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Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint. conditions: Down Syndrome conditions: Gingival Bleeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Biorepair Plus Parodontgel Intensive name: Placebo gel measure: Change in Bleeding on Probing (BOP%) measure: Change in Plaque Control Record (PCR%) measure: Change in Dental mobility measure: Change in Modified Gingival Index measure: Change in compliance measure: Change in product satisfaction sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino" city: Turin zip: 10128 country: Italy lat: 45.07049 lon: 7.68682 hasResults: False
<\|newrecord\|> nctId: NCT06293898 id: BL-M07D1-ST-101 briefTitle: Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors overallStatus: RECRUITING date: 2024-02-09 date: 2025-08-24 date: 2027-08-24 date: 2024-03-05 date: 2024-03-05 name: SystImmune Inc. class: INDUSTRY briefSummary: The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors. conditions: Endometrial Cancer conditions: Cervical Cancer conditions: Ovarian Cancer conditions: Urothelial Carcinoma conditions: Biliary Tract Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 280 type: ESTIMATED name: BL-M07D1 measure: Summary of safety measure: To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SystImmune Recruiting Site status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: SystImmune role: CONTACT lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06293885 id: PLUG-II briefTitle: Pleurodesis Using Hypertonic Glucose acronym: PLUG-II overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-04-30 date: 2025-04-30 date: 2024-03-05 date: 2024-03-05 name: Lawson Health Research Institute class: OTHER briefSummary: Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection. conditions: Air Leak From Lung studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Dextrose 50 name: Standard of Care - No Dextrose 50 measure: Prolonged Air Leak measure: Duration of Chest Tubes measure: Home with Chest Tube sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London Health Sciences Centre city: London state: Ontario zip: N6A 5W9 country: Canada lat: 42.98339 lon: -81.23304 hasResults: False
<\|newrecord\|> nctId: NCT06293872 id: IZC miniscrew briefTitle: Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region overallStatus: COMPLETED date: 2023-02-25 date: 2023-07-10 date: 2023-12-28 date: 2024-03-05 date: 2024-03-05 name: University of Baghdad class: OTHER briefSummary: Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability, pain perception, sinus penetration, secondary stability and failure rate. conditions: Orthodontic Appliance Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ACTUAL name: 12*2 mm length miniscrew measure: failure rate measure: primary stability measure: secondary stability measure: pain perception sex: ALL minimumAge: 15 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: University of Baghdad College of Dentistry city: Baghdad zip: 10011 country: Iraq lat: 33.34058 lon: 44.40088 hasResults: False
<\|newrecord\|> nctId: NCT06293859 id: 5047292 briefTitle: Effect of 12-week Probiotic Consumption Immobilized on Oat Flakes on Blood and Urine Biomarkers and Human Microbiome acronym: FOODBIOMES CT2 overallStatus: COMPLETED date: 2023-02-15 date: 2023-07-07 date: 2023-07-30 date: 2024-03-05 date: 2024-03-05 name: University of the Aegean class: OTHER name: Democritus University of Thrace briefSummary: The purpose of this clinical trial was to evaluate the effects Lactococcus cremoris spp. im-mobilized on oat flakes on human microbiome and blood and urine biomarkers of associated with human health. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 54 type: ACTUAL name: Probiotic oat flakes name: Conventional oat flakes measure: Inflammatory biomarkers sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of the Aegean city: Myrina state: Limnos/Lesvos zip: 81 400 country: Greece lat: 39.87483 lon: 25.06359 hasResults: False
<\|newrecord\|> nctId: NCT06293846 id: IRB-300012108 id: IRB Designation type: OTHER domain: UAB briefTitle: BeFit Toolbox Collaboration: Building Empowerment Through Fitness acronym: BEFIT overallStatus: RECRUITING date: 2024-03-15 date: 2025-12-31 date: 2026-12-31 date: 2024-03-05 date: 2024-03-28 name: University of Alabama at Birmingham class: OTHER briefSummary: This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population. conditions: Low-Income Population conditions: Women's Health studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 50 type: ESTIMATED name: What I Learned at Home measure: Barriers to Physical Activity Self-Report sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham status: RECRUITING city: Birmingham state: Alabama zip: 35233 country: United States name: Kimberly McCall, PhD role: CONTACT phone: 205-934-3378 email: kmccall@uab.edu name: Keith Mcgregor, PhD role: CONTACT phone: 3523598084 phoneExt: Mcgregor email: kmmcgreg@uab.edu name: Keith Mcgregor role: SUB_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False
<\|newrecord\|> nctId: NCT06293833 id: 003315 briefTitle: Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan acronym: ZORALCS overallStatus: ENROLLING_BY_INVITATION date: 2024-09-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-05 date: 2024-03-05 name: University Hospital, Antwerp class: OTHER name: Universiteit Antwerpen name: Belgian Cancer Registry briefSummary: The goal of this clinical trial is to implement lung cancer screening in a targeted high-risk population of heavy (ex-)smokers in Flanders (Belgium). This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation. conditions: Lung Cancer, Nonsmall Cell conditions: Lung Cancer conditions: Smoking Cessation conditions: Lung Cancer, Small Cell studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 700 type: ESTIMATED name: Low-dose CT scan name: Smoking Cessation measure: Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA measure: Responders measure: Number of true and false positive nodules measure: Impact of smoking cessation intervention measure: Success of smoking cessation intervention measure: Evaluation of shared decision making tool sex: ALL minimumAge: 55 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZA city: Edegem state: Antwerp zip: 2650 country: Belgium lat: 51.15662 lon: 4.44504 hasResults: False
<\|newrecord\|> nctId: NCT06293820 id: TL-925-304 briefTitle: A Study Of TL-925 For The Treatment of AC overallStatus: RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-03-05 date: 2024-04-01 name: Telios Pharma, Inc. class: INDUSTRY briefSummary: In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.
The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis. conditions: Allergic Conjunctivitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The sponsor, investigators, and study staff will be masked throughout the study. The study site will have the capacity to unmask in case of emergency.
Following completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject, and the database has been locked. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: TL-925 name: Placebo measure: Ocular Itching measure: Conjunctival Redness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Andover Eye Associates status: RECRUITING city: Andover state: Massachusetts zip: 01810 country: United States lat: 42.65843 lon: -71.137 hasResults: False
<\|newrecord\|> nctId: NCT06293807 id: 20220162HU briefTitle: Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine overallStatus: COMPLETED date: 2022-06-06 date: 2023-04-16 date: 2023-04-16 date: 2024-03-05 date: 2024-03-08 name: The University of Texas Health Science Center at San Antonio class: OTHER briefSummary: Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal. conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized, placebo-controlled, parallel design study. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Both the surgeon and patient will be blinded as to the intervention provided by covering identifying marks of the anesthetic carpules to be administered. Randomization will be assured by random selection of a slip of paper drawn from a sealed envelope assigning the patient to one of three groups. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ACTUAL name: Xylocaine 2 % with 1:100,000 epinephrine name: Bupivicaine 0.5% with 1:200,000 epinephrine name: Placebo measure: Change in pain using Visual Analog Scale (VAS) measure: Number of Ibuprofen administered measure: Number of Tylenol administered measure: Arch Response measure: Number of teeth measure: Type of procedure measure: Gender of patient measure: Age of patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas Health Science Center at San Antonio city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 hasResults: False
<\|newrecord\|> nctId: NCT06293794 id: 22-0991 briefTitle: Decision Support for Heart Failure Prescribing overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2025-09 date: 2024-03-05 date: 2024-03-05 name: University of Colorado, Denver class: OTHER briefSummary: Clinical decision support (CDS) tools can 'nudge' clinicians to make the best decisions easy. Although required by "meaningful use" regulations, more than 40% of CDS lead to no change and the remaining lead to improvements that are modest at best. This is because CDS tools often ignore contextual factors and present irrelevant information. Although many tools have undergone patient-specific optimization, 'traditional CDS' are rarely clinician-specific. For example, a traditional CDS tool for beta blockers and heart failure with reduced ejection fraction (HFrEF) addresses common prescribing misconceptions by stating asthma is not a contraindication and providing a safe threshold for blood pressure. For clinicians without these misconceptions, these statements are irrelevant and distract from key information. A 'personalized CDS' would evaluate clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions. The objective of this research is to create personalized clinician-specific CDS that overcome shortcomings of traditional CDS. The central hypothesis is a personalized CDS that minimizes irrelevant information will lead to a higher rate of prescribing guideline-directed management and therapy (GDMT) for HFrEF compared to a traditional CDS. conditions: Decision Support Systems, Clinical conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Compare traditional and personalized CDS in a pragmatic randomized controlled trial at one health system. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1075 type: ESTIMATED name: Personalized Clinical Decision Support (CDS) name: Traditional Clinical Decision Support (CDS) measure: Number of CDS alerts resulting in the prescription of a recommended medication measure: Number of patients the CDS alerted for measure: Number of alerts that were not outright dismissed measure: Number of prescription orders for guideline directed management and therapies (GDMT) for heart failure sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293781 id: GachonU briefTitle: Application of the Web-based Acceptance and Commitment Therapy for Depression acronym: ACTION overallStatus: RECRUITING date: 2022-12-19 date: 2025-02-28 date: 2025-02-28 date: 2024-03-05 date: 2024-03-05 name: Gachon University class: OTHER briefSummary: PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Web-based ACT name: Treatment as usual measure: Acceptance and Action Questionnaire-II measure: Cognitive Fusion Questionnaire sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kyoung-Sae Na status: RECRUITING city: Incheon state: Please Incheon zip: 21565 country: Korea, Republic of name: Kyoung-Sae Na, MD, PhD role: CONTACT phone: 82324689932 email: ksna13@gmail.com lat: 37.45646 lon: 126.70515 hasResults: False
<\|newrecord\|> nctId: NCT06293768 id: FADOI.05.2018 briefTitle: Continuous Wireless Monitoring for Patients in the Internal Medicine UOC. Randomized Controlled Trial (GreenLineH-T) acronym: GreenLineH-T overallStatus: COMPLETED date: 2019-09-23 date: 2023-12-31 date: 2024-02-20 date: 2024-03-05 date: 2024-03-05 name: Fadoi Foundation, Italy class: OTHER briefSummary: Monocentric prospective controlled randomized in open-label study. The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control), aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition for 5 days compared to a traditional clinical monitoring. conditions: Hospitalization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control). 50 of the patients undergoing continuous monitoring come from the group A and 100 from group B, same ratio in the control group.
Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 208 type: ACTUAL name: continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients) measure: difference in the incidence of major complications at 30 days measure: number of acute patients who in seven days reach the criteria to be discharged or ransferred to the subacute ward measure: Difference in the incidence of major complications at the end of the telemonitoring phase sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale di Albano - Polo H2 city: Roma country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06293755 id: COA022/66 briefTitle: Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-28 date: 2024-03-05 date: 2024-06-25 date: 2024-03-05 date: 2024-03-05 name: Dhurakij Pundit University class: OTHER briefSummary: The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores. conditions: Enlarged Pores studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Microneedle patch name: Intradermal injection measure: Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dhurakij Pundit University city: Lak Si state: Bangkok country: Thailand lat: 13.88724 lon: 100.5792 hasResults: False
<\|newrecord\|> nctId: NCT06293742 id: EC0007 briefTitle: ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants overallStatus: RECRUITING date: 2024-02-09 date: 2024-04-19 date: 2024-04-19 date: 2024-03-05 date: 2024-03-05 name: Eccogene class: INDUSTRY briefSummary: This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in healthy participants. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: ECC5004 name: Midazolam name: Rosuvastatin name: Digoxin name: Atorvastatin measure: Atorvastatin PK parameters: AUC(0-tlast) measure: Atorvastatin PK parameters: AUC(0-inf) measure: Atorvastatin PK parameters: Cmax measure: Rosuvastatin PK parameters: AUC(0-tlast) measure: Rosuvastatin PK parameters: AUC(0-inf) measure: Rosuvastatin PK parameters: Cmax measure: Digoxin PK parameters: AUC(0-tlast) measure: Digoxin PK parameters: AUC(0-inf) measure: Digoxin PK parameters: Cmax measure: Midazolam PK parameters: AUC(0-tlast) measure: Midazolam PK parameters: AUC(0-inf) measure: Midazolam PK parameters: Cmax measure: ECC5004 Safety parameters: Number of participants with adverse events (AEs) measure: ECC5004 Safety parameters: Number of participants with vital sign abnormalities measure: ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: ECC5004 Safety parameters: Number of participants with physical examination abnormalities measure: ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities measure: Atorvastatin safety parameters: Number of participants with adverse events (AEs) measure: Atorvastatin safety parameters: Number of participants with vital sign abnormalities measure: Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG) measure: Atorvastatin safety parameters: Number of participants with physical examination abnormalities measure: Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities measure: Rosuvastatin safety parameters: Number of participants with adverse events (AEs) measure: Rosuvastatin safety parameters: Number of participants with vital sign abnormalities measure: Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: Rosuvastatin safety parameters: Number of participants with physical examination abnormalities measure: Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities measure: Digoxin safety parameters: Number of participants with adverse events (AEs) measure: Digoxin safety parameters: Number of participants with vital sign abnormalities measure: Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: Digoxin safety parameters: Number of participants with physical examination abnormalities measure: Digoxin safety parameters: Number of participants with clinical laboratory abnormalities measure: Midazolam safety parameters: Number of participants with adverse events (AEs) measure: Midazolam safety parameters: Number of participants with vital sign abnormalities measure: Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: Midazolam safety parameters: Number of participants with physical examination abnormalities measure: Midazolam safety parameters: Number of participants with clinical laboratory abnormalities measure: ECC5004 PK parameters: AUC (0-τ) measure: ECC5004 PK parameters: AUC(0-24) measure: ECC5004 PK parameters: tmax measure: ECC5004 PK parameters: t1/2 measure: ECC5004 PK parameters: CL/F measure: ECC5004 PK parameters: Ctau sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eccogene Investigational Site status: RECRUITING city: Anaheim state: California zip: 92801 country: United States name: Eccogene role: CONTACT lat: 33.83529 lon: -117.9145 hasResults: False
<\|newrecord\|> nctId: NCT06293729 id: NGGT006-P-2302 briefTitle: Safety and Efficacy Study of NGGT006 in Refractory Hypercholesterolemia Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-31 date: 2029-03-01 date: 2024-03-05 date: 2024-04-17 name: Suzhou Municipal Hospital class: OTHER briefSummary: This is an early phase 1, open-label, single-center, dose-escalation pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in patients with refractory Hypercholesterolemia diagnosed by gene testing for familial hypercholesterolemia. NGGT006 uses adeno-associated virus (AAV) as a vector, carrying a liver specific promoter and codon optimized human LDLR gene, driving the expression of LDLR protein with normal function and promoting the clearance of low-density lipoprotein cholesterol (LDL-C). conditions: Refractory Hypercholesterolemia conditions: Familial Hypercholesterolemia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: NGGT006 measure: Incidence of treatment-related adverse events (AE) and serious adverse events (SAE) measure: Absolute change and percent change in LDL-C measure: Absolute change and percent change in non-high density lipoprotein cholesterol measure: Absolute change and percent change in apolipoprotein B measure: Absolute change and percent change in total cholesterol measure: Absolute change and percent change in HDL-C measure: Absolute change and percent change in triglycerides measure: Absolute change and percent change in very low-density lipoprotein cholesterol measure: Absolute change and percent change in lipoprotein(a) measure: Absolute change and percent change in apolipoprotein A-I sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293716 id: CVL237-A2001 briefTitle: CVL237 Tablets for APDS/PASLI overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-12-29 date: 2026-03-30 date: 2024-03-05 date: 2024-03-05 name: Convalife (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: This study was designed to evaluate the efficacy and safety of CVL237 tablets in patients with APDS/PASLI (activated phosphoinositol 3-kinase δ syndrome /p110 delta-activated mutation leading to senescent T cells, lymphadenopathy, and immune deficiency). conditions: PI3K and P110delta Hyperactivation Syndrome studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: CVL237 tablets for APDS/PASLI (Activated phosphoinositol 3-kinase delta syndrome /p110 delta-activated Mutation leading to senescent T cells, lymphadenopathy, and immune deficiency) primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Part II is a randomized, double-blind, placebo-controlled study of approximately 30 patients with APDS/PASLI. On day 1, patients were randomly assigned to the trial and placebo groups in a 2:1 ratio to take an oral CVL237 tablet or a placebo CVL237 simulant once daily. Efficacy and safety were evaluated on days 29, 57, and 85. The efficacy of CVL237 tablets in reducing lymphadyopathy will be investigated as measured by changes in the sum of diameter products (SPD) of target lesions selected from MRI or CT imaging according to the Lugano 2014 method, as well as changes in the percentage of naive B cells to total B cells, relative to baseline. The CVL237 tablets will also be evaluated for safety, PK whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 35 type: ESTIMATED name: CVL237 tablets name: CVL237 placebo tablets measure: part 1 : Incidence of Treatment-Emergent Adverse Events measure: part 2:After 84 days of treatment, changes in the sum of diameter product (SPD) of log10 conversion in target lesions and changes in the percentage of naive B cells to total B cells from baseline were observed measure: Cmax measure: t1/2 measure: AUC measure: Tmax sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Public Health Clinical Center city: Shanghai state: Shanghai zip: 201508 country: China name: Yun Ling, ph.D role: CONTACT phone: 18121157875 email: yun.ling@vip.126.com name: Ying Lv role: CONTACT phone: 18916099680 lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06293703 id: 23-1228 briefTitle: Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study) acronym: CLIMB II overallStatus: RECRUITING date: 2024-01-12 date: 2025-12-11 date: 2030-12-11 date: 2024-03-05 date: 2024-03-05 name: Salvador Navarrete class: OTHER briefSummary: The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics. conditions: Morbid Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be a prospective, randomized controlled trial with a 1:1 recruitment allocation ratio coordinated at the Cleveland Clinic Foundation (CCF) primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 262 type: ESTIMATED name: Surgery measure: To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients measure: To compare rates of DM resolution between aRYGB Vs sRYGB by DM subgroup analysis measure: To investigate postoperative efficacy rates of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity measure: To investigate the presence of postoperative vitamin and nutritional deficiencies between the groups. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Salvador Navarrete, MD role: CONTACT phone: 216-219-9211 email: navarrs@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False
<\|newrecord\|> nctId: NCT06293690 id: L23-407 briefTitle: Toripalimab Combined With SBRT for NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-06-30 date: 2026-06-30 date: 2024-03-05 date: 2024-03-06 name: Shanghai Pulmonary Hospital, Shanghai, China class: OTHER briefSummary: This study aimed to evaluate the efficacy and safety of Toripalimab injection (js001) combined with SBRT radiotherapy and neoadjuvant therapy with or without chemotherapy for operable or potentially operable stage IIa to IIIb NSCLC conditions: Non-small Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Toripalimab name: Toripalimab measure: Major pathological remission rate measure: Complete pathological remission rate measure: disease-free survival（DFS） measure: overall survival measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Pulmonary Hospital city: Shanghai state: Shanghai zip: 200000 country: China name: Deping Zhao role: CONTACT phone: 0086-20-65115006 email: zdp1992@163.com name: Deping Zhao role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06293677 id: 2023-01013 briefTitle: Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance acronym: DAR-ARC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03 date: 2026-03 date: 2024-03-05 date: 2024-03-05 name: Centre Hospitalier Universitaire Vaudois class: OTHER name: Unisanté Centre universitaire de médecine générale et santé publique name: FORCE Fondation Recherche sur le Cancer de l'Enfant briefSummary: This clinical trial focuses on children with cancer who face infections after receiving chemotherapy. Chemotherapy affects the bone marrow, leading to a decrease in the production of certain white blood cells, particularly those that defend against bacterial infections (neutrophils). One significant concern is febrile neutropenia, where children experience a fever during a period of low white blood cell count. This condition often results from bacterial infections, necessitating prompt wide-spectrum antibiotic treatment. However, some children eliminate antibiotics in the urine too quickly during febrile neutropenia. Their kidneys function more than they normally do (renal hyperfiltration). This can lead to insufficient exposure to antibiotics to control the infection. The current standard antibiotic regimens do not account for this variable elimination rate. In this study we focus on two antibiotics used in this context: piperacillin-tazobactam and meropenem.
The main questions this study aims to answer are, in these children:
* Would higher doses of antibiotics result in better blood levels of antibiotics?
* Would they have more sides effects with higher antibiotics dosages?
* Would they recover more quickly with higher antibiotic doses? All patients will undergo a blood test upon hospital arrival, including an assessment of renal function. If renal function is normal or diminished, the patient will receive the standard antibiotic dose. Children with increased renal function will be randomly assigned to two groups during each episode of febrile neutropenia. One group will receive standard antibiotic dosages, while the other will receive higher doses to compensate for renal hyperfiltration. Throughout the study, antibiotic levels in the blood will be monitored for all patients. This monitoring will determine if target concentrations can be achieved more quickly with experimental dosages and will allow doctors to readjust the doses if needed. conditions: Febrile Neutropenia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Our study is an open-label, re-randomized controlled trial in multi-episodes settings. So the care team, researchers and patients will be informed of the allocation group. Patients will be able to participate in each episode of febrile neutropenia. At each inclusion the patient may be in a different group. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem name: Standard dosages of piperacillin-tazobactam or meropenem measure: Achievement of antibiotic concentration targets in the intervention group (1i) vs control groupe (1c) measure: Achievement of antibiotic concentration targets in control group 2 measure: Fever duration measure: Side effects of antibiotic therapy measure: Number of dosage adjustments required to achieve the target concentration measure: Difference between eGFR measured by creatinine-based Schwartz formula and other eGFR calculation formulas sex: ALL minimumAge: 61 Days maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Centre Hospitelier Universitaire Vaudois (CHUV) city: Lausanne state: Vaud zip: 1011 country: Switzerland name: Margherita Plebani role: CONTACT phone: +41795563598 email: Margherita.Plebani@chuv.ch name: Pierre-Alex Crisinel role: PRINCIPAL_INVESTIGATOR lat: 46.516 lon: 6.63282 hasResults: False
<\|newrecord\|> nctId: NCT06293664 id: RAHM-2023-006 briefTitle: Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes acronym: α-MSH & T2DM overallStatus: RECRUITING date: 2024-03-04 date: 2024-04-04 date: 2024-04-04 date: 2024-03-05 date: 2024-03-05 name: Dasman Diabetes Institute class: OTHER briefSummary: Alpha-melanocyte stimulatory hormone (α-MSH) is a melanocyte-stimulating hormone produced by the hypothalamus and released from the pituitary gland. It acts as an agonist to the melanocortin 5 receptor (MC5R) in human skeletal muscle, playing a role in glucose uptake and disposal. This study aims to investigate whether α-MSH can enhance glucose tolerance in patients with Type 2 Diabetes Mellitus (T2DM). conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The research involves a double-blinded, randomized, placebo-controlled crossover study to assess the therapeutic potential of α-MSH infusion in T2DM patients. primaryPurpose: SCREENING masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 13 type: ESTIMATED name: α-MSH infusion name: Placebo solutions measure: Difference in the total or incremental area under the curve of glucose and insulin concentration at an OGTT during saline vs. α-MSH infusion measure: Difference in the total or incremental area under the curve of the concentration of metabolites (C-peptide, Glucagon, Gut hormones, α-MSH) during OGTT with saline or α-MSH infusion. measure: Difference in energy intake measured by an ad libitum meal test at the saline vs. α-MSH infusion measure: Adverse events (including flushing) sex: ALL minimumAge: 21 Years maximumAge: 50 Years stdAges: ADULT facility: Dasman Diabetes Institute status: RECRUITING city: Kuwait City country: Kuwait name: Ebaa Al Ozairi, MD role: CONTACT name: Dalal Alsaeed, PhD role: CONTACT name: Carel Roux, MD role: SUB_INVESTIGATOR lat: 29.36972 lon: 47.97833 hasResults: False
<\|newrecord\|> nctId: NCT06293651 id: DA4505_AMST_I/IIa briefTitle: Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2030-04 date: 2024-03-05 date: 2024-03-05 name: Dong-A ST Co., Ltd. class: INDUSTRY briefSummary: This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors. conditions: Locally Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 125 type: ESTIMATED name: DA-4505 name: DA-4505 + Pembrolizumab measure: Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria measure: PK parameters for DA-4505 (Peak Plasma Concentration (Cmax)) measure: PK parameters for DA-4505 (Area Under the Curve (AUC)) measure: PK parameters for DA-4505 (half-life (t1/2)) measure: Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293638 id: 23-1125 briefTitle: Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor acronym: TRaNCE overallStatus: RECRUITING date: 2024-03-25 date: 2026-12-31 date: 2026-12-31 date: 2024-03-05 date: 2024-04-02 name: The Cleveland Clinic class: OTHER briefSummary: The purpose of this study is to collect electrophysiological data related to functional brain network changes in patients undergoing deep brain stimulation for the treatment of essential tremor. Participants will be asked to remain seated with their head inside of a Magnetoencephalography (MEG) recording system as resting-state and task-related data are acquired. Spontaneous electrophysiological activity will be recorded in both the eyes open and eyes closed conditions with the participant seated comfortably. These recordings will be repeated in the DBS OFF and DBS ON states, with the ON state involving specific settings identified as optimal, sub-optimal, or ineffective at achieving tremor control. They will also be repeated following the optional administration non-DBS tremor mitigation techniques, which may include one or more of 1) cooling the limb, 2) oral administration of alprazolam, 3) oral consumption of ethanol (alcohol), or 4) peripheral nerve stimulation. conditions: Essential Tremor studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Alcohol name: Alprazolam name: Cold Therapy name: Peripheral Nerve Stimulation measure: CTCM Coherence measure: Power of oscillatory activity across the CTCM network in response to tremor interventions measure: Essential tremor severity: Tremor Research Group Essential Tremor Rating Scale (TETRAS) measure: Essential tremor severity: Grip force measure: Essential tremor severity: Limb acceleration sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Jeff Negrey, MA role: CONTACT phone: 216-636-5504 email: negreyj2@ccf.org name: James Liao, MD role: PRINCIPAL_INVESTIGATOR name: Ken baker, PhD role: SUB_INVESTIGATOR lat: 41.4995 lon: -81.69541 hasResults: False
<\|newrecord\|> nctId: NCT06293625 id: LEPAGE PHRCK 2022-2 briefTitle: Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced But Resecable Colon Cancer in the Elderly of 70 Years Old or More acronym: FOxTROT2France overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2032-03 date: 2032-03 date: 2024-03-05 date: 2024-03-05 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Colon cancer (CC) is the 5th most common cancer worldwide. Standard care for locally advanced disease is surgical resection followed by 3-6 months of adjuvant chemotherapy (AC) with oxaliplatin and 5-fluorouracil (OxFp).
Almost all of these patients undergo surgery, but many do not receive AC due to frailty (following surgery). This particularly affects patients over 70, who represent the majority of patients diagnosed with CC.
FOxTROT 2, a trial to test the role of NAC in older patients. conditions: Colon Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Folfox name: Surgery measure: DFS (disease Free Survival) sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: CHU Dijon Bourgogne city: Dijon zip: 21000 country: France name: Côme LEPAGE role: CONTACT email: come.lepage@u-bourgogne.fr lat: 47.31667 lon: 5.01667 hasResults: False
<\|newrecord\|> nctId: NCT06293612 id: 22/449-3651 id: 2022-I2M-C&T-B-077 type: OTHER_GRANT domain: CAMS Innovation Fund for Medical Sciences (CIFMS) id: 7244398 type: OTHER_GRANT domain: Youth program of Beijing Natural Science Foundation id: Beijing Hope Run Special Fund type: OTHER_GRANT domain: LC2021A12 briefTitle: Constructing a Multimodal Imaging System to Predict the Risk of Heterochronous Metastasis of Rectal Cancer acronym: MIS-MRC overallStatus: COMPLETED date: 2015-01-01 date: 2018-12-31 date: 2022-11-30 date: 2024-03-05 date: 2024-03-05 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: The goal of this observational study is to construct a multimodal intelligent model to predict the risk of heterochronous metastasis of rectal cancer, which is helpful for individualized diagnosis and treatment and follow-up planning. The main questions it aims to answer are:
* what are the independent risk factors of distant metastasis (DM) in locally advanced rectal cancer (LARC)
* What is the influence weight of the above factors on the heterochronous metastasis of LARC, and how to build a risk-prediction model
This study will not affect or interfere with the routine medical diagnosis and treatment of participants, and will not increase the cost and risk of participants. Participant's information is protected and identified by a unique code. conditions: Locally Advanced Rectal Cancer conditions: Distant Metastasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 302 type: ACTUAL name: No intervention was administrated to the two cohorts. measure: Heterochronous distant metastasis measure: Distant metastasis-free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College city: Beijing zip: 100021 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06293599 id: P.T.REC/012/003131 briefTitle: Effect of Scapular Stabilization Exercises Versus Virtual Reality Exercises in Basketball Players With Scapular Dyskinesia acronym: SD overallStatus: NOT_YET_RECRUITING date: 2024-03-05 date: 2024-07-30 date: 2024-07-30 date: 2024-03-05 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: this study will be conducted to compare virtual reality and scapular stabilizing exercise among basketball player with scapular dyskinesia on scapular muscle performance, rounded shoulder, pain intensity , disability and hand grip strength conditions: Scapular Dyskinesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: scapular stabilization and virtual reality exercise primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: opaque sealed envelope whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: scapular stabilization exercises name: virtual reality exercises name: regular routine exercises measure: agonist antagonist ratio measure: Hand grip strength measure: rounded shoulder posture measure: pain intensity level measure: The disabilities of the arm, shoulder and hand measure: peak force measure: total work measure: work fatigue measure: average power sex: ALL minimumAge: 20 Years maximumAge: 25 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293586 id: MD-11-2022 briefTitle: Comparison Between Peribulbar And Sub-tenon Blocks on Oculocardiac Reflex (OCR) During Pediatric Strabismus Surgery overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-30 date: 2024-03-30 date: 2024-03-05 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: The aim of this study is to compare between peribulbar block and subtenon block as an adjunct to general anesthesia in children undergoing strabismus surgery on oculocardiac reflex (OCR), post-operative analgesia and postoperative vomiting. Both techniques will be compared to intra-operative intravenous (IV) paracetamol combined with general anesthesia as a sole anesthetic technique. conditions: Anesthesia, Local conditions: Ophthalmopathy conditions: Strabismus conditions: Pediatric ALL studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: peribulbar block name: sub-tenon block name: Paracetamol measure: The incidence of intraoperative oculocardiac reflex (OCR) measure: blood pressure measure: heart rate measure: Post-operative pain using the MOPS measure: Post-operative analgesia requirements measure: The incidence of POV using numeric scoring measure: Complications resulting from orbital regional anesthesia were recorded measure: Total intraoperative atropine requirements sex: ALL minimumAge: 6 Years maximumAge: 13 Years stdAges: CHILD facility: Cairo University faculty of medicine status: RECRUITING city: Cairo zip: 11559 country: Egypt name: Essam Nossair, Masters degree role: CONTACT phone: 0201002014809 email: e.nossair92@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06293573 id: 012/005031 briefTitle: Whole- Body Vibration Among Egyptian Elderly With Sarcopenia acronym: WBV overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-11-29 date: 2025-12-01 date: 2024-03-05 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: To investigate and compare between the effectiveness of whole body vibration and aerobic training exercises in management of sarcopenia, muscle mass, physical performance and muscle strength in elderly. conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants will be assigned randomly into three groups of equal number (study group A, study group B, and group C) the randomization will be performed by computerized randomization. Assessors will be blinded to the groups of the subjects. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Whole-body vibration name: aerobic exercises name: resistance exercises measure: Muscle Mass measure: muscle strength measure: timed Up and Go Test (TUG) measure: Gait Speed test measure: 400 m Walking Test measure: Six minute walk test (6MWT) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Therapy city: Dokki state: Giza zip: 12612 country: Egypt lat: 30.03823 lon: 31.2113 hasResults: False
<\|newrecord\|> nctId: NCT06293560 id: H-49046 id: 5U01EY032403-03 type: NIH link: https://reporter.nih.gov/quickSearch/5U01EY032403-03 briefTitle: Microphthalmia, Anophthalmia, and Coloboma Genetic Epidemiology in Children acronym: MAGIC overallStatus: RECRUITING date: 2022-09-25 date: 2027-09 date: 2027-09 date: 2024-03-05 date: 2024-03-05 name: Baylor College of Medicine class: OTHER name: National Eye Institute (NEI) name: National Institutes of Health (NIH) briefSummary: The investigators are inviting families to take part in a research study that will help us better understand the physical characteristics associated with children who have Microphthalmia, Anophthalmia, and Coloboma (MAC) and how changes in their DNA sequence, called genetic mutations, play a role in the risk of developing MAC conditions: Microphthalmia conditions: Coloboma conditions: Anophthalmia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Stage 1 measure: Stage 2 measure: Stage 3 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor College of Medicine status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: EpiCenter role: CONTACT phone: 713-798-2920 email: epicenter@bcm.edu name: Philip Lupo, PhD, MPH role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06293547 id: DIS-2022-295 briefTitle: Clinical Effectiveness and Parental Acceptance of Silver Diamine Fluoride in Preschool Children: A Non-randomized Trial overallStatus: COMPLETED date: 2022-08-10 date: 2023-10-30 date: 2023-12-30 date: 2024-03-05 date: 2024-03-05 name: Cumhuriyet University class: OTHER briefSummary: Silver diamine fluoride (SDF) is a topical fluoride agent that has emerged in recent years and has a strong potential to arrest dentinal caries in early childhood caries. SDF has been developed as an effective non-invasive treatment method, especially in the non-cooperative preschool group, with its advantages such as easy application, low cost, and limited technical difficulties. The aims of this study were as follow: (a) to evaluate the efficacy of 38% GDF in arresting active dental caries lesions and reducing or preventing associated dental pain and infections in at-risk young children; and (b) how SDF treatment is perceived and acceptable by parents. The null hypothesis of the study was that 38% SDF treatment will be effective in arresting active dental caries lesions and reducing the incidence of pain and infection in young children, and is well-accepted by parents. The study group of this clinical research will consist of pediatric patients and their parents who were selected by easily accessible case sampling method and applied to Sivas Cumhuriyet University Faculty of Dentistry Pediatric Dentistry clinic. The working group will consist of a total of 48 children and their parents who meet the inclusion criteria. Parents will also be briefed on the GDF, follow-up instructions, oral hygiene instructions, and dietary education. After a baseline examination including radiographs taken during a standard dental examination, 38% GDF will be applied to carious lesions detected in primary teeth. Carious lesions will be treated with 38% SDF application once or twice. Children will be reassessed at 3-week, 3-month and 6-month follow-up sessions to assess color and structural changes in carious lesions (soft/hard). Parents will be asked to answer a questionnaire including questions about pain or infection symptoms and their views on SDF treatment. conditions: Silver Diamine Fluoride studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study group of this non-randomized, prospective, single-arm clinical research consisted of pediatric patients and their parents who presented to the Department of Pediatric Dentistry, Faculty of Dentistry, Cumhuriyet University, selected using convenient sampling method. For determining the sample size in this study, assuming a 5% alpha error, 80% power, and a cessation rate (35.7%) from a previous study, it was calculated that at least 40 participants should be included. Considering potential patient loss/follow-up, the study group was increased by 20%, resulting in a final decision to include 48 children and their parents in the study. primaryPurpose: TREATMENT masking: NONE count: 48 type: ACTUAL name: Silver Diamine Fluoride measure: Clinical Assessment of Arrested Caries Lesions measure: Parental acceptance of SDF treatment sex: ALL minimumAge: 3 Years maximumAge: 5 Years stdAges: CHILD facility: Sivas Cumhuriyet University city: Sivas state: Merkez country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False
<\|newrecord\|> nctId: NCT06293534 id: PsychThyroid briefTitle: Thyroid Dysfunction in Patients With Major Psychiatric Disorders overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-01-01 date: 2025-02-01 date: 2024-03-05 date: 2024-03-05 name: Assiut University class: OTHER briefSummary: Thyroid dysfunction in major psychiatric disorders in psychiatric patients admitted to psychiatric unit of assiut university hospital conditions: Thyroid Dysfunction studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 173 type: ESTIMATED name: TSH,T3,T4 measure: the level of thyroid hormones among psychiatric patients sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293521 id: 06091995 briefTitle: Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries overallStatus: NOT_YET_RECRUITING date: 2024-05-16 date: 2024-12-31 date: 2025-01-01 date: 2024-03-05 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits conditions: Deep Caries studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Pulpotomy name: Partial Pulpectomy measure: Radiographic assessment measure: Clinical effectiveness measure: Child cooperation measure: Time elapsed till final restoration performed sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: Cairo University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06293508 id: NMRR ID-22-02616-I2I briefTitle: mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public acronym: mBLISS-B overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-03-05 date: 2024-03-05 name: Clinical Research Centre, Malaysia class: OTHER name: Ministry of Health, Malaysia name: National University of Malaysia name: Institute for Health Behavioral Research, Malaysia briefSummary: Late-stage presentation of breast cancer cases are on the rise in Malaysia. Encouraging breast screening practices can assist in early breast cancer detection. Literature has proven that behavior interventions in the form of behavior change health communication using social messaging applications is a viable strategy and potentially effective at motivating breast cancer screening among the public. Such studies are scarce in the South East Asian region, particularly in Malaysia, which is the prime motivation for the current study,
Based on this promising prospect, we designed a randomized controlled trial to study the effects of applying persuasive health communication materials to initiate behavior change among a group of Malaysian women. Materials are delivered in the form of a health communication program over a social messaging application to promote breast cancer screening practices, which is either a clinical breast examination, or a mammogram. We hypothesize that Malaysian women who are exposed to such materials that are designed based on behavior science and behavior change principles will be nudged and hence more likely to attend breast cancer screening compared to a control group. conditions: Breast Neoplasm Female studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1180 type: ESTIMATED name: Standard Health Communication Intervention name: Behavioural Change Health Communication Intervention measure: Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram). measure: Health literacy level measure: Perception based on domains in Health Belief Model measure: Perceived acceptance and usefulness of health communication program measure: Reasons behind participants not participating in breast cancer screening. sex: FEMALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Clinical Research, National Institutes of Health, Malaysia city: Shah Alam state: Selangor zip: 40170 country: Malaysia name: Nicholas Yee Liang Hing, MSc role: CONTACT email: hingyl@moh.gov.my lat: 3.08507 lon: 101.53281 hasResults: False
<\|newrecord\|> nctId: NCT06293495 id: CUT-OUT briefTitle: Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-30 date: 2026-04-01 date: 2024-03-05 date: 2024-03-05 name: Puerta de Hierro University Hospital class: OTHER briefSummary: The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out).
Participants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate. conditions: Proximal Femoral Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, prospective trial with a CE-marked medical devices primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Gamma 3 Nail (Stryker) name: Chimaera Nail (Orthofix) measure: Incidence of cut-out. measure: Functional Ambulatory Categories (FAC) measure: Tip-apex distance measure: Parker index measure: Baumgaertner reduction quality criteria measure: Number of Surgical complications (Intraoperative) measure: Number of Surgical complications (post-operative) sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Hospital Universitario Puerta de Hierro Majadahonda city: Majadahonda state: Madrid zip: 28222 country: Spain lat: 40.47353 lon: -3.87182 hasResults: False
<\|newrecord\|> nctId: NCT06293482 id: CAM5850 briefTitle: Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population acronym: ACE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2028-06 date: 2024-03-05 date: 2024-03-05 name: Cochlear class: INDUSTRY name: NAMSA name: LWB Consulting briefSummary: This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits. conditions: Hearing Loss, Sensorineural conditions: Hearing Loss, Bilateral studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Cochlear™ Nucleus® System measure: Number of device and procedure-related adverse events and serious adverse events measure: Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted measure: Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition measure: Number of device and procedure related adverse events and serious adverse events measure: Proportion of participants who demonstrate a change score of +1 or greater on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6-months post-activation compared to preoperative baseline measure: Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement measure: Mean change on aided word recognition in the unilateral CI alone listening condition at 3 months post activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted measure: Mean change on AzBio sentences in noise at 3 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition measure: Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition measure: Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barrow Neurological Institute city: Phoenix state: Arizona zip: 85013 country: United States name: Shawn Stevens role: CONTACT email: shawn.stevens@commonspirit.org lat: 33.44838 lon: -112.07404 facility: University of Miami city: Coral Gables state: Florida zip: 33146 country: United States name: Meredith Holcomb role: CONTACT email: meredith.holcomb@med.miami.edu lat: 25.72149 lon: -80.26838 facility: Midwest Ear Institute city: Kansas City state: Missouri zip: 64111 country: United States name: Sarah Zlomke role: CONTACT email: sking@saint-lukes.org lat: 39.09973 lon: -94.57857 facility: New York University city: New York state: New York zip: 10016 country: United States name: William Shapiro role: CONTACT email: william.shapiro@nyulangone.org lat: 40.71427 lon: -74.00597 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States name: Sarah Sydlowski role: CONTACT email: sydlows@ccf.org lat: 41.4995 lon: -81.69541 facility: University of Pennsylvania Hospitals city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Tiffany Hwa role: CONTACT email: tiffany.hwa@pennmedicine.upenn.edu lat: 39.95233 lon: -75.16379 facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23219 country: United States name: Daniel Coelho role: CONTACT email: daniel.coelho@vcuhealth.org lat: 37.55376 lon: -77.46026 facility: Virginia Mason city: Seattle state: Washington zip: 98101 country: United States name: Daniel Zeitler role: CONTACT email: daniel.zeitler@virginiamason.org lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06293469 id: IRB00434587 briefTitle: Accelerated Flap Coverage in Severe Lower Extremity Trauma acronym: FLAP ATTACK overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2029-11 date: 2024-03-05 date: 2024-03-08 name: Johns Hopkins University class: OTHER name: McMaster University name: University of Maryland, Baltimore name: Orthopaedic Trauma Association name: Foundation of Orthopedic Trauma briefSummary: The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility). conditions: Open Tibia Fracture conditions: Open Dislocation of Ankle conditions: Extremity Fracture Lower conditions: Extremity Injuries Lower studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 356 type: ESTIMATED name: Accelerated Flap Coverage Surgery name: Standard of Care Flap Timing measure: Clinical status measure: Mortality measure: Amputation measure: Unplanned re-operation measure: Number of days in hospital measure: Quality of life as assessed by the Limb-Q sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293456 id: 23-360 briefTitle: Study of Poetic Dignity Therapy for Sexual and Gender Minority Patients at End of Life overallStatus: ENROLLING_BY_INVITATION date: 2024-01-29 date: 2026-01 date: 2026-01 date: 2024-03-05 date: 2024-03-05 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is to find out if dignity therapy is practical and works well for sexual and gender (SGM) patients in hospice care. SGM includes, but is not limited to, people who identify as lesbian, gay, bisexual, transgender, and/or queer/questioning (LGBTQ+). Dignity therapy is a type of psychotherapy where the clinician asks the patient questions to allow the patient to express their individual life story and ultimately be able to create a legacy document of their experiences that can be shared with their loved ones. conditions: End of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 15 type: ESTIMATED name: Dignity Therapy measure: the number of patients who complete the intervention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Cancer Center city: New York state: New York zip: 10065 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06293443 id: IMU-OP-TT-01 briefTitle: Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System overallStatus: RECRUITING date: 2024-02-15 date: 2024-03-15 date: 2024-04-01 date: 2024-03-05 date: 2024-03-05 name: Medipol University class: OTHER briefSummary: The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests. conditions: Amputation conditions: Amputation; Traumatic, Leg, Lower studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE maskingDescription: participants underwent functional testing at clinical centers count: 24 type: ESTIMATED name: Lower extremity unilateral amputee measure: Amputee Mobility Scale measure: One Leg Standing Test measure: Houghton Scale measure: 8-Shape Walking Test measure: joint range of motion measure: proprioception measure: l test measure: 10 Meter Walking Test sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medıpol University status: RECRUITING city: Istanbul country: Turkey name: Medipol University role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06293430 id: P002 briefTitle: Registry on Luma Vision's VERAFEYE System (ENLIgHT) acronym: ENLIgHT overallStatus: NOT_YET_RECRUITING date: 2024-09-15 date: 2025-03-15 date: 2025-03-15 date: 2024-03-05 date: 2024-03-07 name: LUMA Vision Ltd. class: INDUSTRY briefSummary: The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.
Results from this study will be used to guide development of the VERAFEYE System. conditions: Atrial Fibrillation conditions: Left Atrial Appendage Closure conditions: Atrial Arrhythmia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: VERAFEYE System measure: Clinical Success of procedure measure: Procedural Complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293417 id: HT-EF-01 briefTitle: To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM acronym: ENSEMBLE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-02-01 date: 2027-02-01 date: 2024-03-05 date: 2024-03-07 name: Korea University Anam Hospital class: OTHER briefSummary: The goal of this observational study is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:
* major adverse cardiovascular events within 48 months of the trial duration
* microvascular events within 48 months of the trial duration conditions: T2DM (Type 2 Diabetes Mellitus) conditions: Dyslipidemias studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3958 type: ESTIMATED name: Statin and Ezefeno name: Statin doubling measure: major adverse cardiovascular events and diabetic microvascular events for 48 months measure: proportion of patients achieving Non-HDL-C less than 100mg/dL measure: proportion of patients achieving LDL less than 70mg/dL measure: change in Non-HDL-C at 48month from baseline measure: change in LDL at 48month from baseline measure: change in HDL-C at 48month from baseline measure: change in TG at 48month from baseline measure: change in LDL-C/HDL-C ratio at 48month from baseline measure: change in TC/HDL-C ratio at 48month from baseline sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Korea University Anam Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06293404 id: column flexion id: AnkaraCHBilkent type: OTHER domain: AnkaraCHBilkent briefTitle: The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-04 date: 2024-03-05 date: 2024-03-05 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The effect of two different positions on spinal anesthesia in hip fracture surgery conditions: Hip Fractures conditions: Spinal Anesthesia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Bupivacain measure: Hemodynamic change measure: Hemodynamic change measure: Hemodynamic change measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. measure: Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. measure: To compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of bupivacaine 7.5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral lower measure: To compare the efficacy of bupivacaine 7.5 mg/ml in the duration of sensory block at dermatome T10 level sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293391 id: 2022-11/2097 briefTitle: The Effect of Patient Position Changes on Advanced Cardiac Indices in Cancer Surgery overallStatus: COMPLETED date: 2023-02-01 date: 2023-03-01 date: 2024-02-05 date: 2024-03-05 date: 2024-03-05 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: Esophageal Doppler Monitoring (Deltex CardioQ Esophageal Doppler Monitor, ODM) is used to manage patients' fluid therapy by non-invasively measuring continuous cardiac output with an esophageal probe. The aim of this study was to compare the effects of patient position changes on cardiac indices and vital signs in patients who underwent major abdominal cancer surgery with laparoscopic and open surgery using ODM. conditions: Abdominal Cancer conditions: Blood Pressure conditions: Cardiac Indices studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: cardiac indices in supine and trendelenburg position measure: Cardiac Output measure: Stroke Volume measure: Flow time corrected measure: Peak Velocity measure: Stroke Distance measure: Mean arterial pressure measure: Pulse sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital city: Ankara zip: 06200 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06293378 id: Pengmingli briefTitle: Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis. overallStatus: RECRUITING date: 2024-02-28 date: 2028-10-10 date: 2028-11-10 date: 2024-03-05 date: 2024-04-02 name: The Second Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, changes in fecal flora and metabolites before and after the use of sulfasalazine were observed. conditions: Cirrhosis, Liver conditions: Fibrosis, Liver studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 330 type: ESTIMATED name: Sulfasalazine enteric-coated tablets measure: Serum alkaline phosphatase (ALP) measure: Serum γ-glutamyl transpeptidase (GGT) measure: Serum bilirubin measure: Serum bile acids measure: Serum aspartate aminotransferase(AST) measure: Serum alanine aminotransferase (ALT) measure: Hepatic fibrosis and the improvement of microbial metabolites measure: Changes in immune cells sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: Mingli Peng, Doctor role: CONTACT phone: +8613512362906 email: Peng_mingli@hospital.cqmu.edu.cn name: Yinghua Lan, Doctor role: CONTACT phone: +8613796050629 lat: 29.56278 lon: 106.55278 facility: Chongqing status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: Mingli Peng, Doctor role: CONTACT phone: 13512362906 email: peng_mingli@hospital.cqmu.edu.cn name: Yinghua Lan, Doctor role: CONTACT phone: +8613796050629 lat: 29.56278 lon: 106.55278 hasResults: False
<\|newrecord\|> nctId: NCT06293365 id: CVAY736A2202 id: 2023-508996-35 type: EUDRACT_NUMBER briefTitle: Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-26 date: 2025-07-29 date: 2029-02-08 date: 2024-03-05 date: 2024-04-09 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).
A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS. conditions: Sjögrens Disease conditions: Systemic Lupus Erythematosus conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 140 type: ESTIMATED name: VAY736 1ml PFS name: VAY736 2 ml PFS name: VAY736 2ml AI measure: Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab measure: Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab measure: Cohort 2 (optional): Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab measure: Cohort 2 (optional): Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab measure: Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab measure: Cohort 2 (optional): Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab measure: Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab measure: Cohort 2 (optional): Concentration at the end of a dosing interval (Ctrough) for ianalumab measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Anti-ianalumab antibodies (ADA) measure: Incidence of ADA positive participants sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293352 id: STU00220012 briefTitle: Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-12 date: 2024-03-05 date: 2024-03-05 name: Northwestern University class: OTHER briefSummary: In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in.
There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in.
We know that both the one- and two-stage revision work equally well to heal the infection, but we don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction. conditions: Prosthetic-joint Infection conditions: Knee Infection conditions: Arthroplasty Complications conditions: Joint Infection conditions: Arthroplasty, Replacement, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 153 type: ESTIMATED name: All-cement articulating spacer name: Durable, real-component articulating spacer name: Rigid Spacer measure: 24 month Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 6 week Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 6 week 10-item PROMIS Global Health survey (PROMIS-10) measure: 6 month Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 6 month 10-item PROMIS Global Health survey (PROMIS-10) measure: 12 month Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 12 month 10-item PROMIS Global Health survey (PROMIS-10) measure: 24 month 10-item PROMIS Global Health survey (PROMIS-10) measure: Revision/reoperation for infection (defined by positive culture by MSIS criteria) measure: revision for aseptic failure (defined by negative culture by MSIS criteria) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern Medicine city: Chicago state: Illinois zip: 60611 country: United States name: Orthopaedic Surgery Research role: CONTACT phone: 312-695-0332 email: orthosurveys@nm.org name: Adam I Edelstein, MD role: PRINCIPAL_INVESTIGATOR name: Kevin D Hardt, MD role: SUB_INVESTIGATOR name: Linda I Suleiman, MD role: SUB_INVESTIGATOR name: David W Manning, MD role: SUB_INVESTIGATOR name: William C Thomas, MD role: SUB_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False
<\|newrecord\|> nctId: NCT06293339 id: CoGA-Re briefTitle: Durability of Protection After Single Immunisation With GA2 Sporozoites (CoGA-Rechallenge) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-11-01 date: 2025-05-31 date: 2024-03-05 date: 2024-03-05 name: Leiden University Medical Center class: OTHER briefSummary: This study will assess the durability of protection of a single immunisation with the Genetically Attenuated Parasite 2 (GA2) against controlled human malaria infection by rechallenging previously immunised and protected participants from the CoGA study (NCT05468606) conditions: Malaria,Falciparum studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 14 type: ESTIMATED name: CHMI with 3D7 malaria measure: Protective efficacy measure: Time to parasitaemia measure: Humoral immune responses after homologous CHMI rechallenge measure: Cellular immune responses after homologous CHMI rechallenge sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293326 id: 22553 briefTitle: A First-in-Human Study to Learn How Well a Bi-Layer Calcium Carbonate Antacid Tablet Works Compared to a Standard, Non-Layered Calcium Carbonate Tablet in Healthy Male Participants overallStatus: RECRUITING date: 2024-03-06 date: 2024-06-06 date: 2024-06-06 date: 2024-03-05 date: 2024-04-19 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time. Heartburn is the burning sensation or pain in the chest which occurs when stomach acid rises up in the food pipe (esophagus).
Calcium carbonate tablets are used to treat heartburn, indigestion, and related digestive problems. Calcium carbonate works by neutralizing the excess acid in the stomach. The study treatment is a new bi-layer calcium carbonate tablet that has two layers. One layer quickly releases calcium carbonate aimed to provide quick relief (called immediate release) while the other layer releases calcium carbonate slowly to make the relief last longer (called sustained release).
In this study, bi-layer calcium carbonate tablets will be given to healthy men for the first time. This study will provide information on how the new bi-layer tablet works inside the body.
The main purpose of this study is to learn about how the new bi-layer calcium carbonate tablet changes the average acidity levels (measured using pH) compared to the standard calcium carbonate tablet during the night-time.
For this, researchers will measure the acidity levels in the upper part of the stomach at regular intervals during the night-time.
The participants will be randomly (by chance) assigned to one of two treatment groups:
Participants in the first group will take the treatments at night.
Participants in the second group will take the treatments during the day.
All participants in both groups will take 2 bi-layer tablets and 2 standard tablets after a meal with a gap of 6 to 8 days between treatments. However, in each group, half the participants will receive the bi-layer tablets first while the other half will receive the standard tablets first.
Each participant will be in the study for around 52 days with up to 4 visits to the study site. This includes:
1. visit about 28 days before the treatment starts during which the doctors will confirm that the participant can take part in the study
2. visits for treatment with a gap of 6-8 days between each treatment, and
1 visit 7 to 14 days after the treatment ends during which the doctors will monitor the participants' health.
During the study, the doctors and their study team will:
check participants' overall health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)
take images of the stomach at different times after taking the treatment
measure acidity level (pH) using a device called pH probe that is inserted into the upper part of the stomach
ask the participants questions about how easy it is to take the study treatment
ask the participants what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think it is related to the study treatment, or not.
As this study is conducted in healthy men who will not gain any benefit from this treatment, access to the study treatment after the study is not planned. conditions: Heartburn conditions: Indigestion conditions: Stomach Acid Related Symptoms conditions: Nocturnal Stomach Acid Related Symptoms conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: bi-layer calcium carbonate tablet (BAY1180654) name: Immediate release calcium carbonate tablet (BAY1180654) measure: Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus. measure: Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus. measure: Percentage of total time gastric pH is above pH 3.5 from time of dosing until 8h post-dose during night-time comparing the bi-layer tablet and standard comparator measure: Percentage of total time gastric pH is above pH 3.5 from time of dosing until 6h post-dose during daytime comparing the bi-layer tablet and standard comparator. measure: Change in mean gastric pH measure: Gastrointestinal tract location using scintigraphic images. measure: Initial radiolabel release time, using scintigraphic images measure: Disintegration rate (t50%) of each formulation will be determined quantitatively via analysis of scintigraphic images. measure: Complete radiolabel release time, using scintigraphic images measure: Gastric emptying kinetics of the dispersed radiolabeled material (t50% and t90%) of each formulation will be determined quantitatively via analysis of the scintigraphic images. measure: Participant questionnaire sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: BDD Pharma Bio-imaging Unit status: RECRUITING city: Glasgow zip: G4 0SF country: United Kingdom lat: 55.86515 lon: -4.25763 hasResults: False
<\|newrecord\|> nctId: NCT06293313 id: Inonu-SBF-SO-03 briefTitle: The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level overallStatus: RECRUITING date: 2024-02-28 date: 2024-04-28 date: 2024-08-28 date: 2024-03-05 date: 2024-03-05 name: Inonu University class: OTHER briefSummary: The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test. conditions: Dysmenorrhea conditions: Anxiety conditions: Anxiety Disorders and Symptoms conditions: Pain, Menstrual studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of two groups, a control group and a experimental group wo mindfulness group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The determination of which university would be included in the control and experimental groups in the research was made through a randomization method. The selection was done blindly by an independent academician unrelated to the research. As a result of the randomization, the control group and the experimental groups. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Mindfulness training name: Will not be given any application measure: VAS Pain Scale measure: State and Trait Anxiety Scale sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bartin University status: RECRUITING city: Bartın zip: 74001 country: Turkey name: Simge Öztürk, Ph.D role: CONTACT phone: 05398751788 email: sozturk@bartin.edu.tr lat: 41.63583 lon: 32.3375 hasResults: False
<\|newrecord\|> nctId: NCT06293300 id: 20231056 id: HT94252310608 type: OTHER_GRANT domain: Department of Defense Awarding Office: U.S. Army Medical Research Acquisition Activity (USAMRAA) briefTitle: Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A) overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-08-30 date: 2026-08-30 date: 2024-03-05 date: 2024-04-24 name: University of Miami class: OTHER name: United States Department of Defense briefSummary: The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: BoNT A measure: Change in photophobia measured by Numerical Rating Scale measure: Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA) measure: Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8) measure: Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye). measure: Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25) measure: Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS) measure: Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6 measure: Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5) measure: Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI) measure: Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST) measure: Change in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States name: Mariela Aguilar, PhD role: CONTACT phone: 305-326-6069 email: maguilar1@miami.edu name: Anat Galor, MD/MSPH role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False
<\|newrecord\|> nctId: NCT06293287 id: DJ-2023-02 briefTitle: Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy overallStatus: RECRUITING date: 2024-01-31 date: 2024-11-30 date: 2025-01-30 date: 2024-03-05 date: 2024-03-08 name: Zhongshan Hospital (Xiamen), Fudan University class: OTHER briefSummary: The present investigation is designed as a single-blind, randomized, controlled, bicentric trial. The objective is to ascertain whether the subcutaneous administration of enoxaparin sodium for prophylactic anticoagulation during transradial hepatic arterial infusion chemotherapy (HAIC) can diminish the incidence of radial artery occlusion (RAO) post-procedure conditions: Radial Artery Occlusion studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 156 type: ESTIMATED name: Subcutaneous enoxaparin sodium name: Placebo measure: RAO rate after 24 hours and 21days sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital, Fudan University (Xiamen Branch) status: RECRUITING city: Xiamen state: Fujian zip: 361015 country: China name: BoHeng Zhang, PHD role: CONTACT phone: 0592-3501990 email: zhang.boheng@zs-hospital.sh.cn lat: 24.47979 lon: 118.08187 hasResults: False
<\|newrecord\|> nctId: NCT06293274 id: sdilek5 briefTitle: The Importance of Discharge Education for Mommy Blues overallStatus: RECRUITING date: 2024-01-01 date: 2024-03-30 date: 2024-05-30 date: 2024-03-05 date: 2024-03-22 name: Kocaeli University class: OTHER briefSummary: The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province.
The sample size of the study was calculated using the G\Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G\Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up. conditions: Postpartum Sadness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: Discharge training measure: Motherhood Sadness Scale measure: Edinburgh Postnatal Depression Scale - EPDS sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Kocaeli University status: RECRUITING city: Kocaeli zip: 41380 country: Turkey name: Sena Dilek Aksoy, Ph.D. role: CONTACT phone: +902623034739 email: sena.dilek@kocaeli.edu.tr name: Resmiye Ozdilek, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 39.62497 lon: 27.51145 hasResults: False
<\|newrecord\|> nctId: NCT06293261 id: YMC043 briefTitle: Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia overallStatus: ACTIVE_NOT_RECRUITING date: 2020-06-27 date: 2024-03-31 date: 2024-03-31 date: 2024-03-05 date: 2024-03-05 name: Yuhan Corporation class: INDUSTRY briefSummary: This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia conditions: Hypertension conditions: Hypercholesterolemia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 5047 type: ACTUAL name: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg measure: Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) measure: Change from baseline to 6/12 months in SBP and DBP measure: Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C) measure: Change from baseline to 6/12 months in hs-CRP measure: Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose) measure: Change from baseline to 6/12 months in Diabetes indicator ( HbA1c) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hallym University Sacred Heart Hospital city: Anyang-si country: Korea, Republic of lat: 37.3925 lon: 126.92694 facility: Dong-A University Hospital city: Busan zip: 49201 country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Changwon Fatima Hospital city: Changwon country: Korea, Republic of lat: 35.22806 lon: 128.68111 facility: Gyeongsang National University Changwon Hospital city: Changwon country: Korea, Republic of lat: 35.22806 lon: 128.68111 facility: Soon Chun Hyang University Hospital Cheonan city: Chungbuk country: Korea, Republic of lat: 35.55292 lon: 127.49042 facility: Dankook University Hospital city: Chungnam country: Korea, Republic of lat: 36.27333 lon: 128.02522 facility: Daegu Catholic University Medical Center city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: Keimyung University Dongsan Medical Center city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: Yeungnam University Medical Center city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: Daejeon Eulji Medical Center Eulji University city: Daejeon country: Korea, Republic of lat: 36.32139 lon: 127.41972 facility: Myungji Hospital city: Goyang-si country: Korea, Republic of lat: 37.65639 lon: 126.835 facility: Chonnam National University Hospital city: Gwangju country: Korea, Republic of lat: 35.15472 lon: 126.91556 facility: Chosun University Hospital city: Gwangju country: Korea, Republic of lat: 35.15472 lon: 126.91556 facility: Bundang Jesaeng General Hospital city: Gyeonggi-do country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Cha University Bundang Medical Center city: Gyeonggi-do country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Hallym University Dongtan Sacred Heart Hospital city: Gyeonggi-do country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Korea University Ansan Hospital city: Gyeonggi-do country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: National Health Insurance Service Ilsan Hospital city: Gyeonggi-do country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Samsung Changwon Hospital city: Gyeongsang country: Korea, Republic of lat: 35.3164 lon: 126.93455 facility: Wonkwang University Hospital city: Iksan country: Korea, Republic of lat: 35.94389 lon: 126.95444 facility: Dongguk University Ilsan Hospital city: Ilsan country: Korea, Republic of lat: 35.5 lon: 129.43333 facility: Inje University Ilsan Paik Hospital city: Ilsan country: Korea, Republic of lat: 35.5 lon: 129.43333 facility: Inha University Hospital city: Incheon country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Kwandong University International St.Mary'S Hospital city: Incheon country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Kwangju Veterance Hospital city: Kwangju country: Korea, Republic of lat: 36.9122 lon: 127.1279 facility: Pusan National University Hospital city: Pusan country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Pusan National University Yangsan Hospital city: Pusan country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Gangnam Severance Hospital city: Seoul zip: 06273 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Ewha Womans University Mokdong Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Ewha Womans University Seoul Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Hallym University Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kangdong Sacred Heart Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Korea University Anam Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Korea University Guro Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kyung Hee University Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: National Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Samsung Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Ulsan University city: Ulsan country: Korea, Republic of lat: 35.53722 lon: 129.31667 facility: Wonju Severance Christian Hospital city: Wŏnju country: Korea, Republic of lat: 37.35139 lon: 127.94528 hasResults: False
<\|newrecord\|> nctId: NCT06293248 id: 77979112 briefTitle: Music Application in Patients Undergoing Percutaneous Coronary Intervention overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-10 date: 2023-12-31 date: 2024-05-31 date: 2024-03-05 date: 2024-03-12 name: Kocaeli University class: OTHER briefSummary: This study was planned to examine the effect of music application on recovery in patients undergoing coronary angiography (CAG) and to obtain the opinions of patients and nurses about music.This study was conducted to examine the effect of music application on recovery in patients undergoing CAG and to obtain the opinions of patients and nurses about music.The study was planned as a pre-test, post-test design, single-center, randomized controlled experimental study. The study is planned to be conducted in the CAG unit of a university hospital between July 2023 and December 2023, the study sample will be composed of a total of 210 individuals, 105 in each group (music applied group before and after the procedure = 105, control group = 105) To collect data in the study, the "Patient Information Form", Vital Signs Evaluation Form", "Numerical Rating Scale", State-Trait Anxiety Inventory, "Perianesthesia Comfort Scale" and "Patient Satisfaction Survey on Nursing Care Quality" were used. conditions: Healthy conditions: Nurse's Role conditions: Patient Satisfaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Single (Participant) whoMasked: PARTICIPANT count: 210 type: ESTIMATED name: musical application measure: Means of subjective pain scores measure: Means of body temperature (0C) measure: Means of systolic blood pressure (mmHg) measure: Means of diastolic blood pressure (mmHg) measure: Means of heart rate (/minutes) measure: Means of respiratory rate (/minutes) measure: Means of oxygen saturation (%) measure: Means of subjective anxiety scores measure: Means of Perianesthesia Comfort Scale Scores measure: Means of Patient Satisfaction Survey on Nursing Care Quality Scores sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli University Hospital city: Kocaeli state: Umuttepe Campus, İzmit zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 hasResults: False
<\|newrecord\|> nctId: NCT06293235 id: 2024/2120 briefTitle: Towards Optimal Fertility, Fathering and Fatherhood studY acronym: TOFFFY overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-06 date: 2027-03 date: 2024-03-05 date: 2024-03-05 name: KK Women's and Children's Hospital class: OTHER_GOV briefSummary: This case-control study involving fertile and subfertile couples aims to identify male factors related to pregnancy likelihood, create a fertility index measure combining male and female factors to predict pregnancy likelihood, and examine how male factors relate to the semen physical and biological characteristics. conditions: Reproductive Issues conditions: Fertility Issues studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 960 type: ESTIMATED name: Lifestyle and metabolic indicators measure: Pregnancy rate measure: Fertility index measure: Oxidative stress measure: Semen volume measure: Sperm concentration measure: Sperm total motility measure: Sperm progressive motility measure: Total progressive motile sperm count measure: Single strand sperm DNA fragmentation measure: Double strand sperm DNA fragmentation measure: mRNA level measure: sncRNA level measure: DNA methylation measure: Sperm morphology sex: ALL minimumAge: 21 Years maximumAge: 49 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06293222 id: SCD Support briefTitle: Patient and Public Involvement and Engagement in Research With Children and Young People With Sickle Cell Disorder and Their Families overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-21 date: 2024-04-30 date: 2024-04-30 date: 2024-03-05 date: 2024-03-07 name: King's College London class: OTHER name: Sickle Cell Society briefSummary: Aim: To co-produce resources for inclusive and equitable Patient and Public Involvement and Engagement in research on life-limiting conditions, with children and young people with sickle cell disorder and their families.
Methods: Workshops with a) members of a patient advocacy organisation (Sickle Cell Society n=5) b): i) Children and young people (10-18 years) with sickle cell disorder (n=15) and ii) their siblings (10-18 years, n=10) and iii) their parents (n=15), c) Researchers form the Cicely Saunders Institute Outputs: Resources that enable children and young people with sickle cell disorder and their families to engage in research conditions: Sickle Cell Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Workshops with participants to develop resources that enable children and young people with sickle cell disorder and their families to engage in research sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: King's College London city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06293209 id: Sunpasitthiprasong Hospital id: Sunpasitthiprasong Hospital type: OTHER domain: Sunpasitthiprasong Hospital briefTitle: Effect of Cool Spray and Cold Packs in Reducing Preoperative Edema and Pain in Ankle Fractures in Ubonratchathani acronym: 3-armRCT overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-01 date: 2024-02-28 date: 2024-05-28 date: 2024-03-05 date: 2024-03-05 name: Thai Traditional Medical Knowledge Fund class: OTHER_GOV briefSummary: The use of evaporative coolants in the management of acute musculoskeletal injury has received increasing attention recently. However, its efficacy compared with conventional cryotherapy in treating injured human subjects remains unclear.
The purpose of this study is to compare the efficacy of evaporative coolants with that of ice packs in the preoperative management of edema and pain in patients with an ankle fracture conditions: Ankle Fractures conditions: Swelling conditions: Cryotherapy Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Population
The sample group comprises 30 patients admitted for treatment in the male orthopedic surgery department, female orthopedic surgery department, and accident orthopedic surgery department at Sunpasitthiprasong Hospital, Ubon Ratchathani from August 2023 to January 2024. . primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: 3M cold pack name: Perskindol cold spray name: Placebo measure: swelling measure: pain score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Orthopedics, Sunpasitthiprasong hospital, Ubonratchathani, Thailand. city: Multiple Locations state: Ubonrachathani zip: 34000 country: Thailand hasResults: False
<\|newrecord\|> nctId: NCT06293196 id: 20231107 briefTitle: Effects of Acupoint Massage Around Eyes on Ocular Biological Indexes overallStatus: RECRUITING date: 2023-09-01 date: 2024-03-31 date: 2025-06-30 date: 2024-03-05 date: 2024-03-05 name: Zhongnan Hospital class: OTHER briefSummary: This study aims to investigate whether the acupoint eye exercise could impact the biological parameters of the eye. conditions: Investigating the Effects of Periocular Acupressure on Ocular Biological Indicators studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 55 type: ESTIMATED name: acupressure measure: Changes in blood flow to the eye sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongnan Hospital of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Min Ke, doctor of medicine role: CONTACT phone: 18672395959 email: Keminyk@163.com lat: 30.58333 lon: 114.26667 hasResults: False

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