undergo thyroid surgery. conditions: Thyroid Surgery conditions: Difficult Intubation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ACTUAL name: Thyroid Surgery measure: Compare EGRI and airway ultrasonographic parameters measure: Find which is the best test predicts difficult intubation measure: Finding the incidence of difficult intubation in thyroid surgery sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bilkent City Hospital city: Ankara state: Çankaya zip: 06800 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06369623 id: IRB2023-00466 briefTitle: Monetary Incentive Delay Task for Probing Reward-related Neural Processes acronym: MID overallStatus: RECRUITING date: 2024-04-06 date: 2028-11-30 date: 2028-11-30 date: 2024-04-17 date: 2024-04-17 name: Stony Brook University class: OTHER briefSummary: 150 males and 150 females ages 14-17 years-old will be enrolled in an observational, longitudinal study. There are three planned in-person visits: a baseline assessment, an 18-month follow-up, and a 36-month follow-up. The in-person visits will include assessment of substance use and other individual differences (e.g., reward function, psychiatric history), neuromelanin-sensitive MRI, as well as functional brain activation collected while the participant is at rest (resting-state fMRI) and while the participant completes a Monetary Incentive Delay task. Subjects will also be asked to complete past 90-day substance use assessments remotely every 90 days for 36 months. conditions: Adolescent Development studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 300 type: ESTIMATED name: Monetary Incentive Delay Task measure: Functional Brain Activation from Monetary Incentive Delay Task sex: ALL minimumAge: 14 Years maximumAge: 17 Years stdAges: CHILD facility: Stony Brook Medicine status: RECRUITING city: Stony Brook state: New York zip: 11794 country: United States name: Greg Perlman, PhD role: CONTACT phone: 631-638-1922 email: greg.perlman@stonybrookmedicine.edu name: Roman Kotov, PhD role: CONTACT name: Greg Perlman, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.92565 lon: -73.14094 hasResults: False
<\|newrecord\|> nctId: NCT06369610 id: GMROA2256 id: NCI-2024-03020 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 22-012591 type: OTHER domain: Mayo Clinic Institutional Review Board id: GMROA2256 type: OTHER domain: Mayo Clinic in Arizona briefTitle: Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment Prostate Cancer overallStatus: RECRUITING date: 2024-04-22 date: 2027-04-22 date: 2027-04-22 date: 2024-04-17 date: 2024-04-24 name: Mayo Clinic class: OTHER briefSummary: This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer. conditions: Oligometastatic Prostate Carcinoma conditions: Prostate Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Abiraterone Acetate name: Biospecimen Collection name: Computed Tomography name: Gonadotropin-releasing Hormone Analog name: Magnetic Resonance Imaging name: Positron Emission Tomography name: Questionnaire Administration name: Radiation Therapy measure: Hormonal domain scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Carlos E. Vargas, M.D. role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 hasResults: False
<\|newrecord\|> nctId: NCT06369597 id: Robot2024 briefTitle: A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-03-31 date: 2024-04-17 date: 2024-04-17 name: Sun Yat-sen University class: OTHER briefSummary: This is a randomized controlled trial that will be preceded by a safety trial focusing on the safety and efficacy of robotic telesurgery. The hypothesis is that robotic telesurgery has a non-inferior primary endpoint event rate to local laparoscopic surgery. conditions: Liver Cancer conditions: Renal Cancer conditions: Rectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 177 type: ESTIMATED name: Robotic telesurgery name: Laparoscopic surgery measure: Surgical complication measure: Surgical time (min) measure: Intraoperative blood loss (mL) measure: Postoperative hospitalization days measure: Physician satisfaction measure: Remote metrics sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Sun Yat-Sen University city: Guangzhou state: Guangdong zip: 510080 country: China name: Kuang Ming, PhD role: CONTACT phone: 008687755766 phoneExt: 8576 email: kuangm@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06369584 id: PEPAD briefTitle: Prone Position During ECMO in Pediatric Patients With Severe ARDS acronym: PEPAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-17 date: 2024-04-17 name: Seventh Medical Center of PLA General Hospital class: OTHER name: Gansu Provincial Maternal and Child Health Care Hospital name: Xian Children's Hospital name: Henan Provincial People's Hospital name: People's Hospital of Guangxi name: Guangdong Provincial People's Hospital briefSummary: In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO).
In 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly.
ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P/F\<80mmHg or Oxygen Index (OI) \>40 for over 4 hours or OI \>20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury. conditions: Pediatric Acute Respiratory Distress Syndrome conditions: Extracorporeal Membrane Oxygenation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 7 type: ESTIMATED name: prone position measure: Mortality measure: Failure of supine position measure: ECMO successful weaning rate measure: Total duration of ECMO Support measure: Number of ECMO-free days measure: Duration of mechanical ventilation days after ECMO successful weaning. measure: Duration of Pediatric Intensive Care Unit (PICU) stay. measure: Duration of hospitalization measure: Incidence of brain injury before discharge measure: Number of days with organ failure measure: Number of days alive without organ failure measure: Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes measure: Number of days with hemodynamic support with catecholamines measure: Number of days without hemodynamic support with catecholamines sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: seventh medical center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100700 country: China name: Xiaoyang Hong, M.D. role: CONTACT phone: 13311057633 email: jyhongxy@163.com name: Zhe Zhao role: CONTACT phone: 18500179885 email: derekpicu@outlook.com lat: 39.9075 lon: 116.39723 facility: Gansu Provincial Maternal and Child Health Care Hospital city: Lanzhou state: Gansu zip: 730050 country: China name: Weikai Wang, M.D. role: CONTACT phone: 0931-5188650 email: 35487284@qq.com lat: 36.05701 lon: 103.83987 facility: The Second School of Clinical Medicine, Southern Medical University city: Guangzhou state: Guangdong country: China name: Yuxiong Guo, M.D. role: CONTACT phone: 13423661583 email: 2003kellylaw@163.com lat: 23.11667 lon: 113.25 facility: The People's Hospital of Guangxi Zhuang Autonomous Region city: Nanning state: Guangxi country: China name: Hanwu Huang, M.D. role: CONTACT phone: 15107710327 email: 2503133021@qq.com lat: 22.81667 lon: 108.31667 facility: Henan Children's Hospital city: Zhengzhou state: Henan zip: 450014 country: China name: Feng Wang, M.D. role: CONTACT phone: 0371-85515892 email: wang.f365@163.com lat: 34.75778 lon: 113.64861 facility: Henan Provincial People's Hospital city: Zhengzhou state: Henan zip: 463599 country: China lat: 34.75778 lon: 113.64861 facility: Xi'an Children's Hospital city: Xi'an state: Shaanxi zip: 710002 country: China name: Yi Wang, M.D. role: CONTACT phone: 18591953652 email: wangyichengxian@163.com lat: 34.25833 lon: 108.92861 hasResults: False
<\|newrecord\|> nctId: NCT06369571 id: IRB00439268 briefTitle: Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-01 date: 2027-12 date: 2024-04-17 date: 2024-04-17 name: Johns Hopkins University class: OTHER name: American Heart Association briefSummary: Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol. conditions: Epilepsy conditions: Dyslipidemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: Atorvastatin 10mg name: Modification of dietary fat composition measure: Diet adherence as assessed by 3 day food records measure: Statin Adherence measure: LDL Change measure: Change in weekly seizure frequency measure: Seizure severity questionnaire score measure: Frequency of adverse events measure: Blood ketone change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06369558 id: BiruniUniversi briefTitle: Plyometric Exercise Training in Athletes With Chronic Low Back Pain overallStatus: COMPLETED date: 2024-01-01 date: 2024-04-04 date: 2024-04-04 date: 2024-04-17 date: 2024-04-17 name: Ugur Cavlak class: OTHER name: Biruni University briefSummary: The aim of this study is to examine the effectiveness of plyometric exercise training in the athletes with chronic low back pain. 32 professional volunteer athletes participated in the study. conditions: Low Back Pain, Mechanical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 32 type: ACTUAL name: PLYOMETRIC TRAINING name: CLASSIC PHYSIOTHERAPY PROGRAM measure: VISUAL ANALOG SCALE measure: OSWESTRY DISABILITY INDEX measure: SIT AND REACH TEST measure: VERTICAL JUMP TEST measure: FLAMINGO BALANCE TEST measure: SHUTTLE RUNNİNG (20 MİN.) measure: MANUAL MUSCLE STRENGTH TEST sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Faculty of Health Sciences in Biruni University city: İ̇stanbul state: Zeytinburnu zip: 34010 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06369545 id: BiruniUniver briefTitle: Chronic Pelvic Pain Syndrome in Males overallStatus: RECRUITING date: 2024-01-01 date: 2024-04-04 date: 2024-08-15 date: 2024-04-17 date: 2024-04-17 name: Biruni University class: OTHER briefSummary: The aim of this study is to evaluate the effectiveness of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in individuals diagnosed with chronic pelvic pain syndrome and treated with medication. The study was organized as a randomized controlled trial. The sample size is 30 patients suffering from chronic pelvic pain syndrome. conditions: Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controled Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 38 type: ESTIMATED name: EXERCISE name: TENS name: ESWT measure: VISUAL ANALOUGE SCALE measure: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) measure: ALGOMETER measure: Hospital Anxiety and Depression Scale- HAD measure: Nottingham Health Profile-NHP measure: Digital Muscle Testing measure: Flexibility Measurements measure: ROM Assessments measure: Lasegue Test sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Health Sciences in Biruni University status: RECRUITING city: İ̇stanbul state: Zeytinburnu zip: 34010 country: Turkey name: UGUR CAVLAK, Prof., PhD. role: CONTACT phone: 00905324519644 email: ucavlak@biruni.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06369532 id: ONZ-2023-0460 briefTitle: Combination of Neurostimulation and Psychotherapy to Stop Worrying overallStatus: RECRUITING date: 2024-03-06 date: 2026-02-20 date: 2027-02-20 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Ghent class: OTHER briefSummary: This study aims to investigate whether the combination of transcranial Direct Current Stimulation (tDCS) and cognitive-behavioral therapy (CBT) is more effective for treating repetitive negative thinking (RNT) in patients with the symptom of high rumination. High ruminators will be included (Group1, active tDCS-CBT group; Group2, sham tDCS-CBT group). All patients will receive active or sham tDCS. conditions: Active tDCS conditions: Sham tDCS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants will be allocated into two groups randomly (using a code). The psychotherapist, the study managers and the patients will not be aware of treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 85 type: ESTIMATED name: Active tDCS name: Sham tDCS measure: the therapeutic effect of the combination therapy for repetitive negative thinking measure: the consolidation effect of tDCS on CBT measure: Change of neuroimaging data sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Ghent status: RECRUITING city: Ghent state: East-Flanders zip: 9000 country: Belgium name: Chris Baeken, Prof. role: CONTACT name: Josefien Dedoncker, M.Sc. role: CONTACT lat: 51.05 lon: 3.71667 hasResults: False
<\|newrecord\|> nctId: NCT06369519 id: 2023#17-23 briefTitle: Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma overallStatus: COMPLETED date: 2000-01-01 date: 2020-12-31 date: 2020-12-31 date: 2024-04-17 date: 2024-04-17 name: Peking University First Hospital class: OTHER briefSummary: Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. The goal of this cohort study is to identify prognostic factors, construct predictive nomograms, and optimize management for sporadic BRCC patients. The main questions it aims to answer are:
What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients?
Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments. conditions: Kidney Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3677 type: ACTUAL name: Surgery treatment or local tumor destruction. measure: Overall survival (OS) measure: Cancer-specific survival (CSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital city: Beijing state: Beijing zip: 100034 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06369506 id: PYO.DIS.1904 Protocol ID:4467 briefTitle: Evaluation of Gingival Thickness Measurement at Different Anatomical Landmarks overallStatus: COMPLETED date: 2022-09-10 date: 2023-08-05 date: 2023-12-17 date: 2024-04-17 date: 2024-04-17 name: Ondokuz Mayıs University class: OTHER briefSummary: In this study, the point at which gingival thickness (GT) should be measured was investigated. Measurements were made from three different points. It was classified as thin and thick in two ways, according to the average of these three different points and the point corresponding to the base of the gingival groove, which is frequently used in the literature. And these two classifications were compared. conditions: Gingival Thickness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were divided into two different classifications: "thin" and "thick". The first classification was made by measuring the GT of the point corresponding to the base of the gingival sulcus. GT was defined as thin if ≤1 mm, and thick if \>1 mm. In the second classification, GT was measured from three different points. And according to the average GT of three points, they were equally classified as "thin" and "thick". primaryPurpose: SCREENING masking: NONE count: 50 type: ACTUAL name: GTmeasurement measure: Examining the sensitivities and sensitivities of two different gingival phenotype classifications based on three-point average GT measurement and single-point measurement using Receiver Operating Characteristic Analysis (ROC). measure: Examining the agreement of GT measurements at three different points in 50 patients, 1195 teeth, using Kappa analysis. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayis University Faculty of Dentistry Department of Periodontology city: Samsun zip: 55000 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False
<\|newrecord\|> nctId: NCT06369493 id: OMUKAEK: 2022/210 briefTitle: Examining The Relationship Between Gingival Thickness and Tooth and Gingival Parameters overallStatus: COMPLETED date: 2022-09-01 date: 2023-12-01 date: 2023-12-18 date: 2024-04-17 date: 2024-04-17 name: Ondokuz Mayıs University class: OTHER briefSummary: This study aims to assess whether there is a valid correlation between the identified multiple clinical and morphometric parameters and the gingival thickness. conditions: Gingival Thickness studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 50 type: ACTUAL measure: Evaluation of the correlation between KGW, CW, CL PH parameters of GT measured in "mm" with a digital caliper with 0.001 mm precision in 1200 teeth in 50 participants using Spearman correlation analysis. measure: Evaluation of the effect of GT on keratinized gingival width, measured in "mm" by digital caliper with a precision of 0.001 mm, both by binary logistic regression analysis of 50 participants. measure: Examining the effect of age and gender of 50 participants on the gingival thickness measured in mm using binary logistic regression analysis. measure: Evaluation of researcher reliability by ICC (Intra-Class Correlation Coefficient) in 10 participants in 2 weeks sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayis University Faculty of Dentistry Department of Periodonthology city: Samsun zip: 55200 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False
<\|newrecord\|> nctId: NCT06369480 id: Journal-nr.: R-23057752 briefTitle: Prognostic Factors for Survival in Patients With Cholangiocarcinoma overallStatus: RECRUITING date: 2024-02-01 date: 2024-08-31 date: 2024-08-31 date: 2024-04-17 date: 2024-04-17 name: Rigshospitalet, Denmark class: OTHER briefSummary: The objective of this retrospective study is to determine the survival rates of CCA patients based on different therapeutic approaches. Additionally, we aim to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals. We anticipate that our findings could provide additional evidence for clinical decision-making, improve patient outcomes, and contribute to the knowledge in the field. conditions: Cholangiocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: Resection/Ablation of tumor name: Palliative chemotherapy name: Neoadjuvant chemotherapy name: Stereotatic radiotherapy name: Best supportive care measure: Aim I measure: Aim II sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Hans-Christian Pommergaard, MD DMSc PhD role: CONTACT email: hans-christian.pommergaard@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06369467 id: R5458-668-ALG-2219 id: 2024-511032-27-00 type: REGISTRY domain: EU CT Number briefTitle: Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2026-04-24 date: 2026-04-24 date: 2024-04-17 date: 2024-04-17 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an experimental drug called linvoseltamab when combined with another drug called dupilumab. The study is focused on patients who have IgE-mediated food allergy. If the patient has an allergy, the immune system overreacts to an allergen (eg, certain foods such as peanuts, milk, shellfish) by producing antibodies called IgE. IgE antibodies are released by cells such as plasma cells. These antibodies and allergen bind to other cells that release chemicals, causing an allergic reaction. The aim of the study is to see how safe and tolerable linvoseltamab is when combined with dupilumab.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs
* Whether linvoseltamab when combined with dupilumab has an effect on other types of antibodies in the blood at different times
* How much study drug(s) is in the blood at different times conditions: Food Allergy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: linvoseltamab name: dupilumab measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs measure: Incidence of adverse event of special interest (AESIs) measure: Severity of AESIs measure: Incidence of serious adverse events (SAEs) measure: Severity of SAEs measure: Absolute change in the serum concentration of total IgE over time measure: Percent change in the serum concentration of total IgE over time measure: Time to reach unquantifiable total serum IgE concentration measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum IgG measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin M (IgM) measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin A (IgA) measure: Incidence of participants with unquantifiable concentrations of serum total IgE measure: Absolute change in the serum concentration of food allergen-specific IgE measure: Percent change in the serum concentration of food allergen-specific IgE measure: Time to reach unquantifiable food allergen-specific serum IgE levels sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06369454 id: B7981090 briefTitle: A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-03 date: 2024-08-03 date: 2024-04-17 date: 2024-04-17 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food.
This study is seeking healthy participants who have:
* Aged 18 years or older;
* male who are healthy as determined by medical assessment;
* BMI of 16-32 kg/m2, and a total body weight \>45 kg (99 lb).
All participants in this study will receive a ritlecitinib oral dose in two different forms (solution without food, capsule with or without food).
The study will take up to 3 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 11 days. There will be 3 periods in total, and a washout period of at least 3 days between dosings in Period 1 and Period 2, and at least 7 days between dosings in Period 2 and Period 3 for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first two periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: Ritlecitinib measure: Site of capsule disintegration and MR microsphere dispersion measure: Gastric emptying time measure: Small intestine residence/transit time measure: Colon arrival time measure: Colon (ascending, transverse, descending) residence/transit time measure: Total transit time measure: Maximum plasma concentration (Cmax) measure: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) measure: Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) measure: Time for Cmax (Tmax) measure: Terminal half-life (t1/2) measure: Frequency of adverse events measure: Frequency of abnormal clinical laboratory tests measure: Frequency of abnormal vital signs measure: Frequency of abnormal 12-lead ECG sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06369441 id: Ovation-23-001 briefTitle: Collection of Biological Specimens and Associated Health Information overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2034-04 date: 2024-04-17 date: 2024-04-17 name: Ovation.io, Inc. class: INDUSTRY briefSummary: The purpose of this study is to collect blood samples from a large number of individuals with cancer to create a database for researchers to use in future studies. Researchers may use this database to discover new ways to detect and treat cancer and other diseases. Future studies may use stored blood samples to discover how genes affect health and disease. conditions: Cancer conditions: Other Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED measure: Biorepository sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ovation.io city: Portland state: Maine zip: 04101 country: United States name: Stephanie Balcaitis role: CONTACT phone: 617-795-4947 phoneExt: 2 email: ClinicalAffairs@ovation.io name: Ed Stepanski, PhD role: CONTACT email: ClinicalAffairs@ovation.io name: Pauline Gee, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.66147 lon: -70.25533 hasResults: False
<\|newrecord\|> nctId: NCT06369428 id: CDRB436BFI02 briefTitle: Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients overallStatus: COMPLETED date: 2021-06-23 date: 2023-04-13 date: 2023-04-13 date: 2024-04-17 date: 2024-04-17 name: Novartis class: INDUSTRY briefSummary: This was a retrospective, non-interventional, registry study based on secondary electronic medical record (EMR) data collected in Helsinki and Uusimaa hospital district (HUS data lake), hospital district of Southwest Finland (VSSHP data lake) and Pirkanmaa hospital district (PSHP data lake) as a part of their routine clinical practice. Social Insurance Institution of Finland (SII; reimbursed drug purchases) was utilized in this study to complement the medication data. The metastatic melanoma patients were stratified by first-line treatment and by hospital district. conditions: Metastatic Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1795 type: ACTUAL measure: Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021 measure: Point Prevalence per 100,000 Population measure: Mean Age of Patients at Index Date per Hospital District measure: Mean Length of Follow-up at Index Date per Hospital District measure: Gender at Index Date per Hospital District measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District measure: Number of Patients with Negative BRAF Status at Index Date per Hospital District measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District measure: Number of Patients by Number of Metastatic Organs at Index Date per Hospital District measure: Number of Patients by Location of Metastases at Index Date per Hospital District measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District measure: Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication measure: Overall Survival (OS) measure: Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment measure: Duration of Treatment (DoT) measure: Mean Age at Index Date per First-line (1L) Medication measure: Length of Follow-up at Index Date per 1L Medication measure: Time to Treatment at Index Date per 1L Medication measure: Gender at Index Date per 1L Medication measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication measure: Number of Patients with Negative BRAF Status at Index Date per 1L Medication measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication measure: Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication measure: Number of Patients by Location of Metastases at Index Date per 1L Medication measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication measure: Number of Patients that Received Radiotherapy During 1L Treatment measure: Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment measure: Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment measure: Number of Patients Switched from TT 1L Treatment to IO 2L Treatment measure: Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment measure: Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment measure: Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment measure: Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment measure: Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment measure: Number of Patients Switched from TT 2L Treatment to IO 3L Treatment measure: Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment measure: Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment measure: Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment measure: Number of Healthcare Contacts and Associated Costs per Patient Year measure: Number of Healthcare Contacts and Associated Costs per Patient measure: Number of Healthcare Contacts and Associated Total Costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis city: Basel zip: 4056 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False
<\|newrecord\|> nctId: NCT06369415 id: 04/24/DD-BVMD briefTitle: Health of Babies Born From IVF Versus IVM at 5 Years Old acronym: FM-BABIES-5Y overallStatus: RECRUITING date: 2024-04-16 date: 2025-12-30 date: 2026-03-30 date: 2024-04-17 date: 2024-04-17 name: Mỹ Đức Hospital class: OTHER briefSummary: The investigators conduct a long-term follow-up at five years on offspring born from our randomized controlled trial (RCT) to investigate whether or not there is any difference in developmental outcomes in children born after capacitation IVM (CAPA IVM) compared with conventional IVF in order to give strong evidence about the safety of IVM in women with high antral follicle count. conditions: Infertility conditions: IVF conditions: IVM conditions: Development, Child studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 231 type: ESTIMATED name: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's) measure: Normal ASQ-3 score rate. measure: Normal SDQ score rate. measure: Normal weight rate measure: Thinness rate measure: Overweight rate measure: Obesity rate measure: Score of Communication (ASQ-3 questionnaire) measure: Score of Gross motor (ASQ-3 questionnaire) measure: Score of Fine motor (ASQ-3 questionnaire) measure: Score of Problem solving (ASQ-3 questionnaire) measure: Score of Personal-Social (ASQ-3 questionnaire) measure: Score of Emotional symptoms (SDQ questionnaire) measure: Score of Conduct problems (SDQ questionnaire) measure: Score of hyperactivity/inattention (SDQ questionnaire) measure: Score of peer relationship problems (SDQ questionnaire) measure: Score of prosocial behavior (SDQ questionnaire) measure: The total difficulties score. sex: ALL minimumAge: 5 Years maximumAge: 5 Years stdAges: CHILD facility: Mỹ Đức Hospital status: RECRUITING city: Ho Chi Minh City state: Tan Binh country: Vietnam name: Tuong M Ho, MD, MCE role: CONTACT phone: +84903633377 email: tuongho.ivfmd@gmail.com lat: 10.82302 lon: 106.62965 hasResults: False
<\|newrecord\|> nctId: NCT06369402 id: 0963 briefTitle: Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease acronym: CInCH PAD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-02 date: 2024-04-17 date: 2024-04-25 name: University of Leicester class: OTHER name: University Hospitals, Leicester briefSummary: Background:
Arterial disease of the legs causes symptoms such as pain when walking and may ultimately lead to a leg amputation. Many older people with arterial disease of the legs also have problems with their thinking and memory. Blood flow in the brain may be altered in these people and may be a cause for memory and thinking problems.
Aim:
The aim of this project is to investigate whether people with arterial disease of the legs have altered blood flow in the brain causing problems with memory and thinking.
Research plan:
Twenty people with arterial disease of the legs causing pain while walking and twenty healthy people will have a series of non-invasive assessments. Arterial disease in the legs will be measured using ankle blood pressures before and after walking. Blood flow in the brain will be measured using ultrasound whilst performing memory and thinking tests. Results will be compared between the people with arterial disease in the legs and the healthy people to see if there are any differences in blood flow to the brain and memory and thinking.
Benefits to society:
This project will help determine if there is a link between arterial disease of the legs and memory and thinking problems caused by altered blood flow in the brain. It will enable future research in people with cognitive impairment caused by altered blood supply to the brain and to prevent confusion and further memory and thinking problems in people undergoing surgery for arterial disease of the legs. conditions: Peripheral Arterial Disease conditions: Cognitive Impairment studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Cerebral haemodynamic testing using transcranial Doppler name: Ankle-brachial pressure index name: Six-minute walk test measure: Peak % change of CBv from baseline measure: Autoregulation index (Tieck's model) measure: Absolute score achieved on the Addenboook's cognitive examination (III) measure: Digit span forward and backward scores measure: Claudication distance measure: Maximal walking distance measure: Ankle-brachial pressure index sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glenfield Hospital Leicester city: Leicester state: Leicestershire zip: LE3 9QP country: United Kingdom lat: 52.6386 lon: -1.13169 hasResults: False
<\|newrecord\|> nctId: NCT06369389 id: RC31/23-0417 briefTitle: Real-life Management of Patients Eligible for CAR-T Cell Therapy acronym: CARAVAGE overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2033-12-31 date: 2034-12-31 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Toulouse class: OTHER name: Ligue contre le cancer, France name: Janssen, LP briefSummary: Adoptive immunotherapy using CAR-T cells is now one of the Advanced Therapy Medicines routinely used for relapsed or refractory lymphoid hemopathies. In 2023, in France, 5 types of CAR-T cells have marketing authorization for 6 different indications. However, these marketing authorizations are based on clinical trials involving a limited number of selected patients. Real-life data are essential for assessing the post-authorization use of these innovative treatments. The French national DESCAR-T registry, promoted by LYSARC and in which Toulouse University Hospital plays an active role, is an international reference for this real-life evaluation. It does not, however, allow precise evaluation of patient-centered indicators and care pathways.
With the increasing number of indications and candidate patients, Toulouse University Hospital, the only healthcare facility authorized in the Western Occitanie region to administer CAR-T cells, is faced with growing hospital needs and longer treatment times. In 2023, this has necessitated the implementation of new ambulatory and inter-facility care pathways in collaboration with the referral centers of the Onco-Occitanie Ouest regional cancer network. The selection of patients for CAR-T cell treatment is based on objective clinical criteria linked to the pathology (histology, morphological localization, size and kinetics of the tumor mass) and the patient (physiological age, performance index, comorbidities, patient choice). Because of their innovative nature, in a difficult psychological and physical context for the patient (refractory disease), CAR-T cell care pathways also need to be evaluated in terms of their "quality of life" dimension. The impact of non-biological determinants (also described as social and territorial inequalities in health) such as place of residence and distance from healthcare provision, marital, economic and social status, has never been explored on the accessibility and progress of the CAR-T cell treatment pathway.
The creation of a registry of patients eligible for CAR-T cells at Toulouse University Hospital will enable these lines of research to be explored on the scale of a region with a population of 3 million. conditions: Hemopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 550 type: ESTIMATED name: Patients eligible for CAR-T treatment measure: Overall survival of patients with hemopathy eligible for CAR-T cell therapy measure: Compare progression-free survival and overall survival of patients according to care pathway and type of hemopathy, and investigate clinical and socioeconomic factors associated with better survival measure: Evaluate the time taken to treat patients with CAR-T cells sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Toulouse city: Toulouse state: CHU De Toulouse zip: 31059 country: France name: Pierre BORIES, MD role: CONTACT phone: 0531156415 phoneExt: 33 email: bories.pierre@iuct-oncopole.fr name: Sandra DE BARROS role: CONTACT phone: 0561145982 email: debarros.s@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False
<\|newrecord\|> nctId: NCT06369376 id: ONZ-2022-0072 briefTitle: Electrodiagnostic Approach for Pectoral Nerve Conduction Studies overallStatus: COMPLETED date: 2023-06-30 date: 2023-11-29 date: 2024-04-12 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Ghent class: OTHER briefSummary: Anatomical studies have challenged traditional perceptions of the pectoral nerve structure, revealing a network of three branches rather than the previously accepted medial and lateral branches. This study aims to explore the implications of this updated anatomy on nerve conduction studies of the pectoral nerve and proposes a modified nerve conduction study protocol to enhance diagnostic accuracy.
A study on 25 volunteers was conducted, examining the three parts of the pectoral nerve. Electrode placement followed a detailed methodology ensuring precise data collection. The nerve conduction study was performed bilaterally, exploring latency and amplitude while addressing inter-observer variability and demographic influences. conditions: New Nerve Conduction Protocol for Pectoral Nerve studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 25 type: ACTUAL name: New nerve conduction protocol measure: Latency measure: Amplitude sex: ALL minimumAge: 22 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Gent city: Gent state: Oost-Vlaanderen zip: 9000 country: Belgium lat: 51.05 lon: 3.71667 hasResults: False
<\|newrecord\|> nctId: NCT06369363 id: STUDY000024245 briefTitle: Estrogen Deficiency on Cardiovascular Risk overallStatus: NOT_YET_RECRUITING date: 2025-09 date: 2027-09 date: 2027-11 date: 2024-04-17 date: 2024-04-17 name: Milton S. Hershey Medical Center class: OTHER briefSummary: To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It is hypothesized that estrogen deficiency increases BP, SNA and the pathway activities of the key pro-inflammatory mediators. Those effects are impacted through the downregulation of the estrogen receptor. conditions: Postmenopausal Symptoms conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Placebo name: Estradiol measure: Red blood cell flux measure: Mean arterial pressure (mmHg) measure: baseline plasma TNF-α concentration (pg/ml) measure: One week post-intervention plasma TNF-α concentration (pg/ml) measure: baseline plasma IL-1β concentration (pg/ml) measure: One week post-intervention plasma IL-1β concentration (pg/ml) measure: baseline plasma IL-6 concentration (pg/ml) measure: One week post-intervention plasma IL-6 concentration (pg/ml) measure: baseline plasma estrogen (pg/ml) measure: One week post-intervention plasma estrogen (pg/ml) sex: FEMALE minimumAge: 54 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06369350 id: STUDY000020217 id: 940567 type: OTHER_GRANT domain: American Heart Association briefTitle: Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2025-09 date: 2024-04-17 date: 2024-04-17 name: Milton S. Hershey Medical Center class: OTHER name: American Heart Association briefSummary: In this study, we are trying to see if vitamin B6 can minimize the amplified blood pressure response to exercise following ischemia-reperfusion injury. We are interested in a protein called P2X3, of which function can be blocked by vitamin B6, in the neurons of our nervous system. It is very important for blood pressure regulation. We would like to see if the P2X3 plays a role in patients' rising blood pressure during exercise. The results of the proposed studies will provide a base for those two potential economic and non-invasive inventions to improve the overall health and well-being of PAD patients. conditions: Ischemia Reperfusion Injury conditions: Peripheral Artery Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Vitamin B6 25 MG name: Vitamin B6 50 MG name: Vitamin B6 100 MG name: Placebo measure: baseline blood pressure in mmHg measure: Second visit blood pressure in mmHg measure: baseline heart Rate in beats per minute measure: Second visit heart Rate in beats per minute measure: baseline muscle sympathetic nerve activity in burst/min measure: Second visit muscle sympathetic nerve activity in burst/min measure: baseline walking time in minutes measure: Second visit walking time in minutes sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06369337 id: 014-24 briefTitle: Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-06 date: 2024-04-17 date: 2024-04-22 name: Universidad Europea de Madrid class: OTHER name: Hospital Universitario Ramon y Cajal briefSummary: Acquired dysphagia is one of the most frequent complications suffered by patients in intensive care units (ICU) after orotracheal extubation. Ultrasound has proven to be a useful method in the morphological and kinematic exploration of the main swallowing structures. AIM: to evaluate, through ultrasound procedures, the evolution of the morphology of the tongue and muscles of the floor of the mouth and the hyolaryngeal kinematics in patients intubated \>48h and to correlate these measurements with the possible development of acquired dysphagia. The incidence of dysphagia and ICU acquired weakness (ICUAW) in subjects with \>48h of intubation and the relative risk factors associated with baseline characteristics and clinical variables will be described. METHODOLOGY: Design: Single-center cohort study (Ramón y Cajal University Hospital). Participants: subjects \>18 years old, admitted to an intensive care unit (ICU), with \>48 hours of orotracheal intubation who meet eligibility criteria. Outcomes: the study of socio-demographic and clinical variables related to ICU admission will be included. The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). Measurements will be made of the thickness and echogenicity of the submental and tongue muscles, as well as hyolaryngeal kinematics conditions: Dysphagia, Oropharyngeal conditions: Deglutition Disorders conditions: Mechanical Ventilation Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Ultrasound measure: Thickness of the submental muscles measure: Hyolaryngeal displacement measure: Muscle strength measure: Functional Status measure: Swallowing function measure: Swallowing function measure: Swallowing function sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06369324 id: 05 briefTitle: Efficacy of Pain Neuroscience Education and Physiotherapy in Patients Diagnosed With Spondyloarthritis overallStatus: RECRUITING date: 2024-02-15 date: 2024-04-11 date: 2024-04-11 date: 2024-04-17 date: 2024-04-18 name: Universidad de Extremadura class: OTHER briefSummary: Spondyloarthritis, notably ankylosing spondylitis (AS), represents a chronic rheumatic condition typified by persistent back pain and stiffness. It constitutes a substantial portion of diagnoses within rheumatology units and exhibits a higher prevalence among males. Diagnosis relies upon comprehensive clinical evaluation, including patient history, physical examination, and adjunctive radiological assessments, with genetic predisposition, particularly the presence of the HLA-B27 antigen, playing a significant role.
Management strategies encompass a multidisciplinary approach, with physiotherapy emerging as a cornerstone therapeutic modality. Various exercise interventions, particularly those supervised by trained professionals, demonstrate efficacy in improving pain, stiffness, and overall functional capacity. Furthermore, patient education plays a pivotal role in enhancing treatment adherence and optimizing outcomes by aligning patient expectations with therapeutic goals.
The evolving landscape of spondyloarthritis management underscores the necessity of further research into multimodal treatment approaches, particularly in integrating novel interventions such as electrophysical agents. By elucidating the mechanisms of action and exploring their synergistic effects, clinicians can refine treatment protocols and ultimately enhance the quality of care provided to individuals living with spondyloarthritis. conditions: Spondyloarthropathies conditions: Ankylosing Spondylitis conditions: Exercise Therapy conditions: Physical Therapy Modalities conditions: Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Pain education name: Exercise supervised by external focus name: Therapy by means of electrical stimulation (electro-massage) measure: Numeric Pain Rating Scale (NPRS) measure: Cervical and Lumbar Joint Position Sense Error measure: Cervical Range of Motion (CRoM) measure: Pressure Pain Threshold (PPT) measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measure: Bath Ankylosing Spondylitis Motility Index (BASMI) measure: Bath Ankylosing Spondylitis Functional Index (BASFI). measure: Kinesophobia measure: Catastrophizing Pain measure: Fear-Avoidance Beliefs Questionnaire (FABQ) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine and Health Sciences status: RECRUITING city: Badajoz zip: 06006 country: Spain name: Carlos Fernández-Morales, MSc role: CONTACT lat: 38.87789 lon: -6.97061 hasResults: False
<\|newrecord\|> nctId: NCT06369311 id: 2000037345 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-17 date: 2024-04-17 name: [Redacted] hasResults: False
<\|newrecord\|> nctId: NCT06369298 id: JK07.2.01 briefTitle: Study of JK07 in Patients With Chronic Heart Failure acronym: RENEU-HF overallStatus: RECRUITING date: 2024-03-28 date: 2025-12-31 date: 2026-06-30 date: 2024-04-16 date: 2024-04-18 name: Salubris Biotherapeutics Inc class: INDUSTRY briefSummary: This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure.
There will be 2 cohorts in this study:
Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%.
Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.
Participants in both cohorts will be randomized into either low dose JK07, high dose JK07 or placebo. Participants will have a 2:1 chance of receiving JK07 versus placebo. conditions: Heart Failure With Reduced Ejection Fraction conditions: Heart Failure With Preserved Ejection Fraction studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 282 type: ESTIMATED name: JK07 name: Placebo measure: Safety - Cohort 1 measure: Efficacy - Cohort 1 measure: Safety - Cohort 2 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southern California Heart Specialists status: RECRUITING city: Pasadena state: California zip: 91105 country: United States name: Gregory Giesler role: CONTACT lat: 34.14778 lon: -118.14452 facility: New Generation of Medical Research status: RECRUITING city: Hialeah state: Florida zip: 33016 country: United States name: Karelia Ruiz role: CONTACT lat: 25.8576 lon: -80.27811 facility: Louisiana Heart Center status: RECRUITING city: Covington state: Louisiana zip: 70433 country: United States name: Bruce Iteld, MD role: CONTACT lat: 30.47549 lon: -90.10042 facility: Cardiology and Vascular Associates status: RECRUITING city: Bloomfield Hills state: Michigan zip: 48304 country: United States name: Kirit Patel role: CONTACT lat: 42.58364 lon: -83.24549 facility: St. Louis Heart and Vascular Cardiology status: RECRUITING city: Saint Louis state: Missouri zip: 63136 country: United States name: Harvey Serota role: CONTACT lat: 38.62727 lon: -90.19789 facility: Southwest Family Medicine status: RECRUITING city: Dallas state: Texas zip: 75235 country: United States name: Chriistte Dharma role: CONTACT lat: 32.78306 lon: -96.80667 hasResults: False
<\|newrecord\|> nctId: NCT06369285 id: PUMA-ALI-1201 id: 2024-511497-79-00 type: CTIS briefTitle: A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer acronym: ALISCA-Breast1 overallStatus: NOT_YET_RECRUITING date: 2024-12-31 date: 2027-06-30 date: 2028-12-31 date: 2024-04-16 date: 2024-04-16 name: Puma Biotechnology, Inc. class: INDUSTRY briefSummary: PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer conditions: Metastatic Breast Cancer conditions: Recurrent Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Alisertib name: Endocrine therapy measure: Objective Response Rate (ORR) Within Dose Subgroup measure: Duration of Response (DOR) Within Dose Subgroup measure: Disease Control Rate (DCR) Within Dose Subgroup measure: Progression Free Survival (PFS) Within Dose Subgroup measure: Overall Survival (OS) Within Dose Subgroup measure: Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population measure: Objective Response Rate (ORR) Within Biomarker-Defined Subgroup measure: Duration of Response (DOR) Within Biomarker-Defined Subgroup measure: Disease Control Rate (DCR) Within Biomarker-Defined Subgroup measure: Progression Free Survival (PFS) Within Biomarker-Defined Subgroup measure: Overall Survival (OS) Within Biomarker-Defined Subgroup sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

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