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During the development phase, participants will undergo apheresis to collect stem cells for base-editing correction of the mutation.
During the treatment phase, participants will receive the base-edited cells after chemotherapy with busulfan. Participants will remain in the hospital until their immunity recovers.
Follow-up visits will continue for 15 years. conditions: Chronic Granulomatous Disease (CGD) conditions: X-Linked Chronic Granulomatous Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Base-edited hematopoietic stem and progenitor cells name: Busulfan name: Palifermin name: Filgrastim name: Plerixafor measure: To evaluate the safety of base-edited autologous CD34+ cells measure: To evaluate the efficacy of base-edited autologous CD34+ cells measure: Evaluate the efficiency of base-editing. measure: Evaluate the engraftment capability of base-edited hematopoietic stem progenitor cells. measure: Evaluate the efficiency in restoring gp91phox expression. measure: Evaluate efficacy in restoring NADPH oxidase function. measure: Evaluate clinical efficacy measure: Evaluate the stability of gene correction sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States lat: 38.98067 lon: -77.10026 hasResults: False
<\|newrecord\|> nctId: NCT06325696 id: 10001577 id: 001577-E briefTitle: H01 in Adults With Interstitial Lung Disease (The SOLIS Study) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-22 date: 2024-04-26 name: National Institute of Environmental Health Sciences (NIEHS) class: NIH briefSummary: Background:
Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.
Objective:
To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.
Eligibility:
People aged 18 years and older with interstitial lung disease or lung fibrosis.
Design:
Participants will have at least 7 clinic visits over 5 months.
Participants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:
Spirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.
Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.
Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.
6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.
Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Tests will be repeated at study visits. conditions: Interstitial Lung Disease conditions: Idiopathic Pulmonary Fibrosis conditions: Lung Diseases, Interstitial studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: hymecromone measure: To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD measure: Evaluate the safety and tolerability of oral H01 in participants with progressive ILD. measure: Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01. measure: Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01. measure: Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NIEHS Clinical Research Unit (CRU) city: Research Triangle Park state: North Carolina zip: 27709 country: United States name: NIEHS Join A Study Recruitment Group role: CONTACT phone: 855-696-4347 email: myniehs@nih.gov lat: 35.90567 lon: -78.90497 hasResults: False
<\|newrecord\|> nctId: NCT06325683 id: NCI-2024-01995 id: NCI-2024-01995 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: A072201 type: OTHER domain: Alliance for Clinical Trials in Oncology id: A072201 type: OTHER domain: CTEP id: U10CA180821 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180821 briefTitle: Anti-Lag-3 (Relatlinib) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-06-21 date: 2028-07-15 date: 2028-07-15 date: 2024-03-22 date: 2024-03-22 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlinib) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Relatlinib and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma. conditions: Recurrent Glioblastoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 178 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Lomustine name: Magnetic Resonance Imaging name: Nivolumab name: Relatlimab name: Surgical Procedure measure: Overall survival (OS) measure: OS rate measure: Progression-free survival (PFS) measure: Radiographic response measure: Incidence of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325670 id: 23/50374 briefTitle: Type 2 Diabetes and Binge Eating Disorder (BED) overallStatus: RECRUITING date: 2024-02-23 date: 2024-12 date: 2025-06 date: 2024-03-22 date: 2024-03-22 name: Odense University Hospital class: OTHER name: Jascha Fonden name: Independent Research Fund Denmark briefSummary: The goal of this research project is to improve the treatment of individuals living with both type 2 diabetes (T2D) and Binge Eating Disorder (BED). The research hypothesizes that BED treatment will not only improve BED symptoms but also improve T2D severity and associated cardiovascular risk factors. The research involves a multidisciplinary team, including experts in endocrinology, psychology, and eating disorders.
The main questions it aims to answer are:
* Does treatment for Binge Eating Disorder lead to improvements in BED symptoms?
* Does treatment for Binge Eating Disorder lead to improvements in T2D severity and associated cardiovascular risk factors?
Participants will undergo a comprehensive treatment program targeting both BED and T2D. This program will include psychotherapy sessions focusing on cognitive-behavioral techniques to address binge eating behavior.
Researchers will compare participants' outcomes before and after the treatment program to assess changes in BED symptoms, T2D severity, and associated cardiovascular risk factors. conditions: Diabetes Mellitus, Type 2 conditions: Binge-Eating Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: BED treatment name: Waitlist measure: Number of binge eating episodes measure: Binge Eating Disorder Questionnaire measure: Glucose Sensor Data for Blood Glucose Profile measure: HbA1c measure: Eating Disorder Examination Questionnaire (EDE-Q) measure: Major Depression Inventory (MDI) measure: Problem Areas In Diabetes (PAID20) measure: Lipid profile measure: Body Mass Index (BMI) measure: Blood Pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Region Of Southern Denmark Locations status: RECRUITING city: Odense state: Region Of Southern Denmark zip: 5000 country: Denmark name: Pernille Fiil Nybo, Cand.psych. role: CONTACT phone: +45 2042 7108 email: Pernille.Fiil.Nybo@rsyd.dk name: Jakob Linnet, Dr. med., cand.psych. role: CONTACT phone: +45 2913 8045 email: jakob.linnet@rsyd.dk lat: 55.39594 lon: 10.38831 hasResults: False
<\|newrecord\|> nctId: NCT06325657 id: C3671032 briefTitle: A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants acronym: MORISOT overallStatus: RECRUITING date: 2024-03-12 date: 2025-06-11 date: 2025-06-11 date: 2024-03-22 date: 2024-04-11 name: Pfizer class: INDUSTRY briefSummary: The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother.
The study will look at the safety, tolerability, and immune activity in mothers and their infants.
This study is seeking pregnant women who are:
* Less than or equal to 49 years old and have HIV (Human immunodeficiency virus -
* Receiving standard medical care during the pregnancy
* Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection).
* Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days.
* agree to be present for all study visits, procedures, and blood draws.
Participants will either receive:
* RSVpreF vaccine
* A placebo. A placebo does not have any medicine it but looks just like the study vaccine.
Pregnant participants will be involved in the study from:
* consent during their current pregnancy, and
* for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone. conditions: Respiratory Syncytial Virus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: This is a double-blinded, placebo-controlled study whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 330 type: ESTIMATED name: RSVpreF vaccine name: Placebp measure: Maternal Participants Primary Safety - The proportion of participants reporting systemic reactions measure: Maternal Participants Primary Safety - The proportion of participants reporting local reactions measure: Maternal Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs) measure: Maternal Participants Primary Safety - The proportion of participants reporting Adverse Event of Special Interests (AESIs) measure: Maternal Participants Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs) measure: Infant Participants Primary Safety - The proportion of participants reporting Specific Birth Outcomes measure: Infant Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs) measure: Infant Participants Primary Safety - The proportion of participants reporting SAEs and Newly Diagnosed Chronic Medical Conditions (NDCMCs) measure: Maternal Participants: Secondary Immunogenicity - GMT of NTs for RSV A and RSV B measure: Maternal Participants: Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B sex: ALL minimumAge: 0 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT facility: Synergy Biomed Research Institute status: NOT_YET_RECRUITING city: East London state: Eastern CAPE zip: 5241 country: South Africa lat: -33.01529 lon: 27.91162 facility: Josha Research status: NOT_YET_RECRUITING city: Bloemfontein state: FREE State zip: 9301 country: South Africa lat: -29.12107 lon: 26.214 facility: Worthwhile Clinical Trials status: RECRUITING city: Benoni state: Gauteng zip: 1500 country: South Africa lat: -26.18848 lon: 28.32078 facility: REIMED Reiger Park status: NOT_YET_RECRUITING city: Boksburg state: Gauteng zip: 1459 country: South Africa lat: -26.21197 lon: 28.25958 facility: Wits RHI status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 2001 country: South Africa lat: -26.20227 lon: 28.04363 facility: University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA) status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 2013 country: South Africa lat: -26.20227 lon: 28.04363 facility: Wits VIDA Nkanyezi Research Unit status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 2093 country: South Africa lat: -26.20227 lon: 28.04363 facility: Wits VIDA Nkanyezi status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 2093 country: South Africa lat: -26.20227 lon: 28.04363 facility: Botho Ke Bontle Health Services status: RECRUITING city: Pretoria state: Gauteng zip: 0184 country: South Africa lat: -25.74486 lon: 28.18783 facility: Setshaba Research Centre status: NOT_YET_RECRUITING city: Tshwane state: Gauteng zip: 0152 country: South Africa facility: Qhakaza Mbokodo Research Clinic status: NOT_YET_RECRUITING city: Ladysmith state: Kwazulu-natal zip: 3370 country: South Africa lat: -28.55874 lon: 29.77896 facility: Gole Biomed Research Centre status: RECRUITING city: Polokwane state: Limpopo zip: 0734 country: South Africa lat: -23.90449 lon: 29.46885 facility: MRC Unit on Child And Adolescent Health status: NOT_YET_RECRUITING city: Cape Town state: Western CAPE zip: 7700 country: South Africa lat: -33.92584 lon: 18.42322 hasResults: False
<\|newrecord\|> nctId: NCT06325644 id: 2023H0258 id: CDMRP-PR212399-G type: OTHER_GRANT domain: Departent of Defense briefTitle: Well-Formulated Ketogenic Diet Polycystic Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-22 date: 2024-03-22 name: Ohio State University class: OTHER briefSummary: This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet. conditions: Polycystic Kidney Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Ketogenic Diet name: Ketone/Glucose Monitoring name: CGM/CKM name: Blood Draw name: Body Composition name: Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) . measure: Finger Stick Beta-Hydroxybutyrate measure: Finger Stick Glucose measure: Blood Pressure sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-01-07 uploadDate: 2024-03-19T14:40 filename: Prot_000.pdf size: 409140 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-07 uploadDate: 2024-03-19T14:40 filename: ICF_001.pdf size: 428384 hasResults: False
<\|newrecord\|> nctId: NCT06325631 id: Ankara City Hospital Bilkent briefTitle: Comparative Evaluation of the Results of Facet Joint Injections overallStatus: RECRUITING date: 2023-01-02 date: 2024-03-31 date: 2024-04-30 date: 2024-03-22 date: 2024-03-22 name: Oznur Uzun class: OTHER briefSummary: Low back pain affects 60 to 90% of the total population. It is one of the most common causes of disability in adults. Low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. It is thought that 21 to 41% of low back pain originates from the facet joint. A wide variety of conservative treatments, including intra-articular injections, are used to treat low back pain originating from the facet joint. However, there is still no consensus on the most effective treatment method. With appropriate patient selection, facet joint injections can provide significant improvements in patients' pain scores. After Goldthwait defined the facet joint concept in 1911, Ghormley defined facet joint syndrome in 1933. The source of pain in 40-50% of patients is the lumbar facet joints. Innervation of the lumbar facet joints is provided by the medial branches of the dorsal roots of the spinal nerves. In 1975, Shealy described the coagulation of the articular nerve support of the spinal facet joints with the radiofrequency method. These methods have been further developed over time. The results of facet joint injections are satisfactory in well-selected patient groups. It has been shown that intra-articular steroid injection to the facet joint is superior to systemic steroid use in patients with low back pain. In this study, it was aimed to methodically compare the facet joint injections applied to patients diagnosed with facet syndrome in the outpatient clinic of the Physical Therapy and Rehabilitation Hospital in terms of patient pain scores, application time, effort spent and patient anxiety. Intra-articular injections will be performed under by fluoroscopy or ultrasound guidance or anatomic location. conditions: Low Back Pain, Mechanical conditions: Facet Syndrome of Lumbar Spine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Intra-articular injection to lumbar facet joint measure: Visual Analogue Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ankara Bilkent Şehir Hastanesi status: RECRUITING city: Ankara country: Turkey name: Öznur UZUN, MD role: CONTACT phone: +905052912734 email: soznuruzuns@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06325618 id: 1-10-72-138-23 briefTitle: Lymphedema, Low-grade Inflammation and the Vasculature in Turner Syndrome acronym: TSCOR_V overallStatus: RECRUITING date: 2024-01-08 date: 2027-08 date: 2027-08 date: 2024-03-22 date: 2024-03-22 name: University of Aarhus class: OTHER name: Aarhus University Hospital briefSummary: 100 women with karyotype verified TS, previously examined at 4 study visits during a 19-year period will be asked to participate in a 5th study visit. Healthy age-matched females will be included as controls in a ratio 2:1.
The aim is to examine and quantify the cardiovascular and lymphatic system in women with TS. The investigators will study a possible causal mechanism between the known pathologic phenotype and alterations in these systems to understand, prevent or treat the life-threatening complications in TS. conditions: Turner Syndrome conditions: Cardiovascular Diseases conditions: Lymphedema conditions: Inflammation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: No intervention other than obtaining biopsies name: Indocyanine green (ICG) measure: Grade dysfunction of clinical and subclinical lymphedema using Indocyanine Green Lymphography and Magnetic Resonance Lymphangiography. measure: Detecting low-grade inflammation in Turner Syndrome preforming FDG-PET/CT-scans to locate low grade inflammation. measure: Heat maps of the distribution of wall shear stress in the aorta measure: MRI evaluation and description of vascular abnormalities in Turner Syndrome measure: Cardiac MRI to evaluate function measure: Cardiac MRI to evaluate fibrosis of the myocardium measure: Mapping DNA-methylations patterns in multiple tissues measure: Immunologic changes in Turner Syndrome sex: FEMALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital status: RECRUITING city: Aarhus N zip: 8200 country: Denmark name: Line Balsby, MD role: CONTACT phone: +4520461203 email: libals@clin.au.dk name: Claus Gravholt, MD, Prof. role: CONTACT lat: 56.15674 lon: 10.21076 hasResults: False
<\|newrecord\|> nctId: NCT06325605 id: GRYY-LL-KJ2022-064 briefTitle: Efficacy and Safety of Bifidobacterium Combined With High-frequency Transcranial Magnetic Stimulation in the Treatment of Adolescent Depression overallStatus: COMPLETED date: 2022-03-01 date: 2022-10-31 date: 2022-10-31 date: 2024-03-22 date: 2024-03-22 name: Zhen-Hong Hu class: OTHER briefSummary: A total of 100 patients with adolescent depression who were admitted to our hospital between March 2022 and October 2022 were selected. On the basis of double blinding, these patients were randomly divided into the observation group(n=50) and the control group(n=50) using a random number table. 5S management method was used in the whole process of treatment to improve the hospital environment, increase the work efficiency and reduce the occurrence of cross infection through the effective implementation of the five steps of sort(Seiri), set in order(Seiton), shine (Seiso), standardize(Seiketsu) and sustain(Shitsuke). conditions: Adolescent Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 100 type: ACTUAL name: Bifidobacterium name: High-frequency rTMS name: Escitalopram Oxalate measure: HAMD-24 scores measure: TNF-α measure: IL-1β measure: IL-6 measure: DA measure: 5-HT measure: COR measure: Serum miR-16 measure: Serum miR-195 sex: ALL minimumAge: 13 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Tangshan Workers' Hospital city: Tangshan state: Hebei zip: 063003 country: China lat: 39.63333 lon: 118.18333 hasResults: False
<\|newrecord\|> nctId: NCT06325592 id: REHSIL2023V1.1 briefTitle: Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL overallStatus: COMPLETED date: 2023-10-01 date: 2024-03-01 date: 2024-03-01 date: 2024-03-22 date: 2024-03-22 name: Sichuan Cancer Hospital and Research Institute class: OTHER briefSummary: This study aimed to analyze perioperative information in patients with high-grade squamous intraepithelial lesion (HSIL) undergoing total hysterectomy (TH), offering insights into optimal surgery timing, selecting the operation path, and enhancing surgical operation details. conditions: High-Grade Squamous Intraepithelial Lesions studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 826 type: ACTUAL name: surgical timing and operation path measure: Postoperative fever measure: Postoperative therapeutic use of antibiotics measure: Postoperative complications measure: Postoperative hospitalization days measure: Postoperative hemoglobin measure: Postoperative white blood cell count measure: Postoperative erythrocyte count measure: Postoperative albumin number measure: Postoperative CRP value sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Cancer Hospital and Research Institute city: Chengdu state: Sichuan zip: 610000 country: China lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06325579 id: AA29411356 briefTitle: Immersive Virtual Reality for Dysphagia acronym: IVRys overallStatus: COMPLETED date: 2021-05-24 date: 2023-02-28 date: 2023-03-31 date: 2024-03-22 date: 2024-03-25 name: Sheffield Hallam University class: OTHER briefSummary: People who have suffered a stroke are at high risk of suffering from oropharyngeal dysphagia with long and intensive exercise programmes. Early access to treatment and engaging therapies is very important for recovery. Immersive virtual reality technology presents an innovative treatment that could help patients improve swallowing. The aim of this study is to improve swallowing in stroke patients using two bespoke immersive virtual reality treatment with real-time feedback. The study consisted in a small feasibility study with stroke patients suffering dysphagia (n = 6, aged of 39 to 80 (M=71.17, SD=15.94). Results obtained through interviews with the patients indicated no discomfort reported during the game. All patients reported enjoying the game and feeling engaged and immersive and four out of six patients reported that they would like to use it every day as part of their Speech and Language therapy. The SALT assistant involved in the study stated that the system had the potential to encourage patients to swallow, being more functional than conventional speech therapy. She identified improvements needed for a better functioning of the VR rehabilitation system for Dysphagia. In a future study, wireless headsets will be used, without a laptop, and it will be important to improve the reliability and design of the strain gauge or innovate in the use of a different technology. conditions: Virtual Reality conditions: Dysphagia conditions: Treatment Compliance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 6 type: ACTUAL name: Immersive Virtual Reality for Dysphagia Treatment measure: Feasibility of the system. Semi-structure Interviews with patients and staffs. Qualitative outcomes. measure: Feasibility of the system. Semi-structure Interviews with patients. Quantitative outcomes. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sheffield Hallam University city: Sheffield state: South Yorkshire zip: S1 2NU country: United Kingdom lat: 53.38297 lon: -1.4659 hasResults: False
<\|newrecord\|> nctId: NCT06325566 id: MSB-DR004 briefTitle: Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain acronym: HyaluronicAcid overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-08 date: 2027-08 date: 2024-03-22 date: 2024-03-22 name: Mesoblast, Ltd. class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment. conditions: Degenerative Disc Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Rexlemestrocel-L + HA mixture name: Saline measure: Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Percentage of 30% VAS Pain Responders at 12 Months Post-treatment measure: Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment measure: Percentage of Minimal Pain Responders at 12 Months Post-treatment measure: Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment measure: Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment measure: Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325553 id: 022_2566 briefTitle: Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage Filtered Blood and Comparing With Historical Control acronym: PTR overallStatus: RECRUITING date: 2024-03-30 date: 2025-03-30 date: 2026-03-30 date: 2024-03-22 date: 2024-03-22 name: Siriraj Hospital class: OTHER briefSummary: This research project is evaluate the incidence of platelet refractoriness in newly diagnosed acute leukemia patients receiving PFB during induction and first consolidation phase chemotherapy compared to 2 historical control groups which are patients receiving non-leukocyte depleted blood product group and leukocyte depleted blood product group and demonstrate cost-effectiveness of using blood products with filtered process to prevent clinical platelet refractoriness compare with using HLA-matched blood products after platelet refractoriness occurs conditions: Platelet Refractoriness in Adult Acute Leukemia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 252 type: ESTIMATED measure: Descriptive statistics measure: Inferential statistics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Siriraj hospital status: RECRUITING city: Bangkok zip: 10700 country: Thailand name: weerapat Owattanapanich, MD role: CONTACT phone: 0891081963 email: weerapato36733@gmail.com name: Phakaporn Chamweha, DR role: CONTACT phone: 06855156615 email: phakaporn.cham@gmail.com lat: 13.75398 lon: 100.50144 hasResults: False
<\|newrecord\|> nctId: NCT06325540 id: pulpcapping briefTitle: Clinical Success of Indirect Pulp Capping: 1-Year Follow-Up overallStatus: COMPLETED date: 2023-01-01 date: 2024-02-01 date: 2024-02-15 date: 2024-03-22 date: 2024-03-22 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The goal of this clinical trial is to compare the clinical success of theracal pt, therabase, and biodentine indirect pulp capping on primary molars with deep dentin caries. Indirect pulp capping was used on the primary molars of the participants with deep dentin caries. It is aimed to compare the success of biodentine, which is considered the gold standard used in capping treatments, and the currently marketed Teracal PT and Therabase materials after 1, 6 months and 1 year, with biodentine and with each other, and find out which material is more successful. conditions: Dentin, Carious conditions: Indirect Pulp Capping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Indirect pulp capping will be applied to primary molar teeth with deep dentin caries in 3 groups with 3 different materials(biodentine, thermal pt, therabase). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: patients and the researcher who evaluates the follow-up results of the patients will not know which material was used for indirect pulp coating. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 76 type: ACTUAL name: indirect pulp capping with theracal pt name: indirect pulp capping with therabase name: indirect pulp capping with biodentine measure: successful completion of research measure: unseccessful completion of research sex: ALL minimumAge: 5 Years maximumAge: 9 Years stdAges: CHILD facility: Sağlık Bilimleri Üniversitesi city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06325527 id: YuGarden-01 briefTitle: Cognitive Impairment Cohort Study of the Elderly Population in YuGarden overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2031-04-01 date: 2031-06-01 date: 2024-03-22 date: 2024-03-22 name: Ruijin Hospital class: OTHER briefSummary: The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.
The main questions it aims to answer are:
* incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)
* to build a predictive model for the progression of cognitive impairment conditions: Alzheimer Disease conditions: Neurodegenerative Diseases conditions: Cognitive Impairment conditions: Mild Cognitive Impairment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1872 type: ESTIMATED measure: Incidence of cognitive impairment measure: The change of Mini-Mental State Examination (MMSE) measure: The change of Barthel Index for Activities of Daily Living (ADL) measure: The change of blood biomarkers measure: The change of urine biomarkers measure: The change of feces biomarkers measure: The change of gingival crevicular fluid biomarkers measure: The change of electroencephalogram (EEG) measure: The change of speech information measure: The change of structural MRI measure: The change of functional MRI measure: The change of magnetic susceptibility measure: The change of perfusion MR imaging measure: Positron emission tomography (PET) sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine city: Shanghai state: Shanghai country: China name: Jinwen Xiao role: CONTACT phone: 13917310784 email: jw_xiao78@163.com name: Gang Wang role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06325514 id: NA2024 briefTitle: Artificial Intelligence Based Program to Classify Oral Cavity Findings Based on Clinical Image Analysis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-09-01 date: 2024-03-22 date: 2024-03-26 name: Cairo University class: OTHER briefSummary: This study aims to develop an AI program that can classify oral findings into Normal/variation of normal or an oral disease by clinical photos analysis, aiding in lowering the percentages of false positive and false negative diagnosis of oral diseases. conditions: Oral Cancer conditions: Oral Lichen Planus conditions: Fordyce Granule conditions: Leukoplakia conditions: Erythroplakia conditions: Leukoedemas, Oral conditions: Lichenoid Reaction studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 241 type: ESTIMATED name: Artificial intelligence based program measure: risk stratification sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325501 id: AA-2024-1 briefTitle: Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2025-01-01 date: 2024-03-22 date: 2024-03-22 name: Cairo University class: OTHER briefSummary: Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion.
Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps.
Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia.
Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy. conditions: Myoma;Uterus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Misoprostol 200mcg Tab name: Oxytocin measure: intra-operative blood loss measure: blood transfusion measure: post-operative Hb measure: total surgery time sex: FEMALE minimumAge: 20 Years maximumAge: 48 Years stdAges: ADULT facility: faculty of medicine, Kasr el ainy hospital, Cairo university status: RECRUITING city: Cairo zip: 11562 country: Egypt name: Mohammad A Taymour, MD role: CONTACT phone: 01555761995 email: Mohammadtaymour@gmail.com name: Waleed M Elkhyat role: CONTACT phone: 01005135542 email: Waleed_elkhyat@yahoo.com lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06325488 id: H-23035668 briefTitle: Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease acronym: FORTIFY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-06-01 date: 2024-03-22 date: 2024-03-22 name: Caroline Michaela Kistorp class: OTHER name: Sanofi briefSummary: The overall objective of this study is to investigate Fabry-associated renal organ involvement by using a novel magnetic resonance imaging (MRI) approach, focusing on changes in renal oxygen levels by blood oxygenation-level dependent (BOLD) imaging. Furthermore, to correlate renal oxygenation to the phenotypic presentation of patients with Fabry-associated nephropathy regarding circulating and imaging-derived biomarkers of kidney inflammation, fibrosis and injury as compared with healthy age- and sex-matched controls.
The study will achieve this by:
1) Using a non-invasive, contrast-free MRI protocol focusing on parameters of oxygenation, inflammation, fibrosis, and injury in the kidney.
2) Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-associated nephropathy. conditions: Fabry Disease conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Renal hypoxia (Fabry patients according to renal impairment) measure: Renal hypoxia (Fabry patient vs controls) measure: Renal cortical perfusion (Fabry vs. controls) measure: Renal medullar perfusion (Fabry vs. controls) measure: Renal inflammation (Fabry vs. controls) measure: Renal fibrosis (Fabry vs. controls) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-07-14 uploadDate: 2023-09-18T03:04 filename: Prot_000.pdf size: 808560 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-14 uploadDate: 2024-02-21T07:14 filename: SAP_001.pdf size: 1460496 hasResults: False
<\|newrecord\|> nctId: NCT06325475 id: B.30.2.ATA.0.01.00/530 briefTitle: Comparison of Patients' Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia overallStatus: RECRUITING date: 2024-03-26 date: 2024-07-26 date: 2024-08-26 date: 2024-03-22 date: 2024-03-22 name: Ataturk University class: OTHER briefSummary: The aim of this study was to compare the postpartum recovery of pregnant women who had vaginal delivery with and without neuraxial labor analgesia using the ObsQoR-10 scoring system. conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: labor with neuraxial labor analgesia name: labour without noroaxial labor analgesia measure: ObsQoR-10 scores of postpartum patients sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Atatürk University status: RECRUITING city: Erzurum country: Turkey name: Ayşenur Dostbil role: CONTACT phone: +905333677796 email: adostbil@hotmail.com lat: 39.90861 lon: 41.27694 hasResults: False
<\|newrecord\|> nctId: NCT06325462 id: E2232/2023 briefTitle: The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery overallStatus: RECRUITING date: 2024-02-10 date: 2024-08 date: 2024-12 date: 2024-03-22 date: 2024-03-22 name: Prince Sultan Military Medical City class: OTHER briefSummary: Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Cerebral oximetry, monitored in the frontal cortex using an O3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios. conditions: Cerebral Oxygenation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843 measure: regional cerebral oxygen saturation sex: ALL minimumAge: 18 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince Sultan Military Medical City status: RECRUITING city: Riyadh zip: 11159 country: Saudi Arabia name: Muteb AlOtaibi, M.D. role: CONTACT phone: 00966544793370 email: muteb612@gmail.com name: Rashid Al-Otaibi, M.D. role: SUB_INVESTIGATOR name: Osama Shalaan, M.D. role: SUB_INVESTIGATOR name: Muteb Al-Otaibi, M.D. role: SUB_INVESTIGATOR name: Majid Al-Sherif role: SUB_INVESTIGATOR lat: 24.68773 lon: 46.72185 hasResults: False
<\|newrecord\|> nctId: NCT06325449 id: 5323 briefTitle: Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity acronym: FLOWERS-PCOS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2026-01-01 date: 2024-03-22 date: 2024-03-22 name: Ottawa Hospital Research Institute class: OTHER name: LEAF Weight Loss Clinic briefSummary: The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much?
Participants will complete a 24-week weight loss program (STREAM). During this program they will:
* weigh themselves
* complete regular bloodwork and
* fill out a Quality of Life questionnaire at regular intervals conditions: Polycystic Ovary Syndrome conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Clinic patients with PCOS will be recruited to participate in a 24-week weight loss program. They will all receive the program. There is no control group. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: STREAM program measure: Weight loss measure: Change in Endocrine parameters (EP) as measure by blood test measure: Change in insulin sensitivity (IS) as measure by blood test measure: Change in Lipid profile (LP) as measure by blood test measure: Change in liver enzyme profile (LEP) as measure by blood test measure: Change in Menstrual Cyclicity measure: Quality of Life (QoL) Scale sex: FEMALE minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LEAF Weight Management Clinic city: Ottawa state: Ontario zip: K1J9L3 country: Canada name: Judy Shiau, MD role: CONTACT phone: 613-701-1222 email: dr.shiau@leafwmc.ca name: Julie Laroche role: CONTACT phone: 613-701-1222 email: info@leafwmc.ca lat: 45.41117 lon: -75.69812 hasResults: False
<\|newrecord\|> nctId: NCT06325436 id: scores in variceal bleeding briefTitle: Objective Scores in Variceal Bleeding overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05-01 date: 2026-01-01 date: 2024-03-22 date: 2024-03-22 name: Assiut University class: OTHER briefSummary: To assess the prognostic performance of the ALBI associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores. conditions: Variceal Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 85 type: ESTIMATED measure: assess the prognostic performance of the ALBI_associated scores and new MELD .3 in predicting the short-term outcomes of patients with cirrhosis presenting with acute variceal bleeding. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325423 id: response to NAC in MIBC briefTitle: Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-06 date: 2027-06 date: 2024-03-22 date: 2024-03-26 name: Assiut University class: OTHER briefSummary: Bladder cancer (BC) is the 10th most commonly diagnosed cancer worldwide and the second most common cancer among Egyptian males.
The mainstay of treatment of muscle-invasive BC( MIBC) is neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) or bladder preservation(BP) using maximal transurethral resection of the bladder tumor followed by chemoradiation. The rationale to use NAC before RC or BP is to eradicate micro-metastasis and to downstage the primary tumor.
The 5-year cancer-specific survival for responders to NAC is 90%, in contrast to 30-40% for those not obtaining an objective response. Drawbacks of NAC are disappointing delay of surgery in non-responders and the potential toxicity. So, predictors of response to NAC are necessary to identify patients who may achieve pathologic complete response and will benefit from BP, and the others who may not respond to NAC and spare them NAC toxicity and RC delay.
Tumor microenvironment (TME), including neutrophil extracellular traps (NETs), and CD8+ T lymphocytes is a promising predictor of response to NAC in MIBC.
NETs are reticulated DNA structures decorated with various protein substances (e.g., histones, myeloperoxidase, neutrophil elastase).NETs are involved in tumor growth, metastasis, and treatment resistance. Moreover, NETs can inhibit T cell responses, thereby promoting tumor growth.
On the other hand, immune cells that are present in the TME play a major role in slowing down tumor progression. CD8+T lymphocytes play a central role in immune-mediated control of cancer . Also, they have been found to be a prognostic tool for advanced BC. conditions: Muscle-Invasive Bladder Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 50 type: ESTIMATED name: neoadjuvant chemotherapy measure: Evaluation of the expression of NETs and CD8 in paraffin-embedded TUR biopsies measure: - Response to platinum-based chemotherapy in localized MIBC in relation to: NETs expression, CD8 expression, NET/CD8 ratio and baseline clinicopathological features measure: Local recurrence-free survival (RFS) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325410 id: #11279-20-11-2023 briefTitle: Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience overallStatus: COMPLETED date: 2013-01 date: 2022-12 date: 2022-12 date: 2024-03-22 date: 2024-03-22 name: Zagazig University class: OTHER_GOV briefSummary: over the past decade colon cancer has emerged as the second most deadly and the third most common type of cancer in the world with increasing incidence in Egypt due to life style and diet change. some research showed relation between colon cancer recurrence and advanced tumor staging. To investigators knowledge, this is the first time to be done in Zagazig University.
Data was collected from records in a retrospective cohort study conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ACTUAL name: resection of colorectal cancer measure: age measure: sex measure: medical disease measure: previous surgery measure: CEA measure: tumor grade measure: tumor site measure: tumor size measure: surgical margins of resected tumor measure: neoadjuvant therapy measure: adjuvant therapy measure: diet measure: occupation measure: family history measure: type of surgery(laparoscopic or open) measure: soiling by during surgery measure: hand sewen or stappled anastmosis measure: post operative complications measure: site of recurrence measure: type of resected tumor sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zagazig University Hospitals city: Zagazig zip: 44519 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False
<\|newrecord\|> nctId: NCT06325397 id: IIT #88313865 briefTitle: Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP) overallStatus: RECRUITING date: 2023-10-23 date: 2024-04 date: 2024-06 date: 2024-03-22 date: 2024-03-22 name: Matthew Rauen class: OTHER briefSummary: To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication conditions: Nuclear Cataract studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 75 type: ESTIMATED name: High Intraocular Pressure (IOP) name: Low Intraocular Pressure (IOP) measure: Medication Rescue measure: Physiologic Responses associated with pain/inflammation: measure: Physiologic Responses associated with pain/inflammation: measure: Surgeon Experience: Assessment on patient cooperation measure: Surgeon Experience: Surgeon intraoperative experience measure: Cost- analysis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Wolfe Eye Clinic status: RECRUITING city: West Des Moines state: Iowa zip: 50266 country: United States name: Robyn Kohler, RN role: CONTACT phone: 515-223-8685 phoneExt: 2305 email: rkohler@wolfeclinic.com name: Hillery Joiner role: CONTACT phone: 5152238685 phoneExt: 2085 email: hjoiner@wolfeclinic.com name: Matthew Rauen, MD role: PRINCIPAL_INVESTIGATOR lat: 41.57721 lon: -93.71133 hasResults: False
<\|newrecord\|> nctId: NCT06325384 id: IRAS ID:1008701 briefTitle: Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care acronym: VISION-RWE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-08-31 date: 2025-08-31 date: 2024-03-22 date: 2024-03-22 name: Xim Limited class: INDUSTRY name: Barts & The London NHS Trust name: Mind Over Matter Medtech Ltd name: Health Innovation Wessex briefSummary: A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 500 type: ESTIMATED name: Lifelight name: Blood Pressure Cuff measure: Blood Pressure Measurement Non Inferiority measure: Adherance to Blood Pressure Measurement sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325371 id: 0028201 briefTitle: Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2 acronym: DEDICATE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-06-30 date: 2025-06-30 date: 2024-03-22 date: 2024-03-22 name: University of Turin, Italy class: OTHER briefSummary: This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.
The enrollment period will be of 54 months (01/01/2020-30/06/2024). Minimum sample size will be of 50 Patients. conditions: Aneurysm Abdominal conditions: Arterial Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Visceral aneurysm stenting measure: Efficacy of the stenting in terms of patency and side branches measure: Efficacy of the stenting in terms of aneurysm thrombosis rate measure: Efficacy of the stenting in terms of aneurysm volume assessment measure: Safety in terms of morbidity measure: Safety in terms of mortality measure: Safety in terms of technical issues sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06325358 id: 0040083/23 briefTitle: the EXPOSITION Study acronym: EXPOSITION overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-30 date: 2024-12-30 date: 2024-03-22 date: 2024-03-22 name: University of Pavia class: OTHER name: National Research Council (Consiglio Nazionale delle Ricerche) name: IRCCS National Neurological Institute "C. Mondino" Foundation briefSummary: This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage. conditions: Multiple Sclerosis, Relapsing-Remitting conditions: Environmental Exposure conditions: Lifestyle Factors studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: microRNAs measure: Air quality measure: Nutritional assessment measure: Neurofilament (NfL) measure: Cytokines measure: the Body Mass Index (BMI) measure: Physical activity measure: Quality of life related to MS measure: Sleep Quality measure: Smoking habits measure: Dietary supplements use measure: Adherence to Mediterranean diet measure: Effect of diet on inflammation measure: waist and height ratio (WHtR) measure: Bioelectrical impedance measure: Microbiome and biological biomarkers of oxidative stress and inflammation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Foundation C. Mondino city: Pavia zip: 27100 country: Italy name: Eleonora Tavazzi role: CONTACT phone: 0382 380403 phoneExt: +39 email: eleonora.tavazzi@mondino.it name: Roberto Bergamaschi role: SUB_INVESTIGATOR name: Eleonora Tavazzi role: PRINCIPAL_INVESTIGATOR name: Hellas Cena role: SUB_INVESTIGATOR name: Rachele de Giuseppe role: SUB_INVESTIGATOR name: Beatrice Maccarini role: SUB_INVESTIGATOR name: Aliki Kalmpourtzidou role: SUB_INVESTIGATOR name: Elena Colombo role: SUB_INVESTIGATOR name: Eleonora Rigoni role: SUB_INVESTIGATOR name: Lara Ahmad role: SUB_INVESTIGATOR name: Monica Bianchi role: SUB_INVESTIGATOR name: Veronica Tosca role: SUB_INVESTIGATOR name: Luciana Gracardi role: SUB_INVESTIGATOR name: Romina Sarchi role: SUB_INVESTIGATOR name: Anna Scarabotto role: SUB_INVESTIGATOR name: Matteo Gastaldi role: SUB_INVESTIGATOR name: Ghanya Al-Naqeb role: SUB_INVESTIGATOR name: Federica Loperfido role: SUB_INVESTIGATOR name: Mulubirhan A. Alemayohu role: SUB_INVESTIGATOR name: Maria Cristina Monti role: SUB_INVESTIGATOR name: Cristina Montomoli role: SUB_INVESTIGATOR name: Danilo Porro role: SUB_INVESTIGATOR name: Gloria Bertoli role: SUB_INVESTIGATOR name: Alessia Lo Dico role: SUB_INVESTIGATOR name: Clarissa Consolandi role: SUB_INVESTIGATOR name: Marco Severgnini role: SUB_INVESTIGATOR name: Francesca Costabile role: SUB_INVESTIGATOR name: Stefano Decesari role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06325345 id: 22-5277 briefTitle: RCT of Gut-directed Hypnotherapy in Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-29 date: 2025-04-01 date: 2024-03-22 date: 2024-03-22 name: University Health Network, Toronto class: OTHER briefSummary: This randomized, controlled trial (RCT) will evaluate the effectiveness of gut-directed hypnotherapy for management of Irritable Bowel Syndrome (IBS) in individuals diagnosed with Ehlers-Danlos Syndromes or Generalized Hypermobility Spectrum Disorders (G-HSD). Consenting patients recruited from the Toronto General Hospital GoodHope Ehlers-Danlos Syndrome Clinic will be randomly assigned to one of two groups: (1) standard medical therapy or (2) standard medical therapy plus eight sessions of gut-directed hypnotherapy. The main questions this study will answer are:
1. Is gut-directed hypnotherapy an efficacious treatment for IBS symptoms among individuals with EDS or G-HSD?
2. Does gut-directed hypnotherapy improve other gut symptoms, quality of life, visceral sensitivity, and emotional distress?
3. Is the activity of the parasympathetic nervous system (i.e. the body's "rest and digest" system) associated with IBS symptoms or treatment outcomes among individuals with EDS or G-HSD?
All participants will be asked to meet with a gastroenterologist three times as part of the standard medical therapy. At each physician visit, they will undergo electrocardiogram recording and complete self-report measures of gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Participants randomized to receive gut-directed hypnotherapy will also eight weekly remotely-delivered sessions of gut-directed hypnotherapy delivered by a trained behavioral therapist in between the first and second physician visit. At each session of gut-directed hypnotherapy, a voluntary, pleasant, and dream-like state of deep relaxation will be induced and suggestions made for greater relaxation, abdominal comfort, and normalization of gut function. The first session will also include 30 minutes of education on the nature of the gut-brain axis and hypnotherapy prior to hypnosis.
Researchers will compare study groups to see if participants who engaged in gut-directed hypnotherapy had greater improvement in IBS symptoms, other gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Exploratory analyses will examine the relationships among heart rate variability, an index of parasympathetic nervous system activity, and study outcomes. conditions: Ehlers-Danlos Syndrome conditions: Irritable Bowel Syndrome conditions: Hypermobility Syndrome conditions: Gastrointestinal Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: Gut-directed hypnotherapy name: Standard Medical Therapy measure: IBS Symptom Severity measure: Upper Gastrointestinal Symptoms measure: IBS-related Quality of Life measure: Visceral Sensitivity measure: Emotional Distress measure: Weekly Ratings of GI Health and Medication Use sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Toronto General Hospital city: Toronto state: Ontario zip: M5G 2C4 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06325332 id: RSV00080 briefTitle: BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study) acronym: BEAR overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-22 date: 2024-04-08 name: Sanofi Pasteur, a Sanofi Company class: INDUSTRY briefSummary: The primary objectives of the study are: To estimate the effectiveness of nirsevimab against polymerase chain reaction (PCR)-confirmed RSV (1) lower respiratory tract (LRTD) and (2) related medical encounters.
the secondary objectives are:
1. To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis.
2. To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis.
3. To estimate the impact of nirsevimab on PCR-confirmed RSV.
4. To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis.
5. To estimate the impact of nirsevimab on antibiotic prescription. conditions: Respiratory Syncytial Virus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 33000 type: ESTIMATED name: Nirsevimab measure: Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD) measure: Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis measure: Number of respiratory-related medical encounters measure: Number of respiratory-related medical encounters for LRTD by ICD-10 codes measure: Incidence of PCR-confirmed RSV (first occurrence of season) measure: Number of medical encounters for otitis media by ICD-10 codes measure: Number of antibiotic prescriptions by National Drug Code (NDC) codes sex: ALL minimumAge: 0 Days maximumAge: 12 Months stdAges: CHILD facility: Kaiser Permanente Northern California: Site number 0001 status: RECRUITING city: Oakland state: California zip: 94612 country: United States lat: 37.80437 lon: -122.2708 hasResults: False
<\|newrecord\|> nctId: NCT06325319 id: Ref. No. MA.84/261/02/1/115 briefTitle: Effect of Community Engagement Using M-Mama Champions overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-05 date: 2024-03-22 date: 2024-03-22 name: University of Dodoma class: OTHER name: Stephen Kibusi name: James Tumaini Kengia briefSummary: This study aims to determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women in Bahi, Dodoma. This is a community-based, cluster randomized controlled trial (cRCT) study, whereby 120 first and second-trimester pregnant women will be randomized at a ratio of 1:1 to the intervention and control groups. The intervention of sensitizing pregnant women on Obstetric danger signs, birth preparedness, and complication readiness by the empowered M-MAMA Champions to the intervention arm clusters will be done for one month, a two-hour session will be delivered every two weeks, using participatory learning and action model for women groups to test the effectiveness of M-MAMA Champions in improving literacy level of obstetric danger signs, birth preparedness and complication readiness and its practice among pregnant women.
The following is the hypothesis being tested
Null Hypothesis; There is no difference in improvement of awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women when community engagement is done using M-MAMA Champions compared to routine approaches.
Alternative hypothesis; Community engagement using M-MAMA Champions to improve awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women is more effective than routine approaches.
During each 2-hour session, five (5) women will gather up and discuss the obstetric danger signs, birth preparedness, and complication readiness with the assistance of the M-MAMA Champion as a facilitator. An approved brochure on the concerned subject will be used for sensitization. Baseline data will be collected before and after the intervention.

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