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WALANT anesthesia (Wide Awake Local Anesthesia No Tourniquet) designates a new local anesthesia technique. This technique which allows to maintain the arm or fingers mobility offers several significant advantages:
* Greater precision of the surgical procedure.
* A reduction in discomfort, risks and related adverse effects to anesthesia.
* Faster recovery.
WALANT technique is very comfortable for patient and fits perfectly with principles of Enhanced Recovery in Surgery.
In this context, this study is based on the hypothesis that it is possible to combine arthroscopy and the WALANT anesthesia technique for reducing wrist fractures conditions: Wrist Fractures studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Walanpoigne measure: Failure percentage measure: Pain assessment measure: Patient experience measure: Wrist mobility measure: Functional characteristics of the wrist measure: Functional characteristics of the wrist measure: Complications sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06379542 id: XC8-03-05-2023 briefTitle: Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections overallStatus: RECRUITING date: 2023-12-04 date: 2025-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: Valenta Pharm JSC class: INDUSTRY briefSummary: The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo. conditions: Acute Respiratory Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 252 type: ESTIMATED name: XC8 name: Placebo measure: Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1 measure: Number of cough attacks by day 5, day 8, day 11 and day 15 measure: Time (days) from visit 1 until clinical cough cure is achieved measure: Proportion of patients with presence of ≤ 1 score for the "daytime cough" and "nighttime cough" sections Daytime and nighttime cough scales by days 5, 8, 11, and 15 after visit 1 measure: Change (score) in cough severity by digital rating scale by days 5, 8, 11 and 15 compared to visit 1 measure: Percentage of patients needed acetylcysteine measure: Proportion of patients with complete resolution of all symptoms of acute respiratory infection by days 4, 7, 10 and 14 measure: Percentage of patients with each category of Global Physician-Researcher Assessment of Therapy Effectiveness at visits 2, 3, 4, and 5 measure: Number of adverse events (AEs) measure: Adverse reactions measure: Serious adverse events (SAEs) measure: Percentage of patients with AEs measure: Percentage of patients who interrupted treatment sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: City Pediatric Outpatient Clinic number 5 status: RECRUITING city: Perm zip: 614066 country: Russian Federation name: Olga Perminova, MD, PhD role: CONTACT phone: +7 (912) 882 0549 email: [email protected] lat: 58.01046 lon: 56.25017 facility: Professors' Clinic LLC. status: RECRUITING city: Perm zip: 614070 country: Russian Federation name: Svetlana Teplykh, MD, PhD role: CONTACT phone: +7 (919) 498 2931 email: [email protected] lat: 58.01046 lon: 56.25017 facility: St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44" status: RECRUITING city: Saint Petersburg zip: 192071 country: Russian Federation name: Olga V Trusova, MD,PhD role: CONTACT phone: +7 (812) 417-40-02 email: [email protected] lat: 59.93863 lon: 30.31413 facility: ArsVite North-West, LLC status: RECRUITING city: Saint Petersburg zip: 194223 country: Russian Federation name: Svetlana G Lazareva, MD role: CONTACT phone: +7-812-335-29-58 email: [email protected] lat: 59.93863 lon: 30.31413 facility: PiterKlinika LLC status: RECRUITING city: Saint Petersburg zip: 196158 country: Russian Federation name: Tatiana Pak, MD,PhD role: CONTACT phone: +7 (981) 851 8150 email: [email protected] lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35" status: RECRUITING city: Saint Petersburg zip: 196191 country: Russian Federation name: Tatiana I Antonova, MD, PhD role: CONTACT phone: +7-812-246-46-45 email: [email protected] lat: 59.93863 lon: 30.31413 hasResults: False
<|newrecord|> nctId: NCT06379529 id: USCOPD2022B briefTitle: The COPD CARE Study: Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-09 date: 2025-12 date: 2024-04-23 date: 2024-04-23 name: NuvoAir Medical PC class: INDUSTRY name: Optum, Inc. briefSummary: A 12 month interventional study of up to 1,050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events, reduces healthcare utilization, and lowers the total cost of care compared to a control cohort that receives standard care only. conditions: COPD Exacerbation conditions: COPD conditions: Cardio/Pulm: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pragmatic evaluation of a clinical service using a prospective cohort comparison of intervention vs propensity matched controls. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 1050 type: ESTIMATED name: NuvoAir clinical service measure: Moderate & Severe Exacerbations measure: Severe COPD Exacerbations measure: Major Adverse Cardiac Event measure: 30-Day COPD Related Readmissions measure: All-Cause Hospitalizations measure: All-Cause Readmissions measure: Days Hospitalized due to COPD measure: Cost of Care Related to COPD measure: Medication Adherence measure: Quality of Life (QOL) measure: Short-Acting Beta-Agonists Used measure: Courses of Oral Antibiotics/Steroids measure: Self-efficacy measure: Patient Activation measure: Cat Score measure: mMRC Dyspnea Scale measure: Physical Activity sex: ALL minimumAge: 30 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06379516 id: NB240004-NB-V briefTitle: Process Validation in Dermatology: Assessing Wound Creation Methods and Treatment Efficacy overallStatus: COMPLETED date: 2024-01-17 date: 2024-01-26 date: 2024-02-16 date: 2024-04-23 date: 2024-04-23 name: NovoBliss Research Pvt Ltd class: OTHER briefSummary: The primary objective of this study is to validate controlled methods of wound, including 1%w/v SLS, 3%w/v SLS, and 24-24 times tape stripping, on the forearms of subjects.
The study aims to standardize the procedures for creating wounds and systematically evaluate the effects of these methods on various skin parameters. conditions: Validation of the Process of Wound Creation and Evaluation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Proof of science/concept primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 5 type: ACTUAL name: Moisturising Cream (5%) name: Moisturising Cream (10%) name: Coconut Oil measure: Trans Epidermal Water Loss (TEWL) measure: Skin hydration measure: Skin surface topography measure: Dermatological Assessment sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: NovoBliss Research Pvt Ltd city: Gandhinagar state: Gujarat zip: 382421 country: India lat: 23.21667 lon: 72.68333 hasResults: False
<|newrecord|> nctId: NCT06379503 id: 2021/37-04 briefTitle: Effect of Heart Yoga Applıed To Patıents Undergoıng Cardıovascular Surgery on Sleep, Depressıon And Qualıty of Lıfe overallStatus: COMPLETED date: 2021-12-15 date: 2023-01-18 date: 2023-06-18 date: 2024-04-23 date: 2024-04-23 name: Dokuz Eylul University class: OTHER briefSummary: This type of study is a randomized controlled trial. The aim is to contribute to the literature by comparing the effects of heart yoga on the depression level, sleep and quality of life of patients who do and do not do heart yoga.
The main elements it aims to answer are:
* Heart yoga applied to patients who have undergone heart surgery improves their sleep quality compared to those who have not.
* Heart yoga applied to patients who have undergone heart surgery reduces the level of depression compared to those who have not.
* Heart yoga applied to patients who have undergone heart surgery increases the quality of life compared to those who have not.
Patients who accept the study will practice heart yoga simultaneously with heart yoga videos via an online link every other day for 12 weeks after heart surgery.
Researchers will compare intervention and control groups to see if there are any effects on sleep quality, depression level, and quality of life. conditions: Cardiac Disease conditions: Yoga conditions: Nursing Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: HEART YOGA name: routine nursing care measure: sleep quality measure: depression measure: life quality sex: ALL minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dokuz Eylül Üniversitesi Hastanesi city: İ̇zmi̇r state: Balçova zip: 35330 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
<|newrecord|> nctId: NCT06379490 id: CTA no: 2024-510572-20-00 id: 2024-510572-20-00 type: CTIS id: P-2023-296 type: OTHER domain: Privacy - Region Hovedstaden briefTitle: Ultrasound-guided Infraclavicular Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures overallStatus: RECRUITING date: 2024-04-23 date: 2024-08-01 date: 2025-09-01 date: 2024-04-23 date: 2024-04-24 name: Nordsjaellands Hospital class: OTHER briefSummary: To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations but at the same volume. In addition to motor and sensory blockade during repositioning, feasibility will also be assessed by other patient-related and block-related factors, as well as by factors related to the repositioning and plastering procedure. conditions: Distal Radius Fractures conditions: Lidocaine conditions: Ropivacaine conditions: Fracture Dislocation conditions: Closed Reduction of Fracture and Application of Plaster Cast conditions: Colles' Fracture studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 63 type: ESTIMATED name: Ropivacaine 0.2% Injectable Solution name: Lidocaine epinephrine name: Ropivacaine 0.5% Injectable Solution measure: Block success measure: Degree of sensory and motor blockade measure: Total duration of sensory blockade measure: Total duration of motor blockade measure: Pain intensity before block performance measure: Time to pain relief/lowest pain intensity measure: Pain intensity during closed reduction measure: Pain intensity during cast application measure: Time to pain breakthrough after the blockade has ended measure: Maximum pain intensity after the blockade has ended measure: Duration of maximum pain intensity after the blockade has ended measure: Amount of strong painkillers consumed by patients within 24 hours after closed reduction measure: Grading of closed reduction difficulty measure: Quality of closed reduction evaluated by X-ray imaging measure: Attempts used for closed reduction measure: Grading of casting difficulty measure: The patient's experience of the treatment measure: Occurence of adverse events (AE) and serious adverse events (SAE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University Hospital - North Zealand status: RECRUITING city: Hillerød zip: 3400 country: Denmark name: Anders K. Nørskov, PhD role: CONTACT phone: 48 29 74 59 phoneExt: +45 email: [email protected] name: Kai H. W. Lange, DMSc role: CONTACT phone: 48 29 42 52 phoneExt: +45 email: [email protected] lat: 55.92791 lon: 12.30081 hasResults: False
<|newrecord|> nctId: NCT06379477 id: refractive error surprises briefTitle: Correction of Refractive Error Surprises After Cataract Surgery in Adults overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-06-30 date: 2024-04-23 date: 2024-04-23 name: Assiut University class: OTHER briefSummary: A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. It can cause anisometropia or dominance switch and is a source of patient dissatisfaction due to unmet expectations.The best way to manage refractive surprise is to prevent it. The 2017 NICE guidelines on the management of cataracts provide advice on prevention of refractive surprise through accurate biometry, A-constant optimisation, intraocular lens (IOL) formula selection and avoiding wrong lens implant errors.Benchmark standards for NHS cataract surgery dictate that 85% of eyes should be within 1 dioptre (D) and 55% within 0.5D of target spherical equivalent refraction following surgery. conditions: Refractive Errors studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 63 type: ESTIMATED name: Refractive surgeries measure: Diagnosis and treatment of the resulting refractive error surprises sex: ALL minimumAge: 55 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06379464 id: CALM2303 briefTitle: Screening of New Markers of Gut Microbiota in Stroke and Depression: a Cross-sectional Study overallStatus: RECRUITING date: 2023-09-01 date: 2024-06-30 date: 2024-12-30 date: 2024-04-23 date: 2024-04-23 name: Zhujiang Hospital class: OTHER briefSummary: Objectives of Study: Through the cross-sectional study of stroke and depression, key biomarkers are targeted by screening disease-associated intestinal bacteria, metabolites and immune factors through multi-omics techniques. conditions: Acute Ischaemic Stroke conditions: Depression studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 320 type: ESTIMATED measure: The severity of neurological damage in stroke patients measure: The functional recovery outcomes after stroke measure: The severity of symptoms in patients with depression sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guanzhou state: Guangdong zip: 510145 country: China name: Hongwei Zhou, Professor role: CONTACT phone: 186 8848 9622 email: [email protected] hasResults: False
<|newrecord|> nctId: NCT06379451 id: [2023]YLJSA088 briefTitle: An Clinical Study of NKG2D-CAR-NK Cells for the Treatment of Refractory Recurrent Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: Changzhou No.2 People's Hospital class: OTHER briefSummary: Multiple myeloma (MM) is a malignant disease characterized by the abnormal proliferation of clonal plasma cells. However, multiple myeloma remains an incurable disease and requires the exploration of more effective treatment methods to improve the efficacy of relapsed refractory multiple myeloma and prolong survival time.Currently, clinical application of CAR-T is mostly based on autologous T cell preparation, while relapsed/refractory AML patients have undergone multiple chemotherapy treatments, resulting in impaired self-T cell function, which affects the efficacy and prognosis of CAR-T therapy. Therefore, it is necessary to find new alternative treatments. NK cells are important immune cells in the body and are an important component of innate immunity. Compared with CAR-T cell therapy, CAR-NK cells have unique advantages in adoptive cell therapy. NKG2D receptor is an activating receptor expressed on NK cells, which can recognize NKG2D ligands (NKG2DL) expressed on tumor cells, activating NK cell killing activity through NKG2D-NKG2DL interaction. Therefore, the investigators plan to treat relapsed multiple myeloma by infusing NKG2D-CAR-NK cells to evaluate its efficacy and safety. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: NKG2D Chimeric Antigen Receptor NK Cell Injection measure: Incidence of Dose Limiting Toxicity (DLTs) measure: Treatment Emergent Adverse Events (TEAEs) measure: Objective Response Rate of subjects sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changzhou Second People's Hospital city: Changzhou state: Jiangsu zip: 213000 country: China name: Wei Qin, doctor role: CONTACT phone: +8618796912763 email: [email protected] lat: 31.77359 lon: 119.95401 hasResults: False
<|newrecord|> nctId: NCT06379438 id: 06/16022018 briefTitle: Treatment of Aphtous Ulcers With Photodynamic Therapy overallStatus: COMPLETED date: 2018-03-05 date: 2019-03-01 date: 2019-03-08 date: 2024-04-23 date: 2024-04-23 name: Yuzuncu Yıl University class: OTHER briefSummary: The search for methods that can shorten the treatment process of aphthous ulcers, the etiology of which is not fully understood, continues. The aim of this study was to determine whether photodynamic therapy (PDT) is a clinically effective alternative in the treatment of oral aphthous ulcers. conditions: Oral Ulcer conditions: Aphthous Recurrent Ulcers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Photodynamic therapy (indocyanine green+laser) measure: Ulcer wound healing with diameter measurement measure: Level of recovery measure: Pain evaluation with Visual Analogue Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Yuzuncu Yil University city: Van state: Merkez zip: 65080 country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False
<|newrecord|> nctId: NCT06379425 id: 23-0050 briefTitle: Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries overallStatus: RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-04-23 date: 2024-04-23 name: Northwell Health class: OTHER briefSummary: This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures. conditions: Pain, Postoperative conditions: Postoperative Pain, Acute studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 70 type: ESTIMATED name: Acetaminophen name: Celecoxib name: Gabapentin measure: Time to initiation of active trial of void sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Northwell Health South Shore Surgery Center status: RECRUITING city: Bay Shore state: New York zip: 11706 country: United States name: Kathleen R Catalano, MSN, RN-BC role: CONTACT phone: 631-647-5550 email: [email protected] name: Nirmala Pillalamarri, MD role: PRINCIPAL_INVESTIGATOR name: Steliana Fakas, MD role: SUB_INVESTIGATOR lat: 40.7251 lon: -73.24539 hasResults: False
<|newrecord|> nctId: NCT06379412 id: Zhujianghmy briefTitle: A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Colorectal Cancer overallStatus: RECRUITING date: 2023-07-01 date: 2024-12 date: 2024-12 date: 2024-04-23 date: 2024-04-26 name: Zhujiang Hospital class: OTHER briefSummary: The goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (CRC). The main question it aims to answer is: Are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? Participants will provide biological specimens (blood, feces, colon tissue obtained during surgery) conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: observational study, no intervention measure: HPLC-MS/MS was used to detect peptidoglycan fragment content in biological specimens of 200 participants sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: He Xiaolong, Professor role: CONTACT phone: 186 2007 1640 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False
<|newrecord|> nctId: NCT06379399 id: IRB-2023-1072 briefTitle: Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type mCRC overallStatus: RECRUITING date: 2024-04 date: 2025-03 date: 2025-12 date: 2024-04-23 date: 2024-04-23 name: Wangxia LV class: OTHER briefSummary: This study is a single-center, prospective, single-arm exploratory study aimed at evaluating the efficacy and safety of trifluridine/tipiracil in combination with cetuximab in the treatment of third-line and above RAS/BRAF wild-type metastatic colorectal cancer. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 26 type: ESTIMATED name: Cetuximab name: Trifluridine/Tipiracil measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Overall Response Rate (ORR) measure: Disease Control Rate( DCR) measure: Quality of life: EORTC QLQ-C30 measure: Adverse Events(safety) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310022 country: China name: Wangxia Lv role: CONTACT phone: +86-13757141026 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False
<|newrecord|> nctId: NCT06379386 id: TRACE TAVR Registry briefTitle: Long-term Prognosis and Valve Durability of TAVR overallStatus: RECRUITING date: 2016-01 date: 2025-12 date: 2030-12 date: 2024-04-23 date: 2024-04-23 name: Xijing Hospital class: OTHER briefSummary: This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner. conditions: Aortic Valve Stenosis and Insufficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Transcatheter aortic valve replacement measure: All-casuse mortality measure: Valve-related long-term clinical efficacy measure: Combined early safety and clinical efficacy outcomes measure: Rate of technical success measure: Rate of device success measure: Combined clinical efficacy outcomes measure: Valve-related long-term clinical efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital status: RECRUITING city: Xi'an state: Shannxi zip: 710032 country: China name: Rutao Wang, M.D., Ph.D. role: CONTACT phone: +86-15091095796 email: [email protected] name: Ruining Zhang, BSc role: CONTACT phone: +86-15802990370 email: [email protected] name: Ling Tao, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 hasResults: False
<|newrecord|> nctId: NCT06379373 id: 2023-KLS-190-02 briefTitle: Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention overallStatus: RECRUITING date: 2023-02-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: The First Affiliated Hospital of Zhejiang Chinese Medical University class: OTHER briefSummary: Tourette syndrome is a refractory type of tic disorder. Previous clinical studies have confirmed that Tuina has a good effect on TS, but the mechanism of action is still uncertain. Studies have found that the pathogenesis of TS may be related to immune factors, and patients will accompanied by the overflow of inflammatory factors such as interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) during the onset of the disease. Other studies have found that the serum levels of IgG1, IgG2, IgG3, IgG4, IgGM, IgGA, IgGE, complement C3 and complement C4 are closely related to the pathogenesis of TS, and the abnormal humoral immune response mediated by food intolerance has an important impact on the pathogenesis of mental illness in children. The immune system plays a very complex role in TS. Based on this, we hypothesized that there may be differences in serum humoral immune effector levels between children with TS and healthy children, whether these differences are related to the consumption of certain allergenic foods or not, and so does Tuina spinal balancing can improve the clinical symptoms of children with TS by changing the levels of inflammatory and immune factors in peripheral serum. This study studied the peripheral mechanism of humoral immune effector mediated by Tourette syndrome and the intervention effect of Tuina through comprehensive scale analysis and advanced laboratory technology, which will provide a scientific theoretical basis and a safe and effective method for the treatment of multiple tics, and will have broad application prospects. conditions: Tourette Syndrome in Children conditions: Food Intolerance conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: According to the order of enrollment, the random number table method was used to divide the massage spinal manipulation+ placebo group (oral placebo, each dose: 50mg/time for 4-7 years old, 75mg/time for 7-12 years old, 100mg/time for 10-18 years old, 2 times/d), relaxation manipulation+ western medicine group (oral Typride tablets, each dose: 50mg/time for 4-7 years old, 75mg/time for 7-12 years old, 100mg/time for 10-18 years old, 2 times/d) for 2 consecutive weeks. Both groups were intervened for 2 courses. The observation time points were 2 weeks, 4 weeks, and 3 months before treatment and after treatment. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Spine manipulation; westren medicine measure: Change from Baseline in scores on Yale global Tic severity scale(YGTSS) at Week4 and Week8 measure: Change from Baseline in scores on TCM Syndrome Points at Week4 and Week8 measure: Change from Baseline in difference in the spacing of the lantoine side sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: First Affiliated Hospital of Zhejiang Chinese Medical University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310006 country: China name: xiao Li, Doc. role: CONTACT phone: 0571-87072953 lat: 30.29365 lon: 120.16142 hasResults: False
<|newrecord|> nctId: NCT06379360 id: SZAMLLRM01 briefTitle: Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients overallStatus: RECRUITING date: 2020-11-01 date: 2024-05-01 date: 2028-12-31 date: 2024-04-23 date: 2024-04-24 name: The First Affiliated Hospital of Soochow University class: OTHER briefSummary: HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Apply hypomethylating agent, azacitidine or decitabine as maintenance therapy. primaryPurpose: TREATMENT masking: NONE count: 77 type: ESTIMATED name: Hypomethylating agent, Azacitidine or Decitabine measure: Relapse free survival (RFS) measure: Overall survival (OS) measure: Cumulative incidence of relapse (CIR) sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215006 country: China name: Sheng-Li Xue, M.D. role: CONTACT phone: +86 512 6778 1139 email: [email protected] lat: 31.30408 lon: 120.59538 hasResults: False
<|newrecord|> nctId: NCT06379347 id: FZ 23/41 briefTitle: HOspitalized Patients and Clinical flUid Status, Assessment Using Point Of Care UltraSound acronym: HOCUS-POCUS overallStatus: RECRUITING date: 2024-02-28 date: 2025-03 date: 2025-03 date: 2024-04-23 date: 2024-04-23 name: Flevoziekenhuis class: OTHER briefSummary: Point of care ultrasound (POCUS) of the inferior vena cava (IVC) is a tool for assessing volume status through ultrasonography. Using a point of care ultrasound device, the physician can perform an ultrasound of the vena cava at the bedside. Previous research has demonstrated a correlation between right atrial pressure and the vena cava's diameter. Nonetheless, the majority of research has been conducted in critically ill populations to predict fluid responsiveness in patients with more complex hemodynamics. There is limited data available on the value of IVC ultrasound in the sub-acute setting on the regular ward for clinical decision-making regarding whether a patient is hypovolemic or hypervolemic. This study's objective is to assess the diagnostic utility of point-of-care ultrasonography of the IVC, by using a standardized methodology, performed by qualified ward physicians in a conventional nursing ward. conditions: Volume Status studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: POCUS perfomed on clinica indication measure: Volume status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Flevoziekenhuis status: RECRUITING city: Almere country: Netherlands name: Koen de Heer, MD PhD role: CONTACT lat: 52.37535 lon: 5.25295 hasResults: False
<|newrecord|> nctId: NCT06379334 id: I-22PJ911 briefTitle: Discovering Urinary Protein Biomarkers for Hepatocellular Carcinoma in Chronic Hepatitis B Population overallStatus: ACTIVE_NOT_RECRUITING date: 2020-12-06 date: 2024-12-06 date: 2026-12-06 date: 2024-04-23 date: 2024-04-23 name: Peking Union Medical College Hospital class: OTHER briefSummary: Chronic hepatitis B (CHB) can lead to hepatocellular carcinoma (HCC), imposing a significant health and economic burden globally. Early detection of hepatitis B virus-related HCC (HBV-HCC) in CHB with potential biomarkers has become a pressing and difficult challenge. Recent advancements in urinary proteomics offer a promising approach for HBV-HCC biomarker identification, utilizing Liquid chromatography with tandem mass spectrometry for urine proteome analysis. Differential analysis using limma in R software will uncover upregulated proteins in HBV-HCC. conditions: Hepatocellular Carcinoma conditions: Hepatitis B studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: Urine test measure: upregulated proteins measure: downregulated proteins sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06379321 id: 24-362 briefTitle: A Retrospective/Prospective, Post-market Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System acronym: Hinge overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2034-05-01 date: 2034-05-01 date: 2024-04-23 date: 2024-04-23 name: The Cleveland Clinic class: OTHER name: Stryker Orthopaedics briefSummary: This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).
Clinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years. conditions: Knee Arthropathy conditions: Recurrence conditions: Knee Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 200 type: ESTIMATED name: Triathlon Hinge Knee (THK) System measure: Survivorship sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Florida city: Weston state: Florida zip: 33331 country: United States name: Kaitlin Bernabe role: CONTACT phone: 954-610-8016 email: [email protected] name: Jorge Manrique-Succar role: PRINCIPAL_INVESTIGATOR lat: 26.10037 lon: -80.39977 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States name: Laura Stiegel role: CONTACT phone: 216-442-5511 email: [email protected] name: Alison Klika role: CONTACT phone: 216 444-4954 email: [email protected] name: Matthew Deren, M.D. role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 hasResults: False
<|newrecord|> nctId: NCT06379308 id: IRBN552024/CHUSTE. briefTitle: Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2027-04 date: 2024-04-23 date: 2024-04-23 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates). conditions: Anterior Cruciate Ligament Rupture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: questionaries name: datas of medical record measure: Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) measure: Results of Functional score questionary Tegner Activity Scale (TAS) measure: Results of Functional score questionary Simple Knee Value (SKV) measure: Results of Functional score questionary International Knee Documentation Commitee (IKDC) measure: Surgical complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Saint-Etienne city: Saint-Étienne country: France name: Thomas NERI, MD PhD role: CONTACT phone: (0)477120784 phoneExt: +33 email: [email protected] name: Thomas NERI, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
<|newrecord|> nctId: NCT06379295 id: CHUO-2024-05 briefTitle: Coronary Artery Calcification Assessed on PET/CT acronym: CALCOTEP overallStatus: NOT_YET_RECRUITING date: 2024-05-21 date: 2025-05-21 date: 2025-05-21 date: 2024-04-23 date: 2024-04-23 name: Centre Hospitalier Régional d'Orléans class: OTHER briefSummary: Calcification artery calcium (CAC) scoring is a valuable tool for determining the risk of major adverse cardiac events.
It was found that CAC can be quantitatively assessed, by manual scoring or using deep-learning, on low-dose non ECG-gated, contrast-enhanced or non-enhanced CT scans performed in association of PET acquisition, with a good agreement with standard scans.
The purpose of this study is to determine the impact of a systematic coronary artery calcification evaluation in patients undergoing 18F-FDG PET/CT imaging to improve primary prevention of cardiovascular diseases.
A visual CAC assessment will be made for each patient, dividing them into four groups: none, mild, moderate or heavy CAC. When possible, a CAC score will be computed.
Each patient will complete a questionnaire to collect risk factors, history of cardiovascular diseases and medications. conditions: Coronary Artery Disease conditions: Coronary Artery Calcification studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Questionnaire measure: Prevalence of moderate CAC in participants without history of cardiac disease measure: Prevalence of coronary heart disease among participants measure: Correlation of CAC with the medical indication for PET imaging measure: Prevalence of CAC in young participants (< 45 years old) measure: Prevalence of moderate CAC in participants not taking low-cholesterol drug measure: Prevalence of no CAC in participants taking statins sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06379282 id: FHMS 21-22 263 EGA briefTitle: Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia acronym: HIT-CLL overallStatus: RECRUITING date: 2022-10-14 date: 2025-08-01 date: 2026-08-01 date: 2024-04-23 date: 2024-04-24 name: University of Surrey class: OTHER name: American Society of Hematology briefSummary: This randomised control clinical trial aims to investigate the effects of exercise training and diet on physical and functional fitness and immunological and metabolic changes in adults with chronic lymphocytic leukaemia. Investigators will randomise participants to either 12 weeks of supervised/semi-supervised exercise only, exercise + nutritional guidance, or no exercise. conditions: Chronic Lymphocytic Leukemia conditions: Frailty conditions: Muscle Function conditions: Immune Function conditions: Lipid Cell; Tumor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 132 type: ESTIMATED name: HIT name: EXE+ Nutritional Guidance measure: Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12 measure: Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12 measure: Frailty measure: Muscle Strength and Endurance measure: Muscle Health measure: Change in Quality of Life using the EORCT-QLQ-C30 measure: Change in muscle oxygen metabolism during a single bout of exercise measure: Change in B-CLL Cell Function measure: Change in systemic and cellular bioenergetics measure: Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test measure: Legacy Effect of Intervention on absolute number of CD19+/CD5+ CLL cells sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Surrey status: RECRUITING city: Guildford zip: GU2 7WG country: United Kingdom name: David Bartlett, PhD role: CONTACT phone: 01483 683 45 email: [email protected] lat: 51.23536 lon: -0.57427 hasResults: False
<|newrecord|> nctId: NCT06379269 id: CMUH112-REC3-160 briefTitle: Effectiveness Verification of a Smartphone-based System for Assessment and Health Care on Myofascial Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-06 date: 2024-12 date: 2024-04-23 date: 2024-04-24 name: China Medical University Hospital class: OTHER name: National Cheng Kung University name: National Science and Technology Council briefSummary: Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the identified muscle.With the high penetration rate of smartphones, it would be convenient to utilize smartphones as the assistive technology in the assessment and intervention of MPS. The smartphone-based MPS assessment and care system could eliminate the restrictions of the epidemic, and provide an independent usage, precisely identifying muscle with TrPs and personalized care plan application. Therefore, the purpose of this study is to 1. develop a smartphone-based assessment and health care system for patients with myofascial pain syndrome. And to 2. verify the feasibility and validity of the system assessment function. And to 3. testify the effectiveness of the system health care functions for patient intervention. conditions: Myofascial Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: App healthcare name: Control measure: current pain visual analogue scale measure: functional questionnaire sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06379256 id: 202400364B0 briefTitle: Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2029-03-17 date: 2032-03-17 date: 2024-04-23 date: 2024-04-23 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Radiation therapy (RT) is a highly effective modality for managing localized solid tumors and has become a fundamental component of treating unresectable hepatocellular carcinoma (HCC). Our previous preclinical investigation (Hsieh et al., Science Immunology 2022) revealed that RT can initiate immunogenic cell death and facilitate the cross-presentation of tumor antigens by antigen-presenting cells, thereby augmenting systemic anti-tumor T cell responses in murine tumor models. However, this immune response subsequent to irradiation has not been comprehensively evaluated in clinical trials involving HCC patients. Given that RT represents a standard therapeutic approach for unresectable HCC, our ongoing phase II non-randomized trial aims to prospectively assess immunological responses and dose-volumetric parameters, while identifying predictors of clinical outcomes in patients undergoing definitive RT for HCC. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Photon or proton radiotherapy measure: Progression free survival (PFS) measure: Local control (LC) measure: Time to progression (TTP) measure: Overall Response Rate (ORR) measure: Overall survival (OS) measure: Incidence and severity of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung Memorial Hospital at Linkou city: Taoyuan City zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False
<|newrecord|> nctId: NCT06379243 id: KY-2023-008-02 briefTitle: Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures overallStatus: RECRUITING date: 2023-12-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-23 date: 2024-04-23 name: The Seventh Affiliated Hospital of Sun Yat-sen University class: OTHER name: The Fourth Affiliated Hospital of Guangzhou Medical University name: Huizhou Municipal Central Hospital name: Dongguan Hospital of Traditional Chinese Medicine briefSummary: In this project, IDEAL-IQ technology and PDFF and R2\* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2\*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year). conditions: Osteoporosis Fracture conditions: Osteoporosis Vertebral conditions: Compression Fracture conditions: Perform PVP / PKP Treatment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 560 type: ESTIMATED name: PVP/PKP measure: Non-operative vertebral re-fracture within 1 year after PVP / PKP measure: Visual Analog Score (VAS) at 1 year after PVP/ PKP measure: Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Seventh Affiliated Hospital, Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Kuiqing Lu role: CONTACT phone: 0755-81207263 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False
<|newrecord|> nctId: NCT06379230 id: SH9H-2023-T378-1 briefTitle: A Retrospective Study on Epidemiological Characteristics of Chinese NF1 Patients in Real World (PROMISE) overallStatus: RECRUITING date: 2019-01-01 date: 2022-12-31 date: 2025-02-28 date: 2024-04-23 date: 2024-04-23 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: Background/Rationale: Neurofibromatosis type 1 (NF1) affects about 1 in every 3000 people worldwide. Globally, 30\~50% NF1 patients will develop plexiform neurofibromas (PNs), which grow rapidly in early childhood and can cause disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder and bowel dysfunction. This systemic disease imposes a heavy psychosomatic and financial burden on patients and their caregivers. In NF1 patients, the lifetime risk of MPNST developed from PN is 8% to 13%. The mean age for NF1-associated death was approximately 20 years lower than that for the general population. Limited epidemiological and clinical data of Chinese NF1 patients is available to date. And the treatment pattern of Chinese NF1-PN patients is also unknown.
Objectives and Hypotheses: It is a descriptive study without formal hypothesis. The primary objective of this study is determining the percentage of NF1 patients who develop PN. The secondary objectives of this study include describing the clinical characteristics, tumor progression and treatment pattern of NF1-PN. The exploratory objective is exploring the epidemiological characteristics of other NF1 manifestations.
Methods:
Study design: The study is a retrospective multi-center chart review study. Data Source(s): All the data will be collected by CRF from inpatient and outpatient electronic medical records in every study site from January 1, 2019 to December 31, 2022.
Study Population: Patients who attended the study sites between January 1, 2019 - December 31, 2022 and were diagnosed with NF1 were included in this study. Statistical Analysis: This study is purely descriptive without any formal hypotheses.
Missing data for baseline characteristics will be assessed and addressed as a categorical variable with a level for missingness. All reported measures will be summarized in the study tables. Point estimates and their 95% CIs will be presented in the final analyses. conditions: Neurofibromatosis 1 conditions: Plexiform Neurofibroma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: This study is purely descriptive study. measure: Determine the percentage of NF1 patients developed PN at the baseline. measure: Clinical characteristics of NF1-PN: measure: Tumor progression of NF1-PN measure: Treatment pattern of NF1-PN: measure: The exploratory endpoints: sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing country: China name: Lei Zhang role: CONTACT phone: +86 13683139858 email: [email protected] lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Guangxi Medical University status: RECRUITING city: Nanning state: Guangxi country: China name: Jiping Shi role: CONTACT phone: +86 17758670856 lat: 22.81667 lon: 108.31667 facility: The First Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhengzhou state: Henan country: China name: Minjing Chen role: CONTACT phone: +86 13673665337 email: [email protected] lat: 34.75778 lon: 113.64861 facility: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine status: ACTIVE_NOT_RECRUITING city: Shanghai state: Shanghai zip: 200011 country: China lat: 31.22222 lon: 121.45806 facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Yang Xiao role: CONTACT phone: +86 18884266797 email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False
<|newrecord|> nctId: NCT06379217 id: CAAA617H12101 id: 2023-505655-43 type: EUDRACT_NUMBER briefTitle: NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-06-18 date: 2027-06-04 date: 2027-06-04 date: 2024-04-23 date: 2024-04-23 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gonadotropin Releasing Hormone Receptor (GRPR)) between the start and after the completion of radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC). conditions: Metastatic Neuroendocrine Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned to a treatment arm based on their predominantly expressed target per PET images (based on central read):
* \[177Lu\]Lu-PSMA-617 will be assigned to those with predominant PSMA expression
* \[177Lu\]Lu-DOTA-TATE will be assigned to those with predominant SSTR2 expression
* \[177Lu\]Lu-NeoB will be assigned to those with predominant GRPR expression primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: [68Ga]Ga-PSMA-11 name: [68Ga]GA-DOTA-TATE name: [68Ga]Ga-NeoB name: [177Lu]Lu-PSMA-617 name: [177Lu]Lu-DOTA-TATE name: [177Lu]Lu-NeoB name: L-Lysine HCl-L-Arginine HCl, 2.5 %, name: Gonadotropin-releasing hormone (GnRH) analogues name: GnRH antagonists name: Antiemetics & antinauseants name: Metoclopramide measure: Number/extent of lesions with at least a moderate uptake of any of the Radioligand Imaging (RLI) measure: Percentage changes in qualitative PET parameters. measure: Overall Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of response (DOR) measure: Radiographic Progression-free Survival (rPFS) measure: Proportion of participants with a decline in PSA level measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Radioligand Therapy (RLT) measure: Dose modifications for [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Radioligand Imaging (RLI) measure: Blood radioactivity concentration of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB) measure: Blood mass concentration of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB) measure: Observed maximum blood concentrations (Cmax) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Time of maximum blood concentration (Tmax) occurence of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Area under the blood concentration time curve (AUC) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Total systemic clerance (CL) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Volume of distribution during the terminal phase (Vz) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Terminal half-life (T^1/2) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Absorbed radiation doses of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Time Activity Curves (TACs) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06379204 id: No.2022026 briefTitle: A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test overallStatus: COMPLETED date: 2022-11-04 date: 2023-08-30 date: 2023-09-19 date: 2024-04-23 date: 2024-04-26 name: Taiyuan Central Hospital of Shanxi Medical University class: OTHER briefSummary: Analyze the clinical intervention effects and differences of progressive precision exercise prescriptions formulated by two methods for determining exercise intensity on metabolic syndrome (MS). Compare the effects of the two on the cardiovascular endurance of the MS population and verify the effectiveness of individualized methods in reducing absolute exercise intensity for MS patients. conditions: Metabolic Syndrome X studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ACTUAL name: the maximum physiological value standardized group name: the ventilatory threshold individualized group measure: Peak oxygen uptake sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taiyuan Cardiac Rehabilitation Center city: Taiyuan state: Shanxi zip: 030009 country: China lat: 37.86944 lon: 112.56028 hasResults: False
<|newrecord|> nctId: NCT06379191 id: ZS-3411 briefTitle: The Efficacy of WeChat-based Multidisciplinary Full-course Nutritional Management Program overallStatus: COMPLETED date: 2023-02-01 date: 2023-10-30 date: 2023-10-30 date: 2024-04-23 date: 2024-04-23 name: Peking Union Medical College Hospital class: OTHER briefSummary: As the most malignant type of cancer in the female reproductive system, ovarian cancer (OC) has become the second leading cause of death among Chinese women. Chemotherapy is the main treatment for OC patients, and its numerous adverse effects can easily lead to malnutrition. It is difficult to centrally manage OC patients in the intervals between chemotherapy. The utility of WeChat, an effective and more cost-efficient mobile tool, in chronic disease management has been highlighted. conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 78 type: ACTUAL name: Nutrition intervention model based on WeChat applets measure: patient-generated subjective global assessment (PG-SGA) measure: nutrition-related blood indices, such as total protein (g/L), albumin (g/L), prealbumin (g/L), and hemoglobin (g/L) measure: inflammation-related blood indices, such as leukocytes (10^9/L), lymphocytes (10^9/L), neutrophils (10^9/L), and platelets (10^9/L) measure: nutrition-inflammation composite indices, such as prognostic nutritional index (PNI) and systemic immunoinflammatory index (SII) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06379178 id: 6462e56fe8177 briefTitle: Effect of Oral Colostrum Applications Every 2 Hours and 4 Hours In Order to Achieve Trophic Feeding in Preterm Infants overallStatus: COMPLETED date: 2023-02-19 date: 2023-08-15 date: 2023-08-31 date: 2024-04-23 date: 2024-04-23 name: Gadjah Mada University class: OTHER briefSummary: The goal of this clinical trial is aims to evaluate the effects of applying colostrum orally every 4 and 2 hours in order to achieve trophic feeding in preterm infants. The main question it aims to answer is the optimal frequency of colostrum application that can be applied Participants will be divided by randomization using permutation blocks after meeting the inclusion and exclusion criteria and deemed eligible. These blocks were then randomized using computer software such as Microsoft Excel, determining the sequence for allocation to the control and intervention groups based on the randomization order from the permutation code, every 2 hours and every 4 hours. Researchers will investigate the effects of oropharyngeal colostrum application frequency, every 4 hours and every 2 hours, in order to achieve trophic feeding in preterm infants \<34 weeks gestational age. conditions: Trophic Feeding conditions: Very Low Birth Weight Baby conditions: Preterm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 47 type: ACTUAL name: Oral colostrum application 2 hours name: Oral colostrum application 4 hours measure: Days to Achieve Trophic Feeding sex: ALL maximumAge: 2 Days stdAges: CHILD facility: Neonatal Intensive Care Unit RSUP Dr. Sardjito city: Sleman state: Daerah Istimewa Yogyakarta zip: 55281 country: Indonesia lat: -7.71556 lon: 110.35556 hasResults: False
<|newrecord|> nctId: NCT06379165 id: SYH9015-002 briefTitle: Efficacy and Safety Study of Meloxicam Nanocrystal Injection for the Treatment of Moderate to Severe Pain overallStatus: COMPLETED date: 2023-05-17 date: 2023-07-11 date: 2023-07-13 date: 2024-04-23 date: 2024-04-23 name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery. conditions: Pain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 192 type: ACTUAL name: Meloxicam Nanocrystal Injection name: Placebo measure: PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose) measure: TOTPAR (time-weighted sum of pain relief scores): TOTPAR12, TOTPAR18, TOTPAR24, TOTPAR48. measure: SPID2、SPID6、SPID12、SPID18、SPID18-24、SPID24-48、SPID42-48、SPID48 measure: Time to the first dose of the remedial analgesia measure: Number of times of remedial analgesia administered 0-24h and 24-48h after the first dose measure: Proportion of subjects requiring remedial analgesia measure: The total amount of remedial analgesia used 24 h and 48 h after the first dose measure: The subject's analgesic treatment satisfaction score (0-4 point categorical scale score) measure: The investigator's satisfaction score (0-4 point categorical scale score) for the subject's analgesic treatment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology city: Wuhan country: China lat: 30.58333 lon: 114.26667 hasResults: False
<|newrecord|> nctId: NCT06379152 id: 2024-04-16 briefTitle: Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction overallStatus: RECRUITING date: 2020-09-20 date: 2024-06-30 date: 2024-07-01 date: 2024-04-23 date: 2024-04-23 name: Chongqing Medical University class: OTHER briefSummary: Factors influencing the prognosis of patients with heart failure with preserved ejection fraction (HFpEF) have been extensively studied. Previous studies have found that elevated serum total bilirubin levels are associated with cardiac death, heart failure readmission, and all-cause mortality in patients with chronic heart failure. However, the relationship between direct bilirubin and prognosis in patients with HFpEF is unclear. conditions: Heart Failure With Preserved Ejection Fraction conditions: Prognathism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: The level of direct bilirubin measure: a composite of heart failure rehospitalization or all-cause mortality measure: heart failure rehospitalization measure: all-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing country: China name: Dongying Zhang, doctor role: CONTACT phone: +8613608398395 email: [email protected] lat: 29.56278 lon: 106.55278 hasResults: False
<|newrecord|> nctId: NCT06379139 id: MALDINEY J'InvEst-I 2022 briefTitle: Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients acronym: BIOPAVIR2 overallStatus: RECRUITING date: 2024-03-01 date: 2025-03 date: 2025-03 date: 2024-04-23 date: 2024-04-23 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Biofilm is a microstructure organised into aggregates of microbiological species within a polymeric matrix. As early as the 2000s, the Centers for Disease Control and Prevention (CDC) recognised the possible role of the biofilm lining endotracheal endotracheal tubes in the development of ventilator-associated pneumonia (VAP) , the most common infection in intensive care, with a high morbidity and mortality rate and a significant increase in hospital costs.
Targeting biofilm therefore now appears to be a new area of interest for limiting the risk of VAP, and this rationale has led to the development of an intraluminal for abrading biofilm deposited on the inside of the intubation probe
. Evaluation of this type of strategy nevertheless justifies the introduction of more precise methods for characterisation of the biofilm.
To this end, the investigator carried out an initial clinical study describing the biofilm on intubation probes, BIOPAVIR 1, showing the existence of several biofilm structures, each associated with a specific microbiological signature. Several limitations including a lack of power due to an insufficient number of patients and the use of number of patients, and the use of a confocal microscopy technique with poor axial without the possibility of acquiring metabolic images of the biofilm.
Based on the previous description of biofilm by optical coherence tomography (OCT), and a recent experience with an optimised form of high-resolution OCT, called full-field OCT, the investigator hypothesise that full-field OCT will allow more accurate characterisation of biofilm, due to its high spatial resolution and its potential ability to capture metabolic activity in the biofilm BIOPAVIR 2 proposes to use the performance of full-field OCT to better characterise the biofilm lining endotracheal tubes in patients undergoing mechanical ventilation in intensive care units. This project represents a first step towards understanding the link between the development of biofilm on intubation and the occurrence of VAP conditions: Healthcare Associated Infection conditions: Critically Ill conditions: Endotracheal Tube studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube measure: Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type measure: type of microbiological associated with each shape sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH William Morey status: RECRUITING city: Chalon-sur-Saône country: France name: Thomas MALDINEY role: CONTACT email: [email protected] lat: 46.78333 lon: 4.85 facility: CHU Dijon Bourgogne status: RECRUITING city: Dijon country: France name: Jean Pierre QUENOT role: CONTACT email: [email protected] lat: 47.31667 lon: 5.01667 hasResults: False
<|newrecord|> nctId: NCT06379126 id: Yuting Li05 briefTitle: The Diagnostic and Prognostic Value of TAT, PIC, tPAI·C and TM in Sepsis-induced Coagulopathy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2026-04-20 date: 2024-04-23 date: 2024-04-23 name: The First Hospital of Jilin University class: OTHER briefSummary: In order to evaluate the diagnostic and prognostic value of thrombin-antithrombin complex(TAT), α2-plasmin inhibitor-plasmin complex(PIC), tissue plasminogen activator-inhibitor complex(tPAI·C) and thrombomodulin(TM) in sepsis-induced coagulopathy(SIC), hospitalized patients with sepsis were prospectively included. Plasma TAT, PIC, tPAI·C,TM levels within 24 h after sepsis diagnosis were detected by MCL60 chemiluminescence analyzer. According to the SIC score (≥4), they were divided into SIC group and non-SIC group, and ROC curve analysis was performed according to the biomarker test results. conditions: Sepsis-induced Coagulopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 210 type: ESTIMATED name: Test thrombin-antithrombin complex(TAT), α2-plasmin inhibitor-plasmin complex(PIC), tissue plasminogen activator-inhibitor complex(tPAI·C) and thrombomodulin(TM) measure: Thrombin-antithrombin complex(TAT), α2-plasmin inhibitor-plasmin complex(PIC), tissue plasminogen activator-inhibitor complex(tPAI·C) and thrombomodulin(TM) level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06379113 id: 53211030-2 briefTitle: GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients overallStatus: RECRUITING date: 2022-07-13 date: 2025-03-30 date: 2025-03-30 date: 2024-04-23 date: 2024-04-23 name: Xiaojun Chen class: OTHER briefSummary: To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients. conditions: Endometrial Neoplasms conditions: Atypical Endometrial Hyperplasia conditions: Progesterone Resistance conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 29 type: ESTIMATED name: GnRH antagonist name: Letrozole 2.5mg measure: Complete response rates within 28 weeks of treatment measure: Adverse events measure: Time to achieve complete response measure: Relapse rates measure: Rates of fertility outcomes measure: Compliance sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Obstetrics and Gynecology Hospital, Fudan University status: RECRUITING city: Shanghai country: China name: Xiaojun Chen role: CONTACT phone: 862133189900 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06379100 id: KY20232388 briefTitle: Cerebellar iTBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-08-25 date: 2024-09-25 date: 2024-04-23 date: 2024-04-23 name: Xijing Hospital class: OTHER briefSummary: Study the therapeutic effect and potential neural mechanisms of cerebellar iTBS mode transcranial magnetic stimulation on Alzheimer's disease patients through MRI and EEG. conditions: Transcranial Magnetic Stimulation conditions: Alzheimer Disease conditions: Magnetic Resonance Imaging conditions: Electroencephalogram studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Alzheimer's disease patients were enrolled by expert neurol ogists who were blinded to treatment allocation. rTMS sessions were performed by dedicated technicians. The Cognitive evaluations and analysis of neuro physiological data were performed by expert neurophysiologists blinded to treatment allocation. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: transcranial magnetic stimulation measure: The changes in CDR(Clinical Dementia Rating) measure: The changes in MMSE(Mini Mental State Examination) measure: NPI (Neuropsychiatric Inventory) measure: ADL( Lawton-Brody Activities of Daily Living) measure: DST (Digital Span Test; Forward and Backward) measure: ADAS-cog(Alzheimer's disease assessment scale) measure: DMS(Delayed matching-to-sample task) measure: MEP(Motor evoked potential) measure: MRI measures measure: EEG(electroencephalogram) sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital of Air Force Military Medical University city: Xi'an state: Shaanxi zip: 710032 country: China name: Wen Jiang role: CONTACT phone: 13991905538 email: [email protected] name: Xin Zhang role: CONTACT phone: 13154378732 email: [email protected] lat: 34.25833 lon: 108.92861 hasResults: False
<|newrecord|> nctId: NCT06379087 id: NEO-PIONEER briefTitle: Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-23 date: 2024-04-25 name: Ji Yongling class: OTHER briefSummary: This study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. The efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer are observed. Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer. conditions: Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Anlotinib Hydrochloride Capsule name: Tislelizumab Injection name: Hypofractionated Radiotherapy measure: 1-year EFS Rate measure: pCR Rate measure: MPR Rate measure: Adverse Events (AEs) according to CTCAE (V5.0) (Safety Evaluation) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06379074 id: 2022PMFMSE id: C53D23004250008 type: OTHER_GRANT domain: Italian Ministry of University and Research (MUR) briefTitle: Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health acronym: MOTHERS overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-08-06 date: 2025-10-06 date: 2024-04-23 date: 2024-04-23 name: University of Rome G. Marconi class: OTHER name: University of Bologna name: University of the Italian Switzerland briefSummary: Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes. conditions: Postpartum Depression conditions: Insomnia conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will receive a personal e-mail address to access their reserved area of the study's website. Each e-mail address is created using the pre-defined pseudonymized code, which will be assigned to each participant after screening (participants with sleep difficulties will be randomly assigned a code for condition B1 or B2).
This procedure is designed to increase privacy protection, allow for matching of responses throughout study's phases, and blind outcome assessors to participants allocation.
The personal website areas include contents based on their group allocation:
* A: online questionnaire and sleep diaries;
* B1: online questionnaire and sleep diaries; placebo intervention's contents (videos and pdf);
* B2: online questionnaire and sleep diaries; intervention's contents (videos and pdf); weekly optional private chat with a clinician (a psychotherapist expert in CBT-I and insomnia during pregnancy). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Each participant will be assigned an identification code (ID-code) randomly generated by a computer. The codes associated to participants in Group B will be randomly assigned to intervention (Group B2) or placebo (Group B1). E-mail addresses will be created for each participant using the ID-code to access the private area of the study website. The code will be associated with responses to online questionnaires, actigraphy recording, saliva samples and sleep diaries. whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Improving sleep health and resilience during pregnancy name: Information on pregnancy-related issues measure: Stress reactivity measure: Sleep efficiency measure: Depressive symptoms measure: Insomnia symptoms measure: Anxiety symptoms measure: Valence of affective states measure: Arousal of affective states measure: Emotion regulation measure: Mothers' parenting stress measure: Partners' insomnia symptoms measure: Children sleep difficulties measure: Partners' sleep efficiency measure: Fathers' parenting stress measure: Daytime sleepiness sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy city: Bologna zip: 40126 country: Italy name: Viviana Lo Martire role: CONTACT email: [email protected] name: Debora Meneo, M.Sc role: CONTACT phone: 06377251 email: [email protected] name: Debora Meneo, M.Sc role: PRINCIPAL_INVESTIGATOR name: Elisabetta Baldi, M.Sc role: SUB_INVESTIGATOR name: Silvia Cerolini, PhD role: SUB_INVESTIGATOR name: Viviana Lo Martire, PhD role: SUB_INVESTIGATOR name: Giuliana Simonazzi, PhD role: SUB_INVESTIGATOR name: Sara Curati, B.Sc role: SUB_INVESTIGATOR name: Stefano Bastianini, PhD role: SUB_INVESTIGATOR name: Chiara Berteotti, PhD role: SUB_INVESTIGATOR name: Mauro Manconi, PhD role: SUB_INVESTIGATOR name: Giovanna Zoccoli, PhD role: SUB_INVESTIGATOR name: Francesca Gelfo, PhD role: SUB_INVESTIGATOR name: Chiara Baglioni, PhD role: PRINCIPAL_INVESTIGATOR name: Paola De Bartolo, PhD role: SUB_INVESTIGATOR lat: 44.49381 lon: 11.33875 hasResults: False
<|newrecord|> nctId: NCT06379061 id: MM-01-24 briefTitle: Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-03-31 date: 2024-04-23 date: 2024-04-23 name: Beckman Coulter, Inc. class: INDUSTRY name: MeMed Diagnostics Ltd. briefSummary: The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (\>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance. conditions: Infection, Bacterial conditions: Infection Viral studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Blood Specimen Collection sex: ALL minimumAge: 90 Days maximumAge: 89 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06379048 id: 2021.12.282 briefTitle: The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain overallStatus: COMPLETED date: 2022-03-01 date: 2022-08-31 date: 2022-09-20 date: 2024-04-23 date: 2024-04-23 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair. conditions: Labor; Prolonged, Second Stage conditions: Episiotomy Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 132 type: ACTUAL name: Matress Suturing name: Primary Suturing name: Continuous Subcutaneous Suturing measure: Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score measure: Pain by Visual Analog Scale (VAS) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Cam and Sakura City Hospital city: Istanbul state: Basaksehir zip: 34494 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False