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<\|newrecord\|> nctId: NCT06373874 id: MCBU-SBF-YC-04 briefTitle: The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, in Newborn Heel Blood Collection overallStatus: COMPLETED date: 2023-04-01 date: 2023-05-30 date: 2023-05-30 date: 2024-04-18 date: 2024-04-18 name: Celal Bayar University class: OTHER briefSummary: The researchers gave midwifery students theoretical training on how to take heel blood on a newborn model. Students were asked to take heel blood on the model in the high-reality simulation environment and simulation room. The student's ability to take heel blood before and after taking heel blood in a high-reality simulation environment or on a newborn model in a simulation environment, satisfaction with learning, anxiety and self-efficacy levels were compared. conditions: Students conditions: Educational Problems conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment experimental study with experimental and control group primaryPurpose: OTHER masking: NONE count: 92 type: ACTUAL name: Heel blood collection in a newborn simulation model measure: Skill checklist measure: State and Trait Anxiety Scales measure: Self-Efficacy Scale measure: Student Satisfaction and Self-Confidence in Learning Questionnaire sex: FEMALE minimumAge: 21 Years maximumAge: 32 Years stdAges: ADULT facility: Manisa Celal Bayar University Faculty of Health Sciences, Department of Midwifery city: Manisa zip: 45140 country: Turkey lat: 38.61202 lon: 27.42647 facility: Yonca çiçek okuyan city: Manisa zip: 45140 country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False
<\|newrecord\|> nctId: NCT06373861 id: 20-0482 briefTitle: Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY) acronym: GALAXY overallStatus: RECRUITING date: 2022-04-28 date: 2037-04 date: 2037-04 date: 2024-04-18 date: 2024-04-18 name: University of Colorado, Denver class: OTHER name: Children's Hospital Colorado briefSummary: GALAXY is a registry research study that plans to learn more about individuals with X\&Y variations (also called sex chromosome aneuploidies) through collecting information from medical records.This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. The purpose of the GALAXY Registry is to collect and store this information with the overall goal to improve health outcomes in individuals with X\&Y variations and the care they receive. conditions: Sex Chromosome Aneuploidy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED name: no intervention measure: Health Conditions measure: Prevalence of mental health diagnoses measure: Cardiometabolic diagnoses - prevalence of obesity measure: Cardiometabolic diagnoses - prevalence of dyslipidemia measure: Cardiometabolic diagnoses-prevalence of hypertension measure: Autoimmune diagnoses - prevalence of hypothyroidism and of hyperthyroidism measure: Autoimmune diagnoses - prevalence of diabetes sex: ALL minimumAge: 0 Days maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Hospital Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Shanlee M Davis, MD, PhD role: CONTACT phone: 720-777-6073 email: shanlee.davis@childrenscolorado.org lat: 39.72943 lon: -104.83192 hasResults: False
<\|newrecord\|> nctId: NCT06373848 id: 346 briefTitle: Comparison of Salivary Parameters in Patients Receiving CoQ10 and Vitamin E Supplementation overallStatus: ENROLLING_BY_INVITATION date: 2024-04-20 date: 2024-08-20 date: 2024-09-15 date: 2024-04-18 date: 2024-04-18 name: Islamic Azad University, Tehran class: OTHER briefSummary: Comparison of salivary markers in patients with Initial chronic periodontitis after non-surgical periodontal treatment with CoQ10 supplementation with vitamin E conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment, Randomized, Double-blind, Controlled design. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The study was carried out utilizing a double-blind approach. In order to guarantee objectivity, all three groups - the Vitamin E group, the Coq10 group, and the control group - received medications that were indistinguishable in terms of appearance, packaging, and color. Additionally, to minimize any potential bias, a clinician who had no association with the research labeled the medications as A, B, and C (empty) based on their content, and then distributed them among the patients. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 85 type: ESTIMATED name: Receive 30 mg of Coq10 measure: Total Antioxidant capacity (TAC) of saliva measure: Bleeding on probing sex: ALL minimumAge: 28 Years maximumAge: 35 Years stdAges: ADULT facility: Amirhossein Farahmand city: Tehran zip: 1947833113 country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False
<\|newrecord\|> nctId: NCT06373835 id: EMODEPSIDE_LAOS briefTitle: Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-31 date: 2024-07-31 date: 2024-04-18 date: 2024-04-18 name: Swiss Tropical & Public Health Institute class: OTHER name: National Institute of Public Health, Vientiane, Laos briefSummary: Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials conditions: Strongyloides Stercoralis Infection conditions: Strongyloidiasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Emodepside measure: Cure rate (CR) of emodepside against Strongyloides stercoralis measure: Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin. measure: Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis. measure: Exposure response of emodepside in adults measure: Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373822 id: 2024/18JAN/028 briefTitle: New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs acronym: ADENO-MIRNA overallStatus: RECRUITING date: 2024-03-21 date: 2031-09 date: 2031-09 date: 2024-04-18 date: 2024-04-22 name: Université Catholique de Louvain class: OTHER briefSummary: Objectives:
To identify differentially expressed miRNAs in the blood of adenomyosis patients in view to develop new diagnostic methods
Hypotheses Circulating miRNAs may be abnormally expressed in patients suffering from adenomyosis and could be used to diagnose the disease
Study Design Blood samples will be collected from healthy subjects and adenomyosis patients and miRNAs will be isolated and analyzed to detect potential differences. conditions: Adenomyosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Circulating-mirna measure: Circulating-miRNA as diagnostic biomarkers sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CUSL status: RECRUITING city: Brussel state: Woluwe-Saint-Lambert zip: 1200 country: Belgium name: Emilie Wacheul, MD role: CONTACT phone: 027645246 email: emilie.wacheul@uclouvain.be lat: 50.85045 lon: 4.34878 hasResults: False
<\|newrecord\|> nctId: NCT06373809 id: PDSC1970222 briefTitle: Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy acronym: PDSC overallStatus: COMPLETED date: 2021-10-08 date: 2024-03-31 date: 2024-03-31 date: 2024-04-18 date: 2024-04-18 name: Michael H Carstens class: OTHER name: Ministerio de Salud de Nicaragua name: Wake Forest Institute for Regenerative Medicine briefSummary: This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb. Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose. Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot. Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy. Dose escalation and safety will be documented. Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot. conditions: Diabetic Foot conditions: Diabetic Neuropathies conditions: Diabetic Foot Ulcer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective an open label primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Transplantation of Placenta Derived Stem Cells measure: Foot Ulcer Healing measure: Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes. measure: Vibration: Documenting diabetes-associated lower extremity pathophysiology changes. sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA) city: León state: Leon zip: 21000 country: Nicaragua lat: 12.43787 lon: -86.87804 facility: Hospital Escuela Cesar Amador Molina city: Matagalpa zip: 61000 country: Nicaragua lat: 12.92559 lon: -85.91747 hasResults: False
<\|newrecord\|> nctId: NCT06373796 id: 2024-A00523-44 briefTitle: Ultrasound Index Fat Fraction acronym: FAT-PLUS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-09 date: 2024-04-18 date: 2024-04-18 name: SuperSonic Imagine class: INDUSTRY briefSummary: The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis. conditions: Steatosis of Liver studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Echographic scan measure: FAT PLUS sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373783 id: 2023/05 briefTitle: Ultrasonographic Evaluation of the Connective Tissue Grafts Obtained With Two Different Methods in Root Coverage overallStatus: COMPLETED date: 2023-06-15 date: 2024-01-15 date: 2024-03-16 date: 2024-04-18 date: 2024-04-23 name: Pamukkale University class: OTHER briefSummary: Gingival recession is a clinical problem that increases with age and affects patient comfort. It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth.
Coronally advanced flap (CAF) or tunnel technique (TUN) with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments. The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results. The main indications for root coverage (RC) procedures are aesthetic concern, root hypersensitivity, prevention of cervical abrasion and root caries, improvement of restorative results, and facilitation of plaque control. The use of a subepithelial connective tissue graft (SCGT) combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments.
De-epithelialization of free gingival grafts (DGG) has been proposed, especially when palatal tissue thickness is insufficient (≤2.5 mm) and larger graft size in the apico-coronal or mesio-distal directions is required. In this technique, the graft of the required width and length is separated from the lateral side of the palate, and then the 0.3-0.5 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer.
Ultrasonography (USG) is based on the principle of recording data obtained as a result of ultrasound waves sent with the help of a probe hitting and reflecting on substances of different densities. This technique is widely used in medical practice. In dentistry, the USG method is used to measure the alveolar bone level and the dimensions of the periodontium to evaluate the gingival thickness. It also has functions to evaluate color power and color speed, as well as blood flow.
The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could yield different clinical outcomes in patients with a single buccal gingival recession. This study aims to compare the clinical success of connective tissue grafts obtained by two different surgical methods in covering the root surface with ultrasonography (USG). conditions: Gingival Recession, Localized studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: subepithelial connective tissue graft name: de- epithelize gingival graft name: ultrasonography measure: tissue thickness measure: pulsatility index sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University of the Dentistry city: Denizli zip: 20160 country: Turkey lat: 37.77417 lon: 29.0875 hasResults: False
<\|newrecord\|> nctId: NCT06373770 id: MSRSW/Batch-Fall22/700 briefTitle: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-06-01 date: 2024-09-30 date: 2024-04-18 date: 2024-04-22 name: Superior University class: OTHER briefSummary: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ACTUAL name: Ayres sensory integration therapy name: Behaviour Therapy measure: sensory profile by winnie dunn sex: ALL minimumAge: 2 Years maximumAge: 8 Years stdAges: CHILD facility: RICCER Institute city: Faisalabad state: Punjab country: Pakistan lat: 31.41554 lon: 73.08969 hasResults: False
<\|newrecord\|> nctId: NCT06373757 id: RECO6U/5-2023 briefTitle: Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect overallStatus: COMPLETED date: 2023-03-01 date: 2023-09-01 date: 2023-09-01 date: 2024-04-18 date: 2024-04-18 name: October 6 University class: OTHER briefSummary: The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects. conditions: Chitosan conditions: Nano-hydroxyapatite Hydrogel conditions: Intrabony Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ACTUAL name: Nano-HAP/Chitosan hydrogel measure: Gingival index measure: Plaque index measure: Clinical attachment level measure: Periodontal probing depth measure: Acrylic stent for pocket assessment sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT facility: October 6 University city: Giza zip: 12511 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
<\|newrecord\|> nctId: NCT06373744 id: SYSU-022 briefTitle: Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients overallStatus: COMPLETED date: 2023-01-01 date: 2024-01-01 date: 2024-01-01 date: 2024-04-18 date: 2024-04-18 name: Sun Yat-sen University class: OTHER briefSummary: The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:
How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 597 type: ACTUAL name: cyclophosphamide , methotrexate , vinorelbine ,capecitabine measure: Progression free survival measure: Overall Survival measure: Objective Response Rate measure: Disease Control Rate sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shusen Wang city: Guangzhou state: Gangdong country: China lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06373731 id: SPIAM-301 briefTitle: ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) acronym: ReNEW overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-08 date: 2027-08 date: 2024-04-18 date: 2024-04-22 name: Stealth BioTherapeutics Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared. conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomized (2:1) to once daily 40 mg SC of elamipretide or placebo for 96 weeks of treatment by a central randomization primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Trial personnel and subjects will be masked to treatment until the database is locked at the end of the trial, unless noted below. The Investigator will contact the Sponsor Medical Monitor prior to unmasking any subject's treatment sequence unless in the instance of a medical emergency. In case of an immediate medical emergency, or if directed by the Sponsor, and only if the information is required by the Investigator to manage a subject's AE, a subject's treatment assignment may be unmasked prematurely using the computerized system. The Sponsor must be notified as soon as possible regarding the reason for unmasking. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 360 type: ESTIMATED name: Elamipretide name: Placebo measure: Week 48 Rate of change in the macular area of photoreceptor loss measure: Week 72 Rate of change in the Macular area of photoreceptor loss measure: Week 96 Rate of change in the Macular area of photoreceptor loss measure: Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best-Corrected Visual Acuity (LL BCVA) measure: Proportion of subjects gaining ≥ 15 letters in Low Luminance Best-Corrected Visual Acuity (LL BCVA) sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373718 id: IRB-74553 briefTitle: A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase) overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-06 date: 2027-06 date: 2024-04-18 date: 2024-04-18 name: Stanford University class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target. conditions: Insomnia conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Enrolled participants will be randomized into either the Immediate Treatment group, or the Monitored Control group. Both study groups will receive CBT-I. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: Cognitive Behavioral Therapy for Insomnia measure: Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging measure: Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging measure: Change in Beck Depression Inventory measure: Change in PSG Sleep Efficiency measure: Change in Columbia Suicide Severity Rating Scale measure: Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity measure: Change in Actigraph Number of Arousals as a Measure of Sleep Continuity measure: Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity measure: Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity measure: Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity measure: Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture measure: Change in PSG Number of Arousals as a Measure of Sleep Architecture measure: Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture measure: Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture measure: Change in PSG Sleep Efficiency (SE) as a Measure of Sleep Architecture measure: Change in Sleep Physiology measured by PSG measure: Change in Insomnia Severity Index (ISI) Scale Score measure: Change in 36-Item Short Form Survey (SF-36) Score measure: Change in Beck Anxiety Inventory measure: Change in Respiratory Sinus Arrhythmia (RSA)- measured by PSG sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: Stanford University city: Palo Alto state: California zip: 94304 country: United States name: Pandora Lam role: CONTACT phone: 650-497-5130 email: pal217@stanford.edu name: Andrea Goldstein-Piekarski, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 hasResults: False
<\|newrecord\|> nctId: NCT06373705 id: 74566 id: 1R01HL173845 - 01 type: OTHER_GRANT domain: NIH briefTitle: Cardiac Simulator for Surgical Planning overallStatus: NOT_YET_RECRUITING date: 2026-04 date: 2029-04 date: 2029-04 date: 2024-04-18 date: 2024-04-22 name: Stanford University class: OTHER name: National Institutes of Health (NIH) briefSummary: The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:
To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.
To aid surgeons in envisioning different surgical approaches for each individual patient.
To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.
Participants will:
Consent to being randomized with a 50% chance of receiving standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.
Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group. conditions: Congenital Heart Disease in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1:1 randomization to either receive standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of computer simulation. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: After consent to participate in the study, patient will be entered into a random allocation sequence for standard of care (SOC) or cardiac simulator groups.
Patient and surgeon will both be notified which group they have been assigned to. count: 275 type: ESTIMATED name: Cardiac simulator measure: Mortality measure: Mortality measure: Number of cardioplegic arrest measure: Number of repair revisions needed measure: Time on cardiopulmonary bypass measure: Ventricular function measure: Ventricular function measure: Ventricular function measure: Valvular function measure: Valvular function measure: Valvular function measure: Number of days in hospital post-operation measure: Type of post-operative inotrope sex: ALL maximumAge: 17 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06373692 id: TCM for Asthma Cohort briefTitle: REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-12-30 date: 2024-04-18 date: 2024-04-18 name: Henan University of Traditional Chinese Medicine class: OTHER name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine name: Tianjin University of Traditional Chinese Medicine name: The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine name: Hebei Provincial Hospital of Traditional Chinese Medicine name: Peking University People's Hospital name: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine name: The First Affiliated Hospital of Zhengzhou University name: First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine briefSummary: The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma. conditions: Bronchial Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1508 type: ESTIMATED measure: Asthma control rate measure: Number of exacerbations measure: Asthma exacerbation severity measure: Change in severity of chronic persistent disease measure: The dose used by glucocorticoids measure: Rapid-acting beta2 agonists use drugs and doses measure: Asthma Control Test (ACT) score measure: Asthma Control Questionnaire (ACQ) measure: Asthma Quality of Life Score (AQLQ) measure: Anxiety Self-Assessment Form (SAS) measure: Depression Self-Rating Scale (SDS) measure: Pulmonary function measure: Exhaled nitric oxide (FeNO) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine city: Zhengzhou state: Henan country: China name: Hai-bin Yu, Ph.D role: CONTACT phone: +86 13526671773 email: wwz1231125@163.com lat: 34.75778 lon: 113.64861 hasResults: False
<\|newrecord\|> nctId: NCT06373679 id: Pro00125514 id: 1R01DA056445-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DA056445-01A1 briefTitle: Switch or Quit R01 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-05 date: 2024-04-18 date: 2024-04-18 name: Medical University of South Carolina class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks. conditions: Cigarette Smoking conditions: Smoking Behaviors studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 225 type: ESTIMATED name: Switching to E-Cigarette name: Switching using Medication measure: Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback measure: Greater than 50% reduction in cigarette smoking sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Univeristy of South Carolina city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 hasResults: False
<\|newrecord\|> nctId: NCT06373666 id: SPZ4-02 briefTitle: A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4). overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-18 date: 2024-04-22 name: Spatz FGIA, Inc class: OTHER briefSummary: The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Spatz4 Adjustable Balloon System measure: Successful adjustment procedure at 16 ±2 weeks in > 85% of attempts. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373653 id: SOPHMAN-0922/IV briefTitle: Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes. overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2024-06-30 date: 2024-12-30 date: 2024-04-18 date: 2024-04-18 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI). conditions: Eye Strain conditions: Eye Strain of Both Eyes studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV non-inferiority, open-label, controlled, comparative, multicenter, clinical study. primaryPurpose: TREATMENT masking: NONE maskingDescription: Open-label, count: 100 type: ESTIMATED name: Manzanilla Sophia® name: Meticel Ofteno® measure: Analog visual eyestrain test score measure: Incidence of unexpected adverse events related to the interventions measure: Incidence of conjunctival hyperemia measure: Incidence of sensation of ocular dryness. measure: Incidence of ocular irritation measure: Incidence of sensation of (sleep-crust) measure: Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373640 id: RHM NEU0458 briefTitle: Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage acronym: HAPTO overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2027-03 date: 2028-01 date: 2024-04-18 date: 2024-04-18 name: University Hospital Southampton NHS Foundation Trust class: OTHER briefSummary: The HAPTO study will recruit adult patients with aSAH due to a burst aneurysm. These patients must be scheduled to have their aneurysm treated surgically to prevent further bleeds, and need an external ventricular drain for clinical reasons (to drain fluid and relieve pressure on the brain). At the end of their surgery for their aneurysm, a further drain will be left at the site of the surgery (which is in the basal cisterns) and they will additionally have a drain sited in their lumbar spine. Vancomycin will be given through these drains. Additionally, these drains will allow the fluid in the brain to be collected to measure how haemoglobin levels and vancomycin levels differ between compartments and change over time. Patients will participate in the study over a period from recruitment at three days after aSAH to a maximum of ten days after aSAH. The data will be analysed to determine the relationship in haemoglobin concentrations between different areas of the brain and spine after aSAH, and how vancomycin distribution is related to its route of administration. conditions: Subarachnoid Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: Insertion of drains name: Vancomycin measure: CSF-haemoglobin concentration sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373627 id: 2024-A00534-43 briefTitle: Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease acronym: PEACE-HYPNO overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-05-02 date: 2025-05-03 date: 2024-04-18 date: 2024-04-18 name: Fondation Hôpital Saint-Joseph class: OTHER briefSummary: The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects. conditions: Procedural Pain conditions: Congenital Heart Disease conditions: Heart Surgery conditions: Hypnosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Hypnosis name: Conventional medications used for sedation-analgesia name: Medications used in addition to hypnosis measure: Primary Outcome : Pain evaluation by VAS self-assessment measure: Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal measure: Maximum heart rate measure: Cumulative doses of intravenous analgesics measure: Respiratory depression measure: Parental satisfaction using Visual Analogic Scale (VAS) sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373614 id: 2023/18 briefTitle: The Effect of Foot Massage and Bed Bath on Individuals With Cancer overallStatus: RECRUITING date: 2023-11-20 date: 2024-05-20 date: 2024-06-20 date: 2024-04-18 date: 2024-04-18 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer. conditions: Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: foot massage (intervention group) bed bath (intervention group) control (control group) primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 45 type: ESTIMATED name: foot massage name: bed bath measure: sleep quality measure: fatigue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences status: RECRUITING city: Istanbul state: Uskudar country: Turkey name: Ayşe Kabuk, Dr role: CONTACT phone: 05469596616 email: ayse.kabuk@beun.edu.tr name: Ayşe Kabuk, PhD role: CONTACT phone: +905469596616 email: ayseyalili@gmail.com name: Ayşe Kabuk, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06373601 id: SPAGO briefTitle: SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective acronym: SPAGO overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-02-01 date: 2027-02-01 date: 2024-04-18 date: 2024-04-18 name: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS class: OTHER briefSummary: The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) at 12 months follow-up. conditions: Coronary Artery Disease conditions: Stenosis Coronary conditions: Coronary Artery Lesion conditions: Percutaneous Coronary Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A subject is randomized at a 1:1 ratio either to drug-coated balloon (DCB) angioplasty with a sirolimus-eluting Selution balloon (n=60 subjects) or DCB angioplasty with a paclitaxel-eluting Sequent Please Neo balloon (n=60 subjects). primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: sirolimus-eluting balloon (Selution) name: paclitaxel-eluting balloon (SeQuent Please Neo) measure: In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure measure: Device success (lesion based) measure: Procedure success measure: Angiographic outcomes 1 measure: Angiographic outcomes 2 measure: Angiographic outcomes 3 measure: Angiographic outcomes 4 measure: Device oriented Composite Endpoint (DoCE/ TLF) measure: Acute/subacute/early/late vessel thrombosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373588 id: MP-37-2023-9418 briefTitle: Patient Navigator Intervention for Migrant Children With Special Healthcare Needs Experiencing Care Transitions overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-08 date: 2024-04-18 date: 2024-04-26 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER name: Canadian Institutes of Health Research (CIHR) name: Montreal Children's Hospital of the MUHC name: Unity Health Toronto name: The Hospital for Sick Children name: Women's College Hospital name: National Newcomer Navigation Network name: Centre for Refugee Children, Toronto briefSummary: The goal of this randomized controlled trial is to test if a patient navigator program improves healthcare experiences and outcomes for migrant families caring for a child or youth with special healthcare needs (i.e. chronic health condition).
The main questions are, for migrant families with a child or youth with special healthcare needs:
Does a patient navigator reduces barriers to care? Does a patient navigator improve care coordination, caregiver empowerment, caregiver stress and quality of life? What are the healthcare experiences for families with and without the patient navigator intervention?
Participants will:
* Receive the intervention, i.e., the patient navigator program, or continue with standard of care for 12 months
* Fill out questionnaires at 3 time points on barriers to care, caregiver stress, care coordination, and their child's health conditions: Patient Navigation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-centre, pragmatic, assessor-blinded, parallel randomized controlled trial with an embedded qualitative study. In the control arm, participants will receive a standard information package and care usually provided within their clinics. In the intervention arm, participants will receive support from a trained patient navigator. The patient navigator will contact participants: 1) Within 7 days of randomization; 2) At least once every 3 months up to 12 months; 3) As needed to follow-up on tasks identified in previous visits; and 4) As initiated by the participant. The navigator will tailor the topics addressed during these interactions according to the needs of the participant and compile a care plan with input from the patient, family, and clinicians. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 324 type: ESTIMATED name: Patient Navigator measure: Barriers to Care (BCQ) measure: Effective care coordination measure: Parental empowerment scale measure: Healthcare utilization measure: PROMIS - Pediatric Global Health 7 measure: Short-form survey 12 measure: Patient Health Questionnaire (PHQ-2) measure: Distress Thermometer measure: Perceived stress scale measure: Patient Satisfaction with Interpersonal Relationships with Navigators (PSN-I) sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Unity Health Toronto, Compass Clinic city: Toronto state: Ontario zip: M5B 1W8 country: Canada name: Ahrrabie Thirunavukkarasu role: CONTACT email: athirun@uwo.ca name: Shazeen Suleman, MD MPH FRCPC role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Women's College Hospital, Crossroads Clinic city: Toronto state: Ontario zip: M5S 1B2 country: Canada name: Xinyang Ye role: CONTACT email: xinyang.ye@unityhealth.to name: Meb Rashid role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: CLSC de Parc-Extension city: Montréal state: Quebec zip: H3N 1Y9 country: Canada name: Patricia LI role: CONTACT email: patricia.li@mcgill.ca name: Patricia Li role: PRINCIPAL_INVESTIGATOR name: Juan Carlos Chirgwin role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 facility: Montreal Children's Hospital city: Montréal state: Quebec zip: H4A 3J1 country: Canada name: Melissa Tachdjian role: CONTACT phone: 514-233-1873 email: melissa.tachdjian@rimuhc.ca name: Patricia Li role: CONTACT phone: 438-402-0510 email: patricia.li@mcgill.ca name: Patricia Li role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06373575 id: 2023-SR-891 briefTitle: IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure overallStatus: ENROLLING_BY_INVITATION date: 2024-05-01 date: 2025-04-30 date: 2025-06-30 date: 2024-04-18 date: 2024-04-18 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term. conditions: End-stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Lung and inferior vena cava ultrasound guidance name: Conventional protocol guidance measure: Improvement in pulmonary congestion score measure: Improvement in heart failure symptoms score measure: Total ultrafiltration volume measure: Mean ultrafiltration rate during prolonged hemodialysis measure: Fluid balance (total outflow - total inflow) measure: Lung B-line reduction measure: The change of width of inferior vena cava measure: Incidence of hypotension during prolonged hemodialysis measure: Blood pressure variability during the prolonged hemodialysis measure: In-hospital mortality measure: Length of hospital stay sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangsu Province Hospital city: Nanjing state: Jiangsu zip: 210029 country: China lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06373562 id: Wrestlers briefTitle: Effect of Hypoxic Exposure on Blood Variables in Elite Wrestlers overallStatus: COMPLETED date: 2013-12-02 date: 2013-12-18 date: 2013-12-18 date: 2024-04-18 date: 2024-04-18 name: Poznan University of Physical Education class: OTHER briefSummary: Twelve male wrestlers of the National Polish Team were observed in the study during the camp. The hypoxia group (n=6) participated in sports training and hypoxic exposure, while the control group (n=6) included wrestlers participating only in sports training. The hypoxic group lived and slept in hypoxic rooms. During the camp, all wrestlers followed the same training schedule and diet. In the blood were determined levels of creatine kinase (CK), C-reactive protein (hsCRP) concentration, nitric oxide (NO), morphology, reticulocytes, lipid profile, and ferritin. Also vascular endothelial growth factor (VEGF, VEGFR2, and VEGFR3), erythropoietin (EPO), angiopoietin (Ang 1, Ang 2), endothelial cell adhesion factor-1 (VCAM-1), Erythropoietin (EPO) and hypoxia-inducible factor 1 (HIF-1). Body weight composition was determined. conditions: Hypoxia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Wrestlers in H group were living in hypoxic rooms for 8-14h/d and between that they were participating in sports training. C group was participating in the same training protocol. primaryPurpose: DIAGNOSTIC masking: NONE count: 12 type: ACTUAL name: hypoxia measure: CK measure: hsCRP measure: HIF-1 measure: EPO measure: VEGF, VEGF 2, VEGF 3. measure: Ang 1, Ang 2 measure: VCAM-1 measure: blood count measure: lipid profile measure: ferritin sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373549 id: 2022/183-3896 briefTitle: Investigation of Myocardial Protection Efficacy of Cardioplegia Solutions Used in Open Heart Surgery overallStatus: COMPLETED date: 2022-12-08 date: 2023-07-24 date: 2023-07-24 date: 2024-04-18 date: 2024-04-18 name: Tamer cebe class: OTHER name: Istanbul University - Cerrahpasa (IUC) briefSummary: Cardioplegias are different pharmacokinetic solutions routinely used in cardiac surgery to protect the heart from ischemia and induce arrest. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are used in clinical practice. There is no clear scientific data in the literature that demonstrates the superiority of one cardioplegia over the others. The choice of the appropriate cardioplegia depends on the surgeon's clinical experience and preference. In this study preferred the blood cardioplegia and del Nido cardioplegia, which are commonly used in clinic. Both cardioplegias have different advantages that contribute to their preference in clinical practice.
Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals. The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. In addition to these different usage scenarios, the myocardial protective effects of cardioplegias on cellular redox homeostasis are also among the current research topics. Thesis project can contribute to the current literature and clinical practice on the cardioprotective advantages of cardioplegia solutions and the reasons for their preference in surgery. conditions: Cardiovascular Diseases conditions: Myocardial Reperfusion Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2 type: ACTUAL name: Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions name: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions measure: Evaluation of the myocardial protective effects of different cardioplegia solutions through oxidative stress and redox signaling molecules. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SBÜ. Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi Erişkin Kalp ve Damar Cerrahisi Kliniği city: Istanbul state: Kadıköy zip: 34668 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06373536 id: LMU-RAD-01167 briefTitle: Comparison of MRI-PDFF to TAEUS FLIP Device to Estimate Liver Fat Fraction in Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-09-01 date: 2024-04-18 date: 2024-04-18 name: Endra Lifesciences class: INDUSTRY briefSummary: Primary nonalcoholic fatty Liver disease (NAFLD) is an excess of fat in the liver (steatosis) that is not a result of excessive alcohol consumption or other secondary causes11. NAFLD is defined by the presence of hepatic fat content (steatosis) in ≥ 5% of hepatocytes and is currently the most common liver disease worldwide14 . Non-Alcoholic Fatty Liver Disease (NAFLD) is the world\'s most common liver disease and affects around 33% of the adult population.
Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease (NAFLD), is a growing clinical concern associated with the increasing prevalence of obesity, type 2 diabetes, and metabolic syndrome. NASH is characterized by the presence of hepatic steatosis, inflammation, and hepatocellular injury and is predicted to be the leading indication for liver transplantation by 20201. Patients with NASH have an increased risk of developing cirrhosis and its complications, such as ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, and liver failure. The prevalence worldwide of NAFLD in the general population is estimated at 20-35%2 . Around 2-3% of the population have NASH.
In patients with type 2 diabetes, the prevalence is even over 50% (55.5% globally, 68% in Europe). In Germany, the NAFLD prevalence was 23% in 2016 and will be around 26% in 2030. The prevalence of non-alcoholic alcoholic steatohepatitis (NASH), i.e. the progressive form of NAFLD, is estimated at 4% of the adult population in Germany and will increase to 6% by 2030. This means that NAFLD is already the most common chronic liver disease worldwide and one of the leading causes of liver-related complications (cirrhosis, decompensation, hepatocellular carcinoma, liver transplantation) and deaths. NAFLD and NASH are largely underdiagnosed worldwide. conditions: Steatosis of Liver studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED name: Thermoacoustic imaging, MRI and Ultrasound imaging measure: Thermoacoustic Fat Measurements measure: Estimate Accuracy of Thermoacoustic Fat Fraction measure: Usability Metric measure: Estimate Operator Variability sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum der Universität München Großhadern Klinik und Poliklink für Radiologie city: München zip: 81377 country: Germany name: Monika Dienst, M.Sc. role: CONTACT phone: +49 89 4400 76642 email: monika.dienst@med.uni-muenchen.de name: Dirk-Andre Clevert, Prof. Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 hasResults: False
<\|newrecord\|> nctId: NCT06373523 id: SHIELD briefTitle: MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin acronym: SHIELD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-30 date: 2025-07-30 date: 2024-04-18 date: 2024-04-18 name: Post Graduate Institute of Medical Education and Research, Chandigarh class: OTHER briefSummary: Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change. Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy.The novelty of utilizing the concept of "drug repositioning" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis/hepatic fibrosis in NAFLD patients with Primary Hypothyroidism. conditions: Hepatic Steato-Fibrosis conditions: Non-Alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible subjects will be randomly allocated to either the Dapagliflozin group or placebo group (i.e. control group) primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The placebo pills will be manufactured in identical appearance to the study drug (Dapagliflozin) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dapagliflozin 10mg Tab name: Placebo name: Levothyroxine Replacement daily measure: Change in liver fat content measure: Proportion of participants achieving 1 Stage decrease in steatosis at 6 months asassessed by Transient Elastography measure: Changes in Improvement in hepatic fibrosis measured by non invasive parameters like Fib4 score at 3 and 6 months measure: Changes in Lipid Profile at 3 and 6 months sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PGIMER city: Chandigarh state: Punjab zip: 160012 country: India name: ASHU RASTOGI, MD,DM role: CONTACT phone: 9781001046 phoneExt: 91 email: rastogi.ashu@pgi.ac.in lat: 30.73629 lon: 76.7884 hasResults: False
<\|newrecord\|> nctId: NCT06373510 id: ELCAV briefTitle: Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration of a Non-public Marketed Vaccine in the General Population, Real-life Study acronym: ELCAV overallStatus: NOT_YET_RECRUITING date: 2024-06-20 date: 2027-04-03 date: 2027-04-03 date: 2024-04-18 date: 2024-04-18 name: CerbaXpert class: OTHER briefSummary: The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population .
Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies. conditions: Vaccination Reaction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 10000 type: ESTIMATED name: Blood collection measure: Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA. sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373497 id: IIT2023-08-ATKINS-ATHERO-RT briefTitle: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-04 date: 2026-04 date: 2024-04-18 date: 2024-04-18 name: Katelyn Atkins class: OTHER briefSummary: The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:
1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) /MRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure
2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and
3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction.
Eligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT. conditions: Oligometastatic Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: 18-F-NaF Cardiac PET/MRI and name: CT Angiogram measure: Feasibility of using F-NaF PET/MRI imaging measure: To measure changes in standard uptake value (SUV) measure: To measure changes in coronary microcalcification activity (CMA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cedars Sinai Medical Center city: Los Angeles state: California zip: 90048 country: United States name: Clinical Trial Recruitment Navigator role: CONTACT phone: 310-423-2133 email: cancer.trial.info@cshs.org name: Katelyn Atkins, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Alan Kwan, MD, MS role: SUB_INVESTIGATOR name: Louise Thomson, MD role: SUB_INVESTIGATOR name: Andriana Nikolova, MD, PhD role: SUB_INVESTIGATOR name: Anja Karlstaedt, MD, Phd role: SUB_INVESTIGATOR name: Eric Vail, MD role: SUB_INVESTIGATOR name: Celeste Eno, PhD role: SUB_INVESTIGATOR name: Stephen Shiao, MD, PhD role: SUB_INVESTIGATOR name: Elizabeth McKenzie, PhD role: SUB_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06373484 id: 018-2022 briefTitle: Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents acronym: MATCH-DB overallStatus: RECRUITING date: 2022-10-01 date: 2026-09 date: 2027-09 date: 2024-04-18 date: 2024-04-18 name: Centre for Addiction and Mental Health class: OTHER briefSummary: This study will develop and test whether personalized profiles of children with Disruptive Behaviour Disorder (DBD) and their parents based on important psychological, emotional, and neuropsychological indicators predict their response to child cognitive behavioral treatment and Behavioral Parent Training. conditions: Disruptive Behavior Disorder conditions: Emotional Disorder conditions: Behavioural Disorder conditions: Attention Deficit Hyperactivity Disorder conditions: Conduct Disorder conditions: Oppositional Defiant Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Behavioral Parent Training measure: Changes in parenting skills between baseline, post-treatment, and follow-up (6 months - 1 year) measure: Changes in parenting competencies between baseline, post-treatment, and follow-up (6 months - 1 year) measure: Changes in child emotional and behavioral problems between baseline, post-treatment, and follow-up (6 months - 1 year) sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Centre for Addiction and Mental Health status: RECRUITING city: Toronto state: Ontario zip: M6J 1H4 country: Canada name: Brendan F. Andrade, PhD role: CONTACT phone: 416-535-8501 phoneExt: 33642 email: brendan.andrade@camh.ca lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06373471 id: S-20230101 briefTitle: Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment acronym: IMPROVE overallStatus: RECRUITING date: 2024-04-02 date: 2026-03-31 date: 2026-09-30 date: 2024-04-18 date: 2024-04-18 name: Odense University Hospital class: OTHER name: Velux Fonden name: Danish Cancer Research Foundation name: The Dagmar Marshall Foundation briefSummary: The Improve study is a randomized controlled trial investigating the efficacy of adding comprehensive geriatric assessment and treatment to standard of care compared with standard of care in older, frail patients with hematological cancer. The investigators aim to recruit 152 study participants who will be randomized 1:1 to intervention- or control group. Study participants in the intervention group will receive the intervention comprehensive geriatric assessment and treatment integrated in the cancer treatment. Study participants in the control group will receive cancer treatment and evaluation of comorbidity and frailty as is usual standard at Department of Hematology. Primary endpoint is elderly functional Index at 12 weeks. conditions: Hematologic Malignancy conditions: Treatment Adherence conditions: Treatment Complication conditions: Frailty conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 152 type: ESTIMATED name: Comprehensive geriatric assessment (CGA) and treatment measure: Elderly functional Index measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14). measure: Handgrip strength measure: 30-second chair stand test measure: Treatment toxicity measure: Adherence to hematological cancer treatment measure: Polypharmacy yes/no measure: Unplanned hospital admissions measure: Overall and cancer specific survival sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Odense University Hospital status: RECRUITING city: Odense C zip: 5000 country: Denmark name: Nina Andersen, M.D. role: CONTACT phone: +4540437488 email: nina.andersen@rsyd.dk lat: 55.39594 lon: 10.38831 hasResults: False
<\|newrecord\|> nctId: NCT06373458 id: STUDY-23-01508 briefTitle: Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy overallStatus: RECRUITING date: 2024-04-15 date: 2026-03 date: 2026-05 date: 2024-04-18 date: 2024-04-18 name: Icahn School of Medicine at Mount Sinai class: OTHER name: Pfizer briefSummary: Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli. Although keloids are a common disease, it's exact incidence and prevalence is not known. Despite the debilitating nature of keloids, current treatment modalities are limited in efficacy; there is no universally effective therapy available to patients. The research team hypothesize that ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis. conditions: Keloid studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ritlecitinib measure: Recurrence Rate measure: Change in Detroid Keloid Scale Score measure: Change in Peak keloid tension measure: Change in Detroid Keloid Scale Score (DKS) measure: Change in Pain Numerical Rating Scale (Pain-NRS) measure: Change in Itch-NRS measure: Change in PGIC (Patient Global Impression of Change) measure: Change in DLQI (Dermatology Life Quality Index) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Icahn School of Medicine at Mount Sinai status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Giselle Singer role: CONTACT phone: 212-241-3288 email: giselle.singer@mssm.edu name: Sharlene Martin role: CONTACT phone: 212-241-3288 name: Emma Guttman role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06373445 id: 36264PR596 briefTitle: Interventional Neuromodulation in Fibromyalgia overallStatus: RECRUITING date: 2022-11-01 date: 2023-09-01 date: 2024-04-15 date: 2024-04-18 date: 2024-04-18 name: Tanta University class: OTHER briefSummary: This study was conducted on 40 eligible fibromyalgia patients with sleep disorders. They were randomized to have 20 sessions of active or sham rTMS (1 Hz, 120% of resting motor threshold with total 1200 pules /session) over the right dorsolateral prefrontal area (DLPFC) for 5 sessions/week for 4 weeks. All participants were subjected to baseline evaluation with Fibromyalgia Impact Questionnaire, polysomnography, sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index and The Medical Outcomes Study Sleep Scale respectively.FM patients were reevaluated at 1, 3 months after the end of rTMS sessions. conditions: Neuromodulation and Sleep Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: participants randomly allocated to either no, one, some or all interventions simultaneously primaryPurpose: TREATMENT masking: SINGLE whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: repetitive transcranial magnetic stimulation active stimulation name: repetitive transcranial magnetic stimulation sham stimulation measure: Pittsburgh Sleep Quality Index (PSQI) measure: The Medical Outcomes Study Sleep Scale (MOS ) measure: polysomnography measure: Pittsburgh Sleep Quality Index (PSQI) measure: The Medical Outcomes Study Sleep Scale (MOS) measure: polysomnography sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of medicine status: RECRUITING city: Tanta state: ElGharbia zip: 6620010 country: Egypt name: Marwa Y Badr role: CONTACT phone: 01003639125 phoneExt: Tanta email: drmoroneuro@yahoo.com lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06373432 id: STUDY-22-01607 briefTitle: Frequency of Glucose Monitoring in Labor overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11-26 date: 2024-11-26 date: 2024-04-18 date: 2024-04-18 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth. conditions: Neonatal Hypoglycemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: Fingerstick measure: Neonatal Hypoglycemia sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai West Hospital city: New York state: New York zip: 10019 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06373419 id: RP-1007 briefTitle: TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors overallStatus: RECRUITING date: 2023-10-16 date: 2025-10 date: 2026-10 date: 2024-04-18 date: 2024-04-18 name: Thunder Bay Regional Health Research Institute class: OTHER briefSummary: The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors.
The main question it aims to answer is:
Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors?
Participants will randomized to either TFL of MOSES arm for their bladder resection procedure. conditions: Urolithiasis of Bladder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: TFL name: MOSES holmium laser measure: Presence of muscularis propria measure: Incidence of inconclusive pathology measure: Tumor-free rate (TFR) measure: Total operative time measure: Total procedural time measure: Number of recurrences measure: Total blood loss measure: Rate of complications measure: Number of inconclusive pathology measure: Lasing time measure: Total energy used measure: Frequency and severity of peri-operative complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thunder Bay Regional Health Sciences Centre status: RECRUITING city: Thunder Bay state: Ontario zip: P7B 6V4 country: Canada name: Rabail Siddiqui role: CONTACT phone: (807) 684-6000 email: rabail.siddiqui@tbh.net name: Hazem Elmansy role: SUB_INVESTIGATOR lat: 48.38202 lon: -89.25018 hasResults: False
<\|newrecord\|> nctId: NCT06373406 id: MHB036C-CP001CN briefTitle: A Study of MHB036C for Advanced Solid Tumor overallStatus: RECRUITING date: 2023-05-18 date: 2024-08 date: 2024-12 date: 2024-04-18 date: 2024-04-22 name: Minghui Pharmaceutical (Hangzhou) Ltd class: INDUSTRY briefSummary: Phase I/II, dose escalation and dose expansion study to evaluate the efficacy and safety of MHB036C in advanced malignant tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: MHB036C measure: Incidence of participants with adverse events (AE) measure: Number of participants with dose-limiting toxicity (DLT) measure: Maximum Plasma Concentration (Cmax) measure: The area under the plasma concentration-time curve (AUC) measure: To detectable anti-drug antibodies with treated subjects measure: Objective response rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai zip: 200030 country: China name: Shun Lu, MD role: CONTACT phone: 13601813062 email: shun_lu@hotmail.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06373393 id: 1 briefTitle: SPIRIT: Study of the Patency of Spinal aRteries After the STABILISE Technique acronym: SPIRIT overallStatus: ENROLLING_BY_INVITATION date: 2024-04-16 date: 2024-07-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-22 name: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA class: OTHER name: Cardiovascular Center of the University of Lisbon name: Unidade Local de Saúde Santa Maria briefSummary: The aim of the study is to evaluate the impact of the stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair (STABILISE) technique in the patency of intercostal and lumbar arteries detectable on computed tomography angiography (CTA) in patients with type B aortic dissection and its correlation with the occurrence of spinal cord ischaemia (SCI).
Primary end-point: patency of the intercostal and lumbar arteries on follow-up CTA.
Secondary end-point: spinal cord ischaemia conditions: Aortic Dissection conditions: Spinal Cord Ischemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: STABILISE measure: number of patent intercostal and lumbar arteries measure: number of patients with spinal cord ischemia sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unidade Local de Saúde Santa Maria city: Lisbon zip: 1500 country: Portugal lat: 38.71667 lon: -9.13333 hasResults: False
<\|newrecord\|> nctId: NCT06373380 id: 23-293 briefTitle: A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) overallStatus: RECRUITING date: 2024-04-15 date: 2027-04 date: 2027-04 date: 2024-04-18 date: 2024-04-18 name: Memorial Sloan Kettering Cancer Center class: OTHER name: Hookipa Biotech GmbH name: Naveris briefSummary: The researchers are doing this study to find out if HB-202/HB-201 is an effective treatment for people with HPV 16-positive head and neck squamous cell cancer (HPV 16+ HNSCC) who have received standard treatment for their disease but then tested positive for HPV 16-related tumor DNA in the blood through a test called NavDx. Participants will have no evidence of cancer on imaging scans (radiographically) or by medical examination (clinically). Past studies have shown that a positive NavDx test strongly suggests the possible presence of microscopic cancer, though we do not know if testing positive will definitely lead to the cancer coming back (recurrence). The NavDx blood test has not been approved by the FDA and is considered investigational. conditions: HPV16+ Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a randomized multi-centered, double-blind, placebo-controlled trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The study will be conducted using a double-blind design. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 51 type: ESTIMATED name: HB-200 name: Placebo measure: Disease free survival (DFS) measure: Number of participants with adverse events (type, frequency, severity). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All Protocol Activites) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.70038 lon: -73.59291 hasResults: False
<\|newrecord\|> nctId: NCT06373367 id: 461-24 briefTitle: Preeclampsia Educational Program Study (PrEPS) acronym: PrEPS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2024-11-01 date: 2024-04-18 date: 2024-04-18 name: MemorialCare Health System class: OTHER briefSummary: Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions. conditions: Preeclampsia conditions: Preeclampsia Severe conditions: Preeclampsia Mild conditions: Preeclampsia Postpartum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 36 type: ESTIMATED name: Illustration based application name: Text based application measure: Preeclampsia knowledge score - short measure: Preeclampsia knowledge score - long measure: GAD-7 score measure: 72 hour BP check measure: Postpartum visit measure: Daily BP recordings measure: Accessed material measure: Unplanned readmission sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373354 id: 2023-0924 id: NCI-2024-03341 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2025-12-31 date: 2027-12-31 date: 2024-04-18 date: 2024-04-18 name: M.D. Anderson Cancer Center class: OTHER name: Siemens Medical Solutions briefSummary: To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT. conditions: Architectural Distortions conditions: Breast Tomosynthesis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Digital Breast Tomosynthesis (DBT) measure: Safety and adverse events (AEs) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Tanya Moseley, MD role: CONTACT phone: 713-792-5755 email: tstephens@mdanderson.org name: Tanya Moseley, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06373341 id: NL85317.099.23 briefTitle: Hand and Arm Rehabilitation Using VR acronym: HANDQUEST overallStatus: RECRUITING date: 2024-01-15 date: 2026-01 date: 2027-01 date: 2024-04-18 date: 2024-04-18 name: Medical Centre Leeuwarden class: OTHER briefSummary: Patients admitted to the ICU due to critical illness often experience physical, mental, cognitive, or social issues. Research indicates that inadequate physical recovery is associated with lower handgrip strength, and hand function in ICU patients is lower compared to healthy individuals. To address this, a Virtual Reality (VR) exergame was developed to aid rehabilitation. This study aims to investigate the effect of a 4-week VR-exergame intervention on handgrip strength, hand and arm functionality, balance, mobility, and support needs in ICU patients staying for 48 hours or longer. It is a multicenter mixed-methods randomized controlled trial involving adult ICU patients. The intervention involves a 4-week VR-exergame program. Main study parameters include handgrip strength, hand and arm functionality, range of motion, balance, mobility, and support needs. The burden and risks associated with participation are minimal, as VR-based exercises are deemed safe and voluntary. Overall, the study aims to assess the effect of incorporating VR-based rehabilitation into standard care for ICU patients. conditions: Post-Intensive Care Syndrome conditions: ICU Acquired Weakness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 108 type: ESTIMATED name: VR training for arm and hand rehabilitation measure: Handgrip strength measure: Handgrip strength measure: Arm and hand functionality measure: Arm and hand functionality measure: Arm and hand range of motion measure: Balance and mobility measure: Support need and experience with VR training sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dept of intensive care, Medical Centre Leeuwarden status: RECRUITING city: Leeuwarden state: Friesland zip: 8901 BR country: Netherlands name: Lise Beumeler, PhD role: CONTACT phone: (058) 286 6738 email: lise.beumeler@mcl.nl name: Lise Beumeler, PhD role: PRINCIPAL_INVESTIGATOR name: Carina Bethlehem, MD role: PRINCIPAL_INVESTIGATOR lat: 53.20139 lon: 5.80859 hasResults: False
<\|newrecord\|> nctId: NCT06373328 id: STUDY00006081 briefTitle: Post Pandemic Pneumococcal Carriage Among Children and Adults overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-09 date: 2026-03 date: 2024-04-18 date: 2024-04-18 name: University of Central Florida class: OTHER name: Merck Sharp & Dohme Corporation briefSummary: The PI propose to conduct a genomic epidemiology study of pneumococcal carriage among children and adults in a large metropolitan city. These data will allow PI to assess the post-pandemic population structure, investigate the phylogenetic relationship between isolates from children and adults, and compare pneumococcal populations across diverse geographic areas. conditions: Pneumococcal Carriage studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 900 type: ESTIMATED measure: Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR. measure: Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries. measure: Putative transmission networks between children and adult populations from online questionnaires. sex: ALL minimumAge: 7 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373315 id: 2023/11-18 briefTitle: The Effect of Smartphone and Hand Anthropometry on Pain and Upper Extremity Functions overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-06-30 date: 2025-05-02 date: 2024-04-18 date: 2024-04-18 name: Nigde Omer Halisdemir University class: OTHER briefSummary: Mobile phones have different uses in different disciplines, and this encourages long-term use. For optimum comfort use, it is important to ensure users' awareness when purchasing mobile phones that match their hand sizes. The number of studies in the literature on this subject is limited. In this context, the aim of our study is to investigate the relationship between smartphone and hand anthropometry measurements and upper extremity pain and functions. conditions: Upper Extremity Problem conditions: Smartphone Addiction studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED measure: Hand anthropometric measurements: Hand length measure: Hand anthropometric measurements: Palm length measure: Hand anthropometric measurements: Width of the hand (Metacarpal) measure: Hand anthropometric measurements: Maximum hand spread measurement measure: Gross grip strength measurement measure: Pinch grip strength measure: Measurement of phone dimensions measure: Upper extremity functional status assessment measure: Pain assessment measure: Smartphone addiction sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nigde Omer Halisdemir University, Bor Faculty of Health Sciences city: Niğde state: Nigde zip: 51700 country: Turkey name: Feyza Altindal Karabulut, Assoc. Prof. role: CONTACT phone: +905056263833 email: fztfyz@gmail.com lat: 37.96583 lon: 34.67935 hasResults: False
<\|newrecord\|> nctId: NCT06373302 id: IRAS 323948 briefTitle: Peripheral Arterial Disease Biomarkers acronym: PADBIRD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Norfolk and Norwich University Hospitals NHS Foundation Trust class: OTHER briefSummary: The study aims to determine how expression levels of biomarkers for peripheral arterial disease change over time in response to exercise therapy, surgical or endovascular intervention, and whether they can be used to predict disease progression. conditions: Peripheral Arterial Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 100 type: ESTIMATED measure: Correlation between PAD biomarker levels and walking distance. measure: Change in PAD biomarker levels following exercise therapy. measure: Change in PAD biomarker levels following endovascular intervention measure: To determine whether biomarker levels normalise with improved walking distance. measure: To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention. measure: Levels of biomarkers and (Major Adverse Cardiovascular Events). sex: ALL minimumAge: 50 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373289 id: 000539476 id: 1K23HD113837-01A1 type: OTHER domain: NICHD (pending) briefTitle: Target Oxygen Ranges in Infants With Pulmonary Hypertension acronym: TORPH overallStatus: NOT_YET_RECRUITING date: 2025-07-01 date: 2029-07-01 date: 2030-07-01 date: 2024-04-18 date: 2024-04-18 name: University of Alabama at Birmingham class: OTHER briefSummary: Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease. conditions: Bronchopulmonary Dysplasia conditions: Pulmonary Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Single center, randomized cross-over pilot study with a 1:1 parallel allocation of infants to SpO2 targets of 92-95% (control) and 95-98% (intervention) using a stratified permuted block design. Following 2 weeks of exposure A, infants will cross over to exposure B for 2 weeks with a 1-week washout period. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The PI will perform bedside echocardiography precluding masking to group allocation. All echocardiograms will be further reviewed by a cardiologist masked to group allocation with additional cardiologist review in instances of disagreement. Inter-rater reliability testing will also be performed. whoMasked: OUTCOMES_ASSESSOR count: 39 type: ESTIMATED name: higher oxygen saturation target using Nellcor pulse oximetry sensors name: lower oxygen saturation target using Nellcor pulse oximetry sensors measure: Intermittent hypoxemia event duration measure: Echocardiographic shunting measure: Echocardiographic interventricular septal flattening measure: Echocardiographic tricuspid regurgitation measure: Intermittent hypoxemia frequency measure: Cumulative hypoxemia measure: Brain natriuretic peptide sex: ALL minimumAge: 2 Months maximumAge: 5 Months stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06373276 id: 1511 briefTitle: The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category overallStatus: RECRUITING date: 2024-01-15 date: 2024-04 date: 2024-05 date: 2024-04-18 date: 2024-04-18 name: Dilshaad Basrai Vad class: OTHER briefSummary: The primary goal of this dissertation study is to determine if a home-based multiplanar balance training program with electronic assistance, will be effective in reducing one's fall risk category.
Hypothesis: After 12 weeks, there will be a statistically significant decrease in the fall risk category for individuals in a home-based multiplanar balance training and educational program with electronic assistance as compared to no change in the fall risk category for individuals in an educational control group with electronic assistance Hypothesis: To determine if an individual's fear of falling is lower following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in fear of falling following an educational control group with electronic assistance post-intervention.
Hypothesis: An individual's quality of life will improve following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in the quality of life following an educational control group with electronic assistance post-intervention.
Hypothesis: Adherence and feasibility will be greater with a home-based multiplanar balance training program, with electronic assistance as compared to a control group with electronic assistance.
Hypothesis: There will be a statistically significant inverse relationship between an individual's fear of falling and their fall risk category. conditions: Fall Risk studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants in the multiplanar balance training home-based exercise and educational group (group A) will have a video, as well as written instructions, of the intervention and dosage, along with the five educational brochures loaded on their phone via the SAFE beta app. In the SAFE beta app, the participants will be prompted daily to click on the beta app to watch the demonstration of the interventional exercise. They are then prompted to begin their daily prescriptive intervention, which is a 7-day-a-week program for 12 weeks. Participants can view a video of the exercise intervention in real-time in order to "mirror" the exercises as they are completing the exercises. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The primary investigator, who delivers the treatment, is blinded to to the performance outcome measures. whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: multiplanar balance training exercise with education name: education only measure: Timed up and Go Test measured in Seconds measure: 3 stage balance test measured in seconds measure: 30-second chair stand measured in repeitions sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Metro PT status: RECRUITING city: New York state: New York zip: 10021 country: United States name: dilshaad vad, DPT role: CONTACT phone: 917-478-2444 email: dilshaad.vad@gmail.com name: Lior Cohen, DPT role: CONTACT phone: 9175549511 lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06373263 id: 2024-4165 briefTitle: Evaluating Tools to Communicate Scleroderma Research Results to Patients acronym: SPIN-KT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-06 date: 2024-06 date: 2024-04-18 date: 2024-04-18 name: Lady Davis Institute class: OTHER briefSummary: Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients. The investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort, to identify the most effective methods for communicating study results with patients.
The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. Participants will be randomly assigned to receive the dissemination tool or comparator. Study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. Our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs. conditions: Scleroderma conditions: Systemic Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: OTHER masking: NONE count: 488 type: ESTIMATED name: Plain-language summary name: Dissemination Tool (Infographic) measure: Completeness measure: Understandability measure: Ease of use measure: Please to have received results measure: Intention to participate in future studies measure: Open-ended items sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373250 id: sdilek7 briefTitle: Maternal Consequences of Membrane Stripping overallStatus: RECRUITING date: 2024-04-11 date: 2024-10-11 date: 2024-11-11 date: 2024-04-18 date: 2024-04-18 name: Kocaeli University class: OTHER briefSummary: This study aims to investigate the maternal effects of membrane stripping during vaginal birth. This study was designed as an experimental case-control study. The sample size in the study was determined by Njoku et al in 2023 to assess the effectiveness of membrane stripping applied to participants who had vaginal birth in reducing the incidence of prolonged pregnancy. Calculated based on the study conducted by. The sample size of the study was calculated using G\Power 3.1.9.2, and the mean and standard deviation of the Bishop score in the relevant article were used to calculate the effect size. Using the mean and standard deviation of the relevant article, the blended effect size was calculated as 0.596. The minimum number of individuals that should be included in the sample of this research was calculated using G\Power 3.1.9.2, effect size: 0.596, α= 0.05, power: 0.95 (stripping = 70, control = 70) and at least in each group in the sample size. The sample size was set at 70 participants. The research data will be collected by the researcher using the Informed Volunteer Consent Form, Participant Information Form, Bishop Scoring, Visual Analogue Scale, and Birth Satisfaction Scale Short Form, which were created by the researcher within the framework of the literature on the subject. conditions: Maternal Care for Other Abnormalities of Cervix studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: Membrane stripping group name: Control group measure: Visual analogue scale evaluation of vaginal examination pain measure: Visual analogue scale evaluation of vaginal examination pain measure: Evaluation of the cervix with Bishop score measure: Evaluation of the amount of bleeding measure: Birth Satisfaction Scale Short Form sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Kocaeli University status: RECRUITING city: Kocaeli zip: 41380 country: Turkey name: Burcu Ozturk, M.Sc. role: CONTACT email: 1burcuozturk@gmail.com lat: 39.62497 lon: 27.51145 hasResults: False
<\|newrecord\|> nctId: NCT06373237 id: INC-IG-2024-001 briefTitle: Outcome of Embryos Transferred After Initial Chaotic Results on PGT-A overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-26 date: 2024-05 date: 2026-05 date: 2024-04-18 date: 2024-04-18 name: Inception Fertility, LLC class: INDUSTRY name: Igenomix briefSummary: This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed. conditions: Infertility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED measure: Frequency of embryo re-biopsy measure: Re-biopsy results measure: Embryo disposition measure: Embryo transfer outcome measure: Pregnancy outcome sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Inception Fertility LLC city: Houston state: Texas zip: 77081 country: United States lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06373224 id: 23-037 briefTitle: Cold Saline Irrigation Before Endobronchial Biopsy overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-02 date: 2025-02-02 date: 2024-04-18 date: 2024-04-22 name: TriHealth Inc. class: OTHER briefSummary: Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies. conditions: Lung Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Flush measure: Incidence of unreadable biopsy slides sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bethesda North Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States name: Rachel Baker, PhD, RN role: CONTACT phone: 513-569-6191 email: Rachel_Baker2@trihealth.com lat: 39.12713 lon: -84.51435 hasResults: False
<\|newrecord\|> nctId: NCT06373211 id: APHP230701 id: 2023-506942-22-01 type: OTHER domain: CTIS briefTitle: Early Immunotherapy With Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients With Anti-Hu-associated Paraneoplastic Sensory Neuronopathy acronym: NESPA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-06 date: 2024-04-18 date: 2024-04-18 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer. Despite their autoimmune origin, they have historically shown little response to immunotherapy. The reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. The protocol focuses on patients with anti-Hu antibody sensory neuronopathy. This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin (IVIG) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. The percentage of patients with clinical improvement will be evaluated (ONLS) at 3 months. The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months. conditions: Paraneoplastic Sensory Neuronopathy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Immunoglobulins IV (CLAYRIG) name: Cyclophosphamide IV name: Methylprednisolone IV measure: Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 months measure: Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 and 6 months measure: Percentage of patients with improvement in the ataxic component on the Score of Ataxia scale at 3 and 6 months measure: Percentage of patients with improvement in neuropathic pain on the Numeric Rating Scale (NRS) at 3 and 6 months measure: Percentage of patients with functional improvement on the modified Rankin Score (mRS) at 3 and 6 months measure: Percentage of patients with functional improvement on the Barthel Index (BI) at 3 and 6 months measure: Percentage of patients alive and without tumor progression at 6 months measure: Tolerance to treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Pitié-Salpêtrière city: Paris zip: 75013 country: France name: Dimitri Psimaras, MD role: CONTACT email: dimitri.psimaras@aphp.fr name: Alice LEPRINCE-LAURENGE, MD role: CONTACT email: alice.laurenge@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06373198 id: 0040/2023-versión 1.0 briefTitle: Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-01 date: 2025-01-15 date: 2024-04-18 date: 2024-04-18 name: Hospital El Cruce class: OTHER name: Gilead Sciences briefSummary: Hepatitis C virus (HCV) is a leading cause of morbidity and mortality worldwide. This infection continues to represent a major global public health concern. This is why the introduction of potent antivirals for the treatment of HCV has been one of the major breakthroughs of the current medical era.
From a public health perspective, HCV prevalence will be eliminated if the available treatment also targets those most likely to transmit the virus. Despite this scientific advance, a systematic review from the U.S. described that of the 43% of patients aware of their HCV diagnosis, only 16% started treatment. Clearly, the long-known barriers to accessing this treatment must be broken down in order to administer these effective antivirals. The World Health Organization (WHO) has set the ambitious goal of eliminating viral hepatitis as a public health threat by 2030. This goal is really difficult to achieve, especially in low and middle-income countries. Particularly in Argentina, there is a need to improve diagnosis, access to care, and treatment of viral hepatitis. The prospect of viral hepatitis elimination in our country is daunting due to the complexity of the health system and the cost of implementing different strategies. The most pragmatic approach would be to break down national elimination targets into smaller targets for individual populations, for which treatment and prevention interventions can be delivered more quickly and efficiently. This concept is known as micro-elimination. Focusing on micro-elimination of viral hepatitis means working to achieve the WHO target in specific subpopulations. Subpopulations known to have a higher prevalence of HCV infection include prisoners, people who inject drugs, and patients requiring hemodialysis, among others.
Currently, patient unawareness of HCV infection represents one of the major barriers to treatment. In many cases, the diagnosis of HCV was established many years ago and patients do not seek treatment probably because they do not recognize the urgency of treating this asymptomatic infection. It is our goal, then, to identify the group of individuals who have been diagnosed with HCV infection but are not currently undergoing regular visits with health care professionals. This strategy is now called re-linking to the medical care of patients with chronic HCV. conditions: Hepatitis C Chronic conditions: Hepatitis C studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: standard of care measure: rate of relinked HCV patients measure: proportion of relinked patients who received antiviral treatment measure: Evaluation and characteristics of the treatment established sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06373185 id: 2023/21 briefTitle: Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children acronym: SESPB overallStatus: RECRUITING date: 2024-04-22 date: 2024-05 date: 2024-06 date: 2024-04-18 date: 2024-04-23 name: Giresun University class: OTHER briefSummary: The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases. conditions: Urogenital Diseases conditions: Nerve Block conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled double blind study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Randomisation using a closed envelope method based on computer-generated random numbers was to assign patients to two equal groups. Group 1 received midline US-guided sacral erector spinae plane block and Group 2 received caudal block. The experienced anesthetist who opened the envelope performed the block according to the group code and patients were followed postoperatively by an anesthetist blinded to which block was performed. Patients were also blinded as to which block was performed. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Ultrasound-guided sacral erector spinae plane block name: Ultrasound-guided caudal block measure: Face, Leg, Activity, Cry, Consolability (FLACC) score measure: Analgesic requirement measure: Satisfaction of the patient's parents measure: Satisfaction of the surgeons sex: ALL minimumAge: 1 Year maximumAge: 7 Years stdAges: CHILD facility: Giresun Research and Training Hospital status: RECRUITING city: Gi̇resun state: Central zip: 28100 country: Turkey name: Bilge Olgun Keleş role: CONTACT phone: 05317338805 email: bilge.olgun@hotmail.com name: Dilek Yeniay role: CONTACT phone: 05375521553 email: dilekyeniay@hotmail.com lat: 40.91698 lon: 38.38741 hasResults: False
<\|newrecord\|> nctId: NCT06373172 id: 202005-HR-003 briefTitle: Enhancing Clinical Reasoning Competency acronym: Reasoning overallStatus: COMPLETED date: 2020-05-01 date: 2020-06-01 date: 2023-03-01 date: 2024-04-18 date: 2024-04-18 name: Tongmyong University class: OTHER briefSummary: Enhancing Clinical Reasoning Competency for Undergraduate Nursing Students Using Virtual Simulation-based Education based on the Rasch model
Aims: Clinical reasoning is a core nursing competency that involves analyzing patient-related data and providing appropriate nursing practices. Simulation-based education is effective in improving the clinical reasoning competencies and communication skills of nursing students. This study aimed to verify the effectiveness of virtual simulation-based education. conditions: Clinical Reasoning conditions: Communication conditions: Development, Human studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This quasi-experimental study used a single-group pretest-posttest design to verify the effectiveness of virtual simulation-based education for undergraduate nursing students. primaryPurpose: OTHER masking: NONE count: 37 type: ACTUAL name: virtual simulation-based education program measure: Nurses Clinical Reasoning Scale measure: Communication Skills Scale sex: ALL minimumAge: 20 Years maximumAge: 28 Years stdAges: ADULT facility: Tongmyong Unoversity city: Busan zip: 48520 country: Korea, Republic of lat: 35.10278 lon: 129.04028 hasResults: False
<\|newrecord\|> nctId: NCT06373159 id: 22643 briefTitle: An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-10 date: 2024-09-30 date: 2024-09-30 date: 2024-04-18 date: 2024-04-18 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied.
In observational studies, only observations are made without participants receiving any advice or changes to their healthcare.
DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC.
To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting.

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