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protocolSection identificationModule nctId: NCT06263933, orgStudyIdInfo id: 2023-A01804-41, briefTitle: Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode, acronym: DIPEM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-11-13, completionDateStruct date: 2025-11-13, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Centre hospitalier de Ville-Evrard, France, class: OTHER, descriptionModule briefSummary: Controlled, prospective, qualitative and quantitative trial. The goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. This intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. Three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end., conditionsModule conditions: Psychotic Episode, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A control group and a intervention group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Insight Scale, interventions name: Semi-directional interviews, interventions name: routine care, interventions name: session of mutual assistance with a mediator psychologist, outcomesModule primaryOutcomes measure: The level of the increasing of The INSIGHT scale, secondaryOutcomes measure: The increase of Recovery Scale, secondaryOutcomes measure: The semi-structured interview, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Etablissement Public de Santé de Ville-Evrard, status: RECRUITING, city: Neuilly-sur-Marne, zip: 93330, country: France, contacts name: Rusheenthira Thavaseelan, role: CONTACT, phone: 0143093232, phoneExt: 033, email: r.thavaseelan@epsve.fr, contacts name: Dominique Januel, role: CONTACT, phone: 0143093232, phoneExt: 033, email: d.januel@epsve.fr, contacts name: Dominique Januel, Pr, role: PRINCIPAL_INVESTIGATOR, contacts name: Ilona Arcomano, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 48.85373, lon: 2.54903, hasResults: False |
protocolSection identificationModule nctId: NCT06263920, orgStudyIdInfo id: 288703, briefTitle: Neurofrailty: A Study of Late-onset Epilepsy and Its Associations, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-05, primaryCompletionDateStruct date: 2027-01-12, completionDateStruct date: 2027-01-12, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Lancashire Teaching Hospitals NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: We don't know a great deal about why some people develop seizures in adulthood, but some researchers think that it might tell us something about the brain. A small number of people with first seizure in adulthood go on to experience problems like stroke or dementia later in life. However, stroke and dementia are common diseases, so we don't know whether there is a real association between these conditions. When people develop their first seizure in adult life, this is sometimes called Late-Onset Epilepsy. Through the NeuroFrailty study, we will observe 'brain health' over the years following the onset of a seizure, and I hope that it might give us more information about people with these kinds of seizures.The NeuroFrailty study involves observing people from the time of diagnosis of first seizure. At this time, we will look at investigations such as blood tests, blood pressure, brain scans, alongside other diagnoses which might tell us whether there are differences compared to people without seizures. For some people, we will also look in greater depth at lifestyle including exercise, driving, family planning, and memory assessments.Over the following years, we will look at how things change: for example whether there are changes in memory, new diagnoses, medication changes and how lifestyle has changed. Because there is so little research in this area, it is very difficult to predict what might happen. For example, some people can experience worse memory because of medication side effects; on the other hand, good seizure control following a diagnosis can sometimes lead to improved memory. Over years, it may become clear that some diseases are more likely in people with late-onset epilepsy than in people without such a diagnosis. You will receive a yearly newsletter to keep you updated on everything we learn about late-onset epilepsy.Purpose and BackgroundMost of the time, we do not know why an adult develops epilepsy. Some researchers think there may be a connection between epilepsy which starts in adulthood, and increased risk of stroke or dementia in the future. However, there is very little research or evidence in this area, so we cannot say whether this is true.What does taking part involve?This study is an observational study, which means that the management of participants' seizure disorder will not be affected if they choose to take part in this study. The purpose of this study is to watch participants over the course of several years, to find out more about seizures which start in adulthood.Participants can choose the level of involvement that is right for them.1. LOW involvement. A researcher will check hospital and General Practice (GP records) once or twice per year, for the LIMITED AND SPECIFIC purpose of checking: medications, any new diagnoses, investigations associated with stroke risk (such as cholesterol, blood pressure, heart trace) and any brain scans that have been performed. I will not have access to more detailed information, such as conversations between a participant and their GP.2. HIGH involvement. This involves being contacted by telephone once per year for 15-30 minutes to ask questions assessing memory and enquiring about lifestyle, such as exercise, smoking and alcohol use.3. VERY HIGH involvement. These participants will be contacted for a longer telephone conversation 30-45 minutes once per year about their experience of how epilepsy has affected home life, work and medications.If someone decides in the future that they don't want to be involved, they can withdraw from the study. However, once the study is completely finished, the information will be completely anonymous, which means that I won't be able to find individual's information in order to delete it.Glossary Seizure disorder = any disorder which involved having experienced at least one seizure. First seizure and epilepsy both can be classed as a form of seizure disorder.Neurofrailty = A condition whereby a person is at risk of stroke or dementia., conditionsModule conditions: Late Onset Epilepsy, conditions: Stroke, conditions: Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population?, primaryOutcomes measure: Quality of Life - how of chronic illness is mediated, secondaryOutcomes measure: What is the absolute and relative incidence of stroke and dementia in people after the onset of LOE compared to the background population?, secondaryOutcomes measure: Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lancashire Teaching Hospitals NHS, status: RECRUITING, city: Preston, state: Lancashire, zip: PR2 9HT, country: United Kingdom, contacts name: Kina Bennett, role: CONTACT, phone: (+44) 01772 522031, email: kina.bennett@lthtr.nhs.uk, contacts name: Research Access, role: CONTACT, email: research.access@lthtr.nhs.uk, contacts name: Jasmine Wall, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.76282, lon: -2.70452, hasResults: False |
protocolSection identificationModule nctId: NCT06263907, orgStudyIdInfo id: stellate ganglion block, briefTitle: Stellate Ganglion Block for Prevention of Post Mastectomy Depression, acronym: SGB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: Complications after mastectomy include chronic pain and depression., conditionsModule conditions: Mastectomy, conditions: Pain, Acute, conditions: Pain, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomization into two equal groups using computer-generated random numbers prior to surgery of 70 each; Group S: will receive ipsilateral stellate gangalion block and Group C: will receive no block., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: The anesthesiologist, who will be responsible for opening the envelope and do the block or not according to the group besides, evaluation of its success and covering the skin over the site of ipsilateral stellate gangalion with sterile dressing in both groups, will not be involved in data collection., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Stellate gangalion block, outcomesModule primaryOutcomes measure: incidence of postmastectomy depression, secondaryOutcomes measure: incidence of postmastectomy depression, secondaryOutcomes measure: the need for postoperative antidepressant, secondaryOutcomes measure: acute postoperative pain at the incision site (breast and the axilla), secondaryOutcomes measure: chronic postmastectomy pain at the incision site, secondaryOutcomes measure: incidence of nausea and vomiting, secondaryOutcomes measure: Functional pain in the ipsilateral shoulder, secondaryOutcomes measure: Any complications related to stellate ganglion injection, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06263894, orgStudyIdInfo id: MarmaraU-Ebe-ZDY-01, briefTitle: Alexander Technique on Labor Pain and Anxiety, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-02, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, collaborators name: The Scientific and Technological Research Council of Turkey, descriptionModule briefSummary: This study will examine the effect of the Alexander Technique on labor pain and anxiety during labor. This study is designed as a randomized controlled experimental study. The population of the study consists of primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura City Hospital, D-Block Maternity Hospital between November 2023 and May 2024. In calculating the sample size, G\*Power (3.1.9.6) program was used to calculate the sample size with an error of 0.05, effect level of 0.5, power of 95%, and the required sample size for 2 groups was calculated as 34 people for each group with a total of 68 people., conditionsModule conditions: Labor Pain, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One experimental group and one conventional (control) group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: In order to reduce selection bias in determining the experimental and control groups, a computer-assisted randomization program (https://www.randomizer.org) will be used for pregnant women who meet the inclusion criteria., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Experimental group, outcomesModule primaryOutcomes measure: Decreasing labor pain, primaryOutcomes measure: Decreasing anxiety, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Başakşehir Çam and Sakura City Hospital, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Ayşen Özgür, role: CONTACT, phone: +905393806296, email: aysenozgurr@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06263881, orgStudyIdInfo id: MMH-407-009, briefTitle: Clinical Trial of the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Materia Medica Holding, class: INDUSTRY, descriptionModule briefSummary: Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial., conditionsModule conditions: Community-acquired Pneumonia, conditions: Pneumonia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 370, type: ESTIMATED, armsInterventionsModule interventions name: Raphamin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of patients with clinical cure at the test of cure (TOC) visit, secondaryOutcomes measure: Average duration of antibacterial therapy, otherOutcomes measure: Proportions of patients with a positive response to the initial course of antibiotic therapy after 48-72 hours, otherOutcomes measure: Proportion of patients who discontinue antibiotic therapy after 7 days of treatment (based on physician assessment of clinical symptoms)., otherOutcomes measure: Proportion of patients who required a change in antibiotic 48-72 hours after initiation of therapy., otherOutcomes measure: Time until a persistent decrease in body temperature ≤37.2ºС (according to the patient's diary)., otherOutcomes measure: Proportion of patients who required a second course of antibiotic therapy., otherOutcomes measure: Proportion of patients who required hospitalization during 15 days of follow-up., otherOutcomes measure: Number of antipyretic drug doses taken during 7 days of the initial course of antibacterial therapy (per patient)., otherOutcomes measure: Proportion of patients without infiltration on x-ray/CT 14 days after randomization., otherOutcomes measure: The Presence of Adverse Events (AEs)., otherOutcomes measure: Changes in Vital Signs (Blood Pressure measured in mm Hg), otherOutcomes measure: Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute), otherOutcomes measure: Changes in Vital Signs (Respiratory Rate (Breathing Rate) measured in breaths per minute), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Medical Clinical Center named after N.A. Semashko Federal Medical and Biological Agency, status: RECRUITING, city: Arkhangelsk, zip: 163000, country: Russian Federation, contacts name: Vadim Arkhipovsky, PhD, MD, role: CONTACT, contacts name: Vadim Arkhipovsky, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 64.5401, lon: 40.5433, locations facility: Regional Clinical Hospital # 3, status: WITHDRAWN, city: Chelyabinsk, zip: 454018, country: Russian Federation, geoPoint lat: 55.15402, lon: 61.42915, locations facility: Ivanovo Clinical Hospital named after Kuvayevs, status: RECRUITING, city: Ivanovo, zip: 153025, country: Russian Federation, contacts name: Svetlana Ushakova, PhD, MD, role: CONTACT, contacts name: Svetlana Ushakova, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.99719, lon: 40.97139, locations facility: Central City Clinical Hospital, status: RECRUITING, city: Kaliningrad, zip: 236005, country: Russian Federation, contacts name: Vladimir Rafalsky, Prof., role: CONTACT, contacts name: Vladimir Rafalsky, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.70649, lon: 20.51095, locations facility: Kazan State Medical University/Department of Infectious Diseases, status: RECRUITING, city: Kazan, zip: 420012, country: Russian Federation, contacts name: Irina Kravchenko, MD, PhD, role: CONTACT, contacts name: Irina Kravchenko, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.78874, lon: 49.12214, locations facility: Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology, status: RECRUITING, city: Krasnodar, zip: 350063, country: Russian Federation, contacts name: Marina Avdeeva, Prof., role: CONTACT, contacts name: Marina Avdeeva, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.04484, lon: 38.97603, locations facility: Lomonosov Interdistrict Hospital named after. I.N. Yudchenko, status: RECRUITING, city: Lomonosov, zip: 188531, country: Russian Federation, contacts name: Svetlana Mosolova, MD, role: CONTACT, contacts name: Svetlana Mosolova, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.90612, lon: 29.77253, locations facility: Central Research Institute of Epidemiology, status: RECRUITING, city: Moscow, zip: 111123, country: Russian Federation, contacts name: Antonina Ploskireva, PhD, MD, role: CONTACT, contacts name: Antonina Ploskireva, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Moscow Regional Research Clinical Institute named after. M.F. Vladimirsky, status: RECRUITING, city: Moscow, zip: 129110, country: Russian Federation, contacts name: Svetlana Erofeeva, MD, PhD, role: CONTACT, contacts name: Svetlana Erofeeva, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko, status: RECRUITING, city: Nizhny Novgorod, zip: 603093, country: Russian Federation, contacts name: Vladimir Nosov, MD, PhD, role: CONTACT, contacts name: Vladimir Nosov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.32867, lon: 44.00205, locations facility: LLC "Persona group of companies", status: RECRUITING, city: Nizhny Novgorod, zip: 603155, country: Russian Federation, contacts name: Natalya Eremina, MD, PhD, role: CONTACT, contacts name: Natalya Eremina, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.32867, lon: 44.00205, locations facility: LLC "Professor's clinic", status: RECRUITING, city: Perm, zip: 614070, country: Russian Federation, contacts name: Svetlana Teplykh, MD, PhD, role: CONTACT, contacts name: Svetlana Teplykh, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 58.01046, lon: 56.25017, locations facility: LLC "4D Ultrasound Clinic", status: RECRUITING, city: Pyatigorsk, zip: 357502, country: Russian Federation, contacts name: Daria Saenko, MD, role: CONTACT, contacts name: MD, role: CONTACT, contacts name: Daria Saenko, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.04861, lon: 43.05944, locations facility: St. Petersburg Research Institute of Phthisiopulmonology, status: RECRUITING, city: Saint Petersburg, zip: 191036, country: Russian Federation, contacts name: Yana Startseva, MD, role: CONTACT, contacts name: Yana Startseva, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "Energy of Health", status: RECRUITING, city: Saint Petersburg, zip: 194156, country: Russian Federation, contacts name: Natalya Egorova, MD, role: CONTACT, contacts name: Natalya Egorova, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: City Multidisciplinary Hospital # 2, status: WITHDRAWN, city: Saint Petersburg, zip: 194354, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "Medical Clinic", status: RECRUITING, city: Saint Petersburg, zip: 194356, country: Russian Federation, contacts name: Maxim Bushara, MD, role: CONTACT, contacts name: Maxim Bushara, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "Research Center Eco-Safety", status: WITHDRAWN, city: Saint Petersburg, zip: 196143, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "Zvezdnaya Clinic", status: RECRUITING, city: Saint Petersburg, zip: 196158, country: Russian Federation, contacts name: Artem Sergeenko, MD, role: CONTACT, contacts name: Artem Sergeenko, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: City Pokrovskaya Hospital, status: RECRUITING, city: Saint Petersburg, zip: 199106, country: Russian Federation, contacts name: Oleg Khmelnitsky, PhD, MD, role: CONTACT, contacts name: Oleg Khmelnitsky, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "Meili", status: RECRUITING, city: Saint Petersburg, zip: 199406, country: Russian Federation, contacts name: Irina Nesterovich, PhD, MD, role: CONTACT, contacts name: Irina Nesterovich, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Samara State Medical University/Department of General and Clinical Microbiology, Immunology and Allergology, status: RECRUITING, city: Samara, zip: 443099, country: Russian Federation, contacts name: Alexander Zhestkov, Prof., role: CONTACT, contacts name: Alexander Zhestkov, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.20007, lon: 50.15, locations facility: Smolensk State Medical University, status: RECRUITING, city: Smolensk, zip: 214019, country: Russian Federation, contacts name: Roman Kozlov, Prof., role: CONTACT, contacts name: Roman Kozlov, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.7818, lon: 32.0401, locations facility: LLC "Scientific Medical Center of General Therapy and Pharmacology", status: RECRUITING, city: Stavropol, zip: 355000, country: Russian Federation, contacts name: Olga Ukhanova, Prof., role: CONTACT, contacts name: Olga Ukhanova, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.0428, lon: 41.9734, locations facility: Bashkir State Medical University/Department of Internal Medicine, status: RECRUITING, city: Ufa, zip: 450008, country: Russian Federation, contacts name: Khalida Gantseva, Prof., role: CONTACT, contacts name: Khalida Gantseva, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.74306, lon: 55.96779, locations facility: Regional Clinic Hospital, status: RECRUITING, city: Vladimir, zip: 600023, country: Russian Federation, contacts name: Mikhail Smirnov, MD, role: CONTACT, contacts name: Mikhail Smirnov, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.13655, lon: 40.39658, locations facility: Voronezh Regional Clinical Hospital # 1, status: RECRUITING, city: Voronezh, zip: 394066, country: Russian Federation, contacts name: Natalya Kostina, PhD, MD, role: CONTACT, contacts name: Natalya Kostina, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.67204, lon: 39.1843, locations facility: Clinical Hospital # 2, status: RECRUITING, city: Yaroslavl, zip: 150030, country: Russian Federation, contacts name: Andrey Arshinov, Prof., role: CONTACT, contacts name: Andrey Arshinov, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.62987, lon: 39.87368, locations facility: LLC "Medical Center for Diagnostics and Prevention Plus", status: RECRUITING, city: Yaroslavl, zip: 150040, country: Russian Federation, contacts name: Ekaterina Melnikova, MD, PhD, role: CONTACT, contacts name: Ekaterina Melnikova, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False |
protocolSection identificationModule nctId: NCT06263868, orgStudyIdInfo id: 69HCL23_1090, secondaryIdInfos id: 2023-A02313-42, type: OTHER, domain: ID-RCB, briefTitle: First Observatory of Precocious Puberty., acronym: PAPPEL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.Due to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.The establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.The investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data., conditionsModule conditions: Puberty, Precocious, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 3360, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of recruited patients with at least 80% of the main data collected, primaryOutcomes measure: Missing data rate, primaryOutcomes measure: At least 75% of patients included, eligibilityModule sex: ALL, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: Clinique du Val d'Ouest, city: Ecully, state: Auvergne-Rhône-Alpes, zip: 69130, country: France, contacts name: Emilie Doye, MD, role: CONTACT, phone: 0472118890, phoneExt: 33, email: emilie.doye@chu-lyon.fr, contacts name: Emilie Doye, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77726, lon: 4.77481, locations facility: Clinique du Val d'Ouest, city: Ecully, state: Auvergne-Rhône-Alpes, zip: 69130, country: France, contacts name: Emilie Beaufils, MD, role: CONTACT, phone: 0658187556, phoneExt: 33, email: pediatre.beaufils@gmail.com, contacts name: Emilie Beaufils, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77726, lon: 4.77481, locations facility: Clinique du Val d'Ouest, city: Ecully, state: Auvergne-Rhône-Alpes, zip: 69130, country: France, contacts name: Mélanie Daval Cote, MD, role: CONTACT, phone: 0472193310, phoneExt: 33, email: drdavalcote@yahoo.fr, contacts name: Mélanie Daval Cote, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77726, lon: 4.77481, locations facility: Pediatric practice, city: Lyon, state: Auvergne-Rhône-Alpes, zip: 69006, country: France, contacts name: Prisca DEALBERTI, MD, role: CONTACT, phone: 04 72 83 50 01, phoneExt: 33, email: dr.dealberti@gmail.com, contacts name: Prisca DEALBERTI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Clinique Saint jean, city: Lyon, state: Auvergne-Rhône-Alpes, zip: 69008, country: France, contacts name: Aude Mariani Ecochard, MD, role: CONTACT, phone: 0681560894, phoneExt: 33, email: docteurmariani@yahoo.com, contacts name: Aude Mariani Ecochard, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Pediatric practice, city: Rennes, state: Bretagne, zip: 35200, country: France, contacts name: Livie CHATELAIS, MD, role: CONTACT, phone: 02 99 86 77 57, phoneExt: 33, email: lchatelais@yahoo.fr, contacts name: Livie CHATELAIS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Pediatric practice, city: Chambray-lès-Tours, state: Centre-Val De Loire, zip: 37170, country: France, contacts name: Caroline HASSELMAN, MD, role: CONTACT, phone: 02 46 65 07 45, phoneExt: 33, email: chasselmann@mac.com, contacts name: Caroline HASSELMAN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.33537, lon: 0.70286, locations facility: Pediatric practice, city: Essey-lès-Nancy, state: Grand Est, zip: 54270, country: France, contacts name: Julie AUGER, MD, role: CONTACT, phone: 03 83 21 01 11, phoneExt: 33, email: dr.augerjulie@gmail.com, contacts name: Julie AUGER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.70179, lon: 6.22425, locations facility: Pediatric practice, city: Levallois-Perret, state: Hauts-de-Seine, zip: 92300, country: France, contacts name: Delphine ZENATY, MD, role: CONTACT, phone: 01 70 83 61 23, phoneExt: 33, email: delphine.revco@gmail.com, contacts name: Delphine ZENATY, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.89389, lon: 2.28864, locations facility: Pediatric practice, city: Paris, state: Ile-de-France, zip: 75116, country: France, contacts name: Mélanie AMOUYAL, MD, role: CONTACT, phone: 01 45 25 70 11, phoneExt: 33, email: dramouyal.endocrinoped@gmail.com, contacts name: Mélanie AMOUYAL, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Pediatric practice, city: Fondettes, state: Indre-et-Loire, zip: 37230, country: France, contacts name: Myriam BOUILLO, MD, role: CONTACT, phone: 02 47 66 45 52, phoneExt: 33, email: myriam.bouillo@orange.fr, contacts name: Myriam BOUILLO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.4035, lon: 0.59686, locations facility: Polyclinique Bordeaux rive droite, city: Lormont, state: Nouvelle-Aquitaine, zip: 33310, country: France, contacts name: Aurélie LACOSTE RODRIGUE, MD, role: CONTACT, email: dr.aurelielacoste@free.fr, contacts name: Aurélie LACOSTE RODRIGUE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.87495, lon: -0.51782, locations facility: Pediatric practice, city: Pau, state: Nouvelle-Aquitaine, zip: 64000, country: France, contacts name: Catie CESSANS, MD, role: CONTACT, phone: 06 15 82 62 59, phoneExt: 33, email: pediatre.cessans@gmail.com, contacts name: Catie CESSANS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.3, lon: -0.36667, locations facility: Pediatric Practice, city: Pessac, state: Nouvelle-Aquitaine, zip: 33600, country: France, contacts name: Olivier PUEL, MD, role: CONTACT, phone: 0556453585, phoneExt: 33, email: opuel@free.fr, contacts name: Olivier PUEL, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.81011, lon: -0.64129, locations facility: Clinique rive gauche, city: Toulouse, state: Occitanie, zip: 31300, country: France, contacts name: Adelaïde DURAND, MD, role: CONTACT, phone: 05 67 77 51 31, phoneExt: 33, email: dr.durand@cliniquerivegauche.fr, contacts name: Adelaïde DURAND, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Pediatric practice, city: Saint-Nazaire, state: Pays De La Loire, zip: 44600, country: France, contacts name: Isabelle GUEMAS, MD, role: CONTACT, phone: 02 40 53 88 91, phoneExt: 33, email: isabelleguemas@gmail.com, contacts name: Isabelle GUEMAS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.28333, lon: -2.2, locations facility: Pediatric practice, city: Trélazé, state: Pays De La Loire, zip: 49800, country: France, contacts name: Julie CHEIGNON, MD, role: CONTACT, phone: 02 41 79 08 09, phoneExt: 33, email: julie.cheignon@wanadoo.fr, contacts name: Julie CHEIGNON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.44565, lon: -0.4654, locations facility: Pediatric practice, city: Aix-en-Provence, state: Provence-Alpes-Côte d'Azur, zip: 13090, country: France, contacts name: Céline CASTAINGS-CARLIOZ, MD, role: CONTACT, phone: 06 20 70 02 99, phoneExt: 33, email: celine.carlioz@yahoo.fr, contacts name: Céline CASTAINGS-CARLIOZ, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.5283, lon: 5.44973, locations facility: Pediatric practice, city: Marseille, state: Provence-Alpes-Côte d'Azur, zip: 13008, country: France, contacts name: Hélène Bellon, MD, role: CONTACT, phone: 04 86 97 40 13, phoneExt: 33, email: h.bellon@sfr.fr, contacts name: Hélène Bellon, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Pediatric practice, city: Nice, state: Provence-Alpes-Côte d'Azur, zip: 06000, country: France, contacts name: Frédérique GASTAUD, MD, role: CONTACT, phone: 04 93 13 85 17, phoneExt: 33, email: docteurgastaud.frederique@orange.fr, contacts name: Frédérique GASTAUD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Pediatric practice, city: Marseille, state: Provence-Alpes-Côte-d'Azur, zip: 13012, country: France, contacts name: Catherine BRUE FABRE, role: CONTACT, phone: 04 91 49 29 35, phoneExt: 33, email: catherine.brue@gmail.com, contacts name: Catherine BRUE FABRE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Hôpital Femme Mère Enfant, Hospices civils de Lyon, city: Bron, zip: 69677, country: France, contacts name: Emilie Doye, MD, role: CONTACT, phone: 0472118890, email: emilie.doye@chu-lyon.fr, contacts name: Emilie Doye, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Pediatric practice, city: Paris, state: Île-De-France, zip: 75010, country: France, contacts name: Capucine VIGNON SAVOYE, MD, role: CONTACT, phone: 09 80 46 71 19, phoneExt: 33, email: capucinevignon@free.fr, contacts name: Capucine VIGNON SAVOYE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Pediatric practice, city: Paris, state: Île-De-France, zip: 75011, country: France, contacts name: Isabelle FLECHTNER, MD, role: CONTACT, phone: 01 43 55 17 17, phoneExt: 33, email: drflechtner@gmail.com, contacts name: Isabelle FLECHTNER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Pediatric practice, city: Paris, state: Île-De-France, zip: 75017, country: France, contacts name: Maxime GERARD, MD, role: CONTACT, phone: 06 37 63 83 07, phoneExt: 33, email: m.gerard.endocped@gmail.com, contacts name: Maxime GERARD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06263855, orgStudyIdInfo id: 24-000352, briefTitle: Effect of Large Language Model in Assisting Discharge Summary Notes Writing for Hospitalized Patients, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This pilot study aims to assess the feasibility of carrying out a full-scale pragmatic, cluster-randomized controlled trial which will investigate whether discharge summary writing assisted by a large language model (LLM), called CURE (Checker for Unvalidated Response Errors), improves care delivery without adversely impacting patient outcomes., conditionsModule conditions: Large Language Model, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1015, type: ESTIMATED, armsInterventionsModule interventions name: CURE, outcomesModule primaryOutcomes measure: Rate of patient accrual, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06263842, orgStudyIdInfo id: KFSIRB200-132, briefTitle: Elamrousy Novel Approach of Socket Shield Technique, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2025-02-10, completionDateStruct date: 2025-02-20, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with xenograft.The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using socket shield protocol, while group II patients underwent the same procedure, but the shield/fixture jumping gap was grafted by xenograft. finally group III was grafted by AWTG that was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect., conditionsModule conditions: Implant Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using SSA protocol without grafting, while group II was grafted by xenograft, but group II was grafted with AWTG was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect. Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: neither participant nor the outcome assessor know the group distribution, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: modified Elamrousy approach for socket shield technique, interventions name: conventional socket shield, interventions name: combined socket shild with xenograft, outcomesModule primaryOutcomes measure: Stability Quotient of dental implant (SQDI), primaryOutcomes measure: pink esthetic score (PES), primaryOutcomes measure: Midfacial Mucosal Alterations, secondaryOutcomes measure: facial marginal bone level (FMBL), eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Walid Elamrousy, status: RECRUITING, city: Kafr Ash Shaykh, zip: 76130, country: Egypt, contacts name: walid elamrousy, phd, role: CONTACT, phone: +201005724781, email: Waled_Hammed@den.kfs.edu.eg, contacts name: mostafa fayed, bachelor, role: CONTACT, phone: +201063376252, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False |
protocolSection identificationModule nctId: NCT06263829, orgStudyIdInfo id: 2023-1580, briefTitle: HCV Tappt Adherence Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, collaborators name: Synchronyx, collaborators name: American Society of Health-System Pharmacists, descriptionModule briefSummary: The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting.* The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion, sustained virologic response (SVR) assessment, and SVR achievement rates.* The secondary aim is to assess the efficacy of Tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and SVR achievement.Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period.Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm., conditionsModule conditions: Hepatitis C, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Use of Tappt App, outcomesModule primaryOutcomes measure: Medication adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06263816, orgStudyIdInfo id: CARVECIR, briefTitle: Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial, acronym: CARVECIR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-15, primaryCompletionDateStruct date: 2029-10-15, completionDateStruct date: 2030-06-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Tours, class: OTHER, collaborators name: Centre Hospitalier Universitaire Amiens Picardie, collaborators name: Centre Hospitalier Universitaire Angers, collaborators name: Assistance Publique Hopitaux Paris BEAUJON, collaborators name: Centre Hospitalier Universitaire Caen, collaborators name: Centre Hospitalier intercommunal de Créteil, collaborators name: Hospices Civils de Lyon, collaborators name: Centre Hospitalier Universitaire Grenoble, collaborators name: Centre Hospitalier Universitaire Haut Lévêque, collaborators name: Centre Hospitalier Régional Universitaire Lille, collaborators name: Centre Hospitalier Universitaire Jean Minjoz, collaborators name: Assistance Publique Hopitaux Paris AVICENNE, collaborators name: Centre Hospitalier Universitaire Clermont Ferrand, collaborators name: Assistance Publique Hopitaux Paris LA PITIE SALPETRIERE, collaborators name: Centre Hospitalier Universitaire Pontchaillou, collaborators name: Assistance Publique Hopitaux Paris ST ANTOINE, collaborators name: Assistance Publique Hopitaux Paris PAUL BROUSSE, collaborators name: University Hospital, Montpellier, collaborators name: Assistance Publique Hopitaux Paris HENRI MONDOR, collaborators name: Centre Hospitaliser Départemental de Vendée, collaborators name: Nantes University Hospital, collaborators name: Centre Hospitalier Universitaire Dijon, collaborators name: CHU de Reims, collaborators name: Hôpitaux Universitaires de Strasbourg, collaborators name: University Hospital, Toulouse, descriptionModule briefSummary: Decompensation of cirrhosis is a turning point in cirrhosis course, as associated with a marked decrease in life expectancy. Thus, prevention of decompensation is crucial.The usefulness of carvedilol to prevent decompensation of cirrhosis in patients with TE-LSM ≥ 25 kPa as a surrogate marker for clinically significant portal hypertension, has never been evaluated in a clinical trial., conditionsModule conditions: Asymptomatic Cirrhosis, conditions: Clinically Significant Portal Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will be a national multicentric, phase III, superiority double-blinded randomized controlled trial with two parallel arms: carvedilol versus placebo. The primary end-point will be assessed by the local investigator (hepatologist), blinded of the randomization arm, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 290, type: ESTIMATED, armsInterventionsModule interventions name: Experimental group: Patients will be treated with carvedilol., interventions name: Control group: Patients will receive a placebo., outcomesModule primaryOutcomes measure: To evaluate the effect of low dose carvedilol (<=12.5 mg per day) versus placebo on the occurrence of decompensation of cirrhosis or liver-related death at 36 months, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens Picardie, city: Amiens, country: France, contacts name: NGUYEN KHAC Eric, Dr, role: CONTACT, email: nguyen-khac.eric@chu-amiens.fr, geoPoint lat: 49.9, lon: 2.3, locations facility: CHU Angers, city: Angers, country: France, contacts name: OBERTI FREDERIC, role: CONTACT, email: froberti@chu-angers.fr, geoPoint lat: 47.46667, lon: -0.55, locations facility: CHU Beaujon, city: Assistance Publique Hôpitaux De Paris, country: France, contacts name: RAUTOU PIERRE EMMANUEL, Dr, role: CONTACT, email: pierre-emmanuel.rautou@aphp.fr, locations facility: CHU Jean Minjoz, city: Besançon, country: France, contacts name: WEIL DELPHINE, Dr, role: CONTACT, email: dweil@chu-besancon.fr, geoPoint lat: 47.24878, lon: 6.01815, locations facility: CHU Haut Lévêque, city: Bordeaux, country: France, contacts name: DE LEDINGHEN VICTOR, Dr, role: CONTACT, email: victor.deledinghen@chu-bordeaux.fr, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Caen, city: Caen, country: France, contacts name: OLLIVIER-HOURMAND Isabelle, Dr, role: CONTACT, email: ollivierhourmand-i@chu-Caen.fr, geoPoint lat: 49.18585, lon: -0.35912, locations facility: CH intercommunal de Créteil, city: CH Intercommunal De Créteil, country: France, contacts name: ROSA ISABELLE, dR, role: CONTACT, email: isabelle.rosa@chi-creteil.fr, locations facility: CHU Clermont Ferrand, city: Clermont Ferrand, country: France, contacts name: ABERGEL ARMAND, Dr, role: CONTACT, email: aabergel@chu-clermontferrand.fr, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Hôpital Henri Mondor, city: Créteil, country: France, contacts name: LEROY Vincent, Dr, role: CONTACT, email: vincent.leroy2@aphp.fr, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Hôpital Francois Mitterrand, city: Dijon, country: France, contacts name: MINELLO Anne, Dr, role: CONTACT, email: anne.minello@chu-dijon.fr, geoPoint lat: 47.31667, lon: 5.01667, locations facility: CHU Grenoble, city: Grenoble, country: France, contacts name: HILLERET Marie-Noelle, Dr, role: CONTACT, email: mnhilleret@chu-grenoble.fr, geoPoint lat: 45.16667, lon: 5.71667, locations facility: Centre Hospitalier départemental de Vendée, city: La Roche-sur-Yon, country: France, contacts name: LAGIN Ludovic, Dr, role: CONTACT, email: ludovic.lagin@ght85.fr, geoPoint lat: 46.66667, lon: -1.43333, locations facility: Hôpital Huriez, city: Lille, country: France, contacts name: LOUVET ALEXANDRE, Dr, role: CONTACT, email: alexandre.louvet@chru-lille.fr, geoPoint lat: 50.63297, lon: 3.05858, locations facility: CHU la Croix Rousse, city: Lyon, country: France, contacts name: LEBOSSE FANNY, Dr, role: CONTACT, email: fanny.lebosse@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, locations facility: CHU de Montpellier, city: Montpellier, country: France, contacts name: URSIC Jose, Dr, role: CONTACT, email: jose.ursicbedoya@chu-montpellier.fr, geoPoint lat: 43.61092, lon: 3.87723, locations facility: CHU Hôtel Dieu, city: Nantes, country: France, contacts name: ARCHAMBEAUD Isabelle, Dr, role: CONTACT, email: isabelle.archambeaud@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, locations facility: CHU Avicenne, city: Paris, country: France, contacts name: BLAISE LORAINE, Dr, role: CONTACT, email: lorraine.blaise@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Pitié-Salpêtrière, city: Paris, country: France, contacts name: THABUT DOMINIQUE, Dr, role: CONTACT, email: dominique.thabut@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Saint-Antoin, city: Paris, country: France, contacts name: OZENNE Violaine, Dr, role: CONTACT, email: violaine.ozenne@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU de Reims, city: Reims, country: France, contacts name: BERNARD CHABERT Brigitte, Dr, role: CONTACT, email: bbernard-chabert@chu-reims.fr, geoPoint lat: 49.25, lon: 4.03333, locations facility: CHU Pontchaillou, city: Rennes, country: France, contacts name: JEZEQUIEL Caroline, Dr, role: CONTACT, email: caroline.jezequiel@chu-rennes.fr, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Hôpitaux Universitaires de Strasbourg, city: Strasbourg, country: France, contacts name: TRIPON Simona, Dr, role: CONTACT, email: simona.tripon@chru-strasbourg.fr, geoPoint lat: 48.58392, lon: 7.74553, locations facility: CHU de Toulouse, city: Toulouse, country: France, contacts name: BUREAU Christophe, Dr, role: CONTACT, email: bureau.c@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Hôpital Paul Brousse, city: Villejuif, country: France, contacts name: KOUNIS Ilias, Dr, role: CONTACT, email: ilias.kounis@aphp.fr, geoPoint lat: 48.7939, lon: 2.35992, hasResults: False |
protocolSection identificationModule nctId: NCT06263803, orgStudyIdInfo id: Karataymusic, briefTitle: The Effect of Listening to Music on Chronic Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: KTO Karatay University, class: OTHER, descriptionModule briefSummary: The effects of passive music listening on pain, anxiety and quality of life in patients with chronic low back pain in addition to physical therapy will be examined., conditionsModule conditions: Pain, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: single, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Music listening, classic physical therapy, outcomesModule primaryOutcomes measure: Beck anxiety inventory, primaryOutcomes measure: Visual Analogue Scale, primaryOutcomes measure: Short From-36, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mustafa Savaş Torlak, status: RECRUITING, city: Karatay, state: Eyalet/Yerleşke, zip: 42000, country: Turkey, contacts name: Mustafa S Torlak, role: CONTACT, phone: +905373660138, email: mustafa.savas.torlak@karatay.edu.tr, geoPoint lat: 37.86726, lon: 32.52863, hasResults: False |
protocolSection identificationModule nctId: NCT06263790, orgStudyIdInfo id: NEOUNIPD1(2024), briefTitle: Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University Hospital Padova, class: OTHER, descriptionModule briefSummary: The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn., conditionsModule conditions: Neonatal Disease, conditions: Intubation; Difficult or Failed, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Intubating laryngeal mask, interventions name: Direct laryngoscopy, outcomesModule primaryOutcomes measure: Success at the first attempt, secondaryOutcomes measure: Time of device positioning, secondaryOutcomes measure: Participant's opinion on difficulty of the procedure, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06263777, orgStudyIdInfo id: P.T.REC/012/004142, briefTitle: Early Detection of Children With Developmental Disabilities in Assiut Governorate, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2021-03-15, completionDateStruct date: 2021-09-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Beni-Suef University, class: OTHER, descriptionModule briefSummary: The study aimed to determine the effectiveness of a designed training program for nurses toward early detection of developmental disabilities among children (0-3 years)., conditionsModule conditions: Developmental Disability, conditions: Development Delay, conditions: Motor Delay, conditions: Down Syndrome, conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ACTUAL, armsInterventionsModule interventions name: Nurses training program on early detection of disability, outcomesModule primaryOutcomes measure: Questionnaire of Screening and referral knowledge, primaryOutcomes measure: Questionnaire of Disability Perception, primaryOutcomes measure: questionnaire about Monitoring Practices, primaryOutcomes measure: Follow up, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tayseer Saber Abdeldayem, city: Banī Suwayf, state: Beni-Suef, zip: 62521, country: Egypt, geoPoint lat: 29.07441, lon: 31.09785, hasResults: False |
protocolSection identificationModule nctId: NCT06263764, orgStudyIdInfo id: 23-11-1954, briefTitle: The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: The goal of this quasi-experimental study is to evaluate the effect of listening to the Qur'an recital on quality of life among systemic lupus erythematosus patients. There will be intervention and control groups. Before the intervention, the quality of life of participants will be assessed using the Lupus-QoL questionnaire. After the baseline assessment, participants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days. The control group will not receive any specific intervention and will continue with their usual routine. After the 40-day intervention period, the quality of life of participants in both groups will be assessed using the Lupus-QoL questionnaire. The results will be analyzed to determine if there is a significant improvement in quality of life. Besides, potential confounding factors such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety/depression, comorbidities, age, and economic status will also be collected before and after intervention to evaluate its effect on the quality of life., conditionsModule conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Listening to Qur'an Recital, outcomesModule primaryOutcomes measure: Difference in Quality of Life Pre and Post Intervention, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine Universitas Indonesia -Cipto Mangunkusumo Hospital, Jakarta, Indonesia, status: RECRUITING, city: Jakarta, zip: 10430, country: Indonesia, contacts name: Alvina Widhani, PhD, role: CONTACT, phone: +6281905910034, email: alvina.widhani@gmail.com, contacts name: Karina Wijayanti, MD, role: CONTACT, phone: +6285226207270, email: karinawija@gmail.com, geoPoint lat: -6.21462, lon: 106.84513, hasResults: False |
protocolSection identificationModule nctId: NCT06263751, orgStudyIdInfo id: 202401096, secondaryIdInfos id: 24FIM1268045, type: OTHER_GRANT, domain: American Heart Association, briefTitle: Comparing the Effectiveness of Two Produce Prescription Approaches On Fruit and Vegetable Intake and Food Security, While Exploring Implementation Outcomes Such as Reach, Implementation, Sustainability, and Cost, acronym: NutriConnect, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: Schnuck Markets, Inc., collaborators name: BJC HealthCare, descriptionModule briefSummary: The produce prescription program is one type of food is medicine (FIM) programs, where healthcare providers "prescribe" fruits and vegetables (F\&V) to patients with low household incomes, experience food insecurity, and one or more diet-related diseases. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on F\&V intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes such as reach, sustainability, implementation, and cost., conditionsModule conditions: Food Insecurity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 240 patients will be randomized to three arms: "usual care," NutriConnect Credit, and NutriConnect Delivery with equivalent monetary value to credit. The interventions will last 6 months., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Due to the open study design, the NutriConnect team will not be able to have either patient or research coordinator/Schnucks intervention delivers blinded on group assignment. However, the assignment will be hidden from research faculty, the study biostatistician, and study analyst., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Product prescription program- NutriConnect Credit, interventions name: Product prescription program- NutriConnect Delivery, outcomesModule primaryOutcomes measure: change in F&V intake, secondaryOutcomes measure: Household food insecurity, otherOutcomes measure: Self-reported health status, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barnes Jewish Hospital, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Jing Li, MD, DrPH, MS, role: CONTACT, phone: 314-273-9386, email: l.jing@wustl.edu, contacts name: Adam Hively, MPH, role: CONTACT, phone: 6142021540, email: adamh@wustl.edu, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False |
protocolSection identificationModule nctId: NCT06263738, orgStudyIdInfo id: 2024-248, briefTitle: Cold and Heat Investigation to Lower Levels of Depression, acronym: CHILL'D, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Vail Health Behavioral Health, class: OTHER, collaborators name: Steadman Philippon Research Institute, descriptionModule briefSummary: This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments., conditionsModule conditions: Depression, conditions: Mood Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants who meet inclusion/exclusion criteria will be stratified by use of antidepressant medication and randomized with a 1-to-1 allocation to receive a single session of WBH or a single session of WBH followed immediately by cold plunge (WBH+cold)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The primary outcome data will be collected by trained raters blinded to participant group assignment and study visit number. The randomization list will be prepared by an unblinded study statistician and administered by study personnel with no other involvement in study activities. The participant will be blinded to their treatment assignment until the end of the WBH treatment, at which point they will be directed to either complete a cool-down period in the sauna device or proceed to the cold plunge., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Whole Body Hyperthermia, interventions name: Cold Water Plunge, outcomesModule primaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Warwick Edinburgh Mental Well-Being Scale (WEMWBS), secondaryOutcomes measure: Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety, secondaryOutcomes measure: Sheehan Disability Scale (SDS), secondaryOutcomes measure: Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vail Health Behavioral Health Innovation Center, city: Edwards, state: Colorado, zip: 81632, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 970-445-2489, email: BHIC@vailhealth.org, contacts name: Barry Sandler, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.64499, lon: -106.5942, hasResults: False |
protocolSection identificationModule nctId: NCT06263725, orgStudyIdInfo id: ALyster, briefTitle: Protein Restriction (PR) for Weight Loss, acronym: PR, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, descriptionModule briefSummary: Prolonged dietary protein restriction has been shown to increase energy expenditure in mice simultaneously with an increase in plasma FGF21 levels. In overfeeding studies, a protein-restricted diet reduces weight gain in both mice and humans compared with normal and high-protein diets. Further, in energy balance studies, when lean men are provided with a protein-restricted diet for five weeks, an increase in energy intake was necessary to obtain their body weight. However, whether the effect of a protein-restricted diet is the same when consumed by overweight to obese men has divergent results in both mice and humans., conditionsModule conditions: Diet, Healthy, Body Weight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: Restricted dietary protein, interventions name: Habitual diet, outcomesModule primaryOutcomes measure: Body weight, secondaryOutcomes measure: FGF21, eligibilityModule sex: MALE, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Copenhagen, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False |
protocolSection identificationModule nctId: NCT06263712, orgStudyIdInfo id: 2021-02504 (Project 2), briefTitle: Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 2, acronym: NePsyAssip HT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Bern, class: OTHER, descriptionModule briefSummary: The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment.The overall aim of project 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland).At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2.Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1., conditionsModule conditions: Inhibitory Control, conditions: Self Efficacy, conditions: Suicide Ideation, conditions: Suicide, Attempted, conditions: Locus of Control, conditions: Process Factors, conditions: Movement Synchrony, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Attempted Suicide Short Intervention Program (ASSIP), interventions name: Standard of care plus resource interview group (STAR), outcomesModule primaryOutcomes measure: Differences in Inhibitory Control, primaryOutcomes measure: Differences in Inhibitory Control, primaryOutcomes measure: Differences in Inhibitory Control, secondaryOutcomes measure: Movement analyses, secondaryOutcomes measure: Selective Attention and Interference Control, secondaryOutcomes measure: General Sense of Self-Efficacy, secondaryOutcomes measure: Locus of control, secondaryOutcomes measure: Psychological Pain, secondaryOutcomes measure: Suicidal ideation and behavior, secondaryOutcomes measure: Suicidal ideation, otherOutcomes measure: Mental abilities like attention, working memory and visuomotor speed as well as mental flexibility, otherOutcomes measure: Sociodemographic data, otherOutcomes measure: Diagnostic and Statistical Manual 5 (DSM-V) and International Classification of Diseases 10 (ICD-10) psychiatric disorders, otherOutcomes measure: Depressive symptoms, otherOutcomes measure: Loneliness, otherOutcomes measure: Therapeutic Alliance, otherOutcomes measure: Therapeutic change, otherOutcomes measure: Therapeutic outcomes, otherOutcomes measure: Adherence and Competence, otherOutcomes measure: Physiologically Experienced Emotional Distress and Arousal, otherOutcomes measure: Ecological Momentary Assesment, otherOutcomes measure: Attention and Concentration Abilities, otherOutcomes measure: Dissociative Experience, otherOutcomes measure: Motivational Incongruence, otherOutcomes measure: Motivational Goals, otherOutcomes measure: Suicide-Related Coping, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Psychiatry and Psychotherapy, University of Bern, status: RECRUITING, city: Bern, zip: 3008, country: Switzerland, contacts name: Anja C Gysin-Maillart, Ph.D., role: CONTACT, phone: 0041 31 632 88 11, email: anja.gysin-maillart@unibe.ch, contacts name: Anja C Gysin-Maillart, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False |
protocolSection identificationModule nctId: NCT06263699, orgStudyIdInfo id: S68225, briefTitle: Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease, acronym: Goniometry, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer can be time consuming. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer., conditionsModule conditions: Dupuytren's Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 59, type: ESTIMATED, armsInterventionsModule interventions name: ROM measurement of the MCP and PIP joints in digits 4 and 5, outcomesModule primaryOutcomes measure: Active Extension Deficits (AED), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitaire Ziekenhuizen KU Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Ilse Degreef, Prof. Dr., role: CONTACT, phone: +32 16 33 88 43, email: ilse.degreef@uzleuven.be, contacts name: Anna Tarasiuk, role: CONTACT, phone: +32 16 33 88 18, email: orthopedie.research@uzleuven.be, contacts name: Ilse Degreef, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False |
protocolSection identificationModule nctId: NCT06263686, orgStudyIdInfo id: DAN056, briefTitle: Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults, acronym: YASI-03, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-06-01, primaryCompletionDateStruct date: 2016-11-01, completionDateStruct date: 2016-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Valladolid, class: OTHER, collaborators name: Danone Institute International, collaborators name: University of Seville, descriptionModule briefSummary: In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed., conditionsModule conditions: Immune System, conditions: Innate Inflammatory Response, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 125, type: ACTUAL, armsInterventionsModule interventions name: Pasteurised yoghurt, interventions name: Fresh yoghurt, interventions name: Sterilised yoghurt, outcomesModule primaryOutcomes measure: T-cells, primaryOutcomes measure: IFN-gamma induction, primaryOutcomes measure: IgG, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06263673, orgStudyIdInfo id: 23-008183, briefTitle: Anti-Diabetic Medications to Fight PD and LBD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia., conditionsModule conditions: Lewy Body Dementia, conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Sitagliptin, interventions name: Dapagliflozin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS), primaryOutcomes measure: Change in Mini Mental State Examination, secondaryOutcomes measure: Glucose, secondaryOutcomes measure: Supine blood pressure, secondaryOutcomes measure: Standing blood pressure, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic Florida, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32224, country: United States, contacts name: Zoe A Parrales, BS, role: CONTACT, phone: 904-953-3381, email: parrales.zoe@mayo.edu, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False |
protocolSection identificationModule nctId: NCT06263660, orgStudyIdInfo id: 2022-007, briefTitle: Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-09, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Laureate Institute for Brain Research, Inc., class: OTHER, descriptionModule briefSummary: This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Keto-like supplement, interventions name: Placebo, outcomesModule primaryOutcomes measure: BOLD response during Monetary Incentive Delay Task, secondaryOutcomes measure: BOLD response during Adjective Task, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Laureate Institute for Brain Research, status: RECRUITING, city: Tulsa, state: Oklahoma, zip: 74136, country: United States, contacts name: Teresa Victor, PhD, role: CONTACT, phone: 918-502-5108, email: tvictor@laureateinstitute.org, contacts name: Colleen McCallum, role: CONTACT, phone: 918-502-5180, geoPoint lat: 36.15398, lon: -95.99277, hasResults: False |
protocolSection identificationModule nctId: NCT06263647, orgStudyIdInfo id: HSC-MS-23-0904, secondaryIdInfos id: UG3NR021232, type: NIH, link: https://reporter.nih.gov/quickSearch/UG3NR021232, briefTitle: Incorporation of a Health Equity Approach to Hospital Violence Intervention Programs: The Integration of a Community and Hospital Based Initiatives to Reduce Gun Violence in a Large Metropolitan Area, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-06-01, primaryCompletionDateStruct date: 2028-02-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center, Houston, class: OTHER, collaborators name: National Institute of Nursing Research (NINR), descriptionModule briefSummary: The purpose of this study is to evaluate the effectiveness of Houston-Hospital Violence Intervention Programs (HVIP) in reducing the occurrence of repeat violent events among adults receiving care at Memorial Hermann Hospital in Houston, to determine the impact of the community-engaged Houston-HVIP program on violent re-injury and mental and behavioral health, assess the impact of the Houston-HVIP program on racial and ethnic disparities in those impacted by firearm violence injury and to identify the predictors of implementation success, including dosage, reach, fidelity, and acceptability from the perspective of gun violence victims, health care providers, and community violence intervention specialists, conditionsModule conditions: Firearm Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Participants will be partially blinded in that they will know some information about the intervention but will not be exposed to the details of the intervention or the intervention manual., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Houston-HVIP treatment, interventions name: Enhanced Case Management, outcomesModule primaryOutcomes measure: Repeat violent victimization as assessed by the number of participants who return to the hospital system for a violent injury, primaryOutcomes measure: Repeat violent victimization as assessed by the number of participants who are exposed to repeat violence but not admitted to the hospital captured using the Computer-assisted self-interviewing (CASI) instrument, secondaryOutcomes measure: Change in post-traumatic stress as assessed by the post-Traumatic Stress Disorder Checklist Version 5(PCL-5), secondaryOutcomes measure: Change in aggression as assessed by the Buss-Perry Aggression Questionnaire (BPAQ), secondaryOutcomes measure: Change in general health as assessed by the 12-item Short Form Health Survey (SF-12), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of Texas Health Science Center at Houston, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Sandra McKay, MD, role: CONTACT, phone: 713-500-5666, email: Sandra.McKay@uth.tmc.edu, contacts name: Alexander Testa, PhD, role: CONTACT, phone: (210) 276-9000, email: Alexander.Testa@uth.tmc.edu, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06263634, orgStudyIdInfo id: 2022-206, briefTitle: Hand Exercises in Psoriatic Arthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-05, primaryCompletionDateStruct date: 2024-04-05, completionDateStruct date: 2024-05-05, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Akdeniz University, class: OTHER, descriptionModule briefSummary: This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform home exercises consisting of stretching, mobility and strengthening, 4 days a week for 8 weeks, and the patients' compliance with the exercise will be monitored by phone call once a week. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study., conditionsModule conditions: Psoriatic Arthritis, conditions: Hand Rheumatism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Hand exercises, outcomesModule primaryOutcomes measure: Psoriatic Arthritis Disease Activity Score (DAPSA), primaryOutcomes measure: Hand grip strength measurement, primaryOutcomes measure: Hand fine grip strength measurement:, secondaryOutcomes measure: Nine-Hole Peg Test, secondaryOutcomes measure: Duruöz Hand Index, secondaryOutcomes measure: Michigan Hand Outcome Questionnaire (MHQ), secondaryOutcomes measure: Hand Functional Index (HFI), secondaryOutcomes measure: Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Akdeniz University, status: RECRUITING, city: Antalya, country: Turkey, contacts name: Ayse Ayan, MD, role: CONTACT, phone: +90 242 249 44 00, email: drayseayan@yahoo.com.tr, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False |
protocolSection identificationModule nctId: NCT06263621, orgStudyIdInfo id: 855090, briefTitle: Changing Portion Size Descriptions in a Cafeteria, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-11, primaryCompletionDateStruct date: 2024-05-29, completionDateStruct date: 2024-05-29, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: Restaurant Associates, descriptionModule briefSummary: The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called "standard" instead of "small"?Participants will order lunch as usual in the two cafes (one intervention, one control) for 5.5 months, and all order items will be recorded in the check-out system. One cafe will receive the labeling intervention, while the other will not. Researchers will compare the average calories per order between the two cafes to see if there are differences., conditionsModule conditions: Food Selection, conditions: Obesity, conditions: Weight Gain, conditions: Food Preferences, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Entrees are offered in two different portion sizes at two cafes. The cafes were randomized to either receive the "Standard" portion label for the smaller size (Intervention) or the "Small" portion label for the smaller size (Control). The larger portion was labeled "Large." Daily lunch transaction data will be provided by the cafes., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 12000, type: ESTIMATED, armsInterventionsModule interventions name: Intervention "Standard", outcomesModule primaryOutcomes measure: Average kcal per entree sold, secondaryOutcomes measure: Number of entrée units purchased, secondaryOutcomes measure: Total kcal per transaction, secondaryOutcomes measure: Weekly gross sales, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Courtyard Cafe, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Elements Cafe, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06263608, orgStudyIdInfo id: BUN B3002023000204, briefTitle: Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation, acronym: STAROSA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2028-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University Hospital, Antwerp, class: OTHER, collaborators name: Jessa Hospital, collaborators name: Hasselt University, collaborators name: Universiteit Antwerpen, descriptionModule briefSummary: The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population.Participants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction and symptom burden questionnaires twice: right after the polysomnography examination and after the 3-month treatment., conditionsModule conditions: Atrial Fibrillation, conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 209, type: ESTIMATED, armsInterventionsModule interventions name: (Cardio)Respiratory polygraphy (NOX T3s), interventions name: Polysomnography, interventions name: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV), interventions name: Fitbit smartwatch, outcomesModule primaryOutcomes measure: AF burden before and after CPAP treatment, secondaryOutcomes measure: Obstructive sleep apnea severity agreement between polygraphy and polysomnography, secondaryOutcomes measure: False positive rate of polygraphy, secondaryOutcomes measure: Total sleep apnea burden, secondaryOutcomes measure: CPAP/BiPAP/ASV compliance, secondaryOutcomes measure: Sleep score, secondaryOutcomes measure: Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ), secondaryOutcomes measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ), secondaryOutcomes measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS), secondaryOutcomes measure: Polygraphy negative patients, otherOutcomes measure: User-friendliness of the NOX T3s polygraphy device, otherOutcomes measure: User-friendliness of the Fitbit-based FibriCheck monitoring, otherOutcomes measure: Uptake rate of the advice to patients to undergo a polysomnography examination, otherOutcomes measure: Protocol adherence to smartphone heart rhythm measurements, otherOutcomes measure: The quality of the FibriCheck measurements, otherOutcomes measure: Number of technical issues, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Antwerp, status: RECRUITING, city: Edegem, country: Belgium, contacts name: Lien Desteghe, MSc PhD, role: CONTACT, email: lien.desteghe@uza.be, geoPoint lat: 51.15662, lon: 4.44504, locations facility: Jessa Hospital, status: RECRUITING, city: Hasselt, country: Belgium, contacts name: Lien Desteghe, MSc PhD, role: CONTACT, email: lien.desteghe@jessazh.be, geoPoint lat: 50.93106, lon: 5.33781, hasResults: False |
protocolSection identificationModule nctId: NCT06263595, orgStudyIdInfo id: REB23-1754, briefTitle: Semaglutide and Preoperative Residual Gastric Volumes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Alberta Health services, descriptionModule briefSummary: Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide., conditionsModule conditions: Pulmonary Aspiration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: gastric antral sonography, outcomesModule primaryOutcomes measure: Number of participants presenting with a full stomach, secondaryOutcomes measure: Number of occurrences requiring change in anesthetic management plan, secondaryOutcomes measure: Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume, secondaryOutcomes measure: Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Health Campus, city: Calgary, state: Alberta, zip: T3M 1M4, country: Canada, contacts name: Joanna J Moser, MD, PhD, role: CONTACT, phone: 403-956-3883, email: joanna.moser@ahs.ca, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False |
protocolSection identificationModule nctId: NCT06263582, orgStudyIdInfo id: IGHID12333, briefTitle: Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants., conditionsModule conditions: Cervix Cancer, conditions: Cervix Intraepithelial Neoplasia Grade 3, conditions: Cervix; Intraepithelial Neoplasia, Grade I, conditions: Cervix; Intraepithelial Neoplasia, Grade II, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Artesunate pessary, interventions name: blood draws for pharmacokinetics of the study drug, outcomesModule primaryOutcomes measure: To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin, secondaryOutcomes measure: To determine the area under the plasma concentration versus time curve (AUC) of Artesunate (AS), secondaryOutcomes measure: To determine the maximum concentration of Artesunate (AS), secondaryOutcomes measure: To determine the maximum concentration of dihydroartemisinin (DHA) (Cmax), secondaryOutcomes measure: To determine the time to maximum concentration (Tmax) of Artesunate (AS) following five consecutive days, secondaryOutcomes measure: To determine the time to maximum concentration (Tmax) of dihydroartemisinin (DHA, secondaryOutcomes measure: To determine the half-life (t1/2) of Artesunate (AS), secondaryOutcomes measure: To determine the half-life (t1/2) of dihydroartemisinin (DHA), secondaryOutcomes measure: To determine the apparent clearance (CL/F) of Artesunate (AS), secondaryOutcomes measure: To determine the apparent clearance (CL/F) of dihydroartemisinin (DHA), secondaryOutcomes measure: To determine the volume of distribution (V/F) of Artesunate (AS), secondaryOutcomes measure: To determine the volume of distribution (V/F) of dihydroartemisinin (DHA), secondaryOutcomes measure: Type, frequency, severity, and duration of adverse events, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lumumba Sub-County Hospital, city: Kisumu, country: Kenya, geoPoint lat: -0.10221, lon: 34.76171, hasResults: False |
protocolSection identificationModule nctId: NCT06263569, orgStudyIdInfo id: SDB 2023-002, briefTitle: Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study, acronym: EAGLE, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-24, primaryCompletionDateStruct date: 2023-05-24, completionDateStruct date: 2023-05-24, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: JointResearch, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess the effect of total hip arthroplasty on hip disability and pain compared to non-surgery in patients with hip osteoarthritis, using target trial emulation to emulate a randomized controlled trial., conditionsModule conditions: Hip Osteoarthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 156, type: ACTUAL, armsInterventionsModule interventions name: Total hip arthroplasty, outcomesModule primaryOutcomes measure: Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline, secondaryOutcomes measure: Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OLVG, city: Amsterdam, state: Noord Holland, zip: 1090 HM, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-05-17, uploadDate: 2024-02-08T10:36, filename: Prot_SAP_000.pdf, size: 949604, hasResults: False |
protocolSection identificationModule nctId: NCT06263556, orgStudyIdInfo id: 2023/389, briefTitle: Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2024-11-05, completionDateStruct date: 2024-12-05, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, class: OTHER_GOV, descriptionModule briefSummary: Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS., conditionsModule conditions: Multiple Sclerosis, conditions: Lower Urinary Tract Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized and assigned to either group., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Pelvic floor exercises, interventions name: Transcutaneous posterior tibial nerve stimulation, interventions name: Sham stimulation, outcomesModule primaryOutcomes measure: Incontinence Quality of Life (I-QOL), secondaryOutcomes measure: Post-void residue (PVR), secondaryOutcomes measure: Bladder diary, secondaryOutcomes measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Sibel CAGLAR, role: CONTACT, phone: +905333365651, email: dr.sibelcaglar@gmail.com, contacts name: Arda Can KASAP, role: CONTACT, phone: +905384590119, email: drardakasap@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06263543, orgStudyIdInfo id: 2023-MAH-001, briefTitle: Sequencing Antibody Drug Conjugates in ER+/HER2 LOW MBC, acronym: SERIES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Reshma L. Mahtani, D.O., class: OTHER, collaborators name: Gilead Sciences, descriptionModule briefSummary: The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd., conditionsModule conditions: Breast Cancer, conditions: Metastatic Breast Cancer, conditions: Advanced Breast Cancer, conditions: Hormone-receptor-positive Breast Cancer, conditions: Human Epidermal Growth Factor 2 Low Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Sacituzumab govitecan, outcomesModule primaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Clinical benefit rate (CBR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Global Quality of Life, secondaryOutcomes measure: Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Laboratory and Vital Sign Abnormalities, secondaryOutcomes measure: Growth Factor Support, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA Jonsson Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90404, country: United States, contacts name: Aditya Bardia, M.D., role: CONTACT, phone: 310-586-2093, email: ABardia@mednet.ucla.edu, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Miami Cancer Institute at Baptist Health, Inc., city: Miami, state: Florida, zip: 33176, country: United States, contacts name: Reshma L Mahtani, D.O., role: CONTACT, phone: 786-596-2000, email: rmahtani@baptisthealth.net, contacts name: Krystal Fernandez, role: CONTACT, phone: (786) 596-2000, email: krystal.fernandez@baptisthealth.net, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Winship Cancer Institute at Emory University, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Kevin Kalinsky, M.D., M.S., role: CONTACT, phone: 404-778-0519, email: kkalins@emory.edu, geoPoint lat: 33.749, lon: -84.38798, hasResults: False |
protocolSection identificationModule nctId: NCT06263530, orgStudyIdInfo id: NU22-03-00182, briefTitle: Prognostic Significance of ctDNA in HL, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-02, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Interni hematologicka klinika FNKV, class: NETWORK, collaborators name: Charles University, Czech Republic, collaborators name: General University Hospital, Prague, collaborators name: University Hospital Olomouc, collaborators name: University Hospital Hradec Kralove, collaborators name: University Hospital, Motol, descriptionModule briefSummary: Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age \<60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy., conditionsModule conditions: Prognostic Cancer Model, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identification of tumor specific mutation profiles at dg. of HL based on ctDNA, primaryOutcomes measure: Quantitative analysis of ctDNA level during the first-line chemotherapy, primaryOutcomes measure: Identification of tumor specific mutation profiles at relapse of classical HL, secondaryOutcomes measure: In vitro functional characterization of identified DNA variants and/or mutations, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Hradec Kralove, status: RECRUITING, city: Hradec Kralove, zip: 50005, country: Czechia, contacts name: Alice Sykorova, M.D., Ph.D., role: CONTACT, phone: +420495 832 866, email: alice.sykorova@fnhk.cz, geoPoint lat: 50.20923, lon: 15.83277, locations facility: University Hospital Olomouc, status: RECRUITING, city: Olomouc, zip: 77520, country: Czechia, contacts name: Vit Prochazka, prof. M.D., role: CONTACT, phone: +420588 442 878, email: prochazv@fnol.cz, geoPoint lat: 49.59552, lon: 17.25175, locations facility: University Hospital Kralovske Vinohrady, status: RECRUITING, city: Praha, zip: 10034, country: Czechia, contacts name: Heidi Mocikova, M.D., Ph.D., role: CONTACT, phone: +420267163554, email: heidi.mocikova@fnkv.cz, contacts name: Katerina Klaskova, Ing., role: CONTACT, phone: +420267162880, email: katerina.klaskova@fnkv.cz, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Charles University, status: ACTIVE_NOT_RECRUITING, city: Praha, zip: 12108, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: General University Hospital, status: RECRUITING, city: Praha, zip: 12808, country: Czechia, contacts name: Jan Koren, M.D., role: CONTACT, phone: +420224962541, email: jan.koren@vfn.cz, geoPoint lat: 50.08804, lon: 14.42076, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-30, uploadDate: 2024-02-07T11:30, filename: Prot_SAP_000.pdf, size: 329948, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-30, uploadDate: 2024-02-07T11:43, filename: ICF_001.pdf, size: 82316, hasResults: False |
protocolSection identificationModule nctId: NCT06263517, orgStudyIdInfo id: SPA-S-899-01-21, secondaryIdInfos id: 2021-003124-33, type: EUDRACT_NUMBER, briefTitle: Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-12, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: SPA Società Prodotti Antibiotici S.p.A., class: INDUSTRY, collaborators name: Pharmaceutical Development and Services, descriptionModule briefSummary: The goal of this clinical trial is to to clarify which is the best dose of administration, to select a dose and to confirm the therapeutic efficacy of clodronate in patients with painful knee osteoarthritis (OA). The clinical trial will be divided in two parts.The main questions it aims to answer are:* in Phase II, to assess the safety and tolerability of different escalating doses of intra articular (IA) clodronate* in Phase II, to set a defined therapeutic dose (DTD) to be used in Phase III* in Phase III, to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA, conditionsModule conditions: Osteoarthritis of Knee, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Adaptative, multicenter, randomized, double-blind, parallel-group, placebo controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Randomization list will be performed with Proc Plan procedure by SAS ® Software (release 9.4 or later) software using the block randomization method with block size of 4.Subjects eligible at Baseline will be randomly allocated to receive 2, 5, 10 /2ml or placebo according to the balanced randomization list., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 296, type: ESTIMATED, armsInterventionsModule interventions name: Clodronate, interventions name: Clodronate, interventions name: Clodronate, interventions name: Placebo, outcomesModule primaryOutcomes measure: Efficacy: VAS Reduction, secondaryOutcomes measure: VAS mean changes, secondaryOutcomes measure: VAS mean changes observed 120 minutes after IA, secondaryOutcomes measure: Lequesne Algofunctional Index mean changes, secondaryOutcomes measure: WOMAC mean changes, secondaryOutcomes measure: Range of motion mean changes, secondaryOutcomes measure: Paracetamol consumption, otherOutcomes measure: SAE Reporting, otherOutcomes measure: AE Reporting, otherOutcomes measure: Clinical signs of intolerance Recording, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituti Clinici Maugeri, status: RECRUITING, city: Castel Goffredo, state: Mantova, zip: 46042, country: Italy, contacts name: Lul Abdi-Ali, role: CONTACT, geoPoint lat: 45.29403, lon: 10.473, locations facility: Ospedale San Pellegrino, status: RECRUITING, city: Castiglione delle Stiviere, state: Mantova, zip: 46043, country: Italy, contacts name: Paolo Roberto Ferrari, role: CONTACT, geoPoint lat: 45.3902, lon: 10.48619, locations facility: Ospedale Civile Servizio di Riabilitazione Funzionale, status: RECRUITING, city: Volta Mantovana, state: Mantova, zip: 46049, country: Italy, contacts name: Luisa Selletti, role: CONTACT, geoPoint lat: 45.32192, lon: 10.65891, locations facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga, status: NOT_YET_RECRUITING, city: Orbassano, state: Torino, zip: 10043, country: Italy, contacts name: Filippo Castoldi, role: CONTACT, geoPoint lat: 45.00547, lon: 7.53813, locations facility: Centro Riabilitativo Polifunzionale Teresio Borsalino, status: RECRUITING, city: Alessandria, zip: 15122, country: Italy, contacts name: Marco Invernizzi, role: CONTACT, geoPoint lat: 44.90924, lon: 8.61007, locations facility: IRCCS Ospedale Policlinico San Martino, status: RECRUITING, city: Genova, zip: 16132, country: Italy, contacts name: Matteo Formica, role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Ospedale Israelitico, status: RECRUITING, city: Roma, zip: 00148, country: Italy, contacts name: Maria Chiara Meloni, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Pietro, status: RECRUITING, city: Rome, zip: 00189, country: Italy, contacts name: Alberto Migliore, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Paolo, status: NOT_YET_RECRUITING, city: Savona, zip: 17100, country: Italy, contacts name: Danilo Chiapale, role: CONTACT, geoPoint lat: 44.30905, lon: 8.47715, locations facility: Azienda Ospedaliero Universitaria Senese, status: RECRUITING, city: Siena, zip: 53100, country: Italy, contacts name: Bruno Frediani, role: CONTACT, geoPoint lat: 43.31822, lon: 11.33064, locations facility: Ospedale Policlinico "G.B. Rossi" Borgo Roma, status: RECRUITING, city: Verona, zip: 37134, country: Italy, contacts name: Luca Dalle Carbonare, role: CONTACT, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False |
protocolSection identificationModule nctId: NCT06263504, orgStudyIdInfo id: DM001, briefTitle: The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-10-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: NMSI DENTMASTER, class: OTHER, descriptionModule briefSummary: In influence of complex correction of dental and musculoskeletal systems on the frequency of relapses of functional disorders in patients with somatic pathologies: a randomized pilot study there will be two groups: Group 1 (control group): Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.Group 2 (experimental group): Patients will receive comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.The endpoints will be :Primary endpoint:• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.Secondary endpoints:* Change in pain intensity measured by visual analog scale (VAS).* Improvement of functional indicators of the temporomandibular joint, including range of motion.* Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months., conditionsModule conditions: Malocclusion, conditions: Musculoskeletal Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: at correcting malocclusions or restoring the integrity of the dentition, interventions name: comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system., outcomesModule primaryOutcomes measure: Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition., secondaryOutcomes measure: Change in pain intensity measured by visual analog scale (VAS)., secondaryOutcomes measure: Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion., secondaryOutcomes measure: Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nmsi Dentmaster, city: Novosibirsk, state: Novosibirsk Region, zip: 630090, country: Russian Federation, contacts name: Tatiana A Gatilova, role: CONTACT, phone: 952939919, phoneExt: +7, email: gatilova@dentservice.ru, contacts name: Anastasia V Semivolova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False |
protocolSection identificationModule nctId: NCT06263491, orgStudyIdInfo id: 2023-0413, secondaryIdInfos id: NCI-2024-01325, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL., conditionsModule conditions: Mantle Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Rituximab, interventions name: Pirtobrutinib, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Preetesh Jain, MBBS, MD, DM, PhD, role: CONTACT, phone: (713) 563-8786, email: pjain@mdanderson.org, contacts name: Preetesh Jain, MBBS, MD, DM, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06263478, orgStudyIdInfo id: INCA34176-358, briefTitle: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Incyte Biosciences Japan GK, class: INDUSTRY, descriptionModule briefSummary: This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD)., conditionsModule conditions: Chronic Graft-versus-host-disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: INCA034176, outcomesModule primaryOutcomes measure: Overall Response Rate in the First 6 Cycles, secondaryOutcomes measure: Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score, secondaryOutcomes measure: Overall Response Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Organ-specific Response Rate, secondaryOutcomes measure: Percent reduction in average daily dose (or equivalent) of corticosteroids, secondaryOutcomes measure: Proportion of participants who discontinue corticosteroid use, secondaryOutcomes measure: Number of participants with Treatment-emergent Adverse Events (TEAEs), secondaryOutcomes measure: Change from baseline in Karnofsky/Lansky performance status, secondaryOutcomes measure: Axatilimab pharmacokinetic (PK) in Plasma, secondaryOutcomes measure: Number of Participants with Anti-Drug Antibody (ADA), eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06263465, orgStudyIdInfo id: CALM, briefTitle: Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Zhujiang Hospital, class: OTHER, collaborators name: ZhuHai Hospital, descriptionModule briefSummary: The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis., conditionsModule conditions: Bacterial Vaginosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Lactobacillus cispatus, interventions name: placebo, outcomesModule primaryOutcomes measure: BV recurrence rate, secondaryOutcomes measure: vaginal secretions 16s rRNA gene sequencing, secondaryOutcomes measure: BV recurrence rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhuhai People'S Hospital, status: RECRUITING, city: Zhuhai, state: Guangdong, zip: 519050, country: China, contacts name: Jingya WU, Doctor, role: CONTACT, phone: +8615902057821, geoPoint lat: 22.27694, lon: 113.56778, hasResults: False |
protocolSection identificationModule nctId: NCT06263452, orgStudyIdInfo id: 23-2768, secondaryIdInfos id: 1R01HL157422-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01HL157422-01, briefTitle: Beta-Blocker Influences on Inflammatory and Neural Responses to Stress, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), collaborators name: University of California, Los Angeles, collaborators name: Dartmouth College, descriptionModule briefSummary: The purpose of this study is to map the neural and molecular mechanisms underlying psychological stress-induced changes in inflammation which could reveal new targets for intervention to reduce the risk of cardiovascular disease., conditionsModule conditions: Cardiovascular Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects (n = 60 per condition, N = 120) will either take a one-time, 40mg dose of propranolol or an encapsulated placebo., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: This is a double blind, randomized, placebo-controlled mechanistic clinical trial. The Investigational Drug Service will randomly assign patients to the experimental group (propranolol) or the placebo group. Research staff who have direct contact with the participant will be blind to their condition., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Propranolol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress, primaryOutcomes measure: Change in levels of inflammatory gene expression in response to social stress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Social Neuroscience and Health Laboratory, city: Chapel Hill, state: North Carolina, zip: 27514, country: United States, contacts name: Keely A Muscatell, PhD, role: CONTACT, phone: 916-495-7661, email: kmuscatell@unc.edu, contacts name: Jessica R Cohen, PhD, role: SUB_INVESTIGATOR, contacts name: Kristen A Lindquist, PhD, role: SUB_INVESTIGATOR, contacts name: Samantha E Meltzer-Brody, MD, MPH, role: SUB_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06263439, orgStudyIdInfo id: RNI 2023 MIRAND, secondaryIdInfos id: 2023-A00585-40, type: OTHER, domain: ANSM, briefTitle: Surveillance of HFMD in Pediatric Outpatients, acronym: PMB, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-20, primaryCompletionDateStruct date: 2028-06-20, completionDateStruct date: 2028-06-20, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University Hospital, Clermont-Ferrand, class: OTHER, descriptionModule briefSummary: The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :* to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage* to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV., conditionsModule conditions: Hand, Foot and Mouth Disease, conditions: Herpangina, conditions: Enterovirus Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Throat/buccal swab sample, outcomesModule primaryOutcomes measure: Prevalence of different types of Enteroviruses, secondaryOutcomes measure: Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses, eligibilityModule sex: ALL, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: CHU de Clermont-Ferrand, status: RECRUITING, city: Clermont-Ferrand, zip: 63000, country: France, contacts name: Lise Laclautre, role: CONTACT, email: promo_interne_drci@chu-clermontferrand.fr, contacts name: Audrey Mirand, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False |
protocolSection identificationModule nctId: NCT06263426, orgStudyIdInfo id: IRB00387066, secondaryIdInfos id: U01AI177211, type: NIH, link: https://reporter.nih.gov/quickSearch/U01AI177211, briefTitle: Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-09, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute of Allergy and Infectious Diseases (NIAID), descriptionModule briefSummary: This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV., conditionsModule conditions: Hiv, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: HIV D+/R+, interventions name: HIV D-/R+, outcomesModule primaryOutcomes measure: Cumulative incidence of death and allograft rejection., secondaryOutcomes measure: Participant survival, secondaryOutcomes measure: Graft survival, secondaryOutcomes measure: Type and severity of graft rejection, secondaryOutcomes measure: Time to first rejection, secondaryOutcomes measure: Rate of rejection events over time, secondaryOutcomes measure: Graft function over time measured by eGFR trajectory, secondaryOutcomes measure: Incidence of HIV viremia post-transplant, secondaryOutcomes measure: Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant, secondaryOutcomes measure: Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant, secondaryOutcomes measure: Incidence of surgical and vascular transplant complications post-transplant, secondaryOutcomes measure: Incidence and causes of chronic kidney disease post-transplant, secondaryOutcomes measure: Incidence of post-transplant malignancies, secondaryOutcomes measure: Incidence of de novo donor specific antibody (DSA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Shikha Mehta, MD, role: CONTACT, email: smehta@uabmc.edu, contacts name: Shikha Mehta, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: University of California, Los Angeles, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Joanna Schaenman, MD, PhD, role: CONTACT, email: JSchaenman@mednet.ucla.edu, contacts name: Joanna Schaenman, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: University of California, San Diego, city: San Diego, state: California, zip: 92037, country: United States, contacts name: Saima Aslam, MBBS, role: CONTACT, email: saslam@ucsd.edu, contacts name: Saima Aslam, MBBS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Garrett Roll, MD, role: CONTACT, email: Garrett.Roll@ucsf.edu, contacts name: Garrett Roll, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Yale School of Medicine, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Maricar Malinis, MD, role: CONTACT, email: maricar.malinis@yale.edu, contacts name: Maricar Malinis, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Rush University Medical Center, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Carlos Santos, MD, role: CONTACT, email: Carlos_A_Santos@rush.edu, contacts name: Carlos Santos, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Ochsner Clinic Foundation, city: New Orleans, state: Louisiana, zip: 70121, country: United States, contacts name: Jonathan Hand, MD, role: CONTACT, email: jonathan.hand@ochsner.org, contacts name: Jonathan Hand, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Johns Hopkins University, city: Baltimore, state: Maryland, zip: 21205, country: United States, contacts name: Christine Durand, MD, role: CONTACT, email: cdurand2@jhmi.edu, contacts name: Christine Durand, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Nahel Elias, MD, role: CONTACT, email: elias.nahel@mgh.harvard.edu, contacts name: Nahel Elias, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: New York University, city: New York, state: New York, zip: 10016, country: United States, contacts name: Sapna Mehta, MD, role: CONTACT, email: Sapna.mehta@nyumc.org, contacts name: Sapna Mehta, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Icahn School of Medicine at Mt. Sinai, city: New York, state: New York, zip: 10029, country: United States, contacts name: Sander Florman, MD, role: CONTACT, email: Sander.florman@mountsinai.org, contacts name: Sander Florman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Columbia University, city: New York, state: New York, zip: 10032, country: United States, contacts name: Marcus Pereira, MD, role: CONTACT, contacts name: Marcus Pereira, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Weill Cornell Medical Center, city: New York, state: New York, zip: 10065, country: United States, contacts name: Catherine Small, MD, role: CONTACT, email: Cbs9003@med.cornell.edu, contacts name: Catherine Small, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Pittsburgh Medical Center, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Ghady Haidar, MD, role: CONTACT, email: haidarg@upmc.edu, contacts name: Ghady Haidar, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06263413, orgStudyIdInfo id: 24.12.2266-GHM, briefTitle: Clinical Workflow Optimization Using Artificial Intelligence for Dermatological Conditions, acronym: IDEI_2023, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: AI Labs Group S.L, class: INDUSTRY, collaborators name: Instituto de Dermatología Integral (IDEI), descriptionModule briefSummary: Artificial intelligence (AI) based on imaging holds tremendous potential to enhance visual diagnostic accuracy in the medical field. Amid the COVID-19 pandemic, limited access to in-person healthcare services drove shifts in medical care, hastening the adoption of telemedicine. In this context, AI usage for triage and decision support may be crucial for professionals to manage workload and improve performance. In dermatology, pigmented lesions, acne, and alopecia are three recurring pathology groups with high demand in dermatological centers. Both triage, clinical evaluation, and patient follow-up require in-person resources and specialist dedication. Employing tools like AI can benefit these professionals in reducing such processes and optimizing workload.Advancements in image recognition and interpretation, as well as in artificial intelligence, have spurred innovations in diagnosing various pathologies, including skin conditions. Computer-Aided Diagnosis (CAD) systems and other algorithm-based technologies have demonstrated the ability to classify lesion images with a competency comparable to that of an expert physician.In this study, the Legit.Health tool, developed by AI LABS GROUP S.L., which utilizes artificial intelligence to optimize clinical flow and patient care processes for skin conditions, will be evaluated. The purpose of this tool is to automatically prioritize patients with greater urgency, assign the type of consultation (dermatological or aesthetic), enhance diagnostic capability and detection of malignant pigmented lesions in auxiliary staff, and provide a visual record (photograph) of the condition for later review by external experts.Thus, the main objective of this study is to validate that Legit.Health, based on Artificial Intelligence, improves efficiency in clinical flow and patient care processes, thereby reducing time and cost of patient care through enhanced diagnostic accuracy and severity determination.The secondary objectives focus on measuring the diagnostic performance of Legit.Health:Demonstrate that Legit.Health enhances healthcare professionals\' ability to detect malignant or suspicious pigmented lesions.Demonstrate that Legit.Health improves healthcare professionals\' ability and precision in measuring the degree of involvement in patients with female androgenetic alopecia.Demonstrate that Legit.Health improves healthcare professionals\' ability and precision in measuring the degree of involvement in patients with acne.Additionally, the study aims to assess the utility of this tool:Automate the triage/initial assessment process in patients presenting with pigmented lesions.Evaluate the reduction in healthcare resources usage by the center by reducing the number of triage consultations and directing the patient directly to the appropriate consultation (esthetic or dermatological).Evaluate Legit.Health\'s usability by the patient. Demonstrate that Legit.Health increases specialist satisfaction. Evaluate the reduction in healthcare resources usage by reducing the number of triage consultations and directing the patient directly to the appropriate consultation, whether in aesthetic or dermatological settings.Methodology Study Design Type This is an observational study, both prospective with a longitudinal character and retrospective case series.Study Period This study estimates a recruitment period of 3 months. The total study duration is estimated at 6 months, including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing, data analysis, and preparation of the final study report.The total study duration for each participant with pigmented lesions will be 1-3 months. The duration for patients with acne and alopecia will be 1 day.Study Population Adult patients (≥ 18 years) with skin pathologies treated at the Dermatology Unit of IDEI., conditionsModule conditions: Acne, conditions: Acne Vulgaris, conditions: Alopecia, Androgenetic, conditions: Pigmented Lesions, conditions: Pigmented Skin Lesion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Concordance between the physician's diagnosis and that of the tool., primaryOutcomes measure: Agreement of detected malignancy between the dermatologist and Legit.Health tool, secondaryOutcomes measure: Acne severity, secondaryOutcomes measure: Severity of alopecia, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IDEI Hospital, status: RECRUITING, city: Madrid, zip: 28009, country: Spain, contacts name: Miguel Sánchez-Viera, PhD, role: CONTACT, phone: +34 915740990, email: sanchez.viera@ideidermatologia.com, contacts name: Miguel Sánchez-Viera, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Concetta Alessandro, MD, role: SUB_INVESTIGATOR, contacts name: Alejandra Capote, MD, role: SUB_INVESTIGATOR, contacts name: Pablo López-Andina, MD, role: SUB_INVESTIGATOR, contacts name: Allison Marie Bell-Smythe Sorg, MD, role: SUB_INVESTIGATOR, contacts name: Alejandra Vallejos, MD, role: SUB_INVESTIGATOR, contacts name: Isabel del Campo, MD, role: SUB_INVESTIGATOR, contacts name: Juliana Machado, MD, role: SUB_INVESTIGATOR, contacts name: Raúl Lucas-Escobar, MD, role: SUB_INVESTIGATOR, contacts name: Beatriz Torres, role: SUB_INVESTIGATOR, contacts name: Alfonso Medela, MsC, role: SUB_INVESTIGATOR, contacts name: Taig Mac Carthy, MsC, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06263400, orgStudyIdInfo id: randomized trial, briefTitle: Recovery Levels of Depression Patients and Caregiver Psychoeducation, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Aydin Adnan Menderes University, class: OTHER, descriptionModule briefSummary: To determine the effect of psychoeducation given to patients and caregivers on patients' depression and recovery levels, caregivers' emotional expression and family burden levels., conditionsModule conditions: Psychoeducation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In randomization, among the patients who volunteered to participate in the study, the odd number of patients and their caregivers in the list made according to the order of hospitalization constituted the study group, and the even number of patients and their caregivers formed the control group., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: psychoeducation and follow-up study, outcomesModule primaryOutcomes measure: to patients before training, primaryOutcomes measure: pre-training caregivers, secondaryOutcomes measure: after training, secondaryOutcomes measure: after training, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing, status: RECRUITING, city: Aydın, state: Aydın/Turkey, zip: 09000, country: Turkey, contacts name: şerife öztaban, MsC, role: CONTACT, phone: +905557130105, email: serifeoztaban@gmail.com, contacts name: Filiz ADANA, Phd, role: SUB_INVESTIGATOR, geoPoint lat: 37.84501, lon: 27.83963, hasResults: False |
protocolSection identificationModule nctId: NCT06263387, orgStudyIdInfo id: FILObsLAM_VENAZA, briefTitle: Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine, acronym: VENAZA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: French Innovative Leukemia Organisation, class: OTHER, collaborators name: Acute Leukemia French Association, descriptionModule briefSummary: Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.Venetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN/AZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. Early access to treatment in France is close to real-life setting condition., conditionsModule conditions: AML, Adult, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 230, type: ESTIMATED, outcomesModule primaryOutcomes measure: characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort, primaryOutcomes measure: characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort, primaryOutcomes measure: characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort, secondaryOutcomes measure: characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life, secondaryOutcomes measure: describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amiens CHU, city: Amiens, country: France, geoPoint lat: 49.9, lon: 2.3, locations facility: Angers CHU, city: Angers, country: France, geoPoint lat: 47.46667, lon: -0.55, locations facility: Avignon CH, city: Avignon, country: France, geoPoint lat: 43.94834, lon: 4.80892, locations facility: Bayonne CH, city: Bayonne, country: France, geoPoint lat: 43.48333, lon: -1.48333, locations facility: Besançon CHU, city: Besançon, country: France, geoPoint lat: 47.24878, lon: 6.01815, locations facility: Brest CHU, city: Brest, country: France, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Caen CHU, city: Caen, country: France, geoPoint lat: 49.18585, lon: -0.35912, locations facility: CERGY PONTOISE - CH René Dubos, city: Cergy-Pontoise, country: France, geoPoint lat: 49.03894, lon: 2.07805, locations facility: Hôpital d'Instruction des Armées PERCY, city: Clamart, country: France, geoPoint lat: 48.80299, lon: 2.26692, locations facility: CHU Estaing, city: Clermont-Ferrand, country: France, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Corbeil-Essonnes - Ch Sud Francilien, city: Corbeil-Essonnes, country: France, geoPoint lat: 48.60603, lon: 2.48757, locations facility: Créteil CHU HENRI MONDOR, city: Créteil, country: France, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Dijon CHU, city: Dijon, country: France, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Grenoble CHU, city: Grenoble, country: France, geoPoint lat: 45.16667, lon: 5.71667, locations facility: Le Mans CH, city: Le Mans, country: France, geoPoint lat: 48.0, lon: 0.2, locations facility: CHU Lille, city: Lille, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Limoges CHU, city: Limoges, country: France, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Lyon sud CHU, city: Lyon, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Marseille IPC, city: Marseille, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Meaux CH de l'Est francilien, city: Meaux, country: France, geoPoint lat: 48.96014, lon: 2.87885, locations facility: METZ-THIONVILLE CHR- Hôpital de Mercy, city: Metz, country: France, geoPoint lat: 49.11911, lon: 6.17269, locations facility: Montpellier - Chu Saint Eloi, city: Montpellier, country: France, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Nantes CHU, city: Nantes, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Nice CHU, city: Nice, country: France, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Nimes CHU, city: Nîmes, country: France, geoPoint lat: 43.83333, lon: 4.35, locations facility: Paris La Pitié salpetrière, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Paris Necker, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Paris Saint Louis, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Bordeaux CHU, city: Pessac, country: France, geoPoint lat: 44.81011, lon: -0.64129, locations facility: Reims CHU, city: Reims, country: France, geoPoint lat: 49.25, lon: 4.03333, locations facility: Rennes CHU, city: Rennes, country: France, geoPoint lat: 48.11198, lon: -1.67429, locations facility: roubaix CH, city: Roubaix, country: France, geoPoint lat: 50.69421, lon: 3.17456, locations facility: Centre de Lutte Contre le Cancer H. Becquerel, city: Rouen, country: France, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Institut de Cancérologie Lucien Neuwirth, city: Saint-Priest-en-Jarez, country: France, geoPoint lat: 45.47501, lon: 4.37614, locations facility: Saint Quentin CH, city: Saint-Quentin, country: France, geoPoint lat: 49.84889, lon: 3.28757, locations facility: ICANS - Institut de cancérologie de strasbourg europe, city: Strasbourg, country: France, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Toulouse - IUCT Oncopole - Service d'Hématologie, city: Toulouse, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Tours CHU, city: Tours, country: France, geoPoint lat: 47.38333, lon: 0.68333, locations facility: Troyes CH, city: Troyes, country: France, geoPoint lat: 48.3, lon: 4.08333, locations facility: Nancy CHU, city: vandoeuvre les Nancy, country: France, geoPoint lat: 48.65, lon: 6.18333, locations facility: Versailles CH, city: Versailles, country: France, geoPoint lat: 48.8, lon: 2.13333, locations facility: Villejuif IGR, city: Villejuif, country: France, geoPoint lat: 48.7939, lon: 2.35992, hasResults: False |
protocolSection identificationModule nctId: NCT06263374, orgStudyIdInfo id: 69HCL21_0355, briefTitle: Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery, acronym: MAXIMAND, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-09-30, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Dento-maxillary dysmorphoses are defined as an anomaly in the relative growth of the maxilla and/or mandible. They lead to functional disorders (i.e., disturbances in chewing or oral communication) and aesthetic issues with psychological repercussions on self-esteem, affecting the quality of life of these patients. The multidisciplinary treatment involves orthodontics (duration = 18-24 months), orthognathic surgery involving the maxillary and/or mandibular bone (at 12 months), immediately followed by physiotherapy (duration = 3 months). One main goal after surgery is the recovery of month opening to restore an appropriate orofacial function. Motor imagery (mental rehearsal of a movement without actually moving) is effectively used in athletes and in rehabilitation mainly neurological but so far has not been investigated in maxillofacial rehabilitation. Considering that the effectiveness of rehabilitation is increased when physical and mental practices are combined, this leads to propose this study aiming to investigate whether the addition of motor imagery of the maxillofacial region to maxillofacial physiotherapy (based on a practice of physical therapeutic exercises) modifies the recovery of maximum mouth opening, other ranges of motion, jaw function, and quality of life in patients after orthognathic surgery compared to the addition of a control cognitive task \[watching a non-emotional content film or filling out a crossword or Sudoku grid\] to maxillofacial physiotherapy., conditionsModule conditions: Maxillofacial Abnormalities, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-centric randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: A randomization list will be centrally generated by an independent methodologist for each center and integrated into the electronic case report form. The physiotherapist will disclose the allocation to the participant during the inclusion visit, following clear, transparent, and appropriate information, and obtaining the participant's consent to participate in the study. This disclosure occurs after all measurements have been completed. The inclusion visit is scheduled 30 days ± 8 before the surgery., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Motor imagery of the jaw, interventions name: Control task (Sudoku or Crossword puzzle), outcomesModule primaryOutcomes measure: Maximal mouth opening measured in millimeters using a caliper, secondaryOutcomes measure: Active maximum mouth opening in millimeter using a vernier caliper, secondaryOutcomes measure: Active jaw range of motion (ROM) other than maximal opening, secondaryOutcomes measure: Maxillofacial pain, secondaryOutcomes measure: Body weight mass (kilograms), secondaryOutcomes measure: Orthodontic associated treatment, secondaryOutcomes measure: Compliance with physiotherapy and intervention, secondaryOutcomes measure: Orofacial function, secondaryOutcomes measure: Maxillofacial quality of life, secondaryOutcomes measure: Level of achievement of the goals set by the patient before surgery, secondaryOutcomes measure: Motor imagery capability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cabinet Bataille, city: Lyon, zip: 69003, country: France, contacts name: Guillaume Nainani, role: CONTACT, phone: 0478011908, phoneExt: +33, email: guillaume.nainani@gmail.com, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Cabinet de kinésithérapie Saint Alexandre, city: Lyon, zip: 69005, country: France, contacts name: Caroline Alvarado-Faysse, role: CONTACT, phone: 0437410332, phoneExt: +33, email: c.alvarado.faysse@gmail.com, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Hôpital Henry Gabrielle, city: Saint-Genis-Laval, zip: 69230, country: France, contacts name: Sébastien Matéo, role: CONTACT, phone: 0478865066, phoneExt: +33, email: sebastien.mateo@chu-lyon.fr, geoPoint lat: 45.69558, lon: 4.7934, hasResults: False |
protocolSection identificationModule nctId: NCT06263361, orgStudyIdInfo id: NCH02-2021, briefTitle: Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma., statusModule overallStatus: RECRUITING, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. The aim of this study is to evaluate the MRI imaging characteristics of the peritumoral area (PTA) and to correlate this information to pathological findings., conditionsModule conditions: Cerebral Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: MRI imaging, interventions name: Cerebral biopsy, outcomesModule primaryOutcomes measure: MRI imaging, primaryOutcomes measure: MRI imaging, primaryOutcomes measure: MRI imaging, primaryOutcomes measure: MRI imaging, primaryOutcomes measure: Define immunopathological features, secondaryOutcomes measure: Accuracy of fluoresceine guided stereotactic biopsy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS San Raffaele Scientific Institute, status: RECRUITING, city: Milan, zip: 20132, country: Italy, contacts name: Laura Sincinelli, role: CONTACT, phone: 003926435568, email: sincinelli.laura@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06263348, orgStudyIdInfo id: HMM0601, briefTitle: A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Hua Medicine Limited, class: INDUSTRY, collaborators name: Shanghai Branch, KunTuo Medical Research and Development (Beijing) Co., Ltd., descriptionModule briefSummary: The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin., conditionsModule conditions: Type2diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The marketed product - Dorzagliatin tablet (HuaTangNing®) is used as the study drug. During this study, the dosage and administration of Dorzagliatin tablets will be completely in accordance with the investigator's judgment based on the package insert and the patient's condition., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Dorzagliatin tablets, outcomesModule primaryOutcomes measure: Incidences of ADRs and SAEs, secondaryOutcomes measure: Blood glucose indicators, secondaryOutcomes measure: Response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China-Japan Friendship Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100029, country: China, contacts name: Wenying Yang, MD,PhD, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: China-Japan Friendship Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100029, country: China, contacts name: Bo Zhang, MD,PhD, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06263335, orgStudyIdInfo id: Fatima Jinnah Women University, briefTitle: MBI for Psychological Distress, SI and NSSI Among Young Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-28, primaryCompletionDateStruct date: 2022-05-28, completionDateStruct date: 2022-05-28, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Fatima Jinnah Women University, class: OTHER, descriptionModule briefSummary: Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups., conditionsModule conditions: Psychological Distress, conditions: Suicidal Ideation, conditions: Non-Suicidal Self Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Mindfulness Based Stress Reduction Intervention, outcomesModule primaryOutcomes measure: Psychological Distress, primaryOutcomes measure: Suicidal Ideation, primaryOutcomes measure: Non-Suicidal Self-Injury (NSSI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fatima Jinnah Women University, city: Rawalpindi, state: Punjab, zip: 46000, country: Pakistan, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False |
protocolSection identificationModule nctId: NCT06263322, orgStudyIdInfo id: IRB202200419, secondaryIdInfos id: R21AG073769, type: NIH, link: https://reporter.nih.gov/quickSearch/R21AG073769, briefTitle: The ROAMM-EHR Study, acronym: ROAMM-EHR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-16, primaryCompletionDateStruct date: 2026-10-17, completionDateStruct date: 2026-10-17, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes., conditionsModule conditions: Peripheral Arterial Disease, conditions: Chronic Limb-Threatening Ischemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Randomized Clinical trial. Comparison study to test the feasibility of patient generated health data compared to standard of care post-surgical observation., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, maskingDescription: Participants are masked to whether their PGHD are being sent to their care provider. Care providers are masked to who receives standard of care. Investigators (except for one who will be the point person for randomization) will be masked to intervention assignments. Staff assessors will be masked to whether PGHD are being sent to their care provider., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Actionable remotely generated health data, interventions name: Non-Actionable remotely generated health data, outcomesModule primaryOutcomes measure: 6-min walk distance, secondaryOutcomes measure: self-reported quality of life, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Aging, status: RECRUITING, city: Gainesville, state: Florida, zip: 32611, country: United States, contacts name: Institute_of_Aging, role: CONTACT, phone: 352-273-5919, email: recruit@aging.ufl.edu, contacts name: HOBI_Department, role: CONTACT, phone: 352.627.9467, email: hobi@health.ufl.edu, geoPoint lat: 29.65163, lon: -82.32483, hasResults: False |
protocolSection identificationModule nctId: NCT06263309, orgStudyIdInfo id: Femoralneckfracture, briefTitle: Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Istanbul University, class: OTHER, descriptionModule briefSummary: OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes.METHODS:Design: Retrospective cohort study. Setting: Academic Level I Trauma Center. Patient Selection Criteria: Included were patients with femoral neck fractures treated with DHS or cannulated screws, with follow-up data available.Outcome Measures and Comparisons: Main outcomes were femoral neck shortening, incidence of AVN, and Harris Hip Score (HHS) for functional assessment., conditionsModule conditions: Femoral Neck Fractures, conditions: Femoral Neck Shortening, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Femoral neck shortening measurement, outcomesModule primaryOutcomes measure: Harris Hip score, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University, city: İstanbul, zip: 34093, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06263296, orgStudyIdInfo id: UW 24-055, briefTitle: Smartphone Assisted Self-management Education for Adult Burn Patient at Aftercare, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-06-28, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Queen Mary Hospital, Hong Kong, class: OTHER, descriptionModule briefSummary: Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general populationThere is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care.The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report:1. Higher level of health-related quality of life,2. Higher level of self-efficacy3. Higher level of score in Burn Rehabilitation Knowledge4. Lower pain level, as measured by Numeric Pain Rating Scale; and5. Lower level of itchinessThe desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period. Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care. After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required., conditionsModule conditions: Burns, conditions: Self Efficacy, conditions: Burn Second Degree, conditions: Burns Third Degree, conditions: Quality of Life, conditions: Adherence, Treatment, conditions: Burn Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pilot Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Only subject will be single blinded to the intervention provided, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Self Management Education, outcomesModule primaryOutcomes measure: Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12, primaryOutcomes measure: Change from Baseline in the Generic Quality of life at Week 4 & Week 12, primaryOutcomes measure: Change from Baseline in the Burn Rehabilitation Knowledge Questionnaire, secondaryOutcomes measure: Change from Baseline in the Self efficacy at Week 4 & Week 12, secondaryOutcomes measure: Change from Baseline in the Itchiness of life at Week 4 & Week 12, secondaryOutcomes measure: Change from Baseline in the Pain level at Week 4 & Week 12, otherOutcomes measure: Percentage in the Burn related out-patient clinic attendance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LIU Siu Kwong, city: Hong Kong, country: China, contacts name: Siu Kwong LIU, ANC, role: CONTACT, phone: 852 22557610, email: onceliu@yahoo.com.hk, geoPoint lat: 22.39407, lon: 114.13737, hasResults: False |
protocolSection identificationModule nctId: NCT06263283, orgStudyIdInfo id: PROICM 2023-04 KYO, briefTitle: Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer, acronym: KYOCOL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Institut du Cancer de Montpellier - Val d'Aurelle, class: OTHER, descriptionModule briefSummary: Every year in France, nearly 3,000 women develop a cervical cancer. The average age of women diagnosed is 51. Uterovaginal brachytherapy is one of the reference treatments.To allow this treatment, an applicator is first placed under general anaesthesia in the vaginal zone. Then, the pulsed Dose Rate (PDR) or high dose rate (HDR) uterovaginal brachytherapy requires 2-5 days hospitalization in an isolated room. Uterovaginal brachytherapy requires strict bed rest without movements allowed for the pelvic area until the applicator is removed.Prolonged immobilization, the context of the illness and the intimacy of the area to be treated are all recognized sources of anxiety. According to a study, 40% of patients have post-traumatic stress at 3 months of treatment. A Danish team highlights the significant decrease in physical capacity during and after treatment.Thus, as a recent literature review concludes, there is a real need to develop Non-Pharmacological-Interventions (NPI) to limit the aftereffects. It also seems important to provide support for self-management of symptoms.Among NPI of interest, Yoga is a mind-body practice that can decrease perceived stress. A systematic review confirms that yoga can reduce stress during cancer treatment. This underlines the importance of proposing this practice for patients treated for all types of cancers and further evaluations on the effects of respiratory and meditation exercises. Another team showed the feasibility of respiratory exercise intervention in patients undergoing chemotherapy while also talking about mental health benefits. Finally, a reduction in perceived stress was achieved in women treated with radiotherapy for breast cancer through yoga intervention. A lot of work has been done with promising results without the result of a consensus applicable to all care situations.Moreover, educational requirements are high in women treated to gynecological cancer.Meeting these needs helps to improve quality of life, pain management and drug use.Integrating Patient Educational Project (PEP) therefore seems relevant as an additional tool in patient empowerment. In addition, the fact that a combined Physiotherapy-Yoga-PEP intervention is feasible in women treated for breast cancer allows us to offer adjusted version in patients with brachytherapy.The literature review thus invites us to propose the educational intervention Kine-Yoga-PEP in the very particular context of brachytherapy., conditionsModule conditions: Cervical Cancer, conditions: Brachytherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Control Group: Standard care according to the modalities of each center (concomitant treatment prescription, psychological support, physiotherapy or dietetic are supports that can be proposed if needed) Experimental Group: Standard support with Daily realization of a session of Kine-Yoga supervised by a physiotherapist at J2, J3 and J4 of uterovaginal brachytherapy., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: session of Kine-Yoga, outcomesModule primaryOutcomes measure: Evaluation of the Kine-Yoga-PEP intervention to standard care during the uterovaginal brachytherapy on perceived stress at 15 days of treatment initiation in patients treated for cervical cancer., secondaryOutcomes measure: assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention, secondaryOutcomes measure: Evaluation of the immediate effect of the Kine-Yoga-PEP intervention in the experimental group on perceived stress, pain (overall and due to immobility) and the evolution of these parameters during brachytherapy., secondaryOutcomes measure: Evaluation of the evolution of fatigue during uterovaginal brachytherapy, secondaryOutcomes measure: assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy, secondaryOutcomes measure: Description of the use of anxiolytics by group (experimental vs control), secondaryOutcomes measure: Description of the experiences of patients treated for cervical cancer during uterovaginal brachytherapy receiving a Kine-Yoga-PEP intervention (approximately 20 patients in the experimental group, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06263270, orgStudyIdInfo id: 12-2023-01, briefTitle: Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Cytonics Corporation, class: INDUSTRY, collaborators name: Southern Star Research Pty Ltd., descriptionModule briefSummary: The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are:1. are two doses of CYT-108, delivered 12 weeks apart, safe when injected directly into the joint?2. does administration of CYT-108 result in a reduction in pain, stiffness, and improvement in daily physical function?Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify "disease modification" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment., conditionsModule conditions: Osteoarthritis, Knee, conditions: Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The Phase 1a trial will be a multicenter, double-blind, randomized, placebo-controlled clinical study to evaluate the safety of two doses of CYT-108 (given at Day 1 and Day 85) in participants with mild to moderate primary OA of the knee, followed out to 26 weeks. A Screening Visit will be performed between twenty-eight days to two days before the first dose, (i.e., Days -28 to -2), and if eligible, participants will attend baseline evaluation on Day 1 to confirm eligibility before randomisation to treatment. The first and second doses will be administered on Day 1 and Day 85 (12 weeks post-first dose, with six follow-up visits on Days 8, 29, 57, 85, 113, and 183; Weeks 1, 4, 8, 12, 16, and 26 weeks post-first dose respectively)., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: This study is double-blind, placebo-controlled. Neither the investigator, care providers, patients, nor study sponsor have knowledge of the interventions assigned to each participant., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: CYT-108, a recombinant protease inhibitor, interventions name: Phosphate Buffered Saline (PBS), outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Blood Pressure, primaryOutcomes measure: Heart Rate, primaryOutcomes measure: Respiratory Rate, primaryOutcomes measure: Body Temperature, primaryOutcomes measure: Titer of Human Anti-Drug Antibody, secondaryOutcomes measure: Change in WOMAC Scores (Pain, Stiffness, and Difficulty Performing Daily Activities), secondaryOutcomes measure: Time of Onset, otherOutcomes measure: Concentration of Cartilage Degradation Fragments in Blood Plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emeritus Research, city: Camberwell, state: Victoria, zip: 3124, country: Australia, contacts name: Stuart Game, MD, role: CONTACT, phone: +61 3 9509 6166, email: stuartgame@emeritusresearch.com, geoPoint lat: -37.84205, lon: 145.0694, hasResults: False |
protocolSection identificationModule nctId: NCT06263257, orgStudyIdInfo id: 2023-631, briefTitle: The Effect of Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Busra Nur Temur, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the impact of mandala art therapy on the anxiety and comfort levels of living kidney transplant recipients. While kidney transplantation improves the recipients' quality of life, it may also expose them to psychological, physical, and social challenges post-transplant. This situation can increase recipients' levels of anxiety, making them cope with psychiatric issues and affecting their comfort levels. Feeling psychologically and physiologically comfortable is a crucial component of a successful recovery process for recipients.Mandala art therapy is known as an effective method that supports the mental health, physical functioning, and social and emotional well-being of individuals with health issues. Mandalas can contribute to comfort by promoting inner peace, focusing attention, and encouraging creative expression. This study aims to investigate the impact of mandala art therapy on anxiety and comfort levels in kidney transplant recipients. To achieve this goal, a mixed-methods study using a randomized controlled and nested experimental design is planned.The results of this study will provide valuable insights to healthcare providers by elucidating the impact of mandala art therapy on comfort and anxiety levels in living kidney transplant recipients. This information may guide healthcare professionals in enhancing kidney transplant recipients' psychological and emotional well-being, reducing stress, and promoting higher levels of comfort through mandala art therapy.H0a: There is no effect of Mandala Art Therapy on the perceived anxiety level in living kidney transplant recipients.H0b: There is no effect of Mandala Art Therapy on the comfort level of living kidney transplant recipients., conditionsModule conditions: Anxiety, conditions: Transplant;Failure,Kidney, conditions: Transplant Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: For the intervention group, the first measurement (afternoon of the day before surgery) will include State-Trait Anxiety Inventory and General Comfort Questionaire, the second measurement (Postoperative Day 5 - discharge day) will include State Anxiety Inventory and General Comfort Questionaire. The sessions of the Mandala Art Therapy training program for the intervention group will be conducted as follows: Session 1 on Postoperative Day 5 - discharge day (after the scales), Session 2 on 1st Control (1 week after surgery), Session 3 on 2nd Control (2 weeks after surgery), and the third measurement at 3rd Control (1 month after surgery). For the Control Group, the third measurement (1 month after surgery) will be collected through self-reporting for State Anxiety Inventory and General Comfort Questionaire. This stage aims to conduct a randomized controlled study., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Blinding In this study, blinding of participants and the statistician is planned. Blinding of the researcher implementing the intervention will not be possible. Since participants will not know to which group they are assigned, participant blinding is considered feasible. Data related to the scales (post-test) will be coded as 'A' and 'B' without indicating whether they belong to the intervention or control group. The coded data will be analyzed by a statistician, without knowledge of group allocation. After the statistical analyses are completed, the coding for the intervention and control groups will be revealed. This blinding technique is intended to minimize statistical bias., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Mandala Art Therapy, outcomesModule primaryOutcomes measure: Reduction in anxiety levels, primaryOutcomes measure: Increasing comfort level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06263244, orgStudyIdInfo id: NL83403.018.22, briefTitle: Specifying the Anti-inflammatory Effects of Ziltivekimab, acronym: SPIDER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, descriptionModule briefSummary: The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics., conditionsModule conditions: Atherosclerosis, conditions: Inflammation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, double blind, placebo-controlled trial, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: After informed consent has been obtained, patients will be randomized via computer randomization to either 15 mg ziltivekimab (n=20) or placebo (n=20). On the eCRFs or other documents subjects will be identified by subject ID and randomization number only., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Ziltivekimab, interventions name: Placebo, outcomesModule primaryOutcomes measure: TBRmax coronary arteries, primaryOutcomes measure: monocyte activation marker protein expression, secondaryOutcomes measure: delta PCAT, secondaryOutcomes measure: Correlation delta TBRmax and CCTA derived plaque characteristics, secondaryOutcomes measure: delta SUVmax bone marrow, secondaryOutcomes measure: delta TBRmax ascending aorta, secondaryOutcomes measure: changes monocyte phenotype, secondaryOutcomes measure: changes in hsCRP, secondaryOutcomes measure: changes plasma cytokine and chemokine levels (pg/mL), secondaryOutcomes measure: changes plasma cytokine and chemokine levels (ng/mL), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06263231, orgStudyIdInfo id: IT-03, briefTitle: A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3), acronym: INVINCIBLE-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Intensity Therapeutics, Inc., class: INDUSTRY, collaborators name: Premier Research Group plc, descriptionModule briefSummary: To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen., conditionsModule conditions: Sarcoma,Soft Tissue, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 333, type: ESTIMATED, armsInterventionsModule interventions name: INT230-6, interventions name: Eribulin, interventions name: Trabectedin, interventions name: Pazopanib, outcomesModule primaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with leiomyosarcoma, secondaryOutcomes measure: Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with liposarcoma, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06263218, orgStudyIdInfo id: CCR-2023-200344, briefTitle: Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-12-29, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Hospital do Rim e Hipertensão, class: OTHER, descriptionModule briefSummary: This is a single-center, non-interventional, retrospective study of data, at the level of the individual without identification, extracted from medical records of adult patients undergoing a kidney transplant procedure after 1st from January 2018 until reaching the sample size enrollment (around 500 individuals); this refers to the period of verification of individuals' eligibility for entry into the study. Individuals under strategy preemptive patients who developed CMV infection/disease within 12 months after transplantation. The data will be collected from date of transplant (including pre-transplant clinical history) until completion of at least 12 months after transplantation, or until graft loss, or recipient death or loss to follow-up, when/if applicable., conditionsModule conditions: CMV Infection, conditions: CMV Viremia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of infection, CMV disease, and tissue invasive disease., secondaryOutcomes measure: Incidence recurrent CMV infection/disease, secondaryOutcomes measure: Incidence of refractory CMV infection/disease, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital do Rim, city: São Paulo, zip: 04038-002, country: Brazil, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False |
protocolSection identificationModule nctId: NCT06263205, orgStudyIdInfo id: Dressing, briefTitle: Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques, acronym: Dressing, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-24, completionDateStruct date: 2026-12-24, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, collaborators name: Shanghai Changzheng Hospital, collaborators name: Changhai Hospital, collaborators name: Shanghai East Hospital, descriptionModule briefSummary: The goal of this clinical trial is to assess the effectiveness and safety of non-dressing (exposed wound) versus dressing techniques in postoperative wound management for patients with gastrointestinal tumors. The main questions it aims to answer are:1. Does non-dressing of postoperative wounds in gastrointestinal tumor surgery provide equivalent or better wound healing compared to traditional dressing techniques?2. Can non-dressing of postoperative wounds reduce patient pain and healthcare costs? Participants in this study, who are diagnosed with gastrointestinal tumors and undergoing surgery, will be randomly assigned to either the non-dressing group or the dressing group. The non-dressing group will have their surgical wounds left exposed after initial postoperative care, while the dressing group will receive regular wound dressing changes every 48-72 hours. Researchers will compare these two groups to see if there are differences in the rate of wound complications, pain levels, and overall healthcare costs.This study aims to provide evidence-based recommendations for postoperative wound care in gastrointestinal tumor surgeries, potentially improving patient outcomes and reducing medical expenses., conditionsModule conditions: Gastrointestinal Tumors, conditions: Surgical Wound Infection, conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 816, type: ESTIMATED, armsInterventionsModule interventions name: Non-Dressing of Surgical Wound, interventions name: Regular Dressing Change of Surgical Wound, outcomesModule primaryOutcomes measure: Rate of Postoperative Wound Healing Complications, secondaryOutcomes measure: Patient Pain Levels, secondaryOutcomes measure: Medical Costs Associated with Wound Care, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, city: Shanghai, state: Shanghai, zip: 2000000, country: China, contacts name: Dazhi Xu, MD,PHD, role: CONTACT, phone: 021-64175590, email: xudzh@shca.org.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06263192, orgStudyIdInfo id: AMH-IUI, briefTitle: Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-01, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Jose Antonio Moreno, class: OTHER, collaborators name: Universitat Autonoma de Barcelona, descriptionModule briefSummary: The goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (IAD) in non-sterile women with plasma AMH levels \> and \< 1.1 ng/mL., conditionsModule conditions: Infertility, Female, conditions: Anti-Mullerian Hormone Deficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 342, type: ACTUAL, armsInterventionsModule interventions name: Intrauterine insemination, outcomesModule primaryOutcomes measure: Cummulative pregnancy rate, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fertty International, city: Barcelona, zip: 08010, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06263179, orgStudyIdInfo id: STUDY00007706, secondaryIdInfos id: UL1TR001412, type: NIH, link: https://reporter.nih.gov/quickSearch/UL1TR001412, briefTitle: Feasibility of Aerobic Exercise for Recovery From Work-related Concussion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-14, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: State University of New York at Buffalo, class: OTHER, collaborators name: National Center for Advancing Translational Sciences (NCATS), descriptionModule briefSummary: There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion., conditionsModule conditions: Concussion, Brain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Target Heartrate Aerobic Exercise, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Target Heartrate Aerobic Exercise, outcomesModule primaryOutcomes measure: Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed., secondaryOutcomes measure: Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale, secondaryOutcomes measure: Change in Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Change in Generalized Anxiety Disorder-7 (GAD-7), secondaryOutcomes measure: Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5), secondaryOutcomes measure: Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10), secondaryOutcomes measure: Work Climate Questionnaire - 6-Item Version, secondaryOutcomes measure: Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS), secondaryOutcomes measure: Time to return to work measured in days, otherOutcomes measure: Rate of adverse Events as assessed by questioning the participant, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-26, uploadDate: 2024-01-29T12:18, filename: ICF_000.pdf, size: 252809, hasResults: False |
protocolSection identificationModule nctId: NCT06263166, orgStudyIdInfo id: 5535, briefTitle: The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels: A Randomized Controlled Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: Women who will undergo vaginal examinations randomly assigned to intervention (n = 44) and control (n = 44) groups at a public hospital in Turkey will participate in the study. Stress ball application before vaginal examination will be explained to women in the intervention group. These women will be asked to tighten and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed. Data regarding pain and anxiety outcomes will be collected before and after the examination.The main questions it aims to answer are:* question 1: What is the effect of stress ball application on women's anxiety level during vaginal examination?* question 2: What is the effect of stress ball application on women's pain level during vaginal examination?, conditionsModule conditions: Anxiety State, conditions: Pain, conditions: Exanimation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Stress ball intervention, outcomesModule primaryOutcomes measure: Anxiety change, primaryOutcomes measure: Pain level, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06263153, orgStudyIdInfo id: OSU-23329, secondaryIdInfos id: NCI-2024-00002, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), briefTitle: Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Yuanquan Yang, class: OTHER, collaborators name: Gateway for Cancer Research, descriptionModule briefSummary: This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy., conditionsModule conditions: Bladder Urothelial Carcinoma, conditions: Muscle Invasive Bladder Carcinoma, conditions: Stage II Bladder Cancer AJCC v8, conditions: Stage IIIA Bladder Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Durvalumab, interventions name: Futibatinib, interventions name: Magnetic Resonance Imaging, interventions name: Radical Cystectomy, outcomesModule primaryOutcomes measure: Complete pathologic response rate, secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Pathologic down-staging rate to non-muscle invasive disease, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Frequency and severity of adverse events, including delay in cystectomy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Yuanquan Yang, MD, PhD, role: CONTACT, phone: 614-366-2485, email: Yuanquan.Yang@osumc.edu, contacts name: Yuanquan Yang, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False |
protocolSection identificationModule nctId: NCT06263140, orgStudyIdInfo id: Chula-ARC 001/21, briefTitle: Vitamin D Levels in Non-immediate Drug Hypersensitivity Case-control Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-30, primaryCompletionDateStruct date: 2022-01-15, completionDateStruct date: 2022-02-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: Serum vitamin D levels in drug-induced non-immediate reactions, conditionsModule conditions: Stevens-Johnson Syndrome, conditions: Drug Reaction With Eosinophilia and Systemic Symptom, conditions: Maculopapular Exanthem, conditions: Vitamin D Deficiency, conditions: Drug-Induced Rash, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Serum vitamin D levels, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Chulalongkorn University, city: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06263127, orgStudyIdInfo id: CMUH112-REC2-104, briefTitle: Sensory Motor Interventions on Preterm Infants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-01-10, completionDateStruct date: 2026-01-10, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: China Medical University Hospital, class: OTHER, descriptionModule briefSummary: Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants., conditionsModule conditions: Preterm Infants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: oral stimulation, interventions name: infants massage, outcomesModule primaryOutcomes measure: Oral intake, primaryOutcomes measure: Transition time of oral feeding, secondaryOutcomes measure: weight gain, secondaryOutcomes measure: Hospital stay, secondaryOutcomes measure: Neonatal Neurobehavioral Examination-Chinese Version(NNE-C), secondaryOutcomes measure: Infant/Toddler Sensory Profile-Chinese Version(ITSP-C), secondaryOutcomes measure: Premature Bottle Feeding Questionnaire(PBFQ), eligibilityModule sex: ALL, maximumAge: 34 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: China Medical University Hospital, city: Taichung, zip: 404, country: Taiwan, contacts name: Yu-Rou Chiang, Bachelor, role: CONTACT, phone: 0910-897-089, email: y198473@gmail.com, contacts name: Pei-Yu Yang, Master, role: CONTACT, phone: 0975-681-610, email: Yangpy888@gmail.com, contacts name: Pei-Yu Yang, Master, role: PRINCIPAL_INVESTIGATOR, contacts name: Yea-Shwu Hwang, ScD, role: SUB_INVESTIGATOR, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False |
protocolSection identificationModule nctId: NCT06263114, orgStudyIdInfo id: 00002826, briefTitle: Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Children's Mercy Hospital Kansas City, class: OTHER, collaborators name: Eurofins, descriptionModule briefSummary: Liver transplant rejection is when the body's immune system attacks and damages the liver of a transplant recipient. Currently the best way to see if that is happening is with a liver biopsy. The purpose of this research study is to see if a simple blood test can diagnose if a transplanted liver is being rejected., conditionsModule conditions: Liver Transplant; Complications, conditions: Liver Failure, Acute, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: TruGraf® Liver gene expression panel (GEP), outcomesModule primaryOutcomes measure: Correlation of the TruGraf® Liver GEP with rejection activity index (RAI) on surveillance and for-cause biopsy., secondaryOutcomes measure: Comparison of the GEP to non-rejection injury found on biopsy, secondaryOutcomes measure: Utility of the GEP for monitoring liver injury, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Mercy Hospitals and Clinics, status: RECRUITING, city: Kansas City, state: Missouri, zip: 64108, country: United States, contacts name: Corey Schurman, MA, role: CONTACT, phone: 816-802-1167, email: crschurman@cmh.edu, contacts name: Amber Bagherian, MD, role: CONTACT, phone: 816-234-3016, contacts name: Ryan Fischer, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.09973, lon: -94.57857, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-01-03, uploadDate: 2024-01-08T15:14, filename: Prot_000.pdf, size: 353012, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-10-23, uploadDate: 2024-02-14T12:08, filename: ICF_001.pdf, size: 244224, hasResults: False |
protocolSection identificationModule nctId: NCT06263101, orgStudyIdInfo id: ChaoyangHospital, briefTitle: Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chaoyang Hospital of China Medical University, class: OTHER_GOV, descriptionModule briefSummary: Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI) after colorectal surgery, is characterized by symptoms such as nausea, vomiting, abdominal distension, and delayed bowel movements. The incidence of this issue varies among medical institutions, impacting patient nutrition, prolonging hospital stays, and increasing healthcare costs.The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD. Studies have demonstrated changes in inflammatory cells and factors in the abdominal fluid following abdominal surgery, emphasizing the clinical significance of analyzing drainage fluid to predict postoperative gastrointestinal function.This study analyzes inflammatory markers in drainage fluid following laparoscopic colorectal cancer surgery. The aim is to enhance the accuracy of predicting gastrointestinal recovery outcomes and contribute to the evolving field of Enhanced Recovery After Surgery (ERAS)., conditionsModule conditions: Postoperative Gastrointestinal Dysfunction (POGD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Biochemical testing of abdominal drainage fluid, interventions name: Cytological examination of abdominal drainage fluid, interventions name: Peripheral blood cytology tests, outcomesModule primaryOutcomes measure: Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1, secondaryOutcomes measure: Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3, secondaryOutcomes measure: Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 1, secondaryOutcomes measure: Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 3, secondaryOutcomes measure: Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 1., secondaryOutcomes measure: Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 3., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chaoyang Central Hospital of China Medical University, status: RECRUITING, city: Chaoyang, state: Liaoning, country: China, contacts name: Xinao Fu, role: CONTACT, phone: +8618238692250, email: ailun10211@163.com, geoPoint lat: 41.57028, lon: 120.45861, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-01-08, uploadDate: 2024-02-12T01:53, filename: Prot_000.pdf, size: 182027, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-01-08, uploadDate: 2024-02-12T01:52, filename: SAP_001.pdf, size: 154895, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-08, uploadDate: 2024-02-12T01:37, filename: ICF_002.pdf, size: 277845, hasResults: False |
protocolSection identificationModule nctId: NCT06263088, orgStudyIdInfo id: CASE15223, briefTitle: EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).This study has 3 components as follows-1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment.2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant.3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational/informational material appropriate for participant's diagnosis., conditionsModule conditions: Gastrointestinal Cancer, conditions: Colon Cancer, conditions: Rectal Cancer, conditions: Anal Cancer, conditions: Esophageal Cancer, conditions: Stomach Cancer, conditions: Appendix Cancer, conditions: Pancreas Cancer, conditions: Liver Cancer, conditions: Neuroendocrine Tumors, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm study to address the existing disparities faced by Black participants with gastrointestinal (GI) cancer in accessing crucial biomarker testing, receiving evidence-based care, and participating in clinical trials., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: EQUITY GI, outcomesModule primaryOutcomes measure: Biomarker testing rate of Black participants diagnosed with GI cancer, secondaryOutcomes measure: Clinical trial enrollment rate among black participants diagnosed with GI cancer, secondaryOutcomes measure: Change in Health literacy test among black participants diagnosed with GI cancer, secondaryOutcomes measure: Change in Health literacy score among black participants diagnosed with GI cancer, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Sakti Chakrabarti, MD, role: CONTACT, phone: 216-844-3951, email: sakti.chakrabarti@uhhospitals.org, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False |
protocolSection identificationModule nctId: NCT06263075, orgStudyIdInfo id: 717/2023/Oss/AOUBo, secondaryIdInfos id: 6822, type: OTHER, domain: SirER (Emilia-Romagna Research Information System) platform, briefTitle: Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM), acronym: CRASY-PRAM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: IRCCS Azienda Ospedaliero-Universitaria di Bologna, class: OTHER, descriptionModule briefSummary: Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated.Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses.This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements., conditionsModule conditions: Craniosynostoses, conditions: Hypovolemia, conditions: Hemorrhage, conditions: Hemodynamic Instability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Intraoperative monitoring, outcomesModule primaryOutcomes measure: Hemodynamic events occurring during surgery, secondaryOutcomes measure: Evaluation of changes in volemic status, secondaryOutcomes measure: Evaluation of changes in volemic status, secondaryOutcomes measure: Evaluation of changes in systemic vascular resistance, secondaryOutcomes measure: Evaluation of changes in cardiac function, secondaryOutcomes measure: Evaluation of changes in cardiac function, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 8 Months, stdAges: CHILD, contactsLocationsModule locations facility: IRCCS AOU of Bologna Policlinico Sant'Orsola, status: RECRUITING, city: Bologna, state: BO, zip: 40138, country: Italy, contacts name: Luigia Scudeller, MD, role: CONTACT, phone: 051 2141402, phoneExt: +39, email: luigia.scudeller@aosp.bo.it, contacts name: Barbara Lotito, MD, role: CONTACT, phone: 051 2141296, phoneExt: +39, email: barbara.lotito@aosp.bo.it, contacts name: Lorena Pasini, MD, role: SUB_INVESTIGATOR, contacts name: Fabio Caramelli, MD, role: SUB_INVESTIGATOR, contacts name: Rosario Ruga, Student, role: SUB_INVESTIGATOR, contacts name: Andrea La Placa, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False |
protocolSection identificationModule nctId: NCT06263062, orgStudyIdInfo id: women undergoing colposcopy, briefTitle: Management With Fear of Cancer in Women Undergoing Colposcopy: Randomized Controlled Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-07, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Alanya Alaaddin Keykubat University, class: OTHER, descriptionModule briefSummary: Cervical cancer is the fourth most common cancer in women worldwide. Due to advances in early diagnosis and treatment, the number of survivors of cancer has increased over the past 50 years. Therefore, the current standard of care for the detection of cervical neoplasm, a Papanicolaou smear and then a colposcopic biopsy, requires a high degree of diagnostic accuracy. In particular, the fear of developing cancer after cancer screening tests is becoming an increasingly significant problem, with an impact on psychosocial health in individuals. For people who are afraid of cancer, meditation and awareness training can make it easier for emotions to self-regulate in times of distress and pain. This study aim to conducted to determine the impact of the Awareness-Based Initiation Program on cancer fear and level of awareness in women undergoing colonoscopy., conditionsModule conditions: Cancer Fear, conditions: Cervical Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Awareness-Based Coping with Fear of Cancer Programme, outcomesModule primaryOutcomes measure: The Cancer Worry Scale, secondaryOutcomes measure: Philadelphia Mindfulness Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alanya Alaaddin Keykubat University, status: RECRUITING, city: Alanya, zip: 7400, country: Turkey, contacts name: fatma ozlem uner, MSc, role: CONTACT, phone: +905062972749, email: fatma.uner@alanya.edu.tr, geoPoint lat: 36.54375, lon: 31.99982, hasResults: False |
protocolSection identificationModule nctId: NCT06263049, orgStudyIdInfo id: ejaculation post TURP, briefTitle: Is Ejaculation Preservation TURis the Natural Evolution of the "Gold Standard"., statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence, conditionsModule conditions: Benign Prostatic Hyperplasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 106, type: ACTUAL, armsInterventionsModule interventions name: transurethral resection of prostate, outcomesModule primaryOutcomes measure: post operative antegrade ejaculation, secondaryOutcomes measure: post operative urine continence, eligibilityModule sex: MALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ain shams university, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06263036, orgStudyIdInfo id: Bilgen S, briefTitle: Morphometric Examination of the Larynx, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-01-10, primaryCompletionDateStruct date: 2013-06-10, completionDateStruct date: 2013-06-10, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, descriptionModule briefSummary: Objective: To measure laryngeal dimensions in a sample of Turkish cadavers including males and females of various ages and heights.Patients and Methods: Morphological measurement was performed on 102 laryngeal specimens. Laryngeal cartilages were collected from human cadavers. All dimensions of the cartilages were measured using a thread and vernier calipers. Age, sex, and height were recorded. Results for men and women were compared., conditionsModule conditions: Laryngeal Dimensions in Males and Females, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 102, type: ACTUAL, armsInterventionsModule interventions name: Men, interventions name: Women, outcomesModule primaryOutcomes measure: To measure laryngeal dimensions in cadavers, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06263023, orgStudyIdInfo id: 34L-CP-02-009, briefTitle: A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation, acronym: OPTIMAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: 34 Lives, PBC, class: INDUSTRY, collaborators name: Indiana University Health, collaborators name: University of Miami, collaborators name: MOUNT SINAI HOSPITAL, collaborators name: University of Wisconsin, Madison, descriptionModule briefSummary: This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals., conditionsModule conditions: Organ Preservation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Sub-Normothermic Machine Preservation and Assessment, outcomesModule primaryOutcomes measure: Transplant Allocation Success, secondaryOutcomes measure: 7-Day Delayed Graft Function (DGF), secondaryOutcomes measure: Graft Survival, secondaryOutcomes measure: Patient Survival, secondaryOutcomes measure: Serum Creatinine (sCr), secondaryOutcomes measure: eGFR, secondaryOutcomes measure: Long term data collection- Graft Survival, secondaryOutcomes measure: Long term data collection- Patient Survival, secondaryOutcomes measure: Long term data collection- Serum Creatinine, secondaryOutcomes measure: Long term data collection- eGFR, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Miami Transplant Institute, University of Miami Miller School of Medicine, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Giselle Guerra, MD, role: CONTACT, contacts name: Giselle Guerra, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Indiana University Health, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: William Goggins, MD, role: CONTACT, contacts name: William Goggins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, locations facility: The Mount Sinai Hospital, status: RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Matthew Holzner, MD, role: CONTACT, contacts name: Matthew Holzner, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Wisconsin School of Medicine and Public Health, status: NOT_YET_RECRUITING, city: Madison, state: Wisconsin, zip: 53792, country: United States, contacts name: Jacqueline Garonzik Wang, MD, role: CONTACT, contacts name: Jacqueline Garonzik Wang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False |
protocolSection identificationModule nctId: NCT06263010, orgStudyIdInfo id: CIBS-2023-01, briefTitle: Allopregnanolone as a Regenerative Treatment for Parkinson's Disease, acronym: Allo-PD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-12, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Roberta Brinton, class: OTHER, descriptionModule briefSummary: The goal of this open-label, pilot clinical trial is to test allopregnanolone as a regenerative treatment in patients with Parkinson's disease (PD). The main questions this study aims to answer are:1. Is a large-scale clinical trial testing how well it works in patients with PD feasible?2. Is allopregnanolone safe and well-tolerated in patients with PD.3. Can we see any signals of changes in imaging and clinical scales?Participants will receive a weekly infusion in their vein of allopregnanolone for a total of 12 weeks. There is no placebo so everyone receives allopregnanolone and "Open-label" means the study is not blinded so both the participant and investigators know the assigned treatment., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Allopregnanolone, outcomesModule primaryOutcomes measure: Study completion, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Infusion Reactions, secondaryOutcomes measure: Pharmacokinetics: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Pharmacokinetics: Time of peak concentration (tmax), secondaryOutcomes measure: Pharmacokinetics: Half-life (t1/2), secondaryOutcomes measure: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC), otherOutcomes measure: Dopamine transporter (DaT) SPECT imaging, otherOutcomes measure: MRI: Regional brain volumes, otherOutcomes measure: MRI: Fractional Anisotropy, otherOutcomes measure: MRI: Quantitative anisotropy, otherOutcomes measure: MRI: Functional connectivity, otherOutcomes measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part I (non-motor EDL), otherOutcomes measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part II (motor EDL), otherOutcomes measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part III (motor examination), otherOutcomes measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part IV (motor complications), otherOutcomes measure: Mean rate of change in the Unified Dyskinesia Rating Scale (UDysRS) total score, otherOutcomes measure: Change from baseline in Montreal Cognitive Assessment (MoCA) score, otherOutcomes measure: Change from baseline in Parkinson's disease Questionnaire (PDQ-39)., otherOutcomes measure: Change from baseline in Hamilton Depression Rating Scale (HAM-D), otherOutcomes measure: Cambridge Cognition's Paired Associates Learning (PAL) Test, otherOutcomes measure: Cambridge Cognition's Motor Screening Task (MOT), otherOutcomes measure: Cambridge Cognition's One Touch Stockings of Cambridge (OTS), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Arizona Clinical & Translational Science Research Center, status: RECRUITING, city: Tucson, state: Arizona, zip: 85721, country: United States, contacts name: Dakota Darby, role: CONTACT, email: dakotadarby@arizona.edu, geoPoint lat: 32.22174, lon: -110.92648, hasResults: False |
protocolSection identificationModule nctId: NCT06262997, orgStudyIdInfo id: TU-FTR-AMUTLU-2, briefTitle: Effectiveness of Pilates and Taping in Office Workers With Neck Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-02-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Tarsus University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effectiveness of pilates and kinesiotape applications in office workers with neck pain. In this direction, neck pain and disability, pain threshold, muscle strength, range of motion, core endurance, postural awareness and quality of life will be evaluated., conditionsModule conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One group will receive only pilates training. Other group participants will receive kinesiobant application in addition to pilates training., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The researcher who will do the pilates training and taping and the other researcher who will do the pre-test and post-test are blinded., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Pilates, interventions name: Pilates and Kinesiotape, outcomesModule primaryOutcomes measure: Neck Disability Index, secondaryOutcomes measure: Pain PressureThreshold, secondaryOutcomes measure: Muscle Strength, secondaryOutcomes measure: Range of Motion, secondaryOutcomes measure: Prone Bridge Test, secondaryOutcomes measure: Sits Up Test:, secondaryOutcomes measure: Postural Habits and Awareness Scale, secondaryOutcomes measure: Short Form 36, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tarsus University, status: RECRUITING, city: Mersin, country: Turkey, contacts name: Ali Mutlu, role: CONTACT, contacts name: Ali MUTLU, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False |
protocolSection identificationModule nctId: NCT06262984, orgStudyIdInfo id: 2023/21-754, briefTitle: Therapeutic Play Before Nasopharyngeal Swabbing in Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-03-13, completionDateStruct date: 2024-03-13, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Maltepe University, class: OTHER, descriptionModule briefSummary: The study will be conducted with the randomized controlled experimental method. Children who apply to the Child Health and Diseases Polyclinic and Child Health and Diseases Service and who will have nasopharyngeal swab applied will be divided into two groups by drawing lots. After the randomization children in the therapeutic play group the nasal swab will be shown on the doll to the child by the researcher before being taken. The child is then allowed to play with the doll accompanied by the researcher. No intervention will be performed on children in the control group. The parents will also be found next to their children in both groups during the procedure., conditionsModule conditions: Behavior, Coping, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 68, type: ACTUAL, armsInterventionsModule interventions name: Therapeutic Play, outcomesModule primaryOutcomes measure: Children's emotional manifestation, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Maltepe University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06262971, orgStudyIdInfo id: PCI-LM-Registry-2018, briefTitle: Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-06-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Medipol University, class: OTHER, descriptionModule briefSummary: This hospital-based registry study at Istanbul Medipol University Hospital focuses on documenting and analyzing the clinical and demographic characteristics, procedural-related aspects, and both short and long-term outcomes of patients undergoing left main coronary artery percutaneous coronary intervention (PCI). The study aims to identify predictors for adverse clinical outcomes in patients treated for left main coronary artery disease., conditionsModule conditions: Coronary Artery Disease, conditions: Left Main Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3620, type: ACTUAL, armsInterventionsModule interventions name: Percutaneous coronary intervention, outcomesModule primaryOutcomes measure: Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI, secondaryOutcomes measure: Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR), secondaryOutcomes measure: Procedure-Related Complications Within 30 Days of PCI, secondaryOutcomes measure: Health-Related Quality of Life (HRQoL) Scores One Year After PCI, secondaryOutcomes measure: Rate of stent thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Medipol University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06262958, orgStudyIdInfo id: KUH5703459, briefTitle: Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent, acronym: REAL-SMART, statusModule overallStatus: RECRUITING, startDateStruct date: 2017-08-07, primaryCompletionDateStruct date: 2030-06-01, completionDateStruct date: 2030-06-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Kuopio University Hospital, class: OTHER, descriptionModule briefSummary: ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it, conditionsModule conditions: Alcoholism, conditions: Substance Abuse, conditions: Alcohol Dependence, conditions: Alcohol-Related Disorders, conditions: Substance Use Disorders, conditions: Adolescent Behavior, conditions: Adolescent Problem Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Clients are randomized into two groups: 1) those receiving TAU and 2) those receiving a mini-intervention for substance and alcohol use an add-on treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: ASSIST, interventions name: Treatment as usual, outcomesModule primaryOutcomes measure: Decreased consumption of alcohol, tobacco or substances, secondaryOutcomes measure: BDI scores, secondaryOutcomes measure: GAD scores, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Kuopio University Hospital, status: RECRUITING, city: Kuopio, zip: 70110, country: Finland, contacts name: Sanna Voutilainen, Res. nurse, role: CONTACT, phone: +358447175351, email: sanna.voutilainen@kuh.fi, geoPoint lat: 62.89238, lon: 27.67703, hasResults: False |
protocolSection identificationModule nctId: NCT06262945, orgStudyIdInfo id: YDU/2024/120-1808, briefTitle: Comperasion the Postoperative Effect of Low Laser Therapy and Platelet Rich Fibrin on Mandibular Third Molar Surgery., statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2024-02-06, completionDateStruct date: 2024-02-07, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Beste Erismen, class: OTHER, descriptionModule briefSummary: The aim of this study was investigate the comparison of postoperative effects of low laser treatment and platelet-rich fibrin application on mandibular impacted third molar tooth extraction. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 4 randomly separated groups. In group 1, PRF was applied to the tooth socket. In group 2, PRF was applied to the tooth socket combined with Low Laser Treatment extraorally to the extraction area for three days within surgery day In group 3, Low Laser Treatment was applied to the extraorally to the extraction area for three days within surgery day. In group 4 (control group), tradional osteomy was made. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation. All of the 4 groups patients were prescribed an 875/125 mg amoxicillin/clavulanic acid tablet twice daily for five days., conditionsModule conditions: Impacted Third Molar Tooth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Diagnoses, interventions name: traditional osteotomies, interventions name: platelet rich fibrin, interventions name: Antibiotics, Penicillin, interventions name: low laser therapy, bicure laser, interventions name: Analgesic, outcomesModule primaryOutcomes measure: Visual analogue scale (VAS), primaryOutcomes measure: Visual analogue scale (VAS), primaryOutcomes measure: Visual analogue scale (VAS), primaryOutcomes measure: Visual analogue scale (VAS), primaryOutcomes measure: Trismus, primaryOutcomes measure: Trismus, primaryOutcomes measure: Trismus, primaryOutcomes measure: Trismus, primaryOutcomes measure: Swelling, primaryOutcomes measure: Swelling, primaryOutcomes measure: Swelling, primaryOutcomes measure: Swelling, secondaryOutcomes measure: the number of analgesic tablets, secondaryOutcomes measure: the number of analgesic tablets, secondaryOutcomes measure: the number of analgesic tablets, secondaryOutcomes measure: the number of analgesic tablets, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Near East University, city: Nicosia, state: Lefkosa, zip: 99138, country: Cyprus, geoPoint lat: 35.17531, lon: 33.3642, hasResults: False |
protocolSection identificationModule nctId: NCT06262932, orgStudyIdInfo id: RADS regimen, briefTitle: Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Police General Hospital, Thailand, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen* Repeated dosing regimen* Standard dosing regimen, conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Amiodarone, outcomesModule primaryOutcomes measure: Heart rate, secondaryOutcomes measure: Normal sinus rhythm at 24 hours, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Major adverse cardiovascular events, secondaryOutcomes measure: Phlebitis, secondaryOutcomes measure: Changed in heart rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06262919, orgStudyIdInfo id: CDRB436I1401, briefTitle: Special Drug Use-results Surveillance of Tafinlar/Mekinist, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2031-12-31, completionDateStruct date: 2031-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture., conditionsModule conditions: BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Tafinlar/Mekinist, outcomesModule primaryOutcomes measure: [Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation, primaryOutcomes measure: [Adult patients] overall response rate (ORR), secondaryOutcomes measure: [Pediatric patients] Incidence proportion of ORR, secondaryOutcomes measure: [Pediatric and adult patients] Incidence proportion of PFS, secondaryOutcomes measure: [Pediatric patients] Number of patients with changes in height and body weight and sexual maturation, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novartis Investigative Site, status: RECRUITING, city: Kobe, state: Hyogo, zip: 650-0011, country: Japan, geoPoint lat: 34.6913, lon: 135.183, locations facility: Novartis Investigative Site, status: RECRUITING, city: Akita, zip: 010-8543, country: Japan, geoPoint lat: 39.71667, lon: 140.10826, locations facility: Novartis Investigative Site, status: RECRUITING, city: Osaka, zip: 534-0021, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Novartis Investigative Site, status: RECRUITING, city: Osaka, zip: 550-0015, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, hasResults: False |
protocolSection identificationModule nctId: NCT06262906, orgStudyIdInfo id: BA-VCAP-01, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False |
protocolSection identificationModule nctId: NCT06262893, orgStudyIdInfo id: Shoulder nerve blocks, briefTitle: Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: In this study the investigators aim to compare the effect of the suprascapular- supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on analgesic effect during arthroscopic shoulder surgery, as postoperative pain scores ,postoperative consumption of analgesic rescue medications and diaphragmatic excursion assessment., conditionsModule conditions: Shoulder Arthroscopy Blocks, conditions: Dexamethasone, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Shoulder arthroscopy blocks, outcomesModule primaryOutcomes measure: Postoperative analgesia by visual analog scale (VAS)., secondaryOutcomes measure: Diaphragmatic excursion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assiut University, city: Assiut, country: Egypt, contacts name: Assiut University, role: CONTACT, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06262880, orgStudyIdInfo id: BIO-2305, briefTitle: Dietary Supplementation on Gastrointestinal Barrier Function, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2025-02-06, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Brightseed, class: INDUSTRY, descriptionModule briefSummary: The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. The primary hypothesis is that supplementation with plant derived phenolics will improve gut health compared to placebo., conditionsModule conditions: Intestinal Permeability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: plant derived phenolics, interventions name: Microcrystaline cellulose (MCC), outcomesModule primaryOutcomes measure: 0-2 h urine 13C Mannitol excretion, secondaryOutcomes measure: 2 to 8 h urine 13C Mannitol, secondaryOutcomes measure: 0 to 2 h urine LMR, secondaryOutcomes measure: 2 to 8 h urine LMR, secondaryOutcomes measure: Blood Biomarkers, secondaryOutcomes measure: Blood Biomarkers, secondaryOutcomes measure: Blood Biomarkers, secondaryOutcomes measure: Fecal Biomarkers, secondaryOutcomes measure: Fecal Biomarkers, secondaryOutcomes measure: Inflammatory Biomarkers (Blood), secondaryOutcomes measure: Inflammatory Biomarkers (Blood), secondaryOutcomes measure: Inflammatory Biomarkers (Blood), secondaryOutcomes measure: Inflammatory Biomarkers (Blood), secondaryOutcomes measure: 7-day recall of gastrointestinal symptoms, secondaryOutcomes measure: 7-day recall of gastrointestinal symptoms, secondaryOutcomes measure: Stool frequency, secondaryOutcomes measure: Stool consistency, secondaryOutcomes measure: Body Weight, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Biofortis, status: RECRUITING, city: Addison, state: Illinois, zip: 60101, country: United States, contacts name: Chad Cook, role: CONTACT, geoPoint lat: 41.9317, lon: -87.98896, hasResults: False |
protocolSection identificationModule nctId: NCT06262867, orgStudyIdInfo id: ReadySetFood, briefTitle: Early Allergen System Experience, acronym: EASE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Prollergy dba Ready Set Food, class: OTHER, collaborators name: ObvioHealth, descriptionModule briefSummary: Multiple clinical trials have demonstrated that early allergen introduction, feeding babies common food allergens before six months, decreases children's risk of developing a food allergy. Despite successful food allergy introduction trials showing that food allergies can be prevented, early introduction in the required amount can be challenging for parents. In some studies, less than 20% of parents introduce peanuts before their child is six months old, and few feed them regularly after introduction. Ready. Set. Food! is a direct-to-consumer product that offers a convenient supplement with a daily dose regimen that can be added to breastmilk, formula, or food to make early allergen introduction easy. The formulation includes cow's milk, egg, and peanut, representing the majority of childhood food allergies, and the protein levels are based on doses found to be effective in clinical trials. Over 200,000 infants have used Ready. Set. Food!.This study investigates the effectiveness of introducing common allergens to infants with the goal of preventing food allergies. The study will enroll 1,100 infants stratified by their risk of developing a food allergy who are assigned to either receive Ready. Set. Food! supplements or follow standard allergen introduction practices recommended by their pediatrician.The goal of this study is to assess how Ready. Set. Food! allergen introduction supplements improve the experience of parents introducing allergens, decrease healthcare costs related to food allergies, and decrease food allergy prevalence., conditionsModule conditions: Food Allergy in Infants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1110, type: ESTIMATED, armsInterventionsModule interventions name: Ready. Set. Food! Stage 1 Mix ins, outcomesModule primaryOutcomes measure: The proportion of caregivers who are adherent with the evidence-based guidance for cow's milk, egg, and peanut during the 6 - month period, secondaryOutcomes measure: Frequency of caregiver-reported allergy or food introduction-related adverse events (AEs) after introduction of cow's milk, egg, and peanut, secondaryOutcomes measure: Frequency of caregiver-reported serious adverse events (SAEs) after introduction of cow's milk, egg, and peanut, secondaryOutcomes measure: Frequency of caregiver-reported special interest adverse events (FPIES and anaphylaxis) after introduction to cow's milk, egg, and peanut by 12 months of age, otherOutcomes measure: The proportion of caregivers who are satisfied with introduction of egg, cow's milk, and peanut, otherOutcomes measure: The total allergy-related healthcare costs, otherOutcomes measure: The proportion of participants with food allergy to cow's milk, egg, or peanut, otherOutcomes measure: The proportion of participants with a suspected food allergy, eligibilityModule sex: ALL, minimumAge: 2 Months, maximumAge: 5 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06262854, orgStudyIdInfo id: AOU Careggi Firenze, briefTitle: Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study, acronym: BIG D-FOOT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero-Universitaria Careggi, class: OTHER, descriptionModule briefSummary: This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures., conditionsModule conditions: Diabete Mellitus, conditions: Foot Ulcer, conditions: Osteomyelitis - Foot, conditions: Surgical Procedure, Unspecified, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Granules of calcium sulphate with and without antibiotics are identical and undistinguishable., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Calcium-sulphate granules with tobramicina+vancomicina, outcomesModule primaryOutcomes measure: The composite primary endpoint of this study will be the incidence osteomyelitis recurrence or new osteomyelitis in adjacent sites or tissue infection at the site of osteomyelitis., secondaryOutcomes measure: Proportion of healed patients, secondaryOutcomes measure: Proportion of osteomyelitis recurrence, secondaryOutcomes measure: Proportion of post-surgical tissue infection, secondaryOutcomes measure: Proportion of wound recurrence, secondaryOutcomes measure: Proportion of patients undergoing major amputation, secondaryOutcomes measure: Proportion of patients undergoing new surgical intervention, secondaryOutcomes measure: Ulcer time-to-healing, secondaryOutcomes measure: Osteomyelitis time-to-recurrence, secondaryOutcomes measure: Any serious adverse events, secondaryOutcomes measure: Any non serious adverse events, secondaryOutcomes measure: Proportion of post-surgical dehiscence, secondaryOutcomes measure: Direct medical costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06262841, orgStudyIdInfo id: Murat Kaan Erdem, briefTitle: Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2023-04-01, completionDateStruct date: 2023-04-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Ankara University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life., conditionsModule conditions: Impacted Third Molar Tooth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 21, type: ACTUAL, armsInterventionsModule interventions name: Piezosurgery, interventions name: Conventional burs, outcomesModule primaryOutcomes measure: Change in Oral Health-related Quality of Life, secondaryOutcomes measure: Change in pain, secondaryOutcomes measure: Change in Mouth opening, secondaryOutcomes measure: Operation time, secondaryOutcomes measure: Change in facial swelling, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ankara University Faculty of Dentistry, city: Ankara, state: Çankaya, zip: 06510, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06262828, orgStudyIdInfo id: UW 24-064, briefTitle: HEARTWISE - P-CARDIAC for Chinese: Population-based Study, acronym: HEARTWISE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: Cardiovascular disease (CVD) is one of the prominent diseases that affect many people. One cost-effective solution is to identify people at higher risk of CVD by CVD risk prediction model. China-PAR, TRS-2P, and SMART2 are common risk prediction models for prevention. However, these risk scores were mostly based on the routinely self-check health information and multivariable regression without time-varying consideration. Investigators developed a Machine Learning (ML) based risk prediction model, Personalized CARdiovascular DIsease risk Assessment for Chinese (P-CARDIAC) among a predominantly Chinese population in Hong Kong to estimates the 10 years of secondary recurrent CVD risk for the high-risk individuals. The study objective is to evaluate the accuracy of the P-CARDIAC performance in practice among a large-scale Hong Kong population in medicine specialist outpatient clinic (SOPC) and cardiac clinic. The results will reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Investigators anticipate that the results may help to facilitate P-CARDIAC in clinical setting and provide more practical information with the development of P-CARDIAC., conditionsModule conditions: Cardiovascular Diseases, conditions: CVD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, outcomesModule primaryOutcomes measure: The relationship between P-CARDIAC risk score and heart disease related symptoms, primaryOutcomes measure: P-CARDIAC risk thresholds determination, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: School of Nursing, The University of Hong Kong, city: Hong Kong, country: Hong Kong, contacts name: Sze Ling Celine Chui, PhD, role: CONTACT, phone: (852) 3917 6629, email: cslchui@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-10-31, uploadDate: 2024-01-31T01:00, filename: Prot_SAP_000.pdf, size: 294821, hasResults: False |
protocolSection identificationModule nctId: NCT06262815, orgStudyIdInfo id: 2023-06806-01, briefTitle: The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction, acronym: NGTUBE-OBS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Daniel Wilhelms, class: OTHER, collaborators name: Linkoeping University, descriptionModule briefSummary: Small bowel obstruction (SBO) occurs when the normal movements of the small bowel is obstructed, most commonly due to adhesion related to previous abdominal surgery. This may cause strangulation of the small bowel with reduced blood flow which is a surgical emergency requiring prompt treatment in the operating room. If there are no signs of strangulation or ischemia of the bowel at the time of diagnosis, international guidelines recommend initial treatment with intravenous fluids and nasogastric tube placement. However, there is emerging debate regarding non-selective treatment with nasogastric tube placement in patients with SBO. This management started around 1930 as a means to reduce pain in patients with SBO, in conjunction with other additions to management, like intravenous fluids. However the effect and utility of routine nasogastric tube placement have not been prospectively evaluated. There are a total of three retrospective observational studies in the past decade with a total of 759 patients where 292 (36%) were managed without a nasogastric tube. There was no difference in the rates of conservative treatment failure (requiring surgery), complications (vomiting, pneumonia) or mortality between patients receiving a nasogastric tube and those who didn't. However, the retrospective design of these studies limits their validity. Furthermore, nasogastric tube placement has been shown to be one of the more painful interventions patients may experience in-hospital. This calls into question the patient benefit of routine nasogastric tube placement in patients with SBO and further studies are needed to discern the utility of this intervention.Definitive treatment for SBO is surgical adhesiolysis but there is debate regarding the timing of surgery, particularly in older adults. A large proportion of patients may be managed conservatively with oral contrast and repeated radiological evaluation and the obstruction will resolve in many patients within 24 to 48 hours. This timeframe is dependent on factors related to the disease itself as well as patient related factors like previous surgery and comorbidities. Older patients are at high risk for complications but current available data is insufficient to inform practice in this population. Frailty, a state of increased vulnerability and susceptibility to adverse events, has been shown to be an independent prognosticator in older adults in the Emergency Department(ED) and suggested as a potential measure to risk stratify older adults with SBO. However to the authors knowledge there is no available data on frailty in older adults with SBO and only one prospective observational trial looking at older adults with SBO. Despite SBO being one of the most common surgical emergencies in older adults.To investigate the potential benefit of nasogastric tube placement in patients with SBO and the ability of frailty to prognosticate outcomes in older adults better evidence is needed., conditionsModule conditions: Small Bowel Obstruction, conditions: Frailty, conditions: Nasogastric Tube, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Nasogastric tube placement, interventions name: Clinical Frailty Scale, outcomesModule primaryOutcomes measure: Pain at Emergency Department discharge, secondaryOutcomes measure: Nausea at Emergency Department discharge, secondaryOutcomes measure: Hospital Length of Stay, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Admission for Small bowel obstruction, secondaryOutcomes measure: Emergency Surgery, secondaryOutcomes measure: Emergency Department Length of Stay, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sahlgrenska Universitetssjukhuset, status: RECRUITING, city: Göteborg, country: Sweden, contacts name: Nina Bardhi, MD, role: CONTACT, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Östra sjukhuset, status: RECRUITING, city: Göteborg, country: Sweden, contacts name: Mathias Jerkfelt, MD, role: CONTACT, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Skånes Universitetssjukhus, status: ACTIVE_NOT_RECRUITING, city: Lund, country: Sweden, geoPoint lat: 55.70584, lon: 13.19321, locations facility: Skånes Universitetssjukhus, status: ACTIVE_NOT_RECRUITING, city: Malmö, country: Sweden, geoPoint lat: 55.60587, lon: 13.00073, locations facility: Lasarett i Motala, status: RECRUITING, city: Motala, country: Sweden, contacts name: Jens Wretborn, PhD, role: CONTACT, phone: +46101033000, email: jens.wretborn@regionostergotland.se, geoPoint lat: 58.53706, lon: 15.03649, locations facility: Vrinnevisjukhuset, status: RECRUITING, city: Norrköping, country: Sweden, contacts name: Sigrid Wallden, MD, role: CONTACT, geoPoint lat: 58.59419, lon: 16.1826, locations facility: Sundsvalls sjukhus, status: RECRUITING, city: Sundsvall, country: Sweden, contacts name: Robert Schytzer, MD, role: CONTACT, geoPoint lat: 62.39129, lon: 17.3063, locations facility: Akutmottagningen US Östergötland, status: RECRUITING, city: Linköping, state: Östergötland, zip: 58185, country: Sweden, contacts name: Jens Wretborn, PhD, role: CONTACT, phone: +46101033000, email: jens.wretborn@regionostergotland.se, contacts name: Alaa Hussein, MD, role: CONTACT, phone: +46101033000, email: alaa.hussein@regionostergotland.se, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False |
protocolSection identificationModule nctId: NCT06262802, orgStudyIdInfo id: 123123, briefTitle: Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Radwa Hydar Ragab, class: OTHER, descriptionModule briefSummary: Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions, conditionsModule conditions: Odontogenic Cysts, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Active decompression, outcomesModule primaryOutcomes measure: Volume change, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06262789, orgStudyIdInfo id: 49RC23_0011, briefTitle: RAT-HEMATO : Return to Work After Malignant Hemopathy, acronym: RAT-HEMATO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University Hospital, Angers, class: OTHER_GOV, descriptionModule briefSummary: Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. The return of patients to their "pre-cancer life" can thus become an objective. Indeed, RTW after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). However, many difficulties can interfere with RTW. Many factors have been identified: disease, treatment, patient and occupational factors. The feeling of "return-to-work self-efficacy" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. It corresponds to a cognitive mechanism based on expectations and/or beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case RTW. The majority of studies on RTW concerns solid cancer and are retrospective. Very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. Moreover, very few interventional studies exist. There is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on RTW. The investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early RTW-consultation in patients who have been treated for a hematological malignancy. The investigators hypothesize that this consultation will improve patients' RTW rates and RTW quality., conditionsModule conditions: Leukemia, conditions: Lymphoma, conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: "Return-to-work after cancer" consultation, outcomesModule primaryOutcomes measure: Return-to-work rate at 1 year (percentage), secondaryOutcomes measure: Cumulative incidence of return-to-work at 1 year, secondaryOutcomes measure: Change or not of the professional situation in the 2 arms, secondaryOutcomes measure: Factors influencing return to work, secondaryOutcomes measure: Quality of life (SF-12 score) evolution, secondaryOutcomes measure: Anxiety and depression (HAD scale) evolution, secondaryOutcomes measure: Return-to-work self-efficacy (RTW-SE-11 scale) evolution, secondaryOutcomes measure: Self-assessment of the benefit of the "return-to-work after cancer" consultation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Angers University hospital, city: Angers, country: France, contacts name: PAILLASSA Jérome, MD, role: CONTACT, phone: 02.41.35.45.24, phoneExt: +33, email: jerome.paillassa@chu-angers.fr, geoPoint lat: 47.46667, lon: -0.55, locations facility: Brest University Hospital, Morvan Site, city: Brest, country: France, contacts name: Marie-Anne Couturier, MD, role: CONTACT, phone: 02.98.22.30.37, email: marie-anne.couturier@chu-brest.fr, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Caen University hospital, city: Caen, country: France, contacts name: Ghandi Laurent DAMAJ, MD, role: CONTACT, phone: 02.31.27.21.40, phoneExt: +33, email: damaj-gl@chu-caen.fr, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Rennes University Hospital, Pontchaillou site, city: Rennes, country: France, contacts name: Roch HOUOT, MD, role: CONTACT, phone: 02.99.28.42.91, phoneExt: +33, email: roch.houot@chu-rennes.fr, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Centre Henri Becquerel, city: Rouen, country: France, contacts name: Stéphane LEPRETRE, MD, role: CONTACT, phone: 02.32.08.22.23, phoneExt: +33, email: stephane.lepretre@chb.unicancer.fr, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Rouen University Hospital, city: Rouen, country: France, contacts name: Laetitia ROLLIN, MD, role: CONTACT, phone: 02.32.88.82.69, email: laetitia.rollin@chu-rouen.fr, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Tours University Hospital, Bretonneau Site, city: Tours, country: France, contacts name: Emmanuel GYAN, role: CONTACT, phone: 02.47.47.38.11, email: e.gyan@chu-tours.fr, geoPoint lat: 47.38333, lon: 0.68333, hasResults: False |
protocolSection identificationModule nctId: NCT06262776, orgStudyIdInfo id: SIRZOSTER1.01, briefTitle: Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients, acronym: SIR ZOSTER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Central Adelaide Local Health Network Incorporated, class: OTHER_GOV, collaborators name: National Health and Medical Research Council, Australia, collaborators name: University of Adelaide, collaborators name: Royal Prince Alfred Hospital, Sydney, Australia, descriptionModule briefSummary: The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:1. Are there differences in vaccination immunological responses in kidney transplant patients on different immunosuppression regimens?2. Are there differences in vaccination immunological responses between kidney transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination., conditionsModule conditions: Immunosuppression, conditions: Vaccine Response Impaired, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant zoster vaccine adjuvanted (SHINGRIX), outcomesModule primaryOutcomes measure: Functional T cell memory, secondaryOutcomes measure: Frequency of virus specific T cells, secondaryOutcomes measure: Magnitude of antibody response, secondaryOutcomes measure: Concentration of post-vaccination circulating cytokines, secondaryOutcomes measure: Frequency of polyfunctional T cells, secondaryOutcomes measure: Magnitude of vaccine-induced cross-protective antiviral responses, secondaryOutcomes measure: Frequency of virus-specific T stem cell memory compared to baseline, otherOutcomes measure: Incidence of shingles, otherOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, otherOutcomes measure: Tolerability of vaccination regimen as assessed by EQ-5D, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06262763, orgStudyIdInfo id: HILT for SIJP, briefTitle: High-intensity Laser Therapy for Sacroiliac Joint Pain, acronym: Girls, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-03, primaryCompletionDateStruct date: 2023-04-28, completionDateStruct date: 2024-03-28, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: Effect of high intensity laser on sacroiliac joint pain, conditionsModule conditions: Sacroiliac Joint Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Laser Therapy, interventions name: Traditional exercises, interventions name: Placebo laser, outcomesModule primaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Pressure pain threshold, otherOutcomes measure: Functional disability, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kafr Al-Sheikh University, city: Kafr Ash Shaykh, country: Egypt, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False |
protocolSection identificationModule nctId: NCT06262750, orgStudyIdInfo id: 00375/23, briefTitle: Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study, acronym: SAPIENT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients, conditionsModule conditions: Splanchnic Vein Thrombosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 170, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidenze of bleedings events, primaryOutcomes measure: Incidence of venous and arterial thromboembolic events, primaryOutcomes measure: Rate of progress /stable /regressive, primaryOutcomes measure: incidence of liver related events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UOC Servizio e DH Ematologia, status: RECRUITING, city: Rome, zip: 00168, country: Italy, contacts name: Valerio De Stefano, role: CONTACT, contacts name: Rossella Talerico, role: SUB_INVESTIGATOR, contacts name: Silvia Betti, role: SUB_INVESTIGATOR, contacts name: Francesco Santopaolo, role: SUB_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06262737, orgStudyIdInfo id: RBHP 2023 CHIAMBARETTA, secondaryIdInfos id: 2023-A01121-44, type: REGISTRY, domain: ANSM, briefTitle: Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol, acronym: PISO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-30, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University Hospital, Clermont-Ferrand, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF., conditionsModule conditions: Macular Degeneration, conditions: Diabetic Macular Edema, conditions: Retinal Vein Occlusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: OSDI, secondaryOutcomes measure: OSDI, secondaryOutcomes measure: HM, secondaryOutcomes measure: AM, secondaryOutcomes measure: NIBUT 1, secondaryOutcomes measure: NIBUT 2, secondaryOutcomes measure: Interferometry, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Clermont-Ferrand, status: RECRUITING, city: Clermont-Ferrand, zip: 63000, country: France, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False |
protocolSection identificationModule nctId: NCT06262724, orgStudyIdInfo id: Perforator Flaps, briefTitle: Breast Reshaping Following Massive Weight Loss, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-08-01, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss, conditionsModule conditions: Breast Ptosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All patients were subjected to the same intervention., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Breast auto-augmentation, outcomesModule primaryOutcomes measure: Measurement of breast volume by sono-mammography, secondaryOutcomes measure: Sternal notch to nipple distance, secondaryOutcomes measure: Nipple to inframammary fold distance, secondaryOutcomes measure: Measure of nipple-to-nipple distance, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Ain Shams University, city: Cairo, state: Abbasia, zip: 11591, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06262711, orgStudyIdInfo id: 321917, briefTitle: Effects of Vitamin C on Skeletal Muscle, acronym: VICS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of East Anglia, class: OTHER, collaborators name: The Norfolk and Norwich University Hospitals NHS Foundation Trust, collaborators name: The Quadram Institute Clinical Research Facility, descriptionModule briefSummary: As part of the ageing process muscles become weaker. One of the reasons for this is that mitochondria, the 'engines' that provide energy to fuel muscles, age and work less efficiently. Mitochondria are found in almost all cells in the human body. Mitochondria take in nutrients that are provided from food and break these down to create energy-rich compounds to fuel many different processes in the body. Muscles are loaded with mitochondria because they require a lot of energy. Mitochondria naturally produce small compounds called oxidants that can damage muscle cells and can cause inflammation. The cells in the body have a natural defence system to protect against oxidants, but when mitochondria age and become less efficient, the amount of oxidants that they produce can increase. These oxidants can damage muscles and the mitochondria themselves. Antioxidants, such as vitamin C, may help protect muscles from the damage caused by oxidants, and may help mitochondria work more efficiently. In this study, the investigators will explore whether vitamin C can help mitochondria work more efficiently, which may improve muscle strength, and help older people to remain mobile and independent for longer., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Crossover Assignment, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Double blind masking, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin C, interventions name: Placebo, outcomesModule primaryOutcomes measure: Difference in skeletal muscle mitochondrial function between vitamin C and placebo groups., secondaryOutcomes measure: Difference in skeletal muscle phosphomonoester to phosphodiester ratio (PME/PDE) between vitamin C and placebo groups., secondaryOutcomes measure: Difference in knee extension strength between vitamin C and placebo groups., secondaryOutcomes measure: Difference in hand grip strength between vitamin C and placebo groups., secondaryOutcomes measure: Difference in Short Physical Performance Battery (SPPB) score between vitamin C and placebo groups., secondaryOutcomes measure: Difference in plasma vitamin C between vitamin C and placebo groups., secondaryOutcomes measure: Difference in serum hs-CRP between vitamin C and placebo groups., secondaryOutcomes measure: Difference in serum IL-6 between vitamin C and placebo groups., secondaryOutcomes measure: Difference in serum TNF-α between vitamin C and placebo groups., secondaryOutcomes measure: Difference in plasma P1NP between vitamin C and placebo groups., secondaryOutcomes measure: Difference in plasma CTX between vitamin C and placebo groups., eligibilityModule sex: FEMALE, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of East Anglia, city: Norwich, state: Norfolk, zip: NR4 7TJ, country: United Kingdom, geoPoint lat: 52.62783, lon: 1.29834, hasResults: False |
protocolSection identificationModule nctId: NCT06262698, orgStudyIdInfo id: 81825902.903/148, briefTitle: The Effect of HBM-Based Education on Nursing Students, acronym: HBM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Kafkas University, class: OTHER, descriptionModule briefSummary: The purpose of the study is to investigate the effect of HBM-based education on CAM knowledge, attitudes, and health beliefs related to medication use among nursing students through a randomized controlled trial.Research hypotheses:Hypothesis 01: There is no effect of HBM-based education on CAM knowledge level among nursing students.Hypothesis 1: There is an effect of HBM-based education on CAM knowledge level among nursing students.Hypothesis 02: There is no effect of HBM-based education on CAM attitude level among nursing students.Hypothesis 2: There is an effect of HBM-based education on CAM attitude level among nursing students.Hypothesis 03: There is no effect of HBM-based education on health beliefs related to medication use among nursing students.Hypothesis 3: There is an effect of HBM-based education on health beliefs related to medication use among nursing students., conditionsModule conditions: Nursing, conditions: Evidence-Based Nursing, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The experimental group will receive six weeks of HBM-based training., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Participants were assigned to groups using the "simple randomization method". Participants were not informed of which group they were in. Automated computer-based randomization resulted in the implementation of the experiment with the scheduling scenario and confidential allocation of participants to one of the four intervention branches. The researcher was blind to all conditions until the participants started the computer program and the intervention began. Participants were also unaware of whether the group they were assigned to was an experimental or a control condition. In addition, researchers coding and analyzing data will be blind to randomization and interventions., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Experiment group, interventions name: Pre-post test, outcomesModule primaryOutcomes measure: The TCM Attitude Scale (CACMAS) The GETAT Attitude Scale (CACMAS): The scale, developed by McFadden et al. (2010), consists of 27 items rated on a 7-point Likert scale. Its Turkish validity and reliability were established by Köse et al. (2018)., primaryOutcomes measure: The Medication Health Belief Scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kafkas University Faculty of Health Sciences, city: Kars, zip: 36500, country: Turkey, contacts name: Gönül GÖKÇAY, Asist. Prof., role: CONTACT, phone: 05447915549, email: gonul.gokcay@ogr.sakarya.edu.tr, geoPoint lat: 40.59825, lon: 43.08548, hasResults: False |
protocolSection identificationModule nctId: NCT06262685, orgStudyIdInfo id: 2023-509418-12-00, briefTitle: Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins, acronym: PREVESTATGx, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-02-10, completionDateStruct date: 2025-03-04, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Hospital Universitario La Paz, class: OTHER, collaborators name: Instituto de Salud Carlos III, descriptionModule briefSummary: This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious, cost-efficacious, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol, conditionsModule conditions: Cardiovascular Diseases, conditions: Dyslipidemias, conditions: Statin Adverse Reaction, conditions: Pharmacogenic Myopathy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase IV, multicentre, controlled, randomized, parallel and single-blind adaptive clinical trial nested within the iPHARMGx master protocol study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Subjects will remain blinded to arm assigned because pharmacogenetic phenotype and statin/dose-guidance will only be exclusively accesible to the attending physician, whoMasked: PARTICIPANT, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic lovastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelines, interventions name: Standard of Care (SoC) dosing of atorvastatin, interventions name: Standard of Care (SoC) dosing of simvastatin, interventions name: Standard of Care (SoC) dosing of pitavastatin, interventions name: Standard of Care (SoC) dosing of rosuvastatin, interventions name: Standard of Care (SoC) dosing of prasavastatin, interventions name: Standard of Care (SoC) dosing of lovastatin, interventions name: Standard of Care (SoC) dosing of fluvastatin, outcomesModule primaryOutcomes measure: Incidence of clinically relevant statin-associated musculoskeletal events, secondaryOutcomes measure: Low density lipoprotein cholesterol (LDLc) serum concentration baseline reduction rate, secondaryOutcomes measure: Baseline change in statin therapy prescription, secondaryOutcomes measure: Cost of a statin preemptive pharmacogenetic prescription scheme, otherOutcomes measure: Novel prognostic and predictive genetic biomarkers of statin-related adverse events and efficacy identification, otherOutcomes measure: Death from cardiovascular causes, nonfatal myocardial infarction or hospitalization for unstable angina or resuscitated cardiac arrest, otherOutcomes measure: Difference in percentage in the eight-item Morisky Medication Adherence Scale (MMAS-8) questionnaire score between intervention and control arm, otherOutcomes measure: SAMS intensity reduction of a statin preemptive pharmacogenetic prescription scheme, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital La Paz, city: Madrid, state: Comunidad De Madrid, zip: 28046, country: Spain, contacts name: Stefan Mark Stewart Balbás, MD, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06262672, orgStudyIdInfo id: PR0319R01, briefTitle: Evaluation of Some Parameters in University Students During the COVİD-19 Epidemic Process, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-20, primaryCompletionDateStruct date: 2021-11-20, completionDateStruct date: 2021-11-20, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Kırklareli University, class: OTHER, descriptionModule briefSummary: The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Data regarding people's positive and negative habits from anthropometric characteristics and sleep quality, which is one of the sub-dimensions of healthy lifestyle behaviors, were evaluated, and the relationship between these parameters was examined in detail., conditionsModule conditions: Health Behavior, conditions: Sleep, conditions: Body Weight, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 236, type: ACTUAL, armsInterventionsModule interventions name: Evaluation form, outcomesModule primaryOutcomes measure: Health Promotion Life-Style Profile (HPLP-II), primaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), primaryOutcomes measure: Anthropometric Measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kirklareli University, city: Kirklareli, state: Kayalı, zip: 39000, country: Turkey, geoPoint lat: 41.73508, lon: 27.22521, hasResults: False |
protocolSection identificationModule nctId: NCT06262659, orgStudyIdInfo id: 2023-142, briefTitle: The Effect of Ultrasonography on Blood Flow,Vessel Diameter,and Depth Measurements in Dialysis Patients With Fistula, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-09-10, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kudret Atakan Tekin, class: OTHER, descriptionModule briefSummary: Arteriovenous fistulas (AVF) are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis (HD) treatment. The maturation failure rate of AVFs is approximately 23%. The aim of our study is to compare intraoperative fistula flow and measurements of vascular structures' diameters with postoperative fistula maturation, following the completion of the fistula operation, to reveal the relationship between them. Providing insights into the need for intraoperative intervention and/or postoperative fistula management based on these measurements is intended to contribute to the literature by offering predictions and perspectives., conditionsModule conditions: Arteriovenous Fistula, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Doppler Ultrasonography Assessment, outcomesModule primaryOutcomes measure: intraoperative Arteriovenous Fistula Flow Measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kudret Atakan Tekin, status: RECRUITING, city: Merkez, state: Çorum, country: Turkey, contacts name: Kudret Atakan Tekin, role: CONTACT, phone: 05424912184, email: dr.kudretatakantekin@gmail.com, hasResults: False |
protocolSection identificationModule nctId: NCT06262646, orgStudyIdInfo id: NTEC-2023-677, briefTitle: Video-conferencing FACT for Young Children With Special Needs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, collaborators name: Hong Kong Christian Service, collaborators name: Hong Kong Federation of Youth Groups, collaborators name: Hong Kong Young Women's Christian Association, collaborators name: Yang Memorial Methodist Social Service, collaborators name: Hong Kong Sheng Kung Hui Welfare Council, descriptionModule briefSummary: Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility.Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context.Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up.Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone.Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population., conditionsModule conditions: Autism Spectrum Disorder, conditions: Attention Deficit Hyperactivity Disorder, conditions: Specific Learning Disorder, conditions: Communication Disorders, conditions: Motor Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Eligible parents consenting to participate will be randomly assigned to either the FACT or Control Group in a 1:1 ratio, using the permuted block size of 6 through sequentially numbered, opaque and sealed envelopes with number cards (1=intervention, 2=control). A separate set of random numbers, concealed from the research team and RAs, will be generated by a statistician. Clerical staff uninvolved in the project will administer the randomisation. The research assistant (RA-1), blinded to subject selection, will open the envelopes only after informed consent and baseline assessments are completed. The research assistant (RA-2) is also blinded to group assignments and will conduct assessments/evaluations., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 253, type: ESTIMATED, armsInterventionsModule interventions name: Focused Acceptance and Commitment Therapy, interventions name: Control Group, outcomesModule primaryOutcomes measure: Parenting stress, secondaryOutcomes measure: Parental depressive symptoms, secondaryOutcomes measure: Parental anxiety symptoms, secondaryOutcomes measure: Parental Psychological Flexibility, secondaryOutcomes measure: ACT Core Process Utilization, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Chinese University of Hong Kong, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Pui Tik YAU, role: CONTACT, phone: (852) 3943-9915, email: jamyau@cuhk.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |