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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
<\|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.
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: kurtbeyogluseda@gmail.com lat: 39.9179 lon: 32.86268 hasResults: False
<\|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: zhuji@zjcc.org.cn lat: 30.29365 lon: 120.16142 hasResults: False
<\|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.
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.
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.
Primary outcome is defined as the proportion of subjects achieving fecal disimpaction in each arm.
Secondary outcomes are defined as follows:
1. Total no of Days required to achieve fecal disimpaction in each arm
2. Cumulative dose of PEG required for fecal disimpaction in each arm
3. Proportion of subjects (\> 5 years age) reporting palatability issues in each arm
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: drkalpanapanda@gmail.com name: J Bikrant kumar Prusty, MD role: CONTACT phone: 91-9090205041 email: princejammy142@gmail.com 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
<\|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: stephen.burns@nie.edu.sg lat: 1.28967 lon: 103.85007 hasResults: False
<\|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
<\|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.
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.
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: cjy071949@163.com lat: 46.58333 lon: 125.0 hasResults: False
<\|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
<\|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
<\|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
<\|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.
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.
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.
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.
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
<\|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.
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
<\|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
<\|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:
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: a220242@chamc.co.kr lat: 37.43861 lon: 127.13778 hasResults: False
<\|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.
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.
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.
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.
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.
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
* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time
* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood
The study will have 2 treatment groups.
In Group 1, participants will take:
* BAY2927088 as a single dose on Days 1 and 8.
* Itraconazole once daily on Days 5 to 11.
In Group 2, participants will take:
* BAY2927088 as a single dose on Days 1 and 14.
* 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.
Participants will visit the study clinic:
* at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study
* on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2
* once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up
During the study, the doctors and their study team will:
* perform physical examinations
* collect blood samples from the participants to measure the levels of BAY2927088
* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The 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: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: BAY2927088 name: Itraconazole name: Carbamazepine measure: AUC of BAY2927088 with and without itraconazole measure: Cmax of BAY2927088 with and without itraconazole measure: AUC of BAY2927088 with and without carbamazepine measure: Cmax of BAY2927088 with and without carbamazepine measure: Number of participants with TEAEs measure: Severity of TEAEs sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06348875 id: CLN-PLAN-102v1 briefTitle: Clinical Evaluation of Radiation Reduction for Optimized Safety acronym: CERROS overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-07-15 date: 2024-07-31 date: 2024-04-05 date: 2024-04-05 name: Angiowave Imaging class: INDUSTRY briefSummary: The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques. conditions: Coronary Artery Disease conditions: Myocardial Infarction conditions: Coronary Disease conditions: Coronary Stenosis conditions: Angina Pectoris conditions: Chest Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Segment-level percent diameter stenosis (%DS) measure: Stenosis severity measure: Diagnostic quality measure: Radiation dose - SOC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Corewell Health West city: Grand Rapids state: Michigan zip: 49503 country: United States name: Ryan Madder, MD role: CONTACT phone: 616-391-4327 email: Ryan.Madder@corewellhealth.org name: Timothy Joseph, MD role: CONTACT phone: 616-391-4327 email: stacie.vanoosterhout@corewellhealth.org name: Ryan Madder, MD role: PRINCIPAL_INVESTIGATOR name: Timothy Joseph, MD role: PRINCIPAL_INVESTIGATOR lat: 42.96336 lon: -85.66809 hasResults: False
<\|newrecord\|> nctId: NCT06348862 id: 323/REC/2023 briefTitle: Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-06-30 date: 2024-06-30 date: 2024-04-05 date: 2024-04-05 name: Al-Quds University class: OTHER briefSummary: The aim of the current study is to analyze the effect of listening to Quran or music or natural sounds on anxiety and stress level among patients undergoing MRI. conditions: Anxiety conditions: Stress conditions: MRI Contrast Media Adverse Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double blinded whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 400 type: ESTIMATED name: Listening to either Quran, Music, and or Natural sound measure: Level of Anxiety among patients who underwent MRI measure: Level of Stress measure: Sociodemographic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06348849 id: 0797-11/2023 briefTitle: The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-05 name: Alexandria University class: OTHER briefSummary: The aim of the current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy. conditions: Molar Incisor Hypomineralization conditions: Hypersensitivity studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED measure: Desensitising effect in hypersensitive MIH molars measure: Change in the plaque index scores measure: Change in children's frequency of toothbrushing sex: ALL minimumAge: 7 Years maximumAge: 10 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06348836 id: 2123624-1/2 briefTitle: The Effects of Open Chain Versus Closed Chain Strengthening on Dynamic Valgus During a Step Down Test overallStatus: RECRUITING date: 2024-03-22 date: 2025-02-28 date: 2025-02-28 date: 2024-04-05 date: 2024-04-05 name: Alvernia University class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of different exercises programs in individuals with abnormal knee motion. The main question it aims to answer are:
* In individuals with abnormal knee motion and without knee pain, does a weight-bearing exercise program reduce abnormal knee motion during a step-down test better than a non weight-bearing exercise program? Participants will
* Perform a stepdown test while undergoing motion analysis and electromyograph (EMG) recording.
* Participants will then be placed either into a weight-bearing or non weight-bearing exercise group. Exercises will be performed 3 times per week for 6 weeks.
* Further motion analysis and EMG data will be collected to test for differences. Researchers will compare individual results before and after exercise, and between-group results before and after exercise to see if one exercise program helps improved abnormal knee motion more than the other. conditions: Dynamic Knee Valgus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to either a closed-chain (weightbearing) exercise group or an open-chain (non-weightbearing) exercise group primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Exercise measure: Electromyographic activity of gluteus medius muscle during step-down test measure: Electromyographic activity of quadriceps muscle during step-down test measure: Electromyographic activity of hamstring muscles during step-down test measure: Amount of dynamic knee valgus during step-down test measured with motion analysis sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alvernia University status: RECRUITING city: Reading state: Pennsylvania zip: 19607 country: United States name: James M O'Donohue, DPT role: CONTACT phone: 610-334-1162 email: jim@odfamily.com lat: 40.33565 lon: -75.92687 hasResults: False
<\|newrecord\|> nctId: NCT06348823 id: BritishUE briefTitle: Relationship Between Soft Tissue Volume and Gingival Phenotype: A Novel Classification System overallStatus: RECRUITING date: 2024-02-25 date: 2024-06 date: 2024-10 date: 2024-04-05 date: 2024-04-09 name: Ain Shams University class: OTHER name: British University In Egypt briefSummary: Different classifications to describe alveolar ridge defects have been published over the past years but no single classification has been developed concerning soft tissue volume around teeth or dental implants. Moreover, while several studies investigated the effect of various augmentation techniques and materials on soft tissue volume change and volume stability there is a real gap of knowledge regarding how to evaluate the available soft tissue volume and when to consider it sufficient or deficient which would definitely improve clinical decision making and treatment planing. Therefore, our primary aim was to assess the application of a novel classification system based on the correlation between buccal soft tissue volume and gingival biotypes and, also to assess the sensitivity of such novel method. conditions: Gingival Biotype conditions: Soft Tissue studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 56 type: ESTIMATED name: volume survey measure: soft tissue volume - biotype correlation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahmed Hamdy status: RECRUITING city: Cairo zip: 11234 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06348810 id: DTT2024 briefTitle: Dual-Task Training for People With Mild Cognitive Impairment and Mild Dementia acronym: DTT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-15 date: 2025-01-15 date: 2024-04-05 date: 2024-04-05 name: Taipei Medical University class: OTHER briefSummary: Evidence shows that people with dementia have a higher prevalence of sleep disturbance, cognitive decline, behavioral disturbance, and experience motor dysfunction. These symptoms are interrelated. However, few randomized controlled trial (RCT) studies implement dual-task training for mild cognitive impairment and mild dementia, especially for those who experience sleep problems and behavioral disturbances.
Therefore, this study aims to analyze the effect of dual-task training in improving global cognitive function, executive function, working memory, sleep, behavioral disturbances, balance, and flexibility among people with mild cognitive impairment and mild dementia.
The main questions it aims to answer are:
1. . Does dual-task training affect primary outcomes (global cognitive function, executive function, and working memory)
2. . Does dual-task training affect secondary outcomes (including sleep quality, behavioral disturbances, balance, and flexibility) for people with mild cognitive impairment and mild dementia?"
The length of dual-task training is 6 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 18. While the control group receives the usual care. Researchers will compare the experiment and control groups to see the effect of the dual-task training. conditions: Dementia conditions: Mild Cognitive Impairment conditions: Older Adult studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: eksperimental group receive dual-task training, while control group receive usual care and both conduct at the same time primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Outcomes Assessor will be blind, so they didnt know which is intervention group or control group whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dual-task training name: Usual care measure: Global cognitive function measure: Executive function measure: Working memory measure: Sleep Quality measure: Behavioral disturbance measure: Balance measure: Flexibility sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nursing Home city: Malang state: Jawa Timur zip: 65216 country: Indonesia name: Nur Aini, MSc role: CONTACT phone: +6285234727354 email: d432110003@tmu.edu.tw lat: -7.9797 lon: 112.6304 hasResults: False
<\|newrecord\|> nctId: NCT06348797 id: BHP01-01 briefTitle: Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-07-31 date: 2026-12-31 date: 2024-04-05 date: 2024-04-05 name: Sichuan University class: OTHER name: Chengdu Brilliant Pharmaceutical Co., Ltd. briefSummary: A study to evaluate the safety and feasibility of α-PD-L1/4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with/without bridge radiotherapy. conditions: Small Cell Lung Cancer Extensive Stage studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: α-PD-L1/4-1BB DLL3 CAR-T (BHP01) measure: Dose-limiting toxicity (DLT) measure: Objective Response Rate (ORR) measure: Progression-free survival (PFS) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Overall-Survival (OS) measure: CAR-T cell numbers sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06348784 id: 11 briefTitle: Screening for Ovarian Malignancy overallStatus: COMPLETED date: 2022-01-01 date: 2023-01-01 date: 2023-01-01 date: 2024-04-05 date: 2024-04-05 name: Ain Shams Maternity Hospital class: OTHER briefSummary: Ovarian cancer is the second most common gynecologic malignancy. In 2008, it was the seventh leading cause of cancer deaths in women worldwide. Estimating the risk of malignancy is essential in the management of adnexal masses and several mathematical models and scoring systems have been developed to be used for discrimination between benign and malignant adnexal masses. Knowledge of the specific type of adnexal pathology before surgery is likely to improve patient triage with high accuracy, and it also makes it possible to optimize treatment. The correct identification of stage I cancer is particularly important conditions: Early Detection of Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ACTUAL name: Assesment of Different NEoplasias in the adenexa model name: Risk of malignancy index name: Histopathologic examination measure: Sensitivity, specificity, positive predictive, and negative predictive value of Assessment of Different NEoplasias in the adneXa model for differentiating between benign and malignant ovarian tumors sex: FEMALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AinShams university maternity hospital city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06348771 id: Pro2023001579 briefTitle: Postprandial Inflammation and Nuts (PIN) in Older Adults acronym: PIN overallStatus: RECRUITING date: 2024-03-25 date: 2024-10-30 date: 2025-01-30 date: 2024-04-05 date: 2024-04-05 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice, but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain and inflammation. Given these findings, this study will examine the postprandial effects of meals with 2 levels of saturated fatty acids (SFA) on metabolic endotoxemia, inflammation and satiety, using a randomized cross-over design. The low SFA meal includes peanuts that are high in monounsaturated fatty acids (MUFA) and this will be compared to a high SFA meal. The results of this study have the potential to provide valuable insights into the role of peanuts in promoting health and preventing disease in at-risk older adults. conditions: Healthy Aging conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Higher SFA meal vs higher MUFA (nut) meal in individuals with overweight and obese primaryPurpose: PREVENTION masking: NONE count: 18 type: ESTIMATED name: monounsaturated fatty acids (MUFA) peanut meal measure: Concentration of Endotoxin measure: Concentration of Interleukin-6 measure: Concentration of Glucose and Insulin measure: Concentration of Triglyceride measure: Appetite measure: Concentration of Inflammatory markers measure: Concentration of zonulin measure: Lipid Profile measure: Characterization of the Microbiome measure: Concentration of incretin hormones measure: Concentration of Bone regulating markers sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foran Hall status: RECRUITING city: New Brunswick state: New Jersey zip: 08901 country: United States name: Sue Shapses, PhD role: CONTACT phone: 848-932-9403 email: shapses@rutgers.edu name: Rebecca Serrano, RD MPH role: CONTACT phone: 848-932-9403 email: rcjs@cinj.rutgers.edu lat: 40.48622 lon: -74.45182 facility: Rutgers University - NJ Inst Food Nutrition & Health status: RECRUITING city: New Brunswick state: New Jersey zip: 08901 country: United States name: Sue A Shapses role: CONTACT phone: 848-932-9403 email: shapses@rutgers.edu lat: 40.48622 lon: -74.45182 hasResults: False
<\|newrecord\|> nctId: NCT06348758 id: KAP towards AI briefTitle: Knowledge, Attitudes, And Perceptions of a Group of Egyptian Dental Students Towards Artificial Intelligence acronym: AIKnowledge overallStatus: ENROLLING_BY_INVITATION date: 2024-02-11 date: 2024-06-07 date: 2024-08-07 date: 2024-04-05 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: In the context of this ongoing AI revolution, it is essential to ensure that current and future clinical practitioners are up to date regarding this technology's current state and potential. It is valuable to assess the current attitude of clinical dentists and undergraduate students in dentistry regarding the future role of AI.
To the best of the author's knowledge, there is no study about Egyptian dental students' views and attitudes regarding the application of AI in dental practice. Therefore, this study aimed to evaluate the attitudes and perceptions of a group of dental students in Egypt towards AI. conditions: Health Knowledge, Attitudes, Practice studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 384 type: ESTIMATED name: questionnaire measure: knowledge, attitudes, and perceptions about artificial intelligence in Dentistry sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Cairo University- Faculty of Dentistry city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06348745 id: diaphragmatic ultrasound briefTitle: Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-05-01 date: 2024-04-05 date: 2024-04-08 name: Assiut University class: OTHER briefSummary: * Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.
* Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function.
* Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator. conditions: Diaphragm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: ultrasound measure: diaphragmatic function measure: pulmonary function . sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06348732 id: biomarkers in cardiomyopathy briefTitle: Diagnostic and Prognostic Role of Troponin and Brain Natriuretic Peptide in Pediatric Patients With Cardiomyopathy in Correlation to Echocardiography Findings overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-09 date: 2025-11 date: 2024-04-05 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: This study aims to assess the the role of cardiac biomarkers (troponin and ProBNP) in pediatric Patients with all types of cardiomyopathy in correlation with echocardiography findings . conditions: Cardiomyopathies studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 65 type: ESTIMATED measure: Diagnostic and Prognostic Role of Troponin and Pro BNP in Pediatric Patients with Cardiomyopathy in correlation to Echocardiography findings . sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06348719 id: 35RC21_9732_ROBOT-ECO-GYN briefTitle: Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer. acronym: ROBOT-ECO-GYN overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-10 date: 2027-10 date: 2024-04-05 date: 2024-04-05 name: Rennes University Hospital class: OTHER briefSummary: The standard treatment for endometrial cancer is surgery, as long as the stage of the disease and the patient's condition allow. It consists of hysterectomy (TSH) with bilateral adnexectomy. The recommended surgical approach is the minimally invasive or laparoscopic route, whose oncological safety has been demonstrated by the LAP2 study.
Since 2010 and the arrival of robotic surgery in gynaecology, the robot-assisted laparoscopic approach has gradually been used for endometrial cancer Hysterectomy.
Several studies have suggested that the cost and effectiveness of laparoscopy may vary according to the age and body mass index of the patient.
The investigators therefore hypothesise that robot-assisted laparoscopy may be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France.
The investigators therefore hypothesise that robot-assisted laparoscopy could be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France. The investigators will also test the efficiency of the surgical technique as a function of age and Body mass Index. conditions: Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: As part of this project, we are proposing an original approach by combining a randomized controlled trial with a prospective observational cohort and a retrospective cohort.
This research will therefore consist of 3 complementary studies :
A multicenter, parallel-group, open-label, randomized controlled superiority trial (ratio 1:1) comparing two groups:
* Group 1: laparoscopic robot-assisted hysterectomy
* Group 2: conventional laparoscopic hysterectomy A prospective cohort based on the randomized controlled trial A retrospective cohort primaryPurpose: OTHER masking: NONE count: 1680 type: ESTIMATED name: Robot-assisted laparoscopy name: conventional laparoscopy name: Prospective cohort study name: Retrospective cohort study name: information and consent name: randomization name: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence name: Surgical data collection name: Biological data collection name: Collection of histological data from the surgical specimen name: Phone calls name: Pain assessment name: Collect of data on non-reimbursed transport name: Collect of everyday help name: Collection of the business resumption date name: SF36 questionnaire name: Questionnaire EQ5D-5L name: FIGO Stadium name: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.) name: Collection of adjuvant treatments name: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one name: Collection of data measure: Cost-utility ratio expressed in terms of costs / QALY measure: Operating time measure: Conversion rate measure: Rate and nature of intraoperative complications measure: Post-operative complication rate and nature at D42 (Clavien-Dindo classification) measure: Post-operative complication rate and nature at M6 (Clavien-Dindo classification) measure: Volume of intraoperative blood loss measure: Number of RBC, FFP, PC transfused during hospital stay measure: Visual analogue scale (VAS) of pain 6h after surgery measure: Visual analogue scale (VAS) of pain 24h after surgery measure: Visual analogue scale (VAS) of pain D3 after surgery measure: Analgesic consumption at D1 after surgery measure: Analgesic consumption at D3 after surgery measure: Analgesic consumption at D7 after surgery measure: Analgesic consumption at D42 after surgery measure: EQ-5D-5L at inclusion after surgery measure: EQ-5D-5L at D1 after surgery measure: EQ-5D-5L at D3 after surgery measure: EQ-5D-5L at D7 after surgery measure: EQ-5D-5L at D14 after surgery measure: EQ-5D-5L at D21 after surgery measure: EQ-5D-5L at D42 after surgery measure: EQ-5D-5L at M3 after surgery measure: EQ-5D-5L at M6 after surgery measure: SF-36 at baseline after surgery measure: SF-36 at D3 after surgery measure: SF-36 at D7 after surgery measure: SF-36 at D42 after surgery measure: SF-36 at M6 after surgery measure: Consumption of care: average length of hospital stay measure: Consumption of care: average of number of re-hospitalizations, measure: Consumption of care: average of emergency room visits measure: Consumption of care: average of number of gynecologist consultations measure: Consumption of care: quantity of analgesic(s) measure: Consumption of care: measure: Consumption of care: average of number of work stoppage(s). measure: Time to initiate adjuvant treatment when indicated measure: Vital status at 6 months measure: Gas recovery time measure: QALYs from a collective perspective at D42 measure: QALYs from a collective perspective at M6. measure: Number of patients who underwent each approach measure: QALYs and average costs in relation to care consumption of patients included in the prospective cohort and in the randomized controlled trial according to the approach used and subgroups defined by age (<or> to 75 years) and BMI <or> to 30 kg/m2). measure: Surgical teams' perception of the benefits and limitations of robotic surgery in this indication, as well as perceived barriers and levers to the deployment of robot-assisted surgery in low- or intermediate-risk endometrial cancer. measure: Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale measure: Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX measure: Total annual costs of the foreseeable spread of robot-assisted surgery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Lille, Hôpital Jeanne de Flandre city: Lille zip: 59000 country: France name: Yohan Kerbage role: CONTACT lat: 50.63297 lon: 3.05858 facility: CHU LIMOGES, Hôpital Mère-Enfant city: Limoges zip: 87042 country: France lat: 45.83153 lon: 1.25781 facility: Hôpital Lariboisière/Hôpital Saint Louis city: Paris zip: 75010 country: France name: Cyrille Huchon role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Cochin city: Paris zip: 75014 country: France name: Bruno Borghese role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Européen Georges Pompidou city: Paris zip: 75015 country: France name: Henri Azaïs role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Bichat city: Paris zip: 75018 country: France name: Martin Koskas role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Tenon AP-HP city: Paris zip: 75020 country: France name: Yohann Dabi role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Pitié Salpêtrière city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Lyon Sud - Hospices Civils de Lyon city: Pierre-Bénite zip: 69495 country: France name: Pierre-Adrien Bolze role: CONTACT lat: 45.7009 lon: 4.82511 facility: Hôpital privé des côtes d'Armor city: Plerin zip: 22190 country: France name: Isabelle Jaffré role: CONTACT lat: 48.54249 lon: -2.77983 facility: CHU de Rennes, Hôpital Sud city: Rennes zip: 35200 country: France name: Vincent Lavoue role: CONTACT lat: 48.11198 lon: -1.67429 facility: CHU de Rouen city: Rouen zip: 76031 country: France name: Morgane Perrin role: CONTACT lat: 49.44313 lon: 1.09932 facility: CHU de Saint Etienne city: Saint Etienne zip: 42055 country: France name: Céline Chauleur role: CONTACT lat: 45.43389 lon: 4.39 facility: CHU de Strasbourg - Hôpital de Hautepierre city: Strasbourg zip: 67200 country: France lat: 48.58392 lon: 7.74553 facility: CHU de Tours - Hôpital Bretonneau city: Tours zip: 37044 country: France name: Lobna OULDAMER role: CONTACT lat: 47.38333 lon: 0.68333 hasResults: False
<\|newrecord\|> nctId: NCT06348706 id: Ain Shams University25032024 briefTitle: Effect of Dipeptidyl Peptidase- 4 Inhibitors on Non-Alcoholic Steatohepatitis and Type 1 Diabetes overallStatus: COMPLETED date: 2022-11-10 date: 2023-12-01 date: 2024-01-15 date: 2024-04-05 date: 2024-04-05 name: Ain Shams University class: OTHER briefSummary: Background: Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD) that can precipitate to advanced fibrosis and leads to cardiovascular morbidity and mortality. Many patients with type 1 diabetes mellitus (T1DM) had histological evidence of steatosis and met the histological criteria for NASH. Matrix metalloproteinase-14 (MMP-14) is a type 1 transmembrane proteinase expressed in liver fibrosis and is involved in the development of atherosclerosis and cardiovascular disease. Hepatic dipeptidyl peptidase-4 (DPP-4) expression in NAFLD may be directly associated with hepatic lipogenesis and liver injury. Some studies showed the beneficial effect of dipeptidyl peptidase-4 (DDP-4) inhibitors in NAFLD/NASH for their role in improving hepatic glucose metabolism. Vildagliptin, a DPP-4 inhibitor, could be promising therapeutic agents for NAFLD/NASH.
To the best of our knowledge, no previous study assessed the role of DPP-4 inhibitors in adolescent patients with T1DM and NASH.
Objectives: This randomized-controlled clinical trial assessed the impact of the oral DPP-4 inhibitor, vildagliptin, as an add-on therapy on NASH in adolescents with T1DM as well as its effect on glycemic control, lipid profile, MMP-14 levels and CIMT as a marker for subclinical atherosclerosis.
Methods: This study included 60 adolescents with T1DM and NASH with a mean age 15.6 ± 2.08 years and disease duration ≥ 5 years. Forty age- and sex-matched healthy subjects with a mean age 14.9 ± 3.2 years were enrolled as healthy controls to compare MMP-14 levels. T1DM patients were randomly assigned to receive oral vildagliptin (50 mg daily) with lunch meal for six months or not. Fasting and 2 hours post-prandial blood glucose levels, HbA1c, liver function tests, fasting lipid profile, hepatic steatosis index and triglyceride glucose (TyG) index were assessed. MMP-14 levels were measured by enzyme-linked immunosorbent assay among all patients and healthy controls. CIMT was assessed using Doppler ultrasound and transient elastography with controlled attenuation parameter (CAP) was performed to assess liver stiffness and steatosis stage. conditions: Diabetes Mellitus, Type 1 conditions: NASH studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Dipeptidyl peptidase 4 (DPP-4) inhibitor measure: Number of participants with treatment-related effect on NASH status in adolescents with type 1 diabetes mellitus measure: Number of participants with treatment-related Matrix metalloproteinase-14 (MMP-14) level change measure: Number of participants with treatment-related Glycemic control (HbA1c%) level change sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Nancy Elbarbary city: Cairo zip: 11361 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06348693 id: Gliotherapy briefTitle: Development of Therapeutic Approaches Modulating Molecular Targets Implicated on Cancer Stem Cell-related Aggressiveness overallStatus: RECRUITING date: 2017-04-19 date: 2025-11-21 date: 2025-11-21 date: 2024-04-05 date: 2024-04-05 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Experimental evidence suggests that cancer stem cells (CSCs) may play a key role in the malignancy of these tumors. In fact, due to the hypoxic tumor microenvironment, these cells are able to create compensatory pathways that confer stem-like, angiogenic and pro-tumoral functions. Furthermore, it has been demonstrated that brain tumor stem cells are radio- and chemo-resistant and therefore not treatable with the therapeutic protocols currently in use. To date, in fact, there are no definitive treatments for the eradication of brain tumors. In this scenario, sphingolips, a class of lipid deputized to several physiological functions, are also involved in tumor onset, progression, drug resistance, and aggressiveness. In hypoxic tumor microenvironment, CSCs present a modified rheostat in the metabolism of sphingolipid, in favor of Sphingosine-1-phosphate (S1P).
S1P is an intermediate of sphingolipid metabolism, formed from sphingosine through the action of sphingosine kinases (SK). Increasing evidence suggests that S1P acts as a tumor-promoting signal, predominantly in the extracellular environment, regulating important cellular properties correlated with tumor potential.
The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment. conditions: Glioblastoma conditions: Glioma conditions: Glioma Glioblastoma Multiforme studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: cell isolation from tumor biopsies and biomarker investigation measure: Investigation of molecular and metabolic signature of cancer stem cells to assess specific markers related to gliomagenesis and cancerogenesis. measure: Biomarker investigation measure: Cellular response to pharmacological treatments sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Stefania E Navone, PhD role: CONTACT phone: 0255034268 phoneExt: +39 email: stefania.navone@policlinico.mi.it name: Giovanni Marfia, MD, PhD role: CONTACT phone: 0255034268 phoneExt: +39 email: giovanni.marfia@policlinico.mi.it name: Stefania Navone, PhD role: PRINCIPAL_INVESTIGATOR name: Giovanni Marfia, MD, PhD role: SUB_INVESTIGATOR name: Laura Guarnaccia, PhD role: SUB_INVESTIGATOR name: Laura Begani, MSc role: SUB_INVESTIGATOR name: Marco Locatelli, Md, PhD role: SUB_INVESTIGATOR name: Claudia Fanizzi, MD role: SUB_INVESTIGATOR name: Luigi Schisano, MD role: SUB_INVESTIGATOR name: Antonella Ampollini, MD role: SUB_INVESTIGATOR name: Manuela Caroli, MD role: SUB_INVESTIGATOR name: Giulio Bertani, MD role: SUB_INVESTIGATOR name: Giorgio Fiore, MD role: SUB_INVESTIGATOR name: Antonio D Ammando, MD role: SUB_INVESTIGATOR name: Elena Scagliotti, MSc role: SUB_INVESTIGATOR name: Giorgia Abete Fornara, MSc role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06348680 id: AmasyaU-betuluzun-004 briefTitle: The Effect of Video-assisted Episiotomy Repair Training on Anxiety and Self-efficacy Levels in Midwifery Students overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-04-05 date: 2024-05-15 date: 2024-04-05 date: 2024-04-05 name: Amasya University class: OTHER briefSummary: The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training. conditions: Episiotomy Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 31 type: ESTIMATED name: Video assisted episiotomy repair training measure: State Anxiety Scale measure: Episiotomy Skills Self-Efficacy Scale sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06348667 id: 3184794 briefTitle: Effects of a Short- and Long-term 'Blackboard' Intervention on Ankle Stability in Older Adults overallStatus: RECRUITING date: 2024-03-07 date: 2024-06-10 date: 2024-06-10 date: 2024-04-05 date: 2024-04-05 name: University of Valencia class: OTHER briefSummary: The goal of this clinical trial is to assess the effectiveness of adding specific Blackboard Training (BB) exercises to conventional physiotherapy in improving foot and ankle parameters essential for fall prevention among older adults.
The main questions it aims to answer are:
1. Can the addition of BB exercises improve ankle dorsiflexion mobility?
2. Can the addition of BB exercises enhance single-leg stability and control of mediolateral displacement of the center of pressure?

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