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The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.
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Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling). conditions: Pancreatic Fistula conditions: Acute Pancreatitis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: occurrence of clinically significant FP and/or PAPP during hospitalization following pancreaticoduodenectomy. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Besançon status: RECRUITING city: Besançon zip: 25000 country: France name: Alexandre Doussot, MD, PhD role: CONTACT lat: 47.24878 lon: 6.01815 hasResults: False
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<|newrecord|> nctId: NCT06283147 id: 2023.530 briefTitle: Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care overallStatus: RECRUITING date: 2024-04-01 date: 2025-11-30 date: 2026-04-01 date: 2024-02-28 date: 2024-03-22 name: Chinese University of Hong Kong class: OTHER briefSummary: The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.
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Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):
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1. RAMP Knee-OA group
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2. Usual care group
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Outcomes will be measured at baseline, week 16, week 32, and week 52. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a 52-week, two-arm, parallel, doubled-blinded randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N=114) versus usual care (N=114) on self-reported knee pain and other secondary outcomes. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: All data collection will be performed by trained research assistants blinded to the allocation status of the patients, and statistician will analyse data without referring to allocation information. whoMasked: OUTCOMES_ASSESSOR count: 228 type: ESTIMATED name: Risk assessment and Management Programme - Knee Osteoarthritis measure: Knee pain measure: Physical Function measure: Physical function measure: Lower limb muscle mass measure: Level of physical activity measure: Self-Management efficacy measure: Level of Anxiety measure: Level of Depression measure: Insomnia measure: Loneliness measure: Health related Quality of Life measure: Demographic data sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lek Yuen GOPC status: RECRUITING city: Hong Kong country: Hong Kong name: Cheryl Fung role: CONTACT phone: 26095050 phoneExt: +852 email: cheryllcfung@cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06283134 id: BJCT-CMU1H-02 briefTitle: A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2027-12-01 date: 2027-12-01 date: 2024-02-28 date: 2024-02-29 name: China Medical University, China class: OTHER name: Beijing Bio-Targeting Therapeutics Technology Co., Ltd briefSummary: This is a phase I, open-label clinical study of BioTTT001 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: BioTTT001 hepatic artery infusion name: toripalimab name: regorafenib measure: Incidence of adverse events measure: MTD measure: Overall survival(OS) measure: Progression-free survival (PFS) measure: Objective response rate (ORR) measure: Plasma adenovirus (ADV) copies measure: ADV copies in various sites measure: Serum IL-12 level measure: Serum neutralizing antibody level sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283121 id: BJCT-CMU1H-01 briefTitle: A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2027-11-30 date: 2027-11-30 date: 2024-02-28 date: 2024-02-29 name: China Medical University, China class: OTHER name: Beijing Bio-Targeting Therapeutics Technology Co., Ltd briefSummary: This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer. conditions: Gastric Cancer, Metastatic studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: BioTTT001 intraperitoneal infusion name: SOX regimen name: toripalimab measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283108 id: 23-1183 briefTitle: Gurney Journey: Virtual Reality Distraction overallStatus: RECRUITING date: 2024-03-01 date: 2024-06 date: 2024-06 date: 2024-02-28 date: 2024-03-08 name: Children's Hospital Colorado class: OTHER briefSummary: The aim of this study is to determine whether a software virtual reality (VR) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. This study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. Compliance during anesthesia induction will also be monitored. Participants will be randomly placed into to one of two groups. Group 1 will receive standard care from a Certified Child Life Specialist prior to their surgery. Group 2 will receive standard care from a Certified Child Life Specialist and distraction with a novel virtual reality software program. conditions: Dental Caries in Children conditions: Dental Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 58 type: ESTIMATED name: Standard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience) name: Standard Child Life Preparation and Support measure: Induction Compliance Checklist measure: modified Yale Preoperative Anxiety Scale measure: The Pediatric Behavioral Induction Assessment sex: ALL minimumAge: 5 Years maximumAge: 17 Years stdAges: CHILD facility: Children's Hospital Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Claire Simonsen, BA role: CONTACT phone: 720-777-5313 email: claire.simonsen@childrenscolorado.org name: Joseph Albietz, MD role: PRINCIPAL_INVESTIGATOR name: Jennifer Staab, MS role: SUB_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06283095 id: OSA briefTitle: Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty overallStatus: RECRUITING date: 2023-11-01 date: 2025-11-01 date: 2026-11-01 date: 2024-02-28 date: 2024-02-28 name: ET Zarief class: OTHER briefSummary: The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS. conditions: Obstructive Sleep Apnea of Adult studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: expansion palatoplasty measure: Evaluation the outcome of expansion palatoplasty in management of OSAS. measure: Expansion palatoplasty in Obstructive sleep apnea patients sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASSUIT status: RECRUITING city: Assuit zip: 1 country: Egypt name: Enas T Zarief, physician role: CONTACT phone: 01226270800 email: enas.tharwat23@gmail.com lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06283082 id: 69HCL23_0617 id: ID-RCB type: OTHER domain: 2023-A01406-39 briefTitle: Oxalate Excretion Profile in Patients With a Heterozygous Mutation of the AGXT (Alanine-glyoxylate Aminotransferase) Gene acronym: HETEROX overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-02-28 date: 2024-02-28 name: Hospices Civils de Lyon class: OTHER briefSummary: Primary hyperoxaluria type I (PH1) is a rare genetic disorder responsible for severe lithiasis leading to progressive deterioration of renal function and end-stage renal failure. PH1 is linked to a deficiency in glyoxylate amino transferase (AGXT), which leads to increased endogenous oxalate synthesis and hyperoxaluria. In the urine, urinary oxalate precipitates with calcium, forming insoluble crystals, leading to lithiasis and the development of nephrocalcinosis.
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Non-genetic etiologies of oxalic nephropathy are well known, in particular enteric causes (malabsorptions, bypass, calcium deficiencies, etc.) and sometimes linked to increased oxalate intake in the form of nutritional or vitamin supplements, reinforcing the hypothesis of probably underestimated favouring factors of hyperoxaluria.
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Until now, heterozygous patients with a mutation in the AGXT gene were considered asymptomatic. However, there have been several cases of patients with heterozygous AGXT mutations presenting with lithiasis.
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Consequently, the characteristics of symptomatic and asymptomatic heterozygous patients will be studied in order to define the elements that would explain the expression of the disease (particularities of the AGXT mutation, presence of another heterozygous mutation or favorable living conditions).
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The hypothesis is that there is an increase in hepatic oxalate production in heterozygous patients, which explains why they remain asymptomatic under usual conditions, but could favor stone formation under favorable conditions such as severe calcium deficiency or malabsorption. conditions: Hyperoxaluria (Disorder) studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 25 type: ESTIMATED name: Lithiasis assessment measure: Urinary oxalate and glycolate excretion measure: The prevalence of stones measure: Lithiasis disease severity measure: Lithiasis disease severity measure: Lithiasis disease severity measure: Lithiasis disease severity measure: Predisposing conditions for lithiasis disease measure: Predisposing conditions for lithiasis disease sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CLIMA, pavillon R, Hôpital Edouard Herriot city: Lyon zip: 69003 country: France name: Laurence Derain, MD,PhD role: CONTACT phone: 04 72 11 91 17 phoneExt: +33 email: laurence.derain@chu-lyon.fr lat: 45.74848 lon: 4.84669 hasResults: False
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<|newrecord|> nctId: NCT06283069 id: 45C301 briefTitle: Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters acronym: RICH overallStatus: RECRUITING date: 2023-05-01 date: 2024-12-31 date: 2033-04-30 date: 2024-02-28 date: 2024-02-28 name: Istituto Auxologico Italiano class: OTHER briefSummary: The goal of the study is to build a Register accruing data derived from the compilation of the questionnaire about LifeStyle for a population both of adults and of young boys and girls. The investigators are confident that in this way they will be able to expand the database they already have. The investigators will be able to increase the strength of the correlations between LS indices and health indicators. In particular, the investigators will emphasize the relationship between physical activity, stress, and diet quality on one hand, and on the other, they will focus on physiological parameters, like arterial pressure, gluco-lipid profile, and possible pathologies. conditions: Cardiovascular Diseases conditions: Lifestyle conditions: Nutrition, Healthy conditions: Physical Inactivity conditions: Stress conditions: Sleep studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 100 type: ESTIMATED name: compilation of a questionnaire about LifeStyle measure: weekly physical activity volume measure: nutrition quality measure: weight measure: height measure: blood pressure measure: perception of stress, fatigue, and somatic symptoms measure: glycemia measure: cholesterol measure: creatinine measure: waist circumference measure: heart rate sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan country: Italy name: Luca Giovanelli, MD role: CONTACT phone: +3902619112808 email: luca.giovanelli@unimi.it name: Daniela Lucini, Prof role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06283056 id: DO611073A briefTitle: RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite overallStatus: RECRUITING date: 2022-06-16 date: 2024-06-01 date: 2025-06-01 date: 2024-02-28 date: 2024-02-28 name: InMode MD Ltd. class: INDUSTRY briefSummary: The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits. conditions: Cellulitis of Leg studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, open-label clinical study. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Device treatment measure: Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale measure: Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale measure: Subject assessment of improvement measure: Subject assessment of improvement measure: Subject assessment of improvement measure: Subject assessment of satisfaction measure: Subject assessment of satisfaction measure: Subject assessment of satisfaction measure: Investigator assessment of the skin appearance improvemen measure: Investigator assessment of the skin appearance improvement measure: Investigator assessment of the skin appearance measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment measure: Adverse Event rate measure: Pain Scale sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dermatology & Laser Surgery Center of New York status: ACTIVE_NOT_RECRUITING city: New York state: New York zip: 10028 country: United States lat: 40.71427 lon: -74.00597 facility: Dallas Plastic Surgeon status: RECRUITING city: Dallas state: Texas zip: 75225 country: United States name: Lily Hays role: CONTACT phone: 214-821-9114 email: Lily Hays <lily.hays@dpsi.org> lat: 32.78306 lon: -96.80667 hasResults: False
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<|newrecord|> nctId: NCT06283043 id: 2022/3749 briefTitle: Effect of Motor Function, Depression and Sleep Quality on Attention in Parkinson's Disease overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2024-03-01 date: 2024-03-05 date: 2024-02-28 date: 2024-02-28 name: Inonu University class: OTHER briefSummary: Our study was planned to analyze motor function, endurance and sleep attention information in Parkinson's patients with detailed and objective measurements. conditions: Movement Disorders (Incl Parkinsonism) conditions: Parkinsonian Disorders conditions: Attention Impaired conditions: Movement Disorders, Functional studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 54 type: ESTIMATED measure: TUG measure: 10 m walking test measure: 30 sec sit-stand test measure: berg balance test measure: one leg stance test measure: functional reach test measure: hand dinamometer measure: mobil application measure: Pittsburg Sleep Quality İndex measure: Beck Depression measure: P300 sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu University city: Malatya state: Battalgazi zip: 44280 country: Turkey lat: 38.35018 lon: 38.31667 hasResults: False
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<|newrecord|> nctId: NCT06283030 id: IM-001 briefTitle: Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea overallStatus: COMPLETED date: 2021-12-01 date: 2023-09-25 date: 2023-09-25 date: 2024-02-28 date: 2024-03-07 name: Invicta Medical Inc. class: INDUSTRY name: Vanderbilt University Medical Center briefSummary: This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed. conditions: Sleep Apnea conditions: Sleep Apnea, Obstructive conditions: Sleep Apnea Syndromes conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ACTUAL name: Hypoglossal nerve stimulation measure: Identification and access of the target outcomes measure: Tongue protrusion outcomes measure: Characterization of electrode array outcomes measure: Electrode array placement and removal outcomes measure: Safety outcomes sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt Bill Wilkerson Centre city: Nashville state: Tennessee zip: 37232 country: United States lat: 36.16589 lon: -86.78444 hasResults: False
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<|newrecord|> nctId: NCT06283017 id: IM-002 briefTitle: Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-01 date: 2024-03 date: 2024-03 date: 2024-02-28 date: 2024-03-13 name: Invicta Medical Inc. class: INDUSTRY name: Adelaide Institute for Sleep Health, Flinders University briefSummary: This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed. conditions: Sleep Apnea conditions: Sleep Apnea, Obstructive conditions: Sleep Disorder conditions: Sleep Apnea Syndromes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ACTUAL name: Hypoglossal nerve stimulation measure: Target identification and access outcomes measure: Tongue protrusion outcomes measure: Characterization of lead placement outcomes measure: Lead placement and removal outcomes measure: Safety outcomes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Adelaide Institute for Sleep Health, Flinders University city: Adelaide state: South Australia zip: 5042 country: Australia lat: -34.92866 lon: 138.59863 hasResults: False
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<|newrecord|> nctId: NCT06283004 id: 2024-1/30 briefTitle: Investigation of Walking Training With Different Slope Types in COPD Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-06-01 date: 2026-06-01 date: 2024-02-28 date: 2024-02-28 name: Acibadem University class: OTHER name: Bezmialem Vakif University briefSummary: Chronic obstructive pulmonary disease (COPD) is a disease that continues to generate a great deal of research and this research must continue, both because it is not completely curable and because of the large patient population. The importance and benefits of exercise training in COPD patients are clear. One of the most preferred types of exercise training is the so-called aerobic exercise training, which typically takes the form of walking. A typical walking training does not use a slope or may include an uphill slope. However, recently there have been publications about downhill walking and its benefits in COPD. Walking on a level, uphill, and downhill slope may have the potential to result in different gains by using different muscle groups more. Therefore, this study aimed to compare the effects of walking training on exercise capacity, respiratory functions, muscle strength, and functional status in COPD patients with three different slope types: level, uphill, and downhill. conditions: Pulmonary Disease, Chronic Obstructive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 51 type: ESTIMATED name: Downhill walking training name: Level walking training name: Uphill walking training measure: 6 Minutes Walking Distance (6MWD) measure: Spirometric measurements (Forced vital capacity) measure: Spirometric measurements (First second forced expiratory volume) measure: Spirometric measurements (FEV1/FVC ratio) measure: Spirometric measurements (Peak Expiratory Flow) measure: Spirometric measurements (Maximum Intermediate Expiratory Flow) measure: Muscle strength measurements (skeletal muscles) measure: Muscle strength measurements (respiratory muscles) measure: 30-second sit and stand test measure: Functional performance inventory measure: Dyspnea measure: Fatigue measure: Level of exertion sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282991 id: B7461028 briefTitle: A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled overallStatus: COMPLETED date: 2020-07-22 date: 2021-01-18 date: 2021-01-18 date: 2024-02-28 date: 2024-02-28 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.
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This study is seeking participants who:
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* have lung cancer that could not be controlled.
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* have a type of gene called anaplastic lymphoma kinase. A gene is a part of your DNA that has instructions for making things your body needs to work.
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* have received at least 1 treatment before.
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All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take dacomitinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective. conditions: Non-Small Cell Lung Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 73 type: ACTUAL name: Lorlatinib measure: The treatment pattern from initial diagnosis to current lorlatinib treatment. measure: objective response rate (ORR) measure: overall survival measure: progression-free survival measure: 1-year OS rate measure: time-to-treatment failure for all NSCLC measure: time-to-treatment failure of lorlatinib measure: The clinical nature, incidence, duration, and severity of lorlatinib-related safety profile sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch city: Kaohsiung City zip: 83301 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Chung Shan Medical University Hospital city: Taichung zip: 402 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Taichung Veterans General Hospital city: Taichung zip: 407219 country: Taiwan lat: 24.1469 lon: 120.6839 facility: National Taiwan University Hospital city: Taipei zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Taipei Veterans General Hospital city: Taipei zip: 11217 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Chang Gung Memorial Hospital - Linkou Branch city: Taoyuan City zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06282978 id: GEM-RANTAB id: 2023-504273-21 type: EUDRACT_NUMBER briefTitle: Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes overallStatus: RECRUITING date: 2023-11-23 date: 2025-05 date: 2029-12 date: 2024-02-28 date: 2024-03-06 name: PETHEMA Foundation class: OTHER briefSummary: The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.
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Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.
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Safety refers to the measurement of:
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i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests).
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ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
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iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and infections
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The study consists of a screening/baseline period, a treatment period, and a posttreatment follow-up period. The study includes a periodic review of safety data, that will be independently analyzed by the Data Safety Independent Committee (DSMC) and will recommend how to proceed with the study. conditions: Multiple Myeloma in Relapse studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open label, multicenter, phase II study of Elranatamab as single agent. The primary aiming is to evaluate the efficacy of elranatamab monotherapy in participants with relapsed refractory multiple myeloma (RRMM) who had received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy as evaluated with the rate of complete Response and Undetectable Measurable Residual Disease. Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators. primaryPurpose: TREATMENT masking: NONE maskingDescription: None (Open Label) count: 50 type: ESTIMATED name: Elranatamab (PF-06863135) measure: To evaluate the rate of Undetectable Measurable Residual Disease (uMRD) at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate annually by NGF until loss of response, the rate of Undetectable Measurable Residual Disease (% of patients with MRD negative by NGF method and with a sensitivity level of 10-5) of elranatamab in patients with R/R multiple myeloma. measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in laboratory values in blood and biochemistry tests. measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in physical examination and ECOG performance status scale (0-5). measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in vital sign measurements. measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by pregnancy test. measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in 12-lead ECG. measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in Echocardiogram / MUGA. measure: To determine Circulating Tumor Cells (CTC) at baseline to evaluate its prognostic value. measure: To determine serum BCMA levels and its correlation with response. measure: To do gene expression techniques (RNA sequencing and single cell sequencing studies) coupled with intelligent clinical and molecular data analysis (i.e. machine learning) to identify factors that could predict response to elranatamab. measure: To determine MRD value with alternative methods measure: To characterize patients' immune system measure: To define genomic determinants of response/resistance measure: To evaluate Overall Response Rate of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate Duration of Response of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate Time to first and best response of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate Progression-free survival (PFS) of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate Overall survival (OS) of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate PFS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate OS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate the Incidence of neurologic effects related to elranatamab in patients with relapsed/refractory multiple myeloma. measure: To evaluate the Incidence of cytopenias and infections related to elranatamab in patients with relapsed/refractory multiple myeloma. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínico Universitario de Santiago ~ CHUS status: NOT_YET_RECRUITING city: Santiago De Compostela state: A Coruña zip: 15706 country: Spain name: Marta Sonia Gonzalez Perez, MD role: CONTACT name: Marta Sonia Gonzalez Perez, MD role: PRINCIPAL_INVESTIGATOR lat: 42.88052 lon: -8.54569 facility: Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol status: NOT_YET_RECRUITING city: Badalona state: Barcelona zip: 08916 country: Spain name: Albert Oriol Rocafiguera, MD role: CONTACT name: Albert Oriol Rocafiguera, MD role: PRINCIPAL_INVESTIGATOR lat: 41.45004 lon: 2.24741 facility: Institut Catala d'Oncologia (ICO) Hospital Duran i Reynals status: NOT_YET_RECRUITING city: L'Hospitalet De Llobregat state: Barcelona zip: 08908 country: Spain name: Ana Sureda, MD role: CONTACT name: Ana Sureda, MD role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 facility: Hospital Universitario Marqués de Valdecilla status: NOT_YET_RECRUITING city: Santander state: Cantabria zip: 39008 country: Spain name: Enrique M Ocio San Miguel, MD role: CONTACT name: Enrique M Ocio San Miguel, MD role: PRINCIPAL_INVESTIGATOR lat: 43.46472 lon: -3.80444 facility: Hospital Universitario de Jerez de la Frontera status: NOT_YET_RECRUITING city: Jerez De La Frontera state: Cádiz zip: 11407 country: Spain name: Sebastian Garzon Lopez, MD role: CONTACT name: Sebastian Garzon Lopez, MD role: PRINCIPAL_INVESTIGATOR lat: 36.68645 lon: -6.13606 facility: Hospital Son Llàtzer status: NOT_YET_RECRUITING city: Palma De Mallorca state: Illes Balears zip: 07198 country: Spain name: Joan LL Bargay, MD role: CONTACT name: Joan LL Bargay, MD role: PRINCIPAL_INVESTIGATOR lat: 39.56939 lon: 2.65024 facility: CHU de Gran Canaria Doctor Negrín status: NOT_YET_RECRUITING city: Las Palmas De Gran Canaria state: Las Palmas zip: 35010 country: Spain name: Alexia T Suarez Cabrera, MD role: CONTACT name: Alexia T Suarez Cabrera, MD role: PRINCIPAL_INVESTIGATOR lat: 28.09973 lon: -15.41343 facility: Hospital HM Sanchinarro status: NOT_YET_RECRUITING city: Sanchinarro state: Madrid zip: 28050 country: Spain name: Jaime Perez de Oteysa, MD role: CONTACT name: Jaime Perez de Oteysa, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Clínico Universitario Virgen de la Arrixaca status: NOT_YET_RECRUITING city: El Palmar state: Murcia zip: 30120 country: Spain name: Begoña Navarro de Almenzar, MD role: CONTACT name: Begoña Navarro de Almenzar, MD role: PRINCIPAL_INVESTIGATOR lat: 37.93939 lon: -1.16095 facility: Clinica Universidad Navarra (CUN) status: NOT_YET_RECRUITING city: Pamplona state: Navarra zip: 31008 country: Spain name: Jesus San Miguel Izquierdo, MD role: CONTACT phone: +34 948 296 296 email: sanmiguel@unav.es name: Paula Rodriguez Otero, MD role: PRINCIPAL_INVESTIGATOR lat: 42.81687 lon: -1.64323 facility: H. Clínic i Provincial de Barcelona status: NOT_YET_RECRUITING city: Barcelona zip: 08036 country: Spain name: Joan Bladé, MD role: CONTACT phone: +34 932275428 email: jblade@clinic.cat name: Laura Rossiñol, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital de Cabueñes status: RECRUITING city: Gijón zip: 33394 country: Spain name: María Esther González García, MD role: CONTACT phone: + 34 985 18 50 00 name: María Esther González García, MD role: PRINCIPAL_INVESTIGATOR lat: 43.53573 lon: -5.66152 facility: Instituto de Investigación Sanitaria Hospital 12 de Octubre status: NOT_YET_RECRUITING city: Madrid zip: 28041 country: Spain name: Juan Jose Lahuerta, MD role: CONTACT phone: +34 91 779 28 39 email: jjlahuerta@telefonica.net lat: 40.4165 lon: -3.70256 facility: Hospital Clínico Universitario Salamanca status: RECRUITING city: Salamanca zip: 37007 country: Spain name: Mª Victoria Mateos, MD role: CONTACT phone: +34 923 291 100 phoneExt: 55384 email: mvmateos@usal.es name: Verónica González de la Calle, MD role: CONTACT phone: +34 923 291 100 phoneExt: 55629 email: vgcalle@saludcastillayleon.es name: Mª Victoria Mateos, MD role: PRINCIPAL_INVESTIGATOR lat: 40.96882 lon: -5.66388 facility: C.H. de Toledo (Virgen de la Salud) status: NOT_YET_RECRUITING city: Toledo zip: 45005 country: Spain name: Luis Felipe Casado Montero, MD role: CONTACT name: Luis Felipe Casado Montero, MD role: PRINCIPAL_INVESTIGATOR lat: 39.8581 lon: -4.02263 hasResults: False
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<|newrecord|> nctId: NCT06282965 id: AngT-001 briefTitle: Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury acronym: ANGel T overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-09 date: 2027-09 date: 2024-02-28 date: 2024-02-28 name: University of Arizona class: OTHER name: United States Department of Defense briefSummary: The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).
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The main questions this trial aims to answer are:
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* Is Angiotensin (1-7) safe?
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* Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?
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Participants will:
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* Complete 21 days of study treatment consisting of a once-daily injection.
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* Provide blood samples.
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* Undergo two magnetic resonance imaging (MRI) scans of the brain.
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* Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.
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Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Investigators, study site staff, participants, and caregivers will be unaware of the participant treatment assignments for the duration of the study. The pharmacist will prepare the study treatment and will be unmasked. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Angiotensin (1-7) name: Sterile saline measure: Number of participants with adverse events measure: Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) measure: Cognitive functions after Angiotensin (1-7) treatment as measured by the Montreal Cognitive Assessment (MoCA) measure: Function after Angiotensin (1-7) treatment, as measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) measure: Effects of Angiotensin (1-7) on acute CNS damage biomarker phosphorylated tau (p-tau) measure: Effects of Angiotensin (1-7) on CNS damage biomarker phosphorylated tau (p-tau) after 90 days measure: Effects of Angiotensin (1-7) on brain white matter integrity measure: Effects of Angiotensin (1-7) on length of hospital stay measure: Incidence and duration of delirium as assessed by the Confusion Assessment Method (CAM) measure: Change in suicidal ideation and behavior as assessed by the Patient Health Questionnaire (PHQ-9) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282952 id: 198/2023 briefTitle: NEwborn Infant of a Mother With Obesity - Fecal Microbiome Transplantation, RCT acronym: NEMO-FMT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2028-12-31 date: 2024-02-28 date: 2024-02-28 name: Oulu University Hospital class: OTHER name: University of Oulu name: University of Turku name: Turku University Hospital name: University of Helsinki name: Academy of Finland name: Biocenter Oulu briefSummary: The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section to obese mothers and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are:
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* Could fecal transplant be used improve gut microbiota and prevent overweight or obesity.
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* Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant. conditions: Fecal Microbiota Transplantation conditions: Cesarean Section conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The eligible women are randomized into two groups in which their newborns receive either fecal microbiota transplant from 1) their own mother (50 newborns) or 2) the Microbiome Biobank (50 newborns). The randomization 1:1 is done in blocks of 4 mothers. The study is double blinded. If mother has Group B streptococcus colonization or other infectious disease described in table 1, and microbiota transplant cannot be given or if mother will have non-elective-CS and the microbiome transplant is not available, the mother is included in 3) the observational cohort, which is "open" (not blinded). primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The research statistician performs the computer-generated randomization. The study nurse prepares the fecal transplant according to the randomization. Study participants or investigators are not aware of study group. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Fecal transplant measure: Microbial composition profiles in fecal sample measure: Height in centimeters measure: Height z-score measure: Weight in kilograms measure: Weight-for-length (%) measure: The source of colonization by exclusively shared genes (ESGs) sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06282939 id: 20234314 briefTitle: Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry acronym: OPTIMA overallStatus: RECRUITING date: 2023-11-01 date: 2026-12-01 date: 2027-12-01 date: 2024-02-28 date: 2024-02-28 name: HCA Healthcare Research Institute class: OTHER name: Balt USA briefSummary: This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System.
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The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures. conditions: Intracranial Aneurysm studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: OPTIMA and OPTIMAX Coils manufactured by Balt USA measure: Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score measure: Assess coiling alone or in combination with adjunctive devices for approximately 400 patients measure: Evaluate Coiling with flow diversion for approximately 200 subjects measure: Subgroup analyses will be performed examining: measure: Analyze outcomes of small aneurysms defined as smaller than 5mm measure: Adequate occlusion measure: Packing density measure: Complete occlusion measure: Complete occlusion measure: Recanalization rate measure: Retreatment rate measure: Change in degree of disability measure: The number of coils used in an aneurysm measure: Procedural fluoroscopic time measure: Primary Safety Endpoint measure: Secondary Safety Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Med City Plano status: RECRUITING city: Plano state: Texas zip: 75075 country: United States name: Albert Yoo role: CONTACT phone: 972-566-5411 email: ajyoo74@gmail.com name: Pauline Matheri role: CONTACT phone: 615-329-7274 email: Pauline.Matheri@HCAhealthcare.com lat: 33.01984 lon: -96.69889 hasResults: False
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<|newrecord|> nctId: NCT06282926 id: 324811 briefTitle: Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-09 date: 2024-02-28 date: 2024-02-28 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER name: Manchester Metropolitan University briefSummary: The main objective of this study is to evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair.
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As part of the validation study, the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers. Additionally, TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice, such as tricuspid annular plane systolic excursion (TAPSE), tissue Doppler imaging (TDI), fractional area change (FAC), and global longitudinal strain (GLS).
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Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements, particularly with GLS.
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The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition. The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase. conditions: Tetralogy of Fallot studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 72 type: ESTIMATED name: Echocardiography assessment measure: Evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair. measure: Evaluate the effects of chronic RV volume overload in this population within one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurement of GLS. measure: Compare TTE-3DKBR evaluation to the conventional 2D echocardiography measurements used in routine clinical practice (TAPSE, TDI, FAC, and GLS). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282913 id: ---Oncology-Nursing-2024--- briefTitle: The Effect of Mindfulness Meditation overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2025-12 date: 2024-02-28 date: 2024-02-28 name: Gulhane Training and Research Hospital class: OTHER_GOV briefSummary: Cancer is a disease that causes the most deaths worldwide and is challenging for patients and caregivers both physically and psychosocially. Physicians and nurses working in oncology clinics perform a demanding profession providing compassionate care and treatment to patients struggling with life-threatening diseases. The emotional cost of caring for patients diagnosed with cancer can lead to compassion fatigue, burnout, and decreased psychological well-being among healthcare professionals. For this reason, this research is planned as a randomized controlled study to examine the effect of Mindfulness meditation practice on compassion fatigue, burnout, and psychological well-being in physicians and nurses working in oncology units. conditions: Burnout conditions: Compassion Fatigue conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Mindfulness Meditation measure: compassion fatigue measure: burnout measure: psychological well-being measure: compassion fatigue measure: burnout measure: psychological well-being sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282900 id: 2024-1/15 briefTitle: Pain and Screen Addiction in University Students overallStatus: RECRUITING date: 2024-03-04 date: 2024-05 date: 2024-06 date: 2024-02-28 date: 2024-03-08 name: Acibadem University class: OTHER briefSummary: One of the most important factors why young people spend inactive time is the time they spend in front of the screen. Sedentary screen time refers to time spent using a screen-based device, such as a computer, television, smartphone, or tablet while being sedentary in any environment. The last decade has seen a disturbing increase in the amount of time young people spend in front of screens. Research shows that musculoskeletal disorders in the hand, wrist, arm, and neck occur at a high rate due to long-term and repetitive use of the smartphone, one of the electronic devices. People with musculoskeletal pain often complain of more than one area of pain.
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The primary purpose of this study is to investigate the relationship between university students' use of various screen-based devices, the time they spend in front of the screen, and the number of painful areas they report on the body. Our secondary aim is to evaluate the relationship between pain, and screen time, and physical activity level. conditions: Student studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: University students measure: Investigating the use of screen-based devices measure: Musculoskeletal system evaluation measure: Physical activity assessment sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Acibadem University status: RECRUITING city: Istanbul state: None Selected zip: 34752 country: Turkey name: Elif E Safran, asst. prof. role: CONTACT phone: 500 4047 phoneExt: 216 email: elif.bayraktar@acibadem.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06282887 id: 2021-IIT-002 briefTitle: Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and A Relevant Mediator overallStatus: RECRUITING date: 2021-11-09 date: 2024-11-10 date: 2024-11-10 date: 2024-02-28 date: 2024-02-28 name: Guangzhou Concord Cancer Center class: OTHER briefSummary: The primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through MRI scanning. Physiological data, such as pulse rates and respiration rates will be collected. Furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. The secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation. conditions: Psycho-Oncology studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: All participants will be wearing a headphone, and they will not know if there will be music until they experience and finish the scan process.
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Radiographers are blinding to avoid biases. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 80 type: ESTIMATED name: Music therapy measure: Anxiety measure: Symptom distress measure: Relaxation measure: Pulse rates measure: Respiration rate measure: Scanning efficiency measure: Patient satisfaction level measure: Patient attention to music (only for the music therapy group) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: GuangZhou Concord Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510700 country: China name: Juan Nie, Masters role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06282874 id: CTONG2303 briefTitle: Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-07-01 date: 2027-03-01 date: 2024-02-28 date: 2024-02-28 name: Guangdong Association of Clinical Trials class: OTHER briefSummary: This study is an investigator-initiated, prospective, open-label, single-arm, multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain/ leptomeningeal metastases. conditions: Carcinoma, Non-Small-Cell Lung conditions: Brain Metastases conditions: Leptomeningeal Metastasis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Lorlatinib measure: intracranial objective response rate（iORR） measure: Progression-free survival (PFS) and intracranial PFS（iPFS） measure: Obiective response rate (ORR) measure: Disease control rate (DCR) and intracranial disease control rate (iDCR) measure: Overall survival measure: Number of participants with adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial Perople's Hospital city: Guangzhou state: Other (Non U.s.) zip: 510080 country: China name: Chang Lu role: CONTACT phone: 02083827812 email: luchang@gdpg.org.cn name: Jin-Ji Yang role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06282861 id: ANTES B+ id: 2023-507304-32 type: EUDRACT_NUMBER briefTitle: ANTES B+ Clinical Trial acronym: ANTES B+ overallStatus: RECRUITING date: 2024-02-29 date: 2025-09 date: 2025-09 date: 2024-02-28 date: 2024-03-05 name: Fundacio Privada Mon Clinic Barcelona class: OTHER name: GlaxoSmithKline briefSummary: Current guidelines recommend initial treatment with dual long-acting bronchodilator therapy (LABA-LAMA) in patients with Chronic Obstructive Pulmonary Disease (COPD) of group B (defined by CAT≥10 and none or 1 moderate exacerbation). However, the investigators hypothesize that there is a subgroup of B patients (B+) at a particularly high risk for poor clinical control, characterized by the following:
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* 1 moderate exacerbation in the previous year
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* CAT≥10 despite current treatment with LABA -LAMA
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* Blood eosinophil levels of ≥150 cells/ml
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the investigators further hypothesize that B+ patients could benefit from triple therapy treatment (LABA-LAMA + Inhaled Corticosteroids). Therefore, the main goal of this clinical trial is to compare the efficacy of Trelegy (triple therapy) in improving clinical control in GOLD B+ patients with chronic obstructive disease when compared to standard double therapy (LABA -LAMA).
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The clinical control is a validated composite endpoint that includes two domains, the patient's stability, and the impact of the disease.
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1028 patients will be randomly allocated to receive either the standard therapy or Trelegy and will be monitored by the investigators for 1 year in 2 on-site visits + 2 remote visits. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV, open-label, prospective, pragmatic, interventional, randomized (1:1), multicenter, controlled, 12-month follow-up trial. primaryPurpose: PREVENTION masking: NONE count: 1028 type: ESTIMATED name: Trelegy Ellipta 100/62.5/25Mcg Inh 30D name: Brimica name: Duaklir name: Ultibro name: Ulunar name: Xoterna name: Anoro name: Laventair name: Spiolto Respimat name: Yanimo name: Foradil name: Broncoral name: Formoterol stada name: Oxis name: Formatris name: Formoterol Aldo name: Onbrez name: Oslif name: Hirobriz name: Striverdi name: Beglan name: Betamican name: Inaspir name: Serevent name: Soltel name: Eklira name: Bretaris name: Seebri name: Tovanor name: Enurev name: Spiriva name: Tavulus name: Sirkava name: Braltus name: Gregal name: Incruse name: Rolufta measure: Clinical Control (CC) measure: Clinical Important Deterioration (CID) measure: Patients persistently controlled measure: Time to deterioration measure: Time to no control event of CC - Stability Domain measure: Time to no control event of CC - Impact Domain measure: Time to deterioration event of CID-CAT Exacerbations measure: Time to deterioration event of CID-CAT Spirometry measure: Exacerbation rate measure: Time to first Exacerbation measure: Spirometry changes measure: Independent predictors sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínic Barcelona status: RECRUITING city: Barcelona state: Catalunya zip: 08036 country: Spain name: Àlvar Agustí role: CONTACT phone: 93 227 57 79 email: aagusti@clinic.cat name: Nestor Soler role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06282848 id: HongKongPU_Optometry4 briefTitle: Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate overallStatus: RECRUITING date: 2024-01-01 date: 2026-12 date: 2026-12 date: 2024-02-28 date: 2024-03-07 name: The Hong Kong Polytechnic University class: OTHER name: The University of Hong Kong briefSummary: The goal of this clinical trial is to compare pharmacological and non-pharmacological treatment effects on the children with different predicted myopia progression rate measured by modified multifocal electroretinogram. The main questions it aims to answer are:
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* the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates
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* the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.
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Participants will have baseline and follow-up eye examinations and given either pharmacological treatment with 0.05% atropine or non-pharmacological treatment with DIMS lens for myopia control.
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Researchers will compare the changes of refractive errors and axial length after different types of interventions and investigate the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid. conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Double-blinded whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Atropine 0.05% name: DIMS lens measure: Subjective refraction measure: Axial length measure: mfERG responses measure: Retinal and choroidal thickness sex: ALL minimumAge: 7 Years maximumAge: 9 Years stdAges: CHILD facility: School of Optometry, Hong Kong Polytechnic University status: RECRUITING city: Hong Kong zip: 00000 country: Hong Kong name: Henry HL Chan, PhD role: CONTACT phone: 85227667937 email: henryhl.chan@polyu.edu.hk name: Kaiyip Choi, PhD role: CONTACT phone: 85234002934 email: kaiyip.choi@polyu.edu.hk lat: 22.27832 lon: 114.17469 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-03-02 uploadDate: 2024-02-21T22:59 filename: ICF_000.pdf size: 234773 hasResults: False
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<|newrecord|> nctId: NCT06282835 id: 2023KY242 briefTitle: Eravacycline Combination Therapy for MRAB overallStatus: RECRUITING date: 2024-01-26 date: 2024-10-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Fujian Medical University Union Hospital class: OTHER briefSummary: The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.
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Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time conditions: Pulmonary Infection conditions: Pneumonia, Bacterial conditions: Acinetobacter Baumannii studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Eravacycline Injection measure: Clinical Responded Rate measure: The microbiological clearance rate measure: The all-cause mortality rate within 28 days measure: "Incidence Rate of Adverse Event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Medical University Union hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350000 country: China name: Hui Zhang, Phd role: CONTACT phone: 13015723860 email: xhzh@fjmu.edu.cn lat: 26.06139 lon: 119.30611 hasResults: False
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<|newrecord|> nctId: NCT06282822 id: HFpEF-SWE briefTitle: Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-31 date: 2025-03-01 date: 2024-02-28 date: 2024-02-28 name: First Hospital of China Medical University class: OTHER briefSummary: The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF. conditions: Shear Wave Elastography conditions: Heart Failure With Preserved Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Transthoracic echocardiography measure: Shear wave velocity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282809 id: CSP3325 briefTitle: The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy acronym: GANNON overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2026-01 date: 2024-02-28 date: 2024-04-11 name: HistoSonics, Inc. class: INDUSTRY briefSummary: The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy. conditions: Pancreas Cancer conditions: Adenocarcinoma of the Pancreas conditions: Pancreatic Cancer conditions: Tumor of Pancreas studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective multi-center, single-arm, feasibility trial. primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy measure: Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital de la Santa Creu i Sant Pau city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06282796 id: EPW-CABC-01 briefTitle: Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2028-12-31 date: 2024-02-28 date: 2024-02-28 name: First Hospital of China Medical University class: OTHER briefSummary: This multicenter clinical study aims to build an intelligent and accurate diagnosis and dynamic prediction and early warning model of cardiotoxicity due to anthracycline-based breast cancer chemotherapy, clarify the value of the early warning model in guiding the targeted prevention of myocardial protection, providing an important theoretical basis for reducing the mortality rate of breast cancer and improving the prognosis. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: Echocardiography measure: Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy. measure: Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy. sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Cancer Hospital status: RECRUITING city: Fuzhou state: Fujian country: China name: Weiqin Huang role: CONTACT lat: 26.06139 lon: 119.30611 facility: Dalian Friendship Hospital status: RECRUITING city: Dalian state: Liaoning country: China name: Bo Zhang role: CONTACT lat: 38.91222 lon: 121.60222 facility: Dalian Municipal Central Hospital status: RECRUITING city: Dalian state: Liaoning country: China name: Qingxiong Yue role: CONTACT lat: 38.91222 lon: 121.60222 facility: Liaoning Cancer Hospital & Institute status: RECRUITING city: Shenyang state: Liaoning country: China name: Xiaoxue Zhang role: CONTACT lat: 41.79222 lon: 123.43278 facility: The Third People's Hospital Of Chengdu status: RECRUITING city: Chengdu state: Sichuan country: China name: Min Xu role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06282783 id: 2024-511532-27-00 briefTitle: Studying Topiramate for Re-Activating the HIV-1 Reservoir acronym: STAR overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-04 date: 2025-08 date: 2024-02-28 date: 2024-02-28 name: Erasmus Medical Center class: OTHER briefSummary: Even with current HIV treatments, HIV is still a lifelong disease because it hides in some long-lasting cells in the body. One of the strategies to find a cure for HIV works by finding the virus in these cells, making it visible, and then getting rid of it. This is called the 'shock and kill' approach.
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So far, the drugs tested can find the virus, but they don't get rid of it completely. That's why there need to be new drugs that can do this more effectively. The Erasmus MC HIV Eradication Group (EHEG) has been testing new drugs in the lab and found a drug called topiramate can wake up the virus without harming the cells. The aim of this study is to test topiramate in people living with HIV.
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Most of the people that participate in HIV cure studies are men, even though most people living with HIV around the world are women. Previous research has shown that men and women might respond differently to these treatments. So, in this study, topiramate will be investigated in both men and women. This could help us find a cure that works for everyone. conditions: HIV-1-infection conditions: Hiv conditions: HIV Infections conditions: HIV I Infection studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Topiramate measure: Effect of topiramate as measured by cell-associated HIV RNA measure: Number of treatment-related adverse events as assessed by CTCAE v4.0 measure: Influence of sex on the primary outcome measures measure: The effect of topiramate on the size of the HIV reservoir measured by relevant assays sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Centre city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False
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<|newrecord|> nctId: NCT06282770 id: IRB#23-000444 briefTitle: Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery overallStatus: RECRUITING date: 2023-07-01 date: 2024-07-01 date: 2025-07-01 date: 2024-02-28 date: 2024-02-28 name: University of California, Los Angeles class: OTHER briefSummary: After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients.
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Many possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace. conditions: Spinal Fusion conditions: Chronic Lower Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients will come into clinic for consultation and enrollment in the study. They will have their first study visit where they will be given either and laser diode brace or a placebo brace. They will follow up with the physician after 2 weeks and then at 3, 6, 9 months and at 1 year to evaluate function and symptoms . primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants in this study will not be told which belt is the sham diode brace or which is the functional diode brace. The assessor of the study will also be blinded to which belt each subject has, and data will be analyzed blindly based on patient ID alone. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Laser Diode Brace name: Sham Laser Diode Brace measure: Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS measure: Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI measure: Stony Brook Scar Evaluation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Semel Institute of Neuroscience at UCLA status: RECRUITING city: Los Angeles state: California zip: 90024 country: United States name: Daniel Lu, MD, PhD role: CONTACT phone: 310-267-2975 email: DCLu@mednet.ucla.edu name: Mark Yamamoto, BS role: CONTACT phone: 424-535-9634 email: MTYamamoto@mednet.ucla.edu lat: 34.05223 lon: -118.24368 facility: UCLA Clinical and Translational Research Center status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Daniel Lu, MD, PhD role: CONTACT phone: 310-267-2975 email: DCLu@mednet.ucla.edu name: Adreanne Rivera, BS role: CONTACT phone: 424-946-5712 email: adreannerivera@mednet.ucla.edu lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06282757 id: 202302 briefTitle: Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-05-01 date: 2024-02-28 date: 2024-03-07 name: HAN University of Applied Sciences class: OTHER briefSummary: Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in patients with CMP.
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Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMP
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Study design: Web-based randomized controlled trial.
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Study population: 100 participants
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Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.
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Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ). conditions: Communication conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Video placebo communication name: Video nocebo communication measure: Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ) measure: Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ) measure: Change in openness to VR measured using a single question measure: Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HAN University of Applied Sciences city: Nijmegen state: Overijssel zip: 6525EN country: Netherlands name: Syl Slatman, MSc role: CONTACT phone: +31629684200 email: syl.slatman@han.nl lat: 51.8425 lon: 5.85278 hasResults: False
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<|newrecord|> nctId: NCT06282744 id: OPTIMAL Arabic version briefTitle: Cross Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Outpatient Physical Therapy Improvement in Movement Assessment Log acronym: OPTIMAL overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03 date: 2024-04 date: 2024-02-28 date: 2024-02-28 name: Cairo University class: OTHER briefSummary: Purpose of the study:
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To translate, culturally adapt, and to test the validity and reliability of the Outpatient Physical Therapy Improvement in Movement Assessment Log in Arabic speaking language. conditions: Physical Performance conditions: Outpatients studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 880 type: ESTIMATED name: Outpatient physical therapy improvement in movement assessment log measure: validity and reliability of the Egyptian Arabic language version of Outpatient Physical Therapy Improvement Movement Assessment Log on physical therapy outpatients. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282731 id: ECKIRB1020407 briefTitle: The Changes of Urine Growth Factors Level overallStatus: COMPLETED date: 2013-05-31 date: 2016-09-01 date: 2017-04-27 date: 2024-02-28 date: 2024-02-28 name: En Chu Kong Hospital class: OTHER briefSummary: The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia after medical treatment. conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 74 type: ACTUAL name: Silodosin measure: Urine growth factors level measure: Urine growth factors level measure: Urine growth factors level sex: MALE minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: En Chu Kong Hospital city: New Taipei City zip: 23702 country: Taiwan lat: 25.01111 lon: 121.44583 hasResults: False
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<|newrecord|> nctId: NCT06282718 id: POS-ARI-PC CORE and AUDIT id: 965313 type: OTHER_GRANT domain: European Union id: 10204126 type: REGISTRY domain: ISRCTN id: 55487 type: OTHER domain: NIHR CPMS id: 324504 type: OTHER domain: IRAS briefTitle: A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe acronym: POS-ARI-PC overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-03 date: 2026-03 date: 2024-02-28 date: 2024-02-28 name: European Clinical Research Alliance for Infectious Diseases (ECRAID) class: OTHER name: UMC Utrecht name: University of Oxford name: Universiteit Antwerpen briefSummary: Acute respiratory infection (ARI) is the commonest reason for consulting in community care. Furthermore, new and re-emerging pathogens are often first noticed in primary care (PC). The POS-ARI-PC study is a long-term study, with the aim of describing the nature of ARI in adults and children presenting to PC across Europe. The POS-ARI-PC study will provide critically important data on the presentation and management of ARI, and build a research-ready infrastructure for studies related to the treatment, diagnosis, and prevention of ARI in primary care settings. Additional observational studies will be embedded and use the infrastructure developed in POS-ARI-PC. conditions: Acute Respiratory Tract Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: Age Bands measure: The proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI) measure: Overall illness severity rating measure: Swab samples taken and retrospective viral/microbiological infection analysis performed (multiplex PCR) to identify potential causative pathogens. measure: Proportion undergoing POC (with results) and lab-based investigations measure: Details of prescriptions given on presentation of ARI measure: Details of tests ordered on presentation of ARI measure: Return to usual daily activities measure: Feeling recovered from RTI measure: Use of prescription medication measure: Use of over the counter medications measure: Complications reported associated to ARI presentation measure: Variation in practice and advice from national guidelines, to be fed back to national teams measure: Recommendations on how to improve study processes, recruitment and study communication based on shared understanding and insights from researchers, clinicians, and patients. measure: An understanding of the meaning of study results for European primary care, from the perspectives of clinicians and patients, and recommendations regarding the implementation of findings. measure: An understanding of changing health-seeking behaviour, management and expectations to inform clinical studies and trials measure: Approval for a study-specific appendix (SSA) or an intervention-specific appendix (ISA) of an embedded (non) randomised study for ARI in primary care associated with this POS, measured using the number of embedded studies to this POS-ARI-PC platform over sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06282705 id: 306347 briefTitle: Dose Response Effect of Drop Jumps on Bone Characteristics overallStatus: COMPLETED date: 2023-01-06 date: 2023-12-13 date: 2023-12-13 date: 2024-02-28 date: 2024-02-28 name: Nottingham Trent University class: OTHER briefSummary: The study aims to assess if a 16-week drop jump intervention from different heights shows different bone adaptations. Participants will complete four visits over a period of 16 weeks. An initial consultation will be conducted to ensure participants meet the inclusion criteria following participant recruitment. Estimated load being applied to the bone, will be assessed using non-invasive biomechanical procedures (Inertial Measurement Units, motion analysis, force plates) during drop jumps. Participants will be assigned a drop jump height of 0 cm, 30 cm or 60 cm based on a significant difference in external load at these heights or assigned to a control group where no jumps will be performed. Groups will be matched for body mass to ensure that jump height produces the load. The participants will be asked to perform 40 jumps (20 each side), 4 times per week ensuring jumping bouts are separated by 24 hours. Bone characteristics will be assessed via whole body dual-energy X-ray absorptiometry (DXA) scans and bilateral peripheral Quantitative Computed Tomography (pQCT) scans. Lab based jumping will take place on week 0, week 6, week 12, and week 16 to understand the loading applied during the different jump height groups. pQCT scans will take place on week 0, week 12, week 16 and DXA scans will take place week 0 and week 16. The reasoning of week 12 for pQCT being it may show a significant timepoint for bone formation during the remodelling cycle. During visits participants will complete a health screen, the Bone specific Physical Activity Questionnaire (BPAQ), a food frequency questionnaire and Pittsburgh sleep quality questionnaire alongside consent as tools to monitor any changes to participant lifestyle across the study. Differences in bone characteristics, lab measures and jump heights will be analysed between and within participants.
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The present study aims to use varied drop jump heights to identify an osteogenic dose response effect. Drop jumps have been previously used to expose osteogenic effects in research due to the load produced at impact. Is it possible to identify an optimum height for bone response during impact? If so do we then find anything above this height actually has negative or no effect on a group of individuals? conditions: Healthy Participants conditions: Low Activity Level studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Semi-randomised, matched model. primaryPurpose: BASIC_SCIENCE masking: NONE count: 48 type: ACTUAL name: Diagonal Drop Jumps 0cm name: Diagonal Drop Jumps 40cm name: Diagonal Drop Jumps 60cm measure: BMD as assessed by whole body dual-energy X-ray absorptiometry (DXA). measure: BMC as assessed by whole body dual-energy X-ray absorptiometry (DXA). measure: Total bone area as assessed by whole body dual-energy X-ray absorptiometry (DXA). measure: Trabecular density as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Cortical thickness as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Periosteal circumference as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Axial bone strength (SSIX) as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Axial bone strength (SSIY) as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Polar bone strength (SSIPOL) as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Cortical density as assessed by peripheral quantitative tomography (pQCT) of tibia. measure: Peak impact load as assessed by force plates. measure: Impulse as assessed by force plates. measure: Load rate as assessed by force plates. measure: Jump height as assessed by force plates. measure: Centre of Mass (CoM) velocity as assessed by force plates. measure: Peak acceleration as assessed by Inertial measurement units (IMU). measure: Stiffness as assessed by motion capture. measure: Moments as assessed by motion capture. sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Nottingham Trent University city: Nottingham state: Nottinghamshire zip: Ng11 8NS country: United Kingdom lat: 52.9536 lon: -1.15047 hasResults: False
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<|newrecord|> nctId: NCT06282692 id: UNAIR-MP-INAKTIF-R-005 briefTitle: INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old overallStatus: RECRUITING date: 2023-06-19 date: 2024-05-19 date: 2024-07-19 date: 2024-02-28 date: 2024-02-28 name: Dr. Soetomo General Hospital class: OTHER_GOV name: Indonesia-MoH name: Universitas Airlangga name: PT Biotis Pharmaceuticals, Indonesia briefSummary: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.
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INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents. conditions: COVID-19 Pandemic conditions: COVID-19 Vaccines studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE maskingDescription: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose.
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The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. count: 400 type: ESTIMATED name: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg measure: Vaccine Neutralizing Antibody Profile measure: Incidence of Adverse Events measure: Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum measure: Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA measure: Cellular Immunogenicity Profile measure: Persistence of Antibody Level measure: Whole Genome Sequencing (WGS) of SARS-CoV-2 sex: FEMALE minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Dr. Soetomo General Hospital status: RECRUITING city: Surabaya state: Jawa Timur zip: 67161 country: Indonesia name: Dominicus Husada, MD role: CONTACT phone: +6281232266377 email: dominicushusada@yahoo.com name: Damayanti Tinduh, MD role: CONTACT phone: +6281703293335 email: damayanti.tinduh@fk.unair.ac.id name: Dominicus Husada, MD role: PRINCIPAL_INVESTIGATOR name: Damayanti Tinduh, MD role: SUB_INVESTIGATOR name: Gatot Soegiarto, MD role: SUB_INVESTIGATOR name: Leny Kartina, MD role: SUB_INVESTIGATOR name: Laksmi Wulandari, MD role: SUB_INVESTIGATOR name: Deasy Fetarayani, MD role: SUB_INVESTIGATOR name: Novira Widajanti, MD role: SUB_INVESTIGATOR name: Yudi H Oktaviano, MD role: SUB_INVESTIGATOR name: Aryati Aryati, MD role: SUB_INVESTIGATOR name: Fitriah Munawaroh, MD role: SUB_INVESTIGATOR name: Neneng D Kurniati, MD role: SUB_INVESTIGATOR name: Budi Utomo, MD role: SUB_INVESTIGATOR name: Eko B Khoendori, MD role: SUB_INVESTIGATOR name: Jusak Nugroho, MD role: SUB_INVESTIGATOR name: Maria I Lusida, MD role: SUB_INVESTIGATOR lat: -7.24917 lon: 112.75083 hasResults: False
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<|newrecord|> nctId: NCT06282679 id: KY20220701-03 briefTitle: Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea overallStatus: RECRUITING date: 2022-04-01 date: 2024-03-01 date: 2024-06-28 date: 2024-02-28 date: 2024-02-28 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea. conditions: Rosacea conditions: Botulinum Toxin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Botulinum Toxin Type A Injection [Botox] measure: CEA score measure: GAIS score measure: VISIA red zone score measure: Dermatology Quality of Life Score (DLQI) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Jie Dai status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: jie dai role: CONTACT phone: 02552271117 email: karry_dj@126.com lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06282666 id: KE-0254/150/2019 briefTitle: Lumbar ESPB in Hip Replacement Surgery acronym: ESPB_HIP overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2025-02-01 date: 2025-08-01 date: 2024-02-28 date: 2024-02-28 name: Medical University of Lublin class: OTHER briefSummary: In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed. conditions: Coxarthrosis conditions: Pain, Postoperative conditions: Pain, Acute conditions: Pain, Chronic conditions: Postoperative Pain, Chronic conditions: Analgesia conditions: Quality of Life conditions: Anesthesia conditions: Spinal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups will be randomly allocated to Epidural and ESPB (1:1) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants will not be aware of the type of continuous blockade. Care providers, including doctors and nurses, will not be aware of patient allocation.
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Physiotherapists assessing outcomes will not be aware of patient allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Spinal anesthesia name: lumbar erector spinae plane block name: Epidural analgesia name: patient-controlled analgesia name: Timed Up and Go test name: neuropathic pain symptom inventory name: Lovett test name: Visual analog scale name: Quality of Recovery 40 name: Ability to sit, stand upright, and walk measure: Opiod consumtion with PCA measure: Pain at rest measure: Pain upon activity measure: Lovett test measure: TUG measure: QoR-40 measure: NPSI sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: II Department of Anesthesia and Intensive Care city: Lublin zip: 20-081 country: Poland name: Michał A Borys, M.D. Ph.D role: CONTACT phone: 506350569 phoneExt: +48 email: michalborys1@gmail.com name: Paweł Kutnik, M.D. role: CONTACT phone: 608769410 phoneExt: +48 email: pe.kutnik@gmail.com lat: 51.25 lon: 22.56667 hasResults: False
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