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There is some evidence in the research literature to suggest that when the patient is positioned in a way that helps their airway, like using a device to lift their head and torso 25 degrees , it might help the process of getting enough oxygen work better. The study aims to determine if patients with high BMI can breathe better using a face mask while they are in a head elevated position compared to lying flat on their back. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study is a prospective randomized cross-over trial to be conducted at Mount Sinai Hospital (Toronto, Ontario, Canada). primaryPurpose: PREVENTION masking: NONE count: 38 type: ESTIMATED name: Head position for face mask ventilation during induction supine name: Head position for face mask ventilation during induction head elevated measure: Average tidal volume measure: Predictors for difficult mask ventilation like BMI measure: Predictors for difficult mask ventilation like presence of beard measure: Predictors for difficult mask ventilation like Mallampati classification III or IV measure: Predictors for difficult mask ventilation like age of 57 yo or older. measure: Predictors for difficult mask ventilation like severely limited mandibular protrusion measure: Predictors for difficult mask ventilation like history of snoring. measure: Oropharyngeal airway measure: Insufficient mask ventilation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06305260 id: STUDY00000324 briefTitle: LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40 acronym: LOTUS overallStatus: ENROLLING_BY_INVITATION date: 2023-11-01 date: 2024-12-30 date: 2024-12-30 date: 2024-03-12 date: 2024-03-20 name: MetroHealth Medical Center class: OTHER briefSummary: The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI \>40) obstetric patient population. The main questions it aims to answer are:
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* Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?
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* Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement. conditions: Obesity, Morbid conditions: Labor Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Lumbar Ultrasound measure: Epidural Redirects measure: Total time to epidural space measure: Number of attempts at a different level measure: Epidural replacement rate measure: Patient satisfaction sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MetroHealth Hospital city: Cleveland state: Ohio zip: 44109 country: United States lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06305247 id: CLIN-01194-450 id: 2023-506228-10-00 type: OTHER domain: Ipsen briefTitle: A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours overallStatus: RECRUITING date: 2024-04-03 date: 2028-03-20 date: 2028-03-20 date: 2024-03-12 date: 2024-04-19 name: Ipsen class: INDUSTRY briefSummary: The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.
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The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.
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In this study, all participants will receive the study drug, which will be taken by mouth (orally). conditions: Melanoma conditions: Head and Neck Squamous Cell Carcinoma conditions: Pancreatic Ductal Adenocarcinoma conditions: Colorectal Cancer conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase I is a dose escalation with backfill in participants with selected MAPKm advanced solid tumours.
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Phase IIa (cohort expansion) is an open label randomised study. primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: IPN01194 name: IPN01194 measure: Phase 1: Percentage of participants with dose limiting toxicity (DLT) measure: Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs) measure: Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations measure: Phase 2a: Objective response rate (ORR) measure: Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194 measure: Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194 measure: Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194 measure: Phase 1: Geometric mean ratio of Cmax of IPN01194 administered in fed state relative to fasted state measure: Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state measure: Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state measure: Phase 1: Prolongation of corrected QT interval (QTc) measure: Phase 1: Objective response rate (ORR) measure: Phase 2a: Duration of response (DoR) measure: Phase 2a: Progression-free survival (PFS) measure: Phase 2a: PFS rate at 4 months measure: Phase 2a: Disease control rate (DCR) measure: Phase 2a: Percentage of participants with TEAEs and TE SAEs measure: Phase 2a: Percentage of participants with dose interruptions and permanent treatment discontinuations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Angeles Clinic and Research Institute - California status: NOT_YET_RECRUITING city: Los Angeles state: California zip: 90025 country: United States lat: 34.05223 lon: -118.24368 facility: UC San Diego Health System - La Jolla status: NOT_YET_RECRUITING city: San Diego state: California zip: 92037 country: United States lat: 32.71533 lon: -117.15726 facility: Yale Cancer Center - New Heaven status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510 country: United States lat: 41.30815 lon: -72.92816 facility: Sarah Cannon Research Institute (SCRI) - Nashville status: NOT_YET_RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: Virginia Cancer Specialist status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States lat: 38.84622 lon: -77.30637 facility: Centre Léon Bérard - Lyon status: NOT_YET_RECRUITING city: Lyon country: France lat: 45.74848 lon: 4.84669 facility: Paris Saint-Louis status: NOT_YET_RECRUITING city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Institut de Cancerologie de l'Ouest (St-Herblain) status: NOT_YET_RECRUITING city: Saint-Herblain country: France lat: 47.21765 lon: -1.64841 facility: IGR-Villejuif status: NOT_YET_RECRUITING city: Villejuif country: France lat: 48.7939 lon: 2.35992 facility: Barcelona - Val D'Hebron status: NOT_YET_RECRUITING city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Fundacion Jimenez Diaz - Madrid status: NOT_YET_RECRUITING city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: M.D. Anderson Cancer Center Madrid status: NOT_YET_RECRUITING city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06305234 id: 165-503 briefTitle: A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade) overallStatus: RECRUITING date: 2024-01-20 date: 2033-11-18 date: 2033-11-18 date: 2024-03-12 date: 2024-03-12 name: BioMarin Pharmaceutical class: INDUSTRY briefSummary: This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503. conditions: Phenylketonuria (PKU) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Pegvaliase measure: To evaluate immunologic and inflammatory responses associated with occurrences of measure: Evaluation of immunologic and/or inflammatory responses over time measure: Evaluation of immunologic responses over time sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tulane University School of Medicine status: RECRUITING city: New Orleans state: Louisiana zip: 70112 country: United States lat: 29.95465 lon: -90.07507 hasResults: False
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<|newrecord|> nctId: NCT06305221 id: opioid-free analgesia briefTitle: Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy overallStatus: RECRUITING date: 2024-03-09 date: 2025-03-31 date: 2025-03-31 date: 2024-03-12 date: 2024-04-16 name: Beijing Friendship Hospital class: OTHER briefSummary: The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain. conditions: Opioid-Free Anesthesia conditions: Laparoscopic Sleeve Gastrectomy conditions: Postoperative Vomiting conditions: Postoperative Recovery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Opioid-free Analgesics (esketamine, dexmedetomidine) name: Opioid Anesthetics (sufentanil and remifentanil) measure: 15-item recovery quality scale score 48 hours after surgery measure: 15-item recovery quality scale score 24 hours before surgery measure: Dosage of postoperative analgesics measure: Duration of until postoperative PACU Aldrete score> 9 points measure: anesthesia-related complication measure: time to first exhaust gas after surgery measure: time of first postoperative mobilization measure: Overall benefit of analgesic score satisfaction in pain treatment measure: Acute pain numeric rating scale score measure: Rhodes Index of Nausea, Vomiting, and Retching measure: Rhodes Index of Nausea, Vomiting, and Retching sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: bijia Song status: RECRUITING city: Beijing country: China name: bijia Song role: CONTACT phone: 18309845273 email: songbijia@163.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06305208 id: CCLR-23-018 briefTitle: A UK Registry for Metabolic and Bariatric Endoscopic Interventions acronym: UK-ENDOMAB overallStatus: RECRUITING date: 2024-02-01 date: 2034-02-01 date: 2039-02-01 date: 2024-03-12 date: 2024-03-15 name: Cleveland Clinic London class: OTHER briefSummary: In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to achieve normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. The investigators hope over time this will improve the knowledge of clinicians about treating obesity with endoscopy and support future access and funding to these treatments. conditions: Obesity conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Endoscopic gastric suturing name: Endoscopic gastric plication name: Revisional gastroplasty name: Transoral outlet reduction endoscopy (TORe) name: Duodenal mucosal resurfacing (DMR) name: Intragastric balloon(s) measure: Total body weight loss percentage (TBWL%) measure: Change in glycated haemoglobin (HbA1c; mmol/mol) measure: Change in the number and dose of anti-diabetic medications measure: Procedure time (mins) measure: Inpatient stay (days) measure: Adverse events measure: Change in systolic blood pressure measurements (mmHg) measure: Change in diastolic blood pressure measurements (mmHg) measure: Changes in number and dose of anti-hypertensive medications (n) measure: Changes in low-density lipoprotein cholesterol (mmol/L) measure: Changes in triglycerides (mmol/L) measure: Changes in high-density lipoprotein cholesterol (mmol/L) measure: Changes in total cholesterol (mmol/L) measure: Changes in alanine transaminase (IU/L) measure: Changes in aspartate aminotransferase (IU/L) measure: Changes in Fibrosis-4 Index for Liver Fibrosis measure: Changes in non-alcoholic fatty liver disease fibrosis score measure: Changes in weight (kg) measure: Changes in body mass index (kg/m2) measure: Changes in glycated haemoglobin (HbA1c; mmol/mol) measure: Changes in number and dose of anti-diabetic medications (n) measure: Changes in number and dose of anti-obesity medications (n) measure: Changes in health-related quality of life scores (EuroQol-5D-5L) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic London status: RECRUITING city: London zip: SW1X 7HY country: United Kingdom name: Benjamin Norton, MD role: CONTACT email: cclendoscopyresearch@ccf.org name: Rehan Haidry, MD role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06305195 id: 0107766 briefTitle: Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome overallStatus: RECRUITING date: 2023-08-23 date: 2024-09-01 date: 2026-10-21 date: 2024-03-12 date: 2024-03-12 name: Alexandria University class: OTHER briefSummary: The study aims to assess the beat-to-beat Heart rate variability (HRV) in different stages of metabolic diseases, including pre-diabetic and diabetic patients, compared to non-diabetic individuals.
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Heart rate variability will be compared for some antidiabetic drugs used in different stages of metabolic diseases and correlated to different metabolic and inflammatory mediators. conditions: Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 155 type: ESTIMATED name: heart rate variability test measure: Beat-to-beat Heart rate variability measure: body mass index measure: Valsalva ratio measure: Stand 30:15 ratio measure: deep breath test interpretation measure: Framingham risk score (FRS) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alexandria university status: RECRUITING city: Alexandria country: Egypt name: Hala A. Abo El-Hassan, MSc role: CONTACT phone: 02/01114851485 email: hala.aboelhassan@pua.edu.eg name: Noha A. Hamdy, Dr role: CONTACT phone: 02/01005182151 email: noha.alaaeldine@alexu.edu.eg lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06305182 id: BASEC 2022-01328 briefTitle: Metreleptin in Anorexia Nervosa acronym: METRAN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-02-01 date: 2026-02-01 date: 2024-03-12 date: 2024-03-15 name: Gabriella Milos class: OTHER briefSummary: The treatment of anorexia nervosa often proves to be difficult. There are no drugs that work specifically for the treatment of anorexia nervosa. Experimental administration of metreleptin (synthetically produced leptin) to patients with anorexia nervosa has produced positive results. This study tests the effect of metreleptin in comparison with placebo, which could potentially make treatment easier. The aim of the study is to investigate whether treatment with metreleptin can help to reduce the symptoms of anorexia nervosa and improve mood and weight. conditions: Anorexia Nervosa studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Placebo-controlled, double-blind, randomized trial. The efficacy of Metreleptin in Anorexia Nervosa patients will be tested against an inactive Placebo. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Metreleptin name: Sodium chloride measure: Clinician-rated depression on the 17 point Hamilton Depression Scale (HAMD-17) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Body weight status in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Subjective depression by the Beck Depression Inventory-II (BDI-II) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Functional brain connectivity in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Anorexia Nervosa psychopathology assessed by the Eating Disorders Examination Questionnaire (EDE-Q) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: External rated hyperkinesia assessed by the Structured Inventory for Anorexic and Bulimic Eating Disorders (SIAB, item 42) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Subjective hyperkinesia assessed by the Exercise and Eating Disorders Questionnaire (EED) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Autism symptoms assessed by the Autism-Spectrum Quotient-short version (AQ-k) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Patient's quality of life by items 1, 2, 5, 6, 7, 10, 17, 19, 20, and 22 from the WHO Quality of Life Questionnaire (WHOQOL-BREF) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Visual Analog Scale (VAS) about key Anorexia Nervosa and depression symptoms in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich city: Zurich zip: 8091 country: Switzerland name: Florian Remund, MSc. Business Administration role: CONTACT name: Gabriella Milos, Prof. Dr. med. role: PRINCIPAL_INVESTIGATOR name: Lisa Guth, MSc role: SUB_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False
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<|newrecord|> nctId: NCT06305169 id: 1.4 briefTitle: Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-07-01 date: 2024-03-12 date: 2024-03-12 name: Sandwell & West Birmingham Hospitals NHS Trust class: OTHER briefSummary: Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis.
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The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad.
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To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy.
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A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 440 type: ESTIMATED name: Gastropanel measure: Measurement of the specificity and negative predictive value of serum biomarkers in gastric cancer measure: Creating a scoring system for patients that warrant urgent endoscopy on the cancer pathway sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sandwell General Hospital city: Birmingham state: West Midlands zip: B71 4HJ country: United Kingdom lat: 52.48142 lon: -1.89983 hasResults: False
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<|newrecord|> nctId: NCT06305156 id: CT_BMD_1 briefTitle: Protocol Optimization in CT for the Quantification of BMD overallStatus: RECRUITING date: 2024-03-13 date: 2025-03 date: 2025-03 date: 2024-03-12 date: 2024-03-20 name: Hatem Alkadhi class: OTHER briefSummary: Bone mineral density is an important measurement to detect osteoporosis.
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The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is:
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* How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA
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* How can we optimize the CT scan for bone mineral density
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Participants will undergo:
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* Clinically indicated CT scan on day of inclusion
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* Study related DXA scan on a separate appointment conditions: Osteoporosis, Osteopenia conditions: Bone Loss studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Bone Mineral Density quantification measure: Bone mineral density CT measure: Bone mineral density Dual-energy x-ray absorptiometry (DXA) measure: Correlation between age and bone mineral density measure: Correlation between sex and bone mineral density measure: Correlation between height and bone mineral density measure: Correlation between weight and bone mineral density measure: Correlation between body mass index (BMI) and bone mineral density sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Diagnostic and Interventional Radiology, University Hospital Zurich status: RECRUITING city: Zürich zip: 8091 country: Switzerland name: Hatem Alkadhi, MD, MPH role: CONTACT phone: +41 44 255 36 62 email: hatem.alkadhi@usz.ch lat: 47.36667 lon: 8.54999 hasResults: False
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<|newrecord|> nctId: NCT06305143 id: YFZXYDK202402 briefTitle: Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-07-01 date: 2024-03-12 date: 2024-03-12 name: Shanghai Eye Disease Prevention and Treatment Center class: OTHER name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine briefSummary: The goal of this prospective multicenter open label study is to evaluate the efficacy and safety of intravitreal injection Conbercept (IVC) for the treatment of diabetic macular edema (DME) combined with severe nonproliferative diabetes retinopathy (sNPDR).
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The main questions it aims to answer are:
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* mean changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) in comparison with baseline at 12 months after initial treatment
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* proportion of eyes with visual gain ≥15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) chart and ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score after 12 months of the treatment
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* proportion of eyes actually underwent PRP treatment after 3 and 12 months of the treatment
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* mean changes in BCVA and CMT from baseline to monthly follow-up time point
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* complications and adverse effects conditions: Diabetic Macular Edema studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: Conbercept measure: improvement of visual acuity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Eye Diseases Prevention &Treatment Center status: RECRUITING city: Shanghai state: Shanghai zip: 201103 country: China name: Tao Sun role: CONTACT phone: +8618916576690 email: drsuntao@yeah.net lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06305130 id: KMUHIRB-E(I)-20180214 briefTitle: Prognostic Value of Performance Scores in Patients Undergoing Surgery for Upper Tract Urothelial Carcinoma overallStatus: COMPLETED date: 1988-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-12 date: 2024-03-12 name: Kaohsiung Medical University class: OTHER briefSummary: Aim: to comprehensively evaluate the prognostic value of preoperative ECOG-PS scores and ASA scores in patients undergoing radical nephroureterectomy (RNU) for upper tract urothelial carcinoma.
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Methods: multicentered cohort study conditions: Carcinoma, Transitional Cell (RENI) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2515 type: ACTUAL name: No intervention measure: Overall survival measure: Cancer-specific survival measure: Disease-free survival measure: Bladder recurrence-free survival measure: Number of patients with major postoperative complication measure: Number of patients with postoperative renal failure sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06305117 id: PP202304-37-1 id: 101227 type: OTHER_GRANT domain: Association Ruban Rose briefTitle: Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1 acronym: VRtuose1 overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2025-05 date: 2025-05 date: 2024-03-12 date: 2024-03-12 name: International Agency for Research on Cancer class: OTHER name: Centre Leon Berard briefSummary: The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate the feasibility of implementing in day patient chemotherapy units a distraction strategy combining virtual reality (VR) and music which fits the needs of both breast cancer patients and healthcare providers (i.e., strategy administrators), and to evaluate its impact on patients' (i) perceived anxiety and pain during chemotherapy sessions, (ii) nausea/vomiting and mood disturbances in between chemotherapy sessions, and (iii) quality of life.
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The present project is a non-randomized non-controlled prospective monocentric feasibility study which will focus on evaluating the feasibility of implementing the strategy in the target population and setting.
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In the case that implementation of a distraction strategy combining virtual reality and music to improve quality of life of breast cancer patients during chemotherapy is deemed feasible, the efficacy of using this strategy to improve patients' experience of chemotherapy and long-term quality of life will be evaluated in a future randomized controlled trial informed and optimized by the results of the present work. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Distraction strategy measure: Patients' acceptance rate regarding the use of the distraction strategy. measure: Accessibility of the strategy measure: Duration of use of the strategy by patients measure: Type of video content chosen by participants measure: Type of music content chosen by participants measure: Patients' perception of factors limiting the use of the strategy measure: Healthcare providers' perception of factors limiting the use of the strategy measure: Workload for strategy administrators measure: Strategy administrators ability to use the strategy measure: Patients' satisfaction regarding the use of the strategy measure: Healthcare providers' satisfaction regarding the strategy measure: Prevalence of adverse events related to the use of the strategy measure: Type of adverse events related to the use of the strategy measure: Severity of adverse events related to the use of the strategy measure: Acceptance rate to fill in questionnaires measuring clinical outcomes measure: Time taken to fill in questionnaires measuring clinical outcomes measure: Completeness of questionnaires measuring clinical outcomes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Léon Bérard city: Lyon country: France name: Olivier Trédan, MD role: CONTACT email: olivier.tredan@lyon.unicancer.fr name: Olivier Trédan, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 hasResults: False
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<|newrecord|> nctId: NCT06305104 id: KN-EEC-II briefTitle: Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old. overallStatus: RECRUITING date: 2023-07-18 date: 2024-05-30 date: 2024-06-30 date: 2024-03-12 date: 2024-03-12 name: Chengdu CoenBiotech Co., Ltd class: INDUSTRY name: Beijing Chest Hospital, Capital Medical University name: Wuhan Institute for Tuberculosis Control name: The Public Health Clinical Center of Chengdu name: Xuzhou Infectious Disease Hospital name: Jiangsu Province Centers for Disease Control and Prevention name: Changde First People's Hospital briefSummary: This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old.
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In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis.
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In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old. conditions: Tuberculosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 420 type: ESTIMATED name: 2.5μg/ml EEC name: 5μg/ml EEC name: 5 unit（U） EC measure: Sensitivity of different doses of EEC and control EC in pulmonary tuberculosis patients aged 18 to 65 years ; measure: specificity of different doses of EEC and control EC in healthy subjects aged 18 to 65 years and patients with non-tuberculous lung disease ; measure: The skin test site specific reaction at 4h,8h (only for stage 2);24h, 48h, 72h, 96h, and 7 days after skin test. Those with average diameter of induration/redness is ≥5 mm will be considered to positive. measure: Receiver operator characteristic curve(ROC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug. measure: Area under the curve(AUC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug. measure: In healthy people, patients with tuberculosis and patients with non-tuberculous lung diseases, the consistency rates of the three detection reagents EEC , EC and IGRA were evaluated respectively. measure: Incidence of adverse events and serious adverse events at injection and non-injection sites，abnormal incidence of laboratory indicators and vital signs during the study period. sex: ALL minimumAge: 3 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Chest Hospital status: RECRUITING city: Beijing state: Beijing zip: 101149 country: China name: Tongqun Zhang role: CONTACT phone: 010-89509134 email: Zhangtongqun@sina.com name: Naihui Chu, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Wuhan Institute for Tuberculosis Control status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Min Wang role: CONTACT phone: 13871221841 email: whsfkyyllsc@163.com name: Juan Du, Bachelor role: PRINCIPAL_INVESTIGATOR name: Ronghui Du, Bachelor role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Changde First People's Hospital status: RECRUITING city: Changde state: Hunan zip: 415000 country: China name: Shuxiang Zhou role: CONTACT phone: 0736-7788890 email: 450717196@qq.com name: Tianli Wang, master role: PRINCIPAL_INVESTIGATOR lat: 29.04638 lon: 111.6783 facility: Jiangsu Province Centers for Disease Control and Prevention status: RECRUITING city: Nanjing state: Jiangsu zip: 212400 country: China name: Xiaoyan Ding role: CONTACT phone: 025-83759406 email: ec@jscdc.cn name: Limei Zhu, master role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: Xuzhou Infectious Disease Hospital status: RECRUITING city: Xuzhou state: Jiangsu country: China name: Tingting Liu role: CONTACT phone: 0516-68900929 email: xcyllb123@163.com name: Ruimei Zhang, Bachelor role: PRINCIPAL_INVESTIGATOR lat: 34.18045 lon: 117.15707 facility: Public health clinical center of chengdu status: RECRUITING city: Chengdu state: Sichuan zip: 610066 country: China name: Qing Yang role: CONTACT phone: 028-64369118 email: crbykjk@126.com name: Guihui Wu, master role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06305091 id: 1681559 briefTitle: DNA Methylation Markers in Veterans Exposed to Open Burn Pits overallStatus: RECRUITING date: 2023-03-13 date: 2027-03-31 date: 2027-03-31 date: 2024-03-12 date: 2024-03-12 name: Central Arkansas Veterans Healthcare System class: FED name: United States Department of Defense name: University of Arkansas briefSummary: Background: The VA and DoD estimate that 3.5 million Veterans and Service Members were exposed to open burn pits used for waste disposal during military deployments to countries such as Kuwait, Afghanistan, and Iraq since 1990. Since the lasting adverse effects of this exposure on health are unknown, the VA Airborne Hazards and Open Burn Pit Registry (AHOBPR) was created. More than 209,000 participants to date have answered the registry questionnaire about the extent of exposure to burn pits and other airborne hazards. The questions attempted to quantify the duration of exposure, the severity of acute health effects, and the relative timing of onset or worsening of chronic respiratory, cardiovascular, neurological, and other illnesses. However, the AHOBPR interview lacks specific inquiry about mental health and biomarkers. The proposed study will recruit AHOBPR participants and non-participant for a follow-up enhanced evaluation of their health in a translational research study to better characterize their psychological, physical health profile, and potentially harmful epigenetic and biochemical exposure-related alterations.
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Hypothesis: The investigators hypothesize that 1) the severity of individual exposure to burn pits will be positively correlated with levels of persistent organic pollutants in blood and metals in urine and specific epigenetic alterations in DNA methylation; and 2) levels of toxic chemicals and alterations in the methylation of specific genes will be positively correlated with chronic problems involving the cardiovascular, respiratory, neuropsychiatric and other systems.
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Specific Aims: (1) Describe and quantify relationships of the intensity and duration of exposure with persistent organic chemicals/metals in the registry participants and ascertain their relationships with health outcomes linked to burn pit exposure. (2) Discover and validate DNA methylation marks that best distinguish between individuals exposed to burn pits and those not; then describe and quantify the relationships between DNA methylation, intensity and duration of exposure, and health outcomes. Completion of these aims will allow quantitation of the relationships between toxic chemicals, DNA methylation, and individual health problems.
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Study Design: A clinical study will be conducted at the Central Arkansas Veterans Healthcare System and the University of Arkansas for Medical Sciences. The AHOBPR registry and non-specific recruitment will be used to enroll OBP exposed (N=220) and age and gender-matched unexposed (N=110) veterans. The unexposed veterans will be given the same questions as in the AHOBPR to determine their open burn pit exposure status with a confirmation of no exposure. A single study visit per participant will strengthen the registry by validating its contents using the electronic patient record and adding new study data on physical and mental function, including effects of epigenetic and toxicant measures obtained from blood and urine samples. Linear and logistic regression modeling will be used to determine the relationships described by the study aims while controlling for confounding variables and false discovery rates.
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Long-term and Short-term Impact on Patient Populations: The immediate goal of the study is to measure exposure-related differences in levels of potentially toxic chemicals present in blood and urine and differences in DNA methylation. The study will then determine the relationships between exposure, the biochemical and molecular measures, and the presence of health problems. The value of this information is high since the effects of burn pit exposure are largely unknown but potentially serious. The longer-term goal for this line of investigation is to enable personalized and tailored health management for exposed individuals. The investigators believe that the biochemical and molecular measures may become novel biomarkers that enable the prediction of risk for disease and adverse disease outcomes such that preventative measures can be employed. Furthermore, the results will be highly relevant to other occupations in which exposure to airborne pollutants is high. conditions: Open Burn Pit Exposure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 330 type: ESTIMATED name: Health survey for physical and mental health comorbidities, epigenetic marker and heavy metals in blood and urine samples measure: DNA methylation markers and heavy metals measure: Physical and mental health comorbidities sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Arkansas Veterans Healthcare System (3J/NLR) status: RECRUITING city: North Little Rock state: Arkansas zip: 72114 country: United States name: Kalpana Padala, MD role: CONTACT phone: 501-257-2044 email: kalpana.padala@va.gov name: Trent Trice, BS role: CONTACT phone: 501-257-2403 email: trent.trice@va.gov name: Kalpana Padala, MD role: PRINCIPAL_INVESTIGATOR lat: 34.76954 lon: -92.26709 hasResults: False
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<|newrecord|> nctId: NCT06305078 id: 2023-0528 briefTitle: Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study overallStatus: RECRUITING date: 2023-11-10 date: 2024-08-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Children's Hospital Medical Center, Cincinnati class: OTHER briefSummary: The primary goal of the project is to test personalized medication experiments to inform decisions about future medication use. Our central hypothesis is that our intervention will lead to within subject increases in adolescent involvement in decision making and decreases in uncertainty about future medication use. The investigators view this open label trial as a pilot study to test the feasibility, acceptability, and preliminary efficacy of the medication experiment intervention and therefore warrants further testing in a future larger trial. conditions: Attention Deficit Hyperactivity Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open Label Trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: None (open-label) count: 30 type: ESTIMATED name: Personalized ADHD Medication Experiment measure: Decision-Making Involvement Scale measure: Decisional Conflict Scale (DCS) measure: Behavioral Intention Questions measure: System Usability Scale measure: Implementation of Decision sex: ALL minimumAge: 11 Years maximumAge: 15 Years stdAges: CHILD facility: Cincinnati Children's Hospital Medical Center status: RECRUITING city: Cincinnati state: Ohio zip: 45220 country: United States name: William Brinkman, MD role: CONTACT phone: 513-636-2576 email: bill.brinkman@cchmc.org name: William Brinkman, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-10 uploadDate: 2024-01-26T17:55 filename: Prot_SAP_000.pdf size: 1393239 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-10 uploadDate: 2024-01-26T18:00 filename: ICF_001.pdf size: 1084823 hasResults: False
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<|newrecord|> nctId: NCT06305065 id: 2024.089 briefTitle: Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-05 date: 2024-03-12 date: 2024-03-19 name: Chinese University of Hong Kong class: OTHER briefSummary: REAL INTELLIGENCE™ CORI™ (CORI Surgical System) is a computer-assisted orthopedic surgical system. CORI Surgical System is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures.
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CORI Surgical System is comprised of a console control unit, optical tracking camera, primary and secondary input displays (tablet and optional display monitor), and foot pedal. The CORI Surgical System software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module.
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Yuanhua Orthopaedic Robotic Systems, KUNWU, is an open-platform robotic system that does not restrict surgeons in choosing the type of prosthesis implant. It is the only Orthopaedic Robotic System in Hong Kong registered with the HK Department of Health Medical Devices Control Office (MDCO) as an open platform system. Unlike other manufacturer's implant-based robots (closed systems), Yuanhua's objective is to provide maximum flexibility in choosing the best implant for each patient. Closed system robots not only impact the surgeon's choice of implant for an individual patient but also affect the hospital's implant purchases over multiple years without any negotiation power on pricing. This business model is often referred to as a "razor and razor blade" model.
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The primary objective of this study is to evaluate the use of open and closed platform robotic-assisted TKA procedure in achieving post-operative leg alignment as compared to procedures using standard instruments. The secondary objective of this study is to assess the safety and performance of the robotic-assisted TKA procedure up to 12 months after surgery as compared to procedures using conventional manual instruments. conditions: Knee Osteoarthritis conditions: Total Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Subjects will be randomly assigned to the KUNWU navigational or CORI Surgical System or conventional manual instrumentation groups according to a balanced randomization procedure using a 1:1:1 allocation ratio. To ensure balanced group assignment, a block randomization schedule will be generated. All subjects who sign the ICF and meet all inclusion and exclusion criteria will be randomized in a 1:1:1 randomization allocation ratio. The block size should be sufficiently small to allow approximately equal allocation of subjects in each group should the study be terminated prematurely whilst also being large enough so as the next treatment cannot be guessed. The study is non-blinded. count: 90 type: ESTIMATED name: KUNWU Navigation TKA procedure name: CORI Surgical System TKA procedure name: Conventional TKA procedure measure: Post-operative leg alignment - Hip-knee-ankle axis (HKA axis) measure: Lateral View measure: Standard Radiographic Evaluation - Femoral coronal alignment (FCA) measure: Standard Radiographic Evaluation - Femoral sagittal alignment (FSA) measure: Standard Radiographic Evaluation - Femoral component rotation (FCR) measure: Standard Radiographic Evaluation - Tibial coronal alignment (TCA) measure: Standard Radiographic Evaluation - Tibial slope measure: Standard Radiographic Evaluation - Joint line distance measure: Knee Society Score (KSS) measure: Oxford Knee Score (OKS) measure: HEALTH ECONOMICS/QUALITY OF LIFE - EQ-5D-5L measure: Forgotten Joint Score (FJS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Chinese University of Hong Kong city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06305052 id: estimulation-taste-olfactory id: 65635922.0.0000.5201 type: OTHER domain: CAAE (Certificate of Presentation of Ethical Review) briefTitle: Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-04 date: 2024-04 date: 2024-04 date: 2024-03-12 date: 2024-03-13 name: Professor Fernando Figueira Integral Medicine Institute class: OTHER briefSummary: The objective of this clinical trial is to test the effects of olfactory and taste stimulation with milk or water in premature newborns with a gestational age between 28 and 32 weeks.
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The main question researchers want to resolve is: • Does olfactory and gustatory stimulation in these newborns reduce the time spent with an oral or nasogastric feeding tube and bring forward oral feeding? Participants will be stimulated with milk or water depending on the randomly chosen group. 1: the olfactory stimulus (with smell) will be performed with a sterile cotton swab close to the nostrils immediately before feeding through the tube, 2: the gustatory stimulus (taste) will be performed with a sterile cotton swab on which a drop of milk or water will be applied on the newborn's tongue if they are awake or on their lips if they are sleeping, and is performed immediately before tube feeding. conditions: Weight, Birth conditions: Premature Birth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 63 type: ACTUAL name: Milk name: Water measure: Comparison of the period between the beginning of the intervention and enteral feeding. measure: Describe the gestational age of the newborn measure: Describe the sex of the newborn. measure: Describe the type of birth. measure: Describe the APGAR score. measure: Describe birth weight and birth weight z-score. measure: Describe head circumference at birth and head circumference z-score at birth measure: Describe birth length and birth length z-score. measure: Determine the frequency of rupture of membranes >24h, chorioamnionitis, antepartum hemorrhage, gestational hypertension, pre-eclampsia and prenatal steroids >24h. measure: Compare the time, in days, of feeding via oral/nasal gastric tube. measure: Compare the total duration, in days, of parenteral nutrition (TPN) use. measure: Compare the type of food at discharge (natural, artificial or mixed). measure: Compare weight gain and weight Z score, at 28 days of life and at discharge from the neonatal ICU, as well as anthropometric parameters: head circumference and length with their respective Z score at discharge from the NICU. measure: Compare gestational age (GA) at the time of removal of the oro/nasogastric tube and at discharge from the NICU. measure: Compare the frequency of diagnosis of patent ductus arteriosus requiring treatment, bronchopulmonary dysplasia (BPD), retinopathy of prematurity, intraventricular hemorrhage and necrotizing enterocolitis. measure: Determine the association of treatment time with oxygen therapy (nasal catheter, nasal prong - nasal CPAP, intermittent positive pressure or endotracheal ventilation) in hours. sex: ALL minimumAge: 28 Weeks maximumAge: 32 Weeks stdAges: CHILD facility: Instituto de Medicina Integral Professor Fernando Figueira city: Recife state: Pernambuco zip: 50070-550 country: Brazil lat: -8.05389 lon: -34.88111 hasResults: False
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<|newrecord|> nctId: NCT06305039 id: 2089705 id: 1R01DC020506-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DC020506-01A1 briefTitle: Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments overallStatus: ENROLLING_BY_INVITATION date: 2023-12-19 date: 2028-05-31 date: 2028-05-31 date: 2024-03-12 date: 2024-03-12 name: University of Maryland, College Park class: OTHER name: National Institute on Deafness and Other Communication Disorders (NIDCD) name: Walter Reed National Military Medical Center name: Vanderbilt University briefSummary: Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also "single-sided deafness" (SSD) CI users who use one CI together with good acoustic hearing in their opposite ear. The goal is to measure and understand the impact of large input asymmetries across the two ears. These asymmetries are common in BI-CI listeners and always present in SSD-CI users. Although most CI listeners benefit from a second source of auditory input, this project measures how these asymmetries limit speech understanding and spatial hearing. The long-term goal is countering or compensating for input asymmetries. Electrophysiological measures are used to describe the health of the auditory system. Behavioral measures are used to assess if training improves performance. CT imaging is utilized to describe the placement of the CIs. conditions: Hearing Loss conditions: Hearing Loss, Sensorineural conditions: Cochlear Hearing Loss studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 300 type: ESTIMATED name: Diagnostic tests of cochlear implant or acoustic hearing function name: Targeted aural rehabilitation of the poorer performing ear measure: Perceptual responses to sound level measure: Speech understanding in the presence of masking sounds measure: Computed-tomography scan measure: Electrode impedance (transelectrode impedance matrix) measure: Electrically evoked compound action potentials (ECAPs) measure: Sound Localization measure: Perceptual Fusion measure: Spectrotemporal ripple sensitivity sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walter Reed National Military Medical Center city: Bethesda state: Maryland zip: 20889 country: United States lat: 38.98067 lon: -77.10026 facility: University of Maryland, College Park city: College Park state: Maryland zip: 20742 country: United States lat: 38.98067 lon: -76.93692 hasResults: False
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<|newrecord|> nctId: NCT06305026 id: S-20190160 briefTitle: Protocol for a Diagnostic Test Accuracy of Histological Muscle and Skin Biopsies of Rheumatoid Arthritis Patients Revealing Objective Chronic Widespread Pain Phenomena Related to Fibromyalgia overallStatus: RECRUITING date: 2024-02-07 date: 2024-08-31 date: 2024-08-31 date: 2024-03-12 date: 2024-03-12 name: Hospital of South West Jutland class: OTHER name: Odense University Hospital briefSummary: Background: Chronic widespread pain is challenging in the management of the patient with rheumatoid arthritis (RA), affecting approximately one third of this patient population. However, pain is not always caused by disease activity (inflammation) but can be associated to central pain mechanisms as seen in fibromyalgia (FM). FM is characterized by widespread pain and tenderness; often accompanied by disturbed sleep, fatigue, cognitive impairment, emotional distress and multiple symptoms from various organ systems. Among patients with RA the prevalence of concomitant FM is reported to be 12-17% compared to 1-3% in the general population. In general the pain, felt by the fibromyalgia patients is considered to be due to lower pain thresholds because of abnormal central pain processing. Pain reported by RA patients with concomitant FM could potentially be explained by this phenomenon. Little is known about RA patients fulfilling criteria for FM. Muscles-studies of FM patients have not found any histopathological explanation of the pain felt, however an old study of muscle changes in RA patients found changes that could explain muscle pain. Small fiber neuropathy (SFN) is a condition associated with autoimmune diseases, and evidence suggests that SFN is likely to contribute to the pain observed in FM.
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Objectives: To determine the diagnostic test accuracy (sensitivity and specificity) of both muscle- and skin-biopsies for fibromyalgia phenotyping and detection by clinical referral (RA with concomitant FM) as the reference standard (i.e. fulfilment of 2016 FM criteria).
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Data collection: Will be done as study subjects are included and stored in REDCAP.
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Eligibility criteria for participants and settings where the data will be collected: RA patients will be assessed in the daily clinic in Esbjerg and Odense and examined for concomitant FM (I.e. satisfying the 2016 criteria for FM). Patients will afterwards be invited to participate in the study. Inclusion will continue until 25 RA patients fulfilling FM criteria and thus based on the expected prevalence at least 25 (- and maximum 50) RA patients not fulfilling FM critieria has undergone the index tests.
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Whether participants form a consecutive, random, or convenience series: Participants form a consecutive series.
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Description of the index test and reference standard: Twenty-five RA patients with concomitant FM and more than 25 (- maximum 50 patients) RA patients not fulfilling FM criteria will undergo the index tests. Muscle and skin biopsies will be performed in each group using standardized techniques. The reference standard will be fulfillment of the 2016 criteria for fibromyalgia.
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Estimates of diagnostic accuracy and their precision: Regarding muscle- and skin biopsies sensitivity, specificity and positive predictive value will be calculated using two times two table. Regarding skin biopsies, median values in the two groups (RA +/- FM) will be compared using a two-sample t-test. conditions: Rheumatoid Arthritis conditions: Fibromyalgia, Secondary conditions: Widespread Chronic Pain conditions: Muscle Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Muscle- and skin biopsies measure: Muscle pathology measure: Skin biopsies measure: Cold pressure test measure: Pain pressure threshold (PPT) measure: Computerized Cuff pressure algometry (CPA) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Esbjerg Hospital status: RECRUITING city: Esbjerg zip: 6700 country: Denmark name: Philip R LageHansen, MD role: CONTACT phone: +4530114582 email: philip.rask.lage-hansen3@rsyd.dk name: Philip LageHansen, MD role: PRINCIPAL_INVESTIGATOR name: Torkell Ellingsen, Professor role: PRINCIPAL_INVESTIGATOR lat: 55.47028 lon: 8.45187 hasResults: False
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<|newrecord|> nctId: NCT06305013 id: SIMU PEA 2024 briefTitle: PEA: The Ability of Nurses To Recognize It (PEA: ANTRI) acronym: PEARECOG overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-01 date: 2024-06-01 date: 2024-03-12 date: 2024-04-19 name: Brno University Hospital class: OTHER name: Department of Simulation Medicine, Faculty of Medicine, Masaryk University briefSummary: The Ability to recognize cardiac arrest is crucial in emergency situations and all health care professionals should be able to do so. The identification of pulseless electrical activity can be difficult even if the theoretical knowledge of this state is well known. This research will be performed at the Simulation centre of Medical Faculty, Masaryk university and it will be focused on nurses who will come to the simulation course. All the participants will get prelearning theoretical materials that will contain chapter about pulseless electrical activity and its recognition. In the beginning of the course they will be asked to fill up the questionnaire with four different pictures of patient´s monitor in cardiac arrest. It will be evaluated whether the pulseless electrical activity will be recognized. conditions: Pulseless Electrical Activity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Pulseless electrical activity recognition measure: Pulseless electrical activity recognition, sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty hospital Brno status: RECRUITING city: Brno state: Jihomoravský Kraj zip: 62500 country: Czechia name: Martina Kosinova, MD., Ph.D. role: CONTACT phone: 532234692 phoneExt: 00420 email: kosinova.martina@fnbrno.cz lat: 49.19522 lon: 16.60796 hasResults: False
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<|newrecord|> nctId: NCT06305000 id: 2015-KAEK-80-23-25 briefTitle: Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis overallStatus: NOT_YET_RECRUITING date: 2024-03-27 date: 2025-03-10 date: 2025-05-10 date: 2024-03-12 date: 2024-03-27 name: Biruni University class: OTHER briefSummary: This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is:
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Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone?
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Our study consists of 4 groups:
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Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (\< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples.
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Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis. conditions: Peri-implant Mucositis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Non-surgical treatment name: Free gingival graft measure: Inflammatory parameter levels in peri-implant crevicular fluid measure: Inflammatory parameter levels in peri-implant crevicular fluid measure: Inflammatory parameter levels in peri-implant crevicular fluid measure: Inflammatory parameter levels in peri-implant crevicular fluid measure: Plaque index (Silness & Löe, 1964) measure: Plaque index (Silness & Löe, 1964) measure: Plaque index (Silness & Löe, 1964) measure: Plaque index (Silness & Löe, 1964) measure: Gingival Index ( Löe & Silness,1963) measure: Gingival Index ( Löe & Silness,1963) measure: Gingival Index ( Löe & Silness,1963) measure: Gingival Index ( Löe & Silness,1963) measure: Bleeding on probing (Ainamo & Bay 1975) measure: Bleeding on probing (Ainamo & Bay 1975) measure: Bleeding on probing (Ainamo & Bay 1975) measure: Bleeding on probing (Ainamo & Bay 1975) measure: Keratinized mucosa width measure: Keratinized mucosa width measure: Keratinized mucosa width measure: Keratinized mucosa width measure: Probing depth measure: Probing depth measure: Probing depth measure: Probing depth sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biruni University city: Istanbul country: Turkey name: Ayse E Selman role: CONTACT phone: +905366393184 email: aselman@biruni.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06304987 id: BFH-niCRT-05 briefTitle: Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-05 date: 2024-03-12 date: 2024-03-19 name: Beijing Friendship Hospital class: OTHER name: Peking Union Medical College Hospital name: Peking University Cancer Hospital & Institute name: Changhai Hospital briefSummary: This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer. conditions: Locally Advanced Rectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor Control: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor name: Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor measure: CR measure: AE rate measure: NAR score measure: OPR measure: ORR measure: immune-related adverse event rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06304974 id: BL-B01D1-305 briefTitle: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-03-19 date: 2026-05 date: 2026-05 date: 2024-03-12 date: 2024-03-28 name: Sichuan Baili Pharmaceutical Co., Ltd. class: INDUSTRY name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. briefSummary: This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy. conditions: Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 488 type: ESTIMATED name: BL-B01D1 name: Irinotecan name: paclitaxel name: docetaxel measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Treatment Emergent Adverse Event (TEAE) measure: Cmax measure: T1/2 measure: Anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing state: Beijing country: China name: Lin Shen role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06304961 id: D9180C00011 briefTitle: A Study to Investigate Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration in Healthy Volunteers overallStatus: RECRUITING date: 2024-04-08 date: 2024-09-05 date: 2024-09-05 date: 2024-03-12 date: 2024-04-23 name: AstraZeneca class: INDUSTRY briefSummary: The study will assess the relative bioavailability between two dosage forms of tozorakimab (test dosage form and reference dosage form) and to assess the pharmacokinetic (PK) profiles of both dosage forms. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Tozorakimab measure: Area under the concentration-time curve from time 0 to infinity (AUCinf) measure: Area under the concentration-curve from time 0 to the last quantifiable concentration (AUClast) measure: Maximum observed drug concentration (Cmax) measure: Time to reach peak or maximum observed concentration following tozorakimab administration (tmax) measure: Terminal elimination half-life (t1/2) measure: Terminal rate constant (λz) measure: Apparent total body clearance (CL/F) measure: Apparent volume of distribution based on the terminal phase (Vz/F) measure: Number of participants with adverse events (AEs) measure: Number of participants with presence of Anti-Drug Anitbodies (ADAs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Research Site status: RECRUITING city: Berlin zip: 14050 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False
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<|newrecord|> nctId: NCT06304948 id: Vitamin D and migraine briefTitle: The Link Between Human Cytomegalovirus Gene Expression and Glutamate Level in Migraine;Relation to Vitamin D Deficiency overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-01 date: 2025-02 date: 2024-03-12 date: 2024-03-26 name: Assiut University class: OTHER briefSummary: 1. To correlate serum 25(OH)-vitamin D level with duration, frequency, and severity of migraine headache attacks
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2. To evaluate the relationship between the serum level of vitamin D and other indices in patients with migraine.
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3. To correlate the serum level of glutamate with gene expression of in migraine conditions: Migraine studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 72 type: ESTIMATED measure: The Link between human cytomegalovirus gene expression and glutamate levels in Migraine :relationship to the Vit D Deficiency sex: ALL minimumAge: 15 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06304935 id: IPRF effect post tonsillectomy briefTitle: Injectable Platelet Rich Fibrin Post Tonsillectomy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-07-01 date: 2024-03-12 date: 2024-04-19 name: Assiut University class: OTHER briefSummary: To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy conditions: IPRF Post Tonsillectomy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as control measure: IPRF effect on healing measure: IPRF effect on post tonsillectomy pain and bleeding sex: ALL minimumAge: 5 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304922 id: BRCA 1/2 in cancer ovary briefTitle: BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-03-12 date: 2024-03-12 name: Assiut University class: OTHER briefSummary: The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer. conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer measure: Objective response rate. measure: Progression free survival measure: Overall survival and toxicity sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304909 id: 2080278 briefTitle: Effect of Intravenous Dexmedetomidine Versus Dexamethasone for Management of Repound Pain After Supraclavicular Brachial Plexus Block overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-03 date: 2025-03 date: 2024-03-12 date: 2024-04-23 name: Assiut University class: OTHER briefSummary: Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block. conditions: Trauma Injury studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 111 type: ESTIMATED name: Dexmedetomidine injection measure: The incidence of rebound pain. sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06304896 id: #18240343 briefTitle: Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy acronym: BASiC-CIC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-12-01 date: 2024-03-12 date: 2024-03-12 name: Arab Contractors Medical Centre class: OTHER briefSummary: BASiC-CIC Trial is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate whether repurposing colchicine or a combination of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins will be effective as a prophylactic treatment for the prevention of chemotherapy-induced cardiomyopathy, reduction of major adverse cardiovascular events, and all-cause mortality. conditions: Chemotherapy Induced Systolic Dysfunction studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: Carvedilol name: Ramipril name: Rosuvastatin name: Colchicine name: Placebo measure: Chemotherapy-induced cardiomyopathy measure: Chemotherapy-induced cardiomyopathy measure: Major Adverse Cardiovascular Events measure: All-Cause Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arab Contractors Medical Centre city: Cairo country: Egypt name: Eslam Abbas, MBChB, MSc role: CONTACT phone: 01023054574 phoneExt: +2 email: islam.omr@med.au.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06304883 id: ALZ-801-AD351 briefTitle: Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects acronym: APOLLOE4-LTE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-01 date: 2024-03-12 date: 2024-04-10 name: Alzheon Inc. class: INDUSTRY briefSummary: This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801. conditions: Early Alzheimer's Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a multi-center, open-label, single group, long-term extension study. primaryPurpose: TREATMENT masking: NONE count: 285 type: ESTIMATED name: Experimental: ALZ-801 measure: Primary cognitive efficacy endpoint 1 measure: Primary cognitive efficacy endpoint 2 measure: Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs) measure: Primary imaging biomarker endpoint 1 measure: Primary imaging biomarker endpoint 2 measure: Secondary functional efficacy endpoint measure: Secondary global assessment efficacy endpoint measure: Secondary cognitive efficacy endpoint 1 measure: Secondary cognitive efficacy endpoint 2 measure: Secondary cognitive efficacy endpoint 3 measure: Secondary imaging biomarker endpoint measure: Secondary fluid biomarker endpoint sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xenoscience, Inc. city: Phoenix state: Arizona zip: 85004 country: United States name: Stephen Flitman role: CONTACT phone: 602-274-9500 email: sflitman@xenoscience.com name: Stephen Flitman role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Banner Sun Health Research Institute city: Sun City state: Arizona zip: 85351 country: United States name: Michele R Gutierrez role: CONTACT phone: 623-832-5706 email: Michele.Gutierrez@bannerhealth.com name: Alireza Atri role: PRINCIPAL_INVESTIGATOR lat: 33.59754 lon: -112.27182 facility: ATP Clinical Research city: Costa Mesa state: California zip: 92626 country: United States name: Bobby Shih role: CONTACT phone: 714-277-4472 email: bshih@atpcr.com name: Gustavo Alva role: PRINCIPAL_INVESTIGATOR lat: 33.64113 lon: -117.91867 facility: Torrance Clinical Research Institute city: Lomita state: California zip: 90717 country: United States name: Valeria Herrera role: CONTACT phone: 310-373-8120 email: mraikhel@msn.com name: Marina Raikhel role: PRINCIPAL_INVESTIGATOR lat: 33.79224 lon: -118.31507 facility: Sutter Health city: Sacramento state: California zip: 95816 country: United States name: Dawn R Lenakakis role: CONTACT phone: 916-887-4734 email: Dawn.Lenakakis@sutterhealth.org name: Shawn Kile role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 facility: Tilda Research, Inc. city: Tustin state: California zip: 92780 country: United States name: Shahrnaz Jamshidi role: CONTACT phone: 949-569-6444 email: shahrnaz.jamshidi@tilda.bio name: Erik Geiger role: PRINCIPAL_INVESTIGATOR lat: 33.74585 lon: -117.82617 facility: JEM Research Institute, Headlands Site city: Atlantis state: Florida zip: 33462 country: United States name: Mark Goldstein role: CONTACT phone: 561-968-2933 email: Mgoldstein@jemri.net name: Mark Goldstein role: PRINCIPAL_INVESTIGATOR lat: 26.5909 lon: -80.10088 facility: Bradenton Research Center city: Bradenton state: Florida zip: 34205 country: United States name: Michelle Scott role: CONTACT phone: 941-708-0005 email: michellescott@bradentonresearch.com name: Eric Folkens role: PRINCIPAL_INVESTIGATOR lat: 27.49893 lon: -82.57482 facility: Alphab Global Research city: Jupiter state: Florida zip: 33458 country: United States name: Teresa Villena role: CONTACT phone: 561-301-8286 email: t.villena@aol.com name: Gerald O'Connor role: PRINCIPAL_INVESTIGATOR lat: 26.93422 lon: -80.09421 facility: K2 Medical Research, LLC city: Maitland state: Florida zip: 32751 country: United States name: Gina Cedano role: CONTACT phone: 321-221-7806 email: Gina.Cedano@k2med.com name: Brandon Lenox role: PRINCIPAL_INVESTIGATOR lat: 28.62778 lon: -81.36312 facility: Mount Sinai Medical Center city: Miami Beach state: Florida zip: 33140 country: United States name: Mileidys Herrera role: CONTACT phone: 350-674-2121 phoneExt: 54881 email: Mileidys.herrera@msmc.com name: Ranjan Duara role: PRINCIPAL_INVESTIGATOR lat: 25.79065 lon: -80.13005 facility: Aqualane Clinical Research city: Naples state: Florida zip: 34105 country: United States name: Kelly Calistri role: CONTACT phone: 239-434-0332 email: Kelly@aqualaneresearch.com name: William Justiz role: PRINCIPAL_INVESTIGATOR lat: 26.14234 lon: -81.79596 facility: Headlands Research Orlando city: Orlando state: Florida zip: 32819 country: United States name: Jennifer Thompson role: CONTACT phone: 407-705-3471 email: jennifer.thompson@headlandsresearch.com name: Theodore Lee role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: Progressive Medical Research city: Port Orange state: Florida zip: 32127 country: United States name: Chantelle Funge role: CONTACT phone: 386-304-7070 phoneExt: 3205 email: chantellef@progressivemedicalresearch.com name: Alexander White role: PRINCIPAL_INVESTIGATOR lat: 29.13832 lon: -80.99561 facility: ALZ Research and Treatment Center (A.R.T.C.) city: Stuart state: Florida zip: 34997 country: United States name: David Watson role: CONTACT phone: 772-675-0000 email: dwatson@researchalz.com name: David Watson role: PRINCIPAL_INVESTIGATOR lat: 27.19755 lon: -80.25283 facility: ALZ Research and Treatment Center (A.R.T.C.) city: Wellington state: Florida zip: 33414 country: United States name: David Watson role: CONTACT phone: 561-209-2400 email: dwatson@researchalz.com name: David Watson role: PRINCIPAL_INVESTIGATOR lat: 26.65868 lon: -80.24144 facility: Premiere Research Institute city: West Palm Beach state: Florida zip: 33407 country: United States name: Paul Winner role: CONTACT phone: 561-845-0500 phoneExt: 102 email: Pwinner777@aol.com name: Paul Winner role: PRINCIPAL_INVESTIGATOR lat: 26.71534 lon: -80.05337 facility: Charter Research city: Winter Park state: Florida zip: 32792 country: United States name: Celynez Gomez role: CONTACT phone: 407-337-1000 phoneExt: 3001 email: celynez.gomez@charterresearch.com name: Edgardo J Rivera role: PRINCIPAL_INVESTIGATOR lat: 28.6 lon: -81.33924 facility: Columbus Memory Center city: Columbus state: Georgia zip: 31909 country: United States name: Jonathan Liss role: CONTACT phone: 706-653-8455 email: jliss@researchcmc.com name: Jonathan Liss role: PRINCIPAL_INVESTIGATOR lat: 32.46098 lon: -84.98771 facility: Fort Wayne Neurological Center city: Fort Wayne state: Indiana zip: 46804 country: United States name: Patti Case role: CONTACT phone: 260-436-3991 phoneExt: 2202 email: pcase@fwnc.com name: James Stevens role: PRINCIPAL_INVESTIGATOR lat: 41.1306 lon: -85.12886 facility: Headlands Research Eastern MA city: Plymouth state: Massachusetts zip: 02360 country: United States name: Brandon Hatch role: CONTACT phone: 508-746-5060 email: brandon.hatch@headlandsresearcheema.com name: Donald Marks role: PRINCIPAL_INVESTIGATOR lat: 41.95844 lon: -70.66726 facility: Advanced Memory Research Center city: Toms River state: New Jersey zip: 08755 country: United States name: Anna Brocco role: CONTACT phone: 732-341-9500 email: ABrocco@amrinj.com name: Sanjiv Sharma role: PRINCIPAL_INVESTIGATOR lat: 39.95373 lon: -74.19792 facility: Neurological Associates of Albany city: Albany state: New York zip: 12208 country: United States name: Richard Holub role: CONTACT phone: 518-426-0575 email: research@naaresearch.com name: Richard Holub role: PRINCIPAL_INVESTIGATOR lat: 42.65258 lon: -73.75623 facility: NYU Alzheimer's Disease Research Center city: New York state: New York zip: 10016 country: United States name: Brittany Marti role: CONTACT phone: 212-263-5708 email: Brittany.Marti@nyulangone.org name: Thomas Wisniewski role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Kline Institute for Psychiatric Research city: Orangeburg state: New York zip: 10962 country: United States name: Nunzio Pomara role: CONTACT phone: 845-398-5579 email: Nunzio.Pomara@nki.rfmh.org name: Nunzio Pomara role: PRINCIPAL_INVESTIGATOR lat: 41.04649 lon: -73.94958 facility: University of Rochester Medical Center city: Rochester state: New York zip: 14620 country: United States name: Nancy A Kowalski role: CONTACT phone: 585-602-5205 email: Nancy_Kowalski@urmc.rochester.edu name: Emily Clark role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: Triad Clinical Trials city: Greensboro state: North Carolina zip: 27410 country: United States name: Scott Whitt role: CONTACT phone: 336-235-0991 email: swhitt@triadclinicaltrials.com name: Richard Montgomery role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 facility: AMC Research city: Matthews state: North Carolina zip: 28105 country: United States name: Shereen Bolouri role: CONTACT phone: 704-364-4000 phoneExt: 235 email: ssbolouri@amcneurology.com name: Mohammad R Bolouri role: PRINCIPAL_INVESTIGATOR lat: 35.11681 lon: -80.72368 facility: Center for Cognitive Health city: Portland state: Oregon zip: 97225 country: United States name: Ericka Eyton role: CONTACT phone: 503-548-0908 email: ericka@centerforcognitivehealth.com name: Michael Mega role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Abington Neurological Associates city: Abington state: Pennsylvania zip: 19001 country: United States name: Kareema Murray role: CONTACT phone: 215-957-9250 email: kareemamurray.ana@gmail.com name: David Weisman role: PRINCIPAL_INVESTIGATOR lat: 40.12067 lon: -75.11795 facility: Rhode Island Mood & Memory Research Institute city: East Providence state: Rhode Island zip: 02914 country: United States name: Lynn Rainville role: CONTACT phone: 401-435-8950 email: lrainville@rimmri.com name: John Stoukides role: PRINCIPAL_INVESTIGATOR lat: 41.81371 lon: -71.37005 facility: UT Health Science Center at Houston city: Houston state: Texas zip: 77054 country: United States name: Alexa Bavero role: CONTACT phone: 713-486-0501 email: Alexa.Bavero@uth.tmc.edu name: Paul Schulz role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: Re:Cognition Health city: Fairfax state: Virginia zip: 22031 country: United States name: Maria Toor role: CONTACT phone: 703-520-9703 email: mtoor@re-cognitionhealth.com name: Raymond S Turner role: PRINCIPAL_INVESTIGATOR lat: 38.84622 lon: -77.30637 facility: Northwest Clinical Research Center city: Bellevue state: Washington zip: 98007 country: United States name: Arifulla Khan role: CONTACT phone: 425-453-0404 email: study.coordinator@nwcrc.net name: Arifulla Khan role: PRINCIPAL_INVESTIGATOR lat: 47.61038 lon: -122.20068 facility: OCT Research ULC (dba Okanagan Clinical Trials) city: Kelowna state: British Columbia zip: V1Y 1Z9 country: Canada name: Robert Goldberg role: CONTACT phone: 250-862-8141 email: Robert@oktrials.ca name: Eugene Okorie role: PRINCIPAL_INVESTIGATOR lat: 49.88307 lon: -119.48568 facility: Centricity Research city: Halifax state: Nova Scotia zip: B3S 1N2 country: Canada name: Gagan Oberoi role: CONTACT phone: 902-431-8783 phoneExt: 7107 email: Gagan.oberoi@centricityresearch.com name: Fred Archibald role: PRINCIPAL_INVESTIGATOR lat: 44.64533 lon: -63.57239 facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic city: Ottawa state: Ontario zip: K1Z 1G3 country: Canada name: Richard Bergeron role: CONTACT phone: 613-702-1000 email: rbergeron@cliniquememoire.ca name: Richard Bergeron role: PRINCIPAL_INVESTIGATOR lat: 45.41117 lon: -75.69812 facility: Kawartha Centre - Redefining Healthy Aging city: Peterborough state: Ontario zip: K9H 2P4 country: Canada name: Jill MacPhee role: CONTACT phone: 705-749-3906 phoneExt: 213 email: jill@kawarthacentre.com name: Katie Krause role: PRINCIPAL_INVESTIGATOR lat: 44.30012 lon: -78.31623 facility: Toronto Memory Program city: Toronto state: Ontario zip: M3B 2S7 country: Canada name: Justine Reaume role: CONTACT phone: 416-386-9761 phoneExt: 364 email: jreaume@memorydisorders.ca name: Sharon Cohen role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Re-Cognition Health Ltd Plymouth city: Plymouth state: Devon zip: PL6 8BT country: United Kingdom name: Victoria Evans role: CONTACT phone: +44 1752875604 email: vevans@re-cognitionhealth.com name: Stephen Pearson role: PRINCIPAL_INVESTIGATOR lat: 50.37153 lon: -4.14305 facility: Re-Cognition Health Ltd London city: London state: Greater London zip: W1G 9JF country: United Kingdom name: Josephine E MacSweeney role: CONTACT phone: +44 2033553536 email: emacsweeney@re-cognitionhealth.com name: Josephine E MacSweeney role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: NeuroClin Glasgow Ltd city: Motherwell state: North Lanarkshire zip: ML1 4UF country: United Kingdom name: Jennifer Lynch role: CONTACT phone: +44 1419480206 email: jennifer.lynch@neuroclin.co.uk name: Jennifer Lynch role: PRINCIPAL_INVESTIGATOR lat: 55.78924 lon: -3.99187 facility: Re-Cognition Health Ltd Guildford city: Guildford state: Surrey zip: GU2 7YD country: United Kingdom name: Nicholas Mannering role: CONTACT phone: +44 1483941982 email: NMannering@re-cognitionhealth.com name: Nicholas Mannering role: PRINCIPAL_INVESTIGATOR lat: 51.23536 lon: -0.57427 facility: Re-Cognition Health Ltd Birmingham city: Birmingham state: West Midlands zip: B16 8LT country: United Kingdom name: Conor Clerkin-Oliver role: CONTACT phone: +44 1216550166 email: cclerkin@re-cognitionhealth.com name: Conor Clerkin-Oliver role: PRINCIPAL_INVESTIGATOR lat: 52.48142 lon: -1.89983 facility: Re-Cognition Health Ltd Bristol city: Bristol zip: BS32 4SY country: United Kingdom name: Daniel Lashley role: CONTACT phone: +44 1174623600 email: dlashley@re-cognitionhealth.com name: Daniel Lashley role: PRINCIPAL_INVESTIGATOR lat: 51.45523 lon: -2.59665 facility: Re-Cognition Health Ltd Winchester city: Winchester zip: SO21 1HU country: United Kingdom name: Anna Podonyi role: CONTACT phone: +44 1962588420 email: apodonyi@re-cognitionhealth.com name: Steven J Allder role: PRINCIPAL_INVESTIGATOR lat: 51.06513 lon: -1.3187 hasResults: False
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<|newrecord|> nctId: NCT06304870 id: SYB-reflux briefTitle: Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:
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• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Lidocaine name: Injection measure: Rosenbek penetration-aspiration scale measure: Gastroesophageal Reflux Disease Questionnaire measure: Pressure pain threshold sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304857 id: 2022/ABM/01/00039 id: 2023-506631-15-00 type: OTHER domain: EUCT briefTitle: CardioPROTECTion With Dapagliflozin in Breast Cancer Patients Treated With AnthrAcycline - PROTECTAA TRIAL acronym: PROTECTAA overallStatus: RECRUITING date: 2024-04-15 date: 2026-12-31 date: 2027-12-31 date: 2024-03-12 date: 2024-04-25 name: 4th Military Clinical Hospital with Polyclinic, Poland class: OTHER briefSummary: The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment. conditions: Breast Cancer conditions: Heart Failure studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 188 type: ESTIMATED name: Dapagliflozin name: Placebo measure: Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months. measure: Secondary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 6 months. measure: Change in left ventricular ejection fraction at 6 and 12 months. measure: Change in left ventricular diastolic function at 6 and 12 months. measure: Change in Troponin I after 6 and 12 months. measure: Change in NTproBNP levels at 6 and 12 months. measure: Quality of life at 6 and 12 months assessed using the five-dimensional EQ-5D questionnaire. measure: Occurrence of death from any cause. measure: Composite endpoint of cardiovascular events. measure: Occurrence of death from any cardiovascular reasons. measure: Occurrence of non-fatal myocardial infarction. measure: Occurrence of non-fatal stroke. measure: Occurrence of hypoglycaemia. measure: Occurrence of ionic disorders. measure: Occurrence of renal failure. measure: Occurrence of hypersensitivity to investigated drug. measure: Occurrence of allergic reactions. measure: Occurrence of infection. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 4th Military Clinical Hospital with Polyclinic status: RECRUITING city: Wrocław state: Dolnośląskie zip: 50-981 country: Poland name: Bartosz Krakowiak, PhD, MD role: CONTACT phone: +48 261 660 234 email: bkrakowiak@4wsk.pl lat: 51.1 lon: 17.03333 facility: Lower Silesian Centre for Oncology, Lung Diseases and Hematology status: RECRUITING city: Wrocław state: Dolnośląskie zip: 53-413 country: Poland name: Rafał Matkowski, PhD, MD role: CONTACT lat: 51.1 lon: 17.03333 facility: Military Medical Institute status: NOT_YET_RECRUITING city: Warsaw state: Mazowieckie zip: 04-141 country: Poland name: Paweł Krzesiński, PhD, MD role: CONTACT lat: 52.22977 lon: 21.01178 hasResults: False
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<|newrecord|> nctId: NCT06304844 id: Soh-Med-24-02-06MD briefTitle: Risk of CKD in Diabetic Patients With MAFLD overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-10-01 date: 2025-02-01 date: 2024-03-12 date: 2024-03-18 name: Sohag University class: OTHER briefSummary: This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions. conditions: Type 2 Diabetes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: transient elastography (Fibroscan) measure: Determine the number of participant with eGFR<60 ml/min/1.73 m2 or albuminuria (urinary albumin-to-creatinine ratio (ACR) ⩾3 mg/mmol) in patients with type 2 DM and MAFLD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304831 id: SwissTI briefTitle: Use of Facility Ratings to Improve Satisfaction With Heath Care for Children overallStatus: RECRUITING date: 2024-03-11 date: 2024-06-14 date: 2024-09-06 date: 2024-03-12 date: 2024-04-11 name: Swiss Tropical & Public Health Institute class: OTHER name: Lao Tropical and Public Health Institute briefSummary: Despite increasing options for public and private health care providers in Laos, choosing a high-quality health provider or a facility is difficult because timely and reliable information about providers is not readily available. People rely on social networks or previous experiences to select providers. However, in Laos, only 28% describe their recent visit to a health care provider as high-quality suggesting that while there are increasing options for care, people may need support to find providers that meet their quality needs. Rapid adoption of mobile phones in Laos, particularly in urban areas, offer opportunities to enhance people's access to timely quality information about health care providers. The study team will use mobile phones to collect and disseminate quality information about providers - known to be valued by Laotians - to improve their access to quality care as well as their overall satisfaction with care. conditions: Quality of Health Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: This study consists of a randomized controlled experiment involving 660 mothers with children less than 2 years old. Participants will be randomly assigned to one of two groups: 1) a control group that will not receive any information about providers and 2) an intervention group that will receive biweekly updates about quality ratings based on reviews collected from mothers of young children in the study areas. The unit of randomization will be the individual participant. A simple random number draw generated by the ODK package installed on the tablets will be used to assign participants to treatment and control with equal probability. primaryPurpose: OTHER masking: NONE count: 660 type: ESTIMATED name: Quality ratings of health care providers for children measure: Proportion of mothers that change their preferred health care providers for children for non-urgent care measure: Proportion of mothers satisfied with health care for their children of their most recent visit measure: Number and type of health care providers used in the past 3 months measure: Proportion of mothers that change their most recently visited health care providers for children measure: Proportion of mothers choosing the preferred facility for non-urgent care because of online or digital information sources measure: Proportion of mothers that change their preferred health care providers for children for urgent care measure: Proportion of mothers confident they can identify the best place for getting care for sick children sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lao Tropical and Public Health Institute status: RECRUITING city: Vientiane state: Vientiane Capital country: Lao People's Democratic Republic name: Dr Somphou Sayasane, PhD role: CONTACT phone: +856 20 55 679 60 email: somphou.sayasone@gmail.com lat: 17.96667 lon: 102.6 hasResults: False
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<|newrecord|> nctId: NCT06304818 id: SCTB14-X101 briefTitle: Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours. overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-12-30 date: 2028-12-30 date: 2024-03-12 date: 2024-03-15 name: Sinocelltech Ltd. class: INDUSTRY briefSummary: This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial. conditions: Advanced Malignant Solid Tumours studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 515 type: ESTIMATED name: SCTB14 measure: Dose-Limiting toxicity(DLT) measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304805 id: TGRX-326-1002 briefTitle: TGRX-326 Phase I/II Pharmacokinetic Study overallStatus: COMPLETED date: 2023-12-13 date: 2024-01-12 date: 2024-01-19 date: 2024-03-12 date: 2024-04-10 name: Shenzhen TargetRx, Inc. class: INDUSTRY name: First Affiliated Hospital Bengbu Medical College briefSummary: A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer treatment conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This is a PK assessment study, hence only bio-sample analysis personnel were masked for the type of treatment received for each sample to avoid bias in analysis. Other study personnel, including participants, investigators and staffs were not masked for treatment types. whoMasked: OUTCOMES_ASSESSOR count: 24 type: ACTUAL name: cycle 1: treatment drug name: cycle 1: reference drug name: cycle 1: fasted name: cycle 1: food name: cycle 2: treatment drug name: cycle 2: reference drug name: cycle 2: fasted name: cycle 2: food name: cycle 3: treatment drug name: cycle 3: reference drug name: cycle 3: fasted name: cycle 3: food measure: Plasma Cmax measure: Plasma AUC(0-t) measure: Plasma AUC(0-inf) measure: Plasma Tmax measure: terminal elimination rate constant (lambda-z) measure: Elimination half-life (T1/2-Z) measure: AUC(%Extrap) measure: Plasma volume of distribution (Vz/F) measure: Plasma clearance (CL/F) measure: Adverse events/serious adverse events sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: First Affiliated Hospital Bengbu Medical College city: Bengbu state: Anhui zip: 233004 country: China lat: 32.94083 lon: 117.36083 hasResults: False
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<|newrecord|> nctId: NCT06304792 id: H-22030591 briefTitle: Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer overallStatus: RECRUITING date: 2024-02-01 date: 2028-08-01 date: 2028-08-01 date: 2024-03-12 date: 2024-03-12 name: Rigshospitalet, Denmark class: OTHER briefSummary: The aim of this randomized controlled trial is to examine whether single blastocyst transfer in the first cycle after oocyte retrieval (immediate) is non-inferior to single blastocyst transfer in a subsequent cycle (postponed) in stimulated or programmed cycle frozen embryo transfer (FET). The primary outcome is live birth rate. conditions: Infertility conditions: IVF studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 464 type: ESTIMATED name: Immediate FET in a stimulated or programmed cycle measure: Live birth rate measure: Live birth rate per blastocyst transfer measure: Ongoing pregnancy rate measure: Miscarriage rate measure: Cancelled cycle rate and reason for cancelled cycles measure: Endocrinology of the luteal phase measure: Number of ovarian follicular structures >10 mm measure: Time-to-pregnancy measure: Time-to-live-birth measure: Pregnancy related complications measure: Neonatal outcomes (weight in kilograms) measure: Neonatal outcomes (length in cm) measure: Neonatal outcomes (apgar score at 1, 5 and 10 minutes postpartum) measure: Quality of life based on the Copenhagen Multicenter Psychosocial Infertility (COMPI) stress scale questionnaires sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Fertility Departmen, Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Anja B. Pinborg, Prof., DMSC role: CONTACT phone: 0045 35 45 64 30 email: anja.bisgaard.pinborg@regionh.dk name: Clara Colombo, MD role: CONTACT email: clara.colombo@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06304779 id: V3.0.2023.11.29 briefTitle: The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-31 date: 2025-09-30 date: 2026-06-30 date: 2024-03-12 date: 2024-03-12 name: Shanghai Zhongshan Hospital class: OTHER name: Tianjin Medical University General Hospital name: The Affiliated Hospital of Xuzhou Medical University name: West China Hospital briefSummary: The main purpose of this study is to evaluate the impact of continuous 24-hour intravenous infusion of lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for intra-abdominal infection (IAI).The secondary objectives of this study are to assess the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period, length of hospital stay, and outcomes within 30 days postoperatively. conditions: Postoperative Pulmonary Complications conditions: Intra-abdominal Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Lidocaine group: Patients receive a loading dose of 1.5 mg/kg 2% lidocaine at anesthesia induction, followed by continuous intravenous infusion at 1.5 mg/kg/h until 24 hours postoperatively Control group: Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 428 type: ESTIMATED name: Lidocaine name: Placebo measure: The impact of continuous 24-hour intravenous lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for IAI. measure: the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period measure: To observe the impact of continuous perioperative lidocaine infusion on the levels of neutrophil extracellular traps (NETs) postoperatively sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital,Fudan university city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06304766 id: H-23015954 briefTitle: Open Versus Laparoscopic Ablation of Liver Malignancies acronym: OPTIMAL overallStatus: RECRUITING date: 2023-12-15 date: 2025-12 date: 2025-12 date: 2024-03-12 date: 2024-03-13 name: Rigshospitalet, Denmark class: OTHER briefSummary: The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery. conditions: Hepatocellular Carcinoma conditions: Cholangiocarcinoma conditions: Liver Metastases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment. primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Laparoscopic ablation name: Open ablation measure: Complications measured by the comprehensive complication index. measure: Tumor ablation completeness. measure: Quality of Recovery score (QoR) measure: Quality of Life score (QoL) measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Hans-Christian Pommergaard, MD DMSc PhD role: CONTACT email: hans-christian.pommergaard@regionh.dk lat: 55.67594 lon: 12.56553 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-01 uploadDate: 2023-10-06T05:58 filename: Prot_SAP_000.pdf size: 192543 hasResults: False
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<|newrecord|> nctId: NCT06304753 id: BOT119435 briefTitle: ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction acronym: BOT-IMPROVE-HF overallStatus: RECRUITING date: 2023-10-27 date: 2025-07-01 date: 2025-12-01 date: 2024-03-12 date: 2024-03-12 name: I.M. Sechenov First Moscow State Medical University class: OTHER briefSummary: BOT-IMPROVE-HF is a two-center, parallel group study designed to evaluate the efficacy of up-titration of heart failure treatment using digital remote monitoring after hospitalization due to heart failure decompensation. Patient will be randomized before discharge using a simple computer generated sequence to either remote monitoring or usual care group. Patients' condition in the "remote monitoring" arm will be assessed by mini-program based on a personal messenger and laboratory rests results will be asked by phone call. If these measures show safety and tolerability of the doses of the drugs, they will be increased to target or maximally tolerated doses. The follow-up period will be 6 months - 24 weeks. Patients of the usual care group will be followed by their general practitioner and/or cardiologist. All patients will be contacted after 6 months to assess outcomes. conditions: Chronic Heart Failure With Low Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Telebot measure: All-cause mortality measure: Heart failure decompensation measure: Change in NT-proBNP measure: Change in Quality of life measure: Changes in medical adherence sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University status: RECRUITING city: Moscow zip: 119435 country: Russian Federation name: Maria Kozhevnikova role: CONTACT phone: +7 (499) 248-46-43 email: kozhevnikova_m_v@staff.sechenov.ru name: Aleksei Emelianov role: CONTACT phone: +7 (999) 830-57-85 email: emelyanov_a_v@staff.sechenov.ru lat: 55.75222 lon: 37.61556 facility: State Budgetary Institution of Healthcare of Moscow "A.K. Yeramishantsev City Clinical Hospital of the Department of Healthcare of Moscow". status: RECRUITING city: Moscow zip: 129327 country: Russian Federation name: Maria Kozhevnikova role: CONTACT phone: +74992484643 email: kozhevnikova_m_v@staff.sechenov.ru name: Aleksei Emelianov role: CONTACT phone: +79998305785 email: emelyanov_a_v@staff.sechenov.ru lat: 55.75222 lon: 37.61556 hasResults: False
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<|newrecord|> nctId: NCT06304740 id: IMG-007-102 briefTitle: Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants overallStatus: RECRUITING date: 2024-03-06 date: 2024-09 date: 2024-09 date: 2024-03-12 date: 2024-03-22 name: Inmagene LLC class: INDUSTRY briefSummary: This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: IMG-007 name: Placebo measure: Adverse Event Evaluation measure: Pharmacokinetic Parameters, Cmax measure: Pharmacokinetic Parameters, Tmax measure: Pharmacokinetic Parameters, AUC0-t sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Linear Clinical Research status: RECRUITING city: Perth country: Australia lat: -31.95224 lon: 115.8614 hasResults: False
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<|newrecord|> nctId: NCT06304727 id: 23-5064 id: Easydore type: OTHER domain: 69HCL23_0736 briefTitle: Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment acronym: 1TreSBCD overallStatus: RECRUITING date: 2022-11-21 date: 2024-06-01 date: 2024-06-30 date: 2024-03-12 date: 2024-03-12 name: Hospices Civils de Lyon class: OTHER briefSummary: The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization.
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A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections.
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A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management. conditions: Bronchiolitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: clinical data review measure: Feasibility of the short enteral feeding protocol sex: ALL minimumAge: 8 Weeks maximumAge: 1 Year stdAges: CHILD facility: Hopital Femme Mere Enfant status: RECRUITING city: Bron country: France name: Dominique PLOIN, MD role: CONTACT phone: 0427855642 phoneExt: +33 email: dominique.ploin@chu-lyon.fr name: Côme HORVAT, MD role: CONTACT phone: 0427855634 phoneExt: +33 email: come.horvat@chu-lyon.fr lat: 45.73333 lon: 4.91667 hasResults: False
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<|newrecord|> nctId: NCT06304714 id: 20_RIPH3-16 id: 2022-A00162-41 type: OTHER domain: ANSM (National Agency for the Safety of Medicines and other health products ) briefTitle: Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana acronym: WBOTHROPS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-08 date: 2025-10-08 date: 2024-03-12 date: 2024-03-12 name: University Hospital Center of Martinique class: OTHER name: University Hospital, Lille briefSummary: In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases "hemorrhagins" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage.
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Envenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated.
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The investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes.
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The investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena.
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This study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients. conditions: Snake Envenomation conditions: Thrombi conditions: Coagulopathy conditions: Hemorrhage studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Patients suffering from envenomation by Bothrops measure: Plasma Willebrand factor (VW:Act) activity prior to administration of the anti-venom (Bothrofav® or Antivipmyn-tri®). measure: Plasma VW factor activity (VW:Act/VW:Ag ratio) measure: Hemostasis abnormalities measure: Plasma levels of high-molecular-weight VW factor multimers assessed by electrophoresis technique measure: Plasma concentrations of soluble forms of the endothelial adhesion molecules sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06304701 id: PI-2023-08 briefTitle: Handwritten Text Production in Adults With Autism acronym: PEMTAA overallStatus: RECRUITING date: 2023-11-29 date: 2025-05 date: 2025-05 date: 2024-03-12 date: 2024-03-12 name: Centre Hospitalier de Niort class: OTHER name: University of Poitiers briefSummary: The main objective is to assess the psycholinguistic and graphomotor characteristics of written production in patients with ASD.
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The secondary objectives are:
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* Identifying links between specific deficits of ASD and difficulties in written production.
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