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Participants will be operated and have to attend follow-up visits with MRI after 6 months up to 5 years after surgery. conditions: Meniscus Lesion studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: no masking, patient decides which group count: 40 type: ESTIMATED name: Spongioflex® name: non-operated measure: To evaluate efficacy of the procedure measure: Improvement of International Knee Documentation Committee (IKDC) score (between 0 and 100, the higher the better) measure: Improvement of Knee Injury and Osteoarthritis Outcome Score (KOOS) score (between 0 and 100, the higher the better) measure: Improvement of Visual Analogue Scale (VAS) Pain Score (between 0 and 10, the lower the better) measure: Safety of the patient (adverse events (AE) and serious adverse events (SAE)) measure: Efficacy of the procedure, progression to osteoarthrosis measure: Menuiscus size measure: extrusion of meniscus measure: Size of meniscal extrusion measure: Patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Privatpraxis für Knie und Schulterchirurgie status: RECRUITING city: Dortmund zip: 44137 country: Germany name: Sven Behrendt, MD role: CONTACT phone: +49231 8626064 email: praxis@dr-sven-behrendt.de name: Sven Behrendt, MD role: PRINCIPAL_INVESTIGATOR lat: 51.51494 lon: 7.466 hasResults: False
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<|newrecord|> nctId: NCT06376409 id: NW-HGN-02 briefTitle: Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-04-01 date: 2025-06-01 date: 2024-04-19 date: 2024-04-23 name: Nutraceutical Wellness Inc. class: INDUSTRY briefSummary: A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair. conditions: Hair Thinning studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment 6-month, single-center, prospective interventional study primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Nutrafol Women's Hair Growth Supplement name: Nutrafol Women's Balance Hair Growth Supplement name: Nutrafol Women's Vegan Hair Growth Supplement name: Nutrafol Women's Postpartum Hair Growth Supplement measure: The percent change in hair growth rate at Day 180 relative to baseline (Day 0) measure: The percent change in hair growth rate at Day 90 relative to baseline (Day 0) measure: The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days measure: The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 180 days measure: The change in terminal to vellus ratio measure: The change in terminal to vellus ratio measure: The change in anagen to telogen ratio measure: The change in anagen to telogen ratio measure: The change in average number of hairs per follicular unit measure: The change in average number of hairs per follicular unit measure: The change in total hair width per cm2 measure: The change in total hair width per cm2 measure: The change in mean inter-follicular distance measure: The change in mean inter-follicular distance measure: Subjective assessments of change measured with Consumer Perception Questionnaire at 90 days measure: Subjective assessments of change measured with Consumer Perception Questionnaire at 180 days sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Integrative Skin Science and Research city: Sacramento state: California zip: 95815 country: United States name: Nasima Afzal role: CONTACT phone: 916-750-2463 lat: 38.58157 lon: -121.4944 hasResults: False
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<|newrecord|> nctId: NCT06376396 id: 101103306 briefTitle: Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis acronym: NeuroSolve overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-12 date: 2024-04-19 date: 2024-04-23 name: R-Evolution Worldwide S.r.l. Impresa Sociale class: OTHER name: Muhimbili University of Health and Allied Sciences name: National Institute for Medical Research, Tanzania name: Sokoine University of Agriculture name: University of Zambia name: University Ghent briefSummary: The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis. conditions: Neurocysticercosis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: albendazole and praziquantel name: Albendazole measure: Cyst resolution or reduction in both study arms measure: Seizures frequency measure: Quality of Life questionnaire measure: Headache measure: Serological test results correlation with neuroimaging results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06376383 id: TETT-RHG id: 110500 type: OTHER domain: The Central Denmark Region Committees on Health Research Ethics briefTitle: Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2026-12 date: 2027-09 date: 2024-04-19 date: 2024-04-19 name: University of Aarhus class: OTHER briefSummary: The primary purpose of this randomized controlled trial s to investigate whether surgical reduction of palatine tonsils (tonsillotomy) is a superior treatment compared to complete surgical removal of palatine tonsils (tonsillectomy) in adults patients with obstructive sleep apnea and concomitant enlarged tonsils in regards of perioperative and postoperative morbidity. conditions: Obstructive Sleep Apnea conditions: Tonsillar Hypertrophy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 464 type: ESTIMATED name: Tonsillectomy name: Tonsillotomy measure: Postoperative hemorrhage measure: Postoperative pain measure: Recovery time - Sick leave measure: Morbidity measure: AHI measure: DISE - VOTE sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06376370 id: 16.04.24/2 briefTitle: The Effect of a Computer-Assisted Rehabilitation Program on Epilepsy Patient overallStatus: ENROLLING_BY_INVITATION date: 2024-04-26 date: 2024-06-10 date: 2024-07-28 date: 2024-04-19 date: 2024-04-19 name: Selcuk University class: OTHER briefSummary: The aim of this study is to examine the effects of the RehaCom Computer-Assisted Rehabilitation Program Applied to Epilepsy Patients on Self-Management, Cognitive Function and Quality of Life. conditions: Epilepsy conditions: Computer-assisted Cognitive Rehabilitation conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Application of computer-assisted cognitive rehabilitation program measure: Mini Mental State Test measure: Epilepsy Quality of Life Scale measure: MOXO Test measure: Epilepsy Self-Management Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: ülkü Saygili Düzova city: Selçuklu state: Konya country: Turkey lat: 37.8842 lon: 32.49222 hasResults: False
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<|newrecord|> nctId: NCT06376357 id: 16.04.24/1 briefTitle: The Effect of Foot Massage With Roles on Cancer Patients overallStatus: ENROLLING_BY_INVITATION date: 2024-04-27 date: 2024-06-15 date: 2024-07-30 date: 2024-04-19 date: 2024-04-19 name: Selcuk University class: OTHER briefSummary: It was aimed to examine the roles in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane-based chemotherapy and the effect of foot massage on neuropathy and quality of life. conditions: Breast Neoplasms conditions: Over Cancer conditions: Foot Massage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: Foot Massage with roller measure: EORTC QLQ C-30 Quality of Life Scale measure: CIPN20 Neuropathy Scale measure: One Leg Standing Test measure: Brief Pain Inventory BPI measure: Pain Threshold Assessment Test measure: Two Point Discrimination sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ülkü Saygili Düzova city: Selçuklu state: Konya country: Turkey lat: 37.8842 lon: 32.49222 hasResults: False
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<|newrecord|> nctId: NCT06376344 id: 16.04.24 briefTitle: The Effect of Tennis Ball on Balance and Quality of Life in Cancer Patients With Neuropathy. overallStatus: ENROLLING_BY_INVITATION date: 2024-04-28 date: 2024-06-10 date: 2024-07-10 date: 2024-04-19 date: 2024-04-19 name: Selcuk University class: OTHER briefSummary: This research; It was aimed to evaluate the effect of myofascial release using a tennis ball on balance and quality of life in cancer patients who developed peripheral neuropathy. conditions: Cancer conditions: Neuropathy conditions: Therapy-Associated Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: myofascial release with tennis ball measure: EORTC QLQ C-30- CIPN20 Scale measure: One Leg Standing Test measure: Lateral Reach Test measure: Pain Assessment measure: Pressure Pain Threshold Assessment measure: Two Point Discrimination sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ülkü Saygili Düzova city: Selçuklu state: Konya country: Turkey lat: 37.8842 lon: 32.49222 hasResults: False
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<|newrecord|> nctId: NCT06376331 id: ADHD20240403 briefTitle: Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2027-06-01 date: 2027-07-01 date: 2024-04-19 date: 2024-04-24 name: The Second Hospital of Nanjing Medical University class: OTHER name: SIR RUN RUN hospital of Nanjing Medical University briefSummary: Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention and hyperactivity-impulsivity. ADHD is often accompanied by oppositional defiant disorder and sleep disturbance, and can increase the risk of other psychiatric disorders, functional impairment in academic and occupational performance. Recently, gut microbiota has been implicated in the ADHD via gut-brain axis. In this study, investigators aimed to evaluate the efficacy of WMT for core ADHD symptoms and its comorbidities using specialized questionnaires for ADHD and investigate the underlying mechanism. conditions: Attention-deficit/Hyperactivity Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: washed microbiota transplantation measure: change of Swanson, Nolan and Pelham-IV (SNAP-IV). measure: change of Chinese version of the Conners abbreviated symptom questionnaire (C-ASQ). measure: change of the Sleep Disturbance Scale for Children (SDSC). measure: change of the Gastrointestinal Symptom Rating Scale (GSRS) . measure: the difference of the gut microbe composition between children with ADHD and healthy children by sequencing faecal metagenome. measure: the difference of the serum neurotransmitters between children with ADHD and healthy children measure: intestinal barrier sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu country: China name: Faming Zhang, PhD role: CONTACT phone: 086-025-58509883 email: fzhang@njmu.edu.cn lat: 32.06167 lon: 118.77778 facility: SIR RUN RUN hospital of Nanjing Medical University city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06376318 id: 19-138 briefTitle: Shock and Acute Conditions OutcOmes Platform acronym: ShockCO-OP overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-07-01 date: 2026-01-01 date: 2024-04-19 date: 2024-04-19 name: Saint-Louis Hospital, Paris, France class: OTHER name: University of Helsinki name: University of Ottawa name: University of Leipzig name: University of Nancy name: McGill University name: Mayo Clinic name: University of Paris 5 - Rene Descartes name: University of Toronto briefSummary: In-hospital mortality of patients admitted in the intensive care unit (ICU) for circulatory shock remains high (between 20 and 40%).
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Currently, there are no markers that allow us to classify patients with circulatory shock at higher risk of early and late bad outcomes, or who may better respond to a specific intervention.
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To understand the contribution of biological heterogeneity to circulatory shock independently from its etiology, the ShockCO-OP Research Program aims to use clustering approaches to re-analyze existing clinical and molecular data from several large European and North American prospective cohorts and clinical trials.
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This will enable an improvement in risk prediction and a better patient selection in future clinical trials to assess a personalized therapy (i.e., prospective enrollment based on a biological/molecular signature). conditions: Circulatory Shock conditions: Sepsis conditions: Cardiogenic Shock conditions: Major Trauma conditions: Surgical Shock studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1000 type: ESTIMATED name: Inotrope name: Mechanical circulatory support name: anti-bodies measure: Mortality rate measure: Mortality rate measure: Renal replacement therapy use rate measure: Mechanical circulatory support use rate measure: Vasopressors and inotropes-free days sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Michael's Hospital city: Toronto state: Ontario zip: M5B 1W8 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06376305 id: 176786 briefTitle: EndoBarrier in Obstructive Sleep Apnoea Study acronym: End-OSA overallStatus: COMPLETED date: 2016-03 date: 2019-12 date: 2019-12 date: 2024-04-19 date: 2024-04-19 name: Dr Bob Ryder class: OTHER name: Association of British Clinical Diabetologists briefSummary: Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (windpipe) collapse repeatedly during sleep, blocking the flow of air into the lungs. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is associated with a reduction in the amount of oxygen in the blood (oxygen saturation). People with OSA are at risk of heart disease, high blood pressure, stroke, depression, and premature death. OSA is usually treated using a continuous positive airway pressure (CPAP) machine. This involves the patient wearing a face mask during sleep which is connected to the machine which supplies a constant steam of air to help keep the airways open. This improves the symptoms and hopefully the long-term outlook, but it is an uncomfortable solution. OSA is associated with obesity and weight loss can improve or even cure it. Treatment with EndoBarrier (placement of a thin flexible tube that is placed inside your intestine creating a physical barrier between the intestinal wall and the food so less can be absorbed) can be associated with significant weight loss and can improve blood sugar control in patients with type 2 diabetes related to their weight (diabesity). This study aims to find out if EndoBarrier treatment can improve OSA in patients with diabesity to the extent that some patients no longer require their CPAP machine treatment. conditions: Type 2 Diabetes conditions: Obstructive Sleep Apnoea conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ACTUAL name: EndoBarrier measure: Requirement for continuous positive airway pressure (CPAP) treatment will be assessed by sleep studies at screening and then every 3 months, up to 24 months measure: Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months measure: Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months measure: Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months measure: Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months measure: Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months measure: Weight and Body mass index (BMI) is measured by checking weight in kilograms as well as height (in metres) ( weight and height will be combined to report BMI in kg/m^2) at screening, baseline, and then every 3 months, up to 24 months measure: Composite scores of NAFLD severity derived from the blood measurements of Alanine Aminotransferase in U/L, Aspartate Aminotransferase in U/L, platelets in x10^9/L and serum albumin in g/L as well as age in years and BMI measure: Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, and then at 3, 12 and 24 months measure: Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months measure: Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months measure: Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City Hospital city: Birmingham zip: B18 7QH country: United Kingdom lat: 52.48142 lon: -1.89983 hasResults: False
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<|newrecord|> nctId: NCT06376292 id: Y⒛24-0106 briefTitle: A Prospective Study of Whole-Brain RT Combined With Thiotepa Sheath Injection Combined With Systemic Therapy for the Primary Disease in the Treatment of Meningeal Metastases in Solid Tumors overallStatus: RECRUITING date: 2024-02-01 date: 2026-02-01 date: 2026-02-01 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: The goal of this prospective, single-arm exploratory clinical study is to explore the safty and efficacy of whole-brain radiotherapy combined with Thiotepa sheath injection combined With Systemic Therapy for the Primary Disease in the Treatment of Meningeal Metastases in Solid Tumors
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How works well was the combined therapy？ How safe was combined therapy？ Participants will receive whole brain radiotherapy combined with intrathecal injection of Thiotepa twice a week for a total of 4 weeks. Evaluate the efficacy and safety every 2 cycles.
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Researchers will evaluate whether this combination treatment is safe and whether it is more effective than previous studies. conditions: Solid Tumor Leptomeningeal Metastasis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants will receive a comprehensive treatment plan consisting mainly of whole brain 30Gy/10F radiotherapy combined with intrathecal injection of Thiotepa twice a week for a total of 4 weeks. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Intrathecal Injection of Thiotepa+Radiation+Systemic Treatment of Primary Diseases measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: OS measure: 3-month PFS measure: 6-month PFS measure: 1-year PFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Zhejiang University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Ting Zhang, Prof. role: CONTACT phone: +8615157125533 email: zezht@zju.edu.cn lat: 30.29365 lon: 120.16142 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-12 uploadDate: 2024-03-13T09:04 filename: Prot_000.pdf size: 320618 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-12 uploadDate: 2024-03-13T09:05 filename: ICF_001.pdf size: 156721 hasResults: False
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<|newrecord|> nctId: NCT06376279 id: 2008/351-31 briefTitle: Genetic Diagnosis in Inborn Errors of Metabolism overallStatus: ENROLLING_BY_INVITATION date: 2008-04-29 date: 2030-12-31 date: 2030-12-31 date: 2024-04-19 date: 2024-04-19 name: Region Stockholm class: OTHER_GOV name: Karolinska Institutet briefSummary: Inborn Errors of metabolism comprise a large number of rare conditions with a collective incidence of around 1/2000 newborns. Many disorders are treatable provided that a correct diagnosis can be established in time, and for many diseases novel therapies are being developed. Without treatment, many of the conditions result in early death or severe irreversible handicaps.
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The Centre for Inherited Metabolic Diseases, CMMS at Karolinska university hospital, is an integrated expert center where clinical specialists work closely together with experts in laboratory medicine, combining clinical genetics, clinical chemistry, pediatrics, neurology, and endocrinology. The center serves the whole Swedish population with diagnostics and expert advice on IEM and has a broad arsenal of biochemical investigations designed to detect defects in intermediary metabolism. conditions: Metabolic Disease conditions: Mitochondrial Diseases conditions: Epilepsy in Children conditions: Epilepsy conditions: LHON conditions: Motor Neuron Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: IEM-EP measure: Genetic variant identification using NGS for diagnosis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06376266 id: 202305083RSC briefTitle: Assessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals overallStatus: RECRUITING date: 2023-10-01 date: 2023-12-29 date: 2024-09-30 date: 2024-04-19 date: 2024-04-19 name: National Taiwan University Hospital class: OTHER briefSummary: Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.
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Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals. conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: nutritional supplements measure: the scale of sarcopenia measure: the scale of sarcopenia measure: the scale of sarcopenia sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Geriatrics and Gerontology, National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100 country: Taiwan name: Ding-cheng Chan, DR role: CONTACT phone: +886-2-23123456 phoneExt: 67095 email: dingchengchan@ntu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06376253 id: CGIZ943A12101 id: 2023-507674-41-00 type: OTHER domain: CTIS briefTitle: A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers overallStatus: NOT_YET_RECRUITING date: 2024-09-06 date: 2030-08-30 date: 2030-08-30 date: 2024-04-19 date: 2024-04-19 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-EVS459 and the safety and imaging properties of \[68Ga\]Ga-EVS459 in patients aged ≥ 18 years with advanced high-grade serous ovarian cancer (OC) or locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma (non-sq. NSCLC). conditions: Ovarian Cancer conditions: Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: [68Ga]Ga-EVS459 name: [177Lu]Lu-EVS459 measure: Number of participants with dose limiting toxicities of [177Lu]Lu-EVS459 measure: Incidence and severity of adverse events and serious adverse events of [177Lu]Lu- EVS459 measure: Dose modifications for [177Lu]Lu- EVS459 measure: Dose intensity for [177Lu]Lu- EVS459 measure: Overall response rate (ORR) measure: Duration of Response (DOR) measure: Disease control rate (DCR) measure: Progression free survival (PFS) measure: Area Under the Curve (AUC) of [177Lu]Lu-EVS459 measure: Total body clearance of [177Lu[Lu-EVS459 measure: Observed maximum plasma concentration (Cmax) of [177Lu]Lu-EVS459 measure: Volume of distribution during the terminal phase following intravenous elimination (Vz) of [177Lu]Lu-EVS459 measure: Terminal elimination half-life (T1/2) of [177Lu]Lu-EVS459 measure: Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA) measure: Renal clearance of [177Lu]Lu- EVS459 measure: Absorbed dose of [177Lu]Lu- EVS459 measure: Time-activity curves (TACs) related to [177Lu]Lu-EVS459 uptake in organs and tumor lesions measure: Incidence and severity of adverse events and serious adverse events of [68Ga]Ga-EVS459 measure: Visual and quantitative assessment of [68Ga]Ga-EVS459 uptake in normal tissues and tumor lesions over time sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06376240 id: NL85203.068.23 briefTitle: The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes acronym: PYRAMID overallStatus: RECRUITING date: 2024-03-21 date: 2025-12-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: Maastricht University Medical Center class: OTHER name: Diabetes Fonds briefSummary: Patients with type 2 diabetes have an increased risk of developing vascular complications. Microvascular dysfunction might be caused by the increased production of methylglyoxal under hyperglycaemic conditions. Methylglyoxal is a by-product of glycolysis and forms advanced glycation endproducts (AGEs) on proteins and DNA, thereby disrupting their function. Preventing methylglyoxal accumulation and AGEs formation may offer a therapeutic option for treating microvascular complications in diabetics. Pyridoxamine is a vitamin B6 vitamer that scavenges methylglyoxal and thereby inhibits the formation of AGEs. In this study, the researchers investigate whether pyridoxamine supplementation in type 2 diabetes improves microvascular function in the eye, kidney and skin, and reduces markers of endothelial dysfunction and glycation. conditions: Type 2 Diabetes conditions: Microvascular Function conditions: Retinopathy, Diabetic conditions: Nephropathy, Diabetic conditions: Neuropathy, Diabetic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Pyridoxamine 300mg per day name: Placebo 300mg placebo per day measure: Central retinal artery equivalent of the eye measure: eGFR measure: Microvascular function in skin measure: Markers of endothelial function and glycation in blood plasma. measure: Advanced glycation end products in skin measure: Advanced glycation end products in blood plasma and urine measure: Adipokines and inflammatory markers in blood plasma measure: Methylglyoxal, glyoxal and 3-deoxyglucose in blood plasma. measure: Markers of dicarbonyl stress and oxidative stress in urine measure: Glucose metabolism measure: Liver fat measure: Systolic and diastolic blood pressure measure: Microvascular function eye measure: Urinary albumin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Academic Hospital Maastricht status: RECRUITING city: Maastricht zip: 6229 HX country: Netherlands name: CTCM Clinical Trial Center Maastricht role: CONTACT phone: + 31 (0) 43 387 20 40 email: secretariaat.ctcm@mumc.nl lat: 50.84833 lon: 5.68889 hasResults: False
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<|newrecord|> nctId: NCT06376227 id: jamesdukeryan briefTitle: Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation overallStatus: COMPLETED date: 2020-04-01 date: 2023-05-31 date: 2023-12-28 date: 2024-04-19 date: 2024-04-22 name: Northern Jiangsu People's Hospital class: OTHER briefSummary: Brief Summary
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Background The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.
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Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function. conditions: Rectal Cancer conditions: Left Colic Artery Stenosis (Diagnosis) conditions: Robotic Assisted Laparoscopic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1164 type: ACTUAL name: with or without Left Colic Artery Preservation measure: The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation. measure: The genitourinary function of the patients after the radical resection with or without left colic artery preservation. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou city: Yangzhou state: Jiangsu zip: 225001 country: China lat: 32.39722 lon: 119.43583 hasResults: False
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<|newrecord|> nctId: NCT06376214 id: 2024-02 briefTitle: Daratumumab for Patients With Light Chain Amyloidosis overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-19 date: 2024-04-19 name: Nanjing University School of Medicine class: OTHER briefSummary: This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis. conditions: Light Chain (AL) Amyloidosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Dratumumab / Hyaluronidase Injection [Darzalex Faspro] name: Pomalidomide 4 MG name: autologous stem cell transplantation (ASCT) measure: Hematological complete response rate measure: Organ response rate measure: Time to Next Treatment measure: Progression-free survival measure: Overall survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Clinical Research Center for Kidney Diseases, Jinling Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210016 country: China name: Xianghua Huang, MD role: CONTACT phone: 02580862351 email: hxhszb@163.com lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06376201 id: NFEC-2024-018 briefTitle: A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-09 date: 2024-04-19 date: 2024-04-19 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed. conditions: Invasive Fungal Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 125 type: ESTIMATED name: Amphotericin B cholesterol-sulfate complex for injection measure: Treatment is effective measure: Incidence of the single index in the five criteria of treatment success measure: Completion rate of ABCD treatment for at least 14 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06376188 id: 1582/2021 SimCom briefTitle: Improving Breaking Bad News in Pediatrics by Simulated Communication acronym: SimCom overallStatus: COMPLETED date: 2021-09-01 date: 2022-08-31 date: 2022-09-30 date: 2024-04-19 date: 2024-04-19 name: Medical University of Vienna class: OTHER briefSummary: Breaking bad news, especially a death notice, is an essential part of the medical profes-sional communication. Being inadequately trained in those skills this may result in un-pleasant psychosocial consequences for everyone involved.
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This prospective, single-center, randomized controlled trial evaluated the delivery of a death notice to simulation parents out of the perspective of these parents (professional actors), the participants (students) and by video analysis. The simulation patient has prior unexpectedly died during a simulated resuscitation. The intervention group broke the bad news after receiving a short communication conditions: Communication conditions: End of Life conditions: Pediatric ALL studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 46 type: ACTUAL name: communication training measure: score by simulation parents measure: score by participants measure: score of video analysis sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Vienna city: Vienna zip: 1090 country: Austria lat: 48.20849 lon: 16.37208 hasResults: False
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<|newrecord|> nctId: NCT06376175 id: LL-016 briefTitle: Task Atlas: Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-31 date: 2024-08-31 date: 2024-04-19 date: 2024-04-19 name: Lumos Labs, Inc. class: INDUSTRY briefSummary: Healthy volunteers ages 25-40 from the general US population who meet the eligibility criteria and are enrolled will (a) play Lumosity games at least 20 times each in under 60 days and (b) then complete one session of task-based functional magnetic resonance imaging (fMRI) while playing Lumosity games. conditions: Healthy Adults studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: BOLD response during gameplay measure: Responder rates measure: Structural MRI volumetrics: Volume measure: Structural MRI volumetrics: Cortical thickness measure: Structural MRI volumetrics: Brain-Predicted Age Difference measure: Behavior response: Game score measure: BAMS-7 (Brief Attention and Mood Scale of 7 Items) measure: VGPQ (Video Game Playing Questionnaire) sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: UC Davis Imaging Research Center (IRC) city: Sacramento state: California zip: 95817 country: United States name: Kevin Madore, PhD role: CONTACT lat: 38.58157 lon: -121.4944 hasResults: False
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<|newrecord|> nctId: NCT06376162 id: ITCC-101/APAL2020K id: 2023-505262-28-00 type: CTIS briefTitle: Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-08 date: 2027-08 date: 2024-04-19 date: 2024-04-19 name: LLS PedAL Initiative, LLC class: OTHER name: Kura Oncology briefSummary: The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK). conditions: Relapsed/Refractory KMT2A-r Acute Leukemia conditions: Relapsed/Refractory NUP98-r Acute Leukemia conditions: Relapsed/Refractory NPM1-m Acute Leukemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Ziftomenib name: Cytarabine name: Fludarabine measure: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) measure: Area Under the Plasma Concentration-time Curve (AUC) of Ziftomenib measure: Number of Participants Who Experience an Adverse Event (AE) measure: Number of AEs by Severity measure: Maximum Observed Plasma Concentration (Cmax) of Ziftomenib measure: Minimum Observed Plasma Concentration (Cmin) of Ziftomenib measure: Time to Cmax (Tmax) measure: Truncated AUC (AUC0-t) of Ziftomenib in Combination with FLA Chemotherapy measure: Extrapolated AUC (AUC0-∞) of Ziftomenib in Combination with FLA Chemotherapy measure: Oral Plasma Clearance (CL/F) of Ziftomenib in Combination with FLA Chemotherapy measure: Volume of Distribution (Vz/F) of Ziftomenib in Combination with FLA Chemotherapy measure: Terminal Elimination Half-life (t1/2) of Ziftomenib in Combination with FLA Chemotherapy measure: HSCT Rate measure: Morphological Overall Response Rate (ORR) measure: Flow-based ORR measure: Flow-based Measurable Residual Disease (MRD) Negativity Rate measure: Duration of Response (DOR) measure: Event-free Survival (EFS) measure: Overall Survival (OS) measure: Cumulative Incidence of Relapse (CIR) sex: ALL minimumAge: 0 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06376149 id: 124973 briefTitle: M3-JIA: Making Mindfulness Matter for Children With JIA acronym: M3-JIA overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-12 date: 2026-02 date: 2024-04-19 date: 2024-04-29 name: Lawson Health Research Institute class: OTHER name: Brain Canada briefSummary: The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile arthritis and their parents will attend an 8 week online program called Making Mindfulness Matter (M3). This is a facilitator-led program that integrates knowledge and skills related to mindfulness, social-emotional learning, neuroscience, and positive psychology to promote coping and resiliency for children and families in context of the challenges of pediatric chronic disease. The child program is designed for children 4-12 years of age, with each lesson including a variety of concrete ways to teach children skills based on their age/developmental level. conditions: Juvenile Idiopathic Arthritis conditions: Children conditions: Mental Health conditions: Mental Well-being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The primary objective is to conduct a pilot RCT to evaluate the effectiveness of a live-online mindfulness-based family intervention program, Making Mindfulness Matter (M3©) for children with JIA and their caregiver(s).
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Measures will be obtained via questionnaires at 3 time points: baseline, 9 weeks and 2 months post-intervention.
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Additionally, at the start of each session, parents will complete a one-page semi-structured questionnaire evaluating treatment fidelity and at home utilization of M3© skills. At the end of each session, parent participants will complete a one-page structured questionnaire providing feedback on the session, and facilitators will complete the M3© Adherence Checklist, evaluating whether planned activities were completed, and any modifications made. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participants will be blinded to their group assignment: all participants will be told that they will receive the intervention. Program facilitators will be blinded to participant group assignment order, since sessions for both study arms would run on a rolling basis. The statistician will also be blinded to the group assignment and order. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 74 type: ESTIMATED name: M3 Intervention group name: M3 Waitlist Group measure: conduct a pilot RCT to evaluate the effectiveness of a live-online mindfulness-based family intervention program, Making Mindfulness Matter (M3©) for children with JIA and their caregiver(s). measure: Effects of M3 on health related quality of life of children with JIA measure: Effects of M3 on health quality of life for parents measure: Does M3 have a positive effect on children's severity of JIA measure: Does M3 have a positive effect on children's executive function measure: Does M3 have a positive effect on parents' stress measure: Does M3 have a positive effect on parents' depression and anxiety measure: Does M3 have a positive effect on Child's' depression and anxiety measure: Does M3 have a positive effect on children's resiliency measure: Does M3 have a positive effect on parent resiliency sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD facility: McMaster Children's Hospital, city: Hamilton state: Ontario zip: L8N 3Z5 country: Canada name: Karen Beatie role: CONTACT phone: (905) 521-2100 email: beattik@mcmaster.ca name: Michelle Dr. Batthish role: CONTACT phone: (905) 521-2100 email: batthim@mcmaster.ca name: Michelle Batthish role: SUB_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: London Health Sciences Centre- Children's Hosptial city: London state: Ontario zip: N6J 4L8 country: Canada name: Sarah Wells role: CONTACT phone: 519-685-8500 phoneExt: 56816 email: sarah.wells@lhsc.on.ca name: Roberta Berard role: CONTACT phone: 519-685-8500 phoneExt: 52479 email: roberta.berard@lhsc.on.ca name: Roberta Berard, MD role: PRINCIPAL_INVESTIGATOR lat: 42.98339 lon: -81.23304 facility: Sickids city: Toronto state: Ontario zip: M5G 1E8 country: Canada name: Andrea Knight role: CONTACT phone: (416) 813-1500 email: andrea.knight@sickkids.ca name: Andrea Dr. Knight role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06376136 id: BAT-8010+1006-001-CR briefTitle: An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib/IIa Clinical Study overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-05-24 date: 2026-12-09 date: 2024-04-19 date: 2024-04-19 name: Bio-Thera Solutions class: INDUSTRY briefSummary: This study is a multicenter, open, exploratory Phase Ib/IIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumors(HER-2 expression, including IHC3+, IHC2+/FISH+, and IHC2+/FISH- patients)Tolerance and PK characteristics, to explore the maximum tolerated dose (MTD) and provide recommendations for subsequent clinical studies Recommended dose (RP2D) and rational administration regimen, and preliminary evaluation of antitumor efficacy. There are two main studies In the first stage, the "3+3" dose escalation rule is proposed to explore the safety and tolerance of the drug Sex; The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injection，The safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 108 type: ESTIMATED name: BAT8010 for Injection name: BAT1006 for Injection measure: Dose-limiting toxicity (DLT) measure: vital signs measure: Physical examination measure: Adverse events measure: Clinical laboratory tests measure: Number of participants with abnormal clinical auxiliary tests measure: Duration of Response(DOR) measure: Disease Control Rate (DCR) measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Antibody measure: Antibody sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06376123 id: Nkangarli001 briefTitle: Nomogram for Prediction of Alveolo-arterial Gradient During One-lung Ventilation overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-01 date: 2024-09-15 date: 2024-04-19 date: 2024-04-19 name: Bezmialem Vakif University class: OTHER briefSummary: The cause of hypoxia during one-lung ventilation is a common anaesthetic problem seen during thoracic surgery and is associated with increased fraction of shunted blood. This shunt occurs because the lung not participating in respiration stops saturating the blood with oxygen. The importance of our study is to collect some of the patient's parameters on a nomogram in the preoperative period, to predict the shunt fraction that will occur during one-lung ventilation and to make preparations and interventions accordingly. conditions: One-lung Ventilation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Alveolo-arterial gradient measure: Alveolo-arterial gradient measure: Alveolo-arterial gradient change measure: Alveolo-arterial gradient change sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem Vakif University Dragos Hospital city: Istanbul state: Maltepe zip: 34844 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06376110 id: AviClear-001 briefTitle: Single-Blind Study Assessing the Use of a Topical Antioxidant With A Series of Laser Procedures to Reduce Sebum Production overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-04-19 date: 2024-04-19 name: Austin Institute for Clinical Research class: NETWORK name: SkinCeuticals briefSummary: This is a split-face, single-blind study assessing the use of an antioxidant serum with a series of acne laser treatments to reduce sebum production in healthy male and female subjects between the ages of 18 and 65 years, inclusive, with Fitzpatrick skin types I-VI. conditions: Acne studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 10 type: ESTIMATED name: Topical Antioxidant Serum name: AviClear Laser measure: Change in Product Tolerability measure: Change in Product Efficacy sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06376097 id: D5162R00036 briefTitle: Lung Cancer Screening Program Using Low-dose Tomography and Metabolomic Evaluation in a Public Service. overallStatus: RECRUITING date: 2023-04-19 date: 2025-01-30 date: 2025-01-30 date: 2024-04-19 date: 2024-04-19 name: AstraZeneca class: INDUSTRY briefSummary: Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service. conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Absolute number and frequency of false-negative lung nodules . measure: Assess adherence to smoking cessation treatment in active smokers who enter screening. measure: Assessment of morbidity and mortality in patients undergoing invasive procedures, whether diagnostic or therapeutic. measure: Cost comparasion of treating patients in metastatic setting vs. treating early-stage lung cancer patients, including all costs from the screening program. sex: ALL minimumAge: 45 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB) status: RECRUITING city: Botucatu state: São Paulo zip: 18618-686 country: Brazil name: Erica Hasimoto role: CONTACT phone: (14) 99792-0222 email: ericanh80@hotmail.com lat: -22.88583 lon: -48.445 hasResults: False
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<|newrecord|> nctId: NCT06376084 id: D5161R00055 briefTitle: Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC acronym: FOREFRONT overallStatus: NOT_YET_RECRUITING date: 2024-07-24 date: 2028-02-28 date: 2028-02-28 date: 2024-04-19 date: 2024-04-19 name: AstraZeneca class: INDUSTRY briefSummary: To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS. conditions: Carcinoma, Non-Small-Cell Lung conditions: Lung Neoplasms conditions: Respiratory Tract Neoplasms conditions: Thoracic Neoplasms conditions: Neoplasms by Site conditions: Neoplasms conditions: Lung Diseases conditions: Respiratory Tract Diseases conditions: Carcinoma, Bronchogenic conditions: Bronchial Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 700 type: ESTIMATED measure: Real-World Progression Free Survival (rwPFS) measure: Chemotherapy regimen measure: Duration of chemotherapy (induction and maintenance cycles) measure: Response rate measure: Duration of response measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai state: Shanghai zip: 200030 country: China name: Rong LI role: CONTACT phone: +8621-22200000-5451 email: lrw@hotmail.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06376071 id: fungal rhinosiusitis briefTitle: Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis . overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-06-30 date: 2024-04-19 date: 2024-04-19 name: Assiut University class: OTHER briefSummary: This study aims to assess Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding::
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1. anatomical variations and correlate radiological finding with intraoperative finding.
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2. other associated factors like demographic ,environmental, immunological and climatic risk factors . conditions: Allergic Fungal Rhinosinusitis studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 76 type: ESTIMATED name: functional endoscopic sinus surgery measure: Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06376058 id: 434/06-06-2022 briefTitle: Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section acronym: annie-mariana overallStatus: RECRUITING date: 2024-01-10 date: 2026-01-10 date: 2026-01-10 date: 2024-04-19 date: 2024-04-19 name: Aretaieion University Hospital class: OTHER briefSummary: This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections conditions: Cesarean Section conditions: Local Anesthetic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Chloroprocaine 1% Injectable Solution name: Ropivacaine 0.75% Injectable Solution measure: Time from spinal anesthesia to T10 block (min) measure: Time from spinal anesthesia to T4 block (min) measure: Time of spinal anesthesia to Bromage =3 measure: level of sensory block every 3 min measure: level of sensory block every 15 min measure: highest level of sensory block measure: time from spinal anesthesia to highest level of sensory block measure: duration of sensory block measure: pain at surgical incision measure: pain at neonatal delivery measure: pain at peritoneal manipulation measure: pain at Post Anesthesia Care Unit (PACU) admission measure: pain at Post Anesthesia Care Unit (PACU) discharge measure: need for rescue analgesia intraoperatively measure: Bromage scale every 3 min after spinal anesthesia measure: Bromage scale every 15 min measure: duration of motor block measure: duration of staying in PACU measure: Neonatal Apgar score at 1 minute measure: Neonatal Apgar score at 5 minutes measure: neonatal blood gases measure: incidence of neonatal acidosis measure: incidence of hypotension measure: incidence of bradycardia measure: need for vasoconstrictor measure: need for atropine measure: incidence of nausea/vomiting measure: incidence of dizziness measure: incidence of drowsiness measure: incidence of discomfort measure: incidence of shivering measure: need for rescue analgesia in PACU measure: time from spinal anesthesia to rescue analgesia in PACU measure: incidence of neurological symptoms during hospital stay measure: incidence of neurological symptoms 2 months after the operation measure: incidence of low back pain measure: time from spinal anesthesia to mobilization measure: mother's satisfaction from anesthesia measure: gynecologist's satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 48 Years stdAges: ADULT facility: Aretaieion University Hospital status: RECRUITING city: Athens zip: 11528 country: Greece name: Kassiani Theodoraki, PhD, DESA role: CONTACT phone: 6974634162 email: ktheodoraki@hotmail.com name: Marianna Mavromati, MD role: CONTACT email: marimavr14@gmail.com lat: 37.97945 lon: 23.71622 hasResults: False
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<|newrecord|> nctId: NCT06376045 id: 20220093 briefTitle: A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2026-08-10 date: 2026-10-02 date: 2024-04-19 date: 2024-04-19 name: Amgen class: INDUSTRY briefSummary: The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations. conditions: Asthma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 428 type: ESTIMATED name: Rocatinlimab name: Placebo measure: Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period measure: Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) measure: Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period measure: Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48 measure: Change From Baseline in Pre-BD FEV1 measure: Change From Baseline in Asthma Symptom Diary (ASD) Score measure: Number of Participant Achieving ACQ-6 Response at Week 48 measure: Change From Baseline in ACQ-6 measure: Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score measure: Number of Participants Achieving AQLQ (S) Response at Week 48 measure: Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period measure: Time to First Asthma Exacerbation Event measure: Time to First CompEx Event measure: Number of Participants with a CompEx Event During the Double Blinded Treatment Period measure: Annualized Rate of CompEx Events measure: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels measure: Serum Rocatinlimab Concentrations measure: Trough Concentration (Ctrough) of Rocatinlimab measure: Number of Participants with Treatment-emergent Adverse Events measure: Number of Participants with Serious Adverse Events measure: Number of Participants with Anti-rocatinlimab Antibody Formation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06376032 id: Akili-068 briefTitle: EndeavorOTC® Research Study in College Students overallStatus: RECRUITING date: 2024-01-10 date: 2025-12-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-23 name: Akili Interactive Labs, Inc. class: INDUSTRY name: Landmark College name: Villa Maria College briefSummary: The objective of this study is to evaluate the impact of a digital therapeutic (EndeavorOTC®, also known as AKL-T01A) on clinical symptoms of executive and cognitive functioning in a real-world sample of university students. This study aims to answer whether EndeavorOTC represents a useful intervention for targeting broad cognitive and emotional health among university students. conditions: Attention conditions: Cognition conditions: University Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Eligible students will be randomized\* to two cohorts: the first will receive immediate access to AKL-T01, and the second will complete weekly online surveys and receive access to AKL-T01 after the first group has completed the recommended 6 weeks of use. Regardless of group assignment, all participants will receive full 12-weeks of access to AKL-T01 during the course of the study.
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\*Depending on enrollment numbers for a given semester (e.g., if \<100 students are enrolled and the study is underpowered to conduct between-group comparisons), all participants may be assigned to receive treatment immediately (i.e., single-arm design) and primary study hypotheses may be evaluated according to within-person changes in outcomes. primaryPurpose: OTHER masking: NONE count: 500 type: ESTIMATED name: EndeavorOTC® measure: Computerized Adaptive Test, Mental Health (CAT-MH®) measure: PROMIS Cognitive Function v2.0 - Short Form measure: PROMIS Satisfaction with Participation in Discretionary Social Activities (v1.0) measure: General Academic Self-Efficacy scale (GASE) measure: Mental Health Quality of Life Scale (MHQoL) measure: Adult ADHD Self-Report Scale (ASRS) measure: Patient Health Questionnaire-4 (PHQ-4) measure: System Usability Scale (SUS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Villa Maria College status: RECRUITING city: Cheektowaga state: New York zip: 14225 country: United States name: Laura Pietak role: CONTACT phone: 716-961-2869 email: lpietak@villa.edu lat: 42.90339 lon: -78.75475 facility: Landmark College status: RECRUITING city: Putney state: Vermont zip: 05346 country: United States name: Rick Bryck, PhD role: CONTACT phone: 802-387-6306 email: rickbryck@landmark.edu lat: 42.9748 lon: -72.52176 hasResults: False
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<|newrecord|> nctId: NCT06376019 id: FDASU-RecID11352 briefTitle: Occlusion and Disocclusion Time in Immediately Loaded Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-08-15 date: 2024-09-15 date: 2024-04-19 date: 2024-04-19 name: Ain Shams University class: OTHER briefSummary: complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture. conditions: Edentulous Jaw studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment of the participants in ratio 1:1:1 will take place. For allocation concealment, opaque sealed envelopes will be used. primaryPurpose: TREATMENT masking: NONE maskingDescription: the statistician will be the only one to be blinded count: 27 type: ESTIMATED name: solitary Implant loading with ball attachment name: splinted Implant loading with intra oral welding name: complete denture measure: Assessment of occlusion/disocclusion time sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry Ain Shams University city: Cairo zip: 11361 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06376006 id: 1798538 briefTitle: Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees acronym: EMR-STAT overallStatus: ACTIVE_NOT_RECRUITING date: 2022-05-11 date: 2024-04-01 date: 2024-12-01 date: 2024-04-19 date: 2024-04-24 name: AdventHealth class: OTHER name: Duke University name: University of South Florida name: Stony Brook University name: Atrium Medical Center name: Hofstra University name: Long Island Jewish Medical Center name: Vanderbilt University name: Yale University name: Columbia University name: Geisinger Clinic name: Unity Health Toronto name: University of Virginia name: Baylor University name: University of Kentucky name: Cedars-Sinai Medical Center name: University of Chicago name: University of California, Irvine name: University of Alabama at Birmingham name: Beth Israel Deaconess Medical Center briefSummary: Quality improvement project with the aim to use a standardized assessment tool (EMR-STAT) to establish learning curves and competence thresholds for key cognitive and technical colorectal EMR core skills among advanced endoscopy trainees (AETs). conditions: Competence conditions: Assessment, Self studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 42 type: ESTIMATED name: EMR STAT - Survey measure: Primary Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AdventHealth Orlando city: Orlando state: Florida zip: 32804 country: United States lat: 28.53834 lon: -81.37924 hasResults: False
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<|newrecord|> nctId: NCT06375993 id: ADI-202300103 briefTitle: A Phase 1 Study of ADI-001 in Lupus Nephritis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2027-12 date: 2024-04-19 date: 2024-04-19 name: Adicet Bio, Inc class: INDUSTRY briefSummary: ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion safety/efficacy study in patients with lupus nephritis. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up conditions: Lupus Nephritis conditions: Autoimmune Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: 3+3 Dose Escalation Design primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: ADI-001 name: Fludarabine name: Cyclophosphamide measure: The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort measure: Proportion of treatment emergent and treatment related adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06375980 id: ANKARA_OR_MP briefTitle: Intraoperative Mechanical Power and Ventilation-Associated Lung Injury: Assessing Complications overallStatus: COMPLETED date: 2022-04-01 date: 2022-12-31 date: 2022-12-31 date: 2024-04-19 date: 2024-04-19 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: This study investigates the relationship between intraoperative mechanical power and postoperative pulmonary complications in patients undergoing major abdominal surgery. We record mechanical ventilation parameters and surgical characteristics, assessing the incidence of pulmonary complications within 24 hours postoperatively conditions: Lung Injury conditions: Pulmonary Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 207 type: ACTUAL name: Intraoperative Mechanical Ventilation Strategies measure: Relationship between mechanical power and postoperative pulmonary complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Oncology Training and Research Hospital city: Ankara zip: 06200 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06375967 id: CARPEGIEM briefTitle: EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) acronym: CARPEGIEM overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2027-06 date: 2024-04-19 date: 2024-04-19 name: Hospital Universitari de Bellvitge class: OTHER name: Hospital Clínico Universitario de Valencia name: Hospital General Universitario de Alicante name: Hospital Mutua de Terrassa name: Hospital Universitario Ramon y Cajal name: Hospital General Universitario de Castellón name: Complejo Hospitalario de Navarra name: University Hospital Virgen de las Nieves name: Hospital de Sant Pau name: University of Salamanca name: Complejo Hospitalario Universitario de Santiago name: Complejo Hospitalario Universitario de Vigo briefSummary: The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients. conditions: Malignant Biliary Obstruction conditions: Biliary Tract Neoplasms conditions: Pancreatic Cancer Non-resectable studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 128 type: ESTIMATED name: Endoscopic biliary drainage name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) measure: SAFETY (ADVERSE EVENTS) measure: Recurrent biliary obstruction measure: CLINICAL SUCCESS measure: TECHNICAL SUCCESS measure: BILIARY REINTERVENTIONS (BRI) measure: HOSPITAL STAY measure: MORTALITY measure: COST ANALYSIS sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari de Bellvitge city: L'Hospitalet De Llobregat state: Barcelona, Catalonia zip: 08907 country: Spain name: Joan B Gornals, PhD role: CONTACT phone: +34 93 260 76 82 phoneExt: 2624 email: jgornals@bellvitgehospital.cat name: Julia Escuer Turu, MD role: CONTACT phone: +34 618 27 28 24 email: jescuer@bellvitgehospital.cat name: Maria Puigcerver Mas, MD role: SUB_INVESTIGATOR name: Sandra Maisterra, MD role: SUB_INVESTIGATOR name: Albert Garcia-Sumalla, MD role: SUB_INVESTIGATOR name: Julio G Velasquez-Rodriguez, MD role: SUB_INVESTIGATOR name: Daniel Luna-Rodriguez, MD role: SUB_INVESTIGATOR name: Carme Loras, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Charly Guarner Argente, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Juan J Vila, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Jose R Aparicio, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Jose Lariño, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Rafa Pedraza, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Antonio Rodriguez D'Jesus, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Alberto Alvarez, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Vicente Sanchiz, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 hasResults: False
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<|newrecord|> nctId: NCT06375954 id: CARPEDIEM-2 briefTitle: EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-01 date: 2027-05-01 date: 2024-04-19 date: 2024-04-19 name: Hospital Universitari de Bellvitge class: OTHER name: Hospital Mutua de Terrassa name: Hospital Clínico Universitario de Valencia name: Hospital General Universitario de Alicante name: Hospital Universitario Ramon y Cajal name: Hospital General Universitario de Castellón name: Hospital Álvaro Cunqueiro name: Complejo Hospitalario Universitario de Santiago name: University Hospital Virgen de las Nieves name: Complejo Hospitalario de Navarra name: Hospital de Sant Pau name: University of Salamanca briefSummary: The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction. conditions: Malignant Biliary Obstruction conditions: Pancreatic Cancer conditions: Biliary Tract Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Endoscopic biliary drainage name: Self-expandable metallic stent (SEMS) name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) measure: Delay in days between endoscopic biliary drainage and chemotherapy treatment start measure: Technical success measure: Clinical success measure: AE - biliary drainage measure: AE - surgery measure: Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari de Bellvitge city: L'Hospitalet de Llobregat state: Barcelona zip: 08907 country: Spain name: Joan B Gornals, MD, PhD role: CONTACT phone: + 34 93 260 7682 phoneExt: 2624 email: jgornals@bellvitgehospital.cat name: Maria Puigcerver-Mas, MD role: CONTACT phone: +34 687332007 email: mariapuigcervermas@gmail.com name: Julia Escuer, MD role: SUB_INVESTIGATOR name: Sandra Maisterra, MD role: SUB_INVESTIGATOR name: Julio G Velasquez-Rodriguez, MD role: SUB_INVESTIGATOR name: Albert Garcia-Sumalla, MD role: SUB_INVESTIGATOR name: Daniel Luna-Rodriguez, MD role: SUB_INVESTIGATOR name: Berta Laquente, MD, PhD role: SUB_INVESTIGATOR name: Juli Busquets, MD, PhD role: SUB_INVESTIGATOR name: Carme Loras, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Juan J Vila, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Jose Lariño, MD, PhD role: PRINCIPAL_INVESTIGATOR name: VIcente Sanchiz, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Jose R Aparicio, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Eduardo Redondo, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Charly Guarner-Argente, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Antonio Rodriguez D'Jesus, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Alberto Alvarez, MD, pHD role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 hasResults: False
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<|newrecord|> nctId: NCT06375941 id: ProStars briefTitle: Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars acronym: ProStars overallStatus: RECRUITING date: 2024-03-29 date: 2029-04-01 date: 2034-04-01 date: 2024-04-19 date: 2024-04-19 name: Italian Sarcoma Group class: NETWORK briefSummary: This study will be a multi-institutional, prospective, observational study of patients with localized primary AS of any site within ISG and RTR centers. Patients will be treated according to clinical practice of the center and according to ISG clinical recommendations on localized AS. conditions: Angiosarcoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Observational measure: Demographic characteristics measure: General characteristics measure: Cancer data measure: Origin of Tumor measure: Tumor characteristics measure: Tumor size measure: Tumor aspects measure: Pathological characteristics measure: Tumor phenotype measure: Molecular characteristics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Nazionale Tumori - Milano status: RECRUITING city: Milano zip: 20133 country: Italy name: Palassini Elena role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06375928 id: CARPEDIEM-1 briefTitle: EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-02-01 date: 2026-05-01 date: 2024-04-19 date: 2024-04-19 name: Hospital Universitari de Bellvitge class: OTHER name: Hospital Mutua de Terrassa name: Hospital Clínico Universitario de Valencia name: Hospital General Universitario de Alicante name: Hospital Universitario Ramon y Cajal name: Hospital General Universitario de Castellón name: Hospital Álvaro Cunqueiro name: Complejo Hospitalario Universitario de Santiago name: University Hospital Virgen de las Nieves name: Complejo Hospitalario de Navarra name: Hospital de Sant Pau name: University of Salamanca briefSummary: The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction. conditions: Malignant Biliary Obstruction conditions: Pancreatic Cancer Resectable conditions: Biliary Tract Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Endoscopic biliary drainage name: Self-expandable metallic stent (SEMS) name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) measure: Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP) measure: Technical success measure: Clinical success measure: AE - biliary drainage measure: AE - surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari de Bellvitge city: L'Hospitalet de Llobregat state: Barcelona, Catalonia zip: 08907 country: Spain name: Joan B Gornals, MD, PhD role: CONTACT phone: +34 93 260 76 82 phoneExt: 2624 email: jgornals@bellvitgehospital.cat name: Maria Puigcerver-Mas, MD role: CONTACT phone: +34 687332007 email: mariapuigcervermas@gmail.com name: Julia Escuer-Turu, MD role: SUB_INVESTIGATOR name: Daniel Luna Rodriguez, MD role: SUB_INVESTIGATOR name: Albert Sumalla, MD role: SUB_INVESTIGATOR name: Berta Laquente, MD, PhD role: SUB_INVESTIGATOR name: Juli Busquets, MD, PhD role: SUB_INVESTIGATOR name: Julio Velasquez Rodriguez, MD role: SUB_INVESTIGATOR name: Sandra Maisterra, MD role: SUB_INVESTIGATOR name: Carme Loras, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Charly Guarner Argente, MD, PHD role: PRINCIPAL_INVESTIGATOR name: Jose Lariño, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Rafael Pedraza, MD role: PRINCIPAL_INVESTIGATOR name: Jose Ramon Aparicio, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Vicente Sanchiz, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Eduardo Redondo, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Juan J Vila, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 hasResults: False
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<|newrecord|> nctId: NCT06375915 id: PM-CARE id: PNRR-MAD-2022-12375905 type: OTHER_GRANT domain: Italian Ministry of Health briefTitle: Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy acronym: PM-CARE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-01 date: 2024-04-19 date: 2024-04-19 name: Francesco De Cobelli class: OTHER name: Cardarelli Hospital name: A.O. Ospedale Papa Giovanni XXIII name: AOU Pisana, Pisa, Italy briefSummary: Underlying disease mechanisms are fundamental for correct treatment selection and patient management in highly invasive and debilitating non-transmissible diseases. Even though overall disease burden of cancer may have decreased due to a higher degree of awareness, the availability of high-quality healthcare and early diagnosis may become challenging in certain neoplasms. Cholangiocarcinoma is usually diagnosed at advanced stages due to non-specific presentation and is frequently refractory to chemotherapy, causing a massive impact on patients and their families. Surgery is currently the only curative treatment but is available to only approximately 30% of patients. The combination of interventional- and immune-oncology to standard of care creates the perfect substrate for synergistic mechanisms to fight tumor growth; in situ cell death following transarterial embolization(TARE) elicits immune mediated response, inflammatory response and biomarkers of oxidative stress and increases antigen presenting T-cells which an anti-anti progam death ligand (PD-L)1 can bind to; standard of care can then add on with its known effects.The rationale of a combined- locoregional and systemic - treatment lies in the synergistic effects of each of the treatments. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: radioembolization with Y-90 name: Durvalumab name: Cisplatin name: Gemcitabine measure: Overall response rate (ORR) measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 measure: Median progression free survival measure: Overall response rate measure: Overall response rate measure: Overall response rate measure: Overall response rate measure: Tumor circulating markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor circulating markers measure: Tumor tissue based evaluation measure: Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Quantitative imaging based biomarkers measure: Quantitative biomarkers measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Radiology, IRCCS Ospedale San Raffaele city: Milano zip: 20132 country: Italy name: Francesco De Cobelli, MD role: CONTACT phone: +39022643 phoneExt: 2529 email: decobelli.francesco@hsr.it name: Stephanie Steidler, PhD role: CONTACT phone: +39022643 phoneExt: 6111 email: steidler.stephanie@hsr.it name: Francesco De Cobelli, MD role: PRINCIPAL_INVESTIGATOR name: Francesca Ratti, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06375902 id: 2022289RNA briefTitle: The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them acronym: FRAME overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-04-19 date: 2024-04-19 name: IRCCS San Raffaele class: OTHER briefSummary: Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique conditions: Schizophrenia; Psychosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: PragmaCom measure: Tracking down the difficulties in metaphor comprehension via a behavioural task measure: Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording measure: Evaluation of psychopathology measure: Evaluation of cognition measure: Evaluation of Theory of Mind measure: Evaluation of functioning measure: Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06375889 id: 69HCL24_0250 id: 2024-A00796-41 type: OTHER domain: ID-RCB briefTitle: Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage acronym: APICRASH overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2025-06-13 date: 2025-06-13 date: 2024-04-19 date: 2024-04-19 name: Hospices Civils de Lyon class: OTHER briefSummary: Aneurysmal subarachnoid haemorrhage is a complex pathology, the pathophysiology of which is still imperfectly understood. Its morbidity and mortality remain significant. In addition to the damage sustained by the brain in the immediate aftermath of aneurysmal rupture, which is inaccessible to life-saving treatment, a significant proportion of lesions occur at a distance from the initial event. Delayed cerebral ischaemia is one of the most morbid complications. It combines an inflammatory pattern with vascular dysfunction and neuronal excitotoxicity, leading to avoidable secondary neuronal loss.
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Vascular dysfunction is mediated by a loss of homeostasis between endothelial cells and figurative blood cells, including platelets. However, the interrelationship between these elements and the precise chronology of the dysfunction remain imperfectly described to date.
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It therefore seems appropriate to propose temporal monitoring of platelet activation kinetics over time, combined with concomitant collection of markers of endothelial damage, in order to clarify the vascular chronobiology of this pathology. conditions: Aneuvrysmal Subarachnoid Hemorrhage conditions: Delayed Cerebral Ischemia conditions: Endotheliopathy conditions: Platelets Kinetic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: blood test measure: The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anaesthesiology and Intensive Care medicine department, Pierre Wertheimer hospital city: Bron state: Auvergne-Rhône-Alpes zip: 69005 country: France name: Nicolas Chardon, MD;Msc role: CONTACT phone: 683396245 phoneExt: 33 email: nicolas.chardon@chu-lyon.fr name: Nicolas Chardon, MD;msc role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Neurovascular intensive care unit department, Pierre Wertheimer hospital city: Bron state: Auvergnes-Rhones-Alpes zip: 69005 country: France name: Nicolas Chardon, MD;Msc role: CONTACT phone: 683396245 phoneExt: 33 email: nicolas.chardon@chu-lyon.fr name: Nicolas Chardon, MD;Msc role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 hasResults: False
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<|newrecord|> nctId: NCT06375876 id: 2000034173 id: 15JOVW-22-GG-04755-STOP type: OTHER_GRANT domain: Office on Violence Against Women (OVW) briefTitle: Single Session Intervention to Promote Hope overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-19 date: 2024-04-26 name: Yale University class: OTHER name: Office on Violence Against Women (OVW) briefSummary: The purpose of this study is to develop a brief, self-guided single-session intervention (SSI) that targets the development of, or increase in, hope, and pilot test it for the primary outcomes of feasibility, acceptability/likeability, safety, and changes in hope, and the secondary outcomes of self-worth, empowerment, and emotional wellbeing among women experiencing intimate partner violence (IPV). The study will be conducted in 2 stages: intervention development (Intervention Development Stage), and pilot testing the intervention (Pilot Stage). The focus of this registration is the Pilot Stage. conditions: Domestic Violence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 65 type: ESTIMATED name: Single-session intervention (SSI) measure: Feasibility assessed by percent enrolled measure: Feasibility assessed by time to complete measure: Feasibility assessed by post-intervention survey/process supplement measure: Acceptability/likability assessed using the Program Feeback Scale measure: Safety assessed using end of study survey measure: Change in Hope assessed using Herth Hope Index measure: Change in Hope assessed using Trait Hope Scale measure: Change in Hope assessed using Beck Hopelessness Scale (single item) measure: Change in Self-worth measure: Change in Empowerment assessed using The Personal Progress Scale-Revised (PPS-R) measure: Change in Emotional wellbeing measured by the Patient Health Questionnaire-2 (PHQ-2) measure: Change in Emotional wellbeing measured by the State Joy Scale sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Consultation Center at Yale city: New Haven state: Connecticut zip: 06511 country: United States name: Ashley Clayton role: CONTACT phone: 203-623-9830 email: ashley.clayton@yale.edu lat: 41.30815 lon: -72.92816 hasResults: False
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<|newrecord|> nctId: NCT06375863 id: 44-2023 briefTitle: QT Changes in Geriatric Patients: a Comparison of Spinal and General Anesthesia overallStatus: COMPLETED date: 2023-03-29 date: 2023-05-29 date: 2023-05-29 date: 2024-04-19 date: 2024-04-19 name: Haseki Training and Research Hospital class: OTHER briefSummary: QT interval, defined as the time between the beginning of the QRS complex and the end of the T wave in electrocardiography (ECG), is an indicator of depolarization and repolarization of the myocardium.11 Prolongation of the heart rate corrected QT (QTc) interval reflects electrical instability of ventricles and is associated with life-threatening ventricular arrhythmias, including torsade de pointes, ventricular fibrillation and sudden cardiac death.
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Spinal anesthesia can cause profound prolongation of the QTc interval due to disparity between lumbar and thoracic sympathetic activity following subarachnoid block. Meanwhile inhalational anesthetics, sevoflurane, isoflurane, and desflurane are known to prolong QTc interval and intravenous anesthetics such as propofol, thiopental, etomidate and ketamin can also cause remarkable prolongation of the QTc interval. Moreover laryngoscopy and intubation may contribute to prolongation of the QTc interval because of the sympathetic stimulation.
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Over the years it has been occurred an increase in the proportion of elderly population requiring surgical anesthesia. The incidence of ventricular arrhythmias increases in advancing age even in the absence of underlying heart disease and elderly patients have reduced physiological functions and poor tolerance to anesthesia. However the choice of anesthesia type is critical in this population.
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To the best of knowledge, there was no published study to compare spinal anesthesia and inhalational anesthesia in elderly patients with regard to the QT interval changes. Investigators aimed to investigate the effects of spinal anesthesia on QT, QTc intervals and to compare general anesthesia with sevofluran in elderly patients. conditions: Anesthesia, Spinal conditions: Sevoflurane conditions: Long QT Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 58 type: ACTUAL name: QT and QTc interval measure: QTc interval measure: QT sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Science University, Haseki Training and Research Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06375850 id: Effects of topical sesame oil briefTitle: Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial. overallStatus: RECRUITING date: 2022-06-05 date: 2025-02-11 date: 2025-05-11 date: 2024-04-19 date: 2024-04-19 name: Hospital Universitario Marqués de Valdecilla class: OTHER briefSummary: Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses.
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For the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. These peripheral venous catheter in combination with the highly aggressive treatments for the veins are the cause of the appearance of chemical phlebitis.
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Phlebitis is an inflammation caused by a combination of factors, whether chemical, perfusion of irritating medication; mechanical, due to the puncture site, type and fixation of the catheter and infectious, caused by the colonization of pathogenic agents whose origin is the skin and that migrate inward.
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Phlebitis involves an injury to the wall of the vein, and consequently, the patient will also be at risk of thrombus formation, which in turn leads to thrombophlebitis, deep vein thrombosis or pulmonary embolism.
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The existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling.
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With the use of topical sesame oil, and thanks to its anti-inflammatory properties, the investigators intend to study whether it is effective in preventing the appearance of phlebitis. conditions: Phlebitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Sesame oil name: Saline solution measure: Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically measure: Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Marqués de Valdecilla status: RECRUITING city: Santander state: Cantabria zip: 39008 country: Spain name: Virginia Meneses Campos role: CONTACT phone: +34942202520 email: virginia.meneses@scsalud.es name: Virginia Meneses Campos role: PRINCIPAL_INVESTIGATOR lat: 43.46472 lon: -3.80444 hasResults: False
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<|newrecord|> nctId: NCT06375837 id: bioactive-NCCLs briefTitle: Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites overallStatus: RECRUITING date: 2024-04-15 date: 2024-06-15 date: 2026-06-15 date: 2024-04-19 date: 2024-04-19 name: Hacettepe University class: OTHER briefSummary: The clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Lesions will be divided in three groups: an alkasite-based restorative material (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)), hybrid resin composite (Gradia Direct Anterior, GC, Tokyo, Japan (GD)) and a highly filled flowable resin composite ((G-aenial Universal Flo, GC, Tokyo, Japan (GF)). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria. Descriptive statistics will be performed using chi-square tests. conditions: Tooth Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 33 type: ESTIMATED name: an alkasite-based restorative material name: hybrid resin composite name: a highly filled flowable resin composite measure: Clinical performances of different restorative systems according to FDI criteria (Esthetic properties) measure: Clinical performances of different restorative systems according to FDI criteria (Functional properties) measure: Clinical performances of different restorative systems according to FDI criteria (Biological properties) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University status: RECRUITING city: Ankara country: Turkey name: Fatma Oz role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06375824 id: TCM for Pre-COPD briefTitle: Bufei Recipe Reduces the Incidence Rate of COPD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-10-31 date: 2024-04-19 date: 2024-04-19 name: Henan University of Traditional Chinese Medicine class: OTHER name: West China Hospital name: The First Affiliated Hospital of Zhejiang Chinese Medical University briefSummary: Establish early TCM prevention and treatment program to reduce the incidence rate of COPD. conditions: Preserved Ratio Impaired Spirometry studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 1100 type: ESTIMATED name: Bufei Recipe name: Bufei Recipe placebo measure: Incidence rate of COPD measure: FVC measure: FEV1 measure: FEV1% pred measure: FEV1/FVC measure: IPAG-Q measure: LFQ measure: COPD-PS measure: CAT measure: SF-36 measure: Clinical symptoms measure: Biochemical indicators sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06375811 id: 2000027121_temp briefTitle: Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp acronym: PREGnant overallStatus: RECRUITING date: 2024-03-16 date: 2026-06-30 date: 2026-06-30 date: 2024-04-19 date: 2024-04-23 name: Yale University class: OTHER name: University of Colorado, Denver name: Northwestern University name: University of North Carolina name: Duke University name: Johns Hopkins University briefSummary: A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist. conditions: Infertility conditions: Endometriosis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Half of the subjects (200, randomized or not randomized) will receive elagolix 200mg twice a day (BID) and the other half of subjects will receive placebo BID or SOC IVF (200, placebo or SOC IVF). Elagolix or placebo will be taken for a minimum of 60 days before IVF cycle start. For convenience of IVF cycle scheduling, participants may receive up to an additional 14 days of intervention (elagolix or placebo) beyond the minimum 60 days of pre-IVF treatment, such that the last dose of study intervention (elagolix or placebo) is received no more than 24 hours before start of IVF treatment protocol. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: For participants who agree to be randomized, a computer-generated randomization list will be created by the PREGnant Data Coordinating Center (DCC) and randomization will be performed prior to the first dose of elagolix. Randomization will have random sizes (2, 4, or 6) of blocks and be stratified by site, i.e. whole blocks are assigned to sites. The randomization list will not be available to any person involved in the conduct and evaluation of the trial until the trial is complete and database is declared clean and is released by the DCC. Likewise, treatment allocation information will not be accessible to investigators (except for serious safety concerns), trial staff at the site or central laboratory personnel during the trial. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 288 type: ESTIMATED name: Elagolix 200 MG name: Placebo or SOC IVF measure: Live birth rate measure: Fertilization rate measure: Number of embryos transferred measure: Implantation rate measure: Biochemical pregnancy rate measure: Clinical pregnancy rate measure: Miscarriage rate measure: Overall pregnancy complication rate measure: Gestation age at delivery measure: Infant birth weight sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Colorado Department of Obstetrics & Gynecology status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Katherine Kuhn role: CONTACT phone: 303-724-5276 email: katherine.kuhn@cuanschutz.edu name: Nanette Santoro role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences status: RECRUITING city: New Haven state: Connecticut zip: 06520 country: United States name: Michele Frank role: CONTACT phone: 203-785-6949 email: michele.frank@yale.edu name: Hugn Taylor role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: Northwestern University Department of Obstetrics and Gynecology status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Jessica Almgren-Bell role: CONTACT phone: 312-503-4118 email: jessica.almgrenbell@nm.org name: Emily Jungheim role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Johns Hopkins, Division of Reproductive Science and Women's Health Research status: RECRUITING city: Baltimore state: Maryland zip: 21205 country: United States name: Gaelle Massoud, role: CONTACT phone: 410-583-2763 email: gmassou1@jhmi.edu name: James Segars role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Duke Fertility status: RECRUITING city: Morrisville state: North Carolina zip: 27560 country: United States name: Tifani Panek role: CONTACT phone: 773-706-4202 email: tifani.panek@duke.edu name: Steven Young role: PRINCIPAL_INVESTIGATOR lat: 35.82348 lon: -78.82556 hasResults: False
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<|newrecord|> nctId: NCT06375798 id: 2020137 briefTitle: Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer overallStatus: RECRUITING date: 2020-11-19 date: 2026-11-19 date: 2026-11-19 date: 2024-04-19 date: 2024-04-19 name: Hebei Medical University Fourth Hospital class: OTHER briefSummary: A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery. conditions: Breast Cancer conditions: HER2-negative Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 620 type: ESTIMATED name: radiotherapy measure: LRFS sex: FEMALE minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei country: China name: qimei wang, attending role: CONTACT phone: 18633051639 email: maggie92320@hotmail.com lat: 38.04139 lon: 114.47861 hasResults: False
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<|newrecord|> nctId: NCT06375785 id: LSVT-BIG vs Otago briefTitle: Two Different Exercise Methods in Geriatrics overallStatus: COMPLETED date: 2023-03-01 date: 2023-06-01 date: 2024-03-01 date: 2024-04-19 date: 2024-04-23 name: Halic University class: OTHER name: Fenerbahce University name: Istanbul Galata University name: Biruni University briefSummary: The aim of the study is to compare slow rhythmic exercises with large amplitude exercises in elderly people conditions: Elderly People conditions: Nursing Homes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ACTUAL name: Otago-based (slow rhythmic) exercise group name: LSVT BIG-based (large amplitude) exercise group measure: Timed Up &Go Test measure: Performanz Balance System measure: Functional Reaching Test measure: Six Minute Walking Test measure: Tinetti Balance and Gait Assessment measure: Activity-Specific Balance and Confidence Scale measure: Five Times Sit to Stand measure: Montreal Cognitive Assessment Test measure: KATZ Activities of Daily Living Scale measure: Clinical Frailty Scale sex: ALL minimumAge: 65 Years maximumAge: 80 Years stdAges: OLDER_ADULT facility: Haliç University city: Istanbul state: Eyüpsultan country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06375772 id: 2-DG-02 briefTitle: A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults overallStatus: RECRUITING date: 2024-04-02 date: 2024-08-31 date: 2024-12-31 date: 2024-04-19 date: 2024-04-19 name: G.ST Antivirals GmbH class: INDUSTRY briefSummary: 2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study to investigate the efficacy and safety of 2-Deoxy-D-Glucose as a pre-exposure prophylaxis using the rhinovirus challenge model in healthy study participants. conditions: Acute Nasopharyngitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: 2-Deoxy-D-glucose name: Placebo measure: The difference in the rate of rhinovirus-associated illness between 2-DG and placebo measure: Number of infected subjects measure: Difference in percent of infected subjects measure: Difference in percent of days virus positive measure: Difference in peak nasal virus load measure: Difference in AUC nasal virus load measure: Difference in Total Jackson Symptom Score measure: Duration of illness measure: Difference in percent of days Jackson Symptom Score positive measure: Difference in Peak Jackson Symptom Score measure: Difference in peak total WURSS-21 measure: Difference in AUC total WURSS-21 measure: Occurrence of adverse events (AEs) and adverse drug-reactions (ADRs) measure: Biodistribution of multiple doses of 2-DG in plasma samples measure: Biodistribution of multiple doses of 2-DG in nasal wash samples sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Centre for Human Drug Research status: RECRUITING city: Leiden zip: 2333 country: Netherlands name: Ingrid de Visser- Kamerling, PhD role: CONTACT phone: +31 71 5246400 email: clintrials@chdr.nl lat: 52.15833 lon: 4.49306 hasResults: False
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<|newrecord|> nctId: NCT06375759 id: XWSSB briefTitle: Subarachnoid-Subarachnoid (S-S) Bypass Versus Adhesion Lysis in Spinal Arachnoiditis and Syringomyelia overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2027-04 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: To determine whether Subarachnoid-Subarachnoid (S-S) Bypass results in better patient outcomes with fewer complications and improved quality of life compared to intradural adhesion lysis in individuals with Spinal Arachnoiditis and Syringomyelia. conditions: Syringomyelia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Subarachnoid-Subarachnoid (S-S) Bypass name: Intradural Adhesion Lysis measure: complication measure: improvement or resolution of the syrinx, measure: ASIA score measure: Klekamp and Sammi syringomyelia scale measure: modified Japanese Orthopaedic Association Scores (mJOA) measure: xuanwu syringomyelia scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fengzeng Jian status: RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Yuan Chenghua role: CONTACT email: yuanchenghua@ccmu.edu.cn name: Jian Fengzeng role: CONTACT email: jianfengzeng@xwh.ccmu.edu.cn name: jian guan, dr role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06375746 id: 0091-22-WOMC briefTitle: The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve - a Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-08-31 date: 2024-04-19 date: 2024-04-19 name: Wolfson Medical Center class: OTHER_GOV briefSummary: To determine whether watching a personalized video prior to medically indicated labor induction among term parturients reduces anxiety levels according to the STAI questionnaire, compared to a standard counselling. conditions: Induction of Labor Affected Fetus / Newborn studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Personalized video measure: STAI questionnaire score measure: satisfaction questionnaire sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06375733 id: GFH009X1202 briefTitle: A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL overallStatus: RECRUITING date: 2024-03-20 date: 2026-12-31 date: 2026-12-31 date: 2024-04-19 date: 2024-04-19 name: Zhejiang Genfleet Therapeutics Co., Ltd. class: INDUSTRY briefSummary: This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) conditions: Large B-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 51 type: ESTIMATED name: GFH009 name: Zanubrutinib name: GFH009 name: Zanubrutinib measure: Phase Ib: adverse events(AEs) measure: Phase II: ORR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute status: RECRUITING city: Nanning country: China name: Cen Hong role: CONTACT lat: 22.81667 lon: 108.31667 facility: Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital status: RECRUITING city: Zhengzhou country: China name: Keshu Zhou role: CONTACT lat: 34.75778 lon: 113.64861 hasResults: False
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<|newrecord|> nctId: NCT06375720 id: FujianUTCM-2 briefTitle: Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2025-06-15 date: 2025-12-15 date: 2024-04-19 date: 2024-04-19 name: Lidian Chen class: OTHER name: Peking University Third Hospital briefSummary: To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 350 type: ESTIMATED name: Lower frequency, shorter period of Tai Chi Chuan name: Higher frequency, shorter period of Tai Chi Chuan name: Lower frequency, longer period of Tai Chi Chuan name: Higher frequency, longer period of Tai Chi Chuan name: Standard Health Education measure: Montreal Cognitive Assessment measure: Montreal Cognitive Assessment measure: Wechsler Memory Scale measure: Digit Symbol Substitution Test measure: Trial Making Test part B measure: Stroop Color Word Test measure: Boston Naming Test measure: Rey-Osterrieth Complex Graphics Test measure: Rey Auditory Verbal Learning Test measure: The Pittsburgh Sleep Quality Index (PSQI) measure: 12-Item Short Form Health Survey measure: Blood glucose metabolism index measure: Blood lipid metabolism index measure: functional Magnetic Resonance Imaging measure: Electroencephalogram measure: Heart rate variability measure: Gut microflora sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06375707 id: HERO-KC23 briefTitle: Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer overallStatus: RECRUITING date: 2024-01-09 date: 2025-11 date: 2025-12 date: 2024-04-19 date: 2024-04-19 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER name: Zhejiang Cancer Hospital briefSummary: Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced breast cancer. conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS name: Ribociclib combined with NSAI±OFS measure: Progression Free Survival measure: Progression Free Survival2 measure: Time to treatment failure measure: Overall response rate (ORR) measure: Overall survival(OS) measure: Time To Response (TTR) measure: Clinical benefit rate(CBR) measure: Change from baseline in the global health status/QOL scale score by using FACT-B questionnaire measure: Frequency/severity of adverse events, lab abnormalities sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangsu Provincial People's Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Wei Li, Ph.D role: CONTACT phone: 025-68306360 email: real.lw@163.com name: Wei Li, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06375694 id: IRB00025485 briefTitle: Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN ) acronym: OPEDNPN overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-05 date: 2025-05 date: 2024-04-19 date: 2024-04-19 name: Wake Forest University class: OTHER name: University of South Florida briefSummary: Nitric Oxide (NO) is an important molecule that is produced naturally in the body and that helps maintain healthy blood flow. Low availability of NO contributes to many diseases while administration of NO is therapeutic.
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In addition to being made naturally in the body, NO can be obtained through the diet via the Nitrate-Nitrite-NO cycle. Nitrate, which is abundant in green leafy vegetables and beetroot juice, is partially converted to nitrite by oral bacteria. The nitrate and nitrite are taken up into the blood and nitrite is converted into NO. Remaining nitrate in the blood is taken back up into the mouth by salivary glands and the cycle continues. Emerging studies suggest that the Nitrate-Nitrite-NO cycle may contribute to cardiovascular health. In addition, there have been many studies where dietary nitrate is given to increase NO and treat various conditions.
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The current study rests on the premise that the quality of the oral microbiome plays a major role in the Nitrate-Nitrite-NO cycle and hence cardiovascular health and the efficacy of dietary nitrate interventions. Investigators have begun to identify oral bacterial species that are effective nitrite producers as well as though that are nitrite depleters (those that interfere with nitrite production from nitrate).
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In laboratory experiments, certain bacterial species have been shown to block nitrate to nitrite conversion by other oral bacteria. These nitrite depleting species are found in a commercially available oral probiotic designed to improve oral health. The purpose of this study is to examine if use of the probiotic negatively affects the Nitrate-Nitrite-NO cycle. Nitrate to Nitrite conversion will be assessed by measuring plasma levels of nitrite before and after consumption of nitrate-rich beetroot juice. Dietary nitrate to plasma nitrite conversion will assessed at baseline and after one week of consumption of the probiotic or a placebo (follow-up). The primary hypothesis of this study is that participants that consume the probiotic will have lower nitrate to nitrite conversion at follow-up compared to baseline and that there will be no significant change in nitrate to nitrite conversion between baseline and follow-up for participants who consume the placebo.
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While this study does not aim to treat any specific disease, it is intended to elucidate a basic physiological function that may be relevant to cardiovascular health and certain NO-based therapeutics. conditions: Hypertension conditions: Cardiovascular Diseases conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized into two groups with one group receiving the oral probiotic and the other receiving the placebo. Each group will take their intervention 2X a day for 7 days. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participants will not know which group they are in. The lozenges will be distributed in unmarked bottles whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Herbiotics Oral + Ent Probiotic measure: Dietary Nitrate Conversion to Plasma Nitrite measure: Percentage Lactobaciluus sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06375681 id: 2019-1378: R01 id: 1R01AG076157-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AG076157-01 id: A487400 type: OTHER domain: UW Madison briefTitle: Effectiveness of Cognitive Training in Older and Younger Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-01 date: 2028-01 date: 2024-04-19 date: 2024-04-19 name: University of Wisconsin, Madison class: OTHER name: National Institute on Aging (NIA) briefSummary: The proposed study will enroll 1600 participants to examine the effectiveness of cognitive training. Participants will be randomized into different experimental groups and can expect to participate for up to 15 hours of research over 4 to 8 weeks. conditions: Cognitive Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Following Pre-testing, participants randomly assigned into the full study will be further randomly assigned to a total of 9 unique experimental conditions for the full 2x2x2+1 factorial design.
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The full description of the study's 9 arms will be registered after data collection is completed to preserve the scientific integrity of the study. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: All researchers that have contact with participants will be unaware of the tested hypothesis of the study.
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Participants will be unaware of the experimental conditions.
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Researchers and participants will be unaware (blinded) to the game conditions assigned to the participant, except for researchers in charge of supervising the training part of the study who will be aware what training the participant is undergoing.
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More information on how this was achieved will be registered after data collection is completed to preserve the scientific integrity of the study. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 1600 type: ESTIMATED name: Visual and / or Auditory Cognitive Tasks (1) name: Visual and / or Auditory Cognitive Tasks (2) measure: Change in the difference between the proportion of hits minus false alarms for a given level of the N-back task measure: Change in the proportion of correctly reported sequences in the Corsi Complex task measure: Change in the proportion of correctly reported number and letter sets in the Letter-Number task measure: Change in the difference of response time and accuracy in switch trials minus non-switch trials in the Task Switching Task measure: Change in the difference of response time in (i) switch trials minus non-switch trials and (ii) congruent minus incongruent trials in the Flanker Task measure: Change in the proportion of correctly identified targets in the mixed condition of the Cancellation task measure: Change in the proportion of correct responses on the Useful Field of View (UFOV) Task measure: Change in the proportion of correct responses on the Multiple Object Tracking (MOT) Task measure: Change in the response time and percentage of correct responses in the Mental Rotation Task measure: Change in the percentage of correct responses in the Paper Folding task measure: Change in the sum of correctly solved items in Raven's Advanced Progressive Matrices task measure: Change in the sum of correctly solved items in the UC Matrix Reasoning task measure: Change in the percentage of accuracy in the Shipley Institute of Living Scale measure: Change in the percentage of accuracy in the Mill-Hill Vocabulary Scale measure: Big-5-Inventory 10-item version (BFI-10) Score measure: Behavioral Inhibition/Activation System (BIS/BAS) Score measure: Grit and Conscientiousness Score measure: Meta-Cognition Score measure: Theories of Intelligence - Mindset (Fixed vs Growth) Score measure: Schutte self-report emotional intelligence test (SSEIT) Score measure: Work and Family Orientation (WOFO) Score measure: Brief Pittsburgh Sleep Quality Index (B-PSQI) Score measure: Participant Experience Measure 1 measure: Participant Experience Measure 2 measure: Participant Experience Measure 3 measure: Participant Experience Measure 4 measure: Participant Experience Measure 5 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Riverside city: Riverside state: California zip: 92521 country: United States name: Aaron Seitz, PhD role: CONTACT phone: 951-827-6422 email: aseitz@ucr.edu lat: 33.95335 lon: -117.39616 facility: Northeastern University city: Boston state: Massachusetts zip: 02115 country: United States name: Susanne Jaeggi, PhD role: CONTACT phone: 617-373-3653 email: s.jaeggi@northeastern.edu lat: 42.35843 lon: -71.05977 facility: University of Wisconsin - Madison city: Madison state: Wisconsin zip: 53706 country: United States name: C. Shawn Green, PhD role: CONTACT phone: 608-263-4868 email: cshawn.green@wisc.edu lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06375668 id: CT/NB/140/2020/PR-MS briefTitle: The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-15 date: 2024-01-15 date: 2024-06-15 date: 2024-04-19 date: 2024-04-24 name: Nordic Biotic Sp. z o.o. class: INDUSTRY briefSummary: Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures. Osteoporosis develops as a result of genetic and environmental factors, with the patient's lifestyle playing an important role. Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis, thus new ways of modifying the composition and activity of microbiota have been sought, and the potential role of probiotics has been considered. Probiotics are defined as live microorganisms, which-when administered at appropriate doses-are beneficial to the host's health. Probiotics both modify the gut microbiota composition and directly affect the human body. Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention. The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine (L1-L4). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months. conditions: Osteoporosis, Postmenopausal conditions: Bone Density, Low studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 170 type: ACTUAL name: Probiotic name: Placebo measure: The effect of intervention on bone mineral density measure: Changes in the level of calcium measure: Changes in the level of phosphorus measure: Changes in the level of alkaline phosphatase measure: Changes in the level of vitamin D measure: Changes in the level of C-reactive protein measure: Changes in Body Mass Index (BMI) measure: Changes in type of stools measure: Changes in the number of bowel movements measure: Changes in severity of abdominal pain measure: Changes in severity of bloating measure: Occurrence of adverse events measure: Satisfaction with the intervention sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Private Specialist Practice city: Bytom zip: 41-902 country: Poland lat: 50.34802 lon: 18.93282 facility: Specialist Practice city: Katowice zip: 40-750 country: Poland lat: 50.25841 lon: 19.02754 facility: Clinical Research Center city: Poznań zip: 60-773 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False
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<|newrecord|> nctId: NCT06375655 id: STUDY20240085 briefTitle: Texting to Promote Breastfeeding (TOPS) overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2025-07-31 date: 2025-07-31 date: 2024-04-19 date: 2024-04-24 name: Lydia Furman class: OTHER briefSummary: The purpose of the study is to see if a program of text messages that support and promote breastfeeding for expecting and delivered African-American/Black women (called TEAM2BF), as compared to a national maternal health texting program (called Text4baby), can result in more women being able to breastfeed their infant. Because breastfeeding is healthy for mothers and babies, and because fewer African-American/Black women decide to breastfeed and continue breastfeeding than many other racial and ethnic groups, researchers like us are trying to figure out ways to be supportive to African-American/Black mothers who might be interested in breastfeeding. The investigators will enroll up to 80 mothers and their infants at UHCMC. conditions: Increased Breastfeeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Team2BF name: Text4baby measure: Percentage of participants who do not opt out of receipt of text messages measure: Percentage of participants who said texts were helpful as measured by questionnaire measure: Percentage of participants who would refer a friend/family to the texting program measure: Percentage of participants who are exclusively breastfeeding at 2 months postpartum as measured by participant report/chart review measure: Percentage of participants who are exclusively breastfeeding as measured by participant report/chart review measure: Percentage of participants who are partially breastfeeding as measured by participant report/chart review sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahuja Rainbow Center for Women and Children city: Cleveland state: Ohio zip: 44103 country: United States name: Lydia Furman, MD role: CONTACT phone: 216-675-6691 email: lydia.furman@uhhospitals.org lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06375642 id: SHR1316-HMPL012-HAIC-01 briefTitle: A Single Arm, Single Centered Phase II Trial on the Combination of Adebrelimab, Surufatinib and Irinotecan Liposome-based HAIC in Advanced iCC overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-08-31 date: 2026-08-31 date: 2024-04-19 date: 2024-04-19 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: Southeast Asia and China have the highest incidence of intrahepatic cholangiocarcinoma worldwide, with limited treatment options and large unmet medical needs.
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Hepatic arterial infusion chemotherapy (HAIC) has gradually emerged as a promising treatment option for patients with hepatocellular carcinoma (HCC). Increasing evidence suggests that infusion of HAIC, which maintains high local concentrations of toxic agents in tumors without embolism, provides a significant survival benefit for patients with advanced HCC and is well-tolerated. However, there is limited evidence for the efficacy of HAIC for intrahepatic cholangiocarcinoma.
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Irinotecan liposome (nal-IRI) is a concentrate of an infusion solution containing 5 mg/ml irinotecan trihydrate (irinotecan sucrose salt) active substance, which is encapsulated in liposomes and prevents premature conversion of the drug to SN-38 in the liver. Liposomal irinotecan prolongs the circulation time of the drug in the plasma of patients and prolongs the tumor exposure of the drug compared to conventional irinotecan.Nal-IRI based protocol has shown positive results in the phase III trial of pancreatic carcinoma.
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Adebrelima(SHR-1316) is a recombinant humanized IgG4 antibody that binds efficiently and specifically to human and cynomolgus programmed cell death ligand 1 (PD-L1, CD274, or B7-H1), a cell surface molecule that plays an important role in T cell immune function, and stimulates IFN-γ secretion from mixed lymphocyte reactions (MLRs) of dendritic cells (DCs) and CD4 + T cells.
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Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3, FGFR1 and CSF1R.
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This study aims to evaluate the efficacy and safety of irinotecan liposome-based hepatic arterial infusion chemotherapy combined with adebrelimab and surufatinib in the treatment of intrahepatic cholangiocarcinoma, which may bring significant clinical benefit to the iCC patients with new treatment options. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Adebrelimab measure: Objective Response Rate measure: Disease Control Rate measure: Overall Survival measure: Progress-Free Survival measure: Incidence and severity of AE and SAE measure: Dose suspension rate caused by adverse events measure: dose termination rate caused by adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Cancer Hospital Airport Hospital city: Tianjin state: Tianjin zip: 300308 country: China lat: 39.14222 lon: 117.17667 hasResults: False
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<|newrecord|> nctId: NCT06375629 id: EDAP TMS briefTitle: ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer acronym: ES-HIFU overallStatus: RECRUITING date: 2023-04-20 date: 2027-04-20 date: 2027-04-20 date: 2024-04-19 date: 2024-04-19 name: EDAP TMS S.A. class: INDUSTRY briefSummary: The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: FocalOne measure: Evaluation of adverse events measure: Evaluation of quality of life measure: Evaluation of urinary incontinence measure: Erectile function assessment measure: Urinary Symptoms sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Puerta del Mar status: RECRUITING city: Cadiz zip: 21 11009 country: Spain name: Cristina Salvatierra Pérez, Doctor role: CONTACT phone: +34 956 00 21 00 email: cris_salvatierra86@hotmail.com lat: 36.52672 lon: -6.2891 facility: Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo status: RECRUITING city: Madrid zip: 46 28007 country: Spain name: Carlos Hernández Fernández, Doctor role: CONTACT phone: +34 912 05 38 54 email: carlos.hernandez@salud.madrid.org lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Central De Asturias status: RECRUITING city: Oviedo zip: 33011 country: Spain name: Jorge Garcia Rodriguez, Doctor role: CONTACT phone: +34 985 10 80 00 email: garciajorge70@gmail.com lat: 43.36029 lon: -5.84476 facility: Hospital Universitario Marqués De Valdecilla status: RECRUITING city: Santander zip: 39008 country: Spain name: Mario Dominguez Esteban role: CONTACT phone: +34 942 42 06 26 email: mariodominguezesteban@gmail.com lat: 43.46472 lon: -3.80444 facility: Hospital Consorcio General Universitario de Valencia status: RECRUITING city: Valencia zip: 46014 country: Spain name: Emilio Mr López Alcina, Doctor role: CONTACT phone: +34 960 64 00 78 email: e.lopezalcina@gmail.com lat: 39.46975 lon: -0.37739 hasResults: False
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