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<|newrecord|> nctId: NCT06377033 id: 10877980 briefTitle: Using the EHR to Advance Genomic Medicine Across a Diverse Health System overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2027-06-30 date: 2024-04-22 date: 2024-04-22 name: University of Pennsylvania class: OTHER briefSummary: Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place. |
Innovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and/or patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management. conditions: Genetic Predisposition conditions: Paraganglioma conditions: Pheochromocytoma conditions: ALS conditions: Parkinson Disease conditions: Polyneuropathies conditions: Frontotemporal Dementia conditions: Alzheimer Disease conditions: Cardiomyopathy Non-ischemic conditions: Thoracic Aortic Aneurysm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1000 type: ESTIMATED name: Behavioral nudge measure: Rate of Genetic Testing measure: Rate of Genetic Test Orders/Referrals measure: Rate of Patient Engagement measure: Rate of Pathogenic variants and VUS measure: Rate of Clinician actions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377020 id: 23-2490 briefTitle: Prevention and Choice for Type 2 acronym: PACT2 overallStatus: RECRUITING date: 2024-04-10 date: 2024-10-23 date: 2024-10-30 date: 2024-04-22 date: 2024-04-22 name: University of Colorado, Denver class: OTHER name: American Diabetes Association name: High Plains Research Network briefSummary: People living with prediabetes are advised to lose weight to prevent development of type 2 diabetes by participating in intensive lifestyle interventions (ILI's), such as PreventT2. The PreventT2 program focuses on a low-calorie diet for weight loss. However, many people find it difficult to stick to a low-calorie diet over the long-term. The identification of novel, effective and individualized dietary strategies to produce long-term weight loss is critically important in diabetes prevention. An ILI based on PreventT2 which considers individual preferences, allowing participants to choose among a variety of diets, may result in greater adherence to the diet than a standard PreventT2 intervention. ILIs also need to be available to individuals in a wide range of communities, including Americans living in rural communities, who experience higher rates of obesity and chronic disease, yet have less access to medical care, including programs for diabetes prevention. The investigators plan to develop and carry out a 16-week pilot and feasibility study of a group-based ILI program based on PreventT2 plus choice of dietary strategy (Prevention and Choice for Type2 , PACT2) delivered via videoconference to adults with prediabetes living in rural communities. Successful completion of this project will result in the refinement of an ILI that incorporates personal preferences and is tailored to individuals at high risk for type 2 diabetes living in rural areas where access to such interventions is limited. conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single group pilot and feasibility study primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: PACT2 measure: Body weight measure: Blood pressure measure: Physical activity measure: Energy intake measure: HbA1c measure: 24 hr glucose levels measure: Dietary adherence sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Anschutz Medical Campus status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Elizabeth Thomas, MD role: CONTACT phone: 303-808-2622 email: [email protected] lat: 39.72943 lon: -104.83192 hasResults: False |
<|newrecord|> nctId: NCT06377007 id: WU66290 id: WU66290 type: OTHER_GRANT domain: Walailak individual grant briefTitle: Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION) acronym: ORION overallStatus: RECRUITING date: 2024-01-01 date: 2025-07-30 date: 2025-12-30 date: 2024-04-22 date: 2024-04-26 name: Walailak University class: OTHER briefSummary: Cataract surgery represents a common surgical intervention, encompassing the extraction of the opaque natural crystalline lens, followed by the substitution with an artificial intraocular lens (IOL). To ascertain an IOL possessing optimal power, antecedent to the surgery, preoperative evaluations are conducted through the utilization of a biometric devices. Diverse categories of these instruments are accessible, each harnessing distinct optical methodologies or mathematical algorithms to ascertain the most fitting IOL power. The principal objective of this study was to evaluate the ocular biometry and the predictive precision outcome of a biometer that uses standard keratometry to the prediction accuracy of another biometer that uses Total Keratometry. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 142 type: ESTIMATED name: IOLMaster 700 (Carl Zeiss Meditec AG) name: Argos (Alcon Laboratories, Inc.) measure: Mean absolute prediction error measure: Proportion of eyes with an absolute prediction error equal to or less than 0.25 sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walailak University status: RECRUITING city: Nakhon Si Thammarat zip: 80160 country: Thailand name: Jakkrit.ju Juhong, MD. role: CONTACT phone: 0816773406 email: [email protected] lat: 8.43333 lon: 99.96667 hasResults: False |
<|newrecord|> nctId: NCT06376994 id: IRB00407311 id: 1U24HL169566-01 type: NIH link: https://reporter.nih.gov/quickSearch/1U24HL169566-01 briefTitle: Multi-Center Clean Air Randomized Controlled Trial in COPD acronym: Clean Air overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-09 date: 2028-09 date: 2024-04-22 date: 2024-04-22 name: JHSPH Center for Clinical Trials class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use. conditions: Chronic Obstructive Pulmonary Disease (COPD) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 770 type: ESTIMATED name: Air cleaner name: Sham air cleaner measure: St. George's Respiratory Questionnaire (SGRQ) sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins city: Baltimore state: Maryland zip: 21224 country: United States name: Wendy Lorizio role: CONTACT phone: 410-510-2449 email: [email protected] name: Maggie Maly role: CONTACT phone: 410-550-9527 email: [email protected] lat: 39.29038 lon: -76.61219 hasResults: False |
<|newrecord|> nctId: NCT06376981 id: CHD23_0025 briefTitle: Hyaluronic Acid in Shoulder Tendinopathy acronym: ACCTE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-08 date: 2026-11 date: 2024-04-22 date: 2024-04-22 name: Centre Hospitalier Departemental Vendee class: OTHER briefSummary: Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months. conditions: Shoulder Tendinitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Hyaluronic acid injection name: Corticosteroid injection name: Placebo injection measure: Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHD Vendée city: La Roche-sur-Yon country: France name: Céline COZIC, Dr role: PRINCIPAL_INVESTIGATOR lat: 46.66667 lon: -1.43333 facility: CHU Nantes city: Nantes country: France name: Christelle DARRIEUTORT-LAFFITE, Dr role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 hasResults: False |
<|newrecord|> nctId: NCT06376968 id: BA-G-H-1604 briefTitle: Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis overallStatus: RECRUITING date: 2024-04-22 date: 2025-07 date: 2025-08 date: 2024-04-22 date: 2024-04-29 name: B.Braun Avitum AG class: INDUSTRY briefSummary: The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is: |
• Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires. |
A crossover design is used to compare treatments with or without the BioLogic Fusion function activated. conditions: Renal Dialysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: BioLogic Fusion measure: Post-dialysis body weight sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione status: RECRUITING city: Bologna state: Emilia Romagna zip: 40138 country: Italy name: Annalisa Zucchelli, Prof. role: CONTACT name: Annalisa Zucchelli, Prof. role: PRINCIPAL_INVESTIGATOR lat: 44.49381 lon: 11.33875 hasResults: False |
<|newrecord|> nctId: NCT06376955 id: IRB00014233-1 briefTitle: High Intensity Interval Versus Focused Ultrasound on Insulin Resistance in Diabetics With Abdominal Obesity acronym: diabetic overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2024-08-30 date: 2024-08-30 date: 2024-04-22 date: 2024-04-22 name: Badr University class: OTHER briefSummary: Obesity and diabetes share a common insulin resistance pathway and contribute to chronic hyperglycemia. Both high-intensity interval exercise (HIIE) and focused ultrasound (FUS) have been explored in the context of managing insulin resistance in diabetic individuals with abdominal obesity, though they operate through different mechanisms and have different implications. conditions: Insulin Resistance conditions: Abdominal Obesity conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: High intensity interval exercise name: Focused ultrasound measure: Body mass index measure: Waist circumference measure: Skin fold measure: Value of HbA1c and HOMA-IR hormone sex: FEMALE minimumAge: 25 Years maximumAge: 35 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06376942 id: Int/IEC/2024/SPL-5 briefTitle: A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy acronym: NAFCOF overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2025-04-25 date: 2025-06-15 date: 2024-04-22 date: 2024-04-22 name: Post Graduate Institute of Medical Education and Research, Chandigarh class: OTHER briefSummary: No study has examined the role of inhaled glycopyrrolate on mucus secretion. We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion, thereby decreasing cough, and thus improving patient comfort during bronchoscopy. In this study, we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy. conditions: Subjects Undergoing Flexible Bronchoscopy studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1050 type: ESTIMATED name: Glycopyrronium name: Ipratropium name: Saline measure: Cough count measure: Operator-estimated airway secretion measure: Operator-rated secretions on a visual analogue scale (VAS) measure: Operator-rated cough intensity on a visual analogue scale (VAS) measure: Patient-rated comfort on a visual analogue scale (VAS) measure: Adverse reactions sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bronchoscopy suite, PGIMER city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 hasResults: False |
<|newrecord|> nctId: NCT06376929 id: oralcarbohydrateinpediatric briefTitle: Oral Carbohydrates in Pediatric Surgery and Random Blood Glucose Level overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-09 date: 2024-04-22 date: 2024-04-25 name: Cairo University class: OTHER briefSummary: The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting. conditions: Postoperative Nausea and Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized controlled primaryPurpose: SCREENING masking: NONE count: 120 type: ESTIMATED name: oral carbohydrate containing fluid measure: Mean values of Intraoperative random blood sugar in mg/dl sex: ALL minimumAge: 3 Years maximumAge: 9 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06376916 id: IRB00110863 briefTitle: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR acronym: ATRIUM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-12 date: 2024-04-22 date: 2024-04-24 name: Aurora Health Care class: OTHER briefSummary: The purpose of this prospective, randomized, double-blinded study is to further evaluate the safety and efficacy of varying doses of intravenous magnesium in the treatment of AFF RVR. conditions: Tachycardia Atrial conditions: Atrial Fibrillation conditions: Atrial Flutter With Rapid Ventricular Response studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 153 type: ESTIMATED name: Magnesium Sulfate 2 G name: Magnesium Sulfate 4 G name: Saline measure: Ventricular rate control measure: Time to achieve goal HR (heart rate) measure: Rate of conversion measure: Incidence of hypotension measure: Change in heart rate measure: Clinical need for rescue medication administration measure: Adverse effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advocate Christ Medical Center Emergency Department (ACMC ED) city: Oak Lawn state: Illinois zip: 60453 country: United States name: Marc McDowell, PharmD role: CONTACT phone: 708-684-6230 email: [email protected] lat: 41.71087 lon: -87.75811 hasResults: False |
<|newrecord|> nctId: NCT06376903 id: P.T.REC/012/004860 briefTitle: Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-08-20 date: 2024-09-20 date: 2024-04-22 date: 2024-04-22 name: Cairo University class: OTHER briefSummary: • This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women conditions: Urinary Stress Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Pilates exercise - pelvic floor exercise - home advices measure: • Revised urinary incontinence scale measure: • Quality of Life Questionnaire (QOL) for stress urinary incontinence sex: FEMALE minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06376890 id: Chile24 briefTitle: Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-05 date: 2025-07 date: 2024-04-19 date: 2024-04-19 name: New Mexico State University class: OTHER briefSummary: Diabetes is a major health epidemic facing the United States and New Mexico. Currently, 11.6% of the US population (38.4 million) has diabetes, and 38.0% of US adults have prediabetes. It is estimated that around 70% of prediabetics will develop diabetes in their lifetime. In New Mexico, 48% of adults are at least prediabetic, and 12% of adults in southern New Mexico adults have diabetes. Moreover, major health disparities challenge the southern New Mexico region. Type 2 diabetes mellitus (T2DM) is generally linked with chronic inflammation, obesity, insulin resistance, and ultimately insulin dependence via pancreatic β-cell failure. Lessening pathological inflammation, a critically important factor that contributes to diabetes, can improve the disease. Furthermore, 89.8% of diabetics in the US are overweight or obese, this is a major risk for prediabetes and T2DM, as it causes insulin resistance and pancreatic β-cell dysfunction, Weight loss in people with T2DM and prediabetes has been demonstrated to affect glycemic control and metabolic parameters significantly. The purpose of this proposed study is to explore and establish the beneficial effects of 10 weeks of powdered chili pepper consumption on several parameters related to diabetes and prediabetes. This research will demonstrate how powdered chili pepper consumption can improve systemic inflammation, glycemic control, and body composition, and will provide valuable preliminary data for future funding to further examine these effects in Type 2 diabetics. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area that has health disparities. The first aim is to establish if 10 weeks of powdered red or green chili pepper consumption can significantly improve markers of inflammation, inflammatory capacity, and antioxidant capacity. The second aim is to establish if 10 weeks of powdered red or green chili pepper ingestion has a significant effect on resting blood glucose and insulin levels, connecting peptide (C-peptide) levels, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). The third aim is to determine whether powdered chili pepper consumption for 10 weeks improves resting body composition and metabolic rate. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area with health disparities. Overall, this study will provide valuable insight and background knowledge for the use of chili peppers for the treatment of prediabetes and the prevention of diabetes progression. conditions: Prediabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A 3x2 model with 2 intervention groups (green and red chili) and a control group, and pre and post-intervention measures will be taken. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Only the primary investigator will know the intervention assigned to the participants. whoMasked: PARTICIPANT count: 21 type: ESTIMATED name: Red chili peppers name: Green Chili Pepper name: Placebo measure: Concentration of resting and fasted blood glucose measured in mg/dl measure: Concentration of resting and fasted insulin measured in pmol/L measure: Concentration of circulating C-reactive protein reported as mg/dl. measure: Concentration of circulating interleukin (IL)-1 beta reported as pg/ml. measure: Concentration of circulating interleukin-6 (IL-6) reported as pg/ml. measure: Concentration of circulating interleukin tumor necrosis factor (TNF)-alpha reported as pg/ml. measure: Concentration of circulating superoxide dismutase (SOD) reported as ng/ml. measure: Concentration of circulating glutathione peroxidase reported as pg/ml. measure: Body composition measured as total fat mass and total fat free mass reported in kg. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06376877 id: 2024P000900 briefTitle: Connectomic Targeted TMS Target for Refractory Anxiety acronym: ConTRA overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2028-08-01 date: 2029-02-01 date: 2024-04-19 date: 2024-04-19 name: Brigham and Women's Hospital class: OTHER briefSummary: We will perform a randomized sham-controlled trial of aiTBS to an anxiosomatic circuit in patients with anxiety-related disorders (i.e., panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder). 80 participants with an anxiety-related disorder (defined below) will receive 50 active or sham TMS treatments over 5 days (following the SAINT protocol, which is FDA-cleared for MDD. The primary outcome will be the BAI, with a modified recall window to reflect the short treatment interval. Participants randomized to sham will be offered an open-label crossover extension. conditions: Anxiety Disorders conditions: Mental Disorder conditions: Psychiatric Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Nonresponders may have the option for open label active treatment. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Transcranial magnetic stimulation name: Sham transcranial magnetic stimulation measure: Beck Anxiety Inventory (BAI) measure: Inventory of Depression and Anxiety Symptoms-II measure: Hierarchical Taxonomy of Psychopathology (HiTOP)-Self Report, Distress, Fear, and Mania subfactors measure: State-Trait Anxiety Inventory measure: Penn State Worry Questionnaire (PSWQ) measure: Mood/Anxiety Symptoms Questionnaire: Anxious Arousal (MASQ:AA) measure: Anxiety Sensitivity Index (ASI) measure: Intolerance of Uncertainty Scale (IUS) measure: Beck Depression Inventory (BDI) measure: TCI-R140 (Temperament and character inventory, revised 140-question format) measure: Emotional Conflict Resolution Task measure: Laboratory Fear Extinction Paradigm sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emma Jones city: Boston state: Massachusetts zip: 02115 country: United States name: Emma Jones role: CONTACT email: [email protected] lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06376864 id: RC- FNRA-IG /20-21/SOSC/01 briefTitle: Physical Activity Intervention Effects on Executive Function, Physical Activity and Sedentary Behaviour in Children overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-06-30 date: 2024-07-30 date: 2024-04-19 date: 2024-04-19 name: Hong Kong Baptist University class: OTHER briefSummary: The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children. conditions: Child Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 450 type: ACTUAL name: Activity Breaks measure: Executive function measure: Psychological capacities measure: Working memory measure: Attention measure: Physical activity (min/week) measure: Sedentary behavior (hour) measure: Body weight (kg) measure: Height (cm) sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: Department of Sport, Physical Education, and Health, Hong Kong Bapist University city: Kowloon Tong country: Hong Kong lat: 22.33312 lon: 114.17969 hasResults: False |
<|newrecord|> nctId: NCT06376851 id: CP-910-001 briefTitle: AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management acronym: DECIDE overallStatus: ENROLLING_BY_INVITATION date: 2024-03-27 date: 2026-03-27 date: 2030-03-27 date: 2024-04-19 date: 2024-04-19 name: HeartFlow, Inc. class: INDUSTRY briefSummary: The objective of HeartFlow's DECIDE Registry is to collect observational data about the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA). conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 10000 type: ESTIMATED name: AI-enabled quantitative coronary plaque analysis (AI-QCPA) measure: Primary Endpoint measure: Change in LDL levels measure: Change in HbA1c levels measure: Changes in Non HDL levels measure: Changes in HDL levels measure: Changes in TG levels measure: Changes in weight measure: Reclassification rate of medical management (across the groups) measure: Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG) measure: Number of CV hospitalizations measure: Number of MACE (CV-related death, MI, or CAD hospitalization) measure: Timing of referral to other provider(s) for management measure: Timing of lab orders (Group 1 vs. Group 2) measure: Change in Lp(a) (Group 2) measure: Change in Lp(a) (Group 4 compared to Group 1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moses Cone Memorial Hospital city: Greensboro state: North Carolina zip: 27401 country: United States lat: 36.07264 lon: -79.79198 hasResults: False |
<|newrecord|> nctId: NCT06376838 id: DLV-001-02 briefTitle: To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crow's Feet acronym: dermal filler overallStatus: COMPLETED date: 2020-07-07 date: 2021-10-15 date: 2023-05-04 date: 2024-04-19 date: 2024-04-19 name: DEXLEVO class: INDUSTRY briefSummary: This clinical study is a confirmatory clinical study to prove that the test device, DLMR01, is non-inferior to the control device, Rejuran®, in terms of temporary wrinkle improvement effect on crow's feet and safety. After applying DLMR01, a test device, and Rejuran®, a control device, respectively to wrinkles around the eyes, randomization to compare and evaluate the temporary wrinkle improvement effect and safety of the two clinical study medical devices, subject-evaluator blinding, pair matching, It was designed as a comparative clinical study. conditions: Crow's Feet Lines studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 218 type: ACTUAL name: DLMR01 name: Rejuran measure: Crow's Feet Grading Scale by independent evaluators after 12 weeks of using measure: (1) The improvement rate of wrinkles evaluated using the Crow's Feet Grading Scale measure: (2) The improvement rate of wrinkles assessed using the Crow's Feet Grading Scale by independent evaluators after 2 weeks and 4 weeks of using the medical device both during rest and when smiling was evaluated. sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung-ang University Hospital city: Seoul state: Dongjak-gu zip: 06973 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False |
<|newrecord|> nctId: NCT06376825 id: CSV202401 briefTitle: The Efficacy and Acceptability of an Internet-Based Self-Help Program to Reduce Burnout overallStatus: RECRUITING date: 2024-04-15 date: 2024-06-15 date: 2024-06-15 date: 2024-04-19 date: 2024-04-19 name: Ahmet Nalbant class: OTHER briefSummary: The goal of this clinical trial is to determine whether an internet-based self-help program reduces burnout in teachers. The study will also evaluate the program's acceptability which means assessing the extent to which users complete the program and find it useful. The main questions it aims to answer are: |
* Does the program reduce the level of burnout in teachers? |
* Does the program contribute to an increased sense of meaning for teachers? |
* How much of the program do teachers finish? conditions: Burnout, Professional studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study will be a concurrent multiple-baseline single-case experimental study with participiants randomized to baseline durations. primaryPurpose: TREATMENT masking: NONE maskingDescription: In this study participants will be randomized to different baseline durations and randomization will be done by one of the investigators who are blind to participants assessments. count: 25 type: ESTIMATED name: MyLife: An internet-based self-help program to reduce burnout measure: Burnout Assessment Tool measure: Valued Living Questionnaire measure: Acceptance and Action Questionnaire-2 measure: System Usability Scale measure: Attendance rate measure: Daily measures sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CanSagligi Foundation Center for Contextual Behavioral Science status: RECRUITING city: Istanbul country: Turkey name: Eda Aksoy role: CONTACT phone: +90(216) 269 66 11 email: [email protected] name: Ahmet Nalbant, MD role: PRINCIPAL_INVESTIGATOR name: Havvanur Uysal Akdemir, MS role: SUB_INVESTIGATOR name: Edanur Gürbüz, BA role: SUB_INVESTIGATOR name: Meryem Gökçe Yavuz, BA role: SUB_INVESTIGATOR name: Kaasım Fatih Yavuz, MD role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06376812 id: 23-0320 briefTitle: No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women overallStatus: NOT_YET_RECRUITING date: 2026-05 date: 2029-01 date: 2029-01 date: 2024-04-19 date: 2024-04-19 name: The University of Texas Medical Branch, Galveston class: OTHER briefSummary: This study will test the effects of a physical activity intervention among midlife Hispanic women. conditions: Elevated Blood Pressure conditions: Perimenopause studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Physical activity intervention measure: Days the activity monitor was worn measure: Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months measure: Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months measure: Physical activity as measured by minutes of moderate intensity physical activity at 6 months measure: Physical activity as measured by minutes of moderate intensity physical activity at 6 months measure: Physical activity as measured by minutes of vigorous intensity physical activity at 6 months measure: Physical activity as measured by minutes of vigorous intensity physical activity at 6 months measure: Physical activity as measured by minutes of light intensity physical activity at 6 months measure: Physical activity as measured by minutes of light intensity physical activity at 6 months measure: Physical activity as measured by minutes of total physical activity at 6 months measure: Physical activity as measured by minutes of total physical activity at 6 months measure: Systolic blood pressure measure: Systolic blood pressure measure: Diastolic blood pressure measure: Diastolic blood pressure measure: Abdominal circumference measure: Abdominal circumference measure: Body mass index measure: Body mass index sex: FEMALE minimumAge: 45 Years maximumAge: 50 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06376799 id: 38RC23.0437 id: 2024-A00485-42 type: OTHER domain: ID RCB briefTitle: Which Health-care Professional(s) to Talk About Advance Care Planning ? acronym: QPSPAS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2024-11-02 date: 2024-04-19 date: 2024-04-19 name: University Hospital, Grenoble class: OTHER briefSummary: The goal of this descriptive observational study is to evaluate the preference of French adult patients followed in the context of a oncological disease, regarding the choice of the preferred healthcare professional to discuss advance care planning. |
To this end, voluntary participants will be asked to indicate their preferences by answering a self-questionnaire available in electronic or paper format. conditions: Advance Care Planning conditions: Patient Preference studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 240 type: ESTIMATED name: Self-questionnaire measure: Determining the healthcare professional preferred by cancer patients to talk about advance care planning measure: Determining cancer patients' second choice of healthcare professional to talk about advance care planning measure: Evaluation of patient preferences regarding advance care planning, concerning the form, the moment it should be carried out, whether or not they wish to be accompanied by a relative, and the benefit of systematization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06376786 id: ItaliTTP briefTitle: Italian iTTP Registry overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2030-05-31 date: 2030-05-31 date: 2024-04-19 date: 2024-04-19 name: Fondazione Luigi Villa class: OTHER briefSummary: ItaliTTP is an observational, prospective, single-arm, national, multicenter, non-pharmacological cohort study aimed at better defining and understanding the natural history, disease severity, and clinical outcomes of patients with immune-mediated thrombotic thrombocytopenic purpura (iTTP) in Italy. |
A minimum of 132 consecutive patients with acute iTTP (first event or relapse) will be enrolled for 3 years, with the possibility of extension, with a follow-up period of 3 years. conditions: TTP - Thrombotic Thrombocytopenic Purpura studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 132 type: ESTIMATED measure: Age at onset measure: Sex measure: Birth Country/Region measure: Race measure: Blood group measure: BMI measure: Proportion of patients with comorbidities, including: autoimmune diseases, cancer, HIV infection, hypertension, type 2 diabetes, hypercholesterolemia, cardiovascular disease, chronic renal failure, liver disease, depression. measure: Proportion of acute iTTP episodes preceded by potential triggering factors including: infections, pregnancy, surgery, psychological trauma, vaccination, drugs measure: Incidence, type and severity of clinical manifestations, including: bleeding, cardiovascular, neurological, renal and systemic signs and symptoms measure: Platelet count lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin measure: Hemoglobin lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin measure: Lactate dehydrogenase (LDH) lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin measure: Creatinine lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin measure: Cardiac troponin measure: ADAMTS13 activity measure: Anti-ADAMTS13 antibodies measure: Number of daily therapeutic plasma exchange procedures measure: Proportion of acute iTTP patients treated with rituximab measure: Proportion of acute iTTP patients treated with immunosuppressors other than steroids and rituximab measure: Proportion of iTTP patients treated with caplacizumab measure: Incidence, type and severity of TTP-related drugs adverse events measure: Proportion of iTTP patients achieving clinical remission measure: Proportion of iTTP patients refractory to acute iTTP treatment measure: Proportion of iTTP patients experiencing complications during hospitalization, including: bleeding, thrombosis, neurological, renal, cardiac complications measure: Proportion of iTTP patients experiencing clinical exacerbation measure: Proportion of iTTP patients achieving ADAMTS13 remission measure: Time to clinical response measure: Time to clinical remission measure: Time to ADAMTS13 remission measure: Proportion of iTTP patients with a clinical relapse measure: Proportion of iTTP patients with an ADAMTS13 relapse measure: Time to clinical relapse measure: Time to ADAMTS13 relapse measure: Incidence, type and severity of pregnancy complications in iTTP pregnant women measure: iTTP incidence in Italy sex: ALL minimumAge: 12 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06376773 id: 2022KY123 briefTitle: Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping. overallStatus: COMPLETED date: 2022-06-01 date: 2023-07-01 date: 2023-11-30 date: 2024-04-19 date: 2024-04-19 name: Fujian Medical University class: OTHER briefSummary: Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. This study aimed to identify the most effective drug therapeutics for patients with the mesenchymal subtype of gastric cancer.Based on RNA-seq transcriptome, 234 patients were divided into four molecular subtypes: mesenchymal, immunogenic, metabolic, and classic.Our analysis has revealed that, for neoadjuvant therapy in advanced gastric cancer (AGC), the mesenchymal subtype stands out as the ideal patient population benefiting from Apatinib, without a concurrent increase in postoperative complications. conditions: Advanced Gastric Cancer conditions: Neoadjuvant Therapy conditions: Multi-omics Analysis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 234 type: ACTUAL name: combination chemotherapy with Apatinib or Camrelizumab measure: overall survival measure: objective response rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Medical University Union Hospital city: Fuzhou state: Fujian zip: 350000 country: China lat: 26.06139 lon: 119.30611 hasResults: False |
<|newrecord|> nctId: NCT06376760 id: KY2024-091-02 briefTitle: Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-03-31 date: 2027-03-31 date: 2024-04-19 date: 2024-04-19 name: Beijing Tiantan Hospital class: OTHER briefSummary: To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern. conditions: Insomnia conditions: Digestive Endoscopy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3360 type: ESTIMATED name: No interventions, it is a observational study measure: The total consumption of intravenous anesthetic drug measure: The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope measure: The occurrence of the respiratory and cardiovascular adverse events measure: The occurrence of the other adverse events measure: The incidence of intraoperative recall or awareness measure: The recovery time measure: Duration of patients' PACU stay measure: The ease of operation at this level of sedation evaluated by the gastroenterologists measure: The satisfaction degree of anesthesia effect evaluated by the gastroenterologists measure: Patients' satisfaction measure: Patients' willingness sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Beijing Tiantan Hospital city: Beijing state: Beijing zip: 100070 country: China name: Fang Luo, M.D. role: CONTACT phone: 13611326978 email: [email protected] name: Fang Luo, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06376747 id: KDAR- PBM 2024 briefTitle: The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing Critically Ill Pediatric Patients acronym: PEDPBM overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-08-31 date: 2024-04-19 date: 2024-04-19 name: Brno University Hospital class: OTHER briefSummary: The aim of this prospective randomized study is to evaluate blood loss caused by laboratory blood draws in patients in the paediatric ICU (Intensive Care Unit) of a tertiary hospital among two groups of patients with established long-term or mid-term intravenous access. In the first group, patients will undergo blood draws using the standard method. In the second group of patients, blood draws will be performed using a closed system. conditions: Iatrogenic Anaemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE maskingDescription: Patients will be randomized into two groups: a group with standard blood sampling technique and a group with closed technique blood sampling by using randomizing software. whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: In line sampling name: Standard blood sampling technique measure: Average amount of blood collected for laboratory diagnostic purposes measure: Cumulative amount of blood drawn per day of ICU hospitalization measure: Absolute amount of blood drawn and blood used for laboratory testing measure: Trend of haemoglobin decline over time measure: Incidence of anaemia measure: Incidence of anaemia up to transfusion trigger measure: Frequency of blood product transfusions and their quantity measure: Type and frequency of laboratory tests measure: Incidence of coagulopathy measure: Incidence of catheter-related complications measure: Time to catheter replacement in case of catheter exchange sex: ALL minimumAge: 1 Month maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: KDAR - department of pediatrics anesthesia and resuscitation city: Brno zip: 62500 country: Czechia lat: 49.19522 lon: 16.60796 hasResults: False |
<|newrecord|> nctId: NCT06376734 id: 2024p000528 briefTitle: Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness acronym: Searchlight overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-06-01 date: 2030-06-01 date: 2024-04-19 date: 2024-04-19 name: Brigham and Women's Hospital class: OTHER name: National Institutes of Health (NIH) briefSummary: Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits. conditions: Major Depressive Disorder conditions: Obsessive-Compulsive Disorder conditions: Schizophrenia conditions: Generalized Anxiety Disorder conditions: Mood Disorders conditions: Psychiatric Disorder conditions: Mental Disorder conditions: Depression, Anxiety studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind, randomized controlled crossover trial. Participants will be stimulated at a random location in the prefrontal cortex, which will be mapped to its underlying brain network to determine which network was stimulated. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: All participants will receive real open-label TMS, so there will be no conventional masking. However, participants and investigators will be blinded to which network is being stimulated. count: 180 type: ESTIMATED name: TMS measure: Clustering of multiple behavioral measures sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06376721 id: TREC2024-KY016 briefTitle: Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma overallStatus: RECRUITING date: 2024-04-14 date: 2026-10-31 date: 2027-10-31 date: 2024-04-19 date: 2024-04-19 name: Beijing Tongren Hospital class: OTHER briefSummary: The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment. conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type conditions: T-lymphoblastic Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Treatment with linperlisib in combination with camrelizumab and pegaspargase for advanced or relapsed/refractory ENKTCL patients primaryPurpose: TREATMENT masking: NONE count: 43 type: ESTIMATED name: Linperlisib name: Camrelizumab name: Pegaspargase name: Dexamethasone measure: The best objective response rate（ORR） over 6 treatment cycles measure: Objective Response Rate（ORR） measure: Complete Response （CR） measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Disease Control Rate（DCR） measure: Drug safety sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Liang Wang status: RECRUITING city: Beijing state: Beijing country: China name: Liang Wang, M.D. role: CONTACT phone: +8615001108693 email: [email protected] name: Liang Wang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06376708 id: 3-3-13 briefTitle: Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation overallStatus: COMPLETED date: 2022-09-01 date: 2023-03-01 date: 2023-07-01 date: 2024-04-19 date: 2024-04-19 name: Cairo University class: OTHER briefSummary: comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin conditions: Maxillary Sinus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: use of platelet rich fibrin after maxillary sinus elevation using PEEK primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ACTUAL name: platelet rich fibrin name: Polyether ether ketone measure: Bone quantity measure: Bone quality sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry Cairo University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06376695 id: RADX-P-2407 briefTitle: Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-19 date: 2024-06 date: 2024-10 date: 2024-04-19 date: 2024-04-23 name: Radicle Science class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes conditions: Abdominal Pain conditions: GI Disorders conditions: Digestion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be stratified based on gender at birth then randomized to one of the study arms primaryPurpose: OTHER masking: DOUBLE maskingDescription: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 500 type: ACTUAL name: Radicle GI Health Placebo Control Form 1 name: Radicle GI Health Active Study Product 1.1 Usage measure: Change in GI (Gastrointestinal) Health (1) measure: Change in GI (Gastrointestinal) Health (2) measure: Change in GI (Gastrointestinal) Health (3) measure: Change in GI (Gastrointestinal) Health (4) measure: Change in GI (Gastrointestinal) Health (5) measure: Change in GI (Gastrointestinal) Health (6) measure: Change in feelings of anxiety measure: Change in GI-related Quality of Life (QOL) measure: Change in mood (emotional distress-depression) measure: Minimal clinically important difference (MCID) in GI Health (1) measure: Minimal clinically important difference (MCID) in GI Health (2) measure: Minimal clinically important difference (MCID) in GI Health (3) measure: Minimal clinically important difference (MCID) in GI Health (4) measure: Minimal clinically important difference (MCID) in GI Health (5) measure: Minimal clinically important difference (MCID) in GI Health (6) measure: Minimal clinically important difference (MCID) in feelings of anxiety measure: Minimal clinically important difference (MCID) in GI-related QOL measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression) measure: Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool sex: ALL minimumAge: 21 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radicle Science, Inc city: Del Mar state: California zip: 92014 country: United States lat: 32.95949 lon: -117.26531 hasResults: False |
<|newrecord|> nctId: NCT06376682 id: CA-BO-CIP-0060 briefTitle: EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy acronym: EPIBONE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-12-31 date: 2025-02-28 date: 2024-04-19 date: 2024-04-19 name: Quantum Surgical class: INDUSTRY briefSummary: Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures. conditions: Bone Metastases conditions: Fractures, Bone conditions: Bone Tumor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The Epione device is an image-guided robotized device that assists the physician during CT-guided procedures. primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: CT-guided bone percutaneous procedure measure: Successful instrument insertion with the EPIONE device. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06376669 id: J2421 id: IRB00427823 type: OTHER domain: JHM IRB briefTitle: Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma acronym: SPARE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2030-08 date: 2024-04-19 date: 2024-04-19 name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins class: OTHER briefSummary: This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival. conditions: Renal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Proton Stereotactic Body Radiation therapy (SBRT) measure: Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels measure: Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values measure: Number of PROTON-BASED SBRT treatment Adverse Events measure: Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions measure: Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions measure: Time to locoregional progression measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06376656 id: LRGS/1/2019/SYUC/02/1 briefTitle: Successful Aging and Age-related Decline acronym: MyAgeWell overallStatus: RECRUITING date: 2022-05-20 date: 2029-05 date: 2030-05 date: 2024-04-19 date: 2024-04-19 name: Sunway University class: OTHER briefSummary: Recent studies have shown promising cognitive and physical interventions aimed at slowing down ageing-related declines in quality of life, but they lack strong ecological validity (brief durations, unrealistic goals, no real-world application) and has yet to show robust evidence that such interventions are stable and suitable in the long-term. The investigators aim to examine whether these interventions can, over four years, significantly slow down the normal rate of ageing-related decline. conditions: Aging conditions: Elderly conditions: Cognitive Decline conditions: Physical Decline conditions: Intervention Study studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A cohort of older Malaysian adults will be recruited and assigned to one of the groups, either cognitive stimulation, physical activity, combined cognitive stimulation and physical activity, or non-intervention control. primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: Cognitive stimulation name: Physical activity measure: Changes in cognitive scores measure: Changes in electroencephalogram (EEG) measure: Changes in structural magnetic resonance imaging (MRI) measure: Cost-benefit analysis of intervention measure: Changes in levels of human salivary lactoferrin measure: Changes in levels of human salivary C-reactive proteins measure: Changes in salivary telomere length measure: Changes in depression scores measure: Changes in anxiety scores sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sunway University status: RECRUITING city: Petaling Jaya state: Selangor zip: 47500 country: Malaysia name: Michael J Jenkins, PhD role: CONTACT phone: +60374918622 phoneExt: 7183 email: [email protected] lat: 3.10726 lon: 101.60671 hasResults: False |
<|newrecord|> nctId: NCT06376643 id: InterFACE-AR briefTitle: Augmented Reality to Support Cardiopulmonary Resuscitation overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2025-10-31 date: 2025-10-31 date: 2024-04-19 date: 2024-04-19 name: Johan Siebert, MD class: OTHER name: Geneva Children's Hospital, Geneva, Switzerland name: Alberta Children's Hospital, Calgary, Canada briefSummary: A prospective, multicenter, randomized clinical trial in two tertiary pediatric emergency department. It will assess, amongst pediatric healthcare teams, whether the use of augmented reality supportive devices improves adherence to American Heart Association (AHA) advanced life support guidelines and performance, while reducing medication errors, when compared to groups using the AHA pocket reference card (control) during standardized, simulation-based, pediatric in-hospital cardiac arrest (IHCA) scenarios. Seventy participants will be randomized. The primary endpoint is the time to first dose of epinephrine. conditions: Cardiopulmonary Arrest conditions: Resuscitation conditions: Pediatric studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open-label, prospective, multicenter, cluster randomized controlled clinical trial primaryPurpose: OTHER masking: SINGLE maskingDescription: It will not be possible to blind study participants to study arm allocation due to the nature of the intervention(s), but they will be blinded to study objectives. The statistician will be blinded regarding the allocation of participants to the study arms for results analysis. whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Augmented reality supportive tool name: Conventional method (AHA pocket reference card) measure: Time to first dose of epinephrine measure: Time to initiation of cardiopulmonary resuscitation measure: Time to defibrillation measure: Time to delivery of epinephrine measure: Time to delivery of amiodarone measure: Time to secure definitive airway measure: Medication dosage errors measure: Types of Medication Errors measure: Frequency of Medication Errors measure: Frequency of pauses in cardiopulmonary resuscitation measure: Duration of pauses in cardiopulmonary resuscitation measure: Causes of pauses in cardiopulmonary resuscitation measure: Cardiopulmonary resuscitation quality: Percentage of overall excellent cardiopulmonary resuscitation measure: Cardiopulmonary resuscitation quality: Chest compression fraction measure: Cardiopulmonary resuscitation quality: Peri-shock pause duration measure: Provider workload (NASA-TLX) measure: User Experience Questionnaire (UEQ) measure: System Usability Scale (SUS) measure: Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT) measure: State-Trait Anxiety Inventory (STAI) form Y-1 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alberta Children's Hospital city: Calgary state: Alberta zip: AB T3B 6A8, country: Canada name: Adam Cheng, Prof role: CONTACT phone: 403 955 2633 email: [email protected] name: Jennifer Davidson, RN BSc role: CONTACT email: [email protected] name: Kangsoo Kim, Ass Prof role: SUB_INVESTIGATOR name: Yiqun Lin, PhD role: SUB_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: Geneva Children's Hospital, Geneva University Hospitals city: Geneva zip: 1205 country: Switzerland name: Johan N Siebert, MD, PD role: CONTACT phone: 795534072 phoneExt: +41 email: [email protected] name: Delphine Courvoisier, Prof role: SUB_INVESTIGATOR name: Frederic Ehrler, PhD role: SUB_INVESTIGATOR lat: 46.20222 lon: 6.14569 hasResults: False |
<|newrecord|> nctId: NCT06376630 id: 298-2024 briefTitle: Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI acronym: ESMO-VASCMI overallStatus: RECRUITING date: 2024-01-29 date: 2029-01-29 date: 2030-01-29 date: 2024-04-19 date: 2024-04-19 name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation class: OTHER_GOV briefSummary: Study rationale: to evaluate clinical and prognostic relevance of microvascular dysfunction, coronary flow reserve and cardioprotective effects of iv administration of esmolol in patients with myocardial infarction. |
First substudy is an open randomized trial evaluating the efficacy and safety of early intravenous administration of esmolol in patients with acute ST-segment elevation myocardial infarction (MI) and relative contraindications to administration of other intravenous β1-adrenergic blocker (metoprolol etс.). Сomparison group will include patients who have not received intravenous β1-adrenergic blocker. Secondary outcome in this substudy is the degree of microvascular obstruction and infarct size according to MRI with gadolinium delayed enhancement. |
Second substudy examines the quantitative parameters of coronary physiology in patients with MI and multivessel disease. Changes of coronary physiology measurements over time ((iFR, Pd/Pa, FFR, delta FFR, gradient FFR per time unit (dFFR(t)/dt), pullback pressure gradient (PPG)) measured in the infarct-related artery and in non-infarct-related arteries with diameter stenosis of 50-85% immediately after the completion of a primary percutaneous coronary intervention and during a second hospitalization (30-45 days after STEMI) will be evaluated. The comparison changes of coronary physiology over time with presence of an MVO and infarct size determined by MRI. The model of calculating coronary flow reserve (CFR) based on tridimensional reconstruction of coronary arteries and coronary physiology parameters as measured during coronary angiography will be developed. The influence of coronary physiology parameters measured after complete myocardial revascularization by PCI, and derived CFR in patients with MI on long-term clinical outcomes will be evaluated, based on prospective data collection. |
Primary composite outcome in all substudies will be the sum of adverse cardiac outcomes (congestive heart failure, episodes of recurrent congestive heart failure worsening resulting in hospitalizations, cardiac mortality, MI recurrences, unstable angina, urgent myocardial revascularization) within \> 12 months post-infarction. |
Secondary composite outcome in all substudies is the degree of microvascular obstruction and infarct size evaluated by MRI with gadolinium delayed enhancement. conditions: Myocardial Infarction conditions: Coronary Stenosis conditions: Coronary Microvascular Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 300 pts with MI are to be enrolled. Among them 100 pts with STEMI will be included into the substudy evaluating cardioprotective effects of early iv administration of esmolol. They will be randomized 1:1 by in arms receiving esmolol or no IV beta-blockers. In the esmolol arm the infusion will begin immediately on admission. 200 pts with MI and multivessel disease with non-IRA lesions of 50-85% diameter stenosis will be included into another substudy investigating coronary physiology. All patients will undergo PCI with IRA stenting. 50 stable patients will undergo invasive measurements of coronary physiology. Those will also undergo cardiac MRI. Other 150 pts will not undergo invasive measurements of coronary physiology during initial hospitalization. Pts in both groups will be hospitalized again in 30-40 days after MI. They will undergo stress SPECT or stress echocardiography. All patients will undergo a follow-up coronary angiography with invasive measurement of coronary physiology. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: envelopes whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Esmolol Hcl 10Mg/Ml Inj measure: Composite of adverse cardiac outcomes measure: Degree of microvascular obstruction measure: Infarct size sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NMRCCardiologyRu status: RECRUITING city: Moscow country: Russian Federation name: Andrey Komarov, PhD role: SUB_INVESTIGATOR name: Tatiana Sukhinina, PhD role: SUB_INVESTIGATOR name: Mariy Terenicheva, PhD role: SUB_INVESTIGATOR name: Olga Stukalova, PhD role: SUB_INVESTIGATOR name: Sergey Ternovoy, Academic role: SUB_INVESTIGATOR name: Goar Arutiunian, PhD role: SUB_INVESTIGATOR name: Evgeniy Merkulov, PhD role: SUB_INVESTIGATOR name: Viktor Shitov, MD role: SUB_INVESTIGATOR name: Marina Saidova, PhD role: SUB_INVESTIGATOR name: Aleksey Ansheles, PhD role: SUB_INVESTIGATOR name: Vladimir Sergienko, PhD role: SUB_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False |
<|newrecord|> nctId: NCT06376617 id: MS.24.03.2743 briefTitle: Pattern Of Isolated Fungi From Bronchoalveolar Lavage Among Patients With Bronchial Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-04-20 date: 2025-05-20 date: 2024-04-19 date: 2024-04-19 name: Mansoura University class: OTHER briefSummary: This study is to assess the pattern of isolated fungi from the respiratory air way (bronchial tree) from bronchoalvealar lavage (BAL) in asthmatic patients with uncontrolled or difficult to treat asthma conditions: Bronchial Asthma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: BAL will stained by fungal staining with lactophenol stain as well as culture on Sabouraud dextrose agar. primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: fibroptic bronchoscopy measure: assess the pattern of isolated fungi from the respiratory air way (bronchial tree) from bronchoalvealar lavage (BAL) in asthmatic patients with uncontrolled or difficult to treat asthma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06376604 id: LNT55 briefTitle: Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies overallStatus: RECRUITING date: 2021-09-08 date: 2025-09-01 date: 2025-12-30 date: 2024-04-19 date: 2024-04-19 name: L-Nutra Inc class: INDUSTRY name: University of Tennessee Medical Center briefSummary: This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies. conditions: Cancer, Ovarian conditions: Chemotherapy Effect conditions: Calorie Deficiency conditions: Fasting, Intermittent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Outcomes Assessor count: 30 type: ESTIMATED name: Fasting Mimicking Diet name: Chemotherapy measure: Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire measure: Rate of Adherence measure: Change in Body Weight measure: Change in Body Composition measure: Change in HbA1c measure: Change in Insulin Like Growth Factor 1 (IGF-1) Concentration measure: Change in Fasting Insulin Concentration measure: Change in Fasting Glucose Concentration measure: Change in High-sensitivity C reactive protein Concentration measure: Change in Leptin Concentration measure: Change in planned chemotherapy regimen measure: Number of Hospitalization Days measure: Rate of Chemotherapy Side Effects sex: FEMALE minimumAge: 35 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Tennessee Medical Center status: RECRUITING city: Knoxville state: Tennessee zip: 37920 country: United States name: Jonathan D Boone, MD role: CONTACT phone: 865-305-5622 email: [email protected] lat: 35.96064 lon: -83.92074 hasResults: False |
<|newrecord|> nctId: NCT06376591 id: LUMHS/B12/Temp/12.04.2024 briefTitle: Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation in Healthy Adults With B12 Deficiency overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-07-31 date: 2024-08-31 date: 2024-04-19 date: 2024-04-19 name: Liaquat University of Medical & Health Sciences class: OTHER briefSummary: Vitamin B12, a vital nutrient, plays a crucial role in red blood cell formation, neurological function, and DNA synthesis. Deficiency in B12 can lead to anemia, neurological symptoms such as tingling or numbness, and cognitive impairment. Oral B12 supplementation serves as an effective strategy to address B12 deficiency, especially for individuals with limited dietary intake or absorption issues. Regular B12 supplementation can help restore body B12 levels, alleviate deficiency-related symptoms, and support overall health and well-being. conditions: Vitamin B 12 Deficiency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Oral Vitamin B12 supplement name: Control group measure: Supplementation effect on circulatory vitamin B12 levels measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Liaquat University of Medical and Health Sciences city: Jamshoro zip: 76090 country: Pakistan name: Dr. Ikram Ujjan, MBBS, PhD role: CONTACT phone: 03000506955 email: [email protected] lat: 25.43773 lon: 68.28522 hasResults: False |
<|newrecord|> nctId: NCT06376578 id: 245256 briefTitle: Exercise Interventions for Improving Health in Breast Cancer Survivors overallStatus: COMPLETED date: 2018-09-05 date: 2020-01-30 date: 2020-01-30 date: 2024-04-19 date: 2024-04-19 name: University of Bath class: OTHER briefSummary: Supervised, prescribed exercise has positive effects on body composition, physical functioning, psychological wellbeing and quality of life for patients after breast cancer treatment. However, exercise interventions are often time consuming, commonly take place at a health or fitness facility, and usually require a trained professional to be present. Cost-effective, enjoyable and practical approaches, that can be adopted at home or in local surroundings are needed. For example, an alternative approach is using an electronic physical activity tracking wristwatch to help patients engage with exercise or physical activity. Research demonstrates the importance of structured and supervised exercise for breast cancer survivors. However, it is not known whether other approaches (e.g. home-based exercise and physical activity) alongside the use of personalised technology-enabled feedback, can cause similar improvements to health when compared to structured exercise. The overall aim of this study is to determine whether cardiorespiratory fitness is changed by a technology enabled, remotely delivered exercise intervention and to determine whether this change is similar to the change caused by a partly supervised, prescribed exercise intervention. This study will also determine the influence of both interventions on physical functioning, body composition and blood pressure. conditions: Breast Cancer Female studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: Exercise intervention name: Polar A380 wristwatch physical activity tracker measure: Change in VO2max (maximum oxygen uptake) measure: Change in Body composition measure: Change in physical functioning measure: Change in Psychological measures measure: Change in immune profiles and function sex: FEMALE minimumAge: 35 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bath city: Bath zip: BA2 7AY country: United Kingdom lat: 51.3751 lon: -2.36172 hasResults: False |
<|newrecord|> nctId: NCT06376565 id: 22-000647 id: NCI-2024-02090 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: R01CA271034 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA271034 briefTitle: Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2027-03-31 date: 2028-03 date: 2024-04-19 date: 2024-04-24 name: Jonsson Comprehensive Cancer Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps. conditions: Colorectal Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 1680 type: ESTIMATED name: Best Practice name: Communication Intervention name: Communication Intervention name: Communication Intervention name: Interview name: Interview measure: Stakeholder perspectives on the multilevel intervention (Aim 1) measure: Completion of surveillance colonoscopy (Aim 2) measure: Implementation quality (Aim 3a) measure: Cost effectiveness (Aim 3b) measure: Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA / Jonsson Comprehensive Cancer Center city: Los Angeles state: California zip: 90095 country: United States name: Folasade P. May role: CONTACT phone: 617-620-7806 email: [email protected] name: Folasade P. May role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False |
<|newrecord|> nctId: NCT06376552 id: AI4Cardio briefTitle: Artificial Intelligence for the Prioritization of Genetic Background in Brugada Syndrome acronym: AI4Cardio overallStatus: COMPLETED date: 2018-12-19 date: 2022-06-06 date: 2022-06-06 date: 2024-04-19 date: 2024-04-19 name: IRCCS San Raffaele class: OTHER briefSummary: Brugada Syndrome (BS) is an inherited heart condition that can cause sudden cardiac arrest in young individuals. It's diagnosed through specific changes seen on an electrocardiogram (ECG). Currently, the only treatment option is a cardioverter defibrillator (ICD). Despite advances, much about BS remains unclear, including its genetic basis. This study aims to use advanced genetic sequencing and artificial intelligence to uncover new genetic factors contributing to BS. By understanding these factors better, we hope to improve risk assessment and treatment for affected individuals. conditions: Brugada Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ACTUAL measure: New candidate genes, likely associated with Brugada Syndrome using an AI based approach. measure: Identification of genetic risk factors associated with the worse phenotype. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele city: Milan zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 facility: Milano-Bicocca University city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06376539 id: CEAVEC: 111/2024/Oss/IOR briefTitle: Functional Recovery of Patients Undergoing Resection and Reconstruction of the Lower Limbs for Bone Tumor. acronym: FISIO-ONCO overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-05 date: 2025-04 date: 2024-04-19 date: 2024-04-19 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved. conditions: Bone Neoplasm conditions: Rehabilitation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: Toronto Extremity Salvage Score (TESS) measure: Toronto Extremity Salvage Score (TESS) measure: Range of motion (ROM) measure: Rang of motion - 2 (ROM) measure: Number of participants able to walk measure: Time Up and Go -2 (TUG) measure: Time Up and Go (TUG) measure: Muscle Strength measure: Muscle Strength-2 measure: Number of day from surgery to first walking sex: ALL minimumAge: 12 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06376526 id: 20230236 briefTitle: IMMUNOPLANT for Newly Diagnosed Multiple Myeloma acronym: IMMUNOPLANT overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2027-06-30 date: 2029-06-30 date: 2024-04-19 date: 2024-04-19 name: Dickran Kazandjian, MD class: OTHER name: Regeneron Pharmaceuticals briefSummary: The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Linvoseltamab measure: Minimal Residual Disease (MRD) Negativity Rate measure: Sustained MRD-Negativity Rate measure: Progression-Free Survival (PFS) measure: Overall Survival measure: Number of Participants Experiencing Treatment-Related Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States name: Dickran Kazandjian, MD role: CONTACT phone: 305-243-5001 email: [email protected] name: Dickran Kazandjian, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False |
<|newrecord|> nctId: NCT06376513 id: 69HCL24_0031 briefTitle: Evaluation of Penile Prosthesis Pump Manipulation acronym: ECM3P overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-19 date: 2024-04-19 name: Hospices Civils de Lyon class: OTHER briefSummary: Erectile dysfunction is a highly prevalent pathology. When oral or injectable pharmacological treatments prove ineffective, the treatment of choice is penile prosthesis which provides the possibility of sexual activity with penetration. |
Unfortunately, current prostheses are difficult (or even impossible) to manipulate for some patients. Many patients underutilize their device due to difficulties in using the pump related to mechanical issues (difficult grip, lack of strength, etc.) or sensory issues (altered proprioception, etc.), resulting in an inability to achieve rigidity that allows optimal satisfaction for the patient and/or partners. |
These difficulties correspond to a significant portion of dissatisfaction among patients with penile prostheses. |
Actually, no study has evaluated patients' ability to manipulate the pump of their penile prosthesis, as well as the association between these manipulation abilities, the rigidity of erections with a penile prosthesis, and patient and partner sexual satisfaction. |
In this descriptive study, the primary outcome is to describe the manipulation abilities of patients with penile prostheses during follow-up consultations after prosthesis implantation. |
The secondary outcomes are to estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with |
* Rigidity of erections with penile prosthesis |
* Patient's sexual satisfaction |
* Partner's sexual satisfaction |
* Satisfaction related to pump manipulation conditions: Penile Prosthesis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Evaluation measure: Describing the manipulation abilities of patients with penile prosthesis : overall hand grip strength measure: Describing the manipulation abilities of patients with penile prosthesis : pinch grip strength measure: Describing the manipulation abilities of patients with penile prosthesis : proprioception measure: Describing the manipulation abilities of patients with penile prosthesis :discrimination measure: Describing the manipulation abilities of patients with penile prosthesis :upper limb function for activities of daily living measure: Correlation of manipulation parameters (main outcome) with rigidity of erections measure: Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction modified EDITS measure: Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction QoLSPP measure: Correlation of manipulation parameters (main outcome) with partner's sexual satisfaction measure: Correlation of manipulation parameters (main outcome) with satisfaction related to pump manipulation (self-made questionnaire) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology, Lyon Sud Hospital, city: Pierre-Bénite zip: 69310 country: France name: Nicolas MOREL role: CONTACT phone: + 33 4 72 6788 37 email: [email protected] name: Clément PARAT role: CONTACT phone: + 33 4 72 6788 37 email: [email protected] lat: 45.7009 lon: 4.82511 hasResults: False |
<|newrecord|> nctId: NCT06376500 id: HSEARS20240223001 briefTitle: Effects of tDCS for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-08 date: 2028-02 date: 2024-04-19 date: 2024-04-19 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Globally, 10 million new traumatic brain injury (TBI) cases are estimated annually, with mild traumatic brain injury (mTBI) accounting for 75-90% of all TBI cases. It is estimated that 40-80% of individuals with mTBI may experience the post-concussion syndrome (PCS), which is characterized by a range of physical, cognitive, and emotional symptoms. Although the underlying basis of cognitive dysfunction of patients with persistent PCS remains to be clarified, converging evidence shows that the clinical symptoms is underpinned by abnormal neural information processing as a result of axonal injury due to mTBI. Recent studies have demonstrated abnormalities in both structural and functional cortical connectivity, and a loss of cortical excitability-inhibitory (E/I) balance after TBI. Yet, there is no consensus for treating chronic symptoms of concussion, and PCS remains a chronic and highly disabling condition. One potential treatment option is transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique that has been shown to modify behavior by enhancing connectivity between targeted brain areas. However, research on the therapeutic effect of tDCS on PCS symptoms is limited, and the neurologic mechanisms underlying its effects are not well understood. The proposed study aims to address these knowledge gaps by examining the effects of tDCS on the central nervous system function in patients with PCS, with a specific focus on functional cortical connectivity and cognitive functions such as processing speed and executive function. The study also aims to add value to existing evidence by potentially opening new directions for designing intervention programs for the treatment of PCS after mTBI. conditions: Transcranial Direct Current Stimulation conditions: Post-Concussion Syndrome conditions: Functional Magnetic Resonance Imaging conditions: Magnetic Resonance Spectroscopy 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: tDCS with cognitive training programme measure: Executive function measure: Change in CANTAB® cognitive test - Reaction Time (RTI) measure: Change in CANTAB® cognitive test - Multitasking Test (MTT) measure: Change in CANTAB® cognitive test - Spatial Working Memory (SWM) measure: Exploratory mediator - default mode network (DMN) activation measure: Exploratory mediator - excitability-inhibitory (E/I) ratio sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Hung Hom state: Kowloon country: Hong Kong lat: 22.30715 lon: 114.18532 hasResults: False |
<|newrecord|> nctId: NCT06376487 id: 75202423.2.0000.0071 briefTitle: Pulmonary Aeration and Muscle Thickening Fraction: Association of Electrical Impedance Tomography and Ultrasound overallStatus: RECRUITING date: 2024-05-01 date: 2025-07-31 date: 2026-01-31 date: 2024-04-19 date: 2024-04-19 name: Hospital Israelita Albert Einstein class: OTHER name: Fundação de Amparo à Pesquisa do Estado de São Paulo name: Feculdade de Medicina da Universidade de Sao Paulo - Brasil briefSummary: The goal of this prospective clinical study is to evaluate the effect of different High Flow Nasal Cannula (HFNC) flow rates on diaphragm, rectoabdominal, and oblique thickening fraction, and to determine whether this effect depends on the action of HFNC flow rates on Functional Residual Capacity (FRC) in Infants under 2 years of age with a diagnosis of bronchiolitis and indication for use of HFNC. The main question\[s\] it aims to answer are: |
* If the thickening fraction of the abdominal muscle and diaphragm will change at the different flow rates evaluated |
* If the end-expiration lung impedance (EELZ) will change at the different flow rates evaluated |
The belt will be installed around the chest before the start of the change in flow rates and monitoring with Electrical Impedance Tomography (EIT) will be initiated. Patients will be positioned in dorsal decubitus elevated 10 to 20 degrees and monitoring will be performed continuously during all flow rate variations and also during the ultrasound performance. |
Four different randomized flow rates will be used for evaluation: 2.0 liter.Kg-1.min-1, 1.5 liter.Kg-1.min-1, 1.0 liter.Kg-1.min-1, 0.5 liter.Kg-1.min-1. At the end of the randomized order evaluation the infant will remain in the flow of 0.5 liter.Kg-1.min-1 for 5 minutes and then return to the flow of 2.0 liter.Kg-1.min-1. The EIT parameters, ultrasound assessment, and clinical variables will be collected at the end of the 5-minute stay in each lane. |
The randomization of the order of application of the phases will be carried out in blocks, so that the homogeneity of the sequences is maintained even if the collection is interrupted before reaching the total number of individuals. The blocks will be of size two and four and the test and production lists will be generated with the help of the R packages. conditions: Bronchiolitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A prospective clinical study to evaluated four different flow rate in infants with bronchiolitis using high flow nasal cannula primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Patient will not know the flow rate sequence used during the assessment count: 82 type: ESTIMATED name: Flow rate evaluation measure: diaphragm thickening fraction measure: abdominal muscle thickening fraction measure: EELZ (end-expiration lung impedance) sex: ALL maximumAge: 24 Months stdAges: CHILD facility: Hospital Israelita Albert Eisntein status: RECRUITING city: São Paulo zip: 05653000 country: Brazil name: Milena S Nascimento role: CONTACT phone: 55 11 984520061 email: [email protected] lat: -23.5475 lon: -46.63611 hasResults: False |
<|newrecord|> nctId: NCT06376474 id: HM005PS1S06 briefTitle: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-19 date: 2024-04-19 name: Ganzhou Hemay Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment. conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Hemay005 measure: Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax） measure: Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t） measure: Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf) measure: Relevant pharmacokinetic parameters，half-life (T1/2) measure: Relevant pharmacokinetic parameters，clearance (CL/F) measure: Relevant pharmacokinetic parameters，volume of distribution (Vz/F) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06376461 id: 333874 briefTitle: Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients acronym: GUTPHOS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-12 date: 2024-04-19 date: 2024-04-22 name: University Hospitals of North Midlands NHS Trust class: OTHER briefSummary: Part A Multiple organ dysfunction syndrome is one of the main problems in critically ill patients. Several organ dysfunctions are routinely and systematically monitored in patients admitted to intensive care units. Gastrointestinal dysfunction is currently not included in multiple organ dysfunction scores and lacks a standardised approach. At the same time, investigators earlier studies have shown that gastrointestinal dysfunction plays an essential role in the course of illness in intensive care patients. A tool for measuring dysfunction is needed to enable future studies on interventions to improve gastrointestinal function. The GIDS (GastroIntestinal Dysfunction Score) combines different clinical signs and symptoms commonly observed and documented in patients in the ICU into a scoring system, allowing distinguishing between different grades of severity of dysfunction. The investigators will only use observations documented during the patient's stay in the intensive care unit without additional measurements and calculate gastrointestinal (GIDS) and other organ dysfunction scores. |
Part B Phosphate is an electrolyte commonly measured and often corrected, while the indications and clear guidance for correction are insufficiently studied. The results of this study will assist in specifying indications for the correction of phosphate levels better and refine the management strategies in the future. Only phosphate levels measured as part of routine care will be documented, no additional samples for study purposes will be taken, and the study will not influence the treatment of phosphate disorders. conditions: Gastrointestinal Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Data collection measure: 28 day outcome measure: 90 day outcome measure: ICU length of stay measure: ICU length of stay measure: Hospital length of stay measure: Hospital length of stay measure: Free of organ support sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals of North Midlands NHS Trust city: Stoke-on-Trent country: United Kingdom lat: 53.00415 lon: -2.18538 hasResults: False |
<|newrecord|> nctId: NCT06376448 id: cc-obs-01 briefTitle: An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough overallStatus: RECRUITING date: 2022-10-24 date: 2024-10-04 date: 2025-02-10 date: 2024-04-19 date: 2024-04-19 name: Hull University Teaching Hospitals NHS Trust class: OTHER_GOV briefSummary: Cough has previously been described by the type of cough you have ie such as wet, dry, and chesty, and also by its features such as how often you are coughing its,intensity, and severity, but never has the varying patterns of cough been studied in any detail and it could be that the pattern of the cough is closely related to patient-perceived intensity, frequency and most importantly severity. Cough is a symptom and like any other symptom (such as pain) the severity of it can only be gauged by the patient experiencing it. |
We have created a one-page brand newl questionnaire that shows 4 distinct cough patterns that we believe exist and an empty field designed so that patients can record a pattern of cough they experience which is not already a choice on the questionnaire. The questionnaire also records patients' experience of how frequent, and intense, the cough is, and how it disrupts their lives, on a 1-10 scale (Visual analogue scale), the sum of these scores is collated and this gives us a severity score. The first phase of the project is to determine whether 30 Chronic cough patients understand the questionnaire, and are able to complete it with little direction, and if the cough patterns we identified encompassed all pattern types. second part of the study is to look at how repeatable the questionnaire is when completed over a 6 week period. conditions: Chronic Cough studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: The primary objective of the study is to characterize and identify the different patterns of cough in chronic cough patients measure: measure of cough severity measure: describe any correlation between severity of cough and cough pattern measure: reproducibility of questionnnare sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Redspiratory Medicine, First Floor, Daisy Building, Castle Hill Hospital status: RECRUITING city: Cottingham state: East Yorkshiure zip: HU16 5JQ country: United Kingdom name: Caroline Wright role: CONTACT phone: 01482624067 email: [email protected] name: Rachel H Thompson, Bsc role: CONTACT phone: 01482 461800 phoneExt: Thompson email: [email protected] name: Caroline Wright, Bsc role: PRINCIPAL_INVESTIGATOR lat: 52.50243 lon: -0.7554 hasResults: False |
<|newrecord|> nctId: NCT06376435 id: HBHQ-CTIT-RWS briefTitle: A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-07-01 date: 2026-07-01 date: 2024-04-19 date: 2024-04-19 name: Hebei Medical University Fourth Hospital class: OTHER briefSummary: The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world. |
The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia. |
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