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<|newrecord|> nctId: NCT06360445 id: HD1912BE202201 briefTitle: Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects overallStatus: COMPLETED date: 2022-05-26 date: 2022-08-21 date: 2022-08-21 date: 2024-04-11 date: 2024-04-11 name: CSPC Ouyi Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects were administered a single dose of 100 mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting conditions or 150mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting and Fed conditions. Venous blood samples were collected at pre-dose (0 h), and up to 72 h post dose. This study was to evaluate the bioequivalence and safety of the test formulation and the reference formulation of Olaparib Tablets in healthy subjects. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 2-period Crossover Assignment primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label count: 102 type: ACTUAL name: Olaparib Tablet test formulation 100mg name: Olaparib Tablet reference formulation 100mg name: Olaparib Tablet test formulation 150mg name: Olaparib Tablet reference formulation 150mg measure: Cmax Description: Maximum observed plasma concentration measure: AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time measure: AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration measure: Time of maximum observed plasma concentration (Tmax) measure: Terminal elimination half-life (T1/2) measure: Apparent total body clearance (Cl/F) measure: Apparent volume of distribution (V/F) measure: Number of participants with Adverse Events sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06360432 id: HSEARS20240214001 briefTitle: Effects of the EatWelLog App on Diet Management for Older Adults With Sarcopenic Obesity overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-10-31 date: 2025-04-30 date: 2024-04-11 date: 2024-04-11 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Sarcopenic obesity, characterised by concurrent reduced muscle mass and excess body fat, affects 11% of older adults worldwide, rising to 23% in those over 75. Considering the negative synergistic impact on health, promoting muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies for managing SO. Exercise and nutrition are the primary interventions recommended for SO.
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This project aims to evaluate the effects of the EatWellLog App developed by the investigators' team for local older adults, in improving:
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* their sarcopenic obesity status, measured by all four diagnostic criteria, including grip strength, muscle mass, physical performance and body fat mass (primary outcome), and,
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* nutritional self-efficacy, nutritional status, dietary quality, health-related quality of life, and adherence to diet and exercise regimens (secondary outcomes), by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group.
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The EatWellLog App, designed for older adults with SO, incorporating Klasnja and Pratt's five-strategy framework for mobile health (mHealth) applications development to facilitate health behavioural change. This App supports users with SO in managing daily diets that promote gradual weight loss and muscle mass preservation, adhering to the dietary regimen for this population.
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Forty older adults with SO will be recruited from local community health centres and then randomized to either m-health or control groups. Both groups will receive an 8-week supervised programme separately. The programme consists of personalised dietary modification programme and group-based exercise training which have been tested and used in the investigators' pilot and General Research Fund (GRF) project. Additionally, only the m-health group will be instructed to use the App for daily diet self-management.
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Participants will be assessed on a variety of outcomes immediately after the 8-week supervised programme (T1), which will be compared to the baseline (T0). To explore the possible long-term effects of the intervention, other measurements will be conducted at 3-(T2) and 6-(T3) months after the supervised programme, which will be compared with those conducted at T0. conditions: Sarcopenic Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-arm, assessor-blinded, parallel design pilot randomized control trial (RCT) consisting of a M-health and a control group will be adopted to evaluate the effectiveness of the EatWellLog App in improving older adults' sarcopenic obesity (SO) status and other SO-related parameters by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: An independent assessor who is blinded to the group allocations will assess the participants' outcomes. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Dietary modification program name: Exercise training name: The EatWellLog App measure: Changes of muscle strength measure: Changes of muscle mass measure: Changes of body mass index measure: Changes of waist circumference measure: Changes of fat mass measure: The Short Physical Performance Battery (SPPB) scale measure: Mini Nutritional Assessment (MNA) Short-form measure: Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale measure: Dietary Quality Index-International (DQI-I) measure: EuroQoL 5D (EQ-5D) measure: Diet Adherence measure: Exercise Adherence sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Hong Kong country: Hong Kong name: Amy Cheung, MA role: CONTACT phone: +852 27664145 email: amy-ka-po.cheung@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06360419 id: SOL-MDD-301 briefTitle: Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol acronym: PARADIGM overallStatus: RECRUITING date: 2024-03-18 date: 2025-12 date: 2025-12 date: 2024-04-11 date: 2024-04-11 name: Axsome Therapeutics, Inc. class: INDUSTRY briefSummary: PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Solriamfetol 300 mg name: Placebo measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Incidence of treatment-emergent adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Site status: RECRUITING city: Encino state: California zip: 91316 country: United States lat: 34.15917 lon: -118.50119 facility: Clinical Research Site status: RECRUITING city: Lemon Grove state: California zip: 91945 country: United States lat: 32.74255 lon: -117.03142 facility: Clinical Research Site status: RECRUITING city: Oceanside state: California zip: 92056 country: United States lat: 33.19587 lon: -117.37948 facility: Clinical Research Site status: RECRUITING city: Redlands state: California zip: 92374 country: United States lat: 34.05557 lon: -117.18254 facility: Clinical Research Site status: RECRUITING city: Riverside state: California zip: 92506 country: United States lat: 33.95335 lon: -117.39616 facility: Clinical Research Site status: RECRUITING city: Sherman Oaks state: California zip: 91403 country: United States lat: 34.15112 lon: -118.44925 facility: Clinical Research Site status: RECRUITING city: Upland state: California zip: 91786 country: United States lat: 34.09751 lon: -117.64839 facility: Clinical Research Site status: RECRUITING city: Cromwell state: Connecticut zip: 06416 country: United States lat: 41.5951 lon: -72.64537 facility: Clinical Research Site status: RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Clinical Research Site status: RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States lat: 30.33218 lon: -81.65565 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32801 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32806 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Chicago state: Illinois zip: 60634 country: United States lat: 41.85003 lon: -87.65005 facility: Clinical Research Site status: RECRUITING city: Boston state: Massachusetts zip: 02131 country: United States lat: 42.35843 lon: -71.05977 facility: Clinical Research Site status: RECRUITING city: Saint Charles state: Missouri zip: 63304 country: United States lat: 38.78394 lon: -90.48123 facility: Clinical Research Site status: RECRUITING city: Las Vegas state: Nevada zip: 89102 country: United States lat: 36.17497 lon: -115.13722 facility: Clinical Research Site status: RECRUITING city: Brooklyn state: New York zip: 11235 country: United States lat: 40.6501 lon: -73.94958 facility: Clinical Research Site status: RECRUITING city: Rochester state: New York zip: 14609 country: United States lat: 43.15478 lon: -77.61556 facility: Clinical Research Site status: RECRUITING city: Hickory state: North Carolina zip: 28601 country: United States lat: 35.73319 lon: -81.3412 facility: Clinical Research Site status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73118 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Research Site status: RECRUITING city: Media state: Pennsylvania zip: 19063 country: United States lat: 39.91678 lon: -75.38769 facility: Clinical Research Site status: RECRUITING city: Memphis state: Tennessee zip: 38119 country: United States lat: 35.14953 lon: -90.04898 facility: Clinical Research Site status: RECRUITING city: Wichita Falls state: Texas zip: 76309 country: United States lat: 33.91371 lon: -98.49339 facility: Clinical Research Site status: RECRUITING city: Everett state: Washington zip: 98201 country: United States lat: 47.97898 lon: -122.20208 hasResults: False
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<|newrecord|> nctId: NCT06360406 id: D1346R00009 briefTitle: Real-World Treatment Study of Koselugo (Selumetinib) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2031-09-30 date: 2031-09-30 date: 2024-04-11 date: 2024-04-11 name: AstraZeneca class: INDUSTRY briefSummary: As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea.
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This study will provide information on the Korean patient population that is treated with the study drug. conditions: Neurofibromatosis 1 conditions: Neurofibroma, Plexiform studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 150 type: ESTIMATED measure: Adverse events (AEs) rate measure: Physeal dysplasia occurance rate measure: Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06360393 id: 17384 briefTitle: Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients With Severe Asthma on Biologics acronym: OUTERSPACE-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-02 date: 2026-05 date: 2024-04-11 date: 2024-04-17 name: University Medical Center Groningen class: OTHER name: Trudell Medical International briefSummary: Severe refractory asthma affects about 3.5% of asthma patients, often necessitating biologic therapy in addition to standard treatment. However, little is understood about maintenance and reliever inhalation medication adherence in these cases which might impact overall biologic response. Objectively monitoring inhalation medication adherence remains a significant challenge. The Smart AeroChamber® device, capable of measuring adherence and inhalation technique, is untested in severe asthma patients on biologics, presenting a potentially cost-effective solution to monitor adherence and better understand treatment response.
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This study aims to assess the feasibility of the Smart AeroChamber® device in severe asthma patients on biologic therapy, with objectives to:
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1. Evaluate inhalation medication adherence patterns and inhaler technique, and comparing that adherence data with traditional measures e.g. the Test of Adherence to Inhalers (TAI), and an inhalation technique checklist.
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2. Investigate the association between inhaled medication adherence and clinical outcomes such as exacerbations, short-acting beta-agonists (SABA) use, oral corticosteroids use (OCS), Fractional Exhaled Nitric Oxide (FeNO), blood eosinophil count, and Asthma Control Questionnaire (ACQ) scores.
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3. Assess patient and healthcare provider satisfaction and usability of the Smart AeroChamber® device.
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The study design is prospective and observational, with a sample size of 110 adult patients diagnosed with severe asthma using biologic therapy. Participants will be followed for 12 months, during which they will receive Smart AeroChamber® devices. These devices will measure medication adherence and inhaler technique, and undergo assessments of clinical outcomes at regular intervals. Usability and satisfaction will also be evaluated using the Systems Usability Scale (SUS) in patients and healthcare professionals.
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The study will be conducted across five severe asthma clinics in the Netherlands. Data analysis will involve comparing the inhalation medication adherence data with traditional measures for adherence and inhalation technique, assessing clinical outcomes, and evaluating usability and satisfaction. The findings from this study will provide insights into the feasibility and effectiveness of using digital devices like the Smart AeroChamber® to support medication adherence and possibly improve outcomes in patients with severe asthma on biologic therapy. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Smart spacer measure: Comparative analysis of smart spacer medication adherence and inhaler technique against Test of Adherence to Inhalers (TAI-12) measure: Comparison of smart spacer medication adherence patterns (adherence and inhaler technique) with inhaler checklist examined by pulmonologist or pulmonary nurse measure: Assessing the association of smart spacer assessed adherence with annual exacerbation rate measure: Assessing the association of smart spacer assessed adherence with reliever inhaler use (e.g. SABA) measure: Assess the association of smart spacer assessed adherence with oral corticosteroids use measure: Assess the association of smart spacer assessed adherence with FeNO results measure: Assess the association of smart spacer assessed adherence with blood eosinophils measure: Assess the association of smart spacer assessed adherence with asthma control (ACQ-6) measure: Assess the association of smart spacer assessed adherence with spirometry results measure: Assess usability and patient satisfaction using the System Usability Scale measure: Assess usability and healthcare provider satisfaction using the System Usability Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medisch Centrum Leeuwarden city: Leeuwarden state: Friesland zip: 8934AD country: Netherlands name: Akke-Nynke van der Meer, MD, PhD role: CONTACT phone: +31 58 286 3875 email: a.n.van.der.meer@mcl.nl lat: 53.20139 lon: 5.80859 facility: Isala city: Zwolle state: Overijssel zip: 8025AB country: Netherlands name: Niels Patberg, MD role: CONTACT email: k.w.patberg@isala.nl lat: 52.5125 lon: 6.09444 facility: Stichting Sint Franciscus Vlietland Groep city: Rotterdam state: Zuid-Holland zip: 3118JH country: Netherlands name: Yasemin Türk, MD, PhD role: CONTACT phone: +31 10 461 6161 email: yasemin.turk@Franciscus.nl lat: 51.9225 lon: 4.47917 facility: University Medical Center Groningen city: Groningen zip: 9713GZ country: Netherlands name: Maarten van den Berge, MD, PhD role: CONTACT phone: +31 6 24450194 email: m.van.den.berge@umcg.nl name: Titia Klemmeier, RN role: SUB_INVESTIGATOR name: Huib Kerstjens, MD, PhD role: SUB_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: Foundation Martini Hospital city: Groningen zip: 9728NT country: Netherlands name: Marjolein J van Es, MD, PhD role: CONTACT phone: +31 50 524 5245 email: m.vanes@mzh.nl lat: 53.21917 lon: 6.56667 hasResults: False
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<|newrecord|> nctId: NCT06360380 id: AQP-CLP-004 briefTitle: Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System acronym: REFORM-HF overallStatus: NOT_YET_RECRUITING date: 2024-07-03 date: 2024-11-03 date: 2024-12-29 date: 2024-04-11 date: 2024-04-11 name: AquaPass Medical Ltd. class: INDUSTRY briefSummary: The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.
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Patients will wear a lightweight suit that helps remove excess fluids through their sweat.
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We want to see if AquaPass can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.
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Participants will select if to be treated at their home or in the outpatient clinic. conditions: Chronic Heart Failure conditions: CKD Stage 3 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A prospective, multicenter, single-arm, within-patient-controlled, pivotal trial, enrolling patients with decompensated heart failure and/or CKD stage 2-3 inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥40 mg furosemide or equivalent. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: AquaPass System measure: AquaPass Performance Evaluation measure: AquaPass Safety Evaluation sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360367 id: 2023-00060 briefTitle: mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii overallStatus: RECRUITING date: 2024-04-23 date: 2024-10-22 date: 2024-10-22 date: 2024-04-11 date: 2024-04-12 name: University of Hawaii class: OTHER name: United States Department of Agriculture (USDA) name: Pennington Biomedical Research Center briefSummary: The goal of this 8-week clinical trial is to learn whether the PortionSize Ed mobile app helps to improve healthy eating habits among early adolescents in the Hawai'i-Food and Lifeskills for Youth (HI-FLY) program.
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PortionSize Ed is a dietary assessment and nutrition education mobile app, that provides real-time feedback on adherence to tailored dietary recommendations. HI-FLY is a healthy lifestyle program delivered in schools throughout Hawaii. PortionSize Ed also contains educational videos.
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Participants in this study will be randomly assigned to either the HI-FLY only group (HI-FLY), where they will receive the standard HI-FLY program or to the HI-FLY + PortionSize Ed app (HI-FLY + PSEd) group where they will receive the standard HI-FLY program and a study iPhone with the PortionSize Ed app for the 8-week study. This will allow us to evaluate the effect of the PortionSize Ed app among early adolescents in HI-FLY. conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: HI-FLY Curriculum name: HI-FLY Curriculum + PortionSize Ed app measure: Feasibility- Study enrollment measure: Acceptability- User Satisfaction Survey (USS) scores and qualitative responses measure: Acceptability- Computer System Usability Questionnaire (CSUQ) scores measure: Acceptability- PortionSize Ed app usage data measure: Acceptability- Reason for study drop out measure: Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score measure: Efficacy- Change in HEI-2020 component scores measure: Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey measure: Feasibility- Study Attrition measure: Change in body weight sex: ALL minimumAge: 11 Years maximumAge: 14 Years stdAges: CHILD facility: University of Hawaii at Manoa status: RECRUITING city: Honolulu state: Hawaii zip: 96822 country: United States name: Chloe P Lozano, PhD role: CONTACT phone: 808-956-7095 email: cpanizza@hawaii.edu lat: 21.30694 lon: -157.85833 hasResults: False
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<|newrecord|> nctId: NCT06360354 id: 20230223 briefTitle: A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion overallStatus: RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2028-06-29 date: 2024-04-11 date: 2024-04-22 name: Amgen class: INDUSTRY briefSummary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers. conditions: Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 282 type: ESTIMATED name: AMG 193 name: Gemcitabine name: Nab-paclitaxel name: Cisplatin name: Pembrolizumab name: Modified FOLFIRINOX measure: Number of Participants Experiencing Dose Limiting Toxicities (DLT) measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) measure: Number of Participants Experiencing Serious Adverse Events (SAE) measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) measure: Disease Control (DC) per RECIST v1.1 measure: Duration of Response (DOR) per RECIST v1.1 measure: Time to Response (TTR) per RECIST v1.1 measure: Overall Survival (OS) per RECIST v1.1 measure: Progression-free Survival (PFS) per RECIST v1.1 measure: Maximum Plasma Concentration (Cmax) of AMG193 measure: Time to Maximum Plasma Concentration (tmax) of AMG193 measure: Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope National Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 hasResults: False
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<|newrecord|> nctId: NCT06360341 id: 202301946 briefTitle: Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-01-01 date: 2024-04-11 date: 2024-04-11 name: University of Florida class: OTHER briefSummary: The proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). The proposed research has significant potential to improve self-efficacy (the confidence in one's ability to manage their condition) which is one of the most potent factors for improved health outcomes. conditions: Low Back Pain, Mechanical conditions: Acute Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Individuals in the pilot randomized controlled trial (RCT) intervention will be randomized to either the intervention or routine discharge care (RC) using REDCap randomizer and assigned to RC or Emergency Department Digital Pain Self-Management Intervention (EDPSI) + RC. primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomization to RC or Intervention group will not be masked to the Principal Investigator (PI), co-PI, or to participants. count: 30 type: ESTIMATED name: Emergency Department Digital Pain Self-Management Intervention (EDPSI) name: Routine Discharge Care measure: Improving Self-Management Health Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UF Health Shand's Adult Emergency Department city: Gainesville state: Florida zip: 32608 country: United States name: Alexandria A Carey, MSN, MBA-HC role: CONTACT phone: 661-607-1702 email: alexandria.carey@ufl.edu name: Angela R Starkweather, PhD role: CONTACT phone: (352) 273-6323 email: a.starkweather@ufl.edu lat: 29.65163 lon: -82.32483 hasResults: False
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<|newrecord|> nctId: NCT06360328 id: 033-2024 briefTitle: Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial) acronym: JuniorDoc-VL overallStatus: RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-08-01 date: 2024-04-11 date: 2024-04-15 name: University Hospital Heidelberg class: OTHER briefSummary: Securing the airway through endotracheal intubation (ETI) is a fundamental skill for anaesthetists. It is used during surgery, in the intensive care unit, during periprocedural anaesthesia and in emergency medicine. The clinical relevance of airway management is demonstrated in particular by the fact that the main cause of serious anaesthesia-related complications lies in the area of airway management. increasing technological developments in recent years (e.g. video laryngoscopy \[VL\]) aim to reduce the complication rate in the area of airway management. however, there are currently a large number of VLs available, which differ massively in their application. Therefore, it is essential to systematically collect data and develop structured training in airway management, taking into account current technological developments.While endotracheal intubation is traditionally performed with a direct laryngoscope, indirect video laryngoscopy, with chip-based camera technology at its tip, has been introduced across the board in recent years and is now part of standard clinical and preclinical equipment. Doctors in advanced training are trained with a focus on direct laryngoscopy; the use of and training in indirect video laryngoscopy does not follow any standards; in addition, the decision as to which method of securing the airway is chosen has so far been the responsibility of the individual doctor in anaesthesiology, although there is a tendency for the VL to be associated with a higher success rate in the first intubation attempt, the so-called "first-pass success".The main aim of this clinical prospective, randomised controlled trial is to train anaesthetists in advanced training in conventional direct laryngoscopy on the one hand and indirect video laryngoscopy (VL) on the other, with a focus on tracking the progress of their skills after 200 intubations with regard to first-pass success. conditions: Intubation Complication conditions: Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control group = direct laryngoscopy Intervention group = video laryngoscopy primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: video laryngoscopy measure: Rate of Successful tracheal intubation on the first attempt (First-Pass-Success). measure: Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma. measure: Specify the number of attempts made during laryngoscopy. measure: Compare the level of training with intubation success. measure: Mention any failures or transitions to other rescue techniques. measure: Specify the use of Optimal External Laryngeal Manipulation (OELM) techniques such as backward, upward and rightward pressure (BURP) Cricoid Pressure (CP) or adjustment of the participant's head and neck position. measure: When using VL, record the occurrence of fogging. measure: Assess the glottic view using the Cormack-Lehane-Score (I - IV). (I = good view) measure: assess the glottic view using the Percentage of Glottic Opening Score (POGO) (0%-100%). (0%= no view, 100% best view) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University, status: RECRUITING city: Heidelberg state: Baden-Wuerttemberg zip: 69120 country: Germany name: Davut Deniz Uzun, MD role: CONTACT phone: 0049 62215639349 email: deniz.uzun@med.uni-heidelberg.de name: Felix Schmitt, MD role: CONTACT phone: 0049 62215639421 email: Felix.Schmitt@med.uni-heidelberg.de lat: 49.40768 lon: 8.69079 hasResults: False
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<|newrecord|> nctId: NCT06360315 id: 202201265 briefTitle: Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-02 date: 2024-04 date: 2024-06 date: 2024-04-11 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER briefSummary: Heart failure affects more than 1.5 million people in France, resulting in over 70,000 deaths and more than 165,000 hospitalizations each year. Viral and bacterial infections are frequently associated with episodes of acute heart failure in patients with chronic heart failure (CHF). Lower respiratory tract infections, such as influenza and pneumococcus, are common causes of hospitalization for decompensated heart failure, leading to increased morbidity and mortality. Studies have shown that pneumococcal vaccination can reduce the risks of heart attack or stroke in patients with heart failure. However, despite vaccination recommendations, coverage rates remain low, especially for pneumococcus. In this study, we will evaluate the impact of an incentive letter for pneumococcal vaccination on one-year hospitalization rate in patients with heart failure. conditions: Chronic Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 12000 type: ESTIMATED name: Incentive letter for pneumococcal vaccination to the patient and to the GP measure: 1-year Pneumococcus vaccination rate measure: 1-year all-cause hospital admission rate measure: 1-year specific hospital admission rate measure: 1-year all-cause mortality rate sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montpellier University Hospital city: Montpellier zip: 34090 country: France lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06360302 id: RECHMPL22_0505 briefTitle: Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients acronym: KREBSome-IRC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-11 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER briefSummary: This prospective, multicenter, cross-sectional, repeated-measures comparative study compared functional and biochemical response profiles to exercise between 2 groups of chronically ill patients (chronic renal failure dialysis patients and patients with metabolic syndrome) and a group of healthy subjects.
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The hypothesis is that the addition of plasma metabolic intermediates associated with energy disorders linked to insulin resistance, will improve the sensitivity of the assessment of muscle oxidative metabolism abnormalities, as reported in exercise intolerant subjects.
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In this way, the metabolomics approach during exercise would provide a biological and functional "signature" of insulin resistance of muscular origin, discriminating between insulin-resistant patients, healthy control subjects and dialysis patients, with an exercise metabolic profile approaching that observed in insulin-resistant patients. A better understanding of metabolic abnormalities could guide muscle rehabilitation.
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Participants will be asked to perform an exercise test, with several blood samples taken at different exercise intensities.
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Researchers will compare the metabolic profile of three groups: patients with chronic kidney disease, patients with metabolic syndrome and healthy subjects:
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* V'O2-adjusted lactate at rest and during exercise
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* The combination of exercise energy metabolism intermediates reflecting insulin resistance among Krebs cycle cofactors/substrates, ß-oxidation cofactors/substrates, amino acids conditions: Metabolic Syndrome conditions: Dialysis; Complications studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cross-sectional comparative study with repeated measures primaryPurpose: BASIC_SCIENCE masking: NONE count: 42 type: ESTIMATED name: Exercise test name: Blood sample name: Impedancemetry measure: Compare V'O2-adjusted plasma lactate profile at rest and during exercise (metabolic stress test), between chronic renal failure patients, patients with metabolic syndrome and healthy subjects. measure: Compare between the 3 groups their metabolic profile (Krebs cycle cofactors/substrates) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (ß-oxidation cofactors/substrates) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (amino acids) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (acyl-carnitine profiles) adjusted to V'O2 at rest and during exercise. measure: Anthropometry Comparison between the 3 groups sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie city: Montpellier zip: 34295 country: France name: Jean-Paul CRISTOL, Prof role: CONTACT phone: +33(0)4 67 33 83 15 email: jp-cristol@chu-montpellier.fr lat: 43.61092 lon: 3.87723 facility: Montpellier University Hospital city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06360289 id: ALN-TTR-NT-003 briefTitle: Observational Study of Neurofilament Light Chain (NfL) as a Biomarker in Asymptomatic Carriers of the Transthyretin (TTR) Variants and Patients With Hereditary Transthyretin-mediated (hATTR) Amyloidosis With Polyneuropathy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-11 date: 2024-04-11 name: Alnylam Pharmaceuticals class: INDUSTRY briefSummary: This is a single-center observational study evaluating the potential value of NfL as a biomarker for diagnosis, detection of disease onset, monitoring of disease progression, and treatment response in asymptomatic carriers of TTR variants and symptomatic hATTR amyloidosis patients with polyneuropathy. conditions: Hereditary Amyloidosis, Transthyretin-Related conditions: Asymptomatic Carrier State studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Standard of Care measure: NfL Levels in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline measure: Change in NfL Levels Over Time in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy measure: Correlation Between the NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline measure: Correlation Between the Change in NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy measure: Comparison of the Measured NfL Levels to the Normal Levels Expected to be Seen in the General Population by Using the Existing Reference Ranges and Databases measure: Time to Onset of Active Disease in Asymptomatic Carriers of TTR Variants measure: Disease Progression in Symptomatic hATTR Amyloidosis Patients with Polyneuropathy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Universitaire (CHU) Le Kremlin-Bicêtre Assistance Publique-Hôpitaux de Paris (APHP) city: Paris state: Île-de-France zip: 94270 country: France lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06360276 id: 14012021 briefTitle: Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy overallStatus: COMPLETED date: 2022-03-14 date: 2022-08-02 date: 2022-08-12 date: 2024-04-11 date: 2024-04-11 name: Alexandria University class: OTHER briefSummary: This study aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.
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Hypotheses for research:
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1. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit less fatigue than those who do not.
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2. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit improved coping behaviors than those who do not.
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A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping. conditions: Fatigue conditions: Coping Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Seated Exercises name: Psychoeducational Rehabilitation name: Routine Care measure: Piper Fatigue Scale measure: Mini-Mental Adjustment to Cancer Scale sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Nursing city: Alexandria zip: 56321 country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06360263 id: #1-6/2023 briefTitle: OSSEODENSIFICATION BY DENSAH BURS WITH ACTIVATED PLASMA ALBUMIN GEL FOR SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT overallStatus: RECRUITING date: 2023-07-11 date: 2024-08 date: 2024-08 date: 2024-04-11 date: 2024-04-11 name: Esraa Salem Kamal class: OTHER briefSummary: Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement. conditions: Bone Loss, Alveolar studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Densah bur in combination with activated plasma albumin gel measure: Postoperative pain measure: Implant stability measure: Vertical bone height gain measure: Bone density around implant sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry, Alexandria University status: RECRUITING city: Alexandria country: Egypt name: Esraa S Kamal, BDS role: CONTACT phone: 106 054 3345 phoneExt: +20 email: esraasalemkamal@gmail.com lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06360250 id: B2001-F20220601 briefTitle: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-10-30 date: 2024-10-30 date: 2024-04-11 date: 2024-04-11 name: Changchun BCHT Biotechnology Co. class: INDUSTRY name: The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine name: Anning City First People's Hospital briefSummary: To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation conditions: Clostridium Tetanus studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 190 type: ESTIMATED name: Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation name: Tetanus human immunoglobulin (HTIG) name: Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo name: Adsorbed tetanus vaccine (TT) measure: Safety evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PD evaluation index measure: PD evaluation index measure: PD evaluation index measure: Immunogenicity evaluation index sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06360237 id: ISIS 678354 briefTitle: Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS) overallStatus: AVAILABLE date: 2024-04-11 date: 2024-04-11 name: Ionis Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome (FCS). conditions: Familial Chylomicronemia Syndrome studyType: EXPANDED_ACCESS name: Olezarsen sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360224 id: CASES briefTitle: Collect Flow and Ultrasound Images of Coronary Bypass Grafts acronym: CASES overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2029-05-15 date: 2029-05-15 date: 2024-04-11 date: 2024-04-11 name: Medistim ASA class: INDUSTRY briefSummary: This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG). conditions: Cardiac Bypass Surgery (CABG) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes measure: Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360211 id: 22251 briefTitle: A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants overallStatus: RECRUITING date: 2024-04-17 date: 2024-06-11 date: 2024-06-11 date: 2024-04-11 date: 2024-04-22 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called Epidermal growth factor receptor (EGFR) and Human epidermal growth factor receptor 2 (HER2) mutations.
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Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2 that cause uncontrolled cell growth and increased spread of cancer.
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In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies on people with advanced NSCLC with EGFR or HER2 mutations.
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BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.
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Researchers think that BAY2927088 might affect an enzyme (called CYP3A4) that breaks down drugs in the body. This might make the effects of some drugs weaker or stronger. Midazolam is a drug that is broken down by CYP3A4. By studying the level of midazolam in the blood, researchers can understand how BAY2927088 might influence this enzyme's activity.
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The main purpose of this study is to find out how BAY2927088, taken as a single dose and as multiple doses, affects the level of another drug, called midazolam, in the blood of healthy participants. To achieve this goal, researchers will measure the following for midazolam when participants take it with or without BAY2927088:
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* Area under the curve (AUC): a measure of the total amount of midazolam in participants' blood over time
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* Maximum observed concentration (Cmax): the highest amount of midazolam in participants' blood
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The study will have 3 treatment periods:
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Period 1 (Day 1 to Day 2): On Day 1, participants will take midazolam Period 2 (Day 3 to Day 4): On Day 3, participants will take midazolam with BAY2927088 Period 3 (Day 5 to Day 15): On Days 5 to 13, participants will take BAY2927088 On Day 14, participants will take midazolam with BAY2927088
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Participants will be part of the study for about 8 weeks with at least 3 visits to the study clinic.
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Participants will visit the study clinic:
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* More than/at least once, within 2 to 28 days before the treatment starts
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* Once on the day before the treatment starts and will stay in the clinic until Day 15 of the treatment
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* Once, within 7 to 10 days after they finish treatment for a health checkup
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During the study, the doctors and their study team will:
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* do physical examinations
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* collect blood samples from the participants to measure the blood levels of midazolam and of BAY2927088
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* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
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* ask the participants questions about how they are feeling and what adverse events they are having
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An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. conditions: Advanced Non-small Cell Lung Cancer conditions: EGFR Mutation conditions: HER2 Mutation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: BAY2927088 name: Midazolam measure: Cmax of midazolam when given with and without BAY2927088 measure: AUC of midazolam when given with and without BAY2927088 measure: Number of participants with TEAEs measure: Severity of TEAEs sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: PAREXEL International, Baltimore status: RECRUITING city: Baltimore state: Maryland zip: 21225 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06360198 id: 2022-874/08 briefTitle: The Relationship Between Posture, Sense of Position, Musculoskeletal Discomfort and Anxiety overallStatus: COMPLETED date: 2022-06-30 date: 2022-11-30 date: 2022-12-30 date: 2024-04-11 date: 2024-04-11 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: It is known that posture is affected by various factors such as somatosensation, visual perception and cognition. In addition, it is also thought to affect conditions such as stress and anxiety through receptors. The aim of this study was to investigate the relationship between postural changes such as thoracic kyphosis, musculoskeletal problems, trunk position sense and anxiety in young individuals who were asymptomatic in terms of musculoskeletal problems. conditions: Kyphosis Postural Thoracic conditions: Proprioception conditions: Musculoskeletal System conditions: Anxiety studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 67 type: ACTUAL name: No intervention measure: Throcic Kyphosis measure: Trunk Position Sense measure: Musculoskeletal Discomfort measure: Anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Yıldırım Beyazıt University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06360185 id: Asthma V2 October 2023 briefTitle: Retrospective Study of Patients With Acute Presentation for Asthma to an Emergency Department in UK (RAPAE) acronym: RAPAE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-11 date: 2024-04-11 name: Norfolk and Norwich University Hospitals NHS Foundation Trust class: OTHER briefSummary: Study team will obtain a list of all patients who have been seen in A+E over the past 6 years with a discharge diagnosis of asthma. Their history will be reviewed from their A+E notes. Team will obtain weight and height from Electronic prescribing tool and will obtain compliance information and past medical history from participant's GP records. Team will use participant's postcode to word out socio economic status quintile using office of national statistics tool. The following information will be taken from hospital documentation and from GP records. conditions: Asthma Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED measure: Change in body weight measure: Change in body height sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360172 id: 3-2024 briefTitle: The Feasibility of Motivational Interviewing on Emotional Authenticity, Dispositional Optimism, And Academic Motivation Among Nursing Students: A Randomized Controlled Trial overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-20 date: 2024-06-01 date: 2024-06-15 date: 2024-04-11 date: 2024-04-11 name: Alexandria University class: OTHER briefSummary: Motivational interviewing, or MI, is a collaborative, person-centered counseling technique to uncover and enhance a person\'s motivation for behavior change . MI was first created for the treatment of substance dependence, but it has since been successfully implemented in several fields, including healthcare and education (. Given the vital role that nursing students play in the healthcare system, Saudi Arabia, like many other nations, has realized how important it is to improve the motivation and well-being of its nursing students conditions: Nursing Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Motivational Interviewing measure: Kernis-Goldman Authenticity Inventory measure: The Life Orientation Test-Revised form for Adolescents measure: Academic Motivation Scale sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Alexandria university city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06360159 id: Massage on Newborns briefTitle: Massage for Newborns Receiving Nasal CPAP overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-05-15 date: 2026-05-15 date: 2024-04-11 date: 2024-04-15 name: Sultan Besiktas class: OTHER briefSummary: One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications.
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Gastric-abdominal distension, which is a complication of NCPAP application, is caused by gas entering the stomach and gastrointestinal tract. Feeding intolerance may develop in the newborn due to abdominal distension. In recent studies, it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress. These practices include therapeutic touch, mother's voice, fetal position, white noise, lullaby, wrapping and massage. In the literature, a quasi-experimental study examining the effect of massage (Field massage technique) on the respiration, heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation, but respiration and heart rate decreased after the massage. has been determined. There are studies in the literature examining the effects of therapeutic touch, mother's voice, fetal position, white noise, lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP, reduce stress and pain, and prolong sleep time. However, no research has been found in the literature examining the effects of massage on the stress, comfort and health parameters of newborns receiving nasal CPAP. conditions: Massage conditions: Stress conditions: Newborn conditions: Comfort studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group (Massage): Babies in the intervention group will be massaged three times a day for 3 days, each session lasting 15 minutes, in accordance with the field massage technique. Massage application will be applied 1 hour after the babies are fed. For massage application, apply oil, solution and cream etc. to the baby's skin will not be used. During the massage application, the baby will be placed in prone and supine positions. Massage will be applied to the newborns in the intervention group by the assistant researcher.
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Control group: Apart from clinical routine practices, salivary cortisol samples will be taken from newborn babies in the control group and abdominal circumference of the babies will be measured. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Intervention measure: Stress Level measure: Salivary Cortisol Level measure: Comfort Score measure: Bilirubin Level measure: Nutrient ıntake amount measure: Abdominal Circumference Measurement measure: Defecation Frequency sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06360146 id: 120685123 briefTitle: Early Mobilisation of Post Cardiac Surgery in Geriatrics. overallStatus: ENROLLING_BY_INVITATION date: 2023-04-01 date: 2023-06-01 date: 2024-06-01 date: 2024-04-11 date: 2024-04-11 name: Ahi Evran University Education and Research Hospital class: OTHER briefSummary: Heart and blood vessel problems together referred to as cardiovascular diseases (CVD) include congenital heart disease, cerebrovascular illness, and coronary heart disease.
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Following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer complications.
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After cardiac surgery, older adults who exercise during the recovery period experience fewer difficulties and hospitalizations.
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A total of 100 elderly patients-69 men and 31 women-who had undergone cardiac surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B).
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Older patients undergoing cardiac surgery also experienced improved balance as a result of early mobilization and functional exercises. conditions: Cardiac Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE maskingDescription: Single count: 100 type: ESTIMATED name: Early mobilisation measure: International Physical Activity Questionnaire measure: Two Minute Walking Test sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: İsmail Ceylan city: Kırşehir state: Merkez zip: 40100 country: Turkey lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06360133 id: VVN001-CCS-301 briefTitle: Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-03 date: 2024-04-11 date: 2024-04-11 name: VivaVision Biotech, Inc class: INDUSTRY briefSummary: This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease. conditions: Dry Eye studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 700 type: ESTIMATED name: VVN001 Ophthalmic Solution, 5% name: VVN001 Ophthalmic Solution, Vehicle measure: Corneal Fluorescein Staining measure: Eye Dryness sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eye & Ent Hospital of Fudan University city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06360120 id: 00023098816 briefTitle: Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke overallStatus: RECRUITING date: 2024-04-10 date: 2025-04-10 date: 2025-05-10 date: 2024-04-11 date: 2024-04-11 name: Kafrelsheikh University class: OTHER briefSummary: Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever large-vessel ischemic stroke patients treated with clopidogrel assessed through NIHSS, mRS, and possible adverse effects. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will be composed of 2 arms atorvastatin arm, which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months, All the patients in the two groups received open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Our study was single-blinded to the investigators; an independent statistician generated a computer-generated randomization chart with a block size of four in a one-to-one ratio, and participants were randomly assigned to receive either atorvastatin or rosuvastatin by a specially trained and qualified nurse. None of the investigators included in the study knew the patients' assignments. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included atorvastatin bills, and Drug B included rosuvastatin bills. The statistical analysis was performed by an independent statistician. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Atorvastatin 40 Mg Oral Tablet name: Rosuvastatin 20mg measure: the rate of new stroke at 90 days measure: Value of National Institute of Health Stroke Scale (NIHSS) after one week measure: value of Modified Rankin Scale (mRS) at one week measure: value of Modified Rankin Scale(mRS) at three months measure: rate of composite recurrent stroke, myocardial infarction, and death due to vascular events measure: rate of drug adverse effects measure: Drug adverse effects: all side effects related to the drugs of our study will be reported sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: mohamed_gomaa@med.kfs.edu.eg lat: 31.11174 lon: 30.93991 hasResults: False
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<|newrecord|> nctId: NCT06360107 id: 76729 briefTitle: RCT of a Brief Video Intervention Targeting Peer Inclusion to Reduce Depression-related Stigma in Adolescents overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-11 date: 2024-04-11 name: New York State Psychiatric Institute class: OTHER name: Columbia University briefSummary: The goal of this study is to test the efficacy of a brief video intervention emphasizing peer inclusion on depression-related stigma and stigma outcomes (e.g., help seeking attitudes, secrecy) among adolescents 14-18.
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Timely identification and treatment of depression in adolescents is a public health priority. However, most youth with depression do not seek treatment, and stigma has been identified as the primary barrier to help-seeking. Experiments have found brief video-based interventions (BVIs), 1-2 minute videos similar to those viewed by youth on social media platforms, based on the principle of "social contact" with individuals affected by a stigmatized condition, effective in reducing depression-related stigma and increasing help-seeking among adolescents. However, given the extreme time constraints of these videos, optimizing the messaging is paramount. Prior research has indicated that concerns about peer social inclusion are fundamental in shaping stigma among adolescents.
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In this 3-arm RCT, we will recruit adolescents aged 14-18 using an online crowdsourcing platform, to test the efficacy of a) standard BVI that addresses mental health treatment but does not address concerns about peer inclusion/exclusion, b) novel BVI focused on mental health treatment and peer inclusion, and c) control condition that provides information without social contact. conditions: Depression conditions: Adolescent - Emotional Problem conditions: Stigma, Social conditions: Help-Seeking Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 650 type: ESTIMATED name: brief video measure: Depression Stigma Scale (modified) measure: Ultra-brief Self-stigma of Help-Seeking measure: Adolescent Stigma Scale (modified) sex: ALL minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: New York State Psychiatric Institute city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06360094 id: 1490-0004 id: 2023-510249-79-00 type: REGISTRY domain: CTIS id: U1111-1301-1311 type: REGISTRY domain: WHO Registry (ICTRP) briefTitle: A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis overallStatus: NOT_YET_RECRUITING date: 2024-07-27 date: 2025-07-21 date: 2025-08-06 date: 2024-04-11 date: 2024-04-11 name: Boehringer Ingelheim class: INDUSTRY briefSummary: Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF.
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Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF.
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During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects. conditions: Idiopathic Pulmonary Fibrosis conditions: Progressive Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 230 type: ESTIMATED name: BI 1839100 name: Placebo measure: IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h) measure: IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h) measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm) measure: IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% reduction in 24-h cough frequency (CC/h) measure: IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL) measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm) measure: IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score measure: IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360081 id: 1479-0019 id: 2023-510495-31-00 type: OTHER domain: CTIS id: U1111-1303-4345 type: OTHER domain: WHO briefTitle: A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2024-06-24 date: 2024-06-24 date: 2024-04-11 date: 2024-04-11 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Zongertinib measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72h (AUC0-72h) measure: Maximum measured concentration of the analyte in plasma (Cmax) measure: Time from dosing to maximum measured concentration of the analyte in plasma (tmax) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06360068 id: SLE-SASP POC id: 82371767 type: OTHER_GRANT domain: National Natural Science Foundation of China briefTitle: A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-05-01 date: 2025-05-01 date: 2024-04-11 date: 2024-04-11 name: Qiong Fu class: OTHER briefSummary: The goal of this clinical trial is to learn if sulfasalazine is safe and feasible in the treatment of active lupus erythematosus (SLE). The main questions it aims to answer are:
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Does drug sulfasalazine with stable background treatment help lower the disease activity (SLEDAI) at week 16? How many patients can reach SRI-4 at week 16? Can this regimen help lower the prednisone dosage the patients need at week 16? What about the change of the type I interferon related genes expression at week 16?
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Participants will:
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Take sulfasalazine 750mg/dose, twice a day for 16 weeks. The dosage will be increased to 1000mg/dose within one month, twice a day if the patient could tolerate.
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Visit the clinic once every 4 weeks for checkups and tests. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Sulfasalazine Tablets measure: the change of disease activity (SLEDAI score) measure: the number of patients who can reach SRI-4 measure: the change of prednisone dosage measure: the change of interferon stimulating genes (ISG) expression sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360055 id: M2024130 briefTitle: Effect of Oral D-mannose Tablets on Pharmacokinetics of Dabigatranate in Healthy Adults overallStatus: RECRUITING date: 2024-04-01 date: 2024-11-30 date: 2024-12-31 date: 2024-04-11 date: 2024-04-11 name: Peking University Third Hospital class: OTHER briefSummary: The aim of this study is to investigate the effects of oral D-mannose tablets for 2 consecutive weeks on the pharmacokinetics of dabigatrun etexilate, a P-glycoprotein probe substrate drug, in healthy adults conditions: Health studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: Dabigatran Etexilate name: D-mannose measure: Plasma concentration of dabigatran measure: Serum concentrations of glycoomics such as D-mannose sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Cheng Cui role: CONTACT email: cuicheng1226@163.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06360042 id: MA-HCC-II-021 briefTitle: Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC overallStatus: RECRUITING date: 2024-01-01 date: 2027-03-31 date: 2028-03-31 date: 2024-04-11 date: 2024-04-22 name: Peking University Cancer Hospital & Institute class: OTHER briefSummary: This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC. conditions: Unresectable Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 111 type: ESTIMATED name: Adebrelimab plus Apatinib name: Adebrelimab plus Bevacizumab name: Camrelizumab plus Apatinib measure: 12-month overall survival rate measure: ORR measure: DCR measure: DoR measure: TTR measure: TTP measure: PFS measure: OS measure: safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing state: Beijing country: China name: Jun Zhou role: CONTACT phone: 13366152815 email: Joelbmu@126.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06360029 id: LvL UP briefTitle: The LvL UP Pilot Trial overallStatus: RECRUITING date: 2024-04-15 date: 2024-06 date: 2024-06 date: 2024-04-11 date: 2024-04-17 name: Singapore ETH Centre class: OTHER name: ETH Zurich name: National University of Singapore name: Nanyang Technological University briefSummary: Non-communicable diseases (NCDs), such as cardiovascular disease, diabetes, or cancer, and common mental disorders (CMDs), such as depression or anxiety, represent the primary causes of death and disability worldwide, causing major health and financial burdens. Lifestyle behaviours, including physical activity, diet, stress and emotional regulation, tobacco smoking, alcohol consumption, and sleep are important modifiable risk factors associated with the prevention and management of both NCDs and CMDs.
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LvL UP is a mHealth intervention aimed at preventing NCDs and CMDs in adults from multi-ethnic Southeast Asian populations (Castro et al., 2023). Building upon leading evidence- and theory-based frameworks in the areas of mental health and behaviour change, a multidisciplinary team of researchers developed LvL UP as a holistic intervention centred around three core pillars: Move More, Eat Well, Stress Less.
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The goal of this pilot study is to assess the feasibility of a Sequential, Multiple Assignment, Randomized Trial (SMART) aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP and (ii) establishing the optimal blended approach in LvL UP that balances effective personalized lifestyle support with scalability. The main questions it aims to answer are:
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1. What are the intervention's preliminary, short-term effects? What is the intervention's level of engagement? What is the number of dropouts? What is the percentage of missing data? What is the intervention's responder / non-responder rate after week 4? How easy was to recruit the target sample size and which channels worked best?
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2. Considering the above pilot study results: What is the overall feasibility of the SMART research protocol in its current form? Are there any changes required for the main trial? This includes: recruitment approach, intervention content and delivery (app, provision of human support), and/or trial assessments (online and in-person). conditions: Health Behavior conditions: Noncommunicable Diseases conditions: Mental Health Issue conditions: Lifestyle Risk Reduction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: LvL UP name: LvL UP + MI name: Comparison measure: Mental well-being measure: Subjective well-being measure: Mental health (depression) measure: Mental health (stress) measure: Health-related quality of life measure: Health behaviours (physical activity) measure: Health behaviours (steps) measure: Health behaviours (diet 1) measure: Health behaviours (diet 2) measure: Health behaviours (sleep) measure: Health behaviours (smoking and alcohol consumption) measure: Anthropometry (body weight) measure: Anthropometry (body height) measure: Anthropometry (waist circumference) measure: Anthropometry (hip circumference) measure: Anthropometry (self-reported height and weight) measure: Resting blood pressure measure: Blood metabolic profile measure: LvL UP app: Response time measure: LvL UP app: Duration of app usage measure: LvL UP app: Actual usage of app components measure: LvL UP app: Coaching topic / sub-topic use measure: LvL UP app: Conversational turns measure: LvL UP app: Breeze (slow-paced breathing tool) usage measure: LvL UP app: Access to smartphone sensors (location - obfuscated) measure: LvL UP app: Access to smartphone sensors (location types) measure: LvL UP app: Access to smartphone sensors (raw gyroscope) measure: LvL UP app: Access to smartphone sensors (raw accelerometer) measure: LvL UP app: Access to smartphone sensors (physical activity) measure: LvL UP app: Access to smartphone sensors (WiFi connection status) measure: LvL UP app: Access to smartphone sensors (WiFi networks in range) measure: LvL UP app: Access to smartphone sensors (bluetooth scan) measure: LvL UP app: Access to smartphone sensors (battery % level and charging status) measure: LvL UP app: Access to smartphone sensors (screen on/off) measure: LvL UP app: Access to smartphone sensors (call and SMS metadata) measure: LvL UP app: Access to smartphone sensors (app usage & app name from notifications and action) measure: LvL UP app: Access to smartphone sensors (step count) measure: LvL UP app: Access to smartphone sensors (brightness) measure: LvL UP app: Access to smartphone sensors (breeze audio) measure: LvL UP app: Access to Apple Healthkit & Google Fit data measure: Process evaluation: Health literacy questionnaire measure: Process evaluation: Stages of change questionnaire measure: Process evaluation: Unintended consequences measure: Process evaluation (intervention group participants only): Net promoter score measure: Process evaluation (intervention group participants only): System usability scale measure: Process evaluation (intervention group participants only): Session alliance inventory measure: Process evaluation (intervention group participants only): Self-report habit index measure: Process evaluation (intervention group participants only): MITI-4 measure: Process evaluation (intervention group participants only): UMars measure: Process evaluation (intervention group participants only): Interview measure: Process evaluation (Research team): Field Notes measure: Exploratory aims: Sociodemographic measure: Exploratory aims: Use of digital health technologies measure: Exploratory aims: Ecologic Momentary Assessment of mood state measure: Exploratory aims: Personality measure: Exploratory aims: Work Engagement measure: Exploratory aims: Self-reported sickness absence sex: ALL minimumAge: 21 Years maximumAge: 59 Years stdAges: ADULT facility: Saw Swee Hock School of Public Health status: RECRUITING city: Singapore zip: 117549 country: Singapore name: Shenglin Zheng, MSc role: CONTACT email: shenglin.zheng@u.nus.edu lat: 1.28967 lon: 103.85007 facility: Singapore ETH Center status: ACTIVE_NOT_RECRUITING city: Singapore zip: 138602 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06360016 id: Protocol-RAP briefTitle: Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs acronym: Protocol-RAP overallStatus: COMPLETED date: 2023-02-13 date: 2023-05-31 date: 2024-02-01 date: 2024-04-11 date: 2024-04-11 name: Selcuk University class: OTHER name: University of Malaga briefSummary: Protocol of Self Regulation in Early Learners: The Role of Recreational Activity Program (RAP) RAP, which included fun games and lasted 24 sessions, was applied to the students in the study group. Twenty-four sessions include games that help gain rhythm, balance, and patience. The program is planned according to the game theory model, which aims to have fun for children. The program, which aims to develop children's self-regulation skills based on the essential reflections of the model, will include fun games with simple rules. Before the program was implemented, the researchers informed the experimental group about the research and the program, and verbal consent was obtained from the participants. conditions: Self Regulation conditions: Impulsive conditions: Attention Difficulties conditions: Emotion Regulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pre and post-test with the control group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double (Investigator, Outcomes Assessor) whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Recreation Activity Program measure: Self-Regulation Assessment sex: ALL minimumAge: 5 Years maximumAge: 6 Years stdAges: CHILD facility: Selcuk University city: Konya zip: 42400 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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