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And the final stage, having gained the opportunity to overcome internal obstacles, the doctor is ready to begin mastering specialized digital skills directly related to medical activities: work in medical information systems, remote monitoring, artificial intelligence, medical decision support systems.
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The result of the development of a doctor within this model will be not only digital literacy, but also the development of an internally stable personality that easily overcomes any obstacles not only in training, but also in communication with patients and colleagues. conditions: Digital Competences conditions: Emotional Intelligence conditions: Emotional Burnout conditions: Doctor Patient Relation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: Interview measure: Completing the survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349174 id: 2024-valve-1 briefTitle: Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: A Prospective Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2025-03-20 date: 2025-03-31 date: 2024-04-05 date: 2024-04-05 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:
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Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?
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Participants will:
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undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.
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receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery. conditions: Emphysema conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: bronchoscopic lung volume reduction surgery using endobronchial valve measure: Percentage change in FEV1 relative to baseline measure: Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators measure: Percentage change in RV relative to baseline measure: Percentage change in TLC relative to baseline measure: Percentage change in DLCO relative to baseline measure: Percentage change in SGRQ score relative to baseline measure: Percentage change in mMRC grade relative to baseline measure: Percentage change in 6MWD relative to baseline measure: the incidence of surgical-related adverse events sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan Friendship Hospital city: BeiJing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06349161 id: 1451_02/BVNTW-VNCSKTE briefTitle: Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience overallStatus: COMPLETED date: 2011-05 date: 2013-06 date: 2024-03 date: 2024-04-05 date: 2024-04-05 name: National Children's Hospital, Vietnam class: OTHER briefSummary: Open surgical dismembered pyeloplasty has traditionally been the preferred method for treating ureteropelvic junction obstruction (UPJO), with a success rate exceeding 94%. However, it is associated with drawbacks such as increased postoperative pain, extended hospital stays, and visible scarring. Minimally invasive alternatives, including laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP), have gained popularity since their introduction in 1993, offering comparable success rates to open surgery while providing cosmetic benefits and shorter hospital stays. Nevertheless, these techniques present challenges in pediatric patients, including limited working space, technical complexities, and prolonged operative times. The retroperitoneoscopic one-trocar-assisted pyeloplasty (OTAP) method, introduced in 2007, combines the advantages of minimally invasive surgery with the success rates of standard dismembered pyeloplasty. Despite favorable outcomes reported by several researchers, comprehensive studies regarding long-term follow-up and clinical outcomes are lacking. This study aims to evaluate the long-term outcomes of OTAP, addressing this gap in the medical literature. conditions: Ureteropelvic Junction Obstruction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 70 type: ACTUAL name: One-trocar-assisted pyeloplasty measure: Operative time measure: Conversion to open measure: Extension of skin incision measure: Postoperative complications measure: Median length of hospital stays measure: Median follow up length measure: Post-operative mean APD measure: Post-operative mean DRF measure: Mean incision length measure: Recurrence sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD facility: The National Hospital of Pediatrics city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False
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<|newrecord|> nctId: NCT06349148 id: NESTLE2022QN-0007 briefTitle: The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients overallStatus: RECRUITING date: 2024-01-01 date: 2025-08 date: 2025-12 date: 2024-04-05 date: 2024-04-05 name: SHUANGZHENGJIA class: OTHER briefSummary: The goal of this open-label randomized control trial is to study the effect of immunonutrition in locally advanced cervical cancer (LACC) with standard concurrent chemoradiotherapy. LACC patients undergoing radical synchronous chemoradiotherapy will be randomized into the experimental group receiving enteral immunonutrition therapy and the control group receiving standard enteral nutrition support.The main purpose it aims to answer are:1）Can immunonutrition therapy improve patients' dose-limiting toxicity(DLT) and DLT-free survival? 2）Can immunonutrition therapy improve patients' nutritional status and quality of life? conditions: Cervical Cancers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: enteral immunonutrition name: standard oral enteral nutrition measure: Dose-limiting toxicity measure: DLT-free survival measure: compliance measure: Prevalence of malnutrition measure: Prevalence of sarcopenia measure: QoL (Quality of life) measure: Objective response rate (ORR) measure: laboratory tests measure: 2-year overall survival measure: 2-year progression-free survival sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijing zip: 100021 country: China name: SHUANGZHENG JIA, PhD role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06349135 id: A.Ayman OMFS briefTitle: Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-04-15 date: 2025-12-15 date: 2024-04-05 date: 2024-04-05 name: Aya Ayman Ahmed class: OTHER briefSummary: Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures via Intraoral Versus Extraoral Approaches: Prospective Cohort Study conditions: Mandibular Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2 type: ESTIMATED name: Open Reduction & Internal Fixation measure: IL-17 measure: OPG measure: Blood Loss measure: Operative time sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06349122 id: 2023-509421-41-00 briefTitle: Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth acronym: AUTOP2 overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-03 date: 2028-01 date: 2024-04-05 date: 2024-04-05 name: Assistance Publique Hopitaux De Marseille class: OTHER briefSummary: Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis.
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The main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth.
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The hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%. conditions: Bacterial Vaginosis conditions: Vaginal Dysbiosis conditions: Premature Delivery studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1292 type: ESTIMATED name: Vaginal flora abnormalities screening and quantification using molecular biology technique name: Azithromycine name: Ceftriaxone name: Metronidazole name: Clotrimazole, Vaginal name: Usual Care measure: The rate of preterm birth sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349109 id: PA-WPW briefTitle: Physical Activity in Children With Wolff-Parkinson-White Syndrome overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-05-01 date: 2024-04-05 date: 2024-04-09 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: The aim of this study was to investigate the level of physical activity and its determinants in children with WPW. conditions: Wolff-Parkinson-White Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Cardiopulmonary exercise test name: Atrial-Ventricular Strain Analysis name: Arterial Stiffness Measurement name: Physical Activity Level name: Physical Activity Barriers Assesment measure: The Physical Activity Questionnaire for Older Children Score measure: VO2peak measure: aPWV measure: GLS measure: LASr measure: LASct measure: LAScd measure: Physical activity barriers (Parent) scale score measure: Physical Activity Outcome Expectancies (Child) scale score measure: Physical Activity Home Environment (Child) scale score sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hacettepe University status: RECRUITING city: Ankara country: Turkey name: Haluk Tekerlek, PhD role: CONTACT phone: +905355915009 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06349096 id: ALM-HAR-CLL-23-01 briefTitle: Safety And Efficacy Investigation Of The Effects Of ClearLift Q-Switched Nd:Yag 1064nm Laser Module In The Treatment Of Facial Skin Wrinkles overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2024-10 date: 2024-10 date: 2024-04-05 date: 2024-04-05 name: Alma Lasers class: INDUSTRY briefSummary: Alma Lasers ClearLift is a fractional non-ablative Q-Switched laser, allowing practitioners to use the benefits of a high intensity QS laser for the treatment of aged skin. Alma Harmony ClearLift uses a fractional QS laser to achieve a deep mechanical effect beneath the epidermis via a photoacustic effect. This creates a controlled dermal wound while leaving the epidermis intact. The wound healing process stimulates growth of new collagen, skin contracture and tightening. This procedure is virtually painless with no downtime and is safe for all skin types.
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Based on this background, we have considered an interest to design a study aimed at assessing the efficacy and safety of a treatment course with ClearLift Module in patients with facial skin wrinkles conditions: Facial Skin Wrinkles studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Alma Harmony measure: Primary endpoint measure: Secondary endpoint measure: Secondary endpoint measure: Secondary endpoint measure: Safety & Tolerability measure: Safety & Tolerability sex: FEMALE minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: San Luca Medical Clinic city: Tirana country: Albania name: Arminda Avdulaj, MD role: CONTACT phone: 694488000 phoneExt: +355 email: [email protected] name: Arminda Avdulaj, MD role: PRINCIPAL_INVESTIGATOR lat: 41.3275 lon: 19.81889 hasResults: False
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<|newrecord|> nctId: NCT06349083 id: 23-01227 briefTitle: Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2029-01 date: 2029-01 date: 2024-04-05 date: 2024-04-05 name: NYU Langone Health class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 200 type: ESTIMATED name: Psilocybin name: Inactive Placebo name: Supportive therapy sessions measure: Percent change in the alcohol cue-induced Blood-oxygen-level dependent (BOLD) signal in the lateral prefrontal cortex (PFC) measure: Percent change in the alcohol cue-induced BOLD signal change in the caudate measure: Percent change in alcohol cue-induced BOLD signal change in the ventromedial PFC (vmPFC) measure: Percent change in alcohol cue-induced BOLD signal change in the insula measure: Percent change in negative affective cue-induced BOLD signal change in the dorsomedial PFC (dmPFC) measure: Percent change in negative affective cue-induced BOLD signal change in the supramarginal gyrus measure: Percent change in negative affective cue-induced BOLD signal change in the amygdala measure: Percent change in negative affective cue-induced BOLD signal change in the insula measure: Percent change in alcohol cue-induced functional connectivity in prespecified regions of interest (ROI) measure: Percent change in negative affective cue-induced functional connectivity in prespecified regions of interest (ROI) measure: Percent change in the frequency of failed response inhibition measure: Change in discounting rate (log(k)) measure: Change in number of set-shifting errors measure: Average number of no heavy drinking days measure: Change in phosphatidyl ethanol (PEth) blood levels measure: Change in carbohydrate-deficient transferrin (CDT) blood levels measure: Change in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score measure: Change in PSQI global score measure: Change in patient's self-assessed quality of life (by the SF-36 Questionnaire) measure: Change in Alcohol craving score measure: Change in negative affect score measure: Change in impulsivity score (Barratt impulsivity scale by the subscales and by the total score) measure: Average number of no drinking days measure: Percentage of heavy drinking days measure: Average number of drinks per day measure: Percentage of abstinent days sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06349070 id: 23-00404 briefTitle: RESTORE - Phase II overallStatus: RECRUITING date: 2024-01-26 date: 2027-01-30 date: 2027-03-30 date: 2024-04-05 date: 2024-04-05 name: NYU Langone Health class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity , 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies. conditions: Maternal Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The study is a hybrid type III implementation-effectiveness trial using a longitudinal cluster-randomized trial with a modified stepped wedge design. In Year 1, all 10 clinics start with the low touch strategy, followed by randomization of clinics in Year 2 to either low touch (5 clinics) or high touch (5 clinics), and finally in Year 3, all 10 clinics will transition to the high touch strategy. Starting in Year 2, we will enroll a subsample of subjects into the a prospective cohort of pregnant persons who will participate in surveys at baseline and postpartum. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 900 type: ESTIMATED name: Low Touch - Text Messaging Implementation Strategy name: High Touch - Community Health Worker (CHW) Implementation Strategy measure: Percent adoption of the program measure: Mean number of videos viewed measure: Mean number of sessions completed measure: Level of adherence measure: Adequacy of Prenatal Care Utilization Index Score measure: Number of postpartum follow-up visits attended measure: Number of subjects who had a pre-term delivery measure: Number of subjects with post-partum depression measure: Mean gestational weight gain measure: Percent sustainability (continued adoption) following the M-CHW implementation period measure: Program Costs sex: FEMALE minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYC Health + Hospitals/Bellevue status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: NYU Langone Health status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06349057 id: AnkaraCHBilkent.1 briefTitle: The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-01 date: 2024-12-30 date: 2024-04-05 date: 2024-04-05 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Many drugs have anticholinergic activity. This means that it blocks the muscarinic binding of the neurotransmitter acetylcholine.
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In this study, the anticholinergic burden of the patients in the perioperative period will be calculated with the Anticholinergic Cognitive Burden Scale (ACBS) and patients with a score of 1 or above will be included in the study. Anticholinergic load of drugs used in the intraoperative period; Its effect on postoperative hospital stay, morbidity and mortality following elective heart surgery will be investigated. conditions: Mortality conditions: Postoperative Complications studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: reducing anticholinergic burden measure: Mortality measure: Effects on postoperative recovery measure: Effects on postoperative recovery measure: Postoperative complication measure: Length of stay in hospital and intensive care unit sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seda Kurtbeyoğlu status: RECRUITING city: Çankaya state: Ankara zip: 06800 country: Turkey name: Seda Kurtbeyoğlu role: CONTACT phone: +905388342776 email: [email protected] lat: 39.9179 lon: 32.86268 hasResults: False
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<|newrecord|> nctId: NCT06349044 id: BASIMA briefTitle: A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy/Stereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +/- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies. overallStatus: RECRUITING date: 2024-03-20 date: 2025-12-31 date: 2025-12-31 date: 2024-04-05 date: 2024-04-05 name: Zhejiang Cancer Hospital class: OTHER briefSummary: Based on the interaction between radiation therapy and immunotherapy and the potential potentiation of Probio-M9 for the treatment of ICIs, this study is planned to design an integrated treatment protocol for the first-line treatment of advanced gastrointestinal tumors through the use of macrofractionated radiotherapy as a means of immune activation, combined with the synergistic effect of Probio-M9 microbial agents and PD-1 inhibitors. conditions: Gastroesophageal Junction Adenocarcinoma conditions: Liver Cancer Stage IV conditions: Biliary Tract Cancer conditions: Pancreatic Adenocarcinoma conditions: Colorectal Cancer conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: Hypofractionated radiotherapy/SBRT（5-8 Gy/fx，3-5 fx） name: Anti-PD-1 monoclonal antibody name: Oxaliplatin and Capecitabine name: Anti-VEGF 15mg/kg name: Anti-VEGF 7.5mg/kg name: Gemcitabine and Cisplatin name: Gemcitabine and Albumin paclitaxel measure: ORR measure: ORR measure: adverse effects rate measure: Qol measure: PFS measure: OS measure: Qol sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhengjiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China name: Ji Zhu role: CONTACT phone: 13501978674 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06349031 id: IEC/IMS.SH/SOA/2024/683 briefTitle: Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-15 date: 2024-09-15 date: 2024-04-05 date: 2024-04-12 name: Institute of Medical Sciences and SUM Hospital class: OTHER briefSummary: Childhood constipation is a common but serious gastrointestinal disorder prevalent worldwide. In 90-95% of children, it is of functional origin. Thirty to seventy-five percent of children with functional constipation also have fecal impaction. The treatment strategy for functional constipation includes fecal disimpaction and maintenance therapy to ensure regular bowel movements.
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Polyethylene glycol (PEG) based laxatives have been recommended as the first-line therapeutic agents. The commonly used formulations are PEG 3350 with a molecular weight between 3200- 3700 g/mol and PEG 4000 with molecular weight of 4000 g/mol. Both are shown to be effective in pediatric constipation management in placebo-controlled trials. PEG 3350 + Electrolyte (E) is more widely used than PEG 4000 for the management of constipation. This might be because of the perception that PEG 3350 + E is safer in terms of preventing electrolyte imbalance. However, because of the inclusion of electrolytes, PEG 3350+ E solution taste saltier than PEG 4000. Many patients struggle to tolerate the unpleasant taste resulting in the high incidence of non-compliance. To date, no pediatric trials have compared PEG 4000 versus PEG 3350+E for management of Fecal disimpaction.
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Present study has been planned to evaluate the efficacy \& tolerability of PEG 4000 versus PEG 3350+ E for fecal disimpaction in pediatric functional constipation. Patients between age 1-16 years having functional constipation (as per ROME IV criteria) with fecal impaction will be included. Subjects will be randomly assigned to either PEG 4000 or PEG 3350+E at a ratio of 1:1. They will be stratified into 3 different age groups: 1-5 years, 6-11 years, and 12-16 years. They will receive either of the PEG solutions (as per allocation) at a dose of 1.5 gm/kg/day for 6 consecutive days or till the resolution of fecal impaction whichever is earlier. The resolution of fecal impaction is defined as the passage of clear liquid stool and the disappearance of palpable abdominal fecolith.
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Primary outcome is defined as the proportion of subjects achieving fecal disimpaction in each arm.
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Secondary outcomes are defined as follows:
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1. Total no of Days required to achieve fecal disimpaction in each arm
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2. Cumulative dose of PEG required for fecal disimpaction in each arm
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3. Proportion of subjects (\> 5 years age) reporting palatability issues in each arm
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4. Proportion of subjects discontinuing the treatment due to palatability issues in each arm conditions: Functional Constipation conditions: Fecal Impaction conditions: Constipation - Functional conditions: Constipation Chronic Idiopathic conditions: Pediatric Functional Constipation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: One member of the research group will do the treatment allocation and will not be involved in clinical evaluation and collection of outcome data. Both study medications will be provided by him/her in opaque bottles with identical packaging and labeling. Neither the participants nor the rest of the study personnel will be aware of the treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Administration of Polyethylene Glycol (PEG) 4000 as per treatment allocation to participants name: Administration of Polyethylene Glycol (PEG) 3350 + Electrolyte as per treatment allocation to participants measure: Proportion of subjects achieving fecal disimpaction in Each Arm measure: Total no of Days required to achieve fecal disimpaction in each arm measure: Cumulative PEG dose required for fecal disimpaction in each arm measure: Proportion of subjects reporting palatability issues in each arm measure: Proportion of subjects discontinuing the treatment due to palatability issues in each arm sex: ALL minimumAge: 1 Year maximumAge: 16 Years stdAges: CHILD facility: Institute of Medical Sciences (IMS) and SUM Hospital city: Bhubaneswar state: Odisha zip: 751003 country: India name: Kalpana Panda, MD, DM role: CONTACT phone: 91-9717133189 email: [email protected] name: J Bikrant kumar Prusty, MD role: CONTACT phone: 91-9090205041 email: [email protected] name: Mrutunjay Dash, MD role: SUB_INVESTIGATOR name: Basudev Biswal, MD role: SUB_INVESTIGATOR name: Mamta Devi Mohanty, MD role: SUB_INVESTIGATOR name: Prasant Saboth, MD role: SUB_INVESTIGATOR lat: 20.27241 lon: 85.83385 hasResults: False
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<|newrecord|> nctId: NCT06349018 id: IRB-2023-972 briefTitle: Effects of Isotonic Beetroot Supplementation on Sprint Interval Exercise Performance overallStatus: RECRUITING date: 2024-02-20 date: 2025-02-28 date: 2025-02-28 date: 2024-04-05 date: 2024-04-09 name: Nanyang Technological University class: OTHER briefSummary: This study aims to examine the effects of dietary nitrate supplementation via beetroot juice on sprint interval cycling exercise performance. Twenty-four participants (male or female) will undertake a randomized, crossover trial where they consume either (i) an isotonic beetroot juice drink containing nitrate (12.9 mmol) for 5 days or (ii) an isotonic sports drink (no nitrate) for 5 days. On Day 5 of each trial, participants will come to the laboratory and 2 hours after consuming their allocated drink will complete a 6 bouts of sprint interval exercise. Power output during cycling will be measured as the primary outcome measure. Salivary and plasma measures of nitrate and nitrite will be taken over the course of the morning on Day 5. After a 5-day washout period participants will crossover and begin their second trial. conditions: Exercise Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: DOUBLE maskingDescription: Both isotonic drinks (high nitrate or no nitrate) are deidentified and labelled (coded) by a third party not involved with the research. Randomization and allocation are completed by a third party not involved in the testing. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 24 type: ESTIMATED name: Dietary Supplement: High nitrate isotonic drink name: Dietary Supplement: No nitrate isotonic drink measure: Power output during maximal sprint cycling measure: Salivary nitrate measure: Plasma nitrate and nitrite measure: Muscle oxygenation measure: Sensory evaluation (Acceptance and Preference Test Evaluation by Meilgaard et al 2007) measure: Stroop test sex: ALL minimumAge: 21 Years maximumAge: 40 Years stdAges: ADULT facility: Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University status: RECRUITING city: Singapore zip: 637616 country: Singapore name: Stephen Burns, PhD role: CONTACT phone: 65 67903354 email: [email protected] lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06349005 id: 111 briefTitle: Laryngoscopy and Coronary Artery Bypass Graft Surgery acronym: VL overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-08-01 date: 2024-09-01 date: 2024-04-05 date: 2024-04-05 name: Konya Meram State Hospital class: OTHER briefSummary: In this prospective, randomized, controlled trial, the purpose is to compare Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope in terms of hemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG). conditions: Videolaryngoscopy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 112 type: ESTIMATED name: Tracheal intubation using Storz VL name: Tracheal intubation using Macintosh laryngoscopy name: Tracheal intubation using MacGrath VL name: Tracheal intubation using EzVision VL measure: Hemodynamic response measure: Hemodynamic response measure: Intubation time measure: Visualization of the glottis sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Betul Kozanhan city: Konya zip: 42005 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06348992 id: HMUDQ20240318001 briefTitle: ACT Combined Yoga for Parental Burnout in Parents With Autistic Children overallStatus: RECRUITING date: 2023-09-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-05 name: Harbin Medical University class: OTHER briefSummary: OBJECTIVE: To explore the intervention effect of ACT combined with a yoga intervention program on parenting burnout in parents with ASD.
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METHODS: This study used a combination of qualitative research and quantitative analysis to examine the intervention effects of an ACT-centered intervention program on parenting burnout in parents of children with ASD, and to clarify the evaluations and perceptions of parents with ASD about the research program through qualitative research.
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RESULTS AND CONCLUSION: To clarify the intervention effect of ACT combined with yoga intervention program on parenting burnout of ASD parents. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Acceptance commitment therapy and yoga name: Active Comparator: Mental Health Education Group measure: Measuring parental Burnout Levels measure: Measuring parenting stress Levels measure: Patient-Reported Outcomes Measurement Information System adult profile-57, PROMIS-57 measure: Medical Outcomes Study 36-Item Short-Form Health Survey, MOS SF-36 measure: Acceptance and Action Questionnaire-II, AAQ-II measure: Cognitive Fusion Questionnaire，CFQ-F sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Harbin Medical University Hospital status: RECRUITING city: Daqing state: None Selected zip: 043300 country: China name: Jiayi Chen, Master role: CONTACT phone: 15765962070 email: [email protected] lat: 46.58333 lon: 125.0 hasResults: False
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<|newrecord|> nctId: NCT06348979 id: CEBD 5/2021 briefTitle: Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns overallStatus: COMPLETED date: 2022-01-01 date: 2023-12-30 date: 2024-01-30 date: 2024-04-05 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: This research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area. conditions: Dental Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 110 type: ACTUAL name: Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns name: all ceramic Endocrowns (emax) measure: clinical Fracture measure: clinical performance marginal adaptation sex: ALL minimumAge: 18 Years maximumAge: 38 Years stdAges: ADULT facility: Cairo University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06348966 id: predictors of readmission briefTitle: Predictors of Hospital Readmission for Chronic Obstructive Pulmonary Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05 date: 2026-06 date: 2024-04-05 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: This study is aimed to determine the risk factors for hospital readmission within 6 months in COPD patients conditions: Hospital Radmission for COPD Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 188 type: ESTIMATED measure: assessment of potential predictors of readmission among COPD patients measure: development of early warning model for hospital readmission in COPD patients sex: ALL minimumAge: 25 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06348953 id: Bioactive restorative system briefTitle: Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-11 date: 2025-11 date: 2024-04-05 date: 2024-04-09 name: Cairo University class: OTHER briefSummary: This research study delves into the effectiveness of bioactive and non-bioactive restorative systems in deep carious permanent molars treated with selective caries removal. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue. The study investigates how the choice of restorative material influences the outcomes of selective caries removal procedures in deep carious lesions. By assessing factors such as restoration integrity, pulpal response, and long-term success rates, the research seeks to provide evidence-based insights into the comparative performance of bioactive and non-bioactive restorative systems in this clinical context. conditions: Dental Caries conditions: Dental Diseases conditions: Deep Caries conditions: Tooth Diseases conditions: Tooth Decay conditions: Teeth; Lesion conditions: Caries; Dentin conditions: Dental Restoration Failure of Marginal Integrity conditions: Tooth Demineralization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: selective caries removal and conventional non-bioactive restorative system name: selective caries removal and bioactive restorative system measure: Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5 measure: Functional properties - fracture&retention-marginal adaptation-Radiographic Examination"when applicable"-Scoring system Ordinal 1-5 measure: Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5) measure: Success or Failure sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06348940 id: 83242392 briefTitle: Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-12 date: 2024-06-12 date: 2024-06-12 date: 2024-04-05 date: 2024-04-08 name: Anhui Medical University class: OTHER briefSummary: The majority of cancer patients experience varying degrees of psychological distress and physical symptoms due to the presence of cancer or the process of treatment. These symptoms are closely associated with inflammatory markers and patient prognosis, highlighting the urgent need for effective psychological intervention methods. Behavioral activation, an emerging psychological intervention approach, requires further investigation regarding its potential in alleviating negative emotions among cancer patients. Therefore, the investigators conducted a randomized controlled trial (RCT) to investigate whether (1) behavioral activation can ameliorate negative emotions and physical symptoms in cancer patients; (2) behavioral activation can contribute to improved survival outcomes for these patients; and (3) behavioral activation can enhance NLR levels and other clinical indicators among individuals with cancer.
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The investigators aimed to recruit a total of 390 cancer patients, comprising 170 individuals diagnosed with esophageal and gastric cancer, 100 individuals with colorectal cancer, and 120 individuals with lung cancer. These patients were recruited from the Department of Oncology at the Second Affiliated Hospital of Anhui Medical University between March 2023 and November 2023. They were randomly allocated into two groups: an intervention group (behavioral activation+care as usual, BA+CAU) and a control group (care as usual, CAU). The intervention group underwent an eight-week behavioral activation program (see Detailed Description) designed to promote engagement in meaningful activities that are physically and emotionally rewarding while reducing involvement in maladaptive emotional cycles. Both the intervention group and the control group received standard care along with conventional treatment for their respective cancers.
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This study aims to demonstrate the significant efficacy of behavioral activation in improving negative emotions, somatic symptoms, quality of life, and clinical inflammatory indicators among cancer patients. Furthermore, it may potentially enhance patient survival rates, thereby offering a novel approach for psychological intervention in cancer patients and contributing to multidisciplinary treatment and management strategies. The intervention measures employed in this study do not involve any pharmacological treatments or hazardous activities. For illiterate or less educated patients, the informed consent process and questionnaire collection will be conducted using methods that ensure their full comprehension (e.g., verbal explanations, visual aids). Additionally, patients with evident cognitive impairments were excluded from the study.
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The investigators have implemented a questionnaire system on the WJX website (https://www.wjx.cn/) to collect patient information through both paper and electronic questionnaires. The psychological measurement questionnaires are stored electronically, while socio-demographic data and clinical indicators are collected in the hospital's medical record management system. Subsequently, all data is summarized and saved in local Excel files and SPSS files for specialized analysis by data analysts. Patient names are anonymized within the database, ensuring strict confidentiality of personal information such as contact details and home address.
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Possible statistical methods include descriptive statistical analysis, generalized estimating equation or repeated measures analysis of variance, structural equation modeling, correlation analysis and regression, survival analysis, etc. conditions: Cancer Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 390 type: ESTIMATED name: behavioral activation measure: Sociodemographic data measure: Status of Tumor measure: Body Mass Index, BMI measure: Biochemical index measure: Blood Pressure, BP measure: Nutritional Risk Screening, NRS measure: Visual Analogue Scale, VAS measure: Karnofsky Performance Status Scale, KPS measure: Psychological Distress Thermometer (DT) measure: Hospital anxiety and depression scale (HADS) measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) measure: Pittsburgh sleep quality index (PSQI) measure: Revised Piper Fatigue Scale (PFS-R) measure: International physical activity questionnaire (IPAQ) measure: Brief Resilient Coping Scale (BRCS) measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: General Self-Efficacy Scale (GSES) measure: The activation subscale of Behavioral Activation for Depression Scale (BADS-A) measure: Social Impact Scale (SIS) measure: Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF) measure: The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) measure: Time of Progression-free survival (PFS) measure: Time of Time to progression (TTP) measure: Concentration of C-reactive protein (CRP) measure: Value of Neutrophils to lymphocytes ratio (NLR) measure: Value of Platelet-lymphocyte ratio (PLR) measure: Value of Monocyte-lymphocyte ratio (MLR) measure: Value of Systemic immune inflammation index (SII) measure: Value of Pan-immune inflammation value (PIV) measure: Concentration of Carcinoembryonic antigen (CEA) measure: Concentration of Carbohydrate antigen 19-9 (CA19-9) measure: Concentration of Carbohydrate antigen 72-4 (CA72-4) measure: Concentration of Neuron-specific enolase (NSE) measure: Concentration of Squamous cell carcinoma associated antigen (SCC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital of Anhui Medical University city: Hefei state: Anhui country: China lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06348927 id: DZ2023EI004 briefTitle: Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC acronym: WUKONG-32 overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-10-31 date: 2027-04-30 date: 2024-04-05 date: 2024-04-05 name: Hunan Province Tumor Hospital class: OTHER briefSummary: This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.
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Condition or disease Intervention/treatment Phase Non-Small Cell Lung Cancer Drug: sunvozertinib Drug: anlotinib Phase 2 conditions: Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: sunvozertinib in combination with Anlotinib measure: Progression-free survival (PFS) measure: Objective Response Rate (ORR) measure: Overall survival (OS) measure: Duration of Response (DoR) measure: Adverse events (AEs) according to CTCAE 5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410013 country: China lat: 28.19874 lon: 112.97087 hasResults: False
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<|newrecord|> nctId: NCT06348914 id: 6991 briefTitle: Knowledge of Vital Pulp Therapy in Permanent Teeth Among a Group of Dental Students in Egypt overallStatus: NOT_YET_RECRUITING date: 2024-09-10 date: 2024-11-10 date: 2024-12-30 date: 2024-04-05 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: Conducting this questionnaire will help in collecting information about the extent of knowledge of vital pulp therapy in permanent teeth among dental students in Egypt. This will aid in identifying the knowledge gap, interest, and challenges regarding utilization of vital pulp therapy in permanent teeth. conditions: Vital Pulp Therapy studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 323 type: ESTIMATED name: Knowledge assessment name: Educational Material measure: Knowledge of vital pulp therapy measure: Knowledge after awareness about vital pulp therapy sex: ALL minimumAge: 15 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06348901 id: 2021-09-001 briefTitle: Clinical Utility of Oxford Cognitive Screen Test to Screen Cognitive Impairment in Post Stroke Patients overallStatus: RECRUITING date: 2021-09-01 date: 2025-02-28 date: 2025-02-28 date: 2024-04-05 date: 2024-04-05 name: Bundang CHA Hospital class: OTHER briefSummary: The goal of this type of study: clinical trial is to assess K-OCS clinical utility in participant population. The main aims:
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validate the reliability and validity of the Korean version of the Oxford Cognitive Screen (K-OCS) analyze its sensitivity, specificity, and diagnostic accuracy, and compare its examination participation rates with existing assessment tools to determine the effectiveness of K-OCS in detecting post-stroke cognitive impairment. conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Measurement of K-OCS measure: Measurement of Korean version of mini-mental state examination (K-MMSE) measure: Measurement Korean Version of the Oxford cognitive screen (K-OCS) measure: Measurement of national institute of health care stroke scale (NIHSS) measure: Measurement of fuctional independence meausure (FIM) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center status: RECRUITING city: Seongnam-si state: Gyeonggi-do zip: 13496 country: Korea, Republic of name: Eunyoung Cho role: CONTACT phone: +82-10-2753-0285 email: [email protected] lat: 37.43861 lon: 127.13778 hasResults: False
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<|newrecord|> nctId: NCT06348888 id: 22250 briefTitle: A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-05-30 date: 2024-05-30 date: 2024-04-05 date: 2024-04-05 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 EGFR and 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 with people who have 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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BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced.
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The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine
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* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time
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* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood
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The study will have 2 treatment groups.
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In Group 1, participants will take:
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* BAY2927088 as a single dose on Days 1 and 8.
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* Itraconazole once daily on Days 5 to 11.
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In Group 2, participants will take:
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* BAY2927088 as a single dose on Days 1 and 14.
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* Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2.
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Participants will visit the study clinic:
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