text
stringlengths 0
197k
|
|---|
Postoperative analgesia presents various challenges in vulnerable patient groups suffering from obesity. With the high potential risk of respiratory depression and postoperative pulmonary complications associated with opioid use, such as atelectasis and pneumonia, the availability of other pain management modalities is essential \[14\]. |
Ultrasound-guided erector spinae plane block (ESPB) is a regional anesthesia technique where local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and allowed to diffuse caudally and cranially. It is supposed to provide both visceral and somatic abdominal analgesia \[3\]. |
ESPB is effective, easy to perform, and can be performed in a short time. \[4\] It has been shown efficacy in different conditions such as thoracic surgery, trauma, cardiac surgery, breast surgery, and abdominal surgery \[5\]. However, the main concern with the ESPB block is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity. |
Peripheral nerve blocks in the obese may pose challenges, like difficulties in proper patient positioning and landmark identification. However, Ultrasound guidance may help overcome many difficulties in regional techniques. But as expected, targets are more deeply situated in obese patients and the ultrasound beams are attenuated as they travel a greater distance through tissue layers. Additionally, when crossing a tissue boundary, a portion is reflected back to the transducer creating artifacts like speckling and clutter which are particular problems in the obese patient. \[15\] Few studies examined the use of ESPB in bariatric surgery \[3,6,7\], all indicating potential benefits of the technique in terms of opioid sparing and pain control. To date, the efficacy of ESPB has not been examined in superobese patient. |
So we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB with controls, Local bupivacaine infiltration to the trocar sites, in super obese patients undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of perioperative analgesia for superobese patients undergoing bariatric surgeries. conditions: Erector Spinae Plane Block conditions: Super Obese Patients conditions: Bariatric Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial- single blinded primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: ESPB name: local anaesthetic infiltration name: midazolam and lidocaine name: Bupivacain measure: Total opioid consumption measure: VAS score during first 24 hour postoperative sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Kasr Al Ainy Hospitals status: RECRUITING city: Cairo country: Egypt name: amany ahmea eissa, lecturer role: CONTACT phone: 01001807207 email: [email protected] name: marwa saeed zayed, ass. professor role: CONTACT phone: 01003347560 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06377592 id: G22396 briefTitle: Development and Accuracy Evaluation of Gram Staining Analysis AI overallStatus: RECRUITING date: 2023-05-10 date: 2027-03-31 date: 2027-03-31 date: 2024-04-22 date: 2024-04-22 name: GramEye class: INDUSTRY briefSummary: The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI conditions: Bacterial Infections studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 18000 type: ESTIMATED name: Sample collection without intervention measure: Advanced level of blood culture Gram stain analysis AI accuracy measure: Ordinary level of blood culture Gram stain analysis AI accuracy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Osaka University Hospital status: RECRUITING city: Suita state: Osaka zip: 5650871 country: Japan name: Go Yamamoto role: CONTACT lat: 34.76143 lon: 135.51567 hasResults: False |
<|newrecord|> nctId: NCT06377579 id: FILObsLAM_IVOOBS briefTitle: OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-12-15 date: 2025-03-15 date: 2024-04-22 date: 2024-04-22 name: French Innovative Leukemia Organisation class: OTHER name: Acute Leukemia French Association briefSummary: Mutations in IDH genes are found in numerous cancers and more specifically in acute myeloid leukemia (AML). These mutations target specific amino acids, at positions 140 or 172 of IDH2, and 132 of IDH1. Mutant IDH proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αKG) into D-2 hydroxyglutarate (D-2HG), an oncometabolite which massively accumulates in IDH-mutated cells. At high levels, D-2HG behaves as a competitive inhibitor of αKG and affects the activity of Fe(II)/αKG-dependent dioxygenases. This enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (JHDM histone demethylases) or DNA (methylcytosine hydroxylases of the TET family). As a result, IDH-mutated cells show altered survival, motility, invasiveness and cell differentiation. In AML, IDH1 mutations might be present in 10-15% at diagnosis |
Ivosidenib (IVO) a first-in-class, oral, irreversible inhibitor of mutant IDH1 has shown clinical activity as a single agent in studies involving patients with IDH1 mutated relapsed or refractory (R/R) AML (DiNardo et al. 2018) and in front line settings (Montesinos et al. 2022). In phase II clinical trials, IVO yielded 30-35% of complete response rates both in frontline and R/R settings, with long lasting responses. Based on these results, the FDA (Food and Drug Agency) gave its approval for newly-diagnosed AML IDH1mut patients who are ≥ 75 years old or who have comorbidities and in R/R. However, European Medicines Agency (EMA)'s did not approved IVO due to lack of evidences to support the application. Agios Netherlands B.V. (the company that previously own the drug before Servier Laboratories) withdrew its EMA application. Nevertheless, IVO has been available in France through a compassionate use program (CUP), since February 2020 for R/R patients and March 2022 for first line treatment. |
In this multicentric retrospective study, we aim to evaluate the efficacy and safety of Ivo in two cohorts of IDH1mut AML patients treated within the CUP. The first cohort will concern patients treated in first line setting and the second cohort those treated in R/R disease. Our results might provide new insights regarding IVO in real life settings and support signs of efficacy. This could provide new data for the haematologist community and for another appliance to grant EMA approval of IVO in the setting of R/R IDH1mut AML. conditions: AML, Adult studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 250 type: ESTIMATED measure: characterize the Overall survival (OS) in the both cohort : 1st line and Relapsed/Refractory (R/R) measure: characterize the composite response rate (CRc) at any time during follow-up, for the both cohort : 1st line and Relapsed/Refractory (R/R) measure: characterize the Event Free Survival (EFS) in both cohorts : 1st line and Relapsed/Refractory (R/R) measure: characterize the incidence and relatedness of serious adverse events (SAE), for patients treated by Ivosidenib, for both cohorts : 1st line and Relapsed/Refractory (R/R) measure: describe the management of treatment by Ivosidenib in both cohorts : 1st line and Relapsed/Refractory (R/R) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amiens CHU city: Amiens country: France lat: 49.9 lon: 2.3 facility: Angers CHU city: Angers country: France lat: 47.46667 lon: -0.55 facility: Bayonne CH city: Bayonne country: France lat: 43.48333 lon: -1.48333 facility: Besançon CHU city: Besançon country: France lat: 47.24878 lon: 6.01815 facility: CHU Estaing city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 facility: Créteil CHU HENRI MONDOR city: Créteil country: France lat: 48.78333 lon: 2.46667 facility: Grenoble CHU city: Grenoble country: France lat: 45.16667 lon: 5.71667 facility: Le Mans CH city: Le Mans country: France lat: 48.0 lon: 0.2 facility: Lyon sud CHU city: Lyon country: France lat: 45.74848 lon: 4.84669 facility: Marseille IPC city: Marseille country: France lat: 43.29551 lon: 5.38958 facility: Meaux CH de l'Est francilien city: Meaux country: France lat: 48.96014 lon: 2.87885 facility: Montpellier - Chu Saint Eloi city: Montpellier country: France lat: 43.61092 lon: 3.87723 facility: Nantes CHU city: Nantes country: France lat: 47.21725 lon: -1.55336 facility: Nice CHU city: Nice country: France lat: 43.70313 lon: 7.26608 facility: Orléans CHU city: Orléans zip: 45000 country: France lat: 47.90289 lon: 1.90389 facility: Paris Saint Louis city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Bordeaux CHU city: Pessac country: France lat: 44.81011 lon: -0.64129 facility: ICANS - Institut de cancérologie de strasbourg europe city: Strasbourg country: France lat: 48.58392 lon: 7.74553 facility: Toulouse - IUCT Oncopole - Service d'Hématologie city: Toulouse country: France lat: 43.60426 lon: 1.44367 hasResults: False |
<|newrecord|> nctId: NCT06377566 id: 24-039 briefTitle: A Study of BV-AVD in People With Bulky Hodgkin Lymphoma overallStatus: RECRUITING date: 2024-04-17 date: 2027-04 date: 2027-04 date: 2024-04-22 date: 2024-04-22 name: Memorial Sloan Kettering Cancer Center class: OTHER name: Seagen Inc. briefSummary: The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease. |
BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer. conditions: Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a multicenter, investigator-initiated, single-arm phase II trial. primaryPurpose: TREATMENT masking: NONE count: 71 type: ESTIMATED name: Brentuximab vedotin name: Doxorubicin name: Vinblastine name: Dacarbazine name: Pembrolizumab name: Gemcitabine name: Vinorelbine name: FDG-PET/CT scan measure: progression-free survival measure: overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Craig Moskowitz, MD role: CONTACT phone: 305-243-5302 lat: 25.77427 lon: -80.19366 facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Robert Stuver, MD role: CONTACT phone: 646-608-4308 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (All Protocol Activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Robert Stuver, MD role: CONTACT phone: 646-608-4308 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (All Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Robert Stuver, MD role: CONTACT phone: 646-608-4308 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Robert Stuver, MD role: CONTACT phone: 646-608-4308 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (All Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Robert Stuver, MD role: CONTACT phone: 646-608-4308 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Robert Stuver, MD role: CONTACT phone: 646-608-4308 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (All Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: Robert Stuver, MD role: CONTACT phone: 646-608-4308 lat: 40.70038 lon: -73.59291 hasResults: False |
<|newrecord|> nctId: NCT06377553 id: 2023P000955 briefTitle: PET/MRI for Evaluation of Endometriosis overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2026-05-03 date: 2026-05-03 date: 2024-04-22 date: 2024-04-22 name: Massachusetts General Hospital class: OTHER briefSummary: This study aims to determine if PET/MRI can detect endometriosis and potentially improve upon currently available non-invasive diagnostic capabilities. Specifically, the authors will investigate the ability of PET/MRI to detect and quantify endometriosis, as well as differentiate among subcategories such as inflammatory peritoneal lesions, fibrotic deep infiltrating endometriosis lesions (DIE), and ovarian endometriomas. The authors will compare \[68Ga\]CBP8 or \[18F\]-FAPI-74 PET/MRI imaging versus the current gold standard diagnostic methods, including laparoscopic surgery, clinical follow-up, and follow-up imaging. conditions: Endometriosis conditions: Endometrioma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Radiotracer Injection name: Imaging name: Rectal Ultrasound Gel Injection measure: Diagnostic Accuracy of PET/MR in Preoperative Endometriosis Detection measure: Diagnostic Performance of PET/MRI vs. Conventional Imaging measure: Impact of [18F]-FAPI-74 and [68Ga]CBP8 PET/MRI on Diagnosis and Management in Endometriosis measure: Correlation of Pre-Treatment PET Uptake and Post-Treatment Response in Endometriosis sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School city: Charlestown state: Massachusetts zip: 02129 country: United States name: Onforio Catalano, MD, Ph.D role: CONTACT phone: 617-724-4030 email: [email protected] name: Diandrea Galloway role: CONTACT phone: 617-643-1407 email: [email protected] lat: 42.37787 lon: -71.062 hasResults: False |
<|newrecord|> nctId: NCT06377540 id: 2022LS174 briefTitle: MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-09-01 date: 2027-09-01 date: 2024-04-22 date: 2024-04-22 name: Masonic Cancer Center, University of Minnesota class: OTHER briefSummary: This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant. conditions: Autologous Stem Cell Transplant conditions: Classic Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Pembrolizumab name: Autologous stem cell transplant name: Carmustine name: Etoposide name: Cytarabine name: Melphalan measure: Progression free survival (PFS) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Non-relapse mortality (NRM) measure: Overall Survival (OS) measure: Rate of Complete Metabolic Response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377527 id: 2023-0945 id: NCI-2024-03342 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA) overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2035-12-28 date: 2037-12-28 date: 2024-04-22 date: 2024-04-22 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To develop a database of medical information about patients with MLA in an effort to increase our understanding of the characteristics of MLA, which is the rarest form of endometrial carcinoma. conditions: Mesonephric-like Adenocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 2000 type: ESTIMATED measure: Tumor Registry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Jeffrey How, MD role: CONTACT name: Jeffrey How, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False |
<|newrecord|> nctId: NCT06377514 id: PCOL109PHNG briefTitle: Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-10-31 date: 2025-10-31 date: 2024-04-22 date: 2024-04-22 name: Johnson & Johnson Surgical Vision, Inc. class: INDUSTRY briefSummary: Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial. conditions: Cataracts studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Test IOL Model DEN00V name: Control IOL Model DCB00 measure: Monocular photopic DCIVA (first eyes) at 66 cm measure: Monocular Depth of Focus measure: Monocular Photopic BCDVA at 4m measure: Monocular Photopic DCVA at 100 cm measure: Monocular photopic DCNVA at 40 cm (first eyes) sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377501 id: 804687 briefTitle: Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL) overallStatus: RECRUITING date: 2023-03-07 date: 2024-07-01 date: 2024-07 date: 2024-04-22 date: 2024-04-22 name: University of California, San Diego class: OTHER briefSummary: This study will evaluate the feasibility of an 8-week vegan whole-food, plant-based dietary intervention in subjects with low risk CLL who are undergoing observation. Over the course of 8 weeks, participants will attend weekly group cooking classes via Zoom lead by a RD. Participants will also attend weekly individual meetings with a health coaches to assist with adherence to the dietary intervention. conditions: Chronic Lymphocytic Leukemia Stage A(0) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Whole-food, plant-based diet measure: Adherence to the Dietary Intervention measure: Satisfaction with the Dietary Intervention measure: Cooking Class Adherence measure: Recruitment measure: Retention measure: White blood cell count measure: Absolute lymphocyte count measure: Anthropometric Measures (height, weight, body mass index) measure: Anthropometric Measures (waist circumference) measure: Biomarkers of cardiometabolic health (complete metabolic panel) measure: Biomarkers of cardiometabolic health (hemoglobin A1c) measure: Biomarkers of cardiometabolic health (cholesterol and triglycerides) measure: Concentration of vitamin B12 measure: Concentration of vitamin B9 measure: Concentration of iron measure: Concentration of ferritin measure: Blood pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UC San Diego status: RECRUITING city: San Diego state: California zip: 92093 country: United States name: Ariel Portera, DO role: CONTACT phone: 858-249-6896 email: [email protected] lat: 32.71533 lon: -117.15726 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-02-23 uploadDate: 2024-04-17T18:09 filename: ICF_000.pdf size: 514422 hasResults: False |
<|newrecord|> nctId: NCT06377488 id: CR-6542 briefTitle: Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-06-24 date: 2024-06-24 date: 2024-04-22 date: 2024-04-22 name: Johnson & Johnson Vision Care, Inc. class: INDUSTRY briefSummary: This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity. conditions: Visual Acuity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 155 type: ESTIMATED name: JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at distance 4m measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at intermediate distance 64cm measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at near distance 40cm measure: Subjective Vision CLUE Scores measure: Rotational Stability measure: Absolute Rotation Error measure: Incidence of Unacceptable Lens Fit measure: Slit Lamp Findings measure: Subjective Handling Scores measure: Subjective Comfort Scores measure: Subjective Vision Scores measure: Lens Fit Success sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. James Weber & Associates, PA - City Square Blvd city: Jacksonville state: Florida zip: 32218 country: United States lat: 30.33218 lon: -81.65565 facility: Stam & Associates Eye Care city: Jacksonville state: Florida zip: 32256 country: United States lat: 30.33218 lon: -81.65565 facility: Omega Vision Center city: Longwood state: Florida zip: 32779 country: United States lat: 28.70305 lon: -81.3384 facility: Maitland Vision Center - North Orlando Ave city: Maitland state: Florida zip: 32751 country: United States lat: 28.62778 lon: -81.36312 facility: Mid-State Eye city: Clinton state: Illinois zip: 61727 country: United States lat: 40.15365 lon: -88.96453 facility: Kannarr Eye Care city: Pittsburg state: Kansas zip: 66762 country: United States lat: 37.41088 lon: -94.70496 facility: Birmingham Vision Care city: Bloomfield Hills state: Michigan zip: 48301 country: United States lat: 42.58364 lon: -83.24549 facility: Center for Ophthalmic and Vision Research/Eye Associates of New York city: Manhattan state: New York zip: 10022 country: United States lat: 40.78343 lon: -73.96625 facility: Sacco Eye Group city: Vestal state: New York zip: 13850 country: United States lat: 42.08507 lon: -76.05381 facility: ProCare Vision Centers city: Granville state: Ohio zip: 43023 country: United States lat: 40.06812 lon: -82.5196 facility: Luxe Vision and Optical city: Powell state: Ohio zip: 43065 country: United States lat: 40.15784 lon: -83.07519 facility: Dr. David W. Ferris & Associates city: Warwick state: Rhode Island zip: 02888 country: United States lat: 41.7001 lon: -71.41617 facility: Optometry Group, LLC city: Memphis state: Tennessee zip: 38111 country: United States lat: 35.14953 lon: -90.04898 facility: Tyler Eye Associates city: Tyler state: Texas zip: 75703 country: United States lat: 32.35126 lon: -95.30106 facility: New River Vision Care city: Oak Hill state: West Virginia zip: 25901 country: United States lat: 37.97233 lon: -81.14871 hasResults: False |
<|newrecord|> nctId: NCT06377475 id: 2024-00148 id: 2024-00148 type: REGISTRY domain: EKNZ briefTitle: Fabrication and Insertion of Michigan Splints by Dental Students overallStatus: ENROLLING_BY_INVITATION date: 2024-03-08 date: 2024-05 date: 2025-12 date: 2024-04-22 date: 2024-04-22 name: Juliana Marotti Großhausen class: OTHER briefSummary: The aim of this study is to investigate the potential effects of different jaw relation determination (KRB) techniques on the fabrication of Michigan splints, in particular by comparing conventional methods with a wax plate and the use of an anterior jig. All materials and methods for the fabrication of the Michigan splint are already part of the curriculum of the Clinic for Dental Prosthodontics for first-year Master-students. Therefore, we intend to conduct a retrospective study (for the 2023 cohort) and a prospective analysis of the data (for the 2024 and 2025 cohorts). Questionnaires, models and intraoral scans will be used to evaluate the efficacy and precision of the different KRB methods as well as the fabrication process of the Michigan splint. conditions: Impression Technic, Dental conditions: Jaw Relationship conditions: Bruxism studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 73 type: ESTIMATED name: Jaw relation name: Questionnaire measure: Wax vs JIG Registration measure: Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZB city: Basel zip: 4058 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False |
<|newrecord|> nctId: NCT06377462 id: VEXAS-Registry briefTitle: Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection overallStatus: RECRUITING date: 2024-03-13 date: 2029-12-31 date: 2030-12-31 date: 2024-04-22 date: 2024-04-22 name: Technische Universität Dresden class: OTHER name: Bristol-Myers Squibb name: University Hospital Munich briefSummary: The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers conditions: VEXAS Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Collection of epidemiological data on VEXAS measure: Collection and monitoring of initial disease manifestations measure: Documentation of the treatment approaches and therapy sequences measure: Analysis of clinical-relevant clinical endpoints measure: Describe disease cluster measure: Laboratory diagnostics measure: Correlation clinical endpoints with treatment approaches measure: Quality of life data (QoL), fatigue questionnaire (Facit-F) measure: Accompanying translational research measure: Collection of Biospecimens sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Carl Gustav Carus status: RECRUITING city: Dresden zip: 01307 country: Germany name: Katja Sockel, Dr. med. role: CONTACT lat: 51.05089 lon: 13.73832 hasResults: False |
<|newrecord|> nctId: NCT06377449 id: UIL-CSP-18052023 briefTitle: Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2026-01-01 date: 2024-04-22 date: 2024-04-22 name: Saint Petersburg State University, Russia class: OTHER briefSummary: The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\[s\] it aims to answer are: |
* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods. |
* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified. |
Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients. conditions: Ischemic Heart Disease conditions: Aortic Stenosis, Severe conditions: Aortic Insufficiency conditions: Mitral Stenosis conditions: Mitral Insufficiency conditions: Mitral Stenosis With Insufficiency conditions: Tricuspid Insufficiency conditions: Ascending Aortic Aneurysm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, single-center study with 2 groups of patients (investigating and control arms) primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 186 type: ESTIMATED name: Ultrasound examination of the lungs measure: The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination measure: Postoperative pulmonary complications measure: Cumulative dosage of diuretics measure: Number of nights at home after hospital discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Petersburg State University Clinic city: Saint Petersburg zip: 190020 country: Russian Federation name: Sergei M Efremov, MD, PhD role: CONTACT phone: +79137946090 email: [email protected] lat: 59.93863 lon: 30.31413 hasResults: False |
<|newrecord|> nctId: NCT06377436 id: PRAISE briefTitle: Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme acronym: PRAISE overallStatus: RECRUITING date: 2023-03-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-22 date: 2024-04-22 name: University of Milan class: OTHER briefSummary: The goal of this clinical trial is to implement a personalized training program to prevent functional decline in frail subjects but not yet disable. The purpose of the project is to test the training in a subject at particularly high risk of entering the disabled condition. A total of 80 frail subjects, divide the participants into two groups "Divida Senso Group" (experimental group) and "Standard of care Group" (Control group) will be recruited. |
The expected outcome is to slow down a functional decline not only in isolation in the domains trained by the program. conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Experimental training measure: Changes in the Functional decline measure: Intrinsic Capacity (IC) measure: Intreaction between IC and cardiac autonomic control (CAC) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Gabriella CERRI status: RECRUITING city: Milano zip: 20100 country: Italy name: Gabriella GC CERRI, Full Professor role: CONTACT phone: +393402527675 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06377423 id: A54678775 briefTitle: Comparison Between Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases overallStatus: COMPLETED date: 2021-08-01 date: 2024-01-01 date: 2024-01-10 date: 2024-04-22 date: 2024-04-22 name: Prince Sattam Bin Abdulaziz University class: OTHER briefSummary: Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. The formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years. conditions: Dental Leakage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 28 type: ACTUAL name: Direct technique name: Indirect technique measure: Percentage % of patients with marginal staining sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Ali Elkaffas city: Al Kharj country: Saudi Arabia lat: 24.15541 lon: 47.33457 hasResults: False |
<|newrecord|> nctId: NCT06377410 id: FF-2023-433 briefTitle: Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients acronym: SyProNAC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-30 date: 2026-11-30 date: 2024-04-22 date: 2024-04-22 name: National University of Malaysia class: OTHER briefSummary: As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial. |
Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation. |
Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency . conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Syrup Prospan name: N-Acetylcysteine measure: To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact. measure: to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life. measure: to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry measure: to determine change of Forced Vital Capacity in litres/minute using spirometry measure: to determine adverse effects of Syrup Prospan (in %) measure: to determine adverse effects of N-Acetylcysteine (in %) measure: To assess satisfaction of treatment using the 5 point Likert Scale (1- Not Satisfied, 5 - Most Satisfied) sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National University of Malaysia city: Cheras state: Kuala Lumpur zip: 56000 country: Malaysia name: Mohamed Faisal Abdul Hamid, MBBS (IIUM) role: CONTACT phone: 0391455555 email: [email protected] lat: 3.05 lon: 101.76667 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-02-01 uploadDate: 2024-04-08T19:34 filename: Prot_SAP_ICF_000.pdf size: 1474657 hasResults: False |
<|newrecord|> nctId: NCT06377397 id: IIRPIG-2023-0000070 briefTitle: Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates acronym: SAUNA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2028-04-14 date: 2024-04-22 date: 2024-04-22 name: Indian Council of Medical Research class: OTHER_GOV name: Lady Hardinge Medical College name: King George's Medical University name: Indira Gandhi Institute of Child Health name: Institute of Obstetrics and Gynecology name: Government Medical College, Chandigarh name: Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak name: Government Medical College, Aurangabad name: King Edward Memorial Hospital, Mumbai briefSummary: Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis. |
The goal of this research study is to find out: |
1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life. |
2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life. |
3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes"). conditions: Sepsis conditions: PROM, Preterm (Pregnancy) conditions: Early-Onset Neonatal Sepsis conditions: Preterm Premature Rupture of Membrane conditions: Preterm Birth studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Neonates will be randomized to 1 of the following groups: |
1. Group 1: Intervention group (Selective antibiotic group) |
2. Group 2: Comparison group (Universal antibiotic group) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Project staff, nurses and resident doctors looking after the neonate will not be blinded. The assessment of the primary outcome will be performed by a blinded adjudicator, who is not involved in the recruitment and monitoring of subjects. A part of the case report form (CRF) containing relevant details of all episodes of sickness in the 1st week of life will be detached from the main form and will be sent to the blinded adjudicator. This part will be linked to the main form only by a unique identification number. No patient identifiers or allocation group will be mentioned on the part sent to the blinded adjudicator. whoMasked: OUTCOMES_ASSESSOR count: 1500 type: ESTIMATED name: Antibiotics measure: Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomization measure: Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization measure: All-cause Mortality within 1st 7 days after randomization measure: Blood culture-positive sepsis of any severity within 1st 7 days after randomization measure: Episode of severe sepsis within 1st 7 days after randomization measure: Composite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomization measure: Individual components of composite outcome within 1st 72 hours after randomization measure: Composite of mortality/blood culture positive sepsis/severe sepsis during hospital stay measure: Individual components of composite outcome during hospital stay measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay measure: Composite of mortality/blood culture positive sepsis/severe sepsis during 1st 30 days after randomization measure: Individual components of composite outcome during 1st 30 days measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria measure: Sepsis-related mortality within 1st 72 hours after randomization measure: Sepsis-related mortality within 7 day after randomization measure: Sepsis-related mortality during hospital stay after randomization measure: Sepsis-related mortality during 1st 30 days after randomization measure: Clinical sepsis within 1st 72 hours after randomization measure: Clinical sepsis within 7 days after randomization measure: Clinical sepsis during hospital stay measure: Clinical sepsis within 1st 30 days after randomization measure: Episode of Probable EONS within 72 hours after randomization measure: Episode of Probable EONS within 7 days after randomization measure: Episode of asymptomatic proven EONS within 72 hours after randomization measure: Need for sepsis workup during 1st 72 hours after randomization measure: Need for sepsis workup during 1st 7 days after randomization measure: Need for sepsis workup during 1st 30 days after randomization measure: Need for sepsis workup during hospital stay measure: Cumulative duration of antibiotic therapy during 1st 7 days after randomization measure: Cumulative duration of antibiotic therapy during 1st 72 hrs after randomization measure: Cumulative duration of antibiotic therapy during hospital stay measure: Duration of hospitalization measure: Episodes of healthcare associated infection during hospital stay. measure: Adverse effects until day 30 after randomization measure: Serious adverse effects until day 30 after randomization sex: ALL minimumAge: 0 Hours maximumAge: 4 Hours stdAges: CHILD facility: Post Graduate Institute of Medical Education and Research (PGIMER) city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-02 uploadDate: 2024-04-02T01:02 filename: Prot_SAP_000.pdf size: 213987 hasResults: False |
<|newrecord|> nctId: NCT06377384 id: DHP-33-FLIGHT briefTitle: FLIGHT Study for Childhood Chronic Illness overallStatus: RECRUITING date: 2022-04-20 date: 2025-09 date: 2025-09 date: 2024-04-22 date: 2024-04-23 name: Documenting Hope Project class: OTHER briefSummary: The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care for children with chronic illness. A mixed methods outcomes evaluation will be performed. The primary goal of this study is to evaluate the most feasible and promising strategies to inform a more streamlined and scalable intervention in the future. Up to 14 participants may be enrolled, but fewer are expected to achieve the primary goal of the study. conditions: Chronic Illnesses, Multiple studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: FLIGHT Intervention measure: Total Load Index (TLI) measure: Child Health Inventory for Resilience and Prevention (CHIRP) measure: Children's Sleep Habits Questionnaire (CSHQ) measure: Vineland Adaptive Behavior Scale measure: Sensory Profile 2 measure: Quick Environmental Exposure and Sensitivity Inventory (QEESI) measure: Hayward Environmental Illness Severity Scale measure: Parenting Stress Index, 4th edition (PSI-4) measure: Beck Anxiety Inventory (BAI) sex: ALL minimumAge: 2 Years maximumAge: 15 Years stdAges: CHILD facility: Epidemic Answers status: RECRUITING city: Windsor state: Connecticut zip: 06095 country: United States name: Study Coordinator role: CONTACT phone: 833-935-5543 email: [email protected] lat: 41.8526 lon: -72.6437 hasResults: False |
<|newrecord|> nctId: NCT06377371 id: 23-03025815 briefTitle: Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-22 date: 2024-04-22 name: Weill Medical College of Cornell University class: OTHER name: Curium US LLC briefSummary: The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device. conditions: Meningioma studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Brain Imaging with [Cu64]DOTATATE name: Radio-guided Surgery With Neoprobe Utilization measure: Preoperative [Cu64]DOTATATE PET SUV measure: 1st Post-operative [Cu64]DOTATATE PET SUV measure: 2nd Post-operative [Cu64]DOTATATE PET SUV measure: MRI Size Measurements measure: GTR vs STR Assessment measure: MRI Progression Assessment measure: Target Lesion Neoprobe Count measure: Subtotal Neoprobe Count measure: Reference Background Neoprobe Count measure: SSTR2 expression measure: WHO grade measure: Ki67 Proliferation Index measure: ER/PR expression sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New York-Presbyterian/Weill Cornell Medical Center city: New York state: New York zip: 10021 country: United States lat: 40.71427 lon: -74.00597 hasResults: False |
<|newrecord|> nctId: NCT06377358 id: CEEAH CA31 briefTitle: Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy. overallStatus: COMPLETED date: 2022-05-09 date: 2022-07-25 date: 2023-06-22 date: 2024-04-22 date: 2024-04-22 name: CAPENERGY MEDICAL, SL class: INDUSTRY name: University of Malaga name: Alfonso X El Sabio University briefSummary: The Scope of this study is to assess the visceral and subcutaneous fat loss in patients having Tecar (Radiofrequency) Therapy and its effects on other anthropometric variables, adipokines and inflammation. |
20 obese patients will be treated with Tecar Therapy (Radiofrequency). Each patient will have 4 active, automatic plates placed on the abdomen (200 cm2 per plate), two on the right side of the midline and two on the left side. Energy will be applied for 50 minutes, controlling the temperature. Subsequently, 15 minutes of Capacitive and Resistive manual electrodes will be applied to the abdomen, simultaneously, 20 minutes of Lymphatic Drainage placing one active plate in the foot and the other in the lumbo-dorsal area. Patients will be informed that they will only feel comfortable warmth. Five sessions will be applied from Monday to Friday resting Saturday and Sunday, for 2 weeks. Total 10 sessions. |
Subcutaneous and visceral fat will be measured by MRI. Anthropometric variables (Body Mass Index, Waist to Hip ratio and skinfold) will be also measured. |
Metabolic and inflammatory effects of the RF treatment will be evaluated measuring adipokines (Leptin, adiponectin and resistin) as well as citokines (IL-6, TNF-a and C reactive Protein). |
Results will be analyzed using the SPSS statistics package. A Kolmogorov-Smirnov test will be applied, if the data behaves normally, parametric tests will be applied. If not, non-parametric tests will be performed. The differences between proportions will be analyzed using Fischer's exact test. The differences between the medians will be assessed using the Student's t-test for paired samples and independent samples. conditions: Obesity, Visceral conditions: Obesity; Endocrine studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Tecar Theraty was applied to 20 obese patients in order to assess the effect on the body fat loss, serum adipocytokines and imflammation. It was an interventional study in one group of patients. No controls. No masking. primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Tecar Therapy measure: Visceral fat loss (cm3) measure: Visceral fat loss (g) measure: Subcutaneous fat loss (cm3) measure: Subcutaneous fat loss (g) measure: Tumor Necrosis Factor alfa measure: Interleukin 6 levels measure: C reactive Protein levels measure: Leptin levels measure: Adiponectin levels measure: Resistin levels measure: Total cholesterol changes measure: Total triglycerides changes measure: LDL Cholesterol changes measure: HDL Cholesterol changes measure: Glucose measure: Body Mass Index loss measure: Waist to Hip Index loss measure: Skinfold Thickness (cm) sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inneo Terapia Despi city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-02-01 uploadDate: 2024-03-21T05:39 filename: Prot_SAP_000.pdf size: 597014 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-02-01 uploadDate: 2024-04-11T07:17 filename: ICF_001.pdf size: 543945 hasResults: False |
<|newrecord|> nctId: NCT06377345 id: 202312-00011 briefTitle: Remote Patient Monitoring Solution for Chronic Respiratory Disease Management overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-12-31 date: 2025-03-30 date: 2024-04-22 date: 2024-04-22 name: SingHealth Polyclinics class: OTHER briefSummary: Aim: To evaluate the use of AeviceMD Monitoring System (AeviceMD) asthma in reducing acute exacerbation. |
Methodology: Using a randomized controlled trial design, this project aims evaluate the effectiveness of AeviceMD in improving patients' outcomes in terms of reducing exacerbation, healthcare utilization, improving quality of life, self-efficacy, and cost effectiveness. Paediatric patients above age 7 and adults will be recruited. The data follow-up period is 3 months. It will also evaluate the usability of the device from both patients' and clinicians' perspective. 180 patients (124 adults, 56 pediatrics) and 120 clinicians will be recruited. |
Importance of study: This study will evaluate if the AeviceMD can help improve disease management and reduce recurrence of asthma exacerbation. |
Potential benefits and risk: AeviceMD allows for remote monitoring and tracking of patients' lung sounds, which could be used by patients to monitor their lung condition and prevent an episode of exacerbation or worsening exacerbations culminating in an admission which who further utilize already limited healthcare resources. An exacerbation is an episode of severe shortness of breath, cough, and chest tightening which warrants a visit to a healthcare institution. Through self-monitoring, patients can be empowered to self-manage their asthma, with aid of the asthma action plan which is given to all patients with asthma. AeviceMD can also help provide clinicians with patients' objective lung data. In the primary care setting, care is also fragmented as patients are often followed-up by a different doctor or healthcare providers. Clinicians have no objective data to track patients, and is dependent on patients' self-report and possible recall bias. There is no expected risk with the use of the device. conditions: Asthma conditions: Asthma Attack conditions: Asthma in Children conditions: Asthma Acute conditions: Asthma Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-group randomized controlled trial (RCT) design will be used. The control group will receive the usual care, and the intervention group will receive the Aevice device on top of usual care. Outcomes will be measured at baseline, week 4, and week 12. This is to evaluate the long-term impacts of the Aevice device. Clinicians who have interacted with participants using Aevice will also be invited to participate in an interview and clinician perception survey. A convenience sampling will be used for the recruitment of clinicians. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcomes assessor will not be aware of the participants' group whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: AeviceMD device name: Standard care measure: Rescue therapy measure: Dose of oral Prednisolone use measure: Visit to hospital emergency department measure: Hospitalisation measure: Euro Quality of Life 5 dimensions (EQ5D) measure: Asthma quality of life questionnaire (AQLQ) measure: Pediatric asthma quality of life questionnaire (PAQLQ) measure: Self-efficacy measure: Usability measure: Heart rate measure: Respiratory rate measure: Wheeze detection trend measure: Medication log measure: Duration of device usage measure: Payment sex: ALL minimumAge: 7 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377332 id: X23-0330 briefTitle: Biomarkers of Dementia in Chronic Sleep and Breathing Disorders acronym: ORACLE overallStatus: RECRUITING date: 2023-12-01 date: 2025-07-01 date: 2025-07-01 date: 2024-04-22 date: 2024-04-22 name: Woolcock Institute of Medical Research class: OTHER briefSummary: Chronic obstructive pulmonary disease (COPD), obstructive sleep apnoea (OSA) and overlap syndrome are associated with obstructions in breathing and disturbed sleep. |
Chronic breathing disruptions and poor sleep may lead to cognitive impairment and brain changes linked with early neurodegenerative processes. As such, identifying early markers of cognitive impairment and dementia risk in individuals with chronic respiratory and sleep breathing disorders is crucial for understanding how these diseases may contribute to accelerated brain ageing. This study will comprehensively measure sleep, lung function, cognitive performance and blood-based markers of dementia risk and inflammation. The investigators will use innovative technologies to identify biomarkers of cognitive impairment and dementia risk in people with chronic sleep and breathing disorders. The investigators will also investigate the relationships between disrupted sleep and abnormal breathing and the brain. This research may also inform future early interventions to improve cognition and brain health in chronic sleep and respiratory disease. conditions: COPD conditions: Overlap Syndrome conditions: OSA studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 104 type: ESTIMATED name: High density electroencephalogram (HdEEG) name: Functional near infrared spectroscopy (fNIRS) name: Magnetic resonance imaging (MRI) name: Blood collection name: Neuropsychological battery name: Questionnaires name: Pulmonary Function Test (PFT) name: Cognitive Assessment name: Polysomnogram (PSG) measure: Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk. measure: Blood levels of amyloid beta (Aβ40/Aβ42 ratio). measure: Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep. measure: Brain tissue oxygenation during cognitive tasks and sleep. measure: Hypoxemia as measured by pulse oximetry. measure: Sleep Fragmentation measure: Assessment of premorbid functioning and preinjury through the Test of Premorbid Functioning (TOPF). measure: Assessment of verbal learning and memory through the Rey Auditory Verbal Learning Test (RAVLT). measure: Assessment of mild forms of cognitive dysfunction through Delis Kaplan Executive Functioning System (D-CEFS) neuropsychological assessment. measure: Assessment of speed of processing and executive functioning through the Trail Making Test (TMT). measure: Assessment of verbal fluency through the Controlled Oral Word Association Test (COWAT). measure: Assessment of attention, perceptual speed, motor speed and visual scanning through the Symbol Digits Modalities Test (SDMT). measure: Blood levels of fibrinogen. measure: Blood levels of clusterin. measure: Blood levels of 8-isoprostane measure: Blood levels of C-reactive protein (CRP) measure: Blood levels of erythrocyte sedimentation rate (ESR). measure: Blood levels of plasma tau. measure: Blood levels of neurofilament light chain (NFL). measure: Blood levels of Glial fibrillary acidic protein (GFAP). measure: Blood levels of Apolipoprotein E gene (APOE-4). measure: Blood levels of interleukin-8 (IL-8). measure: Blood levels of interleukin-6 (IL-6). measure: Blood levels of tumor necrosis factor alpha (TNFα). measure: Blood levels of amyloid beta (Aβ40/Aβ42 ratio). measure: Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk. measure: Brain structure: cortical thickness and volumetric brain maps measure: Brain structure: diffusion-weighted imaging measure: Brain function: resting-state BOLD fMRI measure: Brain pathology: T1-weighted, T2-weighted, diffusion-weighted imaging, and FLAIR measure: Assessment of sensorimotor function and comprehension through the Motor Screening Task (MOT) of CANTAB. measure: Assessment of processing and psychomotor speed through the Reaction Time (RTI) test of CANTAB. measure: Assessment of working memory and strategy through the Spatial Working Memory (SWM) test of CANTAB. measure: Assessment of visual episodic memory through the Paired Associate Learning (PAL) test of CANTAB. measure: Sleep Spindles During Non-Rapid Eye Movement (NREM) Sleep measure: Traditional sleep staging. measure: Absolute Electroencephalography (EEG) Power During Rapid Eye Movement (REM) Sleep. measure: Obstructive sleep apnoea (OSA) severity metrics measure: Lung function as measured by clinical pulmonary function tests (PFT) sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Woolcock Institute of Medical Research status: RECRUITING city: Sydney state: New South Wales zip: 2113 country: Australia name: Angela D'Rozario, PhD role: CONTACT phone: 02 9850 3246 email: [email protected] name: Laura Harris, MScMed role: CONTACT phone: 02 9805 3194 email: [email protected] lat: -33.86785 lon: 151.20732 hasResults: False |
<|newrecord|> nctId: NCT06377319 id: 101080905 briefTitle: Decision Support System for Diagnosis and Progression of Heart Failure acronym: STRATIFYHF overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-31 date: 2027-07-31 date: 2024-04-22 date: 2024-04-23 name: Coventry University class: OTHER name: Newcastle University name: University of Cambridge name: University of Novi Sad name: University of Florence name: University of Regensburg name: Utrecht University name: Servicio Madrileño de Salud, Madrid, Spain briefSummary: Heart failure (HF) is a complex clinical syndrome associated with impaired heart function, poor quality of life for patients and high healthcare costs. Accurate risk stratification and early diagnosis in HF are challenging as signs and symptoms are non-specific. Here the investigators propose to address this global challenge by developing novel analytic methods for HF (STRATIFYHF). A prospective clinical study will collect patient-specific data related to medical history, a physical examination for signs and symptoms, blood tests including natriuretic peptides, an electrocardiogram (ECG), an echocardiogram (ultrasound of the heart), cardiovascular magnetic resonance imaging (MRI), demographic, socio-economic and lifestyle data along with novel technologies (cardiac output response to stress (CORS) test and voice recognition biomarkers) from individuals at-risk of developing HF and those with a confirmed diagnosis of HF. STRATIFYHF will use these data to support clinical validation of an artificial intelligence (AI)-driven decision support system (DSS) and mobile application for risk prediction, diagnosis, and progression of HF to enhance patients' quality of life and lead to more cost-effective health care. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1600 type: ESTIMATED name: Cardiac Output Response to Stress (CORS) test measure: Diagnostic accuracy of the DSS measure: Demographic and clinical predictors of risk, diagnosis, and progression of heart failure. sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377306 id: MC study briefTitle: Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes overallStatus: RECRUITING date: 2023-11-05 date: 2026-01-30 date: 2027-01-30 date: 2024-04-22 date: 2024-04-22 name: Wingate Institute class: OTHER name: Weizmann Institute of Science name: Kaplan Medical Center name: Ministry of Innovation, Science and Technology of Israel briefSummary: Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential "noise" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking. |
The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes. |
200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC. |
Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment. conditions: Menstrual Cycle conditions: Athletes conditions: Physical Activity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Effect of training loads and sport performance level on health and sport performance measure: Stool Microbiome measure: Serum metabolomics measure: VO2max measure: Countermovement jump measure: Flexibility measure: Grip Strength measure: Lower leg Strength measure: Blood tests measure: Knee valgus measure: Anthropometric (Height) measure: Psychological questionnaire (Positive-Affect Negative-Affect scale - PANAS) measure: Anthropometric (Weight) measure: Percentage body fat (%) measure: Psychological questionnaire (The Sport Emotion Questionnaire (SEQ) sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Wingate Institute status: RECRUITING city: Netanya country: Israel name: Yotam Shribman, B.Sc role: CONTACT phone: +972-54-5723401 email: [email protected] lat: 32.33291 lon: 34.85992 hasResults: False |
<|newrecord|> nctId: NCT06377293 id: FEMH-IRB-TSAI2024 briefTitle: Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2025-12 date: 2029-06 date: 2024-04-22 date: 2024-04-23 name: Far Eastern Memorial Hospital class: OTHER briefSummary: In patients with kidney failure, disturbances in bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial metabolites are frequent. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, inflammation, protein-energy wasting and dysbiosis. The investigators hypothesize that therapeutic diet intervention reverses these uremic complications and thereby reduces cardiovascular risk in patients with kidney failure. In this study, the investigators crafted 4-week dialysis-specific therapeutic diet to illustrate the clinical implications of therapeutic diet for dialysis patients. conditions: End-Stage Kidney Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A randomized, active-controlled trial with cross-over design primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Laboratory technicians who assess the study outcomes will be masked whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Dialysis-specific therapeutic diet measure: Concentrations of intact fibroblast growth factor 23 (pg/mL) measure: Concentrations of C-terminal fibroblast growth factor 23 (RU/mL) measure: Concentrations of phosphate (mg/dL) measure: Concentrations of calcium (mg/dL) measure: Concentrations of intact parathyroid hormone (pg/mL) measure: Concentrations of bone-specific alkaline phosphatase (μg/L) measure: Concentrations of procollagen-type 1 N-terminal-propeptide (P1NP) (ng/mL) measure: Concentrations of tartrate resistance acid phosphatase-5b (TRACP-5b) (mIU/ml) measure: Concentrations of alkaline phosphatase (ALP) (IU/L) measure: Concentrations of free indoxyl sulfate (mg/L) measure: Concentrations of free p-cresol sulfate (mg/L) measure: Concentrations of pre-albumin (g/dL) measure: Concentrations of albumin (g/dL) measure: Concentrations of C-reactive protein (mg/dL) measure: Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells measure: Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells measure: Absolute number (per μl blood) of monocytes measure: Concentrations of fetuin-A (μg/ml) measure: Concentrations of trimethylamine-N-oxide (TMAO) (μM) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377280 id: NAV-0011 briefTitle: En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device. overallStatus: RECRUITING date: 2024-01-18 date: 2024-10 date: 2024-12 date: 2024-04-22 date: 2024-04-22 name: Wellspect HealthCare class: INDUSTRY briefSummary: This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks. |
Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact. conditions: Bowel Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Navina Mini measure: Patient satisfaction measure: Assessment of clinical benefit measure: Ease of handling measure: Safety Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skåne University Hospital status: RECRUITING city: Malmö country: Sweden name: Louis Banka Johnson, MD role: CONTACT phone: +4640336557 email: [email protected] name: Sara Strandberg role: CONTACT phone: +4640336377 email: [email protected] lat: 55.60587 lon: 13.00073 hasResults: False |
<|newrecord|> nctId: NCT06377267 id: ESR-20-21103 briefTitle: Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial) acronym: STROBE overallStatus: RECRUITING date: 2024-02-06 date: 2024-04 date: 2025-09 date: 2024-04-22 date: 2024-04-22 name: Vall d'Hebron Institute of Oncology class: OTHER briefSummary: Background: |
The study aims to address the challenge of accurately identifying patients with ovarian cancer who would benefit from poly-ADP ribose inhibitors (PARPi) as first-line maintenance therapy. While BRCA1/2-mutated epithelial ovarian cancer (EOC) patients have shown significant benefits from PARPi treatment, the efficacy in homologous recombination deficient (HRD) patients remains inconclusive. Current assays used to estimate HR status do not effectively differentiate between patients who benefit most from PARPi and those who do not, making it inefficient to treat all patients. There is a need for a more accurate HR status testing method to optimize PARPi benefit. This study aims to assess the performance of the VHIO-CARD-300 test in determining HR status compared to SOPHiA DDM™ Dx HRD Solution. |
Summary: |
The study is a prospective, non-randomized trial designed to evaluate the concordance of the VHIO-CARD-300 test in establishing HR status compared to SOPHiA DDM™ Dx HRD Solution. Additionally, it aims to assess the association between HRD status determined by the VHIO-CARD-300 test and treatment efficacy. Patients with advanced FIGO stage III-IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer will be invited to participate. Those eligible will undergo testing with both VHIO-CARD-300 and SOPHiA DDM™ Dx HRD Solution. Patients classified as HRD positive will receive olaparib in combination with bevacizumab, while others will receive bevacizumab alone. Treatment will be administered according to approved doses, with follow-up evaluations conducted until RECIST progression. conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Bevacizumab name: Olaparib measure: Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution measure: Performance Assessment of VHIO-CARD-300 Test for HR Status Identification measure: Association Between VHIO-CARD-300 Test Groups and Efficacy Outcomes(i.e., HRD positive and HRD negative) and efficacy outcomes. measure: Analysis of Progression-Free Survival (PFS) and Overall Survival (OS) in Discrepant HRD Cases measure: Safety and Tolerability of Olaparib Plus Bevacizumab measure: To evaluate the failure rate for the VHIOCARD-300 test and SOPHiA DD Dx HRD Solution. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vall d'Hebron Institute of Oncology status: RECRUITING city: Barcelona country: Spain name: Ana Oaknin role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False |
<|newrecord|> nctId: NCT06377254 id: BB/X015173/1 briefTitle: Multi-organ Responses to CHronic Physical Activity and INactivity acronym: CHAIN overallStatus: RECRUITING date: 2024-03-12 date: 2027-12-17 date: 2028-10-31 date: 2024-04-22 date: 2024-04-22 name: University of Nottingham class: OTHER name: Biotechnology and Biological Sciences Research Council briefSummary: Life expectancy has been increasing for the last 150 years, but the maintenance of health has not kept pace with increased lifespan, and on average, UK adults spend the last decade of life in poor-health, with major consequences for society and the individual. |
Persistent physical inactivity is thought to be a key contributing factor to the risk of poor health and functional decline occurring in middle-aged and older adults. It is therefore concerning that most middle-aged adults spend \>8hrs/day being sedentary, with average step count of 3000-4000 steps/day. |
To be able to holistically assess the effectiveness of future strategies to address age-related decline in health, and devise public health messages to help individuals reach older age in better health, it is essential that the complex physiological effects that activity and inactivity have across biological systems are characterised. |
The goal of this intervention study is to compare the impact of physical activity and inactivity on body functioning. Twenty moderately active participants will decrease their physical activity for six months to match the average amount carried out by middle-aged people in the UK. They will then undertake 3-months of reconditioning training to restore their fitness. In addition, twenty sedentary participants will increase their physical activity to UK recommended levels for six months. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.